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SAMJ: South African Medical Journal

versão On-line ISSN 2078-5135
versão impressa ISSN 0256-9574

SAMJ, S. Afr. med. j. vol.102 no.2 Pretoria Fev. 2012




Corresponding author: Y Pillay ( Note: all authors write in their personal capacities.

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PHC re-engineering may relieve overburdened tertiary hospitals in South Africa



Morongwa Caroline MohapiI; Debashis BasuII

IMPH Hospital Management student. School of Public Health, University of the Witwatersrand, Johannesburg
IIMSc (Med), MPH, MBA, MMed, FCPHM (SA), PhD (Med). Department of Community Health, Charlotte Maxeke Johannesburg Academic Hospital and University of the Witwatersrand




Under the National Health Insurance, a hospital is expected to provide service to patients based on its category. However, in reality the tertiary hospitals offer every level of care, resulting in poor quality of care and over-expenditure. The Polokwane/Mankweng Hospital Complex is a provincial tertiary hospital that delivers tertiary care as well as dealing with some secondary and primary care cases. This study evaluated the hospital casualty department in the Polokwane/Mankweng Hospital Complex. A sample of 250 patients’ records was selected by simple random sampling from a cohort of 14 113 patients who attended the Polokwane Hospital Casualty Department during the 1-year study period. Most patients were admitted in the casualty department as a result of injuries (25%). Only 20% (N=51) of the patients were referred from other health facilities. Half of the patients could have been managed at a regional or district hospital. The overall expenditure for the casualty unit during the 1-year study period was R10 321 401.42 and the combined unit cost was estimated at R731.34 per single emergency care patient excluding the capital costs. Referral systems must be strengthened to manage patients at regional and district level to reduce the burden on the Polokwane/ Mankweng Hospital Complex. It is hoped that the Primary Health Care (PHC) Re-engineering Policy will address this by strengthening the referral system in PHC facilities.




Under the National Health Insurance, a hospital is expected to provide service to patients based on its category, e.g. tertiary hospitals should provide specialist level services (provided by regional hospitals, subspecialty care, and critical care under the supervision of a specialist) and should receive referrals from regional hospitals not limited to provincial boundaries.1 Therefore regional and district hospitals should be able to cater for other levels of care. In reality, the tertiary hospitals offer all levels of care, resulting in poor quality of care and over-expenditure.2 Providing basic services in a tertiary hospital casualty department creates problems for the casualty department and for the entire healthcare system.3

The Polokwane/Mankweng Hospital Complex (comprising two hospitals situated 30 km apart in Polokwane and Turfloop) is a provincial tertiary hospital1 that delivers tertiary care and deals with some secondary and primary care cases. This complex will be home to the new medical school4 and is one of the six flagship hospitals to be built in the next few years.5 The province has five regional hospitals that refer healthcare users to the complex, and 30 district hospitals, most of which, because of the proximity between them and regional hospitals, prefer to transfer patients directly to the complex. During 2006/2007, the number of casualty consultations at the complex reached a total of 41 768.6 This huge patient load affects the quality of care in the hospital casualty department and increases their staff workload. This problem needed to be quantified and addressed before the hospital complex is converted into a fully fledged tertiary hospital.



We aimed to evaluate the hospital casualty department in the Polokwane/Mankweng Hospital Complex in terms of caseload, influencing factors and implications on resource utilisation.



A cross-sectional study design was used. A retrospective record review between April 2008 and March 2009 extracted information from various sources of hospital information systems. A sample of 250 patient records was selected by simple random sampling from a cohort of 14 113 patients who attended the Polokwane Hospital Casualty Department. Data were collected on variables relevant to the functioning of and resource utilisation in the casualty unit of this complex. The project was approved by the University of the Witwatersrand Human Research Ethics Committee (Medical).



Clinical profile. Approximately half of the patients were from the age group 25 - 44 years. More male patients were referred than female. Patients with medical aid bypassed the referral system more often than those without medical aid.

Most patients were admitted in the casualty department as a result of injuries (25%), a similar finding to a study in Mpumalanga.7 Other common conditions were maternal conditions (7%) and cardiovascular diseases (6%) (Fig. 1).

Referral. Only 20% (N=51) of the patients were referred from other health facilities; 45% (N=112) of the patients were discharged, and 5% (N=13) were transferred back to the referring hospital, which implied that they could be managed at a regional or district hospital. Similar trends of non-emergency patients visiting the emergency department occur in other parts of the world.8-10

Almost half of the patients arrived after hours (18h01 - 06h00), indicating the need for after-hours services in primary healthcare (PHC) facilities as well as district and regional hospitals.

Cost. The overall expenditure for the hospital casualty department during this period was R10 321 401.42 (R954 168.45 for pharmacy products, R177 261.16 for other consumables and R 1 866 233.25 for laboratory tests). Personnel expenditure was R7 323 804.

Unit personnel cost per patient was estimated at R518.94 (70.96% of total recurrent cost), while the unit costs for the pharmaceuticals, stores and laboratory tests were R67.23 (9.24%), R12.56 (1.72%) and R132.24 (18.08%) per patient, respectively. Overall the combined unit cost was estimated at R731.34 per single emergency care patient excluding the capital costs.



Appropriate measures to interface between tertiary institutions and other levels of care to provide seamless healthcare at affordable costs for patients and the system seem inevitable. Without these, Polokwane Hospital, and in particular the casualty department, would be used inappropriately by patients as an alternative to other providers of healthcare, namely provincial and district hospitals and other PHC units. This would be at the expense of other patients truly requiring care at a tertiary hospital. The PHC re-engineering11 policy will, it is hoped, address this by strengthening the referral system in PHC facilities.



1. National Health Act (Act 61 of 2003): Regulations: Categories of hospitals. 2011. Government Gazette, 554(34521).        [ Links ]

2. Tanner M. Strengthening district health systems. Bull World Health Organ 2005;83(6):403.        [ Links ]

3. Kobusingye OC, Hyder AA, Bishai D, Hicks ED, Mock C, Joshipura M. Emergency medical systems in low- and middle-income countries: recommendations for action. Bull World Health Organ 2005;83(8):626-631.        [ Links ]

4. Department of Health. Human Resources for Health South Africa 2030. Pretoria: Department of Health, 2011.        [ Links ]

5. National Health Act (Act 61 of 2003): Policy on National Health Insurance. Government Gazette, 554(34523).        [ Links ]

6. Limpopo Department of Health and Social Development. Final Limpopo DHSA 2008/09-11 Annual Performance Plan - Vote 7. 2009. (accessed 7 June 2009).        [ Links ]

7. Nkombua L. The practice of medicine at a district hospital emergency room: Middleburg Hospital, Mpumalanga province. South African Family Practice 2008;50(1):65.        [ Links ]

8. Bezzina A, Smith P, Cromwell D, Eagar K. Primary care patients in the emergency department: who are they? A review of the definition of the 'primary care patient' in the emergency department. Emergency Medicine Australasia 2005;17(5/6):472-479.        [ Links ]

9. Gentile S, Vignally P, Durand A, Gainotti S, Sambuc R, Gerbeaux P. Nonurgent patients in the emergency department? A French formula to prevent misuse. BMC Health Serv Res 2010;15;10:66.        [ Links ]

10. McGuigan T, Watson P. Non-urgent attendance at emergency departments. Emergency Nurse 2010;18(6):34-38.        [ Links ]

11. Department of Health. Re-engineering Primary Health Care in South Africa: Discussion document. Pretoria: Department of Health, 2010.        [ Links ]



Accepted 24 November 2011.



Corresponding author: D Basu (

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DVT prophylaxis in relation to patient risk profiling - the TUNE-IN study



P F WesselsI; W J RibackII

IMB ChB, MMed (Haem), Cert Clin Haem (CMSA). Consultant haematologist, Ampath Laboratory, Pretoria; part-time consultant, Department of Medical Oncology, Steve Biko Hospital, Pretoria; clinical haematologist in private practice, Pretoria
IIMB BCh, DA (CMSA). SANOFI South Africa, Johannesburg




BACKGROUND: Patients in acute hospital care show a high risk for venous thromboembolism (VTE); 52% of patients globally are at risk, with approximately only half receiving appropriate prophylaxis.
OBJECTIVES: The TUNE-IN study's primary objective was to evaluate the use of VTE prophylaxis in the private sector in South Africa in hospitalised patients in relation to patient risk profile, via both a clinical assessment and utilising a modified risk assessment model (RAM). The secondary objective was to evaluate the relationship between prophylaxis and the level of mobility at discharge as well as on days 3, 7 and 14 post discharge.
RESULTS: Of the 608 patients enrolled, 54.1% were evaluated to be at risk for VTE clinically whilst, with RAM assessment, 74.6% were assessed at risk. Adequate prophylaxis was given to only 70.9% of all patients.
CONCLUSION: Data appear to correlate with global findings (ENDORSE study): more than 50% of hospitalised patients are at risk for VTE. Clinical risk assessment does not correlate with RAM utilisation, resulting in possible over-diagnosis of VTE risk in lowand moderate-risk patients, with the converse happening in highand highest-risk patients. Certain risk groups are easily defined for VTE risk (e.g. major orthopaedic surgery), but individual risk assessment is crucial as it often reveals underlying and overlooked risk factors, with BMI and age the most frequently overlooked risk factors.



The ENDORSE study1 found that, globally, more than 50% of hospitalised patients are at risk of VTE, with adequate prophylaxis (according to the 7th American College of Chest Physicians (ACCP) guidelines) being given to approximately only 58% of surgical patients and 40% of medical patients.

The 8th ACCP guidelines2 were published in 2008, followed in 2009 by the South African guidelines.3 Despite consensus and approved guidelines, many patients at risk either do not receive prophylaxis, or receive inadequate prophylaxis. The TUNE-IN study was conducted to evaluate common practice in the assessment of VTE risk and concurrent prescription of prophylaxis in the private healthcare setting in South Africa. Perceived clinical VTE risk, actual VTE risk scoring (using an approved risk assessment model - modified Caprini risk assessment model), actual VTE prophylaxis prescribed, and mobilisation at varying post-discharge dates were collected.



Settings and patients

All patients were enrolled between May 2008 and November 2008 in a regional, prospective, cross-sectional and longitudinal, non interventional, multi-site, observational study. Twenty consecutive patients, admitted for a minimum of one night, were evaluated at each of 29 sites across Gauteng by specialist physicians and surgeons. The sites were selected on the basis that they practised standard care in terms of VTE profiling and prophylaxis among private practitioners in Gauteng. As this condition might result in bias, the selection may not reflect standard of care in all private and public hospitals, but is likely to be a fair representation of practice across the country.

Data collection

Participating sites, when introduced to the study, were asked to evaluate patients at risk for VTE clinically, without using any official scoring system. The patients were then re-evaluated via an approved risk assessment model (RAM) - modified Caprini risk score (Table I). This scoring system assigns different risk factors a specific point value. The total VTE risk is then calculated by adding the risk factors and the patient is then assigned to a risk category (low, moderate, high and highest groups) (Table II). The decision about VTE prophylaxis prescription was left to the treating physician/surgeon, but the recommended VTE prophylaxis for each group was supplied with the RAM. A bleeding risk reminder was also given with the risk assessment form (Table III). Specific recommendations given by the doctor for that specific patient were noted (Fig. 1).





No risk factor score for HIV disease was given; however, as it is a significant risk for VTE, it was noted as an additional comment.

Upon discharge, the patient's mobility and VTE prophylaxis were evaluated. Follow-up assessment of mobility was carried out telephonically on days 3, 7 and 14 (Fig. 1).

Patient characteristics

The study was planned to enroll 650 patients, with a minimum of 385 patients needed for statistical purposes; a total of 608 patients were enrolled, with the following exclusion criteria: <18 years old; already on anticoagulation therapy; and no signed patient informed and data release consent.

The 608 patients comprised 219 medical and 389 surgical patients; the male:female ratio was 49.8:50.2 (Table IV). Diagnoses were reported for 584 patients (365 surgical, 219 medical). The most common surgical patients were orthopaedic; respiratory infection was the most common medical condition resulting in admission. Surgical procedures were reported for all 389 surgical patients, with orthopaedic surgical procedures the largest subgroup.


Statistical analysis

Primary analysis

Risk assessment was done using the modified Caprini RAM score. Relevant risk factors were added to obtain the total risk factor score (TRFS value). The sites then grouped patients into low, moderate, high and highest risk for developing VTE.

Secondary analysis

The level of mobility was measured using a three-level scale. The percentage of patients in each level was determined and this value was then correlated with their TRFS as per the RAM.


Results and discussion

Participating sites clinically evaluated 329 (54.1%) of the total number of patients to be at risk for VTE.

Calculation of the TRFSs in the case report forms for the study were checked by the data management team of SANOFI. Minor data errors were found in the scores of 161 patients (108 surgical and 53 medical), which were subsequently adjusted. After adjustment, none of the patients' risk levels was classified as 'low'. Within the surgical groups, 30.3% of patients fell in the high-risk group, and 54% fell in the highest group. Medical patients were 32% in the high, and 38.4% of patients within the highest, group (Table V).

The TRFS groups were cross-correlated with the initial individual clinical assessments. The results showed that approximately 74.6% of all patients were in the high and highest risk groups, with 67.1% of medical and 74.6% of surgical patients at risk (Fig. 2). This high percentage among surgical patients may be explained by the high number of orthopaedic patients in the total sample. The same figure shows the clinical initial evaluation correlated with the RAM score.



Comparing patients in the high and highest risk categories (RAM) with clinical assessment reveals evidence that approximately 20% of patients were missed for VTE risk if not using a scoring system (Table VI). This finding highlights the possibility in South Africa that, by only performing subjective clinical assessment for VTE, the risk is run of having patients under-diagnosed for high and highest risk, so adding to the health burden of treating VTEs. Conversely, it raises the question of possible over-treating of patients by relying only on clinical assessment and possible overdiagnosis of low-risk patients.

Using the corrected TRFS values compared with clinical evaluation showed that assessing healthcare providers were most accurate in defining the highest-risk group of patients. Fig. 3 graphically shows results of the corrected total RAM score, clinical evaluation, correlation between clinical evaluation and RAM assessment, and prophylaxis prescribed.



