Unheeded FDA alerts sow the seeds of F501 deficiencies. Crecelius suggests medical directors follow these key practices to address FDA alerts: • Develop protocols to direct nursing to automatically order appropriate monitoring tests, if needed. For example, the March 2007 FDA alert on erythopoiesis-stimulating agents (Procrit, Aranasep and Epogen) suggests monitoring patients taking these medications for a hemoglobin above 12 g/dL.
To address FDA alerts, the medical director shouldn't just be in the loop--he should help orchestrate the facility's response to the federal agency's safety concerns.
The survey consequences: Surveyors could cite F501 (medical director) and F329 (unnecessary medications) if they find a "pattern of neglect" in monitoring "adverse consequences of drugs," cautions Charles Crecelius, CMD, MD, PhD, multifacility director of Delmar Gardens in St. Louis, MO.
• Send notices to the attending physicians signed by the medical director and pharmacist noting the potential concern and suggested actions.
• Depending on the severity of the situation, the medical director should request a medication regimen review to ensure compliance with the recommendations in the alert.
In addition: Tallahassee, FL-based attorney Donna Holshouser Stinson suggests medical directors make sure physicians have inservices on issues addressed by an FDA alert.