Off-label use of recommended maternal drugs for antenatal, intrapartum and postpartum complications

Background: Developing new commodities for obstetric-related conditions is impeded by several barriers, including a focus on “recycling” or repurposing commodities from other diseases. WHO guidelines include a comprehensive set of commodities, including medicines that are effective in preventing or reducing maternal and neonatal morbidity and mortality. However, many of the medicines recommended by WHO for pregnant women remain off-label – for example dexamethasone for women at risk of imminent preterm birth and aspirin for prevention of pre-eclampsia.7,8 Off-label use refers to prescription of drugs for an indication other than what is stated on the label for that drug, designated by regulatory approval. Off-label drug use is common in pregnancy, and women are rarely informed the drugs they are prescribed are off-label. Off-label drug use can increase the risk of adverse side-effects or ineffective medicines in populations with limited evidence, have financial implications and can pose ethical concerns for informed consent. There is currently no comprehensive assessment of the regulatory status of drugs recommended in the WHO guidelines for pregnancy related complications. Methods: A complete list of medicines recommended for antenatal, intrapartum and post-partum women will be compiled from WHO recommendations. The regulatory status of each medicine will be assessed according to the key 38 regulatory bodies that form the International Coalition of Medicines Regulatory Authorities, including the US Food and Drug Agency, European Medicines Association, Swissmedic, Medicines and Healthcare Products Regulatory Agency. For off-label drugs, the highest level of evidence for a drug recommendation will be scored according to a pre-specified scoring system. Expected outcomes: This study will provide a comprehensive assessment of the regulatory status of critical medicines to prevent maternal and newborn morbidity and mortality, and the level of evidence supporting their recommendation.