ABSTRACT
OBJECTIVE: Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration policies in these countries poses a challenge for pharmaceutical companies wanting to register medicines in these countries. The recent AMRHI (African Medicines Registration Harmonisation Initiative) has increased the focus on the need for harmonisation. Medicines registration regulations differ across African countries. Anecdotal evidence, based on the experience of pharmaceutical companies on progress towards harmonisation is somewhat different, i.e. that country specific requirements were a barrier to the registration of medicines. The objective of this study was therefore to determine the nature and extent of regulatory hurdles experienced by pharmaceutical companies who wish to register and supply medicines to African countries. METHODS: This cross-sectional descriptive pilot study was conducted across pharmaceutical companies, both local and multinational. These companies were based in South Africa and were also members of Pharmaceutical Industry Association of South Africa (PIASA). The pharmaceutical companies supply both the private and public sectors. An online survey was developed using Survey Monkey. Survey questions focused on the following strands: nature and level of current supply of medicines to African countries by companies, general regulatory requirements, region specific questions and country specific questions across four regional economic communities in Africa, namely; Southern African Development Community (SADC), East African Community (EAC), Economic Community of the West African States (ECOWAS) and Economic Community of Central African States (ECCAS). RESULTS: A total of 33 responses were received to the questionnaire of which 26 respondents were from the PIASA Regulatory working group and 7 were from the PIASA Export working group.It was noted that since most of the regulatory authorities in Africa are resource-constrained, harmonisation of medicine registration policies will contribute positively to ensuring the safety, quality and efficacy of medicines. The experience of pharmaceutical companies indicated that country specific regulatory requirements are a barrier to registering and supplying medicines to African countries. In particular, GMP inspections, GMP inspection fees and country specific labeling were cited as key problems. CONCLUSION: Pharmaceutical companies operating in African markets are experiencing difficulties in complying with the technical requirements of individual African countries. Further research is required to provide a balanced perspective on the country specific regulatory requirements vs. the African Regulatory Harmonisation Initiative (AMRHI).
ABSTRACT
OBJECTIVE: Namibia faces a dual burden of HIV/AIDS and tuberculosis (TB). In 2010, HIV prevalence was 18.8%, the TB case notification rate was 634 cases per 100,000 population and the TB/HIV co-infection rate was 58%. There were 372 cases of drug-resistant TB (DR-TB) in 2009. The objective of this study was to assess the prevalence, profile and outcome of adverse events (AEs) associated with treatment of DR-TB and to explore possible influences of HIV disease on the occurrence of adverse events. METHODS: This was a cross-sectional descriptive study. After ethical approval, data were collected from treatment records of all patients treated for DR-TB at the study facility between January 2008 and February 2010 using a structured data collection form. RESULTS: A total of 141 adverse events of varying severity were experienced in 90% (53/59) of patients.The TB/HIV co-infection rate was 53% (n=31). The prevalence of gastrointestinal tract adverse events (abdominal pains, constipation, diarrhea, nausea and vomiting) was 64%, tinnitus 45%, joint pain 28%and decreased hearing 25%. Abdominal pains, rash, nausea, decreased hearing and joint pain were more common in HIV infected than in HIV uninfected patients. CONCLUSIONS: Adverse events of varying severity are common during treatment of DR-TB, particularly in the intensive phase of therapy. Some adverse events were more prevalent in DR-TB patients co-infected with HIV. The study concludes that the characteristics and risk factors of serious adverse events should be further examined.