SAMJ Vol 108, No 3 (2018) by HMPG

MARCH 2018

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EDITORIALS

The Life Esidimeni tragedy: South Africaâ&#x20AC;&#x2122;s shame CME Bleeding disorders (part 2)

IN PRACTICE

Sport supplement regulation: Overdue and much needed RESEARCH Firearm and non-firearm homicide in Cape Town, 1994 - 2013 Ingested and aspirated foreign bodies in children Heparin and blood gas analysis at point of care

MARCH 2018 PRINT EDITION

GUEST EDITORIALS 4

Intellectual disability in South Africa: Addressing a crisis in mental health services D J Stein, K Sordsdahl, C Lund

Medicolegal storm threatening maternal and child healthcare services B Taylor, J van Waart, S Ranchod, A Taylor

EDITOR’S CHOICE Celebrating 50 years of heart transplant surgery: A missed opportunity to honour Hamilton Naki N Mankahla, S Dlamini, I C Taunyane, S Maqungo, L Cairncross, B Chiliza

IZINDABA 12

EDITORS EMERITUS Daniel J Ncayiyana, MD (Groningen), FACOG, MD (Hon), FCM (Hon) JP de V van Niekerk, MD, FRCR ASSOCIATE EDITORS Q Abdool Karim, A Dhai, R C Pattinson, A Rothberg, A A Stulting, J Surka, B Taylor, M Blockman, J M Pettifor, W Edridge, R P Abratt, D L Clarke

CORRESPONDENCE 11

EDITOR Bridget Farham, BSc (Hons), PhD, MB ChB

30 days in medicine B Farham

HMPG CEO AND PUBLISHER Hannah Kikaya Email: hannahk@hmpg.co.za MANAGING EDITORS Claudia Naidu Naadia van der Bergh

EDITORIALS

TECHNICAL EDITORS Emma Buchanan Kirsten Morreira Paula van der Bijl

Intellectual disability in the Esidimeni tragedy: Silent deaths C Capri, B Watermeyer, J Mckenzie, O Coetzee

The Life Esidimeni tragedy: The courts are also to blame B A Ferlito, A Dhai

The Life Esidimeni tragedy: Some ethical transgressions B A Ferlito, A Dhai

DTP AND DESIGN Clinton Griffin

CONTINUING MEDICAL EDUCATION

CHIEF OPERATING OFFICER Diane Smith | Tel. 012 481 2069 Email: dianes@hmpg.co.za

GUEST EDITORIAL Bleeding disorders (part 2) N Alli

ARTICLE Acquired bleeding disorders N Alli, J Vaughan, S Louw, S Moodly, M Patel

PRODUCTION MANAGER Emma Jane Couzens

SALES MANAGER (CAPE TOWN) Azad Yusuf JOURNAL ADVERTISING Reneé Hinze Ladine van Heerden Makhadzi Mulaudzi Charmalin Comalie

IN PRACTICE 26

ISSUES IN PUBLIC HEALTH Regulating the South African sport supplement industry: ‘Whey’ overdue K Naidoo, R Naidoo, V Bangalee MEDICINE AND THE LAW Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015 T Saidi, T S Douglas HEALTHCARE DELIVERY Maternal near-miss audit in the Metro West maternity service, Cape Town, South Africa: A retrospective observational study I A Iwuh, S Fawcus, L Schoeman

REVIEW 36

Mental illness in the Western Cape Province, South Africa: A review of the burden of disease and healthcare interventions N Jacob, D Coetzee

RESEARCH 41

A longitudinal perspective on violence in the lives of South African children from the Birth to Twenty Plus cohort study in Johannesburg-Soweto L M Richter, S Mathews, J Kagura, E Nonterah

Ethnopharmacological use of potassium permanganate in South African traditional medicine* R A Street, G M Kabera, C Connolly

March 2018, Print edition

ONLINE SUPPORT Gertrude Fani FINANCE Tshepiso Mokoena HMPG BOARD OF DIRECTORS Prof. M Lukhele (Chair), Dr M R Abbas, Mrs H Kikaya, Dr M Mbokota, Dr G Wolvaardt ISSN 0256-9574 HMPG website: www.hmpg.co.za SAMA website: www.samedical.org Journal website: www.samj.org.za

A needs-based approach to equitable allocation of district primary healthcare expenditure in North West Province, South Africa* Y Maharaj, A Robinson, D McIntyre

A retrospective time trend study of firearm and non-firearm homicide in Cape Town from 1994 to 2013* R Matzopoulos, J Simonetti, M Prinsloo, I Neethling, P Groenewald, J Dempers, L J Martin, A Rowhani-Rahbar, J E Myers, M L Thompson

An audit of ingested and aspirated foreign bodies in children at a university hospital in South Africa: The Pietermaritzburg experience* N F Majola, V Y Kong, H Mangray, V Govindasamy, G L Laing, D L Clarke

Surgical skills deficiencies and needs of rural general practitioners in South Africa* D C Porter, J Bezuidenhout, R S du Toit, A O Adefuye

The effect of different forms of heparin on point-of-care blood gas analysis* P Sandler, L N Goldstein

High positive computed tomography yields in the emergency department might not be a positive finding* K Swartzberg, L N Goldstein

Estimating the burden of cervical disease among HIV-infected women accessing screening services in South Africa: A model-based analysis* C J Chibwesha, B Goeieman, S Levin, M Mulongo, M Faesen, A Swarts, S Ramotshela, S Williams, N Rakhombe, S Bruce, P Michelow, C Firnhaber

Restaurant smoking sections in South Africa and the perceived impact of the proposed smoke-free laws: Evidence from a nationally representative survey* M Little, C van Walbeek

ONLINE CONTENTS LISTED IN Index Medicus (Medline) Excerpta Medica (EMBASE) Biological Abstracts (BIOSIS) Science Citation Index (SciSearch) Directory of Open Access Journals (DOAJ) Current Contents/Clinical Medicine SAMJ SUBSCRIPTION RATES Local subscriptions ZAR1 632.00 p.a. Foreign subscriptions ZAR3 744.00 p.a. Single copies ZAR136.00 local, ZAR312.00 foreign Members of the South African Medical Association receive the SAMJ only on request, as part of their membership benefit. Subscriptions: Tel. 012 481 2071 Email: members@samedical.org The SAMJ is published monthly by the Health and Medical Publishing Group (Pty) Ltd, Co. registration 2004/0220 32/07, a subsidiary of SAMA. HEAD OFFICE Health and Medical Publishing Group (Pty) Ltd Block F, Castle Walk Corporate Park, Nossob Street, Erasmuskloof Ext. 3, Pretoria, 0181 Tel. 012 481 2069 Email: dianes@hmpg.co.za EDITORIAL OFFICE Suite 11, Lonsdale Building, Lonsdale Way, Pinelands, 7405 Tel. 021 532 1281 | Cell. 072 635 9825 Email: publishing@hmpg.co.za Please submit all letters and articles for publication online at http://www.editorialmanager.com/samj

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CPD QUESTIONS

Use of editorial material is subject to the Creative Commons Attribution – Non-commercial Works Licence. https://creativecommons.org/licenses/bync/4.0 Printed by TANDYM PRINT

MARCH 2018

Background photo: More than 100 wooden crosses stand at the side of Main Road in Kyalami, Johannesburg, as a silent protest against the Esidimeni tragedy. The accepted number of deaths is currently 140, but the figure could be higher | Jassy Mackenzie

PRINT EDITION

EDITORIALS

The Life Esidimeni tragedy: South Africa’s shame CME Bleeding disorders (part 2)

Box photos: Firearm homicide | Shutterstock; Ingested and aspirated foreign bodies in children – a screw in the right main bronchus | Majola et al.; Drawing a blood sample (simulated clinical scenario) | Mike Wells

March 2018, Print edition

IN PRACTICE

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This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

GUEST EDITORIAL

Intellectual disability in South Africa: Addressing a crisis in mental health services The recent focus on the Life Esidimeni tragedy in South Africa (SA) raises a number of key questions about mental health policies and practices in general in SA, and about policies and practices surrounding intellectual disability in particular.[1] Has SA done enough in the area of mental health? What additional work is needed in psychiatry and mental health in general, and in the field of intellectual disability specifically? In recent decades, rigorous data on the prevalence of mental disorders and on their associated burden have emerged from around the world, and from SA.[2,3] This work has emphasised that there is a large treatment gap, particularly in low-resourced countries. Such data, together with an emphasis on the human rights of those living with mental disorders, has helped lead to the emergence of global mental health as a key discipline.[4] A public mental health approach in SA has also led to a number of important advances. The Mental Health Act of 2002[5] emphasises human rights of patients. Consistent with the World Health Organization’s Mental Health Action Plan, SA has developed a new Mental Health Policy Framework and Strategic Plan (2013 - 2020) that emphasises the value of a primary healthcare approach in reducing the treatment gap.[6] However, ongoing challenges remain. Mental Health Review Boards, established by the Act, are functioning in only some parts of the country, and have not substantially contributed to increased resources for mental health services.[7] Implementation of the mental health policy has not yet occurred, and the ideal of sufficient human resources to meet needs is far from achieved.[2] The attention of mental health administrators in SA is typically focused on individuals with serious mental illness who require admission to acute psychosis units, partly because such patients can be very difficult to manage in the primary care units to which they are first admitted, according to the Act. Clinicians work hard to admit and discharge patients quickly, and to minimise readmissions in the absence of sufficient community resources.[8] Far less attention is paid to common mental disorders. South African Stress and Health (SASH) survey data note the high economic costs of failing to provide appropriate interventions for such patients. [9] But there is little pressure on policy makers to find the relevant funding. Consumer advocacy organisations have emerged, and are certainly attempting to draw attention to this issue. Patients with intellectual disability are particularly at risk of being overlooked, and the Life Esidimeni tragedy is the proverbial canary in the coalmine, representing a crisis in mental health services. We have emphasised elsewhere that maladministration of such services can be and has been deadly.[1] The Life Esidimeni tragedy points to systematic flaws in mental health service planning and implementation in SA. What needs to be done? First, we need to emphasise again that in terms of addressing the treatment gap, it is less expensive for the country to put good health systems in place than not to do so. Mental health is a key issue for sustainable development; return on investment in early diagnosis and intervention is not only high, but it is key if the Sustainable Development Goals (where mental health is now clearly emphasised) are to be met.[10] In addition, we need to emphasise again the human

rights of all patients, including those with mental disorders and with intellectual disability. All provincial departments of health need to ensure that Review Boards are constituted and functioning. Review Boards and civil society organisations need to flex their muscles more in order to secure increased resources for those living with mental disorders. Second, an integrative and convergent approach to mental disorders in general, and intellectual disability in particular, is needed.[11] Some have argued for the importance of primary care screening and management, others for the need for tertiary specialty services: both are needed. Some have emphasised the biomedical aspects of intellectual disability, others have emphasised the sociopolitical contributors to its neglect: both need to be addressed. Based on earlier research to develop norms for community mental health services in SA,[12] the National Department of Health has recently issued a Government Gazette notice providing a licensing framework for non-governmental organisations (NGOs) in community mental healthcare. This needs to be implemented swiftly and with appropriate resources. Third, we need leadership in the field of intellectual disability:[13] key are champions who will introduce innovative services, conduct relevant research, provide policy guidance to government and advocate for the rights of some of the most neglected and vulnerable members of our society. These champions need to come from diverse sectors, including government, academia and NGOs. Courageous leadership is needed by health administrators; they must resist ongoing pressures to ‘save money’ by emphasising the cost-efficiency of treatment as well as the human rights of patients. Clinical-academic leadership is also crucial; medical specialists have not yet established intellectual disability as a specific, albeit cross-disciplinary, subspecialisation: this is a key step in order to promote services, teaching, and research, in primary through tertiary contexts.[14] Dan J Stein Department of Psychiatry and MRC Unit on Risk and Resilience in Mental Disorders, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa dan.stein@uct.ac.za Katherine Sordsdahl, Crick Lund Alan J Flisher Centre for Public Mental Health, Division of Public Mental Health, Department of Psychiatry, Faculty of Health Sciences, University of Cape Town, South Africa

March 2018, Print edition

GUEST EDITORIAL

1. Stein DJ, Chambers C, Daniels I, et al. Death by maladministration: An important category of patient mortality. S Afr Med J 2017;107(4):280-280. https://doi.org/10.7196/SAMJ.2017.v107i4.12389 2. Sorsdahl K, Stein DJ, Lund C. Mental health services in South Africa: Scaling up and future directions. Afr J Psychiatry 2012;15(3):168-171. https://doi.org/10.4314/ajpsy.v15i3.21 3. Williams DR, Herman A, Stein DJ, et al. Twelve-month mental disorders in South Africa: Prevalence, service use and demographic correlates in the population-based South African Stress and Health Study. Psychol Med 2008;38(2):211-220. https://doi.org/10.1017/S0033291707001420 4. Prince M, Patel V, Saxena S, et al. No health without mental health. Lancet 2007;370(9590):859-877. https://doi.org/10.1016/S0140-6736(07)61238-0 5. South Africa. Mental Health Care Act No. 17 of 2002. http://www.gov.za/sites/www.gov.za/files/a17-02. pdf (accessed 9 February 2018). 6. National Department of Health, South Africa. National Mental Health Policy Framework and Strategic Plan 2013 - 2020. 2012. https://www.health-e.org.za/wp-content/uploads/2014/10/National-MentalHealth-Policy-Framework-and-Strategic-Plan-2013-2020.pdf (accessed 9 February 2018). 7. Lund C, Stein DJ, Flisher AJ, Mehtar S. Challenges faced by South African health services in implementing the Mental Health Care Act. S Afr Med J 2007;97(5):352-353. 8. Lund C, Oosthuizen P, Flisher AJ, et al. Pathways to inpatient mental health care among people with schizophrenia spectrum disorders in South Africa. Psychiatr Serv 2010;61(3):235-240. https://doi. org/10.1176/ps.2010.61.3.235

9. Lund C, Myer L, Stein D, Williams D, Flisher A. Mental illness and lost income among adult South Africans. Soc Psychiatry Psychiatr Epidemiol 2013;48(5):845-851. https://doi.org/10.1007/s00127012-0587-5 10. Chisholm D, Sweeny K, Sheehan P, et al. Scaling up treatment of depression and anxiety: A global return on investment analysis. Lancet Psychiatry 2016;3(5):425-424. https://doi.org/10.1016/S22150366(16)30024-4 11. Stein DJ. Philosophy of Psychopharmacology. Cambridge: Cambridge University Press, 2008. 12. Lund C, Flisher AJ. A model for community mental health services in South Africa. Trop Med Int Health 2009;14(9):1040-1047. https://doi.org/10.1111/j.1365-3156.2009.02332.x 13. Tomlinson M, Lund C. Why does mental health not get the attention it deserves? An application of the Shiffman and Smith framework. PLoS Med 2012;9(2):e1001178. https://doi.org/10.1371/journal. pmed.1001178 14. Molteno C, Adnams C, Njenga F. Sub-specialties in psychiatry in Africa â&#x20AC;&#x201C; intellectual disability. Afr J Psychiatry 2011;14(1):1,3.

S Afr Med J 2018;108(3):147-148. DOI:10.7196/SAMJ.2018.v108i3.13171

March 2018, Print edition

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GUEST EDITORIAL

Medicolegal storm threatening maternal and child healthcare services South Africa (SA)’s healthcare system is on the cusp of a perfect storm that has the potential to paralyse service delivery, in particular the delivery of maternal and child services. Since about 2008, the number of medicolegal claims brought against both private and public healthcare providers has accelerated.[1,2] Underpinning this is an under-resourced public sector that is lacking in strong management in many parts of the country, a fragmented private sector that has been criticised for lack of accountability, raised patient expectations and increased awareness by patients of their rights, and SA’s legislative and dispute resolution framework. This trend, together with the associated increase in the value of individual claims, appears to have coincided with promulgation of the Road Accident Amendment Act No. 19 of 2005, which came into effect in August 2008 and capped claims for those who suffered harm on SA roads.[1-3] Given the significant quantum of potential damages that can be claimed in terms of minors with severe disabilities, there is reason to believe that the high number of claims in relation to supposed birth-related injuries reflects, at least in part, a shift of contingency-based litigation from road accident victims to those harmed on the basis of alleged neglect by the healthcare system (the highest proportion of claims brought against government hospitals relate to birth-related injuries, particularly cerebral palsy).[2,4] Efforts by government to mobilise additional financing and human resources to improve access to quality care in SA are being undermined systematically by claims of medical negligence in both the public and private sectors: • By mid-2017, contingent liabilities for alleged medical negligence in the public sector reached in excess of ZAR55 billion, excluding legal expenses, which is a significant portion of the health budget (data on file, National Department of Health). The national budget allocated to health in 2016/2017 was ZAR184.217 billion.[5] • Fear of litigation is causing healthcare professionals to practise defensive medicine whereby doctors ‘perform additional diagnostic examinations, refer patients to specialists and do follow-up procedures, not for the sake of providing better patient care, but rather to avoid the possibility of being sued’.[3] Other than increasing healthcare expenditure unnecessarily, defensive practices are not in the best interests of patient care.[6] In the private sector, defensive practice is often quoted to be contributing significantly to the high caesarean section rate. • In a recent survey commissioned by the South African Society of Obstetricians and Gynaecologists (SASOG) and distributed to its membership of registered specialists, only 12% of 201 survey respondents indicated that they would definitely be practising obstetrics in 5 years’ time; 21% of respondents indicated that they were certain to stop. The median response to the question ‘How likely are you to stop obstetrics in the next 5 years?’ was 75%, meaning that half the cohort was of the view that there was at least a 3 in 4 chance that they would stop obstetrics in the next 5 years. Cost of indemnity insurance, closely followed by the fear and stress of a potential lawsuit, were the predominant reasons cited for these trends (data on file, SASOG). This impending supply-side constraint has access and quality-of-care implications.

The need for multidimensional, collaborative and aligned risk management

To avert a national crisis and navigate the medical industry into calmer waters, risk management initiatives must focus on minimising adverse clinical outcomes, identifying and managing unfounded claims as early as possible, and settling those with merit fairly, in the most expeditious and cost-effective manner. While the current situation appears dire at face value, various industry initiatives aimed at stabilising the market have taken shape in the past year.

Doctor-driven practice protocols and peer review

With avoidance of preventable medical error being key to effective risk management, SASOG has devised a programme aimed at promoting safer deliveries and healthier babies. The approach is modelled on the redesign of the patient safety programme by the Hospital Corporation of America in 2000, at a time when the organisation was experiencing similar challenges of inadequate perinatal outcomes and high rates of litigation. By incorporating features of high-reliability industries such as aviation, this large private healthcare delivery system in the USA managed to improve perinatal outcomes and effect a decline in the frequency and quantum of litigation claims. Standardisation of processes and procedures, the development of unambiguous practice guidelines and effective peer review were key to their approach. It was argued that standard protocols had the two-fold effect of guiding good clinical practice as well as providing a benchmark against which practice could be evaluated. In a court of law, it is typically asked in a situation of alleged medical negligence whether specific protocols were followed in a particular situation. In the absence of these, the standard against which the actions of the defendant will be judged is battled out during trial, guided by medical experts introduced by the opposing parties and, in the US context, decided by jury sympathy. Other than adding significantly to legal costs, such an approach is marred by the imperfections of expert witnesses. Regarding peer review, the importance of a robust process to identify gaps in care that did not rely solely on a local committee that could inadvertently be influenced by the economic relationship (partner v. competitor) of one practitioner with another was recognised. To address substandard levels of care, a national peer review committee was appointed to address the most serious cases of adverse outcomes.[7] Based on such an initiative, SASOG has launched the BetterObs programme, which includes the development and publication of practice protocols and the introduction of a structured local and national peer review process. It furthermore encourages attendance at hospital morbidity and mortality meetings and the completion of delivery reports. In the event of disputes, it makes provision for a panel of recognised experts.[8]

Informed consent

Poor communication is a common cause of patient dissatisfaction. Where disputes arise, patients frequently claim that they were not

March 2018, Print edition

GUEST EDITORIAL

informed of the reasons for and limitations of proposed procedures, including common complications (and that had they been informed fully, they would have chosen a different route of care). To encourage improved communication, SASOG, as well as other surgical societies, are reviewing standards for informed consent. While approaches differ per discipline, the emphasis is on encouraging documented patient feedback, for example, specific choice of test for fetal abnormality screening (a tick-box approach) or descriptive feedback of patients’ understanding of reasons for surgery, as well as anticipated outcomes.

Johannes van Waart Obstetrician, gynaecologist and fertility specialist, private practice, Stellenbosch, South Africa; president, South African Society of Obstetricians and Gynaecologists; and founder of the BetterObs Programme

Conflict resolution

Litigation as a form of resolving disputes and proclaiming who is right and wrong is not only expensive but time-consuming, emotionally draining and lengthy. It has been estimated that 75% of medicolegal cases take more than 5 years to be finalised.[3] Wherever possible, and for the benefit of healthcare providers and patients alike, grievances should be settled in a non-adversarial manner outside of the courts. While the South African Law Reform Commission (SALRC) is investigating potential legislative change to facilitate expeditious, fair and cost-effective conflict resolution, the industry is implementing practical changes aimed at promoting the former. A so-called premediation clause whereby patients agree to a confidential and ‘without prejudice’ meeting to explore the benefits of mediation prior to taking legal action is increasingly forming part of a signed contract between healthcare providers (private hospitals as well as doctors) and patients. Mediation is a process facilitated by an independent, trained person, aimed at seeking win-win solutions between opposing entities and taking into consideration their respective needs, interests and concerns. To protect the delivery of quality care, the SALRC is furthermore researching other judicial risk management solutions relating to contingency-based litigation, the common-law rule in terms of ‘once-and-for-all’ settlement for personal injury claims, structured payments and proposed prescription of guidelines for the calculation of damages.[3]

The way forward

The safe delivery of babies is a benefit prioritised by politicians and society alike.[9,10] Given current trends, it is nevertheless conceivable that soon even those willing to pay for private services may struggle to find access to high-quality obstetric care because of scarcity of qualified staff (similar to specialised paediatric neurosurgery, which is no longer available in the private sector).[11] While important progress has been made to turn the tide in the past year, every effort aimed at creating accurate, complete and integrated health records, analysing and sharing patient outcome and satisfaction data and collaborating on and aligning patient safety and risk management programmes must be continued. Efforts to establish care centres for the disabled, irrespective of causation, through private/ public partnerships are encouraged. On the legal side, a zero-tolerance policy for vexatious claims and plaintiff attorneys chancing their luck is called for. Bettina Taylor Risk specialist, EthiQal/Constantia Insurance (Pty) Ltd, Cape Town, South Africa bettinat@constantiagroup.co.za

Shivani Ranchod Senior Lecturer, Actuarial Science, Faculty of Commerce, University of Cape Town, South Africa

Allan Taylor Head of Clinical Unit, Department of Neurosurgery, Groote Schuur Hospital, Cape Town, South Africa; president, Society of Neurosurgeons of South Africa; and president, Federation of South African Surgical Societies

1. Howarth G, Hallinan E. Challenging the cost of medical negligence. S Afr Med J 2016;106(2):141-142. https://doi.org/10.7196/SAMJ.2016.v106i2.10408 2. Oosthuizen WT, Carstens PA. Medical malpractice: The extent, consequences and causes of the problem. Journal of Contemporary Roman-Dutch Law. https://ssrn.com/abstract=2693960 (accessed 11 February 2018). 3. South African Law Reform Commission. Issue paper 33. Project 141. Medico-legal claims. 20 May 2017. www.lssa.org.za/upload/SALRC%20ip33_prj141_Medico-legal.pdf (accessed 11 February 2018). 4. Rice B. How I pick the doctors I’ll sue. Med Econ 2004;81(20 August):54. http://medicaleconomics. modernmedicine.com/medical-economics/news/clinical/obstetrics-gynecology-womens-health/ how-i-pick-doctors-ill-sue (accessed 11 February 2018). 5. Blecher M, Daven J, Kollipara A, Maharaj Y, Mansfelder A, Gaarekwe O. Health spending at a time of low economic growth and fiscal constraints. In: Padarath A, Barron P, eds. South African Health Review 2017. Durban: Health Systems Trust, 2017. http://www.hst.org.za/publications/South%20 African%20Health%20Reviews/HST%20SAHR%202017%20Web%20Version.pdf (accessed 11 February 2018). 6. Roytowski D, Smith TR, Fieggen AG, Taylor A. Impressions of defensive medical practice and medical litigation among South African neurosurgeons. S Afr Med J 2014;104(11):736-738. https://doi. org/10.7196/SAMJ.8336 7. Clark SL, Belfort MA, Byrum SL, et al. Improved outcomes, fewer cesarian deliveries, and reduced litigation: Results of a new paradigm in patient safety. Am J Obstet Gynaecol 2008;199(2):105.e1-105. e7. https://doi.org/10.1016/j.ajog.2008.02.031 8. BetterObs Programme. https://www.sasog.co.za/NewsEvents/BetterObswebpage (accessed 27 December 2017). 9. National Department of Health, South Africa. Strategic Plan 2014/15 to 2018/19. https://www. health-e.org.za/wp-content/uploads/2014/08/SA-DoH-Strategic-Plan-2014-to-2019.pdf (accessed 11 February 2018). 10. Broomberg J. Consultative Investigation into Low Income Medical Schemes: Final Report. Pretoria: Council for Medical Schemes, 2006. https://www.medicalschemes.com/Publications.aspx (accessed 11 February 2018). 11. Howarth G, Goolab B, Dunne R, et al. Public somnambulism: A general lack of awareness of the consequences of increasing medical negligence litigation. S Afr Med J 2014;104(11):752-753. https:// doi.org/10.7196/SAMJ.8568

S Afr Med J 2018;108(3):149-150. DOI:10.7196/SAMJ.2018.v108i3.13139

March 2018, Print edition

EDITOR’S CHOICE

CME: Bleeding disorders (part 2)

Haemostasis is a physiological process that stops blood loss at the site of injury, while maintaining normal blood flow in the rest of the circulation. This is accomplished in three physiological steps that occur in rapid sequence: (i) vasoconstriction; (ii) formation of a platelet plug (primary haemostasis); and (iii) stabilisation of clot through cross-linking of insoluble fibrin (secondary haemostasis). The fibrin mesh that is incorporated into and around the platelet plug serves to strengthen and stabilise the blood clot. Apart from limiting blood loss, the clot allows for vessel and tissue repair. Anticoagulant mechanisms regulate the coagulation system to ensure formation of a clot that is proportional to the injury. A delicate balance between procoagulant and anticoagulant systems is critical for proper haemostasis and for avoiding pathological bleeding or thrombosis. The clot is finally dissolved by the fibrinolytic system, which also performs the function of preventing blood clots in healthy blood vessels. Bleeding disorders are divided into two broad categories: (i) inherited (discussed in part 1), and (ii) acquired (part 2, current issue).

The Life Esidimeni tragedy

A series of articles[1-4] in this issue of SAMJ cover the appalling tragedy of the fate of seemingly unknown numbers of patients due to, at best, the incompetence of the Gauteng Department of Health and at worst, criminal disregard for the lives of the people concerned. Esidimeni means ‘place of dignity’. It now signifies the disaster in which people continue to die (140 at last count) and go missing after being transferred from Life Esidimeni into the care of nongovernmental organisations (NGOs). Esidimeni is not only a medical maladministration scandal. It is a story about the sociopolitical abuse of people who only matter once they die. Patients are not dead because they were mentally ill or simply medically mismanaged. They died because we are careless. We do not care enough to be clear about the difference between people with mental or psychiatric illness and people with intellectual disability (PWID) (no longer called mentally retarded). Countless Esidimenis are currently happening to people who are still alive. The extent of neglectful and abusive care will again only come to light once they also die of starvation, dehydration, cold and infection. Abominable as the crisis is, it is our (current) high-water mark of an ongoing silent catastrophe, which implies that abuse of the living matters less, if at all, than being neglected to death. It also comments on our nation. We profess to know about discrimination and resultant inequality, yet the PWID at the centre of the Esidimeni tragedy are of the single most disenfranchised and oppressed group in our society. Justice literally means equality and fairness. In the milieu of healthcare and bioethics, justice is the process in which individuals are treated fairly and equally, resulting in the ability to achieve the highest attainable standard of physical, mental and social wellbeing. The Life Esidimeni tragedy occurred as a result of the rushed execution of the Gauteng Mental Health Marathon Project, when the Gauteng Department of Health ‘precipitously’ terminated its contract with Life Esidimeni, a facility that provided ‘highly specialised chronic psychiatric care’ to mentally ill patients. Over 2 000 mentally ill patients, some with comorbid conditions, were hurriedly moved to ill-equipped and unlicensed NGOs in an attempt to curb costs. An investigation by the Health Ombudsman found that these NGOs could not even provide basic healthcare to patients who required ‘highly specialised chronic psychiatric care’. Additionally, the investigation found that in the process of moving patients and in the aftermath thereof, several human rights were violated – specifically the rights to health, life and dignity, resulting in a great injustice to society’s most vulnerable group. The cruel and baseless decision by the Department to move patients resulted in 140 (and counting) deaths.

Mental illness in the Western Cape Province: A review of the burden of disease and healthcare interventions

Neuropsychiatric disorders were ranked third as contributors to disability-adjusted life-years in South Africa (SA). Despite this high morbidity, mental health is often overlooked on the public health agenda. Jacob and Coetzee[5] review evidence on the burden of mental illness in the Western Cape, as well as current provincial interventions to decrease the burden of mental illness. Available evidence supports the need for improved integration of mental health services in primary healthcare and strengthening of community services. Challenges include a lack of capacity due to staff shortages and inadequate availability and allocation of resources. Evidence from large epidemiological studies to quantify the burden of disease as well as cost-effectiveness studies of interventions are required to successfully plan and implement interventions. Similar reviews may provide a national overview of mental health issues as well as allow improvement through better understanding of research and best practices in various provinces.

