Traditional herbal medicine regulatory implementation in Ethiopia: a qualitative study.

Background: Approximately 80% of the Ethiopian population predominantly depends on herbal medicines (HMs) for their primary healthcare needs. Nevertheless, worries regarding the safety, efficacy, and standard of herbal-based treatments have been escalating due to the lack of strong regulatory frameworks. Therefore, the study aimed to assess the presence of regulatory frameworks for traditional herbal medicines and their enforcement in Ethiopia. Methods: The qualitative-phenomenological study design was conducted from November 2021 to March 2022 G.C. The study included 25 regulatory official key informants (KIs) who work for national and regional medicine regulatory agencies, and 15 traditional herbal medicine (THM) practitioners who work at the regional level were purposefully selected for an in-depth interview (IDI). An in-depth interview guide was developed through the purposive sampling technique. The collected data were analyzed using thematic content analysis techniques. Results: The study found that the current national medicine proclamation is deemed inadequate in the regulation of THM. Both conventional and traditional herbal medicines are regulated by a single agency. Weak legal enforcement, a lack of government commitment and support, resource constraints, and inadequate regulatory tools are the main challenges faced in THM regulation. Conclusion: Overall, the study found inadequate legal frameworks and weak THM regulatory implementations in Ethiopia. Consequently, it is critical for all regulatory authorities in Ethiopia to exert their utmost efforts to effectively regulate THM.

Assessment of the extent and monetary loss in the selected public hospitals in Jimma Zone, Ethiopia: expired medicine perspectives.

Introduction: Medicine plays a crucial role in the field of healthcare as a therapeutically significant pharmaceutical product. By effectively preventing diseases, medicine has the power to save countless lives and improve the quality of life for people worldwide. However, despite hospitals' efforts to provide medical care to patients, a significant issue arises from the substantial amount of drugs that go unused due to expiration dates. This problem is particularly prevalent in resource-limited countries like Ethiopia, where the pharmaceutical supply system fails to adequately address the issue of expired drugs in public hospitals, leading to an unsatisfactory situation. Hence, the objective of this study was to assess the economic impact and volume of expired medicines in the selected public hospitals in Jimma Zone, Southwestern Ethiopia. Methods: A hospital-based cross-sectional study design was conducted to assess the economic impact and volume of expired medicines available in the public hospitals in Jimma Zone. All available hospitals that fulfilled the EFDA guidelines were included. The medication expiration rate was calculated by dividing the total monetary value of expired medicines in a year by the total value of medicines received in the same year multiplied by 100. Then, the collected data was cleared, filtered, coded, and quantitatively analyzed using the Microsoft Excel 2010 version. Results: The average medicine waste rate was 4.87% in the fiscal year of 2019/2020 and 2020/2021 in Jimma Zone public hospitals worth 32,453.3 US$. Additionally, the facility wasted an estimated of 2711.44 US$ on the disposal of expired medicines. The expiration of medicines has been linked to several issues, including near-expiry, irrational prescribing practices, and weak participation of clinicians in medicine selection and quantification of the facility. Additionally, only two hospitals had relatively good storage and handling practices. Conclusion: Overall, the expiration rate of medicines in the public hospitals in Jimma Zone was greater than the allowed level of 2%. In order to optimize the allocation of healthcare funds and ensure the appropriate use of pharmacologically significant medications it is vital to conduct a comprehensive examination at the national level within a regional hospitals.

Assessment of the magnitude and contributing factors of expired medicines in the public pharmaceutical supply chains of Western Ethiopia.

