Addressing maternal medication use during breastfeeding using clinical resources and a novel physiologically based pharmacokinetic model-derived metric: A qualitative study.

Introduction: Breastfeeding has major benefits to the maternal-infant dyad and yet healthcare providers have expressed uncertainty about advocating breastfeeding when mothers are taking medications. The tendency for some providers to be more cautious in their advising approach is likely a consequence of limited, unfamiliar, and unreliable existing information on medication use during lactation. A novel risk metric termed the Upper Area Under the Curve Ratio (UAR) was developed to overcome existing resource shortcomings. However, the perception and use of the UAR in practice by providers is not known. The aim of this study was to understand existing resource use and potential UAR use in practice, their advantages and disadvantages, and areas of improvement for the UAR. Methods: Healthcare providers mainly practicing in California with experience advising on medication use during lactation were recruited. One-on-one semi-structured interviews that included questions on current practices when advising medication use during breastfeeding, and approaches to a given a scenario with and without information about the UAR were conducted. The Framework Method was applied for data analysis to construct themes and codes. Results: Twenty-eight providers representing multiple professions and disciplines were interviewed. Six main themes emerged: (1) Current Practice Approaches, (2) Advantages of Existing Resources, (3) Disadvantages of Existing Resources, (4) Advantages of the UAR, (5) Disadvantages of the UAR, and (6) Strategies to Improve the UAR. Overall, 108 codes were identified that illustrated theme topics ranging from a general lack of metric use to the realities of advising. A workflow describing current practice approaches connected all other themes. Almost all disadvantages of existing resources could be overcome by advantages of other resources and the UAR. Several improvements to the UAR were identified to address its shortcomings. Conclusion: Through interviews with providers who use resources to advise on medication use during breastfeeding, an improved understanding of current practice approaches and accessed resources was ascertained. Ultimately, it was found that the UAR would confer multiple benefits over existing resources, and improvements of the UAR were identified. Future work should focus on implementing the suggested recommendations to ensure optimal uptake of the UAR to improve advising practices.

Pharmacokinetic and pharmacodynamic principles: unique considerations for optimal design of neonatal clinical trials.

Core clinical pharmacology principles must be considered when designing and executing neonatal clinical trials. In this review, the authors discuss important aspects of drug dose selection, pharmacokinetics, pharmacogenetics and pharmacodynamics that stakeholders may consider when undertaking a neonatal or infant clinical trial.