SAMJ Vol 104, No 8 (2014)

AUGUST 2014

VOL. 104 NO. 8

521

Menopausal hormone therapy

537

Medical evaluation of children prior to adoption

544

Reporting of child abuse

550PublisheicdablyAthsseociatioctn,othrse,

Ebola – what you need to know Geophagia in pregnancy Loss of detectability of HIV with cART in infants CME: Climate change and health

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The ESSENTIAL MEDICAL REFERENCE for every healthcare professional!

The convenient pocket-sized design enables you to fit it comfortably into your hospital bag or coat pocket, so it can always be at hand for ready reference. South African Medicines Formulary (SAMF), produced by the Division of Clinical Pharmacology of the University of Cape Town, provides easy access to the latest, scientifically accurate information, including full drug profiles, clinical notes and special prescriber’s points.

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AUGUST 2014

VOL. 104 NO. 8

FROM THE EDITOR

517

Mission unstoppable? – the full empowerment of women J Seggie

GUEST EDITORIAL

518

Climate change, human health and the role of environmental health practitioners C Y Wright, A Mathee, R M Garland

520

EDITOR’S CHOICE

EDITOR Janet Seggie, BSc (Hons), MD (Birm), FRCP (Lond), FCP (SA) EDITOR EMERITUS Daniel J Ncayiyana, MD (Groningen), FACOG, MD (Hon), FCM (Hon) CONSULTING EDITOR JP de V van Niekerk, MD, FRCR DEPUTY EDITOR Bridget Farham, BSc (Hons), PhD, MB ChB

CORRESPONDENCE

EDITORIAL SYSTEMS MANAGER Melissa Raemaekers, BSc (Hons), PhD

521

Time to stop preventable deaths from unsterile traditional male circumcision practices L Simbayi, O Shisana, G Setswe, G Gray, F Venter, D Ncayiyana, T Rehle

521

Mammography reporting at Tygerberg Hospital, Cape Town, South Africa R Pitcher, J Lotz, C Ackermann, A Bagadia, R Davis, A-M du Plessis, S Griffith-Richards, R Hattingh, G Wagener

521

HPV vaccine: Why the rush?

L-J van Bogaert

NEWS EDITOR Chris Bateman | Email: chrisb@hmpg.co.za

522

HPV vaccine: Can we afford to hesitate?

K L Richter, G Dreyer, B G Lindeque, M H Botha

HEAD OF PUBLISHING Robert Arendse

524

GeneXpert TB 8: A point-of-care diagnostic pilot P Smith, A van Esch, M Wallace, R Wood, L-G Bekker

524

Professional competence in South Africa J Fagan, G Lindeque, response from S Benatar

IZINDABA

SCIENTIFIC EDITOR Ingrid Nye, BSc TECHNICAL EDITORS Paula van der Bijl, BA, HDipLib Emma Buchanan, BA

PRODUCTION COORDINATOR Bronlyne Granger ART DIRECTOR Brent Meder DTP & DESIGN Anelia du Plessis | Carl Sampson

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TB: The tap’s down a notch – but the water’s polluted Defusing the new drug-resistant TB time bomb Timing their moves, healthcare bodies scrub up for a dust-up Patient lost in the private healthcare mix – Broomberg

535

BOOK REVIEW Postmortem: The Doctor Who Walked Away

536

OBITUARY/HULDEBLYK Boet Dommisse

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SAMJ FORUM

537

POSITION STATEMENT South African Menopause Society revised consensus position statement on menopausal hormone therapy, 2014 F Guidozzi, A Alperstein, J S Bagratee, P Dalmeyer, M Davey, T J de Villiers, S Hirschowitz, T Kopenhager, S P Moodley, P Roos, A Shaw, O Shimange, T Smith, C Thomas, J Titus, Z van der Spuy, J van Waart, on behalf of the Council of the South African Menopause Society

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ISSUES IN MEDICINE Recommendations for the medical evaluation of children prior to adoption in South Africa A F Haeri Mazanderani, N M du Plessis, J Lumb, U D Feucht, M Myburgh, S H Mayaphi, M R Lekalakala, D W Swanepoel, H Georgakis, T Avenant

550

MEDICINE AND THE LAW Mandatory reporting of child abuse in South Africa: Legislation explored M L Hendricks

553

Overturning refusal of a hospital to terminate life support for a brain-dead mother until the fetus was born: What is the law in South Africa?

D J McQuoid-Mason

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August 2014, Vol. 104, No. 8

HMPG BOARD OF DIRECTORS Prof. M G Veller (Chair), Prof. M Lukhele, Dr M Mbokota, Prof. A A Stulting, Dr M R Abbas, Dr G Wolvaardt ASSOCIATE EDITORS Q Abdool Karim, A Dhai, N Khumalo R C Pattinson, A Rothberg, A A Stulting, J Surka, B Taylor, M Blockman ISSN 0256-9574 Publisher website: www.hmpg.co.za SAMA website: www.samedical.org Journal website: www.samj.org.za

EDITORIALS

CONTENTS LISTED IN Index Medicus (Medline) Excerpta Medica (EMBASE) Web of Knowledge Biological Abstracts (BIOSIS) Science Citation Index (SciSearch) Current Contents/Clinical Medicine

555

Ebola virus disease in West Africa – an unprecedented outbreak J Weyer, L H Blumberg, J T Paweska

556

Intimate partner violence: How should health systems respond?

K Rees, V Zweigenthal, K Joyner

558

Professionalism is key in providing services to lesbian, gay, bisexual, transgender and intersex South Africans A Muller

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559

Time to reduce CD4+ monitoring for the management of antiretroviral therapy in HIV-infected individuals W S Stevens, N Ford

Members of SAMA receive the SAMJ only on request, as part of their membership benefit.

561

From informed consent to shared decision-making H Manyonga, G Howarth, M Dinwoodie, P Nisselle, S Whitehouse

RESEARCH 563

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National sentinel site surveillance for antimicrobial resistance in Klebsiella pneumoniae isolates in South Africa, 2010 - 2012 O Perovic, A Singh-Moodley, A Dusé, C Bamford, G Elliott, K Swe-Swe Han, R Kularatne, W Lowman, A Whitelaw, T Nana, J Wadula, R Lekalakala, A Saif, M Fortuin De-Smidt, E Marais A cross-sectional analytical study of geophagia practices and blood metal concentrations in pregnant women in Johannesburg, South Africa A Mathee, N Naicker, T Kootbodien, T Mahuma, P Nkomo, I Naik, T de Wet Loss of detectability and indeterminate results: Challenges facing HIV infant diagnosis in South Africa’s expanding ART programme A F Haeri Mazanderani, N M du Plessis, W N Thomas, E Venter, T Avenant

CONTINUING MEDICAL EDUCATION 578

GUEST EDITORIAL Climate change: One of the greatest threats to public health in the 21st century C Y Wright, M Norval

579

REVIEW Human health impacts in a changing South African climate C Y Wright, R M Garland, M Norval, C Vogel

583

ARTICLES The HIV/AIDS epidemic in South Africa: Convergence with tuberculosis, socioecological vulnerability, and climate change patterns A Abayomi, M N Cowan

584

National policy response to climate change in South Africa R M Garland

585

Socially, politically and economically mediated health effects of climate change: Possible consequences for Africa D C Bowles, C D Butler

586

Climate change and occupational health: A South African perspective T Kjellstrom, B Lemke, O Hyatt, M Otto

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ABSTRACTS

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Plagiarism is defined as the use of another’s work, words or ideas without attribution or permission, and representation of them as one’s own original work. Manuscripts containing plagiarism will not be considered for publication in the SAMJ. For more information on our plagiarism policy, please visit http://www.samj.org.za/index. php/samj/about/editorialPolicies Printed by Creda Communications

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FIRST PUBLISHED IN 1884

Mission unstoppable? – the full empowerment of women In this Women’s Month there is much to reflect on regarding the status of youth, and particularly girls and young women, in the world.

Former British Prime Minister Gordon Brown, serving as United Nations Special Envoy for Global Education, used 16 June, South Africa (SA)’s Youth Day but now marked around the world as The Day of the African Child, to urge the world ‘not to forget the 200 Chibok schoolgirls and to promote the Safe Schools Initiative – aimed at providing safe schools for every girl and boy’.[1] He pledged, with Nigerian President Goodluck Jonathan and Finance Minister Ngozi Okonjo-Iweala, that the school from which the girls were kidnapped by Islamist militants belonging to Boko Haram (which opposes schools that teach a so-called Western curriculum) will be rebuilt. Such atrocities continue.

From our own Phumzile Mlambo-Ngcuka, Executive Director of UN Women, we learn in her statements to the UN Security Council of rape, sexual slavery, and other violations perpetrated by armed forces in the Central African Republic; of the assassination of the Libyan leader and women’s rights advocate Salwa Bugaighis, killed soon after casting her vote in the recent Libyan election, a right she fought for as a member of the National Transitional Council during the 2011 revolution; and, most recently, of the deliberate targeting of women and girls in Iraq and reports of kidnapping, rape and forced marriage by militants of the Islamic State of Iraq and the Levant and other armed groups (received via emails from UN Women, 27 June and 1 July 2014).

SA chose the 2014 Youth Day celebrations to call for quality education, proposing that Youth Month be celebrated under the theme ‘Youth Moving South Africa Forward’.[2] Deputy President Cyril Ramaphosa[3] agreed with the Each One Teach One Foundation that ‘Our schooling environment (in Soweto) is plagued by drug abuse, religious maladies like Satanism, violence including rape and murder, financial challenges and collapsing infrastructure,’ and remarked that SA youth are particularly vulnerable to unemployment, poverty, inequality and low skills levels. Youth unemployment – more than a third of SA youth is unemployed – poses a critical challenge for our country. The hope, Ramaphosa stated, is that ‘if we can effectively address youth unemployment, we will lift millions of South Africans out of poverty, and place our economy on a trajectory of sustainable, inclusive growth’.

The same week saw the Global Summit to End Sexual Violence in Conflict, led by Hollywood actress and UN special envoy Angelina Jolie and UK Foreign Minister William Hague, to deal with the scourge of rape as a weapon of war. The World Health Organization estimates that 150 million women and girls are raped every year in conflict zones (see figure, ‘Where is sexual violence happening in conflict zones?’, p. 519). So are 73 million men and boys.[4] The presence of Jolie lent a cachet to the meeting, which brought together 129 country delegations, including 79 ministers. The man­ date was to agree practical steps to bring an end to impunity – ‘when rape victims start to see the people who abused them pay for their crimes, the world will undergo a sea change’.[5,6] In her Birthday Honours, Queen Elizabeth II bestowed an honorary damehood on Jolie for her work combating sexual violence in war zones; Jolie plans to apply for Namibian (read Commonwealth) citizenhood, so that she may exploit the title in her humanitarian work.[7]

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Hague stated in closing the meeting: ‘We have tolerated and still do tolerate violence and discrimination against women in many forms in all quarters of the world, and women still do not occupy their rightful place in the economics, in diplomacy and government of many nations.

We should not have to be reminded, as governments, that women must have a seat in every forum of decision-making, and it should not be the uphill struggle that it is to overturn the habits of centuries and establish new precedents and norms for full female participation.’[8] The policy paper[9] issued by the UK Foreign and Commonwealth Office made clear that ‘Sexual violence is not a lesser crime: it is an atrocity of the first order and there must be no safe haven for perpetrators anywhere.’ The International Protocol on the Docu­ mentation and Investigation of Sexual Violence in Conflict[10] will help to bring perpetrators to justice, and overcome a key barrier to tackling impunity for sexual violence in conflict.

Girls and women are in a precarious position, even in our relatively sophisticated society as measured by the SA Constitution, which is the envy of many countries. Last month’s Izindaba carried a piece entitled ‘Women doctors have a rougher time’. In acknowledgement of this situation, and in celebration of National Women’s Day on 9 August, some 50 women doctors, led by deputy health minister Gwen Ramokgopa, will formally launch an SA Medical Women’s Association.[11] As stated, ‘with well over half of all medical school graduates now female, there is a serious need to rethink, especially in the public sector, how the healthcare system is geared to embrace this changing reality. We need to look at issues like good security, crèche facilities and job-sharing appointments.’[11] This Women’s Month SAMJ contains much of relevance to women’s issues.

Janet Seggie

Editor janet.seggie@hmpg.co.za 1. UN Envoy Gordon Brown vows new school for kidnapped Nigerian girls. http://www.ndtv.com/article/ world/un-envoy-gordon-brown-vows-new-school-for-kidnapped-nigerian-girls-543379 (accessed 19 June 2014).

2. Youth Day puts quality of education under spotlight. http://www.sabc.co.za/news/a/01e7a0004462f415 8900fd744a7933f3/Youth-Day-puts-quality-of-education-under-spotlight-20141606 (accessed 19 June 2014).

3. Keynote Address by Deputy President Cyril Ramaphosa. http://www.sabc.co.za/news/a/ e8cd78004463b6a290dff4744a7933f3/Keynote-Address-by-Deputy-President-Cyril-Ramaphosa-20141606 (accessed 19 June 2014).

4. Where is sexual violence happening in conflict zones? http://www.bbc.co.uk/newsbeat/27779468 (accessed 19 June 2014).

5. Global Summit to End Sexual Violence in Conflict 4. https://www.gov.uk/government/topical-events/ sexual-violence-in-conflict (accessed 19 June 2014).

6. The Angelina Jolie effect at the sexual violence summit. http://www.theguardian.com/lifeandstyle/ womens-blog/2014/jun/12/the-angelina-jolie-effect-at-the-sexual-violence-summit (accessed 19 June 2014).

7. Queen’s Birthday Honours: Angelina Jolie is appointed a Dame for her campaign to end sexual violence. http://www.independent.co.uk/news/uk/home-news/queens-birthday-honours-angelina-jolie-isappointed-a-dame-for-her-campaign-to-end-sexual-violence-9536120.html (accessed 19 June 2014).

8. Speech: Foreign Secretary closes Global Summit to End Sexual Violence in Conflict. https://www.gov. uk/government/speeches/foreign-secretary-closes-global-summit-to-end-sexual-violence-in-conflict (accessed 19 June 2014).

9. The Policy Paper Chair’s Summary – Global Summit to end Sexual Violence in Conflict. https://www. gov.uk/government/publications/chairs-summary-global-summit-to-end-sexual-violence-in-conflict/ chairs-summary-global-summit-to-end-sexual-violence-in-conflict (accessed 19 June 2014).

10. Statement of Action – Global Summit to End Sexual Violence in Conflict. From: Foreign & Commonwealth Office and the Rt Hon William Hague MP. 13 June 2014. https://www.gov.uk/government/publications/ statement-of-action-global-summit-to-end-sexual-violence-in-conflict (accessed 19 June 2014).

11. Bateman C. Women doctors have a rougher time – new association born. S Afr Med J 2014;104(7):463464. [http://dx.doi.org/10.7196/SAMJ.8539]

S Afr Med J 2014;104(8):517. DOI:10.7196/SAMJ.8676

August 2014, Vol. 104, No. 8

GUEST EDITORIAL

Climate change, human health and the role of environmental health practitioners There is advanced consensus on the anthropogenic roots of climate change.[1,2] Extreme weather events, including storms of increased intensity or frequency, heatwaves, floods and droughts, as well as rising sea levels and crop failure, are among the most significant associated environmental and public health challenges.[3,4] Such climate and environmental changes place at risk the fundamental human resources for health, such as shelter, clean water, air quality, and food security and quality. Environmental health practitioners (EHPs) have for decades played a critical role in monitoring and controlling the quality and health of the human environment.

They now have an equally important role to play with regard to adaptation strategies and measures to protect communities against the challenges of climate variability at a grassroots level.

Climate change impacts on human health

The natural ‘greenhouse effect’ is necessary to maintain a constant, habitable temperature on Earth. However, in recent decades increased emissions of greenhouse gases such as carbon dioxide and methane from anthropogenic activities have intensified this effect, leading to a general warming of ambient temperatures at the earth’s surface, changing rainfall patterns and distribution, altering cloud cover and raising the incidence of extreme weather events.

Projections from climate models used to predict these changes suggest a warming in temperature for southern Africa greater than the global average.[5-7] Regional measurements of temperature in recent decades show that annual maximum and minimum temperatures have been increasing, and moreover that the rate of increase is increasing and that this impact is projected to continue into the future.[8] This has potentially significant implications for quality of life and human health. The direct effects of increased temperature include nausea, headaches, elevated levels of kidney and cardiovascular disease, heatstroke and even death. Indirectly, air quality may be affected by changing the type of chemical pollut­ ants as well as the distribution and quantity of pollens and other allergens,[4,9] leading to detrimental impacts on respiratory health and aggravation of conditions such as asthma and allergic rhinitis.

Increased temperatures may also enhance evaporation and other water cycle processes and lead to a reduction in water availability, reduced water quality and increases in waterborne diseases. There may also be general disruption of agriculture, with concomitant food security risks, displacement of people, and increases in vector- and rodent-borne diseases.

The magnitude of the impact that warming has already had on the health of South Africans is not well understood, and the potential risk to health from future climate change has not been quantified. However, there is a strong consensus that the region will experience negative health impacts from a changing climate.

Additionally, as stated in the most recent Fifth Assessment Report of the Intergovernmental Panel on Climate Change (AR5),[4] the largest health risks resulting from a changing climate will be in those communities and populations currently most impacted on by climate-related diseases. There is therefore a particular need for local on-the-ground action and planning to understand current impacts, decrease vulnerability and mitigate the health impacts of climate change.

518

Environmental health and EHPs

The advent of climate change compels all in the public and environmental health field to reassess the environmental health risks that communities currently face, and decide on the optimal responses going forward. The overall goal of environmental health is to prevent disease through the control of environmental factors that may impact on an individual’s health and wellbeing, and by promoting the creation of health-supportive environments.[10] EHPs are the professionals tasked to implement environmental health services and protect communities from environmental pollution and related harmful effects. In this regard, their broad-based training, skills and expertise, as well as their regulatory powers and location at the environment-public health nexus, make them ideally suited to make an important contribution with regard to adaptation at the local level.[11] In the course of their daily work, EHPs assess environmental health risks, provide information to the public, plan and implement a range of programmes and projects, and create partnerships among, for example, communities, health services, energy providers, housing departments and the private sector.

Intergovernmental Panel on Climate Change AR5 emphasises the need for effective adaptation measures in the health sector for the near term, such as the provision of clean water and sanitation, increased capacity for disaster preparedness and response, improved surveill­ ance and early warning systems and climate change vulnerability mapping.[4] Given their close interactions with communities, EHPs are well placed to play a central and strong role.

While climate and health adaptation has been considered at national level in South Africa (SA) through, for example, the drafting of a National Climate and Health Adaptation Plan, similar initiatives pertaining to climate change and health, and the shaping of roles for local-level EHPs, are still at an early stage at the all-important local level. Health activities and functions that might be considered for EHPs include:[12] • becoming change agents and facilitating adaptive action across sectors • working with individuals, groups, organisations and communities to build capacity and to embrace innovation and creative solutions to climate problems • developing programmes and campaigns to increase awareness of climate and health concerns at community level, especially in high-risk areas (such as cities) and high-risk groups (impoverished communities and groups such as the elderly, the very young, those with pre-existing ill health conditions and those living alone) • initiating or supporting community-based mitigation measures (that may also have health co-benefits), such as facilitating the infrastructure for, and encouraging, walking and cycling, carpooling, green buildings and community greening programmes • strengthening research programmes, and monitoring and surv­ eillance systems to include climate and weather measurements and related ill-health outcomes • considering climate change and greenhouse gas emissions when requested to comment on development proposals • promoting strengthening of planning and development policies (for example, in establishment of flood lines and building standards) • advocating for climate-friendly policies across sectors • ensuring that disaster management and outbreak response plans are in place • facilitating communication of signals from early warning systems.

August 2014, Vol. 104, No. 8

GUEST EDITORIAL

In shaping the roles of EHPs in relation to climate and health adaptation in SA, and making decisions on resource allocation, a range of social factors that affect people’s vulnerability and resistance to a changing climate will also need to be taken into account. For example, poverty, inequality and hazardous living environments increase vulnerability to weather extremes (i.e. heatwaves, floods, droughts, etc.), food insecurity and declining food quality, and altered disease distributions. In Limpopo Province, for example, where only 18% of households have access to an indoor water supply and 22% access to a flush toilet, and only half of all households use electricity for daily cooking,[13] the effects of climate change may be expected to exacerbate the high degree of existing environmental health vulnerability.

The time is now

Dissidence regarding the reality of climate change has diminished, and the debate has shifted to the magnitude of the challenge ahead[11] and the practical adaptation and coping mechanisms needed at all levels.

The time to act is now, and EHPs, at the interface between environment and health, have a crucial role to play. To fulfil their potential, the environmental health profession needs to spearhead discussions regarding critical climate impacts on health and wellbeing and become the stewards of health adaptation measures at the local level.

Caradee Y Wright

CSIR Climate Studies, Modelling and Environmental Health Research Group, Pretoria, and School of Geography, Geoinformatics and Meteorology, University of Pretoria, South Africa cwright@csir.co.za

Angela Mathee

Environment and Health Research Unit, South African Medical Research Council, Johannesburg, South Africa, Faculty of Health Sciences, University of Johannesburg, and School of Public Health, University of the Witwatersrand, Johannesburg

Rebecca M Garland

CSIR Climate Studies, Modelling and Environmental Health Research Group, Pretoria, South Africa, and Climatology Research Group, Unit for Environmental Sciences and Management, North West University, Potchefstroom, South Africa 1. Hegerl GC, Zwiers FW, Braconnot P, et al. Understanding and attributing climate change. In: Solomon S, Qin D, Manning M, et al., eds. Climate Change 2007: The Physical Science Basis. Contribution of Working Group I to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change. Cambridge: Cambridge University Press, 2007:665-745. https://www.ipcc.ch/pdf/assessment-report/ar4/wg1/ar4-wg1chapter9.pdf (accessed 30 June 2014).

2. McMichael AJ, Woodruff RE, Hales S. Climate change and human health: Present and future risks. Lancet 2006;367(9513):859-869. [http://dx.doi.org/10.1016/s0140-6736(06)68079-3] 3. World Health Organization. Protecting Health from Climate Change: Global Research Priorities. Geneva: WHO, 2009. http://www.who.int/globalchange/publications/reports/9789241598880/en/ (accessed 27 January 2014).

4. Smith KR, Woodward A, Campbell-Lendrum D, et al. Human health: Impacts, adaptation and co-benefits.

In: Field CB, Barros V, Dokken DJ, et al., eds. Impacts, Adaptation and Vulnerability. Contribution of Working Group II to the Fifth Assessment Report of the Intergovernmental Panel on Climate Change.

Cambridge: Cambridge University Press, 2014:1-69. http://ipcc-wg2.gov/AR5/images/uploads/WGIIAR5Chap11_FGDall.pdf (accessed 30 June 2014).

5. Christensen JH, Hewitson B, Busuioc A, et al. Regional climate projections. In: Solomon S, Qin D, Manning M, et al., eds. Climate Change 2007: The Physical Science Basis. Contribution of Working Group I to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change. Cambridge: Cambridge University Press, 2007:847-940. https://www.ipcc.ch/pdf/assessment-report/ar4/.../ar4-wg1-chapter11.pdf (accessed 1 July 2014).

6. Engelbrecht FA, McGregor JL, Engelbrecht CJ. Dynamics of the conformal-cubic atmospheric model projected climate-change signal over southern Africa. International Journal of Climatology 2009;29(7):10131033. [http://dx.doi.org/10.1002/joc.1742] 7. Niang I, Ruppel OC, Abdrabo M, et al. Africa. In: Field C, Barros V, eds. Impacts, Adaptation and Vulnerability. Contribution of Working Group II to the Fifth Assessment Report of the Intergovernmental Panel on Climate Change. Cambridge: Cambridge University Press, 2014:1-114. http://ipcc-wg2.gov/AR5/ images/uploads/WGIIAR5-Chap22_FGDall.pdf (accessed 30 June 2014).

8. South African Risk and Vulnerability Atlas. 2013. http://www.sarva.org.za/sadc/download/sadc_handbook. pdf (accessed 27 January 2014).

9. Confalonieri UB, Menne R, Akhtar KL, et al. Human health. In: Parry ML, Canziani OF, Palutikof JP, et al, eds. Climate Change 2007: Impacts, Adaptation and Vulnerability. Contribution of Working Group II to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change. Cambridge: Cambridge University Press, 2007:391-431. http://www.ipcc.ch/publications_and_data/ar4/wg2/en/ch8.html (accessed 1 July 2014).

10. World Health Organization. Promoting Physical Activity and Active Living in Urban Environments.

Geneva: WHO, 2006. http://www.euro.who.int/__data/assets/pdf_file/0009/98424/E89498.pdf (accessed 27 January 2014).

11. Schwartz BS, Parker C, Glass TA, Hu H. Global environmental change: What can health care providers and the environmental health community do about it now? Environ Health Perspect 2006;114(12):1807-1812. [http://dx.doi.org/10.1289/ehp.9313] 12. Losito D, Noble D. Climate change and the role of Canada’s environmental health professionals.

Environmental Health Review 2007;Spring:20-23. http://www.2degreesc.com/Files/Climate%20change%20 and%20the%20role%20of%20Canada’s%20EPHs.%20EHR_Spring07.pdf (accessed 27 Janu­ary 2014).

13. Statistics South Africa. Census in Brief: 2011. Pretoria: Statistics South Africa, 2012. http://www.statssa.gov. za/census2011/Products/Census_2011_Census_in_brief.pdf (accessed 27 January 2014).

S Afr Med J 2014;104(8):518-519. DOI:10.7196/SAMJ.7994

Where is sexual violence happening in conflict zones?[4] (See p. 517.)

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August 2014, Vol. 104, No. 8

EDITOR’S CHOICE

CME: Climate change and population health

Climate change is regarded as one of the greatest threats to public health in the 21st century, and its impacts on human health and wellbeing have already been seen. Some are direct, such as heat, cold, extreme weather events and ultraviolet radiation. Others, such as increases in the incidence and change of distribution of some vector-, food- and water-borne diseases, are still being documented and followed. Infectious diseases are likely to increase as the ecosystems in which the pathogens thrive change. Respiratory health, already known to be adversely affected by particulate pollution, is likely to suffer further as the amount of air pollution rises with increasing surface temperatures.

In 2012 alone, an estimated 37.3 million Africans were negatively affected by hydrometeorological hazards, a 43.3% increase in annual average over the past decade.[1] The African Ministerial Conference on Meteorology in collaboration with the African Union Commission[2] met in May 2014 in Harare, Zimbabwe, to seek to refine the draft Implementation Plan of the Integrated African Strategy on Meteorology (Weather and Climate Services) for the period spanning 2014 - 2018, aimed at building the resilience of communities to cope with adverse impacts of climate change.

CO2 emissions are rising as the oil industry continues to drill, frack, explore the Arctic, liquefy and gasify coal, and liquefy natural gas. ‘The world’, according to Jeffrey Sachs, ‘is wrecking the climate and food-supply systems at a break-neck pace.’[3] And there is evidence that the Intergovernmental Panel on Climate Change (IPCC) report summaries that warn of the impending threats are significantly ‘diluted’ under political pressure from some of the world’s biggest greenhouse gas emitters, including Saudi Arabia, China, Brazil and the USA.[4] Hard on the heels of the release of the most recent IPCC Assessment Report 5,[5] this month’s CME and the SAMJ guest editorial[6] warn of the significant repercussions of climate change on quality of life and human health. Caradee Wright (CSIR, Pretoria) and Mary Norval (Edinburgh University) have drawn together an international team of experts from various fields, and this important issue of CME brings our journal into line with many international medical journals that have recently focused on the effects of climate change on human health.

Ebola virus disease

Weyer et al.[7] tell you all you need to know!

HIV testing of infants

Current South African (SA) guidelines, in line with international standards, advocate routine HIV-1 polymerase chain reaction (PCR) testing at 6 weeks of age for asymptomatic HIV-exposed infants and ‘fast-track’ entry into the HIV treatment programme for those who test positive. Additionally, SA has implemented the World Health Organization 2010 guidelines on HIV and infant feeding, which recommend that HIV-infected mothers should breastfeed their infants and receive antiretroviral drugs simultaneously. Hence, efforts to diagnose HIV in infants occur within the context of an extensive prevention of mother-to-child transmission (PMTCT) programme and antiretroviral therapy (ART) exposure. Furthermore, children already initiated on combination ART (cART) may be retested with HIV-1 PCR assays for ‘confirmatory’ purposes, including assessment prior to adoption.[8] The potential for cART to compromise the sensitivity of HIV-1 PCR assays has been described, but appears to be under-appreciated both by clinicians and the lay public. Similarly, current PMTCT practices

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may lead to repeatedly indeterminate results, probably because ART suppresses the HIV viral load below diagnostic threshold values, with subsequent delays in initiation of cART. Three cases are described that demonstrate that cART in infants can be associated with a loss of detectability of HIV, leading to ‘falsenegative’ HIV-1 PCR results.[9] In the context of adoption of a child, this may potentially have devastating consequences for both the infant and the adoptive parents.

Antimicrobial resistance

The SAMJ will continue to feature the crisis of antimicrobial resis­ tance to antibiotics,[10] a global problem and one that is exercising our own Ministry of Health. In this issue Perovic et al.[11] provide evidence of the high prevalence of extended-spectrum beta-lactamase (ESBL) genes in nosocomial Klebsiella pneumoniae isolates: 68% of 2 774 isolates were ESBL-positive, with marked resistance to third- and fourth-generation cephalosporins (cefotaxime, ceftazidime and cefepime), and 47% of all isolates were resistant to ciprofloxacin and 33% to piperacillin-tazobactam.

Menopausal hormone therapy

The South African Menopause Society 2014 consensus position state­ment on menopausal hormone therapy[12] is a revision of their state­ment published in the SAMJ of May 2007.[13] The revised state­ ment emphasises that commencing hormone therapy during the ‘therapeutic window of opportunity’ maximises the benefit-to-risk profile of therapy in symptomatic menopausal women. It includes a wider range of clinical benefits for hormone therapy, non-hormonal alternatives such as selective serotonin reuptake inhibitors and serotonin noradrenaline reuptake inhibitors for the management of vasomotor symptoms, and an appraisal of bioidentical hormones and complementary medicines used for treatment of menopausal symptoms and of new preparations that are likely to be more commonly used in the future.

JS 1. African Ministerial Conference on Meteorology (AMC). African Ministers responsible for meteorology seek to increase community resilience. http://www.modernghana.com/news/542957/67/ african-ministers-responsible-for-meteorology-seek.html (accessed 17 July 2014).

2. Draft report of the second task force meeting of AMCOMET. http://www.wmo.int/amcomet/ sessions/bureau-task-force-reports (accessed 30 June 2014).

3. Sachs JD. Approach to climate needs crisp change. Sunday Independent, 29 June 2014. http://www. iol.co.za/business/opinion/approach-to-climate-needs-crisp-change-1.1711350#.U7FRfP0XclI (accessed 17 July 2014).

4. Ahmed N. IPCC reports ‘diluted’ under ‘political pressure’ to protect fossil fuel interests. Saudiled coalition sought to make policy summaries as vague as possible to minimise climate action.

The Guardian, 15 May 2014. http://www.theguardian.com/environment/earth-insight/2014/ may/15/ipcc-un-climate-reports-diluted-protect-fossil-fuel-interests (accessed 17 July 2014).

5. IPCC, 2014: Summary for policymakers. In: Climate Change 2014: Impacts, Adaptation, and Vulnerability. Part A: Global and Sectoral Aspects. Contribution of Working Group II to the Fifth Assessment Report of the Intergovernmental Panel on Climate Change (Field CB, Barros VR, Dokken DJ, et al.). Cambridge: Cambridge University Press, 2014:1-32. http://ipcc-wg2.gov/AR5/ images/uploads/WG2AR5_SPM_FINAL.pdf (accessed 17 July 2014).

6. Wright CY, Mathee A, Garland RM. Climate change, human health and the role of environmental health practitioners. S Afr Med J 2014;104(8):518-519. [http://dx.doi.org/10.7196/SAMJ.7994] 7. Weyer J, Blumberg LH, Paweska JT. Ebola virus disease in West Africa – an unprecedented out­ break. S Afr Med J 2014;104(8):555-556. [http://dx.doi.org/10.7196/SAMJ.8672] 8. Haeri Mazanderani AF, Du Plessis NM, Lumb J, et al. Recommendations for the medical evaluation of children prior to adoption in South Africa. S Afr Med J 2014;104(8):544-549. [http:// dx.doi.org/10.7196/SAMJ.7958] 9. Haeri Mazanderani AF, Du Plessis NM, Thomas WN, et al. Loss of detectability and indeterminate results: Challenges facing HIV infant diagnosis in South Africa’s expanding ART programme. S Afr Med J 2014;104(8):574-577. [http://dx.doi.org/10.7196/SAMJ.8322] 10. Mendelson M, Matsoso MP. A global call for action to combat antimicrobial resistance: Can we get it right this time? S Afr Med J 2014;104(7):478-479. [http://dx.doi.org/10.7196/SAMJ.8534] 11. Perovic O, Singh-Moodley A, Dusé A, et al. National sentinel site surveillance for antimicrobial resistance in Klebsiella pneumoniae isolates, South Africa 2010 - 2012. S Afr Med J 2014;104(8):563568. [http://dx.doi.org/10.7196/SAMJ.7617] 12. Guidozzi F, Alperstein A, Bagratee JS, et al. South African Menopause Society consensus position statement on menopausal hormone therapy, 2014. S Afr Med J 2014;104(8):537-543. [http://dx.doi. org/10.7196/SAMJ.8423] 13. De Villiers TJ, Bagratee JS, Dalmeyer JP, et al. South African Menopause Society Council revised consensus position statement on menopausal hormone therapy. S Afr Med J 2007;97(5):354357.

August 2014, Vol. 104, No. 8

PREGNANCY & NUTRITION

PART OF THE RED MEAT IN NUTRITION & HEALTH SERIES

Pregnancy and breastfeeding are probably the most nutritionally demanding periods of any woman’s life The nutritional status of women even before conception and in the early weeks of pregnancy (often when women are still unaware that they are pregnant), can influence critical developmental processes Adequate nutrition before, during and after birth significantly influences both the health and future wellbeing of the mother, and of the child Maternal nutrition is considered a modifiable risk factor which can lower health-care costs, improve birth outcomes and improve the health of the nation

Facts

A healthy pregnancy diet1,2

Nutrients that require special attention during pregnancy include protein, iron, folate (folic acid), B vitamins and certain essential fatty acids Indicators of pre-pregnancy nutrition status and health of the mother such as size, low stature, underweight, overweight and nutrient deficiencies were associated with preterm deliveries and infants that were small for gestational age Pre-pregnancy iron stores predict maternal iron status and the risk of anaemia in later pregnancy The inclusion of foods from animal sources, such as lean red meat, promotes the ingestion of many essential nutrients while simultaneously reducing the Glycaemic Load (GL) of the diet

Lean white or red meat, fish or eggs can be eaten daily.

Lean protein is important for growth at all stages of pregnancy Eat plenty of vegetables and fruit every day Consume low-fat milk, maas or yoghurt every day for strong bones and teeth Eat dry beans, split-peas, lentils and soya regularly Make starchy foods part of most meals. Choose whole grains that are high in fibre, and have a lower Glyceamic Index (GI)

REFERENCES 1. Vorster, H.H. et al. 2013. In press. 2. Moreno, M. et al. 2012. Archives of Pediatrics & Adolescent Medicine, 166(2):200. 3. Abu-Saad, K. & Fraser, D. 2010. Maternal nutrition and birth outcomes. Epidemiologic Reviews, 32:5-25. 4. Schönfeldt, H.C. et al.

2012. Publisher: Red Meat Industry of South Africa, Pretoria.

Selected nutritional requirements for adult women (19-50 years) during pregnancy3 and the nutrient contribution made by a 100g portion of lean lamb4

Nutrient

Daily Requirement

Energy

9200kJ – 12200kJ

Protein

71g

Omega-3 Fatty Acids

Comments Depends on maternal Body Mass Index (BMI), age, physiologic appetite, rate of weight gain

Contribution from 100g cooked lean lamb Amount Percentage 715kJ

5.9 – 7.8%

Based on the intake of complete proteins (containing all 9 essential amino acids) to maintain maternal nitrogen equilibrium, plus protein deposition

25,4g

35.8%

1.4g

Vital for development of brain, central nervous system, and formation of new tissues in foetus

0,04g

2.9%

Iron

27mg

Based on the assumption that 75% of iron consumed is derived from haem iron sources, i.e. animal foods such as meat and eggs

3,1mg

11.5%

Folate

600µg

Vital for cellular reactions including DNA & nucleic acid synthesis, & sustained cell division

10-20µg

1.7 – 3.3%

Healthy Meat

HealthyMeatZA

www.healthymeat.co.za

An educational campaign translating current science into consumer friendly messages.

Supported by the Red Meat Industry of South Africa.

SAMJ_RM_Jan2014

Lamb & Mutton South Africa

CORRESPONDENCE

Time to stop preventable deaths from unsterile traditional male circumcision practices

Dan Ncayiyana Thomas Rehle

To the Editor: Once again the nation is outraged by the now familiar annual tale of how a number of initiates undergoing traditional male circum­cision in several provinces have paid with permanent disability, or the ultimate penalty of death, for taking part in cultural practices that have outlived their value in today’s South Africa. While we respect the rights of people to engage in culturally important initiation practices, it is unacceptable that every year during the winter months a large number of initiates continue to die or be maimed for life. The SAMJ alluded to the ‘Astonishing indifference to deaths due to botched ritual circumcision’ fully a decade ago, [1] and yet this year is seeing a repeat of the now familiar tale – the suffering of innocent young men and boys in order to become men. It was announced on Thursday 3 July 2014 that there had been already 23 initiation fatalities (19 in the Eastern Cape Province, three in Mpumalanga and one in the Western Cape) during this initiation season, which started in July. This is in spite of the supposed ‘zero tolerance to initiation fatalities’ campaign led by the Department of Traditional Affairs together with various stakeholders such as the National House of Traditional Leaders, the Department of Health, the South African Police Services, the Commission for the Promo­t ion and Protection of the Rights of Cultural, Religious and Linguistic Communities and the Congress of Traditional Leaders. Sadly, by the time of submission of this letter a fortnight later, more deaths had occurred. Every year we have been promised action, and every year more young men die or are maimed for life.

We the undersigned concerned scientists and parents call for immediate action by our government to stop the unacceptable deaths and penile amputations among young initiates undergoing traditional male circumcision by abolishing unsterile traditional male circumcision surgical practices with immediate effect. Our nation cannot afford this annual ritual of unwarranted slaughter and maiming of its sons to continue unabated. The time has come to show leadership in dealing with this major public health issue, which is a cause of great concern and embarrassment to all our citizens. We believe that decisive action cannot be postponed any longer. Even one more death or penile amputation of an initiate is one too many to accept.

We call on all traditional leaders from the various communities that engage in traditional male circumcision, and on politicians, to speak out publicly against this practice and follow King Goodwill Zwelithini’s historic and successful call in 2010 for Zulu initiates to be medically circumcised. Let us remember, culture is created, and it can lead to harmful or safe cultural practices. It is in our hands to change this situation once and for all.

Leickness Simbayi Olive Shisana Geoffrey Setswe

Human Sciences Research Council, South Africa

Glenda Gray

Medical Research Council, South Africa

Francois Venter

Wits Reproductive Health and HIV Institute, Johannesburg, South Africa

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Human Sciences Research Council, South Africa profdjn@gmail.com 1. Ncayiyana D. Astonishing indifference to deaths due to botched ritual circumcision. S Afr Med J 2003;93(8):546.

S Afr Med J 2014;104(8):521. DOI:10.7196/SAMJ.8687

Mammography reporting at Tygerberg Hospital, Cape Town, South Africa

To the Editor: The evasive response of Apffelstaedt et al.[1] with regard to the actual mammographic reporting methodology that forms the basis of their research[2] highlights concerns reflected in our letter[3] and raises clinical, ethical and scientific questions.

Apffelstaedt et al. need to explain exactly how they, as clinicians, independently report Tygerberg Hospital mammograms when their only access to the required digital reporting monitors is at a joint weekly meeting with radiologists, in the Division of Radiodiagnosis, at which time reports already generated by radiologists are reviewed.

Richard Pitcher (Head of Division of Radiodiagnosis), Jan Lotz, Christelle Ackermann, Asif Bagadia, Razaan Davis, Anne-Marie du Plessis, Stephanie Griffith-Richards, Retha Hattingh, Georg Wagener

Division of Radiodiagnosis, Department of Medical Imaging and Clinical Oncology, Faculty of Medicine and Health Sciences, Tygerberg Hospital and Stellenbosch University, Tygerberg, Cape Town, South Africa pitcher@sun.ac.za 1. Apffelstaedt J, Dalmayer L, Baatjes K. Mammography reporting at Tygerberg Hospital, Cape Town, South Africa: Response. S Afr Med J 2014;104(7):456-457. [http://dx.doi.org/10.7196/SAMJ.8455] 2. Apffelstaedt JP, Dalmayer L, Baatjes K. Mammographic screening for breast cancer in a resourcerestricted environment. S Afr Med J 2014;104(4):294-296. [http://dx.doi.org/10.7196/SAMJ.7246] 3. Pitcher R, Lotz J, Ackermann C, et al. Mammography reporting at Tygerberg Hospital, Cape Town, South Africa. S Afr Med J 2014;104(7):456-457. [http://dx.doi.org/10.7196/SAMJ.8455]

S Afr Med J 2014;104(8):521. DOI:10.7196/SAMJ.8689

HPV vaccine: Why the rush?

To the Editor: It was disconcerting, not to say frightening, to see that at the time of writing, only weeks after the launch of the national campaign of human papillomavirus (HPV) vaccination of grade 4 girls in South African (SA) public schools, a number of countries had put a moratorium on HPV vaccines. The Japanese government has done so more recently.[1] Austria has rejected the inclusion of HPV in its vaccination schedule. The Green Party MPs at the European Parliament are preparing to call for a moratorium in France.[1] The reasons are many. Evidence of effectiveness has not yet been provided. Clinical trials were carried out without proof of safety, since there was no placebo arm. Adverse reactions as serious as permanent disability or even death (139 deaths so far)[2] are likely to result from the aluminium adjuvant that accumulates in the central nervous system.[3] The goal – the prevention of cervical cancer – remains to be proven. Finally, the two existing vaccines ‘protect’ only against two out of ten or more high-risk HPV types.[3-7] Ever since gaining Food and Drug Administration approval in 2006, Merck has been heavily criticised in the USA for their overly aggressive lobbying campaigns and marketing strategies.[4] Further, the vast majority of publications on the topic have been authored by Merck

August 2014, Vol. 104, No. 8

CORRESPONDENCE

or GlaxoSmithKline (GSK) employees, or researchers employed by or funded by these companies.[8] To declare one’s conflict of interest in a scientific paper does not per se make one unbiased.[8,9] Of note is the fact that even publications by independent researchers rely on data funded by the vaccine manufacturers, which makes their opinion questionable.[4] On the other hand, the reader may point out that the expressed caution­ ary views reflect only a limited number of independent authors. This may be attributable to powerful lobbying by the industry.[4] SA media such as SAfm advertise the campaign and mention GSK’s sponsorship, an overt use by GSK of public media for personal gain.

This use is of concern in view of the billions of US dollars GSK had to pay for bribery in the USA, and is currently under investigation in China, the UK and Poland for the same reason.[10] On air, the argument used to entice parents to have their daughters vaccinated is to prevent 3 000 women from dying of cervical cancer annually. This is misleading, since it will take at least another 20 years to find out if this will materialise.[9] Meanwhile, screening and follow-up remain necessary even for vaccinated women, who may well forget about them in view of the claimed benefits of vaccination.

These are the author’s views and not those of the National Health Laboratory Service or the University of Limpopo. The author declares no financial link or interest with GSK and Merck.

Louis-Jacques van Bogaert

National Health Laboratory Service and University of Limpopo, Polokwane, South Africa louis.vanbogaert@nhls.ac.za 1. Frompovich CJ. International symposium about HPV vaccine problems in Japan. http://www. activistpost.com/2014/international-symposium-about-hpv.html (accessed 7 April 2014).

2. SANE VAX Inc. New death post-Gardasil updated VAERS figures & report that HPV vaccines adverse reactions are 50% higher than other age-related recommended vaccines. http://sanevax.org/newdeath-post-gardasil-updated-vaers-figures-report (accessed 12 May 2014).

3. Tomljenovic L, Spinosa JP, Shaw CA. Human papillomavirus (HPV) vaccines as an option for preventing cervical malignancies: (How) effective and safe? Curr Pharm Des 2013;19(8):1466-1487. [http://dx.doi.org/10.2174/1381612811319080014] 4. Tomljenovic L, Shaw CA. Who profits from uncritical acceptance of biased estimates of vaccine efficacy and safety? Am J Public Health 2012;102(9):e13-e14. [http://dx.doi.org/10.2105/AJPH.2012.300837] 5. Tomljenovic L, Shaw CA. Too fast or not too fast: The FDA’s approval of Merck’s HPV vaccine Gardasil.

J Law Med Ethics 2012;Fall:673-681. [http://dx.doi.org/10.1111/j.1748-720X.2012.00698.x] 6. Tomljenovic L, Shaw CA. Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds? Ann Med 2013;45(2):182-193. [http://dx.doi.org/10.3109/07853890.2011.645353] 7. Gupta S, Kerkar RA, Dikshit R, Badwe R. Is human papillomavirus vaccination likely to be a useful strategy in India? South Asian Journal of Cancer 2013;2(4):193-197. [http://dx.doi.org/10.4103/2278330X.119887] 8. Van Bogaert LJ. Are the currently existing anti-HPV vaccines appropriate for the developing world?

Ann Med Health Sci Res 2013;3(3):306-312. [http://dx.doi.org/10.4103/2141-9248.117924] 9. Yank V, Rennie D. Financial ties and concordance between results and conclusions in meta-analyses: Retrospective cohort study. BMJ 2007;335:1202. [http://dx.doi.org/10.1136/bmj.39376.447211.BE] 10. BBC World News. Current Affairs, 26 April 2014.

S Afr Med J 2014;104(8):521-522. DOI:10.7196/SAMJ.8301

HPV vaccine: Can we afford to hesitate?

To the Editor: Cervical cancer, caused by human papillomavirus (HPV) infection, is highly prevalent in sub-Saharan Africa. The estimated annual incidence of cervical cancer is 35/100 000 women, with 22.5/100 000 associated deaths. This is in stark contrast to the 6.6/100 000 cases and 2.7/100 000 deaths reported in developed countries such as the USA, where HPV vaccination has been available since 2006.[1.2] A vaccine is only approved after extensive clinical trials prove that the benefits of vaccination outweigh any possible risks associated with it. Governmental and non-governmental health organisations scrutinise

522

these clinical trial data through independent medicines review agencies and academic institutions before vaccines are approved and accepted for use (Table 1). Currently, two commercially available HPV vaccines are approved in more than 130 countries, and more than 175 million doses have been distributed world­wide.[3] The USA and Austria in 2006, Australia, Canada, Belgium, France, Germany and Italy in 2007, and the UK and others in 2008 were among the first countries to introduce HPV vaccination as part of their national immunisation programmes.[2] To date, HPV vaccination has been introduced into national vaccination programmes in at least 40 countries,[4] almost all of which have have lower cervical cancer prevalences than South Africa (SA).[2] The safety of both HPV vaccines has been rigorously tested in clinical trials prior to licensing and as part of ongoing postmarketing surveillance.[2] Data from post-licensure passive, active and population-based epidemiological surveillance studies have not shown any differences in conditions such as Guillain-Barré syndrome, stroke, appendicitis, seizures, allergic reactions, anaphylaxis and venous thromboembolism.[2,5] Reputable global leading health organisations, including the South African HPV Advisory Board, endorse the safety and efficacy of HPV vaccination (Table 1).[6] Both vaccines showed almost 100% efficacy against precancerous lesions associated with HPV types 16 and 18, which are responsible for around 70% of cervical cancers. Cross-protection was also reported against some non-vaccine types, which could increase protection to up to 85% of cervical cancers.[7] Cancer endpoints will take decades to observe, and it would not be ethical to allow women in a placebo arm of a trial to develop cervical cancer. Several proximal measures of vaccine efficacy such as persistent infection with HPV, incidence of cervical precancers and genital warts, and markers of immunogenicity were therefore used in previous studies. These are now accepted by the World Health Organization for use in future vaccine trials as appropriate endpoints that accurately predict vaccine efficacy against cancer.[4] Data from ongoing follow-up studies show that HPV vaccines are effective for at least 9.4 years; levels plateau early and then stay unchanged, so mathematical modelling studies have predicted long-lasting protection for at least 20 years. In addition, antibody levels, and therefore predicted vaccine efficacy, are highest in girls who receive the HPV vaccine at a younger age, providing a strong incentive for early vaccination.[4] It can be expected that antivaccine campaigners will take advantage of the HPV vaccine debate, focusing on concerns about safety and isolated reports of adverse events temporally related to vaccination.

It is imperative that healthcare professionals are well informed so they are able to answer questions and dispel the myths surrounding HPV vaccination in order to ensure maximum vaccine coverage and herd immunity. The National Department of Health and the SA government are applauded for the bold decision to implement and finance this lifesaving initiative. It deserves the full support of all medical professionals!

Submitted on behalf of the following members of the South African HPV Advisory Board: M H Botha, N Cooreman, G Dreyer, N P Godi, F Guidozzi, B Koller, B G Lindeque, C Maske, J Moodley, M Moodley, A Mouton, K L Richter, L Rogers, T Slavik, T Smith, R Soeters, C Turner, K Voyi, J Whittaker and A Williamson.

