Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage

References

• SayL,et al.Global causes of maternal death: a WHO systematic analysis.Lancet Glob Health.2014;2:e323e333.
   PubMed Web of Science ®Google Scholar
• Jhpeigo.Business case: investing in production of high-quality oxytocin for low-resource settings. (2014) .http://www.conceptfoundation.org/wp-content/uploads/2015/06/BusinessCase_Oxytocin_web.pdf.
   Google Scholar
• World Health Organization.WHO Recommendations: Uterotonics for the prevention of postpartum haemorrhage. (2018) .https://apps.who.int/iris/bitstream/handle/10665/277276/9789241550420-eng.pdf?ua=1.
   Google Scholar
• World Health OrganizationWHO recommendations for the Prevention and Treatment of Postpartum Hemorrhage. (2012) .http://apps.who.int/iris/bitstream/10665/75411/1/9789241548502_eng.pdf.
   Google Scholar
• Mccormick ML, Sanghvi HCG, Kinzie B, Mcintosh N. Averting maternal death and disability: preventing postpartum hemorrhage in low-resource settings. Int J Gynecol Obstet. 2002.
   Google Scholar
• World Health Organization, UNICEF & UNFPA.WHO/UNICEF/UNFPA joint statement on appropriate management of oxytocin - a key commodity for maternal health. (2019) .https://apps.who.int/iris/bitstream/handle/10665/311524/WHO-RHR-19.5-eng.pdf?sequence=1&isAllowed=y.
   Google Scholar
• World Health Organization.Survey of the quality of medicines identified by the united nations commission on life-saving commodities for women and children. (2015) .
   Google Scholar
• TorloniMR,Gomes FreitasC,KartogluUH,Metin GülmezogluA,WidmerM.Quality of oxytocin available in low- and middle-income countries: a systematic review of the literature.BJOG Int J Obstet Gynaecol.2016;123:2076–86.
   PubMed Web of Science ®Google Scholar
• LambertP,et al.Oxytocin injection quality in Ethiopia: a post-marketing surveillance study in public and private facilities across three regions.J Glob Health Rep.2020;3:e2019081.
   Google Scholar
• Lambert P, Nguyen T-H, McEvoy C, Minhas RS, Wright P, Deadman K, et al. Quality of oxytocin ampoules available in health care facilities in the Democratic Republic of Congo: an exploratory study in five provinces. J Glob Health [Internet]. [cited 2020 May 7];8(2). Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6126516/.
   Google Scholar
• AnyakoraC,et al.Quality medicines in maternal health: results of oxytocin, misoprostol, magnesium sulfate and calcium gluconate quality audits.BMC Pregnancy Childbirth.2018;18:44.
   PubMed Web of Science ®Google Scholar
• India National Institute of Biologics.Survey of extent of problems of spurious and not of standard quality drugs in the country (2014–2016); (2017) .http://www.indiaenvironmentportal.org.in/files/file/National%20Drug%20Survey%202014-16.pdf.
   Google Scholar
• LiuM,et al.The degradation of pharmaceutical oxytocin samples in Nepal and Vietnam.Ann Glob Health.2016;82:534.
   Google Scholar
• StantonC,et al.Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India.BMC Pregnancy Childbirth.2014;14:386.
   PubMed Web of Science ®Google Scholar
• Ghana Food and Drugs Authority (FDA).Laboratory services department & promoting quality of medicines program. post-market quality surveillance project: maternal health care products (oxytocin and ergometrine) on the Ghanaian market. (2013) .
   Google Scholar
• StantonC,et al.Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana.BMJ Open.2012;2e000431.
   PubMed Web of Science ®Google Scholar
• OliverVL,et al.Knowledge, perception and practice towards oxytocin stability and quality: a qualitative study of stakeholders in three resource-limited countries.PLoS One.2018;13:e0203810.
   PubMed Web of Science ®Google Scholar
• HogerzeilHV,WalkerGJ,de GoejeM.Stability of injectable oxytocics in tropical climates: results of field surveys and simulation studies on ergometrine, methylergometrine and oxytocin;1993.
   Google Scholar
• World Health Organization.Annex 10. In:Stability testing of active pharmaceutical ingredients and finished pharmaceutical products;2018.https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1F/Stability_Guideline_WHO_2018.pdf.