Correlating clinical evaluation and high- and highest-risk patients and looking at prescribed prophylaxis revealed:

• Of the 389 surgical patients, 204 (52.4%) had been clinically diagnosed as at risk for VTE. Using a modified RAM, 328 (84.3%) were in the high- and highest-risk levels. Prophylaxis was prescribed for 296 (76.1%) of the patients, and appropriate prophylaxis for 223 (67.9%) out of 328 high-risk patients.

• Of the 219 medical patients, 125 (57.1%) had been clinically diagnosed as at risk for VTE. Using a modified RAM; 154 (70.4%) were in the high- and highest-risk levels. Prophylaxis was prescribed for 161 (73.5%) of the patients, and appropriate prophylaxis for 119 out of 154 (77.2%) of high-risk patients.

• Of all 608 patients, 329 (54.1%) had been clinically diagnosed as at risk for VTE. Using a modified RAM, 482 (79.2%) patients were in the high- and highest-risk levels. Prophylaxis was prescribed for 457 (75.2%) of the patients, and appropriate prophylaxis for 342 out of 482 (70.9%) of high-risk patients.

Prophylaxis, in the context of this study, is important to define - specifically whether it includes only early and aggressive mobilisation.

Treating sites recorded prophylaxis as all forms of prophylaxis, including early and aggressive mobilisation. In this paper, prophylaxis refers to all forms of prophylaxis, whereas 'appropriate prophylaxis' means more than just early and aggressive mobilisation, especially pertaining to the high- and highest-risk groups being compared with clinical risk evaluation.

Reasons for not prescribing prophylaxis

Reasons reported for not prescribing prophylaxis varied, with perception of low risk being the most common. Reasons why prophylaxis was not prescribed were reported for 151 patients (93 surgical, 58 medical). Bleeding risk as reason was given for 13.9% of patients. The high percentage (33.1%) of patients who did not receive prophylaxis owing to early mobilisation could highlight the common misconception that early mobilisation is sufficient prophylaxis, even in high- and highest-risk patients.

Prophylaxis prescribed

The decision regarding prophylaxis was left to the treating physician or surgeon but, as indicated in Table III, the suggested prophylaxis for different RAM risk groups, as per the 8th ACCP and South African guidelines, was made available. To compare current acceptable prophylaxis regimens, only the high and highest RAM groups were evaluated for adequate prophylaxis. Adequate prophylaxis according to RAM assessment guidelines was given in 223 (67.9%) out of 328 surgical patients and 119 (77.2%) out of 154 medical patients, being 342 (70.9%) out of a total of 482 patients. If all patients that were evaluated to be at risk of bleeding were added into the high and highest RAM groups, the percentage adequate prophylaxis would be 70.1% in surgical patients, 82.6% in medical patients, and 74.1% in all patients. These percentages compare favourably with the current trends worldwide (ENDORSE study).

Duration of prophylaxis

The duration of the prophylaxis due to be prescribed to patients was reported initially, and subsequently adjusted at discharge, and days 3, 7 and 14 post discharge. Several variables could compound evaluating the period of prophylaxis by including the fact that different patients were hospitalised for different periods and that prophylaxis was not defined as excluding early and aggressive mobilisation. Clinical events would also have influenced the number of days on prophylaxis. These factors make the evaluation of data difficult, but final data that included all forms of prophylaxis were available for 442 patients (surgical 288; medical 154).

Pharmacological prophylaxis for 35 of the study patients (surgical 25; medical 10) was stopped during their hospital stay. The overall mean duration of post-discharge prophylaxis for surgical and medical patients (7.63 days v. 2.31 days) differs significantly. There was no difference in days of prophylaxis post surgery for different risk groups according to the modified Caprini RAM within the surgical and medical groups of patients respectively.


Mobility was evaluated at discharge, and days 3, 7 and 14 post discharge. Level 1 indicates bed rest or sedentary patients; level 2 was the same as level 1 but with bathroom privileges and patients requiring assistance; and level 3 patients were those capable of physical activity beyond bed and bathroom.

Medical and surgical patients showed a similar trend, with more than 90% of patients achieving level 3 mobility after 7 days. Conversely, at 14 days post discharge, there were 36 patients (surgical 21, medical 15) who were not considered mobile, i.e. their mobility was at level 1 or level 2.



This study used a small group of doctors in private practice, with possible bias in providing prophylaxis as a RAM scoring system was used v. clinical practice.

Data correlate with those of the ENDORSE study: more than 50% of hospitalised patients are at risk of developing thrombosis, and more than 70% of patients received adequate prophylaxis. This study also mirrors the AVAIL-ME study results presented at ISTH 2009, Boston, USA (which, by utilising ACCP guidelines, evaluated VTE prophylaxis prescribed with ACCP recommendations).4

The TUNE IN study noted that, if a structured RAM scoring system is used, a much higher percentage of patients are found to be at risk than that initially clinically evaluated. The two main factors that are underestimated are increased BMI and age.

Bleeding risk as reason for not prescribing prophylaxis is noted in a small percentage of patients (13.9%). Some of the patients in the high- and very high-risk groups (which would correlate with the high-risk group in the ACCP 2008 guidelines for VTE prophylaxis) still only receive early and aggressive mobilisation (approximately 18% of surgical and 9% of medical patients, but bleeding risk might have influenced this result).

There is no correlation between length of prophylaxis post discharge and risk level of an individual patient. Although surgical patients are given prophylaxis for a longer period post discharge, medical patients show the same period of immobility post hospital discharge.

In South Africa, HIV disease is a major risk factor, and this was omitted from the scoring system. Studies to evaluate the use of VTE across a wider spectrum of private and public sector patients should include this risk factor, which would add value to these findings.

Declarations. This study was funded by SANOFI South Africa (Pty) Ltd. Dr Wayne Riback is employed by SANOFI as Senior Medical Advisor. Data analysis was prepared and compiled by the Data Management Department of SANOFI, supported by independent data report via a contracted third party. Ethical approval for the study was obtained from Pharma Ethics and the relevant ethics committees in partaking private hospitals.



1. Cohen AT, Tapson VF, Bermann J-F, et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet 2008;371:387-394.        [ Links ]

2. Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest physicians evidence-based clinical practice guidelines (antithrombotic and thrombolytic therapy), 8th ed.: ACCP Guidelines. Chest 2008;133:381S-453S.        [ Links ]

3. Jacobson BF, Louw S, Mer M, et al. Venous thromboembolism - prophylaxis and therapeutic practice guidelines. S Afr Med J 2009;99(6): 467-473.        [ Links ]

4. Salameh P. AVAIL ME Project. ISTH meeting. Boston: 2009.        [ Links ]



Accepted 19 September 2011.



Corresponding author: P Wessels (

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Sudden and unexpected deaths in an adult population, Cape Town, South Africa, 2001-2005



Marianne TiemensmaI; Elsie Helena BurgerII

IMB ChB, Dip For Med (SA), FC For Path (SA), MMed For Path. Division of Forensic Medicine, Department of Pathology, Stellenbosch University, Tygerberg, W Cape
IIMB ChB, FC For Path (SA) MMed For Path. Division of Forensic Medicine, Department of Pathology, Stellenbosch University, Tygerberg, W Cape




BACKGROUND: According to the regulations of the National Health Act, all 'sudden and unexpected' deaths in South Africa should be referred to Forensic Pathology Services (FPS) for further investigation.
OBJECTIVES: We aimed to determine the final outcomes of forensic postmortem examinations in 'sudden and unexpected' adult deaths referred to Tygerberg FPS between 2001 and 2005.
METHODS: The study was a retrospective descriptive study. Demographic and autopsy data from adult cases of 'sudden and unexpected deaths' referred to Tygerberg FPS were collected and analysed.
RESULTS: Some 816 adult cases of 'sudden' deaths were studied. The presumed manner of death was natural in 645 (79.0%) cases, unnatural in 99 (12.2%), and undetermined in 72 (8.8%). Diseases of the cardiovascular, respiratory and central nervous systems accounted for the majority of natural deaths. Infectious diseases accounted for most deaths in the youngest age group studied (18 - 29 years); however, ischaemic heart disease was the most prevalent cause of death in the total study population.
CONCLUSIONS: This study highlighted the lack of useful preautopsy information and therefore the performance of 'unnecessary' medicolegal autopsies in a resource-limited country. Clinicians could ease the burden by giving useful information when referring cases to FPS. Feedback should be given to family members, especially where the cause of death may have an impact on surviving family members.




Cause of death: The disease, condition or injury that leads directly or indirectly, immediately or subsequently to death.

Manner of death: Refers to the circumstances of how the cause of death arose. The manner of death may be natural, accidental, homicidal, suicidal, iatrogenic or undetermined.

Mechanism of death: Refers to the physiological derangement or biochemical disturbance produced by the cause of death (e.g. hypovolaemia due to a stab wound).

A main function of a forensic pathologist is to assist the court(s) in distinguishing between 'natural' and 'unnatural' deaths. For medicolegal investigations of death (defined in the Regulations of the National Health Act (Act 61 of 2003)), the following are deemed to be deaths due to unnatural causes:

(a) Any death due to physical or chemical influence, direct or indirect, and/or related complications.

(b) Any death, including those deaths which would normally be considered to be a death due to natural causes, which in the opinion of the medical practitioner, has been the result of an act of commission or omission which may be criminal in nature.

(c) Where the death is sudden and unexpected, or unexplained or where the cause of death is not apparent.

Furthermore, procedure-related deaths, as contemplated in section 56 of the Health Professions Act (Act 56 of 1974) (amended according to section 48 of the Health Professions Amendment Act (Act 29 of 2007)) also need to be investigated. The death of a person undergoing, or as a result of, a procedure of a therapeutic, diagnostic or palliative nature, or of which any aspect of such a procedure has been a contributory cause, shall not be deemed to be a death from natural causes as contemplated in the Inquest Act (Act 58 of 1959), or the Births, Marriages and Deaths Registration Act (Act 51 of 1992).

Autopsies are vital to uncover unexpected unnatural deaths in cases of 'sudden and unexpected' deaths, e.g. deaths due to poisoning. There are various definitions of 'sudden and unexpected death'. The World Health Organization defines it as 'Death within 24 hours from the onset of symptoms',2 while Mason defines it as 'Unexpected death following so rapidly from the onset of symptoms that the cause of death could not be certified with confidence by a medical practitioner familiar with the patient.'3

Little is published on the subgroup of cases referred to the Forensic Pathology Services (FPS) in South Africa as 'sudden and unexpected' adult deaths (SUDA). We aimed to: review the outcomes of these cases to provide knowledge which may help future planning of standardised operating procedures (SOPs); determine the demographics of SUDA cases; and assess the quality of pre-autopsy information available to the pathologist.


Material and methods

This was an observational, retrospective, descriptive study that included all adult cases reported to Tygerberg FPS as cases of 'sudden and unexpected' deaths from 1 January 2001 to 31 December 2005. An 'adult' was defined as any person 18 years and older.

'Sudden and unexpected' adult deaths were not specifically defined, but all cases referred to Tygerberg FPS as supposed 'sudden and unexpected' deaths were included. Similarly, strict time limit for existence of symptoms prior to death was not defined.

Copies of postmortem reports, contemporaneous notes, hospital records and collateral information filed in the archive at the Division of Forensic Medicine, Tygerberg, were retrieved and studied. Data were collected and entered using Epidata 3.14 and Microsoft Excel. Information received prior to autopsy, by a forensic pathology officer interviewing a relative or friend, with concomitant completion of a questionnaire, was also reviewed. A forensic pathology officer is an employee of FPS who assists medical personnel with collection and identification of bodies, interviews with relatives, and other mortuary functions. The questionnaire covers basic questions on the deceased person's medical, occupational and social history, medication taken, and circumstances surrounding the death.

Data analysis was performed by the authors. All data were treated confidentially. Ethics approval was obtained from the Health Research Ethics Committee (HREC) of the Health Science Faculty, University of Stellenbosch (Ref. No. N09/09/256).



A total of 13 536 possible unnatural death cases were referred to Tygerberg FPS over the studied period, of which 826 cases were reported as being 'sudden and unexpected' adult deaths; 10 cases in which the final postmortem results were unavailable at the time were excluded. Therefore the total study population comprised 816 cases.

Autopsies were performed in 601 (74.4%) of the 816 cases; the remainder (215/816) were handled as 'view and grant' cases, where a probable natural cause of death could be determined after reviewing the case history and performing an external examination alone.

Table I presents a summary of the demographic findings. The ethnic distribution of our study population approximates that of the total population in the subcouncils served by Tygerberg FPS.5 Death occurred at home in 68.0% of cases.



In the 601/816 cases in which autopsies had been performed, the most common underlying cause of death was ischaemic heart disease, and diseases of the cardiovascular, respiratory and central nervous systems accounted for the majority of natural deaths (Table II).

In females, the most common cause of natural deaths was pneumonia, followed by ischaemic heart disease and pulmonary thrombo-embolism (Fig. 1). The three most common causes of natural deaths in males were ischaemic heart disease, pulmonary tuberculosis (TB) and pneumonia (Fig. 2).





Infectious diseases (pneumonia, meningitis) were the most common causes of death in the youngest age group (18 - 29 years). In all the other age groups, ischaemic heart disease was the most prevalent natural cause of death. Pulmonary TB was prevalent in all age categories (Table III).

In 99/601 cases (16.5% of cases where autopsies were done) the manner of death was found to be unnatural. Death was attributed to acute alcohol poisoning in 35 (5.8%) of these cases with an average blood alcohol concentration level of 0.38 g/100 ml (range 0.25 - 0.62 g/100 ml). Death in 8 others was determined to have been caused by drugs or substances. These substances included tricyclic antidepressants, anticholinergic medication, anticonvulsant medication, morphine and MDMA ('Ecstasy', 4-methylenedioxymethamphetamine).

The percentage of cases in which the cause of death was 'undetermined with postmortem examination alone' was 10.6% (64/601), while the manner of death was undetermined in 12.0% (72/601) of cases where autopsies were done.

Information received prior to autopsy by a forensic pathology officer interviewing a relative or friend of the deceased was reviewed. Information was received in 83.1% (678/816) of all cases, and in 81.4% (489/601) where autopsies had been performed.

After reviewing the history received from the informant and the completed autopsy report in each case, we tried to establish whether the supplied information contributed to the formulation of a cause of death (i.e. whether history and the cause of death could be correlated). This comparison was only done where full autopsies had been performed. Information was found to be most appropriate, and therefore contributed to the formulation of a cause of death, when supplied by a doctor (p=0.001) (Fig. 3).



