Publication: Safety monitoring of drugs - Where do we stand?
Date
2006
Journal Title
Journal ISSN
Volume Title
Publisher
Kathmandu University
Abstract
Drug related complications, a major cause of hospitalizations, lead to huge economic burden and significant human
suffering. New chemical entities enter the market without sufficient safety data on patient population making rare
(Adverse Drug Reactions) ADRs undetected in the clinical trials. ADR monitoring helps in detecting the occurrence
of rare and unknown ADRs and helps in prevention of further occurrence. Several methods are adopted for effective
monitoring of ADRs. An effective ADR monitoring program requires adequate infrastructure and trained manpower.
In developed countries, the ADR monitoring system is well established. In Nepal, the concept of ADR monitoring is
in the infant stage. A simple approach for ADR monitoring may be helpful in starting an ADR monitoring program
in hospital setups in Nepal. Though it is difficult to prevent ADRs, a systematic approach will definitely helps in
minimizing the further occurrence of similar ADRs.
Key words: Adverse Drug Reactions, Causality assessment, Pharmacoeconomics, Pharmacovigilance, Safety
monitoring