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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.
The study design involved research assistants simulating clients to purchase ampoules of oxytocin and ergometrine from different types of points of sale. In an effort to design a representative sample of uterotonic points of sale, one district was selected from each of the three ecological regions of the country (coastal, forest and savannah), which also differ on major socioeconomic indicators. In August 2010, a research assistant travelled throughout the selected districts to compile a list including all pharmacies and chemical shops. In addition, he was asked to compile information on informal points of sale such as markets from which drugs might be purchased from stationed sellers and mobile drug peddlers. All efforts were made to compile an exhaustive list, acknowledging that this is nearly impossible given the informal and transient nature of some points of sale. Upon the research assistant’s return to Accra, pharmacies and chemical shops in each district were consecutively numbered, a random start number was selected and points of sale were systematically selected with a constant sampling interval until a sample of 25 points of sale were identified in each district. In Yendi and Kintampo North, all the chemical shops and pharmacies identified during the listing exercise were selected for a visit. Two months later, a team of nine research assistants simulated clients by visiting each selected point of sale and requested drugs used by pregnant women to hasten their delivery, adding that the drugs were needed for his/her sister, who was soon due to deliver. There was no verbal or written informed consent for this study, as consent of the salesperson would have undermined the simulation. If the salesperson requested a prescription, the client provided a prescription for oxytocin and ergometrine, which was obtained from a Ghana Health Service collaborator in Accra. This was done for the following two reasons: (1) for human subjects purposes to avoid putting the salesperson in the position of being asked to sell drugs to a client without a prescription even after the salesperson had asked for one and (2) to ensure a sufficient sample of ampoules for chemical assay later. If the salesperson recommended that the client go elsewhere, the research assistants substituted the recommended location for the selected site. Purchased ampoules were placed in plastic bags with coded information regarding the date of purchase, expiry date of the ampoule, type of point of sale and district name. These bags were placed in vaccine cold chain carriers just after purchase and were placed in the cold room or refrigerator of the district hospital as quickly as possible and not later than the evening of the day of purchase. Ampoules remained under refrigeration in the district hospitals for 0–13 days before being transported in the cold chain to Accra. In Accra, samples were refrigerated for up to 1 week, after which all samples were submitted to the Ghana Food and Drugs Board. The Food and Drugs Board documented that all ampoules were delivered under cold chain conditions. Samples were refrigerated until analysis. Samples were analysed according to the Finished Pharmaceutical Product specifications of the British Pharmacopoeia, 2010 edition, as all the samples had the British Pharmacopoeia as their specification. The US Pharmacopeia chemical reference standards for ergonovine maleate (ergometrine maleate) RS and oxytocin RS were used as standard comparators in the analysis: for oxytocin, 46 oxytocin units per phial, USP Reference Standard, Lot F1G134, Cat. No. 1491300; and for ergonovine maleate, 100 mg, USP Reference Standard, Cat. No. 24000. The ampoules were tested without blinding to product packaging, as information on the packaging is required for testing. However, the manufacturer name was not included among assay results, as required for ethical approval of the study. This study was approved by institutional review boards at the Ghana Health Service in Accra, Ghana; PATH in Seattle, Washington; and the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland.
