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.

Assuring Access to Safe Medicines in Pregnancy and Breastfeeding.

Scientists and regulators in Europe and the United States continue to seek methods and strategies to improve knowledge on rational use of medicines for pregnant and breastfeeding populations, an important subset of women's health. Regulatory agencies have made strides toward improvement, but much more is needed. Recognizing the importance of international collaboration, we have begun to consider how to address these important public health issues more globally. The health of the child begins with the health of the mother.

How Do Interventions That Exemplify the Joint Principles of the Patient Centered Medical Home Affect Hemoglobin A1C in Patients With Diabetes: A Review.

OBJECTIVE: To review the impact of the Joint Principle of the Patient Centered Medical Home (PCMH) on hemoglobin A1C (HbA1C) in primary care patients with diabetes. METHODS: Systematic review of English articles using approximate terms for (1) the 7 principles of the PCMH, (2) primary care, and (3) HbA1C. We included experimental and observational studies. Three authors independently extracted data and obtained summary estimates for concepts with more than 2 high-quality studies. RESULTS: Forty-three studies published between 1998 and 2012 met inclusion criteria, 33 randomized and 10 controlled before-after studies. A physician-directed medical practice (principle 2) lowered HbA1C values when utilizing nursing (mean difference [MD] -0.36, 95% confidence interval [CI] -0.43 to -0.28) or pharmacy care management (MD -0.76; 95% CI -0.93 to -0.59). Whole-person orientation (principle 3) also lowered HbA1C (MD -0.72, 95% CI -0.98 to -0.45). Studies of coordinated and integrated care (principle 4) and quality and safety interventions (principle 5) did not consistently lower HbA1C when reviewed in aggregate. We did not identify high-quality studies to make conclusions for personal physician (principle 1), enhanced access (principle 6), and payment (principle 7). CONCLUSION: Our review found individual interventions that reduced the HbA1C by up to 2.0% when they met the definitions set by of the Joint Principles of the PCMH. Two of the principles-physician-led team and whole-person orientation-consistently lowered the HbA1C. Other principles had limited data or made little to no impact. Based on current evidence, PCMH principles differentially influence the HbA1C, and there are opportunities for additional research.

Radical pleurectomy/decortication and intraoperative radiotherapy followed by conformal radiation with or without chemotherapy for malignant pleural mesothelioma.

OBJECTIVES: We performed a retrospective review of the efficacy and morbidity of radical pleurectomy/decortication and intraoperative radiotherapy followed by external beam radiation therapy with or without chemotherapy for diffuse malignant pleural mesothelioma. METHODS: A total of 32 patients with diffuse malignant pleural mesothelioma were initially evaluated between January 1995 and September 2000. Three patients were excluded from analysis because of unresectable disease. Two patients died postoperatively, and one patient had recurrent disease previously treated at an outside institution. Of the remaining 26 patients included in the analysis, 24 received intraoperative radiotherapy. External beam radiation therapy was generally started 1 to 2 months after resection and delivered by means of 3-dimensional conformal radiation therapy or with inverse treatment planning intensity-modulated radiation therapy. When given, chemotherapy consisted of 2 to 3 cycles of cyclophosphamide, doxorubicin (Adriamycin), and cisplatin initiated 1 to 2 months after completion of radiation. RESULTS: At the time of data analysis, 5 of 26 patients were alive. The median follow-up was 9.7 months (range, 2-67.6 months). The median overall survival and progression-free interval from the time of the operation were 18.1 and 12.2 months, respectively. The Kaplan-Meier estimates of overall survival and freedom from progression at 1 year were 64% and 50%, respectively. The site of failure was mostly locoregional. However, there were 4 abdominal failures and 1 contralateral lung failure. CONCLUSIONS: Radical pleurectomy/decortication with aggressive radiotherapy with or without chemotherapy might offer an alternative treatment option to those who cannot tolerate extrapleural pneumonectomy.