Harmonization of medical products regulation: a key factor for improving regulatory capacity in the East African Community.

BACKGROUND: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. METHODS: An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance. RESULTS: Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification. CONCLUSIONS: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

National medicines regulatory authorities financial sustainability in the East African Community.

INTRODUCTION: Adequate and sustainable funding of national medicine regulatory agencies (NMRAs) is key for assurance of quality, safety and efficacy of medical products circulating in a market. The study aimed to determine factors affecting NMRAs funding in five East African Community (EAC) countries namely: Burundi, Kenya, Rwanda, Tanzania (Mainland and Zanzibar) and Uganda. METHODOLOGY: An exploratory, mixed method design using both qualitative and quantitative data, was employed. Data from six NMRAs was collected through a combination of semi-structured interviews, questionnaires, and checklists for the period 2011/12-2014/15 while 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs and monitoring and evaluation experts of the respective agencies. NMRA's financing was assessed using six indicators namely, funding policy, financial autonomy, the total annual budget, actual funding per annum, funds received from various sources, and the NMRA expenditure. RESULTS: The average total annual budget for all the EAC countries during the study period 2011-2015 ranged from USD 824,328.67 to USD 10,724,536.50. The low budget in Zanzibar may be attributed to population and pharmaceutical market size. Uganda's attainment of 98.75% (USD 10,656,704) revenue from industry fees is a result of deliberate government policy change from 100% reliance on donor funding over a period of 10 years (1995-2015). On average, the proportion of revenue against budget per annum is 54.8% (USD 458,970.11), 98.7% (USD 10,302,295.25) and 100% (USD 7,375,802.08) for Zanzibar Food & Drugs Agency (ZFDA), Uganda National Drug Authority (NDA) and Tanzania Medicines and Medical Devices Authority (TMDA) respectively. Governments, industry fees and donors are the major sources of funding across all NMRAs in the EAC region, with TMDA and Uganda NDA relying more on industry fees by 73.20% (USD 4,664,777.59) and 98.25% (USD 8,077,238.20) respectively. While Burundi relies solely on government funding, ZFDA, on the other hand, received on average 50.40% (USD 252,557.22) from government and 40.60% (USD 165,303.34) from industry fees and the remaining 9% from donors and other sources. An overall contribution of funds received from donors by each NMRA was the least among other sources of financing. Observation of expenditure patterns indicated operational costs to be the major expense in the majority of the NMRAs, followed by salaries and infrastructure development. The Kenya NMRA has the highest degree of average expenditure across all three categories, with the least average expenditures being marked by Burundi NMRA. The operational costs on average increased considerably in all the NMRAs during the study period. CONCLUSION: Evidence from the EAC suggests that government and industry fees are the main sources of funding while donor contributions vary from country to country. Government policy, legal framework, and fees structure are the key enablers of NMRAs funding sustainability.

Is There a Relationship between Lead Exposure and Aggressive Behavior in Shooters?

Lead exposure has been associated with psycho-neurological disorders. Elevated blood lead levels have been found in shooters. This study assesses the association between the blood lead levels of shooters and their levels of aggression. An analytical cross-sectional study was conducted in Gauteng, South Africa. Participants were recruited from four randomly selected shooting ranges with three randomly selected archery ranges used as a comparison group. A total of 118 (87 shooters and 31 archers) participants were included in the analysis. Aggressiveness was measured using the Buss-Perry Aggression Questionnaire. Shooters had significantly higher blood lead levels (BLL) compared to archers with 79.8% of shooters versus 22.6% of archers found to have a BLL ≥ 5 μg/dL (p < 0.001). Aggression scores were significantly higher in shooters (p < 0.05) except for verbal aggression. In the bivariate and regression analyses, shooters with BLLs ≥ 10 μg/dL were significantly associated with the hostility sub-scale (p = 0.03, adjusted odds ratio (OR) 2.83, 95% confidence interval (CI) 1.103⁻7.261). Shooters have a significantly higher BLL and aggressiveness compared to archers. However, elevated blood lead levels were significantly associated with hostility only. Interventions need to be put in place to prevent continued exposure and routine screening of populations at risk should be implemented.

Medicines Regulation in Africa: Current State and Opportunities.

Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy. This review provides a summary of the current status of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to improve their performance. All countries in Africa (except Sahrawi Republic), have NMRAs but their organizational set-up and functionality is variable. Some are located within Ministries of Health and others are semi-autonomous. There is progressive improvement in regulatory capacity, particularly in quality control and post-marketing surveillance, pharmacovigilance and clinical trials oversight. The African Vaccines Regulatory Forum, African Medicines Regulatory Harmonization Initiative, Network of Official Medicines Control Laboratories and WHO Prequalification Scheme have helped countries strengthen their regulatory capacities. The potential establishment of the African Medicines Agency (AMA) in 2018 is an opportunity to improve NMRAs' capacity in Africa.

Mental health leadership and patient access to care: a public-private initiative in South Africa.

BACKGROUND: Mental health leadership is a critical component of patient access to care. More specifically, the ability of mental health professionals to articulate the needs of patients, formulate strategies and engage meaningfully at the appropriate level in pursuit of resources. This is not a skill set routinely taught to mental health professionals. METHODS: A public-private mental health leadership initiative, emanating from a patient access to care programme, was developed with the aim of building leadership capacity within the South African public mental health sector. The express aim was to equip health care professionals with the requisite skills to more effectively advocate for their patients. The initiative involved participants from various sites within South Africa. Inclusion was based on the proposal of an ongoing "project", i.e. a clinician-initiated service development with a multidisciplinary focus. The projects were varied in nature but all involved identification of and a plan for addressing an aspect of the participants' daily professional work which negatively impacted on patient care due to unmet needs. Six such projects were included and involved 15 participants, comprising personnel from psychiatry, psychology, occupational therapy and nursing. Each project group was formally mentored as part of the initiative, with mentors being senior professionals with expertise in psychiatry, public health and nursing. The programme design thus provided a unique practical dimension in which skills and learnings were applied to the projects with numerous and diverse outcomes. RESULTS: Benefits were noted by participants but extended beyond the individuals to the health institutions in which they worked and the patients that they served. Participants acquired both the skills and the confidence which enabled them to sustain the changes that they themselves had initiated in their institutions. The initiative gave impetus to the inclusion of public mental health as part of the curriculum for specialist training. CONCLUSIONS: Despite the significant adverse social and economic costs of mental illness, psychiatric and related services receive a low level of priority within the health care system. Ensuring that mental health receives the recognition and the resources it deserves requires that mental health care professionals become effective advocates through mental health leadership.

Exposure to lead in South African shooting ranges.

INTRODUCTION: Lead exposure in shooting ranges has been under scrutiny for decades, but no information in this regard is available in respect of African settings, and in South Africa specifically. The aim of this study was to determine the blood lead levels in the users of randomly selected private shooting ranges in South Africa's Gauteng province. METHODS: An analytical cross sectional study was conducted, with participants recruited from four randomly selected shooting ranges and three archery ranges as a comparator group. RESULTS: A total of 118 (87 shooters and 31 archers) were included in the analysis. Shooters had significantly higher blood lead levels (BLL) compared to archers with 36/85 (42.4%) of shooters versus 2/34 (5.9%) of archers found to have a BLL ≥10µg/dl (p<0.001). CONCLUSION: Shooting ranges may constitute an import site of elevated exposure to lead. Improved ventilation, low levels of awareness of lead hazards, poor housekeeping, and inadequate personal hygiene facilities and practices at South African shooting ranges need urgent attention.

Household Factors Associated with Self-Harm in Johannesburg, South African Urban-Poor Households.

INTRODUCTION: Low and middle income countries bear the majority burden of self-harm, yet there is a paucity of evidence detailing risk-factors for self-harm in these populations. This study aims to identify environmental, socio-economic and demographic household-level risk factors for self-harm in five impoverished urban communities in Johannesburg, South Africa. METHODS: Annual serial cross-sectional surveys were undertaken in five impoverished urban communities in Johannesburg for the Health, Environment and Development (HEAD) study. Logistic regression analysis using the HEAD study data (2006-2011) was conducted to identify household-level risk factors associated with self-harm (defined as a self-reported case of a fatal or non-fatal suicide attempt) within the household during the preceding year. Stepwise multivariate logistic regression analysis was employed to identify factors associated with self-harm. RESULTS: A total of 2 795 household interviews were conducted from 2006 to 2011. There was no significant trend in self-harm over time. Results from the final model showed that self-harm was significantly associated with households exposed to a violent crime during the past year (Adjusted Odds Ratio (AOR) 5.72; 95% CI 1.64-19.97); that have a member suffering from a chronic medical condition (AOR 8.95; 95% 2.39-33.56) and households exposed to indoor smoking (AOR 4.39; CI 95% 1.14-16.47). CONCLUSION: This study provides evidence on household risk factors of self-harm in settings of urban poverty and has highlighted the potential for a more cost-effective approach to identifying those at risk of self-harm based on household level factors.