The most common symptoms reported were chest pain (51 cases) and abdominal pain (46 cases). The most common known medical disease reported was hypertension (73 cases) and TB (37 cases). The eventual causes of death in cases where chest pain was reported to be present before death were ischaemic heart disease, ruptured aortic aneurysm and pulmonary thromboembolism. Accordingly, 'chest pain' was the symptom which was most often in keeping with expected symptoms of the eventual cause of death (90.2% - 46/51 cases).

Correlation between a known medical history prior to death, and the cause of death determined after the performance of an autopsy was evaluated. A history of 'ischaemic heart disease' correlated well with the cause of death determined at autopsy (2/2 cases). A history of asthma showed no correlation with the eventual determined cause of death (4/4 cases), while epilepsy, TB and hypertension showed ambiguous results.



Outcomes of cases

The most common organ systems involved in natural deaths (cardiovascular, respiratory and central nervous systems) and the most common cause of death (ischaemic heart disease) were in keeping with SUDA studies in France,6 Jamaica7 and South Carolina.8 Despite diverse settings, the similar outcomes are expected, as diseases or conditions of these organ systems are most likely to be responsible for 'true' SUDA cases, e.g. sudden cardiac death associated with cardiac dysrhythmia secondary to myocardial ischaemia.

Infectious diseases were the most prevalent natural cause of death in the youngest age group studied (18 - 29 years). Routine testing for HIV infection is not performed at our facility because of ethical considerations; therefore the impact of associated HIV infection on the underlying causes of death in these cases is unknown. However, it is suspected to be high, since many infections may present as opportunistic infections; TB is a good example, with a total of 37 deaths ascribed to TB. The impact of HIV disease on deaths in South Africa is seriously underestimated by official statistics, because of under-reporting.9 Ideally HIV testing of indicated cases should be performed, with appropriate management of the outcome of the results, as this may influence surviving family members or partners.

The Western Cape had the highest notification rate of smear-positive TB cases in South Africa in 2002.10 However, as TB is a chronic disease with a range of symptoms and signs, the large number of pulmonary TB cases found in this study was not anticipated. This finding may be explained by a lack of knowledge about the deceased's medical history, rather than the 'suddenness' of the death. Also, some cases arrived at FPS because the deceased did not have a 'regular' medical attendant who was willing to sign the death notification form.

Infectious diseases of the central nervous system as a cause of death (18/61 cases, 29.5% of central nervous system causes) were more common in this study than in other, international studies. A study on sudden unexplained death in adults due to intracranial pathology found the principal intracranial causes of death to be epilepsy (60.1%), spontaneous subarachnoid haemorrhage by ruptured saccular aneurysm (18.8%), and intracranial haemorrhage (18.8%), with meningitis accounting for only 1%.11 The possibility of associated HIV infection in our cases is not known.

In South Africa, the manner of death is not determined by the forensic pathologist, but by the court(s), although the forensic pathologist has an important role in distinguishing between natural and unnatural deaths (see Table I for presumed manner of deaths). The presumed manner of death being unnatural in 99 cases (12.2%) shows the importance of medicolegal autopsies, where a convincing and clear history of natural disease is not available, to uncover 'hidden/unexpected' unnatural causes of death.

Autopsies where no obvious cause of death could be found (negative autopsies) formed 10.6% (64/601) of cases, which is slightly higher than international results, e.g. 2.6% (44/1 691) in the UK National Confidential Enquiry into Patient Outcome and Death study.2

Alcohol poisoning

The role of alcohol in traumatic deaths is frequently reported on; however, little has been published on its role in non-traumatic deaths. Death was attributed to acute alcohol poisoning in almost 6% (35/601) of our cases. This contrasts strongly with a medicolegal series of sudden adult death cases over a 5-year study period in France, where alcohol was 'detected' in only 2 out of 77 cases6 - the exact values of the blood alcohol concentration in these two cases were not supplied. Alcohol is the most frequently abused substance in the Western Cape, with the prevalence of lifetime alcohol use across household surveys ranging from 39% to 64%.12

Information received prior to autopsy

If no case history is available prior to autopsy, subtle pathology may be missed that may have been evident at autopsy if it was expected. It could also result in failure to perform or request special investigations, which may later prove to be important. Information is especially essential in alleged SUDA cases, to ascertain whether the death was indeed 'sudden and unexpected'. An effort should be made to reach family members and the general practitioner and to obtain clinical notes. Clinicians who refer cases to FPS should send detailed referral notes and their contact details. As the presumed manner of death in most of our cases was natural, it could be argued that many of the autopsies were superfluous, and necessitated only by the lack of useful pre-autopsy information.

Factors causing the high frequency of suboptimal information received before autopsy include: relatives may have been too distressed to talk, the deceased may have been unidentified when found, the general practitioner may not have been identified, or the police officer may have sought information that was irrelevant to the pathologist's requirements.13 Further reasons in South Africa include: language barriers, lack of medical training of forensic pathology officers who are the main interviewers of relatives or friends of the deceased, and poor access to transport for family members to attend an interview at the medicolegal facility.

Unfortunately, this study had a limited number of cases available for correlation between the symptoms and medical history, and the cause of death. Regarding distinguishing specific disease symptoms, many studies have shown that the verbal autopsy has different sensitivities and specificities when comparing different diagnoses. Further studies are needed to establish which symptoms and diseases are commonly found in our setting, and may be indicative of natural causes of death, and then a standard verbal autopsy questionnaire14 for the South African context should be developed.

Feedback system

It has been stressed15,16 that feedback regarding the cause of death should be given to relatives, especially where the cause of death could impact on the health of the surviving relatives and close contacts. The prevalence of ischaemic heart disease, pulmonary TB and infectious diseases of the central nervous system was high in this study. These are conditions where feedback could initiate preventive health measures that could save relatives' lives.


Recommendations and conclusions

In this study the majority of cases had a presumed natural manner and cause of death. We recommend the following to improve the quality and quantity of information received prior to autopsy, and possibly to reduce the number of unnecessary autopsies:

• Clinicians should try to obtain the medical history in SUDA cases and only refer these to FPS if no reasonable conclusion regarding a possible natural cause of death can be made, or if other factors necessitating a medicolegal autopsy exist.

• Clinicians should provide forensic pathologists with as much clinical history as possible.

• A Standard Verbal Autopsy Questionnaire should be developed for the South African context, suited to local needs, and preferably be available in local languages.

• Availability of translators to overcome language barriers.



1. Dada MA, McQuoid-Mason DJ. Introduction to Medico-legal Practice. Durban: Butterworths, 2001.        [ Links ]

2. Saukko P, Knight B. Knight's Forensic Pathology. 3rd ed. London: Hodder Arnold, 2004.        [ Links ]

3. Mason JK. Forensic Medicine for Lawyers. 3rd ed. London: Butterworths, 1995.        [ Links ]

4. Lauritsen JM, Bruus M. EpiData (version 3). A comprehensive tool for validated entry and documentation of data. The EpiData Association, Odense Denmark, 2003-2004.        [ Links ]

5. Cape Town Statistics from Census 2001. (accessed 1 November 2010).        [ Links ]

6. De la Grandmaison G, Durigon M. Sudden adult death: a medico-legal series of 77 cases between 1995 and 2000. Med Sci Law 2002;42:225-232.        [ Links ]

7. Escoffery CT, Shirley SE. Causes of sudden natural death in Jamaica: a medicolegal (coroner's) autopsy study from the University Hospital of the West Indies. Forensic Sci Int 2002;129:116-121.        [ Links ]

8. Christiansen LR, Collins KA. Natural death in the forensic setting. A study and approach to the autopsy. Am J Forensic Med Pathol 2007;28:20-23.        [ Links ]

9. Yudkin PL, Burger EH, Bradshaw D, et al. Deaths caused by HIV disease under-reported in South Africa. AIDS 2009;23:1600-1602.        [ Links ]

10. National Tuberculosis Control Program South Africa. Mobilizing against Tuberculosis. South African Plan for TB Control for 2002 to 2005. Pretoria: The Program, 2002.        [ Links ]

11. Black M, Graham DI. Sudden unexplained death in adults caused by intracranial pathology. J Clin Pathol 2002;55:44-50.        [ Links ]

12. Harker N, Kader R, Myers B, et al. Substance abuse trends in the Western Cape: a review of studies conducted since 2000 (Commissioned by the Department of Social Development, Cape Town). www. (accessed 1 February 2011).        [ Links ]

13. Sampson H, Johnson A, Carter N, et al. Information before coronial necropsy: how much should be available? J Clin Pathol 1999;52:856-859.        [ Links ]

14. World Health Organization. Verbal Autopsy Standards. Ascertaining and Attributing Cause of Death. Geneva: WHO, 2007.        [ Links ]

15. Bowker TJ, Wood DA, Davies MJ, et al. Sudden, unexpected cardiac or unexplained death in England: a national survey. QJM 2003;96:266-279.        [ Links ]

16. Lee A, Ackerman MJ. Sudden unexplained death: evaluation of those left behind. Lancet 2003;362:1429-1431.        [ Links ]



Accepted 11 November 2011.



Corresponding author: M Tiemensma (

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An error occurred in the South African Hypertension Guideline 2011 that was published as a supplement to January 2012 SAMJ. The error is in the title of the heading for Table IV, on page 64; the title should read International Diabetes Federation (IDF) definition of metabolic syndrome - and not diabetes. The authors regret this error. The online edition of the Guideline has been corrected.




Persistent failure of the COIDA system to compensate occupational disease in South Africa



Rodney Ehrlich

BBusSc, MB ChB, DOH, FCPHM (Occ Med) (SA), PhD. Centre for Occupational and Environmental Health Research, School of Public Health and Family Medicine, University of Cape Town, and Occupational Medicine Clinic, Groote Schuur Hospital, Observatory, Cape Town




Cases of occupational disease, solvent encephalopathy and occupational asthma are used to exemplify failings of the workers' compensation system in South Africa, that include delays in processing claims, non-response to requests for information, and inadequate assessment of disability. These and other systemic deficiencies in administration of the Compensation for Occupational Injuries and Diseases Act of 1993 (COIDA) reduce access by workers with occupational disease to private medical care, and shift costs to workers and to public sector medical care. Another unintended effect is to promote under-reporting of occupational disease by employers and medical practitioners.
Reforms have been tried or proposed over the years, including decentralisation of medical assessment to specialised units, which showed promise but were closed. Improved annual performance reporting by the Compensation Commissioner on the processing of occupational disease claims would promote greater public accountability. Given the perennial failings of the system, a debate on outsourcing or partial privatisation of COIDA's functions is due.



Two compensation case histories are described and lessons drawn about perennial deficiencies in the system of compensating occupational diseases in South Africa. Compensation system failures demoralise clients and medical practitioners, and transfer the costs of occupational disease to workers and public sector medical facilities. Both patients gave written consent for their case details to be used.


Case 1

A 46-year-old man was seen at the Occupational Medicine Clinic, Groote Schuur Hospital, Cape Town, in April 2000 with a diagnosis of organic solvent encephalopathy.1 He had a 16-year history of working in the raw materials section of a paint manufacturing plant, exposed to a variety of solvents including xylene, toluene, other aromatics, ketones, alcohols and lacquer thinners. A respirator was provided only in the latter years of his employment. He had suffered somnolence and headaches for about 2 years, and more recently inability to remember the product codes.

Neuropsychological testing showed 'relatively global intellectual difficulties and indications of organic impairment'. CT scanning demonstrated generalised brain atrophy. He had no history of alcohol or drug abuse, head trauma or seizures. The only comorbidity was a recent diagnosis of hypertension. A Venereal Disease Research Laboratory (VDRL) test was negative. No HIV test was done. He was removed from exposure to solvents and reported short-term memory improvement and less somnolence. Repeat neuropsychological testing noted substantial improvement in some test scores but persistent severe impairment of verbal memory. The patient accepted voluntary retrenchment in February 2001 and has not sought further employment because of his intellectual difficulties.

The case was reported by the employer to the Compensation Commissioner under the Compensation for Occupational Diseases and Injuries Act, 1993 (COIDA) in August 2000. A final medical report submitted in August 2001 expressed the view that, given his poor powers of concentration and memory including difficulty remembering instructions, the claimant would be unlikely to sustain normal employment. In 2003, the patient was awarded 15% permanent disablement and awarded a lump sum award of approximately R23 000.

In February 2004, the claimant submitted an objection in terms of Section 91 of COIDA on the grounds that 15% was inadequate to compensate for the loss of earnings capacity caused by his severe impairment. The Compensation Commissioner office did not respond to this objection or to 4 written inquiries over the following 4 years.

A complaint regarding both non-response and delay on the part of the Commissioner was lodged with the Public Protector in December 2008. The Public Protector secured an undertaking from the Commissioner that a hearing would be held in September 2009. No reasons for the 4½-year delay were forthcoming. The promised hearing was cancelled without reason and eventually held in February 2010. As of June 2011, no finding from this hearing had been communicated to the claimant - a period of 7 years, without resolution, since the objection was lodged.


Case 2

A 41-year-old female employee of a chicken processing plant was first seen by us in September 2004. She had been employed in the plant for 21 years and had been diagnosed with asthma in 2003. Her main exposure of relevance was to chlorinated water used as a sterilant for wet work with chicken parts, including products of chlorine such as chloramines. Serial peak flow testing showed a clear pattern of decline on work days and improvement on days off.

The case was reported to the Compensation Commissioner by the employer, and a first medical report of an occupational disease was submitted in September 2004 and a final report in December 2005. At that time, her forced expiratory volume in one second (FEV1) was 72% of predicted, and her medication consisted of fenoterol inhaler prn, ipratropium bromide inhaler prn, budesonide 800 µg daily, and oral theophylline 300 mg twice daily, all obtained from her local provincial hospital. Her asthma deteriorated, with persistent severe work exacerbations. After a long period of temporary incapacity leave, she was certified as permanently medically incapacitated for her occupation in December 2006.

She was awarded 20% permanent disablement in 2005 and received a lump sum of approximately R31 000. During 2006, formoterol 50 µg twice daily and prednisone 5 - 10 mg daily were added to her regimen. A request in 2007 to the Commissioner's office to have her ongoing medication costs covered on presentation of a 6-monthly medical assessment and prescription, as per an undertaking made by the Commissioner's office regarding such cases, went unanswered.