   Google Scholar
• KoppDS.Stability testing of pharmaceutical products in a global environment, vol. 4;2006.
   Google Scholar
• World Health Organization.Annex 2 to WHO Technical Report Series, No. 953: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products (Table 2 - updated 6 March 2015). (2015) .http://www.who.int/medicines/areas/quality_safety/quality_assurance/StabilityConditionsTable2UupdatedMarch2015.pdf.
   Google Scholar
• Ahonkhai V, Martins SF, Portet A, Lumpkin M, Hartman D. Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization. PLoS ONE. 2016;11(11):e0166515. https://doi.org/10.1371/journal.pone.0166515.
   Google Scholar
• World Health Organization.Stability testing of active pharmaceutical ingredients and finished pharmaceutical products (Annex 2). (2009) .http://apps.who.int/medicinedocs/documents/s19133en/s19133en.pdf.
   Google Scholar
• NguyenT-H,et al.Temperature stability of oxytocin ampoules labelled for storage at 2°C–8°C and below 25°C: an observational assessment under controlled accelerated and temperature cycling conditions.BMJ Open.2019;9:e029083.
   PubMed Web of Science ®Google Scholar
• World Health Organization.Department of essential medicines and health products. In:Regulation and procurement of life-saving commodities for women and children in Every Woman Every Child (EWEC) countries (2015);2015.
   Google Scholar
• World Health Organization.Annex 4. In:Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part;2012.http://apps.who.int/medicinedocs/documents/s19954en/s19954en.pdf.
   Google Scholar
• Active Pharmaceutical Ingredients | WHO - Prequalification of Medicines Programme. https://extranet.who.int/prequal/content/active-pharmaceutical-ingredients-0.
   Google Scholar
• HallPE,et al.A study of the capability of manufacturers of generic hormonal contraceptives in lower- and middle-income countries.Contraception.2007;75:311–7.
   PubMed Web of Science ®Google Scholar
• World Health Organization.Operational principles for good pharmaceutical procurement;1999. https://doi.org/10.1046/j.1600-0528.2003.00124.x.
   Google Scholar
• TheunissenF,ClepsI,ChineryL,BochatonF,VemerH.Oxytocin quality - evidence for action2018.
   Google Scholar
• Ghana National Health Insurance Authority.National health insurance scheme: medicines list.http://www.nhis.gov.gh/files/2018%20NHIS%20ML.pdf2018.
   Google Scholar
• Management Sciences for Health.Single drug information | international medical products price guideInternational medical products price guide. In: International medical products price guidehttp://mshpriceguide.org/en/single-drug-information/2018.
   Google Scholar
• World Health Organization.WHO good distribution practices for pharmaceutical products (Annex 5).http://apps.who.int/medicinedocs/documents/s18678en/s18678en.pdf.2010.
   Google Scholar
• World Health OrganizationGuide to good storage practices for pharmaceutical practices (Annex 9)2003http://apps.who.int/medicinedocs/documents/s18675en/s18675en.pdf
   Google Scholar
• KartogluU,WidmerM,GulmezogluM.Stability of oxytocin along the supply chain: a WHO observational study.Biol J Int Assoc Biol Stand.2017;50:117–24.
   Google Scholar
• HogerzeilHV,BattersbyA,SrdanovicV,StjernstromNE.Stability of essential drugs during shipment to the tropicsBMJ.1992;304:210–2.
   PubMedGoogle Scholar
• WilsonR,et al.Medicines for maternal health: key data and findings.https://www.unfpa.org/sites/default/files/pub-pdf/Key%20Data%20and%20Findings%20Maternal%20Health%20Medicines-FINAL.pdf2012.
   Google Scholar
• LalondeA,International Federation of Gynecology and ObstetricsPrevention and treatment of postpartum hemorrhage in low-resource settings.Int J Gynaecol Obstet.2012;117:108.
   PubMed Web of Science ®Google Scholar
• DumoulinJG.A reappraisal of the use of ergometrine.J Obstet Gynaecol.1981;1:178–81.
   Google Scholar
• OzawaS,et al.Prevalence and estimated economic burden of substandard and falsified medicines in low- and middle-income countries: a systematic review and meta-analysis.JAMA Netw Open.2018;1:e181662.
   PubMed Web of Science ®Google Scholar
• World Health Organization.A study on the public health and socioeconomic impact of substandard and falsified medical products. (2017) .
