Publication:

Perception of doctors towards Adverse Drug Reaction (ADR) reporting: a cross sectional survey using a validated questionnaire

Background Several studies have shown lack of sufficient knowledge and awareness among doctors on ADR reporting. Knowledge and attitude of doctors about ADR greatly influences extent of reporting. Identifying factors affecting ADR-reporting is vital to enable Pharmacovigilance teams to implement interventions to enhance rate and quality of reporting of ADRs. Hence, this study is done to evaluate perceptions of doctors towards ADR-reporting and to determine barriers for reporting ADR.

Methods Cross sectional study conducted among doctors using a validated questionnaire to assess knowledge, attitude, practice and barriers for reporting ADRs. The questionnaire captured the demographic details, knowledge (14), attitudes (7) and practice pattern (4) towards pharmacovigilance. Descriptive statistics was used to assess the response among doctors.

Results Of 157 doctors who responded to questionnaire, 90% of doctors were aware of pharmacovigilance program mainly through PVG activities by AMC and pharmacology classes. Only 47% doctors reported ADRs. The composite score on knowledge of ADR reporting and on knowledge of ADR burden was found to be moderate. 90% doctors opined ADR monitoring in hospital should be mandatory. 83% doctors opined ADR reporting by one person can make significant difference to community. One-third doctors felt there should be financial reward for ADR-reporting. In suspected cases, 57% doctors include ADR as differential diagnosis. 61% doctors said they will document ADR in patient file and 78% reports to AMC. More than one-third doctors don’t know where and how to report ADR. One-third doctors felt management of patients was more important than reporting ADR. Nearly one-fourth didn’t report fearing legal liabilities, difficulty diagnosing ADR and negative impact on doctors.

Conclusions Knowledge about ADR-reporting and attitude towards it is adequate. But, because of many barriers, actual practice of ADR-reporting is unsatisfactory. Hence, Pharmacovigilance training is essential for doctors to promote and improve ADR-reporting.