SAMJ Vol 104, No 9 (2014)

SEPTEMBER 2014

VOL. 104 NO. 9

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Health in SA prisons – on the anniversary of Biko’s death

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Troponin surveillance after non-cardiac surgery

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Treatments for atrial fibrillation Hepatitis B immunity in children in oncology units Rheumatic heart disease on the decline CME: Medical management of pregnancy

SAMF

SEPTEMBER 2014 VOL. 104 NO. 8 588-644

Hepatitis B vaccine at birth to prevent hepatocellular carcinoma

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SEPTEMBER 2014

FROM THE EDITOR

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Reflections … they called it ‘restructuring’ J Seggie

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EDITOR’S CHOICE

VOL. 104 NO. 9

EDITOR Janet Seggie, BSc (Hons), MD (Birm), FRCP (Lond), FCP (SA) EDITOR EMERITUS Daniel J Ncayiyana, MD (Groningen), FACOG, MD (Hon), FCM (Hon)

CORRESPONDENCE 593

Rationing healthcare in South Africa: Renal replacement therapy – a case in point J Fabian, R Britz, A Sparaco, S Wadee, E Gottlich, T Sideris

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Improved surgical output in district hospitals relies more on softer ingredients than on formal postgraduate training time K Beviss-Challinor

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Access to flucytosine for HIV-infected patients with cryptococcal meningitis – an urgent need N P Govender, G Meintjes, S Banoo

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Shielding blood donors from harm C F Ingram, G R M Bellairs

CONSULTING EDITOR JP de V van Niekerk, MD, FRCR DEPUTY EDITOR Bridget Farham, BSc (Hons), PhD, MB ChB EDITORIAL SYSTEMS MANAGER Melissa Raemaekers, BSc (Hons), PhD SCIENTIFIC EDITOR Ingrid Nye, BSc TECHNICAL EDITORS Paula van der Bijl, BA, HDipLib Emma Buchanan, BA NEWS EDITOR Chris Bateman | Email: chrisb@hmpg.co.za

IZINDABA

HEAD OF PUBLISHING Robert Arendse

597 598 600

CoN – lifeline for patients, noose for healthcare providers?

Promote cheaper generic drugs to patients – and help contain medical inflation Breaching the chasm between what’s law and what’s done

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OBITUARIES Bernard Mandell Jean Mary Sharpe

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BOOK REVIEW Doctors Without Borders: Humanitarian Quests, Impossible Dreams of Médecins Sans Frontières

SAMJ FORUM

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Simplifying trauma airway management in South African rural hospitals M Berry, D Wood

HEAD OF SALES AND MARKETING Diane Smith | Tel. 012-481-2069 Email: dianes@samedical.org

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Should HIV be a notifiable disease? Old questions with some new arguments W D F Venter, A Black, L Allais, M Richter

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Preventing hepatitis B and hepatocellular carcinoma in South Africa: The case for a birth-dose vaccine C W N Spearman, M W Sonderup

PROFESSIONAL ADVERTISING Bronlyne Granger | Tel. 021-681-7000 E-mail: bronlyne.granger@hmpg.co.za

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HMPG BOARD OF DIRECTORS Prof. M G Veller (Chair), Prof. M Lukhele, Dr M Mbokota, Prof. A A Stulting, Dr M R Abbas, Dr G Wolvaardt

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The state of our prisons and what this reveals about our society S Benatar

ASSOCIATE EDITORS Q Abdool Karim, A Dhai, N Khumalo R C Pattinson, A Rothberg, A A Stulting, J Surka, B Taylor, M Blockman

RESEARCH

ISSN 0256-9574

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Utilisation of prehospital intravenous access B H Bester, S Sobuwa

619

The pharmacoeconomics of routine postoperative troponin surveillance to prevent and treat myocardial infarction after non-cardiac surgery A Torborg, L Ryan, G Kantor, B M Biccard

623

A survey on the treatment of atrial fibrillation in South Africa R M Jardine, J Fine, I W P Obel

628

Investigating hepatitis B immunity in patients presenting to a paediatric haematology and oncology unit in South Africa A Büchner, F E Omar, J Vermeulen, D T Reynders

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September 2014, Vol. 104, No. 9

Publisher website: www.hmpg.co.za SAMA website: www.samedical.org Journal website: www.samj.org.za

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Rheumatic fever and rheumatic heart disease in Gauteng on the decline: Experience at Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa A M Cilliers

CONTINUING MEDICAL EDUCATION 635

GUEST EDITORIAL Women’s health and human rights R Burton, L Acquah

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REVIEW Obstetric medicine: Interlinking obstetrics and internal medicine L Acquah, R Burton

640

ARTICLES Papshop: Not a ‘melon’choly Pap smear workshop!

C Gordon

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Pregnancy and cardiac disease C Elliott, K Sliwa, R Burton

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Pregnancy and the kidneys N Wearne

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Rheumatic diseases and pregnancy A Gcelu

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Contraception: Everyone’s responsibility M Patel

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The Milky Way and the Wolfberg Arch in the Cederberg Mountains, South Africa.

Photo and text: Eric Nathan Email: eric@ericnathan.com

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September 2014, Vol. 104, No. 9

FIRST PUBLISHED IN 1884

Reflections … they called it ‘restructuring’[1] I write this on the eve of my second anniversary as Editor-in-Chief (E-in-C) of HMPG. Within six months of my apppointment, I was informed that there would be a restructuring of HMPG. There existed a clear imperative – ‘a negative financial result stretching over the previous seven years’.[2] The triumphant result was that ‘since starting to implement their financial turnaround strategy with the appointment of a CEO to implement such strategy in September 2013, a negative financial result … was turned into a net profit of approximately R1.5 million. Although the strategy implemented included drastic cuts in expenses, strategic imperatives implemented created innovative future solutions and a strengthened working relationship between the SAMA subsidiaries, to the benefit of all SAMA members.’[2] There being some parallels, I followed with interest coverage of events after the appointment in June 2011 of Jill Abramson (JA) as the first female E-in-C of the prestigious New York Times (NYT), especially as in 1962, the Assistant Managing Editor had declared that ‘no woman will ever be an editor at the NYT’.[3] Welcomed by women journalists, JA transformed the NYT’s masthead, elevating many women into editorship positions. Equally compelling was the story of her firing in mid-May of this year.[4,5] The foremost issue facing the NYT as JA took over (as with HMPG, and indeed publishing globally) was financial,[4] reflecting tough economic times and declining revenues from advertising. JA found herself accepting so-called ‘native’ advertising (the practice of publishing an advert – say, for a make of car – in a story about a family travelling to holiday in one of America’s national parks).

Her perceived intrusion of the business side into the newsroom allegedly led to clashes with the company’s CEO. The opinion of the legendary Richard Smith, Editor Emeritus of the BMJ, on editorial independence, defined as ‘a space in editors’ heads – a complex function of their personality, courage, power, and the pressures they feel from owners, business people, and others’,[6] comes to mind.

One of the reasons for JA’s hiring was her impressive comfort with the digital age: as she put it, ‘the digital present is here – digital first’.[7] While acknowledging that the combination of online and print might prove challenging for her readership, JA’s NYT succeeded in recruiting subscribers to its digital version. Depressingly, revenues continued to fall.[3] While the SAMJ and its sister journals are all open access and available free online, HMPG is currently stalled in the digital past.

There is a risk that the research work we publish is overlooked owing to lack of smooth entry into cyberspace libraries such as PubMed Central. We are grateful for SciELO South Africa, established by the Academy of Science of South Africa (ASSAf), which enhances the discoverability/visibility of the published research and through which SAMJ and SAJS (and imminently the sister HMPG titles) are hosted.[8] Plans are well in hand to move the HMPG titles properly into the digital space, as intimated in the Editor’s Choice of September 2012[9] and my editorial of February 2013.[10] Significantly, the SAMJ’s readership (determined by Google Analytics (GA)[11] ) is young, with the majority in the 25 - 44-year age group and many under 24 years (which must mean that medical students are reading us). Im­patient of print, young people belong to the TLDR (too long, don’t read) generation, preferring to receive their reading ‘lite’ on mobile platforms. According to GA, 35% of readers use tablets and phones to access the journal.

HMPG began to point the way with CPD (now exclusively available

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online, a change that has been welcomed by CPD participants) and with CME. Merged with SAMJ, the print CME carries summaries of articles, with full versions available online. The same is envisaged for SAMJ, since ‘readers of research articles rarely look in detail at the results and discussion and prefer to look at the abstract, then at the conclusions and illustrations … the expected (r)evolution is that paper versions will become a by-product of online publication’.[10] This will be implemented as soon as we achieve, to echo JA, digital first.

Some staff in the editorial room at the NYT found JA intimidating, tough and brusque.[4] The head of the Harvard School of Journalism, formerly E-in-C of the Chicago Tribune, and three female journalists agreed that a woman as E-in-C or CEO must be ‘assertive but not aggressive, strong but not too strong, empathic and caring but not motherly’. Would (speculation went) a man have been faulted for being ‘tough’?[12] The alleged official ‘straw that broke the camel’s back’ was JA’s contestation, through lawyers, that she was paid less than her male predecessors.[3] It is acknowledged that female journalists are paid 20% less than males,[12] but the question was asked … why did the NYT, which had previously been sued by its female employees for discriminatory practices, run the risk of underpaying JA? Fortunately, I have no quarrel with my salary. Nor am I guilty of being intimidating or tough, but will own to sometimes being brusque.

So HMPG has turned ‘a negative financial result … into a net profit of R1.5 million’. All good, but belying the reality faced by my small team of academic/editorial staff and one journalist, who hung in there with the company – evidence of extraordinary commitment, to which I wish to pay tribute. They have emerged manifesting no signs of the ‘survivor syndrome’ – decreased levels of morale, involvement, work productivity and trust towards management – that is recog­nised as a common aftermath of the restructuring process.[13] 2015 beckons …

Janet Seggie

Editor janet.seggie@hmpg.co.za 1. Restructuring. http://en.wikipedia.org/wiki/Restructuring (accessed 24 June 2014).

2. Lemmer Y. SAMA’s 2014 National Council meeting. SAMA Insider 2014; July, p. 8.

3. Auletta K. Changing times: Jill Abramson takes charge of the Gray Lady. The New Yorker 2011; 24 October. http://www.newyorker.com/reporting/2011/10/24/111024fa_fact_auletta?currentPage=all (acc­essed 24 June 2014).

4. Auletta K. Why Jill Abramson was fired. The New Yorker 2014; 14 May. http://www.newyorker.com/ online/blogs/currency/2014/05/why-jill-abramson-was-fired.html (accessed 24 June 2014).

5. Auletta K. Jill Abramson and the Times: What went wrong. The New Yorker 2014; 15 May. http://www. newyorker.com/online/blogs/newsdesk/2014/05/jill-abramson-and-the-times-what-went-wrong. html (accessed 24 June 2014).

6. Smith R. Editorial independence at the BMJ. BMJ 2004;329:0-g. [http://dx.doi.org/10.1136/ bmj.329.7457.0-g] 7. Charlie Rose Bloomberg Businessweek Videos. How Jill Abramson intends to lead the New York Times into the vast digital frontier. http://www.businessweek.com/videos/2011-10-26/10-18-ny-timesexecutive-editor-jill-abramson (accessed 15 May 2014).

8. Veldsman S, Gevers W. Increased visibility and discoverability of South African health-related research. S Afr Med J 2014;104(4):287. [http://dx.doi.org/10.7196/SAMJ.7934] 9. Van Niekerk JP. Editor’s Choice. S Afr Med J 2012;102(9):718.

10. Seggie J. There are no schools for medical editors. S Afr Med J 2013;103(2):65-66. [http://dx.doi. org/10.7196/SAMJ.6618] 11. Google Analytics. http://www.google.com/analytics/ (accessed 21 July 2014).

12. Charlie Rose Bloomberg Businessweek Videos. A discussion about the replacement of New York Times executive editor Jill Abramson with Ken Auletta; Dylan Byers; Rebecca Traistter and Ann Marie Lipinski. We conclude with Thierry de Montbrial. http://www.businessweek.com/videos/2014-05-15/ jill-abramson-charlie-rose-05-15 (accessed 16 May 2014).

13. Appelbaum SH, Delage C, Labib N, Gault G. The survivor syndrome: Aftermath of downsizing. Career Development International 1997;2/6:278-286. http://www.researchgate.net/publication/235279297_ The_survivor_syndrome_aftermath_of_downsizing (accessed 24 July 2014).

S Afr Med J 2014;104(9):590. DOI:10.7196/SAMJ.8766

September 2014, Vol. 104, No. 9

EDITOR’S CHOICE

CME: Obstetric medicine

Globally, medical problems in pregnancy are an increasing chall­enge, and in South Africa (SA) they account for almost 50% of all maternal deaths. While HIV remains the major cause of maternal mortality, non-HIV-related medical problems are increasingly significant.

Obstetric physicians have a specific role in managing pregnant and postpartum women with medical problems, and in partnership with obstetricians can contribute to reducing maternal morbidity and mortality. There are physiological changes in almost all systems in pregnancy, and changes in the cardiovascular and respiratory systems and haematological changes are particularly important when assessing the cause and management of medical problems in pregnant women. Medical problems in pregnancy may be unique to pregnancy, exacerbated by it, or unrelated to it. They may be present prior to pregnancy, or present for the first time in pregnancy. Some are worsened by pregnancy. Pregnant women may improve or remain stable, or their disease may predictably or unpredictably deteriorate.

In this issue of CME, Rosie Burton, Letitia Acquah and their team cover most of the major medical problems that generalists will encounter in their pregnant patients, with practical advice on management and referral.

Should HIV be a notifiable disease?

In 1988, when fewer than 100 people with HIV had been identified in SA, the question of notification was discussed in the SAMJ. At the time, the Minister of Health, Nkosazana Dlamini Zuma, strongly advocated notification of HIV. Venter and colleagues[1] rejoin the debate and suggest that its time is past, because access to HIV testing is now widespread and effective therapy is freely available. They argue that in 2014, setting up the notification debate as one of public health v. human rights is misguided; public health benefits are not large or even likely, and do not outweigh the human rights burdens.

Routine postoperative troponin surveillance after non-cardiac surgery

The only way to identify patients who have had a postoperative troponin leak secondary to myocardial ischaemia after non-cardiac surgery (MINS) is to conduct routine postoperative troponin surveillance – especially as 65% of patients suffering a myocardial infarction postoperatively will be asymptomatic and will also not be recognised through serial ECG monitoring. Torborg et al.[2] conclude that this is a potentially cost-effective intervention, provided effective therapy is immediately provided in response to the troponin leak.

The simple and inexpensive introduction of statin and aspirin therapy following diagnosis of MINS has the potential to prevent progression to myocardial infarction; whether such therapy may also decrease mortality is currently unknown.

Hepatitis B

From April 1995, the hepatitis B virus (HBV) vaccine was included in the SA Expanded Programme of Immunisation at 6, 10 and 14 weeks of age. However, no ‘catch-up’ immunisation of older age groups was implemented. Spearman and Sonderup[3] make the case for ensuring a birth dose (within 12 - 24 hours of delivery) of HBV vaccine to all babies to prevent perinatal transmission. This is even more important when the mother has HIV/HBV co-infection, which increases the risk of perinatal transmission. Challenges will be faced in rural areas where there is a higher prevalence of hepatitis B and home births occasionally occur, but studies have confirmed the thermostabilty of HBV vaccines outside the cold chain, assisting access to the birth dose in rural areas. A four-dose schedule will be slightly more costly than the current three-dose schedule.

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The prevalence of HBV infection in patients with haematological malignancies is higher than that in the general population because of the immune suppression induced by cytotoxic chemotherapy. Immune suppression may also lead to reactivation of occult HBV infection and increased HBV replication. A large group of patients attending the paediatric haematology and oncology unit at Steve Biko Academic Hospital in Pretoria did not have sufficient protective antibodies against HBV at first presentation, despite being vaccinated.[4] The authors suggest that since such patients are at risk of hepatitis B infection, active surveillance and continued screening for HBV must be done at first presentation of all patients attending a paediatric haematology and oncology unit, and regularly during treatment and follow-up. A programme to immunise all seronegative patients against HBV should be implemented, and the response to immunisation documented. The use of combined passive-active immunisation should be encouraged, especially in children with haematological malignancies and HIVinfected children. An effective screening and vaccination programme in the unit should protect all patients from contracting HBV.

Treatment of atrial fibrillation in SA

Atrial fibrillation (AF) is the most common cardiac arrhythmia, with a prevalence of 5 - 6% in the 65-year-old population, which increases up to 10% in the population aged >80 years. In SA, the prevalence of AF in the urban Black population has recently been documented to be 7% in a cardiovascular disease cohort (8% of heart failure patients, 4% of hypertensive patients, and 13% of valve disease patients).

However, very little has been published on AF management outside the developed world.

This prompted the Assessment of the Therapeutic Management of Patients with Atrial Fibrillation in South Africa (SAFIR-RSA), involving 302 AF patients (60% male) from 29 centres.[5] The principal objective was to assess the baseline characteristics of patients with AF and the treatment modalities utilised, particularly the use of rate and rhythm control strategies. The study also looked at hospitalisation rates and thromboembolic prevention. The mean age (standard deviation) was 67 (13) years (range 21 - 95). The mean waist circumference was 101.6 (17.8) cm and mean the body mass index 28.8 (5.9) kg/m2, indicating a high prevalence of overweight patients in the cohort.

The single most prevalent clinical characteristic was hypertension (65.9%). Other coronary risk factors (dyslipidaemia 48.3% and diabetes 15.6%) were also frequent. Concomitant structural heart disease was common, with 27.5% having valvular disease (of which 79.5% had mitral valve disease), 26.8% coronary artery disease, and 32.5% heart failure.

Notably, the prevalence of underlying comorbidities such as coronary artery disease, valvular disease and heart failure was similar (~20 - 30% for each) to those reported in the developed world. For stroke prevention, 75.2% were on warfarin, 39.4% on aspirin and 5% on clopidogrel. The authors concluded that AF is a significant burden in cardiology practice in this country, with considerable resource utilisation and morbidity for patients. The survey also highlighted a lack of rigour in applying definitions of rate control and underutilisation of antithrombotic therapy.

Rheumatic fever and RHD in Gauteng

The last epidemiological study of rheumatic heart disease in schoolchildren, undertaken 30 years ago in 1972, found a very high prevalence of 6.9/1 000 in children in Soweto, Johannesburg. A marked decline in children presenting with acute rheumatic fever (ARF) and chronic rheumatic heart disease (RHD) over the past two decades has been observed at Chris Hani Baragwanath Academic Hospital in Soweto.[6] The number of children documented to have ARF and RHD declined from 64 in the year 1993 to 3 in 2010.

September 2014, Vol. 104, No. 9

EDITOR’S CHOICE

This decrease may be attributed to an improvement in socioeconomic conditions and better access to medical care for the referral population over the last two decades, mirroring the improved trend in socioeconomic status of SA’s population over the past 15 years.

There has been an increase in the average annual household income, improved access to amenities such as electricity, and a decrease in the average household size. This improvement in lifestyle, with less overcrowding, may be important in decreasing exposure to the rheumatogenic strains of the streptococcus organism.

JS

1. Venter WDF, Black A, Allais L, Richter M. Should HIV be a notifiable disease? Old questions with some new arguments. S Afr Med J 2014;104(9):607-609. [http://dx.doi.org/10.7196/SAMJ.8468] 2. Torborg A, Ryan L, Kantor G, Biccard BM. The pharmacoeconomics of routine postoperative troponin surveillance to prevent and treat myocardial infarction after non-cardiac surgery. S Afr Med J 2014;104(9):619-623. [http://dx.doi.org/10.7196/SAMJ.7654] 3. Spearman CWN, Sonderup MW. Preventing hepatitis B and hepatocellular carcinoma in South Africa: The case for a birth-dose vaccine. S Afr Med J 2014;104(9):610-612. [http://dx.doi.org/10.7196/ SAMJ.8607] 4. Büchner A, Omar FE, Vermeulen J, Reynders DT. Investigating hepatitis B immunity in patients presenting to a paediatric haematology and oncology unit in South Africa. S Afr Med J 2014;104(9):628631. [http://dx.doi.org/10.7196/SAMJ.7952] 5. Jardine RM, Fine J, Obel IWP. A survey on the treatment of atrial fibrillation in South Africa. S Afr Med J 2014;104(9):623-627. [http://dx.doi.org/10.7196/SAMJ.8111] 6. Cilliers AM. Rheumatic fever and rheumatic heart disease in Gauteng on the decline: Experience at Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa. S Afr Med J 2014;104(9):632634. [http://dx.doi.org/10.7196/SAMJ.8318]

This month in the SAMJ ...

Prof. Wendy Spearman* heads the Division of Hepatology in the Department of Medicine, Faculty of Health Sciences, University of Cape Town, and the liver transplant programme at Groote Schuur Hospital, Cape Town. She has an FCP and a PhD in work on T-lymphocyte proliferative responses. Her work includes both paediatric and adult hepatology and liver transplantation, with research interests including viral hepatitis, acute liver failure, autoimmune liver disease and novel immunosuppressants.

Dr Mark Sonderup* is the senior specialist in the Division of Hepatology in the Department of Medicine, Faculty of Health Sciences, University of Cape Town, and Groote Schuur Hospital, Cape Town. He has an FCP and MMed in work on liver disease in patients with HIV. His research interests include liver disease in HIV, viral hepatitis, drug-induced liver injuries and the porphyrias and their associated liver disease. * Spearman CWN, Sonderup MW. Preventing hepatitis B and hepatocellular carcinoma in South Africa: The case for a birth-dose vaccine. S Afr Med J 2014;104(9):610612. [http://dx.doi.org/10.7196/SAMJ.8607]

Prof. Antoinette Cilliers† is head of Paediatric Cardiology at Chris Hani Baragwanath Academic Hospital, Soweto, Johannesburg, and an adjunct professor in the Department of Paediatrics and Child Health in the Faculty of Health Sciences, University of the Witwatersrand. She holds an MB BCh and a Diploma in Child Health, and is a fellow of the Royal College of Physicians. Her interests include all aspects of clinical, diagnostic and interventional paediatric cardiology, as well as the training of undergraduates and fellows specialising in paediatric cardiology. †

illiers AM. Rheumatic fever and rheumatic heart disease in Gauteng on the decline: Experience at Chris Hani Baragwanath Academic Hospital, Johannesburg, South C Africa. S Afr Med J 2014;104(9):632-634. [http://dx.doi.org/10.7196/SAMJ.8318]

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September 2014, Vol. 104, No. 9

ADVERTORIAL

PROTEIN IN SPORTS

PART OF THE RED MEAT IN NUTRITION & HEALTH SERIES

The connection between the food we eat and our physique, health and physical performance is undeniable. Nutrition has been identified as the single factor that may have more to offer the athlete than any other.1 How much protein do athletes need?

Protein foods need to supply the correct amount of amino acids to build new body protein and repair damaged tissue Sports nutritionists recommend protein intakes varying between 1.2 and 1.7 gram per kg per day2,3 What determines muscle protein synthesis?

Dosage: A dose of 8g to 9g of the essential amino acids has been found to produce maximum muscle protein synthesis.2,3 Translated into food intake this represents eating ±20g of high-quality protein.

Type of Protein: A study found that 20g of high-quality standard food protein (obtained from skim milk, beef steak, boiled eggs and a liquid protein shake) produced excellent results. Results obtained with proteins from plant origin such as soy milk were lower.4 Timing of intake: Eating these foods (in portions delivering a dose of 8g of essential amino acids) as soon as possible after training, produces the most positive results for protein synthesis and repair.

Cooked food portions that will provide 20g protein5 (Portions marked with a * provide all 9 essential amino acids) 70g to 90g lean beef, lamb, pork or turkey* 70g to 90g chicken white meat, without skin* 80g to 110g chicken dark meat, without skin* 75g to 110g liver (beef, lamb or chicken)* 75g to 110g meatballs made with egg* 30g biltong*

High-quality protein from red meat As an important source of protein of the highest quality, 70g to 90g lean red meat can on average provide 20g of protein containing all 9 essential amino acids, namely lysine, threonine, histidine, methionine, phenylalanine, tryptophan, leucine, isoleucine and valine, to the diet. These amino acids are classified as ‘essential’ because they must be obtained from the diet. They are key contributors to muscle growth and assist in the repair of damaged muscle tissue.

NOTE: Athletes and recreational sportsmen and women are urged to adhere to the quantities defined by expert sports nutritionists.3 Excessive protein intake is not desirable, as the surplus amino acids which the body cannot use will be oxidised and thus increase urea levels, which can lead to many undesirable side effects such as gout.

Timing of protein meals: The Pre-Exercise Meal: The pre-exercise meal about 1 to 4 hours before exercise should be high in carbohydrates with a moderate protein content.

Protein intake after training: To be able to refuel, rehydrate and repair damaged muscle tissue, athletes need to combine 20g of high-quality protein with their carbohydrate intake as soon as possible after exercise.2,6 Protein before sleep: A relatively new approach has been suggested7 which recommends ingestion of dietary protein just before sleep to increase the adaptive response of muscles to training and to further improve training efficiency.

90g beef tongue* 80g drained, canned tuna* 100g steamed hake or salmon* 110g canned pilchards in tomato sauce* 150g eggs* (3 large eggs) 190g low-fat cottage cheese* 450ml low-fat plain yoghurt* 3 to 4 glasses of skim or low-fat milk* 120g cooked soybeans 220g chickpeas, lentils or kidney beans 3 cups of cooked rice or pasta

Healthy Meat

HealthyMeatZA

NOTE: Carbohydrate intake should be adequate and contribute at least 50-60% of daily energy, so that protein is not used for fuel. Further, by combining protein with carbohydrates, the release of the hormone insulin will be stimulated which will in turn stimulate the athlete’s muscles to take up amino acids.

REFERENCES 1. Burke & Deakin. Clinical sports nutrition, 2nd ed.; The McGraw-Hill Company PTY Limited: Australia, 2002. 2. Beelen et al. International Journal of Sport Nutrition & Exercise Metabolism 2010, 20, 515-532. 3. Coleman. Clinical Nutrition Insight 2012, 38 (9), 1-3. 4. Burke et al. International Journal of Sports Nutrition & Exercise Metabolism 2012, 22, 452-462. 5. Wolmarans et al. Condensed Food Composition Tables for South Africa; Medical Research Council: Cape Town, 2010. 6. New Zealand Beef & Lamb. Food for sport - Good nutrition to aid performance; New Zealand Beef & Lamb: New Zealand, 2009. 7. Van Loon. Sports Science Exchange, 2013, 26 (117), 1-5.

www.healthymeat.co.za

An educational campaign translating current science into consumer friendly messages.

Supported by the Red Meat Industry of South Africa.

SAMJ_RM_Jan2014

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CORRESPONDENCE

Rationing healthcare in South Africa: Renal replacement therapy – a case in point

To the Editor: The South African Dialysis and Transplant Registry issued its last report on renal replacement therapy (RRT) in South Africa (SA) in 1994, followed by an unfortunate hiatus for 20 years.

The recent publication of the long-awaited South African Renal Registry Annual Report 2012 should be highly commended.[1] The private sector deserves to be acknowledged for its financial support of this initiative. Since 1994, the SA population has increased from 40.436 million to 52.275 million and the treatment rate for end-stage renal disease (ESRD) per million population (pmp) has improved from 70 pmp in 1994 to 164 pmp in 2012.[1] The treatment rate in 2012 for the public sector is essentially unchanged at 73 pmp, compared with 620 pmp (of insured persons) in the private sector. In contrast, the low national kidney transplant rate of 4.7 pmp highlights the dire need for organs.[1] Between 1994 and 2012, the number of public sector treatment centres offering dialysis increased from 26 to 28, while in the private sector there was an increase from 5 to 163.[1] There has been a population-appropriate change in the relative representation of different ethnic groups, with a 64% increase in black patients accessing RRT since 1994 and a drop of 50% in white patients. There are still two provinces in SA – Limpopo and Mpumalanga – with no public dialysis facility.

The annual increase in people requiring RRT worldwide is estimated to be 8%, which is far in excess of the global population growth rate of 1.3%.[2] In the light of a large chronic disease burden in SA, contributed to by both communicable and non-communicable diseases, with chronic kidney disease arising largely from diabetes, hypertension, obesity and HIV,[3] an increase in RRT services beyond 8% is required.

In 2006, Professor M R Moosa of Tygerberg Academic Hospital (TAH), Cape Town, stated: ‘In 1997, the funding of our dialysis unit was capped to allow treatment of 80 patients with [ESRD] and has remained unchanged since.’[4] He showed that 52% of ESRD patients are denied RRT treatment at TAH.[4] Despite ongoing rationing without review and the subsequent denial of treatment, there is very little public awareness and debate around the rationing process and policy that regulates patient access to RRT. There is also no independent body that reviews the medical ethics of rationing in the public sector (which is often centre-specific).

Kidney transplant rates remain low. In 2012, there were no kidney transplants performed in public sector centres in either Free State or KwaZulu-Natal provinces. In Gauteng and the Western Cape, 22 and 21 kidney transplants, respectively, were performed at public sector transplant units. Of the 110 adult cadaveric kidney transplants done in 2012, 43 (39.1%) were in the public sector. The discrepancy between private and public sector transplant rates and regional differences in transplant activity highlight the complexity around organ procurement, organ allocation and transplantation in different regions, which is a separate, complex debate.

In the light of the registry data, the government needs to be made aware of these figures for planning and service provision in the public sector. The Minister of Health, Dr Aaron Motsoaledi, has met with Prof. Razeen Davids, first author of the South African Renal Registry Annual Report 2012,[1] to discuss the data. He has constructively suggested a summit later this year to discuss chronic/ ESRD management strategies.

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June Fabian

Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa, and Research Unit, Wits Donald Gordon Medical Centre, Johannesburg june.fabian@mweb.co.za

Russell Britz

Head of the Division of Transplantation Surgery, Charlotte Maxeke Johannesburg Academic Hospital, South Africa, Department of Surgery, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, and Wits Donald Gordon Medical Centre, Johannesburg

Anna Sparaco

Division of Transplantation Surgery, Charlotte Maxeke Johannesburg Academic Hospital, South Africa, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, and Wits Donald Gordon Medical Centre, Johannesburg

Shoyab Wadee

Nephrologist in private practice, Wits Donald Gordon Medical Centre, Johannesburg, South Africa

Errol Gottlich

Paediatric nephrologist in private practice, Morningside Mediclinic, Johannesburg, South Africa

Tina Sideris

Clinical Psychologist, Wits Donald Gordon Medical Centre, Johannesburg, South Africa 1. Davids M, Marais N, Jacobs J. South African Renal Registry Annual Report 2012. Cape Town: South African Renal Society, 2014.

2. Schieppati A, Remuzzi G. Chronic renal diseases as a public health problem: Epidemiology, social, and economic implications. Kidney Int Suppl 2005;68(Suppl 98):S7-S10.

3. Mayosi BM, Flisher AJ, Lalloo UG, Sitas F, Tollman SM, Bradshaw D. The burden of noncommunicable diseases in South Africa. Lancet 2009;374(9693):934-947. [http://dx.doi.org/10.1016/ S0140-6736(09)61087-4] 4. Moosa MR, Kidd M. The dangers of rationing dialysis treatment: The dilemma facing a developing country. Kidney Int 2006;70(6):1107-1114.

S Afr Med J 2014;104(9):593. DOI:10.7196/SAMJ.8559

Improved surgical output in district hospitals relies more on softer ingredients than on formal postgraduate training time

To the Editor: Mash et al.[1] have suggested that part of the solution to improving surgical and other services at the district hospital may lie in an approach that places full-time specialist family physicians and associate clinicians at district hospitals with periodic outreach from surgical specialists. However, I submit that a solution to district healthcare already exists in the example of Kokstad Medical Centre (KMC), and that it is less reliant on formal specialist family physician training and surgical outreach than on the softer ingredients required to assemble a team of inspired rural practitioners committed to delivering optimal healthcare outcomes.

KMC currently has five full-time general practitioners (GPs) and two assistant GPs of varying ages (29 - 56 years) along with support staff. We operate as rural generalists in Kokstad, Sisonke Health District (SHD), KwaZulu-Natal, in South Africa’s private health sector.

None of the practitioners has spent time in postgraduate specialist family physician posts, although two have MFGP qualifications that have not been granted specialist status.

I believe that KMC effectively addresses surgical need in SHD. For example, during the 5 years ending 31 December 2013, we performed and provided anaesthesia for 280 appendicectomies in addition to performing and/or providing anaesthesia for 868 caesarean sections

September 2014, Vol. 104, No. 9

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(other generalists also use KMC to provide anaesthesia) and the majority of procedures that should be performed by specialist family physicians according to expert consensus.[2] Note that this is the same district in which Kong et al.[3,4] reported alarming morbidity (mean total hospital stay 8 days, re-laparotomy rate 60.5%, mortality 3.5%) and associated cost escalation for patients presenting to public sector facilities with acute appendicitis, largely the result of delayed time to surgical source control, as access to appropriate surgical care in the district was nil. Proof of volume does not prove quality or cost-effectiveness of a service, particularly in a fee-for-service environment; an audit will therefore be undertaken.

Longmore and Ronnie[5] bravely pointed out what local practi­ tioners know to be a significant part of the public health problem: poor human resource management (HRM). I believe good HRM to be a critical part of the solution to district surgical output.

In the near future, I shall expand on the surgical output of KMC and attempt to expound on the ‘softer ingredients’ in order to assess the applicability of this model to the public health domain. For unless these issues are identified, acknowledged and upheld, it is with some degree of scepticism that I await to see how many specialist family practitioners will enter the district healthcare system and indeed deliver their surgical promise, despite being specifically prepared for these challenges.

Kenneth Beviss-Challinor

Kokstad Medical Centre, KwaZulu-Natal, South Africa ken.beviss@gmail.com 1. Mash B, Clarke DL, Aldous C. Well-trained generalists can help improve surgical capacity at district hospitals. S Afr Med J 2014;104(5):323. [http://dx.doi.org/10.7196/SAMJ.7897] 2. Couper ID, Mash B. Obtaining consensus on core clinical skills for family medicine training. S Afr Fam Pract 2008;50(6):41.

3. Kong VY, van der Linde S, Aldous C, Handley JJ, Clarke DL. Quantifying the disparity in outcome between urban and rural patients with acute appendicitis in South Africa. S Afr Med J 2013;103(10):742-745. [http://dx.doi.org/10.7196/SAMJ.7109] 4. Kong VY, Aldous C, Handley J, Clarke D. The cost effectiveness of early management of acute appendicitis underlies the importance of curative surgical services to a primary healthcare programme.

Ann R Coll Surg Engl 2013:95(4):280-284. [http://dx.doi.org/10.1308/003588413X13511609958415] 5. Longmore B, Ronnie L. Human resource management practices in a medical complex in the Eastern Cape, South Africa: Assessing their impact on the retention of doctors. S Afr Med J 2014;104(5):368371. [http://dx.doi.org/10.7196/SAMJ.7751]

Nelesh P Govender

S Afr Med J 2014;104(9):593-594. DOI:10.7196/SAMJ.8599

Access to flucytosine for HIV-infected patients with cryptococcal meningitis – an urgent need

To the Editor: The addition of oral flucytosine to an amphotericin B-containing induction regimen for HIV-associated cryptococcal meningitis (CM) is associated with improved fungal clearance and a 39% reduction in 10-week mortality.[1] Owing to the unacceptably high mortality associated with CM, access to flucytosine needs to be prioritised in South Africa (SA), together with interventions such as earlier detection of cryptococcal disease.[2] The World Health Organization (WHO) recommended amphotericin B and flucytosine as the preferred induction regimen in rapid advice guidelines, and in 2013 included these agents in the WHO Model Lists of Essential Medicines as part of the ‘core list’.[3,4] In line with WHO recommendations, the Southern African HIV Clinicians Society has strongly supported efforts to obtain access to flucytosine in updated clinical guidelines.[5] In 2012, amphotericin B was prescribed for more than 80% of patients with CM at predominantly urban sentinel hospitals.[6] The addition of flucytosine would not add much complexity to this regimen. In a resource-limited setting, Day et al.[1] showed that it was feasible to use flucytosine instead of amphotericin

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B monotherapy with no additional toxicity and with the same panel of monitoring blood tests, i.e. full blood count and urea, electrolytes and creatinine.

Even though flucytosine is a simple, off-patent agent that has been in clinical use for over five decades,[7] there are two major barriers to access in SA. First, while flucytosine is still registered with the Medicines Control Council (MCC), this registration has not been maintained. As a distributor for the innovator company, Roche first registered flucytosine with the MCC in the 1990s, but with­drew the product from the market in the early 2000s. Currently, flucyto­sine is only available for compassionate use through an MCC application (section 21 of the Medicines and Related Substances Control Act 1965), a process that may take several weeks. Second, US Food and Drug Administration (FDA)-approved flucytosine obtained through the innovator company, Meda Pharmaceuticals/Valeant, or a US-based generic manufacturer, Sigmapharm Laboratories, is expensive.[8] Based on an approximate price of R13.00 per 500 mg tablet, a 14-day treatment course for a 50 kg adult at a dose of 100 mg/kg/d would cost R1 820.00.[8] Since amphotericin B currently costs approximately R700.00 for 14 days, adding R1 820.00 inflates the drug cost of induction-phase treatment by >300%.[9] Loyse et al.[10] have suggested that high costs have persisted as a result of a market failure. However, demand for flucytosine can be reinvigorated: surveillance case numbers can be used for drug forecasting by manufacturers (approximately 7 000 cases were diagnosed in 2012[6]), best clinical practice guidelines have been developed,[5] and pooled procurement of flucytosine with other anti-infective agents may increase bargaining power.

While few manufacturers have expressed interest in production of low-cost generic flucytosine, local distributors have expressed willingness to negotiate with manufacturers of FDA-approved flucytosine and apply for fast-track updated registration of the drug.

If these efforts are successful, we motivate that flucytosine should be included in the SA Essential Medicines List for hospitals, along with amphotericin B.

National Institute for Communicable Diseases – Centre for Opportunistic, Tropical and Hospital Infections, National Health Laboratory Service and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa neleshg@nicd.ac.za

Graeme Meintjes

Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, South Africa, and Department of Medicine, Imperial College London, UK

Shabir Banoo

Right to Care and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 1. Day JN, Chau TT, Wolbers M, et al. Combination antifungal therapy for cryptococcal meningitis. N Engl J Med 2013;368(14):1291-302. [http://dx.doi.org/ 10.1056/NEJMc1305981] 2. Govender NP, Roy M, Oladoyinbo S, et al. Phased implementation of screening for cryptococcal disease in South Africa. S Afr Med J 2012;102(12):914-917. [http://dx.doi.org/ 10.7196/samj.6228] 3. World Health Organization. Rapid Advice – Diagnosis, Prevention and Management of Cryptococcal Disease in HIV-infected Adults, Adolescents and Children. Geneva: WHO, 2011. http://www.who.int/ hiv/pub/cryptococcal_disease2011/en/ (accessed 25 July 2014).