   Google Scholar
• Ndomondo-SigondaM,MiotJ,NaidooS,DodooA,KaaleE.Medicines regulation in Africa: current state and opportunities.Pharm Med.2017;31:383–97.
   PubMed Web of Science ®Google Scholar
• World Health Organization.Assessment of medicines regulatory systems in sub-Saharan African countries: An overview of findings from 26 assessment reports.http://apps.who.int/medicinedocs/documents/s17577en/s17577en.pdf.2010.
   Google Scholar
• World Health Organization.WHO support for medicines regulatory harmonization in Africa: focus on East African Community.WHO Drug Inf.2014;28:11–5.
   Google Scholar
• PribludaVS,et al.The three-level approach: a framework for ensuring medicines quality in limited-resource countries.Pharm Regul Aff Open Access.2014;3:1–8.
   Google Scholar
• Ghana Ministry of Health.Ghana pharmaceutical country profile.http://www.who.int/medicines/areas/coordination/Ghana_PSCPNarrativeQuestionnaire_03022012.pdf2012.
   Google Scholar
• LiuH,XiangY,LuY,CrooksRM.Aptamer-based origami paper analytical device for electrochemical detection of adenosine.Angew Chem Int Ed Engl.2012;51:6925–8.
   PubMed Web of Science ®Google Scholar
• WeaverAA,et al.Paper analytical devices for fast field screening of beta lactam antibiotics and antituberculosis pharmaceuticals.Anal Chem.2013;85:6453–60.
   PubMed Web of Science ®Google Scholar
• RavinettoR,PinxtenW,RägoL.Quality of medicines in resource-limited settings: need for ethical guidance.Glob Bioeth.2018;29:81–94.
   PubMedGoogle Scholar
• WHO & UNICEF. WHO/UNICEF Joint Statement: Temperature-Sensitive Health Products in the Expanded Programme on Immunization Cold Chain. https://www.unicef.org/health/files/EPI_cold_chain_WHO_UNICEF_joint_statement_A4_rev2_5-14-15_(3).pdf..
   Google Scholar
• GitauA.Personal communication re: oxytocin in Kenya;2017.
   Google Scholar
• World Health Organization. WHO expert committee on specifications for pharmaceutical preparations: forty-eighth report (annex 3). Geneva: World Health Organization; 2014. p. 387.
   Google Scholar
• PachutoM,SanghoF,DiarraS,CisseS,YeagerB.Options analysis for integration of oxytocin in the epi cold chain in mali. submitted to the us agency for international development by the systems for improved access to pharmaceuticals and services (siaps) programhttp://apps.who.int/medicinedocs/documents/s22348en/s22348en.pdf.2015.
   Google Scholar
• DzradosiM,KhanS,DapaahP,CofieP.Options analysis for integration of oxytocin inthe the expanded program on immunization cold chain: findings from Ghana;2015.
   Google Scholar
• Uganda Ministry of Health, Office of the Permanent Secretary.Use of the UNEPI cold chain in storage and maintaining a cold chain for Oxytocin. (2017) .
   Google Scholar
• World Health Organization & PATH.Integration of vaccine supply chains with other health commodity supply chains: a framework for decision making.https://linkinghub.elsevier.com/retrieve/pii/S0264410X14013589.2013.
   Google Scholar
• World Health Organization, UNICEF & EVM.How to monitor temperatures in the vaccine supply chain.http://apps.who.int/iris/bitstream/handle/10665/183583/WHO_IVB_15.04_eng.pdf;jsessionid=CEDE8BAF65E6171030727FF1875DA5D2?sequence=12015.
   Google Scholar
• HodginsS.Oxytocin: taking the heat.Glob Health Sci Pract.2014;2:259–60.
   PubMedGoogle Scholar
• MullanyLC,et al.Cumulative effects of heat exposure and storage conditions of oxytocin-in-Uniject in rural Ghana: implications for scale up.Glob Health Sci Pract.2014;2:285–94.
   PubMedGoogle Scholar
• AboagyeP,Abu-HaydarE,DedzoM,DzradosiM,DapaahP.Operations research to determine the feasibility of introducing Time Temperature Indicators (TTI) on Oxytocin in Ghana. 2017;43.
   Google Scholar