Comparative Study of Patient Package Inserts of Anti-diabetic Commonly Used Medications Produced in Iran with the Standards of Ministry of Health and Medical Education

Abstract

Introduction: Patient package insert (PPIs) is a source of information available to patients, physicians and pharmacists. If, the PPIs are designed on the principles of rational medicine for patients, but unfortunately most PPIs do not have the required standard. Purpose: The aim of this study was to investigate the compliance of high-consumption Iranian anti-diabetic drug PPIs with the standards of the Ministry of Health and Medical Education in 6 areas including principles of writing, principles of drug description, citation of references, warnings, interactions and side effects. Methods: In this study, 110 PPIs related to high-consumption anti-diabetic drugs from 44 Iranian pharmaceutical companies were collected from various pharmacies in Tabriz and Khoy and their compliance with the standards of the Ministry of Health and Medical Education were investigated. Evaluations were repeated every two weeks or every month to reduce possible errors. In order to obtain quantitative information, PPIs were rated; For each item that was observed in the PPIs, a score of one and for non-compliance, a score of zero was considered. Results: Mean Total compliance of PPIs with the standards was 62.81%. In the six studied areas, the description of the drug with 79.16% showed the highest and the citation of references with 33.40% showed the least compliance with the standards. Warnings and precautions 65.18% were in accordance with the standards. Drug interactions and side effects followed the standards with 53.18% and 60.38%, respectively. Conclusion: Based on the results, it was found that the PPIs of high-consumption anti-diabetic drugs according to the standards of the Ministry of Health and Medical Education do not have the desired quality and up-to-date information; Therefore, close supervision of Iran's Food and Drug Administration in this regard is necessary to correct them by pharmaceutical companies.