The SA HPV Advisory Board is an independent group of clinicians and experts with a special interest in HPV-related disease. The Board is affiliated to the SA Society of Gynaecologic Oncology and the SA Society of Obstetricians and Gynaecologists.

August 2014, Vol. 104, No. 8

CORRESPONDENCE

Table 1. Summary of selected leading health organisations that endorse the safety and efficacy of HPV vaccination Organisation/journal

Available from

World Health Organization’s Global Advisory Committee on Vaccine Safety

http://www.who.int/wer/2013/wer8829.pdf http://www.who.int/vaccine_safety/committee/topics/hpv/130619HPV_ VaccineGACVSstatement.pdf http://www.who.int/immunization/sage/meetings/2014/april/1_HPV_ Evidence_based_recommendationsWHO_with_Appendices2_3.pdf

International Federation of Gynecology and Obstetrics

http://www.figo.org/files/figo-corp/Statement%20on%20Safety%20of%20 HPV%20vaccination%20-%20FINAL%20-%20AUGUST%202013.pdf

Global Alliance for Vaccines and Immunisation. Partners include UNICEF, United Nations, Bill & Melinda Gates Foundation, World Bank

http://www.gavialliance.org/support/nvs/human-papillomavirus-vaccinesupport/

National Cancer Institute, National Institutes of Health, USA

http://www.cancer.gov/cancertopics/factsheet/prevention/HPV-vaccine

Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention, USA

http://www.cdc.gov/hpv/vaccine.html http://www.cdc.gov/hpv/vaccinesafety.html http://www.cdc.gov/vaccines/hcp/ acip-recs/vacc-specific/hpv.html

American College of Obstetricians and Gynecologists

http://www.acog.org/Resources%20And%20Publications/Committee%20 Opinions/Committee%20on%20Adolescent%20Health%20Care/Human%20 Papillomavirus%20Vaccination.aspx

European Medicines Agency, European Union

http://ec.europa.eu/health/sti_prevention/hpv/index_en.htm

Medicines and Healthcare Products Regulatory Agency, UK

http://www.mhra.gov.uk/Safetyinformation/ Generalsafetyinformationandadvice/Productspecificinformationandadvice/Product-specificinformationandadvice-G-L/ HumanpapillomavirusHPVvaccine/index.htm

Joint Committee on Vaccination and Immunisation, UK

http://clinicalvirology.org/~ukcvn/images/stories/aboutus%20linkspdf/HPV_ JCVI_report_18_07_2008virvacc.pdf

Karolinska Institutet, Sweden

http://ki.se/ki/jsp/polopoly.jsp?d=2637&a=168933&l=en&newsdep=2637

Paul Elrich Institut, Agency of the German Federal Ministry of Health

http://www.pei.de/SharedDocs/Downloads/vigilanz/bulletin-zur-arzneimittelsi cherheit/2013/3-2013.pdf?__blob=publicationFile&v=4

Immunise Australia Program, Australian Government Department of Health and Ageing

www.australia.gov.au/hpv

National Centre for Immunisation, Research and Surveillance, Australia

http://www.ncirs.edu.au/immunisation/fact-sheets/hpv-humanpapillomavirus-fact-sheet.pdf

Ministry of Health, Malaysia

http://www.moh.gov.my/attachments/8106

South African HPV Advisory Board (affiliated to the South African societies of Obstetricians and Gynaecologists and Gynaecological Oncologists)

http://www.sasog.co.za/B_HPVPROPHYLACTICVACCINE.asp http://www.sajgo.co.za/index.php/sajgo/article/view/60/pdf_23

Cancer Association of South Africa

http://www.cansa.org.za/files/2013/11/Fact-Sheet-Human-Papilloma-VirusInfection-Cancer-Nov-2013.pdf

HPV = human papillomavirus.

K L Richter

Department of Medical Virology, Faculty of Health Sciences, University of Pretoria and National Health Laboratory Service, Pretoria, South Africa karin.richter@up.ac.za

G Dreyer B G Lindeque

Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of Pretoria, South Africa

M H Botha

Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa

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1. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. Lyon, France: International Agency for Research on Cancer. http://globocan.iarc.fr (accessed 5 May 2014).

2. Markowitz LE, Tsu V, Deeks SL, et al. Human papillomavirus vaccine introduction – the first five years. Vaccine 2012;30(Suppl 5):F139-F148. [http://dx.doi.org/10.1016/j.vaccine.2012.05.039] 3. World Health Organization. GACVS Safety Update on HPV Vaccines. Geneva, 13 June 2013. http://www.who. int/vaccine_safety/committee/topics/hpv/130619HPV_VaccineGACVSstatement.pdf (accessed 5 May 2014).

4. World Health Organization. Evidence based recommendations on human papillomavirus (HPV) vaccines schedules. 11 March 2014. http://www.who.int/immunization/sage/meetings/2014/april/1_HPV_Evidence_based_ recommendationsWHO_with_Appendices2_3.pdf (accessed 12 May 2014).

5. Arnheim-Dahlström L, Pasternak B, Svanström H, et al. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: Cohort study. BMJ 2013;347:f5906 [http://dx.doi.org/10.1136/bmj.f5906] 6. South African Human Papillomavirus Advisory Board. Prophylactic human papillomavirus vaccination against cervical cancer: A summarised resource for clinicians. South African Journal of Gynaecological Oncology 2011;3(1):39-42. [http://www.sajgo.co.za/index.php/sajgo/article/view/60/pdf_23] 7. Malagón T, Drolet M, Boily M, et al. Cross-protective efficacy of two human papillomavirus vaccines: A systematic review and meta-analysis. Lancet Infect Dis 2012;12(10):781-789. [http://dx.doi.org/10.1016/S14733099(12)70187-1]

S Afr Med J 2014;104(8):522-523. DOI:10.7196/SAMJ.8449

August 2014, Vol. 104, No. 8

CORRESPONDENCE

GeneXpert TB 8: A point-of-care diagnostic pilot

To the Editor: The point-of-care (POC) GeneXpert MTB/RIF detects Mycobacterium tuberculosis (MTB) and drug resistance in under 2 hours and was hailed a ‘game-changer’ for tuberculosis (TB) control.[1] Recent results from Evaluating a New Diagnostic Trial (EXTEND) show that while implementing the GeneXpert had more confirmations of TB than sputum microscopy, levels of loss to follow-up and mortality were not reduced in the GeneXpert group.[2] These results are discouraging. However, GeneXpert was not used as a true POC service.

Using the diagnostic at POC, where results are handed to patients at the time and place of sample collection, may yield different outcomes.

The Desmond Tutu HIV Foundation has piloted the GeneXpert in the Tutu Tester Mobile Clinic operating on the Cape Flats in Cape Town, Western Cape Province, South Africa.

The context. The Western Cape has one of the highest incidence rates of TB in the world.[3] The uncontrolled spread of TB has led to its being declared a national emergency.[4] Accessible healthcare promotes health-seeking and enables patients to become more active in their own healthcare.[5] Limited access means that treatable diseases such as HIV and TB go undiagnosed,[6] and many enter care with advanced disease.

Providing POC testing can facilitate entry into the HIV/TB treatment cascade[7] for many in the Cape Town metropole. To facilitate treatment access further, the Foundation has piloted the GeneXpert in underresourced communities with a high burden of disease.

Intervention. Implementing the GeneXpert in the mobile clinic has shortened the diagnostic period. Patient samples can be analysed for TB DNA and the results can be handed back within 2 hours.[8] Most clients leave with their test result and a referral letter to their nearest clinic. This allows for fast-tracking for medication prescrip­ tions.

Through active case finding, mobile clinics reach people who often do not access healthcare and patients are therefore infectious for shorter periods, helping to combat TB transmission. In addition, people who could not wait 2 hours for TB results were followed up telephonically and linkage to care was facilitated with the relevant clinic.

Data to date. In a 3-month period, 66 tests were conducted with HIV-positive clients with low CD4+ counts and clients with World Health Organization TB symptoms. Of these, nine (13.6%) tested positive for MTB. Rifampicin resistance was found in two (22.2%) of nine TB-positive clients (3.0% of 66 tested). Of the nine clients, seven were linked into care within 48 hours (one client linked into care 10 days after testing). All these clients received their first dose of medication on the day of linking to a healthcare facility.

Conclusion. These very preliminary data indicate that the Gene­ Xpert can be used at the point of patient contact, and when doing so, therapy can be initiated on the same day or very soon thereafter.

Philip Smith, Anna van Esch, Melissa Wallace, Robin Wood, Linda-Gail Bekker

Desmond Tutu HIV Centre, Institute for Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, South Africa philip.smith@hiv-research.org.za 1. Evans CA. GeneXpert – a game-changer for tuberculosis control? PLoS Med 2011;8(7):e1001064. [http://dx.doi.org/10.1371/journal.pmed.1001064] 2. Fielding KL, McCarthy KM, Cox H, et al. Xpert as the first-line test in South Africa: Yield, intial loss to follow up, proportion treated. Presented at the 2014 Conference on Retroviruses and Opportunistic Infections (CROI), Boston, MA, 3 - 6 March 2014.

3. Claassens M, van Schalkwyk C, den Haan L, et al. High prevalence of tuberculosis and insufficient case detection in two communities in the Western Cape, South Africa. PLoS ONE 2013;8(4):e58689. [http://dx.doi.org/10.1371/journal.pone.0058689] 4. Abdool Karim SS, Churchyard GJ, Abdool Karim Q, Lawn SD. HIV infection and tuberculosis in South Africa: An urgent need to escalate the public health response. Lancet 2009;374(9693):921-933. [http:// dx.doi.org/10.1016/S0140-6736(09)60916-8] 5. Govindasamy D, Kranzer K, van Schaik N, et al. Linkage to HIV, TB and non-communicable disease care from a mobile testing unit in Cape Town, South Africa. PLoS ONE 2013;8(11):e80017. [http:// dx.doi.org/10.1371/journal.pone.0080017] 6. MacPherson P, MacPherson EE, Mwale D, et al. Barriers and facilitators to linkage to ART in primary care: A qualitative study of patients and providers in Blantyre, Malawi. J Int AIDS Soc 2012;15:18020. [http://dx.doi.org/10.7448/IAS.15.2.18020]

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7. Churchyard GJ, Mametja LD, Mvusi L, et al. Tuberculosis control in South Africa: Successes, challenges and recommendations. S Afr Med J 2014;20;104(3):244-248. [http://dx.doi.org/10.7196/SAMJ.7689] 8. Zeka AN, Tasbakan S, Cavusoglu C. Evaluation of the GeneXpert MTB/RIF assay for rapid diagnosis of tuberculosis and detection of rifampin resistance in pulmonary and extrapulmonary specimens. J Clin Microbiol 2011;49(12):4138-4141. [http://dx.doi.org/10.1128/JCM.05434-11]

S Afr Med J 2014;104(8):524. DOI:10.7196/SAMJ.8461

Professional competence in South Africa

To the Editor: The Colleges of Medicine of South Africa (CMSA) wishes to respond to the editorial by Solly Benatar.[1] The CMSA shares Prof. Benatar’s concern about the need to ensure that new surgeons and gynaecologists have had the necessary practical experience to enter solo clinical practice. Prof. Benatar appropriately raises questions about surgical competence, ‘how many operations specific to the specialty in question newly qualified surgeons are required to have performed’, and ‘how many such operations they have indeed performed before they are allowed to go into practice’.

He also refers to the impact of reductions in tertiary beds, freezing of posts in academic hospitals and reductions in operating time on the capacity to train new generations of specialised practitioners.

While he correctly states that ‘the CMSA surgical fellowships have rules stating that a portfolio of surgical experience must be submitted at the time of applying for the final fellowship examination’, we wish to correct the statement that ‘no mention is made in the rules of the number of operations that should have been done or assisted with, or whether the examiners themselves evaluate the portfolios’.

The Colleges of Otorhinolaryngology, Obstetrics and Gynae­ cology, and Paediatric Surgery do specify on the CMSA website the numbers of procedures that candidates must have performed prior to being admitted to the final examinations. Surgical logbooks are signed off by the heads of departments and submitted to the relevant colleges for scrutiny. Candidates are refused permission to write the final examination if the logbook requirements have not been met.

Johan Fagan Honorary Registrar, CMSA; President of the College of Otorhinolaryngologists of South Africa johannes.fagan@uct.ac.za

Gerhard Lindeque

President, CMSA, South Africa 1. Benatar SR. Professional competence and professional misconduct in South Africa. S Afr Med J 2014;104(7):480-482. [http://dx.doi.org/:10.7196/SAMJ.8492]

Prof. Benatar replies: I am grateful to Profs Fagan and Lindeque for the points of correction they have made regarding the portfolios for the above Colleges. I presume that it is the examiners for each exam­ination session who approve the logbooks, although this is not stated. As no mention is made of all the other surgical colleges, I also pre­sume that their portfolio requirements are not adequately spelt out.

I reiterate my recommendation that ‘It would seem timely to instigate an open investigation of the patient loads, surgical facilities and staffing levels of all training institutions, as well as of the thoroughness and accountability of the evaluation of practical experience, including scrutiny of well-prepared, validated case portfolios, before qualifying surgeons to enter practice as specialists.’

All the CSMA surgical colleges should initiate this process by reviewing their portfolio requirements and ensuring that these rele­ vantly match those of well-recognised colleges internationally.

Solly Benatar

Emeritus Professor of Medicine, University of Cape Town, South Africa solomon.benatar@uct.ac.za S Afr Med J 2014;104(8):524. DOI:10.7196/SAMJ.8703

August 2014, Vol. 104, No. 8

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TB: The tap’s down a notch – but the water’s polluted South Africa (SA)’s drugsusceptible (DS) tubercu­ losis (TB) ‘tap’ may have been turned down a few notches by the sustained HIV/AIDS testing and antiretroviral therapy (ART) campaign, but a growing number of dying, drug-resistant (DR) TB sufferers are desperately awaiting the approval of drugs known to be effective.

This emerged from SA’s top researchers, activists and coalface clinicians across the public and private sectors as they outlined the latest TB countermeasures for 1 500 delegates attending the 4th National TB Conference at Durban’s International Con­ vention Centre between 11 and 13 June this year. Another stark fact to emerge was that only a TB vaccine – the frustrated developers of which are now turning to direct human trials for testing – will turn off the tap of new infections and take SA off the top of the list of countries hardest hit by TB. Bedaquiline, the most effective new TB drug to emerge globally in 40 years, has resulted in promising response to treatment in 75% of patients after 3 months of treatment in the ongoing SA compassionate use programme (almost four times the efficacy of existing locally registered drugs for extensively drug-resistant (XDR) disease). However, at the time of writing, the Medicines Control Council (MCC) had not approved it for anything other than highly controlled compassionate use. A top TB researcher and a senior national health official intimated at the conference that authorisation for more generalised bedaquiline use, and a far cheaper (and therefore more applicable) generic version of linezolid (also a highly effective combination therapy drug), was ‘imminent’. Currently, treatment of DR TB consists of at least four toxic drugs (including an injectable agent), administered over 2 years. It is costly and a painful ordeal for patients, with a significant number of those who survive ending up deaf.

A promising 6-month, five-drug, injectionfree trial, involving both new drugs and funded by the Medical Research Council to the tune of R18 million, is underway, co-led by the University of Cape Town’s pulmonology chief, Prof. Keertan Dheda.

From left, Prof. Keertan Dheda, head of pulmonology at the University of Cape Town and Groote Schuur Hospital, Dr Nazir Ismail, National Health Laboratory Service Reference Laboratory, and Dr Willem Hanekom, Director, SA TB Vaccines Initiative. Picture: Chris Bateman.

More general use for bedaquiline ‘imminent’?

Dheda believed that with about 100 South Africans currently on bedaquiline (com­ passionate use), MCC approval for more general application was ‘imminent’. With full clinical trial data not yet available, it would ‘obviously have to be used in a very responsible way’. ‘How we will use it and with who’ remained open questions. ‘At the end of the day we’ll have to put it into a regimen to trial it before we know how it works, whether it’s efficacious, and how it interacts with other drugs,’ he added. However, at the same time, as lives were being lost it was difficult to withhold the drug from patients who could potentially benefit. With a ‘known’ DR national caseload estimated at 8 000 patients last year (up from 6 500 patients treated in 2012), drug resistance in SA is now the single biggest challenge to a belatedly up-scaled and re-prioritised TB programme. DR TB stands at just below 3% of the total TB caseload, but the strains are virulent, spreading most notoriously from person to person in prisons, in crowded public transport vehicles and in and around the country’s mines. DR TB now consumes nearly half the nation’s TB resources, creating an unsustainable economic equation. Speaker

525

after speaker at the con­ ference dispelled the myth that the ongoing DR TB spread was the result of non-adherence or treat­ ment failure, emphasising that airborne transmission was now the major mode of spread. In non-ventilated environments, catching it is as simple as ‘you breathe out and I breathe in’. Doing the basics right, such as triaging TB and HIV patients, wearing proper masks and dramatically increasing ventilation, was perhaps best illustrated by Dr Gerald Friedland, Professor of Medicine and Epidemiology and Public Health at Yale University in the USA.

Global lessons from Tugela Ferry

Friedland catalogued the ‘rise and fall’ of XDR TB at Tugela Ferry, where it was first detected in 2005 by the local Church of Scotland Hospital veteran chief medical officer, Dr Tony Moll. Friedland said a dramatic correlation with extremely low infection rates was revealed by simply opening all windows and using fans in all TB wards. With ward windows closed and the mechanical ventilator off, one (room) air change per hour was recorded. With windows closed and the mechanical vent on, this rose to 15 air volume changes per

August 2014, Vol. 104, No. 8

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hour, while with all windows open and mixer fans on, more than 60 air changes per hour were recorded. By focusing on airborne infection control, protecting staff with N95 masks, screening for TB at all hospital entrance points and separating and fast-tracking coughing HIV patients, almost half of all anticipated DR TB cases in the hospital environment were avoided.

The proportion of DR TB to DS TB cases at Tugela Ferry (taking into account the introduction of ART) had dropped from 65% in 2005 to zero by last year. Friedland said that a whole array of community-based strategies, including early case finding, rapid diagnosis (with GeneXpert), communitybased treatment and more standard household contact tracing, were ‘brilliantly employed’ in the Msinga district of Tugela Ferry. This had resulted in KwaZulu-Natal (KZN), with top international academic and clinical support, adopting a multipronged multidrug-resistant (MDR)/XDR TB combat protocol that has since been embraced nationally and globally. Between the time a stunned Tony Moll uncovered the first DR (XDR) TB cases (53 in a 350-bed hospital) in January 2005 and January 2008, Tugela Ferry held the world’s single largest known concentration of DR TB (82% of XDR patients and 67% of MDR patients died over this period, as did nine healthcare workers). Fears that this was not simply an isolated ‘outbreak’ were soon confirmed when more than 60 KZN healthcare facilities were found to be affected – before public health officials discovered that it was spread across all nine provinces. Dheda described the Tugela Ferry event as ‘the perfect storm’.

‘You had a very susceptible group [advanced HIV patients] with a virulent TB strain in a very contained environment. At the time there were no ARVs available and no treatment for XDR TB.’ Friedland – and several other epidemiologists and clinicians at the conference who showed complex graphs and bar charts of TB mutations, drug trials and regimens, and the alarming and growing prevalence of MDR TB – took pains to remind their audience constantly that the statistics were actually ‘human beings with the tears removed’.

Motsoaledi: ‘No need for “emergency” – we’re doing all we can’

National health minister Dr Aaron Motso­ aledi rejected urgent calls by healthcare activist groups, including the Treatment Action Campaign (TAC) and Section 27, to declare MDR TB a national health emergency

Yale researcher Dr Gerald Friedland and Tugela Ferry’s Dr Tony Moll. Picture: Chris Bateman.

with ‘war rooms’ in every province, claiming that all available strategies were already being deployed.

‘It’s difficult for me to see the benefits of such a declaration. I believe we have at our disposal all the weapons that civil society is asking for. The question we need to ask ourselves is, are we able to implement these plans?’ He and his national TB chief Dr Lindiwe Mvusi outlined a multipronged newly refined approach to countering TB in all its manifestations, including strategies to deal with populations in prisons, on public transport and in mines and detailing patient follow-up collaboration with SA’s neighbouring countries. Motsoaledi comm­ itted his department to increase existing screening of mineworkers to half a million, plus another 600 000 people in the surrounding mining communities, with both populations benefiting from the resultant treatment. Having secured the signatures of his counterparts in Lesotho, Mozambique and Swaziland to actively syn­ chronise continuity of treatment and referral of mineworkers, plus sharing software on a common database (courtesy of the Bill and Melinda Gates Foundation), the remaining dozen or so nearest countries had so far signed a ‘declaration of intent’.

A common treatment protocol had been developed with colour-coded, patientfriendly drug charts. The Global Fund for HIV/AIDS, TB and Malaria has allocated R500 million to the project, given that five of the countries carrying 80% of the world’s TB burden are situated within the Southern African Development Community. Former Swaziland health minister Benedict Xaba is spearheading the project.

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Mvusi told Izindaba that even if the employer mines had to send treatment to their boarded foreign workers, or patients had to travel back on a regular basis for treatment, her department would help ensure this continuity of treatment as a minimum requirement in addition to any other compensation they deserved. She said that in prisons, from March last year all newly admitted offenders (or on-trial inmates) were being screened for all medical conditions upon entry, with proper guidelines now issued. Anyone who was symptomatic was immediately isolated for at least a week, returning to their cells once started on treatment. A recent study by the mines-funded Aurum Institute found that 4% of surveyed inmates at one Gauteng prison had TB but did not know it and a quarter of inmates were also HIV-positive, skyrocketing their chances of getting TB (an up to 30-fold risk increase). Mvusi said infection control awareness education had been stepped up, including around transferrals between prisons and upon discharge, with strict referral to district hospitals and community clinics.

Longer-term inmates now had to be screened twice a year and X-rayed if symptomatic.

She said that while wholesale rebuilding of prisons to improve ventilation was virtually impossible, Prof. Adriano Duse, head of Clinical Micro­biology and Infectious Diseases at the National Health Laboratory Service (NHLS) and the University of the Wit­waters­ rand, would lead a Council for Scientific and Industrial Research team in conducting infec­tion control risk assessments in prisons and ‘come up with plans’. ‘I just hope they can reach an accommodation between security and ventilation,’ she stressed.

With a ‘known’ DR national caseload estimated at 8 000 patients last year (up from 6 500 patients treated in 2012), drug resistance in SA is now the single biggest challenge to a belatedly up-scaled and re-prioritised TB programme.

New TB guidelines issued

The national health department had also issued new Correctional Services guidelines on voluntary HIV counselling and testing, screening, 6-monthly CD4+ testing for inmates who did not meet HIV treatment initiation requirements, and isoniazid prev­ entive therapy for all candidates who met its strict criteria. Preliminary results from a

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in the context of ‘thousands and thousands of preventable deaths’, including hundreds of healthcare workers, as a result of poor infection control.

GeneXpert trial across all 242 prisons were already showing ‘a very significant reduction in TB’. Mvusi cited the national incidence of TB in SA as standing at 1 003/100 000 people.

Meanwhile SA is seeing about 18% fewer new TB cases annually as a result of the increasing number of HIV-positive people on ARVs following the massive national counselling and testing push over the past several years. Professor Nazir Ismail, head of the National Institute of Communicable Diseases, told delegates that the drop came after year-on-year increases of TB cases peaked dramatically in 2008, before beginning a slow annual decline in lab-confirmed cases that had continued to the present. He was confident that the decline was accurate, because of the 300% increase in the number of people tested for TB since 2004.

GeneXpert’s potential limited by lack of capacity

Ismail revealed that SA was now responsible for at least half of the global GeneXpert rollout. GeneXpert rapidly and simultaneously detects TB and rifampicin resistance, and from 2011 has replaced the slower and less accurate traditional TB tests. A recent trial comparing GeneXpert with smear microscopy had shown 83% accuracy for the former compared with 50% for the latter, GeneXpert detecting TB in most patients within 1 - 3 days (77%) v. smear microscopy which detected half the patients in the same time. Because of its speed, GeneXpert reduced culture-positive drop-out rates from 16% to 9%, a key benefit being that ‘you can do it in front of the patient’. Ismail said it was ‘critical’ to get patients on treatment early to reduce contagion, citing an 80% person-to-person transmission rate in China. GeneXpert was highly feasible in primary care settings, did not require high-tech staff, and increased same-day result rates. Research by Dr Pren Naidoo of the Desmond Tutu TB Centre has shown that on average, MDR TB patients took 16 days to begin treatment following the receipt of their same-day GeneXpert results – strongly underscoring Ismail’s warning.

Since the GeneXpert roll-out, the average time between testing and treatment initiation for regular TB patients had dropped from 4 to 6 days. Patients with MDR TB now started treatment 26 days sooner than previously.

Naidoo said that lab costs had doubled with GeneXpert’s introduction, but this was offset in some parts of the country by increased TB diagnosis. The new technology had ‘incredible potential’, but on its own it could

MDR crisis: ‘Don’t forget to close the DS TB tap’ – Pillay

National Department of Health TB chief Dr Lindiwe Mvusi. Picture: Chris Bateman.

never prove a panacea because of the poor-todysfunctional provincial health system.

Linezolid generic possible by November

Pressurised by treatment activists, lawyers and clinicians during a patient advocacy session, Dr Yogan Pillay, Deputy DirectorGeneral: Strategic Health Programmes in the national health department, surprised many by revealing that linezolid would ‘shortly be coming off patent’ at a much-reduced price.

He said Mvusi’s department would have to make crucial and ‘innovative’ choices about how to use the drug to get the best possible outcomes for the most patients. ‘We’re not just talking specialist XDR TB hospitals here, but much broader than that.’

Pressed on bedaquiline, he said that because of the strict MCC access rules, sufficient safety data would have to be garnered ‘before we can say we can use this outside the clinical access programme’. He speculated that this ‘might happen around November’, before pleading with journalists to source this information from the MCC itself.

‘I’ve been on the [MCC] registrar’s “case” trying to ensure they pass the review of the [generic companies’] dossier on linezolid on the same basis as they approved off-label use of bedaquiline, and to get permission to have it as part of the clinical access programme.’

TAC veteran Mark Heywood asked whether provincial health leadership was competent enough to carry out progressive national health policies under Motsoaledi. He said that the call for a national health emergency came

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Pillay said that with new, lifesaving backup drugs in the offing and with GeneXpert offering new hope, ‘before we even deal with MDR in the way people suggest that we should, we need to deal with regular TB in ways that close the tap. We’re clearly challenged with MDR and XDR, but we need to close the tap of DS TB. We’ve been able to show cure rates and treatment success rates going up [for DS TB] – clearly not fast enough, because we still have about 6% default rates.’

He cited government decisiveness on DS TB, with Motsoaledi accelerating decentralised TB diagnostics and treatment to 2 500 sites in all 52 health districts. The target was to get another 3 000 MDR patients onto treatment over the next 2 years, plus adapt the highly successful nurse-initiated ARV management and treatment (NIMART) to a TB model, thus extending care to thousands more patients via task shifting from scarce doctors.

Vaccines – a radical rethink required

Dr Willem Hanekom, director of the South African TB Vaccines Initiative, currently on sabbatical as deputy director in Global Health (leading the Bill and Melinda Gates Foundation’s TB vaccine programme), said a ‘complete rethink’ was required on TB vaccines. The 15 TB vaccine candidates currently in clinical trials were all developed in ‘virtually the same way’, stimulating the same kind of immunity. All were tested on animals, and ‘we’re not sure the results they show will be successful, ultimately’. While animal testing would continue, the new strategy would be to conduct human testing ‘as early as possible, with safety paramount’.

Using human data to guide scientists was now the preferred path. Many hurdles, including regulatory approval, how to make new candidate vaccines and conducting numerous small studies, had yet to be overcome. The bottom line was that ‘a radical rethink is required to move ahead’, he added.

Chris Bateman chrisb@hmpg.co.za S Afr Med J 2014;104(8):525-527.

DOI:10.7196/SAMJ.8621

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Defusing the new drug-resistant TB time bomb A nationally co-ordinated strategy is urgently needed to avoid the discharge of highly contagious ‘thera­ peutically destitute’ tuber­ culosis (TB) patients back into a careless void, with uniquely tailored solutions including home-based or community care, plus multidisciplinary teams in modernday sanatoria.

This appeal was made at the annual National TB Conference in Durban in midJune by Prof. Keertan Dheda, arguably the country’s leading expert on drug-resistant (DR) TB. He warned that fast-spreading, highly DR TB will further discourage entry to the healthcare professions, aggravating the existing staff shortage crisis and crippling South Africa (SA)’s ability to reduce its quadruple burden of disease.

Dheda, Professor of Medicine and Head of Pulmonology at the University of Cape Town (and also one of the most published and cited TB academics in the country), estimates that several thousand healthcare workers (HCWs) are currently TB-infected (an annual infection rate of 2 - 3%). Acknow­ ledging that successfully combating DR TB will be a ‘massive undertaking’, he appealed for greater emphasis on safety by the national health department via the Occupational Health and Safety Act and creation of user-friendly and closely supervised TB patient-triaging policies – in tandem with better environmental and personal control measures.

When a patient with infectious DR TB is admitted to such a setting, up to 50% of the patients exposed on that ward can become infected within 24 hours.

Hospitals DR TB ‘infection palaces’

Across SA (as in many other parts of the world), patients are admitted to large hospital wards or spend time in crowded outpatient waiting areas – with little or no ventilation. Modelling studies have shown that when a patient with infectious DR TB is admitted to such a setting, up to 50% of the patients exposed on that ward can

Prof. Keertan Dheda, top expert on drug-resis­ tant TB. Picture: Chris Bateman.

become infected – within 24 hours. Dheda’s call for a more effective overall strategy underscores repeated ongoing appeals by the Treatment Action Campaign and Section 27 to declare DR TB a national emergency and for an aggressive push by national health chiefs to beef up infection control policies in hospitals, especially through monitoring and support of the more laggardly provincial health departments. Dheda said that with the country’s heavy patient load and resource constraints, home-based or communitybased care – with suitable logistical support for a specific category of patients, including ventilation grants – would be a pragmatic way forward. ‘They have families, they have to work, some are even driving taxis,’ he emphasised. However, there was also a category of DR TB patients who were unable to work owing to their advanced illness or family circumstances.

Multidisciplinary sanatoria and safe palliation needed

Easily accessible long-term inpatient facili­ties with multidisciplinary teams – the equivalent of modern-day sanatoria – were urgently needed to help these people. ‘We need them [such sanatoria] and we need them right now,’ he emphasised. Also, specially tailored palliative care facilities were required to deal

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with the alarming number of therapeutically destitute TB patients discharged from hospital. ‘They do not die immediately (the median survival rate is two years as we recently showed in a paper in the Lancet) and often go back to a district hospital where there is more disease transmission. They also need to be able to die with dignity – you cannot put them in a standardised hospice setting because of the extraordinary infection control requirements!’ Creative discussions with the Hospice and Palliative Care Association of Southern Africa could prove fruitful, Dheda suggested. Among other things, specially trained nurses with highly effective protection measures were required. Dheda said he was aware of some rare exceptions to the national paucity of specially tailored palliative care facilities: a two-bed facility run by Médecins Sans Frontières in Khayelitsha and another larger one at Nelspoort, also in the Western Cape. While valuable as models, they were mere drops in the required caregiving ocean, with the Nelspoort facility ‘not working very well because it’s too far away from anything’.

Dheda was among a handful of local scientists whose research has helped define TB treatment failure (failing to respond to treatment or culture-converting within 12 months).

The WHO warned that any government doubt and inaction could spawn a full-blown XDR epidemic.

HCW infections – alarming findings

Seminal work on local HCW TB infection (published in 2010 and in colla­ boration with researchers at the University of KwaZulu-Natal) involved a 6-year study at King George V Hospital in Durban, where Dheda and his fellow researchers uncovered 250 HCWs with extensively drug-resistant (XDR) and multidrug-resistant (MDR) TB, who had an infection rate six times higher than the general population (Table 1). In another study recently published in the Lancet, there was an 11% rate of favourable 5-year outcomes (cured or completing treatment) among patients with XDR TB, with mortality at 75%. Notably, half of

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Table 1. MDR- and XDR-infected HCWs, KZN Province Incidence rate ratio (95% CI)

HCWs

General population

Annual MDR or XDR TB incidence (/100 000)

66.8

11.7

5.71 (4.96 - 6.69)

Annual MDR TB incidence (/100 000)

62.3

10.7

5.82 (5.03 - 6.87)

Annual XDR TB incidence (/100 000)

4.5

1.04

4.33 (2.69 - 8.18)

MDR = multidrug-resistant; XDR = extensively drug-resistant; HCWs = healthcare workers; KZN = KwaZulu-Natal; CI = confidence interval; TB = tuberculosis.

XDR TB patients hospitalised on treatment* August 2002 - August 2012 (Period: 10 years) (N=107)

Excluded Transferred out: 6/107

Died in hospital 55% (56/101) Discharged into community 45% (45/101)

Discharged from hospital as treatment failure 42% (19/45) Smear +ve 35% (6/17**) Culture +ve 100%

Unfavourable outcome 89% (17/19)

Deceased 82% (6/17) Treatment failure 18% (3/17)

Discharged from hospital as culture converted 58% (26/45) Smear +ve 5% (1/19**) Culture +ve 0%

Favourable outcome 11% (2/19)

Unfavourable outcome 50% (13/26)

Favourable outcome 50% (13/26)

Cured 100% (2/2)

Deceased 46% (6/13) Treatment failure 15% (2/14) Defaulted 31% (4/13) Re-admitted 8% (1/13)

Cured 100% (13/13)

* As per National Government policy all XDR TB patients required to be admitted ** Smear requested, n patients

Fig. 1. Mortality and outcome after hospital discharge for XDR TB patients, August 2002 - August 2012.

(XDR = extensively drug-resistant; TB = tuberculosis.)

them were HIV-negative. It was also here that his team discovered just how many incurable patients were being discharged into the community – of 107 XDR patients tracked, half made it to discharge, and only half of this (discharged) cohort were ‘culture converters’ (treatment responders) (Fig. 1). ‘So the hopeless cases leave with no palliative care or long-stay community facilities available. They just go home,’ he

said. Studies in two other provinces had similar findings, suggesting that this is happening on a wide scale: ‘it’s not just sporadic’, Dheda emphasised.

Nationally, an estimated 600 - 1 000 known XDR cases annually are being added to the current known tally of 8 000 cases of DR TB, with the World Health Organization (WHO) warning that any government doubt and inaction could spawn a full-blown XDR

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epidemic. By way of comparison (albeit with a First-World country), the USA treated approximately 100 cases of MDR TB last year.

Dheda said that major improvements in laboratory capacity, infection control, the performance of the TB control programme, and treatment regimens for both drugsusceptible (DS) and DR disease will be needed. Added to this, a massive scale-up in diagnosis and treatment of MDR and XDR TB was needed to prevent DR strains from becoming the dominant form of TB, something the government has actively begun. The WHO says that transmission in household and community settings is ‘especially troubling’ when it comes to children younger than 5 years of age, because they are highly susceptible to progression of active disease.

Besides lives lost, cost alone must boost efforts

Management of MDR TB is more complex, costly and time-consuming and less effec­ tive than is management of DS TB. One local study, also from Dheda’s team, analysing the comparative 2011 US dollar costs of diagnosis and treatment of DS TB, MDR TB and XDR TB (based on and assuming adherence to the national SA TB guidelines and using published clinical outcome data), found that the per patient cost of XDR TB was $26 392, four times greater than MDR TB ($6 772) and 103 times greater than DS TB ($257). Despite DR TB comprising only 2.2% of the case burden, it consumed 32% of the total estimated national TB budget of $218 million. The study also found that a decentralised XDR TB treatment programme could potentially reduce costs by $6 930 per case (26%) and reduce the total amount spent on DR TB by 7%.[1] While we ‘have it bad’ (incidence-wise), we are not alone. Dheda said that the highest TB burdens (by TB-infected numbers) were in India and China. The WHO observed in one of its latest reports: ‘Responding to drug-resistant tuberculosis is possibly one of the most profound challenges facing global health.’

Chris Bateman chrisb@hmpg.co.za 1. Pooran A, Pieterson E, Davids M, Theron G, Dheda K. What is the cost of diagnosis and management of drug-resistant tuberculosis in South Africa: PloS ONE 2013;8(1):e54587. [http://dx.doi.org/10.1371/journal.pone.0054587]

S Afr Med J 2014;104(8):528-529.

DOI:10.7196/SAMJ.8622

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Timing their moves, healthcare bodies scrub up for a dust-up Private healthcare organisations across the country are strategising on whether or when to take on the government, which has promulgated a law that effectively allows the Director-General of Health to tell their members where they can ply their trade or set up facilities and equipment.

At least three of the top doctor bodies have banded together to say that the long-dormant Certificate of Need (CoN) provisions in the National Health Act (NHA), suddenly promulgated by President Jacob Zuma this April, are unconstitutional and will create an administrative nightmare, ultimately undermining incentivised public/ private partnerships.

While eager to help government achieve its aim of redistributing health services to match where the biggest burdens of disease are, they are dead set against having to apply for a certificate before they can legally practise in a geographical location of their choice – or continue doing so.

The strategy and timing debate centres on whether to make a legal challenge to the provisions before the regulations, to be drawn up by 1 April 2016, are finalised (based on wide-ranging input from across the health professions), or afterwards. This 2016 date is also the deadline by which all healthcare providers must apply for a CoN. It may well be put back if flustered state lawyers, currently under instruction from a beleaguered national Department of Health (NDoH) to do so, can find the legal wherewithal.

Meanwhile healthcare bodies are atten­ ding a flurry of NDoH ‘stakeholder consul­ tation’ workshops aimed at penning regulations to mitigate the sweeping new legal provisions – while consulting lawyers to protect their rights. Failure to comply with the new law is punishable by a fine, 5 years’ imprisonment, or both. The three doctor bodies, the South African Medical Association (SAMA), the South African Dental Association (SADA), and the SA Private Practitioners Forum (SAPPF) (specialists), agree with the noble intentions of the law, but see it as a blunt and coercive instrument that will have grave unintended consequences.

President Jacob Zuma.

What the law says

All existing healthcare services and estab­ lishments – and those intending to practise or establish themselves before 1 April 2016 – must apply for a CoN by that date, with National Health Director-General, Malebona Precious Matsoso, empowered to grant or deny it. While Matsoso and Minister of Health Dr Aaron Motsoaledi have protested loudly and at length that the law will not be used ‘arbitrarily or punitively’ – Motsoaledi promising that healthcare professionals in existing practices will not be forced to move – the provisions are fairly explicit.

A CoN will be required for anyone: (i) establishing, constructing, modifying or acquiring a health establishment or agency; (ii) increasing the number of beds in, or acquiring prescribed health technology at, a health establishment or health agency; and (iii) providing ‘prescribed’ health services or continuing to operate a health establishment or health agency after the expiration of 24 months from the date on which the relevant addition to the Act took effect (1 April 2014). The Act requires the Director-General of Health to apply her/his mind to several requirements before issuing a certificate. These include consistency of health services, development in terms of planning, equitable distribution and rationalisation of services and resources (including existing public and private facilities

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in an area), and correcting racial, gender, economic and geographical imbalances, taking into account the demographic and epidemiological charac­ teristics of the population to be served, plus furthering the Employment Equity Act within emerging small, medium and micro-enterprises.

The contentious provisions were drafted in 2003 by Dr Kamy Chetty and the State Attorney’s Office during Chetty’s tenure as Deputy Director-General of Service Delivery in the NDoH. This was at a time when nongovernmental bodies and the government were virtually at war over HIV/AIDS, and the quality of law drafting by the State Attorney’s office was coming under question. The draft provisions were put on ice when a storm of protest erupted, with SAMA threatening to take the government to the Constitutional Court to counter the threat to the movement and trade of its 17 000 doctor members. It took nearly a month before dozens of private healthcare professional bodies, hospital associations and non-governmental organisations woke up to the recent ‘fait accompli’, many of them having to scamper to revive institutional memory before they could take a position.

Wide consultation – but will it make a difference?

At the time of writing (4 July), Matsoso had held talks with over two dozen top

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healthcare professional bodies, with several worried independent practitioners putting their practices on hold to travel to Pretoria to get the lowdown for themselves. Matsoso openly admits that many professional bodies

National Minister of Health, Dr Aaron Motsoaledi.

are arriving with lawyers in tow. Initial examination of the legal provisions by their detractors reveals that they not only severely limit the rights of healthcare providers, but arguably those of patients accessing care and medical information (if any existing practices have to close). They could render existing medical businesses worthless (although Matsoso says there is provision for ensuring ‘financial viability’) and, perhaps most insurmountable, create a mountain of red tape with a huge and expensive bureaucracy (more than 70 000 healthcare establishments have to be registered by 1 April 2016). Practical administrative issues such as selling a practice or taking on partners (with debate on grandfathering clauses and whether the CoN applies to individuals as well as practices), and the clashing of the CoN with at least six other existing laws, including the Competition Act, Consumer Protection Act, Promotion of Access to Information Act, Promotion of Equality and Prevention of Unfair Discrimination Act, Health Professions Act and Protection of Personal Information Act, look set to pose a legal nightmare. Matsoso has, by briefing state lawyers, admitted that the 1 April

2016 deadline is unrealistic. A consultative committee consisting of five members repres­ enting all healthcare professional bodies is being set up by her department to inform regulation writing, while all who attended the briefings have been given 30 days to make written submissions.

What the doctors say

Dr Mzukisi Grootboom, SAMA chair­ person, says that in spite of the well­ meaning intensive consultation, the primary legislation is a fait accompli. Of the primary law he says: ‘As South Africans we all know what needs to be done, but we’re not hearing each other. It’s like a dialogue of the deaf. We implement things that pit us against each other. It’s a reflection of the kind and quality of legal professional advice they’re getting.’

SAMA would do all it could to ameliorate the situation, provided Motsoaledi was genuine in ensuring co­operation and avoiding disruption of health services. Grootboom adds: ‘The very intention of improving access may deny it, as doctors suddenly find themselves without licences and unable to practise. Also, the clock is ticking to put all this into practice. We cannot understand why

Fig. 1. National district under-5 inpatient mortality rate and distribution of private doctor practices, 2013. (Source: National Department of Health.)

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Fig. 2. National district maternal mortality ratio and distribution of private doctor practices, 2013. (Source: National Department of Health.)

government would promulgate a section of the law which they know is unconstitutional.’

He refused to rule out Constitutional Court action at a later stage.

Dr Chris Archer, CEO of the SAPPF, the largest body of specialists in the country, says that the NDoH’s central problem is how to deal with the mismatch between the burden of disease distribution and the distribution of health services (as illustrated in Figs 1 and 2). ‘The private sector cannot be expected to supply services in areas of low or non­existent economic activity – and the CoN will not solve that problem.

Innovative public/private partnerships that do not depend on the development of fixed capital­intensive infrastructure offer a possible solution – without the need for a CoN.’ Archer said that even if the Director­General was magnanimous in her application of the law, ‘they still have the power’, asking, ‘what happens when the DG or the Minister of Health change?’. Such a system would also create fertile ground for bribery and corruption and act as a further driver to healthcare workers leaving an already skeletally staffed system. He asked who would invest in infrastructure in their

practices in a ‘Park Lane­type clinic’ if they were unable to ‘on­sell’ the practice upon retirement. No amount of ‘tinkering with regulations’ would succeed in resolving the most contentious issues. The late offer to consult was ‘too little, too late – we genuinely want to assist, but this authoritarian use of legislative power approach will only cause resentment and resistance’, he added.

Maretha Smit, CEO of SADA, said she was ‘constantly amazed at the decisions taken without an understanding of the risks attached and a comprehensive analysis of the downstream impact and potential of where things could go wrong’. She warned that this could result in a dramatic reduction in people wanting to enter the healthcare professions, with dire national implications given current critical staff shortages.

Alienating the professions would simply mean that government ‘won’t be able to reach their targets’. The over­riding focus for practitioners had become ‘how do I survive?’ instead of ‘how do I care?’. ‘If we take the “how do I survive” out of the equation, you’ll get a lot more people saying, “how do I care?”,’ she added. Like many other healthcare professional bodies, both SADA

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and the SPPF are contemplating testing the provisions in the Constitutional Court.

The DG dons the velvet glove

Matsoso, a former World Health Organi­ zation Director of Health Innovation and Intellectual property (Geneva, January 2005 ­ June 2010), stressed: ‘This is not a command and rule, enforcement approach. I want to fix this via consultation on the regulation, reading the primary provisions with others in the NHA, and interacting in a manner that is anything but punitive. We don’t want the kind of outcomes doctors fear. There’s nothing in there that says, “take people from towns and put them in townships” – unless you want to attach redistributive policies to that – but the Act doesn’t say so. Even if it’s implied, it can’t be done contrary to the supreme law of the land, the Constitution.’ She said all ongoing stakeholder consultations include graphic illustration of demographic and epidemiological profiles of different provinces and districts, overlaid with the distribution of professional groupings, from data collected over the years. Motsoaledi’s initial impromptu response to Izindaba

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was: ‘I don’t understand all the objections – I mean [Netcare] Park Lane Clinic [in Parktown, Johannesburg] has more gynaes than Limpopo and Mpumalanga provinces put together! It will be difficult to force them to move – but should we allow more gynaes to move into that small space called Park Lane? I don’t think so!’

Motsoso promised: ‘I’m going to translate the primary law through secondary regulation,’ adding that reading the CoN provisions in isolation from the rest of the NHA ‘leads to misinterpretation’. She said ‘some brilliant ideas’ had come from the biggest objectors, including establishing objective criteria for ‘grandfather clauses’ (to protect established practices) and using a weighting system for different disease conditions, with dentists offering to develop a ‘toolbox’ of packaged services, while GPs suggested she use some of their existing independent practitioner association guidelines. ‘It’s very exciting – if we do this right, we can come up with a do-able

model,’ she said. The NDoH would use the registration data from the Health Professions Council of South Africa and other statutory councils to facilitate the granting of CoNs. A major advantage of the CoN would be its use as a tool to ensure that norms and standards set by the Office for Healthcare Standards Compliance (OHSC) regarding public sector equipment and staff distribution were adhered to. The OHSC had completed setting norms and standards for all public sector primary healthcare facilities, but was still busy working out staff distribution norms for tertiary health facilities, with a ‘major rationalisation process’ due. (It has yet to begin on the private sector – yet another administrative hurdle.) Matsoso said the CoN would also help the NDoH remove a long-standing thorn in its side by giving Pretoria the power to direct how provinces allocate their health budgets instead of being beholden to maverick, often hugely ineffective, provincial political allocation.

Silver lining for the private sector?

One source said that the NDoH was consi­ dering reallocating part of the R9 billion annual health infrastructure budget (given the healthcare staffing crisis) and using it ‘more productively’ to fund public/private partnerships, thereby increasing access to healthcare. Responding to the lack of initial consultation, Matsoso replied: ‘I cannot think of a single government department that says to stakeholders, “before we even start, can we talk about what the issues are?”.’ She described portions of the NHA as ‘bizarre and badly written’, saying it required constant fine-tuning.

Chris Bateman chrisb@hmpg.co.za

S Afr Med J 2014;104(8):530-533.

DOI:10.7196/SAMJ.8653

Patient lost in the private healthcare mix – Broomberg The South African (SA) healthcare system is organ­ ised around the needs of just about every stakeholder except the patient, with a highly fragmented, ‘siloed’ approach where integrated care is the exception and not the rule, says Discovery Health CEO Jonny Broomberg.

Speaking at a healthcare summit held at Discovery’s headquarters in Sandton, Johannesburg, on 28 May, Broomberg said he was excited by the Competitions Commission inquiry into the private healthcare sector because it would bring to the fore much-needed information around real cost drivers. Using US-generated data (because their healthcare system is similar to SA’s), he said that serious empirical research has shown that wastage in their system ranged between 21% and 47%. He conservatively put SA’s wastage at 21%. ‘This doesn’t generate clinical value for patients.

We have the undesirable fee-for-service and separation of health professionals and hospitals. If you tally up over-treatment (5.9%), administrative complexity (4%), failures of care delivery (3.8%), pricing

the highly respected New England Journal of Medicine.

Volumes push medical inflation beyond the consumer price index (CPI)

Discovery Health CEO Dr Jonathan Broomberg.

Picture: Chris Bateman.

failures (3.2%), fraud and abuse (3.1%) and failures of care co-ordination (0.9%), you see that out of every rand we spend on healthcare, 21% is not adding value to patients.’ He said that the data came from

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Singling out SA’s scarce human skills as a major driver of medical inflation, Broom­ berg said that in the manufacturing sector, amazing new technologies usually brought down costs. However, in the healthcare sector, ‘no matter what you do, you somehow can’t bring the price down – you still have to have the surgeon to do the work’.

While the inflation debate had historically focused on prices that hospitals and doctors charged, Discovery’s data over the past 5 years showed that on average premium inflation had increased by 11.5% – with 7% related to prices and 4.5% linked to volume.

This meant that in reality, price increases actually tracked ‘incredibly close’ to the CPI – but with the average medical scheme member consuming 4.5% more doctor and hospital visits than the year before (Fig. 1).

Broomberg said that last year Discovery members made 6.6 million GP visits and 7.9

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million specialist visits (totalling R16 billion, or 48% of expenditure), and that there were 592 000 hospital admissions with 1.9 million days in hospital (costing R12.4 billion, or 37% of expenditure), while 486 000 lives were registered for chronic medication (costing R5.1 billion, or 15% of expenditure) (Fig. 2).

Families belonging to Discovery’s top medical aid plan (Classic Comprehensive) and spending more than R500 000 per annum totalled 15/10 000 in the year 2000.