A retrospective time trend study of firearm and non-firearm homicide in Cape Town from 1994 to 2013

Gunshot injuries from interpersonal violence are a major cause of mortality. In SA, the Firearms Control Act of 2000 sought to address firearm violence by removing illegally owned firearms from circulation, stricter regulation of legally owned firearms, and stricter licensing requirements. Over the past few years, varied implementation of the Act and police corruption have increased firearm availability. Matzopoulos et al.[6] investigated whether changes in firearm availability in SA were associated with changes in firearm homicide rates in a retrospective time trend study (1994 - 2013) using postmortem data. Time trends of firearm and non-firearm homicide rates were analysed with generalised linear models. Distinct time periods for temporal trends were assigned based on a priori assumptions regarding changes in the availability of firearms. Firearm and non-firearm homicide rates adjusted for age, sex and race exhibited different temporal trends. Non-firearm homicide rates either decreased or remained stable over the entire period. Firearm homicide increased at 13% annually from 1994 through 2000, and decreased by 15% from 2003 through 2006, corresponding with changes in firearm availability in 2001, 2003, 2007 and 2011. A 21% annual increase in firearm homicide after 2010 coincided with police fast-tracking new firearm licence applications. Cape Town’s coloured population experienced a significantly greater increase than other population groups following additional exposure to illegal firearms from 2007. The strong association between firearm availability and homicide, and the reversal of a decreasing firearm homicide trend during a period of lax enforcement, provide further support for the association between reduced firearm homicide and stricter regulation. BF 1. Stein DJ, Sordsdahl K. Lund C. Intellectual disability in South Africa: Addressing a crisis in mental health services. S Afr Med J 2018;103(3):147-148. https://doi.org/10.7196/SAMJ.2018.v108i3.13171 2. Capri C, Watermeyer B, Mckenzie J, Coetzee O. Intellectual disability in the Esidimeni tragedy: Silent deaths. S Afr Med J 2018;103(3):153-154. https://doi.org/10.7196/SAMJ.2018.v108i3.13029 3. Ferlito BA, Dhai A. The Life Esidimeni tragedy: The courts are also to blame. S Afr Med J 2018;103(3):155-156. https://doi.org/10.7196/SAMJ.2018.v108i3.13011 4. Ferlito BA, Dhai A.The Life Esidimeni tragedy: Some ethical transgressions. S Afr Med J 2018;103(3):157. https://doi.org/10.7196/SAMJ.2018.v108i3.13012 5. Jacob N, Coetzee D. Mental illness in the Western Cape Province, South Africa: A review of the burden of disease and healthcare interventions. S Afr Med J 2018;103(3):176-180. https://doi.org/10.7196/ SAMJ.2018.v108i3.12904 6. Matzopoulos R, Simonetti J, Prinsloo M, et al. A retrospective time trend study of firearm and nonfirearm homicide in Cape Town from 1994 to 2013. S Afr Med J 2018;103(3):197-204. https://doi. org/10.7196/SAMJ.2018.v108i3.12756

March 2018, Print edition

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Celebrating 50 years of heart transplant surgery: A missed opportunity to honour Hamilton Naki

CORRESPONDENCE

To the Editor: 2017 marked the 50th anniversary of the first human heart transplant in South Africa. To commemorate this, Brink et al.[1] published a guest editorial in the December 2017 issue of the SAMJ. The authors from the Christiaan Barnard Division of Cardiothoracic Surgery at Groote Schuur Hospital gave an overview of the evolution of transplant surgery, from experimental work to clinical translation. This included a brief summary of the significant progress in immune-suppressive drug discovery that has led to the greater success of transplant medicine. A reprint of the teams involved was also published, and as expected reflects the racial environment during that time. It saddened us, however, that in a modern account of this innovative leap in medicine there is still a failure to acknowledge the roles of black members, such as Hamilton Naki, in the laboratory research process towards human surgical transplantation. There have indeed been some inaccurate accounts regarding Naki’s involvement in the transplant team.[2] Clarity about his evolving role as a laboratory technician and later a surgical assistant in the Marais animal laboratory was provided by then Emeritus Prof. John Terblanche[3] in a 2005 letter in the SAMJ. Recognition of Mr Naki’s achievement in the context of his educational background and racial disadvantage led to him being awarded the Order of Mapungubwe, a national honour by former President Thabo Mbeki, and an honorary Master of Medicine degree from the University of Cape Town. To honour such a person does not remove from the tremendous achievement of Prof. Barnard and his surgical team, whose first 2 patients survived longer than those of his US counterparts at the time.[4] However, the failure to even mention Mr Naki seems an ongoing denial of the contributions of black South Africans to the advancement of science. This is a particularly inspiring story of what can be achieved even by the most disadvantaged when people work together regardless of racial background. Inspiration could be drawn from the story of Vivien Thomas. He was a black man, with a high-school diploma, who grew up in the 1900s in the south of the USA. He went on to become a laboratory assistant, contributing to pioneering work in the advancement of cardiovascular surgery. Although he was initially

disregarded, he was later awarded an honorary doctorate and his portrait hangs alongside those of other medical pioneers at Johns Hopkins Medical School to inspire future scientists.[5] In missing such an opportunity to inspire, we are left to wonder whether this was a wilful omission or innocent oversight by the authors. N Mankahla Division of Neurosurgery, Department of Surgery, Groote Schuur Hospital and Red Cross War Memorial Children’s Hospital, Cape Town, South Africa ncedilemankahla@yahoo.com

S Dlamini Division of Infectious Diseases, Department of Medicine, Groote Schuur Hospital and University of Cape Town, South Africa

I C Taunyane Department of Cardiovascular Surgery, Heart Center Freiburg University, Germany

S Maqungo Division of Orthopaedic Surgery, Department of Surgery, Groote Schuur Hospital and University of Cape Town, South Africa

L Cairncross Department of Surgery, Groote Schuur Hospital and University of Cape Town, South Africa

B Chiliza Department of Psychiatry, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 1. Brink J, Pennel T, Seele K, Zilla P. The world’s first human-to-human heart transplant at Groote Schuur Hospital: 50 years later. S Afr Med J 2017;107(12):1035-1036. https://doi.org/10.7196/SAMJ.2017. v107i12 2. Kapp C. Hamilton Naki. Lancet 2005;366(2):22. https://doi.org/10.1016/S0140-6736(05)66811-0 3. Terblanche J. A standard of care? S Afr Med J 2005;95(8):539-540. 4. McKellar S. Clinical firsts – Christiaan Barnard’s heart transplantations. N Engl J Med 2017;377(23):22112213. https://doi.org/10.1056/NEJMp1707919 5. Kennedy DM. In search of Vivien Thomas. Tex Heart Inst J 2005;32(4):477-478.

S Afr Med J 2018;108(3):151. DOI:10.7196/SAMJ.2018.v108i3.13114

March 2018, Print edition

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IZINDABA

30 days in medicine Drug companies withholding information on trial protocols

A study published in the Journal of the Royal Society of Medicine shows that half of commercially sponsored trial protocols contain redactions, meaning that drug companies are withholding information on trial protocols. The authors of the study requested access to 78 commercial and non-commercial trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013, under freedom of information rules. However, they found that access was difficult despite their assurances that individual trials would not be identified. It took 3 years to receive all 79 protocols, and Sanofi-Aventis took legal action. Other companies that withheld information included Merck Sharp & Dohme, Novo Nordisk, Bayer and GlaxoSmithKline. Only three companies supplied unredacted protocols – Abbott, Pfizer and Eli Lilly. Eight of the protocols were excluded from the final results, showing that 17 of 34 protocols for commercially sponsored trials were not redacted, compared with 34 of 36 non-commercial trials. The protocol information most likely to be withheld was evidence of problems with the reliability of the data, such as data analysis, handling of missing data, detection and analysis of adverse events and premature termination of the study. The authors could not identify any legitimate rationale for the redactions, and commented that the amount of redactions in the protocols received was so large that they were rendered useless for assessing the ethical justification for the studies and for identifying discrepancies with subsequent publications. Marquardsen M, Ogden M, Gøtzsche P. Redactions in protocols for drug trials: What industry sponsors concealed. J R Soc Med 2018 (epub 25 January 2018). https://doi.org/10.1177/0141076817750554

Drinking very hot tea linked to oesophageal cancer

Regularly drinking very hot tea, when combined with tobacco or alcohol use, is associated with an increased risk of oesophageal cancer, according to a Chinese study with more than 450 000 participants. However, the study, published in Annals of Internal Medicine, found no increased risk of oesophageal cancer in those who drank hot tea but did not smoke or regularly drink alcohol. Alcohol

consumption and tobacco smoking are already well-established causes of oesophageal squamous cell cancer. The prospective study included 456 155 people aged between 30 and 79 years from 10 areas across China. The participants in the study were asked how often they drank tea and whether they drank it warm, hot or boiling hot. They were also asked about smoking habits and whether they drank 15 g of alcohol or more a day – roughly two units, or a standard glass of wine. During a median follow-up of 9.2 years there were 1 731 new cases of oesophageal cancer. Individuals who drank tea at a high temperature, drank alcohol regularly and smoked had an oesophageal cancer risk five times greater than those who had none of those three habits. The risk of oesophageal cancer was also increased for those who drank hot or burning hot tea if they either smoked or drank excessively. Yu C, Tang H, Guo Y, et al. Effect of hot tea consumption and its interactions with alcohol and tobacco use on the risk of esophageal cancer: A population based cohort study. Ann Intern Med 2018 (epub 6 February 2018). https://doi.org/10.7326/M17-2000

Alcohol more dangerous to the brain than marijuana

Scientists at the University of Colorado Boulder conducted a review of existing imaging data that looked at the effects of alcohol and marijuana, or cannabis, on the brain. Their findings linked alcohol consumption with long-term changes to the structure of white matter and grey matter in the brain. However, the use of marijuana seemed to have no significant long-term effects on brain structure. Study leader Rachel Thayer, of the Department of Psychology and Neuroscience at the University of Colorado Boulder, and colleagues recently reported their results in the journal Addiction. Thayer RE, YorkWilliams S, Karoly HC, et al. Structural neuroimaging correlates of alcohol and cannabis use in adolescents and adults. Addiction 2017;112(12):2144-2154. https://doi.org/10.1111/add.13923

B Farham Editor ugqirha@iafrica.com

March 2018, Print edition

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EDITORIAL

Intellectual disability in the Esidimeni tragedy: Silent deaths Esidimeni means ‘place of dignity’. It now signifies the disaster in which people continue to die (140 at last count) and go missing after being transferred from Life Esidimeni into the care of nongovernmental organisations (NGOs).[1-3] Esidimeni is not only a medical maladministration scandal. It is a story about the sociopolitical abuse of people who only matter once they die. Patients are not dead because they were mentally ill or simply medically mismanaged. They died because we are careless. We do not care enough to be clear about the difference between people with mental or psychiatric illness and people with intellectual disability (PWID) (no longer called mentally retarded). Countless Esidimenis are currently happening to people who are still alive. The extent of neglectful and abusive care will again only come to light once they also die of starvation, dehydration, cold and infection. Abominable as the crisis is, it is our (current) high-water mark of an ongoing silent catastrophe, which implies that abuse of the living matters less, if at all, than being neglected to death. It also comments on our nation. We profess to know about discrimination and resultant inequality, yet the PWID at the centre of the Esidimeni tragedy are of the single most disenfranchised and oppressed groups in our society.

Intellectual disability is not a mental illness

Despite the current national ‘Esidimeni deaths’ discourse, it is not widely understood that at least half of the deceased lived with severe to profound intellectual disability (ID).[4] While psychiatric illnesses frequently accompany ID, these are different conditions and can exist separately. People who live with ID and a comorbid mental illness live with a dual diagnosis. People can live with ID and not have a mental illness.[5] To refer to PWID as being mentally ill obscures distinctions between mental illness and ID, and dismisses particular abilities, vulnerabilities, and care and support needs of individuals who live with either or both.

Adults with intellectual disability are not children

Most adults with ID in South Africa (SA) are treated as children.[6] This disabling practice translates into undignified and abusive treatment. To justify giving children’s NGOs licences to accept adults, Dr M Manamela repeated that ‘mentally ill adult patients have the mind of a child‚ so they could be classified as children’.[1] Firstly, a PhD in psychiatric nursing should afford one the competence to differentiate mental illness from ID, as mentioned above. Secondly, infantilising adults with ID is ironic: in SA they do not enjoy protections similar to children. The Mental Health Care Act No. 17 of 2002 and its General Regulation Amendment lack rights governance for adults with any level of ID living in community settings.[7] No law similar to the Children’s Act No. 38 of 2005 intervenes on behalf of adults.[8] Government is not legally required to intercede in the best interests of vulnerable adults at risk of abuse, neglect and death.

The problem with measuring tragedy in deaths

Esidimeni has been measured in deaths from the start – a tragedy of 94, then 112 … 137 and so on.[4] Measuring the disaster’s enormity by counting deaths is illogical. If the ‘problem’ is only as large as the number of deaths, then there is ‘no tragedy’ if one survives

unthinkable abuse and neglect. If people died because of inhuman(e) care, be sure of two things: 140 people suffered horrifically until they died, and many more are still enduring appalling trauma. By measuring tragedy in deaths, we reveal a binary appreciation of intellectually disabled lives in which ‘alive or dead’ is the only meaningful statistic. This leaves no space for questioning the quality of life of living people and dehumanises PWID.

For love or money?

The NGOs are tasked with the complex care and support needs of intellectually disabled patients, but without sufficient budgets. Faced with this impossibility, it is instead asserted that, above all, ‘these people need love’. Turning NGOs into saintly providers of good deeds to the wretched of the earth obscures the cost of this ‘love’. NGOs accept money to care for these adults. Globally, dependency carers should be paid and trained better, but we cannot create the perception that selfless carers are accepting the needs burdens of PWID out of love. Unhelpfully pitting their needs against one other creates a conflict of interest between paid carers and their burdensome ‘charges’. This ‘love’ can be reframed as the effort of emotion work – affective investment in another’s well-being – during the performance of care labour.[9-11] In a caring society, dependency care relationships are ones of interdependence and mutual respect. The hardest physical work does not result in good care if the point of caring is task completion, regardless of the well-being of care participants.[12]

Avoiding future Esidimeni-like catastrophes

We are in a perpetual care crisis. The current tragedy is an outcome of sweeping, structurally embedded social injustices that will mark us in history if we continue to ignore them. We must face the distressing reality that Esidimeni-like rights violations happen to PWID on a daily basis in pervasive ways.[13] Rights violations against PWID will not stop after one arbitration. For lives of PWID to matter more than death, the following attitudinal changes must infuse ID rights systemisation and implementation:

Practical/systemic risk mitigation solutions

• Specialist residential care is not inexpensive, but provides a service that the state is unable or unwilling to fulfil. The rapid withdrawal of support for PWID from such care must not be repeated. • SA lawmakers must educate themselves on what ‘intellectual disabilities actually mean’, as gazetted in parliament.[14] • The dualist legal system incorporates into domestic laws the United Nations Convention of the Rights of Persons with Disabilities, which SA signed 10 years ago.[15] • A Vulnerable Adults Act legally obliges the state to perform universal safeguarding of adults with ID beyond the inadequate Mental Health Care Act No. 17 of 2002.[7] • Well-regulated community care requirements for PWID are collaboratively approached with urgency by the Department of Social Development and the Department of Health, in consultation with self-advocates, so as to: • remedy lacking public residential care facilities for people with severe and profound ID in particular • uphold the constitutional right PWID have to life, and bodily and psychological integrity.[16]

March 2018, Print edition

EDITORIAL

• Designated ID care facilities are built-for-purpose. Care staff are up-skilled or renewed. • Service initiatives investigate and adapt recognised international policies and guidelines pertaining to good clinical practice and organisational design. • With an eye to the future, the implementation of the Draft South African Policy Framework for the Provision of Quality Education and Support for Children with Severe to Profound Intellectual Disability is ensured.[17] • The transversal treatment of PWID is integrated throughout the public healthcare system. Safe task-shifting to community-based resources takes place. Families caring for adult members with ID are supported. • Appropriate sociopolitical inclusion of PWID and their families begins at birth. Monitoring is lifelong by care and support plans. • The remuneration and training of carers, nurses and other multidisciplinary team members must urgently be overhauled. SA offers specialised ID training, and all health-related training programmes will incorporate more than a few hours of ID training. • De-medicalised ID training becomes an interdisciplinary competence. PWID are consulted on their treatment preferences by integrated practitioners. Future service designs incorporate the expertise of PWID and their families. Continuous professional development requirements keep registered practitioners up-todate on best practice. Trainers with ID broaden practitioner understanding. • Cost-free relational processes balance commodified care of PWID. We consider the purpose and individualisation of care, as well as the power relations integral to all dependency care relationships.[12]

Attitudinal risk mitigation solutions

• We overcome our avoidance of the must-have national conversation on disability exclusion. • PWID are enfranchised and contribute to politicising disability issues, as exemplified elsewhere.[18-20] The estimated SA population is 55 908 865.[21] With an approximated prevalence of 4.1%, >2 000 000 individuals may be living with ID in SA.[21,22] Legislators will vie in future for the sociopolitical approval of >2 million PWID in SA. • We acknowledge that ID care also unfolds in boardrooms and policy documents. During scarce resource distributions we question whose needs are being accommodated – ‘ours’ or ‘theirs’. • Opinions are collected from PWID on issues that directly affect their lives. They are included in policy design.[9-12] • PWID compel good care performance. They select their own carers as their self-identified needs change.[9-12] • Systemic and national ID work is infused by ethics of care practice that helps government and society change one another’s responses to ID. • Ethics of care starts conversations about engaging with people who need help and about our interdependent, inevitable need for care. In our caring society anyone may accept assistance without feeling bad. • We attend to the institutional forms and practices through which we express care. We reject bad ID care and unscrupulous resource distribution. We object to professional power inequalities that leave us feeling uncared for.[12] We do so free from patronisation or retribution. Avoiding future Esidimenis necessitates competent medical administration. It also requires recognition that ID care means

much more than completing tasks without deaths occurring. We take care by thinking about how we undermine opportunities for PWID to live enriching, meaningful and torture-free lives. We care by conducting ourselves constitutionally in our common humanity. Bad care dehumanises PWID by nullifying their material and psychological needs. Good care honours PWID by increasing interpersonal compensation and reassurance because individual powers have failed.[23] Justice D Moseneke said to Dr M Manamela: ‘Maybe you just didn’t care!’.[1] Our point exactly. C Capri Division of Intellectual Disability, Department of Psychiatry and Mental Health, University of Cape Town, South Africa charlotte.capri@uct.ac.za B Watermeyer, J Mckenzie Division of Disability Studies, Department of Health and Rehabilitation Sciences, University of Cape Town, South Africa O Coetzee Division of Intellectual Disability, Department of Psychiatry and Mental Health, University of Cape Town, South Africa 1. Child K. Judge Moseneke to Esidimeni tragedy official: ‘Maybe you just didn’t care!’. TimesLive, 23 November 2017. https://www.timeslive.co.za/news/south-africa/2017-11-23-judge-moseneke-to-esidimenitragedy-official-maybe-you-just-didnt-care/ (accessed 25 November 2017). 2. Chabalala J, Pijoos I. 4 of 144 patients do not form part of Life Esidimeni arbitration process – ombudsman. News24, 6 February 2018. https://www.news24.com/SouthAfrica/News/4-of-144-patients-do-not-formpart-of-life-esidimeni-arbitration-process-ombudsman-20180206 (accessed 19 February 2018). 3. Life Healthcare. Life Esidimeni. https://www.lifehealthcare.co.za/about-us/life-esidimeni/ (accessed 25 November 2017). 4. Makgoba MW. The report into the circumstances surrounding the deaths of mentally ill patients: Gauteng Province – no guns: 94+ silent deaths and still counting. Republic of South Africa: Health Ombud. 2016. https://www.sahrc.org.za/home/21/files/Esidimeni%20full%20report.pdf (accessed 19 December 2016). 5. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Washington, DC: APA, 2013. 6. Capri CH, Swartz L. ‘We are actually, after all, just children’: Caring societies and South African infantilisation of adults with intellectual disability. Disabil Soc 2018;33(2):285-308. https://doi.org/10.108 0/09687599.2017.1409102 7. Republic of South Africa. Mental Health Care Act No. 17 of 2002. 8. Republic of South Africa. Children’s Act No. 38 of 2005. 9. Kittay EF. When caring is just and justice is caring: Justice and mental retardation. Public Culture 2001;13(3):557-579. https://doi.org/10.1215/08992363-13-3-557 10. Kittay EF. The personal is philosophical is political: A philosopher and mother of a cognitively disabled person sends notes from the battlefield. Metaphilosophy 2009;40(3-4):606-627. https://doi. org/10.1111/j.1467-9973.2009.01600.x 11. Kittay EF, Jennings B, Wasunna AA. Dependency, difference and the global ethic of longterm care. J Polit Philos 2005;13(4):443-469. https://doi.org/10.1111/j.1467-9760.2005.00232.x 12. Tronto JC. Creating caring institutions: Politics, plurality, and purpose. Ethics Soc Welfare 2010;4(2):158-171. https://doi.org/10.1080/17496535.2010.484259 13. Drew N, Funk M, Tang S, et al. Human rights violations of people with mental and psychosocial disabilities: An unresolved global crisis. Lancet 2011;378(9803):1664-1675. https://doi.org/10.1016/ s0140-6736(11)61458-x 14. Department of Social Development, South Africa. Draft First Periodic Country Report on the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD). Government Gazette No. 38802:445. 2015. 15. United Nations. Convention on the Rights of Persons with Disabilities (A/RES/61/106). Resolution adopted by the General Assembly on 13 December 2006. New York: UN, 2006. 16. Republic of South Africa. Constitution of the Republic of South Africa: Chapter 2 – the Bill of Rights, Act No. 108 of 1996. 17. Department of Basic Education, South Africa. Call for written submissions from stakeholder bodies and members of the public on the draft policy for the provision of quality education and support for children with severe to profound intellectual disability. Government Gazette No. 40375:48. 2016. 18. Hood I. How will Scots with learning disabilities be voting in the referendum? The Guardian, 16 September 2016. https://www.theguardian.com/society/2014/sep/16/scots-learning-disabilitiesindependence-referendum (accessed 1 November 2016). 19. Kjellberg A, Hemmingsson H. Citizenship and voting: Experiences of persons with intellectual disabilities in Sweden. J Pol Prac Intel Disab 2013;10(4):326-333. https://doi.org/10.1111/jppi.12056 20. The Electoral Commission (United Kingdom). Voters with a disability are reminded there should be no barriers to them casting their vote on 7 May 2015. http://www.electoralcommission.org.uk (accessed 1 November 2016). 21. World Bank. South Africa Overview: World Bank Group. 2017. http://www.worldbank.org/en/ country/southafrica/overview (accessed 7 August 2017). 22. Statistics South Africa. Census 2011: Profile of persons with disabilities in South Africa. http://www. statssa.gov.za/publications/Report-03-01-59/Report-03-01-592011.pdf (accessed 21 August 2015). 23. Morris J. Impairment and disability: Constructing an ethics of care that promotes human rights. Hypatia 2001;16(4):1-6. https://doi.org/10.1353/hyp.2001.0059

S Afr Med J 2018;108(3):153-154. DOI:10.7196/SAMJ.2018.v108i3.13029

March 2018, Print edition

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EDITORIAL

The Life Esidimeni tragedy: The courts are also to blame Most discussions on the Life Esidimeni tragedy focus on the cruel approach of the Gauteng Department of Health (GDoH), while little is said about other major role players that could have averted the tragedy. By dismissing an application in March 2016 to prevent these patients from being discharged from Life Esidimeni, the Courts assisted the GDoH in its deed. This editorial describes international, regional and South African Human Rights Law, the attempts to avert the tragedy through the courts, and the need for those responsible to be held accountable for this injustice.

Human rights law: Background and context

The World Health Organization defines health as a ‘state of complete physical, mental and social well-being and not merely the absence of disease or infirmity’.[1] The Office of the United Nations High Commissioner for Human Rights frames the right to health as ‘…a fundamental part of our human rights and of our understanding of a life in dignity. The right to the enjoyment of the highest attainable standard of physical and mental health …’.[2] The right to health is a fundamental human right crucial for the realisation and enjoyment of other human rights and is therefore an all-inclusive human right interconnecting with others, such as the rights to life and dignity. Human rights are the basis for human dignity, justice, tolerance and mutual respect. People with mental health problems are often exposed to human rights violations, such as inadequate and harmful care and treatment, severe discrimination and inadequate housing and nutrition.[3] These violations are often motivated by misconceptions associated with mental illnesses, which can reduce an individual’s access to adequate healthcare.[3] Poor patient care management, misinterpretation of mental health policies, cost reduction actions and lack of care and compassion, which were all evident in the Life Esidimeni tragedy, can also violate human rights. Mental health and human rights are therefore inseparable. Human rights instruments are important for mental health, as they provide security and protection from harm for mentally ill persons,[4] and also enable them to live a meaningful life. International and regional human rights instruments are significant as ‘they are the only source of law that legitimises international scrutiny of mental health policies and practices within a sovereign country and also because they provide fundamental protections that cannot be taken away by the ordinary political process’.[4] Among these legal instruments is the International Bill of Rights, consisting of the United Nations Declaration of Human Rights (1948) (UDHR), [5] the International Covenant on Civil and Political Rights (1966) [6] and the International Covenant on Economic, Social and Cultural Rights (1976).[7] Although the UDHR is not legally binding, it establishes a set of human rights applicable to all nations. Other legal instruments include the Convention on the Rights of Persons with Disabilities (2006),[8] the Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (1984),[9] and the Convention on the Elimination of All Forms of Discrimination Against Women (1979).[10] Regional human rights instruments include the African Charter on Human and Peoples’ Rights (1981).[11] These human rights legal instruments affirm that every human being has a right to health, life and dignity, including the right not to be treated in a cruel, inhuman or degrading manner or by discrimination, as were the Life Esidimeni tragedy victims.

South Africa (SA)’s Constitution [12] ensures that ‘… every citizen is equally protected by law’, and aims to ‘improve the quality of life of all citizens …’. Constitutional protections are catered for, such as the right to human dignity, the right to life and the right to healthcare. These rights are realised, inter alia, through the National Health Act No. 61 of 2003 [13] and the Mental Health Care Act No. 17 of 2002 (MHCA).[14] The MHCA prohibits unfair discrimination against people with mental illness and other disabilities. It recognises that mentally ill persons ‘may at times require protection ... and that there is a need to promote the provision of mental healthcare services in a manner which promotes the maximum wellbeing of users of mental healthcare services and communities in which they reside’.[14] SA’s human rights protections for mentally ill persons are derived from international and regional law.[15] Thus, having signed and/or ratified these legal instruments, SA is ‘obliged to respect, protect and fulfil the rights enshrined in them’.[12,16] The Bill of Rights of the Constitution[12] states that the courts and other legal bodies ‘must consider international law …’ and that international law, approved by Parliament, binds SA to that law. SA is legally and morally bound to respect these human rights instruments. Despite the international, regional and national protections, more than 140[17] mentally ill patients under the patient care management of the GDoH died under suspicious, unlawful and unjust circumstances. [18] The loss of life resulted from the rushed execution of the Gauteng Mental Health Marathon Project, when the GDoH ‘precipitously’ terminated its contract with Life Esidimeni, a facility that provided ‘highly-specialised chronic psychiatric care’ to mentally ill patients on behalf of the GDoH.[18] This resulted in more than 2 000 patients, some with comorbid conditions, being hurried to non-governmental organisations (NGOs) that were unable to provide basic healthcare or specialised psychiatric healthcare.[18] This was done to curb medical costs and to implement the National Mental Health Policy Framework and Strategic Plan 2013 - 2020 on deinstitutionalisation.[19] The Health Ombudsman’s report into the circumstances surrounding these deaths concluded that the human rights of the Life Esidimeni patients had been grossly violated, specifically their rights to health, life and dignity.[18]

Attempts to avert the tragedy

Many attempts were made by civil society organisations, family members and professional associations to stop the GDoH from removing patients from Life Esidimeni and placing them in institutions that could not provide them with adequate care. Ultimately they had to instigate legal action against the Department.[20] The South African Society of Psychiatrists (SASOP) wrote to the former Gauteng Member of the Executive Council (MEC) for Health, Qedani Mahlangu, about the risks. This letter was seemly ignored and in October 2015, the former MEC terminated the contract with Life Esidimeni.[20] In November 2015, the South African Depression and Anxiety Group, SASOP, the South African Federation for Mental Health and families of the patients pleaded in vain with the GDoH to ‘slow down and follow the correct procedure to ensure proper care for the patients’.[20] In December 2015, litigation was instituted against the GDoH, which was presented with documents citing that patients needed specialised psychiatric healthcare that the NGOs could not provide. This litigation was dropped when the GDoH ‘committed to a consultation and a safe process, in the best interests of the mental healthcare users’.[20]

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EDITORIAL

It promised that no patient would be moved until all parties involved agreed on the process and facilities. The Department reneged on its agreement, and announced in February 2016 that all Life Esidimeni residents would be moved from the facility. In response to the Department’s announcement, in March 2016 SECTION27 and others instigated further litigation against the GDoH to stop the transfer of 54 people to an NGO. Many were adult patients with severe mental disabilities such as schizophrenia, requiring specialised care.[20] The GDoH argued that patients were assessed and concluded that they no longer needed professional care and, claiming that they were not obliged to consult, decided to move them.[20] The Johannesburg High Court ruled in favour of the GDoH, which continued ‘with its plans to discharge and place those who still need medical care to different facilities’.[20]

The failure of the courts

The judicial system, the custodian of human rights law, has not emerged undamaged from the Life Esidimeni tragedy. Its fingerprints are on the death certificates of the more than 140 mentally ill patients, together with those of uncaring, incompetent Gauteng health officials.[17,21] The role the judiciary played in this tragedy therefore cannot be disregarded. More than once, professional bodies, families of the Life Esidimeni residents and stakeholders approached the courts in attempts to intervene and prevent the tragedy. Despite expert witnesses and evidence presented before the courts on why the residents of Life Esidimeni should not be transferred, the judiciary ruled in favour of the GDoH.[21] The second application to the courts in March 2016 to prevent the GDoH from discharging patients from Life Esidimeni was dismissed due to a ‘lack of urgency’.[21] Partial blame for the deaths of the more than 140 patients therefore falls on the judiciary for failing to intervene. It seems that mental health is not considered a matter of urgency in sectors of SA society, including the judiciary. The Life Esidimeni tragedy could have been averted, if only the courts had listened.

Conclusion

The unfortunate deaths of the Life Esidimeni patients is a painful reminder of our unjust society. The Constitution[12] recognises the injustices of the past; however, it seems that we must now recognise the most recent injustices done to the most vulnerable members of our society. If the victims of the Life Esidimeni tragedy are denied justice and we fail to make those responsible accountable, ill-treatment and gross human rights violations of the mentally ill will endure. Although the Gauteng premier, David Makhura, has accepted the Health Ombudsman’s report and accepts that the GDoH

was negligent in its actions,[22] it is too late, as more than 140 innocent people died in a preventable tragedy. B A Ferlito, A Dhai Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa ames.dhai@wits.ac.za 1. World Health Organization. Constitution of WHO: Principles. 2017. http://www.who.int/about/ mission/en/ (accessed 17 July 2017). 2. United Nations Office of the High Commissioner for Human Rights (OHCHR). Fact Sheet No. 31, The Right to Health. 2008. http://www.ohchr.org/Documents/Publications/Factsheet31.pdf (accessed 17 July 2017). 3. Maiese M. Human rights violations. July 2003. http://www.beyondintractability.org/essay/humanrights-violations (accessed 1 September 2017). 4. Arena Ventura CA. International Law, Mental Health, and Human Rights. Center for Civil and Human Rights, University of Notre Dame, 2014:1-9. https://humanrights.nd.edu/assets/134859/ venturamentalhealth.pdf (accessed 1 September 2017). 5. United Nations General Assembly. Universal Declaration of Human Rights. 1948. 217 A (III). http:// www.un.org/en/udhrbook/pdf/udhr_booklet_en_web.pdf (accessed 17 July 2017). 6. United Nations General Assembly. International Covenant on Civil and Political Rights. 16 December 1966, United Nations Treaty Series, vol. 999, p. 171. https://treaties.un.org/doc/publication/unts/ volume%20999/volume-999-i-14668-english.pdf (accessed 1 September 2017). 7. United Nations General Assembly. International Covenant on Economic, Social and Cultural Rights. 1966. United Nations Treaty Series, vol. 993. http://www.ohchr.org/EN/ProfessionalInterest/Pages/ CESCR.aspx (accessed 17 July 2017). 8. United Nations. Convention on the Rights of Persons with Disabilities. New York: UN, 2006. https:// www.un.org/development/desa/disabilities/convention-on-the-rights-of-persons-with-disabilities. html (accessed 17 July 2017). 9. United Nations General Assembly. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment. 10 December 1984. United Nations Treaty Series, vol. 1465, p. 85. https://treaties.un.org/doc/Publication/UNTS/Volume%201465/volume-1465-I-24841-English. pdf (accessed 1 September 2017). 10. United Nations General Assembly. Convention on the Elimination of All Forms of Discrimination Against Women. 18 December 1979. United Nations Treaty Series, vol. 1249, p. 13. http://www.un.org/ womenwatch/daw/cedaw/text/econvention.htm (accessed 1 September 2017). 11. Organization of African Unity, African Charter on Human and Peoples’ Rights (Banjul Charter). 1981. CAB/LEG/67/3 rev. 5, 21 I.L.M. 58 (1982). http://www.achpr.org/files/instruments/achpr/banjul_ charter.pdf (accessed 17 July 2017). 12. South Africa. The Constitution of the Republic of South Africa. Act No. 108 of 1996. http://www.gov. za/sites/www.gov.za/files/Act108of1996s.pdf (accessed 17 July 2017). 13. South Africa. National Health Act No. 61 of 2003. http://www.gov.za/sites/www.gov.za/files/38486_ r10367_gon109.pdf (accessed 17 July 2017). 14. South Africa. Mental Health Care Act No. 17 of 2002. http://www.gov.za/sites/www.gov.za/files/a17-02. pdf (accessed 17 July 2017). 15. Dugard J. International Law: A South African Perspective. Cape Town: Juta & Co., 1994. 16. Friedmann S. The right to health. In: Human Rights and Health. Human Rights & Human Welfare. http://www.du.edu/korbel/hrhw/researchdigest/health/health.pdf (accessed 9 August 2017). 17. Bornman J. Life Esidimeni death toll rises to 143. News24. 10 November 2017. https://www.news24. com/SouthAfrica/News/life-esidimeni-death-toll-rises-to-143-20171110 (accessed 10 November 2017). 18. Makgoba MW. The Life Esidimeni disaster: The Makgoba report. http://www.politicsweb.co.za/ documents/the-life-esidimeni-disaster-the-makgoba-report (accessed 10 July 2017). 19. National Department of Health, South Africa. National Mental Health Policy Framework and Strategic Plan 2013 - 2020. 2012. https://www.health-e.org.za/wp-content/uploads/2014/10/National-MentalHealth-Policy-Framework-and-Strategic-Plan-2013-2020.pdf (accessed 9 August 2017). 20. SECTION27. The Life Esidimeni Case Fact Sheet. http://section27.org.za/wp-content/ uploads/2017/02/Life-Esidimeni-Fact-Sheet-1.pdf (accessed 9 August 2017). 21. Mooney Ford Attorneys. Courts failed dying psychiatric patients. 6 February 2017. http://www.mfp. co.za/courts-failed-dying-psychiatric-patients// (accessed 9 August 2017). 22. Ramkissoon N, Cassim B. Life Esidimeni: The forgotten people of South Africa’s healthcare system. The Daily Vox: Life and Healthcare. 6 February 2017. https://www.thedailyvox.co.za/life-esidimenithe-forgotten-people-of-south-africas-healthcare-system-nikita-ramkissoon-benazir-cassim/ (accessed 9 August 2017).

