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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., Objective: Postpartum hemorrhage can be reduced substantially in home deliveries attended by community-based workers by using Oxytocin-in-Uniject (OIU) devices affixed with temperature-time indicators. We characterized the distribution of time to discard of these devices when stored under normal field conditions in Ghana. Methods: Two drug storage simulation studies were conducted in rural Ghana in 2011 and 2012. Devices were transported under refrigeration from manufacture (Argentina) to storage at the study site. Twenty-three field workers each stored at home (unrefrigerated) 25 OIU devices and monitored them daily to record: (1) time to transition from usable to unusable, and (2) continuous digital ambient temperature to determine heat exposure over the simulation period. Time to discard was estimated and compared with mean kinetic temperature exposure of the devices during the shipment and storage phases and with characteristics of the storage locations using Weibull regression models. We used the time to discard distributions in a Monte Carlo simulation to estimate wastage rates in a hypothetical program setting. Results: Time for shipment and transfer to long-term refrigerated storage and mean kinetic temperature during the shipment phase was 8.6 days/10.3°C and 13.4 days/12.1°C, for the first and second simulation studies, respectively. Median (range) time to discard when stored under field conditions (unrefrigerated) was 43 (6 to 59) days and 33 (14 to 50) days, respectively. Mean time to discard was 10.0 days shorter in the second simulation, during which mean kinetic temperature exposure was 3.9°C higher. Simulating a monthly distribution system and assuming typical usage, predicted wastage of product was less than 10%. Conclusion: The time to discard of devices was highly sensitive to small changes in temperature exposure. Under field conditions typical in rural Ghana, OIU packages will have a half-life of approximately 30 to 40 days based on the temperature monitor used during the study. Program managers will need to carefully consider variations in both ambient temperature and rate of use to allocate the appropriate supply level that will maximize coverage and minimize stock loss.

Objectives Given use of uterotonics for postpartum haemorrhage and other obstetric indications, the importance of potent uterotonics is indisputable. This study evaluated access to and potency of injectable uterotonics in Ghana. Design Study design involved research assistants simulating clients to purchase oxytocin and ergometrine from different sources. Drug potency was measured via chemical assay by the Ghana Food and Drugs Board. Setting The study was conducted in three contrasting districts in Ghana. Outcome measure The per cent of active pharmaceutical ingredient was measured to assess the quality of oxytocin and ergometrine. Results 69 formal points of sale were visited, from which 55 ergometrine ampoules and 46 oxytocin ampoules were purchased. None of the ergometrine ampoules were within British Pharmacopoeia specification for active ingredient, none were expired and one showed 0% active ingredient, suggestive of a counterfeit drug. Among oxytocin ampoules purchased, only 11 (26%) were within British Pharmacopoeia specification for active ingredient and two (4%) were expired. The median percentages of active ingredients were 64% and 50% for oxytocin and ergometrine, respectively. Conclusions The quality of injectable uterotonics in three contrasting districts in Ghana is a serious problem. Restrictions regarding the sale of unregistered drugs, and of registered drugs from unlicensed shops, are inadequately enforced. These problems likely exist elsewhere but are not assessed, as postmarketing drug quality surveillance is generally restricted to well-funded disease-specific programmes relying on antiretroviral, antimalarial and antibiotic drugs. Maternal health programmes must adopt and fund the same approach to drug quality as is standard in programmes addressing infectious disease., Article summary Article focus The need for high-quality uterotonic drugs for the prevention and treatment of maternal mortality and morbidity in poor countries is indisputable. Best practice for long-term storage for all injectable uterotonics is refrigeration, which is a key logistical constraint for scale up of postpartum haemorrhage reduction strategies and is a general challenge for maternity services without consistent electricity. The objectives of the study were to assess the population's access to uterotonic drugs and to assess the chemical potency of ampoules of oxytocin and ergometrine available to the population. Key messages Quality of uterotonics is likely a serious problem in Ghana; 89% of all ampoules tested in this study did not meet the specifications for active ingredient. The low level of active ingredient in these ampoules is not due to old drugs; only 2% of these ampoules had expired. There is little enforcement of the restriction against chemical shops selling uterotonics or of the sale of unregistered uterotonics in these districts. Inactive uterotonics are not restricted to the private sector; uterotonics outside specification were purchased from private and public sources. It is also clear that public and private sources procure unregistered uterotonics. Strengths and limitations of this study An up-to-date listing of points of sale was compiled specifically for this study; a sample of randomly selected sites was visited, and in two of three districts, the selected points of sale represented all the existing accessible chemical sellers and pharmacies. The simulated client approach prevents possible bias in the selection of ampoules to be sent for chemical testing. The number of points of sale selected for visit (25 per district) was based on practical considerations and resulted in a relatively small sample of ampoules available for chemical testing. The sampling frame may not have been 100% exhaustive, given the informal nature of some drug sellers. However, study results were strikingly similar across three diverse districts, and this is unlikely to result from sampling error.