Challenges of Access to Oral Morphine Medicine: Palliative Care at a Crossroads for Cancer Patients in Ethiopia.

Ethiopia registers 77,352 new cases of cancer and 51,865 deaths every year, and the number is showing an increasing trend year to year. Despite the importance of providing palliative care, the country has a long way to go to match the needs of and provide relief for patients with cancer. The promotion and expansion of palliative care services is challenged by a number of problems, among which lack of access to pain-relieving medicine is one of, if not the main, problems raised by health professionals and by various parties involved in health care. Oral morphine is effective and the preferred pain-relieving medicine with tolerable side effects, especially when given by titrating the dose. However, Ethiopia is facing a shortage of oral morphine in health-care facilities and other places where the product is needed. Unless an immediate solution is sought to address the inaccessibility of this medicine, the problem of palliative care will be pronounced and the suffering of patients will continue.

Surface Disinfection Practice in Public Hospitals in the Era of COVID-19: Assessment of Disinfectant Solution Preparation and Use in Addis Ababa, Ethiopia.

Background: Surface disinfection of healthcare facilities with appropriate disinfectants is among the infection control strategies against the spread of coronavirus disease 2019 (COVID-19). As sodium hypochlorite solution (SHS) is a commonly used surface disinfectant, its preparation and proper use should be given a due attention. The current study aimed at assessing the practice of Addis Ababa public hospitals in the preparation and use of SHS. Methods: A cross-sectional observational study was employed to assess the adequacy of disinfectant solution preparation and use. Checklists were used for data collection. Descriptive statistics were used for data analyses, and categorical variables were described by frequencies and percentages. Results: Out of the twelve public hospitals included in the study; only three hospitals checked the potency of the working SHS. Majority of the hospitals (8 hospitals) stored the concentrated SHS products in cool, dry, and direct sunlight protected places. It was only in one hospital where appropriate personal protective equipment was used during the preparation and quality control activities. Surfaces were not cleaned in all hospitals before disinfection; and the rooms were ventilated only in 2 hospitals during the application of the disinfectant solution. Conclusion: The study revealed that the preparations of SHS in the public hospitals did not comply with most of the requirements of good compounding practice. Moreover, standard practices were not maintained in majority hospitals during the use of SHS for surface disinfection. As a control strategy in the spread of COVID-19 and other infections, appropriate corrective actions shall be implemented in the studied hospitals to mitigate the limitations observed in the preparation and use of SHS.

Health professionals' perceptions on local production and bioequivalence study of generic medicines: A cross-sectional survey of physicians and pharmacy professionals in Addis Ababa, Ethiopia.

Local production of generic medicines in developing countries has a critical role to meet public health needs by ensuring the availability of essential medicines and providing patients' relief from the burden of unaffordable medical bills. Compliance with bioequivalence (BE) requirements increase the quality and competitiveness of generic drugs regardless of the source. In this regard, a regional BE center has been established in Addis Ababa, Ethiopia to serve the needs of Ethiopia and neighbouring countries. The present study aimed to assess the knowledge and perceptions of health professionals working in Addis Ababa regarding local production and BE studies of generic medicines. A cross-sectional survey was employed and physician participants working at public hospitals and pharmacists from various practice settings were selected using convenient sampling technique. Data was collected using self-administered structured questionnaire. Descriptive statistics was used to summarize the data and multinomial logistic regression analyses was used to assess predictors of health professionals' perception towards the source of drugs. Statistically significant association was declared at p-value < 0.05. A total of 416 participants responded and 272 (65.4%) of them were male. Nearly half of the study participants (n = 194) preferred the imported products. Compared to physicians, participants with diploma (AOR = 0.40; 95%CI: 0.18-0.91, p = 0.028) and bachelor degree and above holders (AOR = 0.32; 95%CI: 0.15-0.68, p = 0.003) in pharmacy were more likely to prefer locally produced products. Participants who practiced in pharmaceutical industries (AOR = 0.40, 95%CI: 0.22-0.77, p = 0.006) preferred locally manufactured products as compared to those practicing in the hospital. While a majority (321, 77.2%) believed in the advantages of doing BE studies locally, only 106 (25.5%) recognized that local pharmaceutical manufacturers did not implement BE studies for their generic products and lack of enforcement by the national regulatory body was raised as a reason for not conducting BE studies by most of the participants (67.9%). The present study revealed a modest preference by physicians and pharmacy professionals towards locally produced products. Majority of participants supported the idea of doing BE studies locally. However, manufacturers and regulators should devise ways to increase health professionals' confidence in local products. Strengthening local BE study capacity is also highly recommended.

