A SIX MONTH PROSPECTIVE-OBSERVATIONAL STUDY ASSESSING ADVERSE DRUG REACTION MONITORING METHODS AND REPORTING PATTERNS IN A NASCENT ADVERSE DRUG REACTION MONITORING CENTRE OF A TEACHING TERTIARY CARE HOSPITAL
Dr. Zubair Ahmad Ashai*, Dr. Muzaffer Ahmad Pukhta and Dr. Zorawar Singh
ABSTRACT
Pharmacovigilance is detection, assessment and prevention of adverse reactions or any other possible drug related problems. India joined WHO programme for adverse drug reaction monitoring and started pharmocovigilance programme of India which collects adverse drug reactions on spontaneous basis. Consequent upon the start of Pharmacovigilance Programme, after sensitization we started collecting ADRs. The total number of ADRs collected were 76 out of which Medicine department contributed 54(71.05%), Dermatology department 16 (21.05%) and Surgery department 4 (5.26%) over a period of six months. The number of spontaneous ADR reports received were 8 as compared to actively collected ADR reports which were 68, indicating under reporting of ADRs by spontaneous reporting. The active surveillance not only picked up ADRs equally from OPD and IPD but also those ADRs which required admission to the hospital indicating more holistic reporting with active surveillance. Overall the commonest class of drugs causing ADRs were Anticonvulsants (30)39.47%, Antimicrobials 20(26.31%), Anti psychotics 10(13.15%) and Antihypertensives 5(6.57%). Commonest serious ADRs causing class of drugs were Antimicrobials 17(85%), Anticonvulsants 12(40%) and Antihypertensives 1(20%) as compared to other studies. Our results indicated spontaneous reporting should not be relied upon as a large number of ADRs including serious ones are missed.
Keywords: Pharmacovigilance, Adverse Drug Reaction, Monitoring, Surveillance.
[Full Text Article]
[Download Certificate]
Impact Factor : 8.181 
