Abstract
BackgroundMedication safety during pregnancy has drawn global attention, little of which has been reported about the Chinese population. This study aims to describe patterns and risks of medication use among pregnant women in mainland China with reference to the U.S. Food and Drug Administration (FDA) pregnancy risk category.MethodsHospital diagnostic and drug dispensing information of a national representative sample of basic medical insurance (BMI) beneficiaries was obtained from the China Health Insurance Association (CHIRA) database in 2015. Prevalence of use and number of medicines involved in each risk category were calculated. Most commonly used medicines from each risk category were illustrated. Factors associated with the use of category D/X medicines were evaluated through multiple logistic regression.ResultsOut of 11,373 women who had singleton deliveries in 2015, there were 2896 women with records covering their entire pregnancies, 5377, and 7946 women with records through the 2nd, and the 3rd trimester, respectively. It was found that 11.1% pregnant women used at least one medication and a total of 321 medications had been used during pregnancy. Most pregnant women used medicines which were classified FDA category C (66.2%), followed by category B (57.8%), category A (16.8%), category X (7.5%) and category D (5.0%). The most commonly used medicines from category D and X were anxiolytics and hormonal preparations respectively. Women who were from mid-western area (p = 0.045) or used four or more medications (p < 0.001) were more likely to use category D/X medicines.ConclusionsThis study revealed that about one in ten pregnant women used at least one medication during pregnancy in China and a significant number of them used FDA Category D or X medicines. The usage patterns identified in the present study indicate that sub-optimal medicine use might exist warranting further evaluation and intervention in future studies. More efforts are needed to uncover the safety concerns about medication use during pregnancy and improve current information system for clinical practice.
Highlights
Medication safety during pregnancy has drawn global attention, little of which has been reported about the Chinese population
Given there is no authoritative guidance on medication use during pregnancy officially issued in China, in this study, we aimed to (i) describe the patterns and risks of medication use with reference to Food and Drug Administration (FDA) pregnancy risk category among pregnant women derived from a national health insurance database in 2015 in China and (ii) evaluate the factors associated with the use of medicines with potential harms during pregnancy (FDA category D/X)
Most medicines were assigned in FDA category C (38.3%) and B (20.9%), only a few fell in categories with higher risks, and category A held the least number of medications
Summary
Medication safety during pregnancy has drawn global attention, little of which has been reported about the Chinese population. This study aims to describe patterns and risks of medication use among pregnant women in mainland China with reference to the U.S Food and Drug Administration (FDA) pregnancy risk category. The old FDA risk category can provide a rough description of medication use risks during pregnancy on a population basis [6, 9] and has been widely adopted in drug utilization studies both in developed and developing countries [10,11,12,13,14,15]. For the purpose of this study, the term “risks of medication use” will be used to cover both teratogenic and nonteratogenic effects which could be evaluated in the FDA pregnancy risk category [12, 16, 17]
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