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

Abstract

Introduction: Patient package insert (PPI) is a source of available information to provide written instructions to patients, pharmacists and physicians. PPIs play an important role in increasing patients medical acceptance. If these PPIs are designed according to the correct principles, can be effective in rational use of medicine. Purpose: This study was conducted to evaluate the compliance of asthma PPIs commonly used medications produced in Iran with the standards of the Ministry of Health and Medical Education in 6 aspects including principles of writing, principles of drug description, warnings, interactions, side effects and resources. Method: All PPIs were collected from pharmacies in Tabriz and Ardabil between December 2020 and August 2021. Then their compliance with the standards was evaluated. In order to minimize the error, the evaluations were repeated two weeks to one month later. In order to obtain quantitative information, the PPIs were scored and for each criterion that was observed, a score of one hundred was given to that criterion and if the criterion was not observed, a score of zero was assigned to that criterion. Results: The compliance of the PPIs with the standards was 63.11%. In the 6 aspects studied, the description of the drug showed the highest compliance (87.29%) and the resources of the lowest compliance (26.82%) with the standards. Warnings were 71.1% in accordance with the standards. Drug interactions and side effects also followed the standards of 72.19 and 51.2%, respectively. Conclusion: It was found that asthma PPIs are not of good quality according to the standards .Therefore, there is a need for pharmaceutical companies to make reforms and bring them in line with the standards. This requires effective and serious oversight by the Food and Drug Administration.