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Evaluation of Medication Package Inserts in Ethiopia
Haftom Gebregergs Hailu1, Mengistie Yirsaw Gobezie2, Khalid Beshir Tuem1
1Department of Pharmacology and Toxicology, School of Pharmacy, College of Health Sciences, Mekelle University, Mekelle, Ethiopia.
Journal of Environmental and Public Health
|January 31, 2022
Summary
Medication package inserts (MPIs) in Ethiopia lack crucial safety information and local language translations. Regulatory bodies must enforce stricter standards for complete and accessible patient medication information.
Area of Science:
- Pharmaceutical Sciences
- Public Health
- Health Communication
Background:
- Accurate medication information is vital for patient safety and adherence.
- Incomplete patient knowledge can lead to poor treatment outcomes.
- This study assesses medication package inserts (MPIs) in Ethiopia.
Purpose of the Study:
- To evaluate the presentation and completeness of MPIs in the Ethiopian market.
- To identify deficiencies in patient medication information.
- To inform regulatory improvements for medication safety.
Main Methods:
- Cross-sectional document review of MPIs.
- Data collected in February-March 2019.
- Included all MPIs authorized by the Ethiopian Food and Drug Authority (EFDA).
Main Results:
- The average completeness score of 200 MPIs was 18.39 ± 4.30.
- Only 49.5% provided special warnings/precautions; few offered instructions for liquid conversion (4.8%) or tablet splitting (8.7%).
- Local language translation was present in only 1.0% of MPIs.
Conclusions:
- MPIs in Ethiopia are incomplete, lacking vital safety and usage details.
- There is a significant need for improved regulatory oversight and standardization of MPIs.
- Enhancing MPI content and accessibility is crucial for patient safety and effective medication use.
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