Local pharmaceutical research and development capacity in a developing country: a qualitative exploration of perspectives from key stakeholders in Ethiopia.

PURPOSE: Despite its importance in ensuring sustainable healthcare, there are huge challenges with pharmaceutical research and development (R&D) especially for developing countries mainly due to the high investment costs naturally associated with such activities. In this regard, the pharmaceutical sector in Ethiopia, the most populous nation in East Africa, faces numerous challenges. The current study aimed at assessing the R&D capacity of the local pharmaceutical manufacturers from the perspectives of key informants working in the companies and supporting government offices and education institutions. METHODS: A qualitative study design employing in-depth interviews using semi-structured interview guides with flexible probing techniques was used for data collection. The study involved purposively selected participants who represented major stakeholders such as managers in the R&D departments of pharmaceutical manufacturers, officers and leaders in concerned government agencies and researchers in a local university. All transcribed interviews were subjected to thematic analysis and the Qualitative Data Analysis software in family R (RQDA) was used for data analysis. RESULTS: A total of 14 participants were involved in the study and three major themes were identified from the interviews. Current R&D capacity, opportunities and challenges for involvement in R&D were the major themes. Under current R&D capacity, the weak R&D status of local pharmaceutical plants and minimal university-industry linkage were identified. The challenges of pharmaceutical R&D in Ethiopia included weak governmental and managerial support; difficult procurement processes for R&D input; and the high cost of R&D. Availability of trainable human power and planned government incentives were identified as the opportunities. CONCLUSION: Overall, there is a low level of R&D capacity in local pharmaceutical industries and timely interventional strategies should be implemented through collaboration of academia, research institutions and pharmaceutical industries.

Assessment of compliance to packaging and labeling regulatory requirements of locally manufactured alcohol-based hand sanitizers marketed in Addis Ababa, Ethiopia.

BACKGROUND: Following the emergence of the global Coronavirus Disease-2019 (COVID-19) pandemic, alcohol-based hand sanitizers (ABHS) have been extensively used as one of the effective methods of preventing its transmission. The products are dispensed over the counter and used by the general population. Growing concerns have been reported, however, regarding the quality, efficacy and compliance to regulatory requirements calling for objective evidence that can facilitate proactive regulatory measures. OBJECTIVES: The study aimed at assessing the level of compliance to packaging and labeling regulatory requirements of selected locally manufactured ABHS products marketed in Addis Ababa, Ethiopia. METHODS: A cross-sectional study design was employed to randomly collect 25 locally manufactured ABHS products from retail outlets located in Addis Ababa. The manufacturers were grouped under four categories considering their experience in manufacturing, resources and technical capacities. The collected samples were evaluated for compliance to packaging and labeling information regulatory requirements and the results subjected to descriptive analysis. RESULTS: Majority of the products were found to meet most of the packaging, general product description and manufacturer-related information requirements. However, concerning gaps were observed in storage, precaution and warning-related labeling information requirements. The overall compliance of the selected products (to a total of 29 requirements under 5 categories) was 56.9%. The highest level of compliance was for general product information requirements (80.2%) followed by packaging and manufacturer-related requirements accounting for 76.8% and 75.0%, respectively. Low level of compliance was observed for storage condition and precautions (10.2% and 42.4%, respectively). Better overall compliance to packaging and labeling requirements (62.9%) were observed by large pharmaceutical and cosmetics manufacturers, while the lowest compliance level was recorded for medium level pharmaceuticals and cosmetics manufacturers. CONCLUSIONS: Even though most of the selected products were able to comply with the majority of packaging, product description and manufacturer-related requirements, gaps were observed in essential labeling information requirements. Considering the extensive use of ABHS products among diverse population groups and the potential risks associated with inappropriate use of the products, improving regulatory law enforcement practices, strengthening continuing education of manufacturing personnel and raising public awareness is very timely.

Evaluation of quality and antimicrobial efficacy of locally manufactured alcohol-based hand sanitizers marketed in Addis Ababa, Ethiopia in the era of COVID-19.

