Abstract
Background Patients require accurate and reliable information to help them use their medications safely and effectively. Inadequate patient knowledge may contribute to medication nonadherence which could negatively affect treatment outcomes. The 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 The 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, respectively. The 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 The 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. They should also act to the possible standardization of MPIs.
Highlights
Drug treatment is the most common intervention by healthcare providers [1]
Drug products that are authorized by the regulatory body are sold in the Ethiopian market. e pharmaceutical sector mainly relies on imports from foreign countries and as a result, the international market remains the main source of important products that are not yet manufactured nationally
Erefore, the need for quality medication package inserts (MPIs) is indispensable. is study showed that most of the collected MPIs were for antimicrobials (24%). is might be attributed to three reasons. e first one is that communicable disorders are the leading cause of death in Ethiopia according to a 2015s report by the global burden of disease study [26]. e second explanation goes to the culture of inappropriate use of antimicrobials which has been reported in different parts of Ethiopia which might increase their demand [27,28,29,30,31]. e last justification is because self-medication practices even with prescription-only medications including antimicrobials are common phenomena in Ethiopia [32,33,34]
Summary
Drug treatment is the most common intervention by healthcare providers [1]. Patients require accurate and reliable information to help them use their medications safely and effectively [1, 2]. Insufficiency of pharmacological knowledge and communication skill by health professionals might contribute [5]. Both physicians and pharmacists broadly vary in the frequency and types of information they give about drug products [6]. 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]. E purpose of this study was to evaluate the presentation and completeness of medication package inserts (MPIs) which are available in the Ethiopian market. 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 act to the possible standardization of MPIs
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