BACKGROUND: The magnitude of expired medicines in supply chains are increasing globally due to lack of strict control of the supply chain, poor storage management and oversupply of medicines. This situation is very serious in resource-poor countries, including Ethiopia, where the supply of medicines is limited. Therefore, this study aimed to assess the magnitude and the contributing factors of expired medicines in the Public Pharmaceutical Supply Chains of Western Ethiopia. METHODS: Explanatory sequential study design involving mixed quantitative and qualitative approach were employed among 62 public pharmaceutical supply chains of Western Ethiopia from July1 to August 30, 2021. An observational checklist and the self-administered questionnaire were used to review all records of the expired medicine file and to abstract secondary data on the extent, types of expired medicines and its contributing factors. The collected data was cleared, filtered, and coded using Microsoft Excel® 2010, and exported to SPSS version-23 (Amsterdam, Netherland) for statistical analysis. Bivariate logistic regression was used to check association between the outcome and independent variables. Multivariate logistic regression was analyzed when p-value is less than or equal to 0.25 in bivariate binary logistic regression, considering the statistical at p-value < 0.05. Moreover, audio recordings were transcribed and coded for emergent themes using thematic analysis. RESULTS: The study revealed 5% expire rate over past two financial (2012 up to 2013) years and the total amount of expired drugs is estimated at 20 million Ethiopian Birr (ETB). Tetanus antitoxin (TAT), in terms of single drug value, had the highest drug expiry (4,110,426.43ETB: 20%), followed by liquid dosage forms (11,614,266.11 ETB: 57%). The Binary logistic regression result indicated that, poor store management were more likely associated with the magnitude of expired medicine than those with good store management (COR: 10.706, 95% CI: 2.148, 53.348). Multivariate logistic regression revealed that poor store management (AOR: 9.718, 95% CI: 1.474, 64.082) was a significant contributor to the expire rate at 5% (P < 0.05). Most facilities did not have a procedure, and programme for disposing of expired medicines. According to key informants, inadequate inventory management, lack of policy and implementation of standards are the main contributing factors of the medicine's expiration. CONCLUSION AND RECOMMENDATIONS: The current study found that the overall rate of medication expiration is high, at a significant cost to the budget. Inadequate inventory management, lack of policy, and implementation of standards are the main contributing factors to the medicine's expiration, as cited by key informants. Further research is necessary to determine the quality and efficacy of these expired drugs to extend their shelf life to ensure adequate access to drugs in resource-limited settings.

Quality of Antimalarial Drugs in East Africa: A Systematic Review.

Background: The use of poor quality drugs will have multiple consequences with an extended hazard of growing drug-resistant strains. Purpose: The review aimed to provide the quality status of antimalarial drugs in East Africa. Data Source: PubMed, Scopus, Web of Science, and Google Scholar were searched from September 5 to September 12, 2021. Study Selection: The review included articles available as original research targeted at evaluating the quality of antimalarial drugs. For inclusion, data on at least one of the following quality control parameters were required: packaging and labeling, hardness, friability, weight variation/uniformity of weight, disintegration, dissolution, and assay/percentage purity. Mendeley citation manager version 1.19.4 was used to avoid duplication and organize references, and titles and abstracts were primarily used for screening. Data Extraction: The sample collection site, drug name, and the quality control parameters tested were retrieved from the selected studies. Data synthesis:  Totally, 300 antimalarial drug samples from Ethiopia, Kenya and Tanzania were included in this review. No antimalarial drug tested failed the identification and disintegration test. However, 15.93% (36/226), 5.00% (15/300), and 1.90% (3/158) of antimalarial samples failed the dissolution, assay and mass uniformity test, respectively. Moreover, amodiaquine and sulfadoxine/pyrimethamine samples failed dissolution and assay tests. In addition, amodiaquine samples failed the mass uniformity test. However, artemether/lumefantrine and quinine passed all quality control parameters tested. Overall, 19.67% (59/300) of antimalarial drug samples did not meet at least one quality control parameter. And the higher faller rate was reported for sulfadoxine/pyrimethamine accounting for 52.86% (37/70). Conclusions: An unneglected amount of antimalarial drug failed to meet at least one quality control parameter. Strengthening pharmaceutical management systems, including post-marketing surveillance, and providing the resources required for medication quality assurance, are recommended.

Knowledge of Malaria and Its Uncomplicated Treatment with Argemone mexicana L. in Selected Districts of Jimma Zone, Oromia Regional State, Ethiopia: A Community-Based Cross Sectional Survey.

