Research Article
Evaluation of Medication Package Inserts in Ethiopia
Haftom Gebregergs Hailu,
1
Mengistie Yirsaw Gobezie,
2
Khalid Beshir Tuem,
1
Hildana Tewolde Gebremichael,
1
and Solomon Ahmed Mohammed
2
1
Department of Pharmacology and Toxicology, School of Pharmacy, College of Health Sciences, Mekelle University,
Mekelle, Ethiopia
2
Department of Pharmacy, College of Medicine and Health Sciences, Wollo University, Dessie, Ethiopia
Correspondence should be addressed to Solomon Ahmed Mohammed; solomon.ahmed@wu.edu.et
Received 1 July 2021; Accepted 24 December 2021; Published 19 January 2022
Academic Editor: Animesh Jain
Copyright © 2022 Haftom Gebregergs Hailu et al. is is an open access article distributed under the Creative Commons
Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is
properly cited.
Background. Patients require accurate and reliable information to help them use their medications safely and effectively. In-
adequate patient knowledge may contribute to medication nonadherence which could negatively affect treatment outcomes. e
purpose of this study was to evaluate the presentation and completeness of medication package inserts (MPIs) which are available
in the Ethiopian market. Methods. A cross-sectional document review was performed in February and March of 2019. All MPIs
which were authorized by EFDA to sell in the Ethiopian market and available during the data collection period were considered.
Results. e mean overall completeness score of 200 MPIs was 18.39 ± 4.30. Of the 200 MPIs, only 20% were from domestic
pharmaceutical companies. Antimicrobials represented 24% of the total MPIs. Topical preparations, cardiovascular drugs,
gastrointestinal drugs, and nonsteroidal anti-inflammatory drugs, accounted for 12.5%,12.5%, 11%, and 9% of the MPIs, re-
spectively. e majority of the MPIs presented information about the drug’s use during pregnancy and lactation, 77.0% and 74.0%,
respectively. However, only half of the MPIs, 49.5%, gave information about special warnings and precautions. Only a few of the
MPIs provided information about instructions to convert tablets or capsules into liquid forms and the possibility of tablet splitting,
4.8% and 8.7%, respectively. Furthermore, only 1.0% had local language translation. Conclusion. e MPIs available in Ethiopia
provide inadequate information including about the safety of drug products and local language translation. Regulatory authorities
should implement stringent regulations to ensure the provision of vital information which extends beyond checking the mere
presence of an MPI. ey should also act to the possible standardization of MPIs.
1. Introduction
Drug treatment is the most common intervention by
healthcare providers [1]. Patients require accurate and re-
liable information to help them use their medications safely
and effectively [1, 2]. However, inadequate information
provided by healthcare providers is common because of
heavy workloads, many patients unable to retain verbal
information they have been told for a long time [3], and
misunderstanding of verbal information [4]. Insufficiency of
pharmacological knowledge and communication skill by
health professionals might also contribute [5]. Furthermore,
both physicians and pharmacists broadly vary in the fre-
quency and types of information they give about drug
products [6]. As a result, there is consensus among the
medical community about the need for high-quality written
information for patients about their medications [7].
Written information about drug products such as the
medication package inserts (MPIs) is one of the sources that
patients use to obtain information about their medication
[8].
MPIs are leaflets that are packed with both over-the-
counter and prescription medicines to provide specific
information about their indication, administration, pre-
cautions during use, dose/dosage, potential side effects,
and contraindications [5, 9]. MPIs, which are also called
patient package inserts or prescription drug labels, are
provided by the medicine’s manufacturer based on
Hindawi
Journal of Environmental and Public Health
Volume 2022, Article ID 8299218, 7 pages
https://doi.org/10.1155/2022/8299218