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

Abstract

The objective of this paper is to communicate a proposed framework for addressing research limitations and communication barriers that contribute to a lack of data for making clinical treatment decisions about medication use in pregnancy. To address this global public health concern, a cross-stakeholder coalition composed of several workstreams is proposed. The intent is to foster collaborative discussion regarding potential solutions to address gaps in communication, engagement, and data generation and collection. Topic areas that require focus include development of awareness initiatives, cultural transformation efforts, collaboration initiatives, research standards, data compilation projects, and new data capture methods. Objectives to aid these efforts are outlined, and collaboration among researchers, regulators, health care providers, and patients is emphasized.

An assessment of pregnant women's knowledge and use of the Internet for medication safety information and purchase

“…Clemow et al. () stated that healthcare professionals and pregnant women routinely overestimate the teratogenic risks of medicines. This may be one reason why women in our survey said that doctors are reluctant or unwilling to prescribe medications during pregnancy, the other reason being the lack of evidence and readily available information about safety (Thorpe et al., ).…”

“…This suggests women correctly identify the first trimester as the critical time for structural birth defects, although the risks of foetal exposure also extend to other trimesters (Thomas & Yates, 2012). Clemow et al (2014) stated that healthcare professionals and pregnant women routinely overestimate the teratogenic risks of medicines. This may be one reason why women in our survey said that doctors are reluctant or unwilling to prescribe medications during pregnancy, the other reason being the lack of evidence and readily available information about safety (Thorpe et al, 2013).…”

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

“…Cross-stakeholder engagement ( Figure 1) among drug companies, regulatory bodies, clinical research groups, health care providers, and patients can enable effective data integration, foster new data collection methods, enhance communication, and improve patient education. 12 Conclusions Factors leading to a lack of data-supported decision making on medication use in pregnancy include restricted research approaches, limitations of current research methodologies, lack of data and research standards, fragmentation of existing data, inconsistent application of findings to clinical practice, and poor patient communication. Risk-based approaches that do not consider benefit of treatment and litigation concerns are cultural factors that also impede provision of proper medical guidance.…”

“…The third paper is a detailed exploration of issues that must be addressed in order to effect change in cultural, educational, and research paradigms for informed medication use in pregnancy. 12 Existing Data-Strengths and Limitations Table 1 summarizes the methodological strengths and limitations of current research on medicine use in pregnancy.…”

Clinical, Ethical, and Socioeconomic Considerations for Prescription Drug Use During Pregnancy in Women Suffering From Chronic Diseases

“…51 Some have even proposed a ''cultural transformation,'' suggesting that pregnant women should no longer be excluded from clinical trials after 5 years from the approval of a drug. 52 In this context, the FDA will start implementing a new product labeling rule in the United States in June 2015, adding clinical information including a section of ''clinical considerations.'' 53…”