Pharmaceutics
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Item A Queuing Analysis of Medicines Registration System Performance in Ethiopian Food and Drug Authority(Addis Ababa University, 2023) Alamneh,Abebe; Ali,Eskinder Eshetu(Dr.); Marew,TesfaBackground: The limited number of approved medicines and long waiting time for registration are the major challenges limiting the performance of the regulatory system in Ethiopia. Queue analysis is used for characterizing and estimating the queue process and operating variables of the system to alleviate the challenges related to target timelines. Objective: To assess the queuing performance of the registration system at the Ethiopian Food and Drug Authority (EFDA). Methods: A mixed sequential explanatory study design was used for the study. Quantitative data collection involved a review of applications submitted to the EFDA from July 8, 2019 to July 7, 2020. Basic operating characteristics of the registration system performance were executed using single queue multiple server model of the queuing analysis. In-depth interviews with purposively selected registration experts from the EFDA and private organizations were done for the qualitative data collection. Analysis of the interviews involved the thematic analysis approach. Results: Mean arrival rate of applications to the registration system (λ=10.99 services per day) was 23.74% higher than the mean effective service rate of the system (cμ=8.38 services/day). Basic system performance average operating characteristics of the system could not be estimated indicating that an infinite queue of applications built up over time and was hard to achieve any target timeline in EFDA’s current registration system. The qualitative study also showed that the system is being frequently challenged with backlogs. Conclusion: The study documented weak system performance with lengthy registration process. Appropriate measures to improve mean effective registration service rate should be introduced to meet international standards and the agreed citizen’s charter of 2016.Item Anti-TB Medicines Supply Chain Management Practices and Related Challenges in Gurage Zone Public Health Facilities, Southern Ethiopia(Addis Abeba University, 2021-09) Gezahagn, Sifrash; Dr. Ali, Eskinder EshetuIntroduction: Gaps in managing the supply chain of anti-tuberculosis (TB) medicines result in supply interruptions posing significant health-related and economic consequences. Objective: To assess anti-TB medicines supply chain management practices and related challenges in Gurage Zone public health facilities. Methods: A concurrent/parallel explanatory mixed methods design was followed in this study. Institutional based cross-sectional study was conducted from August to September, 2020. Simple random and purposive sampling was used to select study participants. A structured questionnaire and observational check list was used to collect quantitative data and analyzed using Microsoft Excel 2013 and SPSS version 25. For the qualitative part, an interview guide was used to collect data from fifteen key informants and analyzed thematically. Results: Twenty public health facilities (HFs) in Gurage Zone providing TB management and care were included in the study. Majority of the HFs (18, 90%) were using only stock recording cards to control the inventory of anti-TB medicines. The average physical stock count corresponding to inventory recorded count for a set of anti-TB medicines was 76.6%. For a set of anti-TB medicines the average availability was 82.6% and the average stock out duration was 11.23 ± 1.38 days per a year (Min=0, Max=115). The average wastage rate for a set of first-line anti-TB medicines was 4.78%. Qualitative interviews showed the absence of computerized drug management system to manage anti-TB drugs supply chain and the lack of healt h facilit ies’ involvement in drug quantification as major barriers for the effective management of anti-TB medicines supply. Conclusions: The most current version of the national TB treatment guidelines and job aids were not available in the majorit y of public healt h facilities and it was also noted that quantificat ion of ant i-TB drugs was a major problem. In majorit y of the health facilit ies storage condit ion needs early intervent ions and inventory control system was totally manual.Item Assessment of Antimicrobial Resistance Containment Practices in Selected Public Hospitals of Addis Ababa, Ethiopia(Addis Ababa University, 2014-09) Gemeda, Feven; Gedif, Teferi(PhD)Introduction: Ethiopia experiences a heavy burden of infectious diseases with a growing prevalence of disease morbidity and mortality. With the increased intensity of antimicrobial use following the increased burden of infectious disease in Ethiopia, AMR remains being a huge concern in the progress of treating infectious diseases. Health care facilities, particularly those which provide service to large number of patients, are a focal point in the emergence of AMR. Objectives: To assess the AMR containment practices in selected public hospitals of Addis Ababa, Ethiopia. Methods: Cross sectional survey was conducted in six selected public hospitals of Addis Ababa, Ethiopia between September and November, 2013. The study involved the use of mixed method approach. Quantitative data was collected by using structured selfadministered questionnaires whereas the qualitative data collection methods employed key informant interviews and an observation using check list. Results: Of those approached 763 healthcare professionals, 667 completed the survey questionnaires making up 87.4% response rate. The study revealed that as many as 321 (48.1%) of the total respondents had poor knowledge on AMR containment. Physicians and nurses were found to have the largest and lowest proportion of good knowledge level respectively. A significant association (p<0.05) was found between professional qualification and knowledge level of the respondents. The apparent lack of recent training experience was supported by the findings of lower knowledge level about AMR containment. Conclusion and Recommendations: The study revealed poor knowledge level of health care professionals and poor implementation of AMR containment practices in the selected hospitals. Hence, strengthening infection prevention and control practices, ensuring adequate and consistent supply of antibiotics and infection prevention and control materials, organizing training programs on AMR