Specific features of medicines safety and pharmacovigilance in Africa

Abstract

The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products. The developed countries rose to the challenge putting in place systems to ensure the safety of medicines. However, this was not the case for low-resource settings because of prevailing factors inherent in them. This paper reviews some of these features and the current status of pharmacovigilance in Africa. The health systems in most of the 54 countries of Africa are essentially weak, lacking in basic infrastructure, personnel, equipment and facilities. The recent mass deployment of medicines to address diseases of public health significance in Africa poses additional challenges to the health system with notable safety concerns. Other safety issues of note include substandard and counterfeit medicines, medication errors and quality of medicinal products. The first national pharmacovigilance centres established in Africa with membership of the World Health Organization (WHO) international drug monitoring programme were in Morocco and South Africa in 1992. Of the 104 full member countries in the programme, there are now 24 African countries with a further nine countries as associate members. The pharmacovigilance systems operational in African countries are based essentially on spontaneous reporting facilitated by the introduction of the new tool Vigiflow. The individual case safety reports committed to the WHO global database (Vigibase) attest to the growth of pharmacovigilance in Africa with the number of reports rising from 2695 in 2000 to over 25,000 in 2010. There is need to engage the various identified challenges of the weak pharmacovigilance systems in the African setting and to focus efforts on how to provide resources, infrastructure and expertise. Raising the level of awareness among healthcare providers, developing training curricula for healthcare professionals, provisions for paediatric and geriatric pharmacovigilance, engaging the pharmaceutical industries as well as those for herbal remedies are of primary concern.

Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey

“…These responses suggest that the HCPs involved in these CEM programmes had not fully appreciated the rationale for undertaking the CEM study and that pharmacovigilance activities should be considered an integral component of patient care. Although the number of developing countries that have joined the WHO Programme for International Drug Monitoring has increased sharply in recent years [23, 24], pharmacovigilance in many of these countries is not yet seen by HCPs as contributing to clinical decisions and improving treatment outcomes. There is a need for greater pharmacovigilance advocacy and training for HCPs to encourage their ongoing participation in future CEM studies.…”

Pharmacovigilance in resource-limited countries

“…This process took several decades in high-income countries where under-reporting is still a major problem [57]. Recent surveys have demonstrated major gaps and shortcomings in national PV programs in resourcelimited countries, including the paucity of regulatory decisions based on local information [58][59][60]. As the market for newly introduced and expensive medicines in these countries are normally very small, their PV systems should focus on identifying preventable problems related to the use of well-established medicines used by many patients.…”

Awareness and Reporting of Antiretroviral Adverse Events among Clients and Health Care Providers at Kilimanjaro Christian Medical Centre: A Cross-Sectional Study

“…11 In Africa, pharmacovigilance has been progressively growing and its importance in the health-care system is being increasingly realised. 12 Previous studies suggest that HCPs were not reporting due to inadequate knowledge on how to fill the ADR forms and the unavailability of the reporting forms. 10 In 1993, Tanzania officially became a member of the WHO international drug monitoring programme.…”