Clinical Data for Informed Medication Use in Pregnancy: Strengths, Limitations, Gaps, and a Need to Continue Moving Forward

Abstract

The objective of this paper is to explore the strengths, weaknesses, gaps, and needs in research on medication use in pregnancy, where opportunities have been bypassed to develop standards and collaborations for collecting data to better understand how medications can impact clinical outcomes in pregnant women and developing fetuses. The availability of existing data and the methods of its capture are reviewed, including registries, claims and health record databases, and meta-analyses. The paper focuses on why these efforts have not fundamentally provided benefit-risk information and clinical treatment algorithms for medication use in pregnant women. Methodological issues, such as lack of standardization and central data collection, are discussed. Common barriers are examined, including a lack of awareness and education, cultural hurdles, collaboration deficiency, and an insufficient development of new data collection methods.

A Proposed Framework to Address Needs of Clinical Data for Informed Medication Use in Pregnancy

“…A collaborative effort across stakeholders is imperative to address all the gaps identified in current data for medication use in pregnancy. 2 Without the cooperation of industry members that develop and manufacture medications, little progress can…”

“…It is important to tap into and leverage existing initiatives that have had success. 2 For example, OpenMedNet has shown success in combining patient-sourced data with insurance, provider, pharmacy, hospital, and other data sources. 17 The first objective of the Compile Existing Data Work Group should be to map out what data are already available and in what format, noting strengths and limitations.…”

“…17 The first objective of the Compile Existing Data Work Group should be to map out what data are already available and in what format, noting strengths and limitations. 2 A comprehensive directory of ongoing efforts that identifies opportunities for collaboration (eg, registries, claims databases, literature cases, and regulatory submissions) would be of value. This could be followed by actually combining existing data to build benefitrisk assessments while completing a gap analysis to aid other workstream efforts.…”

“…Academic and industry engagement is a key to evidence-and label-based medical information for health care providers (HCPs) and patients, but methodological issues and liability concerns contribute to misinformation and to the avoidance of the study and use of medication in pregnancy, thus limiting informed decision making. 2 A transformation is needed to foster evidence-based decision making in this important and unresolved area of public health. Critical limitations in several areas, each touching multiple stakeholders, need to be addressed.…”

Medicines in Pregnancy Forum: Proceedings on Ethical and Legal Considerations

“…4 Yet medical (including dental) care for these women is often suboptimal because medication in pregnancy data are lacking or insufficiently known. 3,5 Thus, a proactive, collaborative approach to data standardization and collection, data communication, and cultural transformation is needed to improve informed decision making about medicines during pregnancy. 6 At the 2014 annual meeting of the DIA, a Medicines and Pregnancy Forum was held on June 18 in San Diego, California, United States.…”