Why Pharmacovigilance and Adverse Drug Reaction Reporting practices lacks in developing countries; a case study from Pakistan

Objectives: Pharmacovigilance (PV) has the topmost significance in the world, but unluckily, it is not focused in the developing countries like Pakistan. The purpose for this research study is to measure the knowledge, attitude and practice of adverse drug reactions (ADR) reporting and explore the causes of poor ADR reporting behavior among healthcare professionals (HCPs) and patients. Material & Methods: A Cross sectional research carried out in January-March 2021 in major cities of Pakistan. The separate questionnaires were adopted for HCPs and patients. Regression analysis using Statistical Package for Social Sciences (SPSS) was performed. Results: 362 questionnaires were circulated and response rate was 83.4%(n=302). The results revealed that, only 18% of HCPs were aware of the term pharmacovigilance and understand its basic function. However more than 50% of the HCPs mentioned that ADR reporting is neither essential and nor compulsory in their clinical setups while 82.4% of them were not aware where to report ADR in their hospital. 90% of the patients did not have any knowledge and mentioned that their physicians never guided them about ADR reporting. Only 10% patients were aware about ADR but did not know how to report. Conclusions: Above empirical findings suggest that HCPs have inadequate ADR reporting knowledge, practice and lack appropriate behavior, norm and realization of its importance in patient safety. However HCPs and patients have positive attitude towards ADR reporting and need awareness training, simplification of reporting mechanism and appropriate regulatory control. Awareness drive needs to be created in general population to sensitize them on their responsibility towards side effects reporting.

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