A Comparative Study of Drug Package Inserts of High Selling Cardiac Drugs against the Drug Regulations of Iranian Food and Drug Administration

Abstract

Background and Objectives: The Drug Package Insert (PI) is a written information provided by drug manufacturers to deliver essential information for the consumer. This study aimed to investigate quality of the labeling and content of PIs to identify if they meet the criteria of Iran’s Food and Drug Administration (FDA). Material and Methods: A cross-sectional descriptive study was used to evaluate the PPIs of top selling cardiac medications in Iran during March and September 2015 formed the population of this study. We used comparative and descriptive methods in conduction of the study. An evaluation checklist was built based on the regulations of PPI of Iranian Food and Drug Administration (FDA). The presence of criteria was considered as conformity and scored “1” and lacking the criteria was scored “zero”. The descriptive statistics parameters were used for data analysis using SPSS v.20. Results: A total of 66 PPIs of 13 cardiac drugs from top 33 selling medicines were evaluated using 27 criteria. None of the drug boxes included patient and professional package inserts separately, but the criteria of ‘general guidance to patients’ was observed in 59(89.39)of package inserts. About 64.59% of the information in PPI was consistent with the regulations of drug regulation of the FDA of Iran. All PPIs (100%) included brand name, contraindication, keeping conditions, and the name of the manufacturer. the revision date and resources observed in 4 (6.06%) and 19 (28.71%), respectively. Of total 64.59%. Conclusion : PPIs need to be improved by both quantity and quality to be appropriate use of patients and consumers.

Keywords

• drug labeling
• drug package inserts
• drug brochure
• patient information
• drug information
• cardiac medication