Oxytocin injection quality in Ethiopia: a post-marketing surveillance study in public and private facilities across three regions
Publication date: 2020
Research Articles OOxyxytocin injectocin injection qualittion quality in Ethiopia: a posty in Ethiopia: a post-mark-marketing sureting survveillanceillancee study in public and private facilities across three regionsstudy in public and private facilities across three regions Pete Lambert*, Tri-H Nguyen†, Victoria L Oliver‡, Andrew J L McArthur**, Cleo Goodall††, Alula M Teklu‡‡, Bikila Bayissa***, Zelalem Mamo†††, Delayehu Bekele‡‡‡, Michelle P McIntosh**** Keywords: global health https://doi.org/10.29392/joghr.3.e2019081 Journal of Global Health RJournal of Global Health Reportseports Vol. 3, 2019 BackBackgroundground The high prevalence of poor quality essential medicines in low and middle income coun- tries (LMIC) presents considerable risks in terms of both health outcomes and economic cost. Oxytocin injection, the gold standard therapy for management of postpartum haem- orrhage (PPH), presents a particular challenge in this area. Recent studies in India, Nigeria and DRC have identified product failure rates, in terms of low drug content, to be 41%, 74% and 80% respectively. Ethiopia bears a high burden of PPH with over 40% of maternal deaths being directly attributed to haemorrhagic causes. This study assessed the quality of oxytocin injection at points in the public and private supply chains to support national ef- forts to address PPH in Ethiopia. MethodsMethods This study sampled oxytocin injection ampoules from 45 sites across Oromia, Afar regions and the administrative area of Addis Ababa. This included points along the public supply chain from the national point of entry for supplies through regional hubs to points of use (public and private facilities) in urban and rural areas. Collected samples were stored un- der refrigerated conditions until analysis for oxytocin content, known degradation prod- ucts and microbiological quality. RResultsesults Ninety-six percent of ampoules passed all tests, while two samples (4%) contained less than the specified oxytocin content. Both samples were collected from rural facilities in Afar, a remote, poorly resourced region with a very hot climate. All supplies collected were sourced from European stringent regulatory approved (SRA) suppliers and, where storage conditions could be determined, approximately 95% of samples were stored in the refrig- erator at the time of collection. CConclusionsonclusions The study indicates that oxytocin injection in the selected regions is generally of high quality and being stored appropriately. The failed samples detected in Afar suggest chal- lenges remain around maintenance of refrigerated storage in least resourced settings. These findings contrast with recent results in other African countries and support the joint Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia MERQ Consultancy, Addis Ababa, Ethiopia Food, Medicines and Health Care Administration and Control Authority of Ethiopia, Addis Ababa, Ethiopia United States Pharmacopeial Convention – Promoting Quality of Medicines Programme, Addis Ababa, Ethiopia Department of Obstetrics and Gynaecology, St Paul’s Hospital Millennium Medical College, Addis Ababa, Ethiopia Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia * † ‡ ** †† ‡‡ *** ††† ‡‡‡ **** Lambert P, Nguyen T-H, Oliver VL, et al. Oxytocin injection quality in Ethiopia: a post- marketing surveillance study in public and private facilities across three regions. Journal of Global Health Reports. 2019;3:e2019081. doi:10.29392/joghr.3.e2019081 World Health Organization (WHO)/United Nations Children Fund/United Nations Popula- tion Fund statement that the availability of high quality oxytocin injection at the point of use is dependent on procurement of supplies from manufacturers approved by WHO or SRAs and storage at 2-8°C throughout the supply chain. Recent studies have highlighted the issue of substandard and falsified (SF) medicines in low and middle income coun- tries (LMICs). A systematic review estimated the prevalence of SF medicines in these regions to be 13.6% with higher rates in some areas (Africa 18.7%) and therapeutic cate- gories (antimalarials 19.1%). 1 Quantifying the potential economic burden caused by SF medicines is challenging as detailed information is limited, however the same study es- timated the annual financial impact to be between US$ 10 billion to US$ 200 billion. Oxytocin injection, the first line therapy for both the pre- vention and treatment of postpartum haemorrhage (PPH), presents particular challenges in LMICs in terms of the maintenance of high quality products throughout the sup- ply chain. 2 These challenges result in part from the re- quirement for all oxytocin injection to be stored under re- frigerated conditions (ie, 2°C - 8°C) for the duration of the product shelf-life. 3 In low resource settings, the infrastruc- ture to maintain consistent cold chain supply and storage is often lacking, potentially leading to product deterioration. In addition, there are a high number of oxytocin injec- tion manufacturers that supply ampoules into the global market (reportedly in excess of 100, with possibly as many as 300 products). 