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The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Control (CMC) Community hosted a virtual panel discussion on December 9, 2020, to provide a forum to discuss N-nitrosamine control strategies in the pharmaceutical and biotechnology industries. The panel included staff from the US Food and Drug Administration (FDA) and industry subject matter experts. Meeting topics included acceptable intake levels for nitrosamine impurities, definitions of "acceptable level of risk," water as a contributor in nitrosamine risk assessments, nitrosamine impurity control strategies based upon fate/purge data, early vs. late development assessment expectations, application to oncology programs developed under ICH S9, and Drug Master File (DMF) regulatory expectations. During the meeting, divergence in global health authority expectations was additionally discussed. One of the most important outputs from this AAPS panel discussion was the criticality of continued dialog between industry and health authorities to help understand actual versus perceived risks and provide pragmatic, scientifically justified solutions to ensure patients are provided with an uninterrupted supply of safe medicines based on globally harmonized requirements.

OBJECTIVE To examine blood pressure control and prescribing practices in the treatment of hypertension, including the use of sample medications, in rural populations. DESIGN Retrospective chart review of 296 hypertensive patients and surveys of primary care providers serving these patients. SETTING Twenty-seven rural, primary care clinics in North Carolina. OUTCOME MEASURE Blood pressure control, with the practice site as the unit of analysis. RESULTS An average of 29% of patients per clinic had blood pressures that were inadequately controlled. Wide variations existed between clinics in blood pressure control and medication costs. Thirty-two percent of all blood pressure medications used were either angiotensin converting enzyme inhibitors or calcium channel blockers compared with 26% use of diuretics. Virtually all clinics used sample antihypertensive agents and reported that sample medications were an important source of free medications for their indigent patients. Reported sample use by practice was positively correlated with the mean daily hypertensive medication costs. Variations in blood pressure control were not explained by any measured variables, although the sample size was small. CONCLUSIONS Large variations exist within rural North Carolina primary care clinics in blood pressure control and medication costs. We need to study further the relationships of new antihypertensive agents, medication costs, and sample use with blood pressure control, health care costs, and other patient outcomes.

A four-year project of quality-of-care assessment for 37 practices in rural North Carolina used chart abstraction and formal feedback to practitioners to improve compliance standards for 13 adult health maintenance interventions. In 1987, performance of Papanicolaou (Pap) test within two years ranged from 20% to 100% (mean, 61%), mammogram 0% to 70% (mean, 20%), and influenza vaccination 0% to 90% (mean, 59%). Practices received individual results and remediation took place for those practices that performed poorly; a reaudit took place in 1989, with improvement in all measures for all practices, except the influenza vaccination. Compliance results for 1989 were 30% to 100% (mean, 67%) for the Pap test, 10% to 100% (mean, 40%) for the mammography screening, and 5% to 80% for the influenza vaccination. These results suggest that coordinated quality-of-care assessment for rural practices can be performed with a modest administrative burden and substantial benefit to the practices.