A Study on Medication Information in the Package Inserts of Pediatric Antibiotics in Iran

Patient package inserts (PPIs) are the most important and accessible source of information for patients which is expected to contribute with the safe and efficient use of medicines. However, the information in the PPIs is not always appropriate and complete, and may lead to medication errors. The purpose of this study was to evaluate the conformity of pediatric antibiotics’ PPIs with the standards of Iran’s Food and Drug Administration (FDA).

This descriptive cross-sectional study evaluated 51 PPIs related to 13 best-selling pediatric antibiotics in Iran based on the criteria approved by Iran’s FDA. Six categories of criteria as writing and formatting, drug description, warnings and precautions, side effects, interactions, and references were considered in evaluating the extent of conformity.

 In total, 2652 items from 51 PPIs were evaluated. The PPIs content was insufficient in various aspects of conformity with standards in each category (54.8%). Among the six categories, the best match was found in warnings and precautions with 359 items (70.3%). The lowest conformity was found in the reference category with 76 items (18.6%).

 The PPIs of Iranian pediatric antibiotics do not fully meet Iran’s FDA standards. It is strongly recommended that the drug leaflets must be updated based on the standards of Iranian Ministry of Health and Medical Education to overcome this problem.