S Afr Med J 2018;108(3):155-156. DOI:10.7196/SAMJ.2018.v108i3.13011

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EDITORIAL

The Life Esidimeni tragedy: Some ethical transgressions Justice literally means equality and fairness – ‘Justice as fairness’.[1] In the milieu of healthcare and bioethics, justice is the process in which individuals are treated fairly and equally, resulting in the ability to achieve the highest attainable standard of physical, mental and social wellbeing.[2] Justice is also the paramount obligation by states to ensure that all persons are treated fairly and equally in all sectors of society.[3] As custodians of justice, the state has a legal and moral responsibility to ensure that it ‘respects, protects, promotes and fulfils’ the values of human life, ‘dignity, equality and freedom’.[4,5] The Life Esidimeni tragedy occurred as a result of the rushed execution of the Gauteng Mental Health Marathon Project, when the Gauteng Department of Health (GDoH) ‘precipitously’ terminated its contract with Life Esidimeni, a facility that provided ‘highly-specialised chronic psychiatric care’ to mentally ill patients.[6] Over 2 000 mentally ill patients, some with comorbid conditions, were hurriedly moved to ill-equipped and unlicensed non-governmental organisations (NGOs) in an attempt to curb costs. An investigation by the Health Ombudsman found that these NGOs could not even provide basic healthcare to patients who required ‘highly-specialised chronic psychiatric care’.[6] Additionally, the investigation found that in the process of moving patients and in the aftermath thereof, several human rights were violated – specifically the rights to health, life and dignity, resulting in a great injustice to society’s most vulnerable group.[6] The cruel and baseless decision by the Department to move patients resulted in over 140 (and counting) deaths.[7] Justice also concerns ‘democracy and the distribution of power, social roles, and capacity’.[2] The application of justice in the healthcare sector by the state (GDoH) ‘ought to progress hand in hand toward a better’[2] society, but unfortunately, as was seen with the Life Esidimeni tragedy, this was not the case. Recipients of healthcare have specific rights with regard to its delivery, and these rights (life, health and dignity) are interlinked with principles of ethics (autonomy and informed consent, beneficence and non-maleficence).[8] The state therefore has an obligation to ensure that its actions will always be for the benefit of society, and that it will steer away from activities that could harm society.[9] At the forefront of the Life Esidimeni tragedy were Dr Tiego Ephraim Selebano (head of the GDoH) and Dr Makgabo Manamela (director, Mental Health), two qualified health professionals, who together with Qedani Mahlangu, the former MEC (Member of the Executive Council) for Health in Gauteng, were implicated as the three major players responsible for the tragedy.[6] Both Dr Selebano and Dr Manamela have publicly taken oaths that they will not harm patients and that their actions will always be ethical and in the best interests of patients. Moreover, Mahlangu, upon taking office as MEC, promised to uphold South Africa’s Constitution and all other laws of the country.[4] Caring and compassion are core values in the practice of healthcare, especially for the mentally ill, who require additional sensitively considered care. Did Mahlangu and others forget this, or did they choose not to remember?[10] Autonomy is described as a rudimentary ethical principle in healthcare.[8] It is the right of individuals to make choices around their own health issues. In addition, individuals have the right to be involved in the decision-making process pertaining to their healthcare. The concept of informed consent is closely linked to autonomy, as informed consent is ‘the voluntary un-coerced decision made by a competent autonomous individual to accept or reject some proposed course of action’.[8] Patients have the right to be informed about their treatment and care and to give consent before any treatment regimen can begin. However, autonomy and persons with mental illness pose a moral challenge. Individuals with mental illness do not always have the cognitive ability to make sound judgments pertaining to their health, and are therefore sometimes

impaired with regard to the consent process.[11] Nevertheless, even if an individual is found to lack the cognitive capacity to make an informed choice, she or he should still be included as far as possible in the decisionmaking process.[11] The notion of autonomy and informed consent is also promulgated by law. Section 12(2) of the Constitution,[4] the Mental Health Care Act (MHCA) (chapter 3)[12] and the National Health Act (NHA) (chapter 2)[13] all specifically deal with autonomy and informed consent. In certain circumstances, e.g. mental incapacity, individuals may not have the ability to consent. The NHA does, however, make provision for certain individuals to consent on behalf of these patients:[13] ‘A person authorised by the court (e.g. a curator); or in order of priority, the patient’s spouse, partner, parent, grandparent, major child or brother or sister.’ The MHCA[12] stipulates that consent to care and treatment can only be provided by the patient, except where care and treatment is authorised by a court of law or where the mental state of the patient could cause serious harm or death to others or cause serious damage to property. The Act makes it clear that patients should be encouraged to give consent. Family members had the legal authority to provide consent on behalf of the patients at Life Esidimeni, and this included giving consent for patients to be transferred – a decision they were not involved in.[6] Beneficence requires that the patient’s interests be put first – that is, balancing benefits (interests) against risks and costs. Non-maleficence stems from the maxim Primum non nocere, meaning ‘Above all (or first) do no harm’.[14] It is an obligation to avoid harm to the patient or avoid going against the patient’s interests. The character of beneficence rests on three values: preventing the infliction of unnecessary pain, preventing mortality, and preventing the incapacitation of others.[11] In the case of non-maleficence, the three values are do not kill, do not cause unnecessary pain, and do not incapacitate others.[11] Clearly these six values were infringed in the Life Esidimeni tragedy. The patients and their families suffered unnecessary and preventable pain. There was utter disrespect for their dignity and welfare. B A Ferlito, A Dhai Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa ames.dhai@wits.ac.za 1. Bishop L. Ethics background: Principles – respect, justice, nonmaleficence, beneficence. Kennedy Institute of Ethics, Georgetown University. https://www.nwabr.org/sites/default/files/Principles.pdf (accessed 23 October 2017). 2. Tarantola D, Camargo K, Gruskin S. Searching for justice and health. Am J Public Health 2015;105(8):1511-1512. https://doi.org/10.2105/AJPH.2015.302760 3. Duhaime L. Justice definition. In: Duhaime’s Law Dictionary [Online]. 2017. http://www.duhaime.org/ LegalDictionary/J/Justice.aspx (accessed 23 October 2017). 4. South Africa. The Constitution of the Republic of South Africa. Act No. 108 of 1996. http://www.gov. za/sites/www.gov.za/files/Act108of1996s.pdf (accessed 23 October 2017). 5. Fagelson D. Rights and duties: The ethical obligation to serve the poor. Law Inequal 1999;17(1):171199. http://scholarship.law.umn.edu/lawineq/vol17/iss1/5 6. Makgoba MW. The Life Esidimeni disaster: The Makgoba report. http://www.politicsweb.co.za/ documents/the-life-esidimeni-disaster-the-makgoba-report (accessed 10 July 2017). 7. Bornman J. Life Esidimeni death toll rises to 143. News24. 10 November 2017. https://www.news24. com/SouthAfrica/News/life-esidimeni-death-toll-rises-to-143-20171110 (accessed 10 November 2017). 8. Sakellari E. Patient’s autonomy and informed consent. ICUS Nurs Web J 2003;(13):1-9. 9. Heyman SJ. The first duty of government: Protection, liberty and the Fourteenth Amendment. Duke Law J 1991;41(3):507-571. 10. Dhai A. After Life Esidimeni: True human rights protections or lip service to the Constitution? S Afr J Bioethics Law 2017;10(1):2-3. https://doi.org/10.7196/sajbl.542 11. Adshead G. Ethical issues in mental illness. J Med Ethics 1999;25(1):67-68. https://doi.org/10.1136/ jme.25.1.67 12. South Africa. Mental Health Care Act No. 17 of 2002. http://www.gov.za/sites/www.gov.za/files/a17-02. pdf (accessed 23 October 2017). 13. South Africa. National Health Act No. 61 of 2003. http://www.gov.za/sites/www.gov.za/files/38486_ r10367_gon109.pdf (accessed 23 October 2017). 14. Dhai A. Understanding ethics with specific reference to health research. In: Health Research Ethics: Norms and Standards for Researchers and Research Ethics Committee Members. Johannesburg: University of the Witwatersrand, 2017:1-13.

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CME

GUEST EDITORIAL

Bleeding disorders (part 2) Haemostasis is a physiological process that stops blood loss at the site of injury, while maintaining normal blood flow in the rest of the circulation. This is accomplished in three physiological steps that occur in rapid sequence: (i) vasoconstriction; (ii) formation of a platelet plug (primary haemostasis); and (iii) stabilisation of clot through crosslinking of insoluble fibrin (secondary haemostasis). The fibrin mesh that is incorporated into and around the platelet plug serves to strengthen and stabilise the blood clot. Apart from limiting blood loss, the clot allows for vessel and tissue repair. Anticoagulant mechanisms regulate the coagulation system to ensure formation of a clot that is proportional to the injury. A delicate balance between procoagulant and anticoagulant systems is critical for proper haemostasis and for avoiding pathological bleeding or thrombosis. The clot is finally dissolved by the fibrinolytic system, which also performs the function of preventing blood clots in healthy blood vessels. Bleeding disorders are divided into two broad categories: (i) inherited (discussed in part 1);[1] and (ii) acquired (part 2, current issue).[2] This is the second of a two-part CME series on bleeding disorders. Bleeding manifestations from acquired causes are generally less severe than in the inherited forms and the clinical picture is often dominated by features of the underlying disorder. In clinical practice, however, bleeding is frequently a presenting manifestation of systemic disease and necessitates a multidisciplinary team approach. Investigation of abnormal bleeding requires a comprehensive history, thorough physical examination and systematic laboratory work-up. For the laboratory work-up, an algorithmic approach is incorporated in the article in the current issue as Fig. 1.[2] Basic laboratory tests, viz. international normalised ratio, partial thromboplastin time, full blood count and blood smear microscopy, characterise the nature and extent of the coagulation defect/s and provide a basis for further investigations. It is important to understand the mechanism of haemostatic disturbances that may be applicable to specific disease processes, as interpretation of laboratory findings depends to a large extent on clinical circumstances.

This CME aims to provide an approach to diagnosis and management of acquired bleeding disorders encountered in general practice. Elaborate discussion on the wide variety of bleeding disorders is not possible, but more common conditions such as immune thrombocytopenia are discussed in greater detail. Complex haemostatic derangements may occur in specific clinical scenarios with varying degrees of bleeding and thrombosis. These include cardiopulmonary bypass, trauma, massive blood loss, liver transplantation and complications of pregnancy. Such scenarios are influenced by a multitude of factors with varied aetiologies that merit discussion on discipline-specific platforms, and are therefore beyond the scope of this CME. Select therapeutic modalities may fall outside the scope of general practice, but are nonetheless included to familiarise readers with available therapies. The authors are indeed grateful for the opportunity to discuss the subject of bleeding disorders, which is an important and dynamic sphere of coagulation. N Alli Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, and National Health Laboratory Service, Johannesburg, South Africa nazeer.alli@nhls.ac.za

1. Alli N, Vaughan J, Louw S, Schapkaitz E, Mahlangu J. Inherited bleeding disorders. S Afr Med J 2018;108(1):9-15. https://doi.org/10.7196/SAMJ.2018.v108i1.13020 2. Alli N, Vaughan J, Louw S, Moodly S, Patel M. Acquired bleeding disorders. S Afr Med J 2018;108(3):159-165. https://doi.org/10.7196/SAMJ.2018.v108i3.13158

S Afr Med J 2018;108(3):158. DOI:10.7196/SAMJ.2018.v108i3.13157

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This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

CME

Acquired bleeding disorders N Alli,1 MB BCh, FCPathHaem (SA); J Vaughan,1 MB BCh, FCPathHaem (SA), MMed Haem; S Louw,1 MB BCh, FCPathHaem (SA), MMed Haem; S Moodly,1 NDip MedTech, NHD MedTech, MSc Medicine; M Patel,2 MB ChB, FCP (SA), MMed, FRCP (Lond), PhD Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, and National Health Laboratory Service, Johannesburg, South Africa 2 Department of Clinical Haematology, Division of Internal Medicine, Chris Hani Baragwanath Academic Hospital, Johannesburg, and School of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 1

Corresponding author: N Alli (nazeer.alli@nhls.ac.za)

Bleeding disorders are divided into two broad categories, i.e. inherited, discussed in part 1 of this CME series, and acquired, which is the subject of discussion in the current issue. In contrast to inherited haemorrhagic disorders, where generally a single haemostatic abnormality is found, multiple haemostatic defects are commonly present in acquired haemorrhagic diseases. Bleeding is often a presenting manifestation of systemic disease and requires a multidisciplinary team approach. Iatrogenic causes of abnormal haemostasis are of particular importance to the emergency physician. This CME article aims to provide an approach to the diagnosis and management of acquired bleeding disorders encountered in general practice. S Afr Med J 2018;108(3):159-165. DOI:10.7196/SAMJ.2018.v108i3.13158

Acquired bleeding disorders encompass a heterogeneous group of conditions with varied and often complex aetiologies. Clinical evaluation of patients presenting with a bleeding disorder often provides clues as to whether the abnormality resides in coagulation factors, platelets or blood vessels. A detailed history and complete physical examination are therefore imperative for meaningful interpretation of laboratory tests, as complex haemostatic derangements may accompany specific clinical scenarios. Interpretation based solely on laboratory tests may be misleading. For discussion purposes, acquired bleeding disorders are divided into the following groups: (i) clotting factor deficiencies; (ii) abnormalities of platelet number or function; (iii) vascular defects; or (iv) various combinations of the three abovementioned disorders. The last group includes liver disease, disseminated intravascular coagulation (DIC) and chronic kidney disease. Basic laboratory tests (partial thromboplastin time (PTT), international normalised ratio (INR), full blood count (with peripheral blood smear assessment)) and accurate clinical information form a basis for further investigations. To this end, an algorithmic approach is incorporated to serve as a guide (Fig. 1).

Clotting factor deficiencies

Coagulation factor inhibitors

Coagulation factor inhibitors are antibodies

Suspected acquired bleeding disorder

Baseline screening: INR, PTT, FBC and blood smear

INR ↑ PTT ↑ Platelets N

INR ↑ PTT N Platelets N

PTT ↑ INR N Platelets N

Warfarin Early liver disease Early DIC Vit K deficiency

INR ↑ PTT ↑ Platelets ↓

INR N PTT N Platelets N

INR N PTT N Platelets ↓

DIC Liver disease

Blood smear

Red cell fragments Warfarin/super-warfarin Vit K deficiency Liver disease Dys/hypofibrinogenaemia Acquired factor X deficiency*

Does not correct on mixing studies

Heparin Acquired factor inhibitor Antiphospholipid antibody †

Corrects on mixing studies

Consider inherited causes of factor deficiencies

Functional platelet abnormalities (renal failure, antiplatelet agents, hypothermia, hypocalcaemia, acidosis) Vascular defects

Blasts or LER

No evidence of infiltrate MAHA

Leukaemia Bone marrow infiltration

‡

ITP B one marrow aplasia Megakaryocytic suppression Hypersplenism, etc.

Fig. 1. Laboratory approach to a suspected acquired bleeding disorder. (LER = leuko-erythroblastic blood reaction (signifying possible bone marrow infiltration); INR = international normalised ratio; PTT = partial prothrombin time; N = normal; FBC = full blood count; DIC = disseminated intravascular coagulation; vit = vitamin; MAHA = microangiopathic haemolytic anaemia; ITP = immune thrombocytopenia.) (*Associated with amyloidosis; †Antiphospholipid antibodies usually cause thrombosis, not bleeding; however, rare instances of prothrombin deficiency can be associated with bleeding; ‡Except for DIC.)

that neutralise specific coagulation factors. These antibodies can develop against any factor in the coagulation cascade, but factor VIII (FVIII) is most frequently involved, and may develop in patients with inherited haemophilia A as an immune response to factor-replacement therapy, or

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spontaneously as auto-antibodies, resulting in the bleeding condition termed acquired haemophilia. The presence of inhibitors is suspected in a patient with abnormal bleeding without any prior bleeding diathesis, or when a patient with known haemophilia has more extreme bleeding

CME

than usual or fails to achieve haemostasis after factor replacement. Prolongation of the screening clotting assays, i.e. INR and/or PTT, with failure to correct on mixing with normal plasma, should alert the attending clinician to the presence of an inhibitor. Factor inhibitors in inherited haemophilia A and B This has been discussed in part 1 of this series.[1] Acquired haemophilia A Acquired haemophilia A (AHA) is a rare (~1 per million of the population per year), potentially life-threatening auto-immune bleeding disorder due to inhibiting auto-antibodies (inhibitors) against endogenous FVIII. Although documented as a rare condition, AHA is probably under-diagnosed. Mortality in cases of AHA exceeds 20% in patients >65 years of age and those with comorbid disease, such as underlying malignancies. Although death directly due to excessive bleeding is not common, it does contribute to morbidity, thereby increasing the duration and cost of hospitalisation (e.g. delayed wound healing and increased transfusion requirements). Immune modulation therapy to eradicate the inhibitor also contributes significantly to cost and mortality. In contrast to inherited haemophilia, AHA affects both males and females and is most common in the elderly (median age 64 - 78 years). AHA can, however, occur in younger patients in relation to pregnancy and auto-immune diseases. Most cases are idiopathic, but underlying precipitating causes include pregnancy, auto-immune diseases (most commonly rheumatoid arthritis), infection, malignancy and drugs (e.g. interferon alpha). Research suggests that the breakdown of immune tolerance to FVIII is due to both genetic and environmental factors. The majority (94.6%) of patients present with bleeding, which can either be spontaneous or provoked, e.g. after surgery. The site of bleeding is most commonly subcutaneous, followed by the gastrointestinal tract, intramuscular sites and genito-urinary tract. Bleeding in other sites (intracranial and retroperitoneal) can occur, but in contrast to congenital haemophilia, joint bleeding is infrequent. Because of the second-order (non-linear) kinetics of the anti-FVIII antibodies in AHA, FVIII levels are not predictive of bleeding risk and patients can have serious bleeding despite having only modestly reduced laboratory-determined FVIII activity levels. Inhibitors to other coagulation factors Inhibitors to other coagulation factors, i.e. fibrinogen, FII, FV, FVII, FIX, FX, FXI, FXIII and von Willebrand factor, do occur but are rare. Correct identification and quantification are, however, indicated for appropriate therapy. As with haemophilia A, these inhibitors develop either in patients with congenital deficiencies related to exposure to replacement therapy or spontaneously in people without a prior bleeding disorder. As with AHA, precipitating factors for spontaneous development of inhibitors include infections, drug exposure, auto-immune diseases, blood transfusions and underlying malignancies.[2] Diagnosis Depending on the position of the affected factor in the coagulation cascade, the screening assays, i.e. PTT and/or INR, will be prolonged. Other causes of prolonged screening tests, such as lupus anticoagulant and anticoagulant drugs, e.g. heparin, should be excluded prior to identification and quantification of the coagulation factor inhibitor. The most common laboratory observation in AHA is a prolonged PTT that does not correct with mixing with normal plasma after incubation, together with a normal INR, thrombin time and platelet count.[2,3]

Management Management of patients with acquired inhibitors entails: (i) control of bleeding with haemostatic agents, as for inherited haemophilia patients with inhibitors (part 1);[1] (ii) eradication of the inhibitor with immune modulating agents (e.g. corticosteroids and rituximab); and (iii) treatment of the underlying pathogenic disease process. Thrombotic complications, including myocardial infarctions and cerebrovascular accidents, can occur in relation to haemostatic agent administration.[2-6]

Vitamin K deficiency

Vitamin K is responsible for gammacarboxylation of FII, FVII, FIX and FX, as well as for proteins C, S and Z. Gammacarboxylation enables binding to phospholipid membranes via Ca++ bridges. Vitamin K deficiency is encountered in various clinical scenarios and causes include: haemorrhagic disease of the newborn (currently termed vitamin K deficiency bleeding), reduced dietary intake, prolonged antibiotic use, cholestatic liver disease, malabsorption, and drugs, e.g. anticonvulsants and warfarin. The mode of therapy is oral or intravenous vitamin K, and patients with severe bleeding are treated with fresh-frozen plasma (FFP) or prothrombin complex concentrate (PCC).

Anticoagulation and antiplatelet agents

Warfarin Warfarin, a coumarin derivative, inhibits the enzyme vitamin K epoxide reductase and thereby impairs production of vitamin K-dependent coagulation factors, i.e. FII, FVII, FIX and FX, as well as proteins C, S and Z. Patients treated with coumarin derivatives have reduced concentrations of these coagulation factors, with consequent increased risk of bleeding that is amplified when the INR is supratherapeutic (particularly >5). Other factors that increase the bleeding risk include advanced age, a prior history of bleeding, previous stroke, hypertension, other drugs associated with a bleeding risk (such as non-steroidal anti-inflammatory drugs (NSAIDs)), and abnormal liver or renal function. Management of warfarin-associated bleeding depends on the severity of bleeding, the level of the INR and the indication for anticoagulation. For over-warfarinisation without bleeding, stoppage of warfarin with possible oral vitamin K administration is usually sufficient. However, if this is accompanied by significant bleeding, reversal of anticoagulation with factor replacement becomes necessary (Table 1).[7] As for patients scheduled for surgery, anticoagulant reversal must be done before surgery to restore normal coagulation status. Heparin Heparin is an anticoagulant that works by binding to and potentiating the activity of antithrombin, which then inhibits thrombin. Heparin is used for the treatment and prevention of thrombosis. High doses of heparin can cause severe bleeding. In this event, discontinuation of heparin is usually sufficient owing to its short half-life of 8 hours. If rapid reversal of heparin effect is required, protamine sulphate is very effective for unfractionated heparin, but only reverses ~60% of the antifactor Xa activity of low-molecularweight heparin, and has negligible effects on fondaparinux and danaparoid (a mixture of anticoagulant glycosaminoglycans used to treat heparin-induced thrombocytopenia).[8,9] Non-vitamin K antagonist oral anticoagulants Non-vitamin K antagonist oral anticoagulants (NOACs) include thrombin inhibitors, e.g. dabigatran, and FXa inhibitors, e.g. rivaroxaban and apixaban. Outcomes of major bleeding are no worse than with

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Table 1. Management of over-warfarinisation INR 4.0 - 5.0 and no significant bleeding INR 5.0 - 9.0 and no significant bleeding

INR >9.0 and no significant bleeding

Prolonged INR and significant bleeding

Omit one dose Decrease weekly dose by ~10 - 20% and re-check in 5 -7 days Stop warfarin therapy Oral vitamin K 1.0 - 2.5 mg (0.1 - 0.25 mL Konakion) if the patient is at high risk of bleeding* Monitor INR every 2nd day until in therapeutic range Vitamin K may need to be repeated Decrease weekly dose of warfarin by 20% once INR therapeutic range has been reached Stop warfarin therapy Give oral vitamin K 2.5 - 5.0 mg (0.25 - 0.5 mL Konakion)* Vitamin K may need to be repeated Monitor INR daily until therapeutic range has been reached Decrease weekly dose of warfarin by 20% once INR is in the therapeutic range Stop warfarin therapy Administer PCC 50 U/kg or FFP 15 - 20 mL/kg or Bioplasma FDP Administer vitamin K 1.0 - 2.0 mg IVI slowly (can be repeated) Monitor INR daily

INR = international normalised ratio; PCC = prothrombin complex concentrate; FFP = fresh-frozen plasma; FDP = freeze-dried plasma; IVI = intravenous infusion. *Oral vitamin K should be administered with caution to patients with prosthetic heart valves.

vitamin K antagonists. Three NOAC reversal agents are in various stages of development, i.e. idarucizumab for thrombin inhibitors, andexanet for FXa inhibitors, and ciraparantag for all NOACs.[10] Antiplatelet agents Aspirin exerts its antiplatelet effect by irreversibly binding to the enzyme cyclo-oxygenase. Other antiplatelet agents include NSAIDs and adenosine diphosphate (ADP) receptor inhibitors, such as clopidogrel (Plavix). Mild bleeding and bruising may occur in response to trauma or surgery, but are likely to be exacerbated with coexisting medical conditions, such as haemophilia, renal disease and leukaemia. More severe spontaneous bleeds, e.g. from the gastrointestinal tract, occur less frequently. The effect of aspirin and clopidogrel lasts for 5 - 7 days, i.e. the entire lifespan of the platelet.

Abnormalities of platelet number

Platelet defects are typically associated with mucocutaneous bleeding, with the severity depending on the degree of the thrombocytopenia. In general, the risk of bleeding is low when platelets are >80 × 109/L, and significantly increased when the platelet count is <20 × 109/L (where spontaneous bleeding may occur). Platelet transfusion is indicated in all bleeding patients to maintain a platelet count of 50 - 100 × 109/L (depending on the site of blood loss), as well as in selected patients with a platelet count 20 × 109/L as bleeding prophylaxis. Causes of thrombocytopenia are divided into: (i) central (production failure); and (ii) peripheral (reduced survival). These are summarised in Table 2, and some of the more important causes are discussed below.

Immune thrombocytopenia

Immune thrombocytopenia (ITP) is an acquired, auto-immune disorder with the formation of antiplatelet antibodies against platelets and megakaryocytes, resulting in increased destruction and inadequate production of platelets.[11,12] The term ITP refers to immune thrombocytopenia and no longer to the older term idiopathic thrombocytopenic purpura. The threshold for ITP and for clinical thrombocytopenia is defined as a platelet count <100 × 109/L.[13] The incidence of ITP is ~3 - 4.5/100 000/year.[14,15] In South Africa (SA), primary ITP predominantly affects young females.[16]

In Europe, however, the median age is 57 years, with a rising incidence with advancing age (>60 years) and a less marked gender difference.[14,15] The presentation of ITP may be acute or insidious. Three phases of ITP are recognised: (i) newly diagnosed (0 - 3 months from diagnosis); (ii) persistent (3 - 12 months); and (iii) chronic (>12 months).[13] Most adult patients go on to develop chronic ITP. Spontaneous remissions occur in 5 - 11% of adults, mostly in the first year after diagnosis.[17] ITP may be primary (~80% of cases), with no identifiable cause, or secondary (~20% of cases), due to a number of causes. In SA, a paradigm shift has been noted, with an increasing number of patients with secondary ITP, largely due to HIV infection.[16] Primary ITP is a diagnosis of exclusion. Secondary causes need to be excluded, including infections (e.g. HIV), auto-immune disorders (e.g. systemic lupus erythematosus), drugs (e.g. rifampicin, quinine and heparin), and lymphoproliferative disorders (e.g. chronic lymphocytic leukaemia, and lymphoma). In the classic patient with primary ITP (young female, isolated thrombocytopenia, no abnormalities on the peripheral smear such as fragments or atypical cells), a bone marrow aspirate and trephine biopsy (BMAT) is not indicated.[18] However, in patients with a suspected secondary cause, or in whom the presentation is atypical, or in individuals >60 years of age, a BMAT must be performed. Patients with ITP may be asymptomatic (where the platelet count is usually >30 × 109/L) or may present with bleeding, which is typically of the mucocutaneous type. The incidence of major bleeding events, such as intracranial haemorrhage and cavity bleeding, is low. The platelet count remains the best known predictor of bleeding events in ITP. Lymphadenopathy and hepatosplenomegaly are generally not encountered in primary ITP and, if present, indicate another cause or secondary ITP. The decision to initiate treatment is primarily based on whether the patient is symptomatic (bleeding) and the level of the platelet count (<30 × 109/L). The goal of treatment is to stop the bleeding and increase the platelet count to a safe level and not necessarily to achieve a normal platelet count. Therapeutic agents used in the treatment of ITP are presented in Table 3. Corticosteroids (CS) are the mainstay of treatment in newly diagnosed ITP. Prednisone is the preferred initial treatment. Alternative CS include dexamethasone and methylprednisolone.

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Table 2. Causes of thrombocytopenia Spurious (in vitro laboratory artefact) Platelet clumping A clotted sample Reduced survival Immune thrombocytopenia Primary (idiopathic) Secondary (infection, drugs,*† auto-immune disease, lymphoproliferative disorder) Micro-angiopathic haemolytic anaemia Disseminated intravascular coagulation Thrombotic thrombocytopenic purpura Haemolytic uraemic syndrome HELLP syndrome/pre-eclampsia Hypersplenism Production failure Hypoplastic/aplastic anaemia Inherited Acquired Bone marrow infiltration/replacement Malignancy Granulomatous inflammation Myelofibrosis Ineffective megakaryopoiesis Vitamin B12 or folic acid deficiency Drugs, e.g. folate antagonists, such as methotrexate and trimethoprim Infection, such as HIV Myelodysplastic syndrome Direct megakaryocyte suppression Drugs, e.g. thiazides, tolbutamide Alcohol Viral infection of megakaryocytes, e.g. CMV, HIV Thrombopoietin deficiency Liver disease HELLP = haemolysis, elevated liver enzymes, low platelets; CMV = cytomegalovirus. *Including cephalosporins, ciprofloxacin, clarithromycin, fluconazole, penicillins, sulfamethoxazole and vancomycin. † >50 drugs have been associated with definite evidence of immune-mediated thrombocytopenia.

Table 3. Therapeutic agents and dosing schedules employed in the treatment of immune thrombocytopenic purpura in adults Treatment First line

Agent Prednisone Dexamethasone Methylprednisolone Immunoglobulin (IV Ig)

Second line

Azathioprine Mycophenolate mofetil

Dose 1 - 2 mg/kg/day orally/IVI 40 mg/day orally/IVI 1 g/day IVI 1 g/kg/day IVI or 400 mg/kg/day 1 - 2 mg/kg/day orally 1 000 mg bid or 500 mg qid orally 1 - 2 mg/kg/day orally 200 mg bid up to qid orally 1 - 2 mg IVI weekly 375 mg/m2 IVI weekly 3 - 10 mg/kg/week subcutaneously

Cyclophosphamide Danazol Vincristine Rituximab Romiplostim

Duration 2 - 3 weeks, then tapered over 4 - 6 weeks 4 days 3 days 1 - 2 days 3 - 5 days Maximum dose 150 mg/day Minimum 4 weeks Up to or >4 months if necessary At the discretion of the clinician Up to a total of 6 mg 4 weeks >1 year

IVI = intravenous infusion; IV Ig = intravenous immunoglobulin.