containment for healthcare professional, enhancing laboratory service and initiating surveillance of new infections and AMR are the prominent recommendations for improving the AMR containment practice in the assessed hospitalsItem Assessment of Applying Quality Management System on the Supply Chain Performance: A Comparative Study on ISO 9001 Certified and Non-Certified Ethiopian Health Commodities Suppliers(Addis Abeba University, 2021-10) Adamu, Taika; Dr.Ensermu, Matiwos; Dr.Zapata, Daniel; Berhanemeskel, EyerusalmThe Quality management system provides a successful strategy by better controlling process quality. The goal of this study is to assess, in a comparative framework, the supply chain performance of ISO 9001 certified and non-certified health commodities suppliers in Ethiopia with respect to the application of quality management system. To address the research objectives a cross sectional research design was used. The study also used quantitative and qualitative research approaches. Stratified and simple random sampling techniques were applied to select the required sample size from the employees of the case organizations. Primary data from 165 sample population was collected by means of questionnaire with response rate of 80.6% and structured interview has been conducted with purposively selected 16 managers and heads of departments of the organizations under study. Quantitative data obtained from the primary source were analyzed using SPSS version 22 software. Both descriptive and inferential statistics were applied to analyze the data. The result showed that there is an association between quality management system and supply chain performance, and differences have been observed between the ISO 9001 certified and non- certified companies with regard to the application quality management system on the supply chain performance with the mean score values of 4.00 for ISO 9001 certified organizations and 2.70 for non- certified organizations. ISO 9001certified companies scored the highest mean score in all aspects of the variables. Based on the findings of the study ISO 9001 certification is associated with supply chain performance, therefore it is recommendable that the management of non-ISO 9001 certified companies should be cognizant of the importance and benefits of applying quality management system to enhance organizational supply chain performance. The study also provides information why companies are not interested to apply quality management system.Item Assessment of Cold Chain Logistics Management of Pharmaceuticals the Case of Ethiopian Pharmaceuticals Supply Services: A descriptive cross- sectional study(Addis Ababa University, 2023-04) Lemessa,Thewodros; Issa,Arebu( Ass. Prof)Background: Cold Chain Management is a network of facilities and distribution options that performs the usual functions of a standard supply chain cycle but with temperature and humidity control throughout the supply chain stages and entities. A cold supply chain is important within the changing global economy today due to the huge increasing need for the products of temperature controlled industries. Objectives: The main objective of this study was to assess cold chain logistics of temperature sensitive pharmaceuticals including vaccines in Ethiopian Pharmaceutical supply service. Result: In this study, it was identified that factors that influence cold chain logistics of pharmaceuticals; are inadequate vehicles for the distribution of cold chain pharmaceuticals to public healthcare facilities, lack of sufficient storage area for storage of cold chain pharmaceuticals, poor record keeping for unfit for use pharmaceuticals and lack of knowledge among some of staffs working on storage and distribution directorate Ethiopian Pharmaceuticals Service. Methodology: An institution based cross-sectional study was conducted between December 2021 to February 2023 in EPSS central and Addis Ababa no2 which are located in Addis Ababa, Ethiopia, data was collected from 69 respondents working on storage and distribution directorate of EPSS. Descriptive and inferential statistics were carried out to analyze the data. Conclusion and Recommendations:, Insufficient storage space, Lack of cold chain vehicles ,lack of knowledge among some staffs and poor documentations for unfit for use pharmaceuticals were challenges observed at Ethiopian Pharmaceutical supply service and recommendations were given to improve storage conditions and facilities of by availing sufficient storage area and equipment by expanding and constructing additional centralized warehouses, availing sufficient cold chain vehicles, providing on job training for staffs working storage and distribution and improving documentation for unfit for use pharmaceuticalsItem Assessment of complications of anticoagulant therapy at medical wards of Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia(Addis Ababa University, 2014-01) Gebrehiwot, Teklu; Shibeshi, Workineh(PhD); Gebremedhin, Amha(PhD)Anticoagulant therapy is one of the most common form of medical treatment. The most common anticoagulant therapy complications are bleeding and thromboembolic complications. Bleeding is the primary complication. Factors that can affect the complications include age, gender, comorbidities, intensity of anticoagulant effect, length of therapy and concomitant drugs. The objective of the study was to assess complications of anticoagulant therapy at medical wards of Tikur Anbessa Specialized Hospital. A prospective longitudinal study design involving patient follow-up and chart review was conducted from November to June 2014. Chi-square test and Linear Mixed Model regression were employed to examine the relationships and associations between variables. The incidence of complications of anticoagulant therapy was found to be 60 (26%). Bleeding was the most common reported 27 (12.4%) (5.2% major, 10.7% minor), followed by thromboembolism 12 (7.1%), bruising 10 (5.9%), heparin induced thrombocytopenia 9 (5.3%) and skin necrosis 8 (4.7%). Sex, concomitant drugs, intensity of INR/aPTT values, usual trend of coagulation treatment and having coagulation profiles from different laboratory sites had been associated with complications. However, age, comorbidities, length of therapy, number of anticoagulants and anticoagulant therapy related factors were not significant risk factors. The findings of this study indicated that patient on anticoagulant therapy at medical wards were at higher risk