No abstract

Objectives: To analyze the rationality of central nervous system fixed dose combinations used in a tertiary care hospital. Methodology: The study was an hospital based observational study. The data was collected from an annual drug compendium entitled “Hospital Drug List”. Fixed dose combinations (FDCs) enlisted in central nervous system (CNS) sections were selected for the study purpose. The active pharmacological ingredients (APIs) in FDC was checked for approval by Drug Control General of India (DCGI), World Health Organization (WHO) and essential medicine (EML)/national essential medicine list (NEML),both or none and all the ingredients (molecule, excipients) present in the FDC was checked whether banned or under any controversies in India as well as worldwide.  Efficacy and safety of the individual active pharmacological ingredients (APIs) and their combination were searched. Details of each drug were collected [Generic name, Pharmacokinetics, Interaction affected, Pharmacodynamics, and Advantages of FDCs]. The data collected was analyzed by a tool to assess the rationality of fixed dose combinations which is pre-tested and validated by Shah et al., based on WHO guidelines. Result and Discussion: A total of 25 CNS FDCs were taken, on assessment of CNS FDCs 21 (84%) were found to be rational and 4 (16%) were found to be irrational with the mean rationality score of 7.2. By winding up, state of nonbeing, absenteeism of legality and effectiveness of the formulations appeared in to a peculiar combinations and inadequate practice. The approval process of these combinations by various committees should be robust. Keywords:  Rationality; Fixed Dose Combinations; CNS Drugs; Safety and Efficacy.