艾昆纬-妊娠期药物安全：方法和挑战（英）

White PaperDrug Safety in Pregnancy: Methods and ChallengesA review of evaluating maternal exposures and infant health outcomesJOYDEEP SARKAR, PhD KARIN DE HAART, MSc ANNE BROE, PhD MDIAN BONZANI, PhD EMILY BRATTON, PhDTable of contentsExecutive summary 1Introduction 2Regulatory trends and challenges 2Methodologies 3Drug utilization studies 4Prospective pregnancy registry study design 4Single-arm safety — pregnancy surveillance 5Pregnancy outcomes intensive monitoring 5Database studies 8Future directions 9Conclusion 9References 10 iqvia.com | 1This article reviews the current landscape, challenges, and advancements in evaluating drug safety during pregnancy. Particularly for individuals managing chronic illnesses that require ongoing pharmacological treatment, and both maternal and infant health might benefit from continued drug exposure during pregnancy.However, with a lack of data upon drug approval, health care providers lack an evidence base to balans maternal health needs with fetal safety remains a critical concern. Regulators provide guidance on pregnancy exposure study design, implementation, and drug labeling. Ongoing revisions to these guidelines are fostering greater international collaboration and an emphasis on harmonizing methodologies. Despite these advancements, persistent challenges include ethical considerations, data privacy issues, and the need for standardized protocols.Traditional clinical trials often exclude pregnant individuals due to ethical concerns, resulting in a reliance on real-world data and observational studies to generate evidence on medication safety. Recent technological advances, including mobile data collection and expanded real-world data sources, have opened new opportunities to address these evidence gaps and respond to evolving regulatory demands.Overall, the review highlights the importance of leveraging real-world data, innovative methodologies, and global regulatory collaboration to enhance the evidence base, thereby supporting safer and more effective drug therapy decisions for pregnant individuals and their infants.Executive summary2 | Drug Safety in Pregnancy: Methods and Challenges IntroductionDrug exposure during pregnancy is an area of critical concern, particularly for individuals managing chronic illnesses that necessitate ongoing treatment. It is estimated that approximately 10% of pregnancies involve individuals with chronic conditions such as asthma, diabetes, or hypertension.1,2 These conditions often require pharmacological intervention, which poses unique challenges in balancing maternal health needs with fetal safety.For instance, asthma treatment during pregnancy offers a compelling example of the complexities involved. Since the 1960s numerous epidemiological studies have demonstrated that asthmatic females are at increased risk of complications such as preterm birth, low birth weight, or even maternal respiratory distress. Effective treatment plans, including the use of inhaled c