Abstract
The World Health Organization (WHO) recommends the administration of intramuscular antenatal corticosteroids to women at risk of preterm birth to prevent preterm-associated neonatal mortality and morbidity. Poor quality medicines are a major problem for health services in low- and middle-income countries (LMICs), however the quality of antenatal corticosteroids is not well understood. We aimed to conduct a systematic review of available studies describing the quality of recommended injectable antenatal corticosteroids (dexamethasone or betamethasone) in LMICs. Structured search strategy was applied to six databases (MEDLINE, EMBASE, CINAHL, International Pharmaceutical Abstracts, Global Index Medicus, WHO Medicines Quality Database), without year or language restrictions. Any primary study reporting any medicine quality parameter (Active Pharmacological Ingredient, pH and sterility) for injectable dexamethasone or betamethasone was eligible. Two authors independently screened studies for eligibility, extracted data on included studies and applied Medicine Quality Assessment Reporting Guidelines tool to assess study quality. Results were reported narratively, stratified by country of manufacture, organisation type and level of care. In total, 15,547 citations were screened with two eligible studies identified that focussed on dexamethasone quality (no studies of betamethasone were identified). One study included 19 samples from 9 LMICs, and the other included "less than 100 samples" from India. The prevalence of failed dexamethasone samples ranged from 3.14% to 32.2% due to inadequate Active Pharmacological Ingredient. A higher prevalence of failed dexamethasone samples were seen at the point of care and the public sector. Poor quality maternal and newborn health medicines can endanger women and newborns. Though available evidence on antenatal corticosteroids quality in LMICs is limited, results suggested poor quality dexamethasone may be prevalent in some countries. More primary studies are required to confirm these findings and guide policymakers on procurement of good-quality maternal and newborn health medicines.
Highlights
Preterm birth is defined as a baby born prior to 37 weeks’ gestation [1]
We aimed to conduct a systematic review of available studies describing the quality of recommended injectable antenatal corticosteroids in low- and middle-income countries (LMICs)
15,547 citations were screened with two eligible studies identified that focussed on dexamethasone quality
Summary
Preterm birth is defined as a baby born prior to 37 weeks’ gestation [1]. Worldwide, an estimated 14.8 million babies are born preterm each year, with most of these babies (81%) being born in Asia and sub-Saharan Africa [2]. In 2015, the World Health Organization (WHO) recommended the use of a single course of antenatal corticosteroids (24mg of dexamethasone or betamethasone, administered via intramuscular [IM] injections in divided doses) for women who are at risk of imminent preterm birth at 24 to 34 weeks’ gestation [6]. Both dexamethasone and betamethasone were identified in the United Nations Commission on Life-Saving Commodities for Women and Children, and dexamethasone is listed on the WHO Model List of Essential Medicines [7, 8]. We aimed to conduct a systematic review of available studies describing the quality of recommended injectable antenatal corticosteroids (dexamethasone or betamethasone) in LMICs
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