Expired medicines stored in public hospitals of jimma zone, Oromia regional state, ethiopia: volume, quality and Economic loss perspectives

Abstract

Introduction: In various regions of the world, particularly in low and middle income countries lack of access to essential medicines is currently a prevailing problem. In addition, due to different contributing factors large volumes of life saving medicines are not used before their expiration date and resulting huge economic losses. Therefore, assessing the extent, quality expired medicines and economic losses attributed to expiration of medicines in public health facilities of resource limited settings has paramount importance. Objective: This study was aimed to assess the volume, quality and cost associated with expired medicines stored in public health facilities. Method: From July 1, 2021, to September 30, 2021, data on expired medicines was collected, analysed, and samples for quality evaluation were collected from public hospitals in the Jimma zone of Oromia Regional State, Ethiopia. Facility based cross sectional study design was used to assess the volume and cost of the expired medicines stored in the public health facilities. Pharmacopoeia and risk based quality evaluation of ciprofloxacin 500 mg hydrochloride and norfloxacin 400mg tablets which were selected based on predetermined criterion were assessed. The laboratory work was conducted in March 2022. Result: The loss attributed to expiration of medicines available in the public health facilities included for this study was estimated to be 4.82%. This accounts an estimated cost loss of 1795321.7 ETB. Majority of expired medicines available in the facilities were solid (51.99%) and liquid (45.34%) dosage forms. The central nervous system (21.6%) and anti-infective (19.6%) medicines were relatively leading class of medicines expired. In terms of quality evaluation tests, all ciprofloxacin 500mg and norfloxacin 400mg tablet samples examined were within the USP standard limit of 90% to 110% for assay. All of the tested samples contain an intended API. Except for one ciprofloxacin batch that released 78.67% of its content, all analyzed samples passed the USP 30 minute single point dissolution test. For both tested medicines, the risk priority number (RPN) results revealed that the most critical quality characteristic is assay (RPN=189 ciprofloxacin and RPN =378 norfloxacin), followed by identity (RPN=140), and then dissolution (RPN=50). All of the samples tested were found to be within acceptable quality (D ≥0.7–1.0) on the psycho- physical Harrington's scale. Conclusion and Recommendations: The findings revealed that economic loss attributed to expired medicines was relatively significant. The Pharmacopeial and risk based quality evaluation III indicated that the selected expired medicines retained their quality. This showed that some drugs' expiration dates might not always correspond to the time at which they lose their potency. Therefore, the regulatory body should work around it by assessing the quality of various classes of medicines in order to address the potential quality of drugs retained after expiration, which is vital in critical situations such as drug shortages