Platelet transfusions are reserved for patients with severe thrombocytopenia with active bleeding or recent onset of ‘red purpura’, such as oral haemorrhagic bullae. Platelet transfusion is not indicated in patients without bleeding, irrespective of the severity of the thrombocytopenia.

For emergency treatment, intravenous immunoglobulin (IV Ig) and IV/oral CS should be used in combination with platelet transfusions. Emergency splenectomy may rarely be necessary in such patients. For persistent ITP, treatment options include CS and second-line immunosuppressive agents (such as azathioprine and mycophenolate

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mofetil) as steroid-sparing drugs. If these prove unsuccessful, other second-line agents, such as cyclophosphamide, danazol and vincristine, may be considered. Alternative drugs include rituximab and thrombopoietin-receptor agonists (TPO-RAs). The choice of second-line therapies depends on the experience of the clinician, efficacy and safety of the drug, availability, cost and patient preferences. Chronic ITP refers to disease that continues for >12 months. It is likely that the patient has been on intermittent CS and/or other immunosuppressive or second-line therapy, with a variable clinical response. The three major treatment options for chronic ITP include splenectomy, TPO-RAs and rituximab. Each of these options has advantages and disadvantages and treatment must be individualised to the patient. Splenectomy is the most definitive therapy for ITP and is effective for persistent and chronic ITP after failure of CS therapy. It is recommended that splenectomy be delayed for at least 6 months (preferably 12 months) from diagnosis, as there is a chance of spontaneous remission in 5 - 11% of cases.[17] The overall response rate is 70 - 90% (complete response 50 - 60%, partial response 20 30%). The efficacy of open splenectomy and laparoscopic splenectomy is similar. However, laparoscopic splenectomy has fewer surgical complications, including less postoperative pain, earlier diet tolerance and shorter hospital stay. The risk of overwhelming post-splenectomy infection is increased 1.4-fold in the first year after the procedure. Vaccination against Streptococcus pneumoniae, Neisseria meningitides and Haemophilus influenzae is recommended 2 weeks prior to the procedure.[19,20] If relapse occurs post splenectomy, accessory splenic tissue (splenunculi) should be excluded. In two recent local studies it was indicated that splenectomy is beneficial and may be considered as the preferred second-line therapy in chronic ITP and failed CS therapy, especially in the SA public health sector.[16,21] Two TPO-RAs are currently available for use in ITP, romiplostim and eltrombopag. These agents are effective in both splenectomised and non-splenectomised patients, with a response rate of up to 88%. To maintain durable remission, treatment is usually required for months to years before discontinuation. Currently, the high cost of TPO-RAs prohibits their use in the public health sector.[22,23] Rituximab is an anti-CD20 monoclonal antibody, with an offlabel indication in patients with ITP.[24] Remission with rituximab occurs in up to two-thirds of patients but is durable in only onethird. However, the combination of rituximab and high-dose dexamethasone has shown a response rate of 71%, with a durable remission rate of 57%.[25] A higher risk of infection is anticipated with the use of rituximab. Locally, there is an increase in secondary ITP, particularly in association with HIV.[16,21] The presentation of secondary ITP is identical to that of primary ITP, except for an increased likelihood of cytopenias and association of lymphadenopathy and hepatosplenomegaly. The acute management of secondary ITP is identical to that of primary ITP, with the important proviso that the underlying cause be specifically treated (e.g. institution of antiretroviral therapy if patients are HIV-positive, removal of offending drug). With HIV, there is a potentially higher risk of infection, which may be exacerbated by immunosuppressive drugs and splenectomy. Although the duration to platelet recovery is slower in HIV-seropositive patients with ITP, the overall response to treatment is similar to that in the HIVnegative counterpart.[16] Splenectomy has been shown to be effective and safe, irrespective of the HIV status of the patient, and remains an appropriate second-line treatment for ITP.[21]

Micro-angiopathic haemolytic anaemia

Micro-angiopathic haemolytic anaemia (MAHA) encompasses a group of entities that are associated with red cell fragmentation haemolysis and thrombocytopenia (Table 4). Although MAHA may be complicated by thrombocytopenia-related blood loss, the risk of bleeding is significantly higher among patients with DIC. In contrast, bleeding is an unusual complication in thrombotic thrombocytopenic purpura (TTP), despite the thrombocytopenia often being very severe (<10 × 109/L). DIC is characterised by systemic activation of the coagulation cascade with production of microthrombi in the small vessels of multiple organs, resulting in organ dysfunction and consumption of coagulation factors and platelets.[26] It can manifest with bleeding and/or thromboembolism, depending on the rate of fibrinolysis and coagulation factor consumption relative to the compensatory production of these proteins. Causes of DIC include severe sepsis, obstetric calamities, major trauma and some malignancies (particularly acute promyelocytic leukaemia). All of these can result in systemic coagulation activation, either by exposing procoagulant proteins, or by generating procoagulant cytokines. It is diagnosed by demonstrating evidence of the following: • consumption of blood clotting factors, leading to prolongation of the INR and/or PTT, with a decreasing fibrinogen level. Fibrinogen is, however, an acute-phase reactant, and is therefore not invariably low in patients with DIC • consumption of anticoagulant molecules (such as antithrombin) • accumulation of the products of fibrinolysis (such as D-dimers) • a decreasing platelet count. The abovementioned factors are diagnostic in an appropriate clinical setting. Treatment of DIC is aimed at active management of the underlying cause, and symptomatic management of the associated organ and coagulation abnormalities. Treatment options include FFP and platelet transfusions in the event of bleeding, or low-molecularweight heparin therapy when thromboembolic phenomena predominate. The use of antifibrinolytic agents is generally not advised owing to the risk of exacerbation of the microvascular thrombotic process, but may be of benefit in patients with hyperfibrinolysis (typified by very low fibrinogen and markedly elevated D-dimer levels). The mortality rate associated with DIC is high, particularly in the presence of pronounced organ dysfunction or severe coagulopathy.

Organ dysfunction Liver disease

Coagulopathy in patients with liver disease can be difficult to differentiate from laboratory-determined DIC values. Haemostatic abnormalities due to liver disease include: • thrombocytopenia due to thrombopoietin deficiency, hypersplenism (if enlarged spleen) and possible megakaryocytic suppression (secondary to alcohol or hepatitis B or C infection) • coagulopathy due to impaired production of clotting factors by the liver, vitamin K deficiency (e.g. alcohol abuse, obstructive jaundice), production of functionally abnormal fibrinogen (dysfibrinogenaemia) • increased fibrin degradation products due to: (i) impaired hepatic clearance; and/or (ii) hyperfibrinolysis (impaired clearance of tissue plasminogen activator and decreased production of fibrinolytic inhibitors).

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Table 4. Summary of common microangiopathic haemolytic anaemias Microangiopathic entity Disseminated intravascular coagulation

Thrombotic thrombocytopenic purpura

Haemolytic uraemic syndrome

HELLP syndrome/preecclampsia

Common features Anaemia and thrombocytopenia Red cell fragmentation Deranged coagulogram (↑ INR and/or PTT, ↑ D-dimers, ↓ fibrinogen and AT levels)

Causal/risk factors Major trauma Severe infection/sepsis Obstetric accidents Select malignancies Transfusion reaction Giant haemangiomas Liver disease Severe anaemia and thrombocytopenia HIV infection Marked red cell Auto-immune disease fragmentation Drugs (clopidogrel, ± renal impairment ticlodipine, quinine) ± fever Metastatic adenocarcinoma ± fluctuating neurological Allogeneic stem cell/solid-organ manifestations transplantation ADAMSTS13 levels may be low Congenital deficiency of ADAMTS13 (rare) ++ Red cell fragmentation Shiga toxin-associated diarrhoeal illness Marked renal impairment Shigella dysenteriae Moderate anaemia and Escherichia coli thrombocytopenia (O157:H7 & O104:H4) C’3 and C’4 levels may be low in aHUS dysregulation of alternate aHUS C’ pathway Congenital factor H or I deficiency/ antibodies to factor H Anaemia and Risk of recurrence in thrombocytopenia subsequent pregnancies Red cell fragments Raised AST/ALT Hypertension Headache and visual disturbance, RUQ pain, pulmonary oedema

Management Treat underlying cause LMWH in early stages* Platelet/FFP/cryoprecipitate infusion if bleeding

Plasma exchange/infusion Corticosteroids Treat underlying cause Platelet transfusion C/I unless bleeding

Supportive measures A trial of plasma exchange (aHUS) Eculizumab (aHUS) (limited availability) Dialysis – usually for aHUS Emergency delivery by caesarean section

aHUS = atypical haemolytic uraemic syndrome; RUQ = right upper quadrant; INR = international normalised ratio; PTT = partial thromboplastin time; LMWH = low-molecular-weight heparin; AT = antithrombin; HELLP = haemolysis/elevated liver enzymes/low platelet count; ++ = moderate to severe; + = mild to moderate; FFP = fresh-frozen plasma; AST = aspartate transaminase; ALT = alanine transaminase; C’ = complement; C/I = contraindicated. *Particularly useful if the dominant clinical manifestations are thrombotic.

As there is a concomitant depletion of both pro- and anticoagulant molecules in patients with synthetic dysfunction of the liver, bleeding manifestations are often not as severe as would be anticipated from the degree of the laboratory derangements. However, associated renal dysfunction or infection can predispose to bleeding. In particular, gastrointestinal bleeding from oesophageal varices is a concern in patients with portal hypertension, requiring reduction of the portal pressure and ligation of the varices. Coagulation factor, fibrinogen and platelet replacement therapy may be needed, but caution should be exercised against liberal use of FFP in liver disease, as the plasma volume expansion may elevate portal pressure and thereby paradoxically increase the risk of variceal bleeding.[27] Bleeding due to hyperfibrinolysis, diagnosed with viscoelastic tests such as the thromboelastogram (TEG), can respond to antifibrinolytic agents, e.g. tranexamic acid.

Renal disease

Numerous haemostatic disturbances are observed in renal disease, which may predispose to a hypo- or hypercoagulable state. There is no superior pathogenic factor to determine whether a patient would be prone to bleeding or thrombosis, where the dynamics of events are often influenced by comorbid factors.[28] Tendency to bleed is caused by platelet dysfunction (due to accumulation of toxic metabolites, fibrinogen degradation products, anaemia, drugs, etc.) and decreased

FXI/XII level. Desmopressin and/or antifibrinolytics are generally effective in controlling uraemic bleeding.

Vascular defects

Acquired vascular bleeding disorders include the following: Scurvy. Vitamin C promotes peptidyl hydroxylation of procollagen, and its deficiency causes abnormal collagen formation with defective perivascular support. This predisposes to capillary fragility and mucocutaneous bleeding. Treatment is with vitamin C 200 mg daily. Henoch-Schönlein purpura. This idiopathic disorder is primarily a disease of children, but may occur at any age, and is characterised by abdominal colic, arthritis, nephritis and palpable purpura. Biopsy of the skin shows an acute immune-related vasculitis and complement/ immunoglobulin complexes. Treatment entails supportive care and steroids in more severe cases. Paraproteinaemia and amyloidosis. The mechanism of bleeding is multifactorial, including interference with coagulation factor levels/ function, impaired platelet aggregation and deposits of light chain/ amyloid fibrils in cutaneous blood vessels, with increased vessel fragility. Cryoglobulins may similarly deposit in dermal vessels and cause vasculitis and purpura. Management entails treatment of the underlying condition. Senile purpura. In the elderly there is loss of subcutaneous collagen and elastin fibres. Bruising is usually induced by minor trauma.

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Conclusion

Acquired bleeding disorders encompass a heterogeneous group of conditions with varied aetiologies. A detailed history and complete physical examination are imperative for meaningful interpretation of laboratory tests and appropriate treatment. Bleeding is often a presenting manifestation of systemic disease and therefore necessitates a multidisciplinary team approach. Acknowledgements. None. Author contributions. NA: composed subsection and co-ordinated manuscript compilation; JV: composed subsection and manuscript review; SL: composed subsection and manuscript review; MP: composed subsection and manuscript review; and SM: composed subsection. Funding. None. Conflicts of interest. None. 1. Alli N, Vaughan J, Louw S, Schapkaitz E, Mahlangu J. Inherited bleeding disorders. S Afr Med J 2018;108(1):9-15. https://doi.org/10.7196/SAMJ.2018.v108i1.13020 2. Kershaw G, Favaloro EJ. Laboratory identification of factor inhibitors: An update. Pathology 2012;44(4):293-302. https://doi.org/10.1097/PAT.0b013e328353254d 3. Lai JD, Lillicrap D. Factor VIII inhibitors: Advances in basic and translational science. Int J Lab Hematol 2017;39(Suppl 1):6-13. https://doi.org/10.1111/ijlh.12659 4. Wang M, Cyhaniuk A, Cooper DL, Iyer NN. Identification of people with acquired hemophilia in a large electronic health record database. J Blood Med 2017;8:89-97. https://doi.org/10.2147/JBM.S1360605 5. Kruse-Jarres R, Kempton CL, Baudo F, et al. Acquired hemophilia A: Updated review of evidence and treatment guidance. Am J Hematol 2017;92(7):695-705. https://doi.org/10.1002/ajh.24777 6. Oldenburg J, Zeitler H, Pavlova A. Genetic markers in acquired haemophilia. Haemophilia 2010;16(Suppl 3):41-45. https://doi.org/10.1111/j.1365-2516.2010.02259 7. Jacobson BF, Schapkaitz E, Haas S, et al. Maintenance of warfarin therapy at an anticoagulation clinic. S Afr Med J 2007;97(12):1259-1265. https://doi.org/10.7196/SAMJ.194 8. Jacobson BF, Louw S, Buller H, et al. Venous thromboembolism: Prophylactic and therapeutic practice guideline. S Afr Med J 2013;103(4):261-267. https://doi.org/10.7196/samj.6706 9. Warkentin TE, Crowther MA. Reversing anticoagulants both old and new. Can J Anaesth 2002;49(6):S11-S25. 10. Levy JH, Douketis JD, Weitz JI. Reversal agents for non-vitamin K antagonist oral anticoagulants. Nat Rev Cardiol 2018 (epub ahead of print). https://doi.org/10.1038/nrcardio.2017.223 11. Cines DB, McMillan R. Pathogenesis of chronic immune thrombocytopenic purpura. Curr Opin Hematol 2007;14(5):511-514. https://doi.org/10.1097/MOH.0b013e3282ba5552 12. Olsson B, Anderson PO, Jernas M, et al. T-cell mediated cytotoxicity toward platelets in chronic idiopathic thrombocytopenic purpura. Nature Med 2003;9(9):1123-1124. https://doi.org/10.1038/nm921

13. Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: Report from an international working group. Blood 2009;113(11):2386-2393. https://doi.org/10.1182/blood-2008-07-162503 14. Frederiksen H, Schmidt K. The incidence of idiopathic thrombocytopenic purpura in adults increases with age. Blood 1999;94(3):900-913. 15. Neylon AJ, Saunders PW, Howard MR, et al. Clinically significant newly presenting autoimmune thrombocytopenic purpura in adults: A prospective study of a population-based cohort of 245 patients. Br J Haematol 2003;122(6):966-974. https://doi.org/10.1046/j.1365-2141.2003.04547 16. Variava F. Immune thrombocytopenia at Chris Hani Baragwanath Academic Hospital. MMed dissertation. Johannesburg: University of the Witwatersrand, 2014. http://wiredspace.wits.ac.za/jspui/ bitstream/10539/18647/1/ITP%20at%20CHB.pdf (accessed 6 February 2018). 17. Stasi R, Stipa E, Masi M, et al. Long-term observation of 208 adults with chronic idiopathic thrombocytopenic purpura. Am J Med 1995;98(5):436-442. 18. Neunert C, Lim W, Crowther M, et al. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood 2011;117(16):4190-4207. https://doi.org/10.1182/ blood-2010-08-302984 19. Ghanima W, Godeau B, Cines D, et al. How I treat immune thrombocytopenia: The choice between splenectomy or a medical therapy as a second-line treatment. Blood 2012;120(5):960-969. https://doi. org/10.1182/blood-2011-12-309153 20. Cordera F, Hall Long K, Nagorney DM, et al. Open versus laparoscopic splenectomy for idiopathic thrombocytopenic purpura: Clinical and economic analysis. Surgery 2003;134:45-52. https://doi. org/10.1067/msy.2003.204 21. Antel KR, Panieri E, Novitzky N. Role of splenectomy for immune thrombocytopenic purpura (ITP) in the era of new second-line therapies and in the setting of a high prevalence of HIV-associated ITP. S Afr Med J 2015;105(4):408-412. https://doi.org/10.7196/samj.8987 22. Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: A double-blind randomised controlled trial. Lancet 2008;371(9610):395403. https://doi.org/10.1016/S0140-6736(08)60203-2 23. Saleh MN, Bussel JB, Cheng G, et al. Long-term treatment of chronic immune thrombocytopenic purpura with oral eltombopag: Results from the EXTEND study. Blood 2009;114(22):682 24. Auger S, Duny Y, Rossi JF, et al. Rituximab before splenectomy in adults with primary immune thrombocytopenic purpura: A meta-analysis. Br J Haematol 2012;158(3):386-398. https://doi.org/10. 1111/j.1365-2141.2012.09169 25. Ghanima W, Elstrom R, Bussel JB. The combination of three dexamethasone cycles and rituximab yields high response rate in previously treated immune thrombocytopenia (ITP). Haematologica 2011;96:95. 26. Wada H, Matsumoto T, Yamashita Y. Diagnosis and treatment of disseminated intravascular coagulation (DIC) according to four DIC guidelines. J Intens Care 2014;2(1):15. https://doi.org/doi. org/10.1186/2052-0492-2-15.2 27. Kujovich JL. Coagulopathy in liver disease: A balancing act. ASH Hematol Educ Program 2015;2015(1):243249. https://doi.org/doi.org/10.1182/asheducation-2015.1.243 28. Pavord S, Myers B. Bleeding and thrombotic complications of kidney disease. Blood Rev 2011;25:271278. https://doi.org//10.1097/01.ASN/0000081661.10246.33

Accepted 2 February 2018.

March 2018, Print edition

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

IN PRACTICE

ISSUES IN PUBLIC HEALTH

Regulating the South African sport supplement industry: â&#x20AC;&#x2DC;Wheyâ&#x20AC;&#x2122; overdue K Naidoo,1 BPharm; R Naidoo,2 PhD; V Bangalee,1 PhD 1 2

Discipline of Pharmaceutical Sciences, School of Health Sciences, Westville Campus, University of KwaZulu-Natal, Durban, South Africa Discipline of Biokinetics, Exercise and Leisure Sciences, School of Health Sciences, Westville Campus, University of KwaZulu-Natal, Durban South Africa

Corresponding author: V Bangalee (bangalee@ukzn.ac.za)

The South African sport supplement industry has experienced rapid growth in recent years. Despite the massive market demand, this industry remains poorly regulated. From raw ingredient contamination to label compliance discrepancies, the sport supplement industry is an area of growing concern and warrants further public debate. S Afr Med J 2018;108(3):166-167. DOI:10.7196/SAMJ.2018.v108i3.12961

The global sport supplement industry has experienced unprecedented growth in recent years, being equally lucrative in South Africa (SA), where it is growing at an annual rate of 7.7% (in line with the global compound annual growth rate of 6.8%).[1] Despite the massive worldwide and local demand, this industry remains poorly regulated. From raw ingredient contamination to label compliance discrepancies, the sport supplement industry is an area of growing concern. Supplementation to increase athletic performance has been documented as early as 776 BC by the Greek Olympians, who reportedly used substances such as dried figs, mushrooms and strychnine as ergogenic aids.[2] Since then, the industry has evolved, and when the International Olympic Committee (IOC) banned steroids in the 1960s, the focus shifted to enhancing athletic performance by means of supplementation. The use of supplements among athletes is well documented. The literature estimates that it ranges between 40% and 88%, depending on several factors, e.g. type of sport, culture, age and gender.[3] Currently, supplementation is no longer limited to athletes or fitness professionals. Its use has extended to those who visit the gym daily and health-conscious individuals. These people represent a major market for the sport supplement industry because of their increasing numbers and the enhanced accessibility to several sport foods and nutritional supplements.[3] Despite the various health, nutritional and immune improvement claims, the exact benefits of sport supplements have not been well established. Many sport supplements currently on the market are likely to be little more than placebos, containing either grossly under-dosed products or ingredients with no proven benefit.[3] In a largely unregulated industry, consumers who complement their diet with supposedly safe and effective supplements, may be doing so to their own detriment, particularly when these are used in high doses or without medical supervision. A 2001 study illustrated the risk that the lack of governance of the supplement industry can have on the consumer.[4] US researchers conducted a study of over-the-counter pro-hormones (legal at the time), where only 1 of 12 products was found to comply with the regulations of the Dietary Supplement Health and Education Act of 1994. One of the products even contained testosterone, a banned and controlled substance.

In 2004, a study commissioned by the IOC tested 634 non-hormonal sport supplements from 13 different countries.[5] Ninety-four of these products tested positive for anabolic androgenic agents (banned in the World Anti-Doping Agency list and regarded as controlled substances). These agents were not declared on the label and raised the question of how the contamination occurred. Similarly, such agents were also found in seemingly harmless vitamin C and magnesium preparations.[5] Contamination is believed to have been linked to production in a Chinese facility that produced prohormones. The US Food and Drug Administration (FDA) have thus far identified 767 products marketed as dietary supplements with pharmaceutical ingredients, labelled or unlabelled, included in these products. The FDA further acknowledged that these are possibly only a fraction of the hazardous products currently available.[6] The list includes the banned appetite suppressant sibutramine, erectile dysfunction agents sildenafil and tadalafil, the antidepressant fluoxetine, diuretics such as furosemide, as well as banned stimulants and steroids. The lack of control when a new dietary supplement enters the US market exposes consumers to potentially harmful products that have not been screened. Methylsynephrine (a derivative of ephedrine), methylhexanamine, pure caffeine powder and Acacia rigidula, among many other dietary ingredients, were available on the US market before mounting safety concerns led to their withdrawal. Pure caffeine powder resulted in the death of 2 teenage athletes,[7] while methylhexanamine was linked to the death of 2 US soldiers.[8] The US supplement industry represents a case study, highlighting the need for effective premarket control of dietary supplements to ensure a safer and more reputable industry. The SA Institute for Drug-Free Sport shares the abovementioned concerns in their position statement for the use of supplements by athletes. Poor consumer awareness and governance regarding the safety of these products have meant that consumer demand for these substances remains high, with little impetus for companies to change the status quo.[9] The lack of consumer awareness with regard to the supplement industry creates a false perception that products are regulated as medicines.[10] This provides supplement users with an unfounded sense of security that label claims and efficacy adherence have met premarketing control.[11]

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IN PRACTICE

SA consumers find themselves at risk owing to the lack of control in the industry.[12] A study by Opperman and Benade[13] indicated that more than half of the omega-3 fatty acid products available in SA do not adhere to label claims for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) content. Another local study commissioned by Dis-Chem tested 70 different protein products from various SA companies.[14] Local manufacturers Supplements SA and NutriTech were among the lowest rated, with discrepancies in constituent content of up to 80% less than quoted on the label. Among those that ranked highest were Dis-Chem’s house brand, Biogen, and the parent company, USN. A study conducted at an SA National Accreditation System (SANAS)-accredited facility used the Dumas method for the analyses. This method tests the total nitrogen content of a product. A major concern regarding this method is that all amino acids contain nitrogen. Manufacturers may add free-form amino acids (cheaper than protein powder) together with minimal actual protein content and obtain a favourable test result. It would be suitable to follow this up with a test of the amino acid profile of the previously tested products to ensure that the content specified by the manufacturer meets that of the product. The importance of developing research that centres on verifying label adherence of products and consequently naming the noncompliant companies represents the first step in ensuring a reputable supplement industry in the country. The Dis-Chem study highlighted the need for more stringent regulations in the sport supplement industry. Some manufacturers were able to grossly dilute protein powder, with no concern for label compliance, which is extremely concerning for consumers. In SA, the sport supplement market is expected to undergo several regulatory changes within the next few years. This is attributed to the establishment of the SA Health Products Regulatory Authority (SAHPRA), which is due to supersede the Medicines Control Council (MCC) within the next year. Among the expected changes are that products making medicinal claims (e.g. testosterone boosters, fatloss agents) will be marketed as medicines and will consequently fall under the Medicines and Related Substances Act 101 of 1965.[14] Furthermore, products falling outside of this bracket and not sold in tablet, capsule or soft-gel dosage forms are to be marketed as foods (as currently) and will be regulated under the Department of Health R429 Draft Regulations Relating to the Labelling and Advertising of Foods.[15] Such products include whey protein and other protein powder blends. The use of whey protein is particularly popular among athletes and fitness enthusiasts, as research indicates that these products may assist in decreasing body fat[16] and increasing lean muscle mass.[17] The development of the Department of Health R429 Draft Regulations Relating to the Labelling and Advertising of Foods and the concern for label compliance within the sport supplement industry therefore warrant an in-depth test to ascertain label compliance to determine, and maintain, the integrity of the supplement industry in SA. A limited number of studies have analysed the content of products to ascertain ingredient verification and relevant safety data. This can be viewed as a first step towards larger accountability by manufacturers to create a more transparent supplement industry. The advent of the Department of Health R429 Draft Regulations Relating to the

Labelling and Advertising of Foods with regard to product adherence to guideline requirements can be used to determine the readiness of the supplement industry. Furthermore, before more money is spent conducting research on the next potential ergogenic aid, adherence within the local (and international) supplement industry to label claims must be ensured to enable athletes and other individuals to safely and confidently use sport supplements. Acknowledgements. None. Author contributions. All authors contributed to the article. Funding. Research reported in this publication was supported by the Fogarty International Centre (FIC), National Institutes of Health Common Fund, Office of Strategic Coordination, Office of the Director (NIH/CF/OSC/OD), Office of AIDS Research, Office of the Director, NIH (OAR/OD/NIH), National Institute of Mental Health of the NIH (NIMH/NIH) under Award Number D43TW010131. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. Conflicts of interest. None. 1. Insight Survey. Have vitamins and supplements become essential in South Africa? 2016. http:// www.insightsurvey.co.za/blog/a-global-microcosm-the-symmetry-of-sas-vitamin-and-supplementindustry (accessed 20 September 2017). 2. Grivetti LE, Applegate EA. From Olympia to Atlanta: A cultural-historical perspective on diet and athletic training. J Nutr 1997;127(5):860S-868S. https://doi.org/10.1097/00017285-199611000-00004 3. El Khoury D, Antoine-Jonville S. Intake of nutritional supplements among people exercising in gyms in Beirut city. J Nutr Metab 2012;25:1-12. https://doi.org/10.1155/2012/703490 4. Green GA, Catlin DH, Starcevic B. Analysis of over-the-counter dietary supplements. Clin J Sport Med 2001;11(4):254-259. https://doi.org/10.1097/00042752-200110000-00008 5. Geyer H, Parr MK, Mareck U, Reinhart U, Schrader Y, Schänzer W. Analysis of non-hormonal nutritional supplements for anabolic-androgenic steroids – results of an international study. Int J Sports Med 2004;25(2):124-129. https://doi.org/10.1055/s-2004-819955 6. US Food and Drug Administartion. Tainted products marketed as dietary supplements. 2016. http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?filter=&sortColumn=5a&sd=tainted_ supplements_cder&page=1 (accessed 11 January 2018). 7. US Food and Drug Administartion. Tragic deaths highlight the dangers of powdered pure caffeine. 2014. https://blogs.fda.gov/fdavoice/index.php/2014/12/tragic-deaths-highlight-the-dangers-of-powderedpure-caffeine/ (accessed 27 September 2017). 8. Eliason MJ, Eichner A, Cancio A, Bestervelt L, Adams BD, Deuster PA. Death of active duty soldiers following ingestion of dietary supplements containing 1,3-dimethylamylamine (DMAA). Mil Med 2012;177(12):1455-1459. https://doi.org/10.7205/milmed-d-12-00265 9. South African Institute for Drug-Free Sport. Position statement of the South African Institute for DrugFree Sport. The use of supplements in sport in adults. 2011. http://www.drugfreesport.org.za/wp-content/ uploads/2016/03/SAIDS-Position-Statement-ADULTS-version4.pdf (accessed 12 September 2017). 10. Gibson JE, Taylor DA. Can claims, misleading information, and manufacturing issues regarding dietary supplements be improved in the United States? J Pharmacol Experient Ther 2005;314(3):939944. https://doi.org/10.1124/jpet.105.085712 11. Carvey CE, Farina EK, Lieberman HR. Confidence in the efficacy and safety of dietary supplements among United States active duty army personnel. BMC Comp Altern Med 2012;12(1):182. https://doi. org/10.1186/1472-6882-12-182 12. Gabriels G, Lambert M, Smith P, Hiss D. Will the new Consumer Protection Act prevent harm to nutritional supplement users? S Afr Med J 2011;101(8):543-545. https://doi.org/10.1186/s12937-015-0055-7 13. Opperman M, Benade AS. Analysis of omega-3 fatty acid content of South African fish oil supplements. Cardiovasc J Afr 2011;22(6):324-329. https://doi.org/10.5830/cvja-2010-080 14. Schönfeldt HC, Hall N, Pretorius B. Understanding label compliance of high-protein sports supplements to inform regulations. Short report. University of Pretoria. 2015. http://www.up.ac.za/media/shared/238/ final-short-report-protein_-supplements-project.zp70711.pdf (accessed 11 January 2018). 15. Department of Health, South Africa. Foodstuffs, Cosmetics and Disinfectants Act of 1972. Draft Regulations: Relating to the Labelling and Advertising of Foods. Government Gazette No. 37695, 2014. (Published under Government Gazette Notice R429.) 16. Baer DJ, Stote KS, Paul DR, Harris GK, Rumpler WV, Clevidence BA. Whey protein but not soy protein supplementation alters body weight and composition in free-living overweight and obese adults. J Nutr 2011;141(8):1489-1494. https://doi.org/10.3945/jn.111.139840 17. Kerksick CM, Rasmussen CJ, Lancaster SL, Magu B. The effects of protein and amino acid supplementation on performance and training adaptations during ten weeks of resistance training. J Strength Condition Res 2006;20(3):643. https://doi.org/10.1519/r-17695.1

Accepted 13 November 2017.

March 2018, Print edition

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

IN PRACTICE

MEDICINE AND THE LAW

Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015 T Saidi, PhD; T S Douglas, PhD Division of Biomedical Engineering, Department of Human Biology, University of Cape Town, South Africa Corresponding author: T Saidi (trust.saidi@uct.ac.za)

The Medicines and Related Substances Amendment Act 14 of 2015 has brought significant changes in the regulation of medical devices in South Africa (SA). The highlights include the establishment of a regulatory authority â&#x20AC;&#x201C; the SA Health Products Regulatory Authority â&#x20AC;&#x201C; the introduction of a tier-based licensing and registration system, and the restriction of bonusing and sampling for the sale of medical devices. The enactment of the new regulations is a positive development for the SA medical device industry. However, the impact depends on the implementation of these regulations. Conditions that will support the success of the regulations include creating a critical mass of skilled personnel and measures that ensure timely registration. SA can learn from the experiences and practices of other countries that have introduced medical device regulations in recent years. S Afr Med J 2018;108(3):168-170. DOI:10.7196/SAMJ.2018.v108i3.12820

The passing into law of the Medicines and Related Substances Amendment Act 14 of 2015, and the subsequent establishment of the South African (SA) Health Products Regulatory Authority (SAHPRA) by the SA government, are milestones for the health sector. The new regulations amend the Medicines and Related Substances Control Act 101 of 1965 and also include the provisions of the Medicines and Related Substances Act 72 of 2008.[1] Prior to the Medicines and Related Substances Amendment Act 14 of 2015, SA did not have a comprehensive regulatory framework that governed medical devices.[2] Instead, the regulation of medical devices focused on electronic products only (electromagnetic medical devices or radiation-emitting devices), which were required to be registered before being sold, leased, used, operated or applied in SA.[3] Other medical devices were left unregulated, leaving advertisers and marketers few legislative formalities with which to comply.[4] This article assesses the implications of the Medicines and Related Substances Amendment Act 14 of 2015 for the medical device landscape in SA.

