WHY THERE IS A NEED FOR DRUG POST MARKETING SURVEILLANCE?

Sundos Qassim*, Zakia Metwali and Yassin Al Hariri

ABSTRACT

All drug regulatory authorities have great responsibilities in ensuring the safety in addition to the quality and efficacy for all marketed drugs. Data from pre-marketing studies of drugs ensure the quality and the efficacy but lack the power to detect rare adverse drug reactions (ADRs) or events with significant latency. In view of this, post marketing surveillance play a prominent role in monitoring safety profile of marketed drugs.

Keywords: Pharmacovigilance, post marketing surveillance, Adverse drug reactions, spontaneous reporting, adverse drug events, World Health Organization (WHO).