In 2008, an application was made to the Commissioner's office to reconsider the 20% permanent disablement award in view of her total work incapacity and heavy medication load including steroid dependence. In accordance with the schedule for occupational asthma issued by the Commissioner's office, the claimant should be rated at a score of 5 based on lung function impairment and medication need, equivalent to a permanent disablement of 50%.2 Five written requests between 2008 and 2010 remain unanswered as of June 2011.



The COIDA system for occupational diseases in South African has been functioning poorly for a long time.3-13 These cases exemplify perennial problems - delay in finalising claims, non-responsiveness to requests or inquiries, and inadequate assessment of disability.


Case 1 took 2 years to be finalised after the final report was submitted, a typical experience of occupational disease claimants under COIDA.4,8-11 Of 59 occupational dermatitis cases submitted between 2007 and 2009, only 7 (12.3%) had been accepted by 2010 and only 2 claimants confirmed receipt of an award.11 The Commissioner's office had no record of a further 29 of these claims. In Case 1 above, the delay in getting an objection hearing scheduled was even worse - 5 years, and then only after the Public Protector intervened. This was followed by a (so far) 16-month delay in communicating the finding to the claimant.

Non-response to inquiries

In case 1, the patient's clinic file recorded 4 unanswered communications addressed to the Commissioner's office, and in the second case 5. In reply to a previous complaint to the Public Protector, the Commissioner argued that it was impossible to acknowledge or reply to the huge volume of correspondence received by the Commissioner's office.14 The Public Protector rejected this argument in a recent opinion, which affirmed the claimant's right to a response, on both constitutional grounds and in terms of the Promotion of Administrative Justice Act of 2000.12,13

Failure to deal with correspondence or queries is also another way in which costs are shifted to clients. Burdensome delays in submitting and resubmitting documents, and making repeated inquiries and unnecessary visits to medical practitioners, all add to the costs and breed cynicism about the system. The Commissioner's office has recently devoted resources to improving its telephonic inquiry system, but our experience is that such inquiry frequently results in a request for all the documents to be resent or faxed. This experience is shared by others,12,13 which suggests enormous duplication - and/or a chaotic filing system - in the Commissioner's office.

Inadequate assessment of disability

In both of the described cases, low permanent disablement awards were made - 15% and 20% respectively. How these percentages were arrived at is not known since there was no professional communication about these decisions to the medical practitioner. Under the Act, a disablement percentage of 30% or less entails the award of a lump sum - equivalent to about 8 and 10 months' wages in these 2 cases respectively - with no further payments. If disablement is assessed as >30%, inflation-adjusted monthly payments are made for life. In both cases, the worker was forced to give up employment, with little or no chance of re-employment - the first owing to intellectual difficulties and the second to severe asthma. The sums awarded are clearly insufficient to provide income replacement in cases where employment capacity has been lost or to cover the cost of ongoing medication.

The Act provides for payment of medical aid, including medication, for up to 24 months; thereafter, responsibility for medication costs reverts to the claimant. Since many claimants lack medical aid, this reversion effectively transfers these costs to public sector medical services or to patients' pockets if they continue to work but fail to qualify as state patients on income grounds. For the patient with chronic persistent asthma, these costs currently add up to approximately R2 400 per year at state tender prices and up to R8 900 (undiscounted) per year in the private sector. The Commissioner has the discretion to pay these ongoing costs. In a meeting of the Chief of Operations of the Compensation Fund and a Fund medical officer with the Western Cape Provincial Medical Advisory Panel on 18 February 2008 (unpublished minutes), the Fund's officers acknowledged that few, if any, private pharmacies accepted COIDA prescriptions. The Fund officers confirmed that it was policy to reimburse the costs of prescriptions for claimants with occupational disease on submission of 6-monthly medical reports and prescriptions. Our clinic has been unsuccessful in having a single such case afforded this benefit, as exemplified by case 2 above.



COIDA is based on the principle that employees give up their right to common law remedies against their employer in return for a no-fault insurance system.15 Since the Compensation Fund took in R4.8 billion in premiums from private employers in 2009/10, there is a reasonable expectation that the system will be administered efficiently.16 The Fund is also an important form of social insurance and, as a public entity, is subject to constitutional and statutory requirements governing fairness in administrative action, transparency, efficiency and proper use of financial resources.12,13

The 2009/10 Annual Report of the Compensation Fund reports an annual performance target of '70% of new... claims finalized'.16 It further reveals that, of 200 599 'registered claims' (mostly injuries on duty), 69% had been 'finalized'. No information is given on claim ages (i.e. time since receipt and registration), processing backlogs or time to finalisation. A similar information gap exists for occupational diseases. Although the claim is made in the Annual Report that 1 111 out of 2 642 occupational diseases had been 'approved', the origin of this figure of 2 642 is not given, nor a breakdown of claim ages. The term 'approved' also does not specify how long it takes for claimants to receive disablement awards. It is therefore not possible to judge the Fund's performance in settling occupational disease claims from these official statistics.

Although not applicable to the cases above, it is acknowledged that failure of medical practitioners and employers to report occupational disease or to submit required documentation contributes to the problems of delay.8,17,18 Reasons for employers failing to report include: recalcitrance or ignorance, long delay in some instances between exposure and disease, lack of past personnel records, or even disappearance of the company as a going concern.8 Although current employers are required in terms of the Act to report occupational diseases within 14 days of having been informed of the existence of a suspected occupational disease in an employee, delays are the norm. It is not clear that the Commissioner has the wherewithal to act against recalcitrant employers. Employer impunity is one consequence. There is also an obvious circular relationship between underreporting of occupational diseases by medical practitioners and a system that is unable to process claims for these diseases and reimburse practitioners accordingly.

The deficiencies described have several adverse consequences. One effect is to reduce access of workers with suspected occupational disease to private medical practitioners who are reluctant to take on such COIDA patients with only a remote chance of being paid and a good chance of being drawn into unproductive paperwork. This is part of a broader problem of delayed payment to doctors, pharmacists and hospitals for COIDA work.19 The costs of assessment, diagnosis and treatment are then transferred to the public sector (or private medical insurance for the minority of employees with such coverage). The costs of temporary incapacity are also effectively transferred to the worker who has to use statutory sick leave or alternatively remain at work in a situation where removal from adverse exposure conditions may be medically indicated.

Periodic recommendations are made to improve or reform the system. Partly as a result of representations by occupational medicine practitioners, the Commissioner set up a system of provincial medical assessment panels (PMAPs), with 2 successfully operating in Cape Town and Durban. (This author was a member of the Western Cape panel). By the end of its operations, the Western Cape PMAP, operating with a full-time occupational medicine registrar and office manager and a panel of part-time specialists, had dealt with approximately 1 550 claims between January 1994 and March 1998 (Adams S. Quarterly Report of Activities for the Period 1 January 2008 - 14 April 2008. Western Cape Medical Advisory Panel 2008 (unpublished)). The panel had achieved a median delay from claim registration with the Compensation Fund to final medical adjudication of 28 days (mean 107 days). These panels were summarily shut down by the Department of Labour in 2008, in my view on spurious grounds.20-22

In 1998, Baker23 argued for partial privatisation of the Compensation Fund by allowing additional mutual associations to be licensed under COIDA, on the grounds that the Fund had failed to contain costs and was imposing premium increases on employers that were outstripping inflation. Baker mentioned administrative inefficiency as a problem, but did not consider the costs imposed on employers and medical personnel in time and effort wasted in dealing with COIDA matters and benefits delayed or simply foregone by claimants. These costs are externalised but must be taken into account in reviewing the functioning of the COIDA system.

A report by the Public Protector contains recommendations to reduce delays in claims processing and payment, to promote timeous communication with clients and improvement of the telephone call centre within the Commissioner's office.12,13 However, despite the participation of a trade union federation in government, there seems to be little political will to ensure that these recommendations are followed. A full public accounting of the actual situation regarding occupational disease (and injury) claim backlogs and their reasons would be a good start, as the Annual Report of the Compensation Fund provides inadequate information about such matters. A debate on the merits of outsourcing the Fund's administration to proven claims administrators is also due. Such outsourcing could be done without modifying the powers of the Commissioner to set premiums or the State to pursue social insurance policy goals under the Act.



1. Feldman RG, Ratner MH, Ptak T. Chronic toxic encephalopathy in a painter exposed to mixed solvents. Environ Health Perspect 1999;107:417-422.        [ Links ]

2. Republic of South Africa. Department of Labour. Circular Instruction Regarding Compensation for Occupational Asthma. No. 176. Government Gazette 2003:24231(82):6-11.        [ Links ]

3. Myers JE, Garisch D, Cornell JE. Compensation for occupational diseases in the RSA. S Afr Med J 1987;71:302-306.        [ Links ]

4. White NW, Cheadle H, Dyer RB. Workmen's compensation and byssinosis in South Africa: a review of 32 cases. Am J Ind Med 1992;21:295-309.        [ Links ]

5. Ehrlich I. Workmen's compensation in South Africa - an overview. In: Coetzer GJ, Kinghorn J, van der Berg S, eds. Working Documents on the Post-Apartheid Economy. No. 5: Social Safety Nets. Stellenbosch: Stellenbosch Economic Project, 1992:1-9.        [ Links ]

6. Ehrlich RI, White N. Obstacles to submitting occupational disease claims (letter). S Afr Med J 1994;84:227-228.        [ Links ]

7. Ehrlich RI. Compensation for occupational disease: insult to injury. Occupational Health Southern Africa 1995;1:18-19.        [ Links ]

8. Goodman KC, Rees D, Arkles RS. Compensation for occupational lung disease in non-mining industry. S Afr Med J 1994;84:160-164.        [ Links ]

9. Onwuchekwe U, Ehrlich R, Jeebhay M, et al. Failure of the compensation system for occupational diseases and injuries. Occupational Health Southern Africa 2002;8:8-11.        [ Links ]

10. Jeebhay M, Omar F, Kisting S, Edwards D, Adams S. Outcome of workers' compensation claims submitted by the worker's clinic in Cape Town. Occupational Health Southern Africa 2002;8:4-7.        [ Links ]

11. Carman H, Fourie A. The problem of compensation for occupational skin disease in South Africa. Occupational Health Southern Africa 2010;16:12-21.        [ Links ]

12. Public Protector of South Africa. Report on a systematic investigation into allegations of poor service delivery by the Compensation Fund. Report No. 28 of 2009/10. Part 1; 2010. (accessed 21 June 2011).        [ Links ]

13. Public Protector of South Africa. Report on a systematic investigation into allegations of poor service delivery by the Compensation Fund. Report No. 28 of 2009/10. Part 2. 2010. (accessed 21 June 2011).        [ Links ]

14. Mkhwebane-Tshehla BJ. Response to complaint: failure of the Compensation Commissioner to perform statutory functions adequately. Occupational Health Southern Africa 2002;8:16-18.        [ Links ]

15. Supreme Court of Appeal of South Africa (Harms J). Mankayi v Anglogold Ashanti (126/2009)[2010] ZASCA 46.        [ Links ]

16. Republic of South Africa. Annual Report of the Compensation Fund for the year ending March 31 2010. Pretoria: Department of Labour, 2010.        [ Links ]

17. Loewenson R. Occupational disease in Southern Africa: causes and consequences of underreporting. Occupational Health Southern Africa 1998;4:8-22.        [ Links ]

18. Govender M, Ehrlich RI, Mohammed A. Notification of occupational diseases by general practitioners in the Western Cape. S Afr Med J 2000;90:1012-1014.        [ Links ]

19. Bateman C. A costly waiting game. S Afr Med J 2005;6:370-371.        [ Links ]

20. Gantsho M. COID Update. SAMA Insider 2008;June:13.        [ Links ]

21. Naidoo R, Jeebhay M. COID Update (letter). SAMA Insider 2008;September:6.        [ Links ]

22. SAMA (South African Medical Association). Retraction. SAMA Insider 2008;September:6.        [ Links ]

23. Baker M. Is there a case to partially privatise the state compensation fund for occupational injuries and diseases? Occupational Health Southern Africa 1998;4:15-23.        [ Links ]



Accepted 30 June 2011.



Corresponding author: R Ehrlich (





We regret that an error occurred on page 840 of the November 2011 SAMJ, in the guideline 'Recommendations for the management of adult chronic myeloid leukaemia in South Africa'. In the third line of the abstract, as the result of a typographical error, the chromosomal translocation was stated as being between the long arms of chromosomes 9 and 12, when in fact it is chromosomes 9 and 22. The online guideline was corrected on 23 November 2011.

The full reference is: V J Louw, L Dreosti, P Ruff, V Jogessar, D Moodley, N Novitzky, M Patel, A Schmidt, P Willem. Recommendations for the management of adult chronic myeloid leukaemia in South Africa. S Afr Med J 2011;101:840-846.




Nurse initiation and maintenance of patients on antiretroviral therapy: are nurses in primary care clinics initiating ART after attending NIMART training?



David CameronI; Amor GerberII; Melusi MbathaV; Judith MutyabuleIII; Helga SwartIV

IMB ChB, M Prax Med, M Phil, FCFP (SA). Department of Family Medicine, University of Pretoria; and Foundation for Professional Development, Pretoria
IIB Comm, DTE, SLP. Foundation for Professional Development, Pretoria
IIIBFST, B Cur. Foundation for Professional Development, Pretoria
IVHCM. Foundation for Professional Development, Pretoria
VBA (Hons) Psychol. University of South Africa, Pretoria




OBJECTIVES: To determine the percentage of nurses initiating new HIVpositive patients on therapy within 2 months of attending the Nurse Initiation and Maintenance of Antiretroviral Therapy (NIMART) course, and to identify possible barriers to nurse initiation.
METHODS: A brief telephonic interview using a structured questionnaire of a randomly selected sample (126/1 736) of primary care nurses who had attended the NIMART course facilitated by the Foundation for Professional Development (FPD) between October 2010 and 31 March 2011 at primary care clinics in 7 provinces. Outcome measures were the number of nurses initiating ART within 2 months of attending the FPD-facilitated NIMART course.
RESULTS: Of the nurses surveyed, 62% (79/126) had started initiating new adult patients on ART, but only 7% (9/126) were initiating ART in children. The main barrier to initiation was allocation to other tasks in the clinic as a result of staff shortages.
CONCLUSIONS: Despite numerous challenges, many primary care nurses working in the 7 provinces surveyed have taken on the responsibility of sharing the task of initiating HIV-positive patients on ART. The barriers preventing more nurses initiating ART include the shortage of primary care nurses and the lack of sufficient consulting rooms. Expanding clinical mentoring and further training in clinical skills and pharmacology would assist in reaching the target of initiating a further 1.2 million HIV-positve patients on ART by 2012.



