Pharmacovigilance Practices and Activities: Issues, Challenges, and Future Direction

The recent past has seen a rise in awareness regarding pharmacovigilance among stakeholders in developing countries, designated as low- and middle-income countries. The World Health Organization has established guidelines for setting up and running pharmacovigilance centers, and many countries have established their national pharmacovigilance program. Despite increasing awareness and the establishment of pharmacovigilance centers, underreporting is widely recognized as a major limitation. A reporter-friendly adverse drug reaction reporting form, preferably in a local language and with the use of simplified medical terminologies, may be helpful in improving reporting rates. It is important to incorporate new mechanisms for herbal drugs, fixed-dose drug combinations, food supplements, neglected and tropical diseases, and medical devices to capture the vast majority of adverse drug reactions that are not traditionally observed in hospitals. The involvement of consumers and drug manufacturers may provide a more convincing approach to improve reporting. The ultimate success of a pharmacovigilance program depends on commitment from the government and a collaborative approach among all the key stakeholders.