Starting a pharmacovigilance program within a teaching hospital: Challenges and experiences from Lalitpur, Nepal

Pharmacovigilance plays an important role in the rational use of medicines by providing information about adverse drug reactions (ADRs) in the general population. Knowledge of ADRs caused by drugs is important for effective treatment. KIST Medical College has recently joined the national pharmacovigilance program as a regional center. Clinicians, pharmacists, house officers, nurses and other staff are encouraged to report ADRs to the center. The center started functioning from mid-July 2008. The objective of this study was to report the various ADRs presented to the center in its first seven months of operation. Doctors and other health care professionals were briefed regarding the ADR reporting system. An ADR reporting form was designed and circulated to all the departments in the hospital. The reported reactions were analyzed for causality, severity and preventability using different scales. To date, thirty six ADRs have been reported. The majority of the reports (23) were from the Department of Medicine. Other departments like Pediatrics, Obstetrics-Gynecology and Radiology have also reported ADRs. As per the causality assessment, 21 (58.3%) reports were found to be "possible" and 15 (41.6%) were found to be probably associated with the named medication. With respect to severity, 17 (47.2%) reports were mild and 19 (52.7%) were moderate. As per the preventability scale, 8 (22.2%) ADRs were definitely preventable while 28 (77.7%) were not preventable. The ADRs are reported to the Uppsala Monitoring Center through Vigiflow via the Department of Drug Administration.