4. World Health Organization. WHO Model Lists of Essential Medicines. Geneva: WHO, 2014. http:// www.who.int/medicines/publications/essentialmedicines/en/ (accessed 25 July 2014).

5. Govender NP, Meintjes G, Bicanic T, et al. Guideline for prevention, diagnosis and management of cryptococcal meningitis among HIV-infected persons: 2013 update. Southern African Journal of HIV Medicine 2013;14(2):76-86. [http://dx.doi.org/10.7196/SAJHIVMED.930] 6. National Institute for Communicable Diseases. GERMS-SA Annual Report 2012. Johannesburg: National Institute for Communicable Diseases, 2012. www.nicd.ac.za/assets/files/2012_GERMS-SA_ Annual_Report.pdf (accessed 25 July 2014).

7. Loyse A, Dromer F, Day J, Lortholary O, Harrison TS. Flucytosine and cryptococcosis: Time to urgently address the worldwide accessibility of a 50-year-old antifungal. J Antimicrob Chemother 2013;68(11):2435-2444. [http://dx.doi.org/ 10.1093/jac/dkt221]

September 2014, Vol. 104, No. 9

CORRESPONDENCE

12 – 15 Nov 2014 Düsseldorf • Germany

S Afr Med J 2014;104(9):594-595. DOI:10.7196/SAMJ.8713

Shielding blood donors from harm

To the Editor: Eric Klug’s letter in the June SAMJ[1] is particularly topical, as haemovigilance programmes have extended to include donor health in recent years.

Considerable attention has focused on the effects of regular blood donation on iron stores, and consequent risks of iron depletion and iron deficiency anaemia.

There is little doubt that frequent blood donation may result in reduced iron stores. It is also important to note that haemoglobin (Hb) levels may remain relatively normal in spite of reduced iron stores, although changes in the red cell indices may be helpful in suggesting iron deficiency. Females of childbearing age are most at risk of iron depletion due to menstruation, pregnancy, a lower body mass and lower oral iron intake.

There are two blood transfusion services in South Africa (SA). The South African National Blood Service (SANBS) covers the whole of SA with the exception of the Western Cape Province, which is serviced by the Western Province Blood Transfusion Service (WPBTS).

The two services follow similar principles with regard to blood donor screening.

The SANBS screens Hb levels of all donors at each donation using the copper sulphate specific gravity method. If the donor’s blood fails on this test, a HemoCue reading (a bedside Hb monitor) is done. The cut-off for all SANBS donors is an Hb level of 12.5 g/dl. If the donor fails the HemoCue test, they are given a letter of referral to their healthcare practitioner noting whether this is a first or repeat donation, and the number of donations.

Dietary advice is offered to all donors, and in line with best practice, iron supplementation, where available, is given to repeat female donors of childbearing age.

Female donors with Hb levels of 11.1 - 12.4 g/dl and male donors with levels of 11.4 - 12.4 g/dl are deferred from donating blood for 3 months. Female donors with an Hb level of 10.5 - 11.0 g/dl are deferred for 6 months, and those with Hb levels <10.5 g/dl for 12 months.

Male donors with an Hb level of 10.5 - 11.3 g/dl are deferred from donating blood for 6 months, and those with levels <10.5 g/dl for 12 months.

The WPBTS screens all donors at each donation using the HemoCue test. The Hb cut-off level for allowing donors to donate is 12.5 g/dl for females and 13.5 g/dl for males. Regular donors failing to meet the cut-off levels have a sample taken for a full blood count (FBC). No matter what the results are, these donors later receive a letter with their FBC results, reflecting one of the following possibilities: (i) failure of Hb screening test confirmed, but no evidence of anaemia

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8. Loyse A, Thangaraj H, Easterbrook P, et al. Cryptococcal meningitis: Improving access to essential antifungal medicines in resource-poor countries. Lancet Infect Dis 2013;13(7):629-637. [http://dx.doi.org/10.1016/S1473-3099(13)70078-1] 9. Bicanic T, Wood R, Bekker LG, Darder M, Meintjes G, Harrison TS. Antiretroviral roll-out, antifungal roll-back: Access to treatment for cryptococcal meningitis.

Lancet Infect Dis 2005;5(9):530-531. [http://dx.doi.org/10.1016/S14733099(05)70197-3] 10. Loyse A, Bicanic T, Jarvis JN. Combination antifungal therapy for cryptococcal meningitis. N Engl J Med 2013;368(26):2522-2523. [http://dx.doi.org/ 10.1056/ NEJMc1305981#SA1]

CORRESPONDENCE

or iron deficiency; (ii) failure of Hb screening test and evidence of anaemia or iron deficiency; or (iii) false failure of Hb screening test.

Where indicated, donors are advised to see their own clinicians for further investigation and/or treatment. As with the SANBS, routine measurement of ferritin levels is not performed. The WPBTS recently introduced an oral iron replacement programme. A short course (30 tablets) of iron sulphate tablets is offered to those donors most at risk â&#x20AC;&#x201C; currently female donors up to age 50 years who have donated two or more times in the preceding 12 months. This short course is intended only to replace the iron lost through donation, and not as a treatment for iron deficiency or iron deficiency anaemia.

Accompanying information is supplied to explain the programme as well as to warn of side-effects. Research will be conducted over the next 2 - 3 years in order to determine whether ferritin levels are maintained in those donors who receive iron replacement v. those who do not.

There are limited strategies aimed at reducing the risks of iron depletion in blood donors, each with its own challenges. The frequency of donation can be reduced to three or four donations per year. However, this would require a significant increase in the number of active blood donors to ensure that blood stocks are not compromised. Oral iron replacement programmes can be instituted; these are relatively inexpensive (particularly if iron sulphate is used), but the side-effects of oral iron are significant for some patients and compliance is limited â&#x20AC;&#x201C; in a pilot study carried out by the WPBTS, compliance was measured at 70%. Moreover, iron replacement programmes are not without risks, including the potential masking of more sinister causes of iron deficiency. Finally, ferritin levels (the most robust indicator of iron stores) can be measured. As there is no bedside ferritin test, screening would not be in real time. The costs of ferritin screening would need to be recovered (as both blood services are non-profit organisations based on financial models of cost recovery), and the price of blood would rise.

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The blood transfusion services in South Africa benchmark at an international level to ensure blood safety by adopting guidelines put in place by the World Health Organization and the International Haemovigilance Network. Our haemovigilance programme, in addi­ tion to monitoring the safety of the transfusion chain, now includes donor vigilance and monitoring of international trends to minimise harm to donors. As such, the SANBS has embarked on a study of its donors in which an FBC, iron studies and ferritin levels will be done on a cohort of donors nationally; a sample of WPBTS donors will also be included. It is hoped that this will give a baseline for SA donors (rather than relying only on data from international studies). Using this analysis, going forward, interventions regarding frequency of donation, iron supplementation for certain donor groups and a costeffective plan for ferritin monitoring can be established.

Blood donors should be encouraged always to inform their treating clinicians that they are blood donors, and both services encourage this by way of a letter. In addition, both services will explore other avenues to inform blood donors of potential risks of donating, taking care not to deter donors and to ensure that the blood supply is not compromised.

Charlotte Felicity Ingram

South African National Blood Service, Johannesburg, South Africa dr.charlotte.ingram@gmail.com

Gregory Ralph Martin Bellairs

Western Province Blood Transfusion Service, Cape Town, South Africa

1. Klug E, Gebka M, Hellig F, Alison M, Townsend B, Naidoo V. Importance of shielding blood donors from harm. S Afr Med J 2014;104(6):389. [http://dx.doi.org/10.7196/SAMJ.8211]

S Afr Med J 2014;104(9):595-596. DOI:10.7196/SAMJ.8685

September 2014, Vol. 104, No. 9

IZINDABA

CoN – lifeline for patients, noose for healthcare providers?

You could liken the new Certificate of Need (CoN) law to a brightly coloured centipede, signalling hope of better access to healthcare for millions but work endangerment to private specialists, hospital groupings, GPs and other healthcare professional groupings.

In spite of the 12 years it took to hatch – suddenly emerging to spread hope, alarm and confusion in equal measures – full maturity is now expected only well beyond two years. National Health Director-General Precious Matsoso’s chief entomologists (read: state law advisors) have examined the creature and concluded that it will almost certainly curl up and sulk if overloaded with the logistical demands of a 1 April 2016 implementation deadline (70 000 healthcare establishments to have applied for a CoN by then, not to mention tens of thousands of healthcare providers consulted via their groupings to inform regulations before they are actually drafted and published for comment). That’s also the date (which they’re now trying to de-proclaim via President Zuma’s office) by which every single healthcare provider in the country would have had to apply to Matsoso for a CoN, whether they’re setting up, modifying or buying a health establishment, increasing bed numbers, acquiring expensive tech­nology, or simply continuing to practise where they are. The legal animal (hatched as provisions 36 - 40 of the National Health Act) has a noble purpose – to meet the govern­ment’s constitutional obligations of progressive and universal access to health­care – but it’s got lots of legs and a vicious (some say unavoidably necessary) bite: five years’ imprisonment and/or a fine for non-compliance. That it’s in hiber­nation until resuscitated ‘as is’, with a reproclamation that enables a later, more pragmatic implementation date, is merely a temporary respite.

Trust us, we won’t let this creature bite

Speak to its architects and prospective implementers, and they’ll try to reassure you that the increasingly vocal private healthcare provider groups are suffering from chilopodophobia (an irrational fear of centipedes). Privately, some may even whis­

per that a scary and tropically sized centi­ pede is necessary to bend the will of private healthcare providers long accustomed to the hugely skewed access to healthcare that too many of us regard as the norm. They solemnly promise that the animal they’ve engineered is remotely controlled; they’ll not allow it to bite (e.g. no practices will be uprooted via denial of a certificate). Speak to the objectors/detractors (in descending order of decibels: specialists, hospital groupings, allied health professionals, GPs), and they’ll tell you that the creature, as legally constituted, is a formidably large, red-lined creepy-crawly on steroids, with undeniable pincers able to inflict painful and potentially debilitating wounds. Sure, a few legs are being mended, but the creature’s alive and well – and only ‘squashable’ in the courts, probably the Constitutional Court.

While they ‘fully support’ equitable access to healthcare, they have a serious problem with the ‘deeply flawed’ instrument being used. Putting back its implementation date is ‘mere tinkering’. This makes it almost certain that the real battle, led by the specialists and hospital groupings, will play out in the courts. It’s here that the government’s attempt to deal with the mismatch between the geographical placement of critically scarce human healthcare resources and the geographical spread of our quadruple burden of diseases will be picked apart, segment by segment, under the unrelenting spotlight of section 27 of the Constitution. Do the CoN provisions meet the government’s constitutional obligation to adopt ‘reasonable’ legislative and other measures aimed at ensuring progressive, universal access to healthcare? Or do they collectively flout so many other constitutional rights (freedom of movement, trade and competition, access to information) as to warrant amending or striking down? Stir in our healthcare human-resource crisis ...

Will it do more harm than good?

It’s a fascinating debate, but one that will carry little weight with healthcare professionals overwhelmed by a harsh public sector work environment and contemplating the seemingly welcome relief of a move to the local private sector. The CoN could simply add to the steady annual tally of healthcare

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providers heading overseas, many never to return, and prompt a dramatic reduction in the number of young people wanting to enter the healthcare professions, with dire national implications. Those are potent unintended consequences that would fundamentally undermine the law’s intentions. As usual, whenever there’s potential to make a quick and nasty buck in the public sector, this law will also create fertile ground for bribery and corruption between officials and highstakes applicants during the certificate application process.

Izindaba spoke to Matsoso, who ‘correc­ ted’ a hasty interpretation by Western Cape Health MEC Theuns Botha (Democratic Alliance) that her legal bid to reverse the CoN implementation date scrapped the entire law. She also criticised a dysfunctional Free State Health Department, whose beleaguered Health MEC Benny Malakoane (under criminal investigation for tender fraud while serving as Municipal Manager at Matjhabeng Municipality in 2007 and 2010) prematurely published CoN-related regulations – which her department is obviously now more than two years away from doing. Matsoso warned: ‘This is of great concern because it creates confusion in the light of our current discussions with stakeholders.’

Just who stands where?

She added: ‘Nobody wants to write a law where there’s a lack of understanding and conflict. We want to make sure we all understand each other from the beginning.

The law is still there; all that will change is when it comes into force [this to emerge after extensive further stakeholder consultation once the proclamation is withdrawn].’ Her lawyers had assured her that this had been done before. The stakeholder briefing blitz she’d begun would continue apace, with most providers ‘expressing concern’ (her words) over sections 36 and 40 (abbreviated in the box on the next page and discussed above). She said the South African Medical Association (SAMA), in particular, wanted amendments to both provisions and the scrapping of CoN limitations on individuals. So far optometrists, dentists and occupational health practitioners (OHPs) had indicated willingness to work with her, the OHPs needing clarity on how

IZINDABA

industrial clinics would be certified. One helpful suggestion, which she was ‘taking very seriously’, was to ‘use a more staggered approach’ in implementing the law. Labour organisations were backing her, but the Hospital Association of South Africa and the South African Private Practitioners Forum did not want the CoN to apply to them ‘at all’. SAMA (17 000 members) had provided her with a list of all GPs. ‘Now we just have to agree on a date to thrash it all out with the GPs.’ She said consultative processes were being tailored to each healthcare professional grouping, while she intended asking all relevant statutory bodies to help by providing databases to facilitate licensing (a concurrent task of the Office for Healthcare Standards Compliance (OHSC), which will be integral part of the CoN process) – plus certification. The OHSC had completed its initial inspection work in setting minimum norms and standards for primary health care facilities in the public sector, and would now turn its attention to the private sector.

Asked whether she considered her CoN deadline proclamation-scrapping a setback, Matsoso replied: ‘When you consult people and take their concerns into account, you

A snapshot of the Certificate of Need

A CoN will be required for anyone: • Establishing, constructing, modifying or acquiring a health establishment or agency • Increasing the number of beds in, or acquiring prescribed health technology at, a health establishment or health agency • Providing ‘prescribed’ health services, or continuing to operate a health establishment or health agency, after the expiration of 24 months from the date at which the relevant addition to the Act took effect (1 April 2014 – this deadline is now up for change).

The Act requires the Director-General of Health to apply her/his mind to several requirements before issuing a certificate. These include consistency of health services, development in terms of planning, equitable distribution and rationalisation of services and resources (including existing public and private facilities in an area, correcting racial, gender, economic and geographical imbalances, and financial viability), taking into account the demographic and epidemiological characteristics of the population to be served, plus furthering the Employment Equity Act within emerging small, medium and micro-enterprises.

can’t call that a setback – that’s very naive.

We can work collectively. The private sector is a resource for this country. If you want to respond to the burden of disease you have to take into account all your resources.’

Just how she and her political masters do that, and whether they and the private sector can work out an amicable solution,

will either improve or worsen healthcare for us all.

Chris Bateman chrisb@hmpg.co.za S Afr Med J 2014;104(9):597-598.

DOI:10.7196/SAMJ.8774

Promote cheaper generic drugs to patients – and help contain medical inflation The country’s top medical scheme administrator, Dis­ covery Health, calculates that far greater use of cheaper, good­quality gen­ eric drugs will drive down healthcare infla­ tion, saving as much as R1.5 billion per annum for medical scheme members – while a major hospital group has begun promoting use of these medicines through its hospital pharmacies.

This emerged at a pioneering daylong medicine summit convened by the administration and managed healthcare giant in Sandton, Johannesburg, on 15 May this year and attended by representatives of the local and international pharmaceutical industry, private hospital executives and government drug regulation advisors.

Setting the scene for the summit, Discovery Health CEO Jonny Broomberg challenged

his predominantly drug-company audience to enter risk-sharing and ‘payment for value’ agreements, plus volume-based pricing, appealing to them to work with the National Department of Health (NDoH) to keep the cost of medicines affordable in the private sector.

‘We often hear from you that the Department of Health is not supportive of this risk-sharing agreement – my theory is that you guys are not sufficiently motivated to push this approach. We need to work harder with the NDoH to tackle inefficiencies and perversities throughout the medicine supply chain. It doesn’t make sense that many products, especially some generics, maintain such high prices and yet still have the largest market share. This defies market logic,’ he said. Relative to global benchmarks on drug pricing, South Africa (SA)’s private sector pricing was high and rigid, and he predicted

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that ‘the time of arbitrary high pricing because you can’ was coming to an end.

Market ignoring competitively priced drugs – Broomberg

Broomberg said one problem was that the gap between leading generic products and leading ‘original’ brand-name products was far narrower than in most international environments, with many generics entering the SA market at a 20 - 30% price differential to the originator product, compared with up to 90% in developed countries, including the USA and countries in Europe. ‘The second problem is that our market is currently failing to take advantage of competitively priced generics. There are generics very competitively priced in most chronic categories, but somehow our members end up paying for much higher-priced equivalent

September 2014, Vol. 104, No. 9

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generics because of perversities in the supply chain.’ The most expensive generics dominate the market, and money moving between the manufacturers and dispensers was leading to the expensive products being dispensed when better-priced alternatives are available, which Broomberg described as ‘unacceptable’. He said the current Market Inquiry into Private Healthcare under the auspices of the Competition Commission was likely to investigate this. ‘It’s a classic example of market failure ... This kind of approach is damaging the medical scheme environment, and none of us can afford to take the short-term view. We’ve got to think about what happens when people drop out of medical aids because they can’t afford medicines and other high-cost interventions.’

Broomberg said that the rapid growth in the consumption of chronic medication (a windfall for the pharmaceutical companies, although not their fault) needed price adjustments and transparency to allow medical schemes to ‘ensure that we can continue to support patients dealing with these diseases’. He revealed that Discovery Health’s MedXpress offering of free home and work delivery of drugs was being expanded to include the delivery of specialised high-cost medicines direct to doctors’ practices, with an initial focus on the oncology sector.

The company was also combining all its units dealing with medicines into a single entity, enabling pharmaceutical and other companies to interact with Discovery Health through a highly efficient single point of contact.

Boom in chronic medicine use

Discovery Health’s Head of Risk Manage­ ment Strategy, Ismail Rasool, highlighted the ‘enormous cost-containing potential’ if patients started to purchase the lowestpriced generic equivalents currently on the market, putting the saving for the medical schemes that Discovery Health administers at approximately R500 million. Extrapolating this to the other major medical schemes would generate savings of up to R1.5 billion per annum just by shifting current dispensing towards lower-cost rather than the highestcost generics. This alone could reduce premiums by 1 - 2% per year. Putting figures to Broomberg’s assertion on the rapid growth of chronic medication consumption, he said that in 2003, 10% of Discovery Health Medical Scheme members had a chronic condition at an average age of 32. Last year (one decade later) this had increased to 20% at the same age. By the time members were 65, three out of five had a chronic condition, all underlying trends that he described as ‘very worrying’. In the year 2000, the scheme had 15/10 000 lives

claiming more than half a million rands – by 2014, this number had gone up five-fold to 79/10 000, even after adjusting for inflation.

‘So without younger, healthier lives coming into the system, there’s immense pressure on schemes to ensure cost-effective medicines are prescribed and dispensed.

‘It doesn’t make sense that many products, especially some generics, maintain such high prices and yet still have the largest market share. This defies market logic.’

‘The scheme’s total medicine expenditure (including hospital oncology) has gone up by 92% from R4 billion in 2008,’ Broomberg added. Among the diseases of lifestyle driving chronic medicines consumption were hypertension, diabetes and hyper­ lipidaemia. HIV was growing, but at no­where near the same rate, with Discovery Health Medical Scheme now funding 38 000 members for HIV-associated conditions. A particular concern is the impact of expensive new drugs for conditions such as cancer, rheumatoid arthritis and multiple sclerosis.

These, together with a sub-set of similar novelty drugs, are predicted to increase in cost to R2.3 billion by 2020, from almost nothing in 2008. ‘We need to look at risk sharing and alternative reimbursement models to allow medical schemes to manage this cost explosion in a sustainable way.’

SA’s drug spend disproportionate to other similar countries

Discovery Health Medical Scheme data suggest that SA’s private healthcare system spends disproportionately more on medi­ cines, relative to total healthcare expenditure, than in the top ten comparative countries featured in a health systems performance study by the monitor group.

While the use of generics in hospitals had improved, there was ‘room for more’, Broomberg said. Further illustrating Broom­ berg’s concern about the high price point at which generics were being used, Rasool said that the average price difference (brand to generic) in the lowest price band was 60%. The same difference when comparing the mid-range price band was 45%, while the top-priced comparison revealed a 39% difference. During open discussion, Paul Anley, CEO of Pharma Dynamics, one of SA’s foremost distributors of generic drugs, said that the reason for the large percentage

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price gap between brand name and generic drugs in the lowest price range was because they were not being actively marketed. ‘You have to be careful of just putting emphasis on price – because if you don’t tell anybody, you don’t get the switch!’ he warned.

Anley also said inefficiencies in SA legislation meant that patent ‘evergreening’ on original drugs (taking out multiple patents expiring at later and later dates to protect monopolies) worked to the great advantage of many drug companies. ‘They’re often challenged in foreign courts where the patents are quickly set aside. In SA, delays in a hearing for a revocation of a patent can take up to four years. We also don’t have dedicated patent judges and a skills base.’

Very often valid patents ‘on the books’ in SA had long been overturned in most other countries where generics then traded more freely. Anley said his calculations were that if one took the entire (private) branded drug market of R28 billion in SA and divided it by the number of packs sold, you got an average branded price of R219. A similar calculation in the generic market disclosed a figure of R73 – a differential of R146, or 72% across the board. ‘That is the impact that generics are making in pharma,’ he said.

Interviewed during a break, Anley said the total pharmaceutical market in SA stood at about R34 billion (R28 private sector and R5.5 billion state). He emphasised that when more expensive generics entered and gained traction in the market, sales volumes soon reached three times what the original brand was two or three years earlier. Anley cautioned against driving generic prices ‘down to the point where nobody uses them’, and said there was an inbuilt ‘catch 22’: low prices often meant that generic drug companies avoided spending money marketing these products – ‘that’s why they don’t move, not just because of price’. Rasool said Discovery Health’s data confirmed the initial market traction of generics. ‘But what we’re saying is that when people choose generics, it seems the most expensive ones are being used rather than the less expensive ones. This raises questions about the incentives being used to promote these more expensive generics,’ he said.

Support smaller drug companies selling at more competitive prices – MediClinic

Anelia Bezuidenhout of MediClinic said that last year her hospital group put all their pharmaceutical products into groups with prior rankings in price bands before approaching their individual hospitals and

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requesting them to ‘move to number one the better-priced products’. ‘In the beginning there were many stock-outs on the smaller drug companies, but slowly they increased their supplies and expanded their services to help us reach our goal. Yes, it’s true that your smaller company doesn’t deliver the required service, but over time they will!’ she stressed.

In his opening address Broomberg said that with medical inflation running

at 10.3% in SA (three percentage points above the general consumer price index), 6% was a result of changes in the price of goods and services – but the other 4.3% was due to more goods and services being consumed every year by the average medical scheme member. Discovery Health Medical Scheme currently spends R5 billion on ‘outof-hospital’ medications (R1.3 billion on ‘in-hospital’ medications) with 15% of all

claims in medicine, while 486 000 of the scheme’s 2.7 million members are registered for one or more chronic conditions.

Chris Bateman chrisb@hmpg.co.za S Afr Med J 2014;104(9):598-600.

DOI:10.7196/SAMJ.8750

Breaching the chasm between what’s law and what’s done National and provincial health departments are failing dismally when it comes to meeting the mini­mum standards requ­ ired of them by the Constitution, lacking precise plans to give effect to policy and legis­lation. They are also treacle-slow in passing laws vital to help them contain virulent diseases such as multidrugresistant tuberculosis (MDR TB).

This was said by Dr Adila Hassim, co-founder of and head of litigation and legal ices for Section 27, the eponymously serv­ named NGO that has been at the forefront of groundbreaking court actions forcing government to speed up vital treatment access for well over a decade. Speaking at the closing plenary of the 4th National TB Conference in Durban in June, Advocate Hassim said that with 148 people dying of TB every day and MDR TB increasing from 7 350 notified cases in 2007 to 14 161 in 2012, there were now simply too many patients awaiting treatment after diagnosis, and not enough beds available. This was an undeniable public health emergency – which could be mitigated by the simple dint of using available constitutional remedies that spelt out the minimum duties of government. ‘When it comes to TB, almost every single provision [of the Constitution] is implicated in one way or another; these are not just rights, but duties and structures of our government. As lawyers we see what is going wrong in our system,’ she added.

Constitutional framework in place to protect patients, but …

The courts had dealt with three areas so far: patients with drug resistance plus the implications of treatment decentralisation,

Dr Adila Hassim, co-founder of Section 27, and its head of litigation and legal services.

affordable medicines, and prisons and the rights of prisoners. The Constitution spelt out certain minimum standards for policies aimed at achieving progressive access to healthcare for all – and made officials accountable to the public. Legislation and policy, while necessary, were insufficient.

What was needed were precise plans and implementation, with monitoring, budgets, resources and knowledge provided to every facility and healthcare worker. These had to be evidence based, reasonable and flexible.

‘All of this comes out of case law from the Constitutional Court – they are not goodto-have, these are factors that the courts said they’ll take into account when they scrutinise policies!’ she emphasised.

Citing the 2008 ‘Goliath’ case in which four extensively drug-resistant (XDR) TB

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patients who ran away from the Brooklyn Chest Hospital in Cape Town legally contested their compulsory readmission and continued isolation (and lost), Hassim said individual rights could be limited ‘when reasonable and justifiable’. Judge Bennie Griesel, with Judge James Yekiso concurring, ordered that Goliath and his fellow patients be forcefully readmitted if necessary, and isolated at Brooklyn Chest Hospital for a period of three consecutive months or until they had fulfilled the criteria for negative sputum culture conversion for XDR TB. Judge Griesel pointedly noted that the regulations on communicable diseases were in draft form – a situation that persists today, six years later. Hassim said these regulations were ‘not perfect, but they’re bloody good – and deal with a lot of questions being asked, such as what do you do when a patient diagnosed with DR [drug-resistant] TB insists on returning to work – these regulations would help us respond’. The draft regulations set up a communicable diseases advisory board of health professionals from every level of government, the private sector and academia, reporting directly to the National DirectorGeneral of Health. They also restated the duties of all national and provincial health departments and their operational chiefs, setting the bar for infection control and the maintenance of infection control equipment.

They provided clarity on where and when a court order could forcibly isolate a patient.

She was aware of at least four cases besides the much-cited Goliath matter where the courts had also instructed police to ‘go and arrest people in communities’.

Hassim called upon the National Depart­ ment of Health (NDoH) to promulgate the regulations on communicable dis­eases as a matter of urgency, in order to support the

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national leadership and the decentralisation of TB management, which had vastly improved since the contentious XDR infection court cases were heard. When it came to affordable medicines, everyone was ‘familiar’ with the Treatment Action Campaign (TAC)’s nevirapine and antiretroviral roll-out court victories over the Mbeki government, but the focus had now turned to similarly unavailable lifesaving DR TB drugs.

Hassim said the response of Discovery Health Medical Scheme to the TAC’s appeals to pay for a DR TB patient’s expensive but lifesaving linezolid drug treatment was that he could only be treated by government within the public healthcare sector. ‘They said they were obliged by Prescribed Minimum Benefit legislation to fund for diagnostic and initial treatment, but thereafter would refer him to the public sector.’ Linezolid cost R715 per 600 mg tablet in the private sector (R282 for the same tablet in the public sector), while a generic version cost R88, she said, alluding to what was then a Médecins Sans Frontières (MSF) pending application to the Medicines Control Council (MCC) for controlled access to the generic version (ultimately successful). Linezolid was policy-approved by both the World Health Organization and the NDoH. MSF had anticipated that the MCC would take into account the right of access to health services in making its decision, given that exceptional circumstances existed and that there would be certain mortality and morbidity without linezolid or its generic equivalent. In spite of the long delay, the MCC had finally, and

to everyone’s great relief, ‘had a change of heart’, allowing MSF compassionate use of the Indian-manufactured generic Hetero in its clinics from early July.

An excellent example of the paucity of precise plans in place to give effect to national health policy (or of departmental footdragging/dysfunction) was provided by the Department of Correctional Services, most evident in the tragic TB death of Pollsmoor Prison fraud suspect Dudley Lee. Lee, who died in May this year, spent four years in prison, during which he contracted DR TB, before being acquitted in 2004. When the TAC, the Wits Justice Project and the Centre for Applied Legal studies finally brought a turned-down Supreme Court appeal to the Constitutional Court, it was upheld. Hassim quoted the Constitutional Court judges as saying in their 2012 judgment that if any screening and treatment system existed in Pollsmoor Prison, its application was ‘at best sporadic and at least in some respects, non-existent’. That court found that on any standard applied, healthcare practice at the prison fell short of what ‘ought reasonably to have been done’. The Western Cape High Court, which the Constitutional Court instructed to calculate damages, then ordered the Department of Correctional Services to pay Lee R270 000. He never got to see or enjoy any of the money, a tiny portion of which was used to pay for his funeral costs.

He was also posthumously granted legal costs. Hassim said that the lack of healthcare measures at Pollsmoor epitomised the national picture. National Correctional

Services health policy was ‘very specific’ and prison officials were not executing their duties properly, breaking several of their own policy and constitutional provisions.

She said the response at Tugela Ferry to the country’s first MDR TB ‘outbreak’ there (it was the discovery of XDR TB in 53 of his 350 Church of Scotland Hospital patients by Dr Tony Moll in January 2008 that led to the uncovering of the frightening national XDR TB prevalence) had set the bar for a workable, co-ordinated, community-based TB strategy.

‘We need implementation of our fantastic policies, with the NDoH intervening where so many of our local and district health facilities are frankly still dysfunctional,’ she said. The NDoH was legally empowered to intervene where provincial health MECs and heads of department were failing to deliver healthcare, and should help provide greater administrative capacity. ‘We can’t have facilities without oxygen for our patients or ones that don’t comply in any way with infection control policies. Places where windows are not opened – and they get away with it. We are one country and one health system – the most important lesson from the Constitution is that we need a unified approach when it comes to implementing policy. Promulgating communicable disease laws will help us deal with this crisis.’

Bernard Mandell

as an elderly and wise person and in so doing created a better life for all those lucky enough to have known him. He taught not by words, but by example.

Dad was well aware that it was not the years in his life that mattered, but the life in his years. He knew that every moment should be used wisely and every day well lived, and that the gift of life is precious. The Hippocratic Oath was the benchmark by which my father lived his life.

Mahatma Gandhi said: ‘The secret to living is giving. All that is not given is lost. Service is the rent we pay for living here.’ Dissatisfied with the direction medical politics was taking, Dad decided to become an active participant in the then Medical Association of South Africa (MASA) and in

Chris Bateman chrisb@hmpg.co.za S Afr Med J 2014;104(9):600-601.

DOI:10.7196/SAMJ.8751

OBITUARIES My father Bernard Mandell was born in Johannesburg on 22 May 1927. He attended King Edward VII School, matriculating in 1943 at the age of sixteen. He joined the South African Air Force in 1944 as a pupil pilot and graduated from Wits University Medical School in 1952.

After completion of his preregistration he left for the UK, where he held several posts in orthopaedic departments at the St James Hospital for Children and the Royal National Orthopaedic Hospital in London and became a fellow of the Royal College of Surgeons in May 1959.

He married in 1962, and returned to South Africa in 1963 and started private practice. It was then that he assumed his responsibility

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1968 was elected to the Border Coastal Branch Council. He played an active leadership role and in 1987 was elected Chairman of MASA, a position he held until 1996, when he was inaugurated as President of the World Medical Association. He was a Border Coastal Branch federal councillor from 1993 to 2000, and President of the Branch in 2001.

Dad led MASA through the process of giving evidence to the Truth and Recon­ ciliation Commission, at which the Association admitted past errors of commission and omission under the apartheid regime. He played an instrumental role in the transformation that led to the establishment of the new united South African Medical Association.

In his career of more than 45 years, Dad rendered service far beyond the call of duty.

He was the recipient of many awards, the most prestigious being the Gold Medal award from MASA in 1996 for services to the medical profession.

As his family we admired Dad’s patience, kindness, sincerity, honesty and integrity.

Always a gentleman, he could smooth ruffled feathers, tactfully diffuse difficult situations, and firmly stand his ground when he felt that his principles were being challenged.

Dad, rest in peace.

David Mandell East London, Eastern Cape, South Africa dmandell@ecdc.co.za

Jean Mary Sharpe, 1929 - 2014

Jean was born in Johannesburg in 1929, the daughter of May and John Sharpe, who became the mayor of Vereeniging in 1934.

After matriculating from Parktown High School for Girls at age 16, Jean enrolled at Wits medical school. She was one of very few women studying medicine at the time, and graduated MB BCh in 1951. She completed her housemanship at Baragwanath Hospital and was then invited to take up a registrar

post at the Radcliffe Infirmary in Oxford, UK. After qualifying as a specialist obstet­ rician and gynaecologist (MRCOG) in 1956 she returned to Johannesburg, where she worked in the cardiology department at Baragwanath Hospital. She commenced private practice in Johannesburg in 1961. In 1983 she was awarded the FRCOG. Jean was a pioneer in the field of women in medicine, although she refused to belong to any ‘women doctors’ organisation, because she was adamant that she was equal to her male colleagues and that women in medicine should not see themselves as different to men. A passionate teacher, she lectured to student midwives for many years. She was widely loved and respected as a person and as a doctor. Her contribution to the medical profession, especially in the fields of obstetrics and women’s health, was enormous over a period of more than sixty years.

In 1958 Jean married her childhood sweet­ heart, George Ballot. They were married for 51 years and raised four children, all of whom became graduate professionals.

George passed away peacefully with Jean at his side in 2010, at age 85.

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For the past 22 years, Jean worked in association with her daughter Dr Noelene Ballot, in a unique and special relationship.

To her many colleagues, patients and friends, and to her family, she was an inspiration, icon, mentor, teacher and legend. Selfless and with a strong moral conviction, Jean was honest and direct and prepared to fight for what she believed was right. She was an accomplished surgeon and an astute clinician with exceptional diagnostic skills and medical intuition. Known for her intelligence, quick wit, humility, dignity and love of life, she was a great listener and conversationalist.

Jean approached her life and her career with passion, compassion, enthusiasm and energy. She was an accomplished sports­ woman and as a student represented Wits in hockey, tennis and swimming. She played in the Wimbledon qualifying rounds as a young woman, and continued to play tennis until a few months before her death. A spiritual person, she had numerous interests and hobbies including birding, wildlife, photography, handwork, gardening, theatre, music, travel and reading. Her most passionate interest was her family. A devoted matriarch, she developed a successful solo practice while maintaining an active interest in the lives of her children and grandchildren.

Jean passed away suddenly and unex­ pectedly but peacefully at the age of 84, while still working full-time as a specialist. She will be deeply missed by her colleagues, her thousands of patients and her family, and will be remembered for her legacy of selflessness.

Jean is survived by her daughters, Prof.

Daynia Ballot (Professor of Neonatology at Wits), Dr Noelene Ballot (specialist obstet­ rician and gynaecologist) and Jane Ballot, her son Carl Ballot, eleven grandchildren and two brothers.

Noelene Ballot Sandton, Johannesburg, South Africa nsballot@gmail.com

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BOOK REVIEW Doctors Without Borders: Humanitarian Quests, Impossible Dreams of Médecins Sans Frontières

By Renée C Fox. Baltimore, Md: Johns Hopkins University Press, 2014.

ISBN 9781421413549

Médecins Sans Frontières (MSF) has become the most successful and bestknown apolitical, humanitarian endeavour of our time. Founded in 1971 by a small group of French doctors in response to the tragedies and atrocities of the Nigerian Civil War (1967 - 1970), it is now a worldwide movement responding to a wide spectrum of human-made and natural disasters. By 2013 its over 32 500 personnel provided hope and medical assistance to suffering people in more than 67 countries with an annual budget of more than 600 million euros (over 90% from private, non-governmental sources).

MSF’s driving principles include ethical medical practice, independence, impartiality and neutrality, bearing witness and being accountable. All its activities are taken without consideration of race, religion, gender or political affiliation (although often with political implications), and with priority given to those in the most serious and immediate danger – currently people threatened by the Ebola epidemic.

Through her participant/observer involvement with MSF for almost two decades,

Renée Fox, a doyenne of medical sociology, has harnessed her sociological skills and extensive access to MSF documents to portray many insights into this impressive humanitarian movement. She illustrates its global scope, the complexity of its operational methods, its idealistic motivating forces, the internal dilemmas associated with its self-critical attempts to deal with complex (often paradoxical) aspects of humanitarian activities, and the external challenges arising from seemingly endless demands.

The book begins with ‘voices from the field’ (blogs) that the author analyses to record the passionate, courageous and insightful attitudes of many MSF workers.

A description follows of the origins of the movement, its growing pains and crises, and the controversies associated with the imperfect struggle between humanitarianism and the inextricably associated politics. The symbolic and practical importance of the number, severity and variety of humanitarian disasters with which MSF deals, and the many individuals whose suffering it attempts to alleviate, cannot be underestimated in a world scarred by ongoing tragic manifestations of human belligerence and violence. Given the impossibility of covering all MSF’s field activities, Prof. Fox has chosen to illustrate these by recounting in detail its work in South Africa (SA) and Russia.

MSF’s decision to ‘take on’ the HIV/ AIDS pandemic in SA was vindicated by the Khayalitsha project (driven by Dr Eric Goemaere with the support of many activists, and later by the Western Cape Department of Health), which demonstrated the successful application of affordable longterm antiretroviral therapy in resource-poor contexts. By 2013, almost 2 million South Africans were benefiting from enhanced quality of life and improved life expectancy.

Advocacy for and successful implementation of such a programme stimulated the growth and influence of MSF worldwide, and led to the establishment of MSF South Africa to extend MSF’s ‘witnessing’ role and the spirit of SA’s struggle into other parts of Africa.

Together with Olga Shevchenko, MSF’s involvement in post-socialist Russia is explored with a focus on work with the homeless and street children in Moscow, and on the problem of rampant tuberculosis (TB), including the multidrug-resistant variety, in Siberian prisons where, despite atrocious conditions, nearly 7 000 successes

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were achieved among 10 500 patients treated for TB. An important contribution of this book is the explication of MSF’s deliberations on its internal culture and its self-critique, which are characterised by introspection and participatory democracy, accompanied by humility. These qualities are evident in the description of events leading up to the 1999 Nobel Peace Prize award ceremony, the discussions on what should be included in the acceptance speech, the democratic process for deciding who should speak on behalf of MSF, the impact of its powerful message delivered

by James Orbinski, then President of MSF, and the decision to allocate its award money to developing drugs for neglected diseases.

The story of how MSF Greece was ostracised for unilaterally deciding to enter Kosovo, and its subsequent reintegration into MSF International after eight years of critical analysis, debate and negotiation, sheds additional light on MSF’s organisational values, governance structures and methods of implementing its humanitarian principles.