By last year this had increased five-fold (to 79/10 000) – a ‘crisp illustration’ of volume pressures. Premiums meanwhile had increased by between one and a half times and double. The ‘tidal wave’ of noncommunicable diseases pushed up the disease burden over the past 5 years by 17%, but with two-thirds of Discovery’s members now on their Vitality health and fitness programme, ‘we think our numbers are going up more slowly’. Broomberg said chronic patients claimed four times as much as the average member. The disease burden and the unintended consequences of legislation aggravated inefficiencies and costs, and his company’s agenda was now based on the most innovative and progressive healthcare systems in the world. ‘It’s really about value equals quality over cost, putting the patient at the centre. Our [the SA] system is organised around the needs of just about every stakeholder other than the patient … doctors, hospitals, funders … we haven’t designed a system to say what fits the consumer.’

Create multidisciplinary teams to save lives and money

A move towards multidisciplinary teams looking after complicated cases would dramatically reduce costs and improve outcomes. He singled out Dr Carol Benn, who has established three thriving breast cancer clinics at the Chris Hani Baragwanath, Helen Joseph and Milpark hospitals, which draw on the best available expertise in every discipline associated with breast cancer. Daily conferences discuss cases, with input from every professional adding to the overall patient care. Besides fragmentation, the paucity of measurement in healthcare outcomes and cost (‘if you can’t measure it, you can’t manage it’) was a constant thorn in the side of value-based delivery. ‘We need to bring measurement into the way we reward and pay. Linked to that is a shift away from fee for service to what the literature globally calls “bundled payments” (e.g. capitation).

We need to move towards value and quality, not volume,’ he added.

Do the basics right – or lose lives

Using the analogy of standard preflight checks in the aviation industry, Broomberg said that medicine had a lot to learn from this sector. He showed slides of dramatic variations in the death rates for acute heart attacks at individual SA private hospitals (averaging about 7.4%, the global average).

However, in many emergency rooms the essential standard protocols of administering aspirin and beta-blockers the moment the patient arrived were often not followed, accounting for too many unnecessary deaths.

The same variation from hospital to hospital existed for patients on renal dialysis, with complications setting in and infected patients returning to hospital, where they often died. By introducing a standardised kidney care programme, Dis­ covery had seen a 5% improvement in dialysis scores

16% 14%

14.8% 3.9% 12.0%

12% 10%

4.1%

11.5% 10.1%

10.7% 9.6% 4.5%

8% 6%

across their patient population with an exponential increase in lives saved. The setup involved kidney specialists and dialysis centres submitting data to Discovery on the key elements of dialysis, with built-in feedback. Another lifesaving intervention was to cut down dramatically on central line infections. Patients in intensive care units often had a catheter in the chest rather than a drip in the arm. By ensuring that doctors scrubbed hands, put on masks and gowns and observed basic hygiene precautions (which he said took ‘years of work with hospital groups, and then doctors’), Discovery had brought down central line infections among their members (and obviously other patients) from 4/1 000 hospital days to just 1/1 000 hospital days. ‘Getting such an infection doubles hospital costs and has a 12 - 25% mortality rate,’ Broomberg added. Data on antibiotic

4.7%

5.1%

4.5%

5.0%

5.1%

2011

2012

Demand-side drivers: - Adverse selection - Increased disease burden - Ageing

10.9%

4%

7.9%

2%

6.0%

Supply-side drivers: - Fee-for-service system - Fragmentation of care - New technology and procedures - New hospitals

7.0% 0.3% above CPI

0% 2009

2010

2013

Average

Fig. 1. SA medical inflation is not all about tariffs – volume of services is a critical cost driver. (Source: Discovery Health.)

Hospitals 592 000 hospital admissions p.a.

1.9 million days in hospital p.a.

Professionals 6.6 million GP visits p.a.

7.9 million days specialist visits p.a.

R16 bn 48%

R12.4 bn 37%

R5.1 bn 15% Medicine 486 000 lives registered for chronic medication

Fig. 2. Breakdown of Discovery Health claims expenditure, 2013. (Source: Discovery Health.)

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use showed a five-fold variation between hospitals. Adjusted for severity of condition, the data revealed that 77% of inpatients were on antibiotics, with ‘huge overuse’ and wide geographical variations. ‘Healthcare policy and quality experts will always tell you that where you find variation in a healthcare system, you’ve got problems,’ he added.

His company was ‘just scraping the tip of the iceberg’, with interventions that turned quality measurements into better outcomes – and would later this year begin paying doctors more for improved results. ‘You can also ask really simple questions, like do you have a protocol for when a patient arrives with a heart attack?’, he added.

Cash-plan members in the cross-hairs

Broomberg’s presentation revealed that Discovery keeps an eagle eye on members who also have cash plans. This cohort of patients has hospital admission rates 2.5 5.5 times higher than those who don’t – with doctor syndicates being exposed. ‘Take a cash-strapped family that has a hospital cash plan that pays R5 000 per day after day 3 of admission. The temptation to get the doctor to keep you in for 4 or 5 days is huge – and Discovery ends up with a R50 000 hospital bill!’ Most medical schemes were not being sufficiently proactive, with ‘big scams’ involving the active collaboration of crooked doctors constantly on the go. The

biggest culprit geographically was KwaZuluNatal. Asked to specify conditions diagnosed to ‘justify’ medically unsound hospital stays, Broomberg cited haematemesis (vomi­ ting blood, usually involving the upper gastrointestinal tract) as a top culprit. He said that in general, fraud cases had only been proven against a relatively small number of doctors. Where clear identification was possible, Discovery terminated the patient’s membership, reported the doctor to the Health Professions Council of South Africa and cancelled any contract they had with the doctor before recovering the money. ‘What we’re trying to do is shut it off at source. If you have a known cash plan we check up more carefully. I think we’ve created a halo effect with some people moving to other medical schemes.’ Discovery had clawed back R288 million in fraud last year (representing about 1% of contributions). Broomberg estimates the total national healthcare fraud bill at about R8.22 billion. ‘The more bodies we throw at it, the more we get back. Last year we got 14% more back than the previous year – and we haven’t yet reached the bottom of the pond.’ Other scams included pharmacies selling ‘nappies and cosmetics’ and submitting them as medical claims, and card-sharing.

The ‘halo effect’ extended to GPs bust for fraud. ‘You get behaviour change in addition to getting your money back on the day.’ He appealed for other medical schemes to work with his company: ‘We all have to squeeze

BOOK REVIEW Postmortem: The Doctor Who Walked Away

By Maria Phalime. Cape Town: Tafelberg, 2014. ISBN 9780624057604

‘... I had little time to listen to my patients ... was forced to strip away the colour in the stories of patients’ lives in order to get to the black and white of science and fact.’

Postmortem blows the whistle on the sometimes inhumane conditions in facilities meant to provide relief and care. Immense suffering results from mismanagement of sys­ tems and resources. The situation is worsen­ ing as doctors, afraid for their own mental and physical health, walk away from medicine.

Maria grew up in Soweto, dreaming of becoming a doctor. On qualifying, she was horrified to discover poorly resourced faci­ lities, ill patients discharged prematurely for

the next intake, and doctors making critical decisions when they were too exhausted to think straight. No time to reflect or debrief; no time even to show compassion.

Maria didn’t like the person she was becom­ ing. After four years, she gave up medicine.

For ten years, she struggled with selfrecrimination. Postmortem explores the com­ plex issues involved. Are admission criteria for medical school predictive of good doctors?

Could she have been better equipped to deal with the realities? Is it a good or bad thing that newly qualified doctors in understaffed situations have to perform procedures they are not trained for? Is medicine the only way to make an impact on improving people’s quality of life? When should doctors increase their resilience, when should they protest, and when should they walk away? Was walking away a personal failure?

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down, or it’s just a water bed – you squeeze down here and it pops up in another scheme.’

Discovery did not deny that cash plans had a role, ‘but you don’t want them abused and driving up health costs’.

‘Naming and shaming’ hospitals counterproductive

Broomberg said that sustained diplomacy was required to get hospitals, doctors and pathology laboratories to work with medical aids in providing data, ‘otherwise you can push them underground and voluntary reporting becomes impossible’. Asked if he was prepared to release a list of ‘which hospitals to avoid’, Broomberg said his company tried this 5 years ago, to howls of protest over contested data and a quick exit from the public domain.

Some of these clinical coding data were ‘a bit inaccurate’, he confessed, adding that the problem was being speedily rectified to increase the data robustness. This included discerning where weaknesses were attributable to the hospital or the doctors – or both. ‘It’s one thing to go to them privately and give feedback, it’s quite another if you go public – if you’re wrong there can be a lot of damage.’

Chris Bateman chrisb@hmpg.co.za S Afr Med J 2014;104(8):533-535.

DOI:10.7196/SAMJ.8625

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Maria interviewed a psychiatrist and doctors who left medicine about the stresses that medical practitioners face in the field. She discovered that her difficulties were not unique. ‘... [C] oping and resilience is deeply entrenched ... It starts early on in our training – the hours, the workload, the exposure to gruesome pathology and trauma. Dr

Harrison referred to them as “rituals of induction and brutalisation” ... Shutting down and pushing through is often the most expedient way to cope.’

There are pockets in the state health sector where dedicated health carers achieve much with very little. Yet the system is also run through with faults. I hope this book falls into the hands and hearts of the policy

makers and doctors in healthcare forums.

We must object where patients are too sick and too poor to object when the system fails them.

practice at GSH and was appointed head of one of the gynaecology firms, head of the Maternity Centre and head of Undergraduate Education. He was promoted to Associate Professor in 1985 and to Deputy Head of Department in 1987.

Boet was appointed to the Chair of Obst­ etrics and Gynaecology at UCT following the retirement of Emeritus Professor Dennis Davey. He came to this position after some years as a consultant in the Department, during which time he was in charge of the obstetric services as head of the Maternity Centre. Those of us who worked with him each have our own memories of him, but few will dispute that he showed himself to be an intensely practical man, systematic and conscientious, well schooled in his discipline following years of private practice. These attributes alone ensured that he was widely respected by his fellow consultants in both the private and public sectors. As leader of the academic unit, he succeeded in allowing others to grow in skill and expertise without ever seeking to dominate from his position of authority. He was renowned as an outstanding teacher at both under­ and postgraduate level and was a superb role model of professional, competent and compassionate patient care.

Boet was in the Chair when South Africa emerged from the era of apartheid, a time when those in leadership positions were required to take some measure of the spirit of the era, to celebrate the prevailing Zeitgeist.

Boet Dommisse did not fail in this respect, institutionalising this famous moment in our collective history by putting up the new national flag in the departmental seminar room and writing beneath it in his own handwriting a sentiment expressing his commitment in terms of peace, justice and opportunity for all in the country.

Boet always had time for other people and was good at listening. He was also adept at identifying academic talent in his

area of expertise, and nurturing those who subsequently went on to become inter­ national figures in obstetrics. In essence, Boet was a man of the community, for the community. He engaged with the society around him, he nurtured those who grew in his shadow, and he celebrated that which we now hold dear.

In his retirement years, he continued to do just that: he immersed himself in the history of the Simon’s Town village to which he moved and, until the very end, researched, wrote about and spoke about the comm­ unity of which he was a part. He was also a very accomplished photographer. He wrote a number of books, one on his experience of being a GP in a small Karoo town (under a pseudonym), and three coffee­table books on the history of Simon’s Town. In doing so, he left footprints in the hearts and minds of those who remain behind. We will cherish the memory of this quietly enigmatic man, who offered so much and seemed to ask for so little.

Boet also played an influential and important role in national medical organ­ isations. He was active in the South African Medical Association and held several posi­ tions in the South African Society of Obstet­ ricians and Gynaecologists, of which he eventually became President. He was also elected to be the South African representative at FIGO (the International Federation of Gynecology and Obstetrics).

The Department and all who knew Boet will remember him with deep respect and love. He is survived by his wife Anne, his daughters Janette and Susan and son Jannie, and their families.

Dawn Garisch Author of Eloquent Body (Modjaji, 2012), Cape Town, South Africa dawn.garisch@gmail.com

OBITUARY Boet Dommisse

It is with great sadness that the Depart­ ment of Obstetrics and Gynaecology at the University of Cape Town announces the death on 12 July 2014 of Emeritus Professor Boet Dommisse, who headed the Department from 1991 until he retired in 1996. Boet was born in Cape Town and obtained his MB ChB from UCT in 1953, the same year he married his wife Anne.

They subsequently had two daughters and a son. Boet did his internship at Groote Schuur Hospital and then took a senior house officer job at the Peninsula Maternity Hospital in District Six. From 1955 to 1960 he practised as a GP in Williston and was renowned for his dedication, skill and compassion, making house calls and travelling through treacherous terrain. In 1960 he became a registrar in obstetrics and gynaecology at GSH, and in 1964 became a full­time consultant under Professor James Louw. He entered part­time private practice with Dr Cecil Craig in 1965, but remained intimately involved in teaching both under­ and postgraduate students at UCT/GSH. In March 1979 he returned to full­time

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Lynette Denny Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of Cape Town, South Africa lynette.denny@uct.ac.za

FORUM

POSITION STATEMENT

South African Menopause Society revised consensus position statement on menopausal hormone therapy, 2014 F Guidozzi, A Alperstein, J S Bagratee, P Dalmeyer, M Davey, T J de Villiers, S Hirschowitz, T Kopenhager, S P Moodley, P Roos, A Shaw, O Shimange, T Smith, C Thomas, J Titus, Z van der Spuy, J van Waart, on behalf of the Council of the South African Menopause Society F Guidozzi (President, South African Menopause Society (SAMS)), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; A Alperstein, private practice, Kingsbury House, Claremont, Cape Town, South Africa; J S Bagratee, Department of Obstetrics and Gynaecology, Nelson Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa; P Dalmeyer, part-time lecturer, University of Cape Town, and obstetrician/gynaecologist/reproductive specialist, Cape Town; M Davey, private obstetrician/gynaecologist, Westville Clinic, KwaZulu-Natal, South Africa; T J de Villiers, private practice, Cape Town; S Hirschowitz, private practice, Park Lane, Johannesburg, South Africa; T Kopenhager, private practice, Park Lane, Johannesburg; S P Moodley (Executive Committee Member, SAMS), Ethekweni, Umhlanga and Victoria hospitals, KwaZulu-Natal; P Roos, private practice, Vincent Pallotti Hospital, Cape Town; A Shaw, private practice, Knysna Life Hospital, Eastern Cape, South Africa; O Shimange, private practice, Mediclinic, Medforum Hospital, Pretoria, South Africa; T Smith, Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg; C Thomas (Secretary, SAMS), Life Kingsbury Hospital, Cape Town; J Titus, Department of Obstetrics and Gynaecology, Nelson Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban; Z van der Spuy, Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of Cape Town; J van Waart, private practice, Wijnland Fertility Unit, Stellenbosch, Western Cape, South Africa Corresponding author: F Guidozzi (franco.guidozzi@wits.ac.za)

The South African Menopause Society (SAMS) consensus position statement on menopausal hormone therapy (HT) 2014 is a revision of the SAMS Council consensus statement on menopausal HT published in the SAMJ in May 2007. Information presented in the previous statement has been re-evaluated and new evidence has been incorporated. While the recommendations pertaining to HT remain similar to those in the previous statement, the 2014 revision includes a wider range of clinical benefits for HT, the inclusion of non-hormonal alternatives such as selective serotonin reuptake inhibitors and serotonin noradrenaline reuptake inhibitors for the management of vasomotor symptoms, and an appraisal of bioidentical hormones and complementary medicines used for treatment of menopausal symptoms. New preparations that are likely to be more commonly used in the future are also mentioned. The revised statement emphasises that commencing HT during the ‘therapeutic window of opportunity’ maximises the benefit-to-risk profile of therapy in symptomatic menopausal women.

S Afr Med J 2014;104(8):537-543. DOI:10.7196/SAMJ.8423

1. Introduction

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• • • •

Clinicians are expected to practise in accordance with the findings of evidence-based medicine. This implies that the clinician is familiar with the strongest evidence available. It may be difficult for the following reasons: The results of a given clinical trial can often only be applied to the specific population group and circumstances applicable to that specific trial. This is especially important in hormone therapy (HT), where initiation of therapy during the ‘therapeutic window of opportunity’ (between 50 and 60 years of age or within 10 years of onset of menopause) results in a much better benefit-to-risk profile than initiation in older patients.

A small group of individuals may react to medication in a unique way, so studies must be adequately powered.

Statistical significance does not always equate to clinical significance.

Different methods of defining statistical significance may yield different answers when applied to the same data.

Publications often only quote relative risks and ignore the clinically more relevant absolute risks.

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• The patient’s perception is always important. For example, the weak association between postmenopausal HT and breast cancer may be of greater concern to women and the lay press than the stronger association between HT and thromboembolic disease.

• The side-effects of preventive medicine in healthy individuals have different implications to those resulting from the treatment of individuals with disease.

• For many years, the options for use of HT were based mainly on data from observational trials. Although these have generally been superseded by data from large randomised controlled clinical trials (RCTs), when considering HT the large body of observational data derived from women with a similar profile to that seen in everyday practice cannot be completely disregarded in favour of RCT data derived from older asymptomatic women.

• Because there are still major gaps in our knowledge, clinical guidelines are unable to cater for all situations.

• The final decision regarding therapy must be a joint decision between the healthcare provider and an informed patient, based on her current clinical status and ongoing new scientific evidence.

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• The general public is always looking for alternative medical treatment strategies to manage menopausal symptoms. The vast majority are ineffectual and some may be dangerous.

(REM) sleep by decreasing night sweats and improving mood. Further studies are needed to substantiate this and to determine whether type, dose and mode of administration impact on the quality of sleep.[8]

2. Abbreviations used in this statement

3.5 HT and vulvovaginal atrophy (VVA)

ET = oestrogen therapy alone; EPT = oestrogen and progestogen therapy in combination; HT = hormone therapy, which refers to either ET or EPT.

3. Position statement regarding menopausal HT 3.1 HT and quality of life

HT significantly improves menopause-specific quality of life (QoL), mainly through relief of symptoms, and especially vasomotor symptoms (VMSs). It may also result in a global improvement in sense of wellbeing. Health-related benefits depend on the severity of associated menopausal symptoms. Health-related and menopauserelated QoL improves more obviously in women who had significant menopausal symptoms before receiving HT, with considerably less improvement occurring in women without significant symptoms.[1]

3.2 HT and weight gain

Although weight gain associated with HT is a major concern for most women initiating HT, there is very little evidence to support this fear. There is invariably a redistribution of fat mass at the time of menopause, which may become apparent during the menopausal transition with an increase in waist-to-hip ratio. Evidence shows that neither ET nor EPT is responsible for an increase in weight. The route of hormone administration does not appear to have an impact on weight gain.[2]

3.3 HT and VMSs

HT remains the only treatment that consistently has a greater effect than placebo on alleviation of menopause-related VMSs. VMSs generally last 2 - 5 years, but in some individuals may last much longer. Patients reporting VMS for the rest of their lives are not rare. ET is effective in relieving VMS even in low dosages, and this therapeutic effect is enhanced by the addition of a progestogen.

Lifestyle-related strategies may also be of benefit.

VMSs may recur to a varying degree with cessation of HT.[3] In clinical practice, the individual patient is the best judge of the effect of HT on her QoL, particularly if she is symptomatic. Routine monitoring of hormone levels is not advocated unless oestradiol implants are being used.[4-6] In women for whom HT is contraindicated, those who decline treatment, or those who cannot tolerate HT, alternatives include selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs). Although it is not commonly used, gabapentin has also been shown to decrease the occurrence of hot flushes.[7]

3.4 HT and sleep

Sleep disorders are common in the menopause and may be associated with VMSs, depression, anxiety, insomnia, obstructive sleep apnoea, fibromyalgia, restless leg syndrome, comorbid disorders or medi­ cations, or may simply be related to age. HT appears to improve sleep quality and quantity in menopausal women, although this has not been conclusively confirmed in available studies, especially where polysomnography has been used as an assessment tool. HT appears to decrease episodes of awakenings and increase rapid eye movement

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Systemic HT is very effective in reversing VVA. In women who have symptoms related to VVA alone, topical local ET only is appropriate.

In about 15% of women using systemic HT, additional topical vaginal therapy is needed to achieve reversal of the atrophic symptoms.

Vaginal creams, vaginal rings or vaginal tablets are effective options.

Local oestrogen preparations, when used correctly as sole therapy, do not result in sufficient systemic absorption to warrant the use of progestogen for endometrial protection. At present there is not enough evidence to mandate progestogen use in women who persist with any local intravaginal oestrogen preparation beyond 6 months.

Vaginal lubricants or moisturisers, with or without local oestrogen preparations, are also effective options.

When HT is indicated for urological symptoms, local therapy is preferred to systemic therapy.

Local ET improves symptoms of detrusor instability, including urgency, urge incontinence, frequency and nocturia, and reduces the incidence of recurrent urinary tract infections. Sexual function is also improved through the reversal of vaginal skin atrophy with increased vaginal lubrication.[9]

3.6 HT and menopause-associated bone loss

The increased rate of bone resorption following the onset of menopause clearly indicates a hormonal influence on bone density in women. Both transdermal and oral HT are effective in preventing bone loss. Supplementing with calcium and vitamin D is advisable if these are deficient.

HT is effective in decreasing the incidence of all osteoporosisrelated fractures. This is true for both patients at low risk of fracture and patients at high risk of fracture before the age of 60 years or within 10 years of the onset of menopause. HT decreases vertebral and non-vertebral fractures by approximately 50%.[3] In some patients, a degree of fracture prevention persists after cessation of HT. Patients remaining at risk of fracture should receive ongoing therapy with proven bone-sparing medication once HT has been stopped. As some women lose bone rapidly after cessation of HT, close follow-up is needed for women not receiving ongoing treatment.[10]

3.7 HT and coronary heart disease (CHD)

Cardiovascular disease is the major cause of death in older women.

Observational data have indicated that HT may reduce CHD by approximately 50%. This prompted several RCTs. The following conclusions are based on an assessment of the total body of evidence: 3.7.1 HT does not offer secondary protection against CHD. This recommendation is based mainly on the data from the Heart and Estrogen/progestin Replacement Study (HERS), but also from data from the older women subset in the Women’s Health Initiative (WHI) study.

3.7.2 Standard-dose ET may offer primary protection against CHD and lower all-cause mortality in women where therapy was initiated during the ‘therapeutic window of opportunity’. This recommendation is based on data from RCTs, observational studies and meta-analyses.

The evidence that EPT in standard dosages offers primary protection against CHD when initiated in the window of opportunity is not

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as consistent as the data for ET, although the effect on lowering mortality is the same.[3] 3.7.3 In the WHI study, an increase in non-fatal CHD was found in the first year of HT, but final analyses proved this to be statistically non-significant. It was not evident in the younger patients. It is therefore concluded that in women initiating therapy outside the ‘therapeutic window of opportunity’ who are likely to have established coronary artery atherosclerosis, HT is unlikely to offer significant protection and may cause a transient initial increase in adverse events.[11-16]

3.8 HT, insulin resistance and diabetes

Data suggest that combined HT reduces the incidence of diabetes in postmenopausal women, possibly mediated by a decrease in insulin resistance unrelated to body size. HT appears to reduce fasting glucose and fasting insulin levels, but should not be given with the primary intention of preventing diabetes in postmenopausal women.[17]

3.9 HT and stroke

The HERS and Women’s Estrogen for Stroke (WEST) trials, which were both secondary prevention studies, demonstrated a null effect on the combined outcome of non-fatal stroke, fatal stroke or allcause mortality relative to placebo in postmenopausal women with established cardiovascular disease. In the WHI study, a nonsignificant increase in the risk of ischaemic stroke was seen in all age groups. The magnitude of this risk was small, however, particularly in patients younger than 55 years of age, where the absolute increase in risk was 1.5 extra ischaemic strokes per 10 000 HT users per year.

This complication is therefore extremely rare.

A meta-analysis of observational studies has shown a nonsignificant increase in the risk of overall stroke and thrombotic stroke (by approximately 10% and 20%, respectively). The increased risk of stroke associated with HT persists throughout treatment, but decreases after discontinuation.

Observational data suggest that lower doses of oral therapy than that used in the WHI will result in even less risk, and that normal and low-dose transdermal therapy (≤50 µg) are uncommonly associated with an increase in the risk of ischaemic stroke.

There is no role for HT in the primary or secondary prevention of stroke.[18-23]

3.10 Route of administration

Transdermal administration of HT is associated with a lower risk of adverse events, and particularly cardiovascular adverse events, than oral administration. Transdermal HT does not appear to increase the risk of thromboembolic disease significantly. It is therefore prudent to consider the transdermal route in women at high risk for cardiovascular events, namely obese women, smokers and hypertensive women, and especially if there is any history of thrombosis.(3)

3.11 HT and venous thromboembolism (VTE)

The relative risk of VTE increases with the use of HT. In the WHI study the absolute risk of VTE was increased by 18 additional cases per 10 000 women per year with EPT, and 7 cases per 10 000 women per year with ET.[24] The effect is maximal in the first year of treatment and decreases over time. Risk factors include obesity, previous VTE, underlying thrombophilia and initiation of HT after age 60 years. The risk of VTE in the age group 50 - 60 years is very small, but increases four-fold in the 60 - 69-year-old and seven-fold in the 70 - 79-yearold age groups.[25] The route of delivery will impact on risk, with the

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highest risk being associated with oral EPT, followed by oral ET, and the lowest risk being associated with transdermal HT.[26,27]

3.12 HT and breast cancer

The risk of breast cancer associated with HT in menopausal women is a complex issue.

Data suggest that HT may not be causal, but rather a promoter of pre-existing breast cancer. The absolute risk of breast cancer attributable to HT is low and falls into the same risk category as several preventable risk factors that are associated with a similar low relative risk for developing breast cancer. Examples of these are obesity, nulliparity and never having breastfed, having a first pregnancy after the age of 37 years and excessive alcohol intake. The increased risk of breast cancer is primarily associated with the addition of a progestogen to oestrogen therapy. In the WHI study, standard-dose ET was consistently associated with a lower risk of breast cancer than placebo, and at 12 years of follow-up this difference was statistically significant. Standard-dose EPT was associated with an increased risk of breast cancer compared with placebo. It is, however, important to note that on final adjudication and appropriate adjustment, this increase was not statistically significant. Furthermore, the increased risk was confined to women with prior exposure to EPT. The increased risk of breast cancer seems to be related to the duration of hormone use. Observational studies show no increased risk for 15 - 20 years of ET use. Combined conjugated equine estrogen and medroxyprogesterone acetate (CEE/MPA) in the WHI study did not increase breast cancer risk over 7 years in new users.

However, observational studies point to a small increased risk in long-term users of CEE/MPA. This effect was not seen when natural progesterone was used.[28-29] The HT-related increase in breast cancer risk decreases after HT is stopped and disappears by about 5 years.

Breast cancer risk on HT is increased in lean women.[30-33]

3.13 HT and breast density

Higher degrees of mammographic breast density in women not taking HT reflect higher levels of endogenous oestrogen secretion in breast tissue and correlate with increased breast cancer risk.[33] Breast density may be increased by use of ET, but this is more likely to occur with the use of EPT. This increased breast density may impede the diagnostic interpretation of mammograms. In such cases, cessation of EPT for 2 - 4 weeks and repeat breast image screening may be helpful.[34] If available, it would be prudent for women to undergo digital mammography and ultrasound. Thermal screening should be avoided as a diagnostic tool.

Before initiating any HT, it is recommended that the breasts are examined carefully and that mammographic imaging is undertaken and followed conventionally thereafter.

3.14 HT and risk of other cancers

3.14.1 Colorectal cancer There is continuing evidence that oral HT results in an approximately 40% reduction in the incidence of colorectal cancer, and that this benefit is more pronounced in the EPT group.

However, HT is not indicated for primary prevention of colorectal cancer.[35,36] 3.14.2 Endometrial cancer Oestrogen-only therapy should not be prescribed for women with an intact uterus, who should always receive a progestogen

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simultaneously. The primary indication for progestogen use in women on HT is endometrial protection. Combined EPT should not be prescribed for women who have had a hysterectomy, unless they have a history of extensive endometriosis.

Long-term use of continuous combined EPT offers superior protection of the endometrium compared with sequential regimens and hence reduces the risk of endometrial cancer significantly more than sequential HT. The maximum duration of sequential HT should not exceed 5 years, after which continuous combined EPT should be prescribed. Long-term cycle regimens with 3-monthly withdrawal bleeds are not recommended.[37,38] The levonorgestrel intrauterine system plus ET is comparable to other progestogen regimens.

3.14.3 Ovarian cancer There are as many studies showing an increased risk of epithelial cancer as there are studies showing a null effect or a negative effect in HT users compared with non-users. The risk is so small that it is unlikely to influence prescribing habits.[39,40] 3.14.4 Lung cancer Although combined HT does not significantly increase the inci­dence of lung cancer, it does increase death from lung cancer, and the risk continues after cessation of therapy. This should be of concern to users of HT who are smokers or have other risk factors for lung cancer.[41]

3.15 HT in breast and gynaecological cancer survivors

3.15.1 Breast cancer survivors At present, it is prudent not to offer HT routinely to breast cancer survivors for management of menopausal symptoms, even though the data are somewhat controversial. Three randomised trials have addressed this issue, two of which showed an increase in cancer recurrences, while the other did not. None of the three studies showed an increase in death from the disease.[42-44] Data derived from observational studies, including two large metaanalyses, do not show an increase in recurrences or death rate in breast cancer survivors using HT. HT should be prescribed only when patients are fully informed of the current available data and wish to use this therapeutic modality.

There is no evidence to suggest that transvaginal topical oestrogen increases recurrence, so it may be prescribed to patients with intractable symptoms associated with urogenital atrophy.[45] 3.15.2 Gynaecological cancer survivors HT for the management of VMS is not contraindicated in survivors of vulval, vaginal or cervical cancer.

However, in survivors of endometrial or ovarian cancer, even though the data are controversial with many studies finding no detri­ mental effect of HT, it is prudent not to administer HT routinely.[46]

3.16 Alzheimer’s disease (AD) and cognition

There is observational evidence that HT initiated during the ‘therapeutic window of opportunity’ may be protective against AD in later life. However, HT used after the age of 65 years carries an increased risk of all-cause dementia, which is more prevalent with EPT than with ET. HT is not indicated for the prevention or treatment of AD. Short-term memory dysfunction is common in the menopausal transition and is usually self-limiting. HT appears to benefit this dysfunction.[47,48]

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3.17 Primary ovarian insufficiency (POI) (premature menopause)

POI refers to ovarian failure with at least 4 months of amenorrhoea and follicle-stimulating hormone levels in the menopausal range on two occasions within a 4 - 6-week interval, in women younger than 40 years of age. The principles of treatment that apply to women undergoing a natural menopause at ~51 years are not applicable to young women with POI. Data from studies of women with POI show decreased survival, increased cardiovascular risk, increased risk of fracture, sexual dys­ function and possibly increased cognitive dementia and Parkinson’s disease. HT will decrease these risks, alleviate symptoms and preserve bone density, especially after bilateral oophorectomy.[49-51] It is recommended that HT or oral contraception be used at least until the natural age of menopause. For younger women, higher doses are often needed to control symptoms.[52]

3.18 Androgen therapy

Hypoactive sexual desire disorder (HSDD) is the commonest sexual dysfunction in the climacteric. Testosterone levels in women decline as a result of ageing, but not to the extent of the precipitous decline demonstrated by oestrogen in menopause. The reduced levels of testosterone in postmenopausal women are associated with loss of libido, decreased sexual activity, diminished feelings of wellbeing and fatigue. Testosterone is an effective treatment for HSDD in women receiving concomitant ET. Testosterone on its own is not advocated.

Other conditions in which androgen levels are low and in which HSDD is likely to occur include POI, surgical menopause, adrenal insufficiency and hypopituitarism. These women are also candidates for testosterone therapy.[53-55] There are currently no female testosterone therapies registered or available in South Africa (SA). Tibolone, which has weak androgenic, oestrogenic and progestogenic activity and does not increase sex hormone binding globulin, can be used as an alternative to testosterone.[56]

3.19 Targets beyond the obvious

Evidence is accumulating to support the beneficial effects of HT on the skin and, to a certain extent, on the oral cavity.[57,58]

3.20 New combinations and HT preparations

The new third-generation selective oestrogen receptor modulators and oestrogen combination preparations have a favourable impact on breast tissue and will be used more frequently to treat menopausal symptoms and osteoporosis.

• Bazedoxifene with conjugated oestrogens is such a preparation.

• Ospemifene, a new oral oestrogen receptor modulator, has been shown to be effective in reversing the symptoms associated with vulvovaginal atrophy, dyspareunia in particular.

3.21 Bioidentical HT (BHT) for menopausal symptoms

BHT is the use of hormones identical to those secreted in the ovary or adrenal gland, namely oestradiol, oestrone, oestriol, dehydro­ epiandrosterone (DHEA) and testosterone.[59] These are frequently compounded for specific patients in compounding pharmacies.

The Federal Drug Administration reported a study of compounded pharmaceutical products that found significant aberrations with regard to quality and potency of these products.[60] In SA, conventional HT products require mandatory regulation and registration by the Medicines Control Council. This involves regular testing for purity, potency, efficacy and safety. Bioidentical hormone and compounding

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products require no such regulation. There is no evidence to support claims of greater efficacy or safety for BHT compared with conventional HT. The addition of oestriol to oestradiol with or without oestrone does not significantly alter the oestrogenic content of the oestrogen compound and certainly does not reduce the risk of breast cancer as is claimed. The absorption of bioidentical progesterone cream is variable, unpredictable and unreliable, and its use for opposing the effects of oestrogen on the endometrium is therefore not recommended.[61,62] There are no long-term safety studies for BHT, and no procedures exist for reporting adverse events. The use of BHT is not recommended.

3.22 Complementary and alternative medicines (CAMs) and menopausal symptoms

• CAMs are remedies not recognised in conventional medicine.

They have become popular because of the mistaken belief that ‘natural’ medicines have no adverse effect. The term ‘natural’ gives a subliminal message of safety. There is no such thing as natural medicine. All medicinal products are manufactured in factories.

• Phyto-oestrogens are mainly sourced from soy and red clover, which express their pharmacological action through isoflavones.

Most studies have shown a null effect or at most a minimal effect on VMSs in comparison with placebo.[63] • Isoflavones appear to have no serious side-effects, although if high doses are used for long periods of time, they may stimulate the endometrium and breast.

• Black cohosh has no phyto-oestrogenic activity and is thought to have serotonin agonist properties. It appears to have poor efficacy for menopausal symptoms.[64] • Black cohosh has been shown to be hepatotoxic.

• Both isoflavones and black cohosh should be avoided in women being treated for breast cancer.[65] Genistein (an isoflavone) may negate the inhibitory effect of tamoxifen on breast tumour growth.[66]

4. Clinical guidelines

• The menopausal transition should be utilised as a window of opportunity to assess and manage specific as well as general health-related matters. A medical history should be taken and general breast and gynaecological examinations, including cervical cytology, should be done.

• Special investigations should include a fasting lipogram, blood glucose measurement, mammography, thyroid function testing and, for patients considered to be at risk of osteoporosis, measurement of bone density by dual-energy X-ray absorptiometry. Investigations for hypercoagulable states before instituting HT are only required in patients at risk (personal or family history of VTE).

• Lifestyle modifications such as cessation of smoking, adjustment of diet, maintenance of an appropriate body mass index, exercise and stress control should be discussed.

• Treatment of dyslipidaemias, hypertension, diabetes and other medical conditions must be optimised.

• HT should only be initiated for specific proven indications, provided there are no contraindications, and should be individualised according to each patient’s needs. Women need to be fully informed of all risks and benefits regarding HT.

4.1 Indications for HT

• Treatment of VMSs and associated sleep disorders • Symptomatic urogenital atrophy • Prevention of bone loss in women with premature menopause or secondary amenorrhoea, and in women with osteopenia who are at risk of fracture.

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• Treatment of osteoporosis in women in the age group 50 - 60 years and at risk of fracture, with or without VMSs.

4.2 Contraindications

HT should generally not be prescribed in the following circumstances: • Current, past or suspected breast cancer • Known or suspected oestrogen-dependent malignant tumours • Undiagnosed genital bleeding • Untreated endometrial hyperplasia • Previous idiopathic or current VTE • Known arterial CHD • Active liver disease • Porphyria cutanea tarda • Thrombophilia.

4.3 General guidelines

• The duration of HT should be based on the indication for treatment.

• The indication for therapy should be reviewed on an annual basis. The decision whether to continue treatment for the relief of climacteric symptoms may be made by temporarily discontinuing treatment. If symptoms do not recur, HT does not have to be resumed. Topical therapy for relief of urogenital atrophy symptoms may need to be continued long-term.

• Only long-term therapy is effective for the prevention or treatment of osteoporosis. Long-term HT may be considered for bone effects, weighing benefit and risks against those of alternative therapies.

At present there is no compelling evidence to restrict duration of treatment as long as treatment goals are maintained.

• HT should ideally be commenced during the ‘therapeutic window of opportunity’, especially if therapy is to maximise the beneficial impact on the cardiovascular system and the brain.

• Systemic HT should not be initiated in women older than 60 years of age.

• All oestrogens and progestogen formulations, including tibolone, should be considered similar in terms of clinical risks and benefits.

• These statements are applicable to all routes of administration, including transdermal application. The non-oral route avoids the first-pass effect in the liver and is preferable in women with hypertriglyceridaemia, liver disease, migraine, glucose intolerance and an increased risk of VTE, and in those who are smokers.

• Should EPT be required for longer than 5 years, it is recommended to convert from sequential HT to continuous combined HT. • Low-dose therapy has been shown to be effective in symptom control and for prevention of bone loss; the principle of the lowest effective dose should therefore be adhered to.

• Low-dose and ultra-low-dose oestrogen preparations have fewer adverse effects than standard-dose therapy.

• Women with a history of stroke or transient ischaemic attack should be discouraged from initiating HT. • Prior to commencing HT, all patients should be advised to undergo breast screening, including digital mammography (where available) and ultrasound examination. Ideally all menopausal women should have regular mammography.

• Abnormal bleeding is quite common in the first 6 months of using continuous combined HT, especially if the patient is less than 1 year post menopause. If abnormal bleeding or spotting persists for more than 6 months after initiating the HT, endometrial surveillance in the form of an endometrial sampler, determining endometrial thickness by saline hysterography, direct hysteroscopic assessment and biopsy, or a formal diagnostic dilatation and curettage should be considered.

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• The use of bioidentical HT is not recommended. Studies on phyto-oestrogens and botanicals have shown inconsistent results.

Most good studies show no clear benefit and some potential for harm. Further research is required in order to make firm recommendations.

• No published data exist on the use of traditional African medicines for menopausal symptoms.

• No therapy for menopausal symptoms should be initiated without proper clinical assessment, including breast and pelvic examination.

• If HT is contraindicated or not tolerated, effective alternatives for VMSs include SSRIs, SNRIs and gabapentin.

• Provided there are no contraindications, HT can be administered for more than 5 years. Once the decision has been taken to discontinue HT, the dose can be tapered over time before it is stopped totally.

• These statements are applicable to all routes of administration.

5. Conclusion

In order to assist the patient in making informed decisions about her menopausal management, every practitioner needs to be aware of the latest evidence regarding HT. It is anticipated that HT in conjunction with lifestyle modifications will remain the treatment of choice for acute menopausal symptoms for the immediate future. It is to be hoped that ongoing research will be able to identify a patient profile or method of application where longer use of HT is without risk. This will unlock the true potential of HT in the prevention and treatment of osteoporosis and allow new understanding of its role in the primary prevention of cardiovascular disease. Oestrogen receptors are ubiquitous in women. Consequently, even though HT impacts most positively on the management of acute menopausal symptoms, if used from the ‘window of opportunity’ its global benefits extend to a wide number of other organs, especially the cardiovascular system, skeletal system and brain. Provided the patient has no untoward complications and continues to be monitored appropriately, we believe that HT can be prescribed for long-term use, and need not be routinely stopped within 5 years or by age 65 years.

Concern about HT was accelerated by the WHI studies. Many of those data have since been reinterpreted and revisited. This is an ongoing process that may result in this position statement being reviewed and updated again in the future.

Disclaimer. Professor Franco Guidozzi is President of the South African Menopause Society (SAMS) and was chairperson of this guidelines writing committee. The consensus statement on menopausal hormone therapy was reviewed by the Council of the SAMS during 2012 at a meeting supported by an unrestricted educational grant from Adcock Ingram (Pty) Ltd. The present consensus position statement was completed in February 2014. None of the authors of this guideline have any conflict of interest to declare.

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7. ACOG Practice Bulletin No. 141. Management of menopausal symptoms. Obstet Gynecol 2014;123(1):202-216. [http://dx.doi.org/10.1097/01.AOG.0000441353.20693.78] 8. Guidozzi F. Sleep and sleep disorders in menopausal women. Climateric 2013;16(2):214-219. [http:// dx.doi.org/10.3109/13697137.2012.753873] 9. Sturdee DW, Panay N. Recommendation for the management of postmenopausal vaginal atrophy.

Climateric 2010;13(6):509-522. [http://dx.doi.org/10.3109/13697137.2010.522875] 10. Nelson HD. Walker M, Zakher B, Mitchell J. Menopausal hormone therapy for the primary prevention of chronic conditions: Systematic review to update the US Preventative Services Task Force recommendations. Ann Intern Med 2012;157(2):104-113. [http://dx.doi.org/10.7326/0003-4819-1572-201207170-00466] 11. Hodis HN. Postmenopausal hormone therapy and cardiovascular disease in perspective. Clin Obstet Gynaecol 2008;51(3):564-580. [http://dx.doi.org/10.1097/GRF.0b013e318181de86] 12. Grodstein, F, Manson JE, Stampfer MJ. Hormone therapy and coronary heart disease: The role of time since menopause and age at hormone initiation. J Womens Health 2006;15(1):35-44. [http://dx.doi. org/10.1001/archinte.168.8.861] 13. Hodis HN, Mack NJ. A ‘window of opportunity’: The reduction of coronary heart disease and total mortality with menopausal therapies is age- and time-dependent. Brain Res 2001;1379:244-252. [http://dx.doi.org/10.1016/j.brainres.2010.10.076] 14. Schierbeck LL, Rejnmark L, Toffeng CL. Effect of hormone replacement therapy on cardiovascular events in recently postmenopausal women: A randomized trial. BMJ 2012;345:e6409. [http://dx.doi. org/10.1136/bmj.e6409] 15. Hodis HN, Collins P, Mack WJ, Schierbeck LL. The window of opportunity for coronary heart disease prevention with hormone therapy: Past, present and future in perspective. Climateric 2012;15(3):217228. [http://dx.doi.org/10.3109/13697137.2012.656401] 16. Rossouw JE, Prentice RL, Manson JE, et al. Postmenopausal hormone therapy and risk of cardiovascular disease by age and year since menopause. JAMA 2007;297(13):1465-1477. [http://dx.doi.org/10.1001/ jama.297.13.1465] 17. Margolis KL. Effect of oestrogen plus progestin on the incidence of diabetes in post-menopausal women: Results from the Women’s Health Initiative hormone trial. Diabetologica 2004;47(7):11751187. [http://dx.doi.org/10.1007/s00125-004-1448-x] 18. Simon JA, Hsia J, Canley JA, et al. Postmenopausal hormone therapy and risk of stroke: The Heart and Estrogen-progestin Replacement Study (HERS). Circulation 2001;103(5):638-642. [http://dx.doi. org/10.1161/01.CIR.103.5.638] 19. Lobo RA. The risk of stroke in post-menopausal women receiving hormonal therapy. Climateric 2009;12(Suppl 1):81-95. [http://dx.doi.org/10.1080/13697130902835376] 20. Lisabeth L, Bushnell C. Stroke risk in women: The role of menopause and hormone therapy. Lancet Neurol 2012;11(1):82-91. [http://dx.doi.org/10.1016/S1474-4422(11)70269-1] 21. Grodstein F, Manson JE, Stampfer MJ, Rexrode K. Postmenopausal hormone therapy and stroke: Role of time since menopause and age at initiation of hormone therapy. Arch Intern Med 2008;168(8):861866. [http://dx.doi.org/10.1001/archinte.168.8.861] 22. Viscoli CM, Brass LM, Kernan WN, et al. A clinical trial of estrogen-replacement therapy after ischemic stroke. N Engl J Med 2001;345(17):1243-1249. [http://dx.doi.org/10.1056/NEJMoa010534] 23. Lakkegaard E, Jovanovic Z, Heitmann BL, et al. Increased risk of stroke in hypertensive women using hormone therapy. Arch Neurol 2003;60(10):1370-1384. [http://dx.doi.org/10.1001/ archneur.60.10.1379] 24. Scarabin PY, Oger E, Plu-Burean G, on behalf of the Estrogen and Thromboembolism Risk (ESTHER) study group. Differential association of oral and transdermal oestrogen-replacement therapy with venous thromboembolism risk. Lancet 2003;362(9382):428-432. [http://dx.doi.org/10.1016/S01406736(03)14066-4] 25. Canonico M, Plu-Bureau G, Lowe GD, Scarabin P. Hormone replacement therapy and risk of venous thromboembolism in postmenopausal women: Systematic review and meta-analysis. BMJ 2008;336(7655):227-1231. [http://dx.doi.org/10.1136/bmj.39555.441944.BE] 26. Cushman M, Kuller LH, Prentice R, et al., for the Women’s Health Initiative Investigators. Estrogen plus progestin and risk of venous thrombosis. JAMA 2004;292(13):1573-1580. [http://dx.doi. org/10.1001/jama.292.13.1573] 27. Canonico M, Plu-Bureau G, Scarabin PY. Progestogens and venous thromboembolism among women using hormone therapy. Maturitas 2011;70(4):354-360. [http://dx.doi.org/10.1016/j. maturitas.2011.10.002] 28. Fournier A, Berrina F, Clavel-Chapelon F. Unequal risks for breast cancer associated with different hormone replacement therapies: Results from the E3N cohort study. Breast Cancer Res Treat 2008;107(1):103-111. [http://dx.doi.org/10.1007/s10549-007-9523-x] 29. Fournier A, Febre A, Mesrine S, et al. Use of different post menopausal hormone therapies and risk of histology- and hormone receptor-defined invasive breast cancer. J Clin Oncol 2008;26(8):1260-1268. [http://dx.doi.org/10.1200/JCO.2007.13.4338] 30. Bush T, Whiteman M, Flaws J. Hormone replacement therapy and breast cancer: A qualitative review.