Despite the remarkable achievement of the scale-up of antiretroviral therapy (ART) in South Africa over the past 7 years (about 1 million people on ART), the estimated number of people (1.2 million) requiring treatment in the next 2 years exceeds the capacity of the healthcare system if treatment continues to be initiated only by doctors.1-3

In South Africa, there are 69 doctors and 388 nurses per 100 000 population.3 Task-shifting from doctors to nurses for initiating and maintaining ART is a logical strategy to meet the need of increased access.2,4,5 Nurse initiation and maintenance of antiretroviral therapy (NIMART) improves access, is cost effective, is not inferior to doctor managed ART, and achieves similar outcomes of viral suppression, adherence, toxicity and death.4,6 Further motivation to rapidly improve access is evidence showing that more than 80% of deaths during the first year after diagnosis of HIV infection occurred before these patients could be started on ART.7

Because of the need to scale-up access to ART, President Zuma announced on World AIDS Day, 1 December 2009, that any citizen would be able to access counselling, testing and treatment at any health centre.8 This meant increasing the number of sites providing ART from 496 to 4 333.9 The Acting Director-General of Health, Dr K Chetty, authorised professional nurses who had the necessary training and supervision to initiate HIV-infected patients on ART from 1 April 2010. The Foundation for Professional Development (FPD) developed a 5-day NIMART training course that included a revision of basic HIV and opportunistic infections in adults and children, the appropriate investigations, and diagnosis and treatment of HIV, TB and STIs. The theory was reinforced by case study discussions and role-play exercises using the approach of the Integrated Management of Childhood Infections (IMCI) and Practical Approach to Lung Health and HIV/AIDS (Palsa Plus).

Large-scale training of nurses in 7 provinces began in October 2010; by the end of March 2011, 1 736 nurses had attended one of the 39 NIMART courses facilitated by FPD faculty. All participants received a study manual containing all the lecture notes and a file containing the national guidelines on the management of HIV, TB, INH prophylactic therapy (IPT), prevention of mother-to-child transmission (PMTCT) and sexually transmitted infections. The Hlabisa Casebook, a pocket guide of drug interactions and a service directory of health resources in each province were also supplied. Each nurse received a laminated card with the telephone number of the HIV helpline (0800212506). This free service gives the caller access to advice from a clinical pharmacist in the Department of Pharmacology at the University of Cape Town. Nurses were also encouraged to contact the FPD faculty member facilitating the course, if they had clinical questions.

A 60-question multiple choice open book test, with a pass mark of 70%, was administered on the last day of the course. Those who did not pass were given 2 opportunities to rewrite similar tests with different sets of questions. In addition to assessing knowledge, a key aim of the test was to encourage participants to become familiar with the course material.

Following the course, each nurse was encouraged to work in a facility where they could receive weekly mentoring until they were confident to work more independently. Mentoring was available in many sites from the local HIV doctor or a nurse mentor working for one of the PEPFAR-funded partners.



To determine the percentage of nurses initiating new HIV-positive patients on therapy within 2 months of attending the Nurse Initiation and Maintenance of Antiretroviral Therapy (NIMART) course, and to identify possible barriers to nurse initiation.



For quality assurance, a brief telephonic interview using a structured questionnaire was conducted at the end of May 2011 with a randomly selected sample of 126 (7%) of the 1 736 participants of the FPD-facilitated NIMART courses. The number selected from each province was roughly in proportion to the number of nurses from that province attending the NIMART courses (Table I). Verbal consent was obtained at the beginning of the interview, and those who agreed to participate were assured of the confidentiality of their responses that were recorded against a number on the data sheet. About 25% of the nurses initially selected declined to participate. Most said they were too busy at the time. The next participant listed was then contacted. In addition to the questions listed below, participants were asked about the month when they started initiating ART.




The answers were recorded on an Excel spreadsheet, and are summarised in Table II.

At the end of the 5-day course, 60% of the participants were able to achieve at least 70% in the open book exam (Table III).




The key finding was that 62% of the participants were initiating new patients on ART within 2 months of attending a NIMART course; this was an increase of 464% over the number initiating before the course. There was also an increase of 57% in nurses prescribing IPT. The number of nurses initiating ART in children remained very low (9/126). In some areas, policy is still to refer all children needing initiation of ART to the nearest hospital.

It was initially thought that a lack of drugs, inadequate training or a lack of mentoring would be the main barriers to NIMART. However, more than 70% of the participants had previously attended formal training courses in PMTCT and in the management HIV and TB. The supply of antiretroviral drugs and INH was reported as adequate in 80% of facilities, and nearly 60% were receiving at least one visit from a mentor per month. There was no significant association between failing the open book test and the failure to initiate ART. The urgent need to provide ARTs at primary care clinic level has meant that some nurses began initiating even before attending an official NIMART course.

While it is encouraging that 55% had received training in clinical skills through a course in primary health care, good clinical skills are essential for all nurses working in primary care. Of concern is that only 38% of participants have completed a formal training course in dispensing. While following standard treatment protocols is relatively simple, an understanding of the pharmacology of drug interactions in patients on multiple drugs is essential for good clinical practice.

Spontaneous comments from participants about their reasons for not initiating ART included (i) the overall shortage of staff in the clinic, which resulted in them being allocated to other tasks, (ii) lack of a room in the clinic to consult patients, (iii) lack of stationery (files and registers) and (iv) lack of mentoring support. Two participants had been off on maternity leave. Many allocated to other tasks expressed great disappointment at not being able to use their new skills.

Our study has a number of limitations. It was a self-reported telephonic survey, and only nurses attending a NIMART course facilitated by the FPD were surveyed. According to figures presented at the National Department of Health Nerve Centre meeting on 24 June 2011, 7 492 nurses had attended various NIMART courses by that date.



Despite numerous challenges, many primary care nurses working in the 7 provinces surveyed have taken on the responsibility of sharing the task of initiating and maintaining HIV-positive patients on ART. While many factors have contributed to this, 62% of nurses attending the NIMART course facilitated by the FPD have started initiating ART within 2 months. Addressing the shortage of nurses working at primary care facilities, providing additional consulting rooms, arranging further training in clinical skills and pharmacology, together with the expansion of clinical mentoring, are urgently needed if the target of initiating a further 1.2 million HIV-positive patients on ART is to be achieved by 2012.

Competing interests. DC, AM, JM and HS are employed by the FPD but were not involved in developing or teaching the NIMART course.

Financial assistance. The cost of the telephone interviews was paid by the FPD.



1. Klausner JD, Seenta C, O'Bra H, et al. Scale-up and continuation of antiretroviral therapy in South African treatment programs, 2005-2009. J Acquir Immune Defic Syndr 2011;56(3):292-295.        [ Links ]

2. Colvin CJ, Fairall L, Lewin S, et al. Expanding access to ART in South Africa: the role of nurse-initiated treatment. S Afr Med J 2010;100(4):210-211.        [ Links ]

3. Task shifting to tackle health worker shortages. WHO/HSS/2007.03. Geneva: World Health Organization. (accessed 13 March 2011).        [ Links ]

4. Callaghan M, Ford N, Schneider H. A systematic review of task-shifting for HIV treatment and care in Africa. Human Resources for Health 2010;8:8. DOI:101186/1478-4491-8-8 (accessed 13 March 2011).        [ Links ]

5. Miles K, Clutterbuck DJ, Seitio O, Sebego M, Riley A. Antiretroviral treatment roll-out in a resourceconstrained setting: capitalising on nursing resources in Botswana. Bull World Health Organ 2007;85(7):555-560.        [ Links ]

6. Wood R, Fox M, Conradie F, et al. Nurse management is not inferior to doctor management of antiretroviral-naive HIV-infected patients. Conference abstract, 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Cape Town, 22 July 2009. Abstract LBPED03.        [ Links ]

7. Ingle S, May M, Uebel K, et al. Differences in access and patient outcomes across antiretroviral treatment clinics in the Free State province: A prospective cohort study. S Afr Med J 2010;100:675-681b.        [ Links ]

8. Address by President Jacob Zuma on the occasion of World AIDS Day, Pretoria Showgrounds, 1 December 2009. (accessed 13 March 2011).        [ Links ]

9. Budget speech of the honourable Dr A Motsoaledi, Minister of Health, delivered to the National Assembly, Parliament of the Republic of South Africa, 13 April 2010. (accessed 13 March 2011).        [ Links ]



Accepted 12 August 2011.



Corresponding author: D Cameron (




Text messages as a learning tool for midwives



D WoodsI; A AttwellII; K RossIII; G TheronIV

IMD, FRCP, DCH. Perinatal Education Trust, Cape Town, South Africa
IIBA Hons, MA Electric Book Works, Cape Town, South Africa
IIIBA, HDE. Independent researcher
IVBSc Hons, MMed (O&G), FCOG (SA). Department of Obstetrics and Gynaecology, Faculty of Health Sciences, Stellenbosch University, and Tygerberg Hospital, Cape Town, South Africa




The use of cell phone text messaging to improve access to continuing healthcare education in under-resourced settings is not well documented. We aimed to assess whether this method of education is acceptable to South African midwives in both the public and private sectors. Essential healthcare lessons from the Maternal Care book of the Perinatal Education Programme (PEP) were delivered via text message to more than 2 500 midwives each week for a period of 6 months. Each message concluded with a link to a website, where additional information about each lesson could be accessed. Results of a survey, conducted with 50 of the message recipients, demonstrated that the text messages were well received by the midwives; the information was widely shared with colleagues and was believed to improve learning and patient care. Lack of access to the Internet, or failure to utilise this facility to obtain additional information, indicated that limitations still exist in internet-based distance education, especially in the public sector. The use of text messaging promises to provide cost-effective learning opportunities, and improve a wide range of clinical services, such as the management of HIV-infected children and adults.



Cell phones offer many potential learning opportunities for healthcare workers - in particular, midwives, who are vitally important in the management of pregnant women and their newborn infants.1 The use of cell phones to improve access to continuing education for midwives may help to address the need for ongoing training, especially in rural primary care facilities, that cannot be met by expensive, traditional methods of centralised, tutor-based training. This application could contribute to better care for all pregnant women, and therefore assist in lowering the unacceptably high mortality rate of mothers and their infants in South Africa.

Few publications exist for controlled trials of the use of text messaging to improve healthcare in under-resourced settings.2,3 In Kenya, personal text messages to healthcare workers over a period of 6 months significantly improved the management of children with malaria.4

A recent project has brought essential healthcare lessons from the Maternal Care book of the Perinatal Education Programme (PEP) to thousands of midwives through the medium of short message service (SMS) text messaging, using basic cell phones. The project aimed to assess whether this method of education is acceptable to midwives in the South African public and private sectors.

The PEP has been in force for 20 years to enable groups of midwives to take responsibility for their own continuing education.5 The effect of this inexpensive and accessible self-help learning method on their knowledge, clinical skills, attitudes and quality of care in South Africa, has been documented.6



The cell phone numbers of more than 2 500 midwives were provided by the Sister Lilian Centre, which produces a quarterly nursing magazine, Sensitive Midwifery, and manages annual, popular and well-attended refresher courses for midwives.7 Twenty-six short, essential learning messages were selected from the Maternal Care course book of the PEP. Each message, limited to 160 characters, was sent via text message to the midwives every Tuesday over a 6-month period. Each message ended with a link to the Sister Lilian website, which in turn linked to the publisher's website, where the corresponding Maternal Care chapter could be read.8 Therefore, midwives with internet access could retrieve additional information relating to the core message. The cost of sending the text messages was reduced by purchasing large bundles of messages; during the study period, 70 000 text messages were sent at a cost of 34 cents per message.

At the end of the project, 50 recipients were randomly identified: 25 in the public and private sectors, respectively. These midwives were contacted by an independent consultant, and asked to answer 7 short questions; each question had 3 possible answers ranging from positive to negative (Table I). Additional comments were recorded.




All 50 recipients were willing to participate in the survey: 86% enjoyed and learned from the weekly text messages, 72% believed that the messages improved their clinical practice, and 68% regularly shared and discussed the messages with their colleagues. A total of 68% had access to the internet (56% in the public and 80% in the private sector), but only half used the facility. Most (98%) thought that the PEP books would help in their clinical practice, and 84% had already purchased the books or intended to do so. All respondents wanted to receive further text messages on other important topics.

Respondents' comments included: 'I loved the messages and learned a lot; the SMSs were a good reminder of things I already knew', 'I wrote the messages down so I could go back to them', 'I shared the messages with my students', 'I liked that they were short and quick to read', and 'Love the PEP books and use them.' Some found that the messages were too simple and wanted more detailed information; consequently, links to the publisher's website were included in each message. Many looked forward to the weekly messages and asked to be included in future text message projects, as they wanted more information on a wide range of perinatal topics.



This survey demonstrated that text messages via personal cell phones were well received by South African midwives; the information was widely shared with colleagues and was believed to improve learning and patient care. The messages often formed the basis of discussions and student teaching. The lack of access to the Internet, and failure to use this facility to obtain additional information, indicated that internet-based distance education still has limitations, especially in the public sector.

A similar project is planned to provide essential messages on newborn care. We hope to determine whether weekly text messages could improve the standard of knowledge and practice of nurses in primary care facilities. The use of cell phone text messaging promises to provide cost-effective learning opportunities, and improve a wide range of clinical services, such as the management of HIV-infected children and adults.



1. Terry M. Text messaging in healthcare: the elephant knocking at the door. Telemed J E Health 2008;14(6):520-524.        [ Links ]

2. Lester RT, Ritvo P, Mills EJ et al. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet 2010;376(9755):1838-1845.        [ Links ]

3. Pop-Eleches C, Thirumurthy H, Habyarimana JP et al. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting; a randomized controlled trial of text message reminders. AIDS 2011;25(6):825-834.        [ Links ]

4. Zurovac D, Sudoi RK, Akhwale WS et al. The effect of mobile phone text-message reminders on Kenyan health workers' adherence to malaria treatment guidelines: a cluster randomised trial. Lancet 2011;378(9793):795-803.        [ Links ]

5. Woods DL, Greenfield DH. Teaching in under-resourced hospitals: experience in South Africa. NeoReviews 2010;11:5-11.        [ Links ]

6. Perinatal Education Programme. (accessed 11 October 2011).        [ Links ]

7. The Sister Lilian Centre. (accessed 11 October 2011).        [ Links ]

8. Electric Book Works Healthcare Series. (accessed 11 October 2011).        [ Links ]



Accepted 3 October 2011.



