Pharmaceutics
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Item Regulatory Requirements and Enforcement Practices for Importation of Medicines for Personal Use into Ethiopia(Addis Ababa University, 2023-07) Zellek,Mintwab; Gedif,Teferi(Prof.)Background: Evidence shows that some medicines imported for personal use are poor quality and counterfeited. In Ethiopia, although travelers import medicine for their personal use, little is known what medicines, and how frequently is being imported. Objectives: To assess importation patterns, regulatory requirements, and enforcement practice of medicine importation for personal use in Ethiopia. Method: A sequential exploratory mixed methods design was used to assess importation pattern, regulatory requirements and enforcement practices of personal medicine importation in Ethiopia. Secondary documents analysis and one-to-one interviews were used for data collection. Quantitative and qualitative data were analyzed using Microsoft Excel and thematic analysis approach, respectively. Results: Importing medicines for personal use have accelerated dramatically; records show that 56 travelers imported 151 medicines in 2020 and 398 travelers‟ imported 920 medicines in 2021. Releasing medicines without EFDA approval, gaps in the rules and regulations, shortage of some medicines and lack of coordination between key stakeholders were identified as contributing factors for the rise in the importation of personal medications. Conclusion: Importing medicines for personal use without a prescription is a growing concern in Ethiopia. The EFDA should strengthen the regulatory system; restructure existing law enforcement operations for the importation of medicine for personal use, and engage in high- level discussions with stakeholders.Item Assessment of Mobile-Based Vaccine Logistics Management Information System Implementation in Public Health Facilities of Gambella Region, Southwest Ethiopia(Addis Ababa University, 2023-09) Abebaw,Nigus; Mekonen,Zelalem Tilahun( MSc, Ass. Prof)Background: Ethiopia uses a combination of an integrated and interoperable information system to manage vaccines within Ethiopian Pharmaceuticals Supply Service’s (EPSS) supply chain system. Lack of access to reliable and timely data visibility for decision-making and poor vaccine management and efficiency are the challenges in Ethiopia. The mobile-based vaccine logistics management information system-(mBrana) implemented throughout Ethiopia for vaccine logistics information and inventory management. Objective: The aim of this study is to assess mobile-based vaccine logistics management information system implementation in public health facilities of Gambella Regional State. Method: Cross-sectional study design with sequential explanatory mixed data collection methods used in the study. Eighteen health facilities covered in the study and 44 respondents selected through random sampling technique. The quantitative data was analyzed by using descriptive and inferential statistics. Qualitative data analyzed thematically. Results: the analysis and reporting of mBrana has statistical significant effect on perceived usefulness(r=0.315, p=0.037) and usability(r=0.441, p=0.003) for informed decision making at five percent level. The quality of data with timeliness, completeness, and accuracy were 89%, 97%, and 90% respectively. The stock availability as compared with the past six months to the day of data collection visit was reduced 11.7%. The identified challenges for mBrana were administrative (lack of support, poor internet connection, phone damage, staff turnover, lack of ownership, low data package, electric power interruption) and technical challenges (skill gap, communication gap, system configuration challenge, lack of commitment, lack of skill transfer). Conclusion: Data use in mBrana level of agreement is high and has direct relation with perceived usefulness and usability of mBrana. The overall average data quality was 92%. Identified challenges were administrative and technical challenges. It is all important to give attention on boosting the availability vaccines via effective use of digital logistics management system like mBrana in all public health facilities of the region.Item Customs Clearance Practice and Related Challenges in the Ethiopian Customs Commission: a case of Pharmaceutical(Addis Ababa University, 2023-06) Taye, Kaleab; Cho, Denny (PhD); Teshome, Dawit; Coll, AngelicaBackground: Pharmaceutical at ports and/or custom stations need to be cleared in the shortest possible time due to their sense of urgency and requirement of special handling. However, the customs clearance procedure in most countries is time-consuming, leading to unnecessary delays and financial losses. In Ethiopia, there is a paucity of information about pharmaceutical customs clearance practice and related challenges. Objective: To assess pharmaceutical customs clearance practice and to identify challenges in the Ethiopian Customs Commission (ECC). Methods: The study was conducted in ECC from September 2019 to January 2020. A concurrent mixed methods design was employed. Quantitative data (using a structured questionnaire, and data abstraction formats), and qualitative data (using Key Informant interview guide) were collected at the same time frame. Quantitative data were analyzed using descriptive (percentage, frequency, mean and standard deviation) and inferential statistics (t- test and ANOVA). For the qualitative data, thematic analysis was applied. Results: Pharmaceutical transaction worth of $574,487,522 were cleared by the ECC in 2019/2020. Of these, more than half of the pharmaceutical were imported from Europe (57.2 %). Ethiopian Pharmaceutical Supply Agency (EPSS) (63%) was the major importer of the products. The overall mean score for customs and trade facilitation standards was 3.13 (±0.6). On the other hand, 2.85(±0.74) was the overall mean score for efficiency of pharmaceutical custom clearance. This