Obstet Gynecol 2001;98(3):498-508. [http://dx.doi.org/10.1016/S0029-7844(01)01453-3] 31. Chlebowski RT, Hendrix SG, Langer RD, et al. Influence of estrogen plus progestin on breast cancer and mammography in healthy post-menopausal women: The Women’s Health Initiative randomized trial. JAMA 2003;289(24):3243-3253. [http://dx.doi.org/10.1001/jama.289.24.3243] 32. Prentice R, Chlebowski RT, Stefanick ML, et al. Conjugated equine estrogens and breast cancer risk in the Women’s Health Initiative clinical trial and observational study. Am J Epidemiol 2008;167(12):1407-1411. [http://dx.doi.org/10.1093/aje/kwn090] 33. Kerlikowske K, Cook AJ, Buist DSM, et al. Breast cancer risk, breast density, menopause and postmenopausal hormone therapy use. J Clin Oncol 2010;28(24):3830-3837. [http://dx.doi. org/10.1200/JCO.2009.26.4770] 34. Buist DSM, Anderson ML, Read SL. Short term hormone therapy suspension and mammography recall: The radiological evaluation and breast density (READ) randomized trial. Ann Intern Med 2009;150(11):752-765. [http://dx.doi.org/10.7326/0003-4819-150-11-200906020-00003] 35. Henderson KD, Duan L, Sullivan-Halley J, et al. Menopausal hormone therapy use and risk of invasive colon cancer. Am J Epidemiol 2010;171(4):415-425. [http://dx.doi.org/10.1093/aje/kwp434] 36. Long MD, Martin CF, Galanko JA, Sandler RS. Hormone replacement therapy, oral contraceptive use and distal large bowel cancer: A population-based case-control study. Am J Gastroenterol 2010;105(8):1843-1850. [http://dx.doi.org/10.1038/ajg.2010.123] 37. Million Women Study Collaborators. Endometrial cancer and hormone-replacement therapy in the Million Women Study. Lancet 2005;365(9470):1543-1551. [http://dx.doi.org/10.1016/S01406736(05)66455-0] 38. Hill D, Weiss NS, Beresford SAA, et al. Continuous combined hormone replacement therapy and risk of endometrial cancer. Am J Obstet Gynecol 2000;183(6):1456-1461. [http://dx.doi.org/10.1067/ mob.2000.108081] 39. Lacey JV, Mink PJ, Lubin JH, et al. Menopausal hormone replacement therapy and risk of ovarian cancer. JAMA 2002;288(3):334-341. [http://dx.doi.org/10.1001/jama.288.3.334] 40. Riman T, Dickman PW, Nilsson S, et al. Hormone replacement therapy and the risk of invasive epithelial ovarian cancer in Swedish women. J Natl Cancer Inst 2002;94(7):496-504. [http://dx.doi. org/10.1093/jnci/94.7.497] 41. Chlebowski RT, Schwartz AG, Wakelee H, et al. Oestrogen plus progestin and lung cancer in postmenopausal women (Women’s Health Initiative trial): A post-hoc analysis of a randomized controlled trial. Lancet 2009;374(9697):1243-1251. [http://dx.doi.org/10.1016/S0140-6736(09)61526-9]

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42. Van Schoultz E, Rutquist L. Menopausal hormone therapy after breast cancer: The Stockholm Randomized Trial. J Natl Cancer Inst 2005;97(7):533-535. [http://dx.doi.org/10.1093/jnci/dji071] 43. Holmberg L, Anderson H. HABITS (hormonal replacement therapy after breast cancer – is it safe?): A randomized comparison: Trial stopped. Lancet 2004;363(9407):453-455. [http://dx.doi.org/10.1016/ S0140-6736(04)15493-7] 44. Kenemans P, Bundred NJ, Foidart J-M, et al. Safety and efficacy of tibolone in breast-cancer patients with vasomotor symptoms: A double-blind randomized non-inferiority trial. Lancet Oncol 2009;10(2):135-146. [http://dx.doi.org/10.1016/S1470-2045(08)70341-3] 45. Dew JE, Wren BG, Eden JA. A cohort study of topical vaginal estrogen therapy in women previously treated for breast cancer. Climateric 2003;6(1):45-52. [http://dx.doi.org/10.1080/cmt.6.1.45.52] 46. Guidozzi F. Estrogen therapy in gynaecologic cancer survivors. Climateric 2013;16(6):611-617. [http:// dx.doi.org/10.3109/13697137.2013.806471] 47. Whitmer RA. Timing of hormone therapy and dementia: The critical window theory revisited. Ann Neurol 2011;69(1):163-169. [http://dx.doi.org/10.1002/ana.22239] 48. Maki PM. Hormone therapy and cognitive function: Is there a critical period for benefit? Neuroscience 2006;138(3):1027-1030. [http://dx.doi.org/10.1016/j.neuroscience.2006.01.001] 49. Ossewaarde ME, Bots ML, Verbeek M, Peeters PH. Age at menopause, cause-specific mortality and total life expectancy. Epidemiology 2005;16(4):556-562. [http://dx.doi.org/10.1097/01. ede.0000165392.35273.d4] 50. Archer D. Premature menopause increases cardiovascular risk. Climacteric 2009;12(Suppl 1):26-31. [http://dx.doi.org/10.1080/13697130903013452] 51. Gallagher JC. Effects of early menopause on bone mineral density and fractures. Menopause 2007;14(3):567-571. [http://dx.doi.org/10.1097/gme.0b013e31804c793d] 52. Grazziottin A. Menopause and sexuality: Key issues in premature menopause and beyond. Ann N Y Acad Sci 2010;1205(1):254-261. [http://dx.doi.org/10.1111/j.1749-6632.2010.05680.x] 53. Schwenkhagen A. Hormonal changes in menopause and implications on sexual health. J Sex Med 2007;4(Suppl 3):220-226. [http://dx.doi.org/10.1111/j.1743-6109.2007.00448.x] 54. Davis SR. Should women receive androgen replacement therapy, and if so, how? Clin Endocrinol 2010;72(2):149-154. [http://dx.doi.org/10.1111/j.1365-2265.2009.03670.x]

55. Panay N, Al-Azzani F, Bouchard C, et al. Testosterone treatment of HSDD in naturally menopausal women: The ADORE study. Climateric 2010;13(2):121-131. [http://dx.doi.org/10.3109/13697131003675922] 56. Davis SR. The effects of tibolone on mood and libido. Menopause 2002;9(3):162-170. [http://dx.doi. org/10.1097/00042192-200205000-00004] 57. Shu YY, Maibach H. Estrogen and skin. Am J Clin Dermatology 2011;12(5):297-311. [http://dx.doi. org/10.2165/11589180-000000000-00000] 58. Meurman JH, Tarkkila L, Tritinen A. The menopause and oral health. Maturitas 2009;63(1):56-62. [http://dx.doi.org/10.1016/j.maturitas.2009.02.009] 59. Boothby LA. Bioidentical hormone therapy: A panacea that lacks supportive evidence. Curr Opin Obstet Gynecol 2008;20(4):400-407. [http://dx.doi.org/10.1097/GCO.0b013e3283081ae9] 60. ACOG Committee of Gynecologic Practice. Committee opinion No. 322: Compounded bioidentical hormones. Obstet Gynecol 2005;106(5):1139-1140.

61. Taylor M. Unconventional estrogens: Estriol, biest and triest. Clin Obstet Gynecol 2001;44(4):864-879. [http://dx.doi.org/10.1097/00003081-200112000-00024] 62. Sturdee DW, Pines A, on behalf of the International Menopause Society Writing Group. Updated IMS recommendations on postmenopausal hormone therapy and preventative strategies for midlife health.

Climateric 2011;14(3):302-320. [http://dx.doi.org/10.3109/13697137.2011.570590] 63. The North American Menopause Society 2012 Hormone Therapy Position Statement Advisor Panel.

The 2012 hormone therapy position statement of the North American Menopause Society. Menopause 2012;19(3):257-271. [http://dx.doi.org/10.1097/gme.0b013e31824b970a] 64. Nedrow A. Complementary and alternative therapies for the management of menopause-related symptoms: A systemic evidence review. Arch Intern Med 2006;166(14):1453-1465. [http://dx.doi.org/10.1001/archinte.166.14.1453] 65. Nelson HD. Non-hormonal therapies for menopausal hot flashes: A systematic review and metaanalysis. JAMA 2006;295(17):2057-2071. [http://dx.doi.org/10.1001/jama.295.17.2057] 66. Messina M, McCaskill-Stevens W, Lampe JW. Addressing the soy and breast cancer relationship: Review, commentary, and workshop proceedings. J Natl Cancer Inst 2006;98(18):1275-1284. [http:// dx.doi.org/10.1093/jnci/djj356]

Accepted 18 May 2014.

Taking care of your business so you can take care of your patients

For more information contact Wayne Campbell at: +27 (0) 72 424 6724 or +27 (0) 86 134 2544 wayne@medsolutions.co.za | www.medsolutions.co.za

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ISSUES IN MEDICINE

Recommendations for the medical evaluation of children prior to adoption in South Africa A F Haeri Mazanderani, N M du Plessis, J Lumb, U D Feucht, M Myburgh, S H Mayaphi, M R Lekalakala, D W Swanepoel, H Georgakis, T Avenant Ahmad Haeri Mazanderani is a registrar in the Department of Medi­cal Virology, Tshwane Academic Division, National Health Laboratory Service, and University of Pretoria, South Africa. Nicolette du Plessis is a paediatric infectious diseases specialist in the Department of Paediatrics and Child Health, University of Pretoria and Kalafong Hospital, Pretoria. Janet Lumb is a paediatrician working for the Thusanani Children’s Foundation, Gauteng, South Africa. Ute Feucht is principal paediatrician on the Tshwane District Clinical Specialist Team and a senior lecturer in the Department of Paediatrics, Kalafong Hospital and University of Pretoria. Marcelle Myburgh is a clinical virologist in the Department of Medical Virology, Tshwane Academic Division, National Health Laboratory Service, and University of Pretoria. Simnikiwe Mayaphi is a clinical virologist in the Department of Medical Virology, Tshwane Academic Division, National Health Laboratory Service, and University of Pretoria. Ruth Lekalakala is principal pathologist and a senior lecturer in the Department of Medical Microbiology, Tshwane Academic Division, National Health Laboratory Service, and University of Pretoria. De Wet Swanepoel is an associate professor in the Department of Communication Pathology, Faculty of Humanities, University of Pretoria. Hellen Georgakis is a medical officer in the Department of Neurosurgery, Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa. Theuns Avenant is a chief specialist in and head of the Department of Paediatrics at Kalafong Hospital and University of Pretoria.

Corresponding author: A Haeri Mazanderani (ahmad.haerimazanderani@up.ac.za)

The current legislative framework in South Africa (SA) supports adoption as the preferred form of care for children with inadequate or no parental or family support. There are an estimated 3.8 million orphans in SA, with approximately 1.5 - 2 million children considered adoptable. As a means of improving services, newly drafted adoption guidelines from the National Department of Social Development will in future require both non-profit and private sector adoption agencies to obtain a medical report on a child prior to placement. However, no local guidelines specify what an appropriate medical examination entails or how it should be reported. For the purposes of proposing and developing such guidelines, an open forum was convened at the Institute of Pathology, University of Pretoria, in March 2013. These ‘Recommendations for the medical evaluation of children prior to adoption in South Africa’ emanate from this meeting.

S Afr Med J 2014;104(8):544-549. DOI:10.7196/SAMJ.7958

There are an estimated 3.8 million orphans in South Africa (SA).[1] This includes children without a living biological mother, father or both parents. It is further estimated that half of these children have been orphaned on account of AIDS.[2] The number of orphans has risen dramatically over the past 10 years, with double orphans, children who have neither a father nor a mother, increasing from 350 000 to 885 000.[1] The current legislative framework in SA supports adoption as the preferred form of care for children with inadequate or no parental or family support,[3] and approximately 1.5 - 2 million children are considered adoptable.[4] As a means of improving services, newly drafted adoption guidelines from the National Department of Social Development will in future require both non-profit and private sector adoption agencies to obtain a medical report on a child prior to placement.[5] However, in contrast to international adoption practice, no local guidelines exist that specify what an appropriate medical examination entails or how it should be reported. For the purposes of proposing and developing such guidelines, an open forum was convened at the University of Pretoria’s Institute of Pathology in March 2013. The forum was attended by a number of stakeholders, including the South African National Adoption Coalition, and the diverse range of participants included social workers, healthcare professionals and representatives of child protection organisations (CPOs) and civil society groups, as well as adoptive parents. Representatives of the National Department

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of Health, the National Department of Social Development and the South African National AIDS Council were notified and invited to the forum, but did not attend. We anticipate that the recommendations proposed will both raise awareness of the need to implement a national minimum standard for the medical evaluation of children prior to adoption and provide a framework for the details thereof.

Defining guidelines

A cost-effective national minimum standard, completed by a regis­ tered medical practitioner and available for all national adoptions in SA, needs to be introduced. Such a measure should be implemented for all placements categorised as unrelated and related adoptions, with the exception of step-adoption. The need to evaluate children prior to step-adoption, the most popular form of adoption in SA,[3] should be assessed on an individual basis. In addition, all abandoned children should undergo the same comprehensive evaluation, as adoption will be the most appropriate form of care for most of them.

The following recommendations are in keeping with section 28 of the Constitution of the Republic of South Africa,[6,7] which specifies that all children have the right to basic healthcare services and that the child’s best interests are of paramount importance. Furthermore, as the recommendations comprise an essential component of primary healthcare they fall within the ambit of the National Health Act,[8] which ensures that such services are provided free of charge to children under the age of 6 years.

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Inherent challenges

The medical evaluation of children prior to adoption is inherently challenging. Early placement is preferable, but it has to be accompanied by a high standard of medical care if it is to be successful.[9] Placement of children with undiagnosed medical conditions can have negative consequences, both for the children and for the families that adopt them. It is therefore advisable to perform a comprehensive medical evaluation prior to placement, both to ensure appropriate intervention and treatment of the child and to inform prospective adopters regarding likely future medical needs and care. This may prove extremely challenging when resources and expertise are limited, as is the case in SA, where the feasibility of such an undertaking needs to be carefully considered. No matter how extensive the medical evaluation of a child, future problems or pathology can never be completely excluded. Other considerations are the risks of escalating costs, delaying or preventing the placement of a perfectly healthy child on medical or developmental grounds, and creating unnecessary anxiety in the prospective parent(s).

Another challenge is to develop guidelines that are appropriate for a diverse group of children of different ages and with different risk profiles. This problem is further compounded by a lack of data to inform local practice. Implementing national guidelines in the context of fragmented social services may also prove challenging. Adoption services require the participation of numerous stakeholders, including the Department of Social Development, the Department of Home Affairs, the children’s courts, the social workers operating under a registered CPO, and the numerous individuals and organisations that care for children prior to adoption. The role of the Department of Health regarding adoption services has not been clearly delineated.

The Children’s Act[10] states that in certain circumstances the state may be required to pay for a child’s HIV test for the purpose of placing the child in foster care or adoption. Importantly, it also states that consent for HIV testing in children under 12 years of age may be obtained from a designated CPO arranging the placement of the child, as well as from the superintendent or person in charge of a hospital.[11] However, apart from HIV testing, nothing is specifically mentioned regarding the medical evaluation of children being placed for adoption. Indeed, non-profit organisations wishing to obtain medical evaluations for children in their care have reported being turned away from public healthcare facilities on the grounds that such facilities do not provide medical screening services for apparently healthy children being placed for adoption.

Feasibility of implementing guidelines

In SA, approximately 2 000 court-ordered adoptions are processed per year, and the figure is thought to be decreasing.[3] This stands in stark contrast to the number of children being placed in foster care, which has more than doubled since 2004, gauged by the 572 903 Foster Care Grants issued in 2012.[12] The imperative to adequately address the health needs of this vulnerable group, and the additional 1.6 million orphans thought to be living ‘informally’ with extended family members,[13] is reflected by unacceptably high under-5 mortality rates and the inevitable failure of SA to meet Millennium Development Goal 4, aiming at a reduction in child mortality.[14] Although a comprehensive medical assessment at each foster care placement would be ideal, it may prove unrealistic in the context of existing public health services. The nature of adoption as a permanent relationship differentiates it from temporary forms of care, in which social workers can follow children up on an ongoing basis. Adoption therefore represents a cost-effective opportunity for comprehensive medical assessment and intervention.

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There are no official statistics regarding abandoned children, al­th­ ough it is estimated that more than 2 000 babies are abandoned each year.[15] Most of these children will be adoptable, and many of them are neonates when found. This provides an opportunity for clinical and laboratory screening tests as well as medical interventions. These infants should undergo the same medical evaluation as older children prior to adoption.

The medical report on children prior to adoption

In an attempt to ensure that a quality medical evaluation is performed on all abandoned children and children prior to adoption, it is recommended that a standard medical form be developed and adopted at a national level (Appendix 1; available in the online version of this article). The following details need to be documented in such assessments:

Identifying details

Identifying details that need to appear on the medical report should include the name of the child, date of birth or estimated age, and gender. Since children may present for healthcare evaluation before being issued with a birth certificate, as in the case of abandoned children, it is imperative that such children be provided with a name, surname and date of birth. These details should be used consistently and reflected on all laboratory results, the Road to Health booklet (RTHB) or equivalent immunisation record, and the birth certificate once it is issued. This practice should also be maintained in circumstances where the child is unlikely to be cared for by his/her biological parent(s) and when there is uncertainty regarding the name (e.g. the use of maternal or paternal surname). For determination of the age of children other than neonates who have no prior documentation, there are a number of bone and dental age assessment methods that have been described in the medical literature.[16] The Greulich and Pyle method is still commonly used in SA and can be arranged at radiology departments with the relevant expertise in the public health sector. It is important to note that such assessments are estimates at best and cannot accurately determine age.[16]

Medical history

Obtaining a comprehensive history from the biological mother or caregiver at first contact with a healthcare worker is essential, as this may be the only opportunity to do so. Ideally, the RTHB should be completed and a copy of it attached to the medical report. It is recommended that the details listed in Table 1 be explicitly recorded on the medical report, as RTHBs are sometimes inadequately completed.

Medical examination

The medical examination should include details of a full systemic examination with syndromic screening and anthropometric parameters (Table 2).

Special investigations

In addition to a cranial ultrasound scan and opthalmological assessment in selected high-risk cases, all children will require laboratory screening tests (Table 3).

Infectious disease screening An overwhelming number of infectious agents, including viruses, bacteria, parasites and fungi, can be transmitted from mother to child. Some of these pathogens are associated with severe congenital

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Table 1. Medical history details

Table 2. Medical examination

Birth history

Anthropometric parameters

Place of birth

Current weight, height, head circumference

Mode of delivery

Use of standard growth charts

Gestational age

General examination and congenital abnormality screening

Apgar score

General examination

Birth parameters: weight, length, head circumference

eatures of congenital abnormalities including eyes and vision, F ears and nose, mouth and palate, heart, skin, upper and lower limbs, genitalia and anus

Neonatal complications Maternal history

Other congenital abnormalities

Gravidity, parity and previous miscarriage/s or TOP

Systemic examination

Number of live children and their ages

Head and neck, including ENT and eye examination

Death/s and cause/s of death of siblings

Chest, including heart and lungs

Antenatal complications

Abdomen

HIV rapid and ELISA results

Genitalia

If HIV-infected:

Musculoskeletal system

CD4+ cell count

Neurological system

HIV viral load

Development

WHO staging

Other assessment

PMTCT interventions

Vision

TB and TB treatment

Hearing

STI, including RPR results

Speech/language

History of smoking, alcohol and illicit drug use

ENT = ear, nose and throat.

History of familial condition/s (including paternal family) Duration of breastfeeding and date at cessation

Table 3. Special investigations

General medical history

Laboratory screening tests

RTHB availability Growth and immunisation history

HIV-1/2 ELISA

Developmental milestones

HBsAg ELISA

Chronic diseases and medication

Syphilis (treponemal or non-treponemal tests)

revious hospital admissions, with dates, diagnoses and followP up plans

TSH (children <28 days)

TOP = termination/s of pregnancy; ELISA = enzyme-linked immunosorbent assay; WHO = World Health Organization; PMTCT = prevention of mother-to-child transmission; TB = tuberculosis; STI = sexually transmitted infection/s; RPR = rapid plasma reagin; RTHB = Road to Health booklet.

Cranial ultrasound scan in children with a birth weight <2 000 g if <12 months of age at time of assessment Ophthalmological assessment in children with a birth weight <1 500 g regardless of age at time of assessment ELISA = enzyme-linked immunosorbent assay; HBsAg = hepatitis B surface antigen; TSH = thyroid-stimulating hormone.

abnormalities and sequelae that may not be clinically apparent during the newborn period. Infectious diseases may also be acquired after delivery but before adoption. The American Academy of Pediatrics recommends the following infectious disease tests for screening international adoptees: hepatitis B, syphilis and HIV-1/2 serology; tuberculin skin testing or interferon-gamma release assay testing; stool examination for ova and parasites, including Giardia intestinalis; and Cryptosporidium antigen testing.[17] A complete blood count and differential count is also recommended. In addition, the Centers for Disease Control and Prevention lists the following screening tests that may be useful, depending on the child’s country of origin or specific risk factors: hepatitis A, hepatitis C and Trypanosoma cruzi serology; malaria smears; and Helicobacter pylori antigen screening of stool.[18] Taking into account local prevalence, costs and the poor positive predictive value of some of the laboratory tests, we recommend limiting routine screening to exclusion of HIV-1/2, hepatitis B and syphilis (Table 3). Other infectious disease markers

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and haematological testing should only be performed if the medical history suggests a high risk of infection or if clinically indicated.

Investigation for tuberculosis (TB) is only recommended once TB exposure has been established. Because of the high prevalence of intestinal parasites in SA, routine deworming in children >3 years of age, rather than repeated stool sample collection, is considered cost-effective.

All children should have an HIV-1/2 enzyme-linked immunoassay (ELISA) test. An HIV-1/2 ELISA is preferable to a rapid test for reasons of quality control, including standardised reporting, and better sensitivity and specificity. Fourth-generation HIV-1/2 ELISA testing, which has the ability to detect antibodies to HIV-1/2 and p24 antigen simultaneously, reduces the window period to an average of 2 weeks, whereas rapid strips, which can only effectively detect HIV antibodies, have an average window period of 3 - 4 weeks.[19]

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A laboratory diagnosis of HIV-1/2 in a child >18 months of age requires a positive result on two assays and must be confirmed on a second specimen. In children <18 months of age, a positive HIV1/2 ELISA result suggests HIV exposure but not necessarily HIV infection, as maternal antibodies are transferred from the mother to the child. These children should be tested further in accordance with the current South African Antiretroviral Treatment Guidelines testing algor­ithm for infants <18 months of age, which includes immediate HIV-1 poly­ merase chain reaction (PCR) testing for ‘symptomatic infants’.[20] Additionally, immediate HIV-1 PCR testing can be considered for infants of mothers with known poor or non-compliance with prevention of mother-to-child transmission (PMTCT) interventions. However, infants with negative HIV-1 PCR results should have repeat testing as per guidelines.

A negative HIV-1/2 ELISA result adequately excludes HIV infection at the time of testing if no recent exposure has occurred.

However, if a child was breastfed the test should be repeated 6 weeks after cessation of breastmilk feeds. As for all laboratory investigations, the limitations of the HIV assays need to be taken into consideration.

Both qualitative and quantitative molecular HIV assays (i.e. PCR and viral load assays) currently used in the public health sector are not designed to test for HIV-2. Furthermore, in the context of PMTCT practices, repeat HIV PCR testing 4 - 6 weeks after cessation of prophylaxis may be prudent in view of increasing evidence suggesting that molecular HIV testing may not detect low-level viraemia as a result of antiretroviral therapy.[21,22] Since it is not possible to exclude HIV infection completely in early infancy, prospective adoptive parents need to be counselled in this regard.

Screening for hepatitis B is recommended in all children by testing for hepatitis B surface antigen (HBsAg). Since false-negative results can be associated with early infection during the window period, it is advisable to repeat the test in 6 months if it is negative.[18] Falsepositive results can also occur and have been associated with HBsAg testing within 3 weeks of administering hepatitis B vaccination.[23] In children with unknown immunisation records, hepatitis B surface antibody (HBsAb) testing can be used to confirm immunity.

Either non-treponemal (e.g. rapid plasma reagin (RPR), Venereal Disease Research Laboratory (VDRL)) or treponemal (e.g. Treponema pallidum haemagglutination assay (TPHA), fluorescent treponemal antibody-absorption (FTA-ABS), syphilis ELISA) testing can be used for syphilis screening purposes. Should the screening test be positive, a confirmatory test using an alternative assay type needs to be performed. The diagnosis of congenital syphilis can be difficult and results of maternal testing, if available, may prove valuable in this regard.

Herpesviruses have not been included as part of routine laboratory screening because of the poor positive predictive value of both serological and molecular assays. This includes screening for cytomegalovirus (CMV), a leading cause of developmental disabilities.

The prognosis of congenital CMV is highly variable. The majority of patients are asymptomatic at birth (87.3%), and only 13.5% of children develop hearing loss or impaired intellectual performance.

However, hearing loss can occur as late as schoolgoing age in a child born with normal hearing.[24] Similarly, the manifestations of congenital rubella can be delayed in up to 20% of cases,[25] so routine laboratory testing is also not recommended. Testing should rather be based on assessment of individual risk.

Routine hepatitis C testing is not considered necessary in SA because of the low prevalence of hepatitis C, estimated to be <2%,[26] and a low risk of mother-to-child transmission (~10%).[27] Although vertical transmission is reported to be considerably increased in the

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HIV-positive population,[28] HCV/HIV co-infection is uncommon in SA.[26] Testing is therefore recommended only in high-risk cases, such as babies born to intravenous drug users.

Additional blood-borne pathogens that are readily transmitted from mother to child but are usually subclinical during childhood include human T-cell lymphotropic virus types 1 and 2 (HTLV-1 and 2). Although regions of SA are known to be endemic for HTLV-1,[29] the lifetime risk of HTLV-1-associated disease is considered to be only 10%.[30] Until data on the local incidence of mother-to-child transmission become available, informed recommendations are not possible.

Thyroid function and metabolic screening Apart from screening for infectious diseases, blood tests should be performed for congenital hypothyroidism in neonates (i.e. in children who have been identified for adoption at birth, including abandoned neonates). Various algorithms are used globally, each with their own advantages and disadvantages, as outlined by the American Academy of Pediatrics.[31] For children with a birth weight of >2 500 g, thyroid-stimulating hormone (TSH) has proved to be an effective screening test. Since delayed TSH elevation is particularly common in infants of low birth weight (i.e. <2 500 g), testing with a combination of TSH and thyroxine (T4) has better sensitivity in detecting hypothyroidism in such infants, in particular those with thyroid-binding globulin deficiency, central hypothyroidism and hypothyroxinaemia. Screening is recommended 2 - 4 days after birth for term babies and at 2 - 7 days for preterm babies and those in neonatal intensive care units. If the above tests are abnormal, thyroid function tests should be done 2 weeks after delivery and treatment initiated if results suggest congenital hypothyroidism. Although considered rare, routine screening for congenital hypothyroidism is deemed appropriate as the condition is usually asymptomatic and can have devastating neurodevelopmental sequelae if left untreated.

Screening for metabolic disorders can also be considered in newborns prior to adoption, including testing for galactosaemia and phenylketonuria. However, we regard these tests as currently beyond the scope of a feasible national minimum standard appropriate for SA. Where resources allow, they can be incorporated as part of routine neonatal screening programmes.

Allied health professional assessments It is recommended that all children have appropriate speech, language, audiometric, psychological and occupational therapy assessments. A number of developmental screening tools have been developed, and where available these may prove valuable. In particular, the Griffiths Mental Developmental Scales and Bayley Scales of Infant Development, when performed by a suitably trained person, can provide a cost-effective general indicator of subsequent develop­ ment.[32] However, extensive evaluation and treatment is considered beyond the scope of an appropriate national minimum standard. The assessments listed in Table 4 are considered an essential minimum for both identifying and addressing gross developmental disorders in high-risk children prior to adoption in SA. It is recommended that parents take their children for additional assessments in the postadoption period.

Summary of medical evaluation

A summary of the medical evaluation should be made with suggested medical follow-up and intervention if necessary, as well as any findings that may impact on the adoption of the child. As the medical evaluation of a child cannot completely exclude the possibility of

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Table 4. Allied health professional assessments Audiological assessment

An audiological screening test should be performed in children with risk factors for hearing loss, as described in the literature,[33] including the following: Any caregiver concerns or clinical concerns regarding hearing abnormalities Family history of hearing loss ll children with a history of NICU admission or other neonatal risk factors associated with hearing loss, A including in utero infections Postnatal meningitis/encephalitis Craniofacial anomalies and syndromes associated with hearing loss; neurodegenerative disorders Head trauma Medication such as chemotherapy, ototoxic antibiotics, etc.

Delayed speech and language development The following audiological assessments are recommended for these children: hildren <5 years of age should be screened for hearing loss with electrophysiological devices measuring OAE C or ABR hildren who spent ≥5 days in an NICU must be screened with ABR to identify possible cases of auditory C neuropathy hildren ≥5 years of age should be screened with behavioural pure-tone audiometry at 20 dB across 1 000, C 2 000 and 4 000 Hz An abnormal screening test requires a diagnostic audiological assessment to determine whether hearing loss is present. Although children who fail the hearing screening test are at a significantly increased risk, the majority of these children will not have permanent hearing loss[34,35]

Occupational therapy assessment

An occupational therapy assessment is recommended in the following cases: Children with a birth weight <2 000 g (assessed at or after 4 months corrected age) All children >3 years of age If there are any clinical concerns regarding developmental delay

Speech/language therapy assessment

A speech/language therapy assessment is recommended in the following cases: When there are clinical concerns regarding speech and language delays or abnormalities (e.g. cleft palate) In infants with feeding difficulties

Psychological assessment

A psychological assessment should be performed: In all children with a history of abuse If recommended by the social worker or examining clinician Such an assessment may be performed by a clinical psychologist, educational psychologist or clinical social worker

OAE = otoacoustic emissions; ABR = auditory brainstem response; NICU = neonatal intensive care unit.

future pathology, it is recommended that the medical report be considered valid for 3 months from the date of examination if the child is <6 months of age, and for 6 months from date of examination if the child is ≥6 months of age.

Conclusion

An appropriate medical evaluation of children prior to adoption is an essential step towards achieving successful permanent placement of children with inadequate or no parental or family support, and as such represents a cost-effective opportunity to improve the health and well-being of a marginalised group in the SA population. It is hoped that by implementing the proposals outlined above, an effective model will be established for streamlining health services for orphaned and vulnerable children in general. This will ensure that key developmental goals, such as reducing child mortality and combating HIV/AIDS, are better addressed.

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Participants in the forum. Janet Lumb, Nicolette du Plessis, Theunis Avenant, Michelle Meiring, Marcelle Myburgh, Karin Richter, Sue Krawitz, Pam Wilson, Marlene Visser, Nina de Caires, Phyllis Pau, Maretha Bekker, Caroline Rose, Harriet Leisegang, Ruth Lekalakala, Sim Mayaphi, Ute Feucht, Theresa Rossouw, Tahiyya Hassim, Karen Bruyere, Marieke Brauer, Rendani Mafuyeka, Dan Morobadi, Shivani Goolab, Mohamed Said, Tumi Tseledi, Charmaine van Eeden, Charles Persence, Kay McCrindle, Sumayya Carrim, De Wet Swanepoel, Crystal Theron, Ahmad Haeri Mazanderani.

Acknowledgements. The authors thank all the participants, including representatives of the South African National Adoption Coalition, Thusanani Children’s Foundation, New BeginningZ, Tshwane Haven, Child Welfare Tshwane, Johannesburg Child Welfare, Boksburg Child

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Welfare, Impilo, Bright Start Right Start, Good Start Foundation, the Department of Neurosurgery at Chris Hani Baragwanath Academic Hospital and the University of the Witwatersrand, Red Cross War Memorial Children’s Hospital and the University of Cape Town, the departments of Occupational Therapy, Communication Pathology, Ophthalmology, Family Medicine and Paediatrics at the University of Pretoria, and the departments of Chemical Pathology, Medical Microbiology and Medical Virology of the Tshwane Academic Division of the National Health Laboratory Service. We also thank Profs Lorna Jacklin and Haroon Saloojee for reviewing the manuscript.

1. Meintjes H, Hall K. Demography of South Africa’s children. In: Hall K, Woolard I, Lake L, et al., eds.

South African Child Gauge 2012. Cape Town: Children’s Institute, University of Cape Town, 2012:82-85. http://www.ci.org.za/index.php?option=com_content&view=article&id=997&Itemid=399 (accessed 12 June 2013).

2. United Nations Children’s Fund. South Africa Annual Report 2011. Pretoria: United Nations Children’s Fund South Africa, 2011. http://www.unicef.org/southafrica/SAF_resources_annualreport2011.pdf (accessed 13 May 2013).

3. Mokomane Z, Rochat TJ, The Directorate. Adoption in South Africa: Trends and patterns in social work practice. Child & Family Social Work 2012;17(3):347-358. [http://dx.doi.org/10.1111/j.13652206.2011.00789.x] 4. Mokomane Z, Rochat T. The Perceptions, Understanding and Beliefs of People Towards Adoption and Blockages Which Prevent Communities From Adopting Children in South Africa. Pretoria: Human Sciences Research Council, 2010:vii-x.

5. South African National Department of Social Development. Guide to Good Practice on National Adoption. Pretoria: Department of Social Development (in press).

6. Section 28(1)(c) of the Constitution of the Republic of South Africa, 1996.

7. Section 28(2) of the Constitution of the Republic of South Africa, 1996.

8. Section 4(3)(a) of the National Health Act No. 61 of 2003.

9. Gordon RR. Medical Examination of the baby to be adopted. BMJ 1975;2(5961):31-32. [http://dx.doi. org/10.1136/bmj.2.5961.31] 10. Section 131 of the Children’s Act No. 38 of 2005.

11. Section 130(2) of the Children’s Act No. 38 of 2005.

12. Hall K. Income poverty, unemployment and social grants. In: Hall K, Woolard I, Lake L et al., eds. South African Child Gauge 2012. Cape Town: Children’s Institute, University of Cape Town, 2012:86-90. http://www.ci.org.za/index.php?option=com_content&view=article&id=997&Itemid=39 (accessed 12 June 2013).

13. Jamieson L, Proudlock P, Nhenga-Chakarisa T. Legislative developments in 2011/2012. In: Hall K, Woolard I, Lake L et al., eds. South African Child Gauge 2012. Cape Town: Children’s Institute, University of Cape Town, 2012:14-19. http://www.ci.org.za/index.php?option=com_content&view=ar ticle&id=997&Itemid=39 (accessed 12 June 2013).

14. Bhutta ZA, Chopra M, Axelson H, et al. Countdown to 2015 decade report (2000-10): Taking stock of maternal, newborn, and child survival. Lancet 2010;375(9730):2032-2044. [http://dx.doi.org/10.1016/ S0140-6736(10)60678-2] 15. Molatlhwa O. Over 2,000 kids thrown away yearly. Sowetan 2010; 1 July. http://www.sowetanlive.co.za/ incoming/2010/07/01/over-2000-kids-thrown-away-yearly (accessed 9 April 2013) 16. Smith T, Brownlees L. Age Assessment Practices: A Literature Review & Annotated Bibliography.

New York: United Nations Children’s Fund, 2011:13-27. http://www.unicef.org/protection/Age_ Assessment_Practices_2010.pdf (accessed 18 October 2013).

17. American Academy of Pediatrics. Medical evaluation of internationally adopted children for infectious diseases. In: Red Book. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics, 2012:191-193.

18. Centers for Disease Control and Prevention. International adoption. In: Yellow Book. New York: Oxford University Press, 2012:515-521.

19. Brauer M, De Villiers J, Mayaphi SH. Evaluation of the DetermineTM fourth generation HIV rapid assay. J Virol Methods 2013;189(1):180-183. [http://dx.doi.org/10.1016/j.jviromet.2013.01.017] 20. South African National Department of Health. The South African Antiretroviral Treatment Guidelines 2013: PMTCT Guidelines. Pretoria: Department of Health, 2013. http://web.up.ac.za/sitefiles/ file/45/1335/877/PMTCT%20guidelines_March%202013_DoH.pdf (accessed 13 May 2013).

21. Burgard M, Blanch S, Jasseron C, et al. Performance of HIV-1 DNA or HIV-1 RNA tests for early diagnosis of perinatal HIV-1 infection during anti-retroviral prophylaxis. J Pediatr 2012;160(1):60-66. [http://dx.doi.org/10.1016/j.jpeds.2011.06.053] 22. Haeri Mazanderani AF, du Plessis NM, Thomas WN, Venter E, Avenant T. Loss of detectability and indeterminate results: Challenges facing HIV infant diagnosis in South Africa’s expanding ART programme. S Afr Med J 2014;104(8):574-577. [http://dx.doi.org/10.7196/SAMJ.8322] 23. de Almeida Ponde RA. The underlying mechanisms for the ‘isolated positivity for the hepatitis B surface antigen (HBsAg)’ serological profile. Med Microbiol Immunol 2011;200(1):13-22. [http:// dx.doi.org/10.1007/s00430-010-0160-3] 24. Dollard SC, Grosse SD, Ross DS. New estimates of the prevalence of neurological and sensory sequelae and mortality associated with congenital cytomegalovirus infection. Rev Med Virol 2007;17(5):355363. [http://dx.doi.org/10.1002/rmv.544] 25. Bitnum A, Lee E, Ford-Jones, Ryan G. Implications for the fetus of maternal infections in pregnancy.

In: Cohen J, Opal SM, Powderly WG, eds. Infectious Diseases. 3rd ed. Philadelphia: Elselvier, 2010:564-579.

26. Botha JF, Kassianides C, Schneider HR, Song E, Spearman W, van der Merwe SW. South African hepatitis C management guidelines 2010. South African Gastroenterology Review 2010:8(1);20-25.

27. Harrison TJ, Dusheiko GM, Zuckerman AJ. Hepatitis viruses. In: Zuckerman AJ, Banatvala JE, Schoub BD, et al., eds. Principles & Practice of Clinical Virology. 6th ed. Chichester: Wiley-Blackwell, 2009:273-320.

28. Yeung LT, King SM, Roberts EA. Mother-to-infant transmission of hepatitis C virus. Hepatology 2001;34(2):223-229. [http://dx.doi.org/10.1053/jhep.2001.25885] 29. Haeri Mazanderani AF, Ebrahim O. Progressive HIV infection in the presence of a raised CD4+ count: HIV/HTLV-1 co-infection. South African Journal of HIV Medicine 2013;14(2):92-94. [http://dx.doi. org/10.7196/SAJHIVMED.904] 30. Verdonck K, Gonzalez E, Van Dooren S, et al. Human T-lymphotropic virus 1: Recent knowledge about an ancient infection. Lancet Infect Dis 2007;7(4):266-281. [http://dx.doi.org/10.1016/S14733099(07)70081-6] 31. American Academy of Pediatrics, Rose SR, American Thyroid Association, Brown RS, Lawson Wilkins Pediatric Endocrine Society. Update of newborn screening and therapy for congenital hypothyroidism.

Pediatrics 2006;117(6):2290-2303. [http://dx.doi.org/10.1542/peds.2006-0915] 32. Sutcliffe AG, Soo A, Barnes J. Predictive value of developmental testing in the second year for cognitive development at five years of age. Pediatr Rep 2010;2(2):48-50. [http://dx.doi.org/10.4081/pr.2010.e15] 33. Joint Committee on Infant Hearing. Year 2007 Position Statement: Principles and guidelines for early hearing detection and intervention programs. Pediatrics 2007;120(4):898-921. [http://dx.doi. org/10.1542/peds.2007-2333] 34. Health Professions Council of South Africa. Professional Board for Speech, Language and Hearing Profession: Early Hearing Detection and Intervention Programmes in South Africa, Position Statement Year 2007. Pretoria: Health Professions Council of South Africa, 2007. http://www.hpcsa. co.za/downloads/speech_education/early_hearing_detection_statement.pdf (accessed 28 May 2013).

35. American Academy of Audiology. Clinical Practice Guidelines 2011 Childhood Hearing Screen­ing.

Reston: American Academy of Audiology, 2011. http://www.audiology.org/resources/documentlibrary/ Documents/20110926_ChildhoodHearingScreeningGuidelines.pdf (accessed 28 May 2013).

Accepted 17 April 2014.

Appendix 1 is available online at http://dx.doi.org/10.7196/SAMJ.7958

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MEDICINE AND THE LAW

Mandatory reporting of child abuse in South Africa: Legislation explored M L Hendricks Melany Hendricks, MA (Clinical Psychology), MPhil (Applied Ethics), LLB, is the principal clinical psychologist at Stikland Hospital, Cape Town, South Africa, and a senior lecturer in the Department of Psychiatry, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town.

Corresponding author: M L Hendricks (mlh@sun.ac.za)

Legislation concerning mandatory reporting of child abuse in South Africa has been in effect since 2010, with the promulgation of amendment 41 of 2007 to the Children’s Act of 2005. This article explores mandatory reporting legislation in an attempt to improve the reporting practices of healthcare professionals in South Africa.

S Afr Med J 2014;104(8):550-552. DOI:10.7196/SAMJ.8110

The mandatory reporting of abuse of children was placed under the international spotlight with the sent­ encing in the UK of the alcoholic mother of Hamzah Khan (aged 4 years), who died in 2009 from starvation, but whose body was only discovered in 2011.[1] Ques­ tions were raised about the silence of officials, including teachers, social workers and policemen, who were involved with Hamzah at some point but did not intervene on his behalf. Hamzah’s grandfather is quoted as having said: ‘There should be different legislation for social services, schools, doctors, all the agencies, that the moment they suspect anything untoward then the child should be seen.’[1] In South Africa (SA), the father of 2-year-old Theopollus Groepies was sentenced to 25 years in prison for throwing his son against a wall and killing him.[2] Unfortunately, these are not isolated incidents. Violence against children is a universal and all-tooprevalent phenomenon. Despite clear legislation, professionals who have a moral and legal duty to protect children like Hamzah Khan and Theopullus Groepies are not held accountable for non-reporting.

The South African Children’s Act No. 38 of 2005[3] defines a child as a person under the age of 18 years. According to the latest population estimates, there are 15 454 742 children under the age of 14 in SA (from a 2013 mid-year estimate of 52.98 million),[4] and a further 5 168 797 between the ages of 15 and 19. This means that almost 38% of the SA population are legally defined as children.

Thirty per cent of the population is under 15 years of age, with a further 8% between the ages of 15 and 19.[4] Despite progressive children’s rights legislation in line with international conventions, the official statistics for crimes perpetrated against this vulnerable population in SA remain alarmingly high. For the period 2012 - 2013, 495 540 cases of crimes against children were reported.[5] The literature indicates that these crimes are usually underreported, and this statistic is estimated to be at least nine times lower than the actual number.[6] Research into rape in SA revealed that in 84% of all sexual crimes committed against children, the perpetrator is known to the child.[6] Children are subjected to a full spectrum of abuse, including verbal, physical, emotional and sexual abuse.[6]

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Barriers to mandatory reporting

The literature indicates that despite a legal duty to report suspec­ted child abuse, healthcare practitioners internationally and nationally fail to comply with reporting legislation. Among the barriers reported in the international literature is misunderstanding of the child abuse reporting legislation.[7] Other barriers are lack of knowledge regarding child abuse and neglect,[8] and previous negative experiences with child protection services.[7] Some doctors believe that it is better to deal directly with the family,[7] and may even fear potentially harming their professional relationship with the child and family after reporting their suspicion.[7] In addition, allegiance to the patient and the fact that the patient is well known to the practitioner have influenced decisions not to report suspected abuse.[7] There is a paucity of literature concerning mandatory reporting practices in SA. Anecdotally, clinicians have expressed concern about the child’s safety after reporting. Given the scarcity of human and financial resources, these concerns may prove to be justified.

According to the Minister of Social Development,[9] 66 329 social workers are needed to fulfil the obligations that arise as a result of implementation of the Children’s Act, but at the end of 2012 only 16 164 social workers were registered with the Council of Social Workers, giving a social worker/population ratio of 1:3 187. Not all work for the Department of Social Development – some are employed by non-governmental organisations, the Department of Health and the South African Police Service. Additionally, police statistics indicate that there is one policeman serving every 336 citizens (police/population ratio 1:336).[5] Given the scale of the child abuse problem and the lack of resources mandated to protect children, it can readily be deduced that children will not be adequately assisted.

Like their international counterparts, SA medical pract­itioners are anecdotally reported to fear legal reprisal, citing an increasingly litigious society.

This article attempts to analyse the SA legislation in a manner that will eliminate some misunderstandings, enabling healthcare practitioners and other professionals to report abuse of any nature confidently.

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Legislative framework International conventions

The United Nations (UN) and its signatories acknowledge that children are a vulnerable group and provide some guidelines on how children and their rights should be protected by signatories to the Convention on the Rights of the Child.[10] Article 19 of the Convention compels signatory states, of which SA is one, to ‘take all appropriate social and educational measures to protect the child from all forms of physical or mental violence, injury, neglect or negligent treatment, maltreatment or exploitation including sexual abuse’.

Article 19(2) of the Convention makes it clear that measures used to protect children need to be protective and preventive and should encompass the identification, reporting, referral, investigation and treatment of child abuse.

Article 16 of the African Charter on the Rights and Welfare of the Child[11] echoes the obligations set out in the UN Convention.

The Charter obligates the African Union (AU) and its signatories to establish special monitoring units and to provide the necessary support for the abused child and his/her caretakers.

South African legislation

The South African Constitution[12] explicitly addresses the rights of children and affords them specific protection. Section 28(1)(d) holds that ‘every child has the right to be protected from maltreatment, neglect, abuse and/or degradation’. The Children’s Act No. 35 of 2005[3] and its amendment 41 of 2007 (promulgated in 2010)[13] addresses children’s rights in its entirety. Section 110 specifically deals with the protection of children and resonates with the UN Convention and the AU Charter on the protection of children’s rights.

Mandatory reporting of child abuse in South Africa

Section 110 of the Children’s Amendment Act[13] provides details of the right to protection that children are afforded in terms of section 28 of the Constitution.[12] This section compels certain professional sectors to report any child abuse, neglect or maltreatment that is suspected on reasonable grounds to a designated child protection organisation, the provincial department of social development or a police official. If the reporting is done in good faith and substanti­ated to the relevant authorities, the professionals responsible will not be held liable to civil claims as a result of their reporting. The Act further stipulates that the Department of Social Development must assess and further manage the situation in the best interests of the child.

In addition, section 54 of the Sexual Offences and Related Matters Act[14] compels ‘[a] person’ who knows or who has a ‘reasonable belief or suspicion’ of any form of sexual abuse against a child or mentally challenged individual to report it to a police official. If such reporting is done in good faith, in terms of section 54(2)(c), the person repor­ ting cannot be held liable in criminal or civil proceedings.

The following sections of this article aim to elucidate the concepts that appear in section 110 of the Children’s Amendment Act[13] and section 54 of the Sexual Offences and Related Matters Act.[14] Who must report?

Section 110 of the Children’s Amendment Act[13] mandates ‘Any correc­tional official, dentist, homeopath, immigration official, labour inspector, legal practitioner, medical practitioner, midwife, minister of religion, nurse, occupational therapist, physiotherapist, psychologist, religious leader, social service professional, social worker, speech therapist, teacher, traditional health practitioner, traditional leader or member of staff or volunteer worker at a partial care facility, drop-in centre or child and youth care centre’ to report when they suspect

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that a child has been abused ‘in a manner causing physical injury, sexually abused or deliberately neglected’. Ordinary citizens are given the discretion to report abuse but are not compelled to do so in terms of section 110.

The Sexual Offences Act,[14] however, compels all citizens (i.e. all persons living in SA who are entitled to the rights promised by the Con­stit­ution in terms of section 3) who are aware of the sexual exploitation of children to report the offence to the police.

Who must they report to?

Section 110(1) of the Children’s Amendment Act[13] stipulates that suspected child abuse must be reported to child protection organi­ sations, the provincial department of social development or the police. A child protection organisation is defined in the Act as ‘any welfare organization designated in terms of section 107, to render child protection services’. Some provincial websites, notably that of the Western Cape, contain lists of organisations registered in terms of section 107.[13] All reports (even those made to the police) must be referred to the provincial department of social development.[13] The provincial department is tasked with investigating the allegation of abuse and taking appropriate measures to ensure the safety of the child. The department also needs to follow the legal processes if its investigation reveals that there is cause for legal action.[14] When must the reporting be done?

Section 110 of the Children’s Amendment Act[13] (and the reporting form 22) implies that reporting of the suspicion of abuse must be done as soon as the suspicion is formed on reasonable grounds. The purpose of reporting is ultimately to ensure the safety and protection of the child in question. The reporting of a sexual offence must be done ‘immediately’ according to section 54(1)(a) of the Sexual Offences Act.[14] ‘Immediately’ can be interpreted as on becoming aware of the sexual abuse or when there is a reasonable suspicion of abuse of a sexual nature.

The ‘good faith’ principle Both acts state that the reporting has to be done in ‘good faith’. The ‘good faith’ principle is an internationally recognised common-law duty to act honestly, openly and with conscientious impartiality.[15] This principle is intrinsically embedded in, and finds its meaning within, the context of the law of contract. In the context of mandatory reporting legislation, the person reporting must report his/her belief of wrongdoing without any malicious/spiteful intent.

The common-law responsibility to act in good faith encompasses avoidance of an interruption to the relationship of trust that exists between the parties involved in the relationship.[15] The difficulty that arises in the context of mandatory reporting is that the relationship often exists between the perpetrator and the professional. Conflict also arises when the victim is a party to the relationship but demands that the wrongdoing is not reported. The legislation is clear, however: the primary objective, which supersedes all other considerations, is the safety and protection of the child involved.

The ‘good faith’ standard is measured objectively[15] against standards of decency and fairness set by the community (in this instance represented by professionals and professional organisations) and not against the individual’s subjective beliefs of impartiality.

What constitutes reasonable grounds for suspicion/reasonable belief of suspicion?

SA courts have interpreted the phrases ‘reasonable grounds for suspicion/reasonable belief of suspicion’ in several judgments relating

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to the Criminal Procedure Act.[16] Even though ‘grounds’ and ‘fact’ are used interchangeably, ‘grounds’ refers to the reason one believes a certain set of facts, whereas ‘facts’ refers to information obtained from one’s senses.[16] ‘Grounds’[16] must be based on the facts obtained from objectively exploring (with one’s five senses) a particular situation or set of evidence. Once the facts are established by looking, hearing, smelling and sometimes tasting, the facts are usually evaluated. After considering or evaluating the facts from different objective points of view, a conclusion is drawn. If the conclusion remains the same, even when the facts are viewed from different perspectives, one is said to have grounds that a particular set of facts has merit. Up to this point, only one’s subjective interpretation of the facts is contemplated.

The courts, however, apply a measure of objectivity – that of the reasonable person – to ascertain whether the grounds for believing a set of facts are reasonable. The reasonable person refers to a fictional person who is deemed similarly situated to the one reporting. This hypothetical person is given similar characteristics and placed in the same situation as the person in question when the facts were obtained. ‘Reasonable grounds’ are said to exist if this reasonable person would come to the same conclusion under these similar circumstances.[16] In terms of the Sexual Offences Act, reporting can also be based on the ‘disclosure’ of the victim.[17] The English courts have ruled that evidence obtained from a secondary source (eye witness) likewise gives rise to the legal obligation to report to the relevant authorities.[18] Liability Reporting, when supported by a set of facts and done without any malicious intent, will not give rise to any claims of liability. The person reporting will not be held liable for damages under these conditions, even if it is ascertained that there is no abuse or neglect of any kind.

Accountability Professionals, and particularly healthcare professionals, can be held accountable for not reporting abuse of children under the conditions described above. The Health Professions Council of South Africa (HPCSA) guidelines[19] urge members to report any unethical or illegal conduct. According to the Health Professions Act No. 56 of 1974,[20] the HPCSA can order a fine or a suspension for a period of time, or remove a member’s name from the register in the case of a guilty finding.

Furthermore, in terms of section 54(b) of the Sexual Offences and Related Matters Act,[14] failure to report sexual abuse or exploitation of children and mentally handicapped persons is deemed an offence and is punishable with a fine or imprisonment of up to 5 years, or both, if the person is found guilty.

Conclusion

Non-compliance with mandatory reporting legislation on the part of professionals is just one of the challenges faced in the quest to protect and safeguard the children of SA. The SA legislation regulating mandatory reporting is progressive and complies with international conventions for the prevention of child abuse and the protection of children. Even though implementation of the acts related to mandatory reporting is handicapped by an acknowledged shortage

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of human resources, compliance with legislation could materially change the prospects of some children. However, given the lack of human resources, it is not self-evident that the children at risk of abuse in South Africa will be safer or better protected.