BACKGROUND: The coronavirus disease 2019 (COVID-19) has been rapidly spreading across the globe since the World Health Organization (WHO) has declared the disease outbreak as a global pandemic on March 11, 2020. Hand hygiene, via either regular handwashing with soap and water or using hand sanitizers, is among the various measures that need to be followed to control the outbreak of the disease. Alcohol-based hand sanitizers (ABHS) are the "gold standard" for hand disinfection because of their broad antimicrobial spectrum of activity, easy availability, better safety profile, and general acceptability to users. This study aimed at evaluating the physicochemical quality and antimicrobial efficacy of the locally manufactured ABHS marketed in Addis Ababa, Ethiopia. METHODS: A cross-sectional survey was used to collect ABHS from Addis Ababa marketplaces. A total of 25 sample products were randomly selected from different categories of hand sanitizer manufacturers. The physicochemical evaluation of the products was carried out as per the United States Pharmacopoeia and WHO standards. Escherichia coli, Klebsiella spp., Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella spp., and Shigella spp clinical isolates were used for the antimicrobial efficacy test. RESULTS: The Fourier Transform Infrared result confirmed that all the test products met the identification test for ethanol. The majority (68%) of ABHS complied with the test for ethanol content (75-85% v/v). However, only 3 products fulfilled the hydrogen peroxide content (0.112-0.137% v/v). LPC307 showed the maximum zone of inhibition of 12 mm against Escherichia coli whereas MPC204 exhibited only 3 mm. LPC101 was found to be more sensitive to Shigella and Klebsiella Spp with minimum inhibitory concentration values of 20% and 10%, respectively. The sample product LPC101 showed a minimum bactericidal concentration of 20% against Escherichia coli, Pseudomonas aeruginosa, and Klebsiella spp. CONCLUSION: One-third of the tested ABHS did not comply with the WHO ethanol content limit and the majority of the products failed to meet the label claim for hydrogen peroxide content. Besides, nearly all products proved that they have activity against all the tested pathogenic microorganisms at a minimum concentration from 10 to 80%; though, they did not show 99.9% bacteriostatic or bactericidal activities as claimed. The study findings suggested regular monitoring of the quality of marketed ABHS considering the current wide use of these products.

Prescribing Pattern of Dermatological Compounding in Ethiopia: The Case of ALERT Hospital.

BACKGROUND: Skin diseases are among the major contributors of disease burden in Ethiopia affecting individuals of all age. Extemporaneous compounding of topical medications serves as a necessary option to treat skin diseases when manufactured medications could not meet specific patient needs. Different classes of drugs are commonly used for the treatment of dermatologic diseases. Failure to periodically assess the prescribing pattern and patient needs may lead to inappropriate planning and implementation that ultimately compromise the service. Periodic prescription analysis for compounded medications helps to monitor the prescription pattern with respect to medication selection, disease condition, dosage form types and other relevant parameters. The current study was conducted to analyze the pattern of compounding prescriptions for dermatologicals in ALERT hospital. METHODS: A cross-sectional design was conducted by retrospectively evaluating compounding prescription records of January and July, 2021. A total of 460 prescriptions in the hospital community pharmacy were systematically selected. Data related to disease pattern, product selection and dosage form type were extracted and analyzed. Data analysis was done using software for the statistical package for social science version 25.0. RESULTS: A total of 441 prescriptions containing dermatological products for compounding were analyzed. Most patients were female (62.8%) and aged 30-64 years (44.0%). Psoriasis (36.2%), acne vulgaris (15.3%), and rosacea (13.4%) were the top 3 skin diseases for which the compounding preparations were prescribed. Salicylic acid (38.0%) was the most frequently prescribed drug followed by betamethasone (20.2%); while white petrolatum (47.2%) was the most common diluting agent used for compounding. CONCLUSION: Psoriasis was the major dermatologic disease for compounding prescriptions and salicylic acid was the most frequent product used in compounding for treatment of the prescribed skin diseases.

Extemporaneous Compounding Practice for Dermatologic Preparations in Ethiopian Public Hospitals: Regulatory Requirements and Quality Concerns.

Extemporaneous compounding is among the key hospital pharmacy services that promotes pharmaceutical care. It is a long-standing practice in dermatology for patients who need custom-made drug products. The practice of dermatologic compounding practice in Ethiopian public hospitals is found at the beginning and very few hospitals have started the practice so far. This research communication aimed at examining Ethiopian public hospitals' extemporaneous compounding practice for dermatologicals with emphasis on regulatory requirement and quality control activities. To benefit patients from these products, good compounding practice should be obeyed in line with the expansion of the service. Gaps have been observed in the facilities with regard to quality assurance system and compliance with the country's regulatory requirements. This implies a need to take appropriate and timely actions by the responsible stakeholders and expand the service in the country by fulfilling the regulatory requirement.

Adequacy of alcohol-based handrub solution production practice in response to COVID-19 in public hospitals found in Addis Ababa, Ethiopia: a multicentered cross-sectional study.

