Overview and Comparison of Postmarketing Drug Safety Surveillance in Selected Developing and Well-Developed Countries

Abstract

Objectives: After a series of drug withdrawals, the US FDA and the European Medicine Agency implemented risk management guidelines to improve existing pharmacovigilance and drug safety surveillance, but in the developing countries drug safety surveillance remains largely unclear. The purpose of this study was to review the current status of postmarketing surveillance in developing countries as defined by low- and lower-middle-income economies and to compare it with developed countries as defined by high-income economies.

Methods: Using Medline, Cochrane, and other Internet-based search engines, an extensive literature review was performed to identify and evaluate postmarketing drug safety surveillance systems in some developing and well-developed countries. Focus areas were on drug safety regulation, government organization, adverse drug reaction (ADR) reports, and safety monitoring systems. The available data in nine developing countries were compared with that in three developed countries.

Results: There were over 4 million ADR reports worldwide based on the 2006 WHO adverse event reports. About 10% are from developing countries. Eight out of nine selected developing countries have established pharmacovigilance centers, and some of them, like China, Malaysia, and Chile, appear to be actively involved in postmarketing surveillance with different strategies for pharmacovigilance. While Malaysia and China have included drug safety surveillance for traditional medicine, South Africa has focused on antiretroviral drug safety. A paucity of trained and experienced personnel, low literacy rate, limited financial resources, and lack of medication and regulatory guidelines appear to be their major obstacles.

Conclusion: The improvement of drug safety surveillance in the developing countries requires increasing awareness, positive regulatory policy, improving the infrastructure, and better strategies. A cooperative and exhaustive effort by the regulatory authorities and physicians as well as the pharmaceutical industry will be needed to create a functioning pharmacovigilance system in these countries.