Changes in the regulation of medical devices

The Medicines and Related Substances Amendment Act 14 of 2015 brings significant changes to the regulatory regimen for medical devices. It defines medical devices broadly to cover everything from disposable syringes to magnetic resonance imaging (MRI) scanners. Its far-reaching regulatory changes range from the manufacture and distribution to the import, export and wholesaling of mediumand high-risk medical devices.[5] The regulations stipulate new licensing requirements for medical devices, which apply to SA-based companies that manufacture, import, export, distribute and sell wholesale medical devices in the country.[6] They outline licence application processes for manufacturers, wholesalers or distributors of medical and in vitro diagnostic (IVD) devices, procedures for device registration and requirements relating to advertising and labelling.[7] The changes are meant to address the imbalances and gaps in the regulation of medical devices.[1] The highlights of the regulations are discussed below.

Creation of a regulatory body

One of the fundamental changes brought about by the Medicines and Related Substances Amendment Act 14 of 2015 is the establishment of a body responsible for regulatory oversight of medicines, medical devices, complementary medicines, foodstuffs, cosmetics, and related substances.[6,8,9] The Medicines Control Council (MCC) has been replaced as authority by SAHPRA, which is an organ of state outside of the public service, subject to the provisions of the Public Finance Management Act 1 of 1999.[10] SAHPRA is vested with powers to make decisions and act through its board, consisting of 10 15 members with expertise in the fields of medicine, medical devices, IVD devices, vigilance, clinical trials, good manufacturing practice, public health and epidemiology, as well as the law, good governance, financial matters and accounting, information technology and human resource management.[9] SAHPRA is empowered to register medicines, medical devices, complementary medicines, foodstuffs, cosmetics or IVD medical devices.[11] A novel function assigned to SAHPRA is to ensure the periodic re-evaluation or re-assessment and monitoring of medicines, medical devices and IVD devices. The continuous monitoring and evaluation of the safety, efficacy and performance profile of medical devices provide an opportunity for the management of risks throughout the life-cycle.[10] The new regulations empower SAHPRA to liaise with other medicine and medical device regulatory authorities or institutions globally to obtain and exchange information with regard to matters of common interest or specific investigations, and/or to enter into agreements.[7,10] The structure, powers, functions and objectives of SAHPRA, which are clarified through the provisions introduced by means of the 2008 and 2015 Amendments, are wider in scope than those of the MCC.[9]

Tier-based licensing and registration

The new regulations include a four-tier, risk-based classification system for obtaining device licences for manufacturers, importers and distributors. [6] Medical devices and IVD devices are divided into the following classes, depending on risks relating to the patient, the

March 2018, Print edition

IN PRACTICE

user or public health: Class A – low risk; Class B – low-moderate risk; Class C – moderate-high risk; and Class D – high risk. The manufacture, importation, exportation and distribution, as well as the wholesaling of medical and IVD devices, are subject to regulations, depending on the level of risk and the intended use.[6,12,13] All classes of medical devices are regulated in terms of the requirement for a medical device establishment licence, which authorises a company to manufacture, distribute or wholesale medical devices. The establishment licence precedes the registration of medical devices. Domestic manufacturers, distributors and wholesalers are required to apply for licences; foreign-based manufacturers are not.[5] It is mandatory for foreign manufacturers to provide their importers and domestic distributors with basic device information, including Global Medical Device Nomenclature codes, Certificates of Free Sale from reference countries for Class C and Class D devices, and Certificates of Free Sale or Certificates to Foreign Countries for Class B and Class D devices. [6] The 2015 Act prohibits the importation of Class B, Class C or Class D medical or IVD devices that are not registered in SA for personal use, unless authorisation is granted by SAHPRA, stating the specified period and quantity.[6,7] Manufacturers and distributors of moderate- to high-risk Class C and Class D devices and IVD devices are required to show proof of pre-market approval or registration for a medical or IVD device from at least one of the following regulatory authorities as part of their SA registration: the Australian Therapeutic Goods Administration, Brazil’s National Health Surveillance Agency (ANVISA), Health Canada, the European Competent Authority, the Japanese Pharmaceuticals and Medical Devices Agency and the US Food and Drug Administration.[12] The new regulations also have provisions for expedited registration, when the medical or IVD devices in question are in short supply, unavailable, or of national interest, or when the government invites an international tender and such medical or IVD devices are not already registered in SA.[14]

Sale and distribution of medical devices

Under the new Act, only registered products may be sold in SA.[7] The new regulation is explicit in that a manufacturer, wholesaler or distributer of medical or IVD devices is not allowed to manufacture, act as a wholesaler of, or distribute any medical or IVD device, unless it is a holder of a valid licence.[4] The definition of ‘sell’ has been broadened to include advertising, thereby making it all-encompassing.[6] The regulations forbid advertisement of any medical or IVD device, unless it complies with the prescribed requirements.[7] The preceding regulation, the Medicines and Related Substances Control Act 101 of 1965, restricted bonusing and sampling of medicines only, but the new regulations include medical and IVD devices,[4] which means that such devices cannot be supplied and sold in terms of a bonus, rebate or any other incentive scheme.

Implications of the changes

SAHPRA, by virtue of not being an organ of the state, but a selffunded, autonomous and semi-private entity at an arm’s length from the legislature, is empowered to operate without much political interference.[3] It is more independent than the MCC because it falls outside of the National Department of Health and is expected to generate the bulk of its own funding. Such a disposition enables the regulatory body to make its own decisions without being influenced and pressured by external forces. This differs from the previous regulations, which required the Minister of Health to approve new products, medical or IVD devices, resulting in the regulatory body being susceptible to political interference.[9] However, SAHPRA has

been criticised by members of the medical device industry, who are of the view that the classification of medical devices would be more appropriately determined by their manufacturers, as they are experts in the field of medical technology.[1] The Russian medical device regulator, Roszdravnadzor, experienced similar criticism, which led to the passing of a resolution in 2017, allowing medical device manufacturers in Russia to discuss with the authorities specific aspects of the regulatory process and requirements during the registration process.[15] The provision for official consulting and direct communication between manufacturers and regulatory authorities in Russia is meant to ensure transparency and mutual co-operation in the implementation of medical device regulations. The registration and licensing of medical devices by SAHPRA aims to bring into the market products that meet safety, performance and quality requirements. However, considering the previous MCC backlog of >2 000 applications awaiting registration and an average of 3 - 5 years for the registration of medicines,[16] it is likely that the addition of medical devices to the scope of SAHPRA may result in further processing delays, especially if SAHPRA’s processing capacity is not expanded substantially beyond that of the MCC. A study commissioned by the Minister of Health to investigate the slow pace at which medicines were being registered, ascribed delays to a lack of skilled human resources, poor infrastructure and inefficient regulatory processes, as well as the implementation of pro-generics policies without strengthening the regulator to handle the substantial increase in registration of applications that followed.[17] With an added load of registering medical devices, SAHPRA may fail to keep pace with its broadened mandate, as it requires a wide spectrum of expertise to assess the range of products that will need registration. Lessons can be drawn from the Brazilian regulatory body, ANVISA, which experienced significant delays in the authorisation and placing of medical devices on the market, as there were long waiting times of up to 4 years for inspections.[18] The delays presented formidable barriers in the trade of medical devices, which compelled the government to issue a new resolution in 2014, streamlining registration procedures and requirements. Under the new resolution, Class I and Class II medical devices are exempted from certification by ANVISA, but they should be produced according to good manufacturing practices, while Class III and Class IV medical devices do not have to wait for inspection of good manufacturing practices for the process of registration, revalidation or change of products to be initiated.[18,19] This is similar to the case in SA under the new regulations, where Class A medical devices, which are equivalent to Class I and Class II in Brazil in terms of risk levels, do not require a licence for manufacture, import or export. However, all classes of medical devices will be regulated, be it through the establishment licence or the registration process. The skills, knowledge and methods required to regulate medical devices and diagnostic products are different from those for medicines.[20] As SAHPRA will inherit employees from the MCC, whose expertise is in the regulation of medicines, a shortage of skilled personnel to attend specifically to medical devices is likely, unless staff recruitment is undertaken and training is put in place. Regulating medicines and medical devices under the same ambit may result in the latter being compromised. Resources permitting, the creation of a medical device and diagnostic division within SAHPRA, with dedicated and appropriately trained staff, may ensure that medical devices receive sufficient attention. In India, rules with regard to drugs were applied to medical devices, which led to burdensome regulations that delayed the development of the medical device industry.[21] This drove the country to enact the

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Medical Device Rules of 2017, which separate the regulations for medical devices from those designed for the pharmaceutical sector.[22] To speed up the process of registering medical devices, the new regulations in India make provisions for notified bodies, which are nationally accredited third-party entities licensed by the government to audit medical devices and their manufacturing sites for the verification of conformity to the quality management system and all other applicable standards.[21] The new regulations for medical devices in SA do not provide a timeframe for processing registration applications. This is likely to pose formidable challenges, bearing in mind that some devices have short life cycles owing to advances in technology. Lengthy registration processes will adversely impact the saleability of such medical devices, with some becoming obsolete pending registration. It is therefore imperative that mechanisms be put in place that ensure efficiency in the registration system to promote innovation and motivate manufacturers to register their products. Singapore, for example, in addition to setting up an expedited evaluation channel for the registration of Class C and Class D devices in 2013, has adopted a dynamic regulatory system for medical devices with less onerous requirements, lower registration costs and faster access to the market than the previous regulations.[23] The new measures that have been implemented in Singapore are attractive to international companies, which comprise the bulk of the suppliers in the country’s medical device sector. The transition from the sale of medical devices in an unregulated environment to a regulated one can be daunting. SAHPRA, as a new regulatory body, cannot successfully implement medical device regulation on its own unless it is backed by the stakeholders in the medical device industry. For example, the manufacturers possess the necessary expertise and experience to offer valuable insight into how to execute the regulations, while physicians can ensure that they prescribe medical devices that are registered.[24] Thus, the proactive engagement of different stakeholders from the medical device industry as partners in the implementation of the regulations will be beneficial. The coming into effect of the new regulations will not necessarily mean that all unregistered medical devices will disappear from the market after the transitional period. Instead, compliance will take effort and time.

Conclusion

The Medicines and Related Substances Amendment Act 14 of 2015 is a positive development in the regulation of medical devices in SA. Its impact on the medical device industry depends on implementation, and conditions must be created that are conducive to SAHPRA’s execution of its mandate. SA can learn from the examples of other countries, particularly those with similar profiles, to aid SAHPRA in its task. Acknowledgements. The authors thank staff at the Medical Device Unit of the Medicines Control Council for their feedback on the manuscript.

Author contributions. TS and TD conceived and designed the study. TS drafted and TD edited the manuscript. Both authors participated in the analysis of the literature and approval of the final article. Funding. This work is based on research supported by the SA Research Chairs Initiative of the Department of Science and Technology and the National Research Foundation of SA (grant no. 98788). Conflicts of interest. None.

1. Michael H, Mthiyane Z. Medical devices – then and (almost) now: Medical law. Without Prejudice 2016;16(5):54-57. 2. Mueller DB, Govender M, Basu D. A new horizon for the medical device sector in South Africa. S Afr Med J 2014;104(5):326. https://doi.org/10.7196/samj.7611 3. Saidi T. Towards a medical device regulation in South Africa: An assessment of the Medicines and Related Substances Amendment Act of 2015. Health Technol 2016;6(2):83-88. https://doi.org/10.1007/ s12553-016-0135-5 4. Harrison V, Krebs M. Medical devices – South Africa’s changing landscape. 2017. http://www. hlregulation.com/2017/06/05/medical-devices-south-africas-changing-landscape/ (accessed 20 August 2017). 5. Profmed. SA government to enforce the registration of domestic medical devices. 2017. http://www. profmed.co.za/News-Blog/Blog/SA-Government-Domestic (accessed 20 August 2017). 6. Medicines Control Council. Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs. Pretoria: MCC, 2016:1-10. www.mccza.com/Publications/DownloadDoc/5483 (accessed 23 January 2018). 7. South Africa. Medicines and Related Substances Amendment Act, 2015 (Act No.14 of 2015). Government Gazette No. 39585. 2016. 8. Gray A, Vawda Y. Health policy and legislation. S Afr Health Rev 2016;2016(1):3-15. 9. Rogers I, Langbridge S. Meet SAHPRA – New Regulator of Medicines, Medical Devices and IVDs. London: Lexology, 2016. 10. Kirby N. A new regulatory regime for medicines comes into force in SA. 2017. https://www.timeslive. co.za/news/2017-06-15-a-new-regulatory-br-regime-for-medicines-br-comes-into-force-in-sa/ (accessed 20 August 2017). 11. Goemans B. New South African medical device authority established. 2017. https://www. emergogroup.com/blog/2017/06/new-south-african-medical-device-authority-established (accessed 20 August 2017). 12. Eisenhart S. South African medical device regulatory system set for implementation. 2016. https:// www.emergogroup.com/blog/2016/08/south-african-medical-device-regulatory-system-setimplementation (accessed 20 August 2017). 13. Malherbe J. Long-awaited medical device regulations unpacked. 2017. https://www.medicalbrief.co.za/ archives/tag/south-african-health-products-regulatory-authority/ (accessed 20 August 2017). 14. Khan J. Regulation of medical devices in South Africa. https://www.linkedin.com/pulse/regulationmedical-devices-south-africa-jesca-khan (accessed 20 August 2017). 15. Stepanoc A. Medical device regulations in Russia and Eurasian Union. 2017. medicaldevicesinrussia. com/page/2/ (accessed 20 August 2017). 16. Gumede M. New regulator will also oversee medical devices. 2017. https://www.businesslive.co.za/ bd/national/health/2017-06-02-new-regulator-will-also-oversee-medical-devices (accessed 20 August 2017). 17. Leng HM, Sanders D, Pollock AM. Pro-generics policies and the backlog in medicines registration in South Africa: Implications for access to essential and affordable medicines. Generics Biosim Initiative J 2015;4(2):58-63. https://doi.org/10.5639/gabij.2015.0402.014 18. European Commission. Brazil – medical devices will be authorized faster. 2014. www.trade.ec.europa. eu/doclib/html/152695.htm (accessed 20 August 2017). 19. Dun M. Brazil GMP compliance for medical device companies. An overview of ANVISA quality management system requirements for companies selling in Brazil. 2015. http://scrm.kotra.or.kr/kydbm/ include/download.jsp?FILENAME=Brazil_GMP_compliance_whitepaper_Emergo_1490294941827. pdf&ATCHPATH=/was_data2/files/20170324/VC010&FILEPATH=/was_data2/files/20170324/ VC010 (accessed 20 August 2017). 20. News, Medical Chronicle. Medical devices: Regulations sorely lacking. Med Chron 2014:1-7. http://www. samed.org.za/Filemanager/userfiles/Medical_devices_Regulations_sorely_lacking_2014_03_05-1.pdf (accessed 20 August 2017). 21. Taylor NP. India adopts medical device rules, marking long-sought split from drug regulation. 2017. http://www.raps.org/Regulatory-Focus/News/2017/02/07/26772/Asia-Regulatory-Roundup-IndiaAdopts-New-Medical-Device-Regulations-7-February-2017/ (accessed 20 August 2017). 22. Andaman Medical. India: New medical device rules. 2017. http://www.andamanmed.com/india-newmedical-device-rules-2017/ (accessed 20 August 2017). 23. Gross A, Matacic C. Singapore streamlines medical device regulations. 2013. http://www.mpomag.com/issues/2013-03/view_columns/singapore-streamlines-medical-device-regulations (accessed 20 August 2017). 24. Cheng M. Medical Device Regulations: Global Overview and Guiding Principles. Geneva: World Health Organization, 2003.

Accepted 31 October 2017.

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This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

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HEALTHCARE DELIVERY

Maternal near-miss audit in the Metro West maternity service, Cape Town, South Africa: A retrospective observational study I A Iwuh,1,2 MB BS, FCOG, MMed; S Fawcus,2 MB ChB, FRCOG, MA; L Schoeman,2 MB BCh, FRCOG 1 2

Princess Marina Hospital and University of Botswana, Gaborone, Botswana Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of Cape Town, South Africa

Corresponding author: I A Iwuh (paurasi.iwuh1@gmail.com) Background. A maternal near-miss is defined as a life-threatening pregnancy-related complication where the woman survives. The World Health Organization (WHO) has produced a tool for identifying near-misses according to criteria that include the occurrence of a severe maternal complication together with organ dysfunction and/or specified critical interventions. Maternal deaths have been audited in the public sector Metro West maternity service in Cape Town, South Africa, for many years, but there has been no monitoring of near-misses. Objectives. To measure the near-miss ratio (NMR), maternal mortality ratio (MMR) and mortality index (MI), and to investigate the nearmiss cases. Methods. A retrospective observational study conducted during 6 months in 2014 identified and analysed all near-miss cases and maternal deaths in Metro West, using the WHO criteria. Results. From a total of 19 222 live births, 112 near-misses and 13 maternal deaths were identified. The MMR was 67.6 per 100 000 live births and the NMR 5.83 per 1 000 live births. The maternal near-miss/maternal death ratio was 8.6:1 and the MI 10.4%. The major causes of near-miss were hypertension (n=50, 44.6%), haemorrhage (n=38, 33.9%) and puerperal sepsis (n=13, 11.6%). The first two conditions both had very low MIs (1.9% and 0%, respectively), whereas the figure for puerperal sepsis was 18.9%. Less common near-miss causes were medical/surgical conditions (n=7, 6.3%), non-pregnancy-related infections (n=2, 1.8%) and acute collapse (n=2, 1.8%), with higher MIs (33.3%, 66.7% and 33.3%, respectively). Critical interventions included massive blood transfusion (34.8%), ventilation (40.2%) and hysterectomy (30.4%). Considering health system factors, 63 near-misses (56.3%) initially occurred at a primary care facility, and the patients were all referred to the tertiary hospital; 38 (33.9%) occurred at a secondary hospital, and 11 (9.8%) at the tertiary hospital. Analysis of avoidable factors identified lack of antenatal clinic attendance (11.6%), inter-facility transport problems (6.3%) and health providerrelated factors (25.9% at the primary level of care, 38.2% at secondary level and 7.1% at tertiary level). Conclusions. The NMR and MMR for Metro West were lower than in other developing countries, but higher than in high-income countries. The MI was low for direct obstetric conditions (hypertension, haemorrhage and puerperal sepsis), reflecting good quality of care and referral mechanisms for these conditions. The MIs for non-pregnancy-related infections, medical/surgical conditions and acute collapse were higher, suggesting that medical problems need more focused attention. S Afr Med J 2018;108(3):171-175. DOI:10.7196/SAMJ.2018.v108i3.12876

In the past decade, maternal near-miss audits have been introduced as an additional method for monitoring maternal health outcomes. A maternal near-miss describes a life-threatening event or complication occurring during pregnancy or within 42 days after the end of the pregnancy that may lead to acute severe morbidity, but not to death. The near-miss ratio (NMR) is measured per 1 000 live births.[1] Life-threatening conditions (LTCs) are defined as severe pregnancy-related complications that cause organ dysfunction and/ or require major interventions and may result in maternal death. LTCs lead to severe maternal outcomes that include both near-misses and deaths. Globally, much attention has been directed towards reducing maternal mortality, with the Millennium Development Goals and now the Sustainable Development Goals. The latter has the target of ending preventable maternal mortality by reducing the maternal mortality ratio (MMR) by two-thirds by 2030.[2,3] The Confidential Enquiry into Maternal Deaths in South Africa (SA) was introduced in 1998, and triennial reports show the MMR

to be much higher than in developed countries, but slightly lower than the average for sub-Saharan Africa.[4,5] The most recent triennial report shows that the institutional MMR, after an initial steep rise from 150 per 100 000 in 1998, decreased from 176.2 per 100 000 in 2008 - 2010 to 154.1 in 2011 - 2013.[6] The five main causes of maternal mortality in SA for 2011 - 2013 were non-pregnancy-related infections, including HIV-related infections such as tuberculosis and pneumonia (34.7%), obstetric haemorrhage (15.8%), hypertension (14.8%), medical and surgical disorders (11.4%) and pregnancyrelated sepsis (5.2%). Near-miss audits have become part of ongoing monitoring systems in many well-resourced countries, and are now being introduced in several poorly resourced settings. In the UK, where the MMR is <10 per 100 000 live births, there is an ongoing national surveillance system (the United Kingdom Obstetric Surveillance System) that measures and monitors all cases with severe acute maternal morbidity (near-misses). This includes obstetric conditions such as eclampsia, obstetric haemorrhage, pulmonary embolism and

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peripartum cardiomyopathy.[7] One of the first near-miss audits to be performed in a lower-resourced setting was conducted by Mantel et al.[8] in Pretoria in 1998. There have been several near-miss audits in different settings, which have used various definitions of near-miss based on clinical criteria and/or organ dysfunction-based criteria and/or interventionbased criteria.[9-12] In order to standardise definitions of near-misses as well as audit them, the World Health Organization (WHO) developed a very useful tool to assist countries and facilities to set up their own near-miss audits.[13] It includes clear definitions, as well as near-miss data collection forms that can be adapted to local settings. Audits of maternal near-misses give the healthcare system the opportunity to improve insight into issues surrounding quality of care, because near-misses are more frequent than maternal deaths. [14] An indicator called the mortality index (MI) (maternal deaths expressed as a percentage of total numbers of LTCs) is a useful indicator of quality of care.[13,14] When a woman experiences an LTC and survives, practitioners are able not only to identify the positive or negative components of her care, but also to elucidate any difficulties she experienced in seeking care or lack of understanding she had of her health problems.[15] In the Metro West maternity service of Cape Town, SA (formerly the Peninsula Maternal and Neonatal Service), maternal mortality has been systematically monitored since 1953, but there has been no system of measuring and monitoring near-misses.[16]

Objectives

To identify all women with life-threatening obstetric conditions and estimate the NMR, MMR and MI, to identify the severe maternal complications causing the near-misses and maternal deaths, and to perform an in-depth investigation of the near-miss cases for demographic characteristics, clinical factors and avoidable factors occurring in the health system. It was anticipated that the process of conducting this study could provide input to the future development of an ongoing system for monitoring near-misses in Metro West.

Methods

A retrospective observational study was conducted over 6 months between mid-March 2014 and mid-September 2014 in the Metro West maternity service. This service includes nine primary care maternity facilities (midwife obstetric units), which refer all complicated maternal cases to two secondary hospitals, New Somerset Hospital and Mowbray Maternity Hospital, or to the maternity centre at the tertiary hospital, Groote Schuur Hospital (GSH). The sample size was calculated from a practical estimate of 38 000 deliveries per year in Metro West, with an average of 20 - 30 maternal deaths per annum. We used a presumed MI of 10%, which would give a figure of at least 100 women with LTCs during a 6-month period. All near-miss cases managed at the three hospitals were identified weekly by the author, with the assistance of on-site healthcare providers. These cases included near-misses that occurred at primary care facilities and were referred to one or more of the three hospitals. Strict criteria were used to ascertain a case as a near-miss according to the following WHO criteria:[13] (i) the woman sustained a near-miss-defining severe maternal complication such as eclampsia or a ruptured uterus; or (ii) the woman had a severe maternal complication that was insufficient to classify it as a near-miss on its own, but had in addition one or more specified organ dysfunctions, and/or one or more defined critical interventions. The folders of all the near-misses were reviewed and relevant data were entered into a data collection form adapted from the WHO

near-miss form. In addition, the folders were reviewed by two senior obstetric specialists to confirm adherence to the WHO inclusion criteria for near-miss classification, and also to determine avoidable factors in the management of the near-miss cases. The classification of avoidability was done using the criteria used for assessing maternal deaths by the National Committee for Confidential Enquiry into Maternal Deaths, which grouped them into patient-related, administrative and health provider-related factors.[4,5] Maternal deaths occurring during the time period of the nearmiss audit were identified from monthly mortality meetings and the ongoing maternal mortality audit system in Metro West. Live births occurring during the study period in all the 12 facilities of Metro West were obtained from the hospital information system CLINICOM and routinely measured perinatal statistics, for the denominator in measuring ratios.

Results

A total of 112 maternal near-miss cases and 13 maternal deaths in the Metro West maternity service were identified between 15 March 2014 and 15 September 2014. There was therefore a total of 125 women with severe maternal outcomes. There were 19 524 deliveries and 19 222 live births in Metro West maternity facilities during the same time period. Table 1 shows the maternal near-miss indicators. The NMR was 5.83 near-miss cases per 1 000 live births, and the MMR was 67.6 maternal deaths per 100 000 live births. The maternal near-miss/maternal death ratio was 8.6:1 and the MI was 10.4%. Note that these indicators refer to mortality and morbidity in the facilities of Metro West and are institutional ratios. Table 2 shows sociodemographic characteristics of the women with near-misses. Most of the women lived in low-income and high-density areas of Cape Town, with the largest proportions from Gugulethu (38.4%) and Mitchell’s Plain (24.1%). The majority of the women (88.4%) had booked for antenatal care. Twentyfive (22.3%) of the women were HIV-positive. Table 3 presents the clinical complications causing the nearmisses and maternal deaths, and the MI for each complication. Hypertension, obstetric haemorrhage and pregnancy-related sepsis were the most frequent clinical complications causing the nearmisses, accounting for 50 (44.6%), 38 (33.9%), and 13 (11.6%), respectively. Hypertension and haemorrhage had very low Mis of 1.9%, and 0%, respectively, while for pregnancy-related sepsis the figure was higher at 18.9%. Less common conditions causing near-misses were medical/surgical conditions, non-pregnancy-related infections and acute collapse, accounting for 7 (6.3%), 2 (1.8%), and 2 (1.8%) near-misses, respecTable 1. Near-miss and maternal death rates and ratios Near-miss indicator NM cases, n MDs, n Total deliveries, N Live births, n NMR* MMR† SMOR‡ NM/MD ratio MI§

112 13 19 524 19 222 5.83 67.6 6.5 8.6:1 10.4%

NM = near-miss; MD = maternal death; NMR = near-miss ratio; MMR = maternal mortality ratio; SMOR = severe maternal outcome ratio; MI = mortality index. *NMR = NMs/live births × 1 000. † MMR = MDs/live births × 100 000 live births. ‡ SMOR = MDs + MNMs/live births × 1 000. § MI = MDs/MNMs + MDs × 100%.

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tively. Although the numbers were small, these three conditions accounted for proportionately more maternal deaths, with MIs of 66.7%, 33.3% and 33.3% for non-pregnancy-related sepsis, medical/ surgical conditions and acute collapse, respectively. Organ dysfunction occurred in 52 (46.4%) of the 112 nearmisses; 30 women had dysfunction of one organ and 22 dysfunction of two or more. The most common organ dysfunctions were circulatory and respiratory, occurring in 36.6% and 22.3% of nearmisses, respectively. Other organ dysfunctions were renal (13.4%), coagulation (9.8%) and neurological (3.6%). Table 4 shows that the 112 women with near-misses underwent 141 critical interventions (some women had more than one). These included 39 women (34.8%) who had massive blood transfusion (>5Â units of red cells), 34 (30.4%) who had a hysterectomy, 45 (40.2%) who required intubation and ventilation, and 23 (20.5%) who were admitted to the tertiary hospital main intensive care unit. Of note, 19 (50.0%) of women with near-misses from haemorrhage and all 13 with near-misses from pregnancy-related sepsis had a hysterectomy. In terms of health system factors, 63 (56.3%) of the near-misses initially occurred at a primary care facility, and were all referred to the tertiary hospital (GSH); 38 (33.9%) of near-misses initially occurred at the secondary hospitals and 11 (9.8%) at the tertiary hospital (GSH). Table 5 shows the referral patterns: all near-misses occurring at primary care were referred to the tertiary hospital, and 26 of the 38 occurring at the secondary hospitals were referred to the tertiary hospital. Table 2. Sociodemographic characteristics of the patients with near-misses (N=112) Parameter Age (years) <18 18 - 34 â&#x2030;Ľ35 Parity 0 1-4 5 Booking status Booked Unbooked HIV status Positive Negative Unknown

n (%) 4 (3.6) 95 (84.8) 13 (11.6) 46 (41.1) 65 (58.0) 1 (0.9)

Critical intervention Blood transfusion Hysterectomy Ventilation ICU admission

n (%) 39 (34.8) 34 (30.4) 45 (40.2) 23 (20.5)

ICU = intensive care unit.

Table 5. Referral patterns of the patients with near-misses (N=112) Route Primary to tertiary Secondary to tertiary Occurred in tertiary

n (%) 63 (56.3) 26 (23.2) 11 (9.8)

Table 6. Patient-related and administrative avoidable factors in near-miss cases (N=112)* n (%)

99 (88.4) 13 (11.6) 25 (22.3) 85 (75.9) 2 (1.8)

Near-misses, n (%) 50 (44.6) 38 (33.9) 13 (11.6) 7 (6.3) 2 (1.8)

Maternal deaths, n 1 0 3 4 4

Mortality index (%) 1.9 0 19 33.3 66.7

2 (1.8) 112

1 13

33.3 10.4

Table 4. Critical interventions in the patients with nearmisses (N=112)

Primary = midwife obstetric unit; secondary = Mowbray Maternity Hospital or New Somerset Hospital; tertiary = Groote Schuur Hospital.

Table 3. Clinical complications causing near-misses and maternal deaths Causes Hypertension Obstetric haemorrhage Pregnancy-related sepsis Medical/surgical Non-pregnancy-related infection Acute collapse Total

Avoidable factors were classified into patient-related, administrative and healthcare provider-related factors according to the system used in the SA Saving Mothers reports.[4,5] These were identified by the two specialist obstetricians who reviewed the near-miss folders. Table 6 shows that there was a high proportion of cases in which no patient-related or administrative avoidable factors were identified: 78.6% and 81.3%, respectively. Avoidable factors that occurred frequently in these two categories were lack of antenatal clinic attendance and inter-facility transport problems (particularly from primary level to tertiary hospital). Table 7 shows the problems in clinical management by healthcare providers at different levels of care. Most avoidable factors were identified at secondary hospitals (n=25, 65.8%), followed by primary (n=21, 33.3%) and tertiary level (n=10, 90.1%). Sub-standard care was the most common healthcare provider-related factor at secondary

Patient-related factors Lack of information No avoidable factor No antenatal care Infrequent antenatal care Delay in accessing medical help Community problem Administrative factors Lack of information No avoidable factor Transport problems (institution to institution) Delay in initiating care due to overburdened services (e.g. long queues, competing emergencies) Lack of accessible healthcare facilities Lack of available healthcare provision (ICU, blood products) Lack of appropriately trained staff ICU = intensive care unit. *More than one factor applied in some cases.

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2 (1.8) 88 (78.6) 13 (11.6) 7 (6.3) 2 (1.8) 1 (0.9) 2 (1.8) 91 (81.3) 7 (6.3) 4 (3.6)

1 (0.9) 3 (2.7) 3 (2.7)

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Table 7. Healthcare provider-related factors for near-misses at different levels of care Factors involved Not managed at this level Lack of information No factor identified Initial assessment Problem recognition Delay in referring Managed at inappropriate level Wrong diagnosis Substandard care (delay in initiating appropriate treatment) Monitoring problems Total

Level 1 11 (17.5) 4 (6.3) 31 (49.2) 2 (3.2) 5 (7.9) 1 (1.6) 0 2 (3.2) 2 (3.2) 5 (7.9) 63

hospitals. Examples were delayed intervention for prolonged labour, and inadequate monitoring resulting in the discovery that a patient was in shock a few hours after delivery. At primary care level, the most frequent avoidable factors were poor problem recognition and inadequate monitoring. At tertiary level, the main avoidable factor was delay in initiating appropriate treatment (e.g. delay in starting magnesium sulphate and planning delivery when eclampsia was imminent).