BACKGROUND: Proper hand hygiene using alcohol-based handrub (ABHR) is an effective preventive approach for the current Coronavirus Disease 2019 (COVID-19) pandemic and other infections. World Health Organization recommends local production of ABHR solution in healthcare settings which provides a feasible alternative to the use of relatively expensive commercially produced hand sanitizers. The aim of this study was to explore the adequacy of ABHR solution production practice in response to COVID-19 in public hospitals of Addis Ababa, Ethiopia. METHODS: A cross-sectional observational study was applied using assessment checklist for evaluation of the adequacy of ABHR production practice in compounding units of public hospitals. The evaluation was done with regard to the standard requirements as per the checklist. Statistical Package for Social Sciences (SPSS) version 23 was used for data entry and analysis. Descriptive statistics was employed for analyses of data and categorical variables were described by frequencies and percentages. RESULTS: Out of the 13 public hospitals observed in the study, 11 facilities had dedicated premises for compounding of ABHR solution. Seven facilities determined the concentration of ethanol in ABHR solution using alcoholmeters. Only one health facility had a titration kit and performed a strength test for the hydrogen peroxide raw material. Thermal and chemical disinfection processes were practiced for cleaning of recycled dispensing bottles only in 3 and 2 hospitals, respectively. Most of the hospitals (11 facilities) had standard operating procedures (SOPs) for production, but the majority lack SOPs for beyond-use-date assignment (11 facilities), premise and equipment cleaning (12 facilities), and disinfection of recycled bottles (12 facilities). CONCLUSION: Most hospitals have fulfilled the majority requirements of premises required for compounding of ABHR solution in their facilities. Five hospitals did not verify the concentration of ethanol in the ABHR solution which might affect the effectiveness of the product. Generally, lower compliance of the majority studied hospitals to good compounding practice was observed during ABHR solution production especially for product preparation, quality control, and documentation.

Perspectives of compounding pharmacists on alcohol-based hand sanitizer production and utilization for COVID-19 prevention in Addis Ababa, Ethiopia: A descriptive phenomenology study.

BACKGROUND: Globally, the safety of patients and healthcare providers is at risk due to health care-associated infections (HCAIs). World Health Organization and the Centers for Disease Control and Prevention recommend using alcohol-based hand rub (ABHR) for hand hygiene in healthcare settings to prevent HCAIs. Irrational use of ABHR will have undesirable consequences including wastage of products, exposure of healthcare providers to infections and emergence of microbial resistance to the alcohol in hand sanitizers. This study aimed to explore the perspective and experiences of compounding pharmacists on production and utilization of ABHR solution for coronavirus disease in 2019 (COVID-19) prevention in public hospitals of Addis Ababa, Ethiopia. METHODS: A descriptive qualitative study using in-depth interview of 13 key-informants serving as compounding pharmacists in public hospitals of Addis Ababa, Ethiopia, was conducted. The study participants were identified and selected by purposive sampling. All transcribed interviews were subjected to thematic analysis and transcripts were analyzed manually. FINDINGS: The compounding pharmacists in this study had a mean age of 30.6 (±3.1) years and nine of the thirteen participants were men. Ten participants believed that the compounding practice in their respective sites followed the principles of good compounding practice. More than half of the participants did not believe that ABHR products were used rationally in health facilities. They argued that users did not have enough awareness when and how to use sanitizers. Most of the interviewees reported that compounding personnel had no formal training on ABHR solution production. Study participants suggested incentive mechanisms and reimbursements for experts involved in the compounding of ABHR solutions. CONCLUSION: Three of the compounding pharmacists indicated that ABHR production in their setting lack compliance to good compounding practice due to inadequate compounding room, quality control tests, manpower and equipment. Despite this, most study participants preferred the in-house ABHR products than the commercially available ones. Thus, training, regular monitoring and follow-up of the hospital compounding services can further build staff confidence.

Alcohol-Based Handrub Utilization Practice for COVID-19 Prevention Among Pharmacy Professionals in Ethiopian Public Hospitals: A Cross-Sectional Study.