study showed that Pharmaceutical Importers (PI), Local Manufacturers (LM) and EPSS face various challenges in dealing with customs clearance procedure. Some of these include: delays and interruptions in the electronic system (Electronic Customs Valuation System (ECVS)), gaps in valuation system (not being invoice based and inconsistent), and poor pharmaceutical handling, and delays in the inspection of pharmaceutical imports by EFDA officers. Conclusion: Most of customs and trade facilitation standards are not being applied in ECC custom stations and the overall pharmaceutical customs clearance process was found to be inefficient. As a result, EPSS and Pharmaceutical companies are facing numerous challenges and their operations are being affected negatively. Consequently, patients are forced to bear unnecessary costs incurred due to the system inefficiencyItem Assessment of Pharmaceutical Supply Chain Risk management: The Case of Ethiopian Pharmaceuticals Supply Agency(Addis Ababa University, 2021) Tamrie,Manaye; Mitiku,Shiferaw(PhD); Nitsche,Benjamin(PhD)Background: Supply chain risk management is the process of identification, assessment, mitigation, and monitoring of risks. Pharmaceutical suppliers and distributors face multiple risks that disrupt the supply of drugs interms of quantity, quality, and delivery at the right place and time to the right customer. Therefore, caution must be taken as health is critical and pharmaceuticals are unique. Objective: To analyze the pharmaceutical supply chain risks and assess the risk management practice of the Ethiopian Pharmaceuticals Supply Agency. Method: An explanatory and descriptive case study design was employed. Totally, 101 samples were involved in the study selected through purposive sampling technique. An interview guide, questionnaires, and risk checklists were used to collect quantitative and qualitative data from respondents. The Excel-derived failure mode and effect analysis template, and SPSS version 23 were used for the data analysis. Thematic analysis of qualitative data was also employed. Result: Eighty nine risks were identified and categorized into six groups. Among these, supply and demand side risks take the priority in affecting the supply chain operation. Inability to meet customer demand, lead time variability, and poor logistics performance of suppliers are under high risk score categories. Most of the respondents, 45 (44.6%), agreed that the risk management practice at Ethiopian pharmaceuticals supply agency is at its infancy. Risk identification methods being used are found to be risk estimation, previous risk assessment, and brainstorming sessions. The most applicable risk management tools are inventory optimization (29.9%), sales (22.4%), and operation planning tool (27.6%). The overall implementation of risk management strategies are below the average. Supply side (β = -2.171, P ˂ 0.020), process (β = -0.979, P ˂ 0.026), and control (β = -1.694, P ˂ 0.004) risks negatively affect the supply chain performance, while risk management practices (β = 6.440, P ˂ 0.002) affect it positively. ii Conclusion: Supply side risks took the primary position during prioritization followed by demand side and operational risks while environmental risks were at the least position. The overall risk management practice of the Ethiopian pharmaceuticals supply agency is weak. The level of implementation of risk management processes are low while the applicability of risk management tools are above the average level in the last 5 years history of the agency. Supply side, process, and control risks affect the supply chain performance negatively. However, supply chain risk management practices have a positive impact on performance. Recommendation: The Ethiopian pharmaceuticals supply agency should establish a separate team that primarily assess, analyze and control supply chain risks at all hubs. The agency should also be engaged in more scientific methods of risk identification methods like surveys, and risk assessment to identify, control, and minimize impacts of risks.Item Preparation, Characterization and Evaluation of Emulgel Formulation of Local Thyme Essential oil (Thymus Serrulatus Hochst. Ex Benth) for the treatment of Candida Albican skin infection(Addis Ababa University, 2023) Solomon, Atsede; Joseph, Nisha Mary (PhD); Molla,FantahunThe genus thyme is an aromatic evergreen shrub with many branches and a woody base found all over the world, but it is thought to have originated in the Mediterranean region of temperate zones. The genus Thyme is represented in Ethiopia by two endemic species, T. serrulatus and T. schimperi. T. serrulatus is found in Gondar, Bale, Tigray, Wollo, and Semen Showa. Traditionally, this plant has been used primarily to treat fungal infections. However, no research has been conducted to evaluate the plant's emulgel formulation for the treatment of candida albican skin infection. Therefore, the aim of this study was to prepare, characterize and evaluate emulgel formulations of local thyme essential oil (T. serrulatus) for the treatment of candida albican skin infection. The essential oil of T. serrulatus was extracted using a hydro-distillation method with a Clevenger type apparatus. Gas chromatography-mass spectrometry (GC/MS) was used to examine the chemical composition of T.serrulatus oil. Seven emulgel formulations with 2% T.serrulatus oil, various types and concentrations of emulsifying agents (Span 80, Tween 80), gelling agents (Na CMC and HPMC at 1%, 2%, 3%, and 4% concentrations), and 7.5% virgin olive oil and liquid paraffin as oil phases were prepared. The physical appearance (consistency, homogeneity, phase separation, and texture), pH, spreadability, extrudability, viscosity, swelling index, and drug content uniformity of the prepared formulations were characterized and evaluated. Following the selection of the best formula, it was tested for in vitro drug release, in vitro antifungal activity