Problems and challenges faced in consumer reporting of adverse drug reactions in developing countries A case study of Yemen, Nepal and Malaysia.

ABSTRACT

Background: Pharmacovigilance is the “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems”. The most commonly used adverse drug reaction (ADR) reporting system worldwide is spontaneous and voluntary reporting, which forms the backbone of reporting systems. Aims: To explore the current status of consumer involvement in the pharmacovigilance program in three developing countries, Yemen, Nepal and Malaysia. Method: An analysis was carried out for these three countries based on the current status of pharmacovigilance and involvement of consumers in their pharmacovigilance programs. Results: Malaysia has a good system for involving consumers in their national pharmacovigilance system, whereas Yemen still lacks the well-formed national drug policy. Lack of legislation and regulation which govern the import and distribution of drugs in Yemen is a limiting factor for development of consumer pharmacovigilance. Despite establishment of a pharmacovigilance centre, no reports have been released by the centre. The status of pharmacovigilance in Nepal is still in infancy. The regulatory body is assigned to be a national pharmacovigilance center, and coordinates with seven regional centers for pharmacovigilance activities. Nepal also lacks the involvement of consumers in the national pharmacovigilance program. Conclusion: Consumer reporting may be important for developing countries to implement a proper and effective pharmacovigilance program that can reduce morbidity and mortality rates, as well as reducing the economic burden of ADRs.