A Qualitative and Quantitative Comparison of Adverse Drug Reaction Data in Different Drug Information Sources.

Background: For safe use of medicines, awareness regarding the existing knowledge of adverse drug reactions (ADRs) is essential to prevent, identify, and manage them.

Aim: The present study is planned to assess variation in documented ADRs of antihypertensive drugs in various sources of drug information.

Material and Methods: A cross-sectional, observational study was undertaken to analyze the different sources of ADRs-related information. Textbooks, National Formulary India (NFI), Drug Today (DT), and Current Index of Medical Specialties (CIMS) were analyzed for ADRs pertaining to nine antihypertensive groups comprising a total of 44 drugs. ADRs were categorized according to body systems, tabulated, and compared. Quantitative and qualitative analyses of ADRs and serious ADRs were done.

Results and Discussion: Textbooks mostly provided ADRs of drug groups as a whole and not of individual drugs. None of the analyzed sources mentioned all antihypertensive drugs. DT contained information for the maximum number of drugs studied (81.8%) and NFI gave information for 29.7% drugs only. There was a wide variability among various resources while listing ADRs. NFI listed the maximum number of total ADRs, and least ADR information was provided by DT. NFI mentioned the maximum number of serious ADRs (47) for prototype drugs followed by CIMS (36) and DT (8). The quality of data was better in NFI, but none of the resources studied were found to be complete.

Conclusion: No source of information was complete in providing wholesome information of ADRs studied, and there was a wide variability in describing them.