Pharmacovigilance in developing countries

Abstract

Efforts are increasing to ensure that resource poor countries, which bear almost 90% of the global disease burden, have access to effective medicines.1 As a result, drug companies are facing increased pressure from governments, the World Health Organization, and patient lobby groups to remove legal and financial barriers to access.2 However, although these campaigns are necessary and clearly laudable, they are not accompanied by the development or upscaling of processes for monitoring drug safety. Although many drugs have been extensively used and studied in developed countries (thus informing global practice), their safety profile cannot necessarily be generalised to developing countries, where the incidence, pattern, and severity of adverse reactions may differ markedly because of local environmental and genetic influences.3

After the thalidomide disaster in the 1960s, most Western countries developed national pharmacovigilance systems.4 These systems use spontaneous reporting or other pharmacoepidemiological methods to systematically collect and analyse adverse events associated with the use of drugs, identify signals or emerging problems, and communicate how to minimise or prevent harm. Although these processes are not perfect, as exemplified by recent problems,5 they do provide evidence that can be used to institute regulatory action to protect public health.

At the global level, the WHO programme for international drug monitoring at the Uppsala Monitoring Centre collates adverse drug reaction reports via the national pharmacovigilance centres of the 81 member countries (www.who-umc.org). However, currently only six sub-Saharan African countries (South Africa, Zimbabwe, Tanzania, Mozambique, Nigeria, and Ghana) are full members of the programme. In fact, less than 27% of lower middle income and low income economies have national pharmacovigilance systems registered with the WHO programme, compared with 96% of the high income countries in the Organisation for Economic Co-operation and Development. The main reasons for this are lack of resources, infrastructure, and expertise. Thus, although access to medicines is increasing in developing countries, there is a danger that their risk benefit profiles in indigenous populations will not be fully monitored and acted upon.