A three years antimicrobials consumption in Ethiopia from 2017 to 2019: A cross- sectional study.

BACKGROUND: The widespread use and misuse of antimicrobials are the major driving factor for antimicrobial resistance (AMR) that threatens the health of human beings globally. Thus, monitoring antimicrobial consumption at national level is crucial to prevent and contain AMR. Nevertheless, there is no well-established system for recording and reporting of antimicrobial consumption in Ethiopia. Hence, the national antimicrobial consumption survey was conducted to generate evidence for decision-making on the appropriate use of antimicrobials in Ethiopia and tackle AMR. METHODS: All imported and locally manufactured antimicrobials from 2017 to 2019 were from the Ethiopian Food and Drug Authority and local manufacturers database, respectively. Data were collected and analyzed descriptively in accordance with the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) and defined daily doses (DDD) classification and methodology. RESULTS: The average DDD/1,000 inhabitants for all antimicrobials was 15.36. The DDD/1,000 inhabitants fell down sharply from 37.03 in 2017 to 4.30 in 2018, before slightly rising to 4.75 in 2019. The majority of the consumed antimicrobials were comprised of oral antimicrobials (98.6%), while parenteral antimicrobials made up 1.4%. Tetracyclines (35.81%), fluoroquinolones (20.19%), macrolides (13.92%), antiretrovirals (10.57%), and cephalosporins (9.63%) were the most frequently consumed classes of antimicrobials during the three years period. About 75.83% of the consumed antimicrobials fall under the WHO AWaRe classification and 67.87% of antimicrobial consumption was from the WHO Access class medications, with Watch and Reserve classes accounting for 32.13% and <1%, respectively. Similarly, about 86.90% of the antimicrobials fall under the Ethiopian AWaRe classification, with Access, Watch, and Reserve accounting for 87.73%, 12.26%, and <1%, respectively. CONCLUSION: Due to the peculiarities of our settings, our findings may have some similarities and differences with similar studies from other countries. Hence, we recommend for all concerned bodies to work collaboratively to improve monitoring of antimicrobial consumption at different levels of the Ethiopian healthcare tier system. Future work is necessary to establish a strong system of reporting of antimicrobial consumption patterns in Ethiopia.

Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis.

BACKGROUND: New medicines have become available for the treatment of drug-resistant tuberculosis (DR-TB) and are introduced in sub-Saharan Africa (SSA) by the national TB programs (NTPs) through special access schemes. Pharmacovigilance is typically the task of national medicines regulatory agencies (NMRAs), but the active drug safety monitoring and management (aDSM) recommended for the new TB medicines and regimens was introduced through the NTPs. We assessed the strengths and challenges of pharmacovigilance systems in Eswatini, Ethiopia, Nigeria and Tanzania, focusing on their capacity to monitor safety of medicines registered and not registered by the NMRAs for the treatment of DR-TB. METHODS: Assessment visits were conducted to all four countries by a multidisciplinary team. We used a pharmacovigilance indicator tool derived from existing tools, interviewed key stakeholders, and visited health facilities where DR-TB patients were treated with new medicines. Assessment results were verified with the local NMRAs and NTPs. RESULTS: Most countries have enabling laws, regulations and guidelines for the conduct of pharmacovigilance by the NMRAs. The relative success of NTP-NMRA collaboration is much influenced by interpersonal relationships between staff. Division of roles and responsibilities is not always clear and leads to duplication and unfulfilled tasks (e.g. causality assessment). The introduction of aDSM has increased awareness among DR-TB healthcare providers. CONCLUSION: aDSM has created awareness about the importance of pharmacovigilance among NTPs. In the future, a push for conducting pharmacovigilance through public health programs seems useful, but this needs to coincide with increased collaboration with between public health programs and NMRAs with clear formulation of roles and responsibilities.

Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles.

INTRODUCTION: The Smart Safety Surveillance (3S) concept is based on the understanding that, when faced with competing pharmacovigilance priorities, countries will have to invest judiciously, by focusing on new priority products, sharing work and resources with other countries when possible and building national competence for those activities that cannot be delegated. METHOD: The 3S principles were applied to Armenia, Brazil, Ethiopia, India, Peru and Thailand using three priority products: bedaquiline, rotavirus vaccine and tafenoquine. A baseline assessment of pharmacovigilance preparedness was used to identify gaps and establish a work plan. The impact was measured by comparing pre and post 3S-intervention outcomes, which included the number and quality of reports (completeness scores) in the WHO global database of Individual Case Safety Reports, VigiBase, and number of structural indicators met. The implementation period was 9-18 months, ranging from March 2018 (earliest started) until May 2020 (latest). RESULT: An increase in adverse drug reaction (ADR) reporting was demonstrated in Armenia (bedaquiline), Brazil (TB and malaria medicines), India (rotavirus vaccine) and Ethiopia (TB medicines). Completeness scores were above 0.5 at baseline in all countries, and reports improved in quality for Brazil (TB), Peru (malaria), Thailand (malaria) and India (immunization). The number of structural indicators met increased by more than double for Ethiopia. Ethiopia and India demonstrated an increased capacity for signal detection and signal evaluation. Armenia, Brazil, Peru and Thailand showed increased capacity to assess risk management plans following the implementation of 3S principles. CONCLUSION: The 3S concept has demonstrated success in different ways across the six countries. Activities focused on three products for a proof of concept of the 3S principles, with the expectation that the project impact will be sustained through strengthened systems, to guide pharmacovigilance activities of other products in the future. It is important to continue monitoring the countries to understand if the gains and successes of the current 3S project are sustainable.

Analgesic and Anti-Inflammatory Effects of 80% Methanol Extract of Leonotis ocymifolia (Burm.f.) Iwarsson Leaves in Rodent Models.

BACKGROUND: Pain and inflammation are the major health problems commonly treated with traditional remedies mainly using medicinal plants. Leonotis ocymifolia is one of such medicinal plants used in folkloric medicine of Ethiopia. However, the plant has not been scientifically evaluated. The aim of this study was to evaluate analgesic and anti-inflammatory effects of the 80% methanol leaves extract of Leonotis ocymifolia using rodent models. METHOD: The central and peripheral analgesic effect of the extract at 100, 200, and 400 mg/kg dose levels was evaluated using hot plate and acetic acid induced writhing rodent models, whereas carrageenan induced paw edema and cotton pellet granuloma methods were used to screen anti-inflammatory effect of the extract at the same dose levels. Acute toxicity test was also done. Data were analyzed using one-way ANOVA followed by Tukey's post hoc test and p < 0.05 was considered significant. RESULTS: The extract did not produce mortality up to 2000 mg/kg. All tested doses of the extract showed significant analgesic effect with maximum latency response of 62.8% and inhibition of acetic acid induced writhing. Maximum anti-inflammatory effect was recorded at 6 h after induction, with 75.88% reduction in carrageenan induced paw edema. Moreover, all tested doses of extract significantly inhibited the formation of inflammatory exudates and granuloma formation (p < 0.001). CONCLUSION: The study indicated that the extract was safe in mice and it has both analgesic and anti-inflammatory effect in rodent models.