Discussion

The current study used the WHO near-miss audit tool for defining and investigating near-misses, as well as calculating rates and ratios.[13] However, we adapted the WHO list of severe maternal complications to include the additional categories of acute collapse/ thromboembolism, non-pregnancy-related infections and medical/ surgical disorders. The WHO criteria for organ dysfunction and critical interventions were strictly followed in order to identify cases as near-misses. We added a section to the audit tool that enabled a quality of care assessment by two independent specialists who evaluated cases for avoidable factors. These modifications of the WHO audit tool appeared to add value to the data and could be considered when the WHO near-miss audit tool is next updated. In our setting we were able to apply the WHO criteria for ascertaining near-misses because of ready availability of laboratory services for evaluating organ failure and sufficient access to lifesaving interventions such as blood products and intensive care. In many poorly resourced settings these are not available, which would limit the identification of near-miss cases.[17] A recent near-miss study in Tanzania modified the WHO criteria to be more reliant on clinical criteria and less on stringent laboratory criteria and intervention criteria (e.g. 2 units of blood rather than 5 units).[18] This modification may be relevant for poorly resourced settings. Our study identified 13 maternal deaths and 112 maternal nearmisses. The NMR was 5.83 per 1 000 live births, which is comparable to studies in Pakistan, India and Baghdad, with rates of 8.6, 4.4 and 5.06, respectively.[19-21] Our NMR was higher than in several developed countries, such as Canada, the UK and Scotland, where the NMR was 0.7, 1.2 and 1.34 per 1 000, respectively.[20] Possible explanations for this finding are the higher proportion of women in our study population living in poverty, a higher prevalence of HIV, and a less well developed health system. A study in the USA had an MMR of 6.5 deaths per 100 000 live births, which is 10 times lower than the MMR in our study.[11] However, the NMR was 8.1 per 1Â 000, which is higher than the NMR of 5.83 in our study. A possible

Level 2 12 (31.6) 1 (2.6) 1 (2.6) 1 (2.6) 3 (7.9) 0 0 3 (7.9) 10 (26.3) 7 (18.4) 38

Level 3 0 2 (18.2) 1 (9.1) 0 0 0 1 (9.1) 0 4 (36.4) 3 (27.3) 11

explanation could be that lowering of MMRs may translate to a high NMR because women who survived but almost died will join the pool of women who end up as near-misses. The severe maternal outcome ratio of 6.5 per 1 000 in our study is similar to the rate of 5 per 1 000 found in a recent population-based study in Pretoria, SA.[22] Our study found an overall MI of 10.4%, which is slightly lower than those in the Pretoria study, which had an overall MI of 14%,[22] and the Pakistan and Baghdad studies, with MIs of 12 % and 11%, respectively.[19,21] Our MI was very low for hypertensive disorders (1.9%) and haemorrhage (0%), and higher for pregnancy-related sepsis (18.9%). The Pretoria study also had a low MI for haemorrhage of 2%,[22] whereas in Pakistan it was much higher at 17.2%.[19] An audit in Johannesburg on morbidity and mortality from obstetric haemorrhage in caesarean deliveries showed an MI of 7% (93 near-misses and 7 maternal deaths),[23] and although our study did not focus on morbidity/mortality from caesarean deliveries, we found a caesarean section rate of 62.5% and 33.9% of near-misses due to obstetric haemorrhage, with an MI of 0%. The lower MI in SA studies could reflect better prevention and/or management of obstetric haemorrhage in SA. Similarly, the MI for hypertensive disorders in our study was found to be low, at 1.9%; this is lower than the Pretoria studyâ&#x20AC;&#x2122;s MI of 13.6%.[22] The relatively low MIs for direct obstetric conditions in the Metro West maternity service compared with other low-resource settings reflect reasonable quality of care and a functional health system. There are clear referral guidelines, and the levels of care in the maternity system are interconnected via clinical outreach and a wellestablished system of clinical governance and emergency transport. There are also regular mortality meetings and in-service training at all levels of care. Clear protocols exist for prevention and management of obstetric emergencies. These are particularly effective for obstetric haemorrhage and eclampsia/severe pre-eclampsia, where clinical management tends to be aggressive. The tiered system of care allows the tertiary level to provide critical individualised care for very sick women. Of note, 56.3% of near-misses occurred at primary care facilities and were referred timeously to tertiary level. The Pretoria study had a corresponding figure of 39.3%.[21] However, in terms of avoidable factors, our study showed that 26.3% of the near-miss cases at secondary level had substandard care, while 36.4% of the near-miss cases at tertiary level had substandard care. These findings are consistent with the findings in another recent study in Pretoria[24] looking at the barriers to obstetric care in maternal near-miss cases, where 36% were found to have received substandard care.

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The high MIs associated with medical disorders and acute collapse (33.3% and 33.3%, respectively) in our study are consistent with other studies,[19,21,22] but our MI for non-pregnancy-related infections was very high at 66.7%, reflecting the disease burden of the HIV epidemic in SA. These high MIs suggest that these conditions need more focused attention, although their numbers as causes of deaths and near-misses were probably too small to draw conclusions. Notably, with regard to AIDS-related infection, recent policies and clinical management protocols show extended scope and coverage. A significant reduction in HIV-related maternal mortality is the major reason for SA’s recent fall in MMR.[6] Despite the results showing comparatively low MIs in Metro West there is still considerable room for improvement, as evidenced by the description of healthcare provider avoidable factors for near-misses. Study limitations The study was only done over a 6-month period, so the numbers were not sufficient to compare maternal deaths with near-misses or to draw conclusions about the less common causes of near-misses. In addition, risk factors for near-misses could not be identified because background demographic and clinical data were not available for the whole obstetric population during the study period. The lack of population data also meant that comparisons of near-miss rates in different areas of Cape Town could not be calculated The study design did not enable in-depth interviews of the women with near-misses about factors related to social determinants and their experiences of accessing and receiving care, as has been done in some settings.[15] We also did not do any medium- or long-term follow-up of the women with near-misses to assess the impact of the severe morbidity on their subsequent physical and emotional wellbeing, which could have been considerable.

Conclusions

The NMR and MMR in Metro West were lower than in some other developing countries, but higher than rates in high-income countries. The most common conditions resulting in near-misses were obstetric haemorrhage, hypertensive disorders and pregnancy-related sepsis, but the MIs for these conditions were low, reflecting good quality of care and referral mechanisms for these conditions. The MIs for non-pregnancy-related infections, medical/surgical conditions and acute collapse were much higher, suggesting that medical problems may need more focused attention. The barriers to obstetric care are the avoidable factors at all three levels and substandard care, which seem to be common problems. The study showed that the WHO near-miss audit tool was effective for measuring severe maternal morbidity and quality of care in the Metro West maternity facilities. Near-miss auditing was found to be feasible, and ongoing routine audits would be valuable for the Metro West maternity service. This would require institutionalisation of the near-miss identification and monitoring systems.

Acknowledgements. We thank the staff of Metro West for assisting with identification of cases and Dr Greg Petro for assisting with statistics. Author contributions. IAI and SF developed the proposal. IAI performed the research with input from SF and LS for assessing folders for substandard care. IAI did the final write-up, assisted by SF. Funding. None. Conflicts of interest. None. 1. Pattinson R, Say L, Souza J, van den Broek N, Rooney C. WHO Working Group on Maternal Mortality and Morbidity Classification. Bull World Health Organ 2009;87(10):734-734. https://doi.org/10.2471/ BLT 0.9.071001 2. UNICEF. Millennium Development Goals, 2010. unicef.org/mdg/maternal.html (accessed 14 February 2018). 3. World Health Organization. Target and Strategies for Ending Preventable Maternal Mortality. Geneva: WHO, 2014. 4. Theron GB. Saving Mothers: Report on the Confidential Enquiries into Maternal Deaths in South Africa S Afr Fam Pract 2000;2(7):5-http://www.safpj.co.za/index.php/safpj/article/view/2134/2698 (accessed 14 February 2018). 5. Pattinson RC, ed. Saving Mothers: Fifth report on Confidential Enquiries into Maternal Deaths in South Africa 2008 - 2010. Pretoria: National Department of Health, 2012. http://sanac.org.za/wpcontent/uploads/2015/12/Report_on_Confidential_Enquiries_into_Maternal_Deaths_in_South_ Africa.pdf (accessed 14 February 2018). 6. Gebhardt GS, Fawcus S, Moodley J, Farina Z. Maternal death and caesarean section in South Africa: Results from the 2011 - 2013 Saving Mothers Report of the National Committee for Confidential Enquiries into Maternal Deaths. S Afr Med J 2015;105(4):287-291. https://doi.org/10.7196/SAMJ.9531 7. Sarris I, Bewley S, Sangeeta A, Oxford Specialty Training in Obstetrics and Gynecology. New York: Oxford University Press, 2009:298, Maternal collapse, box 10.1. 8. Mantel GD, Buchmann E, Rees H, Pattinson RC. Severe acute maternal morbidity: A pilot study of a definition of a near miss. Br J Obstet Gynaecol 1998;105(9):985-990. 9. Fitzpatrick C, Halligan A, Phelan D. Near miss maternal mortality. Ir Med J 1992;85(1):37. 10. Ronsmans C. Severe acute maternal morbidity in low income countries. Best Pract Res Clin Obstet Gynecol 2009;23(3):305-331. https//doi.org/10.1016/i.bpobgyn.2009.01.001 11. Kuklina EV, Meikle SF, Jamieson DJ, Whiteman MK, Barfield WD, Hills SD. Severe obstetric morbidity in the United States 1998 - 2005. Obstet Gynecol 2009;113(2 pt 1):293-299. https://doi.org/10.1097/ AOG.0b013e3181954e5b 12. Olufemi T Oladapo, Adewale O, Adetola O, Olusoji J. Near-miss obstetric events and maternal deaths in Sagamu, Nigeria. Reprod Health 2005;2:9. https://doi.org/10.1186/1742-4755-2-9 13. World Health Organization. Evaluating the quality of care for severe pregnancy complications: The WHO near-miss approach for maternal health. 2011. http://www.who.int/reproductivehealth/ publications/monitoring/9789241502221/en/ (accessed 14 February 2018). 14. Souza JP, Cecatti JG, Haddad SM, et al. The WHO maternal near miss approach and the maternal severity index model: Tools for assessing the management of severe maternal morbidity; PLoS One 2012;7(8):e44129. https://doi.org/10.1371/journal.pone.0044129 15. Hinton L, Locock L, Knight M. Experience of quality of care of women with near miss maternal morbidities in the UK. Br J Obstet Gynecol 2014;121(Suppl 4):20-23. https://doi.org/10.1111/14710528.12800 16. Fawcus SR, van Coeverden de Groot HA, Isaacs S. A 50 year audit of maternal mortality in the Peninsula maternal and neonatal service, Cape Town (1953 - 2002). BJOG 2005;112(9):1257-1263. https://doi.org/10.1111/j.1471-0528.2005.00601.x 17. Van den Akker T, Beltman J, Leyten J, Mwagomba B Meguid T. The WHO maternal near miss approach: Consequences at Malawian district level. PLoS One 2013;8(1):e54805. https://doi.org/10.1371/journal. pone.0054805 18. Nelissen E, Mduma E, Broerse J, et al. Applicability of WHO maternal miss criteria in a low-resource setting. PLoS One 2013;8(4):e61248 https://doi.org/10.1371/journal.pone.0061248 19. Mushtapha R, Hashmi H. Near miss obstetrical events and death. J Coll Physicians Surg Pak 2009;19(12):781-785. https://doi.org/12.2009/JCPSP.781785 20. Chhabra P. Maternal near miss, an indicator for maternal health and maternal care. Indian J Community Med 2014;39(3):132-137. https://doi.org/10.4103/0970-0218.137145 21. Jabir M, Abdul-Salam I, Suheil DM, et al. Maternal near miss and quality of maternal Care in Baghdad. BMC Pregnancy Childbirth 2013;13:11. https://doi.org/10.1186/1471-2393-13-11 22. Soma-Pillay P, Pattinson RC, Langa-Mlambo L, Nkosi BSS, Macdonald AP. Maternal near miss and maternal death in the Pretoria Academic Complex, South Africa: A population-based study. S Afr Med J 2015;105(7):578-583. https://doi.org/10.7196/SAMJnew.8038 23. Maswine TS, Buchmann E, Near-miss maternal morbidity from severe haemorrhage at caesarean section: A process and structure audit of system deficiencies in South Africa. S Afr Med J 2017;107(11):1005-1009. https://doi.org/10.7196/SAMJ.2017.v107i11.12340 24. Soma-Pillay P, Pattinson RC. Barriers to obstetric care by maternal near-misses: A descriptive study. S Afr Med J 2016;106(11):1110-1113. https://doi.org/10.7196/SAMJ.2016.v106i11.10726

Accepted 6 November 2017.

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This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

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Mental illness in the Western Cape Province, South Africa: A review of the burden of disease and healthcare interventions N Jacob, MB ChB, FCPHM, MMed (Public Health Medicine); D Coetzee, BA, MB BCh, DTM&H, FFCH (SA), MS (Epidemiology) Western Cape Government: Health, Cape Town; and School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa Corresponding author: N Jacob (nisha.jacob@uct.ac.za)

Neuropsychiatric disorders were ranked third as contributors to disability-adjusted life-years in South Africa (SA). Despite this high morbidity, mental health is often overlooked on the public health agenda. This article reviews evidence on the burden of mental illness in the Western Cape Province of SA, as well as current provincial interventions to decrease the burden of mental illness. Available evidence supports the need for improved integration of mental health services in primary healthcare and strengthening of community services. Challenges include a lack of capacity due to staff shortages and inadequate availability and allocation of resources. Evidence from large epidemiological studies to quantify the burden of disease as well as cost-effectiveness studies of interventions are required to successfully plan and implement interventions. Similar reviews may provide a national overview of mental health issues as well as allow improvement through better understanding of research and best practices in various provinces. S Afr Med J 2018;108(3):176-180. DOI:10.7196/SAMJ.2018.v108i3.12904

Mental health has a major impact on health at both individual and population level. The recent national tragedy resulting in the death of more than 94 mental healthcare users in Gauteng Province, South Africa (SA), has cast a spotlight on public mental healthcare and associated systemic inadequacies. Based on the revised national disability-adjusted life-year (DALY) estimates from the SA National Burden of Disease Study,[1] neuropsychiatric disorders were ranked third, after HIV/AIDS and other infectious diseases, as contributors to the burden of disease, surpassing other non-communicable diseases (NCDs).[1] Globally, there is an increasing recognition of mental illness. In 2007, the Western Cape Provincial Department of Health embarked on the Burden of Disease Reduction Project.[2] A Mental Health Workgroup (MHW) was established to make recommendations on interventions to reduce the burden of mental illness in the province. Although a large focus of the report was on interventions addressing upstream determinants of health, downstream service interventions were also proposed. In this review, we briefly assess evidence regarding the current burden of mental illness in the Western Cape as well as service-related interventions that have been implemented following recommendations from the 2007 MHW.

Methods

Evidence for this review was obtained from a comprehensive literature review and interviews with 10 key mental health experts in the province, including programme managers, psychiatrists and members of the provincial Mental Health Policy Working Group. The main search engines used were PubMed and Google Scholar. Key search terms included ‘mental health’ AND ‘South Africa’ AND ‘Western Cape’ AND ‘prevalence mental illness’ AND ‘mental health interventions’. All relevant articles published in English from 1990 to 2015 were included. Reference lists were scanned further. Unpublished literature, including provincial reports, was sourced from key stakeholders. Only key references are presented in this article.

Review findings

The burden of mental illness

The burden of mental illness can be assessed within four major categories, viz.: 1. Prevalence or incidence of mental illness 2. Risk factors for mental illness 3. Consequences in terms of DALYs 4. Social and economic costs. In the Western Cape, there are currently limited reliable data on the burden of mental illness. The only routine mental health indicators at primary healthcare (PHC) services are the number of mental health clients aged <18 years and ≥18 years. These data are obtained mainly from mental health nurses at primary-level facilities and are likely to capture only individuals with serious mental illness who are referred to mental health nurses. Patients with more common, less severe mental illness are not likely to be included in mental health service data. There are also no indicators on substance use. Data on psychiatric admissions and 90-day readmission rates are collected at secondary and tertiary levels of care. There are limited epidemiological studies quantifying the burden of mental illness in the Western Cape and in SA at large. The available data are summarised below. Prevalence and incidence Adults The South African Stress and Health Survey (SASH) conducted in 2004 remains the main source of mental health prevalence data for SA.[3] This study was the first large-scale population-based study of common mental disorders in SA.[3] It showed that the 12-month prevalence of common mental disorders among SA adults was 16.5%, that the lifetime prevalence for any disorder was 30.3%, and that the Western Cape had the highest 12-month and lifetime prevalence in SA (39.4%).[3] In the Western Cape, the prevalence of anxiety disorders was 18.9%, that of mood disorders 13.7% and that

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of substance use disorders 20.6%.[3] Confidence intervals for these proportions were not made available. When stratified by province, the sample sizes for the SASH study were small and subject to random error. Another limitation of the study was the exclusion of individuals with psychotic disorders, which meant that the overall lifetime prevalence of mental disorders was underestimated. Although a relatively small proportion of the population is affected by these disorders, they have a major impact on health services. Suicide data are often used as a proxy for mental illness burden, since ~90% of people who commit suicide have a psychiatric disorder at the time of their death.[2] Suicide accounted for ~11% of all unnatural deaths in 2012,[4] although suicide figures in isolation are a gross underestimation of underlying mental disorders.[2] The 2007 MHW recommended that mortality data on injuries may be a more appropriate proxy measure for the mental health burden than suicide data.[2] In 2012, interpersonal violence was among the top five causes of mortality in all Western Cape districts and was the second most common cause of years of life lost among men.[4] These data had remained fairly consistent over the preceding 3 years. The prevalence of mental disorders at primary-level facilities is likely to be underestimated, as the SASH study revealed that only 25% of participants meeting the criteria for a mental disorder sought treatment, owing to a low perceived need for mental healthcare and poor mental health literacy.[3,5] Mental health service data underestimate the burden as a result of underdiagnosis and poor access to mental healthcare due to structural and attitudinal barriers.[5] Children and adolescents The SASH study excluded children and adolescents, and data on the prevalence of mental illness in this group are lacking. Kleintjes et al.[6] estimated that the unadjusted prevalence of any mental disorder among children and adolescents in the Western Cape was 17%.[6] The adjusted prevalence estimate for generalised anxiety disorder was 11%, that for post-traumatic stress disorder (PTSD) 8% and that for major depressive disorder and dysthymia 8%.[6] In 2011, 11% of non-natural deaths in the 10 - 14-year age group and 10% in the 15 - 19-year age group were due to suicide.[4] Although some suicides may be impulsive, these figures point to the need for improved mental health among adolescents. Morojele et al.[7] showed that 41.4% of grade 8 - 10 learners in Western Cape schools were at medium risk and 14.9% at high risk for mental health problems. Female learners were more likely to be at high risk.[7] Risk factors Pertinent downstream risk factors for mental illness include comorbidities such as HIV as well as NCD, disorders during the perinatal period, substance abuse and experience of trauma.[2,8] HIV A synergistic interaction exists between HIV and mental illness, with depression, anxiety, PTSD and alcohol abuse being the most prevalent disorders among people living with HIV.[9] Depression, anxiety and stressful life events are associated with a worsened course of illness among those with HIV.[9] Furthermore, mental disorders are associated with poor adherence to antiretroviral treatment.[9] Mental illness is also a risk factor for HIV infection owing to impaired judgement and insight and associated high-risk behaviour. Few studies have been conducted on the burden of mental illness among individuals with HIV. Myer et al.[9] showed that 19% of those

attending routine HIV follow-up care in Cape Town had mental disorders, including depression, PTSD and alcohol dependence. NCDs A similar synergistic interaction exists between NCDs and mental illness.[2] Mental disorders and other NCDs have similar risk factors, e.g. alcohol abuse is associated with depression and anxiety disorders and is also a risk factor for cardiovascular disease.[2] Depression and anxiety both increase the risk for hypertension, and depression is an independent risk factor for stroke and type 2 diabetes.[2] A high level of comorbidity between NCDs and mental illness is expected, although data in the Western Cape are largely limited to facility data, so are likely to be underestimated. Disorders in women Numerous studies show that women are more likely to have depression, anxiety disorders and severe mental disorders.[3,10] Women have an increased risk of mental health disorders during the perinatal period, and these disorders are associated with increased maternal morbidity and mortality, and adverse child health outcomes.[2,10] Studies in the Western Cape show a high prevalence of various common mental disorders among pregnant women.[10] Of major concern was the large proportion of pregnant women with multiple risk factors for adverse perinatal outcomes, including depression and alcohol use.[10] Substance abuse and experience of trauma Alcohol and other psychoactive substances are widely recognised risk factors for mental illness and injuries.[3] Substance abuse contributes to a large proportion of non-natural deaths in the province.[4] The extensive use of methamphetamine (commonly known as â&#x20AC;&#x2DC;tikâ&#x20AC;&#x2122;), particularly among adolescents, is of major concern in the Western Cape.[7] Studies showed a marked increase in admissions and re-admissions due to methamphetamine abuse.[7,8] Morojele et al.[7] found that >60% of adolescent learners reported having witnessed a community member being beaten, 40% had observed a stabbing and 12% had witnessed forced sexual intercourse in a 12-month period.[7] These factors further contribute to mental health problems, including PTSD, anxiety disorders and mood disorders. Consequences of mental illness in terms of DALYs DALYs are valuable indicators to quantify the burden of mental illness, as both morbidity and mortality are included.[1] This is particularly useful when mortality rates are low.[1] In 2005, the World Health Organization attributed 31.7% of all years lived with disability to neuropsychiatric conditions, including depression, alcohol use disorders, schizophrenia, bipolar mood disorders and dementia.[1] In SA in 2000, neuropsychiatric disorders ranked third in DALYs. [1] It is challenging to derive accurate DALY estimations, as there are intensive data requirements and disability weights used in SA for DALY estimations are not context specific.[1,11] In order to develop more accurate burden measures, experts recommend that disability weights should be empirically assessed in SA rather than based on data from different countries.[1,11] Societal/economic costs Limited evidence is available on the societal and economic costs of mental illness in the Western Cape. Although DALYs provide some information on societal costs, they do not include indirect costs such as caregiver burnout or the negative impact on the family. Direct economic costs include the cost of medical care and services, whereas indirect costs include lost productivity, unemployment and

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disability benefits. Indirect costs tend to outweigh direct costs in most studies.[11] In the private sector, medication costs are notably high; however, no data are available for the public sector.[11] Staff expenditure also contributes significantly to the direct costs of mental healthcare.[11] Lund et al.[11] estimated the indirect costs of mental illness through lost earnings at USD4 798 (ZAR54 121) per adult with major depression and anxiety disorders per annum. Projections of the total annual cost of these disorders in lost earnings were USD3.6 billion in 2003.[11] This indicates that mental illness has a significant economic impact.

Mental health interventions in the health services

Mental health interventions may target individuals or populations, and span all levels of prevention, viz. primordial, primary, secondary and tertiary prevention. The 2007 Burden of Disease Reduction report[2] detailed core intervention areas for mental illness, viz.: • Multiple deprivation. Interventions aimed at improving quality of living as well as providing employment and education. • Substance abuse. Population-level interventions for substance abuse such as the enforcement of regulatory legislation, increased costs of alcohol, and reduced availability of alcohol. • Mental health services. Interventions that target health facilities across all levels of care, e.g. integration of mental health services in general medical services, community programmes, dedicated psychiatric services, etc. • Trauma. Mental health intervention at trauma facilities and through occupational groups that work with trauma victims to improve treatment of post-traumatic states that may precipitate or exacerbate mental illness. • Preschool education. The development of quality early-childhood development programmes to reduce the burden of mental illness. • Recreation. Involvement in recreational activities from early childhood is considered essential in the prevention and management of negative life events. The majority of these interventions address upstream factors associated with mental health, requiring an intersectoral approach in the development of primordial and primary prevention strategies. This article primarily focuses on health service-related interventions in the Western Cape, which are mainly directed towards secondary and tertiary prevention strategies. Although the South African Mental Health Care Act[12] mandates the integration of mental health services into PHC, many barriers exist globally, as listed in Table 1.

Recommended service-related interventions

Various service-related interventions were recommended by the 2007 MHW. More recently, Petersen et al.[8] conducted a systematic review of research conducted in mental health services in South Africa from 2000 to 2010 and identified key recommendations, many of which overlap with the abovementioned interventions. Table 2 categorises the main recommended interventions for the Western Cape from the available literature. Since economic evaluations of these interventions are limited, they have been assessed qualitatively based on the key requirements for successful implementation, i.e. training, human resources and dedicated allocation of resources (denoted with *). The final column shows current interventions in the province, which are explained in further detail below. Available evidence as well as legislation strongly supports integrated primary mental healthcare packages and strengthening of community-based services.[8] Horizontal integration is particularly suited to the SA setting, given the growing prevalence of comorbidities.[8] The SASH study showed that most adults utilised general medical services rather than specific mental health services for mental health problems.[3] Integrated interventions at primary-level facilities could improve coverage for those at risk for mental disorders who access healthcare services, thereby increasing the impact and cost-effectiveness of interventions as well as improving overall health outcomes by increasing adherence for all chronic diseases. Strengthening of community-based services is well supported by the literature.[8,13] Task shifting is one of the many methods recommended to integrate mental health within primary-level care.[8] Task shifting involves the provision of mental health at community and clinic levels using lower levels of healthcare workers. Primary-level services are strengthened by training current medical professionals, community health workers (CHWs) and counsellors in mental health. This approach is less costly than alternative staffing models that rely on specialist personnel.[8] Petersen et al.[8] motivated for the addition of mental health counsellors with a 4-year bachelor of psychology degree to the staff at PHC clinics.[8] The roles of such counsellors would include support to community mental health workers, screening and referral of severe cases and counselling services for PTSD.[8] A number of interventions in the Western Cape require additional non-specialist staff. Although these innovations are more costeffective than the use of specialist personnel, the addition of a cadre of lower-level mental health workers would require considerable funding. Training and task-shifting using existing personnel may be the least costly option in resource-constrained settings. A concern is the over-burdening of already pressured staff, leading to poor uptake of task-shifting approaches.

Table 1. Barriers to integration of mental health services into PHC High burden of disease Pressured PHC services where staff have multiple tasks, high patient loads, limited supervision and poor referral networks Lack of political will, particularly the absence of mental health on the public health priority agenda Lack of public mental health leadership[8] The stigma of mental illness, viewed as a sign of weakness and disgrace[5] Lack of knowledge regarding the prevalence and nature of mental illnesses[10] Under-resourced health facilities in terms of staff, infrastructure and medication Poorly trained nursing staff Lack of appropriate screening tools Insufficient skilled counsellors, psychologists and psychiatrists[8] PHC = primary healthcare.

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Table 2. Recommended interventions to enhance mental health services Recommended interventions Training General interventions A. Integration into general medical services at all levels of care, particularly in the following services: • Antenatal and postnatal • HIV/AIDS • Trauma • NCD Task-shifting. Training of general medical staff (including nurses and * doctors) to deliver basic mental health services including screening and interventions for substance abuse and dependences Task-shifting. Employment of new cadres of low-level healthcare * workers Ensure appropriate referral networks B. Development of community-based mental health services Improve community-based rehabilitation and care facilities Task-shifting. Training of CCWs in mental health screening, counselling and adherence support Mental health awareness initiatives in the community C. Improve infrastructure at all levels of care D. Ensure that psychotropic medication is universally available at primary-level services E. Promote culturally appropriate care F. Services provided in African languages, particularly isiXhosa and Afrikaans in the Western Cape Specialist interventions A. Employ dedicated mental health professionals at district hospitals B. Make provision for specialist and subspecialist psychiatry posts at all levels of care C. Provide adequate substance dependence treatment services D. Improve integration between mental health and substance services

Human resources

Resource allocation

Current intervention

PACK

PMHP; counselling in EC centres

* *

* * *

DoH/NPO partnerships for CCWs NGOs

* *

NCD = non-communicable disease; PACK = Practical Approach to Care Kit; PMHP = Perinatal Mental Health Project; EC = emergency centre; DoH = Department of Health; NPO = non-profit organisation; CCW = community care worker; NGO = non-governmental organisation. *Key requirement for implementation of the interventions listed in the first column.

Integrated mental healthcare in the Western Cape

The Mental Health Policy Working Group is currently developing the Mental Health Policy Framework for the province, using a life-course approach. Service-related interventions are being developed, piloted and rolled out in the province. The main focus is the integration of mental health in PHC as well as the strengthening of community-based services. The Practical Approach to Care Kit (PACK), adopted by the Western Cape, is a comprehensive clinical practice guideline for use by clinicians to diagnose and manage common conditions at primary level in an integrated manner, including mental illness.[14] The mental health module includes diagnosis and management guidelines for voluntary and involuntary admission procedures, depression, anxiety, substance abuse, psychosis and dementia.[14] The Perinatal Mental Health Project (PMHP) is another primarylevel intervention in selected facilities, providing psychiatric screening, counselling and treatment services to pregnant women. [11] Women are screened at their first antenatal visit to identify those at risk, who are then referred to an on-site counsellor for further management and referral if necessary. This validated screening tool may be used by lay workers, CHWs, nurses and other healthcare workers.

Interventions targeting those at risk, such as pregnant women, promote mental wellness by increasing the adaptive capabilities of women, improving agency and productivity as well as general living conditions, [11] thus reducing expenditure on health. The Substance Use and Trauma Intervention (STRIVE) study, conducted in 2012/2013, describes another intervention using the integrated care approach to decrease substance abuse and its negative effects among patients attending emergency centres (ECs) in the Western Cape.[15] The cost-effectiveness of interventions delivered by trained peer counsellors in the emergency setting was evaluated.[15] The intervention reduced substance abuse and depressive symptoms among EC patients.[15] The cost of employing peer counsellors was approximately five times less than that of appointing a trained clinical psychologist to screen and deliver the intervention. Again, although the intervention was cost-effective, the feasibility of appointing new cadres of staff at various facilities in the province needs further exploration.

Home and community-based care services in the Western Cape

Strengthening of community-based services is an important intervention described in the literature. Community-based services

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are delivered by CHWs or community care workers (CCWs), community rehabilitation workers and lay counsellors. In the Western Cape, community-based services are provided through contracts with non-profit organisations (NPOs) employing about 3 500 CCWs, supported and supervised by NPO-appointed professional nurses. While initial community-based services were specialised, e.g. tuberculosis and HIV home-based care, the services are becoming more integrated and comprehensive. CCWs can play an important role in the prevention of mental illness through health promotion, screening and adherence support. A recent provincial discussion document (unpublished) outlines the framework for home- and community-based care services in the Western Cape. Core competencies for CCWs include knowledge on mental health and other NCDs, as well as counselling skills. There is, however, variability in the training and functions of CCWs from different NPOs, although the current service package attempts to standardise the services provided. The National Department of Health is developing a standardised, comprehensive training qualification for CHWs, but the proposed training qualification incorporates very basic mental health training. Both the PACK and PMHP propose that CCWs receive adequate training and support to screen, refer and provide basic care for those in psychological distress as part of their routine tasks. An area of debate is whether CCWs should be trained as generalists, who incorporate mental health into their routine tasks, or as specialists with an exclusive focus on mental health issues. Given the resource constraints, a generalist approach appears more feasible, but the expectation that multiple health issues should be covered in routine CCW tasks may be overwhelming and important aspects of the health encounter may be neglected. Studies comparing the cost-effectiveness of generalist and specialist CCWs are required to provide more robust evidence for such debates.