of bleeding followed by thromboembolic complications. Availability of coagulation laboratory reagents at Tikur Anbessa Specialized Hospital and preparing guidelines on anticoagulant therapy harmonized with the laboratory values is recommended. Key words: Complication, bleeding, thromboembolism, skin necrosis, bruising, HIT, INR, aPTT, anticoagulantsItem Assessment of Dot Implementation in Tigray, Northern Ethiopia(Addis Ababa University, 2009-07) Alisani, Seid; Gedif, Teferi (PhD); Tadesse, Zerihun (PhD)Mycobacterium tuberculosis infects one third of the world's population. Ethiopia ranks seventh in the world & third in Africa with TB prevalence. TB is the leading cause of morbidity, the third cause of hospital admission and the second cause of hospital death in Ethiopia. TB patients take drugs for very long period of time. Hence, adherence is a major problem. To resolve this issue, the World Health Organization recommends the strategy of Directly Observed Therapy-Short Course (DOTS) which includes Directly Observed Treatment (DOT) to ensure a better patient adherence. The observer may be a health worker or a trained and supervised community member. Studies elsewhere show varying results on the effectiveness of Community Based DOT (CBDOT) compared to Health Facility Based DOT (HBDOT) option. In Ethiopia, although attempts have been made to assess quality of DOT implementation, comparative effectiveness of CBDOT versus HBDOT programs has not yet been assessed. This study was conducted to assess effectiveness of DOT implementation in CBDOT and HBDOT program areas in Tigray region. The study also aimed to compare implementation practice between the two DOT options and identify the factors affecting DOT implementation. The study was a comparative cross sectional study conducted between October and December, 2008. Both quantitative and qualitative methods were used for data collection. The quantitative methods used were retrospective review of Unit TB Registers avai lable in the health faci lities, prospective observation of DOT observers' practice, exit interview of TB patients and selfadministered questionnaire for health profess ionals. The qualitative method used was Focus Group Discussions (FGD) for both groups. A total of 378 patients, 118 from Hintalo Wajirat (CBDOT) and 266 from Enderta (HBDOT) Woredas, registered from September 2005 to February 2008 treatment outcomes were reviewed retrospectively from Unit TB Registers. Effectiveness was measured by success rate. Treatment was successful for 101 (88.6%) and 181 (87.4%) new TB patients in CBDOT and HBDOT program areas, respectively. For new sputum smear positive pulmonary TB cases treatment was successful for 19 (90.5%) patients in CBDOT and 28 (84.8%) patients in HBDOT options. CBDOT option was as effective as HBDOT in treating TB patients and can achieve good treatment outcomes. CBDOT option also reduced transfer out of TB patients.This study found out that DOT implementation as indicated by observation of DOT provider practice was comparable for CBDOT and HBDOT program areas. This indicated that CBDOT observers can practice DOT like HBDOT providers. Hence, CBDOT can complement HBDOT and could be a viable alternative in areas where people live faraway from health facilities. The study also identified access, acceptability of DOT option and DOT providers, awareness of patients and providers, support to the patient, incentive to CBDOT providers, health improvement, documentation and supervision as factors that could affect DOT implementation. Voluntary Community Health Workers are available in each and every village and are willing to render service to their villagers. National/regional policy should be adopted to equip them with proper training and provide supportive supervision so that they tremendously increase both access and quality of DOT. Mechanisms should be devised to ensure that health workers develop supportive attitude and facilitate wide scale deployment of voluntary Community Health Workers. Key words: TB, DOT, CBDOT, HBDOT, Effectiveness, Treatment success and TigrayItem Assessment of Essential Medicines Shortages and Contributing Factors in Public Health Facilities in Southern Nation, Nationalities and Peoples‟ Region of Ethiopia(Addis Abeba University, 2021-08) Mossa, Dargicho Ahmed; Prof. Fenta, Teferi Gedif (B.pharm,MPH,PhD); Bilal, Arebu Issa (B.Pharm, MSc, Ass Professor)Background: Essential medicines shortages pose a serious challenge for health care facilit ies in Southern Nat ions, Nat ionalit ies and Peoples‟ Region, often affecting health care system. The objectives of the study were to identify the causes of essential medicines shortages and to point out solutions to prevent this problem in public health facilities of the Region. Methods: A mixed methods design was applied to assess stock outs of essential medicines and its contributing factors in 30 public health facilities. The quantitative data were analyzed using SPSS version 20; while the qualitative data was categorized into themes based on the study objectives and analyzed manually. Results: The average stock out on the day of visit was 9(30%) with the 4(24%) of the items were with below minimum stock level., 6(38%) were in safe stock level ,and 3(16%) were in overstock level. The average stock out duration of selected essential medicines was 74 days. Sub-optimal use of the Logistics information system, poor quantification and distribution practices, limited number of human resources for supply chain management and inadequate skills, insufficient budget and irrational prescribing and dispensing practices were raised by the key informants as contributing factors for the medicines shortages in the Region. Conclusion: - Southern Nations, Nationalities and Peoples‟ Region has experienced shortages of essential medicines. Factors such as poor logistic management information system, lack of skill in logistics activities, less commitment, weak monitoring and evaluation systems, irrational prescribing and dispensing practices and insufficient budget allocation and its mismanagement contributed to the shortages.Item Assessment of Factors Affecting Vaccines Cold Chain Management Practices in Public Health Centers Found in Sebeta Town and the Surrounding Woreda of Oromia Regional State(Addis Ababa University, 2023) Getachew,Fikadu; Temesgen,Busha(PhD); Teshome, Dawit( M.Sc)Introduction: Curing and prevention of diseases are challenging circumstances for health-care