Prof. Fox’s description of the 2004 ‘La Mancha’ process (named after Don Quixote’s allegorical encounter with powerful forces) portrays deliberations aimed at better defining the basic raison d’etre of MSF and how it should be governed. This process, together with the consequent La Mancha Agreement, confirmed MSF’s values (as documented in the 1995 Chantilly Agreement), consolidated its mode of operation, and documented its shortcomings and future challenges.

The book concludes with an account of MSF’s 40th anniversary celebration, the reunion with some surviving founders, reminiscences about its past activities, and visions for the future.

Prof. Fox’s carefully researched and eloquently written epic book, remarkably completed and published in her mid-eighties, is a treasured and monumental depiction of MSF’s courageous and persistent commitment to millions of people in distress. Like many volunteers whose lives have been transformed through their work with MSF, those who read this book will be similarly inspired.

Solomon Benatar Bioethics Centre, University of Cape Town, South Africa, and Joint Centre for Bioethics, University of Toronto, Canada solomon.benatar@uct.ac.za

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SAFETY FIRST Protecting healthcare workers. Protecting South Africa.

South Africa’s high burden of communicable diseases poses a major occupational hazard for healthcare workers1. There is an ever-present risk of the transmission of blood borne pathogens such as HIV, Hepatitis B and Hepatitis C among healthcare workers.

Needlestick injuries, poorly ventilated consulting rooms, inadequate protective clothing, inconsistent standards for infection control measures and poor application of infection control measures, all elevate the risk.

Healthcare workers have the power to protect themselves against this risk. But only if they are well informed, committed and unfailing in applying tried and tested safeguards.

Awareness and education Understand the nature of risk

SAFETY

Access and share information on how to limit risk

A culture of safety Implement simple safety precautions and existing policies Adopt safety engineered devices

WORK ENVIRONMENT

Advocacy and collective action Collaborate through professional organisations

OCCUPATIONAL RISK

Participate in initiatives for uniform guidelines 1

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CLINICAL PRACTICE

Simplifying trauma airway management in South African rural hospitals M Berry, D Wood Michael Berry is a UK trainee in anaesthesia and intensive care. He worked for a year in the resuscitation unit at Ngwelezane Hospital, KwaZuluNatal, South Africa. Darryl Wood is an emergency medicine specialist at the University of KwaZulu-Natal and Ngwelezane Hospital. He is currently undertaking a research sabbatical and completing his PhD. Corresponding author: M Berry (michael.berry1@nhs.net)

South African emergency centres witness high levels of trauma. Successfully managing a compromised trauma airway requires considerable skill and expertise. In the rural healthcare setting, clinics and hospitals are often staffed by junior doctors without formal advanced airway training. Current airway management algorithms tend to ignore lack of resources and skill. We therefore propose a simplified guideline for the rural hospital practitioner. Our algorithm offers a step-by-step approach, with the aim of providing an easy sequence to follow that will ensure successful airway management and patient safety. The paucity of advanced airway equipment in most rural hospitals is taken into consideration.

S Afr Med J 2014;104(9):604-606. DOI:10.7196/SAMJ.8064

Trauma care in rural emergency centres

South Africa (SA) is a middle-income country characterised by high levels of trauma. Road traffic accidents and interpersonal violence are common.

This situation is fuelled by rapid urbanisation as well as socioeconomic disparities.[1] The injury burden typically peaks over weekends and on paydays and public holidays. Consequently, many emergency centres are inundated with victims of blunt and penetrating trauma. The annual estimated trauma incidence in KwaZulu-Natal (KZN), the most populous province in SA, is 12.9/1Â 000 population.[2] Comparing these figures with European data, e.g. for London, UK, where the incidence of trauma is around 0.5/1 000, clearly demonstrates the high trauma load in SA.[3] Many trauma patients in KZN present outside urban centres to facilities that are often basic and frequently understaffed.[4] The skill sets of hospital staff vary significantly, with many smaller hospitals commonly relying on inexperienced junior doctors with minimal training and equipment to manage all aspects of major trauma.

Ensuring that the airway is patent and protected is the most crucial initial intervention in the treatment of trauma patients.[5]

Current practice and its limitations

The management of the trauma airway can be hugely challenging, and differs significantly from airway emergencies encountered in the operating room in an elective setting.[6] Haemodynamic instability, time pressure, risk of aspiration, the need for cervical spine protection, penetrating neck trauma and facial injuries represent some of the issues that make trauma airway management difficult.[6] Moreover, for similar reasons it is rarely possible to assess the airway comprehensively in an attempt to predict potential difficulties and prepare accordingly. Dealing with such situations requires a level of clinical experience that is often not available in the rural hospital environment. Guidelines presented by the Emergency Medicine Society of South Africa (EMSSA), the Difficult Airway Society (DAS) in the UK and the American Society of Anesthesiologists (ASA) are

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comprehensive and provide many useful pointers on how to deal with these situations.[7-9] Nevertheless, useful as these guidelines are, in our opinion they fail to address a number of fundamental issues.

Firstly, the guidelines are not specific to the trauma patient requiring prompt intubation. Most discuss a variety of rapidsequence intubation (RSI) techniques and commonly focus on the elective theatre setting. For example, both the ASA and the DAS emphasise waking the patient up following failed intubation, which is seldom appropriate or safe in critically injured trauma patients.[8,9] Secondly, an experienced airway provider is frequently not immediately available to manage a trauma airway. It is well known that under circumstances of acute stress, decision-making and the ability to process new information are severely impaired.[10] Most algorithms have many intermediate steps with confusing amounts of arrows and/or explanatory text spread over a number of pages, which renders them impractical in an emergency.[7-9] Thirdly, both SA and international protocols incorporate airway adjuncts and techniques that are not commonplace in rural emergency centres.[7-9] Furthermore, the suggested resort to use of unfamiliar or infrequently used equipment, such as fibreoptic techniques, under pressure seems counterintuitive.[7-9] Finally, supraglottic airway (SGA) devices should be used much earlier and play a key role in rescuing the emergency trauma airway in the hands of inexperienced staff. Initiating bag-mask ventilation or other airway adjuncts prior to using an SGA when oxygenation and ventilation are compromised makes little sense in our opinion, particularly since face-mask ventilation is often done poorly in an emergency situation, increasing the risk of gastric insufflation and pulmonary aspiration.[11] We therefore suggest a single-page practical management guideline taking the above challenges into account. Since the safety of the patient is paramount, the aim is to provide clear guidance to ensure gas exchange in situations where a junior doctor with limited experience is faced with managing the trauma airway.

Our protocol is primarily a modification of the emergency airway management algorithm used at the Shock Trauma Center (STC) of

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the University of Maryland (Baltimore, USA), as well as incorporating elements of the EMSSA protocol.[7,12] It is a simplification of these guidelines and adapted for use in the rural hospital trauma setting, in a situation where loss of the airway is imminent and the option to reverse the anaesthetic, as well as awaken the patient, is not possible.

The protocol takes into account that the operator may only have basic skills. Aware that equipment is often rudimentary, we elected not to include adjuncts more advanced than a bougie, SGA devices and tracheostomy tubes. We designed our algorithm seeking procedural simplicity and utilising minimum recommended equipment for an emergency centre, as suggested by EMSSA.[13] The algorithm is illustrated in Fig. 1 and provides a step-by-step approach to managing a compromised trauma airway in the rural healthcare setting.

In opting for visual clarity, we used a single-page layout with a simple three-step approach (intubation – rescue device – surgical airway) outlined on the left-hand side of the page. The decision tree in our guideline is limited to two branches, which greatly reduces the

number of decisions that a doctor needs to make in a stressful situation, allowing it to be used at the patient’s bedside in an emergency.

A similar three-step approach is integral to the STC protocol and has been validated in a study of 6 088 emergency trauma intubations over a 10-year period.[12] This retrospective survey, the largest reported, confirms an overall high success rate, with no patient dying of a hypoxic cardiac arrest during airway management. Of note, a mere 21 patients required an emergency cricothyroidotomy or tracheotomy.[12] Despite obvious limitations to this study (retrospective, specialist trauma centre, resource-rich setting), the results are compelling.

In keeping with other international airway guidelines we have purposefully not included a description of anaesthetic induction agents, or indications or preparations for an RSI.[8,9,12] Such additional information would crowd the algorithm unnecessarily and would be counterproductive in achieving clarity. A discussion of the various RSI drugs is best dealt with in a separate guideline.

Initial tracheal intubation Pre-oxygenate with 100% O2 • Cricoid pressure • Direct laryngoscopy • If poor view Reposition the head Reduce cricoid ETT introducer/bougie

Succeed

Tracheal intubation

2 attempts only

(Check position clinically & with capnograph if available)

Succeed

Confirm ventilation, oxygenation & CVS stability then Intubation through the LMA/iLMA with the ETT

Failed intubation Call for help

• LMA or iLMA • Not more than two insertions • Oxygenate & ventilate

Failed ventilation & oxygenation

Emergency cricothyroidotomy (call surgical team if available)

Failed intubation via iLMA or LMA

• Leave LMA/iLMA in situ • Discuss with senior on call re definitive airway

Fig. 1. Trauma airway protocol. (ETT = endotracheal tube; CVS = cardiovascular system; LMA = laryngeal mask airway; iLMA = intubating laryngeal mask airway.)

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Furthermore, our protocol does not aim to be all-encompassing, but maps out a series of critical steps to ensure safe airway management under pressure. Head positioning, for example, remains crucial in the subset of patients in whom it can be undertaken safely (e.g. single gunshot abdomen), but neck extension cannot be recommended when an injury to the cervical spine is suspected. A bougie is a simple, widely available intubation adjunct that often proves helpful and can be used safely with little training. Cricoid pressure in the RSI scenario remains controversial,[14] and in some parts of the world (e.g. mainland Europe) the use of cricoid pressure is no longer routinely recommended.[15] When cricoid technique is poor, it can worsen laryngoscopy views and limit success of intubation.[8,11,12] In the UK, and to a lesser extent in SA, cricoid pressure continues to be part of national guidance, which is why we have included it.[7,8] Calling for help remains an integral part of all emergency airway algorithms. However, in the SA context rural hospitals frequently have only one doctor on site after hours, with limited senior support.

We have designed our protocol with this in mind. Should the primary intubation attempt fail, rapid use of an SGA device can be life saving.

Although not a definitive airway, an SGA is easy to insert and can improve the patient’s gas exchange.[12] SGAs can also be used as a conduit for intubation if the operator feels confident enough, particularly with the intubating laryngeal mask.[8,11,12] It is therefore our view that given the precarity of the skills on the ground and the clinical condition of these patients, an SGA is life saving.[6,12] The aim should be oxygenation and ventilation with the final endpoint of a safely inserted secure airway.

While emphasising the need for technically simple interventions, the proposed algorithm includes a surgical airway as a last resort.

Unfortunately, it is a skill that most doctors will have very little opportunity to practise. Nonetheless, it remains a vitally important intervention that all doctors dealing with emergency airways need to be prepared to carry out. If SGA placement is not successful, an emergency cricothyroidotomy or tracheotomy is performed imme­ diately in order to secure the patient’s airway.

Conclusion

Management of the emergency trauma airway is difficult. As pointed out, haemodynamic compromise, cervical immobility, direct airway trauma, oropharyngeal bleeding and the need for immediate action all complicate airway management.[6,11] Trauma patients who need an

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emergency airway intervention require rapid and decisive decisionmaking in the face of incomplete information and management via a preplanned airway algorithm that includes rescue techniques in the event of failure.[6] Despite many useful publications in the literature, there seems to be an absence of concise, practical point-of-care guidelines to the lowest common denominator, i.e. the junior doctor.[6-9] We hope that our emergency airway protocol addresses some of these shortcomings and assists junior doctors to provide the best care possible for trauma patients under difficult circumstances. We urge SA medical bodies to consider this algorithm, designed for rural healthcare practitioners with minimal experience, when drawing up future guidelines on airway management.

1. Norman R, Matzopoulos R, Groenewald P, Bradshaw D. The high burden of injuries in South Africa.

Bull World Health Organ 2007;85(9):695-702. [http://dx.doi.org/10.2471/BLT.06.037184] 2. Hardcastle TC, Samuels C, Muckart DJ. An assessment of the hospital disease burden and the facilities for the in-hospital care of trauma in KwaZulu-Natal, South Africa. World J Surg 2013;37(7):1550-1561. [http://dx.doi.org/10.1007/s00268-012-1889-1] 3. Healthcare for London: Incidence of major trauma. NHS London, 2011. http://www.londonhp.nhs.uk/ wp-content/uploads/2011/03/Major-Trauma-Incidence.pdf (accessed 16 November 2013).

4. Hardcastle TC, Finlayson M, van Heerden M, Johnson B, Samuel C, Muckart DJ. The prehospital burden of disease due to trauma in KwaZulu-Natal: The need for Afrocentric trauma systems. World J Surg 2013;37(7):1513-1525. [http://dx.doi.org/10.1007/s00268-012-1852-1] 5. Hardcastle TC, Goff T. Trauma unit emergency doctor airway management. S Afr Med J 2007;97(9):864-867.

6. Horton CL, Brown CA 3rd, Raja AS. Trauma airway management. J Emerg Med 2014;46(6):814-820. [http://dx.doi.org/10.1016/j.jemermed.2013.11.085] 7. Emergency Medicine Society of South Africa Practice Guideline EM015. Rapid sequence intubation.

EMSSA, 2010. http://emssa.org.za/documents/em017.pdf (accessed 24 November 2013).

8. UK Difficult Airway Society Guidelines. Rapid sequence induction guidelines. UK Difficult Airway Society, 2006. http://www.das.uk.com/guidelines/rsi.html (accessed 24 November 2013).

9. Apfelbaum JL, Hagberg CA, Caplan RA, et al. Practice guidelines for management of the difficult airway: An updated report by the American Society of Anesthesiologists task force on management of the difficult airway. Anesthesiology 2013;118(2):251-270. [http://dx.doi.org/10.1097/ ALN.0b013e31827773b2] 10. Petrosoniak A, Hicks CM. Beyond crisis resource management: New frontiers in human factors training for acute care medicine. Curr Opin Anaesthesiol 2013;26(6):699-706. [http://dx.doi. org/10.1097/ACO.0000000000000007] 11. Langeron O, Birenbaum A, Amour J. Airway management in trauma. Minerva Anesthesiol 2009;75(5):307-311.

12. Stephens CT, Kahntroff S, Dutton RP. The success of emergency endotracheal intubation in trauma patients: A 10-year experience at a major adult trauma referral center. Anesth Analg 2009;109(3):866872. [http://dx.doi.org/10.1213/ane.0b013e3181ad87b0] 13. Emergency Medicine Society of South Africa Practice Guideline EM004: Emergency Centre Equipment. EMSSA, 2008. http://emssa.org.za/documents/em004.pdf (accessed 12 December 2013).

14. Butler J, Sen A. Best evidence topic report. Cricoid pressure in emergency rapid sequence induction.

Emerg Med J 2005;22(11):815-816. [http://dx.doi.org/10.1136/emj.2005.030205] 15. Theiler L, Fischer H, Voelke N, Basciani R, Hasty F, Greif R. Survey on controversies in airway management among anaesthesiologists in the UK, Austria and Switzerland. Minerva Anestesiol 2012;78(10):1088-1094.

Accepted 14 May 2014.

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OPINION

Should HIV be a notifiable disease? Old questions with some new arguments W D F Venter, A Black, L Allais, M Richter Francois Venter is an HIV clinician in the Wits Reproductive Health and HIV Institute (RHI), Johannesburg, South Africa, and an associate professor in the School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg. He is interested in improving public sector health. Andrew Black is a pulmonologist at the RHI with an interest in infectious diseases. Lucy Allais is Professor of Philosophy and Director, Wits Centre for Ethics, at the University of the Witwatersrand and a senior lecturer at the University of Sussex in the UK. She works on a variety of topics in ethics and bioethics. Marlise Richter, of Sonke Gender Justice and visiting researcher at the African Centre for Migration and Society, University of the Witwatersrand, and the School of Public Health and Family Medicine, University of Cape Town, South Africa, works on issues of gender-based violence, with a specific focus on sex workers.

Corresponding author: W D F Venter (fventer@wrhi.ac.za)

HIV notification enters national debate regularly, often introduced by politicians and supported by many individual healthcare workers. We argue that its proponents advance confused or poorly informed rationales for making HIV notifiable. We present reasons why making HIV notifiable would be inappropriate in South Africa, why the public health benefits of a notification programme are not even likely, and why there are risks of public health and human rights harms.

S Afr Med J 2014;104(9):607-609. DOI:10.7196/SAMJ.8468

Should HIV be notifiable in South Africa (SA)?

When this question was first discussed, decades before widespread access to antiretro­viral therapy (ART), the answer was a resounding ‘no’.[1-3] As we outline below, medical staff, politicians and the public have continued to ask the question about HIV notification since then, but the debate lost traction in SA at the turn of the century. However, during the June 2012 African National Congress (ANC) policy conference, the party expressed support for a notification policy for HIV,[4] which has refocused attention on the debate for the first time in over a decade.[5,6]

The history of the HIV notification debate in SA

HIV is reportable in many developed and developing countries.[7] The SA HIV landscape has changed enormously in the last few years, including the provision of broad-based HIV testing ensuring that over half the nation knows their status, with free access to ART.[8] In the context of increasing argument that HIV should be de-exceptionalised, it might be thought that established public health measures should once again be considered. Yet there has been no formal discussion on notification in the new era of widespread HIV testing and antiretroviral access. Do the changes in the HIV epidemic in SA justify reopening the debate and a new call for HIV notification, as we see from the ANC policy conference? We argue that they do not.

In 1988, when fewer than 100 people with HIV had been identified in SA, the question of notification was discussed in the SAMJ by prominent medical scientists, who recommended ‘detailed study and discussion and consultation with the groups at risk’ before a notification decision was made.[3] At the time testing for HIV was not routine; clinically defined AIDS usually triggered confirmatory HIV testing. This is in stark contrast to the current situation, where access to HIV testing is widespread and effective therapy is freely available.

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In the 1980s and 1990s, notification was seen by some as an antidote to secrecy and a necessary step to deal with HIV pragmatically.[9,10] At the time, the Minister of Health, Nkosazana Dlamini Zuma, strongly advocated the notification of HIV: ‘We can’t afford to be dictated to by human rights or AIDS activists. We want to know who is dying of AIDS, and relatives and partners must be notified. It is time we treated AIDS as a public health issue like TB. We don’t go about treating that with secrecy.’[11] In a response to human rights violations and stigma surrounding people living with HIV/AIDS, human rights advocates strongly resisted this classic public health approach to the epidemic.

They emphasised the need for an individual’s confidentiality and argued that there was little personal or public health benefit to making HIV notifiable.[12] HIV notification continued to be repeatedly raised by health officials and politicians (by Dlamini Zuma in 1997, against the advice of the Department of Health’s own National STD/HIV/ AIDS Review and National AIDS Advisory Committee, by the New National Party and the Inkatha Freedom Party, and most recently at the 2012 ANC policy conference),[2,4.6,13-15] often linked to a demand for quarantine.[16,17] The SA government prepared draft guidelines for reporting HIV in 1999, but never passed them. Concerns at the time were comprehensively discussed in the legal literature.[6,12,16]

Justification for disease notification

What is notification? The SA disease notification system mirrors policies in many other countries, where ‘notification’ is a legal obligation on the part of healthcare workers to report to public health authorities, by patient name (and in some states in the USA by a patient number) an identified specific disease (usually an infectious disease) that is thought to have implications for the public. In SA, a specific case report form needs to be submitted within 24 hours for certain categories of infection (e.g. rabies, polio, cholera), and within 7 days for other conditions (e.g. tuberculosis (TB), hepatitis B).[18] Traditionally, the justification for a notification system is to alert authorities about diseases that require immediate public

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health intervention, for evaluation of changing disease patterns and identification of communities that require special responses. The SA Department of Health’s official justification for notification is similar, with the wording ‘to plan and implement health promotional and intervention strategies’.[19] With illnesses such as cholera and polio, early warning can lead to immediate interventions that can protect populations (cutting off a contaminated water source for cholera, vaccine mop-ups in polio). This area of public health has attracted little controversy among medical ethicists or human rights groups, other than raising concerns about possible breaches of confidenti­ ality.[20] However, in other respects notification has come into conflict with human rights protagonists, for example over the forced testing for venereal disease in Britain and the USA over 100 years ago.[21,22] Although in theory legal sanction is available if healthcare workers do not comply, no health professional has recently been investigated, let alone sanctioned. (Multiple attempts by the authors over 18 months to get this information from the Health Professions Council of South Africa (HPCSA) were only successful after the direct intervention by the HPCSA ombudsman.)

What are the arguments for HIV notification?

HIV is contagious, preventable and treatable, making action-orien­ tated public health interventions appealing. ART for those who are infected has revolutionised the disease, with a near-normal life expectancy with good adherence.[23] Added to this has been the finding that effective ART can completely arrest transmission.[24] As with other HIV debates about ‘disclosure’, the issue of HIV notification is often regarded as pitting human rights against public health.[25] Here, however, we focus on the question of whether notification is a useful public health measure.

Traditional reasons for making a disease ‘notifiable’ are: • Diseases that may require immediate public health intervention and follow-up. This implies urgency and action in the midst of rapidly evolving disease epidemiology. However, the HIV epidemic is stable and well documented, with well-established prevention and treatment programmes, and excellent research in the fields of both behaviour and uptake of prevention interventions.

Notification would not add any additionally useful information.

• Evaluation of changing disease patterns. SA has some of the most sophisticated HIV statistics in the world, in an epidemic that has been well documented since the early 1990s, through the government’s antenatal surveys, Statistics South Africa’s analysis of death certificates, and the Human Sciences Research Council’s regular household surveys.[8,26,27] It is unlikely that notification, as discussed below, could match the rigour of these ongoing projects. Finally, HIV is asymptomatic for years and even decades.

Notification would probably find only the sick, or when someone tests voluntarily, which is a poor way to understand changing transmission patterns.

• Identification of communities that may require special responses. Vulnerable groups that require special responses have already been identified as so-called ‘key populations’ in SA’s current AIDS policy, with tailored HIV treatment and prevention responses.[28] Acute HIV, which is very infectious, is very rarely identified using current testing strategies, so using notification as a means of ‘outbreak control’ is not feasible. This means that even if an outbreak occurs in a specific community, it seems unlikely that it will be recognised rapidly. More conventional active research and surveillance would be a better mechanism to identify outbreaks.

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‘HIV-specific’ reasons advanced are: • Notification will give us more accurate statistics. This is often quoted as justification for HIV notification, including by a previous Minister of Health.[2] In one Indian state, it is advanced as the sole reason – to obtain better data.[29] As discussed, SA has very robust HIV statistics. Proponents are also usually unaware that notification data are notoriously badly collected, with severe under-reporting documented for many diseases.[1,22,30,31] • Notification will allow us to warn sex partners at risk of contracting HIV. Suppose citizen X tests positive, an investigative team is deployed to provide advice and support, and a letter is sent or a phone call made to tell their partner that he or she may be at risk of contracting, or have contracted, HIV. In addition to concerns over confidentiality, the negative consequences of such a practice are obvious: once it becomes known that testing will lead to some form of forced disclosure, patients will simply either not come forward for testing, or stop reporting who their sex partners are. The resources required to investigate, inform and verify every newly diagnosed case of HIV in SA each year would be prohibitive, even if we only limited it to current sexual partners. Follow-up and the continued warning of new partners for all patients not on ART or with detectable viral loads would also be required. The poor state of TB contact tracing, a far less ambitious project, demonstrates the practical challenges inherent in such a system. Finally, notification is not needed to warn sexual partners, as there is clear guidance from the HPCSA’s Ethical Guidelines for Good Practice with Regard to HIV on disclosure of HIV status to a third party. These set out the narrowly prescribed conditions under which a healthcare worker may have a duty to warn sexual partners, and the procedures for doing so against a patient’s wishes.[32] • Notification would allow us to isolate people with HIV. This argument occasionally surfaces, often with reference to a romanticised version of Cuba’s HIV policy that involved quarantine of people with HIV.[33,34] It appeals to an authoritarian public health streak that is seen in many discussions on provision of preventive healthcare. The ethical and human rights arguments against it are compelling and straightforward. HIV-negative people’s rights are not removed in a consensual sex environment. As well as being hugely impractical, trying to protect HIV-negative people who can in fact take actions to protect themselves by somehow isolating the 15% HIV-positive section of the population (the equivalent of the entire population of Mpumalanga and Limpopo combined) would infringe fundamental human rights without any possible proportionate justification. Sex is largely a voluntary act between consenting adults, and risk reduction is possible through the use of condoms or other safe sex practices. Non-disclosure of HIVpositive status is covered by current legal frameworks, allowing prosecution in most legal systems, so notification is not needed for this reason. It is interesting to note that since the lifting of its incarceration policy many years ago, Cuba has not witnessed a dramatically increased HIV rate. A second area that poses more debate is the issue of quarantine of seroconverters, at which stage HIV is hyperinfectious. However, we do not have any evidence of reckless behaviour after a positive diagnosis, and simple counselling has been found to be effective in certain US states, where acute seroconversion patients are identified and contacted and prevention counselling initiated.[35] Even in more dangerous and widely communicable diseases, such as multidrug-resistant TB, incarceration is controversial.[17] Punitive measures for HIV seroconverters are unnecessary, draconian, and inconsistent with human rights.

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Critics of notification argue that it could increase stigma. However, the data to support this claim from countries that have implemented notification systems does not appear to be any more than anecdotal, and even if it were true, it might not provide sufficient reason by itself not to have a notification system, if the public health benefits were substantial. Critics have also raised fears about violation of confidentiality, but again there do not appear to be reported data to back this up. Even if cases did occur, sanctions are available against healthcare staff, as with all health confidentiality issues. In many countries or states, notification systems have been implemented with little reported evidence of such problems. However, SA has many examples of people being discriminated against, fired and even murdered on disclosing their HIV status in communities, so care is required, as legal channels cannot offer absolute protection.[6] Confidentiality is a fundamental ethical tenet of medical practice, and should not be casually dispensed with, especially when social harms on HIV forced disclosure are well documented.

Given the effectiveness of interventions to prevent mother-tochild transmission (PMTCT) of HIV, it could be argued that HIVinfected infants may be a unique group where notification could lead to immediate investigation. Notification could fulfil a role in alerting health authorities of breakdowns in prevention systems, much like reports of vaccination-preventable diseases such as measles, or water contamination in the case of cholera. The current monitoring systems for PMTCT are sufficiently robust to detect system failures, but they lack the rapid investigation and response component that notification would allow for. However, the notification of HIVinfected infants may have negative consequences such as pregnant women refusing antenatal testing of themselves or postnatal testing of their babies. This would decrease the uptake of PMTCT interventions and treatment of HIV-infected infants, and worsen rather than improve the PMTCT programme. Finally, there are a large number of other ‘system failure’ markers that are not notifiable, including drug stock-outs, needlestick injuries, antibiotic resistance, and even health staffing levels. It seems peculiar and ineffective to focus only on PMTCT. We are not arguing that notification has no role in other diseases.

We think there is a compelling public health reason for urgent notification of illnesses such as polio and cholera, even where confidentiality is compromised, although we believe that compromise should and could easily be minimised by restricting this information to health officials. However, several of our arguments could apply to other diseases that are currently deemed ‘notifiable’ in SA, and we believe that a debate on why and how notification occurs and a review of the current notifiable diseases list is overdue.

Conclusion

Notification broadly can sometimes be a valuable adjunct to public health, but not in the generalised HIV epidemic in SA. Collectively, proponents of notification overstate the need for accurate statistics and the range of practical interventions available to act on successful HIV notification, underplay the possible harm of forced disclosure in communities, and are too cavalier about violating confidentiality.

Notification is not necessary for proper planning or provision of treatment, notification of sex partners is unenforceable, there are currently good guidelines to deal with patients unwilling to disclose their status to sex partners, and better HIV statistics are available elsewhere.

There are substantive disadvantages, including creation of yet further bureaucracy and allied cost, inadvertent disclosure of HIV status in communities where this is dangerous, and the possibility of driving the disease underground, after several years of human rights and health

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gains, undermining gains in getting people tested and on treatment.

Notification with attached legal sanctions on sexual behaviour would fundamentally affect the freedoms of a large segment of the population, and, as with most legislation on consensual sex, would be unenforceable and simply contribute to stigma and undermine autonomy.

In 2014, we need to let this debate go. Setting up the notification debate as one of public health versus human rights is misguided. It is quite easy, in the case of HIV notification, to respect both.

Acknowledgements. Prof. Moosa Patel, Division of Clinical Haematology, Department of Medicine, Chris Hani Baragwanath Academic Hospital and University of the Witwatersrand, asked the question. Dr Black and Prof. Venter are funded by the US President’s Emergency Plan for AIDS Relief (PEPFAR).

1. Abdool Karim SS, Abdool Karim Q. Under-reporting in hepatitis B notifications. S Afr Med J 1991;79(5):242244.

2. Colvin M. Should AIDS be notifiable? S Afr Med J 1999;89(2):147-148.

3. Ijsselmuiden CB, Steinberg MH, Padayachee GN, et al. AIDS and South Africa – towards a comprehensive strategy: Part I. The world-wide experience. S Afr Med J 1988;73(8):455-460.

4. Mataboge M, du Plessis C. ANC wants new Constitution. City Press, 3 March 2012. http://www.citypress.co.za/ news/anc-wants-new-constitution-20120303-2/ (accessed 15 May 2014).

5. Daniels A. Aids should become a notifiable disease, readers. IOL News, 25 May 2009. http://www.iol.co.za/ news/south-africa/aids-should-become-a-notable-disease-readers-1.444410#.U3WRkShklyU (accessed 15 May 2014).

6. AIDS Law Project. Submission on regulations relating to communicable diseases and the notification of notifiable medical conditions. 1999. http://www.section27.org.za/wp-content/uploads/2010/04/RegulationRelating-to-Communicable-Diseases-1999-ALP.pdf (accessed 15 May 2014).

7. Wikipedia. List of notifiable diseases. 2014. http://en.wikipedia.org/wiki/List_of_notifiable_diseases (accessed 15 May 2014).

8. Shisana O, Simbayi LC, Zuma K, Jooste S, Zungu N, Labadarios D. South African National HIV Prevalence, Incidence and Behaviour Survey, 2012. Cape Town: HSRC Press, 2014.

9. Vlaminckx BJ, Boucher CA. [HIV should become a notifiable disease]. Ned Tijdschr Geneeskd 2007;151(48):2672.

10. Mae P. Medical confidentiality and the public disclosure of HIV status. Journal of South Pacific Law 2004;8(1). http://www.usp.ac.fj/index.php?id=13269 (accessed 2 August 2014).

11. Cherry M. South Africa reveals plans to make AIDS a notifiable disease. Nature 1999;399(6734):288. [http:// dx.doi.org/10.1038/20489] 12. South African Law Reform Commission. Aspects of the Law Relating to AIDS (Project 85). Pretoria: South African Law Reform Commission, 1997.

13. Helen Suzman Foundation. Aids notification 1999. http://www.hsf.org.za/resource-centre/focus/issues-11-20/ issue-15-third-quarter-1999/aids-notification (accessed 2 August 2014).

14. Taitz L. Zuma makes doctors report AIDS patients. Sunday Times 1999. http://ww1.aegis.org/news/ suntimes/1999/ST990402.html (accessed 15 May 2014).

15. Sidley P. South Africa plans to make AIDS a notifiable disease. BMJ 1999;318(7194):1308. Epub 1999/05/14. [http://dx.doi.org/10.1136/bmj.318.7194.1308] 16. Cameron E. Legal and human rights responses to the HIV/AIDS epidemic in South Africa. Stellenbosch Law Review 2006;1(17):47-90.

17. Carstens P. The involuntary detention and isolation of patients infected with extreme resistant tuberculosis (XDR-TB): Implications for public health, human rights and informed consent: Case. Obiter 2009;30(1):420429.

18. Department of Health. Public health surveillance system. Epidemiological Comments 2011;2(1). http:// www.doh.gov.za/docs/reports/2012/epicomments2.pdf (accessed July 2013; document no longer available at website).

19. Department of Health. Disease notification system. Undated. http://www.doh.gov.za/show.php?id=2662#list (accessed July 2013; document no longer available at website).

20. Ministry of Ethics. Consent and confidentiality. Undated. http://ministryofethics.co.uk/index.php?p=6&q=7 (accessed 15 May 2014).

21. Kiani A. Making TB a notifiable disease. Dawn blog, 2012. http://dawn.com/2012/07/23/making-tb-anotifiable-disease/ (accessed 15 May 2014).

22. UNAIDS. The role of name-based notification in public health and HIV surveillance. 2000. http://data.unaids. org/Publications/IRC-pub01/jc338-name-based_en.pdf (accessed 15 May 2014).

23. Miller V, Hodder S. Beneficial impact of antiretroviral therapy on non-AIDS mortality. AIDS 2014;28(2):273274. [http://dx.doi.org/10.1097/QAD.0000000000000079] 24. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011;365(6):493-505. [http://dx.doi.org/10.1056/NEJMoa1105243] 25. Pieterse M. The interdependence of rights to health and autonomy in South Africa. S Afr Law J 2008;125(3):553-572.

26. Abdool Karim SS, Churchyard GJ, Abdool Karim Q, Lawn SD. HIV infection and tuberculosis in South Africa: An urgent need to escalate the public health response. Lancet 2009;374(9693):921-933. [http://dx.doi. org/10.1016/S0140-6736(09)60916-8] 27. Rehle TM, Hallett TB, Shisana O, et al. A decline in new HIV infections in South Africa: Estimating HIV incidence from three national HIV surveys in 2002, 2005 and 2008. PLoS One 2010;5(6):e11094. [http://dx.doi. org/10.1371/journal.pone.0011094] 28. South African Department of Health. The National Strategic Plan on HIV, STIs and TB 2012-2016. http:// www.sahivsoc.org/upload/documents/National_Strategic_Plan_2012.pdf (accessed 15 May 2014).

29. Jha S. Aids/HIV to be a notifiable disease in Biha. Times of India 2002; 9 November. http://timesofindia. indiatimes.com/city/patna/Aids/HIV-to-be-a-notifiable-disease-in-Bihar/articleshow/27706909.cms (accessed 15 May 2015).

30. Weber I. Evaluation of the notifiable disease surveillance system in Gauteng Province, South Africa. University of Pretoria, 2007. http://upetd.up.ac.za/thesis/available/etd-07302008-141155/unrestricted/dissertation.pdf (accessed 15 May 2014).

31. Abdool Karim SS, Dilraj A. Reasons for under-reporting of notifiable conditions. S Afr Med J 1996;86(7):834836.

32. Health Professions Council of South Africa. Ethical Guidelines for Good Practice with regard to HIV. Pretoria: HPCSA, 2007. http://www.hpcsa.co.za/Uploads/editor/UserFiles/downloads/conduct_ethics/rules/generic_ ethical_rules/booklet_11_hiv.pdf (accessed 2 August 2014).

33. Hoffman SZ. HIV/AIDS in Cuba: A model for care or an ethical dilemma? Afr Health Sci 2004;4(3):208-209.

34. Anderson T. HIV/AIDS in Cuba: Lessons and challenges. Rev Panam Salud Publica 2009;26(1):78-86. [http:// dx.doi.org/10.1590/S1020-49892009000700012] 35. Pilcher CD, Fiscus SA, Nguyen TQ, et al. Detection of acute infections during HIV testing in North Carolina.

N Engl J Med 2005;352(18):1873-1883. [http://dx.doi.org/10.1056/NEJMoa042291]

Accepted 20 June 2014.

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Maintaining muscle mass and preventing sarcopaenia in the elderly:

important benefits of dairy protein Sarcopenia is defined as the age-related loss of skeletal muscle mass and strength.1 This condition is associated with disability and lower functional independence, which significantly impact on the ability to perform activities of daily living and quality of life.1 Aging, exercise and sarcopaenia

R

esistance exercise has the ability to increase muscle protein mass and strength,2,3 which over time can result in improved muscle protein synthesis and muscle hypertrophy.3 By preserving muscle mass, metabolic rate is maintained, which reduces the risk of obesity and its comorbidities.2 There is a growing body of evidence that has highlighted the potential of milk-based proteins to enhance the benefits of exercise in maintaining and enhancing muscle mass in older adults.

Milk-based proteins Dairy products are rich in nutrients and have a high palatability, making them beneficial in the diet of both healthy and frail elderly persons.4 In addition, milk proteins such as whey and casein have a high biological value and quality2,5 due to their different absorption rates in the digestive system. Whey proteins, also termed ‘fast proteins’, remain in a liquid state in the stomach, which increases amino acid availability and absorption. Whey protein is therefore thought to support rapid increases in muscle protein synthesis. In contrast, caseins, or ‘slow proteins’, clot at the low pH of the stomach, resulting in a slower availability of amino acids5 and are therefore more likely to support sustained increases in muscle protein synthesis and decreases in muscle protein breakdown.2,3,5 In addition to the whey and casein proteins, milk and other dairy products are also a good source of leucine,5,6 which is especially important in stimulating muscle protein synthesis.6

Conclusion Milk-based proteins have biological effects that may improve the beneficial effects of exercise, since these proteins are an effective protein source for stimulating muscle protein synthesis and slowing muscle protein breakdown, so improving muscle mass. The anabolic effect of milk may be an effective, practical and cost-effective way to maintain muscle mass and strength in the healthy elderly and promote fast recovery in the frail and malnourished elderly.

Reviewing the evidence Hartman et al.7 showed that over a 12-week period, the intake of milk after resistance training sessions resulted in greater increases in muscle mass in healthy young adults than in comparable participants who were supplemented with soy. Another study compared the effects of fat-free milk and soy milk after exercise in young, healthy men and found that although both foods promoted muscle mass maintenance and gains, the consumption of milk however resulted in greater muscle protein synthesis.8 The researchers concluded that incorporating milk consumption in a resistance training programme supports accrual of lean muscle mass.

Recently, Bjorkman et al.9 undertook a randomised cross-over trial in older persons (mean age = 69.5 years) with polymyalgia rheumatica. These participants consumed regular milk or a whey-enriched dairy product, which had an associated high leucine content, after exercise for eight weeks. The two products resulted in similar improvements in muscle mass and function, but the whey product tended to prevent accumulation of body fat. These results were confirmed in young adults who consumed different sources of milk-based proteins: the consumption of whole milk, skim milk, and skim milk plus carbohydrate all improved muscle synthesis after resistance training.10 Cermak et al.11 conducted a meta-analysis to examine whether protein supplementation augments the effects of resistance exercise in younger and older subjects. Data from six randomised clinical trials related to the impact of protein supplementation in untrained older subjects were combined. Five studies included only dairy protein (whey, milk or casein) and one included a combination of egg, meat and dairy. Although the individual studies failed to find a significant benefit of protein supplementation with regard to fat-free mass gain, the combined data from 215 older subjects showed that protein supplementation resulted in 38% more fat-free mass and a 33% increase in strength when compared with a placebo.

