Published December 31, 2018 | Version v3
Journal article Open

How is oxytocin cold chain in peripheral areas? And is it still effective uterotonic?

Creators

  • 1. Akademi Kebidanan Bina Husada Tangerang
  • 2. Akademi Kebidanan Husada Gemilang, Tembilahan
  • 3. Politeknik Kesehatan, Kementrian Kesehatan Jambi Jurusan Kebidanan, Jambi

Description

Background. World Health Organization (WHO) has recommended oxytocin as an optional uterotonic medicine to prevent and handle postpartum haemorrhage. However, there is much worry about the quality of oxytocin in developing countries.

Aim: To describe the condition of oxytocin cold chain in the peripheral area, from the source until before being applied to the patients.

Method. Mixed method with sequential exploratory strategy was used in this study. Qualitative design used phenomenological approach and quantitative method used cross-sectional approach. Data collecting was done through in-depth interviews using interview guidelines. Participants were oxytocin suppliers, persons in charge of drug warehouses in medical centres, and medical personnels helping childbirth. Samples were selected using purposive sampling. Data collecting was done from November 2017 to February 2018 in Indragiri Hilir Regency, the Province of Riau, Indonesia. There were 32 participants getting involved in in-depth interviews, 123 respondents filled in questionaires and all were verified using supporting data.

Results. Findings of this study describe oxytocin cold chain including drugstores, delivery process, duration of delivery, oxytocin handling, oxytocin orders, kinds of medicine, medicine chests, and electricity in medicine supliers, drug warehouses and medical centres.

Conclusion. Most of the cold chain of oxytocin is not maintained from drug suppliers, drug warehouses, health care providers to the patients. Deviation tolerance of oxytocin cold chain can not be used as a justification. There is a consequence of oxytocin potential decline for every deviation. The government should examine unregistered and below standard medicine manufacturers, and encourage law enforcement for every violation.