professionals. Immunization has been identified as one of the most cost-effective health interventions in preventing diseases. Too high or too low temperature makes vaccines loss their effectiveness and potency irreversibly and permanently. So, good management and handling of vaccines is necessary. Storage area, storage equipment, transportation protocols, transportation systems, the working staff, etc. are some of the factors that may affect the cold chain and logistics of vaccines at different settings. Objectives: The objective of this study is to assess the factors affecting the vaccines cold chain management practices. Methods: A mixed method was implemented to identify the factors affecting the vaccines cold chain management practices at Sebeta town and Sebeta Hawas Woreda from Aug 2022 to Oct 2022 G.C. and Census method and Purposive sampling techniques were used. Result: Age of the respondents fall in the range of 24 to 48 years with a mean age and standard deviation (SD) of 25.95±3.81. All the respondents know that freezing and heat affect the potency of vaccines. 95.8% of the respondents know that OPV is the most heat sensitive vaccine whereas 97.9% of the respondents know that a contingency plan for power supply is important. Labeling vaccines with time and date of reconstitution is known by 95.8% of the vaccines handlers. 10.5% of the vaccinators and the vaccine handlers do not know that keeping foods and other items with vaccines affect quality of vaccines. Information management system, man power availability and storage facilities are highly significant factors that affect the vaccines cold chain management practice indicating the R square from the regression is 0.586. Conclusion: Despite high percentage of good knowledge and positive attitude, poor availability and adherence to cold chain guideline, insufficient number of man power, insufficient storage space in some health centers and low coverage of EPI trainings are determinant factors that directly or indirectly affect the vaccines cold chain management practice in the study area.Item Assessment of Factors Influencing Medicine Market Authorization Process in Ethiopia(Addis Abeba University, 2020-06) Mekonnen, Sefanit; Dr. Messele, Bruck(PhD); Genete, Getachew(M. Pharm)Introduction: To provide safe, quality and effective medicine for the society, medicine has to be registered as per the regulatory requirement of a country. However, there is a reported delay in the market authorization process which has contributed to the shortage of life saving medicines. Therefore, studying those factors that influence medicine market authorization process will have an important role in addressing the problem in depth. Objective: The aim of this study was to assess the factors influencing medicine market authorization process in Ethiopia. Methods: A sequential, mixed method study using quantitative and qualitative methods was used. For the quantitative part, retrospective data on applications submitted through Medicine Registration Information System (MRIS) at Ethiopian Food Medicine Health Care Administration and Control Authority (EFMHACA) from July 1, 2016 to Dec 30, 2018 were collected. For the qualitative part, in-depth interviews were held with selected participants from EFMHACA, local representative of foreign pharmaceutical industries (LRFPIs) and local pharmaceutical industries (LPIs) about the challenges they face on the market authorization process. The collected quantitative data was entered to SPSS version 20 for analysis. Bivariate analysis was used to correlate the association between the dependent and independent variables. The qualitative data was analyzed using thematic analysis. Results: Among 317 new applications submitted through MRIS since 2016, only 18% were approved for Market Authorization (MA); whereas the majority of applications were still in process of registration. The identified factors that hinder MA approval were the limitation of resource, inadequate training and impracticality of regulation by applicants and EFMHACA. Conclusion and recommendations: MA process takes a long time due to impeding factors from EFMHACA, LRFPIs and LPIs sides. It is therefore recommended that EFMHACA install sufficient number of qualified personnel; whereas, for LRFPIs and LPIs, building the capacity of their staffs will improve the MA process.Item Assessment of HIV treatment outcome among mentally disordered patients at Amanuel Mental Specialized Hospital, Addis Ababa, Ethiopia(Addis Ababa University, 2015-12) Ibrahim, Nebila; Gedif, Teferi (PhD); Alem, Atalay(Professor)Assessment of HIV treatment outcome among mentally disordered patients at Amanuel Mental Specialized Hospital, Addis Ababa, Ethiopia. Nebila Ibrahim Addis Ababa University, 2015 Human immunodeficiency virus infection usually leads to clinical diseases that affect almost every organ system and present with a wide range of symptoms and syndromes. Accurate assessment and diagnosis of systemic as well as central nervous system impairment requires close medical and psychiatric management. Therefore, psychiatric disorders associated with HIV/AIDS should be accurately identified and treated as its impact on health is substantial. The aim of this study was to assess the HIV treatment outcome among mentally disoredred patients following their treatment at Amanuel Mental Specialized Hospital. A retrospective study was conducted from September 2010 to August 2013 among HIV positive patients (N=337). Data on socio-demographic characteristic of patients, HIV stage based on WHO classification, the type of psychiatric disorder, medication, treatment outcome, and CD4 count were collected from patients’ chart. Among the 337 study participants, 138 (40.9%) were diagnosed to have a psychiatric condition. Out of these patients, more than 70% and 90%, respectively, showed an improvement in their CD4 count and WHO class over the three years period. The adherence among the HIV infected mentally ill patients was rated to be good in 39%, fair in 47%, and poor in 67% of the patients. Compared to psychiatric patients, the adherence of non-psychiatric HIV patients to their ART medication was significantly higher (OR = 3.06; P=0.046). Forty one percent of the study participants had opportunistic infection; of these 73.2 % were psychiatric patients. Overall, the co-occurrence of HIV and Psychiatric illness did not influence the treatment outcome. However, this does not completely exclude the attention needed