Nosocomial Outbreak of New Delhi Metallo-ß-Lactamase-1-Producing Gram-Negative Bacteria in South Africa: A Case-Control Study.

OBJECTIVE: New Delhi metallo-ß-lactamase (NDM)-producing Gram-negative bacteria have spread globally and pose a significant public health threat. There is a need to better define risk factors and outcomes of NDM-1 clinical infection. We assessed risk factors for nosocomial infection with NDM-1-producers and associated in-hospital mortality. METHODS: A matched case-control study was conducted during a nosocomial outbreak of NDM-1-producers in an adult intensive care unit (ICU) in South Africa. All patients from whom NDM-1-producers were identified were considered (n=105). Cases included patients admitted during the study period in whom NDM-1 producing Gram-negative bacteria were isolated from clinical specimens collected ≥48 hours after admission, and where surveillance definitions for healthcare-associated infections were met. Controls were matched for age, sex, date of hospital admission and intensive-care admission. Conditional logistic regression was used to identify risk factors for NDM-1 clinical infection and associated in-hospital mortality. FINDINGS: 38 cases and 68 controls were included. Klebsiella pneumoniae was the most common NDM-1-producer (28/38, 74%). Cases had longer mean hospital stays (44.0 vs. 13.3 days; P < 0.001) and ICU stays (32.5 vs. 8.3 days; P < 0.001). Adjusting for co-morbid disease, the in-hospital mortality of cases was significantly higher than controls (55.3% vs. 14.7%; AOR, 11.29; P < 0.001). Higher Charlson co-morbidity index score (5.2 vs. 4.1; AOR, 1.59; P = 0.005), mechanical ventilation days (7.47 vs. 0.94 days; AOR, 1.32; P = 0.003) and piperacillin/tazobactam exposure (11.03 vs. 1.05 doses; AOR, 1.08; P = 0.013) were identified as risk factors on multivariate analysis. Cases had a significantly higher likelihood of in-hospital mortality when the NDM-1-producer was Klebsiella pneumoniae (AOR, 16.57; P = 0.007), or when they had a bloodstream infection (AOR, 8.84; P = 0.041). CONCLUSION: NDM-1 infection is associated with significant in-hospital mortality. Risk factors for hospital-associated infection include the presence of co-morbid disease, mechanical ventilation and piperacillin/tazobactam exposure.

Lead exposure in young school children in South African subsistence fishing communities.

BACKGROUND: Lead is an established toxic substance, with wide-ranging health effects, including neurodevelopmental decrements and behavioural problems, even at low levels in blood. Anecdotal reports of lead melting to make fishing sinkers in South African subsistence fishing communities prompted the conduct of an epidemiological study in two South African fishing villages to investigate the extent of lead melting and the associated risks in children. OBJECTIVES: The objectives of the study were to determine the extent of lead melting, and the blood lead distributions and associated risk factors in children. METHODS: Cross-sectional, analytical studies were undertaken among 160 young school children in the fishing villages of Struis Bay and Elands Bay located along the south-eastern and western South African coastline, respectively. Blood samples were collected for lead content analysis, and anthropometric and hemoglobin measurements were taken. Questionnaires were administered to obtain information about socio-economic status and risk factors for lead exposure. RESULTS: Blood lead levels ranged from 2.2 to 22.4 µg/dl, with the mean blood lead level equalling 7.4. Around 74% of the children had blood lead levels ≥5 µg/dl and 16% had blood lead levels ≥10 µg/dl. Socio-economic factors, and lead melting practices were strongly associated with elevated blood lead levels. CONCLUSIONS: Blood lead levels in these remote subsistence fishing communities were unexpectedly elevated, given the absence of local lead industries or other obvious sources of lead exposure. Lead exposure and poisoning is an important, yet neglected, public health concern in South African subsistence fishing communities, and potentially on the entire African continent.