Other interventions in the Western Cape

Community follow-up of discharged patients by hospital teams known as Assertive Community Teams was established in the Western Cape in 2007. There is evidence that this type of intervention may be particularly effective where community mental health services are inadequate.[16] Given the high cost and resource requirements for this intervention, improved community mental health services may be more cost-effective. Other provincial mental health interventions include nongovernmental organisation-led initiatives as well as research-driven interventions including the Programme for Improving Mental Health Care (PRIME), the Emerging Mental Health Systems in Low- and Middle-income Countries (EMERALD) project, the Africa Focus on Intervention Research for Mental Health (AFFIRM) project, and Project MIND. Feedback from such research should be presented to all stakeholders in order to strengthen policy development.

Recommendations

Evidence on the burden of mental disease in the Western Cape is limited, and largely outdated. A population-based epidemiological study to estimate the burden of mental disease is recommended. Current mental health service indicators are poorly reflective of the true burden of disease, and there is a need for more valid indicators. The main areas of intervention that may be feasible and effective are: • Strengthening community-based services through training of CCWs

• Integration of mental health services through task-shifting of existing staff at PHC, antenatal, postnatal, trauma, HIV and NCD services • Consideration of employment of a new cadre of mental health staff at subdistrict or facility level who may function at facility and community level. Given the limited evidence available locally and nationally, there is a need for economic evaluations of mental health interventions.

Conclusion

Mental illness contributes significantly to the burden of disease in the Western Cape. Although this review focuses on one province, many issues are pertinent to any under-resourced setting. A concerted effort by policy makers is required to ensure that appropriate information on mental illness is captured and interventions are based on sound evidence. Although many promising interventions are underway, there is a need to bolster mental health services at all levels of healthcare. An evidence-based intersectoral approach is required to optimise mental health in the population and truly achieve health for all. Acknowledgements. Juliet Evans, Crick Lund, Peter Milligan and Marinda Roelofse. Author contributions. NJ conducted the review. DC made significant intellectual contributions. Funding. Western Cape Government: Health. Conflicts of interest. None. 1. Bradshaw D, Norman R, Schneider M. A clarion call for action based on refined DALY estimates for South Africa. S Afr Med J 2007;97(6):438-440. 2. Myers JE, Naledi NT. Western Cape Burden of Disease Reduction Project: Overview of the Report. Cape Town: University of Cape Town on behalf of the Provincial Department of Health, 2007. http:// www.capegateway.gov.za/Text/2007/10/cd_volume_1_overview_and_executive_summaries180907. pdf (accessed 12 April 2015). 3. Herman AA, Stein DJ, Seedat S, Heeringa SG, Moomal H, Williams DR. The South African Stress and Health (SASH) study: 12-month and lifetime prevalence of common mental disorders. S Afr Med J 2009;99(5):339-344. 4. Groenewald P, Evans J, Morden E, et al. Western Cape Mortality Profile 2012. Cape Town: South African Medical Research Council, 2015. 5. Bruwer B, Sorsdahl K, Harrison J, Stein DJ, Williams D, Seedat S. Barriers to mental health care and predictors of treatment dropout in the South African Stress and Health Study. Psychiatric Serv 2011;62(7)774-781. https://doi.org/10.1176/ps.62.7.pss6207_0774 6. Kleintjes S, Flisher A, Fick M, et al. The prevalence of mental disorders among children, adolescents and adults in the Western Cape, South Africa. S Afr Psychiatry Rev 2006;9(3):157-160. https://doi. org/10.4314/ajpsy.v9i3.30217 7. Morojele N, Myers B, Townsend L, et al. Survey on Substance Use, Risk Behaviour and Mental Health Among Grade 8 - 10 Learners in Western Cape Provincial Schools, 2011. Cape Town: South African Medical Research Council, 2013. 8. Petersen I, Lund C. Mental health service delivery in South Africa from 2000 to 2010: One step forward, one step back. S Afr Med J 2011;101(10):751-757. 9. Myer L, Smit J, Roux LL, Parker S, Stein DJ, Seedat S. Common mental disorders among HIV-infected individuals in South Africa: Prevalence, predictors, and validation of brief psychiatric rating scales. AIDS Patient Care STDS 2008;22(2):147-158. https://doi.org/10.1089/apc.2007.0102 10. Meintjes I, Field S, van Heyningen T, Honikman S. Creating capabilities through maternal mental health interventions: A case study at Hanover Park, Cape Town. J Int Dev 2015;27(2):234-250. https:// doi.org/10.1002/jid.3063 11. Lund C, Myer L, Stein DJ, Williams DR, Flisher AJ. Mental illness and lost income among adult South Africans. Soc Psychiatry Psychiatr Epidemiol 2013;48(5):845-851. https://doi.org/10.1007/s00127012-0587-5 12. South Africa. Mental Health Care Act No. 17 of 2002. http://www.gov.za/sites/www.gov.za/files/a17-02. pdf (accessed 9 February 2017). 13. Naledi T, Barron P, Schneider H. Primary health care in SA since 1994 and implications of the new vision for PHC re-engineering. In: South African Health Review 2011. Durban: Health Systems Trust, 2011:17-28. 14. Practical Approach to Care Kit. Knowledge Translation Unit, University of Cape Town Lung Institute. http://knowledgetranslation.co.za/programmes (accessed 5 May 2015). 15. Dwommoh RAK. Brief Interventions to Address Substance Use in Emergency Departments in the Western Cape: A Cost-effectiveness Analysis. Cape Town: University of Cape Town, 2014. https:// open.uct.ac.za/handle/11427/6031 (accessed 12 April 2015). 16. Botha UA, Koen L, Galal U, Jordaan E, Niehaus DJ. The rise of assertive community interventions in South Africa: A randomized control trial assessing the impact of a modified assertive intervention on readmission rates; A three year follow-up. BMC Psychiatry 2014;14:56. https://doi.org/10.1186/1471244x-14-56

Accepted 20 November 2017.

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This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

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A longitudinal perspective on violence in the lives of South African children from the Birth to Twenty Plus cohort study in Johannesburg-Soweto L M Richter,1 PhD; S Mathews,2 PhD; J Kagura,3 PhD; E Nonterah,1 MB ChB, MSc Department of Science and Technology-National Research Foundation Centre of Excellence in Human Development, Office of the Deputy Vice-Chancellor (Research and Postgraduate Affairs), University of the Witwatersrand, Johannesburg, South Africa 2 Children’s Institute, Faculty of Health Sciences, University of Cape Town, South Africa 3 Developmental Pathways to Health Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 1

Corresponding author: L M Richter (linda.richter@wits.ac.za) Background. Violence against children is a significant cause of personal suffering and long-term ill health, poor psychological adjustment, and a range of social difficulties, including adverse effects intergenerationally. Objectives. Using a large corpus of longitudinal data collected in the Birth to Twenty Plus cohort, to give an overview of exposure to and experience of violence, as well as perpetration of violence, across childhood, reported contemporaneously by several informants. This overcomes limitations of retrospectively recalled information collected from one person at one point in time. Methods. We identified 280 data points relating to exposure to and perpetration of violence in 14 of the 21 waves of data collection from birth to 22 years of age. Data were classified into four developmental stages (preschool, primary school years, adolescence and young adulthood) and seven categories (exposure to violence in the community, home and school; exposure to peer violence; being a victim of violence, excluding sexual violence; sexual violence; and perpetration of violence). Both descriptive and inferential statistics were employed to analyse the data. Results. Over the past two decades, only 1% of the sample had not been exposed to or experienced violence in their home, school and/or community. Two-thirds of children of schoolgoing age were reported as having been exposed to community violence, and more than half of all children to violence in their home. Reports of sexual violence increased from 10% among primary school-aged children to ~30% among adolescents and young adults. Over the course of their lives, ~40% of children were reported as having been exposed to or being victims of five or six of the categories of violence coded in this analysis. High levels of violence perpetration were reported across childhood. Age and gender differences in exposure to and experience and perpetration of violence were evident, and all categories of violence were more prevalent among poorer and more disadvantaged groups. Conclusions. Very high levels of violence were reported in all the settings of urban South African children’s lives: home, community, school, among peers and in their intimate relationships. Children and youth were also reported to perpetrate high levels of violence. The personal and social costs of violence are very high, resulting in major public health problems due to its avoidable effects on short- and long-term mental and physical health and social adjustment, and intergenerationally. S Afr Med J 2018;108(3):181-186. DOI:10.7196/SAMJ.2018.v108i3.12661

‘South Africa, a country not at war, faces an unprecedented burden of morbidity and mortality arising from violence and injury.’ (Seedat et al.[1]) Violence against children (VAC) is an abrogation of children’s human rights under Section 28 of the Constitution of South Africa (SA), and under regional and international rights conventions to which SA is a signatory. It is also a significant cause of personal suffering and long-term ill health, poor psychological adjustment and a range of social difficulties, including adverse effects intergenerationally.[2,3] While VAC is pervasive, it is largely undocumented and inadequately researched because of barriers to reporting.[4] In acknowledgement of this, a 2014 UNICEF report on VAC is entitled Hidden in Plain Sight. [5] A little bit is known about the tip of the iceberg of VAC – serious physical, sexual or emotional abuse, usually attributed to the violent predisposition of atypical individuals, whether in or out of the family. We know much less about widespread and continuous violence in the everyday lives of children, including in SA.[6]

What we do know is that violence contributes significantly to child mortality in SA. A national mortuary-based survey found that three children a day are murdered, and that three out of four children aged <5 who are killed die as a result of fatal abuse by a carer at home. [7] Data assembled by the South African Medical Research Council indicated that in 44% of sexual offences reported to the police, the victim is a child. Most rapes of children (an estimated 84%) are perpetrated by men known to the child; in schools, the men are often teachers.[8] Physical punishment is widely practised in SA, with nearly 60% of parents reporting that they hit their children, the majority with a belt or other object. The most common age for beatings of children is 3 - 4 years.[9] Children are also exposed to various forms of emotional violence and neglect. The results of one study found that 35 - 45% of children had witnessed their mother being beaten, and 15% reported that one or both of their parents had been too drunk to care for them.[1] Beyond these statistics, SA lacks systematic research into the scale and forms of violence experienced by children, limiting our ability to

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respond adequately to a significant public health problem. VAC takes several forms within a general definition, different forms of violence frequently occur together, and violence occurs in all settings in which children find themselves – at home, in school, in the community and among peers, as well as more recently in cyberspace.[10] A 2015 national survey of 9 730 young people between 15 and 17 years of age who recalled lifetime experiences of violence attempted to fill the gap.[11] Despite methodological challenges, the study confirmed the pervasiveness of VAC, with 20% of young people reporting having experienced some form of sexual abuse in their lifetime, 30% being beaten by an adult caregiver, 16% emotional abuse and 20% feeling neglected by their parents. Based on these prevalence data, the economic cost of sexual, physical and emotional violence perpetrated against children in SA, and neglect of children – including disabilityadjusted life-years lost due to death and ill health, reduced earnings and welfare costs – is estimated as being ZAR196 billion, or 4.9% of SA’s gross domestic product.[12]

Objective

Taking advantage of a large corpus of longitudinal data collected in the Birth to Twenty Plus (Bt20+) cohort, to give a perspective of exposure to and experience of violence, as well as perpetration of violence, across the time span of childhood, reported contemporaneously by several informants from infancy to young adulthood. These data overcome several limitations of retrospectively recalled information collected from one person at one point in time.

Methods

Bt20+ is a longitudinal study of children born in 1990 in the greater Johannesburg-Soweto metropolitan area, assessed on 21 occasions between pregnancy and 22 years of age. Currently, the study follows >2 000 children and families throughout Gauteng Province. The enrolment methods, attrition and profile of the Bt20+ cohort are documented in detail elsewhere.[13] On enrolment, the cohort was demographically representative of the study area, with the majority being black African and equal numbers of males and females. Bt20+ is the largest and longest-running study of child and adolescent health and development in Africa, and tracks exposures and outcomes in physical, educational, social and psychological domains.[13] Ethical approval was obtained from the Human Research Ethics Committee of the University of the Witwatersrand, Johannesburg (ref. no. M010556).

Data collection instruments across the time span of the study were scrutinised for items relating to exposure to violence, direct experience of violence, and perpetration of violence. In 14 of the 21 waves of data collection, 280 data points relating to exposure to and perpetration of violence were identified and included in this analysis. Variables were classified into groups: mother’s reports of violence during her own childhood, during her pregnancy and during the preschool years of the Bt20+ child’s life; and reports of violence when children were of primary school age (6 - 13 years), adolescents (14 17 years) and young adults (18 - 22 years). Data were further classified according to whether the violence was reported by the mother, the father, the child or the child’s teacher at school; whether it occurred in the home, at school, in the workplace or in the community; whether the violence was sexual; and whether it was perpetrated by peers or others. Seven categories were created: (i) exposure to violence (seeing or hearing violent episodes) in the community, (ii) at home and (iii) at school; (iv) exposure to peer violence; (v) direct experience of violence (excluding sexual violence); (vi) direct experience of sexual violence; and (vii) perpetration of violence. Some of the data were collected as part of questions on family and community wellbeing, child behavioural adjustment, etc., although in five data waves (7, 11, 13, 15 and 18 years) aspects of violence were examined as specific topics. The 280 variables, by sample size and data collection wave, are shown in Table 1. Examples of the categories are: exposure to violence in the community (hearing gunshots), at home (seeing parents physically fighting) and at school (seeing a child beat up another); exposure to peer violence (witnessing gang violence); direct experience or being a victim of violence (mother beating the index child; being attacked at school); direct experience of sexual violence (being forced to have sex); and perpetration of violence (picking a fight, forcing someone to have sex). Responses to items were classified as binary variables – ever or never. Multiple answers to a question (e.g. never, once or twice, a few times, many times) were collapsed into two mutually exclusive responses, ‘yes’ (once or twice, a few times, many times) and ‘no’ (never). Both descriptive and inferential statistics were employed. Data are described using frequencies and cross-tabulations for categorical data and medians with interquartile ranges (IQRs) for skewed continuous data. Analyses were stratified according to gender, and differences were tested with Pearson’s χ2 test, and a non-parametric two-sample Wilcoxon rank-sum (Mann-Whitney) test for skewed

Table 1. Number of variables analysed by data collection wave Age data collected (14 waves) Antenatal Child age 6 months 4 years 5 years 7 years 10 years 11 years 12 years 13 years 14 years 15 years 16 years 18 years 22 years

Respondent Mother Mother Mother Mother Mother and teacher Child and mother Child and mother Child Child Child and mother Child Child Child, father and mother Child

Sample size at each wave 1 595 1 907 1 858 625 - 1 660 477 - 2 016 1 248 1 794 1 493 1 647 2 024 1 985 1 928 1 993 1 602

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Number of variables (N=280) 4 3 9 13 13 5 22 3 16 10 70 3 101 10

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Results

Characteristics of the Bt20+ sample at enrolment are shown in Table 2. The demographics of a few cases changed over the long time scale under consideration; for example, there was a small proportion of marriage and re-marriage, but this detail is not included here. There were no significant differences between boys and girls in terms of the characteristics examined. Numbers of respondents who answered each question vary by age group, as shown in Table 3, which depicts the proportion of children reported as having been exposed to, having experienced or having perpetrated violence in the seven categories of violence indicated previously. An overall violence score based on six categories of violence, excluding perpetration, was calculated by allocating a score of zero if the child did not report any instance of violence for any of the six categories and a score of 1 if the child reported any instance of exposure to violence in any one category across time points. A maximum score of 6 refers to exposure to all categories of violence (Fig. 1). Less than 1% of the sample had not experienced violence in any of the six categories, and 36% had experienced all six categories of violence. The violence score differed by gender (p<0.0001), with a greater proportion of boys (44.4%; 95% CI 38.1 - 44.8) than girls (30.6%; 95% CI 58.3 - 64.9) reporting a score of 6.

We further determined the differences in proportions between each of the six categories of violence (excluding perpetration) and sociodemographic variables: maternal age, education and marital status, household socioeconomic status (SES), and population group. More black children reported experiencing domestic (91.4%; χ2(3)=12.8165, p=0.005) and personal violence (90.9%; χ2(3)=13.3859, p=0.004) than any other population group. The lower socioeconomic groups reported higher proportions of sexual violence (lowest 53.8%, middle 47.6%, highest 38.1%; χ2(2)=24.3942, p<0.0001) and peer violence (lowest 77.1%, middle 70.3%, highest 68.3%; χ2(2)=12.0829, p<0.002). We further explored the independent influence of each of the sociodemographic variables on each of the six categories of violence in a univariable logistic regression analysis. Compared with black children, coloured and Indian children were 63% (OR 0.37, 95% CI 0.19 - 0.72; p=0.003) and 78% (OR 0.22, 95% CI 0.04 - 0.95; p=0.044) less likely to experience domestic violence and Indian children were 94% (OR 0.06, 95% CI 0.01 - 0.53; p=0.012) less likely to report personal experience of violence. The middle (OR 0.78, 95% CI 0.62 - 0.97; p=0.031) and highest (OR 0.53, 95% CI 0.41 - 0.68; p<0.0001) household SES groups were

Children, %

data at a statistical significance level of p<0.05. The differences in proportion of the six classes of violence (excluding perpetration) and sociodemographic variables were examined using Pearson’s χ2 test or Fisher’s exact test where appropriate, as well as independent association of these classes of violence and sociodemographic characteristics using a univariable logistic regression analysis. Odds ratios (ORs) and 95% confidence intervals (CIs) are reported, and p<0.05 is considered statistically significant. The concentration of violence among children across time points and across types of violence was examined by creating a total violence score from six categories of violence (excluding perpetration) and expressed as quartiles due to skewness of the scores. All analyses were performed using Stata version 13 (StataCorp, USA).

Males

100 90 80 70 60 50 40 30 20 10 0

Females Total

Overall violence score

Fig. 1. Percentage of children who experienced violence according to the overall violence score (1 - 6 across all time points) by gender.

Table 2. Sociodemographic characteristics of the sample by child gender Maternal age (years), median (IQR) Population group, n (%) White Black Coloured Indian Marital status, n (%)* Married Living together Separated/divorced/widowed Single Maternal educational status, n (%)† No formal education Primary education Some secondary Secondary education Post-school training Household asset score, median (IQR)

Males (N=1 589, 48.6%) 25 (14 - 46)

Females (N=1 681, 51.4%) 25 (13 - 48)

Total (N=3 270) 25 (13 - 48)

109 (6.9) 1 245 (78.4) 176 (11.1) 59 (3.7)

97 (5.8) 1 321 (78.6) 207 (12.3) 56 (3.3)

206 (6.3) 2 566 (78.5) 383 (11.7) 115 (3.5)

602 (38.1) 96 (6.1) 21 (1.3) 860 (54.5)

597 (35.8) 117 (7.0) 26 (1.6) 929 (55.7)

1 199 (36.9) 213 (6.6) 47 (1.4) 1 789 (55.1)

20 (1.4) 203 (14.1) 630 (43.9) 417 (29.0) 166 (11.6) 10 (0 - 13)

27 (1.8) 204 (13.7) 626 (41.9) 475 (31.8) 161 (10.8) 10 (0 - 13)

47 (1.6) 407 (13.9) 1 256 (42.9) 892 (30.5) 327 (11.2) 10 (0 - 13)

*Data missing for 22 respondents. † Data missing for 341 respondents.

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846 (23.5) 647 (16.7) 828 (23.8) 662 (36.3) 1 674 (23.7) 1 309 (26.6)*** 569 (42.7) 5 748 (52.8) 1 143 (47.8)** Perpetration of violence

Statistically significant differences between males and females for the different time points across the different categories of violence: *p<0.05, **p<0.01, ***p<0.0001.

822 (32.4) 818 (88.8) 1 660 (27.2)*** 1 650 (89.3) 777 (6.9) 825 (63.4) 740 (13.0) 797 (66.9) 1 517 (9.9)*** 1 622 (65.1) -

763 (66.8) 748 (61.0) 1 511 (63.9)* -

less likely to experience sexual violence compared with the lowest household SES group. They were also less likely to experience peer violence (middle OR 0.70, 95% CI 0.54 - 0.90; p = 0.006, highest OR 0.64, 95% CI 0.48 - 0.84; p = 0.002). In order to examine the concentration of violence exposure and experience across time, the data were classified into quartiles, with the highest quartile (quartile 4) reporting violence across all time points by answering yes to >75% of questions in the respective violence category; the lowest quartile answered yes to <25% of questions in that category. As Table 4 shows, nearly half of the children (47.6%) had intense personal experience of or exposure to violence, answering in the affirmative to 75% of questions in all categories of violence, bar sexual violence, across all time points. Forty-eight percent and 49.2% of children experienced this concentration of violence exposure in their communities and at home, respectively.

838 (22.2) 832 (89.8)

799 (26.7) 850 (58.1) 751 (35.8) 829 (62.7) 1 550 (31.1)*** 1 679 (60.4)* 805 (51.2) 821 (93.2) -

1 185 (34.2) 1 633 (82.7)*

574 (36.6) 804 (80.2)

611 (31.9) 829 (85.0)

1 609 (51.2) 1 646 (95.8)***

804 (51.2) 825 (98.4)

812 (72.9) 766 (81.7) 1 578 (77.2)*** 800 (52.1) -

1 281 (89.4)

627 (90.1)

654 (88.7)

1 599 (50.0)

799 (47.8)

850 (42.5) 829 (41.9) 1 679 (42.2) 825 (86.5) 821 (80.1) 1 646 (83.4)*** 8 237 (51.8) 793 (49.1) 1 616 (50.4) 605 (51.9) 598 (47.8) 1 203 (49.9) -

Violence category Exposure to violence in the community Exposure to violence in home Exposure to violence at school Exposure to peer violence Personal experience of violence (excl. sexual violence) Sexual violence

256 (32.5)

Time periods of violence against or perpetrated by child Primary school Adolescence (7 - 13 years), n (%) (14 - 17 years), n (%) Total Males Females Total Males Females 1 679 829 850 1 603 802 801 (66.0)* (66.3) (68.4) (93.3)* (92.0) (94.6) Maternal history of abuse Early childhood During During (birth - 6 years), n (%) childhood, pregnancy, n (%) n (%) Total Males Females 412 (43.7) 1 139 574 565 (20.5) (18.5) (22.5)

Table 3. Reports of violence across time periods, by gender and categories of violence

Young adulthood (18 - 22 years), n (%) Total Males Females 1 678 829 849 (77.9)** (81.1) (74.8)

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Discussion

Only 1% of this sample of children in the Soweto-Johannesburg area had been spared exposure to or experience of violence in their home, school and/or community over the past two decades. While several published and unpublished reports attest to the high levels of violence to which SA children are exposed, the extensive data reported here, over the course of childhood and across several contexts, variously reported by parents, children and teachers, document the saturation of violence in the everyday lives of children. Two-thirds of children of schoolgoing age were reported to have been exposed to community violence, such as hearing gunshots or seeing someone attacked, the figure rising in adolescence and young adulthood. More than half of all children, increasing from childhood into adolescence, were reported to have been exposed to violence in their home. Close to half of preschool children were reported to have been victims of violence, most often through physical punishment by parents. The figure for personal experience, i.e. being a victim of violence, reached 96% among adolescents. These high rates are comparable to figures reported two decades ago in poor innercity areas in the USA,[14] and a more recent national survey in the USA found that nearly half of American children reported being assaulted at least once in the previous year. [15] Violence at school was reported to be experienced by about a third of primary school-aged children, the figure dropping in

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Table 4. Concentration of violence across all time for each of six categories of violence, expressed in quartiles Violence category Exposure to violence in the community Exposure to violence in the home Exposure to violence at school Exposure to peer violence Personal experience of violence (excluding sexual violence) Personal experience of sexual violence

Median time points (IQR) 2 (0 - 4) 1 (0 - 4) 1 (0 - 3) 1 (0 - 3) 2 (0 - 4)

Quartile 1 (lowest), n (%) 0 0 0 0 0

Quartile 2, n (%) 5 (0.3) 2 (0.1) 52 (3.2) 0 5 (0.3)

Quartile 3, n (%) 840 (51.9) 793 (50.6) 779 (48.6) 466 (39.3) 846 (52.1)

Quartile 4 (highest), n (%) 774 (47.8) 771 (49.2) 773 (48.2) 720 (60.7) 774 (47.6)

1 (0 - 3)

158 (16.4)

251 (26.0)

555 (57.6)

adolescence. Reports of sexual violence build up across childhood, from 10% among primary school-aged children to ~30% among adolescents and young adults. All categories of violence were more prevalent among poorer and more disadvantaged groups. Around 40% of children have been exposed to or experienced five or six of the categories of violence coded in this analysis over the course of their lives, i.e. they are polyvictimised, with few safe areas at home, at school, in their community, in the company of their peers or in their intimate relationships with others. Exposure to violence has severe consequences for children, including extended periods of stress, powerlessness and depression, which affect school and social adjustment. Exposed children are at risk of becoming insensitive to future violence exposures, uncaring towards others, and becoming violent themselves,[16] although effects vary between children, including by gender.[17] Long-term effects into adulthood of childhood exposure to violence and abuse include poor mental health, drug and alcohol abuse, risky sexual behaviour, criminality, and neglectful or abusive parenting, leading to a vicious cycle of violence and poor functionality.[18,19] Our data indicate that SA children behave violently to others, although perpetration is not dealt with in detail here. In the preschool years, close to half of the sample were reported to be aggressive, starting fights with and bullying other children. In the primary school years, violent behaviour was reported of or by >65% of children, rising in adolescence to 89% and declining to about a quarter in young adulthood. However, in young adulthood, perpetration was more serious than hitting others, more often taking the form of threatening someone with a gun or knife, hurting a partner, forcing someone to have sex with them, and beating up or robbing a person. These data show that reports of violence vary across childhood, for which there are a number of possible explanations. For one, patterns and levels of violence in a society change. For example, in an earlier paper using Bt20+ data, we documented a shift from pre1994 exposure to state-sponsored political violence and politically motivated inter-ethnic violence to post-2014 exposure to criminal and family violence.[20] Second, a developmental pattern in aggressive behaviour is commonly observed, with higher rates among very young children that decline as children mature and are socialised,[21] although a decline was not seen among the Bt20+ sample. Except for adolescence where perpetration is equally high, violence perpetrated by males exceeds that by females, being more than double that for females by young adulthood. As has been reported in other studies, more males than females are exposed to violence in their communities, at school and with their peers. While males typically experience more physical violence, reviews estimate a two to three times higher risk for sexual abuse among girls compared with boys.[22] In the primary and adolescent years, we found higher rates of sexual violence against boys, although these require careful examination, as boys engage in more sexual behaviour than girls. There are, however, concerns that abuse of boys

is underestimated,[23] and specifically that current assessments of sexual abuse may not adequately capture boys’ experiences of non-contact and mixed forms of abuse, and that boys under-report abuse because of fears of being labelled homosexual.[24] Rates of reported sexual abuse of males nearly comparable to those for females have been reported from studies in sub-Saharan Africa, one using Bt20+ data.[11,25,26]

Study strengths and limitations

The strength of this analysis is that it is prospective rather than retrospective, and covers the full range of childhood and young adult years, in a variety of settings and through reports from multiple informants. An additional strength is that ongoing data are being collected on the third generation of Bt20+, i.e. children of the cohort, and a further round of adult data is currently being collected at a participant age of 27 years. This will enable the long-term and intergenerational effects of violence to be tracked through the study. A weakness is that the data are assembled from several different sources (self and other report, behavioural rating scales) and we did not assess the consistency of information across these sources. The number and specificity of questions about violence during the age periods also varied. It would be helpful if VAC is included in largescale longitudinal studies, such as the National Income Dynamics Study, using standard questions to ensure consistency in questions and response formats across time. While the number of white (6.3%), coloured (11.7%) and Indian (3.5%) participants in the analysis prevents specific conclusions being drawn about these groups, the proportions are not markedly different from the SA population as reflected in the 2011 census (8.9%, 8.9% and 2.5%, respectively, with black Africans making up 79.2% of the population).[27]

Conclusions

Exposures to and experiences of violence are pervasive in the lives of SA children and young adults, at least among those living in dense urban areas such as Soweto-Johannesburg. Very high levels of violence are reported to occur in all the settings of children’s lives: at home, in the community, at school, among peers and in their intimate relationships. Children and youth are also reported to be perpetrators of violence, although comparable data are not available against which to evaluate the findings. The personal and social short- and longterm costs of violence are very high, with effects into subsequent generations, yet SA does not yet have a strong focus on reducing violence and children’s exposure to and experience of violence. Available evidence indicates that early intervention is needed to prevent or reduce young children’s exposure to violence and other causes of toxic stress. Effective and sustainable interventions are needed to address violence as a major public health problem. Acknowledgements. None. Author contributions. LMR is the principal investigator of Bt20+ and conceptualised and wrote the first draft. SM contributed to the writing of

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the paper. JK gave oversight to the statistical analysis, and EN undertook the statistical analysis. All authors read, contributed to and approved all versions of the article. Funding. Funding was received from the European Union (EuropeAid/134258/M/ACT/ZA PSPPD2/CfP2/2014/15/3), through the Programme to Support Pro-Poor Development in South Africa, the DST-NRF Centre of Excellence in Human Development, University of the Witwatersrand, and the Wellcome Trust (UK). Conflicts of interest. None. 1. Seedat M, van Niekerk A, Jewkes R, Suffla S, Ratele K. Violence and injuries in South Africa: Prioritising an agenda for prevention. Lancet 2009; 374(9694):1011-1022. https://doi.org/10.1016/s01406736(09)60948-x 2. Gilbert R, Widon C, Browne K, et al. Burden and consequences of child maltreatment in high-income countries. Lancet 2009;373(9657):68-81. https://doi.org/10.1016/s0140-6736(08)61706-7 3. Maniglio R. The impact of sexual abuse on health: A systematic review of reviews. Clin Psychol Rev 2009;29(7):647-657. https://doi.org/10.1016/j.cpr.2009.08.003 4. Ravi S, Ahluwalia R. What explains childhood violence? Micro correlates from VACS surveys. Psychol Health Med 2017;22(1):17-30. https://doi.org/10.1080/13548506.2017.1282162 5. United Nations Children’s Fund. Hidden in Plain Sight: A Statistical Analysis of Violence Against Children. New York: UNICEF, 2014. 6. Richter L, Dawes, AR. Child abuse in South Africa: Rights and wrongs. Child Abuse Rev 2008;17(2):7993. https://doi.org/10.1002/car.1004 7. Mathews S, Abrahams N, Jewkes R, Martin L, Lombard C. The epidemiology of child homicides in South Africa. Bull World Health Organ 2013;91:562-568. https://doi.org/10.2471/blt.12.117036 8. Jewkes R, Levin J, Mbananga N, Bradshaw D. Rape of girls in South Africa. Lancet 2002;359(9303):319320. https://doi.org/10.1016/s0140-6736(02)07530-x 9. Dawes A, de Sa S, Kropinwnicki Z, et al. Corporal Punishment of Children: A South African National Survey. Cape Town: Human Sciences Research Council, 2005. 10. Aboujaoude E, Savage MW, Starcevic V, Salame, WO. Cyberbullying: Review of an old problem gone viral. J Adolesc Health 2015;57(1):10-18. https://doi.org/10.1016/j.jadohealth.2015.04.011 11. Burton P, Ward C, Artz L, Leoschut L. The Optimus Study on Child Abuse, Violence and Neglect in South Africa. Cape Town: Centre for Justice and Crime Prevention and University of Cape Town, 2015. 12. Fang X, Fry DA, Ganz G, Casey T, Ward CL. The Economic Burden of Violence Against Children in South Africa: Report to Save the Children South Africa. Georgia State University, and Universities of Cape Town and Edinburgh, 2016. https://www.savethechildren.org.za/sci-za/files/47/47ab7077-1d0d4c37-8ae2-161b18ae427a.pdf (accessed 12 February 2018).

