Background Children in resource-limited countries are more likely to die from treatable conditions than those in higher resource settings due to a lack of the right essential medicine at the right time. Globally millions of children die every year from conditions that could be treatable with existing medicines before they reach their fifth birthday. This study aimed in assessing the availability and affordability of essential medicine for children in selected health facilities of southern nations, nationalities, and peoples’ regions (SNNPR), Ethiopia. Method A medicine outlets-based cross-sectional study was conducted to assess the availability, affordability, and prices of the 30 selected essential medicines (EMs) for children in 30 public and 30 private medicine outlets in SNNPR from March 29 to May 5, 2019, applying WHO and Health Action International (HAI) tools. Availability was expressed as the percentage of sampled medicine outlets per sector that the surveyed medicine was found on the day of data collection. The amount of daily wages required for the lowest-paid government unskilled worker (LPGW) to buy one standard treatment of an acute condition or treatment for a chronic condition for a month was used to measure affordability and median price ratio for the price of EMs. The results Availability varied by sector, type of medication, and level of health facilities. The average availability of EM was 57.67% for the public sector and 53.67% for the private sector. Ceftriaxone, SOR, zinc sulfate, and cotrimoxazole were the most widely available types of medications in the two sectors. The median price ratios (MPR) for the cheapest drugs LP were 1.26 and 2.24 times higher than their International Reference Price (IRP) in the public and private sectors respectively. Eighty-two percent of LP medicines in the public and 91 % of LP medicines in the private sectors used in the treatments of prevalent common conditions in the region were unaffordable as they cost a day’s or more wages for the LPGW. Conclusion Availability, affordability, and price are determinant pre-requisite for EMs access. According to the current work, although fair availability was achieved, the observed high price affected affordability and hence access to EMs.

Background: Effective inventory management ensures an uninterrupted supply of safe, effective, and affordable pharmaceuticals which could be achieved through developing ABC-VEN (Always, Better, Control-Vital, Essential, Desirable) and FSN-XYZ (Fast, Slow, Nonmoving-High, Medium, Low Value) matrix analysis. ABC-VEN matrix analysis is used to control inventory according to their annual consumption and on their functional importance whereas, FSN-XYZ matrix analysis is applied to control inventory by identifying the items to be discarded and the amount saved during the closing of annual accounts. Objective: To evaluate inventory management in selected health facilities of West Arsi zone, Oromia regional state for the year 2016-2018. Methods: Facility-based cross-sectional descriptive study complemented with a qualitative study was conducted in fourteen health facilities. Data were collected from goods issuing vouchers for the year 2016-2018 to perform ABC-VEN matrix analysis. The frequency of issue was collected to perform FSN analysis and the value of each closing stock was taken to get XYZ analysis. Results: From the ABC-VEN matrix analysis, 26.6% of items were Category I of which the highest proportion were taken by class A and V items consuming 84.7% of annual drug expenditure (ADE). The remaining 49.2% and 24.2% of the drugs accounted for only 13.2% and 2.1% of the ADE being category II and III, respectively. Based on FSN-XYZ matrix analysis findings, category I with 41.% item share account for the highest budget (average 86.5% of values). Of this category, the XN group-non-moving and high-cost drugs had the high value (20%) which need managerial measure. In category III, the ZN group items, being 25% of drugs, only had 2.2% of value-that may increase wastage, inventory holding cost, and shortage of storage space. Conclusion: The matrix analysis for inventory control is a strong tool that enables one to identify items requiring close monitoring. The coupled ABC-VEN matrix analysis, combining their individual advantages-inventory's cost and its functional importance help in achieving a meaningful inventory management. However, to control the stock at an appropriate level with minimum shortage and oversupply, it has to be supported by XYZ-FSN matrix analysis. The XYZ-FSN matrix benefits the health facilities to determine the level of inventory with high value in dead-stock, and to take measures like transferring to others, discarding, or saving.

Background: Auditable pharmaceuticals service and transaction system (APTS) is unique in its systems strengthening approach. It is a data-driven package of interventions designed to establish accountable, transparent, and responsible pharmacy practice. The objective of this study was to assess the outcome performance of pharmaceuticals services among selected hospitals with and without the APTS system in SNNPR, Ethiopia. Methods: A cross-sectional comparative facility-based study was conducted at public hospitals by using an intervention and control approach to estimate the significance of the difference between average performances of APTS and non-APTS hospitals. A case-tocontrol ratio was applied to decide the number of sites and a simple random lottery sampling technique was employed to select control sites. The sample size formula was used to determine the proposed population for patient care indicator assessment. Epidata version 3.1 and SPSS version 23 were used for analysis. The study was conducted from March 1 to 30, 2019. Results: APTS implemented hospitals attained 92.3% patient satisfaction on the overall pharmacy services compared to 47.5% for non-APTS hospitals. They have improved essential drugs (EDs) availability, minimum stock-outs, and reduced wastage rates, unlike control groups. They undertook workload analysis to assess human power sufficiency; generate reliable information from accurate recording culture for decision making; practiced transparency and accountability through conducting physical inventory and daily sales tracking/ management system; and made budget utilization rationale applying ABC analysis, VEN analysis, ABC/VEN reconciliation, and stock status analysis (SSA) that non-APTS hospitals did less/not. Conclusion: In general, higher performances were observed in APTS implemented hospitals than non-APTS hospitals regarding patient knowledge, satisfaction, and medicine availability at stores. In all cases, it needs improvement to achieve target values.