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References

  • Avanti, C et al. (2011). A new strategy to stabilize oxytocin in aqueous solutions: I. the effects of divalent metal ions and citrate buffer. AAPS J, 13, 284-290.
  • Barends, DM. (1990). Normen voor het gehalte van geneesmiddelen [Standards on drug content]. Pharm Weekbl, 125, 956-958.
  • BKKBN, et al. (2013). Indonesia demographic and health survey 2012. Indonesia: Badan Kependudukan dan Keluarga Berencana Nasional (BKKBN), Badan Pusat Statistik (BPS), Kementrian Kesehatan, MEASURE DHS, ICF International.
  • Campos, RC et al. (2006). Estabilidad máxima de los medicamentos termolábiles fuera de nevera. Farm Hosp, 30, 33-43.
  • Connors, KA et al. (1986). Chemical stability of pharmaceuticals. A handbook for pharmacists, 2nd ed, New York, John Wiley and Sons.
  • Hawe, A et al. (2009). Towards heat-stable oxytocin formulations: analysis of degradation kinetics and identification of degradation products. Pharm Res, 26, 1679-1688. [DOI: 10.1007/s11095-009-9878-2].
  • Hodgins, S & Lukulay, PH. (2017). The impact of thermal stability of oxytocin on access, and the importance of setting proper product specifications. Int J Gynecol Obstet, 136, 253-254. [DOI: 10.1002/ijgo.12071].
  • Hogerzeil, HV et al. (1993). Stability of injectable oxytocics in tropical climates: results of field surveys and simulation studies on ergometrine, methylergometrine and oxytocin. WHO, Action Programme on Essential Drugs, Safe Motherhood Research Programme. Retrieved from http://apps.who.int/iris/bitstream/10665/59411/1/WHO_DAP_93.6.pdf
  • Hollander, E et al. (2003). Oxytocin infusion reduces repetitive behaviors in adults with autistic and asperger's disorders. Neuropsychopharmacology, 28, 193-8.
  • ICM & FIGO. (2004). International Confederation of Midwives; International Federation of Gynaecologists and Obstetricians. Joint statement: management of the third stage of labour to prevent post-partum haemorrhage. J Midwifery Womens Health, 49, 76-77.
  • Indrayani et al. (2017). Please understand why village midwife performance is not optimum! Bangladesh J Med Sci, 16, 505-514. [DOI: 10.5281/zenodo.1323177] Retrieved from https://www.banglajol.info/index.php/BJMS/article/view/33603/22631.
  • Jafarov, A et al. (2011). Comparative table of core and complementary medicines on the WHO essential medicines list from 1977-2011. World Health Organization. Retrieved from http://www.who.int/entity/medicines/publications/essentialmedicines/EMLsChanges1977_2011.xls
  • Karikari-Boateng, E. (2013). Post-market quality surveillance project maternal health care products (oxytocin and ergometrine) on the Ghanaian market. Accra, Ghana: Ghana Food and Drugs Authority (FDA) Laboratory Services Department, Promoting the Quality of Medicines Program.
  • Khan, KS et al. (2006). WHO analysis of causes of maternal death: a systematic review. Lancet, 367, 1066-1074.
  • Miller, S et al. (2004). CEU: Prevention and treatment of postpartum hemorrhage: new advances for low-resource settings. J Midwifery Women's Health, 49, 283-292. [DOI: 10.1016/j.jmwh.2004.04.001].
  • Moucheraud, C et al. (2015). Bedside availability of prepared oxytocin and rapid administration after delivery to prevent postpartum hemorrhage: an observational study in Karnataka, India. Glob Health Sci Pract, 3, 300-304.
  • Mullany, LC et al. (2014). Cumulative effects of heat exposure and storage conditions of oxytocin-in-uniject in rural Ghana: implications for scale up. Glob Health Sci Pract, 2, 285-294. [DOI: http://dx.doi.org/10.9745/GHSP-D-14-00043].
  • Nassta, GC et al. (2013). Effect of freezing on oxytocin ampules. N Engl J Med, 368, 2145-2146. [DOI: 10.1056/NEJMc1209761].
  • Parraga, LP et al. (2011). Thermolabile drugs. Operating procedure in the event of cold chain failure. Farm Hosp, 35, 190.e1-28.
  • Phanouvong, S et al. (2011). Assessment of the conformity or non-conformity of oxytocin injection in ampoules in selected Provincial and District Health Offices, Primary Health Care Centers and Village Midwife Clinics in Indonesia. Study report: USAID, PATH. p1-26.
  • Stanton, C et al. (2012). Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana. BMJ Open, 2, 1-7;e000431. [DOI: 10.1136/bmjopen-2011-000431].
  • Stanton, C et al. (2014). Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India. BMC Pregnancy Childbirth, 14, 1-12.
  • Torloni, MR et al. (2016). Quality of oxytocin available in low- and middle-income countries: a systematic review of the literature. BJOG, 123, 2076-2085. [DOI: 10.1111/1471-0528.13998].
  • Vaart, FJVD et al. (1990). Bereiding, op of onder de maat? [Manufacture, up to standard?]. Pharm Weekbl, 125, 953.
  • Weeks, A. (2015). The prevention and treatment of postpartum haemorrhage: what do we know, and where do we go to next? BJOG, 122, 202–212. [Doi: 10.1111/1471-0528.13098].
  • Westhoff, G et al. (2013). Prophylactic oxytocin for the third stage of labour to prevent postpartum haemorrhage. Cochrane Database Syst Rev, CD001808.
  • WHO. (2009). WHO statement regarding the use of misoprostol for postpartum haemorrhage prevention and treatment. Geneva: Department of Reproductive Health and Research. Retrieved from http://apps.who.int/iris/bitstream/10665/70053/1/WHO_RHR_09.22_eng.pdf
  • WHO. (2010). WHO model list of essential medicines; 16th list (updated). Geneva: World Health Organization. Retrieved from http://apps.who.int/iris/bitstream/10665/70643/1/a95060_eng.pdf
  • WHO. (2010). Oxytocin: adopted text for The International Pharmacopoeia: final text for addition to The International Pharmacopoeia (June 2010). 4th ed. Geneva: World Health Organization.
  • WHO 2012. WHO recommendations for the prevention and treatment of postpartum haemorrhage, Geneva, Switzerland, World Health Organization. Retrieved from http://www.who.int/medicines/publications/pharmacopoeia/Oxytocin-mono_QAS07241FINALJune10.pdf
  • Widmer, M et al. (2016). Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: Study protocol for a randomized controlled trial. Trials BMC, 17, 1-9.