Abstract

ASSESSMENT OF RATIONALITY OF FIXED DOSED COMBINATIONS (FDCs) PRESCRIBED IN MEDICINE OUTPATIENT DEPARTMENT OF A TERTIARY HEALTHCARE INSTITUTE

Dr. Abhilasha Rashmi*, Dr. Sudhir Pawar, Dr. Swapnil Jamdade and Dr. Pranesh Pawaskar

ABSTRACT

Background: Fixed Dose Combinations (FDCs) are defined by WHO as combination of two or more active ingredients in a fixed ratio of doses. As the risk-benefit assessment is essential before choosing a combination therapy, this study was done about the presence of CDSCO/ WHO listed FDCs in the OPD prescriptions and their rationality assessment. Methods: It was done by the Department of Pharmacology from September 2017 to February 2018. All prescriptions from Medicine OPD of a tertiary healthcare hospital were screened for FDCs. Each FDC was checked for its presence in recent CDSCO and WHO essential medicines list. Parameters recorded were- 1. Name of combination drugs with doses. 2. Drug class. 3. Year of approval by CDSCO. 4. Rational/ Semi rational/ Irrational based on Rationality Scoring Scale. Rationality assessment was done according to standard reference books. Drug interactions were checked by the “Drug Interaction Checker” provided by www.webmd.com. Results: Number of prescriptions analysed were 700, in which 241 (34.4%) FDCs were present. Due to repetitions, actually 31 categories of FDCs were found. Out of these, 25.8% were rational, 70.9% semi rational and 3.3% irrational. 67.7% were approved while 32.3% not approved by DCGI. 80.9% of them were approved after the year 2000 and rest before that. Among the nonapproved FDCs, 20% were rational and 80% semi rational. Conclusions: Though the prevalence of FDCs in the prescriptions is high, only about 26% of them fulfil the rationality criteria. About 68% FDCs were DCGI approved while 32% were not. Hence, drug regulatory bodies should take urgent action to stop the free flow of irrational FDCs and to encourage rational FDCs.

Keywords: Fixed dose combinations, Rationality scoring scale, Rational, Semi rational, Irrational.