Background: With the problems of increasing levels of drug resistance and difficulties to afford and access effective antimalarial drugs in poor and remote areas, herbal medicines could be an important and sustainable source of treatment. Argemone mexicana L. (AM) is a medicinal plant known long ago in several countries for treatment of numerous diseases including malaria. The aim of this study was to conduct a survey on the use of AM in the prevention and treatment of uncomplicated malaria in selected districts of Jimma Zone, Oromia Regional state, Ethiopia. Methods: A community-based cross-sectional study was conducted in two selected districts in Jimma Zone, southwest Ethiopia. In total, 552 participants from 17 kebeles (villages/communities) and 18 traditional healers of the districts were interviewed. Data collection was conducted from April 27 to May 18, 2020 using pre-tested structured questionnaires. The data were analyzed using Epi Info 7.0 and the descriptive statistics were used to summarize the results. Results: The study indicated that AM is available, known by 39.8% of the respondents and used for prevention and treatment of malaria by 5.7% of the population. All traditional healers interviewed knew the plant, and 44.4% use it for treatment of malaria. In addition, AM is especially used to treat malaria, amoebiasis, diarrhea, cough, and tuberculosis. Conclusion: The availability and use of AM to treat malaria was verified in both community and traditional healers. AM, which was found effective as antimalarial plant in high Plasmodium falciparum endemicity in Mali, is also well known and accepted in these areas of Ethiopia for the treatment of malaria. Further research is needed to assess wether AM is also effective against malaria in Ethiopia where P. vivax and P. falciparum coexist.

Evaluation of Policy Governing Herbal Medicines Regulation and Its Implementation in Ethiopia.

Background: Ethiopia is one of the world's oldest countries, with a fascinating history of herbal medicine. However, there is a lack of evidence for the regulatory framework for herbal medicines and its implementation. Thus, the aim of this study was to evaluate the policy governing herbal medicines regulation and its implementation in Ethiopia. Methods and Materials: An archival review, a semi-structured interview with key informants, a cross-sectional study involving traditional healers, and an institution-based cross-sectional survey were conducted from June 15, 2020 to December 25, 2020. The qualitative data was transcribed using Microsoft Word 10, whereas the quantitative data was recorded and analyzed using SPSS 20 computer statistical software. The study's findings are summarized using descriptive statistics. In addition, multiple logistic regressions were performed to identify factors affecting regulation of herbal medicine (HM) in Ethiopia. Variables with p<0.05 were considered potential predictors. Results: According to all key informants, Ethiopia has yet to adopt distinct policies and laws on herbal medicine that may provide an independent regulatory framework. Similarly, the majority of respondents in an institution-based survey indicated that there were no defined policies (n=52, 57.3%), laws (n=53, 59.6%), or registration systems (n=67, 75.3%) for herbal medicine. However, traditional healers claimed that they are licensed by either the Woreda Health Bureau (n=21, 95.5%) or the Regional Health Bureau (n=1, 4.5%) to legally practise traditional herbal medicine. Besides, no traditional healer is licensed by Ethiopian Food and Drug Administration (EFDA) or Ministry of Health. Conclusion: Ethiopia has yet to adopt distinctive herbal medicine policies and laws to provide an independent herbal regulatory system. Despite the fact that the EFDA has a mandate for herbal medicine regulation, traditional healers are licensed by the woreda and regional health bureaus, thus more investigation is needed.

Quality-by-Design Principles Applied to the Establishment of a Pharmaceutical Quality Control Laboratory in a Resource-Limited Setting: The Lab Water.

Quality-by-design (QbD) is defined as a systematic approach to design and develop a product/service based on sound science and quality risk management. It is already frequently applied in the pharmaceutical industry mainly in the development of pharmaceutical products and analytical methods but is not well established in the setup of facilities like quality control (QC) laboratory (lab). Therefore, lab QbD (lQbD) concept is introduced considering lab water purification system as an example. The water purification system comprising distillation unit coupled with Nanopure Analytical Ultrapure Water System combined with a 0.2-micron filter was established in Jimma University Laboratory of Drug Quality (JuLaDQ). The consistent capability of the established water purification system was evaluated through routine monitoring of the critical quality parameters (i.e., physicochemical, HPLC-DAD chromatogram total peak area, and resistivity) of freshly prepared lab water for a period of one year. In addition, quality of different grade water (tap water, distilled water (before and/or after cleaning distillation unit), and fresh ultrapure water (18.2 MΩ × cm at 25°C)) used in JuLaDQ was evaluated. The results of routine analysis of water quality revealed that HPLC global peak area at 210 and 254 nm could serve as one of the discriminatory control strategies to evaluate the capability of water purification system to produce the desired quality of lab water; and thus, we proposed a specification limit of 5,000 mAU∗s and 5,500 mAU∗s for global peak area at 254 and 210 nm, respectively, as system suitability parameter.