Recommendations

Increasing efforts to prevent child abuse and protect the children of SA may necessitate multiple and diverse interventions. Logically, however, a good starting point would be to enhance existing attempts to ensure the safety of our children. To this end, it is recommended that mandatory reporting practices be studied so that barriers to reporting can be more specifically addressed. Both professionals and the public need to be educated regarding children’s rights and their obligation, moral if not legal, to report abuse of any nature. Public health officials, educators and all persons working with children must be trained to identify abused children and those at risk of abuse. The Department of Social Development must ensure that all relevant parties know where to find social workers who specifically deal with child abuse and are trained in the correct reporting procedure. Social workers who are mandated to investigate and manage cases of child abuse should preferably be placed in community health settings and police stations, as these are typically the first point of call for abused children.

1. Thornton L. Amanda Hutton’s dad brands his daughter ‘evil’: ‘Can she even be a part of the human race?’ The Mirror 2013; 4 October. http://www.mirror.co.uk/news/uk-news/amanda-huttons-dadbrands-daughter-2336731#ixzz2kbTCDsxo (accessed 4 October 2013).

2. Otto J. 25 years for killer dad. Cape Argus 2013; 17 October. http://capeargus.newspaperdirect.com/ epaper/viewer.aspx (accessed 18 October 2013).

3. South African Government. The Children’s Act No. 38 of 2005. Pretoria: Government Printer, 2005. http://www.justice.gov.za/legislation/acts/2005-038%20childrensact.pdf (accessed 15 April 2014).

4. Statistics South Africa. Mid-year population estimates. May 2013. http://www.statssa.gov.za/ publications/P0302/P03022013.pdf (accessed 15 October 2013).

5. South African Police Service. Crime statistics overview in South Africa 2012/2013. 2013. http://www. saps.gov.za/statistics/reports/crimestats/2013/downloads/crime statistics presentation.pdf (accessed 8 October 2013).

6. Seedat M, Van Niekerk A, Jewkes R, Suffla S, Ratele K. Violence and injuries in South Africa: Prioritizing an agenda for prevention. Lancet 2009:374(9694):1011-1022. [http://dx.doi.org/10.1016/ S0140-6736(09)60948-X] 7. Flaherty, EG, Sege, R. Barriers to physician identification and reporting of child abuse. Pediatr Ann 2005;34(5):349-356. [http://dx.doi.org/10.3928/0090-4481-20050501-08] 8. Pietrantonio AM, Wright E, Gibson KN, Alldred T, Jacobson D, Niec A. Mandatory reporting of child abuse and neglect: Crafting a positive process for health professionals and caregivers. Child Abuse and Neglect 2013;37(2-3):102-109. [http://10.1016/j.chiabu.2012.12.007] 9. Parliamentary Monitoring Group. QUESTION1398/2013. 2013. http://www.pmg.org.za/node/36640 (accessed 10 October 2013).

10. United Nations Children’s Emergency Fund. Convention on the Rights of the Child. 1989. http://www. ohchr.org/EN/ProfessionalInterest/Pages/CRC.aspx (accessed 14 November 2013).

11. Organization for African Unity. African Charter on the Rights and Welfare of the Child. 1990. http:// www.childinfo.org/files/fgmc_AfricanCharterontherightsandwelfareofthechild.pdf (accessed 14 Nov­ em­ber 2013).

12. South African Government. The Constitution of the Republic of South Africa 1996. Pretoria: Govern­ ment Printer, 1996. www.thehda.co.za/uploads/images/unpan005172.pdf (accessed 15 April 2014).

13. South African Government. Children’s Amendment Act No. 41 of 2007. Pretoria: Government Printer, 2010.

14. South African Government. Sexual Offences and Related Matters Act 2007. Pretoria: Government Printer, 2007.

15. Powers PJ. Defining the undefinable: Good faith and the United Nations Convention on the contracts for the international sale of goods. Journal of Law and Commerce 1999:18(2):333-354.

16. Bekker PM, Geldenhuys T, Joubert JJ, Swanepoel JP, Terblanche SS, Van der Merwe SE. The exercise of powers and the vindication of individual rights. In: Joubert JJ, ed. Criminal Procedure Handbook. 7th ed. Cape Town: Juta & Co., 2005:83-87.

17. Bhana A, Swartz S, Davids A. Standards for reporting of sex/sexual activity of minors in a research context. S Afr Med J 2010;100(10):642-644.

18. Jerrard R. Internet law book reviews. http://www.rjerrard.co.uk/law/cases/oharra.htm (accessed 14 October 2013).

19. Health Professions Council of South Africa. Guidelines for Good Clinical Practice in the Health Care Professions. Booklet 1. HPSCA. Pretoria: HPCSA, 2008.

20. South African Government. Health Professions Act No. 56 of 1974. Section 15B. Government Gazette, 1975.

Accepted 4 June 2014.

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MEDICINE AND THE LAW

Overturning refusal of a hospital to terminate life support for a brain-dead mother until the fetus was born: What is the law in South Africa?

D J McQuoid-Mason David McQuoid-Mason is Professor of Law at the Centre for Socio-Legal Studies, University of KwaZulu-Natal, Durban, South Africa, and publishes and teaches in medical law.

Corresponding author: D J McQuoid-Mason (mcquoidm@ukzn.ac.za)

In a Texas case the court granted a husband an order for the removal of life support from his brain-dead pregnant wife after a hospital tried to keep her on it until the fetus was born. In South Africa the court would have issued a similar order, but for different reasons. Here, unlawfully and intentionally subjecting a pregnant corpse to life-support measures to keep a fetus alive against the wishes of the family would amount to the crime of violating a corpse.

S Afr Med J 2014;104(8):553-554. DOI:10.7196/SAMJ.8164

In a recent American case,[1] the court ordered a hospital to remove life support from a person’s braindead pregnant wife, finding that the woman could not be regarded as a ‘patient’ because she was dead.

Therefore, the Texas Health and Safety Code stating that ‘life support’ must be given to ‘pregnant patients’[2] did not apply to her.[3] A South African court faced with the same situation would have issued a similar order for the removal of life support, but for different reasons, because there is no such Code here.

The Munoz case

Mrs Munoz was 14 weeks pregnant when a suspected pulmonary embolism left her brain dead. When the fetus was at 23 weeks’ gestational age, Mr Munoz sued the hospital after the doctors told him that a Texas law forbade them to withdraw life support from his dead wife until the fetus’s birth or a miscarriage occurred.[4] He asked the court to order the hospital to remove his wife from ‘any respirators, ventilators or other “life support”, and to release the body to her family for proper preservation and burial’.[5] He argued that the Texas Health and Safety Code[2] disallowing the withdrawal of life-sustaining treatment from pregnant patients did not apply to dead people or their fetuses, and that the hospital was treating his wife’s body in a criminal manner and was violating her constitutional rights.[5] Mr Munoz did not mention that the fetus was ‘distinctly abnormal’,[4] because it was not relevant to the case.

The court only considered the first argument and held that the Texas Health and Safety Code[2] did not apply because Mrs Munoz was dead. It ordered the withdrawal of treatment and release of the body, and found it unnecessary to rule on any of the other grounds mentioned in the application.[3] South Africa has no law similar to the Texas Code,[2] so such a ruling would not have been given if Mrs Munoz had died in this country. However, a similar result could have been achieved in South Africa, because of the criminal law protection afforded to deceased persons and the lack of legal status of a fetus in South African law.

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The rights of the dead under the common law

According to the common law, a person’s legal personality ends with death, and a dead person has neither rights nor obligations.[6] However, it protects corpses and regulates their disposal.[7] Dead persons may also preserve their wishes in a valid will in terms of the Wills Act,[8] or ask their next of kin to do certain things for them – even if the latter are not legally enforceable. If there is no will, the deceased person’s next of kin (e.g. a spouse) could therefore request a hospital to maintain the corpse with life support until the child is born. However this only applies if such treatment will not be medically futile, as in the Munoz case where the fetus was ‘distinctly abnormal’.[4] In Canada, a Mrs Robyn Benson who had been declared brain dead when she was 22 weeks pregnant was treated with life support for 6 weeks to enable the child to be born, at her husband’s request.[9]

Violation of a corpse

Although a dead person has no civil claim for interference with their personality rights such as their body, it is a crime to unlawfully and intentionally violate a corpse.[10] However, it would be a good defence if the alleged perpetrators genuinely believed that they had obtained the necessary consent to interfere with the body[10] (e.g. in terms of the National Health Act[11] or the Inquests Act[12]). Otherwise, unlawfully subjecting a corpse to intrusions by life-support mechanisms could be regarded as the crime of violating a corpse in South African law.[10] Mr Munoz’s lawyer stated that the fetus was ‘gestating within a dead and deteriorating body, as a horrified family looks on in absolute anguish, distress and sadness’.[4] Had this case arisen in South Africa, the doctors and hospital would have been acting contrary to good morals (contra bonos mores) and unlawfully. The legal convictions of society would have been outraged[13] that the corpse of a pregnant dead woman, carrying a grossly defective fetus, was being subjected to life-support mechanisms against the wishes of her family.

In South Africa, the doctors and hospital would not be able to raise the defence that they mistakenly believed that they were bound

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to preserve the fetus by a statute like the Texas Code,[2] because there is no such law here. They would be guilty of the common-law crime of violating a corpse by subjecting her dead body to life support.[10]

The fetus and the law

South African law does not regard the fetus as a person, and it is not protected by the Constitution or the common law unless it is born alive.[14] It is not murder to destroy a viable fetus – it is abortion – because a fetus is not regarded as a human being.[15] If the facts of Munoz case are applied to South Africa, no action could have been brought on behalf of the fetus. The death of a fetus is a natural consequence of its mother’s death and the courts would not have interfered. The court would have ordered the hospital to withdraw the life-support treatment and to release Mrs Munoz’s body to her husband.

Conclusions

Unlawfully and intentionally subjecting a dead pregnant woman to life-support measures to keep a fetus alive, where the deceased has not made a will to that effect and against the wishes of the family, may result in a criminal charge of a violating a corpse.

A pregnant deceased woman’s body may be subjected to life support until the baby is born at the request of the next of kin (e.g. a spouse or partner) – provided that it is medically justifiable.

Doctors accused of violating a corpse by subjecting a pregnant deceased woman’s body to life support may raise the defence that they genuinely believed that they had the necessary consent for their conduct.

1. Munoz v John Peter Smith Hospital, Tarrant County District Court, Texas, 24 January 2014 (unreported). Sapa-AP-AFP. Switch of my dead wife, plea. The Mercury 28 January 2014:5.

2. Section 166.049 of Texas Health and Safety Code, 1989.

3. Judgment. Munoz v John Peter Smith Hospital Cause No. 096270080-14 Tarrant County District Court 96th Judicial District Texas 24 January 2014 (unreported). http://thaddeuspope.com/images/ MUNOZ_202053415-Judges-Order-on-Munoz-Matter.pdf (accessed 12 February 2012).

4. Lupkin S. Why Texas foetus might have had ‘abnormalities’ before mother was brain dead. World News. http://abcnews.go.com/Health/texas-fetus-abn (accessed 12 February 2012).

5. Janicek JH, Plaintiff ’s Attorney. Plaintiff ’s Motion to Compel Defendants to remove Marlise Munoz from ‘Life Sustaining’ Measures and Application for Unopposed Expedited Rule. Tarrant County District Court, Texas. 14 January 2014. http://www.scribd.com/199665794/munoz-versus-John-PeterSmith-Hospital (accessed 12 February 2014).

6. Neethling J, Potgieter JM, Visser PJ. Law of Delict. 4th ed. Durban: LexisNexis Butterworth, 2001:259.

7. Christison A, Hoctor S. Criminalisation of the violation of a grave and of a dead body. Obiter 2008;28(1):23-43.

8. Section 2(1) of the Wills Act No. 7 of 1953.

9. Brain-dead woman gives birth to a healthy son, life support removed. http://www.all4women.co.za/ news/brain-dead-woman-gives-birth-to-healthy-son-life-support-removed (accessed 24 March 2014).

10. S v Coetzee 1993 2 SACR 191 (T).

11. National Health Act No. 63 of 2003.

12. Inquests Act No. 58 of 1959.

13. Clarke v Hurst NO 1992 (4) 636 (D).

14. Christian Lawyers Association of South Africa v Minister of Health 1998 (4) SA 1113 (T).

15. Cf. S v Mshumpa 2008 1 SACR 126 (E).

Accepted 19 March 2014.

Ahmad Haeri Mazanderani*† is a registrar in the Department of Medical Virology, Tshwane Academic Division of the National Health Laboratory Service and University of Pretoria. He is a member of the board of management of Child Welfare Tshwane and co-founder and director of the Good Start Foundation, a public benefit organisation assisting orphaned and vulnerable children. Ahmad’s research interests include HIV early infant diagnosis and HIV/ HTLV-1 co-infection. His interest in adoption medicine arose after meeting his daughter, Jamila, on a ward round. Since then Jamila has decided most things for him. As she grows into the most incredible little person, Ahmad hopes that other children in need of alternative care can be provided with the appropriate medical and social services necessary for a better future. Jamila hopes for the same. * Haeri Mazanderani AF, Du Plessis NM, Lumb J, et al. Recommendations for the medical evaluation of children prior to adoption in South Africa. S Afr Med J 2014;104(8):544-549. [http://dx.doi.org/10.7196/SAMJ.7958] †

Haeri Mazanderani AF, Du Plessis NM, Thomas WN, et al. Loss of detectability and indeterminate results: Challenges facing HIV infant diagnosis in South Africa’s expanding ART programme. S Afr Med J 2014;104(8):574-577. [http://dx.doi.org/10.7196/SAMJ.8322]

Angela Mathee*† is director of the Medical Research Council’s Environment and Health Research Unit and of the World Health Organization (WHO) Collaborating Centre for Urban Health. She is a founding member of the Public Health Association of South Africa, and a member of WHO guidelines development groups for lead poisoning prevention and for housing and health. She holds a doctorate in public health from the University of the Witwatersrand for her work on lead exposure in South African children, and a master’s in environmental epidemiology and policy from the London School of Hygiene and Tropical Medicine. She is a Visiting Professor at the University of Johannesburg and an Associate Professor at the University of the Witwatersrand. Her key research interests are currently lead exposure in SA, urban environmental health and the health implications of extreme weather events. * Mathee A, Naicker N, Kootbodien T, et al. A cross-sectional analytical study of geophagia practices and blood metal concentrations in pregnant women in Johannesburg, South Africa. S Afr Med J 2014;104(8):568-573. [http://dx.doi.org/10.7196/SAMJ.7466] †

Wright CY, Mathee A, Garland RM. Climate change, human health and the role of environmental health practitioners. S Afr Med J 2014;104(8):518-519.

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EDITORIAL

Ebola virus disease in West Africa – an unprecedented outbreak Ebola virus disease (EVD) is one of the most feared diseases known to mankind. This is because of the high mortality rate (up to 90%) associated with the disease, and also its propensity for person-to-person spread through close contact with infected tissues and body fluids of affected persons, particularly in the unprotected home-care setting and during preparation of bodies for burial, while spread is amplified in hospitals with poor infection control practices. The disease has nevertheless remained rare since its initial description in 1976, with no more than 2 000 cases diagnosed before 2014.[1] This is why the current outbreak of EVD in West Africa is of particular concern. Not only has the outbreak been raging for more than 6 months – to date, more than 800 cases of EVD have been recorded in the three affected countries of Guinea, Liberia and Sierra Leone[2] – but it accounts for more than a third of the cases of EVD ever reported. Indications are that at the time of writing the outbreak is far from over. It is also noteworthy that this is the first recorded outbreak of EVD in this region of Africa. Historically EVD has been recorded in several central African countries, including the Democratic Republic of Congo (DRC), Sudan, Gabon, Uganda and Congo, with cases imported to South Africa (SA), The Netherlands, Italy and the USA.[1-3] The current outbreak was officially reported by the World Health Organization (WHO) on 23 March 2014. Contact tracing has led to an index case involving a 2-year-old child who died on 6 December 2013 in the Guéckédou Prefecture of Guinea.[4] To date, a total of 408 cases from Guinea, 305 from Sierra Leone and 131 from Liberia have been recorded.[2] The total case tally is probably underestimated owing to inaccessibility of some of villages in the affected areas and reluctance to co-operate on the part of the local communities. The outbreak appeared to have started to wane in April, with certain affected areas not reporting any cases for weeks, but resurged in May, setting off a second wave of cases reported in Sierra Leone and Liberia, and again in Guinea.[2,5,6] The West African outbreak has proved particularly challenging to contain.[6,7] Certainly the extent of its spread across three countries in itself complicates all efforts, as co-ordination must be achieved across three separate healthcare jurisdictions involving the different healthcare authorities and role players in each of the countries. The affected regions generally represent resource-poor settings, with healthcare systems struggling to meet the everyday healthcare needs of the communities they serve. A haemorrhagic fever outbreak requires a comprehensive and intensive public health response that would put even an ideal healthcare system to the test. Substantial external support is always required during these events to ensure appropriate clinical management of patients, sufficient infection control procedures in difficult healthcare environments, intensive contact tracing to identify the chains of transmission of the virus (key to eventually containing the disease from further spread), appropriate risk communication to the affected communities, and comprehensive logistical support to tie everything together.

Specialised and rapid laboratory responses are required to confirm or exclude diagnosis in suspected cases. Laboratory testing in this setting must also provide a differential diagnosis for Lassa fever, a haemorrhagic fever endemic to and commonly reported from the affected areas, among other likely causes of disease that may present with similar clinical features. Community perceptions, fears and reluctance to co-operate can be especially problematic, and communication barriers must be bridged by well-designed

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and understandable health messages. The prolonged nature of the outbreak is also imposing a burden on the support teams that are expected to work long hours away from home. A summit was co-ordinated by the WHO in Ghana in July 2014 to address these very issues, strategise resources for the months ahead, and put an action plan on the table.[6] EVD is caused by the Ebola virus, a filovirus that is thought to be har­boured by specific arboreal bat species in the affected reg­ions.[1] The current theory regarding the ecology of the virus holds that the virus is harboured by these bat species (bat-to-bat transmission, pathology and immunity features in bats are still to be definitively described) with incidental spillover (mechanism of transmission still to be proven) of the virus to other animal species (various species of antelope and primate have been found to be infected with Ebola virus). The virus may then spill over to the human population through contact between infected animals and humans, or direct contact with infected bats. The mode of transmission to the human population remains to be elucidated. Once the virus has entered the human population, outbreaks of EVD are often characterised by transmission of the virus in close family clusters and in the nosocomial setting.[1] Five strains of Ebola virus, which are genetically and antigenically distinct, have been identified over the years. These include the Tai Forest, Reston, Sudan, Zaire and Bundibudyo viruses (Bundibudyo virus was identified for the first time during an outbreak in Uganda in 2008). The latter three strains have been associated with sizeable outbreaks in sub-Saharan Africa, with mortality rates of 30 - 90%. These viruses differ in geographical spread, and the Zaire Ebolavirus has been associated with the most fatal outbreaks to date.[1] The mortality rate of the current outbreak fluctuates with the identification of new cases, but is reported to be in the range of 60 - 70%.[2,6] The current outbreak is caused by a variant of Zaire Ebolavirus with 97% sequence identity to strains isolated from the DRC and Gabon, suggesting a parallel evolution of this virus in the affected area as opposed to introduction from these endemic areas.[4] Common clinical features of patients during this outbreak have included fever and severe diarrhoea with vomiting; however, bleeding manifestations have not been a regular finding.[4] Generally, early signs and symptoms of EVD are very nonspecific and need to be differentiated from other causes of acute febrile illness that occur in the area, notably malaria, typhoid and bacterial dysentery. The typical signs and symptoms of EVD include fever, chills, malaise, myalgia and often a maculopapular rash. The disease progresses rapidly to multisystem involvement that may include systemic, gastrointestinal, respiratory and vascular features.[1] Patients may present with an apparent acute abdomen, and the surgical interventions that may follow represent a further risk for infection on the part of healthcare workers. Haemorrhagic manifestations, if present, may include petechiae, ecchymoses, bleeding from venepuncture sites and mucosal haemorrhages.

Clinical management of cases involves employing strict isolation procedures and providing symptomatic and supportive treatment as required. No specific antiviral treatments or pre- or post-exposure vaccines have been approved or registered for use against EVD. Various drugs and vaccine candidates are reportedly at various stages of evaluation.[1] Interestingly, ribavirin which is broadly effective against many haemorrhagic fever viruses, appears to have no effect on Ebola virus.[8] To date, no cases of EVD related to this outbreak have been reported in or confirmed to have been exported to SA. In 1996 EVD

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was confirmed in a nurse working in a Johannesburg hospital, who was probably exposed during a procedure performed on a medical practitioner who was being investigated for an unknown febrile illness with jaundice. He presented to the Johannesburg facility as a self-referral from his work place in Libreville, Gabon. The patient was probably infected while caring for patients during an EVD outbreak in Gabon at that time. Tragically, the nurse died, and the diagnosis of EVD was confirmed retrospectively on the doctor, who survived.[3] The risk of EVD in SA travellers to the regions affected by the current outbreak would be considered low, given that casual contact with infected persons does not pose a risk. However, although malaria is much more likely, a high index of suspicion needs to be in place for EVD, or other haemorrhagic fevers such as Lassa fever, in any patient presenting with an unexplained fever who has been travelling in the affected regions. Healthy persons returning from these areas do not require quarantine. The National Institute for Communicable Diseases has the capacity for rapid, reliable and specialised differential diagnoses of viral haemorrhagic fevers, including EVD, which is integral to the response to any suspected case(s) that may present to SA healthcare facilities.

Jacqueline Weyer Centre for Emerging and Zoonotic Diseases, National Institute for Communicable Diseases, National Health Laboratory Service, Sandringham, Johannesburg, South Africa

Lucille H Blumberg Division for Surveillance and Outbreak Response, National Institute for Communicable Diseases, National Health Laboratory Service, Sandringham, Johannesburg, South Africa Janusz T Paweska Centre for Emerging and Zoonotic Diseases, National Institute for Communicable Diseases, National Health Laboratory Service, Sandringham, Johannsburg, South Africa Corresponding author: L H Blumberg (lucilleb@nicd.ac.za) 1. Feldmann H, Geisbert TW. Ebola haemorrhagic fever. Lancet 2011;337:849-862. [http://dx.doi. org/10.1016/S0140-6736(10)60667-8] 2. Centers for Disease Control and Prevention. Outbreak of Ebola in Guinea, Liberia and Sierra Leone. http://www.cdc.gov/vhf/ebola/outbreaks/guinea/ (accessed 9 July 2014).

3. Richards GA, Murphy S, Jobson R, et al. Unexpected Ebola virus in a tertiary setting: Clinical and epidemiological aspects. Crit Care Med 2000;28(1):240-244. [http://dx.doi.org/10.1097/00003246200001000-00041] 4. Baize S, Pannetier D, Oestereich L, et al. Emergence of Zaire Ebola Virus disease in Guinea – preliminary report. N Engl J Med 2014. Epub: 16 April 2014. [http://dx.doi.org/10.1056/NEJMoa1404505] 5. Dixon MG, Schafer IJ. Ebola viral disease outbreak – West Africa 2014. MMWR Morb Mortal Wkly Rep 2014;63(25):548-551.

6. World Health Organization. Ebola virus disease, West Africa updates. http://www.afro.who.int/en/ clusters-a-programmes/dpc/epidemic-a-pandemic-alert-and-response/outbreak-news/4217-ebolavirus-disease-west-africa-7-july-2014.html (accessed 9 July 2014).

7. Waddington C. Ebola outbreak in Guinea: A different type of regional stability threat. Africa Conflict Monthly Monitor 2014;May:47-50.

8. Ignatyev G, Steinkasserer A, Streltsova M, et al. Experimental study of possibility of treatment of some haemorrhagic fevers. J Biotechnol 2000;83:67-76. [http://dx.doi.org/10.1016/S0168-1656(00)00300-X]

S Afr Med J 2014;104(8):555-556. DOI:10.7196/SAMJ.8672

Intimate partner violence: How should health systems respond?

Intimate partner violence (IPV) is a common and devastating feat­ure of partnerships worldwide, and South Africa (SA) is no exception. In 2013, the publication of World Health Organization (WHO) clinical and policy guidelines for responding to IPV and sexual violence[1] supported the growing acknowledgement that IPV should be viewed as an issue directly related to health, and outlined an appropriate response from policy makers and healthcare providers. IPV is important to health systems because of the wide-ranging and serious health effects experienced by exposed women, as well as the unique opportunity afforded to healthcare providers to enquire about violence. IPV and gender inequality are also features of the complex network of causes driving the HIV epidemic in sub-Saharan Africa. In SA, where there is an extremely high burden of interpersonal violence, gender-based violence and HIV, IPV should be treated as a priority health concern.

For health services, one of the major implications is that healthcare providers should be supported in enquiring about and responding to IPV during healthcare encounters. There is sufficient evidence that intervening for IPV in a primary healthcare setting can be beneficial.

A recent systematic review of interventions found that 76% of 17 included studies showed reductions in IPV or improvement in other health outcomes.[2] Universal screening for IPV is controversial, although the need to identify cases non-routinely in healthcare settings is widely accepted. The US Preventive Services Task Force has recommended universal screening for IPV in women of child­ bearing age since 2013.[3] However, more recently a rigorously conducted randomised controlled trial (the WEAVE study) found

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no difference in primary outcomes between women who were routinely screened for violence and a control group.[4] This trial, in addition to prior evidence,[5,6] has led to the expert conclusion that universal screening for IPV is ineffective in improving health.[7] Although screening is able to identify women experiencing IPV, uptake of interventions is impeded by numerous barriers and is often low, and current intervention approaches have not yet proved beneficial in asymptomatic women.

Enquiring about and discussing violence in specific cases during healthcare encounters (case finding) has been recommended as an alternative approach,[7,8] followed by more complex, individualised interventions. This approach has been demonstrated to be feasible, with a cluster randomised controlled trial showing that training and support can significantly increase the number of women identified and referred to services in the absence of universal screening.[9] Women who have experienced IPV have consistently described an appropriate response by healthcare providers to be nonjudgemental, understanding and empathetic.[10] Women want their healthcare providers to understand the complexities and consequences of living with violence, and the difficulties they face because of it.[11] They also want an acknowledgement from their providers that what they are experiencing is abuse, and that it is unacceptable and wrong.[12] These features are highlighted in the WHO guidelines, which recommend that healthcare providers enquire about IPV when it may be relevant, and then provide women-centred care by maintaining confidentiality, supporting women in a non-judgemental manner, asking about a history of violence, and helping women to access information and increase their safety.[1] Examples of encounters dur­

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ing which IPV should be raised include those concerning symptoms of common mental health disorders, alcohol and substance abuse, chronic pain or other unexplained symptoms, sexually transmitted infections and pregnancy or family planning.

Overall, the appropriateness of the healthcare encounter depends on the empathetic and non-directive attitude of the provider, the attention paid to emotional issues and the maintenance of confidentiality. If these elements are present, women experiencing IPV usually view the issue of violence being raised by a healthcare provider as supportive and helpful.

Despite the knowledge that healthcare provider intervention in IPV can be of benefit to patients, the evidence base informing the scaleup of IPV interventions and their integration into health systems is lacking.[13] IPV interventions are complex, and require colla­boration between many sectors such as health, social services and criminal justice, as well as systems that facilitate these. They therefore require more than provider training to enable effective programme functioning within a health system.

Examples of published investigations do, however, provide lessons of interest to those wishing to institute an appropriate response to IPV. In Malaysia, the national scale-up of One Stop Crisis Centres, an integrated health sector response to IPV, was investigated.

Factors relating to health system structure and organisation, as well as external policy constraints, were found to be barriers to implementation.[13] Several system-level factors arising from this case study could be applicable in other contexts. Commitment at policy level was found to be necessary, which could be communicated to service delivery level by incorporating appropriate indicators into routine reporting. Adequate training, as well as adjustments to service delivery to ensure that providers had the necessary time and privacy available to them, was required. Finally, flexibility of the model was important to allow its implementation at different levels of care.

An investigation of the integration of gender-based violence laws into the regional health systems of Spain found institutionalisation to be a challenge.[14] Advances were often made through the actions of highly motivated individuals, raising concerns about sustain­ ability. Budget allocation was found to be a key component of institutionalising change. It was also noted that since IPV is complex to respond to, protocols, while necessary, were insufficient and need to be supported by adequate training.[14] In SA, Vezimfilho, a model health sector response to IPV, was developed and implemented in four districts.[15] Important findings from an evaluation of the implementation process included the need for a systemic response, with political commitment, policies, protocols and effective referral systems being essential.[15] In addition, training and capacity building needed to include addressing values and attitudes towards IPV and gender norms, as well as interpersonal skills in healthcare providers. Support from managers in the health system and strong relationships between multiple stakeholders were found to be key to a sustainable approach.[15] System-level barriers to implementation included insufficient staff and lack of confidence in managerial support, while on a societal level providers’ attitudes and perceptions relating to gender hampered implementation.[15] The societal barriers relating to gender imply that a comprehensive health sector response requires advocating for wider social change.

In conclusion, there is sufficient evidence that IPV is a pervasive, serious public health concern, and that addressing IPV in health services has the potential to improve outcomes. Furthermore, in countries such as SA, addressing IPV and gender inequality should form an integral part of HIV prevention programmes.

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For policy makers, there is an urgent need for policies and protocols that clearly frame IPV as an important health issue and support healthcare providers in enquiring about and responding to IPV. There is also a need for comprehensive undergraduate and in-service training, both allowing intervention for IPV to be viewed as an integral part of a healthcare provider’s job, and imparting the knowledge and skills to enable this.

Individual healthcare providers should familiarise themselves with the content of the WHO clinical and policy guidelines for responding to IPV and sexual violence against women. They should enquire about IPV, support women who have disclosed violence in a nonjudgemental manner, and encourage their management structures to develop protocols if these do not exist.

For researchers, there is a need for the development and evaluation of health sector responses to IPV, to assist health systems in determining the most appropriate models of care, and how these can be integrated into current systems, in the context of multiple systemic and societal barriers. Further research is needed to explore how best to support health services in providing IPV care, how to operationalise intersectoral approaches to IPV in health systems, and how to improve access to, including acceptability of, services. The need for this research should not prevent health systems from implementing IPV care, but should guide the development of rigorous, contextually appropriate evaluations.

Kate Rees Virginia Zweigenthal Division of Public Health, Faculty of Health Sciences, University of Cape Town, South Africa Kate Joyner Nursing Division, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa Corresponding author: K Rees (reeskste@gmail.com) 1. World Health Organization. Responding to Intimate Partner and Sexual Violence Against Women: WHO Clinical and Policy Guidelines. Geneva: WHO, 2013. http://www.who.int/reproductivehealth/publications/ violence/9789241548595/en/ (accessed 28 May 2014).

2. Bair-Merritt MH, Lewis-O’Connor A, Goel S, et al. Primary care-based interventions for intimate partner violence: A systematic review. Am J Prev Med 2014;46(2):188-194. [http://dx.doi.org/10.1016/j. amepre.2013.10.001] 3. Moyer VA. Screening for intimate partner violence and abuse of elderly and vulnerable adults: US Preventive Services Task Force recommendation statement. Ann Intern Med 2013;158(6):478-486. [http:// dx.doi.org/10.7326/0003-4819-158-6-201303190-00588] 4. Hegarty K, O’Doherty L, Taft A, et al. Screening and counselling in the primary care setting for women who have experienced intimate partner violence (WEAVE): A cluster randomised controlled trial. Lancet 2013;382(9888):249-258. [http://dx.doi.org/10.1016/S0140-6736(13)60052-5] 5. Klevens J, Kee R, Triack W, et al. Effect of screening for partner violence on women’s quality of life: A randomized controlled trial. JAMA 2012;308(7):681-689. [http://dx.doi.org/10.1001/ jama.2012.6434] 6. MacMillan H, Wathen C, Jamieson E, et al. Screening for intimate partner violence in health care settings: A randomized trial. JAMA 2009;302(5):493-501. [http://dx.doi.org/10.1001/jama.2009.1089] 7. Jewkes R. Intimate partner violence: The end of routine screening. Lancet 2013;382(9888):190-191. [http:// dx.doi.org/10.1016/S0140-6736(13)60584-X] 8. Joyner K, Mash B. A comprehensive model for intimate partner violence in South African primary care: Action research. BMC Health Serv Res 2012;12:399. [http://dx.doi.org/10.1186/1472-6963-12-399] 9. Feder G, Davies RA, Baird K, et al. Identification and referral to improve safety (IRIS) of women experiencing domestic violence with a primary care training and support programme: A cluster randomised controlled trial. Lancet 2011;378(9805):1788-1795. [http://dx.doi.org/10.1016/S01406736(11)61179-3] 10. Robinson L, Spilsbury K. Systematic review of the perceptions and experiences of accessing health services by adult victims of domestic violence. Health Soc Care Community 2008;16(1):16-30. [http://dx.doi. org/10.1111/j.1365-2524.2007.00721.x] 11. Narula A, Agarwal G, McCarthy L. Intimate partner violence: Patients’ experiences and perceptions in family practice. Fam Pract 2012;29(5):593-600.

12. Chang JC, Cluss PA, Ranieri L, et al. Health care interventions for intimate partner violence: What women want. Womens Health Issues 2005;15(1):21-30.

13. Colombini M, Mayhew SH, Ali SH, Shuib R, Watts C. An integrated health sector response to violence against women in Malaysia: Lessons for supporting scale up. BMC Public Health 2012;12:548. [http:// dx.doi.org/10.1186/1471-2458-12-548] 14. Goicolea I, Briones-Vozmediano E, Ohman A, Edin K, Minvielle F, Vives-Cases C. Mapping and exploring health systems’ response to intimate partner violence in Spain. BMC Public Health 2013;13:1162. [http:// dx.doi.org/10.1186/1471-2458-13-1162] 15. Jacobs T, Jewkes R. Vezimfilho : A model for health sector response to gender violence in South Africa. Int J Gynecol Obstet 2002;78(Suppl 1):51-56.

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Professionalism is key in providing services to lesbian, gay, bisexual, transgender and intersex South Africans I recently interviewed a young gay man who was hospitalised after he fractured both his arms while fleeing a group of men who threatened to beat him up for being gay. The nurse in the emergency ward to which he was admitted abruptly changed her caring attitude towards him when he explained why he was running away from his attackers. She asserted that he deserved the attack, berated him for his ‘un-Christian’ behaviour, and ridiculed him in front of other nurses. He has not attended any health facility since this experience. In another interview, a young lesbian woman described her attempt to get tested for HIV at a voluntary counselling and testing facility. Upon hearing that she had had sex only with women, the HIV counsellor told her that she did not qualify for an HIV test because she was not at risk, and told her to go home.

In my experience researching and teaching healthcare for lesbian, gay, bisexual, transgender and intersex (LGBTI) people, these nurses’ reactions are not surprising. Sexual and gender minority health is hardly covered in medical or nursing school. Many doctors and nurses have never learned to challenge their own attitudes towards sexual and gender minorities, nor have they received information about the health needs of this population. As a result, otherwise knowledgeable and competent health professionals are not informed about the basic issues that are essential for providing adequate care to sexual and gender minorities.

Such educational gaps persist despite a growing number of reports that indicate a need for greater attention to be paid to the health of LGBTI people. In the USA, the Healthy People 2010 report of the Department of Health and Human Services[1] identified LGBTI Americans as one of six groups that are most affected by health disparities. A 1999 report from the American Institute of Medicine, which evaluated the strength of existing research on the physical and mental health of lesbian women, suggested that ‘misconceptions about risk … can negatively affect both the ability of lesbians to seek health care and access treatment’.[2] In South Africa (SA), we know that 10% of women who identify themselves as lesbian or bisexual or have occasional sex with women are infected with HIV,[3] but this knowledge is not usually included in infectious disease education.

Women who have sex with women (WSW) are not mentioned in the Department of Health’s current National Strategic Plan for HIV, TB and STIs.[4] Given the current dearth of sexual and gender minority health content in health professions curricula, it appears that not enough is done to educate our doctors and nurses about the medical needs of this population. In their turn, WSW are ignorant or misinformed about their health risks and, perceiving themselves not at risk for HIV, do not engage in safer sex.[5] Similarly, it is known that gay men and men who have sex with men (MSM) have higher levels of HIV infection than the general population.

Studies by Lane et al.[6] and Rispel et al.[7] suggest that the prevalence of HIV among MSM in Johannesburg and Durban is as high as 34 - 50%.

The current National Strategic Plan recognises MSM as a key at-risk population, yet if prevalence trends among MSM are not acknowledged in health professions education, doctors and nurses are unlikely to pay adequate attention to the necessary messages of prevention and treatment that the National Strategic Plan calls for.

The disparities in health between sexual and gender minorities and the general population go much further than infectious disease. Studies from the USA have shown that lesbian, gay, bisexual and transgender

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people battle with depression, anxiety and other mental health conditions more often than their socioeconomically matched heterosexual peers.[8] While sexual orientation per se is of course not a pathological condition (the American Psychological Association recognised its prejudice and removed homosexuality from its DSM classification in 1972), the discrimination, homophobia and violence faced by sexual and gender minorities puts them at considerable risk for mental and physical ill health. As a result, researchers who have demonstrated how social exclusion leads to poorer health outcomes among sexual and gender minorities have recently requested that sexual orientation and gender identity be classified as a social determinant of health.[9] In SA, the surge in cases of so-called ‘corrective rape’ – violence against gender non-conforming women – provides a compelling example of why it is important to take sexual orientation and gender identity into account when assessing people’s risk of being victims of violence.[10] As the experience of the young man recounted above suggests, lack of knowledge about health risks and disparities, and lack of recognition of the social context in which they live, are not the only barriers that LGBTI people face when accessing healthcare. Recent local studies confirm that this young man’s story is not an isolated incident.

Lane et al.[11] report that all the gay men in their study who visited public clinics in the Soweto area experienced name-calling, ridiculing or other forms of discrimination. Similarly, 60% of transgender respondents in a study by Stevens[12] had negative experiences in public clinics. This ties in with an SAMJ report on the sidelining of transgender patients in health facilities.[13] The non-governmental organisation (NGO) OUT LGBT Wellbeing, based in Pretoria, reports that 12% of gay men and lesbian women in Gauteng Province and 13% in KwaZulu-Natal delayed seeking treatment at clinics because of fear of discrimination, while 6% of participants in Gauteng and 5% in KwaZulu-Natal had been refused treatment because of their sexual orientation.[14,15] These findings are not surprising, given that 61% of South Africans think that homosexuality is ‘not acceptable’.[16] As part of the broader community, doctors and nurses tend to share the attitudes and values of the general population.

Article 9 of the SA Constitution[17] grants sexual and gender min­ orities protection from discrimination based on sexual orientation.

The ethical rules of conduct for health professionals registered under the Health Professions Act of 1974[18] state that practitioners should at all times act in the best interests of the patient, respect patients’ choices and dignity, and maintain the highest standards of personal conduct and integrity (section 27A). The Health Professions Council of South Africa (HPCSA)’s core ethical values and guidelines for good practice elaborate on these obligations and highlight that health professionals should make sure that ‘their personal beliefs do not prejudice their patients’ health care’.[19] Gender and sexual orientation are specifically named as examples in which personal beliefs might affect the treatment offered to a patient (section 5.1.5). The HPCSA guidelines state that doctors and nurses have an ethical obligation to treat LGBTI patients in a non-discriminatory and non-judgemental manner, regardless of their own personal beliefs and attitudes towards homosexuality. Sadly, the findings reported in the previous paragraph suggest that in many clinics and hospitals this is not the case.

What can we do to decrease discrimination against sexual and gender minorities, and to improve healthcare for this vulnerable population? Attitudes, knowledge and skills are inter-related, and the education of health professionals is key. Doctors and nurses play

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a crucial role in ensuring that sexual and gender minorities receive competent, non-discriminatory and non-judgemental care. We need to provide our health professionals with the clinical knowledge and skills to provide adequate care to lesbian women, gay men, bisexual men and women, and transgender and intersex people. We need to include sexual and gender minority health information in the existing medical and nursing curricula, and offer the same information in continuing professional development courses.[20] We need to ensure that health prevention and promotion messages and materials address the needs of sexual and gender minorities; that HIV prevention includes condoms and lubricants for anal sex, and dental dams for female oral sex; that general practitioners know about the basic health needs of transgender people in order to provide support and advice about specialised services; and that health professionals are aware of the existence of specialised services for sexual and gender minorities such as ANOVA health centres (for MSM), or services provided

by NGOs such as Triangle Project in Cape Town and OUT LGBT Wellbeing in Pretoria. We need to become aware of how our language and our own assumptions can exclude people: for example, that we should use the word ‘partner’ rather than ‘boyfriend’ or ‘husband’ when enquiring about a woman’s relationship.

Most importantly, however, we need to emphasise the ethical and constitutional obligations of health professionals to provide nondiscriminatory and non-judgemental services, regardless of their own beliefs about sexual and gender minorities. Health professionals need to become competent, supportive care providers for LGBTI patients – and not potentially serve as gatekeepers to care.

Alexandra Muller Health and Human Rights Division, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa Corresponding author: A Muller (alexandra.muller@uct.ac.za)

1. US Department of Health and Human Services. Healthy People 2010: Understanding and Improving Health. 2nd ed. Washington, DC: Government Printing Office, 2000.

2. Solarz AL, ed. Institute of Medicine. Lesbian Health – Current Assessment and Directions for the Future. Washington, DC: National Academy Press, 1999.

3. Sandfort TGM, Baumann LRM, Matebeni Z, Reddy V, Southey-Swartz I. Forced sexual experiences as risk factor for self-reported HIV infection among southern African lesbian and bisexual women. PLoS One 2013;8(1):e53552. [http://dx.doi.org/10.1371/journal.pone.0053552] 4. Department of Health. National Strategic Plan for HIV, TB and STIs 2012 - 2016. Pretoria: National Department of Health, 2012.

5. Matebeni Z, Reddy V, Sandfort T, Southey-Swartz I. ‘I thought we are safe’: Southern African lesbians’ experiences of living with HIV. Cult Health Sex 2013;15(Suppl, May):34-47. [http://dx.doi.org/10.108 0/13691058.2013.764016] 6. Lane T, Raymond HF, Dladla S, et al. High HIV prevalence among men who have sex with men in Soweto, South Africa: Results from the Soweto Men’s Study. AIDS Behav 2011;15(3):626-634. [http:// dx.doi.org/10.1007/s10461-009-9598-y] 7. Rispel LC, Metcalf CA, Cloete A, Reddy V, Lombard C. HIV prevalence and risk practices among men who have sex with men in two South African cities. J Acquir Immune Defic Syndr 2011;57(1):69-76. [http://dx.doi.org/10.1097/QAI.0b013e318211b40a] 8. Mayer KH, Bradford JB, Makadon HJ, Stall R, Goldhammer H, Landers S. Sexual and gender minority health: What we know and what needs to be done. Am J Public Health 2008;98(6):989-995. [http:// dx.doi.org/10.2105/AJPH.2007.127811] 9. Logie C. The case for the World Health Organization’s Commission on the Social Determinants of Health to address sexual orientation. Am J Public Health 2012;102(7):1243-1246. [http://dx.doi. org/10.2105/AJPH.2011.300599] 10. Mkhize N, Bennett J, Reddy V, Moletsane R. The Country We Want to Live in – Hate Crimes and Homophobia in the Lives of Black Lesbian South Africans. Cape Town: HSRC Press, 2010.

11. Lane T, Mogale T, Struthers H, McIntyre J, Kegeles SM. ‘They see you as a different thing’: The experiences of men who have sex with men with healthcare workers in South African township communities. Sex Transm Infect 2008;84(6):430-433. [http://dx.doi.org/10.1136/ sti.2008.031567] 12. Stevens M. Transgender Access to Sexual Health Services in South Africa? Cape Town: Gender Dynamix, 2012.

13. Bateman C. Transgender patients sidelined by attitudes and labelling. S Afr Med J 2011;101(2):91-93.

14. Wells H. Levels of Empowerment Among Lesbian, Gay, Bisexual and Transgender (LGBT) People in KwaZulu-Natal, South Africa. Pretoria: OUT, 2006.

15. Wells H, Polders L. Levels of Empowerment Among Lesbian, Gay, Bisexual and Transgender (LGBT) People in Gauteng, South Africa. Pretoria: OUT, 2006.

16. Pew Research Center. A global study on societal acceptance of homosexuality. June 2013. http://www. pewglobal.org/files/2013/06/Pew-Global-Attitudes-Homosexuality-Report-FINAL-JUNE-4-2013.pdf (accessed 5 May 2014).

17. Department of Justice and Constitutional Development. The South African Constitution, 1996.

Pretoria: Department of Justice and Constitutional Development, 1996. http://www.justice.gov.za/ legislation/constitution/constitution.htm (accessed 2 July 2014).

18. Republic of South Africa. The Health Professions Act 56 of 1974. Government Gazette, 2006. http:// www.gov.za/documents/download.php?f=172610 (accessed 2 July 2014).

19. Health Professions Council of South Africa. General Ethical Guidelines for the Health Care Professions.

Pretoria: HPCSA, 2008.

20. Muller A. Strategies to include sexual orientation and gender identity in health professions education.

African Journal of Health Professions Education (in press).

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Time to reduce CD4+ monitoring for the management of antiretroviral therapy in HIV-infected individuals The relative importance of laboratory monitoring in HIV/AIDS programmes in low- and middleincome countries has been the subject of considerable debate over the past decade. The recent changes in South Africa (SA)’s HIV treatment guidelines focus primarily on maintaining a low viral load (VL) (preferably undetectable VL: <40 copies/ml) to reduce the risk of transmission and drug resistance.[1] Monitoring of HIV/AIDS and associated opportunistic infections represents a significant challenge to resourcelimited countries, where the potential total cost of disease monitoring may exceed the annual health budget. Many obstacles are noted in the provision of affordable and accessible laboratory monitoring for HIV/AIDS, including limited laboratory infrastructure, absence of technical skills, high reagent costs and large capital outlay costs for sophisticated equipment.[2] CD4+ cell count testing has been central to monitoring disease progression, determining the need for antiretroviral therapy (ART), and assessing response to treatment. Efforts continue to expand access to CD4+ measurement capacity, and a rich research and development pipeline promises a range of point-of-care CD4+ tests

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that can potentially improve linkage to care and reduce time to treatment initiation.[3] National and international guidelines generally recommend a CD4+ test at baseline and then 6-monthly thereafter.[4,5] The threshold for initiation of ART based on a public health approach and World Health Organization (WHO) recommendations has increased from ≤200 cells/μl in the original 2002 WHO guidelines to ≤350 cells/μl in 2010 and ≤500 cells/μl in 2013, with the proviso that individuals with CD4+ counts <350 cells/μl remain the priority treatment group.[6] In addition, it is recommended to start certain high-risk populations on treatment irrespective of CD4+ cell count, such as HIV-infected pregnant or breastfeeding women, patients with active tuberculosis and/or hepatitis B with severe chronic liver disease, children <5 years of age, and the HIV-infected partner in serodiscordant couples.[6] While there remains a clear role for the CD4+ count in establishing baseline health status and focusing treatment provision on patients at higher risk of death, the role of CD4+ in the monitoring of ART efficiency once patients have started ART is under scrutiny. In SA, a bold step was made to recommend against routine CD4+ monitoring after

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the first year on ART.[7] Treatment targets using the 2010 monitoring guidelines[7] would have meant that an estimated 7 million CD4+ tests would have been conducted in the 2013/2014 fiscal year, requiring a doubling of laboratory CD4+ capacity. For these reasons, and the fact that ART is altered on the basis of VL monitoring rather than the CD4+ count, stopping routine CD4+ for monitoring ART beyond the first year was recommended, unless the individual was ill. This single change has reduced the CD4+ cost estimates in SA by 51% (data modelled between 2013 and 2017), resulting in potential savings of over R740 million over the 5-year period (K Schnippel, personal communication).

Studies have questioned the reliability of CD4+ monitoring as opposed to VL monitoring in determining the need for a change in treatment to second- or third-line regimens. A recent meta-analysis of seven studies that assessed the accuracy of clinical or immunological criteria to define virological failure found very poor sensitivity (26.6%) and positive predictive values (49.4%).[8] The consensus reached from several studies is that VL testing is the most reliable method of determining treatment failure.[9] Questioning the value of the CD4 + test has also gained momentum globally, and a recent analysis of data from the USA found that patients with CD4+ counts >300 cells/µl and virological suppression (defined as a VL <200 copies/ml) were unlikely to experience a dip in CD4+ count below 200 cells/µl; rather, 97% of individuals maintained CD4+ counts above 200 cells/μl for a period of 4 years.[10] Similar studies among adults in Uganda[11] and children in SA[12] have confirmed that the CD4+ cell count does not decline significantly in the vast majority of patients who respond to treatment and are virologically suppressed. Reflecting this growing evidence base, the WHO released a technical document in March 2014 summarising the considerations in support of a move towards stopping routine CD4+ monitoring where VL monitoring is available.[13] In the most recent WHO guidelines,[14] access to VL monitoring is recommended as the preferred approach to support adherence, detect treatment failure early, assess transmission risk and avoid keeping individuals on failing regimens, especially as rates of drug resistance begin to rise in developing countries. Resources and research and development should therefore be channelled to both VL and HIV drug resistance testing.

So what could be the future role of the CD4+ cell count in settings where VL monitoring is available? Many countries with a high HIV burden will probably continue to use the CD4+ cell count to determine ART eligibility. The count at presentation also provides valuable information about disease risk and the need for prophylaxis, diagnosis and treatment of certain opportunistic infections. CD4+ cell counts will therefore continue to be of value for pre-ART patients, but more efforts are required to make them more meaningful and reduce the currently high attrition rates (only 57% of SA patients initially determined as being not yet eligible for treatment return for repeat CD4+ testing and eventually ART,[15] and similar challenges are reported from the USA[16]). Point-of-care CD4+ testing has been promoted as one way to improve linkage to care, and while there is evidence of reduced pre-ART attrition associated with the use of point-of-care CD4+ devices,[17] other efforts are also needed to ensure maintenance of linkage to care.