One trial involving the intake of milk-based proteins during or after exercise in the elderly has reported conflicting results. A randomised, controlled trial in healthy middle-aged and older men could not demonstrate any added benefits of milk consumption over that of resistance exercise training alone.12 In this trial, however, milk was not consumed directly after exercise, meaning that the benefit of exercise-induced blood flow and the potential of amino acids to improve muscle protein synthesis after exercise were not utilised.3 The authors acknowledge that the timing of milk consumption could have been the reason for the lack of impact in that trial.12

Journal 40 July 2014.indd 1

REFERENCES 1.

2.

3.

4.

Walston JD. 2012. Curr Opin Rheumatol, 24:623–627.

Phillips SM et al. 2009. J Am Coll Nutr, 28:343–354.

Forbes SC et al. 2012. Endocrine, 42:29–38.

Van Staveren WA et al. 2011. J Am Coll Nutr, 30(5 Suppl 1):429S–437S. 5. Gryson C et al. 2013. Cll Nutr, http://dx.doi.org/10.1016/j. clnu.2013.09.004.

6. Norton C et al. 2013. Int Dairy Tech, 66(3):317–320.

7. HartmanJW et al. 2007. Am J Clin Nutr, 86:373–381 8. Wilkinson SB et al. 2007. Am J Clin Nutr, 85:1031–1040.

9. Bjorkman MP et al. 2011. J Nutr Health Aging, 15:462–467.

10. Elliot TA et al. 2006. Med Sci Sports Exerc, 38:667–674.

11. Cermak NM et al. 2012. Am J Clin Nutr, 96:1454–1464.

12. Kukuljan S et al. 2009. J Appl Physiol, 107:1864–1873.

AN INITIATIVE BY THE CONSUMER EDUCATION PROJECT OF MILK SA For further information contact:

Tel: 012 991 4164 • Fax: 012 991 0878

www.rediscoverdairy.co.za info@rediscoverdairy.co.za

2014/07/28 11:43:25 AM

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ISSUES IN MEDICINE

Preventing hepatitis B and hepatocellular carcinoma in South Africa: The case for a birth-dose vaccine C W N Spearman, M W Sonderup Wendy Spearman heads and Mark Sonderup is the senior consultant in the Division of Hepatology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, South Africa.

Corresponding authors: C W N Spearman (wendy.spearman@uct.ac.za), M W Sonderup (msonderup@samedical.co.za)

Hepatitis B is a global public health issue, with some 2 billion people having current or past infection. In Africa, 65 million are chronically infected, an estimated 2.5 million of them in South Africa (SA). Hepatitis B and the associated complications of cirrhosis and hepatocellular carcinoma are entirely vaccine preventable. SA was one of the first ten countries in Africa to introduce universal hepatitis B vaccination in April 1995, but has no birth dose or catch-up programme. Although universal infant vaccination in SA has been successful in increasing population immunity to hepatitis B, improvements in terms of implementing protocols to screen all pregnant mothers for hepatitis B surface antigen (HBsAg) and ensuring full hepatitis B coverage, especially in rural areas, is required. The World Health Organization has recommended a birth dose of hepatitis B vaccine in addition to the existing hepatitis B vaccine schedule in order to further decrease the risk of perinatal transmission. We recommend that SA implement a birth-dose vaccine into the existing schedule to attenuate the risk of perinatal transmission, prevent breakthrough infections and decrease HBsAg carriage in babies born to HIV-positive mothers.

S Afr Med J 2014;104(9):610-612. DOI:10.7196/SAMJ.8607

Globally some 250 - 400 million people are chroni­cally infected with hepatitis B, with sub-Saharan Africa (sSA) and South-East Asia being disproportionately affected. Compared with the 1.5 million deaths annually due to HIV/AIDS, which are declining, hepatitis B mortality is on the rise with 500 000 - 1.2 million deaths annually. This relates in part to hepatocellular carcinoma (HCC), the fifth most common malignancy and the third leading cause of cancer-related death worldwide, despite the fact that hepatitis B is an entirely vaccine-preventable disease.[1]

Burden of disease

The prevalence of hepatitis B varies geographically, with 45% of the global population living in endemic areas (â&#x2030;Ľ8% prevalence of hepatitis B surface antigen (HBsAg)), notably the Asia-Pacific and sSA region.[1,2] An estimated 65 million people in Africa are chronically infected, 2.5 million of them in South Africa (SA).[3,4] In endemic countries, the majority of infections occur either perinatally or horizontally during early childhood and mostly before the age of 5 years, although in hepatitis B e-antigen (HBeAg)-positive mothers, perinatal transmission is considerably higher. The risk of chronicity depends on the age of acquisition, decreasing from 70 - 90% with perinatal infection to 25 - 60% in early childhood, 6 - 10% for ages 5 - 20 years and 1 - 5% for adults aged >20 years.[1] In SA, horizontal child-to-child transmission dominates from 6 months to 5 years of age and seroprevalence varies between genders, between ethnic groups and between urban and rural areas.[4-7] Highlighting this, an Eastern Cape Province community-based cross-sectional HBsAg prevalence study of 2 299 children aged 0 - 6 years before the introduction of hepatitis B immunisation demonstrated that 10.4% children were HBsAg-positive, increasing from 8.1% at 0 - 6 months to 15.7% at 61 - 72 months.[8] Adult-acquired hepatitis B is poorly understood

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in SA, but probably represents a relatively small component of the chronic hepatitis B virus (HBV)-infected population.

Given that 15 - 25% of infected patients may develop cirrhosis, liver failure or hepatocellular carcinoma, there is a need for improved surveillance of acute and chronic HBV infection in Africa to better understand the economic burden of HBV infection and its complications. In SA there is the dual burden of hepatitis B and HIV, although with current antiretroviral regimens containing effective anti-HBV drugs, those with co-infection are at least accessing therapy. The HIV programme does not automatically test for HBsAg, which is unfortunate given that surveillance data would provide epidemiological information and allow for targeted interventions such as vaccinating partners of those infected with hepatitis B. Equally, no antenatal testing is performed, therefore not allowing for measures to reduce the risk of mother-to-child transmission of HBV.

Hepatocellular carcinoma

HCC is a significant cause of cancer mortality in sSA, and 46 000 new cases are diagnosed annually. The age-standardised incidence of HCC is as high as 41.2/100 000 persons/year, with prognosis being poor and 92% dying within 1 year of the onset of symptoms.[8] HBV, a vaccine-preventable disease, accounts for 60 - 80% of HCC, which can develop even in the absence of cirrhosis. Furthermore, given that the HBV DNA incorporates itself into the host hepatocyte genome, even those with occult hepatitis B virus infection (i.e. HBsAgnegative with detectable serum HBV DNA), or those with previous exposure, are at risk of HCC.[9]

Vaccination

The seroprevalence of HBsAg in SA before the introduction of hepatitis B vaccination in 1995 ranged from 0.2% to 9.6%, with serological evidence of past exposure to hepatitis B (HBsAg-negative,

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HB core IgG-positive) ranging from 5% to 76%.[3,5,6] Marked differences between ethnic groups were noted. HBsAg rates were considerably higher in rural areas: 15.5% in the Eastern Cape (former rural Transkei), compared with 7.4% in urban Durban and 1.3% in Soweto. In rural areas, HBeAg seroprevalence was also higher in HBsAg-positive mothers: 12% in HBsAg-positive mothers from rural areas compared with 0% in HBsAg-positive pregnant women in Soweto. A 2.6:1 male/female predominance is well documented.[5,7] Universal infant vaccination is the most effective way to reduce the global burden of HBV, and the World Health Organization (WHO) recommended its incorporation into the Expanded Programme of Immunization (EPI) in 1991.[10,11] This proved exemplary in Taiwan, where universal vaccination, introduced in 1984, together with a catch-up vaccination programme and improved maternal screening, resulted in a decrease in the prevalence of HBsAg positivity in children aged <15 years from 9.8% in 1984 to 0.7% in 1999.[12,13] Furthermore, the prevalence of HCC in children aged 6 - 9 years decreased from 5.2 cases/million population in 1984 to 1.3/million in the first vaccination cohort.[14,15] To date, 183 countries worldwide and 45 in the WHO Africa region have incorporated hepatitis B vaccination into the EPI. It is estimated that this has prevented more than 1.3 million deaths.

The global vaccination coverage with three doses is 75% (41 - 89%), while birth-dose coverage occurs in 94 WHO member countries. Of concern is low birth-dose coverage in countries where there is a high risk of perinatal and early childhood transmission. At present, 38 out of 56 Global Alliance for Vaccines and Immunization (GAVI)-eligible countries are not providing a birth dose, and in Africa birth coverage stands at only 23%, with full coverage with three doses, not including a birth dose, at only 67% (50 - 79%). In South-East Asia, the rate of birth coverage is 10% and that of full coverage 41%.[1,16] The 2010 official vaccine coverage rate of 97% in SA is probably overestimated given the potentially reduced coverage in rural areas and a WHO reported coverage of 56% in 2007.[17] Birth-dose coverage is important in preventing perinatal trans­ mission. This has been demonstrated in China, where a partnership between GAVI and the Chinese government supported a free birthdose vaccine; in combination with the up-scaling of the full vaccine schedule, <1% of Chinese children are now hepatitis B-infected.[18] SA was one of the first 10 countries in Africa to introduce uni­versal HBV vaccination (6-, 10- and 14-week schedule) in April 1995, but currently has no birth dose and no catch-up programme. Obvious benefit has already been achieved, with the overall seroprevalence of HBsAg declining from 12.8% to 3% in some studies. A 2 - 3-year follow-up of 186 infants vaccinated in 1995 with Hepaccine B showed seroprotection (anti-hepatitis B surface antibody (anti-HBsAb) ≥10 mIU/ml) in 93% and 76.8% initially and 3 years later, respectively.

No children were positive for HBsAg, HBV DNA or anti-hepatitis B core antibody (anti-HbcoreAb).[19] In the Eastern Cape, of 1 213 fully vaccinated 12 - 24-month-old infants born after 1995, none were HBsAg-positive, 0.9% (9/986) were anti-HBcoreAb-positive, 0.3% (4/1 213) were HBV DNA-positive and 84.6% (834/986) had protective anti-HBsAb levels. In contrast, 7.8% (39/498) unvaccinated 12 - 24-month-old infants born before 1995 were HBsAg-positive, 1.9% (4/203) were anti-HBcoreAb-positive, and 6.5% (30/459) had occult hepatitis B infec­tion.[20] Another study assessed the efficacy of universal vaccination 5 years after the implementation of the programme in 598 infants from Limpopo Province aged 8 - 72 months (mean 23.3). Of the infants, 86.8% (519/598) were anti-HBsAbpositive (titre ≥10 mIU/ml), 0% HBsAg-positive and 0% HBV DNApositive; however, 0.9% (5/582) of infants aged 8 - 11 months were

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anti-HBcoreAb-positive.[22] Similarly, assessment of the efficacy of universal HBV vaccination in 770 healthy 18-month-old babies from rural areas of the nine provinces 1 year after vaccination revealed that 87% were anti-HBsAb-positive (titre ≥10 mIU/ml), 0.4% HBsAgpositive and 0.5% anti-HBcoreAb-positive, compared with historical controls of 10.1% HBsAg seroprevalence in children aged 0 - 6 years.[23]

Influence of HIV

HIV/HBV co-infection increases the risk of perinatal transmission.

Reduced seroprotection in under-2-year-old HIV-positive v. negative children has been demonstrated. Here 78.1% (57/73) v. 85.7% (197/230) were anti-HBsAb-positive (titre ≥10 mIU/ml) and 2.7% (2/73) v. 0.4% (1/230) HBsAg-positive, with an equivalent antiHBcoreAb positivity of 3% and 2.7%, respectively.[24] A 2007 antenatal study comparing 1 420 HIV-positive and negative mothers noted higher anti-HBcoreAb positivity (39.2% v. 30.1%) in HIV-infected women, while 6.2% were HBsAg-positive.[25] HIV also reduces transfer of maternal anti-HBs. Only 21% of HIVexposed v. 54% of unexposed babies had protective levels of anti-HBs, suggesting that 79% of babies born to HIV-positive mothers have no protective anti-HBs until after the first hepatitis B vaccination at 6 weeks of age.[3,26] Breakthrough infections can occur, mainly in HIVexposed/infected babies.[24] In 9 355 pregnant women from antenatal clinics in the Western Cape Province, no difference was seen between prevalences of HBsAg in HIV-positive and negative women (3.4% (53/1 543) v. 2.9% (44/1 546)) and HBeAg (18.9% (10/53) v. 17.1% (7/41)).

However, HBV DNA levels were much higher in HIV-positive women, at 9.72 × 107 IU/ml v. 1.19 × 106 IU/ml in HIV-negative women, implying that the risk of perinatal transmission would be elevated. [27]

Need for a birth-dose vaccine

Although universal infant vaccination in SA has demonstrated increased population immunity to hepatitis B, there is still significant room for improvement given the absence of screening of pregnant women for HBsAg as well as the absence of a catch-up vaccination programme such as that implemented in Taiwan. Full coverage with three doses needs to be achieved, especially in rural areas where HBsAg seroprevalence is highest. To prevent perinatal transmission, a birth dose of the vaccine preferably needs to be administered within 12 hours of delivery, and certainly within 24 hours. The hepatitis B monovalent vaccine can be administered together with oral polio and BCG. SA must consider a four-dose schedule consisting of a monovalent birth dose followed by three doses of monovalent vaccine, given together with the routine infant vaccines or as a combination vaccine at 6, 10 and 14 weeks. Challenges will be faced in rural areas where there is a higher prevalence of hepatitis B, home births occa­ sionally occur and birth BCG coverage is lower (70 - 79%).[3] Studies have confirmed the thermostability of HBV vaccines outside the cold chain, assisting access to the birth dose in rural areas.[29] A four-dose schedule, essentially requiring the addition of a birth dose to the existing schedule, is slightly more costly than a three-dose schedule.

However, it is easier to implement and does not immunologically compromise infants who may not access a birth dose. A four-dose approach is also recommended for improved immunogenicity if penta- or hexavalent vaccines are used in the EPI schedule.

It is unfortunate that recent a request to GAVI, co-signed by 76 global groups, to fund a birth-dose vaccine in all countries not undertaking this routinely, has not been favourably received.

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Immunity from vaccination, although good, tends to decline at a time when there is increased risk of acquisition of hepatitis B due to sexual activity or risky lifestyle behaviour such as injecting drug use. A Chinese study assessed the long-term efficacy of postnatal active-passive vaccination (HBIG) in 8 733 high-school students.

Among those who did not receive HBIG, there was a significant negative association between hepatitis B vaccination dosage and HBsAg positivity. The adjusted odds ratios for those who received 4, 3 and 1 - 2 doses were 1.00, 1.52 (95% confidence interval (CI) 0.91 - 2.53) and 2.85 (95% CI 1.39 - 5.81), respectively. Notably, onesixth of students who had received four-dose coverage had lost their immunological memory against HBsAg by the age of 15 years.[28]

Conclusion

A strong case exists for the implementation of a birth dose of hepatitis B vaccine in addition to the current schedule, as recommended by the WHO, to decrease the risk of perinatal transmission, prevent breakthrough infections, and decrease HBsAg carriage in HIVpositive babies. An adolescent booster dose, although not routinely recommended, merits consideration, as immunological memory against HBsAg is lost in a significant number of adolescents by the age of 15 years.

1. World Health Organization Position Paper. Hepatitis B vaccines. WHO Wkly Epidemiol Rec 2009;84(40):405-420. http://www.who.int/wer/2009/wer8440.pdf?ua=1 (accessed 16 June 2014).

2. Kramvis A, Kew MC. Epidemiology of hepatitis B virus in Africa, its genotypes and clinical associations of genotypes. Hepatol Res 2007;37(Suppl 1):S9-S19. [http://dx.doi.org/10.1111/j.1872034X.2007.00098.x] 3. Burnett RJ, Kramvis A, Dochez C, Meheus A. An update after 16 years of hepatitis B vaccination in South Africa. Vaccine 2012;30(Suppl 3):C45-C51. [http://dx.doi.org/10.1016/j.vaccine.2012.02.021] 4. Robson SC, Kirsch RE. National strategy for viral hepatitis: Recommendations and guidelines for management in South Africa. S Afr Med J 1991;80(7):347-356.

5. Kiire CF. The epidemiology and prophylaxis of hepatitis B in sub-Saharan Africa: A view from tropical and subtropical Africa. Gut 1996;38(Suppl 2):S5-S12. [http://dx.doi.org/10.1136/gut.38.Suppl_2.S5] 6. Kew MC. Hepatitis B virus infection: The burden of disease in South Africa. Southern African Journal of Epidemiology and Infection 2008;23(1):4-8.

7. Vardas E, Mathai M, Blaauw D, McAnerney J, Coppin A, Sim J. Preimmunization epidemiology of hepatitis B virus infection in South African children. J Med Virol 1999;58(2):111-115. [http://dx.doi. org/10.1002/(SICI)1096-9071(199906)58:2<111::AID-JMV2>3.0.CO;2-B] 8. Kew MC. Epidemiology of hepatocellular carcinoma in sub-Saharan Africa. Ann Hepatol 2013;12(2):173-182.

9. Kew MC, Welschinger R, Viana R. Occult hepatitis B virus infection in Southern African blacks with hepatocellular carcinoma. J Gastroenterol Hepatol 2008;23(9):1426-1430. [http://dx.doi.org/10.1111/ j.1440-1746.2008.05481.x]

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18. Cui F, Liang X, Gong X, et al. Preventing hepatitis B though universal vaccination: Reduction of inequalities through the GAVI China project. Vaccine 2013;31(Suppl 9):J29-J35. [http://dx.doi. org/10.1016/j.vaccine.2012.07.048] 19. Mphahlele MJ, Tshatsinde EA, Burnett RJ, Aspinall S. Protective efficacy and antibody follow-up of hepatitis B vaccine within the South African expanded programme on immunisation. S Afr Med J 2002;92(8):612-613.

20. Hino K, Katoh Y, Vardas E, Sim J, Okita K, Carman WF. The effect of introduction of universal childhood hepatitis B immunization in South Africa on the prevalence of serologically negative hepatitis B virus infection and the selection of immune escape variants. Vaccine 2001;19(28-29):39123918. [http://dx.doi.org/10.1016/S0264-410X(01)00121-9] 21. Tsebe K, Burnett RJ, Hlungwani NP, et al. The first five years of universal hepatitis B vaccination in South Africa: Evidence for elimination of HBsAg carriage in under 5-year-olds. Vaccine 2001;19(2829):3919-3026. [http://dx.doi.org/10.1016/S0264-410X (01)00120-7] 22. Schoub BD, Matai U, Singh B, et al. Universal immunization of infants with low doses of a low-cost plasma-derived hepatitis B vaccine in South Africa. Bull World Health Organ 2002;80(4):277-281.

23. Simani OE, Leroux-Roels G, François G, Burnett RJ, Meheus A, Mphahlele MJ. Reduced detection and levels of protective antibodies to hepatitis B vaccine in under 2-year-old HIV positive South African children at a paediatric outpatient clinic. Vaccine 2009;27(1):146-151. [http://dx.doi.org/10.1016/j. vaccine.2008.10.004] 24. Burnett RJ, Ngobeni JM, François G, et al. Increased exposure to hepatitis B virus infection in HIV-positive South African antenatal women. Int J STD AIDS 2007;18(3):152-156. [http://dx.doi. org/10.1258/095646207780132523] 25. Jones CE, Naidoo S, De Beer C, Esser M, Kampmann B, Hesseling AC. Maternal HIV infection and antibody responses against vaccine-preventable diseases in uninfected infants. JAMA 2011;305(6):576584. [http://dx.doi.org/10.1001/jama.2011.100] 26. Andersson MI, Maponga TG, Ijaz S, et al. The epidemiology of hepatitis B virus infection in HIV-infected and HIV-uninfected pregnant women in the Western Cape, South Africa. Vaccine 2013;31(47):5579-5584. [http://dx.doi.org/10.1016/j.vaccine.2013.08.028] 27. Wu TW, Lin HH, Wang LY. Chronic hepatitis B infection in adolescents who received primary infantile vaccination. Hepatology 2013;57(1):37-45. [http://dx.doi.org/10.1002/hep.25988] 28. Hipgrave DB1, Maynard JE, Biggs BA. Improving birth dose coverage of hepatitis B vaccine. Bull World Health Organ 2006;84(1):65-71. [http://dx.doi.org/10.2471/BLT.04.017426]

Accepted 25 July 2014.

September 2014, Vol. 104, No. 9

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2014/08/18 4:19 PM

EDITORIAL

The state of our prisons and what this reveals about our society In the third decade of a new South Africa (SA), major challenges are being faced in almost every aspect of life, ranging from meeting minimum daily subsistence requirements, through providing education and primary healthcare, to the functioning of our legal system and governance at local and national levels.

While in this context levels of crime and corruption are reaching new heights, we should not lose sight of the need for humane and accountable approaches to crime and imprisonment. The 37th anniversary on 12 September of Steve Biko’s death under inhumane conditions and without adequate medical care in prison provides an opportunity to remember past failings and to reconsider the lessons these hold for our society.

In the Steve Biko era, medical care for prisoners was provided through the District Surgeon Services under the control of the Department of Health. Failure to treat Steve Biko adequately was explained by the breakdown in professional ethical behaviour of the district surgeons, who succumbed to pressure from the Special Branch of the Security Police. Their personal professional defaults were paralleled by failure of health professional bodies to act appropriately.

In 1994, Divisions of Human Rights Watch published a report on conditions in SA prisons.[1] Much attention was correctly devoted to emphasising the ethical responsibilities of doctors in caring for prisoners and detainees and to exhorting the medical profession to meet its self-proclaimed standards.[1] Since 1994, the Health Professions Council of South Africa has encouraged medical educators to promote knowledge of professional responsibilities generally and of responsibilities to prisoners specifically.[2] In 1995, contrary to what would have seemed most appropriate, the National Department of Health began to dismantle the District Surgeon Services. It became possible for the Department of Correctional Services to appoint nurses and other medical staff to deliver healthcare in SA prisons (see, for example, advertisements for jobs in the Department of Correctional Services[3]). The rights of prisoners to healthcare have been spelled out in some detail,[4] but it is doubtful whether these rights are remotely met. The retrogressive step of diverting some responsibilities for healthcare away from the Department of Health towards the Department of Correctional Services made it possible to dilute the loyalty of some health professionals to their patients by ranking allegiance to prison authorities higher than professional responsibility to patients. Not surprisingly, this is associated with greater reluctance of health professionals to work in prisons and has the potential to subvert the primary role of healers. In comparison, it should be noted that there were beneficial effects in 2006 when prison healthcare services in England and Wales were transferred into the National Health Service.[5] Health services in the public sector have in general deteriorated over recent years, and such deterioration in our prisons has been documented in official reports from the Judicial Inspectorate of Prisons (Annual Reports of Prisons and Prisoners). Conditions under which prisoners are held became more unhygienic and inhumane as occupancy rates increased from 121% in 1995 to 161% in 2002. Since then the occupancy rate was reduced to 144% in 2008 (with a range of occupancy rates of 100% to over 200% across correctional facilities in the country), but conditions remain far from adequate. The annual death rate in our prisons increased from 1.65/1 000 prisoners in 1995 to 9.1/1 000 in 2004, but then fell to 6.4/1 000 in 2008. At the

613

end of March 2009, SA correctional centres held a total of 165 230 inmates. It was recently reported that the Minister of Justice and Correctional Services had announced that through a strategy to diminish overcrowding, the prison population in SA was reduced from 187 006 in 2004 to 157 170 by end of March 2014.[6] SA’s overcrowded, poorly ventilated prisons house 40 000 more inmates than they should, and at least ten prisons have over 200% occupancy. Pollsmoor Prison in Cape Town holds 4 162 prisoners (238% occupation), with 60 - 80 awaiting trial.[7] Our prisons have been described as ‘melting pots’ for tuberculosis (TB) infection, with TB the most common cause of death among prisoners. Prisons are also notorious for being sites where multidrug-resistant (MDR) TB flourishes, and MDR TB is on the rise in SA. Crime is related to poverty, and the disparities in wealth in SA are among the widest in the world. The adverse effects of links between poverty and crime are exacerbated by the links between poverty and TB.[8] As noted in the 2008 Annual Reports of Prisons and Prisoners,[9] ‘At most of these overcrowded facilities, there are few, if any, appropriate rehabilitation programmes and extremely limited recreational or work opportunities, in the form of gardening, farming, workshops or factories, available to inmates.’ The majority of prisoners spend up to 23 hours per day in their cells, each in a space smaller than a single mattress, with limited toilet and ablution facilities and in generally unhygienic conditions. The report goes on to note that ‘this constitutes an extremely unsatisfactory, and indeed unacceptable, environment for the care and development of offenders whom the Department has undertaken to rehabilitate and reintegrate into the community’. The 2012/2013 Annual Report[10] notes that as a result of poor prison conditions inmates are becoming increasingly frustrated, which, together with gangsterism, has resulted in several uprisings.

It is generally agreed that crime is a major problem in SA (as in many other societies) and that the prison system serves an essential social function. If, however, the system is abusive towards those who are incarcerated, often the most vulnerable in society, this should be considered unacceptable. It is arguable from experience in other countries that crime and imprisonment are of greater cost to society if rates and duration of imprisonment are increased (inmates serving a sentence in excess of 5 years increased from 49% in 1998 to 67% in 2008/2009), delays in trials are increased (30% of inmates are still awaiting trial), and rehabilitation is ignored.

The system of inspection by the Inspecting Judge in SA is clearly beneficial and the annual reports provide analysis and reporting of conditions and statistics, with appropriate noting of severe shortcomings. Inadequate medical care was a critical factor in Steve Biko’s death, and we need to ask why in our current democracy, even with recognition of the complexity of the challenges facing healthcare in the public sector, prison healthcare services have declined in quality rather than improved. It should be conceded that after considerable advocacy, more effort has been made to provide effective medications for TB and HIV/AIDS, both of which are infectious and eminently treatable. However, only nurses with primary healthcare experience are permitted to give antiretroviral treatment, and these comprise less than 25% of a total of 800 professional nurses in the employ of Correctional Services. On any given day it has been noted that there are 21 000 inmates who are HIV-positive, yet less than half of the country’s HIV-positive inmates receive antiretroviral treatment.[11] The present reality of continued mistreatment of prisoners by authorities who are meant to protect them could perhaps be changed if the medical profession would work through appropriate channels

September 2014, Vol. 104, No. 9

EDITORIAL

to influence Correctional Services to improve medical care and rehabilitation. From 2006 to 2008, attempts were made by a small group of health professionals at the University of Cape Town to engage in such an effort with the support of Judge Fagan, then Judge of Prisons. The South African Medical Association (SAMA) was persuaded that its intervention as an influential medical body could effect some changes. Arrangements were made for representatives of the small group concerned, together with senior members of SAMA, to meet with the Minister of Correctional Services and his representatives. At two meetings reassurances were given that these issues would receive significant attention. Regrettably, and despite many subsequent communications with SAMA, this agenda has not been pursued.

The Africa Watch Prison Project group was approached to repeat its previous study, but also failed to respond. Several other international organisations that were incensed about conditions in our prisons during the apartheid era are seemingly no longer interested – perhaps because there has been a reduction in respect for civil rights and healthcare rights of prisoners in their own societies, as exemplified by continuing detention without trial and brutalising forced-feeding at Guantanamo Bay,[12] and the recent reports of violence and brutality on Rikers Island.[13,14] A report from the Institute of Medicine reveals the involvement of US physicians in torture.[15] It is notable from the 2010/2011 Correctional Services Report[13] that torture (only electric shock treatment is specified) in SA prisons continues (and, like unnatural deaths, may even have increased), despite our country’s ratification of the United Nations agreement on torture. In addition, it was noted that the absence of mental healthcare in prisons is associated with suicide.[16] Despite recent investigations by the SA Human Rights Commission at the Groenpunt Prison, conditions in our prisons have not had a significant public profile.[17] In relation to health and human dignity in our prisons and to recently exposed excesses of police brutality,[18] our society has at best become inattentive and at worst complacent.

Helen Zille, who exposed Biko’s death when she was a journalist, notes a striking commonality between the SA at the time of Biko’s death in 1977 and the SA of today.[19] As noted almost a decade ago in the columns of this journal: ‘… the whole correctional service process, from police to judicial system to prisons, provides an image of the social and psychological health of our society’.[20] If the way a country treats prisoners, and those not yet convicted of crimes, is a measure of its civilisation and a marker of its vigilance over professional activities, we must surely be found wanting in our responses to crime and the responsibilities

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of our correctional services. These shortcomings mirror many other failures, now increasingly well documented, in a society with the potential and aspiration to do so much better.[21] Solomon Benatar Bioethics Centre, University of Cape Town, South Africa, and Joint Centre for Bioethics, University of Toronto, Canada Corresponding author: S Benatar (solomon.benatar@uct.ac.za) 1. Africa Watch Prison Project, Divisions of Human Rights Watch. Prison Conditions in South Africa.

New York: Human Rights Watch, 1994.

2. Health Professions Council of South Africa: Ethics Rules and Regulations. http://www.hpcsa.co.za/ conduct_rules.php (accessed 21 February 2014).

3. Job Vacancies Department of Correctional Services. http://www.dcs.gov.za/Vacancies/DCS%20 AD2.20102011.pdf (accessed 25 July 2014).

4. Muntingh L. Prisons in a democratic South Africa – a guide to the rights of prisoners as described in the Correctional Services Act and Regulations. Cape Town, 2006. http://cspri.org.za/publications/ research-reports/Prisons%20in%20a%20Democratic%20South%20Africa%20-%20a%20Guide%20 to%20the%20Rights%20of%20Prisoners%20as%20Described%20in%20the%20Correctional%20Services%20Act%20and%20Regulations.pdf (accessed 14 July 2014).

5. Hayton, P, Boyington J. Prisons and health reforms in England and Wales. Am J Public Health 2006;96(10):1730-1733. [http://dx. doi.org/10.2105/AJPH.2004.056127] 6. People’s Assembly. MPs address overcrowding in prisons, parole hearings and state of correctional facilities. http://www.pa.org.za/blog/mps-address-overcrowding-prisons-parole-hearings-a (accessed 25 July 2014).

7. Wood R. Right to care in South Africa. 2012. https://www.facebook.com/rtcsa/posts/234287843340645 (accessed 14 July 2014).

8. Benatar SR, Upshur R. Tuberculosis and structural poverty: What can be done? C 3 Conference on Strategies to Overcome Poverty & Inequality, Cape Town, 3 - 7 September 2012. http://www.carnegie3. org.za/docs/papers/20_Benatar_Tubercolosis%20and%20structural%20poverty%20-%20what%20 can%20be%20done.pdf (accessed 14 July 2014).

9. Annual Reports of Prisons and Prisoners 2008. Civil society prisons reform initiative. http://cspri.org. za/resources/other-resources (accessed 26 January 2014).

10. Judicial Inspectorate for Correctional Services. Annual Report for 2012/2013. http://judicialinsp.dcs. gov.za/Annualreports/ANNUAL%20REPORT%202012%20-%202013.pdf (accessed 28 July 2014).

11. Prisons lack proper HIV/Aids care. http://www.enca.com/south-africa/prisons-lack-proper-hivaidscare (accessed 26 January 2014).

12. Best served with olive oil: Gitmo staffer describes force feeding to RT. 31 October 2013. http://rt.com/ news/guantanamo-force-feeding--013/ (accessed 21 February 2014).

13. Winerip M, Schwirtz M. Rikers: Where mental illness meets brutality in jail. New York Times 2014; 14 July. http://www.nytimes.com/2014/07/14/nyregion/rikers-study-finds-prisoners-injured-by-employees. html?ref=nyregion&_r=0 (accessed 28 July 2014).

14. McMillan C. What I saw on Rikers Island. New York Times 2014; 23 July. http://www.nytimes. com/2014/07/24/opinion/cecily-mcmillan-on-brutality-and-humiliation-on-rikers-island.html?_r=0 (accessed 28 July 2014).

15. Grady D, Carey B. Medical ethics have been violated at detention sites, a new report says. New York Times 2013; 4 November. http://www.nytimes.com/2013/11/05/health/medical-ethics-violated-atdetention-sites-group-says.html?pagewanted=all (accessed 3 August 2014).

16. Correctional Services 2010/11 Annual Report: Input by Civil Society Prison Reform Initiative, Judicial Inspectorate, NICRO, Auditor-General, Parliamentary Researcher. http://www.pmg.org.za/ print/report/20111011-department-correctional-services-2011-budgetary-review-committees-res (accessed 26 January 2014).

17. Precense C. Uprisings as inmates’ frustration increases. Cape Times 2013; 2 October: p. 7.

18. Fokazi S. Shocking new stats on police brutality. Cape Times 2013; 27 March: p. 11.

19. Ndendze B. Striking commonality between Biko’s SA in 1977 and today says Zille. Cape Times 2013; 6 September: p. 4.

20. Van Niekerk JP. Lock up and stay: South Africa’s sick prisons. S Afr Med J 2005;95(5):281.

21. Habib A. South Africa’s Suspended Revolution: Hopes and Prospects. Johannesburg: Wits University Press, 2013.

S Afr Med J 2014;104(9):613-614. DOI:10.7196/SAMJ.8608

September 2014, Vol. 104, No. 9

RESEARCH

Utilisation of prehospital intravenous access B H Bester, BTech (Emerg Med Care); S Sobuwa, MSc (Med) Emerg Med Department of Emergency Medical Sciences, Faculty of Health and Wellness Sciences, Cape Peninsula University of Technology, Cape Town, South Africa Corresponding author: S Sobuwa (sobuwas@cput.ac.za) Objective. To describe the use of intravenous (IV) therapy in the South African (SA) prehospital setting, and to determine the proportion of prehospital IV cannulations considered unnecessary when graded against the South African Triage Score (SATS) chart.

Methods. The study was conducted in the prehospital emergency medical care setting in the Western Cape Province, SA. Using a descriptive research design, we looked at the report forms of patients treated and transported by personnel currently employed in the public sector, serving the urban and rural areas stipulated by the municipal boundaries. All medical and trauma cases in which establishment of IV access was documented for the month of April 2013 were included. Interhospital transfers, unsuccessful attempts at IV access and intraosseous cannulation were excluded.

Results. When graded against the SATS, prophylactic IV access was not justified in 42.3% of the total number of cases (N=149) in which it was established, and therefore added no direct benefit to the continuum of patient care. It is worth noting that 18.8% (n=39) of the IV lines were utilised for fluid administration, as opposed to 9.2% (n=19) for the administration of IV medications.

Conclusion. In view of the paucity of studies indicating a direct benefit of out-of-hospital IV intervention, the practice of precautionary, protocol-driven prophylactic establishment of IV access should be evaluated. Current data suggest that in the absence of scientific evidence, IV access should only be initiated when it will benefit the patient immediately, and precautionary IV access, especially in non-injured patients, should be re-evaluated.

S Afr Med J 2014;104(9):615-618. DOI:10.7196/SAMJ.7969

Emergency care providers are responsible for the management and transportation of critically ill or injured patients. These patients often require immediate interventions such as defibrillation or intravenous (IV) therapy. According to Seymour et al.,[1] obtaining IV access is a commonly performed prehospital procedure. However, it can potentially have a wide range of complications, including thromboembolism and sepsis.[2] This study sought to investigate and evaluate the purpose of establishing prehospital IV access and to explore issues surrounding justification of this procedure.

Prehospital IV access is mainly established for one of two reasons, to administer fluid therapy in the haemodynamically unstable patient or as a drug administration route.[2] Currently, standard procedures state that the predominant means (excluding intraosseous access) involves setting up the entire IV line comprising the selected catheter and the administration set, plus the selected IV fluid bag. Prehospital staff members do not currently have the option of establishing a heparin or saline lock for maintaining IV access.

Objective

To describe the use of IV therapy in the South African (SA) pre­ hospital setting. We first sought to determine the number of peripheral IV lines established during a one-month period (April 2013). From this, we could work out the proportions of cases in which IV access was established for drug administration, for fluid resuscitation or as a prophylactic measure. Finally, we sought to determine the proportion of unutilised IVs that could be regarded as unnecessary when graded against the South African Triage Scale (SATS).

615

Methods

Study design and setting

This was a retrospective, descriptive study based on the positivist paradigm. It was conducted in a prehospital emergency medical care setting in the Western Cape Province, SA, and was based on patient report forms (PRFs) of patients who were treated and transported by emergency care providers in the Western Cape serving the immediate urban and rural associated areas stipulated by the municipal boundaries.

The ambulance station serves a geographical area of 1 538 km² and a population of approximately 210 000 people spread across rural and urban areas. There is one secondary hospital, situated in an urban area, which receives all yellow, orange and red colour-coded patients within the municipal boundaries. Patients requiring computed tomography scans, magnetic resonance imaging, long-term ventilator support, major surgery or specialist care are referred to the level 1 trauma centre approximately 50 km away.

Sampling strategy

A non-randomised sampling technique was used – all PRFs that met the eligibility criteria were entered into the research project.

The target population consisted of all prehospital emergency care providers at a selected ambulance station who were eligible and permitted by the Health Professions Council of South Africa Professional Board of Emergency Care (HPCSA PBEC) to establish IV access. All medical and trauma cases for the month of April 2013 in which establishment of IV access was documented were included in the study. Interhospital transfers, unsuccessful attempts at IV access and intraosseous cannulations were excluded. Children ≤8

September 2014, Vol. 104, No. 9

RESEARCH

20

Proportion of IV lines established for documented indications

It is notable from Fig. 3 that 18.8% (n=39) of the IVs set up for fluid administration were actually utilised for that purpose, as opposed to 9.2% (n=19) of those set up for administration of IV medications. The data that raise considerable concern are the 72.0% of cases (n=149) in which IV access served as prophylactic only.

Medications were administered in 9.2% (n=19) of the total cases (Fig. 4).

The most frequently administered IV drug was dextrose (n=11, 57.9%), followed by benzodiazepines (n=5, 26.3%).

Proportion of unjustified prophylactic IVs according to the SATS

Of the total number of prophylactic IVs established, 57.7% (n=86) were considered justifiable when scored against the SATS.

14

10

5

3

2

2

Trauma category

Blunt force trauma

Uncontrolled/ internal bleeding

Motor vehicle accidents

Fall from height

Burns

Penetrating trauma

0

Fig. 1. Distribution of intravenous access in trauma cases.

40

3

11

9

26

17 5

8 Overdose

9

15

Maternity

20

30

20

13

Medical category Fig. 2. Distribution of intravenous access in medical cases.

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September 2014, Vol. 104, No. 9

All other

Vomiting and diarrhoea

Shortness of breath

Hypo-/ hyperglycaernia

General malaise

Dizziness and collapse

Convulsions

Chest pains

Cerebrovascular accidents

0

Results

A total of 242 documented cases in which it was intended to establish prehospital IV access were identified during the study period. Establishment of access was successful in 207 cases and unsuccessful in

complaint. The second most common com­ plaint was shortness of breath (n=26, 15.7%).

This category included asthma, chronic obstructive pulmonary disease exacer­ bations and other pathologies leading to shortness of breath.