against Candida albicans ATCC using the disc diffusion method, skin irritation on rat skin, and three-month stability study. According to the GC/MS analysis, the extracted thyme serrulatus essential oil was light yellowish in color and contained 22 compounds. The essential oil's main constituents are thymol (36.92%), O-cymene (26.05%), carvacrol (19.15%), and -terpinine (8.24%). Seven of the prepared emulgel formulations (F3, F6, F7, F10, F11, F14, and F15) demonstrated acceptable physicochemical properties with creamy white to pale white color appearance and excellent homogeneity, consistency, texture, and pleasant odor. Furthermore, no phase separation or aggregates were observed. The pH of the formulations was within an acceptable range for skin. The viscosity, spreadability and extrudability were optimum for the better patient compliance. In both the blank and drug-loaded emulgel formulations, the swelling index was rapidly increased and maintained for 90 minutes. VI The drug content uniformity in five emulgel formulations was within the official pharmacopeia limit (F6, F10, F11, F14, and F15) 95%, 90.8%, 98.2%, 101.3%, and 97.5%, respectively. The thyme serrulatus oil emulgel drug release was good after 6 hour release time. Thyme serrulatus oil emulgel exhibited a strong inhibition zone (36 mm) of antifungal activity against the tested pathogen, a wider zone of inhibition than the marketed miconazol cream (28mm). The result of irritation test showed no edema and erythema. Thyme serrulatus oil emulgels maintained their Physico-chemical stability at 30 ±5℃ /65±5 RH and at 5 ±3 ℃ storage conditions. From this, the result of this study demonstrated the potential application of emulgel formulation of thyme serrulatus oil with acceptable physico chemical properties for the treatment of candida albicans skin infectionItem 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 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 Optimal Pharmaceutical Replenishment Policy: The Case of Selected Health Centers in Addis Ababa(Addis Ababa University, 2023) Demissie,Bezawit Negash; Rothkopf,Alexander(PhD); Tilahun,Zelalem(Ass. Prof.)Background: The primary goal of inventory management is to establish a replenishment policy that informs when and how much to order and how to maintain an appropriate stock level while optimizing various tradeoffs, such as carrying and re-ordering costs. The need for the healthcare sector to reduce costs has motivated many hospitals to adopt new technology to enhance existing operations. Since 2009, Integrated Pharmaceuticals Logistics System (IPLS) has been used in Ethiopian public health facilities to manage inventory. To the investigator's knowledge, the optimality of the replenishment system to the respective health facilities was not well investigated. Objectives: This study aimed to determine an optimal replenishment policy for managing inventory for selected health centers in Addis Ababa, Ethiopia. Methods: A multiple case study design was used in ten selected health centers. This study primarily uses quantitative data from the pharmacy stores’ database system. Three years of data were extracted from the digital bin card and entered into the pre-tested excel-data extraction tool. Once the data was sufficiently cleaned, a descriptive statistic and correlation using Microsoft Excel 2019 and IBM SPSS version 26. A simulation-optimization approach was used to show the current total inventory cost and develop an optimal replenishment policy. Result: The monetary amount of the program medicines issued from the health centers within three years was 93,922,330.05 ETB, in which Anti-retroviral treatments took the highest percentage, 78.69%, followed by Mother and child health products, 10.8%. When the demand frequency is observed, there is zero demand 50% of the time; this shows high intermittent demand. Demand variability significantly correlates (𝑟 = 0.84) with the health centers' total cost. The lowest total cost was observed in the replenishment policy of every other month with a target customer service level of 90% and realized customer service level of 92.7%. The highest total cost was observed in the replenishment policy of every month with target customer service level of 99% with a total cost of 141,706.4 ETB with realized customer service level of 99.4%. Conclusion: The analysis showed the segregation of products based on their characteristics has a potential advantage since the demand pattern significantly varies among products. The study showed the current IPLS method of determining order up to level resulted in less customer service level and increased the likelihood of overstock. Based on the simulation-optimization model, the less costly replenishment model is 90% target customer service level and every other month replenishment, but it is important to set a target service level based on product characteristics and integrate segregation of products, including the price and demand variability to achieve the optimal replenishment. Recommendation: Health centers may integrate characteristics of products, financial parameters, longer historical data and standard deviation of demand to identify order quantity and review period. The findings from this study can be used to commence further investigation in the fitness of IPLS inventory control system by considering other alternatives with technical and financial feasibility.Item Pharmacy Professionals’ Acceptance of Electronic Health Commodity Management Information Systems: An Evaluation of Health Facilities in Addis Ababa(Addis Ababa University, 2023) Getachew,Nardos; Eshetu, Eskinder(PhD)Introduction: The electronic Health Commodity Management Information System (e- HCMIS), also known as DAGU, was developed locally to help in improving the health commodity supply chain in Ethiopia. However, there is paucity of information on the acceptability of the system for the end users. Objective: To investigate pharmacy professionals’ acceptance of the e-HCMIS and identify its determinants in public hospitals of Addis Ababa. Methods: A facility-based cross-sectional descriptive study, following a sequential explanatory mixed method approach with both qualitative and quantitative methods of data collection, was done. The study included 10 public hospitals in Addis Ababa. The quantitative approach used structured questionnaire based on extended Technology Acceptance Model 3 (TAM-3). Key informant interviews were done to clarify and contextualize the quantitative findings. Structural equation modeling with maximum likelihood estimation were used to analyze quantitative data. Qualitative interviews were thematically evaluated. Results: There were a total of 237 survey respondents, response rate of the study was 96.19%. TAM-3 explained 49.2% of the variance of behavioral intention to use e-HCMIS. The study found that Perceived Usefulness and Perceived ease of use were significant predictors of behavioral intention. Job relevance was a predominant factor for perceived usefulness; perceived enjoyment and computer anxiety were predominant factor for perceived ease of use. The qualitative study revealed perceived usefulness, management support, ownership and perceived ease of use were the major determinants of behavioral intention. iii Conclusion and Recommendation: Given the importance of perceived usefulness and perceived ease of use, including a more user friendly design and scaling up the level of application of the system are recommendedItem solation, Evaluation and Optimization of Waste Derived Citrus Aurantifolia Peel Pectin as a Polymer in Furosemide Floating and Bioadhesive Matrix Tablet Formulation(Addis Ababa University, 2023) Abdela,Ebrahim; Belete, Anteneh(PhD); Mulualem,YohannesThe Citrus aurantifolia (Christm) Swingle species can be found in many parts of the world including the subtropical and tropical areas. It is a small shrubby tree, about 5 m length and has fruit has globule to oval nearly 3-6 cm diameter with a color range from light yellow to purple. Some studies revealed that citrus waste derived pectin- becoming promising way for based gastro- retentive (floating and bioadhesive) drug delivery systems formulation due to pectin’s economic, environmental and health related benefits. However, the floating and bioadhesive ability of the citrus aurantifolia peel pectin is not yet established. The bioavailability of furosemide is irregular through oral route and subjected to inter- or intra-subject variability. Hence, on the basis of its physico- chemical properties, it is a candidate drug for gastro-retentive formulations. Therefore, this study aimed to evaluate the potential of citrus Aurantifolia peel pectin as a polymer for preparing floating and bioadhesive matrix tablet using furosemide as a model drug. The citrus peel pectin was extracted from local citrus aurantifolia tree fruit peel using hot water extraction technique and characterized for several physicochemical properties such as the presence of carbohydrate, loss on drying, total ash, pH, water solubility index, swelling power, relative solubility, moisture sorption-desorption pattern, viscosity, powder flow properties and its compatibility with the model drug were investigated. Wet granulation method was employed to prepare the furosemide granules and the prepared granules were evaluated for particle size and distribution, bulk and tapped densities, compressibility index and Hausner ratio, angle of repose, flow rate, and the friability of the formulated tablets were evaluated. Other tablet quality parameters including friability, hardness, thickness, diameter, weight variation and content uniformity were assessed and in acceptable pharmacopeial standard. Based on the preliminary investigation, the pectin (10-40%) and effervescent agent (NaHCO3) (5-20%) concentrations were significantly affecting the response variables (p value < 0.05) such as floating duration (FD), bioadhesive strength (BS), swelling index (SI), drug release at 1 hr (DR1hr) and drug release rate (DRR)). Hence, further optimization study was conducted using central composite design (CCD) approach of design-expert 13 software. Both numerical and graphical optimization techniques were used for optimization. The Citrus aurantifolia tree fruit peel yielded 34.4% (w/w) purified pectin with light yellow color. Its pH and ash values were 4.6 and 2.29%, respectively. It showed solubility in hot water. The equivalent weight, methoxy content, anhydronic acid, and the degree v of esterification were 81.5, 13.84, 91.68, and 85.49, respectively which showed high methoxy pectin. The purified pectin powder had a Carr’s index of 36.6, Hausner ratio of 1.36 and angle of repose 32.78o which necessitates to conduct wet granulation technique. The compatibility study using FTIR and DSC analysis revealed that furosemide and citrus peel pectin were compatible. The drug release kinetic analysis of 13 formulations as per the CCD revealed best fits for Higuchi model with diffusion and erosion release mechanisms. The optimization results indicated that quadratic model was selected for swelling index and linear for the other responses. The adequacy of the model was evaluated using analysis of variance (ANOVA). Accordingly, the model provided an optimum formulation at 22.3% of pectin concentration and 5 % of effervescent agent. Under this condition, the software predicted floating duration (14.07 %), bioadhesive strength (28.57gm), swelling index (254.08%), drug release at 1hr (27.86%) and drug release rate (28.045 % / h-1/2). The optimization result predicted the optimized value of the independent variables to achieve desired responses was evaluated. The validity of this optimum formulation was confirmed experimentally. Based on the experimental studies, the validity of the model or software prediction was confirmed and the relative error are less than 5%. The flowability of the granule of optimized tablet