13. Richter L, Norris S, Pettifor J, Yach D, Cameron N. Cohort profile: Mandela’s children: The 1990 Birth to Twenty study in South Africa. Int J Epidemiol 2007;36(3):504-511. https://doi.org/10.1093/ije/dym016 14. Bell C, Jenkins E. Community violence and children on Chicago’s Southside. Psychiatry 1993;56(1):4653. https://doi.org/10.1080/00332747.1993.11024620 15. Finkelhor D, Ormrod R, Turner H, Hamby S. The victimization of children and youth: A comprehensive, national survey. Child Maltreat 2015;10(1):5-25. https://doi.org/10.1177/1077559504271287 16. Abrahams N, Jewkes R. Effects of South African men’s having witnessed abuse of their mothers during childhood on their levels of violence in adulthood. Am J Public Health 2015;95(10):1811-1816. https:// doi.org/10.2105/ajph.2003.035006 17. Evans SE, Davies C, DiLillo D. Exposure to domestic violence: A meta-analysis of child and adolescent outcomes. Aggress Violent Behav 2008;13(2):131-140. https://doi.org/10.1016/j.avb.2008.02.005 18. McDougall P, Vaillancourt T. Long-term adult outcomes of peer victimization in childhood and adolescence: Pathways to adjustment and maladjustment. Am Psychol 2015;70(4):300-310. https://doi. org/10.1037/a0039174 19. Young JC, Widom CS. Long-term effects of child abuse and neglect on emotion processing in adulthood. Child Abuse Negl 2014;38(8):1369-1381. https://doi.org/10.1016/j.chiabu.2014.03.008 20. Barbarin OA, Richter L, de Wet T, Wachtel A. Ironic trends in the transition to peace: Criminal violence supplants political violence in terrorizing South African blacks. Peace Confl 1998;4(3):283-304. https:// doi.org/10.1207/s15327949pac0403_6 21. Tremblay RE. The development of aggressive behavior during childhood: What have we learned in the past century? Int J Behav Dev 2000;24(2):129-141. https://doi.org/10.1080/016502500383232 22. Barth J, Bermetz L, Heim E, Trelle S, Tonia T. The current prevalence of child sexual abuse worldwide: A systematic review and meta-analysis. Int J Public Health 2013;58(3):469-483. http://doi.org/10.1007/ s00038-012-0426-1 23. Watkins B, Bentovim A. The sexual abuse of male children and adolescents: A review of current research. J Child Psychol Psychiatry 1992;33(1):197-248. https://doi.org/10.1111/j.1469-7610.1992.tb00862.x 24. Pereda N, Guilera G, Forns M, Gomez-Benito M, et al. The international epidemiology of child sexual abuse: A continuation of Finkelhor. Child Abuse Negl 2009;33(6):331-342. https://doi.org/10.1016/j. chiabu.2008.07.007 25. Richter L, Komárek A, Desmond C, et al. Reported physical and sexual abuse in childhood and adult HIV risk behaviour in three African countries: Findings from Project Accept (HPTN-043). AIDS Behav 2014;18(2):381-389. https://doi.org/10.1007/s10461-013-0439-7 26. Richter L, Mabaso M, Ranjith J, Norris S. Early sexual debut: Voluntary or coerced? Evidence from longitudinal data in South Africa – the Birth to Twenty Plus study. S Afr Med J 2015;105(4):304-307. https://doi.org/10.7196/SAMJ.8925 27. Statistics South Africa. Census 2011. Statistical release P0301.4. Pretoria: Stats SA, 2012.

Accepted 14 August 2017.

March 2018, Print edition

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RESEARCH

Ethnopharmacological use of potassium permanganate in South African traditional medicine R A Street,1 PhD; G M Kabera,2 PhD; C Connolly,3 MPH Environment and Health Research Unit, South African Medical Research Council, Durban; and Discipline of Occupational and Environmental Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa 2 Department of Statistics, University of South Africa, Florida Campus, South Africa 3 Biostatistics Unit, South African Medical Research Council, Durban, South Africa 1

Corresponding author: R A Street (renee.street@mrc.ac.za)

Background. Potassium permanganate (KMnO4), which is widely available, is often used by traditional health practitioners (THPs) in South Africa (SA) without taking its potentially harmful properties into account. The crystalline KMnO4 salt is sold at traditional medicine markets and shops throughout SA. However, to date, traditional uses of KMnO4 remain undocumented. Objective. To describe KMnO4 use by THPs in KwaZulu-Natal, SA. Methods. This sub-study is part of a larger study investigating substances used in SA traditional medicine that are collectively known as imikhando in isiZulu – literally translated as ‘ore’. THPs (N=201) were interviewed in the local language (isiZulu) by trained interviewers. Information on the reasons for using/not using KMnO4, the source of information on its use and modes of administration were collected. Results. KMnO4 was used as a constituent of traditional medicine by 158 (79%) THPs. Their knowledge of KMnO4 use was acquired predominantly from fellow THPs (n=134; 85%). Reasons for use included skin rash or wounds (n=99, 63%) and to treat aches, pains and swelling (n=74; 47%). The main modes of administration were in the bath (n=94; 60%), orally (n=67; 42%) and in herbal compresses (n=66; 42%). The principal reason of the 43 THPs for not administering KMnO4 was not knowing how to use it (n=29; 71%). Conclusions. This study has identified traditional medicine users at risk of manganese toxicity owing to commonly used sociocultural practices. In particular, reports of oral ingestion and use in enemas are cause for concern. This public health issue needs regulatory measures and education programmes to enlighten the population against possible harm caused by KMnO4 exposure. S Afr Med J 2018;108(3):187-189. DOI:10.7196/SAMJ.2018.v108i3.12606

Full article available online at https://doi.org/10.7196/SAMJ.2018.v108i3.12606

A needs-based approach to equitable allocation of district primary healthcare expenditure in North West Province, South Africa Y Maharaj,1 BSc, BSc Hons, MPH (Health Economics); A Robinson,2 MB ChB, DHSM, FCPHM; D McIntyre,3 BCom, MA, PhD Family Health International (FHI360), Pretoria, South Africa North West Provincial Department of Health, Mafikeng, South Africa 3 Health Economics Unit, School of Public Health and Medicine, Faculty of Health Sciences, University of Cape Town, South Africa

Corresponding author: Y Maharaj (yasteel.maharaj@gmail.com) Background. Inequity in resource allocation and expenditure exists in the South African (SA) health system at provincial and district level. Needs-based resource allocation has been utilised in developed and developing countries to promote equity. Objectives. To assess current spending patterns on primary healthcare (PHC)-level care at district level, and ultimately to promote equity in district PHC spending using a needs-based resource allocation approach in North West Province, SA. Methods. Data on PHC expenditure in 2013/14 were derived from the Vulindlela system. Data on key indicators of need for health services in each district were collated from various sources published online. Alternative needs-based formulae were calculated, and sensitivity analyses were conducted to assess the impact of key assumptions.

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Results. The analysis produced four possible needs-based formulae. The districts of Bojanala and Dr Kenneth Kaunda in North West are relatively under-resourced, while Ngaka Moderi Molema and Dr Ruth Segomotsi Mompati are relatively over-resourced. The results suggest that, in moving towards each districtâ&#x20AC;&#x2122;s equity target, a relative redistribution of resources should be undertaken over several years, preferably in the context of an annual increase in the real overall provincial PHC health budget, to avoid any absolute budget cuts for relatively overresourced districts. Conclusions. Inequity in PHC expenditure exists between the districts of North West. A needs-based resource allocation approach can promote equity across districts. Any formula selected by the Department of Health will need to be refined over time as more up-to-date and accurate data become available. It is recommended that for the initial phase the formula be based on population size, which will need to be updated at regular intervals. The same would apply to other indicators of need selected for the formula. Important areas for refining the formula over time are: (i) estimating the differential cost of providing care in rural v. urban areas, as assumptions were used in this study; and (ii) identifying a more comprehensive burden of disease indicator for which data are available at district level in the province. S Afr Med J 2018;108(3):190-196. DOI:10.7196/SAMJ.2018.v108i3.12588

Full article available online at https://doi.org/10.7196/SAMJ.2018.v108i3.12588

A retrospective time trend study of firearm and nonfirearm homicide in Cape Town from 1994 to 2013 R Matzopoulos,1,2 PhD; J Simonetti,3 MD, MPH; M Prinsloo,2 MPH; I Neethling,2 MSc; P Groenewald,2 MB ChB, MPhil (Public Health); J Dempers,4 FC For Path (SA); L J Martin,5 FC For Path (SA); A Rowhani-Rahbar,3,6 MD, PhD; J E Myers,1 PhD; M L Thompson,7 PhD School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa Burden of Disease Research Unit, South African Medical Research Council, Cape Town 3 Harborview Injury Prevention and Research Center, University of Washington, Wash., USA 4 Department of Forensic Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa 5 Department of Forensic Medicine, Faculty of Health Sciences, University of Cape Town, South Africa 6 Department of Epidemiology, University of Washington, Wash., USA 7 Department of Biostatistics, University of Washington, Wash., USA 1 2

Corresponding author: R Matzopoulos (richard.matzopoulos@uct.ac.za) Background. Gunshot injuries from interpersonal violence are a major cause of mortality. In South Africa (SA), the Firearms Control Act of 2000 sought to address firearm violence by removing illegally owned firearms from circulation, stricter regulation of legally owned firearms, and stricter licensing requirements. Over the last few years, varied implementation of the Act and police corruption have increased firearm availability. Objectives. To investigate whether changes in firearm availability in SA were associated with changes in firearm homicide rates. Methods. This was a retrospective time trend study (1994 - 2013) using postmortem data. Time trends of firearm and non-firearm homicide rates were analysed with generalised linear models. Distinct time periods for temporal trends were assigned based on a priori assumptions regarding changes in the availability of firearms. Results. Firearm and non-firearm homicide rates adjusted for age, sex and race exhibited different temporal trends. Non-firearm homicide rates either decreased or remained stable over the entire period. Firearm homicide increased at 13% annually from 1994 through 2000, and decreased by 15% from 2003 through 2006, corresponding with changes in firearm availability in 2001, 2003, 2007 and 2011. A 21% annual increase in firearm homicide after 2010 coincided with police fast-tracking new firearm licence applications. Cape Townâ&#x20AC;&#x2122;s coloured population experienced a significantly greater increase than other population groups following additional exposure to illegal firearms from 2007. Conclusions. The strong association between firearm availability and homicide, and the reversal of a decreasing firearm homicide trend during a period of lax enforcement, provide further support for the association between reduced firearm homicide and stricter regulation. S Afr Med J 2018;108(3):197-204. DOI:10.7196/SAMJ.2018.v108i3.12756

Full article available online at https://doi.org/10.7196/SAMJ.2018.v108i3.12756

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An audit of ingested and aspirated foreign bodies in children at a university hospital in South Africa: The Pietermaritzburg experience N F Majola,1 MB ChB; V Y Kong,1 MSc, PhD, MRCS; H Mangray,1 FCS (SA); V Govindasamy,1 FCS (SA); G L Laing,1 MSc, PhD, FCS (SA); D L Clarke,1,2,3 MPhil, MBA, PhD, FCS (SA) Department of Paediatric Surgery, Grey’s Hospital, Pietermaritzburg, South Africa Department of Surgery, Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa 3 Department of Surgery, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 1 2

Corresponding author: V Y Kong (victorywkong@yahoo.com) Background. The ingestion or aspiration of foreign bodies (FBs) by children is a common problem around the world. Our centre in Pietermaritzburg, South Africa, has a dedicated paediatric surgical service, and all patients with an ingested or aspirated FB are managed under the direct care of a paediatric surgeon. Objectives. To review our centre’s experience with this problem by means of a retrospective audit and use the data to develop and refine appropriate local management guidelines. Methods. Grey’s Hospital has a hybrid electronic medical registry (HEMR) that captures patient data on admission, after a procedure and on discharge. The HEMR was reviewed and all patients with an appropriate International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10) code indicating an ingested or aspirated FB were identified and retrieved for review. Results. A total of 105 cases of FB ingestion or aspiration in children <12 years of age from January 2012 to December 2014 were identified from the HEMR. The patients’ ages ranged from 4 months to 10 years (mean 3 years and 6 months), and 59.0% (n=62) were male and 41.0% (n=43) female. A total of 107 FBs were removed (two patients each had two coins removed). The commonest FBs were coins (n=77, 71.9%), followed by batteries (n=6, 5.6%), plastic toys (n=5, 4.7%), buttons (n=5, 4.7%), screws/washers (n=3, 2.8%), seeds (n=2, 1.9%), needles (n=2, 1.9%), bones (n=2, 1.9%), a marble (n=1, 0.9%), a rubber eraser (n=1, 0.9%), a curtain hook (n=1, 0.9%), a nail (n=1, 0.9%) and a wood speck (n=1, 0.9%). Of the FBs, 67 (62.6%) were in the oesophagus, 17 (15.9%) in the respiratory system, 14 (13%) in the intestine and 9 (8.4%) in the oral cavity. The average time from ingestion/aspiration to presentation was <48 hours. Of the FBs, 67 (62.6%) were removed via rigid oesophagoscopy and 13 (12.1%) via rigid bronchoscopy, 13 (12.1%) were passed rectally, and 9 (8.4%) were removed via grasping forceps in the oral cavity, 4 (3.7%) via thoracotomy and 1 (0.9%) via emergency laparotomy. A total of 15 complications included mucosal ulceration/slough (n=6, 40.0%), oesophageal perforation (n=3, 20.0%), aspiration pneumonia (n=3, 20.0%), and tracheal perforation, lung collapse and contact bleed (n=1 each, 6.7%). No patient presented in respiratory distress or needed emergency airway management, and there were no deaths. Conclusions. The development of a dedicated paediatric surgery service and the implementation of management protocols have resulted in excellent outcomes for this problem. S Afr Med J 2018;108(3):205-209. DOI:10.7196/SAMJ.2018.v108i3.12590

Full article available online at https://doi.org/10.7196/SAMJ.2018.v108i3.12590

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Surgical skills deficiencies and needs of rural general practitioners in South Africa D C Porter,1 MB ChB, FCS (SA); J Bezuidenhout,1 DTechEd; R S du Toit,2 MB ChB, MMed, FCS (SA); A O Adefuye,1 MB ChB, MSc, PhD 1 2

Division Health Sciences Education, Office of the Dean, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa Department of Surgery, School of Medicine, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa

Corresponding author: A O Adefuye (adefuyeao@ufs.ac.za) Background. At present, much of the global surgical workforce consists of non-specialist physicians (general practitioners (GPs)) whose only formal surgical training was in medical school as an undergraduate. However, there is widespread concern that GPs do not have the skills necessary to deliver essential surgical care in a rural setting. This requires that a specific training programme be developed to train rural GPs in essential surgical skills for rural settings. Objectives. To perform a critical analysis to determine essential surgical skills required by GPs in rural South Africa, with the intention of developing the contents of an accredited continuing professional development (CPD) learning programme to address needs identified. Methods. This was a descriptive study in which a desk-top review analysis and a questionnaire survey were used to obtain both qualitative and quantitative data on essential skills required for rural surgical practice. Results. Of 300 GPs, 102 (34.0%) completed the questionnaire. Some of the skills listed as essential for rural surgical practice were removal of foreign objects not in the visual axis (90.0%), packing of epistaxis (93.0%), haematoma drainage (78.3%) and wound debridement and suturing (96.0%). The study also identified the outcomes and essential content of a proposed CPD programme to provide GPs in the rural setting with the required surgical skills. Conclusions. Enhancing skills of GPs in essential surgical techniques and procedures through an accredited CPD short learning programme will ensure that adequate and comprehensive essential surgical care is provided to people living in rural communities. S Afr Med J 2018;108(3):210-216. DOI:10.7196/SAMJ.2018.v108i3.12611

Full article available online at https://doi.org/10.7196/SAMJ.2018.v108i3.12611

An assessment of the isoniazid preventive therapy programme for children in a busy primary healthcare clinic in Nelson Mandela Bay Health District, Eastern Cape Province, South Africa F Black,1 MB ChB, MPhil (Maternal and Child Health); F Amien,2 BChD, MChD (Community Dentistry); J Shea,1 MSc, HPE 1 2

Department of Paediatrics and Child Health, Child Health Unit, Faculty of Health Sciences, University of Cape Town, South Africa School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa

Corresponding author: F Black (fayeblack@gmail.com) Background. Tuberculosis (TB) is a significant contributor to the international and national burden of disease. Global estimates suggest that there were 10.4 million new cases of TB in 2015. Children accounted for ~10% of these cases, although in South Africa (SA) this figure is thought to be higher. Despite clear evidence that isoniazid preventive therapy (IPT) can reduce the risk of progression from TB infection to disease in TB contacts, IPT has been poorly implemented in SA national TB control programmes. Objectives. To determine current practices regarding the identification and management of child contacts (<5 years of age) at a primary care clinic in the Nelson Mandela Bay Health District, Eastern Cape Province, SA.

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Methods. A cross-sectional descriptive study was conducted using a retrospective record review of infectious TB index patients aged ≥15 years. Folders of index patients with bacteriologically confirmed pulmonary TB, who started TB treatment between 21 October 2011 and 28 February 2014, were included. A sample size of 246 child contacts was required to obtain adequate power. A 95% confidence interval (CI) was used to determine statistically significant results. Results. Index patient records (N=491) were assessed and 261 child contacts identified. In a high percentage of index patient folders (87.5%; n=430), contacts were documented, although only 0.53 child contacts were identified per index patient. Of the 261 child contacts identified, 184 (70.5%) were screened for TB, 2 started TB treatment and 108/184 (58.7%) started IPT. For the remaining 74 (40.2%) children, there was no documentation of further management. Only 4 (3.7%) children completed the 24-week IPT course. Male patients reported fewer child contacts (χ2 =7.31; p=0.01; odds ratio (OR) 0.6; 95% CI 0.42 - 0.86) and were less likely to bring contacts for screening (χ2=8.98; p=0.003; OR 0.41; 95% CI 0.24 - 0.72). Retreatment index patients were also less likely to bring contacts for screening (χ2=6.37; p=0.01; OR 0.45; 95% CI 0.25 0.81) and those who were screened were less likely to initiate IPT (χ2=4.05; p=0.04; OR 0.54; 95% CI 0.3 - 0.95). Conclusions. Despite contacts being well documented, child contacts were poorly identified. The fall-out of children at each step from identification to IPT completion was unacceptably high. Contacts of male patients and retreatment index patients were at greater risk of poor management. Recommendations to improve IPT delivery at national and local level include a review of the national IPT guidelines, considering the relative success of shorter courses of TB prophylaxis, the use of standardised IPT stationery, staff training and the involvement of community health workers in contact management. S Afr Med J 2018;108(3):217-223. DOI:10.7196/SAMJ.2018.v108i3.12639

Full article available online at https://doi.org/10.7196/SAMJ.2018.v108i3.12639

The effect of different forms of heparin on point-of-care blood gas analysis P Sandler, MB ChB, Dip PEC (SA); L N Goldstein, MB BCh, MMed (Emergency Medicine), FCEM (SA), Cert Critical Care (SA) Division of Emergency Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: L N Goldstein (drg666@gmail.com) Background. Point-of-care blood gas analysis plays an integral role in the management of critically ill and injured patients presenting to the emergency department (ED). While the use of specially manufactured syringes containing electrolyte-balanced dried heparin is recommended when processing these specimens, alternatives including manually self-prepared syringes washed with liquid heparin or heparin vacutainers are still often used. Objectives. To assess the effect of two concentrations of liquid heparin and the use of heparin vacutainers on the reliability of blood gas analysis results compared with the recommended standard of dried heparin syringes in the ED setting. Methods. Blood samples were drawn from 54 patients attending a tertiary-level hospital ED. Individual samples were distributed equally among each of four different collection devices: a dried heparin syringe, self-prepared syringes washed separately with 1 000 IU/mL and 5 000 IU/mL liquid heparin, and a heparin vacutainer. Results obtained from the standard dried heparin syringes were compared with those from the other three methods. Results. For both the liquid heparin cohorts, partial pressure of carbon dioxide (pCO2), potassium (K+), sodium (Na+), ionised calcium (iCa2+) and haemoglobin had >20% of results falling beyond the total allowable error. iCa2+ and K+ results were most affected in the 5 000 IU/mL cohort and iCa2+ and Na+ in the 1 000 IU/ml cohort. pCO2, pH and iCa2+ were the most significantly affected in the heparin vacutainer cohort. Conclusions. Use of liquid heparin can result in significant negative bias in the majority of blood gas analytes, especially electrolytes. Heparin vacutainer use can result in unacceptable variations in the respiratory analytes. While standard dried heparin syringes may not always be available, it is of vital importance that practitioners be aware of these biases and limitations when using substitutes. S Afr Med J 2018;108(3):224-229. DOI:10.7196/SAMJ.2018.v108i3.12626

Full article available online at https://doi.org/10.7196/SAMJ.2018.v108i3.12626

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High positive computed tomography yields in the emergency department might not be a positive finding K Swartzberg, MB ChB, DipEC (SA); L N Goldstein, MB BCh, MMed, FCEM (SA), Cert Critical Care (SA) Division of Emergency Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: K Swartzberg (kylen.swartzberg@gmail.com) Background. There is growing pressure to reduce unnecessary computed tomography (CT) imaging requests that the radiology department receives from the emergency department (ED); however, information on acceptable usage rates and diagnostic yields remains scanty. Objectives. To describe the indications, clinical categories and positive yield rates of patients receiving CT scans in the ED. Methods. A retrospective record review was done of all patients who received CT scans at an urban, adult academic ED during a 4-month period. Primary outcomes were to establish CT scan usage and positive yield rates. Other outcomes included analysis of indications, demographics and anatomical areas scanned. Results. Scans (n=1 010) were analysed. The median age of patients was 36 (range 4 - 93) years. Male patients received 64.3% of all scans, as well as 75.7% of the scans performed for trauma. The majority of the scans were for trauma patients. However, non-trauma patients had a higher positive yield; the non-trauma positive yield rate was 61.8% compared with the trauma positive yield rate of 47.1% (p<0.001). The majority of scans performed were of the head (58%) and neck (20%), with lowest positive yield rates of 48.9% and 17%, respectively. The overall CT scan usage rate was 4.6% and overall positive rate 53.8%. Conclusions. A negative CT scan does not necessarily mean that the test was not indicated. Higher positive yield rates may reflect insufficient use of CT scanning by the ED. Local guidelines should be established to ensure judicious and effective clinical use of CT scans. S Afr Med J 2018;108(3):230-234. DOI:10.7196/SAMJ.2018.v108i3.12635

Full article available online at https://doi.org/10.7196/SAMJ.2018.v108i3.12635

Estimating the burden of cervical disease among HIV-infected women accessing screening services in South Africa: A model-based analysis C J Chibwesha,1,2 MD, MSc, FACOG; B Goeieman,1 MB BCh; S Levin,1 FRCOG; M Mulongo,1 MB BCh; M Faesen,1 FCOG (SA); A Swarts,1,3 MSc; S Ramotshela;1,3 S Williams;1 N Rakhombe;1 S Bruce;1 P Michelow,4,5 MB BCh, MSc; C Firnhaber,1,3 MD, MS Right to Care, Helen Joseph Hospital, Johannesburg, South Africa Division of Global Womenâ&#x20AC;&#x2122;s Health, Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, NC, USA 3 Clinical HIV Research Unit, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand and Helen Joseph Hospital, Johannesburg, South Africa 4 Department of Anatomical Pathology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 5 National Health Laboratory Service, Johannesburg, South Africa 1 2

Corresponding author: C J Chibwesha (carla_chibwesha@med.unc.edu) Background. Cervical cancer remains the second most common cancer among women worldwide, with much of the global burden occurring in low- and middle-income countries. HIV-infected women are at increased risk of human papillomavirus infection, preinvasive cervical disease and invasive cervical cancer (ICC). Funded through the United States Presidentâ&#x20AC;&#x2122;s Emergency Plan for AIDS Relief (PEPFAR) and working in collaboration with the South African (SA) Department of Health, our team supports cervical screening integrated within public sector HIV clinics in SA. Objectives. To estimate the burden of cervical disease among HIV-infected women accessing screening services supported through our programme.

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Methods. We constructed conditional probability models to estimate the burden of grade 1 and grades 2/3 cervical intraepithelial lesions (CIN1 and CIN2/3) and ICC among two cohorts: one consisting of 3 190 HIV-infected women for whom only cytology results were available for analysis, and another consisting of 75 358 HIV-infected women for whom neither cytology nor histology results were available. Parameter estimates for the models were derived from routinely collected programmatic data and published clinical trials. Results. Between January 2009 and November 2015, 75 358 HIV-infected women underwent Pap smear screening in public sector clinics supported by our cervical cancer prevention programme. Based on modelling analysis, we estimate that 46 123 cases of CIN1 (range 45 500 49 608), 13 598 cases of CIN2/3 (range 12 749 - 14 828), and 104 cases of ICC (range 61 - 186) occurred in this population. Conclusions. Our findings highlight the magnitude of cervical disease among HIV-infected women in SA. S Afr Med J 2018;108(3):235-239. DOI:10.7196/SAMJ.2018.v108i3.12627

Full article available online at https://doi.org/10.7196/SAMJ.2018.v108i3.12627

Restaurant smoking sections in South Africa and the perceived impact of the proposed smoke-free laws: Evidence from a nationally representative survey M Little, MA (Economics), C van Walbeek, PhD (Economics) Economics of Tobacco Control Project, Southern Africa Labour and Development Research Unit, School of Economics, University of Cape Town, South Africa Corresponding author: M Little (megan.little1@gmail.com) Background. The South African Minister of Health announced in 2016 that he intends to introduce tobacco control legislation that will prohibit smoking in restaurants. This will substantially strengthen the Tobacco Products Control Act (1993, as amended), which currently allows restaurants to have a dedicated, enclosed indoor smoking area. Objectives. To analyse current smoking policies of restaurants, whether and how these policies have changed over the past decade, and restaurateurs’ attitudes to the proposed legislative changes. Methods. From a population of nearly 12 000 restaurants, derived from four websites, we sampled 2 000 restaurants, stratifying by province and type (independent v. chain) and disproportionately sampling small strata to ensure meaningful analysis. We successfully surveyed 741 restaurants, mostly by phone. We also surveyed 60 franchisors from a population of 82 franchisors. Results. Of the restaurants sampled, 44% were 100% smoke-free, 44% had smoking sections outside, 11% had smoking sections inside, and 1% allowed smoking anywhere. Smoking areas were more common in independent restaurants (62%) than franchised restaurants (43%). Of the restaurants with a smoking section, 33% reported that the smoking sections were busier than the non-smoking sections. Twentythree percent of restaurants had made changes to their smoking policies in the past 10 years, mostly removing or reducing the size of the smoking sections. Customer requests (39%), compliance with the law (35%) and cost and revenue pressures (14%) were the main reasons for changing smoking policies. Of the restaurant respondents 91% supported the current legislation, while 63% supported the proposed legislative changes; 68% of respondents who were aware of the proposed legislation supported it, compared with 58% of respondents who were not aware of the proposed legislation. Conclusions. In contrast to the vehement opposition to the 1999 legislation, which resulted in restaurants going partially smoke-free in 2001, there was limited opposition from restaurants to the proposed legislative changes that would make restaurants 100% smoke-free. Support for the proposed legislation will probably increase as the restaurant industry and the public are made more aware of the proposed legislative changes, although public opinion is vulnerable to tobacco industry-led campaigns. S Afr Med J 2018;108(3):240-244. DOI:10.7196/SAMJ.2018.v108i3.12683

Full article available online at https://doi.org/10.7196/SAMJ.2018.v108i3.12683

March 2018, Print edition

CAREERS & CLASSIFIEDS Ladine Van Heerden Tel: 012 481 2121 | E-mail: ladinev@hmpg.co.za Makhadzi Mulaudzi Tel: 012 481 2156 | E-mail: makhadzim@hmpg.co.za We accept credit card payments - Visa or MasterCard.

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The convenient pocket-sized design enables you to fit it comfortably into your hospital bag or coat pocket, so it 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), a joint initiative of the can always be at hand for ready reference. South African Medicines Formulary (SAMF), a joint initiative of the University of Cape Town’s Division of Clinical Pharmacology and the Health and Group, PublishingGroup, MedicalPublishing andMedical Health the University of Cape Town’s Division of Clinical Pharmacology and publishers for the South African Medical Association, provides easy access to the latest, scientifically accurate publishers for the South African Medical Association, provides easy access to the latest, scientifically accurate information, including full drug profiles, clinical notes and special prescriber’s points. Th e thoroughly updated information, including full drug profiles, clinical notes and special prescriber’s points. The thoroughly updated 12th edition of SAMF is your essential reference to the rational, cost-effective and safe use of medicines. 12th edition of SAMF is your essential reference to the rational, cost-effective and safe use of medicines.

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True (A) or false (B): SAMJ Mental illness in the Western Cape Province, South Africa (SA): A review of the burden of disease and healthcare interventions 1. Neuropsychiatric disorders were ranked third as contributors to disability-adjusted life-years in SA. 2. Based on the revised national disability-adjusted life-year (DALY) estimates from the SA National Burden of Disease Study, neuropsychiatric disorders were ranked third, after HIV/AIDS and other infectious diseases, as contributors to the burden of disease. A retrospective time trend study of firearm and non-firearm homicide in Cape Town from 1994 to 2013 3. SA had one of the worldâ&#x20AC;&#x2122;s highest homicide rates in 2000, estimated to be five and eight times higher than the global average for females and males, respectively. 4. In the USA, firearm ownership is not known to be a significant predictor of firearm homicide rates An audit of ingested and aspirated foreign bodies in children at a university hospital in SA: The Pietermaritzburg experience 5. The ingestion or aspiration of foreign bodies (FBs) by children is a common problem around the world. 6. Aspiration of an FB can be life-threatening, as the FB can acutely occlude the proximal airway. An assessment of the isoniazid preventive therapy programme for children in a busy primary healthcare clinic in Nelson Mandela Bay Health District, Eastern Cape Province, SA 7. Global estimates suggest that there were 10.4 million new cases of TB in 2015. 8. The burden of childhood TB can be greatly reduced by active contact tracing and diligent prescribing of chemoprophylaxis to patients in whom active TB has been excluded.

CME Acquired bleeding disorders 11. Regarding clotting factor deficiencies, coagulation factor inhibitors are antibodies that neutralise specific coagulation factors. 12. The presence of inhibitors is suspected in a patient with abnormal bleeding without any prior bleeding diathesis, or when a patient with known haemophilia has more extreme bleeding than usual or fails to achieve haemostasis after factor replacement. 13. Acquired haemophilia A is a rare condition, affecting ~1 per million of the population per year. 14. In contrast to inherited haemophilia, acquired haemophiliaÂ A affects both males and females and is most common in the elderly (median age 64 - 78 years). 15. Vitamin K deficiency is encountered in various scenarios, and the causes include haemorrhagic disease of the newborn (currently termed vitamin K deficiency bleeding). 16. Therapy for vitamin K deficiency is oral or intravenous vitamin K. 17. Warfarin impairs production of vitamin K-dependent coagulation factors. 18. Management of warfarin-associated bleeding depends on the severity of bleeding, the level of the international normalised ratio and the indication for anticoagulation. 19. Heparin is an anticoagulant that works by binding to and potentiating the activity of antithrombin, which then inhibits thrombin. 20. Platelet defects are typically associated with mucocutaneous bleeding, with the severity depending on the degree of the thrombocytopenia.

Estimating the burden of cervical disease among HIV-infected women accessing screening services in SA: A model-based analysis 9. Despite the availability of cost-effective prevention strategies, cervical cancer remains among the most common cancers worldwide. 10. In sub-Saharan Africa, where the vast majority of disease occurs, cervical cancer is the leading cause of cancer death among women.

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March 2018, Print edition

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