4 Many of these suppliers operate in coun- tries that do not adhere to stringent manufacturing quality standards and will supply into countries where marketing authorisations have not been obtained. 5 Consequently, the quality of oxytocin ampoules at the time of manufacture varies considerably between suppliers, with inappropriate labelling around storage conditions and high impurity lev- els being examples of identified deficiencies. 6 As a result of these factors, multiple studies have found that the quality of oxytocin products available in low and middle income countries does not consistently meet inter- nationally recognised standards. Torloni et al. conducted a systematic review of studies examining the quality of oxy- tocin in Africa, Asia and Latin America. 7 Four eligible stud- ies conducted evaluations in eight African countries and found a mean of 57.5% of ampoules did not contain the specified content of oxytocin. Subsequent studies in Nigeria and the Democratic Republic of Congo showed a higher in- cidence of ampoules failing to meet content specifications. 6, 8 Given these findings and that PPH is estimated as the leading global cause of pregnancy-related deaths (approx- imately 20%), with these deaths occurring overwhelmingly in the low and lower-middle income countries, internation- al efforts are focussing on strategies to improve oxytocin quality. 3, 9 Ethiopia is a country that bears a high burden of ma- ternal mortality. World Health Organisation data estimates that 11,000 maternal deaths occurred in Ethiopia in 2015, making it the fourth largest contributor to the total number of maternal deaths worldwide. 10 A recent Federal Ministry of Health (FMoH) Maternal Death Surveillance and Re- sponse initiative (Ethiopian Public Health Institute, 2016) highlighted that just over 30% of maternal deaths in the country are due to PPH. 11 With an aim to improve out- comes, the Government of Ethiopia has targeted maternal health as a major priority in its Health Sector Transforma- tion Plan (2015/2016 – 2019/2020), and specific focus has been directed toward addressing the burden of PPH. 12 Although the national medicine regulatory authority has undertaken small scale oxytocin post-marketing surveil- lance sample testing in previous years, no published studies have examined the quality of oxytocin ampoules in Ethiopia. Oxytocin injection quality may be compromised at the point of entry into the country (due to substandard manufacture) and/or at the point of use, particularly in low resource regions where distances to rural facilities are great and supporting infrastructure to maintain controlled supply and storage can be poor. This study, conducted in partnership with Ethiopian gov- ernment authorities, aimed to assess the quality of oxytocin ampoules at a number of healthcare facilities and distribu- tion/supply outlets in selected areas of Ethiopia. The study used purposeful sampling in two regions (Oromia and Afar) and one administrative centre (Addis Ababa) to i) better un- derstand the oxytocin injection quality landscape and ii) guide government initiatives to address PPH, inform future research and support global efforts to address poor oxytocin quality. METHODS Methodology and results have been reported according to World Health Organization (WHO) Guidelines on the Con- duct of Surveys of the Quality of Medicines. 13 SURVEY PERIOD Samples were collected from 45 public and private facilities across two regions and the city administration over the pe- riod of October 10-24, 2017. SELECTION OF SAMPLING AREAS The study collected samples from two regions and one city administration: Oromia, Afar and Addis Ababa respectively. The Oromia and Afar regions were selected as contrasting settings to provide information into geographical varia- tions. Oromia is a large, better resourced region and has the highest population in the country. Afar is an emerging re- gion that lacks infrastructure, endures high ambient tem- peratures and requires supply chains to accommodate large distances between supply hubs and healthcare facilities. As such, Afar represents a setting with the greatest barriers to maintaining oxytocin quality. The selection of these regions ensured this study com- plemented the previous unpublished post-marketing activi- ties conducted by the Ethiopian Food, Medicine and Health- care Administration and Control Authority ((FMHACA), now the Ethiopia Food and Drug Authority, assessing oxy- tocin quality in Addis Ababa and five different regions (Tigray, Southern Nations, Nationalities and Peoples Re- gion, Benishangul-Gumuz, Somali and Amhara). Within Oromia and Afar, collection sites in both urban and rural ar- eas were targeted to understand within-region variations in quality that may arise due to disparities in cold chain relia- bility between