was found excellent as the angle of repose was found to be <300 while the Carr’s and Hausner ratios were determined as < 10 and < 1.11 respectively. In conclusion, the results of this study enable to suggest that waste-derived citrus pectin can be used as an abundant alternative pharmaceutical excipient in the formulation and manufacture of floating and bioadhesive matrix tablets, leading to the formulation of an optimal floating and bioadhesive formulationItem Comparative in-vitro equivalence studies of some locally manufactured and imported generic BCS Class III drug products against their comparator counter products(Addis Ababa University, 2023) Nigussie,Tsegaye; Gebre-Mariam,Tsige(Prof.)According to the Biopharmaceutical classification system (BCS), active pharmaceutical ingratiate (API) classified into four classes (BCS Class I-IV) based on aqueous solubility and intestinal permeability. BCS Class III medications are highly soluble and poorly permeable, and they are among the drug products that require documented evidence of bioequivalence study. In addition to the permeability problems, there may be differences between generic and innovator products in terms of the type, source, and quantity of ingredients, manufacturing method and process, and machinery used for production, and these factors can bring major differences in dissolution and bioavailability. The objective of this study was therefore to compare the in vitro equivalence of four locally manufactured and imported BCS Class III drug products, namely, Metoclopramide hydrochloride 10 mg tablets, Cloxacillin sodium 500 mg capsules, Metformin hydrochloride 500 mg tablets, and Enalapril maleate 5 mg tablets against their comparator counter products (MTF3, CLX3, MCP3, and ENA3), respectively. The selected drug products and their comparator counter products were purchased from retail pharmacies found in Addis Ababa, Ethiopia. For each drug product, physical properties such as weight uniformity, hardness, thickness, diameter, and friability were determined using appropriate equipment as per the USP monograph. The assay content and content uniformity for each drug product were also determined as per their respective procedures in the USP monograph and validated methods. In vitro dissolution profiles were performed according to monograph methods and validated methods, and in vitro drug release tests were also done to assess equivalence of the products investigated. The results of weight variation content uniformity, and assay content indicated that all the investigated drug products were within the pharmacopeia requirements. Similarly, all products investigated complied disintegration time tests (i.e., ≤ 30 min) of immediate- release drug products. Except for two generic products of metformin hydrochloride tablets MTF2 (62.66%±9.74), and MTF4 (78.71%±6.86), all the drug products included in this study fulfilled the acceptance criteria for dissolution (i.e., Q ≥ 80% at 30 min). The in-vitro equivalence of these products was assessed by statistical, model- independent, and mode-dependent methods. One generic products of metformin hydrochloride (MTF2) and all generic products of metoclopramide hydrochloride showed significant difference (p < 0.05) in dissolution profiles with comparator II products. Of the five generic products of metformin hydrochloride film coated tablets [MTF2 (32.88), MTF4 (39.80) and MTF6 (49.94)] and generic products of metoclopramide hydrochloride [MCP1 (37.04) and MCP2 (41.56)] failed to meet the f2 acceptance criteria. This means that these products are not interchangeable. However, cloxacillin sodium capsules and enalapril maleate tablets complied with the f2 > 50 acceptance criteria. In conclusion, this study showed that all the generic products of metformin hydrochloride tablets, metoclopramide hydrochloride tablets, enalapril maleate tablets, and cloxacillin sodium capsules complied the quality specifications of weight uniformity, hardness, friability, disintegration, and assay. Three generic products brands of metformin hydrochloride MTF2, MTF4, and MTF6, and both generic products brands of metoclopramide hydrochloride (MCP1 and MCP2) did not show in-vitro equivalence with their comparator products. All generic products of cloxacillin sodium capsules and enalapril maleate tablets included in this study met model independent fitting factor specifications, were statistically insignificant (P>0.05) in dissolution profiles and can be considered equivalent to their comparator counter product.Item Vaccine Logistics System Practices in Public Health Facilities of Arsi Zone, South East Ethiopia(Addis Ababa University, 2023) Yeshitela,Yetnayet; Mitiku,Shiferaw(PhD); Tilahun, Zelalem(PhD candidate); kleineidam,Julia(MSc)This study examines the Vaccine logistics system practices in public health facilities of the Arsi zone. Vaccines are very sensitive biological products; they lose their potency if they are exposed to a temperature beyond the recommended ranges. Supply chains play a significant role in improving health, saving lives, and reducing child mortality. A well-functioning supply chains need the network of staff, equipment, vehicles, and data to get vaccines safely from manufacturer to end user. The main objective of the study was to examine current vaccine logistics system practices at health facility. The study was conducted among 24 health facilities of Arsi zone, focus on vaccine logistics handling and storage, inventory management and logistics management information system. Descriptive statistics was used. The quantitative data was collected by data abstraction formats and self-administered questionnaires and analyzed using SPSS version 25.0. and the qualitative data was collected through in-depth interview with the heads of the health facility and mother and child health coordinators and analyzed using thematic analysis. Results of the study revealed that the inventory control system used by all facilities in