Corresponding author: D Woods (

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Comparative MIC evaluation of a generic ceftriaxone by broth microdilution on clinically relevant isolates from an academic hospital complex in South Africa



Warren LowmanI; Naseema AithmaIII; Johan F CoetzeeIV; Adriano G DusèII; Mervyn MerV

IMB BCh, MMed (Microbiol), FCPath (SA) (Microbiol). Department of Clinical Microbiology and Infectious Diseases, School of Pathology, University of the Witwatersrand; and Infection Control Services Laboratory, National Health Laboratory Services, Johannesburg
IIMB BCh, DTM&H, MSc (Med), MMed (Microbiol), FCPath (Microbiol) (SA). Department of Clinical Microbiology and Infectious Diseases, School of Pathology, University of the Witwatersrand; and Infection Control Services Laboratory, National Health Laboratory Services, Johannesburg
IIIMT. Infection Control Services Laboratory, National Health Laboratory Services
IVBSc, MB ChB, MMed (Anes), FCA (SA), PhD. Department of Anaesthesiology and Critical Care, Stellenbosch University, Tygerberg, W Cape
VMB BCh, Dip PEC (SA), FCP (SA), MMed (Int Med), FCCP, FRCP (Lond). Department of Medicine, Charlotte Maxeke Johannesburg Academic Hospital and University of the Witwatersrand




We evaluated the in vitro microbiological efficacy of a generic ceftriaxone product against several clinically significant organisms collected from sterile sites. The minimum inhibitory concentration (MIC) of each was determined simultaneously with the reference and the generic ceftriaxone product. Comparative analysis of MICs between the two products for each isolate was performed using both categorical (interpretive) agreement and essential (actual MIC value) agreement. A total of 260 isolates were tested. Overall, there was categorical agreement of 98.9% and essential agreement of 95.8%. The categorical agreement for all isolates (96.7 - 100%) accorded with international standards, as no very major errors were seen and the major error rate was less than 3%. Of the 90 isolates of E. coli (40), Klebsiella spp. (40) and Salmonella spp. (10), 87.6% had an MIC less than or equal to 0.12 mg/l. The generic ceftriaxone product showed equivalent efficacy by MIC determination to the reference formulation. Ceftriaxone remains a viable and useful antimicrobial agent against a variety of clinically relevant organisms in our setting.



The use of generic pharmaceutical agents is entrenched in South Africa, with resource limitation being the primary motivation. The clinical efficacy, in vivo performance and subsequently the role of generic antimicrobial formulations in treating serious bacterial infections, is much debated.1 Ceftriaxone is an extended-spectrum cephalosporin, first released in South Africa under the brand Rocephin. Since then, many generics have been marketed, including Fresenius Kabi's in 2005. To our knowledge, the only microbiological comparison of a generic product with Rocephin was done by Liebowitz and Slabbert in 2005.2 Ceftriaxone has since fallen out of favour as a 'workhorse antibiotic' as a result of concerns over collateral damage.3 Because of the escalating problem of drugresistant pathogens and the limited armamentarium with which to treat them, it is important to re-evaluate and consider the role of ceftriaxone.

We compared the minimum inhibitory concentrations (MICs) of several clinical isolates from various sites, between the Fresenius Kabi (FK) generic ceftriaxone (intravenous) and a pharmaceutical-grade reference ceftriaxone powder.


Materials and methods


A total of 260 clinical isolates were tested including: Enterobacteriaceae (112), Streptococcus pneumoniae (52), Streptococcus pyogenes (5), Streptococcus agalactiae (3), viridans streptococci (2), Staphylococcus aureus (30) and Haemophilus influenzae (56). Phenotypic identification of all isolates was done according to standard microbiological procedures.4

Antimicrobial susceptibility testing (AST)

Broth microdilution (BMD) in accordance with the Clinical and Laboratory Standards Institute (CLSI) guidelines5,6 was utilised. All BMD plates were prepared in duplicate, one containing the FK generic ceftriaxone, and the other the pharmaceutical-grade ceftriaxone reference powder (Abtek, Liverpool, UK). Plates were thawed prior to testing, inoculated with a standardised inoculum, and then incubated for 16 - 20 hours (Enterobacteriaceae and S. aureus) or 20 - 24 hours (streptococci and haemophilus). MICs were read independently by 2 observers. Batches of isolates were tested in conjunction with appropriate reference quality control strains.

Analysis of AST

Comparison of MIC was done using categorical and essential agreement. All MICs were interpreted according to CLSI clinical breakpoints, as stated in the guideline Performance Standards for Antimicrobial Susceptibility Testing; Nineteenth Informational Supplement, M100-S19.6

A very major error (VME) constitutes a resistant isolate by reference ceftriaxone designated susceptible by generic ceftriaxone. A major error (ME) constitutes a susceptible isolate by reference ceftriaxone designated resistant by generic ceftriaxone. A minor error (mE) is designated by intermediate susceptibility according to reference ceftriaxone and generic ceftriaxone, either sensitive or resistant. Percentage error rates were calculated accordingly:

VME = (no. VME/no. resistant strains tested) x 100

ME = (no. ME/no. sensitive strains tested) x 100

mE = (no. mE/total no. strains tested) x 100

Essential agreement was based on the number of generic MICs within one doubling dilution of the reference MIC. The accepted international standard for essential agreement between two systems is >90%.7



Overall levels of categorical and essential agreement for the Enterobacteriaceae were 99.1% (111/112) and 97.3% (109/112) respectively (Table I); 57 of the Enterobacteriaceae isolates were obtained from blood cultures.

The S. pneumoniae isolates were all from sterile sites and demonstrated an overall level of categorical and essential agreement of 98.1% (51/52) and 92.3% (48/52) respectively. A single minor error (error rate = 1.9%) was noted (Table I).

The H. influenzae isolates demonstrated an overall level of categorical and essential agreement of 100% (56/56) and 94.6% (53/56) respectively (Table I); 43 isolates were obtained from sterile sites.

The S. aureus isolates gave a 96.7% (29/30) level of categorical and essential agreement and demonstrated a single ME (error rate of 4.4%). The range of MICs for S. aureus was from 4 to >64 mg/l, with an MIC50 of 4 mg/l.



The MIC is an in vitro microbiological assay used worldwide to determine the susceptibilities of micro-organisms to particular agents. The decision on whether or not to use a particular antimicrobial agent is based on the information derived from MICs. It would therefore seem prudent to evaluate a generic product using this same platform that is used daily in clinical microbiology laboratories. Comparing the MICs of the generic and the originator is indicative of in vitro efficacy.

In our study, the majority of the Klebsiella spp., E. coli and Salmonella spp. isolates that tested resistant to ceftriaxone were extended-spectrum β-lactamase (ESBL) producers. In the absence of ESBL production, ceftriaxone remains a useful antimicrobial option for these isolates, as 86.7% of isolates had an MIC <0.12 mg/l. These low MICs highlight that ceftriaxone requires consideration because of diminishing therapeutic options and efforts to conserve the limited armamentarium of antimicrobials. Isolates were not preselected, and were collected as consecutive isolates from routine cultures. In contrast, only 40.9% (9/22) of Enterobacter spp. had an MIC <0.12 mg/l, which probably reflects chromosomal AmpC β-lactamase production, in addition to ESBL production.

The S. pneumoniae isolates demonstrated acceptable levels of concordance for meningeal and non-meningeal isolates. This is important, given the different breakpoints depending on the site of infection. The bulk of ceftriaxone use is aimed at treating meningeal pathogens; therefore we tested insufficient numbers of other streptococci to make firm comparative conclusions. There was, however, 100% categorical agreement for the 10 isolates tested.

The absence or rare occurrence of resistant strains of H. influenzae means that there are no defined resistant breakpoints for this organism. Isolates are typically exquisitely sensitive to ceftriaxone, and this was highlighted by a MIC50 <0.015 mg/l for all isolates.

An overall categorical agreement of 98.9% (257/260) and essential agreement of 95.8% (249/260) have highlighted the comparable in vitro efficacy of a generic ceftriaxone. Categorical agreement is determined by defined breakpoints, and this determines whether or not an antimicrobial agent would be prescribed on the basis of antimicrobial susceptibility testing.

There are limitations concerning conclusions from this study. The MIC is a microbiologically defined static end-point that does not address the pharmacokinetic and pharmacodynamic considerations of antimicrobial action. Of greater concern are generic agents that fail to demonstrate bio-equivalence and, in the case of antimicrobial agents, failure to demonstrate in vitro microbiological efficacy. The inferior quality of some generic medicines in Nigeria was highlighted, with almost 50% of agents not complying with set pharmacopoeial standards.8 There are few published reports on the quality of generic antimicrobial agents in South Africa and, with the increasing supply and demand for generic substitution, the necessary controls must be in place to monitor their quality. Furthermore, in the absence of therapeutic efficacy studies, post-marketing surveillance is crucial. There may be publication bias in the reporting of generic antimicrobial agent studies, given the controversy surrounding the issue.

In summary: we demonstrated an excellent level of concordance, using the MIC as a measure of microbiological activity, between a generic ceftriaxone formulation and a reference pharmaceuticalgrade powder. Taking into account the controversy and reports of inferior quality of some generic antimicrobial agents, we believe that comparative MIC determination serves as a basis for their initial evaluation.

Acknowledgements. We thank Dr Olga Perovic for assisting in development of the study protocol; the National Institute of Communicable Diseases' GERMS-SA programme for donating H. influenzae isolates; and the Fresenius Kabi Advisory Board for their guidance in this project.

Funding.This work was supported by Fresenius Kabi.

Competing interests. The authors received honoraria from Fresenius Kabi. Editorial assistance was provided by Samantha Hopfield, Editorial Director of Anatomy Publishing Partners, and was funded by Fresenius Kabi.



1. Schito GC, Keenan MH. Predicting the clinical efficacy of generic formulations of ceftriaxone. J Chemother 2005;17 Suppl 2:33-40.        [ Links ]

2. Leibowitz L, Slabbert M. Comparative in vitro activity of generic injectable cephalosporins. Southern African Journal of Epidemiology and Infection 2005;20:82-84.        [ Links ]

3. Paterson DL. "Collateral damage" from cephalosporin or quinolone antibiotic therapy. Clin Infect Dis 2004;38 Suppl 4:S341-345.        [ Links ]

4. Murray PR, Baron EJ, Jorgensen JH, Landry ML, Pfaller MA, eds. Manual of Clinical Microbiology, 7th ed. Washington DC: ASM Press, 2007.        [ Links ]

5. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard - Seventh Edition. Wayne, Pennsylvania: CLSI WVR, 2006.        [ Links ]

6. Performance Standards for Antimicrobial Susceptibility Testing; Nineteenth Informational Supplement, M100-S19. Wayne, Pennsylvania: CLSI WVR, 2006.        [ Links ]

7. Jorgensen JH. Selection criteria for an antimicrobial susceptibility testing system. J Clin Microbiol 1993;31(11):2841-2844.        [ Links ]

8. Taylor RB, Shakoor O, Behrens RH, et al. Pharmacopoeial quality of drugs supplied by Nigerian pharmacies. Lancet 2001;357(9272):1933-1936.        [ Links ]



Accepted 19 September 2011.



Corresponding author: W Lowman (

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Management guidelines for acute infective diarrhoea/gastroenteritis in infants



D F Wittenberg

MB ChB, MD, FCP (Paed) (SA). Department of Paediatrics and Child Health, School of Medicine, Faculty of Health Sciences, University of Pretoria




BACKGROUND: Acute onset vomiting and diarrhoea is one of the most common illnesses of infancy, and is second only to respiratory illnesses as a cause of childhood deaths worldwide. Existing guidelines for management of diarrhoea are often ignored in public and private practice, possibly because of a perception that the guidelines are too simple, or because of expectations of the need to give 'real' drug therapy to stop diarrhoea.
OBJECTIVES: This guideline provides a problem-based approach to the basics of present-day management of acute gastroenteritis, and discusses the evidence for the recommendations.
RECOMMENDATIONS: Each episode of diarrhoea must be seen as an opportunity for caregiver education in the prevention of the illness, in the 'what' and 'how' of oral rehydration and re-feeding, and in the recognition of when to seek help. The vast majority of patients recover rapidly, but serious complications do occur and must be recognised and managed correctly.
VALIDATION: The guidelines are endorsed by the Paediatric Management Group (PMG) in South Africa.
CONCLUSION: The aim of management is to help the child to maintain or regain hydration, and to recover from diarrhoea, with careful attention to adequate oral rehydration and judicious re-feeding.



Acute onset vomiting and diarrhoea is one of the most common illnesses of infancy. Caused by acute infection with a variety of viruses, bacteria and parasites, the condition is easily recognised by caregivers and is usually managed at home. Numerous traditional and folk remedies exist, owing to the common and well-recognised nature of the condition; these might have been tried before the child is brought for medical attention.

In this era of highly prevalent HIV infection, it must be remembered that each episode of acute infective diarrhoea may occur in a patient with unsuspected pre-existing HIV infection; each healthcare contact should be an opportunity to establish the child's HIV status for optimal management.

Acute diarrhoea has several risks and complications; it may lead to life-threatening dehydration and electrolyte disturbances. When diarrhoea is not halted, there is a risk of disturbed digestion and absorption of nutrients with nutritional deterioration. Worldwide, diarrhoea is second only to respiratory illnesses as a cause of childhood deaths.1


1. Prevention

Gastroenteritis is caused by intestinal infection owing to contamination of food, water or hands. All health professionals should ensure caregiver education in the following main principles of prevention:

• Full and exclusive breast-feeding on demand: this protects against intestinal infections2,3 and prevents exposure to environmental contamination. Thriving breast-fed babies under 6 months of age do not require water supplements, even in hot weather.4,5

• Full immunisation including rotavirus vaccines: the new rotavirus vaccines are safe and reduce the severity of infection and prevent deaths, but they do not prevent all cases of rotavirus diarrhoea.6

• Provision of safe water for drinking and food preparation.

• Proper hand-washing hygiene after toilet use and before food preparation and feeding.

• Safe disposal of human and other waste.


