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

Abstract

Background: 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.

Objective: To identify, critically appraise and synthesise the findings of studies on the quality of oxytocin available in LMIC.

Search strategy: We searched seven electronic databases, without language restriction.

Selection criteria: Studies reporting results of tests to assess quality of oxytocin samples from LMIC.

Data collection and analysis: Study selection, data extraction and quality assessment were performed in duplicate. Results are presented descriptively.

Main results: 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).

Conclusion: There is a high prevalence of poor-quality oxytocin samples in LMIC countries, mainly due to inadequate amounts of active ingredient.

Tweetable abstract: Systematic review points to problems with quality of oxytocin samples from low- and middle-income countries.

Keywords: Low and middle-income countries; oxytocin; postpartum haemorrhage; quality; sterility.