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      Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana

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          Abstract

          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.

          Related collections

          Most cited references 5

          • Record: found
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          • Article: not found

          Assessing the global availability of misoprostol.

          To assess the worldwide availability of misoprostol. Documenting the extent of misoprostol use in obstetrics-gynecology is difficult because the drug typically is unregistered for such indications. Data for 2002-2007 on annual sales (measured in weight) to hospitals and retail pharmacies, plus manufacturer prices per 200-microg misoprostol, were analyzed for medications containing misoprostol alone or combined with a nonsteroidal anti-inflammatory drug (NSAID); regional and country-specific trends were identified. Consumer prices per pill are documented for all formulations of registered medications. Of the misoprostol sold worldwide, 70% was misoprostol-NSAID-combination drugs; of this, 91% was sold in North America and Western Europe. Asia sold the most misoprostol-only drugs; sales increased dramatically in Bangladesh (by 128%) and India (646%), where various low-price brands are sold. Misoprostol sales decreased in Latin America but increased in the Middle East-North Africa and Sub-Saharan Africa; these regions generally had low amounts sold per population. Availability is improving in some low-income regions where misoprostol could significantly reduce maternal deaths due to postpartum hemorrhage and unsafe abortion.
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            • Abstract: found
            • Article: not found

            Stability of essential drugs during shipment to the tropics.

            To determine whether present methods of international transport of essential drugs by sea adversely affect their quality. Controlled longitudinal study of drug shipments sent by sea from Unicef in Copenhagen to Lagos; to Mombasa and by land to Kampala; and to Bangkok. 11 essential drugs were stored in four locations on board the ships. Main shipping routes from Unicef, Copenhagen, to tropical countries. Temperature and relative humidity in the test packs during the journey. Amount of active ingredient in the drugs before and after shipment. Temperatures recorded within the test packs range from -3.5 degrees C to 42.4 degrees C and were 3-12 degrees C higher than the ambient temperature. Relative humidity within the packs ranged from 20% to 88%. Differences between the locations on board were negligible. Ergometrine injection, methylergometrine injection, and retinol capsules lost 1.5-5.8% of their activity. Ampoules of ergometrine showed a large variation in the amount of active ingredient after shipment, with three of 80 samples having concentrations 60% below those stated. Ampicillin, benzylpenicillin, phenoxymethylpenicillin, and tetracycline were not affected by transport. Drugs were exposed to a much higher temperature and humidity than is recommended by the manufacturer, especially in tropical harbours and during inland transport. Except for ergometrine and methylergometrine the transport would not affect clinical effectiveness.
              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              The quality and stability of essential drugs in rural Zimbabwe: controlled longitudinal study.

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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2012
                3 May 2012
                3 May 2012
                : 2
                : 3
                Affiliations
                [1 ]Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
                [2 ]PATH, Accra, Ghana
                [3 ]PATH, Seattle, Washington, USA
                Author notes
                Correspondence to Cynthia Stanton; cstanton@ 123456jhsph.edu
                Article
                bmjopen-2011-000431
                10.1136/bmjopen-2011-000431
                3346944
                22556159
                © 2012, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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