to be given to these patients regarding adequate ART treatment. Therefore, further studies should be done to come up with optimum management of HIV positive patients with mental illness. Key words: Mental illness, HIV in Ethiopia, treatment outcome and Amanuel Mental Specialized HospitalItem Assessment of Hypertension Treatment Pattern At Selected Health Facilities in Addis Ababa and Consumption of Antihypertensive Drugs(Addis Ababa University, 2009-10) Teshale, Mewael; Gedif, Teferi (PhD); Tesfaye, Fikru (PhD)Background : Hypertens ion a long with other chronic diseases is on the rise in I~ thi opia. In fac t, the threats of non communicable diseases are not emerging rather they are well advanced and causing do uble burden to the society along with in fectious diseases. Unhealthy life sty le is the dcterminant for this dilemma. Needless to say, it needs time ly in tervention to tack le the problem. Despite or this fac t, studies on hypertension arc very few. This study assesses the treatment pattern to hypertension and consumption of antihypertensi ve drugs. Objective: To assess hypertension treatment pattern and consumption of anti hypertensive drugs. Methodology: An institution based cross sectional study involving retrospective data collection techniques (record review for the last five years and exit interview) was conducted between September and October 2008 . Results: The most commonl y prescribed drugs either alone or in combination were methyldopa, nifed ipine. hydrochlorothiazide. enalapril and atenolol. Treatment sh ift occurs freque ntly from thera peutic class to another on the basis of in effecti veness of the drug to adeq uate ly control blood pressu re, reason not known and side effect. Monoth erapy is favo red regard less of scx. Furosemide is the most consumed antihypertensive drug and nifedipine ranks the first with regards to cost of sales of antihypertensive drugs. Conclusion and recommendations: Methyldopa, ni fed ipine, hydrochlorothiazide, enalapri l and atenolol are widely used drugs for the treatment of hypertens ion whi ch is in accord with standa rd treatment guideli ne of the country. Future longitudinal research should be done to describc consumption trend of antihypertensive drugs.Item Assessment of Implementation status and challenges of pharmaceutical reverse logistics: The case of selected public hospitals in Addis Ababa, Ethiopia(Addis Abeba University, 2021-09) Zekariyas, Zerihun; Jabena, Tariku (PhD)Ethiopia procures more than 16-billion-birr worth of pharmaceuticals and medical supplies per year to more than 4000 public health facilities across the country but with very little consideration for reverse logistics. In Ethiopia, the average wastage rate of medicines is 3.9%. In spite of the efforts that the Ethiopian Ministry of Health and the Ethiopian Pharmaceutical Supply Agency have put in place to ensure efficiency in supply chain, and availability of medicines at all times, however, significant quantities of pharmaceuticals have been expiring in facility pharmacy stores and have been causing a challenge in supply chain system. The objective of the study is to assess the implementation status and challenges of pharmaceutical reverse logistics in the case of selected public hospitals in Addis Ababa, Ethiopia. Therefore, a descriptive cross-sectional study design and qualitative study was employed in six public hospitals in which 12 are key informant interviews. The quantitative data was collected through questionnaires, data abstraction formats and checklist and analyzed using SPSS version 20 and Microsoft Excel 2016. The qualitative data was collected through in-depth interview with the heads of the hospitals, pharmacy directorates and pharmacy case team leaders and analyzed using thematic analysis. The results were presented using, graphs, percentages, mean scores, standard deviations and written texts. Majority of the respondents 47% agree that there is unclear reverse logistics practice in their respective hospitals. Overstocks are common at the hospital level, most hospitals 66% experience overstocks, 28% rarely experiences overstock and 6% experience no overstock. Redistribution has the highest grand mean score as compared to other reverse logistics activities such as recycling, recalling and disposal during the study period. Moreover, there is data invisibility to trace and track the implementation status of reverse logistics. This all, in turn made the public hospitals to turn their face from the practical implementation of reverse logistics. Reverse logistics management should get attention in the pharmaceuticals supply system of the country for the proper management of unused medications for disposal and usable for redistribution. It is recommended to give training for pharmacy professionals on proper quantification of pharmaceuticals and attention must be given to the whole picture of reverse logistics rather than sticking only to waste management. Otherwise, the negative impact of reverse logistics may end up in financial loss to health sector and environmental unfriendliness.Item Assessment of Inventory Management Practices of Essential Medicines for Mental Health in Public Hospitals of Addis Ababa, Ethiopia(Addis Ababa University, 2023) Wana,Yitbarek; Dejene,Michael (MD, MPH, MSc)Introduction: Mental health is a state of well-being in which an individual realizes his or her own abilities, can cope with the normal stresses of life, can work productively, and is able to make a contribution to his or her community. Even in settings like low- and middle-income countries where the burden from infectious and nutritional conditions remains overwhelming, at least 9% of the overall burden of disease is attributable to mental disorders. Global mental health has documented that effective interventions exist for the large majority of mental health disorders. However About two-thirds of people with diagnosable mental health disorders do not receive treatment. Objective: To assess inventory management practices of essential medicines for mental health at public health facilities in Addis Ababa, Ethiopia. Methods: A sequential mixed study was employed. A facility based quantitative method was conducted using checklist, structured and semi structured questionnaire followed by qualitative method to explain the challenges and opportunities. Microsoft Excel Spreadsheet and SPSS version 20 was used to encode and analyze the data. Spearman’s rho was used to determine