15

Abdominal pains

The researcher accessed all the PRFs for the month of April 2013. All those that indicated establishment of IV access were selected for analysis. The PRFs were then assigned to one of three groups (A, B or C). Group A consisted of all PRFs in which IV access was established for the indication of fluid administration (i.e. all cases in which 200 - 2 000 ml fluid was given for fluid resuscitation). Fluids included 0.9% sodium chloride and Ringer’s lactate. Group B consisted of all PRFs that indicated IV medication administration and included all cases in which medications were administered via the IV route; all other administration routes were omitted. Group C included all PRFs that indicated establishment of IV access, but documented that no fluid or IV medication had been administered (classifying these as prophylactic IV access).

Baseline vital signs and the assigned SATS colour codes were documented and entered into a worksheet on Microsoft Excel 2010 for analysis. The colour codes assigned by the attending providers were then reviewed by analysing the baseline vital signs against the SATS. Correct colour codes were confirmed.

The SATS was used to determine whether IV access was justified or unjustified based on the descriptions indicated by the colour codes. IV access was considered justified in all cases in which patients were colourcoded orange (serious cases with potentially unstable physiology or potentially life/limbthreatening pathology) and red (resusci­ tation/physiologically unstable). These tri­ age codes are associated with an increased morbidity and mortality rate.[3] IV access was considered unjustified in all green and yellow colour-coded patients.

Ethics approval to conduct the study was granted by the Research Ethics Committee of the Department of Emergency Medical Sciences, Cape Peninsula University of Technology. Access to the PRFs was given by the emergency medical service provider following ethics approval.

Cases, n

Data collection

31 (n=7 patients colour-coded green, n=5 yellow, n=13 orange, n=6 red); 4 patients refused consent for IV access. According to the study design, only cases in which IV access was successful were included. It was determined that IV access was successfully established in 17.9% (n=207) of the total recorded primary calls (N=1 157).

The 207 calls in which IV access was successfully established comprised 166 primary medical complaints and 41 traumarelated calls. The trauma calls were divided into categories (Fig. 1). In the majority of trauma cases, the chief complaint was penetrating trauma (n=15, 36.6%). The average on-scene time for the documented trauma cases was calculated as 21 minutes.

Of the trauma patients, 26.8% (n=11) were colour-coded yellow, 41.5% (n=17) orange and 31.7% (n=13) red. Only 26.8% (n=11) of the trauma patients received fluid boluses, ranging between 300 ml and 2 000 ml.

The distribution of the 166 cases in which the primary complaint was medical is shown in Fig. 2. The leading complaint was convulsions (n=30, 18%). This included all actively convulsing, post-ictal patients and compos mentis patients who were reported to have had convulsions as a chief

Cases, n

years of age were also excluded, because the HPCSA PBEC does not permit intermediate life support (ILS) providers to initiate IV therapy in this age group. There were 26 ILS providers and 5 advanced life support providers who were permitted to perform IV therapy.

RESEARCH

160

149

IV access set up, n

140 120 100 80 60

39

40

19

20 0 Fluid administration

Medical administration

Prophylactic

Indication for IV access Fig. 3. Distribution of intravenous utilisation. (IV = intravenous.)

5% 11% Dextrose (n=11) Diazepam (n=5) 26%

Furosemide (n=2)

58%

Adrenaline (n=1)

Fig. 4. Distribution of intravenous medications administered.

This means that 63 prophylactic IVs (42.3%) were not necessary according to the SATS. None of the patients whose prophylactic IV was considered to be unjustified showed any deviations in their vital signs outside the normal ranges. The study design did not enable us to determine the criteria providers used to determine the need for initiation of prophylactic IV access.

Discussion

Prehospital IV initiation has been a conten­ tious issue for decades. The debate is whether to ‘scoop and go or stay and play’.[4] Our results suggest that the majority (72.0%) of the IVs were established with the primary intention of keeping the vein open, should medications or IV access be required at a later stage. This does not appear to aid the continuum of patient care or provide direct benefit to the patient. The other indications were distributed between immediate medication administration and fluid management. Fluid boluses were administered in 18.8% (n=39) cases, ranging

from dehydrated or hypovolaemic patients to cardiac patients.

Our findings are similar to those of Kuzma et al.,[5] who concluded that only 17% of prehospital­initiated IVs were utilised and that 83% were considered prophylactic management. Their findings also suggested that IV utilisation rates were higher in patients with abnormal vital signs. This was our motivation for finding out whether IV placement would be justified according to the nationally accepted SATS. The SATS is a triage tool derived from the Cape Triage Score.[3] It is a combination of the previously used Trauma Early Warning Score and another trauma score, and is currently used in multidisciplinary settings, including the prehospital setting and the emergency department. The SATS ensures that patients who are colour­coded red (resuscitation cases) are a priority and therefore receive immediate attention.[3] The triage system also makes provision for patients colour­ coded yellow, who present physiologically as

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stable, and red patients (resuscitation cases) to be separated from each other by an orange colour code denoting potentially life­ or limb­threatening pathology.

Schwarzman and Rottman[6] discovered that nearly 95% of patients attended to by paramedics received prehospital IV access, which was set up for prophylactic indications or to administer single or multiple bolus medications. In their experimental study, they established heparin locks directly onto the IV catheter for all patients who needed medications and established full IV lines for all patients who required immediate fluid management. A total of 102 patients were included in the study, of whom 97% were treated with heparin locks, only 4 receiving full IV infusion drips in the prehospital setting, although a total of 20 (19.6%) patients had full IV infusion drips established after being treated in the emergency department.

This implies that full IV infusion drips were required by an additional 16 patients in the prehospital setting. Using heparin locks instead of the full conventional drip establishment resulted in a 60% reduction in total cost, and the authors further concluded that heparin locks are a safe, convenient and cost­effective method for maintaining prophylactic or drug access routes in the prehospital emergency setting.

In their retrospective case series, Gausche et al.[7] evaluated the concordance between IV access establishment and supply costs. They discovered that patients who presented with chiefly medical complaints were more likely to have received discordant overtreatment than patients who had trauma complaints (61% v. 32%; p<0.001). Their data showed that 73% of patients who presented with chest pain received discordant overtreatment. The study also suggested that approximately 91% of excess supply cost was due to paramedics treating patients via full IV access lines instead of saline locks. Although heparin and saline locks are not currently in the prehospital scope of practice in SA, it can be argued that the use of saline locks for maintaining prehospital prophylactic IV access has potential cost benefits. Our data indicated that approximately 72% (149/207) of patients in whom IV access was established received no immediate benefit from the procedure, as no medications or fluid resuscitation were indicated at the time.

Sixty­three of the 149 prophylactic IVs were unwarranted when graded against the SATS. The practice of prophylactic IV access in the prehospital setting appears to have no added advantages for the wellbeing of the patient.

The current estimated cost for IV infusion initiation ranges from R48.80 to R151.00,

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compared with the cost for a saline lock of R5.70 - R14.00 per item (as quoted in April 2013). It can be argued that IV access should be set up in patients who will directly benefit from medications or fluids; however, the costs involved in the establishment of prophylactic IV access mean that it remains questionable. The total estimated costs for prophylactic IV use for the month of April 2013, calculated on the abovementioned quotes (R48.80 - R151.00), was an average of R14 885.10 (R7 271.20 - R22 499.00). Assuming that patients did not receive fluid administration within the first 24 hours of arrival at hospital, a saline lock would probably have been sufficient for maintaining IV access in most cases. This would have resulted in a significant reduction in the costs associated with IV access (calculated as R13 417.45). We could not establish why the prehospital emergency care providers determined the need to establish prophylactic IV access, as a different study method would have been required to elicit possible reasons.

Whatever the benefits of a procedure, the HPCSA PBEC, which is the standards-generating body for prehospital emergency care in SA, has a clear set of ethical principles to which providers are obliged to adhere in performing everyday duties. Two main principles are beneficence, which requires the provider to act in the best interests of the patient at all times, and non-maleficence, which means that providers should do no further harm.[8] If providers are establishing IV access prophylactically, the question is: ‘What is the risk v. benefit ratio of performing this procedure, and is it considered ethical practice?’ There are a number of possible complications associated with the initiation of IV therapy, ranging from local skin irritation to life-threatening air embolism.[2] Zarate et al.[9] determined rates of phlebitis in trauma patients in relation to whether IV access was established in the prehospital or emergency department setting. The rate of phlebitis was 2.92% in patients whose IV access was initiated by a registered nurse in the emergency department, 6.09% when initiated by an emergency medical technician, and 7.78% when initiated by a paramedic in the prehospital care setting. How can a provider who is cognisant of the risks and possible complications involved in performing this procedure justify initiating prophylactic IV therapy that is not utilised?

Another factor that makes unused, unnecessary prophylactic IV access initiation unethical is the increased time before the patient is delivered to definitive care. Carr et al.[10] found that establishing IV access at the scene took between 3 minutes 17 seconds and 5 minutes 40 seconds, which ultimately delays transportation to the hospital or definitive care facility. However, it is not clear whether this brief added time contributes to adverse outcomes. Carr et al.[10] suggest that providers should plan carefully and decide on proper intervals of performing procedures that may result in a significant delay in transportation.

This also opens the discussion on performing life-saving procedures en route rather than at the scene, should the individual scenario allow it. Some authors[4,11] suggest that patients with blunt trauma should receive fluid resuscitation to restore compromised organ perfusion and that a permissive hypotensive resuscitation strategy be followed in patients with uncontrollable bleeding. Prehospital fluid resuscitation may decrease blood viscosity, thus increasing flow by disrupting soft early clots.[12] Diluting the clotting factors may also prevent clot formation.[13] Haut et al.[14] concluded that patients who received prehospital IV fluid resuscitation were significantly more likely to die (odds ratio (OR) 1.11; 95% confidence interval (CI) 1.05 1.17). This was shown to be true for patients with penetrating trauma (OR 1.25; 95%, CI 1.08 - 1.45), hypotensive patients (OR 1.44; 95% CI 1.29 - 1.59), patients with severe head injuries (OR 1.34; 95% CI 1.17 - 1.54), and patients who required immediate surgery (OR 1.35; 95% CI 1.22 - 1.50), and suggests that administration of prehospital fluids has great potential for harm, especially in patients suffering

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from trauma. These findings also indicate that the routine use of prehospital IV fluid administration in patients with trauma-related injuries (particularly penetrating trauma) should be re-evaluated.

Study strengths and limitations

This is the first study to investigate the utilisation of IV therapy in the SA prehospital setting. It indicates that a significant proportion of IV infusions are administered prophylactically, resulting in overtreatment and cost wastage. We did not aim to provide reasons for, or explain, what motivated the emergency care providers in deciding which patients should receive prophylactic IV access, as a qualitative methodology design would have been required to explain the phenomenon. We also focused only on medications administered intravenously and disregarded any that were administered via the oral, subcutaneous, intramuscular, buccal, rectal, sublingual or nasal routes. Intraosseous infusions were also excluded from the study, as only advanced life support providers in the study setting had this scope of practice. Intraosseous infusions are usually only established when peripheral IV establishment is unsuccessful. It can be assumed that if intraosseous access was established, there was a clearly identifiable indication for immediate drug or fluid administration, which would be justified by the SATS.

Conclusion

Setting up IV access is a commonly performed prehospital procedure.

Based on this study, approximately one out of every five patients seen by emergency care providers in the prehospital setting would receive IV access. Of concern was the proportion of these proce­ dures revealed to be unnecessary when graded against the SATS. Saline locks would probably suffice, and result in a major reduction in the cost of maintaining IV access and providing a means of IV medication administration. The question whether the emergency medical services provider should be establishing IV access in the prehospital setting remains controversial. We recommend the development of prehospital IV access establishment guidelines to ensure direct benefit from this procedure.

References 1. Seymour CW, Cooke CR, Hebert PL, Rea TD. Intravenous access during out-of-hospital emergency care of noninjured patients: A population-based outcome study. Ann Emerg Med 2012;59(4):296-303. [http://dx.doi. org/10.1016/j.annemergmed.2011.07.021] 2. Sanders MJ. Mosby’s Paramedic Textbook. 4th ed. St Louis, MO: Elsevier Mosby, 2010:359-363.

3. Gottschalk SB, Wood D, DeVries S, Wallis LA, Bruijns S. The Cape Triage Score: A new triage system for South Africa. Proposal from the Cape Triage Group. Emerg Med J 2006;23(2):149-153. [http://dx.doi.org/10.1136/ emj.2005.028332] 4. Geoghegan J, Dennis A, Manji M. Hypotensive resuscitation. Trauma 2010;12(3):149-153. [http://dx.doi. org/10.1177/1460408610368743] 5. Kuzma K, Sporer KA, Michael GE, Youngblood GM. When are prehospital intravenous catheters used for treatment? J Emerg Med 2009;36(4):357-362. [http://dx.doi.org/10.1016/j.jemermed.2007.11.054] 6. Schwarzman P, Rottman SJ. Prehospital use of heparin locks: A cost-effective method for intravenous access.

Am J Emerg Med 1987;5(6):475-477. [http://dx.doi.org/10.1016/0735-6757(87)90164-1] 7. Gausche M, Tadeo RE, Zane MC, Lewis RJ. Out-of-hospital intravenous access: Unnecessary procedures and excessive cost. Acad Emerg Med 1998;5(9):878-882. [http://dx.doi.org/10.1111/j.1553-2712.1998.tb02817] 8. Health Professions Council of South Africa. Guidelines for Good Practice in the Health Care Professions: General Ethical Guidelines for the Health Care Profession: Booklet 1. Pretoria: HPCSA, 2008:3. http://www. hpcsa.co.za/downloads/conduct_ethics/rules/generic_ethical_rules/booklet_1_guidelines_good_prac.pdf 9 (accessed 13 March 2013).

9. Zarate L, Mandleco B, Wilshaw R, et al. Peripheral intravenous catheters started in prehospital and emergency department setting. J Trauma Nurs 2008;15(2):47-52. [http://dx.doi.org/10.1097/01.JTN.0000327326.83276. ce.]

10. Carr BG, Brachet T, David G, Duseja R, Branas CC. The time cost of prehospital intubation and intravenous access in trauma patients. Prehosp Emerg Care 2008;12(3):327-332. [http://dx.doi. org/10.1080/10903120802096928] 11. Levett D, Vercueilb A, Grocottc M. Resuscitation fluids in trauma 1: Why give fluid and how to give it. Trauma 2006;8(1):47-53. [http://dx.doi.org/10.1191/1460408606ta358oa] 12. Shaftan GW, Chiu CJ, Dennis C, et al. Fundamentals of physiologic control of arterial haemorrhage. Surgery 1965;58(5):851-856.

13. Bickell WH, Bruttig SP, Millnamow GA, et al. The detrimental effects of intravenous crystalloid after aortotomy in swine. Surgery 1991;110(3):529-536. [http://dx.doi.org/ 10.1097/00132586-199236030-00060] 14. Haut ER, Kalish BT, Cotton BA, et al. Prehospital intravenous fluid administration is associated with higher mortality in trauma patients: A National Trauma Data Bank Analysis. Ann Surg 2011;253(2):371-377. [http:// dx.doi.org/10.1097/SLA.0b013e318207c24]

Accepted 30 April 2014.

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The pharmacoeconomics of routine postoperative troponin surveillance to prevent and treat myocardial infarction after non-cardiac surgery A Torborg,1 MB ChB, FCA (SA); L Ryan,1,2 MB ChB, FCA (SA); G Kantor,3,4 MB ChB, FRCP (Canada); B M Biccard,1 MB ChB, FCA (SA), FFARCSI, MMedSci, PhD erioperative Research Group, Department of Anaesthetics, Nelson R Mandela School of Medicine, College of Health Sciences, P University of KwaZulu-Natal and Inkosi Albert Luthuli Central Hospital, Durban, South Africa 2 Department of Anaesthetics, Grey’s Hospital, Pietermaritzburg, KwaZulu-Natal, South Africa 3 Department of Anaesthesiology, Faculty of Health Sciences, University of Cape Town, South Africa 4 Department of Anesthesiology and Perioperative Medicine, Case Western Reserve University, Cleveland, Ohio, USA 1

Corresponding author: B M Biccard (biccardb@ukzn.ac.za) Background. A postoperative troponin leak that was previously considered clinically insignificant has been independently associated with 30-day mortality in unselected surgical patients ≥45 years of age following non-cardiac surgery.

Objectives. To determine whether routine troponin surveillance following non-cardiac surgery and initiation of aspirin and statin therapy in troponin-positive patients is cost-effective.

Methods. Pharmacoeconomic analysis to determine the cost-effectiveness of routine postoperative surveillance for patients aged ≥45 years undergoing non-cardiac surgery. We compared the total expected cost of hospital care of patients who received routine troponin surveillance and subsequent introduction of statin and aspirin therapy for 30 days in troponin-positive patients with the cost of hospital care of patients who did not receive troponin surveillance. We estimated a 25% relative risk reduction following statin and aspirin therapy for postoperative vascular mortality and non-fatal myocardial infarction.

Results. Routine troponin surveillance with initiation of aspirin and statin therapy was cost-effective, with an incremental cost of –R16 724 per event avoided.

Conclusion. Routine postoperative troponin surveillance in non-cardiac surgical patients ≥45 years of age requiring a postoperative night in hospital is potentially cost-effective.

S Afr Med J 2014;104(9):619-623. DOI:10.7196/SAMJ.7654

A postoperative troponin leak following noncardiac surgery is independently associated with 30-day mortality.[1] Importantly, even what was previously considered an insignificant troponin leak (4th-generation troponin T >0.02 ng/ml) has been independently associated with 30-day mortality (odds ratio (OR) 2.41; 95% confidence interval (CI) 1.33 - 3.77) in unselected patients aged ≥45 years who underwent non-cardiac surgery.[1] Over 40% of the population-attributable risk for 30-day mortality could be explained by the postoperative troponin leak.[1] If generalisable, these data have wide-ranging public health implications. Firstly, of unselected patients aged ≥45 years undergoing non-cardiac surgery, over 11% are expected to have a prognostically important postoperative troponin leak.[1] Considering that over 200 million surgical procedures on adults are performed annually worldwide,[2] and potentially half of these patients are ≥45 years of age, it is expected that more than 5 million people will suffer a major perioperative cardiovascular event (i.e. cardiovascular mortality or myocardial infarction) within 30 days of surgery,[1] and over 10 million will have a postoperative troponin leak of prognostic importance.[1] Should routine postoperative troponin surveillance be considered in this group of patients? Approximately a third of patients who have a postoperative troponin leak have a documented perioperative myocardial infarction.[3] Targeting all patients with a troponin leak

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after non-cardiac surgery, since it indicates a myocardial injury, may be justified, as 30-day and intermediate-term mortality is significantly increased even in patients who do not fulfil study criteria for a perioperative myocardial infarction.[1,4,5] Unfortunately there is no prospective randomised evidence of the utility of therapy for improving cardiovascular outcomes following a perioperative myocardial infarction. There are, however, good observational cohort data from a primary preventive trial of perioperative myocardial infarction showing that statins and aspirin given at the time of perioperative myocardial infarction were independently associated with decreased 30-day mortality, with adjusted ORs of 0.54 (95% CI 0.29 - 0.99) and 0.26 (95% CI 0.13 0.54), respectively.[6] Whether statin and aspirin therapy may also decrease mortality in patients who sustain a postoperative troponin leak secondary to myocardial ischaemia (which is now known as myocardial injury after non-cardiac surgery (MINS)), without fulfilling the Universal Definition of Myocardial Infarction,[7,8] is currently unknown.

Consideration of the economics of routine postoperative troponin surveillance is therefore warranted, as it is possible that the simple and inexpensive introduction of statin and aspirin therapy in patients who have a postoperative myocardial infarction may have a public health benefit, and should this benefit extend to MINS, it could be profound.

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The aim of this study was to determine whether routine troponin screening is cost-effective if a 25% relative risk reduction (RRR) in postoperative myocardial infarction and vascular mortality is achieved.

Methods

This pharmacoeconomic analysis determined the cost-effectiveness of routine postoperative surveillance for patients aged ≥45 years undergoing non-cardiac surgery.[1] It compared the total expected cost of hospital care of patients receiving routine troponin surveillance and subsequent introduction of statin and aspirin therapy for 30 days in troponin-positive patients with the cost of hospital care in patients who have not received troponin surveillance. We expected at least a 25% RRR in major cardiovascular complications (postoperative myocardial infarction and vascular death) at 30 days postoperatively should patients receive statin and aspirin therapy following a troponin leak. Based on the PeriOperative ISchemic Evaluation (POISE), trial we believed this to be a conservative estimate.[6] Using either the upper CIs (smallest treatment effect) or the point estimates (expected treatment effect) of the cardiovascular protection associated with statin and aspirin in patients who had an infarction, one would expect an RRR for 30-day mortality of 0.53 (0.99 for statins × 0.54 for aspirin) and 0.14 (0.54 for statins × 0.26 for aspirin), respectively.[6] From the Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Study data,[1] we determined the incidence of troponin-positive patients postoperatively (11.6%) and the expected mortality (1.9%). The expected incidence of cardiovascular complications associated with a troponin leak is shown in Fig. 1. In the VISION study, 45% of the deaths reported at 30 days were secondary to vascular causes. Vascular deaths were defined as deaths following a myocardial infarction, cardiac arrest, stroke, cardiac revascularisation procedure, pulmonary embolus or haemorrhage, or due to an unknown cause.[1] We estimated that 37.3% of patients who have a postoperative troponin leak[6] would have a clinical diagnosis of non-fatal myocardial infarction (3.96% of the VISION cohort). Furthermore, we expected 73.4% of these complications to occur during the same admission for non-cardiac surgery, and the remaining 26.6% to occur after discharge but earlier than 30 days.[1] Following initiation of statin and aspirin therapy in troponinpositive patients, we estimated a 25% RRR for vascular mortality and non-fatal myocardial infarction. We did not consider any efficacy associated with statin and aspirin therapy in patients who sustained MINS and did not fulfil the criteria for a perioperative myocardial infarction, as currently there are no data on the efficacy of these therapies in MINS. All costs used were averages based on private healthcare costs in South Africa (SA). The costs of troponin surveillance were based on costs from two private laboratories. We considered the cost of troponin surveillance for the first 3 postoperative days, i.e. postoperative days 1, 2 and 3, and the cost of 30 days of low-dose aspirin (80 - 100 mg daily) and statin (generic atorvastatin 40 mg daily) therapy in patients who were troponin-positive. Average drug costs for aspirin and atorvastatin were obtained from Discovery Health. We used a drug dispensing fee of R25.

The costs of all adverse events used in this analysis were based on average Discovery Health costs for the period January 2011 - June 2011 for hospital admissions classified using Discovery’s Diagnosis Related Groups (DRG) system (Table 1). We used the following costs: (i) the average hospital cost of all fatal myocardial infarctions was used for the cost of a fatal myocardial infarction occurring after hospital discharge; and (ii) the average hospital cost of a non-fatal myocardial infarction (without complications) was used for the

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attributable cost of a non-fatal myocardial infarction occurring after hospital discharge. The cost of in-hospital myocardial infarctions was calculated as 155% of the DRG average cost of a non-cardiac surgery hospital admission, based on the work of Dimick et al.,[9] which showed that in-hospital cardiovascular complications following noncardiac surgery increased adjusted expenditure by 155% compared with a non-cardiac surgical admission with minor complications. We only adjusted for the cost of the in-hospital complication, and not for duration of stay, as cardiovascular complications associated with surgery have not been associated with an increase in the duration of hospital stay.[10] Screening for troponins will also result in increased subsequent cardiovascular risk stratification of patients. We therefore included the cost of three in-hospital screening electrocardiograms (ECGs) in order to diagnose a perioperative myocardial infarction, and four specialist cardiologist consultations (two inpatient and two outpatient visits), a full lipid profile, and measurement of glycated haemoglobin (HbA1c) for the expected proportion of diabetics in the troponin-positive cohort (based on the VISION data)[1] for further risk stratification.

We constructed a monetary balance sheet in SA rands (ZAR) for the outcomes for a troponin surveillance group and a no-troponin surveillance group. All costs were calculated as the proportional cost per patient. For example, if 11.6% of patients were troponinpositive, the cost of treating troponin-positive patients with statins and aspirin would be 0.116 × the cost of drug therapy. Similarly, the drug dispensing fee of R25 is therefore 0.116 × R25 as a proportional cost per individual.

We also considered the cost-effectiveness of postoperative troponin surveillance. A common definition of cost-effectiveness is whether the average per capita contribution to the national gross domestic product (GDP) over a year is greater than the cost of a particular secondary preventive intervention.[11] The average Non-cardiac surgery ≥45 years

Troponin leak 11.6%

Death 0.98%

Vascular death Non-vascular death 0.47% 0.51%

Non-fatal troponin leak 10.62%

Perioperative Myocardial injury myocardial 6.66% infarction 3.96%

Fig. 1. Expected cardiovascular complications following a troponin leak in patients ≥45 years of age undergoing non-cardiac surgery.

Table 1. Discovery Health’s Diagnosis Related Groups (DRGs) used in the study DRG 53310: acute myocardial infarction without complications and comorbidities DRG 53320: acute myocardial infarction with complications and comorbidities DRG 53330: acute myocardial infarction with major complications and comorbidities

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per capita contribution to the GDP in SA is approximately R49 134.[12] By definition, therefore, a cost-effective intervention would cost less than R49 134 per event avoided.

Table 2. Average costs used in the pharmacoeconomic analysis Cost (ZAR) Troponin surveillance, drug costs and cardiovascular risk stratification

Results

Troponin surveillance (3 days)

732.00

The average costs for troponin surveillance and the treatment of cardiovascular complications are shown in Table 2. The pharmaco­economic analysis is shown in Table 3.

Aspirin for 30 days

18.26

Atorvastatin for 30 days

95.60

ECG (three in hospital)

237.90

Discussion

Full lipid profile

250.50

HbA1c

131.75

Cardiology consult

379.95

This pharmacoeconomic analysis suggests that routine troponin surveillance in patients ≥45 years of age undergoing non-cardiac surgery that requires a postoperative night in hospital is potentially cost-effective should statin and aspirin therapy decrease myocardial infarction and vascular mortality by 25%. Routine troponin surveillance was associated with a R32 410 increase in cost per event avoided, which remains cost-effective as it is less than the annual per capita contribution to the GDP. The fact that routine troponin surveillance is potentially cost-effective is important, as over 65% of patients who have a postoperative myocardial infarction are asymptomatic,[3,4] and without troponin surveillance these cases will therefore be missed.

Although we have not considered any risk reduction associated with aspirin or statin therapy in patients with MINS in this pharmacoeconomic analysis, we would recommend that initiating these therapies after a diagnosis of MINS be considered in order to prevent a progression to myocardial infarction or vascular death. It is possible that these interventions may decrease subsequent cardiovascular morbidity in MINS patients who do not progress to myocardial infarction.

As a troponin leak is the largest contributor to 30-day postoperative mortality with a population-attributable risk of over 40%, when considered with preoperative and surgical risk factors[1] routine postoperative ECG surveillance would not be an acceptable substitute for troponin surveillance.

In conclusion, in the majority of cases the only way to identify patients who have had a myocardial infarction after non-cardiac surgery is to conduct routine postoperative troponin surveillance, and this is a potentially cost-effective intervention.

Statin and aspirin therapy

We did consider that introducing statin and aspirin therapy could increase drug-associated morbidity. The incidences of adverse events asso­ ciated with postoperative statin and aspirin therapy are based on two individual data meta-analyses of aspirin and statin therapy.[13,14] Statin therapy was not associated

Cardiovascular complications Non-fatal myocardial infarction

27 684.26

Fatal myocardial infarction

59 145.94

Additional cost of an in-hospital cardiovascular complication

70 363.80

ZAR = South African rands; ECG = electrocardiogram; HbA1c = glycated haemoglobin.

Table 3. The cost per patient (in ZAR) of troponin* or no troponin surveillance in SA non-cardiac surgical patients ≥45 years of age Troponin surveillance

No troponin surveillance

Direct and indirect costs of troponin surveillance and therapy (A) Cost of troponin surveillance for 3 days

732

0

Cost of statin and aspirin therapy for 30 days

13.21

0

Drug dispensing fee

2.9

0

Costs of perioperative cardiovascular complications (B) Cost of fatal myocardial infarction

581.15

660.32

ost of non-fatal myocardial infarction without C complications

1 988.76

2 336.84

Total cost per patient (C = A + B)

3 318.02 (C1)

2 997.16 (C2)

Total incremental cost for surveillance and therapy (D = C1 – C2)

320.86

Absolute risk reduction

0.99

NNT to prevent 1 event

101

Total incremental cost (E = D × NNT)

32 409.80

Cost-effectiveness in SA patients (F = E – R49 134)[11]

–16 724.20

SA = South African; NNT = number-needed-to-treat; RRR = relative risk reduction. *Scenario based on a 25% RRR in vascular mortality only and non-fatal myocardial infarction only.

with significantly increased rhabdomyolysis in an individual patient data analysis of over 90 000 patients from randomised controlled trials,[13] and no adverse effects are therefore expected for statin therapy.

Aspirin has been shown to increase major gastrointestinal bleeding (0.03% per year of therapy).[14] Theoretically this could lead to a 0.0025% (0.03%/12 months) increase in gastrointestinal bleeding within 30 days of surgery, or a number-needed-to-harm of 40 000. A surgical meta-analysis suggests

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that the risk of postoperative bleeding is increased by a factor of 1.5 (median, interquartile range 1.0 - 2.5); however, only after transurethral prostatectomy (TURP) were there any deaths possibly attributable to bleeding.[15] The issue of increased bleeding risk following TURP has been challenged by subsequent authors, and a randomised controlled trial evaluating the effect of lowdose acetylsalicylic acid on bleeding after TURP[16] showed that while postoperative blood loss was increased in patients receiving

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aspirin therapy, there was no significant difference in operative blood loss, median time to catheter removal, length of hospital stay or the incidence of readmission to hospital due to secondary haemorrhage. As a result, the meta-analysis by Burger et al.[15] makes no recommendations regarding perioperative aspirin use, and suggests that a controlled trial of surgical patients is needed.

The recently published PeriOperative Ischemic Evaluation-2 (POISE-2) trial[17] did, however, show that aspirin given during surgery increased perioperative bleeding, and this risk remained until the 8th postoperative day. What is currently unclear is whether the initiation of aspirin therapy following a troponin leak in the postoperative period carries a similar bleeding risk to that in the POISE-2 trial. We would encourage vigilance once aspirin is initiated in the postoperative period, until such time as there are data to inform this issue.

We would still recommend initiation of aspirin therapy in patients who are troponin-positive postoperatively, as in secondary prevention trials aspirin decreases serious vascular events (numberneeded-to-treat (NNT) 67) and coronary events (NNT 100),[14] and this is consistent with the observational data from the POISE trial in surgical patients.[3] Troponin screening in an at-risk population and the initiation of aspirin therapy in those with increased troponin levels is therefore likely to be a cost-effective intervention.

There are a number of compelling reasons to believe that this pharmacoeconomic analysis may be conservative, and the benefits associated with routine troponin surveillance and statin and aspirin therapy may be larger than what is presented here.

Firstly, it is possible that routine troponin surveillance may also decrease subsequent morbidity and mortality associated with MINS through institution of appropriate treatment of underlying coronary artery disease, especially as MINS is associated with increased longterm cardiovascular morbidity.[5] We would expect further benefit in patients with MINS, as these patients have been shown to have an increased risk of non-fatal cardiac arrest and subsequent coronary revascularisation.[6] It has been shown in a meta-analysis of over 170 000 patients that the addition of statin therapy significantly decreases subsequent coronary revascularisation,[18] so there may be additional cost-saving benefits associated with treating postoperative myocardial injury that have not been calculated here.

Secondly, it is likely that statin and aspirin therapy may also decrease non-vascular mortality in addition to vascular mortality. A postoperative troponin leak is independently predictive of all-cause mortality, and this may be because an early postoperative myocardial injury often precedes further non-cardiac complications, aggravating their severity, which results in death.[1] A postoperative troponin leak may therefore also be an initiating event in a non-vascular postoperative death. Importantly, and consistent with this conclusion, is that statins and aspirin were associated with a reduction in allcause mortality in the POISE study.[3] It is therefore possible that if statin and aspirin administration decreased all-cause mortality and all myocardial injury after non-cardiac surgery by 25%, there would be an overall cost saving with aspirin and statin therapy following routine troponin surveillance for non-cardiac surgery.

Thirdly, both statin and aspirin in secondary prevention trials have also decreased subsequent fatal and non-fatal stroke.[14,18] This pharmacoeconomic analysis only considered fatal stroke, which is part of the definition of vascular mortality.[1] It is also possible that the costs we have used in this pharmaco­ economic analysis are conservative. Davenport et al.[10] have suggested that cardiovascular complications associated with surgery increase costs by 459% as opposed to the 155% used in this analysis, which would result in a cost saving associated with routine troponin surveillance of R16 700 per event avoided in our analysis.

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Furthermore, the predicted costs of treating myocardial infarctions in 2011 across all medical aid providers was R78 869,[19] which is higher than the Discovery Health costs for the same period used in this analysis. If the average cost of all medical aid providers was used in our model, there would have been an absolute cost saving per event avoided. Both these possible scenarios change this intervention from a cost-effective intervention to a cost-saving intervention.

An outcome that may change the cost-effectiveness of this pharmacoeconomic analysis is out-of-hospital sudden death, which is associated with no additional cost. When we considered this scenario for all out-of-hospital deaths in the analysis, routine troponin screening remained cost-effective.

Finally, it is important that the finding of a postoperative troponin leak does not lead to an unnecessary increase in expenditure associated with subsequent inappropriate coronary angiography investigation.

We would advise against routine coronary angiography if the patient does not fulfil current accepted indications for this procedure. This is because significant differences exist between spontaneous (medical) myocardial infarctions and myocardial infarction following surgery.[20] The postoperative patient is exposed to an environment associated with haemodynamic instability, procoagulation, sympathetic stress and potential bleeding and hypoxia,[21] and as such the pathophysiology of the perioperative myocardial infarction is likely to be different to the myocardial infarction characteristic of medical patients.[22] These factors may partly explain the predominance of ST-segment depression with surgical myocardial infarctions.[3,23] We would recommend a conservative approach to coronary angiography in patients with a postoperative troponin leak, until such time as the coronary computed tomography angiography data from the VISION study are published.[24] Furthermore, as there are no prospective studies on managing perioperative myocardial infarctions and MINS, the current recommendations for coronary angiography in these patients include very specific scenarios that probably occur in a very small group of patients (in the region of 2 - 3% of patients who have a documented myocardial infarction).[25,26] Finally, although our pharmacoeconomic analysis was conducted for troponin surveillance of all non-cardiac surgical patients ≥45 years of age requiring an overnight hospital stay, the recently published MINS study showed that low-risk surgery was independently protective for the development of MINS (hazard ratio 0.72; 95% CI 0.55 - 0.99).[7] We would therefore not recommend routine troponin surveillance for lowrisk surgical procedures as defined in the VISION study.

Study limitations

There are limitations that may affect the accuracy of this pharmaco­ economic analysis. The analysis was conducted without consideration of potential postoperative troponin surveillance that is already conducted following some high-risk surgical procedures. This would not change the outcome of this analysis, as we therefore overestimated the cost of this suggested change to routine troponin surveillance. However, the importance of our analysis is that it suggests that extending the scope of troponin surveillance is potentially cost-effective, provided effective therapy is immediately provided when a troponin leak is detected.

Furthermore, there are no data indicating that interventions for MINS decrease subsequent major adverse cardiac events in low-risk patients.

We therefore cannot include this analysis in the pharmacoeconomic analysis, although it is an area that may be associated with a large public health benefit, should efficacy be shown in these patients. This is an area of perioperative medicine that requires urgent investigation. Based on the increased mortality and cardiovascular morbidity,[5,7] we would recommend considering these patients for subsequent secondary prevention for coronary artery disease.

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Conclusion

This pharmacoeconomic analysis suggests that routine postoperative troponin surveillance is a potentially cost-effective intervention in all patients ≥45 years of age undergoing inpatient non-cardiac surgery.

References 1. Devereaux PJ, Chan MT, Alonso-Coello P, et al. Association between postoperative troponin levels and 30day mortality among patients undergoing noncardiac surgery. JAMA 2012;307(21):2295-304. [http://dx.doi. org/10.1001/jama.2012.5502] 2. Weiser TG, Regenbogen SE, Thompson KD, et al. An estimation of the global volume of surgery: A modelling strategy based on available data. Lancet 2008;372(9633):139-144. [http://dx.doi.org/10.1016/S01406736(08)60878-8] 3. Devereaux PJ, Xavier D, Pogue J, et al. Characteristics and short-term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery: A cohort study. Ann Intern Med 2011;154(8):523-528. [http://dx.doi.org/10.1059/0003-4819-154-8-201104190-00003] 4. Van Waes JA, Nathoe HM, de Graaff JC, et al. Myocardial injury after noncardiac surgery and its association with short-term mortality. Circulation 2013;127(23):2264-2271. [http://dx.doi.org/10.1161/ CIRCULATIONAHA.113.002128] 5. Levy M, Heels-Ansdell D, Hiralal R, et al. Prognostic value of troponin and creatine kinase muscle and brain isoenzyme measurement after noncardiac surgery: A systematic review and meta-analysis. Anesthesiology 2011;114(4):796-806. [http://dx.doi.org/10.1097/ALN.0b013e31820ad503] 6. Devereaux PJ, Xavier D, Pogue J, et al. Characteristics and short-term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery: A cohort study. Ann Intern Med 2011;154(8):523-528. [http://dx.doi.org/10.1059/0003-4819-154-8-201104190-00003] 7. Botto F, Alonso-Coello P, Chan MT, et al. Myocardial injury after noncardiac surgery: A large, international, prospective cohort study establishing diagnostic criteria, characteristics, predictors, and 30-day outcomes.

Anesthesiology 2014;120(3):564-578. [http://dx.doi.org/10.1097/ALN.0000000000000113] 8. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD. Third Universal Definition of Myocardial Infarction. J Am Coll Cardiol 2012;60(16):1581-1598 [http://dx.doi.org/10.1016/j.jacc.2012.08.001] 9. Dimick JB, Chen SL, Taheri PA, Henderson WG, Khuri SF, Campbell DA Jr. Hospital costs associated with surgical complications: a report from the private-sector National Surgical Quality Improvement Program. J Am Coll Surg 2004;199(4):531-537. [http://dx.doi.org/10.1016/j.jamcollsurg.2004.05.276] 10. Davenport DL, Henderson WG, Khuri SF, Mentzer RM Jr. Preoperative risk factors and surgical complexity are more predictive of costs than postoperative complications: A case study using the National Surgical Quality Improvement Program (NSQIP) database. Ann Surg 2005;242(4):463-438; discussion 468-471. [http://dx.doi. org/10.1097/01.sla.0000183348] 11. Ortegon M, Lim S, Chisholm D, Mendis S. Cost effectiveness of strategies to combat cardiovascular disease, diabetes, and tobacco use in sub-Saharan Africa and South East Asia: Mathematical modelling study. BMJ 2012;344:e607. [http://dx.doi.org/10.1136/bmj.e607] 12. Department of Health, South Africa. Millenium Development Goals. Goal 8: Develop a Global Partnership for Health. http://www.statssa.gov.za/nss/Goal_Reports/GOAL%208-DEVELOP%20A%20GLOBAL%20 PARTNERSHIP%20FOR%20DEVELOPMENT1.pdf (accessed 16 April 2014).

13. Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: Prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005;366(9493):12671278. [http://dx.doi.org/10.1016/S0140-6736(05)67394-1] 14. Baigent C, Blackwell L, Collins R, et al. Aspirin in the primary and secondary prevention of vascular disease: Collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009;373(9678):1849-1860. [http://dx.doi.org/10.1016/S0140-6736(09)60503-1] 15. Burger W, Chemnitius JM, Kneissl GD, Rucker G. Low-dose aspirin for secondary cardiovascular prevention – cardiovascular risks after its perioperative withdrawal versus bleeding risks with its continuation – review and meta-analysis. J Intern Med 2005;257(5):399-414. [http://dx.doi.org/10.1111/j.1365-2796.2005.01477.x] 16. Nielsen JD, Holm-Nielsen A, Jespersen J, Vinther CC, Settgast IW, Gram J. The effect of low-dose acetylsalicylic acid on bleeding after transurethral prostatectomy – a prospective, randomized, double-blind, placebocontrolled study. Scand J Urol Nephrol 2000;34(3):194-198.

17. Devereaux PJ, Mrkobrada M, Sessler DI, et al. Aspirin in patients undergoing noncardiac surgery. N Engl J Med 2014;370 (16):1494-503. [http://dx.doi.org/10.1056/NEJMoa1401105] 18. Baigent C, Blackwell L, Emberson J, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: A meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 2010;376(9753):1670-1681. [http://dx.doi.org/10.1016/S0140-6736(10)61350-5] 19. Bergh M, Marais CA, Miller-Janson H, Salie F, Stander MP. Economic appraisal of dabigatran as first-line therapy for stroke prevention in atrial fibrillation. S Afr Med J 2013;103(4):241-245. [http://dx.doi.org/10.7196/ samj.6471] 20. Ryan L, Rodseth RN, Biccard BM. The treatment of perioperative myocardial infarctions following noncardiac surgery. Southern African Journal of Anaesthesia and Analgesia 2012;18(2):86-93. [http://reference.sabinet. co.za/webx/access/electronic_journals/medsajaa/medsajaa_v18_n2_a4.pdf] 21. Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: A review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ 2005;173(6):627-634. [http://dx.doi.org/10.1503/ cmaj.050011] 22. Biccard BM, Rodseth RN. The pathophysiology of perioperative myocardial infarction. Anaesthesia 2010;65(7):733-741. [http://dx.doi.org/10.1111/j.1365-2044.2010.06338.x.]

23. Landesberg G, Shatz V, Akopnik I, et al. Association of cardiac troponin, CK-MB, and postoperative myocardial ischemia with long-term survival after major vascular surgery. J Am Coll Cardiol 2003;42(9):15471554. [http://dx.doi.org/10.1016/j.jacc.2003.05.001] 24. Sheth T, Butler C, Chow B, et al. The coronary CT angiography vision protocol: A prospective observational imaging cohort study in patients undergoing non-cardiac surgery. BMJ Open 2012;2(4):e001474. [http:// dx.doi.org/10.1136/bmjopen-2012-001474] 25. Biccard BM. Detection and management of perioperative myocardial ischemia. Curr Opin Anaesthesiol 2014;27(3):336-43. [http://dx.doi.org/10.1097/ACO.0000000000000071] 26. Biccard BM. Peri-operative myocardial infarction. Southern African Journal of Anaesthesia and Analgesia 2010;16(1):44-46.

Accepted 30 April 2014.

A survey on the treatment of atrial fibrillation in South Africa R M Jardine,1 FCP (SA); J Fine,2 FCP (SA) Neurology, BMus (Musicology); I W P Obel,3 FCP (SA), FACC Linmed Hospital, Benoni, Gauteng, South Africa Sanofi, Midrand, Gauteng, South Africa 3 Milpark Hospital, Johannesburg, South Africa 1 2

Corresponding author: R M Jardine (jardinerm@gmail.com) Background. The burden of cardiovascular disease is expected to escalate in developing countries. However, studies and guidelines concerning atrial fibrillation (AF) are restricted to the developed world.

Objectives. To assess the treatment modalities of AF in South Africa.

Methods. A cross-sectional, observational, multicentre, national registry of the treatment of 302 patients with AF was conducted from February 2010 to March 2011. Specific drug use for rate or rhythm control, as well as drug use for stroke prevention, was surveyed. Events during the 12 months prior to the survey were also characterised, including non-drug treatments, resource utilisation and complications.

Results. The single most prevalent clinical characteristic was hypertension (65.9%). Rhythm control was being pursued in 109 patients (36.1%) with class Ic and class III antiarrhythmic agents, while rate control, mainly with beta-blockers, was pursued in the remainder of the patients. Concomitant use of other cardiovascular drugs was high, and 75.2% of patients were on warfarin for stroke prevention. There was a high burden of AF-related morbidity during the preceding year, with 32.5% reporting a history of heart failure, 8.3% a stroke and 5.3% a transient ischaemic attack. Therapeutic success, as defined by either the presence of sinus rhythm or rate-controlled AF, was achieved in 86.8% as judged clinically by the treating physician, but in only 70.2% according to the electrocardiogram criterion of heart rate ≤80 bpm.

Conclusion. There were no striking differences from previously reported registries worldwide. The lack of application of strict rate control criteria is highlighted.

S Afr Med J 2014;104(9):623-627. DOI:10.7196/SAMJ.8111

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Atrial fibrillation (AF) is the most common cardiac arrhythmia, with a prevalence of 5 - 6% in the 65-year-old population, increasing up to 10% in the >80 years population.[1-4] Despite the improvement in primary and secondary prevention of predisposing underlying cardiac conditions such as ischaemic heart disease and hypertension, the prevalence of AF continues to rise in developed countries due to ageing and increasing obesity of the population.[3,5,6] The treatment of AF is undergoing significant revision throughout the world and in a number of ways, especially with regard to stroke prevention, ablation for rhythm control, and novel antiarrhythmic drugs. This has triggered a number of guidelines[7,8] and guideline updates,[9,10] as well as a number of registries and surveys on AF and AF management in various parts of the world (e.g. Nieuwlaat et al.[11] and Camm et al.[12]). In South Africa (SA), the prevalence of AF in the urban black population has recently been documented to be 7% in a cardiovascular disease cohort (8% of heart failure patients, 4% of hypertensive patients, and 13% of valvular disease patients).[13] However, very little has been published on AF management outside the deve­loped world. This prompted the Assessment of the Therapeutic Management of Patients with Atrial Fibrillation in South Africa (SAFIR-RSA). The principal objective of the study was to assess the baseline characteristics of patients with AF and the treatment modalities utilised, particularly the use of rate and rhythm control strategies. The study also looked at hospitalisation rates and prevention of thromboembolism.

Methods

SAFIR-RSA was a prospective cross-sectional, non-interventional, observational disease registry carried out in 29 medical institutions spanning nine urban centres in SA. Patients were largely drawn from the private insured medical sector and therefore represent a relatively affluent stratum of the population.

Secondary evaluation criteria

These included: (i) the proportion of patients with controlled AF, defined as either in sinus rhythm (SR) (recorded during the visit) or at heart rate control target (≤80 bpm at rest); and (ii) the incidence of clinical outcomes in the year preceding the inclusion, defined as hospitalisations for AF and other related cardiovascular events such as stroke, transient ischaemic attack, heart failure and myocardial ischaemia.

Statistical analysis

The data from all the participating medical centres were combined and treated as one dataset for the purposes of the analysis. Data analysis was performed with SAS statistical software, Release 9.2 (SAS Institute, USA). Continuous variables are reported as mean (standard deviation (SD)) and non-continuous variables as number/percentage of patients. The statistical analysis was mainly of a descriptive nature, and sub-analyses were not prespecified in the protocol. Post-hoc subanalyses were performed using Fisher’s exact test. A p-value of <0.05 was considered statistically significant.

Results

The study population consisted of 302 AF patients (59.9% male) from 29 centres, enrolled from 18 February 2010 to 9 March 2011.

The mean age was 67 (SD 13) years (range 21 - 95). The mean waist circumference was 101.6 (SD 17.8) cm and the mean body mass index (kg/m2) 28.8 (SD 5.9), indicating a high prevalence of overweight patients in the cohort.

Clinical characteristics

The study protocol was approved by an independent ethics committee, and written informed consent was obtained from patients before study entry in accordance with Helsinki (1964) ethical recommendations. Adult patients (≥21 years) with electrographically documented AF were enrolled in the registry. Patients were excluded if they had developed AF within 3 months of cardiac surgery, had acute AF apparently precipitated by non-cardiac conditions (e.g. pneumonia), or had recently participated in an AF trial.

The single most prevalent clinical characteristic was hypertension (65.9%). Other coronary risk factors were also frequent (dyslipidaemia 48.3% and diabetes 15.6%). Concomitant structural heart disease was common, with 27.5% having valvular disease (of whom 79.5% had mitral valve disease), 26.8% coronary artery disease, and 32.5% heart failure; 28.5% of these patients had New York Heart Association class III or IV symptoms. In keeping with these comorbidities, 27.5% of patients had a history of previous cardiac or vascular interventions.

Non-cardiac comorbidities were not common, comprising thyroid disease in 14.2% (3.3% hyperthyroid and 10.9% hypothyroid) and renal disease in 10.9% (Table 1).

The time course of AF was paroxysmal in 32.1% of patients, persistent in 21.2% and permanent in 46.7%. During the preceding 12 months, 40.7% of patients had experienced symptoms of AF.

Procedure

Pharmacological treatment

Patients

A medical history taken at enrolment included recording each patient’s treatment, the clinical presentation of AF, the presence or absence of comorbidities, and all data pertaining to the primary and secondary outcomes (see below). The physicians or cardiologists in each participating medical centre completed a standardised 6-page case report form for every enrolled patient.

Primary evaluation criteria

These included: (i) the prevalence of AF treatment modalities, namely the proportion of patients receiving rhythm control agents (class I and III) and/or rate control agents (class II and IV, and cardiac glycosides), cardioversion, ablation or other procedures; and (ii) the use of treatments to prevent thromboembolism, namely the proportion of patients taking vitamin K antagonists, acetylsalicylic acid or other antiplatelet agents. Any other cardiovascular treatments were also noted.

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The drug therapy at the time of the survey visit is listed in Table 2. For the purposes of this analysis, ‘rhythm control’ was defined as the chronic use of class Ic or class III drugs for the maintenance of SR, and all others were deemed ‘rate control’. Rhythm control was being pursued in 109 patients (36.1%) with class Ic and class III agents, while rate control was pursued in the remainder (63.9%). Amiodarone accounted for 79.4% of class III drugs used. A number of patients in the rhythm control group were receiving rate control medications in addition, but this number is not extractable from the data. Beta-blockers were the most frequently used rate control drugs. Combinations of beta-blockers, digoxin and rate-controlling calcium channel blockers were often employed. Concomitant use of other cardiovascular drugs was high, especially diuretics (53.0%), statins (44.0%), angiotensin-converting enzyme inhibitors (39.1%) and angiotensin receptor blockers (22.5%).

For stroke prevention, 75.2% were on warfarin, 39.4% on aspirin and 5.0% on clopidogrel.

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Control of AF

Table 1. Clinical characteristics History of condition n (%)

Treated for condition in preceding 12 months n (% of those with condition)

Cardiac risk factors (N=302) Smoking Current

27 (9.0)

Former

123 (40.7)

Never

142 (47.0)

Hypertension

199 (65.9)

198 (99.5)

Diabetes*

47 (15.6)

44 (93.6)

Dyslipidaemia

146 (48.3)

127 (87.0)

Coronary artery disease

81 (26.8)

23 (28.4)

Myocardial infarction

34 (11.3)

4 (11.8)

Peripheral arterial disease

9 (3.0)

1 (11.1)

Carotid stenosis

3 (1.0)

Cardiac comorbidities (N=302)

Valvular heart disease

83 (27.5)

9 (10.8)

Arrhythmia other than AF†

42 (13.9)

11 (26.2)

Total

83 (27.5)

20 (24.1)

Cardiac and vascular interventions (N=83) PCI

23 (27.7)

CABG

16 (19.3)

Carotid intervention

1 (1.2)

Valvular surgery

25 (30.1)

CABG + valvular surgery

3 (3.6)

PCI + CABG

4 (4.8)

PCI + valvular surgery

1 (1.2)

PCI + carotid intervention

1 (1.2)

Unknown

9 (10.9)

Prevention of thromboembolic complications

Non-cardiac comorbidities (N=302) Thyroid disease

43 (14.2)

Renal disease

33 (10.9)

AF = atrial fibrillation; PCI = percutaneous coronary intervention; CABG = coronary artery bypass graft. *97.9% had type 2 diabetes. † 60.4% had atrial flutter.

Events and hospitalisations in the preceding 12 months

Treatments for AF in the preceding 12 months included pharmacological cardioversion (17.5%), electrical cardioversion (13.2%), catheter ablation (4.2%) and pacemaker implantation (5.3%). Interestingly, a number of patients had an unusually large number of cardioversions in the previous year: 6 patients had two attempts at electrical cardioversion, 2 underwent three attempts, and a further 2 underwent four attempts. One patient had six pharmacological cardioversion attempts.

Of the total cohort, 104 patients (34.4%) had required hospitalisation during the previous 12 months, with a third of these

patients requiring multiple hospitalisations.

AF-related morbidity requiring hospitali­ sation was particularly frequent for heart failure (11.6% of study patients, 35/98 with heart failure), and for stroke, transient ischaemic attack and peripheral embolism (3.9% of study patients, 12/58 with these conditions) (Table 3). Haemorrhage occ­urred in 23 patients (7.6%) during the preceding year, but was considered to be serious enough to warrant hospitalisation in only 8 cases.

One patient had intracranial haemorrhage.

The mean duration of hospital stay was 5.2 days. The average number of outpatient consultations for AF or other cardiovascular reasons in the preceding year was 1.74.

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The rhythm status of patients at the time of the survey is shown in Table 4. Only 85 patients (28.1% of the total study cohort) were in SR; notably, 31 of these were on rate control medications alone. Of the patients in AF at the time of the survey, 81.5% were judged in the opinion of the enrolling investigator to be satisfactorily rate controlled. However, when utilising a strict electrocardiogram (ECG) criterion of rate ≤80 bpm, only 58.4% of patients in AF would fulfil this definition.

Using the ‘lenient’ rate control criterion of ≤110 bpm proposed by the RACE II trial,[8] 90.6% of patients would fulfil this definition.

‘Therapeutic success’ as defined by either the presence of SR or rate-controlled AF was achieved in 86.8% of the total population on the basis of the clinicians’ clinical judgement, but only in 70.2% as judged by the EGC criterion of rate ≤80 bpm.

A post-hoc sub-analysis was performed to compare the strategies of rhythm control with rate control (Table 5). Patients prescribed rhythm control medications were somewhat younger, had more medication changes in the preceding year, had more hospitalisations for AF or cardiovascular reasons, and underwent pharmacological and electrical cardioversion more frequently than the rate control group. The rhythm control group had significantly more hospitalisations for coronary artery disease (50.0% v. 16.3%), myocardial infarction (28.6 v. 0%) and heart failure (57.6% v. 25.8%).

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The mean CHA2DS2-VASc score (congestive heart failure or left ventricular dysfunction, hypertension, age ≥75 (2 points), diabetes, stroke (2 points), vascular disease, age 65 - 74, sex category) for the entire cohort of patients was 3.08, and there was no significant difference in scores of patients on warfarin v. those not on warfarin (3.12 v. 2.96, respectively). Of patients not using vitamin K antagonists, 78.6% had CHA2DS2VASc scores ≥2.

There was a poor correlation between the actual CHA2DS2-VASc score and use of anticoagulation, as follows: score of 0 (65%); score of 1 (83%); score of 2 (68%); score of 3 (76%); score of 4 (79%); score of 5 (76%); score of 6 (81%); score of 7 (25%, 1/4 patients); score of 8 (100%, 4/4 patients).

Discussion

The primary outcome measure in the SAFIRRSA survey was to evaluate the incidence of AF treatment modalities and thromboembolic prevention treatments in a cross-sectional

RESEARCH

Table 2. Medication at time of visit, N=302 patients Medication

n (%)

Cardiovascular

109* (36.1)

Table 3. AF morbidity in preceding 12 months Hospitalised in preceding 12 months n (% of those with condition)

Ic

9 (3.0)

Diagnosis

History of condition n/N (% )

III

102 (33.8)

Heart failure (N=302)

98 (32.5)

35 (35.7)

NYHA class

Rhythm control agents

Rate control agents Beta-blockers (excluding sotalol)

180 (59.6)

I

22/98 (22.5)

HR-lowering CCBs

40 (13.2)

II

48/98 (49.0)

76 (25.2)

III

26/98 (26.5)

IV

2/98 (2.0)

243 (80.4)

Cardiac glycosides Other Beta-blockers (not prescribed for AF)

44 (14.6)

Diuretics

160 (53.0)

Dihydropyridine CCBs

43 (14.2)

<30

7/243 (2.9)

ACE inhibitors

118 (39.1)

30 - 40

26/243 (10.7)

Angiotensin II receptor antagonist

68 (22.5)

41 - 50

33/243 (13.6)

Vasodilators

10 (3.3)

>50

177/243 (72.8)

Other antihypertensives

19 (6.3)

Stroke (N=302)

36 (11.9)

3 (8.3)

Statins

133 (44.0)

TIA (N=302)

16 (5.3)

7 (43.8)

Other lipid-lowering agents

7 (2.3)

2 (33.3)

45 (14.9)

Peripheral embolic events (N=302)

6 (2.0)

Oral antidiabetic agents Insulin

13 (4.3)

LVEF (%) in preceding 12 months (N=302)

AF = atrial fibrillation; NYHA = New York Heart Association; LVEF = left ventricular ejection fraction; TIA = transient ischaemic attack.

Antithrombotic Vitamin K antagonist

227 (75.2)

Acetylsalicylic acid

119 (39.4)

Clopidogrel

15 (5.0)

Other antiplatelet/anticoagulant agents

5 (1.7)

INR in past 6 months

218 (96.0)†

HR = heart rate; CCBs = calcium channel blockers; AF = atrial fibrillation; ACE = angiotensin-converting enzyme; INR = international normalised ratio. *Two patients were on both class Ic and class III agents. † 75 missing values.

representative cohort of patients with AF in SA. The results clearly showed that the majority of patients were receiving rate control therapy (63.9%), usually in the form of beta-blockers, either alone or in combination with other rate control agents. Rhythm control therapy for the remainder of the patients consisted primarily of class III agents. Concomitant use of other cardiovascular drugs was high in both treatment strategies. Since the patient cohort included the elderly, with a high frequency of other cardiac risk factors and structural heart disease, it is not surprising that the majority were being treated with a rate control strategy. According to European Society of Cardiology guidelines, rate control is a reasonable strategy in elderly patients in whom the level of symptoms related to AF is deemed acceptable.[8] Nevertheless, the findings do suggest that clinicians in SA apply lenient rate control criteria and judge patients to be rate controlled with a resting pulse rate of less than 110 bpm.

There were no striking differences in the baseline clinical character­ istics of this study population when compared with other worldwide registries. Notably, the prevalence of underlying comorbidities such as coronary artery disease, valvular disease and heart failure in the present study is similar (~20 - 30% for each) to those reported in the developed world.[8] This is perhaps not surprising because, although the aim of this study was to focus for the first time on SA patients, the cohort was largely

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derived (88.7%) from insured patients, a more affluent sector of the population that would more closely approximate a First-World setting.

The racial groups of the sub­jects, frequently used as a proxy for socio­ economic status, are unknown.

The primary outcome measure of the SAFIR-RSA survey also included an assess­ment of the use of thromboembolic prevention treatments. The novel oral anti­coagulants were not yet in use at the time of the survey. The findings show that the large majority of patients (75.2%) were receiving warfarin for stroke prevention.

There were, however, a significant number of patients not receiving anticoagulation who, with CHA2DS2-VASc scores ≥2, should have had thromboembolic prevention therapy according to current treatment guidelines.[10] Nearly all the patients on warfarin had had international normalised ratio monitoring during the previous 6 months. This diligent monitoring may account for the low rate of hospitalisation for haemorrhage of only 2.6% (8 patients) during the preceding year, compared with rates of 6.8 - 7.2% reported in other observational studies on older patients with AF receiving warfarin.[14] In the present survey, hospitalisations for coronary artery disease, myocardial infarction and heart failure occurred more frequently in the group on antiarrhythmic agents. It is not clear whether these developments are a result of antiarrhythmic drug therapy, or whether rhythm control is preferred as a strategy in patients with these conditions.

Study limitations

There are a number of limitations to this study. The patient sample does not necessarily reflect the true cross-sectional population of AF patients in SA, as most had medical insurance coverage. Site selection bias is likely, with over-representation of cardiologists with specialisation or particular interest in AF. Case selection bias may also have been introduced because it was not mandated that consecutive cases be included at each site. Investigator knowledge of the sponsor

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Table 4. Current control at time of the survey n (%)

Total patients, N

In SR at visit

85 (28.1)

302

In AF at visit

217 (71.9)

68 (22.5)

Investigator opinion

177 (81.5)

217

ECG criterion, HR ≤80 bpm

125 (58.4)

214*

ECG criterion, HR ≤110 bpm

194 (90.6)

214*

Investigator opinion

262 (86.8)

302

ECG criteria

210 (70.2)

299*

Symptomatic In AF but rate controlled

Therapeutic success (in SR or in AF with rate controlled)

SR = sinus rhythm; AF = atrial fibrillation; ECG = electrocardiogram; HR = heart rate. *3 patients in AF did not have ECGs.

References

Table 5. Sub-analysis of rate control v. rhythm control strategies

Rate control (N=193)

Rhythm control (N=109)

p-value*

Age (years)

68.3

65.3

0.05

Pharmacological cardioversion, n (%)

6 (3.2)

47 (43.9)

<0.001

Electrical cardioversion, n (%)

16 (8.4)

24 (22.2)

0.001

AF at visit, n (%)

162 (83.9)

55 (50.5)

<0.001

Rate control, n (%)

141 (88.1)

36 (65.4)

<0.001

Hospitalisation for AF or CV reasons, n (%)†

49 (25.4)

55 (50.5)

<0.001

History of CVD, n (%)

51 (27.0)

30 (27.8)

0.892

8/49 (16.3)

15/30 (50.0)

0.002

20 (10.5)

14 (13.0)

0.57

0 (0)

4/14 (28.6)

0.022

64 (33.3)

34 (31.2)

0.789

16/62 (25.8)

19/33 (57.6)

0.004

Hospitalisation for CVD, n/N (%)

†

History of MI, n (%) Hospitalisation for MI, n/N (%)

†

History of CHF, n (%) Hospitalisation for CHF, n (%)†

AF = atrial fibrillation; CV = cardiovascular; CVD = cardiovascular disease; MI = myocardial infarction; CHF = chronic heart failure. *Fisher’s exact test except for age, where Student’s t-test was used. Significance values should be interpreted with caution, as the study was not designed for this comparison. † Preceding 12 months.

may have introduced an additional bias in favour of patients on amiodarone.

Conclusions

The data in the SAFIR-RSA survey conform to similar registries in the developed world.

Despite the focus on a relatively affluent sub-sector of the SA population, resulting in a near duplication of studies carried out in other developed countries, this is the first epidemiological study generating data on management of AF in SA. AF is a significant burden in cardiology practice in this country, with considerable resource utilisation and morbidity for patients. This survey highlights a lack of rigour in applying definitions of rate control and under-utilisation of

antithrombotic therapy. Although only a ‘snapshot’, clinicians should be aware of these findings and attempt to improve drug utilisation and patient outcomes.

Acknowledgements.

This survey was sponsored by Sanofi, Midrand, Gauteng, SA. Prof. Herman Schoeman of Clinstat CC, Pretoria, SA, performed the statistical analyses. Mrs Catherine Jardine provided secretarial assistance. The following physicians and cardiologists are acknowledged for their participation: M Alison, L Bushidi, G A Cassel, C Corbett, A J Dalby, G C Ellis, C P Franklin, D J Gilmer, T J Gray, M Heradien, J King, R D V Lamparelli, G Letcher, L Lombard, H Louw, E

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Maree, J McKibbin, R Moodley, I W P Obel, A Okreglicki, A Roodt, F A Snyders, R Spammer, A Stanley, S N Thackersee, H Theron, N van der Merwe, P D Whitfield, R Zeelie.

Conflict of interest. RMJ reports receipt of a contractual fee from Sanofi-Aventis as Principal Investigator, and also lecture fees and travel expenses from Aspen Pharmaceuticals, Bayer Healthcare, Boehringer-Ingelheim, BristolMyers Squibb, Cipla-Medpro, Medtronic and Sanofi-Aventis. JF is a medical advisor at Sanofi. IWPO is a consultant and investigator for Medtronic and has received lecture fees and travel expenses from Medtronic, BoehringerIngelheim and Bayer Healthcare.

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1. Greenlee RT, Vidaillet H. Recent progress in the epidemiology of atrial fibrillation. Curr Opin Cardiol 2005;20(1):7-14.

2. Furberg CD, Psaty BM, Manolio TA, Gardin JM, Smith VE, Rautaharju PM. Prevalence of atrial fibrillation in elderly subjects (the Cardiovascular Health Study). Am J Cardiol 1994;74(3):236241. [http://dx.doi.org/10.1016/0002-9149(94)90363-8] 3. Feinberg WM, Blackshear JL, Laupacis A, Kronmal R, Hart RG. Prevalence, age distribution, and gender of patients with atrial fibrillation: Analysis and implications. Arch Intern Med 1995;155(5):469-473. [http://dx.doi.org/10.1001/ archinte.155.5.469] 4. Wattigney WA, Mensah GA, Croft JB. Increased atrial fibrillation mortality: United States, 1980-1998. Am J Epidemiol 2002;155(9):819-826. [http://dx.doi.org/10.1093/aje/155.9.819] 5. Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: National implications of for rhythm management and stroke prevention: The Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) study.

JAMA 2001;285(18):2370-2375. [http://dx.doi.org/10.1001/ jama.285.18.2370] 6. Ryder KM, Benjamin EJ. Epidemiology and significance of atrial fibrillation. Am J Cardiol 1999;84(9A):131R-138R. [http://dx.doi. org/10.1016/S0002-9149(99)00713-4] 7. Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines: Developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Executive summary.

Eur Heart J 2006;27(16):1979-2030. [http://dx.doi.org/ 10.1093/ eurheartj/ehl176] 8. Camm AJ, Kirchhof P, Lip GY, et al. Guidelines for the management of atrial fibrillation: The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology. Eur Heart J 2010;31(19):2369-2429. [http://dx.doi.org/ 10.1093/eurheartj/ ehq278] 9. Wann LS, Curtis AB, January CT, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (updating the 2006 guideline). Heart Rhythm 2011;8(1):157-176. [http://dx.doi.org/I10.1016/j.hrthm.2010.11.047] 10. Camm AJ, Lip GYH, De Caterina R, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation.

Eur Heart J 2012;33(21):2719-2747. [http://dx.doi.org/10.1093/ eurheartj/ehs253] 11. Nieuwlaat R, Capucci A, Camm AJ, et al. Atrial fibrillation management: A prospective survey in ESC member countries – the Euro Heart Survey on Atrial Fibrillation. Eur Heart J 2005;26(22):2422-2434. [http://dx.doi.org/10.1093/eurheartj/ ehi505] 12. Camm AJ, Breithardt G, Crijns H, et al. Real life observations of clinical outcomes with rhythm- and rate control therapies for atrial fibrillation – RECORDAF (Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation). J Am Coll Cardiol 2011;58(5):493-501. [http://dx.doi.org/10.1016/j.jacc.2011.03.03] 13. Sliwa K, Carrington MJ, Klug E, et al. Predisposing factors and incidence of newly diagnosed atrial fibrillation in an urban African community: Insights from the Heart of Soweto Study.

Heart 2010;96(23):1878-1882. [http://dx.doi.org/10.1136/ hrt.2010.206938] 14. Gomes T, Mamdani MM, Holbrook AM, Paterson JM, Hellings C, Juurlink DN. Rates of haemorrhage during warfarin therapy for atrial fibrillation. CMAJ 2013;185(2):E121-E127. [http://dx.doi. org/10.1503/cmaj.121218]

Accepted 20 June 2014.

RESEARCH

Investigating hepatitis B immunity in patients presenting to a paediatric haematology and oncology unit in South Africa A Büchner, MB ChB, DCH (SA), FCPaed (SA); F E Omar, MB ChB, FCPaed (SA), Cert Med Oncol (Paed); J Vermeulen, MB ChB, FCPaed (SA), Cert Med Oncol (Paed); D T Reynders, MB ChB, MRCPCH (Lond), FCPaed (SA), Cert Med Oncol (Paed) Paediatric Haematology and Oncology Unit, Steve Biko Academic Hospital, Pretoria, South Africa Corresponding author: A Büchner (ane.buchner@up.ac.za) Background. Hepatitis B is an important public health concern in South Africa (SA). The hepatitis B virus (HBV) vaccine was introduced into the South African Expanded Programme on Immunisation (EPI-SA) in 1995. There is no ‘catch-up’ programme in place. The duration of protection after hepatitis B vaccination in the SA population is unknown. Waning of vaccine-induced immunity leaves people at risk of acquiring hepatitis B infection in settings where the prevalence of infection is high and horizontal transmission is likely.

Objective. To assess immunity to HBV in patients at presentation to a paediatric haematology and oncology unit.

Methods. An audit of hepatitis profiles was done of all new patients seen in the unit from January 2012 to December 2013. Patients were classified as immune (antibody levels to hepatitis B surface antigen (anti-HBs) >100 mIU/ml), low immune (anti-HBs 10 - 100 mIU/ml) and not immune (anti-HBs <10 mIU/ml).

Results. Of the 210 patients included (median age 6.5 years), 84 (40.0%) had no immunity to hepatitis B despite presumed vaccination as part of the EPI schedule. Six patients tested positive for hepatitis B core antibody (anti-HBc), consistent with previous infection. No patients had active hepatitis B infection (hepatitis B surface antigen-positive). Most human immunodeficiency virus (HIV)-infected patients were not immune to HBV (80.0%).

Conclusion. A significant number of children in SA are not immune to hepatitis B despite vaccination being part of the EPI-SA. Combined passive-active immunisation should be considered for all oncology patients in settings where exposure to HBV is possible. Consideration should also be given to offering booster vaccination to the population as a whole.

S Afr Med J 2014;104(9):628-631. DOI:10.7196/SAMJ.7952

The prevalence of hepatitis B virus (HBV) infection in patients with haematological malignancies is higher than that in the general population.[1] The higher prevalence can be explained by the immune suppression induced by cytotoxic chemotherapy, which leads to increased susceptibility.[2,3] Immune suppression may also lead to reactivation of occult HBV infection and increased HBV replication.

Horizontal transmission of HBV during early childhood is consid­ ered the main route of infection in developing countries.[4-9] This transmission of HBV is unrelated to sexual, perinatal or parenteral exposure. Transmission between family members may occur in communities with poor socioeconomic and hygienic conditions, and with long periods of close interaction.[10] The mode of horizontal transmission is uncertain, but contact with body fluids, mainly saliva, is a prominent feature.[7,8,11] Vaccination is recommended for individuals at risk of HBV infection as a result of percutaneous or mucosal exposure to blood or blood products, as well as for those at risk of severe hepatitis B infection.[5] Patients in oncology units, transplant candidates, and individuals receiving frequent blood or blood product transfusions should be vaccinated.[1,5] From April 1995, the HBV vaccine was included in the South African Expanded Programme of Immunisation (EPI-SA) at 6, 10 and 14 weeks of age. No ‘catch-up’ immunisation of older age groups was implemented.[4] In 2010, 94% of children in South Africa (SA) were reported to be fully immunised against HBV (received three doses) in their first year of life.[6,8] However, according to the World Health Organization (WHO), only 56% of babies in SA received all

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three doses.[8] Current reports on children vaccinated against HBV in SA have found a low prevalence of hepatitis B surface antigen (HBsAg) positivity, ranging from none in children with unknown HIV status to 2.7% in HIV-positive children.[8,9] The effectiveness of the HBV vaccine is assessed by measuring antibody levels to HBsAg (anti-HBs) levels in the serum. Various studies conducted after the inclusion of HBV vaccine in the EPISA immunisation schedule have shown the vaccine to be highly immunogenic and effective.[8] Protective levels of anti-HBs, defined as >10 mIU/l in healthy, immune-competent children,[8] were found in 78 - 87% of healthy children, with none or very few children positive for HBsAg or HBV DNA. The vaccine was also tested in babies with HIV infection, in whom it has proved to be less effective. For example, protective levels of anti-HBs achieved through immunisation were found in 78.1% of HIV-positive patients in comparison with 85.7% of HIV-negative patients.[8] The duration of HBV-vaccine-induced immunity after primary immunisation during infancy is not known.[12,13] Although specific antibody levels decline rapidly after vaccination, protection through immune memory is thought to extend into adulthood. The waning of vaccine-induced immunity could leave adolescents and adults at risk of HBV infection.[13]

Objective

This study reports on an audit of records of children presenting to a haematology and oncology unit. Our primary objective was to investigate serological evidence of previous exposure to HBV or vaccine immunity to HBV at first presentation. A secondary objective was to identify patients at risk of contracting hepatitis B infection

September 2014, Vol. 104, No. 9

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Methods

A hospital-based audit was done using patient records of all children who presented to the paediatric haematology and oncology unit at Steve Biko Academic Hospital (SBAH), a tertiary academic hospital in Pretoria, SA, during the period 1 January 2012 - 31 December 2013. Demographic data (age and gender) and diagnosis of each patient were documented on presentation. HBV serology results for all patients (irrespective of the diagnosis) were reviewed.

Serological screening for hepatitis A, B and C is routinely done on all new patients on presentation to the unit. Screening for HBV includes serological testing for HBsAg, anti-HBs and antibodies to hepatitis B core antigen (anti-HBc). Hepatitis B e-antigen (HBeAg) and antibodies to hepatitis B e-antigen (anti-HBe) are only tested for when HBsAg is positive (in patients with hepa­titis B infection). Immunoassays using Abbott ARCHITECT i2000 (Abbott Diagnostics, Germany) were used for HBV sero­ logical testing.

Anti-HBs levels of >100 mIU/ml were defined as complete protection against hep­ atitis B infection, levels of 10 - 100 mIU/ml as partial protection and levels of <10 mIU/ml as no protection. Antibody levels of >100 mIU/ ml are recommended for ensuring protection against hepatitis B infection in immunecompromised patients.[14-17] Data were analysed with SSPS version 21. All proportions are reported as per­ centages with 95% confidence intervals (CIs). Differences between proportions were com­ pared using the χ2 test. A threshold of significance of p=0.05 was used for all analyses.

Results

A total of 210 patients who presented to our unit between 1 January 2012 and 31

December 2013 were included. None had received previous immunosuppressive therapy. Table 1 summarises the diag­noses and anthropometric data. Diagnoses were as follows: 41 (19.5%) leukaemia, 31 (14.8%) lymphoma (21 non-Hodgkin’s lymphoma, 10 Hodgkin’s lymphoma), 92 (43.8%) solid tumours, and 46 (21.9%) benign or nonmalignant haematological conditions.

The solid tumour group did not include any patients with primary liver tumours (hepatoma, hepatoblastoma or hepatocellular carcinoma). Of the 210 patients, 25 (11.9%) were HIV-infected, and of these eight (32.0%) were newly diagnosed on presentation to the unit. There were 130 boys and 80 girls in the study group. The median age of the study group as a whole was 6.5 years (range 3 weeks - 17.6 years), that of the leukaemia/ lymphoma group 7.3 years (range 4 weeks 16.7 years), that of the solid tumour group 4.9 years (range 3 weeks - 17.6 years), and that of the group with benign or non-malignant haematological conditions 7.9 years (range 3 weeks - 15.7 years).

Active hepatitis B infection (HBsAg) was not detected in any of the patients during screening at the time of presentation to the unit. Six patients (2.9%) had evidence of previous infection with anti-HBc detected in serum, but no current active infection (HBsAg-negative). One of the six patients with evidence of previous infection was HIV-positive and not yet on antiretroviral treatment.

Of the 210 patients in the study, 84 (40.0%; 95% CI 33.3 - 47.0) were sero­negative for HBV, and 78 (37.1%; 95% CI 30.6 - 44.0) had anti-HBs titres of 10 - 100 mIU/ml, considered to be insufficient in a population of immune-compromised patients. Only 48 patients (22.9%; 95% CI 17.4 - 29.2%) had anti-HBs titres >100 mIU/ml and were therefore protected against acquiring HBV (Fig. 1). Of the 25 HIV-positive patients, 20 (80.0%; 95% CI 59.3 - 93.2) had no immun­ ity to HBV (anti-HBs titres <10 mIU/ml) (Fig. 2). There was a significant difference in immunity against HBV between the 1 5-years age group and the over-12 age group

100 90 80 70 Patients, %

through horizontal transmission. The overall aim of the study was to provide a basis on which a further preventive strategy could be developed if deemed necessary.

60 50 37.1%

40 30

40.0%

22.9%

20 10 0 Protected

Insufficient immunity

Not immune

Fig. 1. Hepatitis B immunity in the study group. (Protected = antibody levels to hepatitis B surface antigen (anti-HBs) >100 mIU/ml; insufficient immunity = anti-HBs 10 - 100 mIU/ml; not immune = anti-HBs <10 mIU/ml.)

Table 1. Diagnoses, gender and ages of children presenting to the paediatric haematology and oncology unit at SBAH (N=210) Characteristic

Leukaemia

Lymphoma

Solid tumours

Haematological conditions*

Other†

N (%)

41 (19.5)

31 (14.8)

92 (43.8)

24 (11.4)

22 (10.5)

Males, n (%)

24 (58.5)

26 (83.9)

51 (55.4)

17 (70.8)

12 (54.5)

Median

5.8

10.3

4.9

7.9

6.7

Range

0.1 - 16.7

2.3 - 15.3

0.1 - 17.6

0.6 - 13.9

0.1 - 15.7

Age (years)

SBAH = Steve Biko Academic Hospital. *Non-malignant haematological conditions include severe aplastic anaemia and sickle cell anaemia. † Include benign eye conditions and healthy sibling donors.

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(p=0.005). In the age group 1 - 5 years, 26 of 71 patients (36.6%; 95% CI 25.5 - 48.9) had sufficient immunity (anti-HBs titres >100 mIU/ml), while in the over-12 age group only four of 40 (10.0%; 95% CI 2.8 23.7) did so. In the <1-year age group, five infants were <8 weeks of age and had therefore not received the first dose of HBV vaccine and had no protective immunity.

In the group with benign or nonmalignant haematological conditions, 12 of the 46 patients (26%; 95% CI 14.2 - 41.0) had anti-HBs levels of >100 mIU/ml, and in the leukaemia/lymphoma group only nine of 72 patients (12.5%; 95% CI 5.9 - 22.4) did so (Fig. 3).

is not possible to comment on the decline of HBV immunity in the study patients, because their HBV serology was not repeated.