urban and rural settings. Addis Ababa is the administrative centre of Ethiopia with greatest population density and serves as the entry point for all publicly pro- cured oxytocin supplies and therefore constitutes the start Oxytocin injection quality in Ethiopia: a post-marketing surveillance study in public and private facilities across three. Journal of Global Health Reports 2 of the public supply chain. SAMPLING DESIGN AND SELECTION OF SAMPLE COLLECTION SITES This section summarises the sampling methodology used based on a detailed operating procedure provided to the sampling teams (Appendix S1 in the Online Supplementary Document). Drug products for public provision in Ethiopia are pur- chased and distributed by the Pharmaceutical Funding and Supply Agency (PFSA) within the FMoH. Oxytocin is not manufactured locally and so all product is internationally supplied, entering the country either via Addis Ababa air- port or overland. This study aimed to sample material at the PFSA storage facilities at the airport, at the central stor- age facility and at regional hubs in Oromia and Afar, which, combined with samples from healthcare facilities supplied by these centres, would be used to assess quality of am- poules at all points along the public supply chain. In each region, one regional PFSA distribution hub was selected and then public healthcare facilities supplied by the chosen regional hub were identified in accordance with the predetermined sampling schedule including hospitals and health centres. Private healthcare facilities were select- ed on the basis of proximity to selected public facilities to assist in the efficiency of collection. In addition, collection sites targeted included the PFSA storage facility at Addis Ababa airport (first port of entry) and the PFSA central store in Addis Ababa where public oxytocin supplies are stored immediately post-importation. Samples were collected at all levels of the public health- care system from tertiary referral hospitals to rural health centres. It was hypothesised that the consistency of cold chain supply and storage may decrease in lower tier facili- ties and rural settings where resources are fewer and pow- er interruptions may be more frequent and protracted. In addition, private supply outlets and healthcare clinics were sampled to understand public versus private variations. SAMPLE COLLECTION AND TRANSPORTATION Sampling was conducted by collection team(s) comprising a minimum of two trained collectors using either an overt sampling or a mystery shopper strategy as appropriate. Overt sampling was used at all public facilities with prior approval from an appropriate facility representative. Im- portantly, the FMoH Maternal and Child Health Directorate provided a letter of authorisation that assisted in the ap- proval at the facility level. Where appropriate (public facil- ities), samples collected for analysis were replaced by re- searchers with ampoules purchased prospectively PFSA. Samples collected from private facilities used a mystery shopper approach. The sampling plan aimed to collect samples from 48 fa- cilities. The target number of ampoules per sample was 25 ampoules to allow replicate assay testing, investigative work and microbiological (sterility and endotoxin) testing. If multiple batches were held at a facility, collectors would seek to collect a sample for every batch present. In cases where a limited number of ampoules were available, a min- imum of nine ampoules were collected per sample. Sample details such as facility information, number of ampoules, batch number, manufacturer information and storage conditions were recorded using a sample collection form (Appendix S2 in the Online SupplementarOnline Supplementary Docu-y Docu- mentment). After collection, samples were retained in cool boxes un- til they were returned to Addis Ababa where they were stored under refrigerated conditions (2-8°C). Once samples from all regions were available in Addis Ababa, samples were divided and shipped under ambient conditions to Monash Institute of Pharmaceutical Sciences (MIPS) and the Quality Control Laboratory at EFMHACA for analysis (total storage and shipping time=24 days). All samples re- ceived at these locations were stored at 2-8°C until the time of analysis. A temperature logger recorded the temperature of sample storage post-collection and during shipping to MIPS, and indicated no evidence of significant temperature excursions during this time. TESTING LABORATORIES Testing was conducted at the following three sites as de- scribed in Table 1: Oxytocin injection quality in Ethiopia: a post-marketing surveillance study in public and private facilities across three. Journal of Global Health Reports 3 TTable 1. Summarable 1. Summary of sample testing (full sample)y of sample testing (full sample) TTestest Method/ SpecificationMethod/ Specification No. of AmpoulesNo. of Ampoules CommentsComments TTesting at EFMHAesting at EFMHACACA Appearance USP 3 Uses same ampoules as assay testing Labelling USP Assay USP Triplicate testing