Knowledge, attitude and practice of pharmacovigilance among Nepalese health professionals

Introduction: Although Nepal joined the WHO program for International Drug Monitoring in 2006, published data about Nepalese health professionals’ understanding of pharmacovigilance and spontaneous reporting of adverse drug reactions (ADRs) is limited. Objectives: The purposes of this study were to: (1) investigate awareness, knowledge, attitude, and practice (KAP) of pharmacovigilance among health professionals and (2) gain insight into the ADRs reported for statins in Nepal. Methods: 125 health professionals (doctors, pharmacists/assistant pharmacists, and nurses) were recruited from health care institutions (hospitals, clinics, pharmacies) in Kathmandu, Nepal. Electronic and paper survey data were collected with the use of a validated questionnaire between April and December 2018. The multiple-choice questionnaire was structured to assess the KAP of pharmacovigilance, and ADRs associated with statins, and consisted of two open-ended questions for health professionals to give suggestions for the improvement of the pharmacovigilance system. Statistical Package for the Social Sciences (SPSS, version 25) was used to analyze the demographic and pharmacovigilance data. The main outcome measures were KAP of pharmacovigilance and ADRs reported for statins. Results:100 (80%) participants (44 doctors, 32 pharmacists / assistant pharmacists, 24 nurses) completed the self-administered questionnaire. Pharmacovigilance knowledge, attitude, and practice scores were 71%, 81%, and 53%, respectively. There was a significant difference between the number of knowledgeable health professionals (71 vs. 29%, p < 0.05) and had a favorable attitude (81 vs. 19%, p < 0.05) toward pharmacovigilance and ADR reporting compared with those who did not. The number of participants who did not report ADR was higher than those who did (90 vs. 10%, p < 0.05). The adverse reactions associated with statins were muscle symptoms (62%), elevated activity of liver enzymes (24%), and gastrointestinal symptoms (9%). Conclusion: Despite the knowledge and willingness of health professionals to report ADRs, the practice of pharmacovigilance remains low in Nepal. There is a need for clear and enforceable regulations for monitoring and reporting ADRs, and effective educational interventions to promote pharmacovigilance practices.