Background: Malaria is a complex disease and main community health problem in Africa and the top leading cause of outpatient visits, admissions, and deaths in Ethiopia. Its effective management is possible through early diagnosis and immediate treatment employing antimalarials. The quality of these drugs has to be good enough to attain their intended purpose. However, there are treatment failures resulted from the consumption of falsified and substandard antimalarials. Therefore, the current study was undertaken to evaluate the quality of two commonly used antimalarial drugs [chloroquine phosphate and quinine sulfate tablets] and to determine whether the quality of these drugs was affected by the origin, brand and sample collection sites in SouthWest Ethiopia. Methods: Random sampling based on Ethiopian malaria eco-epidemiological strata map, with different levels of medicines outlets, was applied to select sampling sites. Results: Sixty samples were bought from 43 drug retails (pharmacy, drug store, and drug vendor) in twelve different geographical locations of SouthWest Ethiopia between June and July 2016. Visual inspection was done for all samples before the lab experiment. A 28.3%, 31.7%, and 6.8% of samples failed to comply with the Pharmacopoeial quality standards for visual inspection, hardness and weight variation tests, respectively. Statistical analysis revealed that origin and geography from which samples were collected significantly affects the active pharmaceutical content of both drugs at P < 0.05 level. Significant variation was observed for chloroquine samples within batches of the same manufacturing and between origins. Conclusion: This study indicated that all the chloroquine and quinine tablets met the quality specification concerning friability, dissolution and assay. Out-of-specification results for weight variation, hardness and visual inspection tests for the chloroquine tablets are signs of substandard/ spurious/falsely labeled/falsified/counterfeit actions that may compromise the quality of these drugs. Besides, within the acceptance limit, the origin of drugs and collection sites have found to determine the quality which raises good manufacturing practice and storage (drug supply chain system) issues to be evaluated.

Background. Persistent postmarket quality evaluation helps produce clear information on the current quality status of the different brands of a given drug and hence introduces a biopharmaceutical and therapeutically equivalent list of the products to the prescribers and users of it. This in turn facilitates access to essential medicines by breaking the high-cost barrier imposed by a few expensive brands of the product. This study was aimed at determining the quality and evaluating the equivalence of doxycycline hyclate capsules and tablets in Jimma, Ethiopia. Methods. Ten brands of doxycycline hyclate capsules and tablets were tested for product identity, dosage uniformity, assay, and in vitro dissolution; and tablets were tested for friability and hardness. Results. All investigated brands of doxycycline complied with the USP for dosage uniformity, an assay of the active ingredient, and single-point dissolution tests. One brand, D09, failed both hardness and friability tests. Comparisons of dissolution profiles applying fit factors confirmed that only brands D04, D06, and D07 had similarities with the innovator. Ratio test approaches also showed that significant variability exists between test products and comparators. Weibull model was found to provide the best adjustment curve for all brands, from model-dependent approaches employed for explaining the overall release of drug from the dosage forms. Conclusions. Doxycycline is a biowaiver product. Hence, in vitro dissolution evaluation suffices its market approval. In this quality assessment study, however, the samples passed quality control tests, except D09 brand which failed friability; it has been revealed that five out of eight brands had problems with interchangeability. Only three doxycycline hyclate brands were found to be equivalent to the comparators.

