Abstract

REFINED INFORMATION NEEDED IN PACKAGE INSERTS OF ANTI-MICROBIAL DRUGS CURRENTLY AVAILABLE IN INDIA

Swapan Kumar Dutta*, Himangshu Mahato, Tanima Saha, Swati Bhattacharyya, Supreeti Biswas.

ABSTRACT

Objective: Accurate and reliable product information is essential for the safe and effective use of medications, thereby our aims were to survey the presentation and completeness of important clinical information provided in t he package inserts for anti-microbial drugs in India. Methods: Package inserts accompanying anti-microbial medications were collected over a period of four weeks from pharmacies surrounding a Tertiary Care Hospital of Eastern India. They were analysed as per Indian Drugs & Cosmetic Rules 1945, for clinically important information. Results were interpreted in absolute number and percentage. Results: During the period of survey 500 (Five hundred) package inserts were collected, out of which fifty (50) were discarded as they were not anti-microbial. Most of the inserts satisfied the requirements regarding information provided about dosage, indications, contra-indications, pharmacodynamics, pharmacokinetics, adverse effects, drug interactions and safety alerts etc. Complex technical terms were found in most inserts. Information regarding safety in paediatric and geriatric groups was inadequate in some. Conclusion: Refined information needed to be given in package inserts to minimize the risks to the patients. Pharmaceutical companies should be more careful to ensure that complete and relevant information is provided to the patients in a lucid language to make it comprehe nsive and easily understandable for better patient compliance for the benefit of the patient.

Keywords: Package inserts, Eastern India, anti-microbial.