Safety monitoring of drugs--where do we stand?

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.