this study were pull system, though there are conditional pushes from their suppliers, the supplier of the facilities were woredas health office. Only (8.3%) facilities reported conditional push system, storage units and equipment were available in all 24 health facilities and 100% stored vaccines. Half of health facilities 12 (50.0%) did not have access to a generator/solar out of this only 10(41.7%) had functional back up and only 3(12.5%) had a voltage stabilizer connected to the refrigerator, 23(95.8%) have thermometer out of 23 only 14(58.3%) thermometer was placed inside refrigerator, all health facilities suppliers are Woreda health office out of this 17(70.8%) of the health facilities used vaccine reporting and requesting form,5(20.8%) health facilities prepared their own forms to order vaccines from suppliers and 2(8.3%) health facilities that used government requesting voucher(model 20). and the study identified that the most challenges affecting logistics system were lack of training in logistics system, lack of training in vaccines logistics system, difficulty of obtaining continuous supplies, The shortage of human resources in the facility and power interruption. These findings indicate that appropriate actions are needed to ensure vaccines logistics system in all public health facilities.Item Assessment of Procurement Lead Time Reducing Practices and Challenges: The Case of Ethiopian pharmaceutical Supply Service Central, Addis Ababa(Addis Ababa University, 2023) Negera,Biyensa; Temesgen,Busha(PhD)Background: The government of Ethiopia is focusing on availing of pharmaceuticals at an affordable price, accessible to all citizens through the Ethiopian pharmaceutical supply service. Procurement lead reduction has strategic importance for service to increase the availability of pharmaceuticals. But, there are no clear strategies and practices devised to reduce the procurement lead time in Ethiopia pharmaceutical supply service central. Objective: To assess procurement lead time reducing practices and challenges in the Ethiopian Pharmaceutical supply service central Methods: Descriptive and explanatory studies were designed. Primary and secondary data were collected using self-administered questionnaires and data collecting tools respectively. For collecting the primary data, all technical staff of inbound logistics were involved in filling out the questionnaire whereas for the secondary data, 229 pharmaceuticals were selected using stratified and systematic random sampling techniques from 2769 pharmaceuticals received in the first semiannual of 2012 E.C. The data were analyzed using Statistical Package for Social Science and Microsoft excel. The results were presented in tables, figures, and narratives. Results: The majority of the respondents said that the Ethiopian pharmaceutical supply service uses six practices to tighten its supply chain and strengthen partnerships, automates six procurement processes and uses seven practices to streamline its procurement operations. However, the majority respondents rated the supply chain integration and strengthening partnerships, procurement processes automation and procurement operations streamlining are poorly effective. Regarding the effect of the key procurement lead reducing practices; frequent procurement, and the fast mode of shipment have a significant positive effect on procurement lead time. But sourcing from local suppliers, and automating purchase order have an insignificant positive effect on the procurement lead time. The majority of respondents strongly agreed on two and agreed on ten challenges that they negatively affect procurement lead time reduction in Ethiopian pharmaceutical supply service. Conclusion and Recommendation: In Ethiopian pharmaceutical supply service central, all procurement lead time reducing practices are not used. But, all challenges of procurement lead time reduction were identified. By using all practices and minimizing the challenges, Ethiopian pharmaceutical supply service can increase the effectiveness of the strategies. It is also important to analyze the cost-benefit of the key practices that have a significant positive effect on procurement lead time.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 Assessment of Workforce Composition and Job Satisfaction among Regulatory Health Professionals in Addis Ababa(Addis AbabaUniversity, 2023) Haileyesus,Habtamu; Gedif, Teferi(Prof.); Issa, Arebu(Ass. Prof)Introduction: Health workforce is crucial for a regulatory health system and for optimal performance of the regulatory health system, the health care provider needs to be adequately trained and satisfied. The aim of this study was to assess workforce composition and job satisfaction of regulatory health professionals working in Addis Ababa. Objectives: To assess workforce composition and job satisfaction among regulatory professionals in Addis Ababa. Methods: By using cross sectional design, randomly 5 sub cities from Addis Ababa starting from July up to September 2021 was conducted. Respondents were selected by using a simple random sampling technique. Data were collected by self-administered questionnaire. The collected data were entered and analyzed using SPSS version 21. For regression analysis, significant level of p<0.05 was used. Result: Majority of the health regulatory professionals were health officers and environmental health professionals. Only 12.4% of professionals working in the health regulatory field were pharmacy background. Close to 47% of professionals working in health regulatory affairs in Addis Ababa were satisfied and > 50% of participants had a high intention to leave the work area. More than 50% of work experience <5 years were less satisfied [AOR=0.25 (0.09, 0.67)]. Conclusions This study demonstrates the current status of regulatory professionals’ variety and their job satisfaction level. Most regulatory health services are provided by public health and environmental health