2. Management guidelines: acute diarrhoea

In view of the frequency and importance of the condition, best practice guidelines for management of diarrhoea have been published by the World Health Organization (WHO),7,8,9 American Academy of Pediatrics (AAP),10 and European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN),11 among others. The use of these guidelines has been described in numerous countries;12,13 however, they are often ignored in practice, more frequently than those for other paediatric conditions such as asthma.14,15 Reasons for this include doctors' unwillingness to be imposed upon, failure by doctors to keep pace with changing views on hydration and nutrition, a perception that the guidelines are too simple, and parental expectations of 'real' drug therapy to stop diarrhoea.


3. Acute gastroenteritis: what are the problems?

Vomiting is largely attributed to local factors and poor gastric emptying, and should not be treated with antiemetic drugs.16 Cyclizine and prochlorperazine have not proven useful and may carry a higher risk of toxic side-effects in young infants, and in the presence of dehydration. Ondansetron is moderately effective,17 but the cost and quantity required for a clinically significant effect negates general recommendation.

Abdominal pain is usually spasmodic due to disordered motility, or is associated with colitis in dysentery. Metoclopramide should be considered in severe pain, at a dose of 0.1 mg/kg of body mass to a maximum of 10 mg; a total daily dose of 0.5 mg/kg should not be exceeded.16 The extrapyramidal side-effects of metoclopramide in young infants should warrant caution. Frequent small oral sips of a clear hypotonic glucose-containing fluid correct ketosis and prevent gastric overdistension, in addition to contributing to rehydration. In early gastroenteritis, solids or foods with a high protein, fat or fibre content slow down gastric emptying and may aggravate vomiting. Substitution with a clear, hypotonic fluid may result in earlier cessation of vomiting.

Diarrhoea is the manifestation of secretion/absorption disturbance and disordered motility: a symptom of damage already done in the infected gut. Antidiarrhoeal medication is not advised. Antidiarrhoeal formulations aim to reduce intestinal motility, reduce secretion of water and electrolytes, and adsorb fluid and toxins, thereby reducing the number of stools seen in the diaper; however, none treat the cause of diarrhoea or actual pathology, and their use may be associated with more side-effects in young children than in adults. Furthermore, adsorbents (e.g. kaolin) hide the true extent of water loss, risking underestimation of the amount of fluid required for hydration in severe diarrhoea.

Antibiotic therapy is not indicated in the majority of cases caused by viral infection.18 In bacterial infection, antibiotic therapy generally does not shorten the length of diarrhoea, except when administered early in the case of dysentery (ciprofloxacin for 3 days is recommended).7 Rather, antibiotics are required to prevent or limit the spread of infection to others (e.g. early in cholera), and should be prescribed for evident parenteral infection (e.g. urinary tract infection or otitis media).

Probiotics have variable effect in specific circumstances,19,20 and are generally not required, but could be considered in diarrhoea associated with nosocomial infections or antibiotic use. Probiotics are sometimes added to commercial preparations of oral rehydration solutions (e.g. Hydrachoice).21

Vitamin and mineral supplementation is required where the patient's nutritional state or history suggests the possibility of deficiencies. Zinc acetate (10 - 20 mg/day for 2 weeks) reduces the duration of diarrhoea and recurrence risk in developing countries.22 - 28 To date, no comparable studies are available in developed countries; however, it is known that zinc has an effect on mucosal functions involved in absorption of water and rehydration.23,24

Dehydration is the main acute risk of acute gastroenteritis. Watery stools develop as a result of a secretion-absorption imbalance of the gut mucosa; however, glucose-linked sodium absorption with secondary water uptake is maintained even in secretory states like cholera. This is the basis of oral rehydration therapy (ORT). Hypotonic fluids with a sodium content of 45 - 65 mmol/l (e.g. Rehidrat, Sorol) allow more rapid rehydration than fluids with a higher sodium content,29 but hypertonic sugar-based drinks with little sodium (e.g. cola and sports drinks) may result in osmotic aggravation. A home-made salt-and-sugar solution (SSS) (half a teaspoon of salt plus 8 teaspoons of sugar per litre of water) is useful, but of unpredictably variable concentration, and is therefore best used in the early stages before dehydration has set in.

Dehydration occurs because fluid loss exceeds fluid intake. In general, signs of dehydration lag behind water loss. The best guide to the risk of developing dehydration is the frequency of watery stools: assuming a deficit of 10 ml/kg of body mass for each watery stool. This amount of fluid should be offered to the child in addition to usual fluid intakes.

Initially, the emphasis is on maintaining fluid intake despite vomiting, offering feeds according to tolerability. Small frequent liquid feeds are better tolerated than large volumes or solids. Feeds should be followed with clear hypotonic fluids such as SSS, or even dilute juices or mildly sweetened tea - as much as the child wants, in small quantities. Commercial rehydration fluids are also suitable. Taste may be an issue in the case of anorexia or vomiting; caregivers may need to be creative in adapting or hiding the taste of rehydration fluids.

Once the child shows signs of dehydration, ORT takes precedence over feeding. The clinical signs of dehydration are variable;30 the degree of dehydration is most accurately predicted with a combination of the observer's experience,31,32 the measured acute weight loss, and the presence of metabolic acidosis.33 Placed together, these allow an assessment of whether dehydration is mild, moderate or severe. In particular, capillary filling time must be noted: a capillary refill time (CFT) >3 seconds in a dehydrated child indicates the need for intravenous resuscitation in addition to rehydration.

Initially, an isotonic solution - such as Lactated Ringer's or Normal Saline - should be chosen for resuscitation. If the circulation has improved after 1 - 2 boluses of 20 ml/kg, given rapidly, the fluid can be changed to a rehydration fluid such as half-strength Darrow's solution with 5% dextrose, at a rate of 10 ml/kg/h. If the circulation has not improved after the second bolus, a third bolus of 20 ml/kg should be started, with transfer to hospital for intensive monitoring and care.

Patients receiving intravenous rehydration must be reassessed regularly, as the fluid administration rate may require adjustment, up or down, depending on the rate of improvement and ongoing loss.

ORT achieves faster rehydration and is associated with fewer admissions than parenteral rehydration.34,35 A hypotonic solution is recommended with a 45 - 65 mmol/l sodium content, approximately 2% glucose (111 mmol/l), and potassium and bicarbonate or citrate for alkali replenishment. Commercial rehydration solutions comply with these recommendations.

Oral rehydration solutions, provided in small frequent sips by teaspoon at a rate of 15 - 25 ml/kg/h, avoid gastric distension and vomiting. Manuals such as the Integrated Management of Childhood Illnesses,8 the South African Essential Drugs List (Hospital Level, Paediatrics) and the WHO Manual on the Management of Diarrhoea,9 provide recommended volumes of solutions to be given per hour. Most children are able to rehydrate within a few hours before they are ready to commence with small feeds. In the face of ongoing diarrhoea, extra fluids must still be offered for thirst and prevention of further dehydration.


4. Metabolic problems and electrolyte disturbances

These occur because of the loss of sodium, bicarbonate and potassium associated with watery stools. The electrolyte status of patients with severe diarrhoeal dehydration, circulatory disturbances or metabolic acidosis should be ascertained.

Metabolic acidosis is almost always present if the patient has significant dehydration, and is identified by more rapid deep respirations with a clear chest on auscultation. Unless metabolic acidosis is severe, sodium bicarbonate is usually not required, as rehydration allows for correction. Rehydration fluid contains alkali in the form of citrate or bicarbonate. A wide anion gap may suggest the possibility of severe ketosis, salicylate intoxication or lactic acidosis.

• Large amounts of potassium are lost in diarrhoeal stools. Metabolic acidosis is associated with further urinary potassium loss. In acidosis, a shift of intracellular potassium to the extracellular compartment results in a spurious elevation of the serum level, despite intracellular potassium loss. All children suffering from severe diarrhoea should receive oral potassium chloride: 125 mg 8-hourly if under 1 year of age, and 250 mg 8-hourly if over 1 year of age, until dehydration and acidosis are corrected.

Sodium disturbances occur frequently. Sodium content of the stool water varies from plasma-like in secretory diarrhoea (such as cholera), to very low in pure osmotic diarrhoea. In general, serum sodium is inversely related to the state of the intracellular water compartment, i.e. raised serum sodium reflects intracellular dehydration. Hypo-and hypernatraemia management should follow recommended guidelines; however, where ORT is possible, the process of rehydration usually allows metabolic homeostasis to be re-established.

Blood glucose disturbances occur in severely ill young children as a result of glycogen depletion with lack of intake, or in association with the stress response of dehydration. Blood glucose estimation should be performed by finger-prick test in all dehydrated children.


5. Feeding during diarrhoea

Intestinal infection does affect the digestive and absorptive function of the gut, and diarrhoea is a symptom of this malfunction. The degree and extent of mucosal damage is influenced by:36

• Age- infants under 3 - 6 months of age may be expected to have more severe intestinal injury from gut infection.

• Type and site of infection - viral diarrhoea involves the mucosal villi and can be expected to affect digestion and absorption, while toxigenic diarrhoea (e.g. cholera) does not affect the mucosal structure. Infection in the upper small gut affects digestion and absorption more than that in the colon.

• Pre-existing medical condition that affects the patient's recovery (e.g. HIV).

• Pre-existing nutritional state and lack of breast-feeding - malnutrition results in predisposition to mucosal atrophy, and superimposed gut infection increases the risk of maldigestion (e.g. lactose intolerance).

In a well-nourished child, infection-induced mucosal damage may recover rapidly without a need for modified feeds.37,38 Once rehydrated, the child's usual feeds should be reintroduced. At first, it may be necessary to give smaller volumes more frequently to avoid vomiting; the diarrhoea may continue for a short while. Initially, the child may be unable to take full feeds and may lose weight, but the aim is to achieve full-volume feeding within 1 - 2 days. There is no need to dilute or otherwise modify the usual feeds, provided that they are tolerated.

Breast milk is a hypotonic fluid that can be utilised simultaneously for hydration maintenance and feeding; breast-feeding should continue and even be increased during diarrhoea. Other milk formulas should not be used to hydrate the patient because of the high solute load, but after recovery from diarrhoea, extra food should be offered for nutritional recovery.

In malnourished children, acute gastroenteritis may be more severe, and recovery may be delayed. Greater vigilance is needed in suspecting possible maldigestion and malabsorption. Children should be monitored until full recovery from diarrhoea and resumption of weight gain.

Persisting diarrhoea (longer than 2 weeks after acute onset diarrhoea) is a more serious condition; it is associated with nutritional deterioration and much of the mortality from diarrhoea.39,40 Small intestinal mucosal injury or bacterial overgrowth should be suspected and diagnosed by appropriate means if: (i) the persisting diarrhoea is associated with weight loss and a continued need for rehydration fluids; (ii) the child is under 6 months of age or is malnourished, or (iii) a complication such as lactose intolerance exists. Feed modification and substitution is usually required in a planned stepwise progression.


6. Caregiver education

Acute diarrhoea is predominantly a problem of fluids and feeding - both being heavily dependent on the caregiver's understanding and reactions.


7. Conclusion

The aim of management is to help the child to maintain or regain hydration, and to recover from diarrhoea. With careful attention to adequate oral rehydration and judicious re-feeding, acute infective diarrhoea should not be a frightening condition to caregivers.

Endorsement. The guidelines are endorsed for publication by the Paediatric Management Group (PMG) in South Africa.



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19. Szajewska H, Mrukowicz JZ. Probiotics in the treatment and prevention of acute infectious diarrhea in infants and children: a systematic review of published randomized, double-blind, placebo-controlled trials. J Pediatr Gastroenterol Nutr 2001;33(S2):S17-25.        [ Links ]

20. Guandalini S, Pensabene L, Abu-Zikri M, et al. Lactobacillus GG administered in oral rehydration solution in children with acute diarrhoea: a multi-centre European trial. J Pediatr Gastroenterol Nutr 2000;30:54-60.        [ Links ]

21. Passariello A, Terrin G, de Marco G, et al. Efficacy of new hypotonic oral rehydration solution containing zinc and probiotics in the treatment of childhood acute diarrhoea: a randomised controlled trial. J Pediatr 2011;158(2):288-292.e1.        [ Links ]

22. Scrimgeour AG, Lukaski HC. Zinc and diarrheal disease: current status and future perspectives. Curr Opin Clin Nutr Metab Care 2008,11:711-717.        [ Links ]

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28. Patro B, Golicki D, Szajewska H. Meta-analysis: zinc supplementation for acute gastroenteritis in children. Aliment Pharmacol Ther 2008;28(6):713-723.        [ Links ]

29. Santosham M, Fayad I, Abu Zikri M, et al. A double blind clinical trial comparing WHO oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose. J Pediatr 1996;128(1):45-51.        [ Links ]

30. Mackenzie A, Barnes G, Shann F. Clinical signs of dehydration in children. Lancet 1989;2:605-607.        [ Links ]

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33. Colletti JE, Brown KM, Sharieff GQ, Barata IA, Ishimine P. The management of children with gastroenteritis and dehydration in the emergency department. J Emerg Med 2010;38(5):686-698.        [ Links ]

34. Hartling L, Bellemare S, Wiebe N, et al. Oral versus intravenous rehydration for treating dehydration due to gastroenteritis in children. Cochrane Database Syst Rev 2006;3:CD004390.        [ Links ]

35. Spandorfer PR, Alessandrini EA, Joffe MD, Localio R, Shaw KN. Oral versus intravenous rehydration of moderately dehydrated children: a randomized controlled trial. Pediatrics 2005;115:295-301.        [ Links ]

36. Gracey M. Nutritional effects and management of diarrhea in infancy. Acta Paediatr Suppl 1999;88(430):110-126.        [ Links ]

37. Walker-Smith J, Sandhu BK, Isolauri E, et al. Recommendations for feeding in childhood gastroenteritis. Medical position paper on behalf of ESPGAN. J Pediatr Gastroenterol Nutr 1997;24:619-620.        [ Links ]

38. Sandhu BK, Isolauri E, Walker-Smith J, et al. Early feeding in childhood gastroenteritis. A multicenter study on behalf of the European Society of Paediatric Gastroenterology and Nutrition Working Group on Acute Diarrhoea. J Pediatr Gastroenterol Nutr 1997;24:522-527.        [ Links ]

39. Teka T, Faruque AG, Fuchs GJ. Risk Factors for death in under-age-five children attending a diarrhoea treatment centre. Acta Paediatr 1996;85(9):1070-1075.        [ Links ]

40. Victora CG, Huttly SR, Fuchs GJ, et al. International differences in clinical patterns of diarrhoeal deaths : a comparison of children from Brazil, Senegal, Bangladesh and India. J Diarrhoeal Dis Res 1993;11(1):25-29.        [ Links ]



Accepted 31 October 2011.