Antiretroviral treatment failure and associated factors among HIV patients on the first-line antiretroviral therapy at Mizan-Tepi University teaching hospital, Southwest Ethiopia: A cross-sectional study.

ABSTRACT: The use of Antiretroviral therapy (ART) has become a standard of care for the treatment of HIV infection. The therapy restores immune function and reduces HIV-related adverse outcomes. However, treatment failure erodes this advantage and leads to an increased morbidity and compromised quality of life in HIV patients. Thus, this study aimed to assess anti-retroviral treatment failure and associated factors among HIV patients on the first line ART at Mizan-Tepi University Teaching Hospital. A cross-sectional study was undertaken among adult patient who have been on ART and attending ART Clinic of Mizan-Tepi University Teaching Hospital from September 2014 to September 2018. Data were collected retrospectively by reviewing patients' medical charts using a standard structured questionnaire. Data were entered into Epi data version 4.0.2 and then exported to SPSS version 21.0 for analysis. To identify the predictors of anti-retroviral treatment failure, multiple stepwise backward logistic regression analysis were done. P value < .05 was considered as statistically significant. Among 221 patients included in the study, 118 (53.39%) were females. The mean weight of study participants at ART initiation was 57.04 kg. Of the 221 patients on the first line ART, 10 (4.5%) experienced treatment failure. Of these patients, 5 (50%) and 3 (30%) experienced virological failure and clinical failure, respectively. Functional status (AOR: 3, CI: [1.13-6.5], P < .001) and low baseline CD4 cell count (AOR: 4.3, CI: [3.4-10.6], P < .0001) were found to be an independent predictors of treatment failure. The rate of first-line ART treatment failure in the study setting was substantial. Functional status and low baseline CD4 cell count were found to be an independent predictors of virological, clinical and immunological failure. Therefore, more attention should be given for the lifestyle of pateints' on ART and maximize virological tests for monitoring treatment failures.

Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia.

BACKGROUND: While the research findings confirm the existence of private drug retail outlets that do not comply with regulatory standards in many low-income countries, there are a lack of reports that evaluate the quality of medicines obtained from these firms. Therefore, the aim of this study was to evaluate the regulatory compliance of the retails and associated quality of amoxicillin in Southwestern Ethiopia. METHODOLOGY: Forty-two drug retail outlets in Jimma town were evaluated using an inspection checklist developed by the Ethiopian regulatory authority, and dispensers from these retail outlets were interviewed using the pretested structured questionnaire. The drug outlets were coded and categorized into noncompliant and compliant drug retail outlets. The physicochemical quality of amoxicillin capsules obtained from these retail outlets were evaluated following methods described in the US Pharmacopoeia. RESULTS: The present study revealed that about 54.76% drug retail outlets were compliant with the regulatory standard. Factors like income of retail outlet, experience of dispenser, and training regarding good storage practice were associated with status of regulatory compliance (p-value <0.05). The identification, dissolution, and assay results indicated that all amoxicillin samples obtained from both noncompliant and compliant drug retail outlets complied with pharmacopoeial specification limit. Besides, the independent unequal variance t-test revealed that there is no significant difference between mean dissolution and assay of API of the amoxicillin samples obtained these drug retail outlets (p-value >0.05). CONCLUSION: The regulatory compliance of private drug retail outlets in Jimma town is not satisfactory. Moreover, the laboratory findings revealed that all samples of amoxicillin capsules compiled with pharmacopoeial specifications acceptance for packaging and labeling information, identification, assay, and dissolution. However, despite the fact that assays of the amoxicillin from retail outlets are within the required specification, the assays of amoxicillin obtained from noncompliant retail outlets appears to be slightly degraded, which may potentially demonstrate the impact of noncompliance of the drug retail outlets on the quality of medicines.

Patients Satisfaction with Pharmaceutical Care and Associated Factors in the Southwestern Ethiopia.

