Journal of Pharmacovigilance

A study on analysis of fixed drug combinations widely prescribed in India

3^rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

October 27-29, 2014 Hyderabad International Convention Centre, India

Bettina Lavanya Magdaline S, Vasanthi C and Darling Chellathai

Scientific Tracks Abstracts: J Pharmacovigilance

Abstract:

Objective: Fixed drug combination is the combination of two different drugs in a single pharmaceutical formulation. Rational FDC?S of two drugs can be advantageous, but inappropriate combination could be dangerous. The advantages are convenient in Dose Scheduling, Patient Compliance, Enhanced Effect and Minimisation of Side effects. The disadvantages are the pharmacokinetics characteristics of two drugs may not match and dose of any component may not be independently adjusted. The identification of adverse effect of particular component is difficult. FDC are widely prescribed in India for various therapeutic targets. Hence this study was undertaken to analyse the FDC commonly prescribed in India. Methodology: Data of the widely prescribed FDC using CIMS, CIMS Asia.com, Medscape, Indian drug review, local hospital drug Formulary etc. were collected. It was analysed the data comparing with the FDC in the WHO list and NLEM (National List of Essential Medicines) 2011. Results: From the analysis of the data it was found that around 70 FDC do not comply with the criteria developed by essential medical list of WHO or NLEM of India or both. Out of the 70, 23 were with antibiotics, 20 with analgesics and remaining with sedatives, antihistamines and vitamin preparation. Very few FDC, even contain banned drugs. Conclusion: Hence it is claimed the FDC are valuable therapy and also widely prescribed and they need to be developed based on the rationality of pharmacokinetic and pharmacodynamic parameters and clinical studies are needed to evaluate the safety and efficacy.

Biography :

S Bettina Lavanya Magdaline has completed her MBBS in Balaji Medical College. At present she is pursuing MD Pharmacology (1st year) in Sri Ramachandra Medical College.