Assay (spare) USP 6 To allow repeat testing if first test found ampoules to be out of specification TTesting at MIPSesting at MIPS Investigative Testing (descriptive) In-house methods 3 Testing to identify degradants/ impurities Microbiological TMicrobiological Testingesting Validation (sterility) USP <71> 8 Microbiological testing subcontracted to Chemical Analysis Ltd (Melbourne) Sterility Testing Endotoxin Testing USP <71> USP<85> 5 TTotalotal 2525 USP - United States Pharmacopeia, MIPS – Monash Institute of Pharmaceutical Sciences, EFMHACA - Ethiopian Food, Medicine and Healthcare Administration and Control Authority Oxytocin injection quality in Ethiopia: a post-marketing surveillance study in public and private facilities across three. Journal of Global Health Reports 4 TTable 2. Number of facilities from which samples wable 2. Number of facilities from which samples were cere collecollected in each region and areated in each region and area AreaArea Facility typeFacility type CityCity/Region/Region Addis AbabaAddis Ababa OromiaOromia AfarAfar Urban PFSA Hub 1 1 1 Public hospital 3 3 1 Public health centre 3 3 3 Private pharmacy 3 3 1 Private Hospital 2 - - Private Clinic 1 3 1 Rural Public hospital - 3 1 Public health centre - 3 5 QUALITY TESTS PERFORMED AND TEST METHODS AND SPECIFICATIONS USED Sample testing was conducted in accordance with Table 1. Where incomplete samples were collected (<25 ampoules), assay testing was prioritised and microbiological testing conducted on a discretionary basis. Microbiological testing was conducted per batch ie, where a single batch was col- lected from multiple sites only one sample was used for mi- crobiological testing. DEFINITION OF COMPLIANCE OF SAMPLES WITH STANDARDS All samples found to be out-of-specification were retested to verify results obtained. All data was subject to review and approval by quality control functions at all testing sites. RESULTS OVERVIEW OF SAMPLES COLLECTED Complete samples of 25 ampoules were collected from 39 facilities while reduced numbers of ampoules were collected from a further six facilities. All samples comprised a mini- mum of 10 ampoules. All samples collected comprised 1 mL ampoules labelled to contain 10 IU oxytocin solution for in- jection. MANUFACTURERS AND BATCHES Samples collected were identified as being supplied from the following three manufacturers: Most samples comprised ampoules from a single batch of product from a given manufacturer, however samples from five facilities comprised multiple batches from a single manufacturer. SITES OF SAMPLE COLLECTION Samples were collected from 45 facilities across the regions. The sites comprised hospitals, health centres, maternal and child health centres and pharmacies from across the public, private and NGO sectors in addition to regional PFSA stor- age hubs (Table 2). The following deviations from the pro- posed sample collection sites were necessary: REGISTRATION STATUS OF SAMPLED PRODUCTS All samples were supplied from European-based, stringent regulatory authority approved manufacturers. However, at the time of sampling, the Novartis product was the only product registered by EFMHACA (according to the EFMHA- CA website). These samples comprised 7% of the samples collected during the study. The RotexMedica product was registered in December 2017 shortly after this survey was completed. STORAGE CONDITIONS OF SAMPLED PRODUCTS Where possible, the storage conditions at the time of col- lection were recorded. Thirty three samples were collected from functional refrigerators, while two samples were not stored in refrigerated conditions. The storage conditions of the remaining 10 samples could not be verified. TESTING RESULTS Individual sample results are provided in Table S1 in the Online SupplementarOnline Supplementary Documenty Document. Samples from two sites did not meet the US pharmacopeial assay specifications (90-110% of specified content) with the mean content of oxytocin being 78.8% and 78.3% of label claim in each sam- ple. Both samples were collected from rural public health centres in Afar. Further analysis of these ampoules revealed the presence of known degradation products of oxytocin. The samples from these sites passed all other tests. All other samples passed all tests. DISCUSSION INTERPRETATION OF THE RESULTS The quality of the oxytocin samples collected during this • Medicine Quality Control Laboratory, EFMHACA, Ad- dis Ababa, Ethiopia • HMST Laboratory, MIPS, Melbourne, Australia • Chemical Analysis Ltd, Melbourne, Australia • RotexMedica GmbH (38 samples) • Biologici Italia Laboratories S.r.l (4 samples) • Novartis AG (3 samples) • Collection of samples from the PFSA storage facility at Addis Ababa airport was not possible as no oxy- tocin products were stored at this location at the time of the study. • The protocol targeted three private healthcare facili- ties in Afar for sample collection. However, collection at this number of sites was not possible as the re- quired number of oxytocin ampoules were available only at one out of six private healthcare facilities vis- ited. In order to maintain sample numbers, two addi- tional public health centres in Afar were sampled. Oxytocin injection quality in Ethiopia: a post-marketing surveillance study in public and private facilities across three. Journal of Global Health Reports 5 study was generally high, in contrast to published studies conducted in other sub-Saharan countries. 