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

Abstract

BackgroundOxytocin 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. ObjectiveTo identify, critically appraise and synthesise the findings of studies on the quality of oxytocin available in LMIC. Search strategyWe searched seven electronic databases, without language restriction. Selection criteriaStudies reporting results of tests to assess quality of oxytocin samples from LMIC. Data collection and analysisStudy selection, data extraction and quality assessment were performed in duplicate. Results are presented descriptively. Main resultsThe 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. Tweetable abstractSystematic review points to problems with quality of oxytocin samples from low- and middle-income countries. Tweetable abstract Systematic review points to problems with quality of oxytocin samples from low- and middle-income countries. This article includes Author Insights, a video abstract available at