Cumulative effects of heat exposure and storage conditions of Oxytocin-in-Uniject in rural Ghana: implications for scale up

Mullany, Luke C.; Newton, Sam; Afari-Asiedu, Samuel; Adiibokah, Edward; Agyemang, Charlotte Tawiah; Cofie, Patience; Brooke, Steve; Owusu‐Agyei, Seth; Stanton, Cynthia

doi:10.9745/ghsp-d-14-00043

Cited by 20 publications

(20 citation statements)

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“…Limited data suggest that OT is resistant to freeze-thaw cycle in urines [21]. OT used as a drug was stable for 12 months at 4°C and for 1 month at 25°C [22]. However, these conditions do not reflect the conditions of our study.…”

Section: Discussionmentioning

confidence: 69%

Oxytocin and bone status in men: analysis of the MINOS cohort

Breuil

Fontas²,

Chapurlat

et al. 2015

Osteoporos Int

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Section: Discussionmentioning

confidence: 69%

Oxytocin and bone status in men: analysis of the MINOS cohort

Breuil

Fontas²,

Chapurlat

et al. 2015

Osteoporos Int

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“…Vaccine vial monitors (VVM = TTI for vaccines) have been used for all WHO prequalified vaccines since 1996 and are included among the minimum requirements in all international tenders by all United Nations procurement agencies and any member states . A simulation study involving TTIs with oxytocin used VVM type 30 (meaning that VVM will reach its discard point in 30 days if kept at 37°C constant temperature), found that a considerable number of oxytocin samples were rejected although they were still within acceptable specifications . However, we must note that VVM is not a potency indicator and is designed to warn health workers on the impact of time and temperature on the product with a reasonable safety margin.…”

Section: Discussionmentioning

confidence: 99%

Quality of oxytocin available in low‐ and middle‐income countries: a systematic review of the literature

Torloni

Freitas

Kartoglu

et al. 2016

BJOG

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Background Oxytocin is the drug of choice for preventing and treating postpartum haemorrhage, an important cause of maternal death. Oxytocin is widely available in low and middle-income countries (LMIC) but there are concerns about its quality.Objective To identify, critically appraise and synthesise the findings of studies on the quality of oxytocin available in LMIC.Search strategy We searched seven electronic databases, without language restriction.Selection criteria Studies reporting results of tests to assess quality of oxytocin samples from LMIC.Data collection and analysis Study selection, data extraction and quality assessment were performed in duplicate. Results are presented descriptively.Main results The search identified 2611 unique citations; eight studies, assessing 559 samples from 15 different countries were included. Most samples were collected from facility level settings (n = 509) and from the private sector (n = 321). The median prevalence of oxytocin samples that failed quality tests was 45.6% (range 0-80%), mostly due to insufficient amounts of active pharmacological ingredient. Over one-third of the samples (n = 204) had low (<90%) oxytocin content indicating substandard medicine; two samples had no active ingredient, suggesting possible counterfeit drugs. The proportion of low fails was higher in samples collected in Africa than in Asia or Latin America (57.5% versus 22.3% versus 0%, respectively, P < 0.0001), in private than in public sectors (34.0% versus 25.3%, P = 0.032) and in facilities than in central distributors (37.9% versus 22.0%, P = 0.030). ConclusionThere is a high prevalence of poor-quality oxytocin samples in LMIC countries, mainly due to inadequate amounts of active ingredient.

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“…The Uniject single-use prefilled syringe, which does not require additional sterile equipment, eliminates the need for dosage estimation and can be used by unskilled personnel ( Diop et al, 2016 , Tsu et al, 2003 , Tsu et al, 2009 , Althabe et al, 2011 , Strand et al, 2005 , Stanton et al, 2013 ). However, the Uniject devices still require maintenance of cold-chain supply, and a study in rural Ghana highlighted that the single-use prefilled syringe was highly sensitive to small changes in ambient temperature and could expire in as few as 6 days ( Mullany et al, 2014 ). The preferred approach would be the development of a heat-stable, non-parenteral oxytocin formulation as identified by the UN Commission on Life-saving Commodities for Women and Children ( United Nations, 2012 ).…”

Section: Discussionmentioning

confidence: 99%

Safety, Tolerability and Pharmacokinetics of Single Doses of Oxytocin Administered via an Inhaled Route in Healthy Females: Randomized, Single-blind, Phase 1 Study

et al. 2017

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BackgroundThe utility of intramuscular (IM) oxytocin for the prevention of postpartum hemorrhage in resource-poor settings is limited by the requirement for temperature-controlled storage and skilled staff to administer the injection. We evaluated the safety, tolerability and pharmacokinetics (PK) of a heat-stable, inhaled (IH) oxytocin formulation.MethodsThis phase 1, randomized, single-center, single-blind, dose-escalation, fixed-sequence study (NCT02542813) was conducted in healthy, premenopausal, non-pregnant, non-lactating women aged 18–45 years. Subjects initially received IM oxytocin 10 international units (IU) on day 1, IH placebo on day 2, and IH oxytocin 50 μg on day 3. Subjects were then randomized 4:1 using validated GSK internal software to IH placebo or ascending doses of IH oxytocin (200, 400, 600 μg). PK was assessed by comparing systemic exposure (maximum observed plasma concentration, area under the concentration-time curve, and plasma concentrations at 10 and 30 min post dose) for IH versus IM oxytocin. Adverse events (AEs), spirometry, laboratory tests, vital signs, electrocardiograms, physical examinations, and cardiac telemetry were assessed.FindingsSubjects were recruited between September 14, 2015 and October 12, 2015. Of the 16 subjects randomized following initial dosing, 15 (IH placebo n = 3; IH oxytocin n = 12) completed the study. IH (all doses) and IM oxytocin PK profiles were comparable in shape. However, systemic exposure with IH oxytocin 400 μg most closely matched IM oxytocin 10 IU. Systemic exposure was approximately dose proportional for IH oxytocin. No serious AEs were reported. No clinically significant findings were observed for any safety parameters.InterpretationThese data suggest that similar oxytocin systemic exposure can be achieved with IM and IH administration routes, and no safety concerns were identified with either route. The inhalation route may offer the opportunity to increase access to oxytocin for women giving birth in resource-poor settings.

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Cumulative effects of heat exposure and storage conditions of Oxytocin-in-Uniject in rural Ghana: implications for scale up

Abstract: Oxytocin-in-Uniject devices could be stored 30 to 40 days without refrigeration under typical field conditions, with wastage levels below 10%, based on simulation studies.

Cited by 20 publications

References 5 publications

Oxytocin and bone status in men: analysis of the MINOS cohort

Oxytocin and bone status in men: analysis of the MINOS cohort

Quality of oxytocin available in low‐ and middle‐income countries: a systematic review of the literature

Safety, Tolerability and Pharmacokinetics of Single Doses of Oxytocin Administered via an Inhaled Route in Healthy Females: Randomized, Single-blind, Phase 1 Study

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