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

Abstract

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. To identify, critically appraise and synthesise the findings of studies on the quality of oxytocin available in LMIC. We searched seven electronic databases, without language restriction. Studies reporting results of tests to assess quality of oxytocin samples from LMIC. Study selection, data extraction and quality assessment were performed in duplicate. Results are presented descriptively. 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). There is a high prevalence of poor-quality oxytocin samples in LMIC countries, mainly due to inadequate amounts of active ingredient. Systematic review points to problems with quality of oxytocin samples from low- and middle-income countries.