Abstract:
Aim: To evaluate the Package inserts (PIs) for presentation, accuracy, completeness of clinical information and grade them according to the scores obtained. Material and Methods: An observational study conducted by the Department of Pharmacology, Sri Devaraj Urs Medical College from March to August 2014. PIs were analyzed for five leaflet characteristics and for 25 criteria listed by the Indian Drug and Cosmetic Rules, 1945. Each criteria was scored for presence of information as ‘1’, absence as ‘0’. Total score of >20 was graded as ‘A’, 10-20 as ‘B’ and <10 as ‘C’. Data was expressed as percentage. Results: Three hundred and sixty three PIs were analyzed. Considering the quality and texture, 80.2% were categorized as good and 19.8% as bad. All PIs were legible. Generic names were used in 99.2%. Content of active ingredients, indication for use were listed in 96.9% and 99.2% respectively. Posology details were mentioned in 97.2% and contraindications were given in 91.5% PIs. Undesirable effects were listed in 92.6%. Manufacturer’s name and address was provided in 88.1%. PI with grade A, B and C were 10.2%, 83.8% and 6.1% respectively. Conclusion: Majority of the PIs were of grade B which suggests that most of the relevant information was mentioned except few criteria.
Key words: Information tool, Package insert, Rational prescribing, Posology, Generic name.