BACKGROUND: An evaluation of patient satisfaction with service provided in the health care system has been globally recognized as the measure of health care service quality. However, there is a lack of research findings that indicate patient satisfaction with newly implemented patient-oriented pharmaceutical care (PC) service provided by clinical pharmacists in Ethiopia. Therefore, the current study is aimed to determine the level of patient satisfaction and associated factors with PC service provided by clinical pharmacists in the Southwestern Ethiopia. METHODOLOGY: A facility-based cross-sectional study design was employed among patients admitted to Medical wards in Jimma University Medical Center (JUMC) (n=219) from May to June 2021. The pretested interviewer-administered questionnaire containing structured questions on a 5-point Likert scale was appropriately completed and returned for statistical analysis. For the analysis of data, Statistical Package for Social Sciences (SPSS) was used. The associations between status of patient satisfaction and predictors were determined at 5% (p<0.05) level of significance by employing multivariate logistic regression. RESULTS: The current study revealed that more than half (56%) of the respondents were satisfied with clinical pharmacy service. From 30% of drug therapy problems (DTPs) reported, non-adherence was the most prevalent (11.4%), while the dose being too low and adverse effects (0.9%) were the least reported. Moreover, the assignment particular clinical pharmacist (AOR: 2.091, 95% CI: 1.028, 4.255), previous admission (AOR: 0.459, 95% CI: 0.244, 0.86), number of medications taken per day (AOR: 1.929, 95% CI: 1.996, 3.739) and length of hospital stay (AOR: 2.236, 95% CI: 1.124, 4.446) were significantly associated with patient satisfaction. CONCLUSION: The present study revealed that patient satisfaction towards PC was low. Lack of specific clinical pharmacist assignment, previous history of admission, number of medications taken per day and length of hospital stay are revealed as the major factors affecting the level of satisfaction. In addition, current findings implicate that clinical pharmacist collaboration with a multidisciplinary team is essential to increase patient satisfaction.

Current Awareness of Health Professionals on the Safety of Herbal Medicine and Associated Factors in the South West of Ethiopia.

BACKGROUND: Recently, the World Health Organization has strongly evidenced the importance of herbal medicine safety monitoring within the existing pharmacovigilance system through active involvement of health professionals. However, there is a widespread lack of awareness among health professionals about the safety of herbal medicines. Thus, this study assessed the current awareness of health professionals on the safety of herbal medicine in the South West of Ethiopia. METHODOLOGY: The study employed a cross-sectional study design involving multistage sampling among health professionals (n=286) working in the medical center of Jimma University, January to February, 2021. The pre-tested self-administered questionnaire containing structured questions on a five-point Likert scale was appropriately filled and returned for statistical analysis. For the analysis of data, Statistical Package for Social Sciences (SPSS) was used. The associations between status of awareness and predictors were determined at 5% (p<0.05) level of significance by employing multivariate logistic regression. RESULTS: The study revealed around 51.8% of respondents had a good awareness regarding herbal medicine safety. Working experience of 6-10 years (AOR: 0.215, 95% CI: 0.093, 0.499), having training (AOR: 0.357, 95% CI: 0.166, 0.770), and practice of safety monitoring (AOR: 0.169, 95% CI: 0.077, 0.370) were significantly associated with awareness of safety of herbal medicine. CONCLUSION: This study revealed that awareness of health professionals regarding safety of herbal medicine is not satisfactory. The years of experience, training, and practice of safety monitoring of herbal medicine are the major factors affecting status awareness. Therefore, the National Regulatory Authority must urgently facilitate integrated and consistent training for all health professionals.

Medicines dispensing practice during the era of COVID-19 pandemic: a commentary.

The coronavirus disease 19 (COVID-19) pandemic is putting a huge strain on healthcare systems and is a turning point for the beginning of a global health crisis of an unprecedented condition. As such, the provision of quality pharmacy services particularly, dispensing practice with pre-existing challenges in resource-limited settings is a grave concern in the era of the COVID-19 pandemic. Thus, in this commentary we described the pattern of dispensing practice in the midst of the COVID-19 pandemic by evaluating the current condition of drug dispensing practice in drug retail outlets of Jimma Town.