PURPOSE: Rubbing the hands with alcohol-based handrub (ABHR) is globally recommended as the preferred approach to prevent healthcare-associated infections in most routine encounters with patients, except in cases handwashing with soap and water is advised. Inappropriate utilization of ABHR could have detrimental effects, most importantly during the coronavirus disease (COVID-19) pandemic, which include exposure of healthcare professionals to healthcare-associated infections and the development of resistant microorganisms. In a hospital setting, the utilization of ABHR among frontline healthcare workers including pharmacy professionals is low. Therefore, the purpose of this study was to explore the current practice of hand rubbing among pharmacy professionals in public hospitals of Addis Ababa during the pandemic of COVID-19. METHODS: The study was a cross-sectional study using a self-reported questionnaire conducted among pharmacy professionals in public hospitals found in Addis Ababa from 10th May to 9th June, 2020 to recognize ABHR utilization rate. Data were collected on a sample of 384 pharmacy professional by a self-administered questionnaire. Data analysis was done using software for the statistical package for social science version 25.0. To identify the significant predictors of ABHR utilization practice bivariable and multivariable logistic regressions were carried out. Crude odds ratio and adjusted odds ratio with 95% confidence interval were calculated to determine the predictors. RESULTS: Out of 384 participants, three hundred and four participants were included in the final analyses after the exclusion of incomplete responses. Female participants represented 41.4% of the study participants. More than half (58.9%) of the pharmacy professionals had sufficient knowledge on ABHR utilization for COVID-19 prevention. Similarly, 56.6% of pharmacy professionals had positive attitude towards ABHR for COVID-19 prevention. But only 35.9% of the study participants had good ABHR utilization practice. CONCLUSION: Despite the modest level of knowledge and attitude towards ABHR, pharmacy professionals' utilization practice of ABHR for COVID-19 prevention was found to be suboptimal. Provision of ABHR solutions through hospitals and increasing the awareness of pharmacy professionals on ABHR needs to be encouraged.

Increased Production of Alcohol-Based Hand Rub Solution in Response to COVID-19 and Fire Hazard Potential: Preparedness of Public Hospitals in Addis Ababa, Ethiopia.

BACKGROUND: According to the World Health Organization (WHO), alcohol-based hand rubs (ABHRs) are regarded as the "gold standard" for hand disinfection in healthcare facilities. Local production of ABHRs in health facilities is recommended by WHO due to its availability and affordability reasons. However, fire hazard is a concern in health facilities during ABHRs production, storage, or use from dispensers. OBJECTIVE: To evaluate the preparedness of public hospitals found in Addis Ababa, Ethiopia towards potential fire hazards during ABHR production and storage practices. METHODS: A cross-sectional observational study was applied. An assessment checklist was used for evaluating public hospitals' measures taken for the potential fire hazards during ABHR production and storage practice. Statistical Package for Social Sciences (SPSS) version 23 was used for data entry and analysis. RESULTS: Out of the 13 public hospitals observed in the study, fire extinguishers were not available in more than half of the hospitals' (7 hospitals) compounding premises. Also, 57.1% of the hospitals without fire extinguishers were manufacturing beyond the WHO 50 liters limit of ABHR solution at once under such unfavorable conditions. Moreover, ethanol and the oxidizing agent hydrogen peroxide were not stored separately in eight hospitals. CONCLUSION: None of the hospitals were found to be well prepared for the potential risk of fire associated with ABHR solution production and storage practice. Generally, the practices taken by the studied hospitals for preventing the fire risk and minimizing the damage if fire hazards occurred during ABHR production and storage were not satisfactory. On the safety and precautions measures taken for the risk of fire, Tikur Anbessa Specialized Hospital (TASH), Amanuel Mental Specialized Hospital (AMSH), and Eka Kotebe General Hospital (EKGH) showed a relatively better preparedness compared to others. ABHR solutions should be manufactured and stored in a way that limits the risk of ignition and follows standard fire safety measures.

Hand Sanitizers Marketed in the Streets of Addis Ababa, Ethiopia, in the Era of COVID-19: A Quality Concern.

Hand hygiene is one of the least expensive measures proven to be effective in preventing the transmission of coronavirus disease 2019 (COVID-19). When access to handwashing facilities is limited, hand sanitizers offer a viable alternative for hand hygiene. Since the appearance of the first case of COVID-19 in Ethiopia, the demand for hand sanitizers, especially alcohol-based handrubs (ABHRs), was found to be increased. In the country, more than 100 manufacturers are engaged in the production of ABHRs. Besides, there are similar products without labels available for sale in the streets of Addis Ababa for which their nature and source are not clearly known. Generally, hand sanitizers marketed in the streets of the city are against the country's regulatory requirement. The Ethiopian Food and Drug Authority should inspect manufacturers regularly and evaluate the quality of hand sanitizers in the market, especially those obtained from the streets of the city, and take appropriate measures on those products and manufacturers which fail to meet the regulatory requirements.