Assessing the quality of antenatal corticosteroids in low- and middle-income countries: A systematic review

Background: 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. Methods: 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. Results: 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. Conclusions: 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.