comparative review of package inserts with the criteria of package inserts of IRI FDA and US FDA

Abstract

Abstract Introduction: Patient package insert (PPI) is the first and highly applied source of drug information for the patients studying PPI Aim: The purpose of this study was to evaluate the compliance of the top selling PIs in Iran, 21March 2014 to 22September2014 with the r of the guidebook of the Food and Drug Administration of Iran and the United States, as well as to examine the readability and comprehensibility of the drug guide sheets and evidence-based information Pls Methods and material: 158 patient package insert for top selling oral drugs during march to September 2015 stated by social security organization,. The latest guidelines for the Food and Drug Administration regulation of Iran and the United States were prepared and the checklist was extracted from the titles. The readability of the Pls was calculated using the Flesch-Dayani Reading, and for the purpose of checking the evidence based on the information contained in the PPls, a database was used to search for evidence-based suggestions. Result: The findings indicate that information on issues such as drug use, drug contraindication, and side effects are seen in most of the PPIs. However, the references to the date and time of reviewing the PPIs are the ones found in most PPIs. The drug has been ignored. Calculating the readability of the PPIs indicates that the PPIs in Iran have been written at grade 11-10th levels and are not appropriate for the general public's literacy level. In the case of evidence-based discussion, most PIs have been based on clinical evidence of drug use. Conclusion: The results of study showed that the general percentage of conformity was not acceptable and it required the improvement and conformity of information from quantitative and qualitative aspects for the patients and consumers.