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The historical approach of monitoring both CD4+ and VL in patients on ART, developed in high-income settings, is a misuse of scarce laboratory resources. HIV programmes should prepare for a shift away from CD4+ for routine monitoring of stable ART patients. This will require moving away from CD4+ for routine ART monitoring where VL testing is routinely available, as in SA, and therefore utilisation of VL as the benchmark of treatment success.

Disclaimer. This article represents the views of the authors and does not necessarily represent the views of their organisations.

Wendy S Stevens Department of Molecular Medicine and Haematology, University of the Witwatersrand and National Health Laboratory Service, Johannesburg, South Africa Nathan Ford Department of HIV/AIDS, World Health Organization, Geneva, Switzerland Corresponding author: W S Stevens (wendy.stevens@nhls.ac.za) 1. South African Antiretroviral Treatment Guidelines 2013. 2014. http://www.kznhealth.gov.za/ medicine/2013_art_guidelines.pdf (accessed 3 July 2014).

2. Glencross DK, Mendelow BV, Stevens WS. Laboratory monitoring of HIV/AIDS in a resource-poor setting. S Afr Med J 2003;93(4):262-263.

3. World Health Organization/UNITAID. UNITAID/HIV/AIDS: Diagnostic Technology Landscape.

Semi-annual Update 2013. Geneva: WHO, 2013. http://www.unitaid.org/images/UNITAID_2013_Semiannual_Update_HIV_Diagnostics_Technology_Landscape.pdf (accessed 20 March 2014).

4. British HIV Association. Treatment of HIV-1 Positive Adults. 2013. http://www.bhiva.org/documents/ Guidelines/Treatment/2012/ (accessed 20 March 2014).

5. World Health Organization. Consolidated Guidelines on the Use of Anti-retrovirals for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach. 2013. Geneva: WHO, 2013. http://www.who.int/hiv/pub/guidelines/arv2013/download/en/ (accessed 20 March 2014).

6. Doherty M, Ford N, Vitoria M, Weiler G, Hirnschall G. The 2013 WHO Guidelines for Antiretroviral Therapy: Evidence-based recommendations to face new epidemic realities. Curr Opin HIV AIDS 2013;8(6):528-534. [http://dx.doi.org/10.1097/COH.0000000000000008] 7. South African Antiretroviral Treatment Guidelines 2010. 2011. http://www.uj.ac.za/en/corporateservices/ ioha/documentation/documents/art%20guideline.pdf (accessed 3 July 2014).

8. Rutherford GAA, Easterbrook P, Horvath T, Vitoria M, Penazzato M, Doherty M. Predicting treatment failure in adults and children on antiretroviral therapy: A systematic review of the performance characteristics of the World Health Organization’s 2010 criteria for virological failure. AIDS 2014;28(Suppl 2):S161-S169. [http://dx.doi.org/10.1097/QAD.0000000000000236] 9. Reynolds SJ, Nakigozi G, Newell K, et al. Failure of immunologic criteria to appropriately identify antiretroviral treatment failure in Uganda. AIDS 2009;23(6):697-700. [http://dx.doi.org/10.1097/ QAD.0b013e3283262a78] 10. Gale HB, Gitterman SR, Hoffman HJ, et al. Is frequent CD4+ T-lymphocyte count monitoring necessary for persons with counts ≥300 cells/µL and HIV-1 suppression? Clin Infect Dis 2013;56(9):1340-1343. [http:// dx.doi.org/10.1093/cid/cit004] 11. Reynolds S, Sempa J, Kiragga AN, et al. Is CD4 monitoring needed among Ugandan patients achieving a virological response to ART? Presented at the 21st Conference on Retroviruses and Opportunistic Infections (CROI), Boston, 3-6 March 2014. Abstract 561.

12. Davies M-A, Fatti G, Stinson K, et al., for the IeDEA Southern Africa Pediatric Collaboration. Can CD4 monitoring in virologically suppressed children on antiretroviral therapy be reduced or stopped?

Presented at the 18th International Workshop on HIV Observational Databases, Sitges, Spain, 27-29 March 2014.

13. World Health Organization. Supplement to the 2013 Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach. Geneva: WHO, 2014.

14. Gupta RK, Jordan MR, Sultan BJ, et al. Global trends in antiretroviral resistance in treatment-naive individuals with HIV after rollout of antiretroviral treatment in resource-limited settings: A global collaborative study and meta-regression analysis. Lancet 2012;380(9849):1250-1258. [http://dx.doi. org/10.1016/S0140-6736(12)61038-1] 15. Clouse K, Pettifor AE, Maskew M, et al. Patient retention from HIV diagnosis through one year on antiretroviral therapy at a primary health care clinic in Johannesburg, South Africa. J Acquir Immune Defic Syndr 2013;62(2):e39-e46. [http://dx.doi.org/10.1097/QAI.0b013e318273ac48] 16. Mayer KH. Introduction: Linkage, engagement, and retention in HIV care: Essential for optimal individual- and community-level outcomes in the era of highly active antiretroviral therapy. Clin Infect Dis 2011;52(Suppl 2):S205-S207. [http://dx.doi.org/10.1093/cid/ciq043] 17. Wynberg E, Cooke G, Shroufi A, Reid SD, Ford N. Impact of point-of-care CD4 testing on linkage to HIV care: A systematic review. J Int AIDS Soc 2014;17:18809. [http://dx.doi.org/10.7448/IAS.17.1.18809]

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From informed consent to shared decision-making ‘Every human being of adult years and sound mind has a right to determine what shall be done with his own body.’[1] Morality in medicine was long dominated by paternalism: the belief that you could do almost anything to a patient as long as the principles of beneficence (best interests) and non-maleficence (no harm) were upheld.[2] Kant and Mill reflected on autonomy and self-determination in philosophy, but it is only a century ago that the concept of informed consent, a strong expression of autonomy, was introduced into the law in the New York judgment quoted above.[1] Respect for autonomy and self-determination was introduced into South African (SA) law in 1967 in Richter and Another v Estate Hammann[3] and subsequently secured in Castell v De Greef[4] in 1994.[5] The SA Constitution[6] reflects the importance of an individual’s rights and the right for patient self-determination, and the doctrine of informed consent was codified in sections 6, 7 and 8 of the National Health Act.[7] The Act provides for the patient’s right to self-determination and the requirement for informed consent, and sets out the nature and scope of the information that should be disclosed. The disclosure should be done in a language the patient understands, and the patient’s literacy level should be taken into consideration.[7] While the law sets out the minimum requirements of informed consent, shared decision-making places the patient at the centre of care and may be seen as the pinnacle of patient-centred care.[8,9] Shared decision-making is an approach whereby doctors and patients make decisions together using the best available evidence.

Patient autonomy is respected. Patients can engage with the healthcare process, as they are encouraged to consider the options available to treat or manage their condition (and the likely benefits and harms of each) so that they can communicate their preferences and help select the best course of action.[10] Shared decision-making has become more prominent partly because there is an ethical imperative to involve patients properly in decisions about their care, and partly because there is increasing evidence that this approach has benefits.[10] There has been a shift in patient attitudes – the doctor no longer ‘knows best’. Instead, patients have – and rightly – come to expect that ‘no decision is made about me, without me’. (This phrase has been widely used in the literature for some years, but its origin is obscure. It is used frequently as a catchphrase, encapsulating the basic tenet of shared decision-making, for example in the title of a UK Department of Health response[11] to a White Paper entitled ‘Equity and Excellence: Liberating the NHS’.)

Table 1 illustrates the shift in attitudes from paternalism to shared decision-making.

A recent study by Politi et al.[12] concluded that ‘We should not assume that certain groups of patients don’t want to or can’t

participate in decisions about their healthcare.’ We should assume that all patients want to be involved, unless they specifically give a contrary signal, for example ‘Whatever you think, doctor.’ Even then, the doctor needs to understand that a patient’s asking that the doctor make the decision is a decision in itself. Should an adverse outcome occur, a patient may then claim that s/he had wished to be more involved in the decision-making, which emphasises the importance of documenting the decision-making process.

For shared decision-making to work, a joint approach is needed where listening and sharing information takes centre stage. Doctors cannot possibly know everything about a patient’s value system, their beliefs, or their fears – all of which may influence their treatment decisions. Equally, patients cannot possibly know all the medical options available. Gawande[13] suggests that in the ‘arsenal’ that is now available to treat over 13 000 possible diagnoses, there are approximately 6 000 drugs and 4 000 possible procedures. This has substantially increased the complexity of decision-making for doctors.

As a result, patient preferences are often also misdiagnosed.[14] Certain information should be shared with all patients, for example, the treatment proposed and possible side-effects and complications.

This is the case even if a patient asks that the doctor ultimately make the decision about treatment. Other information might be added because it is especially pertinent to a particular patient, e.g. in the light of their past medical or present social and occupational history.

Good medical practice requires the doctor to check that the patient has understood the information provided and has been offered an opportunity to seek clarification. It is therefore not enough to just ‘transmit’ information – it is necessary to check whether the patient has both received it and absorbed it. This is especially pertinent in SA, where there are eleven official languages and use of an interpreter is required where a language barrier exists.

Respect for patients’ autonomy extends to accepting their right to make their own decisions. Even if the practitioner does not believe that the decision is in a patient’s best interests, provided it is reached after full consideration of the available options and is therefore an informed decision, the patient is entitled to fulfil his/her right to self-determination.

Some core principles are relevant: • While patients can decline and request treatment, they cannot demand treatment.

• While doctors can suggest treatment, they cannot impose treatment.

• In the absence of an emergency, doctors can choose not to treat a patient.

What does the above mean in practice?

A number of models outline the steps required for the shared decision-making process to be valid. For example, Professor Glyn Elwyn and his colleagues recommend three main stages in the

Table 1. The shift in attitudes from paternalism to shared decision-making Doctor’s orders (paternalistic approach): Prescriptive doctor – passive patient

The doctor tells the patient what is needed. This satisfies passive patients.

Patient’s choice: Informative doctor – active patient

The doctor simply provides information about the pros and cons of the various options available for treatment, but gives no recommendation. This satisfies the active, assertive patient.

Shared decision-making

An interactive process occurs that begins with engagement between doctor and patient and ends with a decision jointly made, or with which both doctor and patient are comfortable.

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EDITORIAL

discussion – Choice Talk, Options Talk and Decision Talk – with multiple steps in each stage.[15] That model, and most of the others suggested in the literature, include the following as components of the doctor’s role in the shared decision-making process: • Listening. Most patients you see have an idea about what is wrong with them and what treatment they anticipate you will provide. It is generally recommended that the patient’s views be elicited first, and that the doctor seeks to understand what the patient already knows, what is important to them and what their expectations of treatment are.

• Informing. Only then should the doctor add his/her own views, based on a clinical assessment, as well as such information as is necessary to add to – or correct – the patient’s existing knowledge.

• Discussing. Having established the patient’s expectations at the start, the next step is to discuss the diagnosis and treatment options and address the patient’s expectations – even if this means explaining gently why they cannot be met. The benefits and risks of the various options available should be addressed, as set out in section 6 of the National Health Act.[7] This includes the option, and possible consequences, of no treatment. Clinical decision supp­ ort tools can be very helpful, for example the ‘Option Grid’.[16] Preprepared option grids on a number of common topics are available for open use on the Option Grid website.[16] • Deciding. As the discussion proceeds, the range of options will narrow as the doctor or the patient expresses a reluctance to proceed with some. This will usually lead to one preferred, and mutually agreed, decision. If more than one option is still on the table, either the doctor will say to the patient, ‘Well, we both seem to be happy with either [option A and B], so which would you prefer?’ or the patient will say ‘I’m comfortable with either of those, so whichever you think, doctor.’ Any recommendation made should take into account the preferences, values and expectations of the patient. It is important to check the patient’s understanding of the options available, the risks involved and the consequences of the decision made. If agreement cannot be reached, it may be advisable to obtain a second opinion or otherwise stop the process.

• Documenting. It is essential to document the key elements of the above discussion in the patient’s notes, including details of options and risks. The note does not have to be voluminous, but it must be more than ‘Agreed – lap choly. Risks discussed.’ Ask yourself: ‘If other doctors read these notes, will they know what we discussed and how we came to agree on what is to happen next?’

There is now a voluminous literature about shared decision-making.

Two websites in particular are well worth studying, one from the UK[17] and one from the USA.[18] Another excellent reference, from the Kings Fund, is ‘Making shared decision making a reality: No decision about me, without me’.[19] Shared decision-making is an extension of the informed consent process. It has to engage the patient to be meaningful. If we just set out to meet the requirements for ‘informed consent’, we risk seeing each patient only as a clinical problem – a disorder of anatomy or physiology to be diagnosed and treated. But each patient brings their own personality, experience, knowledge, and indeed ‘baggage’ to the

562

clinical encounter. If we do not allow them to bring these elements to a discussion about treatment options, we do them a disservice. ‘ We must not see any person as an abstraction. Instead, we must see in every person a universe with its own secrets, with its own sources of anguish, and with some measure of triumph.’[20] Howard Manyonga Medical Protection Society Educational Workshop Faculty Member and Wits Reproductive Health and HIV Institute, Johannesburg, South Africa Graham Howarth Head of Medical Services in Africa, Medical Protection Society, Victoria House, 2 Victoria Place, Leeds, UK Mark Dinwoodie Head of Member Education, Medical Protection Society, Victoria House, 2 Victoria Place, Leeds, UK Paul Nisselle Senior Consultant, Educational Services, Medical Protection Society, Victoria House, 2 Victoria Place, Leeds, UK Sarah Whitehouse Senior Writer and Editor, Medical Protection Society, Victoria House, 2 Victoria Place, Leeds, UK Corresponding author: G Howarth (graham.howarth@mps.org.uk) 1. Schloendorff v Society of New York Hospital 1914, 211 NY 125, 105 N.E. 92.

2. Dhai A. Informed consent – 2008. South African Journal of Bioethics and Law 2008;1(1):28-30. http:// www.sajbl.org.za/index.php/sajbl/article/view/5/9 3. Richter and Another v Estate Hammann 1967, (3) SA 226 (C).

4. Castell v De Greef 1994, (4) SA 408 (C).

5. Britz R, Le Roux-Kemp A. Voluntary informed consent and good clinical practice for clinical research in South Africa: Ethical and legal perspectives. S Afr Med J 2012;102(9):746-748. [http://dx.doi.org/10.7196/ SAMJ.5498] 6. South African Government. The Constitution of the Republic of South Africa 1996. Pretoria: Government Printer, 1996. www.thehda.co.za/uploads/images/unpan005172.pdf (accessed 15 April 2014).

7. National Health Act 61 of 2003. http://www.saflii.org/za/legis/consol_act/nha2003147/ (accessed 7 July 2014).

8. Stiggelbout AM, Van der Weijden T, De Wit MPT. Shared decision making: Really putting patients at the centre of healthcare. BMJ 2012;344:e256. [http://dx.doi.org/10.1136/bmj.e256] 9. Barry MJ, Edgman-Levitan S. Shared decision making – the pinnacle of patient-centered care. N Engl J Med 2012;366(9):780-781. [http://dx.doi.org/10.1056/NEJMp1109283] 10. Elwyn G, Laitner S, Coulter A, Walker E, Watson P, Thomson R. Implementing shared decision making in the NHS. BMJ 2010;341:c5146. [http://dx.doi.org/10.1136/bmj.c5146] 11. NHS. Liberating the NHS: Nothing about me, without me. https://www.gov.uk/government/uploads/ system/uploads/attachment_data/file/216980/Liberating-the-NHS-No-decision-about-me-without-meGovernment-response.pdf (accessed 7 July 2014).

12. Politi MC, Dizon DS, Frosch DL, Kuzemchak D, Stiggelbout AM. Importance of clarifying patients’ desired role in shared decision making to match their level of engagement with their preferences. BMJ 2013;2:347:f7066. [http://dx.doi.org/10.1136/bmj.f7066] 13. Gawande A. The Checklist Manifesto: How to Get Things Right. New York: Metropolitan Books, 2009.

14. Mulley A, Trimble C, Elwyn G. Stop the silent misdiagnosis: Patients’ preferences matter. BMJ 2012;345:e6572. [http://dx.doi.org/10.1136/bmj.e6572] 15. Elwyn G, Frosch D, Thomson R, et al. Shared decision making: A model for clinical practice. J Gen Intern Med 2012;27(10):1361-1367. [http://dx.doi.org/10.1007/s11606-012-2077-6] 16. Option Grid Collaborative. http://www.optiongrid.org (accessed 19 March 2014).

17. The Health Foundation. http://shareddecisionmaking.health.org.uk/basics-of-shared-decision-making/ (accessed 19 March 2014).

18. Informed Medical Decisions Foundation. http://www.informedmedicaldecisions.org (accessed 19 March 2014).

19. Coulter A, Collins A. Making shared decision making a reality: No decision about me, without me. 2011. http:// www.kingsfund.org.uk/publications/making-shared-decision-making-reality (accessed 19 March 2014).

20. Skoot R. The Immortal Life of Henrietta Lacks. New York: Crown, 2010.

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National sentinel site surveillance for antimicrobial resistance in Klebsiella pneumoniae isolates in South Africa, 2010 - 2012 O Perovic,1,2 MD, DTM&H, FCPath (SA) (Microbiol), MMed (Microbiol); A Singh-Moodley,1,2 BSc, BMedSc (Hons), MMedSc, PhD; A DusĂŠ,2 MB BCh, DTM&H, MSc Med, MMed, FCPath (SA) (Microbiol); C Bamford,3 MB ChB, DCH, MPhil, FCPath (SA) (Microbiol), MMed; G Elliott,4 MB ChB, FCPath (SA) (Microbiol), MMed (Microbiol), MBA; K Swe Swe-Han,5 FCPath (SA) (Microbiol), MMed (Microbiol), DTM&H, PDIC, MBBS; R Kularatne,2 BSc, MB ChB, MSc Med (Microbiol), FCPath (SA) (Microbiol), DTM&H, Dip HIV Man (SA); W Lowman,2,6 MB BCh, MMed, FCPath (SA) (Microbiol); A Whitelaw,7 MB BCh, MSc, FCPath (SA) (Microbiol); T Nana,2 MB BCh, DTM&H, FCPath (SA) (Microbiol), MMed; J Wadula,2 MD, FCPath (SA) (Microbiol), DTM&H, PDIC; R Lekalakala,8 BSc, MB ChB, MMed, DTM&H, PDIC; A Saif,1 MSc Med (Microbiol); M Fortuin De-Smidt,1 BSc, BSc (Hons), MB ChB, MSc; E Marais,1 PhD entre for Opportunistic, Tropical and Hospital Infections, National Institute for Communicable Diseases, National Health Laboratory Service, C Johannesburg, South Africa 2 Department of Clinical Microbiology and Infectious Diseases, School of Pathology of the University of the Witwatersrand and National Health Laboratory Service, Johannesburg, South Africa 3 Division of Medical Microbiology, Department of Clinical Laboratory Sciences, Faculty of Health Sciences, University of Cape Town and National Health Laboratory Service, Groote Schuur Hospital, Cape Town, South Africa 4 InterSystems, Sandton, Johannesburg, South Africa 5 Department of Medical Microbiology, Inkosi Albert Luthuli Hospital, Durban, South Africa, and Microbiology Department, National Health Laboratory Service, University of KwaZulu-Natal, Durban 6 Wits University Donald Gordon Medical Centre, Parktown, Johannesburg, South Africa 7 Division of Medical Microbiology, Faculty of Medicine and Health Sciences, Stellenbosch University and National Health Laboratory Service, Tygerberg Hospital, Cape Town, South Africa 8 Department of Medical Microbiology, University of Pretoria and Tshwane Academic Division, National Health Laboratory Service, Pretoria, South Africa 1

Corresponding author: O Perovic (olgap@nicd.ac.za, olga.perovic@nhls.ac.za) Background. The increasing rates of antimicrobial resistance observed in the nosocomial pathogen Klebsiella pneumoniae are of major public health concern worldwide.

Objectives. To describe the antibiotic susceptibility profiles of K. pneumoniae isolates from bacteraemic patients submitted by sentinel laboratories in five regions of South Africa from mid-2010 to mid-2012. Molecular methods were used to detect the most commonly found extended-spectrum beta-lactamase (ESBL) and carbapenemase resistance genes.

Methods. Thirteen academic centres serving the public healthcare sector in Gauteng, KwaZulu-Natal, Free State, Limpopo and Western Cape provinces submitted K. pneumoniae isolates from patients with bloodstream infections. Vitek 2 and MicroScan instruments were used for organism identification and susceptibility testing. Multiplex polymerase chain reactions (PCRs) were used to detect blaCTX-M, blaSHV and blaTEM genes in a proportion of the ESBL isolates. All isolates exhibiting reduced susceptibility to carbapenems were PCR tested for blaKPC and blaNDM-1 resistance genes.

Results. Overall, 68.3% of the 2 774 isolates were ESBL-positive, showing resistance to cefotaxime, ceftazidime and cefepime. Furthermore, 46.5% of all isolates were resistant to ciprofloxacin and 33.1% to piperacillin-tazobactam. The major ESBL genes were abundantly present in the sample analysed. Most isolates (95.5%) were susceptible to the carbapenems tested, and no isolates were positive for blaKPC or blaNDM-1.

There was a trend towards a decrease in susceptibility to most antibiotics.

Conclusion. The high proportion of ESBL-producing K. pneumoniae isolates observed, and the prevalence of ESBL genes, are of great concern. Our findings represent a baseline for further surveillance in SA, and can be used for policy and treatment decisions.

S Afr Med J 2014;104(8):563-568. DOI:10.7196/SAMJ.7617

The increasing prevalence of serious hospitaland community-acquired infections is of great concern, with patients dying as a result of emerging antimicrobial resistance. Antibiotic-resistant organ­ isms are widespread globally, both in developed and developing countries.[1] These organisms are a major threat to public

563

health, reduce the effectiveness of empiric antimicrobial treatment options, and increase morbidity, mortality and healthcare expenditure.

A national surveillance system for antimicrobial resistance is essential to establish a baseline of the extent of the problem, to follow trends of resistance, and to form the basis for recommendations of appropriate antimicrobial use to clinicians and other healthcare providers. A

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RESEARCH

national system also controls for differences in case selection, data management and demo­graphic descriptions of regional popu­ lations. To meet this need, a national laboratory-based antimicrobial resistance surveillance system for nosocomial path­ ogens was established in 2010, which included Klebsiella pneumoniae as a sentinel organ­ism by which to monitor resistance.

K. pneumoniae is an important noso­ comial pathogen, with the highest preva­ lence of resistance to third- and fourthgene­ ration cephalosporins among the Enterobacteriaceae. The spread of class A or group 2be extended-spectrum betalactamases (ESBLs) in Enterobacteriaceae is of public health concern. The most frequently detected and clinically important ESBLs belong to the TEM, SHV, and CTX-M families, and K. pneumoniae commonly produces all three groups of enzymes.[2] In the past decade, CTX-M enzymes have emerged as the most prevalent type. There are more than 100 different types, which can be broadly divided into five groups based on their amino-acid identities: CTX-M1, CTXM2, CTX-M8, CTX-M9 and CTX-M25.

Enzymes are characterised by epidemiological differences, and some have even been shown to spread beyond the hospital environment into the community.[2] Of further public health concern are the recent emergence of K. pneumoniae strains capable of producing carbapenem-hydrolysing enzymes and the apparent ease of spread of resistance mechanisms by mobile genetic elements.[2] There are few published reports on national antimicrobial resistance rates of K. pneumoniae in South Africa (SA), with data primarily emanating from the private sector,[3] regional studies with limited numbers of local isolates[1] or certain clinical settings.[4] To date, molecular data on ESBL K. pneumoniae in SA are based on detailed studies of small populations. Essack et al.[5] examined blaSHV and blaTEM genes in 25 isolates, and found a high degree of diversity in terms of plasmids present, genes detected and the combination of genes within isolates.

In a study of ESBL K. pneumoniae from seven countries in 2003, blaTEM-10, blaTEM-12, blaTEM-63, various blaSHV-2 and blaSHV-5 types, blaCTX-M2 and blaCTX-M3 genes were detected in 27 SA isolates.[6] A more recent study on 53 ESBL clinical pathogens from Pretoria detected blaTEM, blaSHV and blaCTX-M-1 genes, although the contribution of the 31 K. pneumoniae isolates in this group was not specified.[7] This diversity in enzyme production and the prolific nature of K. pneumoniae as a nosocomial pathogen highlight the need for further investigation

into the genes responsible for these enzymes in the SA setting.

In this study, we determined the anti­ biotic susceptibility profiles of K. pneumo­ niae isolates from bacteraemic patients with positive blood cultures from sentinel sites representing five SA regions. We used national laboratory-based surveillance data to characterise the third- and fourthgeneration cephalosporin-resistant and carba­ p enem-resistant phenotypes and genotypes of K. pneumoniae from 2010 to 2012.

Methods

Patient selection

Thirteen academic centres serving the public healthcare sector in SA were included, and participation was voluntary. The sites represented regions in Gauteng, KwaZuluNatal, Free State, Limpopo and Western Cape provinces. Isolates of K. pneumoniae from patients with bloodstream infections were submitted, with a 3-week exclusion thereafter to avoid duplicate isolates of the same organism.

Phenotypic methods

K. pneumoniae isolates were submitted on Dorset transport media. Organism identification was confirmed using the Vitek 2 GN card (Biomerieux, France).

Susceptibility testing and determination of ESBL phenotype was performed on the MicroScan Walkaway (Siemens Healthcare Diagnostics, USA), using NM37 panels.

Categorical results and susceptibility profile of each antimicrobial agent tested were based on 2012 Clinical Laboratory Standards Institute (CLSI) interpretative criteria,[8] the European Committee on Antimicrobial Susceptibility Testing guidelines[9] and/ or the MicroScan recommendations. The MIC50 and MIC90 (minimum inhibitory concentrations needed to inhibit the growth of 50% and 90% of organisms, respectively)

were determined. The Agresti-Coull interval method was used to calculate confidence intervals, and a χ2 test was performed to analyse trends in antibiotic susceptibility.

A p-value of <0.05 was deemed statistically significant.

Genotypic methods

Two hundred and seventy ESBLproducing isolates were randomly selec­ ted (approximately 14% per region) and screened for the presence of ESBL genes.

DNA was extracted from half a loop (~2 mm in diameter) of bacterial culture.

This was resuspended in 400 µl trisethylenediaminetetraacetic acid buffer (pH 8.0), vortexed briefly, heated at 95°C for 25 minutes and pelleted by centrifugation.

The supernatant was aliquoted and stored at –70°C for further use.

The LightCycler 480 instrument (Roche Applied Science, Germany) and LightCycler 480 Probes Master kit (Roche Diagnostics, USA) were used for real-time polymerase chain reaction (PCR). The blaTEM and blaSHV genes were amplified by multiplex real-time PCR using the primers shown in Table 1.

The primers were selected for specificity by GenBank comparisons and PCR products from control strains were sequenced. The limit of detection was determined to be 750 colony-forming units (cfu)/ml for blaTEM and 4 000 cfu/ml for blaSHV. The reaction conditions were 0.5 μM primers, 0.2 μM probes, denaturation for 95°C for 5 minutes, and then 45 cycles of 95°C for 10 seconds, 55°C for 30 seconds and 72°C for 1 second.

The blaCTX-M PCR was a multiplex assay targeting blaCTX-M groups M1 and M2-9 using primer and probe sequences as described previously.[10] Detection of blaNDM-1 and blaKPC genes was performed on isolates with reduced susceptibility to carbapenems as described previously.[11] Reduced susceptibility to carbapenems was defined according to the CLSI guidelines of 2012.[8] Strains from the

Table 1. Primer and probe sequences for blaTEM and blaSHV gene detection SHV Forward Primer

5ʹ-CAG CAG GAT CTG GTG GAC TAC T-3ʹ

SHV Reverse Primer

5ʹ-GTC AAG GCG GGT GAC GTT-3ʹ

SHV A Primer

5ʹ-AAG GCG GGT GAC GTT GTC-3ʹ

SHV S Primer

5ʹ-CCG GTC AGC GAA AAA CAC-3ʹ

SHV Probe

5ʹ-Cy5-TCT GGC GCA AAA AGG CAG TCA-BBQ-3ʹ

TEM Forward Primer

5ʹ-AAG TTC TGC TAT GTG GTG CGG TA-3ʹ

TEM Reverse Primer

5ʹ-TGT TAT CAC TCA TGG TTA TGG CAG C-3ʹ

TEM A Primer

5’-GTA AGA TGC TTT TCT GTG ACT GGT GA-3ʹ

TEM S Primer

5ʹ-AGT TCT GCT ATG TGG TGC GGT ATT A-3ʹ

TEM Probe

5ʹ-FAM-TGC GGC GAC CGA GTT GCT CTT-BBQ-3ʹ

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demonstrated an ESBL phenotype (68.3%) with marked resistance to third- and fourthgeneration cephalosporins. The distribution of isolates according to province, and ESBL rates, are shown in Table 2. A breakdown of susceptibility by agent for the 3-year period is presented in Fig. 1.

Reduced carbapenem susceptibility was noted in only 124 (4.5%) of isolates (Table 2).

The carbapenemase genes blaNDM-1 and blaKPC

American Type Culture Collection (ATCC) or the National Culture Collection Laboratory of the National Institute for Communicable Diseases were used as positive controls.

Results

A total of 2 774 discrete K. pneumoniae isolates were received and included in the antimicrobial susceptibility testing over the 3-year period. The majority of isolates

Table 2. Provinces of submission of K. pneumoniae isolates 2010 - 2012 and proportion of isolates found to be ESBL-positive or to have reduced susceptibility to carbapenems

Province

Isolates submitted 2010 2012, N

ESBL-positive isolates 2010 - 2012, n (%)

Reduced carbapenem susceptibility, n (%)

Gauteng

1 737

1 207 (69.5)

75 (4.3)

Western Cape

620

414 (66.8)

25 (4.0)

KwaZulu-Natal

268

203 (75.7)

15 (5.6)

Free State

134

59 (44.0)

7 (5.2)

Limpopo

15

12 (80.0)

2 (13.3)

Totals

2 774

1 895 (68.3)

124 (4.5)

ESBL = extended-spectrum beta-lactamase.

Year 2012

Year 2011

Year 2010 87.2 91.8 91

Colistin 27.6 27.1 28.3

Trimethoprim/sulfamethoxazole

90.6 92.3 91.9 88 91.9 89.3

Tigecycline* Fosfomycin 41.2 42.9 44.7

Nitrofurantoin

96.8 98.9 98.1 98.9 96.9 97.2 94.5 97.8 96.1

Antimicrobial agents

Meropenem Imipenem Ertapenem 75.4 74.1 76.1

Levofloxacin 51.1 50.4

Ciprofloxacin

59

24.1 26.2 30.5 24.5 26.4 30.3

Ceftazidime Cefotaxime/cefepime Cefoxitin Piperacillin/tazobactam

27.3 28.9

Amoxicillin/clavulanate

64.5 67.8 68.5

37.5 28.6 30.2 34.7 30.4 33.3 39.3

Tobramycin Gentamicin

94.5 96.7 94.7

Amikacin 0

10

86.6 88.2 87.5

20 30 40 50 60 70 Susceptible, %

80 90 100

Fig. 1. Percentage susceptibility to antimicrobial agents, 2010 - 2012. Confidence intervals were a maximum of Âą2% for all antibiotics for each year. Susceptibility percentages for cefotaxime and cefepime were identical. (*European Committee on Antimicrobial Susceptibility Testing guidelines.[9])

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were not detected in any of the 124 isolates and the presence of other carbapenemaseproducing genes was not investigated.

Susceptibility to aminoglycosides over the 3-year period was variable, with 95.3% susceptible to amikacin but only 31.1% and 31.3% susceptible to tobramycin and gentamicin, respectively (Fig. 1). Susceptibility to levofloxacin (75.2%) was higher than to ciprofloxacin (53.5%). Sixty-seven (66.9%) per cent of all isolates were susceptible to piperacillin-tazobactam (MIC50 = 8 Âľg/ml) for the 3 years, and susceptibility to cefoxitin was high at 87.4% (Table 3).

Trend analysis was performed on the isolates, comparing the susceptibility rates between 2010, 2011 and 2012 (Table 4).

Small but statistically significant declines in susceptibility rates were noted for many antibiotics, including amoxicillin/ clavulanate, tobramycin, gentamicin, ciprofloxacin, ceftazidime and cefotaxime.

Molecular characterisation was performed on 270 ESBL-positive isolates. All phenotypically ESBL-positive isolates were confirmed to possess one or more of the blaCTX-M, blaSHV and blaTEM genes, with 93.0% of the isolates tested expressing more than one resistance gene (Fig. 2).

Discussion

Gauteng contributed the majority of isolates in the study (62.6%), probably because it is the most populous province with the largest academic centres. The high percentage of bacteraemic K. pneumoniae that were resistant to third-generation cephalosporins (68.3%) is of serious public health concern.

Rates of resistance in a 2006 study from SA private laboratories showed 52% resistance to cefuroxime, 46% to ceftriaxone and 44% to cefepime.[3] A study of resistance at seven public sector hospitals between 2010 and 2012 reported an overall level of ESBL detection of 65%.[12] Our study shows a similar rate (68.3%) of resistance to extended-spectrum cephalosporins. The difference between the private and public sectors may indicate a dramatic increase in development of resistance in the interim, and/or a difference in sampling and resistance patterns between these sectors.

Also, because they are referral centres, the academic centres that submitted isolates in this study potentially contributed a disproportionate number of patients who were more likely to harbour ESBL isolates.

Globally, reports show a trend towards an increase in resistance of K. pneumoniae to third-generation cephalosporins.[13] While rates of resistance are low in some countries,

RESEARCH

Table 3. Antibiotic MIC50, MIC90 and breakpoints for 2 774 K. pneumoniae isolates 2010

2011

2012

MIC interpretive breakpoints (µg/ml)*

Antibiotics

MIC50

MIC90

MIC50

MIC90

MIC50

MIC90

S

Amikacin

≤8

16

≤8

16

≤8

16

≤16

R ≥64

Gentamicin

>8

>8

>8

>8

>8

>8

≤4

≥16

Tobramycin

>8

>8

>8

>8

>8

>8

≤4

≥16

Amoxicillin/ clavulanate

16/8

>16/8

16/8

>16/8

16/8

>16/8

≤8/4

≥32/16

Piperacillin/ tazobactam

≤8

>64

≤8

>64

≤8

>64

≤16/4

≥128/4

Cefoxitin

≤8

16

≤8

16

≤8

16

≤8

≥32

Cefotaxime

>32

>32

>32

>32

>32

>32

≤1

≥4

Ceftazidime

16

>16

16

>16

>16

>16

≤4

≥16

Cefepime

>16

>16

>16

>16

>16

>16

≤8

≥32

Ciprofloxacin

≤0.5

>2

≤0.5

>2

1

>2

≤1

≥4

Levofloxacin

≤1

>4

≤1

>4

≤1

>4

≤2

≥8

Ertapenem

≤0.5

≤0.5

≤0.5

≤0.5

≤0.5

≤0.5

≤0.5

≥2

Imipenem

≤2

≤2

≤2

≤2

≤2

≤2

≤1

≥4

Meropenem

≤1

≤1

≤1

≤1

≤1

≤1

≤1

≥4

Nitrofurantoin

64

>64

64

>64

64

>64

≤32

≥128

Fosfomycin

≤32

>32

≤32

>32

≤32

>32

≤64

≥256

≤1

≤1

≤1

≤1

≤1

≤1

≤1

>2

Trimethoprim/ sulfamethoxazole

>4/76

>4/76

>4/76

>4/76

>4/76

>4/76

≤2/38

≥4/76

Colistin†

≤2

≤2

≤2

≤2

≤2

4

≤2

≥2

Tigecycline

†

MIC50 = minimum inhibitory concentrations needed to inhibit the growth of 50% of organisms; MIC90 = minimum inhibitory concentrations needed to inhibit the growth of 90% of organisms; S = susceptible; R = resistant. * Clinical Laboratory Standards Institute guidelines, 2012.[8] † European Committee on Antimicrobial Susceptibility Testing guidelines.[9]

100% 90% 80% 70%

50

60%

77

81

50%

82 100

40% 30%

31

SHV, TEM, CTX-M1 SHV, TEM, CTX-M2 TEM, CTXM-1 SHV, TEM SHV, CTXM-1 CTXM-1 SHV

20% 12

10% 0%

4

10

FS (16)

GA (164) KZ (31) LP (4) Province (isolates, n)

WC (55)

Fig. 2. Distribution of ESBL genes as percentages in 270 isolates tested. Percentages of the most frequent combinations are shown as data labels. (ESBL = extended-spectrum beta-lactamase; FS = Free State; GA = Gauteng; KZ = KwaZulu-Natal; LP = Limpopo; WC = Western Cape.)

e.g. 11.5% in 2010 in the USA,[13] higher rates have been observed in other regions.[14]

This laboratory-based surveillance also underlines the endemic distribution of all

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three major groups of ESBL genes throughout five regions of SA. The almost identical susceptibility pattern to cefotaxime, ceftazidime and cefepime suggests that there are multiple copies of several ESBL genes in the sample, which is supported by the genotypic results. A limitation of the study is that the genotypic data represent only 14% of K. pneumoniae isolates from selected academic or referral laboratories, and may not be fully representative at a national level. The phenotypic data support the genotypic data, however, being fairly representative of all isolates sampled in this survey. These results are also a first indication of the extensive prevalence of blaSHV, blaTEM and blaCTX-M genes in geographically distinct regions of SA. Susceptibility to carbapenems was high, with only 4.5% of isolates showing reduced susceptibility. However, carbapenem-resistant Enterobacteriaceae have been described in SA,[15] and levels of carbapenem resistance need to be monitored closely. It must also be noted that the breakpoints for ertapenem

RESEARCH

have since been revised by the CLSI.[8] A limitation of this study is that we only tested for blaNDM-1 and blaKPC genes and did not investigate for other potential mechanisms of carbapenem resistance.

For piperacillin-tazobactam, the MIC50 was within the susceptible breakpoint while the MIC90 was above the resistant breakpoint. Overall susceptibility was 66.9%, and piperacillin-tazobactam may therefore be a potentially useful agent for treatment. However, there is still debate concerning the use of piperacillintazobactam to treat infections with ESBLproducing Enterobacteriaceae. There is some evidence that outcomes may be worse if the piperacillin-tazobactam MIC is 8 - 16 mg/l, with suggestions that if piperacillintazobactam is used to treat organisms with these MICs, prolonged infusions or more frequent dosing may be needed.[16] The 87.4% susceptibility to cefoxitin suggests that plasmid-mediated AmpC enzymes are not particularly prevalent in this sample. The disparity in ciprofloxacin and levofloxacin resistance (21.7% diff­ erence) is intriguing and although we do not have genotypic data to support it, it may represent an increase in quinolone resistance mechanisms (e.g. plasmid-mediated mech­ anisms; enzymatic modification) other than the conventional target site mutations, where one would expect cross-resistance[17] as 61.5% ESBL of K. pneumoniae iso­lates were resistant to ciprofloxacin.

Among all aminoglycosides, amikacin exhibited the best activity, although this must be interpreted with caution as the stipulated breakpoints are high consid­ ering that this is a concentration-dependent agent. The MIC50 and MIC90 of 8 µg/ml and 16 µg/ml, respectively, indicate that for many isolates the probability of achieving adequate serum levels is quite low.

Overall, the MIC50 and MIC90 to most agents have not changed over the 3-year period, although the ability to detect smaller differences may have been limited by the methodological system employed for susceptibility testing. The one exception was colistin, for which a significant increase in MIC90 was noted in 2012 (p=0.001) (Table 4). This is alarming, as colistin represents the mainstay of the treatment of most of our extensively drug-resistant Gram-negative pathogens (including carbapenem-resistant K. pneumoniae).[18] Trends in susceptibility showed a significant decrease over the study period for most antimicrobial agents, with a few exceptions, e.g. piperacillin-tazobactam, levofloxacin and tigecycline.

Table 4. Statistical significance of antibiotic susceptibility rates for K. pneumoniae, 2010 - 2012 p-value* Antibiotics

2010 v. 2011

2011 v. 2012

2010 v. 2012

Amikacin

0.041

0.012

0.908

Gentamicin

0.013

0.145

<0.001

Tobramycin

0.056

0.428

0.015

Amoxicillin/clavulanate

<0.001

0.397

<0.001

Piperacillin/tazobactam

0.713

0.105

0.103

Cefepime

0.087

0.295

0.014

Cefoxitin

0.668

0.252

0.616

Ceftazidime

0.058

0.272

0.007

Ciprofloxacin

0.001

0.749

0.003

Levofloxacin

0.37

0.481

0.771

Ertapenem

0.05

<0.001

0.166

Imipenem

0.774

0.002

0.016

Meropenem

0.14

<0.001

0.141

Nitrofurantoin

0.488

0.42

0.194

Fosfomycin

0.076

0.003

0.468

Tigecycline

0.736

0.15

0.417

Trimethroprim/sulfamethoxazole

0.602

0.768

0.796

Colistin

0.591

<0.001

0.028

*Statistically significant values in bold.

A limitation of this study was that com­ prehensive patient demographic details were unavailable, and it was not possible to determine accurate trends in patient age, ward and gender. This information will be obtained in future surveys, allowing for more detailed analyses of antimicrobial resistance patterns, and how they change over time.

These surveillance results should be used together with hospital-specific data as tools in antimicrobial stewardship programmes and for the development of empiric therapy guidelines for healthcare-associated infec­ tions. Ongoing antimicrobial resistance sur­ v­ eillance, performed in a systematic and standardised manner, could be used as a tool to monitor the effectiveness of antimicrobial stewardship programmes that have been implemented in various centres across the country. Moreover, it provides a foundation for the systematic surveillance of important hospital pathogens that could be expanded and enhanced over time.

Conclusion

SA appears to have a relatively high percentage of ESBL-producing K. pneumoniae isolates in comparison with other geographical regions, which is of great concern, and a significant increase in ertapenem resistance over the

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surveillance period. This study presents the antibiotic resistance patterns of invasive K. pneumoniae isolates and gives an indication of the prevalence of resistance genes. Our findings provide important baseline data for further site-specific analysis of K. pneumoniae isolates, as well as a platform for enhanced surveillance of K. pneumoniae antimicrobial resistance in the country. Additionally, when analysed in conjunction with patient demographic and clinical details these data are important for the development of empiric therapy guidelines for management of sepsis in SA healthcare institutions.

Acknowledgements. This study was supported

by GERMS-SA (the Group for Enteric, Respiratory and Meningeal disease Surveillance in South Africa). We thank Ms Serisha Naicker, Mr Elias Khomane, Mrs Zazi Molebatsi and Mrs Marshagne Smith for assistance with the laboratory work and Ms Penny Crowther for assistance with our database.

References 1. Ashley EA, Lubell Y, White NJ, et al. Antimicrobial susceptibility of bacterial isolates from community acquired infections in SubSaharan Africa and Asian low and middle income countries.

Trop Med Int Health 2011; 16 (9):1167-1179. [http://dx.doi. org/10.1111/j.1365-3156.2011.02822.x]

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2. Gutkind GO, Di Conza J, Power P, et al. β-lactamase-mediated resistance: A biochemical, epidemiological and genetic overview. Curr Pharm Des 2013; 19(2):164-208. [http://dx.doi. org/10.2174/138161213804070320] 3. Brink A, Moolman J, da Silva MC, et al. Antimicrobial susceptibility profile of selected bacteraemic pathogens from private institutions in South Africa. S Afr Med J 2007;97(4):273-279.

4. Brink AJ, Botha RF, Poswa X, et al. Antimicrobial susceptibility of Gram-negative pathogens isolated from patients with complicated intra-abdominal infections in South African hospitals (SMART Study 2004-2009): Impact of the new carbapenem breakpoints. Surg Infect (Larchmt) 2012; 13(1):43-49. [http:// dx.doi.org/10.1089/sur.2011.074] 5. Essack SY, Hall LM, Pillay DG, McFadyen ML, Livermore DM. Complexity and diversity of Klebsiella pneumoniae strains with extended-spectrum beta-lactamases isolated in 1994 and 1996 at a teaching hospital in Durban, South Africa. Antimicrob Agents Chemother 2001; 45(1):88-95. [http://dx.doi. org/10.1128/AAC.45.1.88-95.2001] 6. Paterson DL, Hujer KM, Hujer AM et al. Extended-spectrum beta-lactamases in Klebsiella pneumoniae bloodstream isolates from seven countries: Dominance and widespread prevalence of SHV- and CTX-M-type beta-lactamases. Antimicrob Agents Chemother 2003;47(11):3554-3560. [http://dx.doi. org/10.1128/AAC.47.11.3554-3560.2003] 7. Ehlers MM, Veldsman C, Makgotlho EP, et al. Detection of blaSHV, blaTEM and blaCTX-M antibiotic resistance genes in randomly selected bacterial pathogens from the Steve Biko Academic Hospital. FEMS Immunol Med Microbiol 2009; 56(3):191-196. [http://dx.doi.org/ 10.1111/j.1574-695X.2009.00564.x] 8. Performance Standards for Antimicrobial Susceptibility Testing: Twenty-Second Informational Supplement. Clinical and Laboratory Standards Institute. M100-S22 (Vol. 32, No. 1): 2012:45-61.

9. The European Committee on Antimicrobial Susceptibility Testing (EUCAST). Breakpoint tables for interpretation of MICs and zone diameters. http://www.eucast.org (accessed 3 July 2014).

10. Birkett CI, Ludlam HA, Woodford N, et al. Real-time TaqMan PCR for rapid detection and typing of genes encoding CTX-M extended-spectrum beta-lactamases. J Med Microbiol 2007;56(1):52-55. [http:// dx.doi.org/10.1099/jmm.0.46909-0]

11. Centers for Disease Control and Prevention. Multiplex real-time PCR detection of Klebsiella pneumoniae carbapenemase (KPC) and New Delhi metallo-β-lactamase (NDM-1) genes. 2012. http://www.cdc.gov/ HAI/settings/lab/kpc-ndm1-lab-protocol.htm (accessed 3 July 2014).

12. Bamford C, Bonorchis K, Ryan A, et al. Antimicrobial susceptibility patterns of selected bacteraemic isolates from South African public sector hospitals, 2010. South African Journal of Infectious Diseases 2011;26(4):243-250.

13. Braykov NP, Eber MR, Klein EY, et al. Trends in resistance to carbapenems and third-generation cephalosporins among clinical isolates of Klebsiella pneumoniae in the United States, 1999-2010. Infect Control Hosp Epidemiol 2013;34(3):259-268. [http://dx.doi.org/10.1086/669523] 14. Mendes RE, Mendoza M, Banga Singh KK, et al. Regional resistance surveillance program results for twelve Asia-Pacific nations (2011). Antimicrob Agents Chemother 2013;57(11):5721-5726. [http:// dx.doi.org/10.1128/AAC.01121-13] 15. Lowman W, Sriruttan C, Nana T, et al. NDM-1 has arrived: First report of a carbapenem resistance mechanism in South Africa. S Afr Med J 2011;101(12):873-875.

16. Nguyen HM, Shier KL, Graber CJ. Determining a clinical framework for use of cefepime and β-lactam/βlactamase inhibitors in the treatment of infections caused by extended-spectrum-β-lactamase-producing Enterobacteriaceae. J Antimicrob Chemother 2014;69(4):871-880. [http://dx.doi.org/10.1093/jac/ dkt450] 17. Robicsek A, Strahilevitz J, Jacoby GA, et al. Fluoroquinolone-modifying enzyme: A new adaptation of a common aminoglycoside acetyltransferase. Nat Med 2006; 12(1):83-88. [http://dx.doi.org/10.1038/ nm1347] 18. Visser Kift E, Maartens G, Bamford C. Systematic review of the evidence for rational dosing of colistin. S Afr Med J 2014; 104(3):183-186. [http://dx.doi.org/10.7196/SAMJ.7011]

Accepted 11 April 2014.

A cross-sectional analytical study of geophagia practices and blood metal concentrations in pregnant women in Johannesburg, South Africa A Mathee,1,2,3 PhD; N Naicker,1,2 MB BCh, MMed, FCPHM, PhD; T Kootbodien,1 MB ChB, MPH; T Mahuma,1 MA (Anthropology); P Nkomo,1 MSc (Med) (Epidemiology and Biostatistics); I Naik,4 MSc; T de Wet5,6 PhD Environment and Health Research Unit, South African Medical Research Council, Johannesburg, South Africa School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 3 Faculty of Health Sciences, University of Johannesburg, South Africa 4 Analytical Services Department, National Institute for Occupational Health, Johannesburg, South Africa 5 Department of Anthropology and Development Studies, Faculty of Humanities, University of Johannesburg, South Africa 6 Centre for Anthropological Research, University of Johannesburg, South Africa 1 2

Corresponding author: T Kootbodien (tkootbodien@mrc.ac.za)

Background. Geophagia, a form of pica, has been shown to be widely practised in sub-Saharan Africa, especially among pregnant women.

Objective. To assess the prevalence of geophagia and examine exposure to selected metals and associated risk factors in women attending an antenatal clinic at Rahima Moosa Mother and Child Hospital, Johannesburg, South Africa, during June and July 2010.

Methods. We conducted a cross-sectional study on a convenience sample of 307 pregnant women, ranging in age from 18 to 46 years.

Structured interviews were conducted to understand geophagia practices. Blood samples were collected to determine haemoglobin values and concentrations of arsenic, cadmium, mercury and lead. Statistical analyses using the χ2 test, Wilcoxon’s rank-sum test and logistic regression analyses were performed as appropriate.