the association between inventory management practice and performance. The critical value (p<0.05) was considered significant. Results: Of twenty six medicines of mental health included under this study 28% were considered vital by public hospitals and 42.5% available on the day of visit. The mean stock out and frequency of stock out was found to be 0.73 and 0.86 respectively with average stock out duration of 95 days within six months of study period. Chlorpromazine, olanzapine, sertraline, clonazepam, Lithium carbonate, Lamotrigine, Phenobarbitone and promethazine tablets were out of stock at least once at each facility. The mean wastage rate of medicine for mental health was 4.5% with a value of 494,231.40 birr within six months of review, irregular consumption was the major reason for expiry. Conclusion: Essential medicines of mental health were routinely not available in public hospitals and the practice was found poor and different between categories of medicines and from one public hospital to the other. Antipsychotics were found to be most available and anticholinergics were not found in any of the facilities under study on the day visit. Second generation antipsychotics and antidepressants were most frequently stocked out items. The responsiveness by the supplier was poor as it was not able to refill those items whenever the facilities requested nevertheless of frequent stock outs, hence stock out at the source was the major reason for stock out.Item Assessment of Knowledge, Attitude and Practices on Regulatory Food Hygiene and Safety Requirements among Cake and Ice-cream Manufacturers and Workers and Trends of Regulatory Measures in Addis Ababa, Ethiopia(Addis Abeba University, 2021-12) Abebe, Getachew; Dr.Tamene, Aynadis; Girma, TewodrosBackground: Poor knowledge, attitude and practices of hygiene can contribute to the outbreaks of food borne illness. Most foods, including cake and ice cream products, could be affected by food borne pathogens, mainly due to poor hygienic conditions and inappropriate food handling practices. Inadequate knowledge, negative attitude and poor practices on food hygiene and weak regulation practices are among the factors responsible for the occurrence of poor hygienic conditions and inappropriate food handling practices. Objective: To assess the level of knowledge, attitude and practice on regulatory food hygiene and safety requirements among cake and ice-cream workers and trend of regulatory measures in Addis Ababa, Ethiopia. Methods: For knowledge, attitude and practices of workers assessment, a cross-sectional survey was conducted in purposely selected 5 sub cities and 108 manufacturers. 236 workers were selected by simple random sampling technique and interviewed using structured questionnaire. For the assessment of trends of regulatory measures, data were collected from 10 inspection team leaders (9 sub cities' food medicine and health care administration office and one Addis Ababa food medicine and health care administration authority) using a structured questionnaire. Data was entered using EPI info version 7.2 and cleaning and analysis was performed by using SPSS version 25. Result: The mean age and work experience of workers in the cake and ice-cream manufacturing companies were 30.03 and 5.72, respectively. About 46.6 % (110) of participants had no formal education. Only 2.5% of participant's field of study was related to their job.72.9 %, 37.3% and 59.3% of participants had poor knowledge, attitude and practice level about food hygiene and safety regulatory requirements, respectively. The total measure taken by the regulatory bodies on non complaints of requirements was 129 and 99 by 1 st and 2 nd half year of 2019, respectively. It was also 115 and 128 by the 1 st and 2 nd half years of 2020, respectively. Warning, lockdown and withdrawal from work were the major regulatory measures taken by the regulatory bodies. Conclusion/recommendation: Most workers do have poor knowledge and practice towards food hygiene and safety regulatory parameters. Though most of the workers knew the importance of hand washing practices, practically they were not complying. In contrast to the knowledge level, overall, more than half of the participants had good level of attitude towards food hygiene and safety regulatory requirements. The overall level of food hygiene and safety regulatory practices was poor. Though the sum total practice level was poor, the majority of them were also good at some specific requirements. The present study also pointed out that most of the regulatory measures taken by the regulation bodies on non-fulfillment were simple type of measures like warning.Item Assessment of Leishmaniasis treatment commodities management and Leishmaniasis treatment pattern in public health facilities of Amhara Region, Ethiopia(Addis Abeba University, 2020-08) Mekuria, Basazinew; Prof. Gedif, Teferi; Prof. Hailu, AsratBackground: The Pharmaceutical logistics system in Ethiopia is consistently hindered by several systemic problems that cause frequent stockouts of critical pharmaceuticals. It is even worse when it comes to the supply chain management of neglected tropical diseases, including leishmaniasis. Objective: To assess leishmaniasis treatment commodit ies’ management and treatment pattern in public health facilities of Amhara Region. Method: A descriptive cross sectional survey design was used for the study and a total of 18 health facilities found in Amhara Regional State were included in the study. Information on availability, inventory and storage practices of leishmaniasis treatment commodities and treatment pattern from health facilities were collected using structured questionnaires. In addition, in-depth interviews with key informants were conducted to identify challenges on leishmaniasis treatment commodities, and treatment pattern using interview guide. Three data collectors were trained and involved in data collection process. Data was entered and analyzed using Statistical Package for Social Sciences (SPSS) version 20. Descriptive statistics were used to calculate mean and percentage figures. The qualitative data was transcribed and summarized thematically. Results: Utilization of bin cards and Receiving and Requisition Form (RRF) for leishmaniasis treatment commodities were reported in 10(55.6%) of the facilities, whereas 11(61.1%) health facilities used Internal Facility Report and Resupply (IFRR) for leishmaniasis treatment commodities. Fourteen (77.8%) and 7(38.9%) of the health facilities experienced stockouts of one or more commodities during the past one year and on the day of the visit, respectively. Five (100%) and 10(62.5%) facilities were stockout with mean frequency (range) of stockout 3.6(3-4) and 1.6(0-3) for Amphotericin B and rk39 test kit in the past one year, respectively. The mean number of days (and range) of stockouts of health facilities were 86(0-160) for Sodium Stibogluconate and 153(128- 192) for Amphotericin B in the study period (March 2018-Feburary 2019). A total of 18221 leishmaniasis suspected patients in a period, from January 2016- December 2018, were tested by rk39, aspiration, and skin smear test, out of which 6261 were positive. Out of 6261 total leishmaniasis positive cases, the highest annual prevalence, 2414(38.6%), was reported in 2018. In the Amhara Region, 1245 in 2016, 1169 in 2017, and 1349 in 2018 leishmaniasis cases were managed. Out of 1147 patients with leishmaniasis treated in the study facilities in the period (March 2018-Feburary 2019) 122(76.2%) and 317(83.9%) were treated with Amphotericin B and combined Sodium Stibogluconate with Paromomycin for recommended duration respectively whereas 4(33.3%), and 155(26%) of patients treated with Paromomycin and Sodium Stibogluconate monotherapy were below the recommended duration respectively. The highest co- infection with leishmaniasis in the study period (March 2018-Feburary 2019) was severe acute malnutrition which is 38 patients. Out of the received leishmaniasis commodities, 5% of Sodium Stibogluconate, 8.6% of Paromomycin, and 7% of rK39 test kit were expired in the study period (March 2018-Feburary 2019) while 69.3% and 35.8% of rK39 test kit and Paromomycin from stock on hand were near expiry. From the total assessed facilities, two hospitals, 88.2%, and 94.1% perform storage condition guideline criteria which is above the recommendation, and only 11.11% of health facilities maintain acceptable storage conditions. Conclusion: The majority of health facilities had poor inventory management practice for leishmaniasis treatment commodities. Most health facilities experienced one or more commodities stocked out at the time of the visit and during the past year preceding the survey. Amphotericin B was the most frequently stocked out commodity in the health facilities. Some patients took treatment below the recommended duration which is contrary to established treatment guideline protocol. The storage condition of most health facilities was inadequate, and there was an expired and a large number of near expiry products in the health facilities. Generally, there was poorly organized leishmaniasis treatment commodities management in the region.Item Assessment of Medicine Regulatory Performance In South - West Ethiopia: The Case of Ilu-Ababora Zone, Oromia Regional State(Addis Ababa University, 2023) Girma, Tesfahun; Habte, Bruck Messele(PhD); Fato,Abdulkadir WolyeiIntroduction: The implications of ineffective pharmaceuticals regulation is becoming a major problem worldwide. Therefore, in order to address this issue and provide access to high-quality medications, every country should meet the minimum standards of a functional pharmaceuticals regulation. Objective: - To assess medicine regulatory performance in Ilu-Ababora zone, Oromia regional state, south west Ethiopia Methods: A sequential mixed methods (quantitative method followed by qualitative research approaches) was conducted from July to September 2022 G.C. in Ilu-Ababora zone using document review, simulated client visit method and semi-structured interviews. The study participants were regulatory professionals and healthcare providers working in Zonal Health Office, selected Woreda Health Offices and both public and private medicine retail outlets including private clinics. The data was analyzed using descriptive methods for the quantitative part and thematic analysis for the qualitative part. Results: Majority 91.66% of retail outlets from the total 24 issued non prescribed antibiotics at three distinct demand levels. In Ilu-Ababora zone there were 3,944 human health related facilities to be inspected by the zonal health department regulatory teams in collaboration with each woredas regulatory teams. But, at the zonal health department there were only two inspectors. All the woredas except Mettu City Administration, which has two inspectors, has one or none inspectors assigned. They didn’t have separate vehicle as well as no budget breakdown for regulatory activities. The regulatory performance is currently very poor. Performance influencing factors like widening of control area, scarcity of resources, capacity building problem, information iv leakage, lack of attention from the stakeholders, communication-related issues, and lack of awareness from the society were identified. Increased circulation of unsafe products, compromising patient’s quality of care, and monetary costs were reported as major concerns. As important interventional tactics, sector experts suggested enhancing capacity building techniques, involving sector stakeholders, and strengthening the regulatory structure. Conclusion: Despite the availability of comprehensive medicine regulations in Ethiopia, the results of this study show that the enforcement of these regulations is weak and the way regulations are currently being implemented in this area is not very effective and is still in the early stages of development.Item Assessment of Medicine use and associated outcomes among pregnant women visiting antenatal care units in Public Health Facilities in Butajira, South Central Ethiopia(Addis Abeba University, 2020-09) Woldesenbet, Deribe; Prof. Gedif, Teferi (B. Pharm, MPH, PhD); Ashenef, Ayenew(Msc)Introduction: Medicine use during pregnancy is a growing trend in the world. Medicines easily cross the placental barrier into the fetal body and are present also in the maternal milk. Exclusion of pregnant women from clinical trials has left questions about the safety of medicines in pregnancy. There were no such studies which assess the medicine use pattern and associated outcomes among pregnant women in Butajira. Hence this study attempted to fill such gaps. Objective: To assess medicine use pattern and associated outcomes among pregnant women visiting antenatal care unit in public health facilities in Butajira. Methods: Institution based prospective cohort study design was employed by interviewing pregnant women who were on