22 The safety of medicines is an essential part of patient safety. Global drug safety 23 depends on strong national systems that monitor the development and quality of 24 medicines. Poor quality medicines do not meet official standards for strength, quality, 25 purity, packaging and labelling. Hence, this study determines in-vitro quality 26 attributes of glibenclamide 5mg tablet marketed in Addis Ababa according to 27 drug monograph specifications. All tested brands meet the requirements for physical 28 inspection & complied specification for friability and hardness. Besides, the tested 29 brands met USP 38 specification for assay (99.96% to 108.85%) and for content 30 uniformity (AV values ranges from 3.35 to 10.04). In-vitro release tests were carried 31 out in phosphate buffer of 7.5 and 8.5 pH and showed drug release of ≥ 75%, met 32 USP 38 requirements. However, significant difference with respect to dissolution 33 profile among tested brands GL4 and GL6 were confirmed with comparator product 34 through model independent approach. Moreover, DE values were studied and 35 confirmed that GL4 and GL6 were not therapeutically interchangeable with innovator 36 product. 37 3 38 Introduction 39 Glibenclamide, which is also Glyburide in USA, is a second-generation sulfonylurea 40 oral hypoglycemic agent used in the treatment of noninsulin-dependent diabetes. It is 41 a Biopharmaceutical classification system (BCS) class II drug that has high 42 permeability and poor water solubility (Figure 1).[1] It is one of the most prescribed 43 long-acting anti-hyperglycemic agents that lower the blood glucose acutely by 44 stimulating the release of insulin from the pancreas, an effect dependent upon 45 functioning beta cells in the pancreatic islets. [2] 46 47 Figure 1. Chemical structure of Glibenclamide 48 49The food and Drug Administration (FDA) has dictated that in order for the generic 50 drugs to be approved, they have to pass many guided tests and examination for their 51 physicochemical characteristics, contain the same active constituents and strength, in 52 addition, to be bioequivalent to their innovator product. [3] 53 54 The quality concern of drugs is as old as drugs themselves. Despite all the advances 55 made over the years, this concern has not disappeared. In the recent past, the 56 unregulated proliferation of pharmaceutical industries and products has brought with 57 it many diverse problems of varying magnitude. [4] The use of ineffective, poor 58 quality, harmful medicines can result in therapeutic failure, exacerbation of disease, 59 resistance to medicines and sometimes death. It also undermines confidence in health 60 systems, health professionals, pharmaceutical manufacturers and distributors. Money 61 spent on ineffective, poor quality medicines is wasted -whether by consumers or 62 governments. [5] 63 64 The safety, efficacy, and quality of the medicines should be ascertained to provide a 65 desired pharmacological effect. Substandard drugs have been defined as those which 66 do not meet qualit...

Background: Children in resource-limited countries are more likely to die from treatable conditions than those in higher resource settings due to a lack of the right essential medicine at the right time. Globally millions of children die every year from conditions that could be treatable with existing medicines before they reach their fifth birthday. This study aimed in assessing the availability and affordability of essential medicine for children in selected health facilities of southern nations, nationalities, and peoples’ regions (SNNPR), Ethiopia. Method: A medicine outlets-based cross-sectional study was conducted to assess the availability, affordability, and prices of the 30 selected EMs for children in 30 public and 30 private medicine outlets in SNNPR from March 29 to May 5, 2019, applying WHO and Health Action International (HAI) tools. Availability was expressed as the percentage of sampled medicine outlets per sector that the surveyed medicine was found on the day of data collection. The number of daily wages required for the lowest-paid government unskilled worker (LPGW) to buy one standard treatment of an acute condition or treatment for a chronic condition for a month was used to measure affordability and median price ratio for the price of EDs. Results: Availability was varied by sectors, type of medicines, and level of health facilities. The average availability of EMs was 57.67% in the public sector and 53.67% in private sectors. Ceftriaxone, ORS, zink sulfate, and cotrimoxazole were the most widely available medicine types in both sectors. The median price ratios (MPR) for lowest-priced (LP) medicines were 1.26 and 2.24 times higher than their international reference price (IRP) in the public and private sectors respectively. Eighty-two percent of LP medicines in the public and ninety-one percent of LP medicines in the private sectors used in the treatments of prevalent common conditions in the region were unaffordable as they cost a day’s or more wages for the LPGW.Conclusion: Availability, affordability, and price are determinant pre-requisite for EMs access. According to the current work, although fair availability was achieved, the observed high price affected affordability and hence access to EMs.

Persistent post market quality evaluation helps produce clear information on the current quality status of the different brands of a given drug and hence introduces biopharmaceutically and therapeutically equivalent list of the products to the prescribers and users of it. This in turn facilitates access to essential medicines by breaking the high cost barrier imposed by few expensive brands of the product. This study was aimed at determining the quality and evaluating equivalence of doxycycline hyclate capsules and tablets in Jimma, Ethiopia. Ten brands of doxycycline hyclate capsules and tablets were tested for physic-chemical parameters. All investigated brands of doxycycline complied with the USP for dosage unifor&not;mity, assay of active ingredient and single-point dissolution tests. One brand, D09 failed both hardness and friabilty tests. Comparisons of dissolution profiles applying fit factors confirmed that only brands D04, D06 and D07 had similarity with innovator. Ratio test approaches also showed significant variability existence between test products and comparators. This may question the product&rsquo;s being categorized as a &lt;biowaiver&gt; to mean in-vitro dissolution evaluation suffices its market approval. This work, however, found equivalence problems between &lsquo;comparators&rsquo; and interchangeability issues among doxycycline different brands already distributed in the market.