Corresponding author: D F Wittenberg (

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Progress of preventing mother-to-child transmission of HIV at primary healthcare facilities and district hospitals in three South African provinces



Ashraf GrimwoodI; Geoffrey FattiII; Eula MothibiIII; Brian EleyIV; Debra JacksonV

IMB ChB, MPH. Kheth'Impilo AIDS free living, Cape Town
IIMB ChB, MPH. Kheth'Impilo AIDS free living, Cape Town
IIIMB ChB, FCP, Dip HIV Man. Kheth'Impilo AIDS free living, Cape Town
IVMB ChB, BSc (Hons), FCPaed. Paediatric Infectious Diseases Unit, Red Cross War Memorial Children's Hospital, and Department of Paediatrics and Child Health, University of Cape Town
VRNC, MPH, DSc. School of Public Health, University of the Western Cape, Cape Town




Improving national prevention of mother-to-child transmission (PMTCT) services in South Africa has been challenging. PMTCT outcomes were analysed at 58 primary- and secondary-level antenatal facilities across seven high HIV burden sub-districts in three provinces, over an 18-month period during which new South African PMTCT clinical guidelines were implemented and a nurse quality mentor programme was expanded. Early infant HIV DNA polymerase chain reaction test positivity reduced by 75.2% from 9.7% (95% confidence interval (CI) 8.1 - 11.5%) to 2.4% (95% CI 1.9 - 3.1%) (p<0.0005). HIV test positivity at 18 months of age decreased by 64.5% from 10.7% (95% CI 7.2 - 15.1%) to 3.8% (95% CI 2.4 - 5.6%) (p<0.0005). PMTCT outcomes have improved substantially at these facilities.



Since the introduction of prevention of mother-to-child-transmission (PMTCT) strategies, vertical transmission of HIV has declined in low- and middle-income countries over 20 years from 20 - 40% to 2.8% in the best-case scenarios.1 In wealthy countries, transmission rates are below 2%.2,3 In South Africa, the revised clinical guidelines introduced in 2010 included starting dual zidovudine/nevirapine prophylaxis commencing from 14 weeks' gestation or lifelong antiretroviral treatment (ART) for pregnant women with World Health Organization stage III or IV HIV disease and/or CD4 cell counts below 350 cells/µl.4 However, improving South African PMTCT outcomes has been challenging owing to inadequate coverage and sub-optimal implementation of PMTCT programmes.5,6

Kheth'Impilo (KI) is a non-governmental organisation supporting South African Department of Health HIV care facilities. KI provides health worker and health system strengthening (including HIV and TB integration, infrastructure support and data collection systems). Nurse quality mentors (QMs), whose key role is to assist facilities to reach the HIV and AIDS National Strategic Plan PMTCT goals, have recently been introduced.

To evaluate progress in PMTCT services over an 18-month period during which the QM programme was scaled up, PMTCT outcomes were analysed at 58 KI-supported primary and secondary level antenatal services, across seven high HIV burden sub-districts in three South African provinces (KwaZulu-Natal, Mpumalanga and the Eastern Cape).



QMs are professional nurses experienced in maternal, newborn and child health. They focus on quality improvement of PMTCT services through a process of mentoring and support of antenatal clinic nurses. KI's QMs support several antenatal care sites within a sub-district to improve quality of care, including basic antenatal care, family planning, integrated management of childhood illness and the Expanded Programme for Immunization. Mentorship involves identifying gaps in service delivery, assisting with developing solutions, improving patient management, improving patient flow, and ensuring that good-quality data are collected. Data registers are developed where they do not exist.

A KI community-support services programme for pregnant women and mother-infant pairs linked to health services, comprising patient advocates, site facilitators and community co-ordinators, provides adherence and psychosocial support. The programme encourages early antenatal booking, treatment adherence, HIV testing of household members, and HIV DNA polymerase chain reaction (PCR) tests for infants 6 weeks after birth, 6 weeks after weaning, and at 18 months of age.

All pregnant women attending antenatal facilities supported by KI between October 2009 and March 2011 were included, during which time the number of supported sites increased from 14 to 58. Routine facility data according to the data elements in the PMTCT register were collected and aggregated monthly at facility level, forming part of the District Health Information System. Data quality is checked by QMs to ensure accuracy, and gaps identified are corrected. Crosssectional data from six consecutive quarters were analysed. Primary outcomes were positivity rates for PCR tests at 6 weeks of age and HIV antibody tests at 18 months of age. Linear trend in outcomes was assessed using the Cochrane-Armitage test. Existing electronic data from routine monitoring of patients (involving aggregated patient counts) were analysed for this report. No procedures were performed on patients in addition to those performed routinely. Patient-identifying data were not captured electronically.



As the number of KI-supported sites increased during the study period, the number of women booking at supported sites increased from 5 104 to 9 789 per quarter (Table I). Between Q1 2010 and Q1 2011, it was evident that increasing proportions of women were on ART at booking, rising from 3.6% to 5.4% among all women (p<0.0005), and from 30.9% to 37.8% among known HIV-positive women (p=0.024). From Q1 2010 onwards, almost 100% of women with unknown HIV status had an HIV test, up from 83% in Q4 2009. A decreasing proportion of HIV-positive women did not know their status at booking (from 72.2% to 66.1%; p<0.0005), and the proportion of women retested for HIV at 32 weeks' gestation increased from 25.6% to 46.2% (p<0.0005). Despite the booking HIV test positivity rate decreasing from 37.2% to 29.1%, the estimated overall proportion of women who were HIV positive at delivery remained around 40% (p=0.74). An increasing proportion of newly diagnosed HIV-positive women started triple ART (from 16.8% to 21.6%; p<0.0005), due to the change in guidelines to initiate triple ART at higher CD4 cell counts.

There was a substantial (75.2%) reduction in early PCR test positivity from 9.7% (95% CI 8.1 -11.5%) to 2.4% (95% CI 1.9 -3.1%) over the study period (p<0.0005). The estimated proportion of missing PCR results ranged between 0% and 14% per quarter. A 64.5% reduction in 18-month HIV test positivity was found, declining from 10.7% (95% CI 7.2 -15.1%) to 3.8% (95% CI 2.4 - 5.6%) (p<0.0005). The relative proportion of children receiving 18-month HIV tests versus 6-week PCR tests was low, but improved during the last quarter from 19.1% to 24.4%.



PMTCT outcomes improved substantially during a period in which new PMTCT guidelines were implemented at sites receiving support from nurse QMs and community-based adherence supporters. Substantial reductions in early PCR and 18-month HIV test positivity rates are encouraging compared with previous outcomes in resourcelimited settings.3,7 The high rates of HIV testing, antiretroviral treatment and prophylaxis uptake, and an almost twofold increase of the 32-week gestation HIV retest rate, indicate a strengthening health system.

The national ART programme demonstrates increased access through more women being on triple ART at booking, and increasing numbers of pregnant women starting triple ART. This contributes to maintaining the high antenatal prevalence of HIV due to increased survival of women on ART. The national HIV counselling and testing campaign shows greater impact, as more HIV-positive women know their status at booking; however, two-thirds still do not know their status when booking.

Many challenges to South African PMTCT programmes remain. Pregnant women need to book earlier, and facilities should accommodate them without turning them away for later appointments. Women may seroconvert during late pregnancy or breastfeeding, potentially resulting in vertical transmission. Retesting of HIV-negative women through their antenatal phase to the end of breastfeeding is required. This may be done through community outreach by community care workers and can include testing of household members. CD4 cell testing of mothers and early PCR testing in infants need to be increased, which may be facilitated by point of care CD4 and PCR technology. Longer-term outcomes of children are poorly reported in this and other South African studies owing to difficulties in follow-up of mothers and children.8 This is best addressed through community care workers who understand PMTCT and support mothers through their pregnancy to after weaning, ensuring regular testing of children at local clinics. Children should also receive HIV testing at 18 months regardless of HIV exposure history. Mixed feeding is a challenge, as exclusive feeding has become stigmatised as an indicator of HIV infection. Exclusive breastfeeding should be clearly promoted as the ideal norm for all breastfeeding mothers as per government guidelines.

Improved data collection systems for accurate routine reporting, and further health systems implementation research, are needed as health services strive toward reaching UNAIDS' vision of zero HIV transmission and HIV-related maternal mortality by 2015. To achieve this, however, adult HIV prevention efforts with routine HIV counselling and testing continue to be imperative.

Sources of support: President's Emergency Plan for AIDS Relief.

Conflicts of interest: Nil to declare.



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Accepted 12 December 2011.



Corresponding author: G Fatti (




How times have changed - HIV and AIDS in South Africa in 2011



At the International AIDS Conference in 2006, the UN envoy on AIDS, Stephen Lewis, described the South African government as 'Obtuse, dilatory and negligent about rolling out treatment', and its AIDS policy as 'more worthy of a lunatic fringe than of a concerned and compassionate state ... [and] wrong, immoral [and] indefensible ... The government has a lot to atone for. I'm of the opinion that they can never achieve redemption.'1 During this period, the media accused the government, under former President Mbeki, of being denialist and nicknamed the late Minister of Health, Manto Tshabalala-Msimang, 'Dr No' and 'Dr Beetroot' because of her antipathy towards antiretroviral therapy and for advocating the virtues of nutrition.2,3

Despite Lewis' pessimism, South Africa is now well on its way to redemption! In October 2009, President Zuma gave a speech described by the Treatment Action Campaign (TAC) as an historic comment on AIDS, which banished AIDS denialism and ushered in a new health era in South Africa.4 He acknowledged that South Africa had a large HIV and AIDS problem, and after citing the impact of HIV and AIDS on individuals, families and South African society said: 'Let me emphasise that although we have a comprehensive strategy to tackle HIV and AIDS that has been acknowledged internationally, and though we have the largest antiretroviral programme in the world, we are not yet winning this battle.'5 What policy changes did government endorse, and what are their effects?

On World AIDS Day 1 December 2009, President Zuma announced significant changes to the national AIDS prevention and treatment policies. Pregnant women would be eligible for antiretroviral therapy (ART) at 14 weeks rather than 24 weeks, all HIV-positive children under 1 year of age would be eligible for ART irrespective of CD4 count, and TB/HIV co-infected patients and multidrug-resistant TB patients with a CD4 count of <350 cells/µl would be eligible for ARVs. To increase access further, President Zuma launched a national HIV counselling and testing (HCT) campaign to test 15 million people and screen them for TB by June 2011. This news made headlines the world over, signalling a new beginning and a break with the past.6,7

On 12 August 2011, the Minister of Health announced the results of the HCT campaign, and the Deputy President announced that all HIV-positive patients with a CD4 count <350 are eligible for ARVs, so that South Africa now fully complies with WHO ART guidelines.8 Truly an achievement!

The HCT scale-up policy required changes in the way health services were provided. In 2009, the Department of Health (DoH) planned to prepare an additional 500 public ART facilities per quarter and to initiate 500 000 new patients on ART between April 2010 and June 2011. To decrease waiting times at facilities, the DoH introduced provider-initiated counselling and testing (PICT) and nurse-initiated and managed ARV treatment (NIMART). In contrast to voluntary counselling and testing (VCT), PICT requires that every person accessing care at a public facility be offered an HIV test by their healthcare provider (and be screened for TB), regardless of the health service sought, while NIMART allows nurses to initiate adults and children onto ART. In April 2010, 3% of patients in facilities were offered HIV tests and 390 nurses were trained in NIMART. To improve on this baseline, targets were set for provinces, districts and facilities to improve their HCT and NIMART performances. By June 2011, the DoH increased the percentage of clients being offered HIV tests in facilities to 8% and has trained 7 492 professional nurses in diagnosing and prescribing for HIV and AIDS.

During the campaign, the private sector performed over 315 000 HIV tests; the public health sector performed 13.3 million HIV tests and 8 million TB screenings and initiated 429 530 patients onto treatment. With 2 million HIV-positive tests reported during the campaign and more than 1.4 million cumulatively initiated on treatment since 2004 - up from less than 100 000 in 2005 - it became clear that an equally strong effort was needed to ensure good-quality ART data and to support good clinical management.

An October 2010 review found over 40 patient management systems and various non-standard non-networked monitoring systems in the public sector for monitoring ART data. To address this challenge, in May 2010 the National Health Council (NHC, comprising Ministers and health MECs) adopted a standardised register and clinical stationery to assist with capturing and tracking patient information at health facilities. The paper register adopted by the NDoH was a modified version of a register used in the Western Cape that had been implemented since the start of the ART programme. This paper register formed the first tier of a three-tier monitoring system approved by the NHC in December 2010.

A non-networked electronic register and a networked electronic medical record comprise tiers 2 and 3. The tiered approach provides the tools to standardise ART monitoring with a system that best suits the varied needs of facilities with a goal to facilitate standardised reporting. The system and supports information management as well as patient management throughout the provinces and nationally. The NDoH plans to have the electronic register working in at least one facility per district by March 2012.

South Africa has moved from pariah status to a country acclaimed for its progressive HIV policies. This is clearly the result of the right leadership at the right time! The implementation of these policies is already beginning to show dividends, as illustrated by the recently released Statistics South Africa estimates of decreasing infant and under-5 mortality rates as well as increased life expectancy rates - which they attribute largely to increased access to ARVs.

This editorial has tried to illustrate the gains that have been made in combating HIV. Clearly this summary does not do justice to a highly complex set of interventions and continuing challenges or to the role played by researchers, academics, public sector managers, front-line health workers and our development partners. However, to eliminate the scourge of HIV and AIDS and its terrible twin TB, much more needs to be done - strengthening the health system based on the primary health care approach is but one strategy that is required to achieve all of the Millennium Development Goals.


Y Pillay
National Department of Health

C White
N McCormick

Clinton Health Access Initiative



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7. Dugger CW. Breaking with past, South Africa issues broad AIDS policy. New York Times website, 2009. (accessed 25 August 2011).        [ Links ]

8. South African Press Association. ARV program open to all now. 2011. (accessed 1 September 2011).        [ Links ]



Corresponding author: Y Pillay ( Note: all authors write in their personal capacities.

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