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.

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.

The term compounding generally refers to the practice of combining, mixing, or altering ingredients of a drug product to create a medication tailored to the needs of an individual patient. Compounding has long been a common activity within the practice of pharmacy. The scope of pharmacy compounding includes the compounding of sterile products, a practice that is especially prevalent within hospitals, home infusion pharmacies, and, more recently, outsourced compounding facilities. Reports of patient morbidity and mortality associated with compounded products have led many over the years, including the US Food and Drug Administration (FDA), to call for more stringent federal oversight of pharmacy compounding to ensure patient safety. A tipping point was reached in 2012 with the emergence of a multistate outbreak of fungal meningitis and other infections in patients who received contaminated steroid injections compounded by the New England Compounding Center in Framingham, Massachusetts. This article describes the history of the practice and regulation of pharmacy compounding, culminating in the passage by Congress of the Compounding Quality Act of 2014.

To raise awareness and promote dialogue leading to action, this article provides proceedings on ethical and legal considerations associated with medicine use during pregnancy discussed during the 2014 DIA Medicines and Pregnancy Forum. A key focus of discussion at the forum was "When is it ethically appropriate to include or unethical not to include pregnant patients in clinical studies, and how can ethical barriers be addressed?" Also debated was the question "What are the most appropriate methods to collect and share data on medication use in pregnancy, and what is the best process for sharing such information?" Goals of the forum were to gain participant alignment on answers to these ethical questions, offer rationale for the answers, and provide insight into which stakeholders might be needed to facilitate discussion and action. Participants felt that under the right circumstances, drug research in pregnant women is justified and necessary. Multiple ideas and opinions on the handling of pregnant patients in clinical research, treating pregnant women in clinical practice, and communicating data to physicians and patients are presented.

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