Analysing post-apartheid gender and racial transformation in medical education in a South African province.

INTRODUCTION: In light of global concerns about insufficient numbers of doctors, midwives, and nurses, the World Health Organization (WHO) has identified the scale-up of the production of medical professionals who are competent and responsive to community needs as urgent and necessary. Coincident with this imperative, South African medical schools have also had to consider redressing apartheid-era inequities in access to medical education and changing the racial and gender profile of medical graduates to be representative of the population. In this article, we explore progress and challenges with regard to transformation, defined as intentional and planned changes aimed at addressing historical disadvantages, in the Gauteng Province of South Africa. METHODS: A cross-sectional, descriptive analysis was conducted using data on medical school admissions and graduations from the Health and Education Departments for the period 1999-2011. Admission and graduation statistics of 1999, 2005, 2008, and 2011 were analysed according to race and gender. RESULTS: The results show that there has been progress in transforming the race and gender composition of medical students and graduates, in line with the transformation strategies of the South African government. In 1999, black African enrolments and graduates were conspicuously low in two of the three medical schools in the Gauteng province. By 2011, an almost six-fold increase in black African student enrolments was seen in one medical school that was previously designated as a white institution. In contrast, at the historically black medical school, whites only represented 0.40% of enrolments in 1999 and 7.4% in 2011. Since 1999, the number and proportion of female medical enrolments and graduates has also increased substantially. CONCLUSION: While there has been progress with redressing historical disparities and inequities in terms of race and gender, further efforts are needed to ensure that student intakes and graduations are in line with the South African population profile.

Rodent control in urban communities in Johannesburg, South Africa: from research to action.

INTRODUCTION: Rodents are troublesome urban pests, with potentially serious health implications. Preventive efforts require greater understanding of social contexts in which they are prevalent. This study aimed to determine rodent prevalence and identify factors associated with rodent infestations in urban residential settings. METHODS: The Health, Environment and Development study is a longitudinal panel study conducted in five settlements across Johannesburg. Data on socio-economic status, domestic behaviour and housing quality are collected annually. Logistic regression revealed risk factors for rodent prevalence at household level. RESULTS: Rodents are a major household problem in all study areas (prevalence 54%). Factors associated with increased prevalence of rats included lower income, living in informal areas, overcrowding, cracks in dwelling walls and internal damp. CONCLUSION: Socio-economic status, housing quality, domestic behaviour and environmental health services are associated with exposure to rodents in urban Johannesburg communities. This information served as a platform to launch rodent awareness campaigns at study sites.

The South African national health insurance: a revolution in health-care delivery!

A brief overview of the Green Paper on the National Health Insurance (NHI) policy of South Africa is presented. It describes the intention of the NHI to ensure equity, address the inequalities presented by the current private and public health system and present an ambitious plan to change the face of the South African health care system over the next fourteen years. It provides the context of the currents system that provides the case for the change. It also provides some detail on the structure of the proposed new Re-engineered Primary Health Care system as well as the future financing of this bold new health care system for South Africa. The challenge will be in its implementation.

Introduction of concept of cost centre management in a public hospital in South Africa.

BACKGROUND: Information on hospital unit costs is valuable to health policy makers, managers, and researchers. Its importance is recognised internationally by the World Health Organization (WHO) and nationally by the South African Department of Health. Although some projects had attempted to introduce this concept in South Africa, none of them became sustainable. OBJECTIVES: To identify the cost centres in a large public hospital (Johannesburg Hospital) and to determine factors influencing its implementation and lastly, to provide future directions for successful and sustainable operation through transfer of skills. METHODOLOGY: Setting of the study was Johannesburg Hospital, a public sector hospital in South Africa. The study has used context analysis technique to analyze the operational environment of the hospital. RESULTS: The study identified three types of cost centres: Overhead, Intermediate, and Final. The context analysis showed remarkable differences in comparison with Italian public hospitals. Various important factors were identified during this study, which may be classified into three broad categories: external, internal, and process. DISCUSSION: Focus of hospital management should shift from cost minimisation. It should also consider other factors such as number of patients, levels of patients, clinical outcomes, clinical governance, organisational efficiency, and organisational culture, which might play a significant role. This requires expertise in clinical economics, which is not readily available in developing countries like South Africa. Training of hospital staff in the new way of thinking, internal communication, and regular feedback are probably other important factors to its success. CONCLUSION: A stepwise approach based on proper planning and a context analysis should be used for successful implementation of this type of activity in a public hospital setting.

