Pharmacist Role In Drug Efficacy & Safety Implementation On FDC; A Pilot Study

Most of the patients in current scenario are treated with more than one anti-hypertensives and most often with fixed dose combinations. Hence the use and efficacy of fixed dose combination are controversial and is the most debated issue in Indian perspective  The aim of this randomized pilot study was to evaluate the rationality and side effect profile of fixed dose anti-hypertensive combinations used in our hospital. A total of 25 hypertensive patients prescribed with anti-hypertensive FDCs were randomly selected and their outpatient record were monitored and recorded for a period of 2 weeks. The data was then suitably analyzed. Out of the 13 FDCs, only one FDC (7.69%) have its APIs present in both EML of WHO and NLEM of India. There was no established evidence in terms of therapeutic efficacy and safety for the 3 combinations (23.07%).76.92% of FDCs were cost effective when compared with their individual components. 11 FDCs (84.61%) provide published literature on the reduction of either dose of individual drugs or their adverse effects. Only one FDC was found to be irrational in this study. Giddiness (33.33%) was the most frequently seen side effect among the prescribed FDCs. During this limited study period with only 13 anti-hypertensive FDCs, we were able to find an irrational FDC, which clearly show an urgent need to conduct further studies on evaluating the rationality of FDCs as a whole. As a clinical pharmacist, our immense role in evaluating the rationality of FDCs could enable the DCGI to withdraw irrational FDCs from the market.