M R Torloni1, C Gomes Freitas1, U H Kartoglu2, A Metin Gülmezoglu3, M Widmer3. 1. Evidence Based Healthcare Post-Graduate Programme, Department of Internal Medicine, São Paulo Federal University, São Paulo, Brazil. 2. Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland. 3. Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
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.
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.
Authors: Natalie Carvalho; Mohammad Enamul Hoque; Victoria L Oliver; Abbey Byrne; Michelle Kermode; Pete Lambert; Michelle P McIntosh; Alison Morgan Journal: BMC Med Date: 2020-07-28 Impact factor: 8.775
Authors: Maria Regina Torloni; Mercedes Bonet; Ana Pilar Betrán; Carolina C Ribeiro-do-Valle; Mariana Widmer Journal: PLoS One Date: 2020-07-10 Impact factor: 3.240
Authors: Victoria L Oliver; Peter A Lambert; Kyu Kyu Than; Yasmin Mohamed; Stanley Luchters; Snigdha Verma; Ranjana Yadav; Vishwajeet Kumar; Alula M Teklu; Moti Tolera; Abebaw Minaye; Michelle P McIntosh Journal: PLoS One Date: 2018-09-25 Impact factor: 3.240