7 A contributing factor to these positive results is likely that all samples col- lected were supplied by European manufacturers approved by stringent regulatory authorities. In addition to the high manufacturing standards, all samples were labelled for re- frigerated storage and the majority (at least 73%) were stored in the cold chain at the time of collection, with only 4% of samples observed as being stored under ambient con- ditions. The Ethiopian Emergency Obstetric and Newborn Care (EmONC) Assessment Report (2016) details a review of 3780 healthcare facilities and observed a similar pro- portion that stored oxytocin in refrigerated conditions. 14 This is largely in accordance with international recommen- dations, most specifically the recent joint WHO/United Na- tions Children Fund (UNICEF)/United Nations Population Fund (UNFPA) statement aimed at the procurement, supply and use of high quality oxytocin injection products. This statement recommends that all oxytocin products be pro- cured from stringent regulatory or WHO approved suppliers and be stored in the cold chain throughout the distribution chain with labelling to that effect. 3, 15 Other studies conducted in resource limited settings have found that oxytocin ampoules have originated from manufacturers without stringent regulatory assessment and often with labelling that does not require refrigerated storage of the product. 6, 8, 16 Qualitative studies among stakeholders have found that this labelling leads to confu- sion as to the relative stability of differently labelled prod- ucts and undermines evidence that routine ambient storage risks product degradation, particularly in countries with hot climates (ie, the majority of low and middle income coun- tries). 17 The two samples from the current study that failed assay testing were collected at public rural facilities in Afar, a poorly resourced region with a very hot climate. Additional testing revealed the presence of oxytocin degradation prod- ucts in these samples suggesting heat exposure. Given that samples collected from the PFSA regional hub in Afar passed testing, these samples were likely exposed to ele- vated temperatures during supply from the regional hub and/or storage at the facility. In one case the sample was stored in non-refrigerated conditions at the time of collec- tion, which supports this hypothesis. The storage condi- tions of the second sample could not be verified. Only 7% of samples collected (one of the three products found on the market) comprised a product that had been approved and registered by EFMHACA at the time of collec- tion, including only one sample from public facilities. The mechanism by which the other products were procured and entered the country is probably through the stringent reg- ulatory authorities approved products recognition scheme but the reasons why these products were not in the ap- proved medicines list is unknown and warrants further in- vestigation. It is possible that unregistered products can be procured legally under waiver arrangements to cover stock shortages, but this would need to be verified. RECOMMENDATIONS While the quality of oxytocin sampled in this study was high, the incidence of PPH in Ethiopia also remains high. Therefore, given the small geographical scope of the study, further investigations are warranted to verify these results on a national basis. The data collected in Afar indicates that the public sup- ply chain in this region may present a risk to oxytocin injec- tion quality at the point of use, and a review of these sys- tems should be prioritised. Similarly, a wider review should take a risk-based approach and focus initially on regions of least resource with high ambient temperatures and those with high maternal mortality due to PPH. Ninety-three percent (93%) of samples (2/3 of the prod- ucts) collected were unregistered at the time of collection. Further investigations are recommended to understand the provenance of these products and review procurement pro- cedures in both public and private sectors. LIMITATIONS OF METHODOLOGY One limitation of this study is that the number of sample sites and the geographical spread of sample locations with- in each region was small. Therefore, these results should be considered indicative of those locations, but are not repre- sentative of the regional or national situation. The sample sites of this study should be used to guide the design of fu- ture studies to identify geographic gaps where further in- vestigation is warranted to provide a more comprehensive picture of nation-wide oxytocin quality. Overt sampling was conducted at public facilities and it was not always possible for collection teams to witness from where within the facility samples were being provided. This represents a second limitation as it was not always possible to confirm that the samples and their reported or observed storage conditions were representative of the stock avail- able. For example a recent qualitative study found that in one facility a small batch of oxytocin ampoules were stor- age refrigerated, while the larger facility stock was stored at room temperature. 