The Prevalence and Health Implications of Violence in Impoverished Communities in Johannesburg

Abstract:The experience of violent crime can have a significant impact on the physical and psychological well-being of victims and their families. This paper looks at household experience of violence in five impoverished sites in the city of Johannesburg; South Africa. Five sites were purposefully selected to reflect the prevailing housing profiles in settings of relative impoverishment in Johannesburg. A structured questionnaire was used to obtain information on demographic profiles; socioeconomic data; environmental conditions and health status. Bivariate analyses were conducted to assess the relationship between household experience of violence; and potential risk factors and health/social outcomes. Overall; members of 28 of households had been a victim of violence in the year preceding the study. Across sites; experience of violence within households ranged from 21 to 36. Perceptions of drug abuse (p=0.01) and drug peddling (p=0.03) as being major problems in the neighbourhood; and living in a house of poor quality (p=0.01); were significantly associated with household experience of crime. In households with experience of violence; fear of crime (p=0.03) and depression (p 0.001) were elevated; and levels of exercise in men were decreased (p

Poverty, health and policy: a historical look at the South African experience.

The resurgence of interest in links between health and development raises interesting questions about the process of research, policy-making, and implementation in the field of health and poverty. To learn about the process in South Africa, we examined three commissions of inquiry relating poverty and health -- in 1929, 1942, and the early 1980s. Power relations of the players were a decisive factor and determined the type and nature of the research conducted.

Comparative costs of inpatient care for HIV-infected and uninfected children and adults in Soweto, South Africa.

BACKGROUND: HIV/AIDS creates a massive burden of care for health systems. A better understanding of the impact of HIV infection on health care utilization and costs may enable better use of limited resources. METHODS: We compared public sector inpatient costs of HIV-infected versus uninfected adults and children at a large hospital in Soweto, South Africa. Daily hotel costs estimated from hospital financial data and total patient visits were combined with utilization, abstracted from patients' charts, and costed using government price lists to estimate total inpatient costs. RESULTS: A total of 1185 eligible records were included over a 6-week period in 2005. Eight hundred twelve were from HIV-infected patients, and of these, 77 were on antiretroviral (ARV) therapy. The mean length of stay (LOS) and mean drug and intravenous fluid utilization of HIV-infected adults not on ARVs was greater than those of uninfected adults, resulting in a $200 higher total average admission cost. Patients on ARVs had longer LOS and incurred a total average admission cost of $750 more than HIV-infected adults not on ARVs. CONCLUSIONS: Inpatient costs were greater for this selected group of HIV-infected adults, and even higher for the small proportion of individuals receiving ARVs. Budget allocations should incorporate case mix by HIV and ARV status as a key determinant of hospital expenditure.

Training of disaster managers at a masters degree level: from emergency care to managerial control.

The world has faced huge disasters over the last few decades and concerns have been expressed by nearly all international agencies involved that there is a scarcity of managerial skills to deal with the mitigation and management of disasters. Disaster risks are also on the increase throughout Africa and Southern Africa because of changes in the development process, settlement patterns and conflicts in the region. Emergency physicians are but one important resource in dealing with disasters. The need for a comprehensive multisectoral approach to disasters and more importantly to deal with its mitigation is becoming increasingly evident, especially in developing countries. Hence, the need for specially trained professionals in disaster management. In an effort to improve national, regional and continental capacity, and in support of the South African Disaster Management Act, the University of the Witwatersrand, Johannesburg, South Africa, has developed a Master of Public Health degree in Disaster Management. The MPH is aimed at preparing professionals from health and allied fields to play leadership roles in the management, improvement and evaluation of health and the health-care system. Emergency physicians have an important role to play in the development of disaster medicine and disaster management programmes and it is important that they engage in this activity, collaborating with colleagues of various other disciplines as appropriate. The following paper outlines the background to the programme and the current programme.