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Evaluation of Medication Package Inserts in Iran.
Shahriyar Shahbazi Khamas1, Atefeh Jafari2, Morvarid Zarif-Yeganeh3
1Students' Research Committee, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Gilan, Iran.
Journal of Research in Pharmacy Practice
|August 2, 2019
Summary
Package inserts (PIs) in Iran show improvement but lack completeness. Most PIs are missing crucial information, necessitating stricter regulatory oversight for patient safety.
Area of Science:
- Pharmaceutical Sciences
- Drug Safety and Regulation
Background:
- Package inserts (PIs) are essential for safe medication use.
- No prior studies evaluated PIs in Iran.
- Assessing PI completeness is vital for public health.
Purpose of the Study:
- To evaluate the completeness of PIs for top-selling medications in Iran.
- To identify gaps in PI information based on regulatory and expert criteria.
Main Methods:
- Cross-sectional observational study of 100 top-selling medications in Iran.
- PIs assessed against Iran Food and Drug Administration (IFDA) criteria and expert pharmacist comments.
- Data collected in January 2017.
Main Results:
- 37% of medications lacked PIs.
- No PI met all IFDA requirements.
- High percentages for medication name, description, adverse reactions, patient counseling, warnings, precautions, pregnancy/lactation, and storage conditions were noted, but completeness varied.
Conclusions:
- Iranian PIs have improved but require more accurate and updated information.
- Stricter IFDA supervision of pharmaceutical companies is needed.
- IFDA regulations should be revised to align with international standards (e.g., FDA).
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