RESUMO
Background: Since its launch as a standardized treatment for multidrug-resistant tuberculosis (MDR-TB) in Ethiopia in April 2018, the safety profile of the shorter injectable regimen under a programmatic setting has not been well studied. Thus, this study aimed to assess the status of adverse events in patients treated with a shorter injectable regimen in Ethiopia. Methods: This is a retrospective cohort study. Data were collected using a structured data abstraction form and analyzed using SPSS, version 25, both descriptively and analytically. Logistic regression was conducted to assess predictors, and Kaplan-Meier analysis was used to examine the time to AEs and survival experiences. Results: Of 256 patients, 245 (95.7%) were eligible for the study. Of 245, 107 (43.7%) patients experienced at least one AE. In total, 276 AE cases were observed out of which the most common were nausea/vomiting (20.3%), dyspepsia (18.1%), and ototoxicity (11.6%). Of 276 AEs, approximately 49 (17.8%) were serious. AEs led to drug discontinuation, dose modification, and regimen change in 29 (27%), 15 (14%) and 10 (9.3%) patients, respectively. Only 19.2% of 276 the overall AEs and 22.6% of 62 AE of special interest (AESI) were reported to the National Pharmacovigilance Center. Conclusion: Although the observed extent of AEs associated with the shorter regimen (SR) seemed to be moderate, it significantly influenced the treatment schemes and patient conditions. Reporting of AEs was low, irrespective of their severity and AESI. Therefore, strengthening the implementation of active drug safety monitoring and management is required.
RESUMO
OBJECTIVE: This study aimed to explore the perspectives of key decision makers on out-of-pocket (OOP) payment for medicines and its implications in the Ethiopian healthcare system. DESIGN: A qualitative design that employed audiorecorded semistructured in-depth interviews was used in this study. The framework thematic analysis approach was followed in the analysis. SETTING: Interviewees came from five federal-level institutions engaged in policymaking (three) and tertiary referral-level healthcare service provision (two) in Ethiopia. PARTICIPANTS: Seven pharmacists, five health officers, one medical doctor and one economist who held key decision-making positions in their respective organisations participated in the study. RESULT: Three major themes were identified in the areas of the current context of OOP payment for medicines, its aggravating factors and a plan to reduce its burden. Under the current context, participants' overall opinions, circumstances of vulnerability and consequences on households were identified. Factors identified as aggravating the burden of OOP payment were deficiencies in the medicine supply chain and limitations in the health insurance system. Suggested mitigation strategies to be implemented by the health providers, the national medicines supplier, the insurance agency and the Ministry of Health were categorised under plans to reduce OOP payment. CONCLUSION: The findings of this study indicate that there is widespread OOP payment for medicines in Ethiopia. System level constraints such as weaknesses in the supply system at the national and health facility levels have been identified as critical factors that undermine the protective effects of health insurance in the Ethiopian context. Ensuring steady access to essential medicines requires addressing health system and supply constraints in addition to a well-functioning financial risk protection systems.
