Abstract : 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 prospective observational study was to evaluate the rationality of fixed dose anti-hypertensive combinations used in our hospital. The study was conducted in the cardiology department of multispeciality tertiary care hospital in South India. A total of 150 hypertensive patients prescribed with anti-hypertensive FDCs were randomly selected and their outpatient records were monitored and documented in a specially designed proforma for a period of six months. During the study period, 150 patients met the selection criteria, a total of 26 different anti-hypertensive FDCs were found, among them 9 were irrational. Among the 26 different anti-hypertensive fixed dose combinations analyzed, 19 FDCs (73%) were found to be rational and 7 combinations (27%) were found to be irrational for using in hypertension with a mean of 8.6 ± 2.7. During this limited study period with only 26 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.
The Indian laws are not properly defined to grant marketing approvals of FDCs by State or Central Drug Controlling Authorities. Hence this study enlightens the role of clinical pharmacist in defining the efficacy, safety, suitability, rationality & withdrawal of FDCs.