professionals.Item Green Synthesis of Honey based Silver Nanoparticles for Ampicillin Delivery against Drug Resistance Escherichia Coli(Addis Ababa University, 2023) Tadesse,Engidashet Fekade; Birhanu,Gebremariam (PhD); Molla,Fantahun(Asst.Prof)The efficiency of antibiotics is currently being limited by the critical public health issue of antimicrobial resistance. Neonatal mengitus, which is predominantly caused by Escherichia coli (E. coli), is the most common infection. Its management has becoming more challenging due to the emergence of antibiotic resistance. The goal of the current study was to synthesize AgNPs from honey's aqueous extract to deliver ampicillin (AMP) and boost its potency against AMP-resistant E. coli. Important operating parameters were under control. One factor at a time method was employed for optimizing the effects of temperature, time, pH, silver nitrate and honey concentrations, and the ratio of the mixing amount of aqueous extracted honey and silver nitrate solutions. AMP was loaded into AgNPs by changing the incubation period and AMP concentration. The AMP-loaded AgNPs were characterized using UV-vis spectroscopy, Fourier transform infrared (FTIR), X-ray diffraction (XRD), differential scanning calorimetry (DSC), Dynamic light scattering (DLS), and Scanning electron microscope (SEM). The in vitro drug release profile AMP loaded AgNPs was evaluated at pH 1.2, 6, 7.3, 7.4 and 8. The in vitro antibacterial capability of AMP, AgNPs and AMP loaded AgNPs and honey against E.coli was examined using the disc diffusion method. The optimized AgNPs had a 49 0.572nm crystal size and a spherical and uneven shape. X-ray energy dispersive spectroscopy, verified the purity of the manufactured AgNPs. UV-visible and FTIR spectra of the AMP loaded AgNPs revealed separate bands for both the AMP and AMP loaded AgNPs. Optimized AMP-loaded AgNPs had loading contents of 48.08 % and 96.3% entrapment efficiency. A regulated release of AMP over 24 hours was achieved with a pH medium of 7.3 and pH 7.4. Inhibitory zones for AgNPs, and AMP loaded AgNPs were 10.00± 0.6673 and 17.2 1.686mm, respectively where it was null for honey and AMP. AMP loaded AgNPs demonstrated substantially potent antibacterial action as compared to AMP and AgNPs alone. Thus, against AMP-resistant E. coli, the AMP-loaded AgNPs has shown encouraging results.Item Time-Based Process Mapping and Exploring Factors Affecting the Pharmaceutical Supply Chain Process in Saint Peter Specialized Hospital(Addis Ababa University, 2023) Chemeda,Abebech; Gedif, Teferi( Prof.); Teshome,Dawit (MSC, MA)Introduction: Time has become the most important factor in this competitive business environment. Time-based competition is a strategy by which a firm makes better use of time as a resource to acquire a competitive advantage. In the pharmaceutical supply chain context, there is a lack of objective evidence regarding how long the entire processes take, which activities are value-adding and which are not, and factors affecting the time are known little. Objective: to perform time-based process map and explore factors affecting the pharmaceutical supply chain process in Saint Peter Specialized Hospital Method: Facility based sequential triangulation quantitative and qualitative study design and observational process mapping and document review used for data collection. Quantitative and qualitative data analyzed using a thematic analysis approach used for qualitative data. Result: Process map of pharmaceutical supply chain at Saint Peter specialized Hospital have mapped by dividing into three such as process map of acquiring pharmaceuticals from EPSS, Acquiring pharmaceutical from private supplier and reporting and resupplying of pharmaceuticals from store. . The Time Based Process Mapping showed that from7 % to84.8 % were Non Value Adding. And the factors contributing for these Non Value Adding were unavailability of enough vehicles, not giving priority for pharmaceutical procurement, lack of Standard Operating Procedure, work load & lack of commitment of staff, Shortages of budget to procure pharmaceuticals, an and discrepancy between PO and Invoice of the product during receiving. Conclusion: Process mapping of pharmaceutical supply chain highlight a clear road that pharmaceuticals pass through to reach a customer in Saint peter`s specialized hospital. And it revealed the value adding and non value adding activities of the SPSH pharmaceuticals supply chain from ordering to receiving and reporting and supplied from the store were from 8.1% to 84.3% were non value adding time.Item Availability, Affordability and Price of Anti-Malaria Medicines in Gamo Zone, South Ethiopia Region(Addia Ababa University, 2023) Yacob,Meron; Gedif,Teferi(Prof.); Sahila,Muluwork(MSc)Malaria is a major public health problem in Ethiopia and has been consistently reported as one of the leading causes of morbidity and mortality. Frequent stock depletion and shortage of anti- malaria medicines were observed in public health facilities of Ethiopia. The aim of this study was to assess the availability, affordability and price of anti- malaria medicines in Gamo Zone, South Ethiopia Region. The study employed a mixed methods research design, combining both qualitative and quantitative data collection techniques. This study was conducted in one General Hospital, two primary hospitals, fifteen health centers, six health posts, ten private drug stores and the Ethiopian Pharmaceutical Supply Service of Arbaminch Hub. A two-stage cluster sampling technique was implemented to select twenty-four public health facilities and 10 private drug stores from the Zone. Record review, an observational check list and an in-depth interview were used as a data collection technique. The data was analyzed using Excel for quantitative descriptive analysis and thematically for qualitative data. The median percent availability of adult dosage forms of Artemether +Lumefantrine and Chloroquine was