routine antenatal care visit and waiting them until they give birth. Study participants were waited from March, 2018-November, 2018. Interview included recent medicine use history. Clinical data was obtained by abstracting the records of women who attended Antenatal Care follow up. Result: A total of 399 pregnant women were included in this study, of whom 382(95%) of them had taken at least one medicine during pregnancy, and 24(6%) of them had self-medicated themselves. From prescribed medicines for pregnant women, Iron with folic acid was the most (937, 71.5%) prescribed medicine while Zingeber officinale; ginger was the most (4, 36%) used traditional medicinal herbs used by the pregnant women. Medicines were prescribed from all FDA pregnancy risk categories. In this regard, from the total of medicines used by pregnant women, 978(73.3%) were from FDA pregnancy category A, 194(14.5%) were from category B, 128(9.6%) were from category C, 25(1.9%) were from category D, and 1(0.08%) were from FDA pregnancy category X. From 377 study participants with outcomes of pregnancy (Apgar score, birth weight and term of delivery); 56(15%) had poor pregnancy outcomes while 321(85%) had good pregnancy outcomes. Conclusion: The majority of the study population used safe and appropriate medications. However, though low, a limited number of pregnant women were exposed to medications with potential risk for the fetus. Besides, although few, pregnant women reported the use of traditional medicinal herbs for which pregnancy risk level was not assigned. No statistically significant association was observed between medicines used in this study and pregnancy outcomes.Item Assessment of Medicines Expiry and its Contributing Factors in Public Health Facilities of South Gondar Zone, Amhara Region,Ethiopia(Addis Abeba University, 2021-03) Nigussie, Abraham; Prof.Gedif, TeferiIntroduction: High availability of expired medicine is not only a burden to a health care system but it also shows existence of a supply chain gap. So, it is imperative to explore contributing factor for expiry at each stage of the supply chain. In Ethiopia, although there are reports that reveal the presence of expired medicines in the country, information on the type and extent of medicines expired as well as its contributing factor and disposal methods is scanty. The objectives of this study were therefore, to determine extent (including financial value) and type of expired medicines, to explore the reasons for expiry and to assess disposal practice of expired medicines in the health care facilities of South Gondar Zone. Methods: A sequential explanatory mixed method where a descriptive cross-sectional study complemented by using qualitative approach was conducted from July 8-2017 to July 7-2018. For the quantitative part, Microsoft excel was applied for the analysis. For the qualitative part, data was collected through in-depth interview with the key informants and analyzed thematically. Previous records or reports of expired medicines in all health facilities were used to determine the type and financial value of expired medicine that were received by health facilities of South Gondar Zone during the fiscal year 2017/18.Eighteen key informants were also interviewed to explore main reasons for medicines expiry within the health facilities and the disposal practices applied. Results: Medicines worth of 2,304,830.51 Ethiopian birr were expired in public health facilities of South Gondar during the study period, giving expiry rate of 6.45 %. Of these, anti-infectives were the most commonly expired group of medicines. Medicines delivered for various programs particularly for HIV/AIDS had the highest share in medicines expiry in term of value. Delivery of medicines through push system, delivery of near to expire medicines by supplier, and lack of communication and coordination in the health facilities were identified as major reasons for medicines expiry. Burning of unused medicines in open container and pouring iv fluids into the hole were commonly used methods to disposed unused medicines. Conclusion: To reduce expiry: making delivery based on consumption that has longer shelf life with most effective communication between health care structures should take to promote regular supply, and rational use of medicines. Disposing expired medicine by adhering to the national standard on drug management protocols to stop contamination.Item Assessment of multi drug resistant tuberculosis rate and associated factors in public health facilities of Dessie City Administration, North East Amhara, Ethiopia.(Addis Ababa University, 2015-12) Shegaw, Gashaw; Gedif, Teferi (PhD)Assessment of multi drug resistant tuberculosis rate and associated factors in public health facilities of Dessie City Administration, North East Amhara, Ethiopia. Gashaw Shegaw Addis Ababa University, 2015 The history of TB treatment has observed sequential development of resistance to anti-TB drugs. MDR-TB is defined as an MDR-TB suspect who is sputum culture positive and whose TB is due to Mycobacterium TB that are resistant in-vitro to at least INH and RMP. The emergence of MDR-TB is a threat for the populations of resource limited countries. In Ethiopia MDR-TB is becoming a challenge, because of poor adherence to treatment, TB/HIV co-infection, a few diagnostic and treatment facilities and inadequate trained health professionals. Dessie is densely populated town with high flow of people within the region as well as from neighborhood regions. It is also vulnerable for counterfeit anti-TB drugs through contraband. The aim of this study is to determine rate of MDR-TB and to identify associated factors in Dessie City Administration, North East Amhara, Ethiopia. A facility based retrospective cross sectional study design employing medical records review of TB registration books supplemented by key informants’ interviews which cover retrospective review period of July 1, 2012 to June 30, 2014. Prevalence rate of MDR-TB for combined, new and retreated TB cases of all form from public health facilities, were found to be 2.1/100, 0.3/100 and 21.6/100 respectively. Adherence of TB patients to TB treatment (COR=9.0, 95% CI [1.03-78.57]) and previous history of TB treatment (AOR=66.87, 95% CI [6.94-644.10]) were found to be a risk factors for MDR-TB. And related to TB type all MDR-TB cases were dominantly pulmonary TB. Key words: Tuberculosis, Multi drug resistance, Rate, Associated factors, anti TB drugs.