Results. Mean parity was 1.4 and the mean (standard deviation) gestational age 30.3 (6.0) weeks. Geophagia was reported by 60 women (19.5%), and the majority purchased soil from street vendors (83.3%). The prevalence of anaemia in the study sample was 16.9% (95% confidence interval 13.1 - 21.6%). Geophagic women had significantly higher blood lead levels than non-geophagic women (2.1 v. 1.4 µg/dl; p<0.001). Anaemia, the use of African traditional medicines and craving of non-nutritive substances in a previous pregnancy were associated with geophagia.

Conclusions. Geophagia is practised by a considerable proportion of pregnant women in Johannesburg, especially migrant women. Greater vigilance in respect of pica, especially geophagia, may be needed as part of antenatal care programmes to avoid potentially detrimental health effects of the practice.

S Afr Med J 2014;104(8):568-573. DOI:10.7196/SAMJ.7466

Geophagia (intentional ingestion of soil/sand, clay blocks and mud) is defined as a form of pica, and has been known for centuries.[1] A variety of reasons for geophagia have been postulated, including religious,

568

cultural, nutritional and medicinal practices, famine, perceived enhancement of personal appearance, pregnancy-related cravings, and enjoyment of the taste, texture or smell of the substance consumed.[1-3] Although the prevalence varies widely, geophagia

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continues to be practised in many parts of the world. It appears to be more common in children than in adults, in women than in men, in black people than in white people, in rural areas than in urban areas, and in pregnant women than in non-pregnant women.[4] Pregnant women have been identified as a group in which geophagia is particularly widespread, and studies undertaken in Dar es Salaam (Tanzania) and Nairobi (Kenya) showed prevalences of 64% and 74%, respectively.[5,6] Few studies have described the practice of pica and geophagia in South Africa (SA). One of the first to be reported was an investigation of 12 children in Cape Town with pronounced globin levels signi­ geophagia and haemo­ ficantly lower than those in a control group.[7] Geophagia was also reported in schoolchildren from KwaZulu-Natal Province, and was asso­ ciated with elevated levels of helminthic infections.[8] There is a paucity of studies of pica in pregnant SA women.[1] One study reported that pica levels are highest in black African women from both rural and urban areas (44% and 38%, respectively).[9] Among 240 Xhosa-speaking women aged 20 - 60 years from the Eastern Cape Province, 75% rep­orted practising geophagia at some point in their lives. The frequency of soil inges­tion varied from occasionally to several times a day, and three-quarters of the participants reported that their family members and friends were aware of their habit, and that they had encountered both approval and disap­ proval.[10] Rural women obtained soil from a variety of locations, including local hills, moun­ tains, gardens, riverbeds and termite mounds, while those in urban areas mainly pur­chased soil from street vendors.[10,11] Most clays were heated before sale, for example by baking or boiling, which enhances the colour and may reduce the microbial load.[11] While strongly held beliefs about the nutritional benefits and detoxifying effects of geophagia exist,[12] ingestion of soil has been shown to interfere with the bioavailability of micronutrients (leading to micronutrient deficiencies), and may result in geohelminthic infec­tions, anaemia, hypokalaemia, peritoneal mesothelioma and intestinal obstruction or perforation.[2,4,8] Geo­ phagic behaviour may also increase exposure to metal contaminants in the soil, including arsenic and lead – for example, elevated concentrations of arsenic were found in the baked clay (sikor) widely con­sumed by pregnant Bangladeshi women in the UK.[3] A study in New York found women who practised pica to have higher blood lead levels than other women.[13] Geophagia has also been associated with maternal dental injury, constipation, and dysfunctional labour due

to intestinal obstruction. Possible fetal effects include low birth weight and lead exposure.[4] SA case studies have reported hypokalaemia and iron deficiency anaemia among pregnant women practising geophagia.[14,15] Despite being a well-established practice, geophagia during pregnancy remains an under-reported and understudied phenomenon,[1,4] in part because it is often done covertly. This article describes the findings of a study of geophagia in an urban setting (Johannesburg, SA) and reflects on the implications for antenatal healthcare in SA and elsewhere.

Methods

We conducted a cross-sectional study, fun­ ded by the South African Medical Research Council, at the Rahima Moosa Mother and Child Hospital in Westbury, Johannesburg, during June and July 2010. Based on the prevalence of pica among pregnant women described by Walker et al.,[9] a sample of 288 pregnant women was required to obtain a 95% confidence interval (CI) and a power of 90%, assuming a non-response rate of 20%.

Pregnant women attending for routine ante­ natal care clinic visits, who were ≥18 years of age and at ≥20 completed weeks’ gestation, were invited to participate. The study was explained to all prospective participants, and an information sheet was provided detailing the key elements of the study: completion of a questionnaire, donation of a blood sample for metal content analysis, and a haemoglobin test. A convenience sample of 333 pregnant women consented to participate in the face-to-face structured interview. In total 26 women were excluded, 15 because of incomplete questionnaires, ten who could not provide a blood sample and one who went into labour during the interview, leaving a final study sample of 307. The overall study response rate was 92.1%.

The interview questionnaire was admin­ istered in English by fieldworkers trained to obtain information on partici­ pants’ socio­ economic status, obstetric history, past medical history and pica practices. Women who reported geophagic practices were asked to

identify their sources of soil. Venous blood samples of approximately 7 ml were drawn from the participants by professional nurses using aseptic techniques and collected into sterile ethylenediaminetetra-acetic acid (EDTA)-containing tubes. Blood samples were stored on ice and transported to the analytical laboratory on the day of fieldwork. Haemo­ globin values were measured using a Hemocue Hb 201+ haemoglobinometer. Women with anaemia were referred to an antenatal clinic for further investigation and treatment. Samples of maternal whole blood were also analysed for levels of arsenic, cadmium, mercury and lead. All analyses were performed using the inductively coupled plasma-mass spectrometry (ICP-MS) technique, with certified standards and reference materials used throughout.

Statistical analysis

Data were processed using Stata statistical software (version 11.0). Blood metal concen­ trations were not normally distributed and were presented using the geometric mean, 95% CI, median and range. Anaemia was ined as a haemoglobin value <10.5 g/dl. def­ Nominal variables were described using the χ2 test or Fisher’s exact test, as appropriate.

Odds ratios (ORs) and 95% CIs were calculated using logistic regression to predict the sociodemographic characteristics and metal concentrations associated with geophagia. In multivariate regression analyses, variables with no significant effect measures were removed from the model in a stepwise manner and data were presented only for the best-fit model. A p-value of 0.05 was considered significant.

Ethical approval

Ethical approval for the study was obtained from the Human Research Ethics Committee of the University of the Witwatersrand, Johannesburg. Written consent forms were completed and signed prior to data collection and blood sampling. Participants were informed that participation was voluntary, and of their right to with­draw at any time without detrimental consequences.

Table 1. Prevalence of pica and geophagia in the study sample Substance ingested

Pica prevalence in the total sample (N=307), %

Type of pica (N=70), n (%)

Soil, clay and/or stones

19.5

60 (85.7)

Chalk

0.7

2 (2.9)

Toilet tissue

0.7

2 (2.9)

Charcoal

0.7

2 (2.9)

Other*

1.3

4 (5.7)

Total

22.8

70 (100)

Matches (n=1), talcum powder (n=1), Vicks rub (n=1), cigarette ash (n=1).

*

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Results

Profile of the study population

The mean (standard deviation (SD)) age of the sample of women, 80.5% of whom had been born in SA, was 30 (6.1) years. Participants who had been born outside SA’s borders (19.5%) were from the following countries: Zimbabwe, Malawi, Nigeria, Zambia, Ethiopia,

Mali, Kenya, Somalia, Lesotho, Mozambique, Uganda, India, the Democratic Republic of the Congo, Ivory Coast, Rwanda and the Republic of Congo. A large proportion (94.1%) of the women had achieved secondary or tertiary education, 40.4% were unemployed, and 16.9% reported a monthly household income of less than ZAR1 000 (±US$125). Over half (53.8%) of the participants were from house­

Table 2. Crude ORs for sociodemographic and pregnancy-related risk factors for geophagia Total sample (N=307), n (%)

Subjects reporting geophagia practices (N=60), n (%)

Crude OR

18 - 30

185 (60.3)

38 (63.3)

1

>31

122 (39.7)

22 (36.7)

0.7

Risk factor

95% CI

p-value

0.38 - 1.21

0.186

1.23 - 4.41

0.010

1.04 - 7.65

0.040

Sociodemographic factors Maternal age (years)

Nationality SA

247 (80.5)

41 (68.3)

1

Non-SA

60 (19.5)

19 (31.7)

2.3

Secondary/tertiary

289 (94.1)

53 (88.3)

1

None/primary

18 (5.9)

7 (11.7)

2.8

Education

Household monthly income <R1 000 or no income at all

52 (16.9)

11 (18.3)

1

R1 000 - 5 000

165 (53.8)

42 (70.0)

1.3

0.60 - 2.70

0.530

>R5 000

90 (29.3)

7 (11.7)

0.3

0.11 - 0.87

0.026

≥4

133 (53.8)

23 (38.3)

1

<3

114 (46.2)

37 (61.7)

1.9

1.05 - 3.34

0.033

0.12 - 0.87

0.025

0.36 - 2.35

0.865

1.39 - 14.37

0.012

Household size

Maternal smoking No

249 (81.1)

55 (91.7)

1

Yes

58 (18.9)

5 (8.3)

0.3

No

273 (89.2)

53 (89.8)

1

Yes

33 (10.8)

6 (10.2)

0.9

Maternal alcohol intake

Traditional medicines* No

295 (96.1)

54 (90.0)

1

Yes

12 (3.9)

6 (10.0)

4.7

20 - 32

185 (60.3)

38 (63.3)

1

33 - 36

77 (25.1)

14 (23.3)

0.8

0.43 - 1.69

0.663

≥37

45 (14.6)

8 (13.4)

0.8

0.35 - 1.94

0.678

Pregnancy-related factors Gestational age (weeks)

eported craving in previous R pregnancy No

180 (58.6)

19 (31.7)

1

Yes

67 (21.8)

31 (51.7)

7.3

3.71 - 14.3

<0.001

Not pregnant previously

60 (19.6)

10 (16.6)

1.7

0.73 - 3.88

0.212

1.39 - 5.19

0.003

Haemoglobin (g/dl) ≥10.5

255 (83.1)

42 (70.0)

1

<10.5

52 (16.9)

18 (30.0)

2.6

OR = odds ratio; CI = confidence interval; SA = South African. * Includes isihlambezo, imbiza and morroto.

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holds comprising four or more individuals. The mean gestational age was 30.3 (6.0) weeks. The mean parity was 1.4, and 22.6% of the women were nulliparous. Haemoglobin value determinations showed that 16.9% were anaemic (95% CI 13.1 - 21.6%). Among those who had been pregnant previously, 21.8% reported having craved non-food substances during their previous pregnancy.

Of the study sample, 22.8% reported ingesting a variety of nonfood substances during the current pregnancy (Table 1). The majority of those with pica (85.7%, 19.5% of the total sample) were ingesting soil, clay or stones (geophagia). Of those who reported geophagia, 83.3% purchased soil from street vendors. Twelve women (3.9% of the total sample) also reported taking African traditional plant-based medicines (isihlambezo, imbiza or morroto wa-tshwene). Threequarters of those with pica had not informed health personnel of their practice. Reasons for non-disclosure included fear of censure, not having been asked about pica practices (had they been asked they would have disclosed), and a perception that pica was a normal, expected development during pregnancy and there was therefore no need to report it as unusual behaviour. Most of those who disclosed their pica behaviour to health personnel were advised to cease, while others were prescribed iron tablets, and one woman was counselled to decrease the amount of soil ingested.

Table 2 describes the univariate sociodemographic and pregnancyrelated factors associated with geophagia. Of the participants 10.8% and 18.9%, respectively, reported using alcohol and tobacco during the current pregnancy. Tobacco use was more widespread in nongeophagic women (21.5%, compared with 8.3% in the geophagic group; p=0.02, Fisher’s exact test), but levels of alcohol consumption were similar in the two groups. Consumption of African traditional medicines such as isihlambezo was more widespread in geophagic women (10.0% compared with 2.4% in non-geophagic women; p=0.007, χ2 test). Of the women who practised geophagia, 51.7% (31/60) reported having craved non-food substances in a previous pregnancy, compared with 14.6% (36/247) in the non-geophagia group (p=0.001, χ2 test). There were no differences across the two groups with regard to pregnancy-related symptoms such as morning sickness, heartburn, constipation and moodiness, bleeding during pregnancy, or reported levels of urinary tract infections. Geophagic women had significantly lower mean haemoglobin levels than nongeophagic women (11.2 g/dl v. 12.0 g/dl; p=0.002, Wilcoxon ranksum test).

Women who practised geophagia were more likely to have been born outside SA (crude OR 2.3; 95% CI 1.23 - 4.41) and to have lower educational status (never been to school or had only primary school

Table 3. Distribution of blood metal concentrations in the total sample (N=307) Metal

Geometric mean

95% CI

Median (range)

Reference level (μg/dl) (% > reference level)

Lead

0.83

0.90 - 1.04

1.4 (1.0 - 9.9)

5* (2.3)

Mercury

0.76

0.71 - 0.81

0.6 (0.5 - 21.2)

5† (1.6)

Cadmium

0.24

0.21 - 0.26

0.2 (0.1 - 14.3)

Smokers: 3.36‡ (1.8)

Arsenic

0.84

0.79 - 0.89

0.8 (0.2 - 5.9)

10‡ (0)

Non-smokers: 1.12 (2.4) CI = confidence interval. *Tong et al.[16] † World Health Organization (1996).[22] ‡ Hazardous Chemical Substances Regulations, 1995: Occupation, Health and Safety Act, 1993 (Act No. 85 of 1993).[23]

Table 4. Blood metal concentrations according to geophagia status n

Geometric mean

95% CI

Median (range)

No geophagia

247

1.44

1.37 - 1.52

1.30 (1.00 - 9.90)

Geophagia

60

2.06

1.79 - 2.37

2.00 (1.00 - 8.60)

p-value*

Lead (μg/dl) <0.001†

Mercury (μg/l) No geophagia

247

0.77

0.71 - 0.83

0.64 (0.50 - 21.24)

Geophagia

60

0.72

0.62 - 0.83

0.57 (0.50 - 11.15)

No geophagia

247

0.83

0.78 - 0.89

0.83 (0.24 - 5.89)

Geophagia

60

0.86

0.75 - 0.98

0.82 (0.29 - 3.94)

0.183

Arsenic (μg/dl) 0.664

Cadmium (μg/l) Smoking No geophagia

53

0.52

0.40 - 0.67

0.59 (0.10 - 4.70)

Geophagia

5

0.31

0.11 - 0.85

0.18 (0.15 - 0.80)

No geophagia

194

0.20

0.18 - 0.22

0.17 (0.10 - 14.25)

Geophagia

55

0.20

0.17 - 0.24

0.18 (0.10 - 4.23)

0.319

Non-smoking

CI = confidence interval. * Wilcoxon rank-sum test. † Statistically significant difference.

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0.901

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education) (crude OR 2.8; 95% CI 1.04 7.65). Geophagic women also tended to be part of a smaller household (crude OR 1.9; 95% CI 1.05 - 3.34). Only 3.8% of women used traditional African medicines; how­ever, those who did so had a higher likelihood of being geophagic (crude OR 4.7; 95% CI 1.39 14.37). In addition, women who reported having craved non-food substances in a previous pregnancy (crude OR 7.3; 95% CI 3.71 - 14.31) and those with anaemia (crude OR 2.6; 95% CI 1.39 - 5.19) were more likely to practise geophagia.

Blood metal analyses

Table 3 shows the distribution of levels of lead, mercury, cadmium and arsenic in the blood samples collected, while Table 4 summarises the blood metal distributions in relation to geophagia status. The majority of women had blood metal distributions that were below international reference levels. For example, only 2.3% of the study sample had a blood lead level that exceeded the current reference level of 5 µg/ dl of the Centers for Disease Control and Prevention in the USA.[17] The geometric mean blood lead level in geophagic women was 2.1 µg/dl, as opposed to 1.4 µg/dl in non-geophagic women (p<0.001, Wilcoxon rank-sum test). Univariate analysis of the association between geophagia and blood lead levels showed a weak but significant association (crude OR 5.81; 95% CI 1.26 26.69; p=0.024). Levels of mercury, arsenic and cadmium were not similarly elevated in women with geophagia. However, among women with geophagia, those from outside SA had a small but significantly elevated geometric mean blood mercury concentration (0.97 µg/l) compared with SA women (0.62 µg/l; p<0.001, Wilcoxon rank-sum test).

Table 5 shows the results of multivariate modelling to examine the relationships between factors related to geophagia practices and metal concentrations. In the final model, geophagia was not associated with maternal age, alcohol intake, gestational age or elevated blood mental concentrations. After adjusting for education levels and household size, geo­ phagia practices in this study sample were strongly associated with being born outside SA (OR 2.74; 95% CI 1.27 - 5.92; p=0.010), and there was a weak but significant association with ingestion of traditional medicines (OR 6.74; 95% CI 1.75 - 26.04; p=0.006). Geophagia in the current pregnancy was also associated with having craved non-food substances in a previous pregnancy (OR 8.00; 95% CI 3.82 16.77; p<0.001), and women who practised geophagia had an increased likelihood of

Table 5. Multivariate associations of factors with geophagia among pregnant women Risk factor

Adjusted OR

95% CI

p-value

1.27 - 5.92

0.010

0.79 - 8.7

0.116

0.77 - 2.87

0.235

1.75 - 26.04

0.006

Nationality SA

1

Non-SA

2.7

Education Secondary/tertiary

1

None/primary

2.6

Household size ≥4

1

<3

1.7

Traditional medicines No

1

Yes

6.7

Reported craving in previous pregnancy No

1

Yes

8.0

3.82 - 16.77

<0.001

Not pregnant previously

1.5

0.64 - 3.72

0.333

1.19 - 5.46

0.015

Anaemia Hb ≥10.5 g/dl

1

Hb <10.5 g/dl

2.6

OR = odds ratio; CI = confidence interval; SA = South African; Hb = haemoglobin.

being anaemic (OR 2.55; 95% CI 1.19 - 5.46; p=0.015).

Discussion

The prevalence of geophagia in the current study is not as widespread as observed in earlier studies in other African countries (where levels around 64 - 74% have been reported)[5,6] or elsewhere in SA.[10] This may indicate a declining trend, or low levels of practice of geophagia in the our setting.

Nevertheless it remains an important public health concern that one-fifth of the women recruited into this study intentionally ingested soil, and were at elevated risk of the concomitant detrimental maternal and fetal health effects. Furthermore, underreporting is a possibility, since there is evidence from this study that geophagia was practised in a clandestine fashion. While some women readily reported their pica behaviour to health personnel (and were usually advised to desist or decrease the habit, or were prescribed iron supplements), others deliberately concealed the practice, fearing censure. Others believed pica to be a normal and expected development in pregnancy and did not consider there to be any need to report or seek advice in respect of the habit.

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Despite no significant association between geophagia and blood lead concentrations being observed in the multivariate model, it is suggested that caution and further investigation is warranted, especially in the light of such associations being observed elsewhere.[13] Given the known toxicity[16] and transplacental movement properties[17] of lead, there is a particular need for vigilance in African settings where lead exposure is a public health concern.[17] Geophagia was not associated with elevated blood levels of cadmium, arsenic or mercury in this study.

However, women born outside SA were shown to have higher blood mercury levels than their local counterparts; we can suggest no explanation for this finding at this stage.

The association between geophagia and depressed haemoglobin levels was confirmed in this study. Geophagia has been shown to exacerbate the existing physiological risk of anaemia during pregnancy.[18] A further potential concern is the finding that women who were geophagic also tended to consume isihlambezo, a collective term used to describe a wide range of African traditional medicine formulations usually used during the last trimester of pregnancy to promote health and facilitate childbirth.[19] The use of certain isihlambezo ingredients has been

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associated with detrimental preg­nancy outcomes such as death due to hepatorenal failure, low birth weight, meconium staining of amniotic fluid and fetal distress.[19] Screening for pica or geophagia does not currently constitute part of the standard antenatal assessment programme in SA. In this study one-fifth of women reported geophagia, and studies undertaken elsewhere provide evidence that levels may be even higher in other settings.[5,6,10] Given the high prevalence of geophagia, its association with depressed haemoglobin levels, and the potential for elevated blood lead levels and simultaneous use of isihlambezo (with its own potential concomitant health risks), it may be prudent to include active screening for pica or geophagia in the prenatal care programme in SA. Such a step may prove to be a powerful mechanism for antenatal education and identification of a range of maternal and fetal health risks, such as elevated blood lead levels, anaemia, geohelminthic infections, micronutrient deficiencies, intestinal obstruction or perforation, low birth weight and fetal distress. Since this study shows geophagia to be particularly prevalent in pregnant women from countries elsewhere in Africa, similar measures may be of benefit across a large cross-section of the African continent, as well as in African diaspora communities across the globe.[13,20,21]

Conclusion

Twenty per cent of pregnant women in this study undertaken in Johannesburg, SA, were geophagic, and at risk of anaemia and potentially lead exposure and other adverse health outcomes.

Geophagia does not currently form part of the standard prenatal screening package in SA, but its inclusion potentially constitutes a powerful mechanism for antenatal education and the identification of a range of detrimental health outcomes.

References 1. Woywodt A, Kiss A. Geophagia: The history of earth-eating. J R Soc Med 2002;95(3):143-146. [http:// dx.doi.org/10.1258/jrsm.95.3.143] 2. Njiru H, Elchalal U, Paltiel O. Geophagy during pregnancy in Africa: A literature review. Obstet Gynecol Surv 2011;66(7):452-459. [http://dx.doi.org/10.1097/OGX.0b013e318232a034]

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3. Al-Rmalli SW, Jenkins RO, Watts MJ, et al. Risk of human exposure to arsenic and other toxic elements from geophagy: Trace element analysis of baked clay using inductively coupled plasma mass spectrometry. Environ Health 2010;9(1):79. [http://dx.doi.org/10.1186/1476-069X-9-79] 4. Simpson E, Mull JD, Longley E, et al. Pica during pregnancy in low-income women born in Mexico.

West J Med 2000;173(1):20-24. [http://dx.doi.org/10.1136/ewjm.173.1.20] 5. Nyaruhucha CN. Food cravings, aversions and pica among pregnant women in Dar es Salaam, Tanzania. Tanzan J Health Res 2009;11(1):29-34.

6. Ngozi PO. Pica practices of pregnant women in Nairobi, Kenya. East Afr Med J 2008;85(2):72-79. [http://dx.doi.org/10.4314/eamj.v85i2.9609] 7. Lanzkowsky P. Investigation into the aetiology and treatment of pica. Arch Dis Child 1959;34(174):140148. [http://dx.doi.org/10.1136/adc.34.174.140] 8. Saathoff E, Olsen A, Kvalsvig JD, et al. Geophagy and its association with geohelminth infection in rural schoolchildren from northern KwaZulu-Natal, South Africa. Trans R Soc Trop Med Hyg 2002;96(5):485-490. [http://dx.doi.org/10.1016/S0035-9203(02)90413-X] 9. Walker AR, Walker BF, Jones J, et al. Nausea and vomiting and dietary cravings and aversions during pregnancy in South African women. Br J Obstet Gynaecol 1985;92(5):484-489. [http://dx.doi. org/10.1111/j.1471-0528.1985.tb01353.x] 10. George G, Ndip E. Prevalence of geophagia and its possible implications to health â&#x20AC;&#x201C; a study in rural South Africa. Presented at the 2nd International Conference on Environmental Science and Development (IPCBEE), Singapore, 26-28 February 2011. http://www.ipcbee.com/vol4/37ICESD2011D10046.pdf (accessed 2 July 2014).

11. Ekosse GIE, de Jager L, Ngole V. Traditional mining and mineralogy of geophagic clays from Limpopo and Free State provinces, South Africa. African Journal of Biotechnology 2010;9(47):8058-8067. [http://dx.doi.org/10.5897/AJB10.296] 12. Johns T, Duquette M. Detoxification and mineral supplementation as functions of geophagy. Am J Clin Nutr 1991;53(2):448-456.

13. Thihalolipavan S, Candalla BM, Ehrlich J. Examining pica in NYC pregnant women with elevated blood lead levels. Matern Child Health J 2013;17(1):49-55. [http://dx.doi.org/10.1007/s10995-012-0947-5] 14. McKenna D. Myopathy, hypokalaemia and pica (geophagia) in pregnancy. Ulster Med J 2006;75(2):159-160.

15. Chaushev P, Dreyer M, Gledhill R. Hypokalemic myopathy due to ingestion of earth. J Neurol 2003;250(1):114-115. [http://dx.doi.org/10.1007/s00415-003-0934-2] 16. Tong S, von Schirnding YE, Prapamontol T. Environmental lead exposure: A public health problem of global dimensions. Bull World Health Organ 2000;78(9):1068-1077.

17. Goyer RA. Transplacental transport of lead. Environ Health Perspect 1990;89(6):101-105. [http:// dx.doi.org/10.1289/ehp.9089101] 18. Kwong WT, Phyllis F, Semba RD. Interactions between iron defeciency and lead poisoning: Epidemiology and pathogenesis. Sci Total Environ 2004;330(1):21-37. [http://dx.doi.org/10.1016/j. scitotenv.2004.03.017] 19. Veale DJ, Furman KI, Oliver DW. South African traditional herbal medicines used during pregnancy and childbirth. J Ethnopharmacol 1992;36(3):185-191. [http://dx.doi.org/10.1016/0378-8741(92)90043-Q] 20. Klitzman S, Sharma A, Nicaj L, et al. Lead poisoning among pregnant women in New York City: Risk factors and screening practices. J Urban Health 2002;79(2):225-237. [http://dx.doi.org/10.1093/ jurban/79.2.225] 21. Abrahams PW, Follansbee MH, Hunt A, et al. Iron nutrition and possible lead toxicity: An appraisal of geophagy undertaken by pregnant women of UK Asian communities. Appl Geochem 2006;21(1):98108. [http://dx.doi.org/10.1016/j.apgeochem.2005.09.015] 22. World Health Organization. Trace elements in human nutrition and health. 1996. http://www.who.int/ nutrition/publications/micronutrients/9241561734/en/ (accessed 2 July 2014).

23. Hazardous Chemical Substances Regulations, 1995: Occupation, Health and Safety Act, 1993 (Act No. 85 of 1993). http://www.labour.gov.za/DOL/downloads/legislation/acts/occupational-health-and-safety/ amendments/Amended%20Act%20-%20Occupational%20Health%20and%20Safety.pdf (accessed 2 July 2014).

Accepted 15 May 2014.

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Loss of detectability and indeterminate results: Challenges facing HIV infant diagnosis in South Africa’s expanding ART programme A F Haeri Mazanderani,1 MB ChB, Dip HIV Man (SA); N M du Plessis,2 MB ChB, MMed (Paed), FCPaed (SA), Dip Allerg (SA), Dip HIV Man (SA), Cert ID Paed (SA); W N Thomas,2 MD; E Venter,2 MB ChB, DCH (SA); T Avenant,2 MB ChB, MMed (Paed), FCPaed (SA) 1 2

epartment of Medical Virology, Tshwane Academic Division, National Health Laboratory Service, and University of Pretoria, South Africa D Paediatric Infectious Diseases Division, Department of Paediatrics, Kalafong Hospital and University of Pretoria, South Africa

Corresponding author: A F Haeri Mazanderani (ahmad.haerimazanderani@up.ac.za) Background. Early infant diagnosis with rapid access to treatment has been found to reduce HIV-associated infant mortality and morbidity considerably. In line with international standards, current South African guidelines advocate routine HIV-1 polymerase chain reaction (PCR) testing at 6 weeks of age for all HIV-exposed infants and ‘fast-track’ entry into the HIV treatment programme for those who test positive. Importantly, testing occurs within the context of increasing efforts at prevention of mother-to-child transmission (PMTCT) by means of maternal and infant antiretroviral therapy (ART). In addition, infants already initiated on combination ART (cART) may be retested with PCR assays for ‘confirmatory’ purposes, including assessment prior to adoption. The potential for cART to compromise the sensitivity of HIV-1 PCR assays has been described, although there are limited and conflicting data regarding the effect of PMTCT regimens on HIV-1 PCR diagnostic sensitivity.

Methods. We describe a case series of three infants with different ART exposures in whom HIV diagnosis, confirmation or the result of retesting for adoption purposes were uncertain.

Results. These cases demonstrate that ART can be associated with a loss of detectability of HIV, leading to ‘false-negative’ HIV-1 PCR results in infants on cART. Furthermore, current PMTCT practices may lead to repeatedly indeterminate results with a subsequent delay in initiation of cART. Conclusion. The sensitivity of HIV-1 PCR assays needs to be re-evaluated within the context of different ART exposures, and diagnostic algorithms should be reviewed accordingly.

S Afr Med J 2014;104(8):574-577. DOI:10.7196/SAMJ.8322

Early infant diagnosis with rapid access to treatment has been found to reduce HIV-associated infant mortality and morbidity considerably.[1] In line with international standards, current South African (SA) guidelines advocate routine HIV-1 polymerase chain reaction (PCR) testing at 6 weeks of age for asymptomatic HIV-exposed infants and ‘fast-track’ entry into the HIV treatment programme for those who test positive.[2,3] Importantly, HIV infant diagnosis forms part of a larger package of services for the prevention of mother-to-child transmission (PMTCT) of HIV. These include the provision of effective combination antiretroviral therapy (cART) to all HIV-infected pregnant women irrespective of CD4+ T-cell count or World Health Organization (WHO) staging, and nevira­ pine prophylaxis for 6 weeks to HIV-exposed infants.[2] Additionally, SA has implemented the WHO 2010 guidelines on HIV and infant feeding, which recommend that HIV-infected mothers should breastfeed their infants and receive antiretroviral drugs simultan­ eously.[4,5] Efforts to diagnose HIV in infants therefore occur within the context of an extensive PMTCT programme and ART exposure.

Furthermore, children already initiated on cART may be retested with HIV-1 PCR assays for ‘confirmatory’ purposes, including assessment prior to adoption.

Whereas treatment with cART in infants is known to be capable of reducing HIV titres to levels below PCR diagnostic threshold values,[6] there are limited and conflicting data regarding the effect

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of maternal and/or infant antiretroviral PMTCT exposure on the sensitivity of HIV-1 PCR assays. Some studies have reported that the results of HIV-1 DNA PCR assays do not vary according to maternal or infant antiretroviral prophylaxis,[7] whereas others have suggested that the duration of exposure to certain antiretroviral agents influences the age at which HIV-1 can be detected.[8] A recent publication reported that 11% of HIV-1-infected children had false-negative PCR results during ART prophylaxis.[9] However, studies have yet to determine the performance of diagnostic testing in infants receiving daily nevirapine prophylaxis. Similarly, there are limited data regarding the sensitivity of HIV-1 PCR assays in infants breastfeeding from mothers taking cART, either alone or as part of a combination of PMTCT practices as per the current SA guidelines.

Methods

The paediatric infectious diseases division and medical virology dep­ artment of a tertiary hospital in SA were recently consulted regarding three cases in which HIV diagnosis, confirmation or the result of retesting for adoption purposes were uncertain in infants with different ART exposures. The cases are summarised in Table 1, with details of the respective diagnostic assays used.

Diagnosis of HIV-1 infection

All HIV-1 PCR testing, except for a single HIV-1 DNA PCR in case 1, was performed with the COBAS AmpliPrep/COBAS TaqMan (CAP/

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Breastmilk

Mixed feeds VL : 268 840 cps/ml 18 weeks

575

ART = antiretroviral therapy; cART = combination ART; NVP = nevirapine; cps = copies; PCR = polymerase chain reaction; VL = viral load; bDNA = branched DNA testing. *COBAS AmpliPrep/COBAS TaqMan HIV-1 qualitative test (Roche Molecular Systems, USA). † Abbott RealTime HIV-1 assay (Abbott Molecular, USA). ‡ AMPLICOR HIV-1 DNA test, v1.5 (Roche Molecular Systems, USA). § COBAS AmpliPrep/COBAS TaqMan HIV-1 test, v2.0 (Roche Molecular Systems, USA). ¶ VERSANT HIV-1 RNA 3.0 assay (bDNA) (Siemens Healthcare Diagnostics, USA).

†

PCR*: Indeterminate 12 weeks

Breastmilk VL¶: 2 504 cps/ml 10 weeks cART PCR*: Indeterminate PCR*: Indeterminate cART PCR*: Negative VL†: < detectable 40 weeks

18 weeks

PCR*: Indeterminate VL†: 255 cps/ml

Breastmilk 9 weeks cART PCR*: Negative VL§: < detectable cART DNA PCR : Negative 36 weeks

12 weeks

VL†: 270 cps/ml

Breastmilk 8 weeks cART VL§: < detectable 10 weeks cART

‡

VL†: < detectable 31 weeks

PCR*: Indeterminate NVP VL†: 92 920 cps/ml 10 days

8 weeks

PCR*: Indeterminate PCR*: Positive

Breastmilk 6 weeks NVP

ART exposure

NVP PCR*: Indeterminate PCR*: Indeterminate

HIV Results Age

4 weeks

ART exposure

NVP

HIV results

PCR*: Positive

Age

6 weeks

ART exposure

NVP

HIV results

PCR*: Positive

Age

Birth

Case 1: HIV-infected child on cART, evaluated prior to adoption at 36 weeks

Table 1. Case series with ages, HIV-1 results and ART exposure

Case 2: Formula-fed NVP-exposed infant, mother on cART but died

Case 3: Breastfed NVP-exposed infant, mother on cART

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CTM) HIV-1 qualitative test (Roche Molecular Systems, USA).

The CAP/CTM is a total nucleic acid real-time PCR assay that detects both HIV-1 proviral DNA and HIV-1 RNA,[10] and is the only test available for HIV-1 qualitative PCR testing in the public health sector in SA. Testing is performed at designated early infant diagnostic laboratories, all of which have been certified by the South African National Accreditation System (SANAS ISO 15189:2007). Testing is performed on either whole ethylenediaminetetra-acetic acid (EDTA) blood or dried blood spot (DBS) specimens. The latter have proven to be of particular value for outlying public healthcare facilities, where DBS cards facilitate specimen collection, storage and transport. Evaluation of the CAP/CTM assay using clinical specimens from HIV-exposed children in SA has revealed a limit of detection of 1 090 copies/ml and sensitivities of between 98.8% and 99.7%.[11,12] Criteria that define low-positive results as indeterminate have been adopted by all early infant diagnostic centres in SA, and are determined by a cycle threshold value of >33 and/or a fluorescence intensity value of <5 (Fig. 1).[13] These norms are based on research data that showed poor specificity for the CAP/CTM assay at these values.[12] Indet­erminate results are reported with a standard comment requesting an additional specimen for repeat testing.

An alternative HIV-1 qualitative PCR assay was used in case 1 at 36 weeks of age. A SANAS-accredited private laboratory performed an HIV-1 DNA PCR test on peripheral blood mononuclear cells (PBMCs) using the AMPLICOR HIV-1 DNA test, v1.5 (Roche Molecular Systems, USA).

Quantification of HIV-1 RNA

HIV infection is confirmed and monitored by means of viral load (VL) testing, which is currently performed on either the Abbott RealTime HIV-1 assay (Abbott Molecular, USA) (limit of detection <40 RNA copies/ml) or the COBAS AmpliPrep/ COBAS TaqMan HIV-1 test, v2.0 (Roche Molecular Systems, USA) (limit of detection <20 copies/ml). Both are tested on plasma.

An alternative HIV-1 RNA test was used in case 3 at 10 weeks of age. A SANAS-accredited private laboratory performed an HIV-1 RNA VL on plasma using the VERSANT HIV-1 RNA 3.0 assay (branched DNA) (Siemens Healthcare Diagnostics, USA).

Results Case 1

An infant given up for adoption at birth was diagnosed with in utero HIV infection on the basis of a positive HIV-1 PCR result within 48 hours of birth and a confirmatory HIV-1 VL of 92 920 copies/ml. The birth mother had been on and off cART for 2 years. A cART regimen of abacavir, lamivudine and ritonavir-boosted lopinavir was initiated at 16 days of age. On routine follow-up at 31 weeks of age the child was found to be virologically suppressed with normal growth and development.

At 36 weeks, the social workers responsible for placement of the child requested repeat HIV testing prior to adoption.

HIV-1 DNA PCR testing performed on PBMCs was negative.

At 40 weeks of age, the HIV-1 PCR and VL were repeated and tested negative and less than detectable, respectively.

Case 2

Case 2 documents the HIV-1 PCR results of an exclusively formula-fed infant who received nevirapine syrup as part of the

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Fluorescence intensity

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35 30 25 20 15 10 5 0

CH1: Target

0

2

4

6

8

Cycle# 33.0

Channel 1

10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 Cycle

Fig. 1. Real-time HIV-1 PCR graph demonstrating cycle time cut-off of 33.0 and fluorescence intensity cut-off of 5. (PCR = polymerase chain reaction.)

PMTCT programme (the mother, who was on cART, died shortly after delivery). At 6 weeks of age the infant tested HIV-1 PCR-positive and was subsequently referred to paediatric HIV services for confirmatory testing and cART initiation. At 8 weeks of age, cART was initiated and a specimen sent for confirmatory HIV-1 qualitative PCR testing.

The patient was still being given daily nevirapine syrup at the time of testing. An indeterminate HIV-1 PCR result led to an HIV-1 VL being performed at 10 weeks, which was reported as less than detectable.

A repeat HIV-1 PCR and VL were then performed at 12 weeks, with negative and less than detectable results, respectively. At 18 weeks further specimens were taken and HIV-1 PCR testing was performed at two different laboratories, both yielding indeterminate results.

Case 3

A breastfed infant whose mother had been initiated on a cART regi­ men of tenofovir, lamivudine and efavirenz during late pregnancy presented at 4 weeks of age with a lower respiratory tract infection complicated by empyema. HIV-1 qualitative PCR testing was performed four times between 4 and 6 weeks of age on account of repeatedly indeterminate results. Initiation of cART was further delayed because of a low baseline HIV-1 VL result of 270 copies/ml.

This was repeated the following week, with a similarly low VL of 255 copies/ml. At the time, national guidelines for the initiation of ART in infants required a confirmatory HIV VL of >10 000 RNA copies/ ml. Concerns about possible laboratory contamination or suboptimal amplification prompted the decision to perform branched DNA testing, which although yielding a higher VL (2 504 copies/ml) was not considered significant for diagnostic purposes. An additional HIV-1 qualitative test performed at 12 weeks yielded another indeterminate result. The HIV diagnosis was finally confirmed at 18 weeks with a VL of 268 840 copies/ml. This was performed on the same assay as the initial HIV VL testing that had yielded low RNA titres. Internal control suppression was not noted with any of these results.

Discussion

The cases described above demonstrate that cART in infants can be associated with loss of detectability of HIV, leading to ‘falsenegative’ HIV-1 PCR results. Similarly, current PMTCT practices may lead to repeatedly indeterminate results, probably because of ART suppressing the HIV VL below diagnostic threshold values, with subsequent delays in initiation of cART. Case 1 is a complex case, with the prospect of adoption complicating counselling to caregivers, social services and future adoptive parents.

Although a clear diagnosis of HIV was made at birth on the basis of a positive HIV-1 PCR result and a confirmatory VL of 92 920 copies/ml, social services requested further HIV testing at 36 weeks as part of a

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medical evaluation prior to adoption. Repeat HIV-1 PCR testing once cART has been initiated can, however, result in a loss of detectability of HIV-1 on account of supressed target DNA and RNA.[6] The subsequent inability to detect HIV early in the course of treatment can prove challenging as far as counselling and retention in care are concerned. The problem has become even more complex now that the possibility of a functional cure has entered the equation.[14] Diverse practices in adoption services, especially with regard to the diagnosis of HIV and the interpretation of HIV results in the context of cART, may potentially have devastating consequences for both the infant and the adoptive parents. Although SA has approximately 3.8 million orphans[15] and the current legislative framework supports adoption as the preferred form of alternative care, no national guidelines regarding the appropriate medical evaluation of children prior to adoption have yet been developed.[16] Similar difficulties to those in case 1 can be experienced when trying to confirm HIV status in infants already initiated on cART where the results of baseline testing are either uncertain or not available. The second case highlights the difficulties of confirmatory testing in the context of ‘fast-track’ entry into the treatment programme. According to the current national testing algorithm, infants who test positive with an HIV-1 PCR assay require a detectable HIV VL to confirm infection. However, these guidelines state that cART initiation should not be delayed by waiting for the VL result and that it should be commenced within 7 days of receiving a positive HIV-1 PCR result.[2,3] This can cause diagnostic difficulties if initial confirmatory testing yields indeterminate results or was performed some time after initiation of cART. Although the potential for cART to compromise the sensitivity of HIV-1 PCR assays has been described in the medical literature,[6] it appears to be under-appreciated by both clinicians and the lay public. Of similar concern is the effect PMTCT regimens may have on the sensitivity of HIV-1 PCR assays. Both case 2 and case 3 suggest that diagnostic difficulties can be associated with different types of prophylactic infant ART exposure. Both direct exposure in the form of infant nevirapine syrup (case 2) and passively ingested ART in breastmilk when a mother is taking cART (case 3) are associated with indeterminate HIV-1 PCR results. Although these cases do not amount to incontrovertible proof of PMTCT regimens compromising PCR assay sensitivity, they are supported by similar reports in the medical literature.[17] Furthermore, a recent publication suggests that HIV-1 PCR testing with the CAP/CTM assay 2 weeks after singledose nevirapine exposure resulted in a markedly reduced sensitivity of 83%, well below WHO standards.[18,19] Of particular concern is the possibility that combination infant ART exposure (i.e. simultaneous ART ingestion in breastmilk and in the form of nevirapine syrup,

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as per current guidelines) may be sufficient to suppress HIV-1 replication below the limit of detection of the CAP/CTM assay. This is of further relevance in health settings such as SA that utilise DBS specimens, as a lower specimen volume (approximately 60 μl) than for whole EDTA blood (100 μl) is tested.

Case 3 also demonstrates how repeatedly indeterminate HIV-1 PCR results can delay cART initiation, potentially resulting in a poor clinical outcome. HIV-1 PCR testing at 6 weeks has already been found to delay cART initiation in SA’s public health sector beyond the time of peak HIV-related infant mortality.[20] Further delays may therefore have fatal consequences, or other serious implications including failure to follow up, the development of drug resistance, negative psychosocial consequences for the caregiver, and considerable cost implications for the public health sector. Although ART levels in untreated breastfed infants have not been sufficiently studied, it has been demonstrated that ART taken by nursing mothers is expressed in significant concentrations in breastmilk.[21] During weaning the decreased intake of breastmilk implies subsequent reduction of ART exposure. This could have led to the significantly elevated VL in case 3, supporting the possibility that ART secretion in breastmilk may compromise the sensitivity of the HIV-1 PCR assay.

Essentially, all three cases raise concerns regarding the sensitivity of HIV-1 PCR assays in the context of ART exposure. They also alert us to the possibility of overestimation of the efficacy of SA’s PMTCT programme, as the data available are for children <2 months of age who are still exposed to ART.[22] Importantly, earlier validation studies of the CAP/CTM assay were performed at a time when less ART-intensive PMTCT regimens were provided to infants.

Although improvements in the sensitivity of the assay may address these challenges effectively, validation studies are needed to assess performance in the context of SA’s PMTCT programme. This is of particular relevance as SA embarks on rolling out a new version of the current PCR assay, the CAP/CTM v2.0, which has a reportedly more sensitive limit of detection than the previous assay.[23]

Conclusion

We have described a case series of infants with different ART exposures in whom the diagnosis of HIV or the confirmation thereof led to uncertainty. These cases suggest that children exposed to ART can have false-negative and repeatedly indeterminate HIV-1 PCR results, posing significant challenges to the current PMTCT and early infant diagnostic programmes in SA. Further studies are needed to re-evaluate the sensitivity of HIV-1 PCR assays in the context of ART exposure, and infant diagnostic algorithms need to be reviewed accordingly.

Acknowledgments. We thank the diagnostic staff at the Department of Medical Virology, Tshwane Academic Division of the National Health Laboratory Service, for their valuable contribution, Drs Sergio Carmona

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and Michelle Bronze for their kind assistance with testing samples of one of the cases described, and Denis Dionysiou for assistance with Fig. 1. We also thank Prof. Gayle Sherman for reviewing the manuscript.

References 1. Violari A, Cotton MF, Gibb DM, et al. Early antiretroviral therapy and mortality among HIV-infected infants.

N Engl J Med 2008;359(21):2233-2244. [http://dx.doi.org/10.1056/NEJMoa0800971] 2. South African National Department of Health. The South African Antiretroviral Treatment Guidelines 2013: PMTCT Guidelines. Pretoria: Department of Health, 2013. at http://web.up.ac.za/sitefiles/file/45/1335/877/ PMTCT%20guidelines_March%202013_DoH.pdf (accessed 13 May 2013).

3. South African National Department of Health. The South African Antiretroviral Treatment Guidelines 2013.

Pretoria: Department of Health, 2013. http://www.doh.gov.za/docs/policy/2013/ART_Treatment_Guidelines_ Final_25March2013.pdf (accessed 11 October 2013).

4. World Health Organization. Guidelines on HIV and Infant Feeding 2010. Principles and Recommendations for Infant Feeding in the Context of HIV and a Summary of Evidence. Geneva: World Health Organization, 2010. http://www.who.int/maternal_child_adolescent/documents/9789241599535/en/ (accessed 23 December 2013).

5. The Tshwane declaration of support for breastfeeding in South Africa. South African Journal of Clinical Nutrition 2011;24(4):214.

6. Persaud D, Ray SC, Kajdas J, et al. Slow human immunodeficiency virus type 1 evolution in viral reservoirs in infants treated with effective antiretroviral therapy. AIDS Res Hum Retroviruses 2007;23(3):381-390. [http:// dx.doi.org/10.1089/aid.2006.0175] 7. Dunn DT, Simonds RJ, Bulterys M, et al. Interventions to prevent vertical transmission of HIV-1: Effect on viral rate in early infant samples. AIDS 2000;14(10):1421-1428. [http://dx.doi.org/10.1097/00002030200007070-00016] 8. Prasitwattanaseree S, Lallemant M, Costagliola D, Jourdain G, Mary JY. Influence of mother and infant zidovudine treatment duration on the age at which HIV infection can be detected by polymerase chain reaction in infants. Antivir Ther 2004;9(2):179-185.

9. Burgard M, Blanch S, Jasseron C, et al. Performance of HIV-1 DNA or HIV-1 RNA tests for early diagnosis of perinatal HIV-1 infection during anti-retroviral prophylaxis. J Pediatr 2012;160(1):60-66. [http://dx.doi. org/10.1016/j.jpeds.2011.06.053] 10. Roche® COBAS® AmpliPrep/COBAS® TaqMan HIV-1 Qual Test [package insert]. Branchburg, NJ: Roche, 2010.

11. Stevens W, Erasmus L, Moloi M, et al. Performance of a novel human immunodeficiency virus (HIV) type 1 total nucleic acid-based real-time PCR assay using whole blood and dried blood spots for diagnosis of HIV in infants. J Clin Microbiol 2008;46(12):3941-3945. [http://dx.doi.org/10.1128/JCM.00727-09] 12. Maritz J, Preiser W, van Zyl GU. Establishing diagnostic cut-off criteria for the COBAS AmpliPrep/COBAS TaqMan HIV-1 qualitative test through validation against the Amplicor DNA test v1.5 for infant diagnosis using dried blood spots. J Clin Virol 2012;53(2):106-109. [http://dx.doi.org/10.1016/j.jcv.2011.12.002] 13. Maritz J, van Zyl GU, Preiser W. Irreproducible positive results on the Cobas Ampliprep/Cobas TaqMan HIV1 Qual Test are different qualitatively from confirmed positive results. J Med Virol 2014;86(1):82-87. [http:// dx.doi.org/10.1002/jmv.23811] 14. Persaud D, Gay H, Ziemniak C, et al. Absence of detectable HIV-1 viremia after treatment cessation in an infant. N Engl J Med 2013;369(19):1828-1835. [http://dx.doi.org/10.1056/NEJMoa1302976] 15. Meintjes H, Hall K. Demography of South Africa’s children. In: Hall K, Woolard I, Lake L, et al., eds. South African Child Gauge 2012. Cape Town: Children’s Institute, University of Cape Town, 2012:82-85. http://www. ci.org.za/index.php?option=com_content&view=article&id=997&Itemid=399 (accessed 12 June 2013).

16. Haeri Mazanderani AF, du Plessis NM, Lumb J, et al. Recommendations for the medical evaluation of children prior to adoption in South Africa. S Afr Med J 2014;104(8):544-549. [http://dx.doi.org/10.7196/SAMJ.7958] 17. Connolly MD, Rutstein RM, Lowenthal ED. Virologic testing in infants with perinatal exposure to HIV receiving multidrug prophylaxis. Pediatr Infect Dis J 2013;32(2):196-197. [http://dx.doi.org/10.1097/ INF.0b013e3182787c29]zvh 18. Lilian RR, Kalk E, Bhowan K, et al. Early diagnosis of in utero and intrapartum HIV infection in infants prior to 6 weeks of age. J Clin Microbiol 2012;50(7):2373-7237. [http://dx.doi.org/10.1128/JCM.00431-12] 19. World Health Organization. WHO Recommendations on the Diagnosis of HIV Infection in Infants and Children. Geneva: WHO, 2010. http://whqlibdoc.who.int/publications/2010/9789241599085_eng.pdf (accessed 23 December 2013).