high (82%) and (84%) respectively in Public Health Facilities. The median availability of Artesunate injection and Primaquine tablet was 40% and Rectal Artesunate was unavailable in Public Health Facilities. The market price of Chloroquine tablet and Quinine injection was 0.3 and 0.9, respectively. A three days treatment of uncomplicated cases of malaria caused by Artemether + Lumefantrine costs the lowest paid unskilled government worker their 2.9 days wage. According to the Key informants, unavailability of anti-malaria medicines in Ethiopian Pharmaceutical Supply Service, poor Quality of reporting and requisition form, lack of training on new updates on the national malaria Guideline were the main contributing factor for the unavailability of anti- malaria medicines in their facilities. This study found low availability of Anti- malaria medicines in public health facilities. The study also demonstrates that, there was a gap in regularly distribution of Artesunate injection. Low supply of anti-malaria medicines, poor RRF data quality, lack of training on new updates were identifying as a contributing factor for low availability of medicines in facilities, emphasizing the need for continuous and sustainable availability of these medicines for the prevention, treatment, and elimination of malaria.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 Preparation, Characterization and Evaluation of Cross-Linked Sweet Potato [Ipomoea batatas (L.) Lam.] Starch for Sustained Release Tablet Formulation(Addis Ababa University, 2023) Woldeyohannes,Asnake; Birhanu,Gebremariam(Dr.); Wondu,KebedeAlong with cellulose and chitin, starch is one of the most prevalent biopolymers on earth and serves as a significant reserve polysaccharide in higher plants. Starch is an important ingredient in many products used in the food, pharmaceutical, and other industries. Despite its importance, starch is rarely regarded as an ideal raw material because of its uncomplimentary properties. Thus, modifications such as physical, chemical and enzymatically modifications are necessary to produce starch derivatives with improved pharmaceutical properties. The aim of this study was to chemically cross-link sweet potato (Ipomoea batatas (L.) Lam) starch using sodium hexametaphosphate and evaluate its potential for sustained release applications. Sweet potatoes (Ipomoea batatas (L. Lam)) starch was extracted, and then it was subjected to three different concentrations (10%, 15% and 20%) of SHMP treatment to create cross-linked sweet potato starches (CLSPSs): 10%-CLSPS, 15%-CLSPS, and 20%-CLSPS, at a temperature of 55°C, and the cross-linking process took place for 8 hours. The degree of cross-linking for 10%-CLSPS, 15%-CLSPS, and 20%-CLSPS were 67.73% +1.86, 75.35% + 2.99, and 77.45% ± 0.34, respectively. Increasing the concentration of sodium hexametaphosphate used for cross-linking starch leads to higher degree of cross-linking, which in turn reduces the solubility and swelling power of the starch. This is because the cross-linking process produces a more rigid and compact structure, making it more difficult for water molecules to penetrate and interact with the starch molecules. Moreover, in the moisture sorption study, it was observed that the water uptake capacity of the starch decreased with an increase in cross-linking. Furthermore, the cross-linked starch exhibited improved physical properties such as enhanced compressibility, powder density, flowability, and heat stability as compared to its native starch. X-ray crystallography showed that the CLSPSs had a crystal structure with a diffraction angle of 15.33°, 17.22°, and 22.96°, and nearly the same crystallinity as the native starch. SEM photographs showed minor morphological differences as it is observed on the powder surfaces of both native and CLSPS. The Fourier Transform Infrared Spectroscopy and Differential scanning calorimetry investigations supported the conclusion that there was no incompatibility between the model drug glibenclamide and CLSPS polymer. IX Tablets were prepared using various amount of cross-linked starch by direct compression method the prepared tablets were evaluated for the physical properties such as weight variation, thickness, hardness, friability, disintegration time and in vitro drug release studies. Preliminary studies result suggested the drug release characteristics from matrix tablets could be influenced by the concentration of cross-linking agent, and the ratio of cross-linked starch. Additionally, the suitability of methods used for determining these characteristics was also assessed. According to the study's results, the prepared tablets had satisfactory physical properties and met the standards. The tablets prepared with 10%-CLSPS showed a glibenclamide release percentage of 88% at 6 hours, while the tablets made with 15%-CLSPS released 85% of the drug at the same time. The tablets prepared with 20%-CLSPS released 81.2% of the drug close to 12 hours. The tablet matrix gelling capabilities of CLSPS, which created a gel-like network around the drug particles and slowed the rate of drug release, were thought to be responsible for the sustained- release properties of the tablets. The Higuchi's model and the Kors meyer Peppa's models were determined to best fit in-vitro dissolution data after being subjected to numerous drug release kinetics models. It was identified that the "n" value for the diffusional release exponent, which indicates that drug release processes involved both polymer erosion and diffusion, ranged between 0.6303 and 0.7367. The drug release pathways were consequently categorized as anomalous or non- Fickian diffusion. In conclusion, the study findings suggest that cross-linked sweet potato starch is a more favorable option for utilization in pharmaceutical formulations due to its superior sustained- release properties. Therefore, it can be considered as a viable substitute polymer for achieving sustained-release effects.