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1. NEW FDA GUIDANCE SEEKS TO REDUCE USE OF UNAPPROVED DRUGS 2. COMING SOON: QUALITY MEASURES FOR TREATING SEPSIS PATIENTS 3. PAY PER VIEW: ASSESS YOUR FIRE RISK TO REACT QUICKLY 4. CHECK IT OUT: PATIENT SAFETY MONITOR SPONSORS A FREE TALK GROUP

Patient Safety Monitor Alert, October 22, 2003

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1. NEW FDA GUIDANCE SEEKS TO REDUCE USE OF UNAPPROVED DRUGS

In an effort to ensure the safety and effectiveness of certain unapproved, yet widely marketed drugs, the Food and Drug Administration (FDA) is seeking comments on a draft compliance policy guide it released October 17.

FDA estimates that, in the United States today, perhaps as many as several thousand drug products are marketed illegally without required FDA approval. Federal law requires drug makers to demonstrate the effectiveness of their drugs.

Some unapproved drugs include medicines that were developed and marketed before modern standards for drug approval were established, including products with potential safety risks, products that lack any evidence of their usefulness, and products that are "clearly fraudulent."

The guidance encourages drug companies to sponsor these drugs through the drug approval process. It also describes the agency's enforcement approach, giving the highest priority to those products which pose the most likely risk to public health, either because of inherent safety concerns about the drugs, or because there are alternative treatments available that have been shown to be safe and effective in accordance with the law.

For example, the guidance states that the FDA will continue to give priority to enforcement actions involving unapproved drugs that

1. have potential safety risks 2. lack evidence of effectiveness 3. constitute health fraud

The FDA is seeking public comments for 60 days from its release date of Oct. 17. Click here to download the guidance.

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2. COMING SOON: QUALITY MEASURES FOR TREATING SEPSIS PATIENTS

The VHA Health Foundation is collaborating with researchers at Johns Hopkins University and the Joint Commission on Accreditation of Healthcare Organizations to develop, test, and disseminate quality measures for the treatment of patients with severe sepsis.

Defined as a range of clinical conditions caused by the body's immune response to infection or trauma, sepsis ranges from a systemic inflammatory response to organ dysfunction to multiple organ failure. It strikes an estimated 750,000 people, and results in 215,000 deaths, annually. Although specific therapies can reduce mortality of septic patients, quality measures for them have never been developed.

"Developing and implementing sepsis measures at the national level can make a tremendous difference in the quality of health in this country," says Linda DeWolf, vice president of the Irving, Texas-based VHA Health Foundation. "Our hope is that the collaboration will serve as a model for developing other measures of quality in the future."

The Baltimore-based Johns Hopkins will conduct the initial literature review, establish an advisory panel and develop and test the candidate measures. The VHA will develop an electronic reporting system and lead a trial of 20 ICUs that will test sepsis measures through its Transformation of the ICU program, a collaborative of leading hospitals nationwide.

The JCAHO will act as a consultant for developing recommended performance measures and plans to test the measures next year.

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3. PAY PER VIEW: ASSESS YOUR FIRE RISK TO REACT QUICKLY

An infant undergoing an operation at Duke Medical Center in Durham, NC, recently suffered burns after the surgical drapes caught fire.

Such tragedies occur at least 100 times each year, and past evidence suggests that many operating room (OR) fires are caused by human error, not mechanical problems.

Learn how to reduce your organization's fire risk and how to train staff on fast responses by purchasing this week's pay-per-view story. The cost is just $10.

Click here to learn more. "Briefings on Patient Safety" subscribers received this article as part of their October 2003 newsletter.

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4. CHECK IT OUT: PATIENT SAFETY MONITOR SPONSORS A FREE TALK GROUP

Share ideas and get helpful advice from your colleagues. Subscribe to our FREE talk group, Patient Safety Talk. You'll be able to chat with your peers and help each other solve challenging issues. Post messages, ask questions, or give advice!

Visit our website to sign up now!

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Questions? Comments?

Contact: Wendy Johnson, Managing Editor

Patient Safety Monitor

wjohnson@hcpro.com

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