Healthcare providers' use of a concise summary to prescribe for lactating patients.

BACKGROUND: Most breastfeeding individuals take at least one prescription drug, yet limited data from lactation studies are available to inform the safety of these drugs during breastfeeding. As a result, healthcare providers (HCPs) rely on available information about safety of drugs used during pregnancy or on personal experiences to inform prescribing/counseling decisions for breastfeeding individuals. To improve risk communication regarding drugs used during lactation, the U.S. Food and Drug Administration published the Pregnancy and Lactation Labeling Rule (PLLR) in 2015, which added a narrative summary of available risk information to the lactation section of Prescribing Information (PI). Prior studies on labeling in PLLR format revealed that although HCPs found these details valuable, they regarded the narrative as too long to support decision-making during patient encounters. OBJECTIVE: This qualitative study's objective was to assess the utility of adding a concise summary to the Lactation subsection of PI to complement the narrative and succinctly communicate to busy HCPs a drug's risks when used during lactation. The concise summary consisted of a bolded headline, bulleted descriptions of available study findings and potential adverse reactions, and recommendations for risk mitigation. METHODS: Twenty-five online focus groups were conducted with five segments of HCPs to obtain their feedback on the concise summary and discuss their prescribing/counseling decisions for four fictitious prescription drugs including one vaccine. RESULTS: HCPs utilized the concise summary to make initial prescribing/counseling decisions. Many also used the labeling narrative for a comprehensive benefit-risk assessment. CONCLUSION: The findings indicate a need to continue to improve communication about safety of drugs used during lactation, and that the concise summary may help facilitate this communication. The study also highlights the need to educate HCPs about PI limitations when clinical data are lacking and the need to encourage clinical studies to be conducted to support actionable recommendations about use of prescription drugs during lactation.

¡Cocinar Para Su Salud! Development of a Culturally Based Nutrition Education Curriculum for Hispanic Breast Cancer Survivors Using a Theory-Driven Procedural Model.

We developed a theory-based dietary change curriculum for Hispanic breast cancer survivors with the goal of testing the effects of the intervention on change in dietary intake of fruits/vegetables and fat in a randomized, clinical trial. Social cognitive theory and the transtheoretical model were used as theoretical frameworks to structure curriculum components using the Nutrition Education DESIGN Procedure. Formative assessments were conducted to identify facilitators and barriers common to Hispanic women and test the degree of difficulty and appropriateness of program materials. Focus groups provided valuable insight and informed preimplementation modifications to the dietary program. The result was a systematically planned, evidence-based, culturally tailored dietary intervention for Hispanic breast cancer survivors, ¡Cocinar Para Su Salud! (Cook for Your Health!). The methodology described here may serve as a framework for the development of future dietary interventions among diverse and minority populations. Short- and long-term study results will be reported elsewhere.