17 It should also be noted that the data collected about oxy- tocin storage conditions in this study presents only a sin- gle time point of information. While these data do speak to the knowledge and practice of stakeholders towards refrig- erated storage of oxytocin, limited inferences can be made about the temperatures the products had been exposed to from the point of entry until the time of collection. Al- though it was beyond the scope of the current study, re- search to understand the time-course of temperatures asso- ciated with oxytocin supply and storage is warranted. At five locations, insufficient ampoule numbers were col- lected to allow the conduct of microbiological testing. It was outside the scope of this study to understand why lim- ited ampoule numbers were available at certain sampling sites, but further investigation may be warranted. CONCLUSIONS This study indicates that the quality of oxytocin at the loca- tions sampled in Ethiopia is high, with oxytocin ampoules universally supplied from European-based, stringent regu- latory authority approved manufacturers. All supplies were labelled for refrigerated storage with most being stored ac- cordingly in facilities at 2-8°C in accordance with recent WHO/UNICEF/UNFPA recommendations. However, there are indications that deficiencies may exist in cold chain in- frastructure and/or supply and storage procedures in rural resource-constrained areas with the potential to compro- mise oxytocin quality. A review of procurement and registration procedures is warranted to understand the high proportion of product sampled during this study that was unregistered by EFMHA- CA. Further post-marketing surveillance studies assessing additional collection sites and regions are required to un- derstand the quality of oxytocin supplies in other regions of Ethiopia to better understand the national situation. Oxytocin injection quality in Ethiopia: a post-marketing surveillance study in public and private facilities across three. Journal of Global Health Reports 6 ACKNOWLEDGEMENTS The authors gratefully acknowledge the support of the Ethiopian FMoH Maternal and Child Health Directorate and all participating facilities in the conduct of this study. The study design was approved by the Institutional Review Board of St Paul’s Hospital Millennium Medical College (reference number PM23/76). Funding:Funding: The study was funded through a grant to Monash University from the Reproductive Health Supplies Coalition Innovation Fund (ref. MAC.2042-01361263-GRT) with supplementary funding from an unrestricted grant to Monash University from the McCall MacBain Foundation. CCompeting interests:ompeting interests: The authors completed the Unified Competing Interest form at www.icmje.org/coi_disclo- sure.pdf (available on request from the corresponding au- thor). MPM is the co-inventor of a patent describing a nov- el, heat stable, powder formulation of oxytocin. PL, VLO, MPM, THN, AJLM and CG were supported by funding from the Reproductive Health Supplies Coalition and the McCall MacBain Foundation. AMT and BB received funding support from the Reproductive Health Supplies Coalition through Monash University. ZM and DB declare no competing inter- ests. Correspondence to: Professor Michelle McIntosh, PhD 381 Royal Parade Parkville VIC 3052 Australia email@example.com This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC- BY-4.0). View this license’s legal deed at http://creativecommons.org/licenses/by/4.0 and legal code at http://creativecom- mons.org/licenses/by/4.0/legalcode for more information. Oxytocin injection quality in Ethiopia: a post-marketing surveillance study in public and private facilities across three. Journal of Global Health Reports 7 REFERENCES 1. Ozawa S, Evans DR, Bessias S, et al. 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Journal of Global Health Reports 8 Background Methods Results Conclusions METHODS Survey period Selection of sampling areas Sampling design and selection of sample collection sites Sample collection and transportation Testing laboratories Quality tests performed and test methods and specifications used Definition of compliance of samples with standards RESULTS Overview of samples collected Manufacturers and batches Sites of sample collection Registration status of sampled products Storage conditions of sampled products Testing results DISCUSSION Interpretation of the results Recommendations Limitations of methodology CONCLUSIONS Acknowledgements References
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