Long-Term Care Survey Alert

Published on Fri Apr 13, 2007 PDF

Unheeded FDA alerts sow the seeds of F501 deficiencies.

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.

Crecelius suggests medical directors follow these key practices to address FDA alerts:

• 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.

• 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.

In addition: Tallahassee, FL-based attorney Donna Holshouser Stinson suggests medical directors make sure physicians have inservices on issues addressed by an FDA alert.