Background: There is a growing concern about the increasing number of irrational fixed-dose combinations (FDCs), which impose unnecessary financial burden, increase the occurrence of adverse drug reactions, and ultimately reduce the quality of life.
Aims and Objective: To study the prescribing frequency of FDCs and to evaluate the rationality of FDCs prescribed in psychiatric patients.
Materials and Methods: This prospective study was carried out in Pharmacology and Psychiatry Department of a tertiary care teaching hospital in Rajasthan, India. The data were collected in a case record form from patients of all ages and from either sex, who visited the outpatient department of psychiatry. Data were analyzed with the help of well-known comprehensive seven-point criteria by Panda et al, which were developed by carefully studying the guidelines of the World Health Organization and Committee for Proprietary Medicinal Products, Europe.
Result: Total 383 drug formulations were prescribed in 200 patients of which 107 (27.93%) were in the form of FDCs. Most frequently prescribed FDC was escitalopram + clonazepam (22.44%), followed by amitriptyline + chlordiazepoxide (13.08%). The maximum score for the seven-point criteria for assessing the rationality of FDCs was 14, with each criterion carrying a score of 2. Scores obtained in this study ranged between 5 and 14 with an average of 8.79.
Conclusion: Most of the FDCs were irrational according to the criteria used and only 28.57% of the FDCs were found to be rational considering safety and efficacy as the most important criteria for rationality. So, drug regulatory bodies should take urgent action to stop the free flow of irrational FDCs.
Key words: Rationality; Irrational; Fixed-Dose Combinations; Drug Regulatory Bodies
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