Factors that increase susceptibility to HBV infection and reactivation in paediatric oncology patients may include frequent prolonged hospital admissions, severe immune-compromised states, a need for frequent blood product administration, and destruction of mucous membranes following cytotoxic chemotherapy.[1,2] Active immunisation against HBV has been shown to be effective in patients with cancer.[3]

100 90

Discussion

80.0%

80

Patients, %

70 60 50 40 30 16.0%

20 10

4.0%

0 Protected

Insufficient immunity

Not immune

Fig. 2. Hepatitis B immunity in the subgroup of patients with HIV. (Protected = antibody levels to hepatitis B surface antigen (anti-HBs) >100 mIU/ml; insufficient immunity = anti-HBs 10 - 100 mIU/ml; not immune = anti-HBs <10 mIU/ml.)

100 90 80 70 Patients, %

None of the patients in this study had active hepatitis B infection at initial screening and only six had evidence of previous infection. This rate of exposure to HBV is in keeping with the prevalence in SA (range 0 - 2.7%) and reflects the protective effect of the immunisation received as part of the EPI-SA. There were, however, a large number of patients (77.1%) in the study with sub­ optimal anti-HBs titres of <100 mIU/ml.

While there is no consensus about what level of antibodies against HBV is pro­ tective in immune-compromised patients, it is accepted that a level of >10 mIU/ml after immunisation decreases the risk of a child with a normal immune response becoming a chronic carrier, despite the declining antibody level.[14-17] The immune memory capable of protecting against chronic or symptomatic hepatitis B infection persists even after antibody levels decline to <10 mIU/ml.[12] This immune memory has been shown to be protective in a large percentage of healthy children, but has not been assessed in patients on immunosuppressive therapy. The defects in immunological functioning caused by intensive chemotherapy may adversely affect the immune memory so that it may not be protective in childhood cancer patients.[18] Despite being vaccinated as part of the EPI-SA, patients have acquired HBV in the paediatric oncology unit at SBAH.[7] Previous studies have shown that HBV immunity declines with age.[6,8,12,13] We were able to demonstrate a significant difference in levels of immunity to HBV in our patients.

However, when comparing the 1 - 5-year age group with the over-12 group in this study, this difference in immunity may be overestimated when the size of the study population (N=210) is taken into account. It

The role of passive immunisation using a specific immune globulin containing a high titre of anti-HBs (HBIG) in combination with hepatitis B vaccine has been well described in the setting of post-exposure prophylaxis following perinatal exposure for infants born to HBsAg-positive mothers.[19] HBIG is also used for protection against severe recurrent HBV infection in liver transplant patients.[19] The combination of intravenous HBIG with HBV vaccination in children with malignant diseases has been studied in Poland[20] and India.[21] In both these studies,

60 50

40.3%

47.2%

40 30 20

12.5%

10 0 Protected

Insufficient immunity

Not immune

Fig. 3. Hepatitis B immunity in the subgroup of patients with leukaemia/lymphoma. (Protected = antibody levels to hepatitis B surface antigen (anti-HBs) >100 mIU/ml; insufficient immunity = antiHBs 10 - 100 mIU/ml; not immune = anti-HBs <10 mIU/ml.)

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combined passive-active immunisation offered better protection against nosocomial HBV infection than active immunisation alone. The cost implication of offering solely passive prophylaxis during intensive chemotherapy of patients with leukaemia and non-Hodgkin’s lymphoma led to discontinuation of this protocol and a recommendation for simultaneous passive and active immunoprophylaxis from the start of such therapy.[20] HIV-positive patients in this study had very low levels of immunity to HBV. We could find no published reports on immunity to HBV of HIV-infected children compared with HIV-negative children.

Among unimmunised adults, patients with AIDS were reported to have significantly decreased anti-HBs titres compared with a control group of HIV-negative adults.[22] Adults with HBV/HIV co-infection have significantly higher HBV viral loads and for this reason are highly infectious, with an increased risk of transmitting HBV to close contacts and susceptible health workers.[22] This is especially relevant and dangerous in a paediatric haematology and oncology unit where patients are continuously in close contact with each other and where there have been previous reports of HBV transmission.[7] Patients with underlying HIV disease at the time of cancer diagnosis should be given combined passive-active immunisation to offer the best possible protection against HBV infection.[23] Acute hepatitis infection caused by HBV could lead to delays in chemotherapy and for this reason worsen the patient’s cancerrelated prognosis.[1] Most children infected with HBV develop chronic hepatitis and therefore have an increased risk of developing cirrhosis and hepatocellular carcinoma.[3] The complications of chronic hepatitis could potentially have a detrimental effect on the long-term morbidity of this group of patients.

Conclusion

A large group of patients attending our paediatric haematology and oncology unit did not have sufficient protective antibodies against HBV at first presentation, despite being vaccinated as part of the EPI-SA. These patients are at risk of hepatitis B infection. Active surveillance and continued screening for HBV must be done at first presentation of all patients attending a paediatric haema­ tology and oncology unit, and regularly during treatment and follow-up. A programme to immunise all seronegative patients against HBV should be implemented, and the response to immunisation documented. The use of combined passive-active immunisation should be encouraged, especially in children with haematological malignancies and HIV-infected children. Implementation of an effective screening and vaccination

631

programme in the haematology and oncology unit should protect all patients from contracting HBV. References 1. Lalazar G, Rund D, Shouval D. Screening, prevention and treatment of viral hepatitis B reactivation in patients with haematological malignancies. Br J Haematol 2007;136(5):699-712. [http://dx.doi. org/10.1111/j.1365-2141.2006.06465.x] 2. Gigliotti AR, Fioredda F, Giacchino R. Hepatitis B and C infection in children undergoing chemotherapy or bone marrow transplantation. J Pediatr Hematol Oncol 2003;25(3):184-192. [http:// dx.doi.org/10.1097/00043426-200303000-00002] 3. Meral A, Sevinir B, Günay U. Efficacy of immunization against hepatitis B virus infection in children with cancer. Med Pediatr Oncol 2000;35(1):47-51. [http://dx.doi.org/10.1002/1096911X(200007)35:1<47::AID-MPO8>3.3.CO;2-E] 4. Kew MC. Hepatitis B virus infection: The burden of disease in South Africa. South African Journal of Epidemiology and Infection 2008;23(1):4-8.

5. Spearman CWN, Sonderup MW, Botha JF, et al. South African guideline for the management of chronic hepatitis B: 2013. S Afr Med J 2013;103(5):335-349. [http://dx.doi.org/10.7196/samj.6452] 6. François G, Dochez C, Mphahlele MJ, et al. Hepatitis B vaccination in Africa: Mission accomplished?

South African Journal of Epidemiology and Infection 2008;23(1):24-28.

7. Willers E, Webber L, Delport R, Kruger M. Hepatitis B – a major threat to childhood survivors of leukaemia/lymphoma. J Trop Pediatr 2001;47(4):220-225. [http://dx.doi.org/10.1093/tropej/47.4.220] 8. Burnett RJ, Kramvis A, Dochez C, Meheus A. An update after 16 years of hepatitis B vaccination in South Africa. Vaccine 2012;30(S3):C45-C51. [http://dx.doi.org/10.1016/j.vaccine.2012.02.021] 9. Tsebe KV, Burnett RJ, Hlungwani NP, et al. The first five years of universal hepatitis B vaccination in South Africa: Evidence for elimination of HBsAg carriage in under 5-year-olds. Vaccine 2001;19(2829):3919-3926. [http://dx.doi.org/10.1016/S0264-410X(01)00120-7] 10. Doganci T, Uysal G, Kir T, et al. Horizontal transmission of hepatitis B virus in children with chronic hepatitis B. World J Gastroenterol 2005;11(3):418-420.

11. Kidd-Ljunggren K , Holmberg A, Bläckberg J, Lindqvist B. High levels of hepatitis B virus DNA in body fluids from chronic carriers. J Hosp Infect 2006;64(4):352-357. [http://dx.doi.org/10.1016/j. jhin.2006.06.029] 12. Hammitt LL, Hennessy TW, Fiore AE, et al. Hepatitis B immunity in children vaccinated with recombinant hepatitis B vaccine beginning at birth: A follow-up study at 15 years. Vaccine 2007;25(3940):6958-6964. [http://dx.doi.org/10.1016/j.vaccine.2007.06.059] 13. Chaves SS, Fischer G, Groeger J, et al. Persistence of long-term immunity to hepatitis B among adolescents immunized at birth. Vaccine 2012;30(9):1644-1649. [http://dx.doi.org/10.1016/j. vaccine.2011.12.106] 14. Jack AD, Hall AJ, Maine et al. What level of hepatitis B antibody is protective? J Infect Dis 1999;179(2):489-492. [http://dx.doi.org/10.1086/314578] 15. Hofmann F, Kralj N. Criteria for successful hepatitis B vaccination in adults: Results of a case study.

Infection 2009;37(3):266-269. [http://dx.doi.org/10.1007/s15010-008-7410-y] 16. Tong NK, Beran J, Kee SA, et al. Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. Kidney Int 2005;68(5):2298-2303. [http://dx.doi. org/10.1111/j.1523-1755.2005.00689.x] 17. Han K, Shao X, Zheng H, et al. Revaccination of non- and low-responders after a standard three dose hepatitis B vaccine schedule. Hum Vaccin Immunother 2012;8(12):1845-1849. [http://dx.doi. org/10.4161/hv.21818] 18. Yu J, Chou AJ, Lennox A, et al. Loss of antibody titers and effectiveness of revaccination in postchemotherapy pediatric sarcoma patients. Pediatr Blood Cancer 2007;49(5):656-660. [http://dx.doi. org/10.1002/pbc.21277] 19. Mahoney FJ. Update on diagnosis, management, and prevention of hepatitis B virus infection. Clin Microbiol Rev 1999;12(2):351-366.

20. Styczynski J, Wysocki M, Koltan S, Kurylak A. A nine-year experience of immunoprophylaxis against hepatitis B virus infection in children with cancer: Results from a single institution in Poland. J Hosp Infect 2001;48(4):298-303. [http://dx.doi.org/10.1053/jhin.2001.1017] 21. Somjee S, Pai S, Parikh P, et al. Passive active prophylaxis against hepatitis B in children with acute lymphoblastic leukaemia. Leuk Res 2002;26(11):989-992. [http://dx.doi.org/10.1016/S01452126(02)00044-9] 22. Mayaphi SH, Rossouw TM, Masemola DP, et al. HIV/HBV co-infection: The dynamics of HBV in South African patients with AIDS. S Afr Med J 2012;102(3):157-162.

23. Van den Berg R, van Hoogstraten I, van Agtmael M. Non-responsiveness to hepatitis B vaccination in HIV seropositive patients: Possible causes and solutions. AIDS Rev 2009;11(3):157-164.

Accepted 2 April 2014.

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Rheumatic fever and rheumatic heart disease in Gauteng on the decline: Experience at Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa A M Cilliers, MB BCh, FCPaed Paediatric Cardiology Unit, Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa, and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg Corresponding author: A M Cilliers (antoinette.cilliers@wits.ac.za) Background. The incidence of rheumatic fever (RF) and its complications has waned over the past three to four decades throughout the Western world, but RF remains a problem in developing countries and in the indigenous populations of some well-resourced countries. A marked decline in children presenting with acute rheumatic fever (ARF) and chronic rheumatic heart disease (RHD) has been observed over the past two decades at Chris Hani Baragwanath Academic Hospital (CHBAH) in southern Gauteng Province, South Africa, which mainly serves the periurban population of Soweto.

Objectives. To analyse the observed decline in ARF and RHD, and consider the reasons for the decrease.

Methods. Review of children with ARF and RHD captured on a computerised database of all children seen in the Paediatric Cardiology Unit at CHBAH during 1993 - 2010.

Results. The records of 467 children with ARF and RHD were retrieved from the database. The majority provided addresses in Gauteng, Soweto and North West Province. The number of children documented to have ARF or RHD declined from 64 in 1993 to 3 in 2010. Onethird of the patients underwent surgery, the majority mitral valve repair. Most of the patients requiring surgery had addresses in parts of Gauteng other than Soweto and other provinces, with relatively few originating from Soweto.

Conclusion. The decline in the number of children with ARF and RHD presenting to CHBAH may be attributed to an improvement in socioeconomic conditions and better access to medical care for the referral population over the past two decades.

S Afr Med J 2014;104(9):632-634. DOI:10.7196/SAMJ.8318

Acute rheumatic fever (ARF) is a delayed complication of pharyngeal infection with a rheumatogenic strain of the group A streptococcus organism, usually occurring in childhood. Devastating complications arising from chronic rheumatic heart disease (RHD) and its associated heart valve damage include severe valve regurgitation, heart failure, strokes and infective endocarditis, usually affecting both younger schoolgoing and economically active, childbearing members of society. The cardiac sequelae pose major medical and surgical challenges in economically deprived regions of the world, where ARF and RHD are most prevalent.

The reduced incidence of ARF in First-World countries is thought to be due to good hygenic conditions and readily available access to healthcare. The introduction of antibiotics has helped to reduce the disease burden, but to a lesser extent than changes in the environment.[1] Although ARF and RHD have become rare in developed countries, pockets of the disease persist among the indigenous populations of prosperous countries such as New Zealand and Australia. The high incidence is thought to be related to poverty, overcrowding, an increased frequency of sore throats and skin infections, and poor access to medical care for the indigenous people in these countries.[2] The last published epidemiological study of RHD in schoolchildren in South Africa was undertaken 30 years ago in 1972 by McClaren et al.,[3] who reported a very high prevalence of 6.9/1 000 in schoolchildren in Soweto, Johannesburg. A more recent echocardiographic screening programme in school-aged children using clinical criteria of a pathological murmur and definite RHD diagnosed using echocardiography showed the highest incidence

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in New Zealand of 7.6/1 000, with lower prevalences of 4.9/1 000 in Uganda, 2.3/1 000 in Mozambique and 0.9/1 000 in India.[4] The incidence of ARF is not well studied on the African contin­ ent.[5] The estimated incidence in some developing countries is thought to exceed 50/100 000 children. The explosion of ARF in the Pacific Island areas and Australia has revealed extraordinarily high rates of 80 - 100/100 000 in the indigenous population of New Zealand and 245 - 351/100 000 in Aborigine children in central and northern Australia.[6] A study undertaken in 2006 and 2007 by the Adult Cardiology Unit at Chris Hani Baragwanath Academic Hospital (CHBAH), Soweto, which deals with patients older than 14 years, showed a high incidence of new patients (23.5/100 000) presenting with RHD for the first time.[7] In contrast, there has been a noticeable decline of ARF and RHD among children under the age of 14 years at the same hospital over the past two decades. Although the hospital mainly serves the population of Soweto and patients referred from several secondary hospitals in southern and eastern Gauteng and North West Province, the perception is that most patients with severe disease requiring open-heart surgery do not originate from these areas. The official referral catchment area for the Paediatric Cardiology Unit at CHBAH has remained largely unchanged over the past 20 years.

Objective

To review the observed decline in numbers of children seen at the Paediatric Cardiology Unit at CHBAH with a diagnosis of ARF and RHD and those undergoing corrective valve surgery over the past two decades.

September 2014, Vol. 104, No. 9

RESEARCH

Method

100 90 80 70 60 50 40 30 20 10 0

Patients, n

Foreign

Western Cape

Eastern Cape

Free State

KwaZulu-Natal

Mpumalanga

Limpopo

Norht West

Soweto

Origin

Fig. 1. Origin of patients with RHD and ARF. (RHD = rheumatic heart disease; ARF = acute rheumatic fever.)

35 30 25 20 15 10 5 0

ARF RHD

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Patients, n

45 40

Year

Fig. 2. RHD and ARF trends, 1993 - 2010. (RHD = rheumatic heart disease; ARF = acute rheumatic fever.)

45 40 35 Patients, n

A total of 467 children were referred to the Paediatric Cardiology Unit with ARF or RHD during the years 1993 - 2010. The majority of patients provided addresses in parts of Gauteng other than Soweto, followed by Soweto and North West (Fig. 1).

A marked decline in the numbers of children presenting with ARF or RHD occurred during the study period (Fig. 2). Patients with ARF numbered 207/467 (44.3%). Twenty-two patients with ARF were seen in 1993 and only three in 2010. One hundred and thirteen patients were female and 94 male (Fig. 3), with no statistical difference between males and females (p=0.158). The remaining children (260/467, 55.7%) were referred with RHD and damaged heart valves. Forty-two were seen in 1993 and none in 2010. Of these patients, 138 were female and 122 male (Fig. 3), with no significant difference between the genders (p=0.2). The male/female ratio was 1.2:1 for both the ARF and the RHD groups. The patients with ARF ranged in age from 4 to 16 years, the youngest being a 4-year-old girl admitted in the mid-1990s with moderate mitral regurgitation, who had an address in eastern Gauteng. The children with RHD ranged in age from 3.8 years (a child from North West) to 14.9 years.

A third of the patients (137/467) required open-heart surgery to correct leaking valves, the majority undergoing mitral valve repair (Fig. 4). Eight patients (age range 7 - 14 years) underwent mitral valve balloon angioplasty for treatment of severe mitral stenosis. The average age at surgery was 9.3 years, the youngest patient being a boy who underwent mitral valve repair for severe mitral regurgitation at 4½ years and was referred from a secondary care hospital in southern Gauteng. Although Soweto is the main drainage area for CHBAH, the majority of the patients who needed surgery originated from outside Soweto and were referred from secondary hospitals in southern and eastern Gauteng and North West, from other provinces such as Limpopo, KwaZulu-Natal and the Eastern Cape, and from surrounding southern African countries such as Zimbabwe and Mozambique (Fig. 5). Despite an increase in referral of patients with HIV infection, especially in the early 2000s (Fig. 6), only three patients, two with ARF and one with RHD, were found to be HIVpositive at the time of presentation.

ARF

Gauteng other

Results

RHD

30 25

Female

20

Male

15 10 5 0

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Analysis of every child referred to the Paediatric Cardiology Unit from within CHBAH as well as those referred from outside the hospital over the 17-year period 1993 - 2010 was captured on a computerised database maintained by the author. Demographic data such as age, gender, origin, initial presentation with either ARF or RHD, and surgical intervention were recorded.

Year

Discussion

An analysis of the prevalence of RHD and the incidence of ARF in southern Gauteng is not possible from this retrospective review, because not all children with rheumatic fever (RF)-related illnesses in these areas are referred to CHBAH. Although CHBAH mainly serves the community of Soweto, it also functions as a tertiary care referral hospital for surrounding secondary hospitals in southern and eastern Gauteng and adjacent provinces such as North West. Another factor confounding prevalence and incidence calculations is that patient origins cannot be confirmed, resulting in a documented referral population that may be inaccurate and invalid.

A previous study undertaken between 1993 and 1995 that examined the geographical origins of paediatric patients with RF/RHD referred to three Gauteng academic hospitals (Helen Joseph, Chris Hani Baragwanath and Johannesburg General) showed that 70.2% of patients with RF/RHD with documented addresses originated from outside

633

Fig. 3. Males and females presenting with ARF and RHD, 1993 - 2010.

(RHD = rheumatic heart disease; ARF = acute rheumatic fever.)

Soweto. The referral catchment areas of the three hospitals were not reported on separately, but grouped together. In addition, the patient age range for the study cohort was not reported. A large proportion of the workload of the three hospitals was derived from patients from outside the borders of Gauteng: 32.7% were not from Gauteng, and 51% of these had severe RHD, defined as requiring surgery or balloon valvuloplasty. A third of all the patients (32.9%) needed surgery or balloon valvuloplasty. The non-Gauteng severe RF/RHD patients were predominantly referred from Northern Province, Mpumalanga, North West and KwaZulu-Natal.[8] The majority of children who were referred for open-heart surgery from CHBAH in this study also did not originate from Soweto; most were referred from secondary hospitals in

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1. DiSciascio G, Taranta A. Rheumatic fever in children. Am Heart J 1980;99(5);635-658. [http://dx.doi. org/10.1016/0002-8703(80)90739-5] 2. White H, Walsh W, Brown A, et al. Rheumatic heart disease in indigenous populations. Heart Lung Circ 2010;19(5-6):273-281. [http://dx.doi.org/10.1016/j.hlc.2010.02.019] 3. McLaren MJ, Hawkins DM, Koornhof HJ, et al. Epidemiology of rheumatic heart disease in black schoolchildren of Soweto, Johannesburg. BMJ 1975;3(5981):474-478.

4. Roberts K, Colquhoun S, Steer A, Remenyi B, Carapetis J. Screening for rheumatic heart disease: Current approaches and controversies. Nat Rev Cardiol 2013;10(1):49-58. [http://dx.doi.org/10.1038/ ncardio.2012.157] 5. Tibazarwa KB, Volmink JA, Mayosi BM. Incidence of acute rheumatic fever in the world: A systematic review of population-based studies. Heart 2008;94(12):1534-1540. [http://dx.doi:10.1136/ hrt.2007.141309] 6. Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal diseases. Lancet Infect Dis 2005;5(11):685-694. [http://dx.doi.org/10.1016/S1473-3099(05)70267-X] 7. Sliwa K, Carrington M, Mayosi BM, Zigriadis E, Mvungi R, Stewart S. Incidence and characteristics of newly diagnosed rheumatic heart disease in urban African adults: Insights from the Heart of Soweto study. Eur Heart J 2010;31(6):719-727. [http://dx.doi:10.1093/eurheart/eurheart/ehp530] 8. Clur S-A. Frequency and severity of rheumatic heart disease in the catchment area of Gauteng hospitals, 1993-1995. S Afr Med J 2006;96(3):233-237.

9. Statistical Release Census 2011 Product. http://www.statssa.gov.za/census 2011/products.asp (accessed 3 January 2014).

10. Leatte A, Shung-King M, Monson J. Healing inequalities: The free health care policy. South African Child Gauge 2006. http://www.ci.org.za/depts/ci/pubs/pdf/general/gauge2006/gauge2006healing.pdf (accessed 10 March 2014).

11. Arguiedas A, Mohs E. Prevention of rheumatic fever in Costa Rica. J Pediatr 1992;121(4):569-572. [http://dx.doi.org/10.1016/S0022-3476(05)81146-1]

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Balloon valvotomy

Surgical valvotomy

Av repair

40 35

Surgery total

30

Other Gauteng

25

Soweto

20

Other provinces

15

Foreign

10 0

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

5

Origin of surgical patients

Fig. 5. Origin of patients undergoing surgery for RHD, 1993 - 2010. (RHD = rheumatic heart disease.)

140 120 100 ARF

80

RHD

60

HIV pos.

40 20 0

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

References

AV replacement

45

Patients, n

Research approval. Permission to undertake this research was obtained from the Human Research Ethics Committee, University of the Witwatersrand, and the Medical Advisory Committee of CHBAH.

DV replacement

Fig. 4. Types of surgical procedure done, 1993 - 2010. (MV = mitral valve; DV = double valve; AV = aortic valve.)

Conclusion

The number of children presenting to CHBAH with ARF and chronic RHD has declined dramatically over the past two decades.

An improvement in socioeconomic conditions with an increase in household income, better living conditions and less overcrowding, as well as improved availability of medical care, are likely to be contributory factors.

MV replacement

MV repair

80 70 60 50 40 30 20 10 0

Surgical procedure

Patients, n

Gauteng and North West, and their origins could not be proven. Severe cases needing heart surgery (29% of all patients) have declined over the 17 years of the study, which may reflect a drop in poverty levels and an increase in the availability of primary healthcare associated with RF prevention programmes provided to the referral population of CHBAH over the past two decades.

The Census 2011 Statistical Release Document[9] demonstrates an improved trend in the socioeconomic status of SA’s population over the past 15 years. There has been an increase in the average annual household income and in access to amenities such as electricity, as well as a decrease in the average household size.

This improvement in lifestyle, with less overcrowding, may be an important factor decreasing exposure to the rheumatogenic strains of the streptococcus organism.

The decline in ARF and RHD in children presenting to CHBAH may also be attributed to improved access to healthcare for the general population over the past two decades, and more specifically the introduction of free healthcare to children under the age of 6 years in 1994.[10] Increased access to and availability of penicillin in the primary healthcare setting was found to be effective in reducing the incidence of ARF in Costa Rica[11] and Cuba.[12] Various sociopolitical dynamics could explain the peaks in the numbers of patients with ARF and RHD seen in the early 1990s and early 2000s (Fig. 2). The peak in the 1990s mirrors the civil unrest in the townships, particularly on the Witwatersrand,[13] which marginalised residents and cut off access to medical care, while the peak in the early 2000s may reflect the massive increase in cross-border migration from Zimbabwe, mainly of women, children and the elderly seeking humanitarian assistance.[14] Many of these displaced individuals settled in informal settlements in Gauteng, not disclosing their countries of origin, and making use of medical facilities.

Patients, n

RESEARCH

Year

Fig. 6. ARF and RHD v. HIV-infected patients, 1993 - 2010. (RHD = rheumatic heart disease; ARF = acute rheumatic fever; HIV pos. = HIV-positive.)

12. Nordet P, Lopez R, Duenas A, Sarmiento L. Prevention and control of rheumatic fever and rheumatic heart disease: The Cuban experience (1986-1996-2002). Cardiovasc J Afr 2008;19(3):135-140.

13. Kynoch G. Reassessing transition violence: Voices from South Africa’s township wars, 1990-4. Afr Aff (Lond) 2013;112(447):283-303. [http://dx.doi.org/ 10.1093/afraf/adt014] 14. Ngwato Polzer T. South African Government and Civil Society Responses to Zimbabwean Migration (SAMP Policy Brief No. 22). 2008. http://www.migration.org.za/person/tara-polzer-ngwato (accessed 3 January 2014).

Accepted 13 May 2014.

September 2014, Vol. 104, No. 9

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GUEST EDITORIAL

Women’s health and human rights ‘The health of mothers and their children is the key to achieving development and equity’ – Deputy President Cyril Ramaphosa at the World Health Organization (WHO)’s Partnership for Maternal, Newborn and Child Health Forum held in Johannesburg during July 2014.[1] Indeed, the health and economic status of women and children usually provide an accurate overview of national viability.

As September 2015 rapidly approaches, it is obvious that inadequate progress has been made towards achieving the three inter-related Millennium Development Goals (MDGs) concerning women, as set out by members of the United Nations (UN) in 2002.[2] These MDGs are: MDG 3 (promote gender equality and empower women); MDG 5 (improve maternal health, reducing maternal mortality, and universal access to reproductive health), and MDG 6 (combating HIV/AIDS and other diseases). Lack of progress in any of these goals undermines progress in the others.[3] South Africa (SA) is not on track to meet these goals.[4] HIV/AIDS has been the major health issue affecting women of reproductive age and maternal health in SA since 2000, when HIV infection meant certain death, and health policy was based on the AIDS denialist stance of the government of that time.[5] There was no national programme providing access to antiretroviral drugs, either for treatment of HIVpositive adults and children, or for prevention of mother-to-child transmission (PMTCT). Instead of progressing towards the MDG targets, SA has been retrogressing from 2000 to date. The mortality rate among women of reproductive age has increased, and maternal deaths continue to rise.[6] MDG 5 sets a target to reduce maternal mortality by 75% from the 1990 levels. In SA, evidence suggests that maternal deaths quadrupled between 1998 and 2007.[7] Failure to address MDG 6 in terms of a public sector antiretroviral programme, means that achieving MDG 5 in the proposed timeframe is not possible.

Failure to effectively fight against HIV/AIDS has also undermined MDG 4 to reduce the ‘under-5 mortality rate’ by two-thirds. Subsequently, the absence of a national PMTCT programme resulted in thousands of preventable child deaths.[8] Deaths of both parents from HIV/AIDS have orphaned their numerous surviving, but orphaned, children.

SA is now emerging from these desperate times. However, as health workers in the state sector will readily acknowledge, there remains much more to be achieved. Although HIV infection is still the most common cause of maternal mortality, there have been many positive changes.

Eligibility for highly active antiretroviral therapy (HAART) has expanded since the national roll-out in 2004. SA now has the largest antiretroviral therapy (ART) programme in the world.[9] Since 2013, all pregnant and breastfeeding women have become eligible to initiate HAART, irrespective of their CD4+ count.[10] It was announced in July 2014 that all pregnant women may continue lifelong HAART.[11] The vertical transmission rate of HIV is 2.7% at 6 weeks’ gestation, which underscores the effectiveness of the PMTCT programme.[12] What is the way forward after the MDGs? Global health priorities must still include women and children beyond 2015. Attention is now focused on health issues and women’s empowerment from a human rights’ perspective.[13] The 2009 UN Human Rights Council Resolution on Maternal Mortality recognised that preventable maternal mortality is not just a public health issue, but also a human rights issue.[14] High rates of maternal morbidity and mortality are therefore seen not only as unacceptable, but also as a violation of human rights. Priorities for health should involve addressing universal coverage of healthcare; inequity in access to care; educating and empowering women; gender equality; and poverty reduction.

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Reproductive rights and responsibilities are central to enabling women to manage and control their fertility, continue their education, and fully participate in economic, social and political life. The right to control reproductive health means that unmet needs for contraception must be targeted.[15] Within a human rights framework, this means that women need to have the ability and knowledge to make informed choices about contraceptive methods and have accessible services. Reproductive rights are also central to reducing maternal deaths; unintended pregnancies have a higher rate of maternal mortality and morbidity, as well as late presentation to antenatal care.

Prioritising women’s rights means that health workers need to look beyond the medical issues in their interactions with patients. The human rights context of healthcare also needs to be considered. The International Federation of Gynecology and Obstetrics (FIGO) has developed a framework for integrating human rights and women’s health.[16] This includes looking at how the healthcare system supports or infringes upon human rights, in terms of women’s health, and how healthcare encounters could be improved to respect human rights, and ensure quality healthcare. In terms of improving women’s health in SA, this provides a roadmap for the way forward.

R Burton Guest editor rosie@polka.co.za

L Acquah Guest editor acquah.letitia@mayo.edu 1. South African Press Association (SAPA). Maternal child health ‘key to equity’. Cape Times, 1 July 2014.

2. United Nations. Millennium Development Goals. http://www.un.org/millenniumgoals (accessed 29 July 2014).

3. Gerntholtz L, Gibbs A, Willan S. The African Women’s Protocol: Bringing attention to reproductive rights and the MDGs. PLoS Med 2011;8(4):e1000429. [http://dx.doi.org/10.1371/journal.pmed.1000429] 4. Government of South Africa. Millennium Development Goals: Country Report 2010. http://www.statssa. gov.za/news_archive/Docs/MDGR_2010.pdf (accessed 21 July 2014).

5. Cullinan K, Thom A, eds. The Virus, Vitamins and Vegetables. Johannesburg: Jacana Media, 2009.

6. National Committee on Confidential Enquiries into Maternal Deaths. Saving Mothers 2008 - 2010: Fifth Report on the Confidential Enquiries into Maternal Deaths in South Africa. Pretoria: National Department of Health, 2012. http://www.doh.gov.za/docs/reports/ (accessed 3 July 2013).

7. Garenne M, McCaa R, Nacro K. Maternal mortality in South Africa: An update from the 2007 community survey. J Popul Res (Canberra) 2011;8(1):89-101.

8. Chopra M, Daviaud E, Pattinson R, Fonn S, Lawn J. Saving the lives of South Africa’s mothers, babies and children: Can the health system deliver? Lancet 2009:374:835-846. [http://dx.doi.org/10.1016/S01406736(09)61123-5] 9. Mayosi BM, Lawn JE, van Niekerk A, et al. Health in South Africa: Changes and challenges since 2009.

Lancet 2012;380:2029-2043. [http://dx.doi.org/10.1016/50140-6736 (12)61814-5] 10. National Department of Health. The South African antiretroviral treatment guidelines 2013. PMTCT Guidelines. http://www.sahivsoc.org/upload/documents/2013%20ART%20Guidelines-Short%20Combined%20 FINAL%20draft%20guidelines%2014%20March%202013.pdf (accessed 23 July 2014).

11. Cullinan K. Lifelong ARVs for pregnant women says Health Minister. Health e-news, 24 July 2014. http:// www.health-e.org.za/2014/07/24/lifelong-arvs-pregnant-women-says-health (accessed 29 July 2014).

12. National Department of Health. Effectiveness of the National Prevention of Mother-to-Child Transmission (PMTCT) Programme in South Africa. 2011 National SAPMTCT Survey Results. http://www.mrc.ac.za/ healthsystems/SAPMTCTEExecSummary2012.pdf (accessed 23 July 2014).

13. World Health Organization. Targets for ending preventable maternal mortality. Consensus statement. http://who.int/reproductivehealth/publications/maternal_perinatal_health/consensus-statement.pdf?ua=1 (accessed 23 July 2014).

14. United Nations Human Rights Council. Eleventh session. Resolution 11/8. Preventable maternal mortality and morbidity and human rights. http://www.who.int/pmnch/events/2010/A_HRC_RES_11_8.pdf (accessed 23 July 2014).

15. World Health Organization. Ensuring human rights in the provision of contraceptive information and services.

Guidelines and recommendations. 2014. http://apps.who.int/iris/bitstream/10665/102539/1/9789241506748_ eng.pdf?ua=1 (accessed 23 July 2014).

16. Global Library of Women’s Medicine. http://www.glowm.com/ womens_health _rights (accessed 29 July 2014).

S Afr Med J 2014;104(9):635. DOI:10.7196/SAMJ.8725

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REVIEW

Obstetric medicine: Interlinking obstetrics and internal medicine L Acquah,1 MD, MSc, FACP; R Burton,2 BSc (UK), MB BS (London), PhD (London), MRCOG (UK), FCP (SA), Cert ID Phys (SA) 1 2

ayo Clinic Hospitals, Division of Hospital Internal Medicine, Rochester, Minn, USA M Department of Medicine, Kayelitsha Hospital, Cape Town, and Obstetric Infectious Diseases Clinic, Groote Schuur Hospital, Cape Town, South Africa

Corresponding author: R Burton (rosie@polka.co.za)

Medical problems account for almost 50% of all maternal deaths in South Africa. The most recent report of the National Committee on Confidential Enquiries into Maternal Deaths (NCCEMD) (2008 - 2010) stated that 40.5% of deaths were due to non-pregnancy-related infections, which are mostly HIV-related, and 8.8% were due to medical or surgical disorders.

Obstetric physicians have a specific role in managing pregnant and postpartum women with medical problems and, in partnership with obstetricians, can contribute to reducing maternal morbidity and mortality. There are physiological changes in almost all systems in pregnancy. For example, changes in the cardiovascular, respiratory and haematological systems are particularly important when assessing the cause and management of medical problems in pregnant women. Such problems may be unique to pregnancy, exacerbated by pregnancy, or unrelated to pregnancy. They may be present prior to pregnancy, or present for the first time in pregnancy. Some medical problems are worsened by pregnancy. Pregnant women may improve or remain stable, or their disease may predictably or unpredictably deteriorate.

This article discusses the role of obstetric physicians in managing medical problems in pregnant women. A case is described of a pregnant woman with common medical problems, resulting in a serious complication when treatment is interrupted.

S Afr Med J 2014;104(9):636-639. DOI:10.7196/SAMJ.8724

Medical problems account for almost 50% of all maternal deaths in South Africa (SA). The most recent report of the National Committee on Confidential Enquiries into Maternal Deaths (NCCEMD) (2008 - 2010) stated that 40.5% of deaths were due to non-pregnancy-related infections, which are mostly HIV-related, and 8.8% were due to medical or surgical disorders (Table 1).[1] The institutional maternal mortality ratio for SA during this time was 176/100 000 live births, the highest since reporting began in 1998. Maternal deaths have increased with each NCCEMD report, largely because of increasing deaths from HIV/ AIDS. Developed countries such as the USA have a significantly lower maternal mortality ratio. However, this has also increased substantially in recent years, from 6.6/100 000 live births in 1987 to 13.3/100 000 live births in 2006.[2] Globally, medical problems in pregnancy are presenting an increasing challenge. In SA, HIV remains the major cause of maternal mortality, and tuberculosis (TB) and other respiratory infections

636

are the most common causes of death. However, non-HIV-related medical problems are increasingly significant. In many developing countries, postpartum haemorrhage secondary to an atonic uterus is the most common cause of death.[3] Pulmonary embolism causes most maternal deaths in resource-rich countries.[4] Confidential Enquiries into Maternal Deaths allow avoidable factors to be analysed and corrective measures to be implemented.

Common avoidable factors include lack of problem recognition, substandard care, disparity in healthcare resources, inequity in access to care and lack of expertise among healthcare workers.[5] Many doctors working in maternity units have little training or experience in internal medicine. Obstetrics and Gynaecology is primarily a surgical specialty, with neither undergraduate nor postgraduate training including medical problems in pregnancy. Equally, internal medicine programmes do not address pregnancy; therefore doctors working in this field – from interns to consultants – have little exposure to pregnant women. Obstetric physicians are internal medicine specialists who have training and experience in managing

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Table 1. Causes of maternal mortality in South Africa (adapted from Saving Mothers 2008 - 2010[1]) Causes

%

Direct maternal deaths

46.3*

Obstetric haemorrhage

14.0

Hypertension

14.0

Pregnancy-related sepsis

5.3

Embolism

1.9

Indirect maternal deaths

49.3*

Non-pregnancy-related infections

40.5

HIV-positive

87.3

HIV-negative

5.2

Unknown, or declined testing

Table 2. Medical problems in pregnancy[7] Medical problems unique to pregnancy Eclampsia, pre-eclampsia ELLP syndrome (haemolysis, elevated liver enzymes, low H platelets) Acute fatty liver of pregnancy Medical problems exacerbated by pregnancy ardiac disease: stenotic valvular lesions, cyanotic heart disease, C primary pulmonary hypertension Common medical problems unrelated to pregnancy Pneumonia HIV-related opportunistic infections Medical problems which are more severe in pregnancy

7.5

Infuenza

Major subcategories Tuberculosis

26.9

Malaria

Other pneumonia

26.7

Varicella zoster pneumonitis

Pneumocystis jirovecii pneumonia

13.3

Cryptococcal meningitis

4.2

Other meningitis

8.7

Medical and surgical disorders

8.8

Major subcategories Cardiac disease

36.5

Respiratory disease

18.4

Central nervous system

8.4

Gastrointestinal tract

4.7

Table 1 shows that medical problems cause almost half of all maternal deaths in South Africa. Non-pregnancy-related infections, which are mostly HIV-related, greatly outnumber the four most common direct causes of death. Note: Only selected causes are shown; therefore percentages do not add up to 100%. *Of all maternal deaths.

pregnant women with medical problems. In partnership with obstetricians, they have a significant role in optimising management and can contribute to reducing maternal morbidity and mortality from medical causes.[6,7]

What is obstetric medicine?

Obstetric medicine is a specialty of internal medicine that focuses on managing the medical problems of women with significant comorbidities that may exist prior to pregnancy, or arise during pregnancy or in the puerperium. There are physiological changes in almost all systems in pregnancy. For example, changes in the cardiovascular, respiratory and haematological systems are

637

particularly important when assessing the cause and management of medical problems in pregnant women.[7] Obstetric physicians work with obstetricians and other physicians to co-ordinate and comprehensively manage the medical problems of vulnerable pregnant and postpartum women. Obstetric medicine is an established sub-specialty of internal medicine in Australia.

