The Quality of Iranian and Foreign Patient Package Inserts: What do Pharmacists Say?

Yadollah  Azarmi; Moslem  Najafi; Zahra  Gholizadeh-Gharbalchi; Tahereh  Eteraf-Oskouei

doi:10.18502/ijre.v21i3.20506

Yadollah Azarmi Associate Professor, Department of Pharmacology and Toxicology, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
Moslem Najafi Professor, Department of Pharmacology and Toxicology, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
Zahra Gholizadeh-Gharbalchi Pharmacist, Department of Pharmacology and Toxicology, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
Tahereh Eteraf-Oskouei Professor, Department of Pharmacology and Toxicology, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran

DOI: https://doi.org/10.18502/ijre.v21i3.20506

Keywords: Patient package inserts, Drug guide criteria, Satisfaction, Tabriz pharmacists

Abstract

Background and Objectives: Patient package inserts (PPIs) are the accessible source of drug information which is expcted to contribute with the safe and efficient use of medicines. The aim of this study was to evaluate the satisfaction of pharmacists in Tabriz with the quality of Iranian and foreign PPIs.

Methods: The present study is a descriptive cross-sectional study. The study sample consisted of 170 pharmacists working in community pharmacies in Tabriz, who completed a validated questionnaire with confirmed reliability and validity. The questionnaire included items regarding the scientific quality of Iranian and foreign PPIs. The study data were presented and analyzed using means, percentages, and frequencies.

Results: Pharmacists were satisfied with the size of the PPIs, font size and font type of the Iranian PPIs (42.4%) and the foreign PPIs (72.3%). With respect to the amount and method of drug use information in PPIs, satisfaction was higher for foreign PPIs than for Iranian PPIs (P=0.017). Satisfaction with the expression of side effects, contraindications, how to adjust the dose of the drug in the underlying diseases and the necessary warnings for children and the elderly in the PPIs of Iranian medicines was significantly less than foreign medicines (P<0.001). Most of the pharmacists agreed to design specific brochures for medical staff and patients.

Conclusion: The results of the present study demonstrated pharmacists’ dissatisfaction with the scientific quality and the availability of sufficient, up-to-date information in domestic drug brochures for the safe use of medicines. Therefore, standardizing the structure of brochures by utilizing the experiences of other countries, using digital innovations and visual tools, implementing user-friendly tests, and continuous monitoring by Iranian Food and Drug Administration are essential.