20. Lilian RR, Kalk E, Technau K-G, Sherman GG. Birth diagnosis of HIV infection on infants to reduce infant mortality and monitor for elimination of mother-to-child transmission. Pediatr Infect Dis J 2013;32(10):10801085. [http://dx.doi.org/10.1097/INF.0b013e318290622e] 21. Shapiro RL, Holland DT, Capparelli E, et al. Antiretroviral concentrations in breast-feeding infants of women in Botswana receiving antiretroviral treatment. J Infect Dis 2005;192(5):720-727. [http://dx.doi. org/10.1086/432483] 22. Goga AE, Dinh T-H, Jackson DJ, for the SAPMTCTE study group. Evaluation of the effectiveness of the national prevention of mother-to-child transmission (PMTCT) programme measured at six weeks postpartum in South Africa, 2010. South African Medical Research Council, National Department of Health of South Africa and PEPFAR/US Centers for Disease Control and Prevention, 2012. http://www.hst.org.za/ publications/evaluation-effectiveness-national-prevention-mother-child-transmission-pmtct-programme(accessed 24 June 2013).

23. Roche® COBAS® AmpliPrep/COBAS® TaqMan HIV-1 Qualitative Test, version 2.0 [package insert].

Branchburg, NJ: Roche, 2013.

Accepted 14 May 2014.

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GUEST EDITORIAL

Climate change: One of the greatest threats to public health in the 21st century The impact of climate change on human health and well-being has already been observed. Direct effects such as those related to heat, cold, floods, storms and solar ultraviolet radiation have been documented.[1] Some vector-, food- and water-borne diseases and other infectious diseases influenced by ecosystems are likely to increase in incidence. Respiratory health is affected by near-surface ozone exposures, episodes of acute air pollution, and aero-allergens. Indirect health impacts also exist. For example, changes in agricultural production, and loss of crop yield and the nutritional value of food have detrimental effects on nutrition.

Increasing ambient temperatures can lead to loss of work capacity and occupational health concerns. The impact on mental health, mass migration, conflict and violence associated with changes in climate should not be underestimated.

South Africa (SA) may be considered as one of the countries facing the greatest challenges regarding climate change and health from threats of rising sea levels to drought and flooding. Current projections suggest a higher rise in temperature in SA than the global average.[2-4] This may lead to direct effects, including increased headaches, nausea, exhaustion, heat stroke and even mortality. In addition, atmospheric changes in air pollution may also be affected, which aggravate existing conditions of asthma and allergic rhinitis.

Changes in health-support needs and services may be required, e.g. reduced availability and quality of water, and food security risks decreasing an individual’s ability to cope with existing and emerging diseases. The increasing occurrence of extreme weather events, together with loss of property and family support, may cause anxiety, depression and stress. Such events may also cause damage to traffic infrastructure, leading to an increase in the incidence and severity of road traffic accidents, currently among the top five causes of premature death in the SA. The deterioration of environmental conditions may lead to population displacement and immigration into SA from neighbouring southern African countries, resulting in increased pressure on services and local environmental conditions. Violence and interpersonal crime, already a major cause of morbidity and mortality in SA, may increase. Occupational climate health-related risks are a serious concern. The mining and farming sectors are particularly susceptible to the threat of warmer temperatures, leading to heat exhaustion, inability to work, and loss of productivity.

This month’s CME aims to highlight some of the impacts of climate change on human health in SA. A collaborative review article[6] gives an overview of the Fifth Assessment Report of Working Group II on Human health: Impacts, adaptation and co-benefits[1] and considers the issues pertinent to SA. The complex HIV/AIDS disease burden and its vulnerability to a changing climate are outlined by Prof. Akin Abayomi and Maureen Cowan.[7] In light of these expected health impacts, Dr Rebecca Garland[8] discusses the steps taken by SA to

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address the threats and risks of a changing climate on public health.

Her article emphasises the need for action by all key stakeholders, including government agencies, healthcare professionals, researchers and community members to address effectively the challenges posed by climate change on public health. An article by Devin Bowles and Prof. Colin Butler[9] considers the so-called ‘tertiary’ health effects of climate change, which are socially, politically and economically mediated. Examples include increased under-nutrition, migration, conflict and health system strain. Prof. Tord Kjellstrom and colleagues[10] describe climate conditions in the workplace as occupational health hazards threatened by climate change.

C Y Wright Climate Studies, Modelling and Environmental Health Research Group, Council for Scientific and Industrial Research, Pretoria, and Department of Geography, Geoinformatics and Meteorology, University of Pretoria, Pretoria, South Africa cwright@csir.co.za

M Norval Biomedical Sciences, University of Edinburgh Medical School, Edinburgh, UK mary.norval@ed.ac.uk 1. Smith KR, Woodward A, Campbell-Lendrum D, et al. Human health: Impacts, adaptation and co-benefits. In: Field CB, Barros V, Dokken DJ, et al., eds. Impacts, Adaptation and Vulnerability.

Contribution of Working Group II to the Fifth Assessment Report of the Intergovernmental Panel on Climate Change. Cambridge, UK: Cambridge University Press, 2014.

2. Christensen JH, Hewitson B, Busuioc A, et al. Regional climate projections. In: Solomon S, Qin D, Manning M, et al. Climate Change 2007: The Physical Science Basis. Contribution of Working Group I to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change. Cambridge, UK: Cambridge University Press, 2007.

3. Engelbrecht FA, McGregor JL, Engelbrecht CJ. Dynamics of the conformal-cubic atmospheric model projected climate-change signal over southern Africa. International Journal of Climatology 2009;29(7):1013-1033. [http://dx.doi.org/10.1002/joc.1742] 4. Niang I, Ruppel OC, Abdrabo M, et al. Africa. In: Field CB, Barros V, Dokken DJ, et al., eds. Impacts, Adaptation and Vulnerability. Contribution of Working Group II to the Fifth Assessment Report of the Intergovernmental Panel on Climate Change. Cambridge, UK: Cambridge University Press, 2014.

5. The Times (UK).Global warming threat to health. 29 March 2014;12:01. http://www.thetimes.co.uk/ tto/opinion/letters/article4048102.ece (accessed 9 July 2014).

6. Wright CY, Garland RM, Norval M, Vogel C. Human health impacts in a changing South African climate. S Afr Med J 2014;104(8):579-582. [http://dx.doi.org/10.7196/SAMJ.8603] 7. Abayomi A, Cowan MN. The HIV/AIDS epidemic in South Africa: Convergence with tuberculosis, socioecological vulnerability, and climate change patterns. S Afr Med J 2014;104(8):583. [http://dx.doi. org/10.7196/SAMJ.8645] 8. Garland RM. National policy response to climate change in South Africa. S Afr Med J 2014;104(8):584. [http://dx.doi.org/10.7196/SAMJ.8605] 9. Bowles DC, Butler CD. Socially, politically and economically mediated health effects of climate change: Possible consequences for Africa. S Afr Med J 2014;104(8):585. [http://dx.doi.org/10.7196/ SAMJ.8604] 10. Kjellstrom T, Lemke B, Hyatt O, Otto M. Climate change and occupational health: A South African perspective. S Afr Med J 2014;104(8):586. [http://dx.doi.org/10.7196/SAMJ.8646]

S Afr Med J 2014;104(8):578. DOI:10.7196/SAMJ.8606

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REVIEW

Human health impacts in a changing South African climate C Y Wright,1,2 PhD (Public Health); R M Garland,1,3 PhD (Chemistry); M Norval,4 DSc (Virology); C Vogel,5 PhD (Geography and Environmental Studies) Climate Studies, Modelling and Environmental Health Research Group, Council for Scientific and Industrial Research, Pretoria, South Africa Department of Geography, Geoinformatics and Meteorology, University of Pretoria, Pretoria, South Africa 3 Climatology Research Group, Unit for Environmental Sciences and Management, North West University, Potchefstroom, South Africa 4 Biomedical Sciences, University of Edinburgh Medical School, Edinburgh, UK 5 Centre for Environmental Management, Department of Geography, Geoinformatics and Meteorology, University of Pretoria, Pretoria, South Africa 1 2

Corresponding author: C Y Wright (cwright@csir.co.za)

Climate change is projected to lead to warmer temperatures, especially in southern Africa, where the warming is predicted to be 2째C higher than the global increase. Given the high burden of disease already associated with environmental factors in this region, this temperature increase may lead to grave challenges for human health and quality of life. HIV/AIDS, poverty, food and water insecurity together with inequality and unemployment will further complicate the manner in which we will need to address the challenges of a changing climate.

The health impacts are direct, such as increased temperatures leading to heat exhaustion, and indirect, such as likely increases in infectious diseases from contaminated water and changes in the distribution and/or magnitude of vector-borne diseases. The most effective measures for adapting to climate change to ensure healthy populations are to implement basic public health systems and services. These range from a continuous supply of clean water to adequate primary healthcare services. Support for required interventions is required not only from government, but also from healthcare professionals and communities. The need for disease surveillance, data capturing and more focused research is paramount.

S Afr Med J 2014;104(8):579-582. DOI:10.7196/SAMJ.8603

Projections show that the impacts of a changing climate in Africa will vary by region, and that southern Africa will experience, on average, a warming of approximately 2째C higher than the predicted average global increase by the end of the century, with possible changes in the frequency and intensity of rainfall across various regions. These temperature and rainfall changes may lead to serious challenges when compounded by local vulnerabilities. A high burden of existing diseases, in particular HIV/AIDS, poverty, water and food insecurity, and often inadequate public health services, increase the vulnerability to climate-related health threats.

The latest findings of the Intergovernmental Panel on Climate Change (IPCC)[1] confirm that the largest human health risks caused by climate change will be among communities and populations currently most affected by climate-related diseases. It is clear that human influences have led to the warming climate currently being experienced, which will continue into the future. Extreme weather events and Arctic ice loss, among other changes, have resulted from an estimated average temperature rise of just less than 1째C since the turn of the 20th century (similar information is not available for South Africa (SA)). Unless an immediate and concerted effort is made to reduce greenhouse gas emissions, future threats of further global warming, i.e. a rise in sea level, loss of biodiversity, exacerbation of climate-related diseases, will continue to increase.

In southern Africa, the need for more focused research and intervention, control and eradication of vector- and water-borne diseases, respiratory conditions and cardiovascular illnesses, among others, is paramount. While a number of other factors including governance and better and more critical health-focused research are needed, it is clear that an integrated, multidisciplinary and co-ordinated response is required to curb the health risks projected

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from future climate changes. This article considers these health risks in the SA context, highlighting areas that need special attention.

A South African perspective

For SA, empirical evidence from regionally measured temperatures in recent decades shows that the rate of increase in annual maximum and minimum temperatures has been rising.[2] Based on sophisticated climate model ensembles, including the General Circulation Model projections and relevant downscaling of these models to more localised situations, climate projections for SA and the rest of Africa indicate a future warming in temperature of >2째C than the global average.[2,3] Given such changes, there will probably be significant health consequences for climate-related diseases and subsequently the quality of life for South Africans. Table 1 shows the top ten causes of death in SA, based on the most recent data for this type of analysis. A quadruple burden of disease is evident, with HIV/AIDS, chronic diseases, poverty-related conditions and injuries appearing as the leading causes of mortality. Climate change may increase these figures, as well as adding emerging or re-emerging diseases to the total burden.

Direct effects Temperature

Internationally, there is ample evidence of the links between weather and health; however, there is very little information on these relationships in tropical and sub-tropical developing and emerging countries.[4] The majority of studies have been performed in temperate climates and/or industrial economies.[4] In these studies, the threshold value where health is impacted by heat varies, as does the portion of the population that are most vulnerable to health impacts from extreme temperatures.[4] In SA, the large concern for

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public health is around extreme hot events, rather than extreme cold events, and how the impact of these events may change into the future.

Model projections for temperature in a changing climate for the globe and the African region indicate increases in temperature and heat waves, both of which have the potential to impact adversely on human health. Physiologically, when the temperature of the human body rises above 38°C, heat exhaustion can occur, while heat stroke is possible >40.6°C[4] (see the article

by Kjellstrom et al.[5]). However, exposure to ambient temperatures higher than body temperature may have major health impacts, ranging from respiratory and cardiovascular effects to death. For example, Baccini et al.[6] investigated the impact of heat on mortality in 15 European cities. They identified temperature thresholds associated with a minimum mortality rate; for the 15 cities these thresholds ranged from an apparent temperature of 21.5°C in Ljubljana, Slovenia, to an apparent temperature of 32.7°C in Athens, Greece. Apparent temperature aims to describe how hot it feels, and was calculated using a combination of temperature and dew point.[7] In general, the temperature-mortality relationship follows a non-linear, U, J or V shape, with health impacts from heat increasing rapidly and non-linearly at temperatures above those associated with minimal mortality. [6,8,9] Only one study has investigated such a relationship in Cape Town, SA. However, the results were inconclusive and it is unclear how these results might apply to other parts of the country.[10] Previous work in SA has focused on occupational health.[11,12] As there is evidence that there is already a rate of increase in maximum and minimum temperatures in SA,[13] there is a major potential impact of extreme temperatures on health. Additional research is needed to understand the magnitude of the potential problem and to identify vulnerable communities.

Indirect effects Infectious diseases

The spread of enteric, water-borne diseases is likely to alter with changing climatic conditions in SA. Flooding and droughts affect the flow of rivers, leading to more contamination by enteroviruses and other pathogenic micro-organisms. Drinking water supplies may become polluted with faeces, resulting in outbreaks of diarrhoeal diseases such as cholera and dysentery.

The incidence and distribution of vectorborne diseases are predicted to change in

SA. The geographical spread and disease burden of malaria may alter, depending on how well control programmes are adapted.

Tick-borne encephalitides, dengue fever and plague are predicted to increase.[14] The last recorded death from plague in SA was in Coega in 1982,[15] but anecdotal evidence suggests that rat infestations are on the rise, especially in the City of Tshwane, Gauteng.

Thought may also need to be given to food-borne infections, such as salmonellosis, which is relatively common in SA and may increase with changing temperatures in the future, particularly where the electricity supply is unreliable or non-existent. Changes in land use caused by altered rainfall patterns and temperatures may lead to population displacement, violence and increased risktaking behaviours, which could cause a rise in the transmission of sexually transmitted infections such as HIV (see the article by Abayomi and Cowan[16]).

Respiratory illnesses

Mining, traffic, industry, biomass burning and domestic fuel burning are among the key contributors to air pollution in SA. Despite the implementation of stricter air quality legislation, air pollution is still a serious problem in the country, particularly on the Highveld, in the Vaal Triangle, the Durban South Basin and large cities, such as Johannesburg and Cape Town.

Climate change and air pollution are closely interlinked, given that in SA they are primarily driven by emissions from the combustion of fossil fuels. While this means that there are significant co-benefits for climate and air quality from reducing atmospheric emissions, the challenges to enact such decreases are large. Changes in emissions are likely to be

varied here – possible reductions in the release of industrial greenhouse gases compared with continued domestic reliance on the burning of wood and coal. Currently, mortality from lower respiratory illnesses ranks sixth in the country’s burden of disease profile.

However, this may be exacerbated should, for example, surface-levels of tropospheric ozone, air-borne pollens and spores, and other air pollutants increase. Poor air quality also affects cardiovascular health, weakening this system and increasing the risk of stroke and cardiac failure. Additionally, changes in meteorology and climate, such as largescale weather circulation patterns, rainfall, temperature and cloud cover, can have an impact on the transport and formation of pollutants, and thus climate change may have a direct effect on air pollution in SA. It is likely that surface-level ozone and particulate matter,[4] two factors that currently contribute greatly to air pollution in SA, could be most affected by climate change.

Indoor air pollution is also a grave concern – smoky cooking fuels are a serious health hazard in developing countries, including SA, especially for women and children.

Approximately 20% of SA households are exposed to smoke from burning fossil fuels. [17] While the electrification programme in SA aims to bring electricity to all households, studies show that some households prefer not to use electricity for cooking and heating because of the cost and also for cultural reasons. These and other issues may hinder interventions that strive to reduce air pollution and associated health impacts.

Impacts on agriculture, production and fisheries

food

Direct health-related impacts and attribution to climate change stresses are

Table 1. All-person top 10 specific causes of death in South Africa, 2000[36] Rank

Cause of death

Premature mortality burden – years of life lost*

%

1

HIV/AIDS

4 665 410

39.0

2

Homicide/violence

902 592

7.5

3

Tuberculosis

595 277

5.0

4

Road traffic accidents

489 979

4.1

5

Diarrhoeal diseases

452 827

3.8

6

Lower respiratory infections

449 010

3.8

7

Low birth weight

393 763

3.3

8

Stroke

318 083

2.7

9

Ischaemic heart disease

284 438

2.4

10

Protein-energy malnutrition

171 433

1.4

*Premature mortality was estimated using the standard global burden of disease method to calculate years of life lost. Age weighting, time discounting of 3% per annum and standard life expectancies based on the West model levels 25 and 26 were used.

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hard to identify (some of these are addressed in the accompanying article by Bowles and Butler[18]). Other perhaps indirect but equally important associations, including food security via food ingestion, are even more difficult to attribute to changes in the climate system.

Notwithstanding these limitations, there is a growing cohort of plausible assessments showing that the links between climate change, agriculture, such as in the crop, livestock and fishery sectors, food security and ultimately health, are important and need to be the focus of more intensified research (see the latest IPCC 5th Assessment Reports[1]). Some of these interactions are highlighted below.

Climate change, including variability, most notably periods of extreme floods and drought, is well known to have significant impacts on agriculture in SA and the rest of the African continent.

For example, the droughts associated with the early 1980s and 1990s triggered severe shortfalls in crop and livestock production and prompted the establishment of Vulnerability Assessment Committees to enable interventions based not only on cereal shortfalls but also on the role of HIV/AIDS and other factors influencing access to food.[19,20] More recent assessments [1] show that climate change will continue to have a negative impact on parts of Africa, with ‘knock-on’ consequences for the environment and society. Africa will be affected by drought, largely in the northern and southwestern portions of the continent, while towards the east, areas of increased rainfall are usually predicted. Climate variability and the role of critical drivers for the African continent, such as the El Niño Southern oscillation,[21] have had and will continue to have a critical influence on the links between climate, agriculture, food security and health, although these linkages require more investigation. Water is a vehicle through which certain factors that impact on health are transmitted, with significant outbreaks of cholera, often after a high rainfall event or period (see, for example, links to human health, climate change and water quality[22]).

The role of ‘human dimensions’, political economy and ‘power’ relations should not be ignored when examining the very important linkages and ‘nexus’ between climate change, global environmental change, globalisation, agriculture, food security and the growing ‘hot spots’ of global environmental change in various African urban and peri-urban centres.[23-28] Climate change does not occur in a vacuum and the impacts are therefore not imprinted on a blank, neutral canvas. Some emerging concerns are profiled below.

Just as in the medical or any other scientific field, how one frames the problem (the paradigm used in the case of climate and

environmental change),[29] and governance and government (how the problem is managed),[30] are important starting considerations that can profoundly shape the resultant narrative and understanding of the impact of climate change on health. The interacting roles of food price shocks, economic stability that influences access to food[4] and land, including land tenure issues, agricultural support and the growing role of land grabs and biofuels,[4] all ultimately influence who accesses food and health resources. Issues of equity and justice, such as who decides what is grown, where and how it is grown and in terms of health, and who accesses insurance in times of stress,[31] are critical dimensions that also shape the relationship between health and climate change.

Designing appropriate interventions at various scales to bolster and enhance the resilience of food systems to various changes, including in the climate and associated ‘socioeconomic and cultural dimensions’, therefore requires more careful and focused research. Some systemic analyses of the issue are emerging.

The recent Consultative Group on International Agricultural Research (CGIAR) Climate Change, Agriculture and Food Security (CCAFS)32] research effort provides a useful set of results, particularly regarding food systems and climate change and implications for a range of security issues, including health. More local efforts and practical research and intervention, together with the re-examination of community-based approaches to primary healthcare, are needed. These can have policy implications for effective climate change strategies.[33]

Concluding remarks

Apart from the need to address the root cause of climate change and curb carbon dioxide emissions, there is also a requirement to respond to the health risks of a changing climate by making appropriate choices and decisions. It has been found that the risks of climate change come from a vulnerability or lack of preparedness, and exposure of people or assets overlapping with hazards that trigger climate events or trends.[3,4] Climate change also interacts with other stresses to increase risk. This is the case for many of the climate-related human diseases faced by populations (often the most vulnerable ones).

It has been reported[3,4] that the most effective measures for adapting to climate change to ensure healthy populations are to implement basic public health systems and services. These include providing clean water, sanitation and essential primary healthcare (including vaccination and child health services), increasing disaster preparedness and response, raising awareness and education, and alleviating poverty. Currently, approximately

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91% of SA households have access to piped water – inside the yard or dwelling, or outside the yard,[34] indicating that significant efforts can achieve such goals. Actions that reduce greenhouse gas emissions may also result in co-benefits, e.g. a shift to cleaner energy sources reduces health-damaging and climate-altering air pollutants.

While it seems that many of the actions needed to address climate change and alleviate subsequent health impacts are aimed at international and national decision-makers and implementers of policy, there are several that can be considered by health scientists and medical professionals. Lobbying for the adoption of renewable energy sources and influencing the attitudes and behaviour of key professionals in the abovementioned organisations are important.

Alliances of medical and other health professionals, such as The Global Climate and Health Alliance, and Health Care Without Harm, promote working together to ensure that health is integrated into global, national and local responses to climate change. They also encourage the health sector to mitigate and adapt to climate change. In a letter to the Editor of The Times,[35] more than 60 leading physicians and medical scientists called for an urgent response to climate change, emphasising that no action will inevitably lead to great human suffering. SA health scientists and others working in the health sector are urged to prepare for changes, seek co-benefits and collaborate to ensure the health and well-being of the entire population.

References 1. Intergovernmental Panel on Climate Change (IPCC). http://www.ipcc.ch (accessed 25 June 2014).

2. Department of Environmental Affairs, Agriculture, Forestry and Fisheries. Long-Term Adapation Scenarios, 2013/2014. http://www.environment.gov.za (accessed 25 June 2014).

3. Niang I, Ruppel OC, Abdrabo M, et al. Africa. In: Field CB, Barros V, Dokken DJ, et al., eds.

Impacts, Adaptation and Vulnerability. Contribution of Working Group II to the Fifth Assessment Report of the Intergovernmental Panel on Climate Change. Cambridge, UK: Cambridge University Press, 2014.

4. Smith KR, Woodward A, Campbell-Lendrum D, et al. Human health: Impacts, adaptation and co-benefits.

In: Field CB, Barros V, Dokken DJ, et al., eds. Impacts, Adaptation and Vulnerability. Contribution of Working Group II to the Fifth Assessment Report of the Intergovernmental Panel on Climate Change.

Cambridge, UK: Cambridge University Press, 2014.

5. Kjellstrom T, Lemke B, Hyatt O, Otto M. Climate change and occupational health: A South African perspective. S Afr Med J 2014;104(8):586. [http://dx.doi.org/10.7196/SAMJ.8646] 6. Baccini M, Biggeri A, Accetta G, et al. Heat effects on mortality in 15 European cities. Epidemiology 2008;19(5):711-719. [http://dx.doi.org/10.1097/EDE.0b013e318176bfcd] 7. Steadman RG. The assessment of sultriness. Part II: Effects of wind, extra radiation and barometric pressure on apparent temperature. J Appl Meteorol 1979;18:874-885. [http://dx.doi.org/10.1175/15200450(1979)018<0874:TAOSPI>2.0.CO;2] 8. Ballester J, Robine JM, Herrmann FR, Rodó X. Long-term projections and acclimatization scenarios of temperature-related mortality in Europe. Nature Communications 2011;2:358. [http://dx.doi.org/10.1038/ ncomms1360]

9. McMichael AJ, Woodruff RE, Hales S. Climate change and human health: Present and future risks. Lancet 2006;367:859-869. [http://dx.doi.org/10.1016/S0140-6736(06)68079-3] 10. McMichael AJ, Wilkinson P, Kovats RS, et al. International study of temperature, heat and urban mortality: The ‘ISOTHURM’ project. International Journal of Epidemiology 2008;37:1121-1131. [http://dx.doi. org/10.1093/ije/dyn086] 11. Wyndham CH. A survey of causal factors in heat stroke and of their prevention in the gold mining industry.

Journal of the South African Institute of Mining and Metallurgy 1965;66:125-156.

12. Mathee A, Oba J, Rose A. Climate change impacts of working people (the HOTHAPS initiative): Findings of the South African pilot study. Global Health Action 2010:3. [http://dx.doi.org/10.3402/ gha.v3i0.5612] 13. Davis C. Climate Risk and Vulnerability: A Handbook for Southern Africa. South African Risk and Vulnerability Atlas. Pretoria: Council for Scientific and Industrial Research, 2011.

14. Myers J, Young T, Galloway M, Manyike P, Tucker T. A public health approach to the impact of climate change on health in southern Africa – identifying priority modifiable risks. S Afr Med J 2011;101(11):817-820.

15. Department of Health. National Plague Control Guidelines. Pretoria: Department of Health, 2003.

16. Abayomi A, Cowan MN. The HIV/AIDS epidemic in South Africa: Convergence with tuberculosis, socioecological vulnerability, and climate change patterns. S Afr Med J 2014;104(8):583. [http://dx.doi. org/10.7196/SAMJ.8645] 17. Norman R, Barnes B, Mathee AM, Bradshaw D, and the South African Comparative Risk Assessment Collaborating Group. Estimating the burden of disease attributble to indoor air pollution from household use of solid fuels in South Africa in 2000. S Afr Med J 2007;97(8):764-771.

18. Bowles DC, Butler CD. Socially, politically and economically mediated health effects of climate change: Possible consequences for Africa. S Afr Med J 2014;104(8):585. [http://dx.doi.org/10.7196/SAMJ.8604] 19. Vogel CH, Moser S, Kasperson R, Daebelko G. Linking vulnerability, adaptation and resilience science to practice: Pathways, players and partnerships. Global Environmental Change 2007;17:349-364. [http:// dx.doi.org/10.1016/j.gloenvcha.2007.05.002] 20. Drimie S, Gillespie S. Adaptation to climate change in southern Africa: Factoring in AIDS. Environmental Science and Policy 2010;13(8):778-784. [http://dx.doi.org/10.1016/j.envsci.2010.07.03] 21. Landman WA, Botes S, Goddard L, Shongwe M. Assessing the predictability of extreme rainfall seasons over southern Africa. Geophysical Research Letters 2005;32:L23818. [http://dx.doi. org/10.1029/2005GL023965] 22. Department of Water Affairs. National Water Resources Strategy: Water for an Equitable and Sustainable Future. 2nd ed. Pretoria: Department of Water Affairs, 2013.

23. Devereux S, Maxwell S. Food Security in Sub-Saharan Africa. Pietermaritzburg: ITDG Publishing and University of Natal Press, 2001.

24. Institute of Development Studies (IDS). New Directions for African Agriclture. IDS Bulletin 2006;36:2.

25. Leichenko RM, O’Brien KL. Environmental Change and Globalization, Double Exposures. Oxford: Oxford University Press, 2008.

26. Fussel H-M, Ebi KL. Assessing vulnerability and human health. In: Patt AG, Schroter D, Klein RJ, de la Vega-Leinart, AC, eds. Assessing Vulnerability to Global Environmental Change – Making Research Useful for Adaptation Decision Making and Policy. London: Earthscan, 2009:115-132.

27. Ingram JSI, Ericksen P, Liverman D, eds. Food Security and Global Environmental Change. London: Earthscan, 2010.

28. Crush J, Frayne B, Wade P. The crisis of food insecurity in African cities. Journal of Hunger and Environmental Nutrition 2012;7:271-292. [http://dx.doi.org/10.1080/19320248.2012.702448] 29. Bohle HG, Downing TE, Watts MJ. Climate change and social vulnerability: Towards a sociology and geography of food insecurity. Global Evironmental Change 1994;4:37-48. [http://dx.doi.org/10.1016/09593780(94)90020-5] 30. Desada H, Sewankambo N, eds. CIGI (The Centre for International Government Innovation) Special Report: Climate Change in Africa: Adaptation, Mitigation and Governance Challenges. Waterloo, Canada: CIGI, 2009.

31. Thomas DSG, Tywman C. Equity and justice in climate change adaptation amongst natural resourcedependent societies. Global Environmental Change 2005;5:115-124. [http://dx.doi.org/10.1016/j. gloenvcha.2004.10.001] 32. Consultative Group on International Agricultural Research (CGIAR). http://www.cgiar.org (accessed 25 June 2014).

33. Marcus TS. Community Orientated Primary Care: Origins and History. Pretoria: Minuteman Press, 2014.

34. Statistics South Africa. Census 2011. Pretoria: Government Printer, 2011.

35. The Times (UK). Global warming threat to health. 29 March 2014;12:01. http://www.thetimes.co.uk/tto/ opinion/letters/article4048102.ece (accessed 9 July 2014).

36. Medical Research Council of South Africa (MRC). Initial estimates from the South African National Burden of Disease Study, 2000. MRC Policy Brief 2003(1). http://www.mrc.ac.za/policybriefs/initialestimates.pdf (accessed 9 July 2014).

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ARTICLE SUMMARY

The HIV/AIDS epidemic in South Africa: Convergence with tuberculosis, socioecological vulnerability, and climate change patterns A Abayomi,1 MB BS (London), MRCP (UK), FCPath Haem (SA), MPhil, FRCP (Edin); M N Cowan2 ivision of Haematology, Department of Pathology, Faculty of Medicine and Health Sciences, Stellenbosch University, and National Health D Laboratory Service, Tygerberg Hospital, Cape Town, South Africa; and Margo Lutzi MAMIE Foundation, Registered Humanitarian and Environmental Non-Governmental Organisation, Ibadan, Nigeria 2 Department of Biology, University of Virginia, Charlottesville, Virginia, USA 1

Corresponding author: A Abayomi (abayomi@sun.ac.za)

The human immunodeficiency virus and acquired immunodeficiency syndrome (HIV/AIDS) pandemic presents a destructive linkage with rapidly progressing global climate change. Rising temperatures mediated by the greenhouse effect and other alterations in ecological balance negatively affect the vulnerability and resilience of biospheres. Recent global climate assessments, including the Fifth Assessment Report (AR5) of the United Nations Intergovernmental Panel on Climate Change, maintain that estimations for these conditions are on the rise, threatening human lifestyles, health, and global biodiversity. HIV/AIDS becomes intertwined with this scenario, especially in southern Africa, where rates of infection are high and coping strategies are low. Persons living with HIV/AIDS (PLWHA) experience weakened physiology owing to compromised adaptive immunity. This disposition leads to increased biological stress on infected individuals, possibly limiting their ability to respond to environmental stressors projected to increase with current climate change patterns.

Attached to South Africa (SA)’s HIV/AIDS epidemic is the highest convergence with Mycobacterium tuberculosis (TB) in the world.

Over 50% of new HIV cases are coupled with active TB infection,

including multidrug-resistant TB (MDR-TB) and extremely drugresistant TB (XDR-TB) strains. In areas of SA where HIV/AIDS prevalence is as high as 40%, this scenario confers an inordinately high disease burden complex. It is thus becoming increasingly clear that there is a distinct interplay between HIV/AIDS, TB, and climate change, with each one exacerbating the effects of the other two in an unrestrained positive feedback loop.

Combating the SA HIV-TB ‘syndemic’ is economically draining, but the impact of climate change must be contingently addressed. To maximise efficacy, climate change mitigation strategies such as the reduction of carbon emissions need to be paired with transformative adaptation strategies, including the development of ‘green’ energy infrastructures, sustainable agricultural practices in commercial and local communities, and a continued collaborative scientific effort, to assess vulnerability and resilience. These efforts occur at international and regional levels across Africa and need to be mainstreamed down to local levels to be optimally effective, because global climate change poses a direct ecological and public health threat to PLWHA and healthy individuals.

S Afr Med J 2014;104(8):583. DOI:10.7196/SAMJ.8645

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ARTICLE SUMMARY

National policy response to climate change in South Africa R M Garland, PhD (Chemistry) Climate Studies, Modelling and Environmental Health Research Group, Council for Scientific and Industrial Research, Pretoria, South Africa, and Climatology Research Group, Unit for Environmental Sciences and Management, North West University, Potchefstroom, South Africa Corresponding author: R Garland (rgarland@csir.co.za)

The South African government has taken several steps in response to climate change and the associated threats to human health. The National Climate Change Response Plan White Paper defines governmentâ&#x20AC;&#x2122;s vision for effective climate change response and transitioning to a climate-resilient, low-carbon economy. The Paper identified potential health challenges for South Africa (SA), including vector- and water-borne diseases and heat stress. The National Climate Change and Health Adaptation Plan (the Plan) prepared by the National Department of Health then expands on these challenges, raising not only additional health challenges, but also related physical and socioeconomic risk factors, such as natural disasters, food insecurity, hunger and malnutrition, and housing and settlements.

Community participation was adopted as one of the guiding principles for implementing the Plan, especially as behavioural change is likely to be important for adaptation and coping strategies.

Multisectorial co-operation is also imperative because many of the climate-related health risks involve multiple multidisciplinary stakeholders to implement appropriate interventions.

Addressing inequalities and poverty in SA is critical to ensure that the health impacts from climate change are mitigated, particularly as current evidence suggests that the largest health risks are probably among communities already most impacted by climate-related diseases. More research is needed to determine the most vulnerable communities. The technical report on Climate Change Implications for Human Health in South Africa, produced by the Long-Term Adaptation Scenarios Flagship Research Programme for South Africa, recommended that a quantitative vulnerability and risk assessment for the health sector be carried out as an important next step to identify the climate impacts that are most critical and the communities that are at greatest risk. Furthermore, tailored monitoring and evaluation systems, linked with climate surveillance, will provide an opportunity to collet health data on key health risks to inform decision-making.

S Afr Med J 2014;104(8):584. DOI:10.7196/SAMJ.8605

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ARTICLE SUMMARY

Socially, politically and economically mediated health effects of climate change: Possible consequences for Africa D C Bowles,1 MA; C D Butler,2 BMed, PhD National Centre for Epidemiology and Population Health, Australian National University, Canberra, Australia Faculty of Health, University of Canberra, Australia

1 2

Corresponding author: D C Bowles (devin.bowles@anu.edu.au)

Climate change is increasingly recognised as this century’s greatest threat to health. In this article we discuss why this is plausible, with particular reference to Africa.

Socially, politically and economically mediated (‘tertiary’) climate change effects are likely to have most profound and adverse health consequences, significantly exceeding the probable burden of direct effects and contagious diseases. The scale of tertiary effects is influenced by regional climate change effects and the baseline social, political and economic circumstances of an area. Climate change will disproportionately harm the African environment, which also has a high concentration of politically fragile states, widespread poverty and limited education. These factors will exacerbate the tertiary health consequences and inhibit effective adaptation.

Decreased economic growth

Climate change will hinder the development of new sources of income, in Africa generally and for subsistence farmers in particular.

Without rapid and substantial mitigation, climate change is widely anticipated to limit future economic growth, which could be further depressed by widespread migration and increased risk of conflict.

Under-nutrition, migration and conflict

Climate change is expected to retard or reverse progress towards solving world hunger. A decline in crop productivity is predicted in many regions, while much of Africa is experiencing rapid population growth. Contracting and changing the availability of agricultural land will contribute to migration, probably leading to hundreds of millions of additional migrants globally this century. The majority of climateassociated migration is likely to occur within and between developing countries, and much will be rural to urban. Recipient areas could see a decline in health if the number of immigrants exceeds the available economic opportunities and infrastructure.

Migration associated with climate change may also increase violent conflict. Migration can lead to the spreading of ethnic tensions, conflictsteeped ideologies, arms and combatants, and consequently facilitate a kind of civil war ‘contagion’ or new violence against migrants. The risk

of civil conflict will escalate as climate change deprives people of their livelihoods and worsens local resource scarcity, increasing demands on the state and simultaneously undermining its capacity to meet those demands.

As conditions worsen, successful revolts will become more likely, with unscrupulous leaders inciting conflict to strengthen their support base and erode civil society. A recent meta-analysis found that each standard deviation change of the climate towards warmer temperatures or more extreme rainfall is accompanied by a 14% increase in intergroup conflict.

Health systems

Several convergent forces stemming from climate change are anticipated to harm health system capacity. Physical infrastructure will be at greater risk from extreme weather events, and may require relocation of individuals. Reduced economic growth will undermine funding. Migration could lead to geographical mismatches between health infrastructure and demand. Simultaneously, climate change would multiply the demands on health systems. Direct effects of climate change and altered patterns of infectious disease, along with a decrease in economic growth, will worsen human health.

Prospects for Africa

Africa seems set to experience some of the worst health effects of climate change. Adaptation to climate change is frequently recommended.

However, reliance on adaptation as the primary response is unlikely to fully succeed, deepening the health gap between rich and poor, both within and between countries. Institutional adaptation in most of Africa will be hindered by lack of financial capital, weak governance, reduced institutional capacity, and lack of relevant expertise. Widespread maladaptation, including solutions that compound other problems or limit future adaptation strategies, is probable. At the level of households, poverty and reduced opportunities will preclude effective adaptation for millions. In Africa, as in the rest of the world, the mirage of a planet well adapted to climate change should not distract from the primary challenge of mitigation.

S Afr Med J 2014;104(8):585. DOI:10.7196/SAMJ.8604

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Climate change and occupational health: A South African perspective T Kjellstrom,1,2 MME (Stockholm), Med Dr (Stockholm); B Lemke,3 PhD; O Hyatt,1 PhD; M Otto,3 MME Health and Environment International Trust, Mapua, New Zealand United Nations University, International Institute of Global Health, Kuala Lumpur, Malaysia 3 Nelson-Marlborough Institute of Technology, Nelson, New Zealand 1 2

Corresponding author: T Kjellstrom (kjellstromt@yahoo.com)

The effects of climate change on human health have been analysed in a number of international documents, but occupational health has not been given visibility. Some effects are directly caused by exposure to climate conditions, while others are indirectly linked to climate via drinking water, food access or changes in disease vector ecology. It is well known that physical work creates much surplus heat inside the body, which needs to be released to the environment to avoid a dangerous core body temperature. The release of body heat depends on the external air temperature and humidity, air movement over the skin (wind speed), heat radiation (from the sun) and clothing worn. For some agricultural workers, changing patterns of vector-borne diseases (e.g. malaria and dengue fever) will create new or increased risks. In addition, emergency workers are at risk of injuries during violent weather and workers handling chemicals (e.g. solvents) may be exposed to higher levels of these products.

Clinical illness affects labour productivity and economic output, but research to date has indicated that the physiological effects of heat and the loss of work capacity are of even greater importance. The first analysis of the economic impacts in South Africa (SA) indicates that

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an additional US$300 000 of production output may be lost each year until 2030 as a result of the increase in heat exposure in the workplace due to climate change.

Weather station data from SA show ongoing increasing temperature trends, particularly during the warmest months, and spatial geographical analysis using ‘grid cells’ can link the current trends to modelled future trends. For example, the trend in East London shows that the heat stress index may increase by 2 - 4°C by the end of the century. A heat distribution map shows that this level of increase brings much of SA into the range of ‘moderate to high risk’ of occupational heat exposure.

Prevention of these potential climate change health and productivity impacts involves general application of basic occupational health management practices for workplaces with a high level of heat exposure: unlimited access to drinking water, regular rest periods, supervision and training. Technical and engineering solutions to reduce heat exposure are needed in certain situations. In addition, the slowing down and limitation of global climate change will protect future generations of workers from the risks identified in this article.

S Afr Med J 2014;104(8):586. DOI:10.7196/SAMJ.8646

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ABSTRACTS

Screening and lifestyle counselling and ischaemic heart disease

The conclusion was that the intervention had no effect on ischaemic heart disease, stroke or mortality at a population level after 10 years.

A recently published paper in the British Medical Journal reported on a Danish study on the effect of systematic screening for risk factors for ischaemic heart disease, followed by lifestyle counselling. The study looked at the 10-year development of ischaemic heart disease at a population level using a randomised controlled community-based trial in the suburbs of Copenhagen, Denmark.

The participants were 59 616 people aged 30 - 60 years, who were randomised according to age and sex, and included an intervention group (n=11 629) and a control group (n=47 987).

The intervention group was invited for screening, risk assessment and lifestyle counselling four times in five years. All those found to have an unhealthy lifestyle were offered individually tailored lifestyle counselling at all visits – at baseline and after one and three years.

Those found to be at high risk of ischaemic heart disease were offered a further six sessions of group-based lifestyle counselling on smoking cessation, diet and exercise. After five years all were invited to a final counselling session. Those in need of treatment were referred to their general practitioner, while those in the control group were not invited for screening.

The primary outcome measure was the incidence of ischaemic heart disease in the intervention group compared with that in the control group. Secondary outcome measures were stroke, stroke and ischaemic heart disease combined, and mortality.

A total of 6 091 (52.4%) people in the intervention group participated at baseline. Among 5 978 people eligible at five-year follow-up (59 died and 54 emigrated), 4 028 (67.4%) attended. A total of 3 163 people died in the 10-year follow-up period. Among 58 308 without a history of ischaemic heart disease at baseline, 2 782 developed ischaemic heart disease. Among 58 940 without a history of stroke at baseline, 1 726 developed stroke. No significant difference was seen between the intervention and control groups at the primary end-point (hazard ratio for ischaemic heart disease 1.03; 95% confidence interval 0.94 - 1.13) or at the secondary end-points (stroke 0.98; 0.87 - 1.11; combined end-point 1.01; 0.93 - 1.09; total mortality 1.00; 0.91 - 1.09).

Jørgensen T, Jacobsen RK, Toft U, Aadahl M, Glümer C, Pisinger C. Br Med J 2014;348:g3617. [http://dx.doi.org/10.1136/bmj.g3617]

Burden of childhood TB in 22 high-burden countries: A mathematical modelling study

Diagnosing tuberculosis (TB) in children under 15 years is a challenge. As the authors of this study, recently published in the Lancet Global Health, point out, under-reporting can result when children do present to health services. There are no direct estimates available and World Health Organization (WHO) estimates use paediatric notifications, adjusting for incomplete surveillance by the same factor as adult notifications. This study estimated the incidence of infection and household exposure in the 22 countries with a high burden of disease, using a mechanistic mathematical model that combined estimates of adult TB prevalence in 2010 with aspects of the natural history of paediatric TB. The model accounted for age, Bacillus Calmette-Guérin (BCG) vaccination and HIV infection.

The median number of children estimated to be sharing a household with a person with infectious TB in 2010 was 15 319 701 (interquartile range (IQR) 13 766 297 - 17 061 821). In 2010, the median number of Mycobacterium tuberculosis infections in children was 7 591 759 (5 800 053 - 9 969 780), and 650 977 children (424 871 - 983 118) developed disease. Cumulative exposure meant that the median number of children with latent infection in 2010 was 53 234 854 (41 111 669 - 68 959 804). The model suggests that 35% (23 - 54) of paediatric cases of TB in the 15 countries reporting notifications by age in 2010 were detected. India is predicted to account for 27% (22 - 33) of the total burden of paediatric TB in the 22 countries. The predicted proportion of TB burden in children for each country correlated with incidence, varying between 4% and 21%.

The model shows that the incidence of paediatric TB is higher than the number of notifications, particularly among young children, showing a great need for preventive treatment.

Dodd P, Gardiner E, Coghlan R, Seddon JA. Lancet Global Health. Early Online Publication, 9 July 2014. [http://dx.doi.org/10.1016/S2214-109X(14)70245-1]

The full version of each article is available online. Use the QR code above to access.

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PULSE

Metropolitan Health goes big with healthbridge

The health insurer can now fully process claims from both specialists and general practitioners, instantly. healthbridge recently announced the integration of all Metropolitan Health schemes into its systems, meaning that specialist medical practices (e.g. urologists, ophthalmologists, dermatologists) can now receive immediate responses on their claims, indicating the payment outcome. They join the general practitioners who have been enjoying the benefits of immediate, fully processed responses for some years now.

The move is significant in terms of the number of medical practices involved, given that Metropolitan Health is one of the largest medical aid administrators in the country, covering nearly 1.3 million families. healthbridge offers instant, fully processed claiming for thousands of medical practices, not just through Metropolitan Health, making them the largest provider of fully processed claims in the healthcare sector.

Covering 85% of insured lives, this translates into enormous operational savings for medical practices in terms of admin, efficiency and speed of payment:

• Reduced admin. After sending a claim, the response takes seconds rather than days; the medical practice knows, before the patient has left the practice, whether they are covered and for how much.

Rejected claims can be fixed and re-submitted immediately, instead of waiting up to 2 weeks for the remittance.

• Faster payment times. The immediate response means the pract­ ice can be certain of catching the weekly payment run at the medical aid. Patients are given comfort by knowing upfront what they owe, and have the option to settle their account before they leave.

• Improved cash flow. Faster payment from both the medical aid and the patient means that the medical practice banks their money faster, which translates into less bad debt and greater profitability.

Says health­bridge MD Luis da Silva: ‘Ever since we pioneered fully processed claiming in the early 2000s, our goal as a company has always been to bring grea­ter operational effici­encies to the health­ care sector. It’s good for doctors and patients alike. This is another milestone on that journey.’

August 2014, Vol. 104, No. 8

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Effective in 2014, the CPD programme for SAMJ will be administered by Medical Practice Consulting: CPD questionnaires must be completed online at www.mpconsulting.co.za True (A) or false (B): Ebola virus disease (EVD) in West Africa 1. EVD spreads from person to person through close contact with infected tissues and body fluids of affected persons (particularly in the unprotected home care setting, during preparation of bodies for burial and in hospitals with poor infection control practices).

2. EVD is caused by the Ebola virus, a filovirus that is thought to be harboured by specific arboreal bat species in the affected regions.

National sentinel site surveillance for antimicrobial resistance in Klebsiella pneumoniae isolates, South Africa (SA) 2010 - 2012 3. The increasing rates of antimicrobial resistance observed in the nosocomial pathogen K. pneumoniae are of major public health concern worldwide.

4.

SA appears to have a relatively high percentage of extendedspectrum beta-lactamase-producing K. pneumoniae isolates in comparison with other geographical regions.

Challenges facing HIV infant diagnosis in SA’s expanding ART programme Current SA guidelines, in line with international standards, 5. advocate routine HIV-1 polymerase chain reaction testing at 6 weeks of age for asymptomatic HIV-exposed infants and ‘fasttrack’ entry into the HIV treatment programme for those who test positive.

6. SA has implemented the World Health Organization 2010 guide­ lines on HIV and infant feeding, which recommend that HIVinfected mothers should breastfeed their infants and receive antiretroviral drugs simultaneously.

South African Menopause Society (SAMS) revised consensus position statement on menopausal hormone therapy (HT), 2014 7. Commencing HT during the ‘therapeutic window of opportunity’ (between 50 and 60 years of age or within 10 years of onset of menopause) maximises the benefit-to-risk profile of therapy in symptomatic menopausal women.

8. There is good evidence that oestrogen therapy, and oestrogen and progestogen therapy in combination, induce weight gain and excacerbate the increase in waist-to-hip ratio that occurs at the time of menopause.

9. HT remains the only treatment that consistently has a greater effect than placebo on alleviation of menopause-related vasomotor symptoms.

10.

Local therapy is preferred to systemic therapy for urological symptoms (detrusor instability, including urgency, urge incon­ tinence, frequency and nocturia).

Human health impacts in a changing SA climate 11. In SA, empirical evidence from regionally measured temperatures in recent decades shows that the rate of increase of annual maximum and minimum temperatures has been increasing.

12. Physiologically, when the temperature of the human body rises above 38°C, heat exhaustion can occur, while heatstroke is possible above 40.6°C. The HIV/AIDS epidemic in SA: Convergence with tuberculosis, socioecological vulnerability, and climate change patterns 13. SA now has one of the highest global rates of active tuberculosis infection with an incidence of 530 000 in 2013, of which 62.2% are HIV-positive cases.

14. Increased air pollution as a result of warming in SA will contribute to an increase in respiratory diseases such as tuberculosis and pneumonia.

National policy response to climate change in SA 15. Heat stress is one of the nine health and environmental risks identified by the national Department of Health’s adaptation plan.

16. Addressing inequalities and poverty in SA is critical in order to ensure that health impacts from a changing climate are mitigated across all communities and populations.

Socially, politically and economically mediated health effects of climate change: Possible consequences for Africa 17.

Reports by the Intergovernmental Panel on Climate Change have consistently warned that climate change will impose disproportionate harm on the African environment, with drought intensification a particular problem.

18. Climate change is likely to improve progress towards solving world hunger.

Climate change and occupational health: An SA perspective 19. Workplace heat exposure is a well-known occupational health hazard.

20. Heat acclimatisation can help to mitigate the effects of working in very high temperatures.

CPD questions include articles from CME. The full versions of each article can be found on the SAMJ website (http://www.samj.org.za)

A maximum of 3 CEUs will be awarded per correctly completed test.

INSTRUCTIONS 1. Read the journal. All the answers will be found there.

2. Go to www.mpconsulting.co.za to answer the questions.

Accreditation number: MDB001/007/01/2014 (Clinical)

August 2014, Vol. 104, No. 8

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VOL. 104 NO. 8

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544

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The ESSENTIAL MEDICAL REFERENCE for every healthcare professional!

The convenient pocket-sized design enables you to fit it comfortably into your hospital bag or coat pocket, so it can always be at hand for ready reference. South African Medicines Formulary (SAMF), produced by the Division of Clinical Pharmacology of the University of Cape Town, provides easy access to the latest, scientifically accurate information, including full drug profiles, clinical notes and special prescriber’s points.

The thoroughly updated 11th edition of SAMF is your essential reference to the rational, cost-effective and safe use of medicines.

Please direct all order queries to: Edward – Fax: 086 600 6218 email: edwardm@hmpg.co.za Tax invoice to be posted on dispatch of order.