Other countries, including the USA and Canada, where there are formal training programmes in this field, are working towards accreditation. Since there are few obstetric physicians in most countries, those available play an important role in training other physicians, obstetricians, non-specialist doctors and midwives.

Medical problems in pregnancy may be unique to pregnancy, exacerbated by pregnancy or unrelated to pregnancy. They may be present prior to pregnancy or present for the first time during pregnancy. Some medical problems are worsened by pregnancy (Table 2).[7] Pregnant women may improve or remain stable, or their disease may predictably or unpredictably deteriorate. The expected changes in maternal physiology, baseline disease characteristics and extent to which treatment is optimised are all important factors in determining how a specific disease will respond to pregnancy. Medical problems may also affect pregnancy outcomes, with increased risk of preterm delivery, growth restriction, stillbirth and neonatal loss.

The best time to ensure optimal management of chronic medical problems is before pregnancy. However, women are often given no advice on whether pregnancy may worsen their medical condition, or whether their medical problem is likely to cause complications during pregnancy. Medical advances have significantly enhanced the life

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expectancy and quality of life of many patients with chronic diseases, including HIV infection. Women whose medical problems would previously have resulted in premature death or severe disability now want to live ‘normal lives’, and desire children. As maternal age and the prevalence of obesity increase, it is likely that common comorbidities such as cardiovascular disease, chronic hypertension and diabetes mellitus may become increasingly prevalent in pregnant women, and contribute towards increasing maternal morbidity and mortality.

The case study below involves common medical problems.

However, their management in pregnancy can be challenging, and without optimal treatment may lead to serious complications.

Case study

A 28-year-old woman presented to her clinic at 20 weeks’ gestation with her first pregnancy. She had the following baseline medical problems: • diabetes mellitus type 1, poorly controlled diabetes, and a random finger prick glucose of 16 mmol/L • chronic kidney disease secondary to diabetes, pre-pregnancy glomerular filtration rate 40 mL/min, with 3 g proteinuria/24 h • chronic hypertension – also poorly controlled, and a blood pressure (BP) of 150/100 mmHg • HIV-negative on testing on day of presentation.

She has not received any pre-pregnancy counselling. She would have greatly benefited from good control of her diabetes and hypertension prior to pregnancy and a thorough discussion of the risks both she and her infant may encounter during her pregnancy.

Gradually, she has become heat intolerant with associated palpitations and irritability. Her examination revealed a highly anxious diaphoretic woman, with tachycardia at 140 beats/minute, BP 155/96 mmHg, asymmetrical proptosis, fine tremors and an enlarged, palpable thyroid. She was transferred to the obstetric ward of her local hospital and reviewed by the obstetric team and an obstetric physician.

She needed optimal control of her diabetes and hypertension, and close monitoring of both for the duration of her pregnancy. The patient was at increased risk of pre-eclampsia owing to her diabetes and hypertension, and of deteriorating renal function because of her diabetic nephropathy. Fetal risks of diabetes in pregnancy include congenital abnormalities, macrosomia, intrauterine death, respiratory distress syndrome and neonatal hypoglycaemia.

She developed symptoms and signs of thyrotoxicosis, confirmed with thyroid function tests that showed thyroid-stimulating hormone (TSH) 0.01 mU/L and T4 of 43 pmol/L. Many clinical features are common in normal pregnancy, including heat intolerance, tachycardia, palpitations and a palpable thyroid. However, symptoms and signs that support hyperthyroidism include tremor, persistent

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tachycardia, weight loss and lid lag. Exophthalmos persists after treatment and therefore does not confirm new hyperthyroidism in the absence of other features.

She was diagnosed with Graves’ hyperthyroidism, the most common cause of hyperthyroidism during pregnancy.[7-9] TSH receptor-stimulating antibodies (TRAbs) were positive. There are less common causes of thyrotoxicosis, including multinodular goitre and subacute thyroiditis. There are also uncommon causes that are specific to pregnancy, because the alpha sub-unit of the beta human chorionic gonadotropin (hCG) molecule can mimic TSH. These include hyperemesis gravidarum that has high beta hCG levels that peak at 10 - 12 weeks’ gestation, and which was therefore unlikely in this patient. Trophoblastic hyperthyroidism may also occur. An ultrasound scan did not reveal a complete hydatidiform mole or other findings consistent with gestational trophoblastic disease.

She was started on high-dose carbimazole and propranolol.

Carbimazole crosses the placenta, and can cause fetal hypothyroidism and goitre, and rarely a fetal abnormality called aplasia cutis, in which there are patches of absent skin on the scalp. Short-term use of propranolol is safe in pregnancy. She was discharged to follow up at an obstetric medicine clinic.

At 24 weeks’ gestation she developed severe hypertension, worsen­ ing proteinuria and deteriorating renal function. She was admitted to the antenatal ward, where the admitting doctor discovered that she was taking her carbimazole and propranolol erratically. She also missed her appointments due to worsening fatigue, and the clinic staff did not have a policy in place to follow up women who have defaulted. She had not been taking her treatment for hypertension, and had not been monitoring her blood sugar and increasing her doses of insulin. One week after admission to restart and maintain her on adequate doses of her medications, she improved and was discharged home. Unfortunately, she did not attend further clinic appointments.

At 28 weeks’ gestation she presented as an emergency case to her obstetric unit. She had a productive cough with haemoptysis and dyspnoea, severe nausea with vomiting, and agitation with psychotic features. She had pain in her left leg and thigh. Her vital signs were as follows: temperature 39 - 40°C, pulse 140 beats/minute at an irregular rate and rhythm, oxygen saturation on room air 85%, respiratory rate 30 breaths/minute, and BP 160/110 mmHg. She appeared jaundiced and could not sit still. She was highly impatient with caregivers and had pressured speech. She had fair air entry with diffuse wheezes throughout her lungs. Extremities revealed 3 - 4+ pitting oedema from feet to thighs. She had peri-orbital oedema, jaundice, and proptosis with lid lag. Her jugular veins were distended, she had a third heart sound and a flow murmur. Her right upper abdominal quadrant was tender on mild palpation. She had no nystagmus, but had hyperreflexia with 4 beats of clonus. Her skin was warm and wet without a rash. At this point creatinine was 220 μmol/L, with 7 g protein/24 h.

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What is the most likely diagnosis?

• Severe pre-eclampsia with lower respiratory tract infection or TB? • Venous thromboembolism: acute deep venous thrombosis of the left lower extremity and pulmonary embolism?

• Worsening diabetic nephropathy, or an additional cause of deteriorating kidney function?

• Thyroid crisis (thyroid storm)?

• Congestive heart failure secondary to a thyroid crisis?

She had developed a severe life-threatening condition, i.e. a thyroid storm (an exaggerated thyrotoxicosis), which was precipitated by her uncontrolled Graves’ hyperthyroidism.[10,11] She had acute cardiorespiratory distress (congestive cardiac failure with atrial fibrillation, pulmonary oedema, haemoptysis and peripheral oedema). She also had thermoregulatory changes (hyper-pyrexia), gastrointestinal involvement (jaundice, nausea, vomiting), and central nervous system dysfunction (severe agitation, psychosis).

There was no evidence of deep vein thrombosis. She needed urgent management by her multidisciplinary team, which includes an obstetrician, junior obstetric doctors, an obstetric physician, an endocrinologist and midwives. If she was at a level 1 hospital without physicians on site, telephonic consultation was indicated. She needed referral when stabilised (to a high-care or an intensive care unit).

Thyroid crisis and congestive cardiac failure in pregnancy are managed in the same manner as in non-pregnant patients. Her cardiac failure needed immediate medical management and possibly intubation. In terms of her thyroid crisis, she needed beta-blockade, e.g. propranolol 60 - 80 mg orally every 4 - 6 hours. Controlling her tachycardia would improve her cardiovascular function.

Beta-blockade could worsen her cardiac failure owing to negative ionotropic effects, and therefore had to be administered extremely cautiously. She was given carbimazole, with Lugol’s iodine (potassium iodine-iodide solution) started at least one hour later. Administration of iodine was delayed for one hour so that the iodine would not be utilised by the thyroid gland to synthesise new thyroid hormone.

She might have a polyglandular deficiency due to her diagnosis of Graves’ hyperthyroidism and diabetes mellitus, i.e. potential hypoadrenalism. Therefore, her severe life-threatening autoimmune condition might benefit from glucocorticoids, e.g. hydrocortisone 100 mg every 8 hours.[12]

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She responded well to treatment, and was discharged home a week later. She is now 29 weeks pregnant, and still faces significant maternal and fetal risks from her diabetes, nephropathy, hypertension and hyperthyroidism. She needs close follow-up for the remainder of her pregnancy, involving both obstetricians and physicians. A multidisciplinary obstetric medicine clinic would be ideal; at each consultation, her medical problems, obstetric problems and potential fetal complications can be reviewed. Timing and mode of delivery will need to be discussed and paediatricians will also need to be involved. Even if she delivers at term without further complications, her baby will need neonatal unit admission for hypoglycaemia monitoring. There is also a risk of fetal or neonatal thyrotoxicosis due to transplacental passage of TRAbs. References 1. National Committee on Confidential Enquiries into Maternal Deaths. Saving Mothers 2008 - 2010: Fifth Report on the Confidential Enquiries into Maternal Deaths in South Africa. Pretoria: National Department of Health, 2012. http://www.health.gov.za/docs/reports/2012/savingmothersexec.pdf (accessed 21 July 2014).

2. World Health Organization. Trends in Maternal Mortality: 1990 to 2008 Estimates Developed by WHO, UNICEF, UNFPA and the World Bank. Geneva: World Health Organization, 2010. http:// whqlibdoc.who.int/publications/2010/9789241500265_eng.pdf (accessed 19 July 2014).

3. World Health Organization. Mother-Baby Package (WHO/RHT/MSM/94.11, Rev1). Geneva: World Health Organization, 1998.

4. Bourjeily G, Paidas M, Khalil H, Rosene-Montella K, Rodger M. Pulmonary embolism in pregnancy.

Lancet 2010;375(9713):500-512. [http:dx.doi.org/10.1016/S0140-6736(09)60996-X] 5. Silal SP, Harris B, Birch S, McIntyre D. Exploring inequalities in access to and use of maternal health services in South Africa. BMC Health Serv Res 2012;12:120. [http://dx.doi.org/10.1186/1472-696312-120] 6. Nelson-Piercy C, Mackillop L, Williams DJ, Williamson C, de Swiet M, Redman C. Maternal mortality in the UK and the need for obstetric physicians. Br Med J 2011;343:d4993. [http://dx.doi.org/10.1136/ bmj.d4993] 7. Nelson-Piercy C. Handbook of Obstetric Medicine. 4th ed. London: Informa Health Care, 2010.

8. Neale D, Burrow G. Thyroid disease in pregnancy. Obstet Gynecol Clin North Am 2004;31(4):893-905. [http://dx.doi.org/10.1016/j.ogc.2004.09.001] 9. Stagnaro-Green A (Chair), Abalovich M, Alexander E, et al. and the American Thyroid Association Taskforce on Thyroid Disease During Pregnancy and Postpartum. Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease During Pregnancy and Postpartum. Thyroid 2011;21(10):1081-1225. [http://dx.doi.org/10.1089/thy.2011.0087] 10. Burch HB, Wartofsky L. Life-threatening thyrotoxicosis. Thyroid storm. Endocrinol Metab Clin North Am 1993;22:263.

11. Nayak B, Burman K. Thyrotoxicosis and thyroid storm. Endocrinol Metab Clin North Am 2006;35:663686. [http://dx.doi.org/10.1016/j.ecl.2006.09.008] 12. Tsatsoulis A, Johnson EO, Kalogera CH, Seferiadis K, Tsolas O. The effect of thyrotoxicosis on adrenocortical reserve. Eur J Endocrinol 2000;142(3):231. [http://dx.doi.org/10.1530/eje.0.1420231]

Resources in Obstetric Medicine • Reference 7 is a practical guide to investigation and management of medical problems in pregnancy.

• Journal: Obstetric Medicine: The Medicine of Pregnancy: obmed.rsmjournals.com • International Society of Obstetric Medicine: http://www.isomnet.org

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ARTICLE SUMMARY

Papshop: Not a ‘melon’choly Pap smear workshop!

C Gordon, MB ChB, Diploma in HIV Management, Diploma in Mental Health Department of Obstetrics and Gynaecology, Faculty of Health Sciences, Groote Schuur Hospital and University of Cape Town, South Africa Corresponding author: C Gordon (c.gordon@uct.ac.za)

As Head of Undergraduate Education in the Department of Obstetrics and Gynaecology at the University of Cape Town, South Africa, I have a particular interest in the competencies needed to perform primary care gynaecological procedures, one of which is the Pap smear. I was approached by a group of keen volunteer Student Health and Wellness Centres Organisation (SHAWCO) students to assist with Pap smear training to roll out a pilot screening programme at student-run after-hours clinics in Cape Town, and at rural health promotion clinics. This article describes a novel approach to teaching the Pap smear technique, using fruit and toilet rolls, which can easily be replicated in resource-constrained areas.

Cervical cancer is the leading cause of cancer mortality in subSaharan Africa (SSA), and the human papillomavirus (HPV) is responsible for the vast majority of cervical pre-cancer and cancer lesions. Even though the HPV vaccine is being rolled out in South African government clinics and there are more effective ways of screening (e.g. HPV DNA testing), Pap smears will remain a critical secondary cancer prevention intervention in SSA owing to a lack of infrastructure required for HPV DNA testing.

A particular problem in gynaecology is the often embarrassing nature of the gynaecological examination, both for students (especially males) and patients. The latter are often reluctant to be examined by students, who then struggle to practise on real patients and thus rate their pelvic examination or Pap smear-taking skills poorly. Healthcare providers are less likely to do Pap smears if they lack confidence, and valuable screening opportunities may then be lost. As teachers, we must improve confidence in these areas to alleviate what I call ‘the fear of fumbling’.

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I wanted the workshop to be fun, empowering, and as authentic as possible. It comprised a brief talk contextualising the burden of disease and rationale for taking Pap smears. Context is essential, as screening is more likely to occur if healthcare providers understand the rationale behind the procedure.

The necessary equipment was described, followed by a step-bystep demonstration. Skills training should begin with the teacher performing the procedure in silence, as it would actually be done, followed by a verbal explanation of each step.

I used toilet roll inners and blocks of sweet melon as a vagina/ cervix unit. Students practised the speculum insertion on the gynaecological models, but soon deserted these in favour of the toilet roll/melon units. They held the units at the approximate height and angle of a real vagina, and began inserting speculae into the toilet rolls and performing the Pap smears on the melon cervices.

Students all gave extremely positive feedback on the workshops, found the melon Pap smears great fun, and thought them more authentic than Pap smears on the models. They felt confident in speculum insertions and Pap smears. When polled after having done actual smears, they thought that the melon Pap smears had improved their ability to perform the procedure more than learning on a model, although most required supervision for the first one or two to assist with finding the cervix. Students branded the workshops as ‘Papshops’, and the name has stuck. Increasing numbers of students are now taught by peers already trained in prior Papshops, thereby expanding the teaching workforce. To date, during 2013 - 2014, Papshop students have performed almost 300 Pap smears for eligible women in under-resourced areas.

S Afr Med J 2014;104(9):640. DOI:10.7196/SAMJ.8728

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ARTICLE SUMMARY

Pregnancy and cardiac disease C Elliott,1 MB ChB, FCOG (SA), MMed; K Sliwa,2,3,4 MD, PhD, FESC, FACC; R Burton,1,3 BSc (UK), MB BS (London), PhD (London), MRCOG (UK), FCP (SA), Cert ID Phys (SA) Division of Obstetrics and Gynaecology, Faculty of Health Sciences, Groote Schuur Hospital and University of Cape Town, South Africa Hatter Institute for Cardiovascular Research in Africa, Department of Medicine, Faculty of Health Sciences, University of Cape Town, South Africa 3 Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, South Africa 4 Soweto Cardiovascular Research Unit, University of the Witwatersrand, Johannesburg, South Africa 1 2

Corresponding author: C Elliott (elliottcath@hotmail.com)

Medical disorders in pregnancy are one of the top five causes of maternal mortality South Africa (SA), cardiac disease (CD) being the main contributor to this group. In developed countries, surgically corrected congenital heart disease (CHD) comprises the greater proportion of maternal deaths from CD. In SA and other developing countries, acquired heart disease such as rheumatic heart disease and cardiomyopathies are the major causes, although CHD remains significantly represented.

The care of pregnant women with CD requires attention to diagnostics, treatment and continuous follow-up. Vital to the success and safety of pregnancy is a systematic, accurate and realistic risk assessment with reference to potential maternal and fetal complications and anticipated adverse outcomes during pregnancy and postpartum.

The primary physiological adapation of the circulatory system in normal pregnancy is peripheral vasodilatation, which results in a decrease in peripheral vascular resistance. To accommodate this, the cardiac output (CO) increases by approximately 40%, which is mainly achieved by an increase in stroke volume (SV) and secondarily due to an increase in pulse rate (PR). These variables are expressed by the equation CO = SV Ă&#x2014; PR. The systemic blood volume increases by approximately 50% antenatally and again by 50% at delivery, when a massive autotransfusion of blood from the involuting uterus into the general circulation occurs. In the presence of CD, these circulatory changes may have an adverse effect on maternal morbidity and mortality and fetal outcome.

Diagnosing cardiac disease

Both congenital and acquired heart disease may present for the first time during pregnancy. Symptoms of CD include increasing shortness of breath, decreased effort tolerance, orthopnoea, paroxysmal nocturnal dyspnoea, syncope, palpitations and chest pain. However, some of these symptoms are common in pregnant women with a normal heart. Examination of healthy pregnant women may reveal

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peripheral oedema, an increased heart rate, and a (sometimes loud) physiological murmur. Symptoms that allow distinction between physiological and pathological changes include inability to perform daily tasks due to worsening dyspnoea, New York Heart Association (NYHA) class III or IV, and trouble sleeping because of dyspnoea.

Physiological breathlessness of pregnancy is typically worse at rest, and improves with exertion. Resting tachycardia, pathological murmur or signs of cardiac failure all require urgent investigation.

All women need an electrocardiogram (ECG); normal ECG changes in pregnancy are left axis deviation, ST segment changes, inverted T waves and atrial and ventricular ectopic beats. Echocardiography is almost always required to define structural abnormalities and assess cardiac function.

Assessment of risk

The effect of pregnancy on CD and of the condition on pregnancy needs to be considered. The ability to tolerate a pregnancy depends on the haemodynamic significance of any lesion, initial functional class (NYHA classes III and IV give a worse prognosis), presence of cyanosis and presence of pulmonary hypertension.

There are various risk scoring systems to determine risk of maternal morbidity and mortality in pregnancy, of which the World Health Organization (WHO) system is considered the most accurate. The best time to assess risk is before pregnancy to allow an opportunity for counselling and for surgical interventions that may be necessary.

Pregnant women with CD need to be referred to a combined cardiology and obstetric clinic. The risk score will determine how often a woman needs to be reviewed by the clinic. There is a direct relationship between the complexity and severity of maternal CD and fetal and neonatal outcomes. In general, the greater the maternal risk, the greater the risk to the fetus.

S Afr Med J 2014;104(9):641. DOI:10.7196/SAMJ.8762

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ARTICLE SUMMARY

Pregnancy and the kidneys N Wearne, BA Med Sci (University of Sydney), MB ChB Honours (University of Sydney), FCP (SA), Cert Nephrology (SA) Division of Nephrology and Hypertension, Department of Medicine, Faculty of Health Sciences, Groote Schuur Hospital and University of Cape Town, South Africa Corresponding author: N Wearne (nicola.wearne@uct.ac.za)

Hypertension and renal disease in pregnancy present a unique set of clinical challenges and can cause a feeling of trepidation, even in the most experienced physician. However, before disease can be established it is important to understand the substantial physiological changes that may occur during a normal pregnancy. Because of the nature of these normal physiological changes, quantifying proteinuria and measuring glomerular filtration rate are best determined by obtaining 24-hour urine samples.

Renal disease may take several forms. Acute kidney injury in pregnancy can be caused by any of the disorders leading to renal failure in the general population. There are also pregnancy-related complications characteristic of each trimester, which may result in renal failure, e.g. pre-eclampsia and the HELLP (haemolysis, elevated liver enzymes, and low platelets) syndrome. Pregnancy may be the first medical review for women with a previously undiagnosed renal problem. Patients may have pre-existing renal disease such as diabetic nephropathy. In addition, women are living with renal transplants and renal diseases, such as lupus nephritis, which require immunosuppression.

Hypertensive disorders of pregnancy, including pre-eclampsia, are the commonest medical complications in pregnancy, and remain the most prevalent direct causes of maternal mortality in South Africa (SA). Pre-eclampsia appears to be initiated by abnormal implantation of the placenta, leading to hypoperfusion and ischaemia, which in turn lead to the release of several placental anti-angiogenic factors.

Clinically, vascular endothelial dysfunction and microangiopathy are present in the mother, but not in the fetus. Both pre-existing

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hypertension and renal disease increase the risk of pre-eclampsia, which predisposes to preterm delivery, and maternal morbidity and mortality. Pre-eclampsia continues to claim the lives of thousands of mothers and neonates yearly.

Pregnancy outcomes are determined by baseline creatinine levels, hypertension and degree of proteinuria. The risk of progression of chronic kidney disease increases as the renal function deteriorates.

Once the creatinine is >176 Âľmol/L, two-thirds of patients have decreasing renal function and one-third require dialysis. The stress of greater renal blood flow in the normal pregnancy and the inability of the glomerulus to regulate intraglomerular pressure, which normally remains unaltered during pregnancy, may exacerbate renal damage in the setting of pre-existing disease. In SA, the management of chronic kidney disease is complicated by the restricted access to dialysis in the state sector. To ensure the best outcome for mother and child, pre-pregnancy counselling and review of pre-pregnancy medication are essential. This is especially true in the setting of renal disease where medications such as angiotensin converting enzyme inhibitors, angiotensin receptor blockers and mycophenolate mofetil are particularly teratogenic and need to be discontinued prior to conception.

Renal patients and those with hypertension are at high risk of complications. Regular antenatal assessments with a multidisciplinary team are required to monitor blood pressure, proteinuria, diabetic control and fetal wellbeing.

S Afr Med J 2014;104(9):642. DOI:10.7196/SAMJ.8765

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ARTICLE SUMMARY

Rheumatic diseases and pregnancy A Gcelu, MB ChB, FCP (SA), Cert Rheum (SA) Division of Rheumatology, Department of Medicine, Faculty of Health Sciences, Groote Schuur Hospital and University of Cape Town, South Africa Corresponding author: A Gcelu (ayanda.gcelu@uct.ac.za)

Rheumatic diseases predominantly affect young women of childbearing age; therefore these conditions are of major interest in pregnancy.

Conception induces a variety of hormonal and immunoregulatory factors in the maternal body, which are necessary during pregnancy and for fetal survival. In addition, pregnancy causes elevation of prothrombotic factors.

Pregnancy can be challenging in patients with rheumatic diseases owing to changes in immune function, which may have an effect on underlying disease activity. Conversely, rheumatic diseases with their autoimmune dysfunction and treatment may have a significant impact on pregnancy outcomes. Treatment options can be limited during pregnancy. Major challenges are to distinguish disease activity from normal physiological changes that may occur during pregnancy, and pregnancy-related complications.

Effects of pregnancy on rheumatic diseases

Pregnancy and the rheumatic diseases can interact, ranging from spontaneous improvement to aggravation of disease symptoms.

Rheumatoid arthritis (RA) and other inflammatory athritides such as psoriatic arthritis improve in up to 65% of patients during pregnancy, while ankylosing spondylitis remains active in about 70% of patients until the second trimester. The majority of patients have recurrent disease, particularly in the initial 3 - 12 months postpartum, with up to 62% of RA and all other arthritis patients requiring an increase in drug therapy within the first 6 months.

Patients with systemic lupus erythematosus (SLE) have an increased incidence of lupus flares, with a significantly increased rate in the third trimester and postpartum period. The risk of lupus flares during pregnancy is increased in patients with active disease 6 - 12

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months before conception, in those who discontinue medication, particularly hydroxychloroquine, and in those with active lupus nephritis at conception.

Effects of rheumatic diseases on pregnancy

Pregnant women with rheumatic diseases may have an increased risk of adverse maternal and fetal outcomes. Risks in the mother depend on disease activity before conception and throughout pregnancy, extent of organ involvement and presence of, for example, antiphospholipid antibodies (aPLs). Risks for the fetus are related to maternal disease activity, presence of autoantibodies (aPLs and antibodies to Ro/SSA and La/SSB) and maternal therapy. SLE patients have a 2 - 4-fold higher rate of pregnancy complications, especially those with co-existing antiphospholipid syndrome and higher disease activity. Transmission of maternal Ro/SSA or La/SSB antibodies during pregnancy occurs between 16 and 32 weeksâ&#x20AC;&#x2122; gestation. This may cause neonatal lupus syndrome and complete heart block in neonates.

Serious organ manifestations of systemic sclerosis can threaten the outcome of pregnancy, the greatest risk to mother and fetus being renal crisis and pulmonary hypertension.

Drug treatment during pregnancy

An adjustment in drug therapy in patients who are planning to become pregnant and those who are already pregnant is necessary to ensure that the underlying maternal disease is controlled and that the drugs are safe.

S Afr Med J 2014;104(9):643. DOI:10.7196/SAMJ.8763

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ARTICLE SUMMARY

Contraception: Everyone’s responsibility M Patel, MB ChB, FCOG (SA), MMed O&G, Cert Reproductive Medicine (SA) Reproductive Medicine Unit, Department of Obstetrics and Gynaecology, Groote Schuur Hospital and University of Cape Town, South Africa Corresponding author: M Patel (m.patel@uct.ac.za)

Millennium Development Goal 5 addressed the need to improve maternal health by reducing the maternal mortality ratio by 75% and achieving universal access to reproductive health by 2015. This includes access to contraception. The Confidential Enquiries into Maternal Deaths (2008 - 2010 triennium) in South Africa (SA) quoted the institutional maternal mortality ratio as 176.22/100 000 live births (4 867 deaths). A key preventive measure to reduce the lifetime probability of dying from pregnancy-related causes is to ensure access to family planning.

According to the Population Reference Bureau, Family Planning Worldwide 2013, use of modern methods of contraception in married women or women in union was 59.8%, with injectable contraceptive use being the most prevalent at 28.4%, sterilisation 15%, the pill 10.9%, and male condoms 4.3%, while intrauterine device (IUD) use was the least prevalent at 1%.

The SA National Department of Health launched the National Contraception and Fertility Planning Policy and Service Delivery Guidelines and National Contraception Clinical Guidelines in 2012.

Five key action areas were identified: • providing quality contraceptive health services • stimulating community awareness • placing integration into practice – integration of contraceptive and fertility-planning services into other health services • strategic multisectoral collaboration • evidence-guided planning and provision.

Of importance is that the policy addresses the prevention of pregnancy as well as the planning for pregnancy.

The World Health Organization Medical Eligibility Criteria aim to assist in accessing quality care in family planning by reviewing the latest clinical and epidemiological evidence available for different

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contraceptive methods, pertaining to their use in certain medical conditions. The website, which is easily accessible and user friendly, is regularly updated when evidence changes.

In the past, two methods have dominated contraceptive use in SA, i.e. the hormonal oral contraceptive and the progestogen-only injectable contraceptive. Currently, there is a move towards an expanded method mix, which includes promoting existing methods and addressing underutilised methods such as the IUD. There is also a phased introduction of other long-acting reversible contraceptives (LARCs), e.g. the single-rod implant.

LARCs are administered less than once per month and include the implant, the intrauterine contraceptives and the injectable contraceptives. The advantage of LARCs is that typical use equals perfect use, which is similar to that of male and female sterilisation.

The continuation rates of LARCs, as defined by the percentage of women who continue using them at one year, remain high compared with other methods.

Counselling provided by the expert caring for a woman with a complex medical or surgical condition emphasises the importance of contraception and fertility planning and gives the woman confidence that the contraceptive advice will not conflict with the treatment of her condition. Compliance and service quality include adequate counselling by well-trained staff with adequate and appropriate equipment and supplies. Counselling must include information regarding the effectiveness of various methods, their mode of action, correct use, potential side-effects, health risks, benefits and when to return for follow-up. Return to fertility after discontinuation of use, and sexually transmitted infection prevention, must also be discussed.

S Afr Med J 2014;104(9):644. DOI:10.7196/SAMJ.8764

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RADIOGRAPHER (ULTRASOUND) REMUNERATION: GRADE 1: R227 583 PER ANNUM GRADE 2: R268 083 PER ANNUM GRADE 3: R315 795 PER ANNUM (PLUS A NON-PENSIONABLE RURAL ALLOWANCE OF 12% OF BASIC ANNUAL SALARY) SERVICE BENEFITS: 13TH CHEQUE, EMPLOYER’S CONTRIBUTION TO THE PENSION FUND, HOUSING AND MEDICAL AID ALLOWANCE Requirements: Minimum educational qualification: An appropriate qualification that allows registration with the Health Professions Council of South Africa (HPCSA) as a Radiographer (Ultrasound). Registration with a professional council: Registration with the HPCSA as a Radiographer (Ultrasound) (Independent Practitioner). Experience: Grade 1: None after registration with the HPCSA in Radiography (Ultrasound) in respect of RSA qualified employees • 1 year’s relevant experience after registration with the HPCSA in Radiography (Ultrasound) in respect of foreign qualified employees, of whom it is not required to perform community service as required in South Africa. Grade 2: Minimum of 10 years’ relevant experience after registration with the HPCSA in Radiography (Ultrasound) in respect of RSA qualified employees • Minimum of 11 years’ relevant experience after registration with the HPCSA in Radiography (Ultrasound), in respect of foreign qualified employees, of whom it is not required to perform community service as required in South Africa. Grade 3: Minimum of 20 years’ relevant experience after registration with the HPCSA in Radiography (Ultrasound), in respect of RSA qualified employees • Minimum of 21 years’ relevant experience after registration with the HPCSA in Radiography (Ultrasound) in respect of foreign qualified employees, of whom it is not required to perform community service as required in South Africa. Inherent requirements of the job: A valid driver’s licence • Willingness to travel within the district. Competencies (knowledge/skills): Good verbal and written communication skills in at least two of the three official languages of the Western Cape • Extensive knowledge of the Department of Radiography (Ultrasound) techniques, protocols, PACS and RIS • Thorough knowledge of radiation protection, quality assurance and equipment safety • Computer literacy (Windows, MS Word, MS Excel, MS PowerPoint, LOGIS and Clinicom) • Knowledge and experience in different diagnostic modalities such as screening and CT • Good interpersonal skills and knowledge of theatre, mobile, trauma, medical emergency and general radiography protocols • Knowledge of Patient Archiving and Communication Systems 55761607.

Duties (key result areas/outputs): Coordination facilitation and effective management (including monitoring and evaluation of programme objectives, goals and targets) of Women and Maternal health programmes • Effective implementation of appropriate projects to improve the Women and Maternal Health programmes within Matzikama and Cederberg Sub-district • Provide support/supervision to all staff within the programmes • Liaison with role players • Effective and efficient operational management within the Radiographer (Ultrasound) department, including Human Resource Management, Finances and Asset Management where applicable • Involvement in the training programme, in conjunction with HRD. Note: The successful candidate has to do outreach visits to Citrusdal Hospital every Tuesday and Clanwilliam Hospital every Thursday, except on public holidays.

Enquiries: Dr JB van Dyk, tel. 027 213 2039 PLEASE SUBMIT YOUR APPLICATION FOR THE ATTENTION OF MR M JULIUS, TO THE MANAGER: MEDICAL SERVICES: VREDENDAL HOSPITAL, PRIVATE BAG X21, VREDENDAL 8160.

INSTRUCTIONS TO APPLICANTS: Z83 forms (obtainable from any Government department or www.westerncape.gov.za) must: Be completed in full, clearly reflect the name of the position, name and date of the publication (candidates may use this as reference), be signed, accompanied by a comprehensive CV, the names of 3 referees and certified copies of ID, driver’s licence and qualification/s. A separate application form must be completed for each post. Applications without the aforementioned will not be considered. Applications must be forwarded to the address as indicated on the advertisement. No late, faxed or e-mailed applications will be accepted. CV’s will not be returned. Excess personnel will receive preference. Applications, which are received after the closing date, will not be considered. Further communication will be limited to short-listed candidates. If you have not received a response from the Department within 3 months of the closing date, please consider your application as unsuccessful. It will be expected of candidates to be available for selection interviews on a date, time and place as determined by the Department.

As directed by the Department of Public Service & Administration, applicants must note that further checks will be conducted once they are short-listed and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records and previous employment.

The Department of Health is guided by the principles of Employment Equity. Disabled candidates are encouraged to apply and an indication in this regard will be appreciated.

Closing Date: 12 September 2014 119718 SAMJayandambanga.co.za ayandambanga.co.za 117940 FIN MAIL

: 4

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Netcare Limited – Specialist opportunities Netcare operates a private Hospital Group, Primary Care Network, National Renal Care and Medical Emergency service in SA and in the UK. • • • • •

54 private hospitals 9 296 registered beds 341 operating theatres Over 1,2 million patients admissions per year 90 Netcare pharmacies located in hospitals and Primary Care facilities.

Various opportunities for the services of specialists exist at Netcare Hospitals, nationally with a focus on: • • • •

Cardiologists Gynaecologists Neurosurgeons Vascular surgeons

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For more information please contact: Sanet Wolfaardt 011 301 0134 or 082 942 1969, e-mail: sanet.wolfaardt@netcare.co.za

Netcare VCD 7403 | 08.2014

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CPD

SEPTEMBER 2014

Effective in 2014, the CPD programme for SAMJ will be administered by Medical Practice Consulting: CPD questionnaires must be completed online at www.mpconsulting.co.za

True (A) or false (B): Should HIV be a notifiable disease?

1. The justification for a notification system is to alert authorities to diseases that require immediate public health intervention, to evaluate changing disease patterns, and to identify communities that require special responses.

Rheumatic fever and rheumatic heart disease in Gauteng on the decline 10. Acute rheumatic fever is a delayed complication of a pharyngeal infection with a rheumatogenic strain of the group A streptococcus organism, occurring mostly in adulthood.

Routine postoperative troponin surveillance to prevent and treat myocardial infarction after non-cardiac surgery 2. A postoperative troponin leak following non-cardiac surgery is independently associated with 30-day mortality.

3.

Approximately a third of patients who have a postoperative troponin leak have a documented perioperative myocardial infarction.

4.

Over 65% of patients who have a postoperative myocardial infarction are symptomatic.

5. Routine postoperative electrocardiographic surveillance would be an acceptable substitute for troponin surveillance.

Obstetric medicine: Interlinking obstetrics and internal medicine 11. Non-pregnancy-related infections are the most common cause of maternal mortality in SA. 12. Women of reproductive age with chronic medical problems should be evaluated before conception to ensure optimal management, and minimise maternal and fetal risks in pregnancy.

A survey on the treatment of atrial fibrillation (AF) in SA 6. AF is the most common cardiac arrhythmia, with a prevalence of 5 - 6% in the 65-year-old population, increasing to 10% in the population aged >80 years.

Pregnancy and cardiac disease 15. Congenital heart disease is the most common cause of heart disease in pregnant women in SA. 16. A normal electrocardiogram in pregnancy can show ST-segment depression and T-wave inversion.

Hepatitis B immunity in patients presenting to a paediatric haematology and oncology unit 7. The prevalence of hepatitis B virus (HBV) infection in patients with haematological malignancies is higher than that in the general population.

8.

Despite being vaccinated as part of the South African (SA) Expanded Programme on Immunisation, patients are known to have acquired HBV in the paediatric oncology unit at Steve Biko Academic Hospital, Pretoria.

9. Factors that increase susceptibility to HBV infection and reacti­ vation in paediatric oncology patients include frequent prolonged hospital admissions, severe immune-compromised states, a need for frequent blood product administration, and destruction of mucous membranes following cytotoxic chemotherapy.

Papshop: Not a ‘melon’choly Pap smear workshop!

13. Cervical cancer is the leading cause of cancer mortality in subSaharan Africa.

14. HPV vaccine is not available in the public health system in SA.

Pregnancy and the kidneys 17. Pre-existing renal disease predisposes to pre-eclampsia.

18.

In pregnancy there is decreased reabsorption of glucose and bicarbonate, leading to glycosuria and bicarbonaturia.

Rheumatic diseases and pregnancy 19. Antiphospholipid antibody syndrome is associated with venous and arterial thrombosis and pregnancy loss.

Contraception: Everyone’s responsibility 20. Weight gain is the leading cause of discontinuation of use of Implanon NXT.

CPD questions include articles from CME. The full versions of each article can be found on the SAMJ website (http://www.samj.org.za)

A maximum of 3 CEUs will be awarded per correctly completed test.

INSTRUCTIONS 1. Read the journal. All the answers will be found there.

2. Go to www.mpconsulting.co.za to answer the questions.

Accreditation number: MDB001/007/01/2014 (Clinical)

September 2014, Vol. 104, No. 9

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Blood pressure elevator.

As a member of the South African Medical Association you can expect to receive special treatment.

Simply inform your nearest Mercedes-Benz dealer of your SAMA status to take advantage of exclusive offers*, preferential service bookings and a 6 year/100 000km maintenance plan. *Not in conjunction with other Mercedes-Benz Fleet Programmes/Offers. Excludes AMG and Limited Edition models.

Vehicle specifications may vary for the South African market.

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• Oral contraception1 • Hirsutism1

Tried, tested and trusted in South Africa for 22 years2

REFERENCES: 1. Ginette Package Insert 2. Ethinyl oestradiol and cyproterone acetate combination

AUG 2014 S4 Reg. No. 33/21 .8.2/0185

Cipla Medpro (Pty) Ltd. Reg. No. 1995/004182/07, Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA. Website: www.cipla.co.za Customer Care: 080 222 6662

For more information contact Rael Landau Tel: (27) (11) 488 2424 | email: rael@landau.co.za | website: www.landau.co.za

SEPTEMBER 2014

VOL. 104 NO. 9

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Health in SA prisons – on the anniversary of Biko’s death

613

Troponin surveillance after non-cardiac surgery

619

Treatments for atrial fibrillation Hepatitis B immunity in children in oncology units Rheumatic heart disease on the decline CME: Medical management of pregnancy

SAMF

SEPTEMBER 2014 VOL. 104 NO. 8 588-644

Hepatitis B vaccine at birth to prevent hepatocellular carcinoma

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The ESSENTIAL MEDICAL REFERENCE for every healthcare professional!

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

The thoroughly updated 11th edition of SAMF is your essential reference to the rational, cost-effective and safe use of medicines.

Please direct all order queries to: Edward – Fax: 086 600 6218 email: edwardm@hmpg.co.za Tax invoice to be posted on dispatch of order.