Risk Watch e-column
February 2006
An update of risk management news, issues and items of interest
FDA Revises Format of Drug Package Insert
The FDA has unveiled a revision to the format of prescription drug information, commonly called the package insert. Federal regulators hope that this will help to reduce the 300,000 preventable adverse events that occur annually in U.S. hospitals—many of which stem from confusing medical information.
The new packaging is designed to give the most up-to-date information in an easy-to-read format, focusing the attention of both physician and patient on the key facts about the drug. According to the FDA, the goal is to reduce the complexity of prescription information and make it more understandable, memorable and accessible.
This is the first revision to prescription drug package inserts—which are alternatively referred to as professional labels and prescription information—in more than 25 years. The new format requires that the package insert for new and recently approved products meet specific graphical requirements. The requirements also reorganize important information, which allows it to be accessed quickly.
The key changes include the following:
- A new section called Highlights, which provides immediate access to the most important prescribing information about benefits and risks
- A table of contents for easy reference to detailed safety and efficacy information
- The date of initial product approval, making it easier to determine how long a product has been on the market
- A toll-free number and Internet reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects
- Patient counseling information, which is designed to help physicians advise their patients about the uses and limitations of the medication and to guide discussions about potential risks associated with taking it.
For additional information go to www.fda.gov.
(Source: FDA)
Mesotherapy Not Proven as a Safe Alternative to Liposuction
According to a report in the April 15, 2005, Journal of Plastic and Reconstructive Surgery, the official medical publication of the American Society of Plastic Surgeons (ASPS), patients should be wary of mesotherapy until the safety and effectiveness of the procedure can be confirmed. Touted as a nonsurgical alternative to liposuction, mesotherapy involves the injection of medications and plant extracts into layers of fat and connective tissue under the skin.
Although the practice of mesotherapy has been around for decades in Europe, it has only recently been introduced in the United States. There is no standardization in mesotherapy; the types of drugs that are used vary from physician to physician as does the quantity and frequency of injections. Currently, no drug is approved by the FDA for use in mesotherapy.
Recent studies have found that liposuction is the only surgical method that has been proven to safely and effectively remove fat. ASPS statistics show that liposuction was the most popular cosmetic surgical procedure in 2004 with more than 325,000 procedures performed in the United States that year.
(Source: American Society of Plastic Surgeons)
Test May Miss Heart Disease in Women
A February 1, 2006, Los Angeles Times article reported that angiography, the standard test for detecting heart disease, does not identify the disease in one out of six women who have it—causing physicians to send sick women home with a clean bill of health.
Although high cholesterol levels in men tend to lead to blockages that can be seen on an angiogram, the same conditions in women result in a general narrowing of the arteries that does not show up. The findings, the results of the Women’s Ischemia Syndrome Evaluation, appeared in a series of papers published in a supplement to the February 7 issue of the Journal of the American College of Cardiology.
The eight-year study followed 1,000 women in Florida, Pennsylvania and Alabama who had chest pains and other cardiovascular symptoms but whose angiograms showed no evidence of a blockage.
The study identified a new disorder, coronary microvascular syndrome, which accounts for 15% of all coronary artery disease in women, said C. Noel Bairey Merz, MD, who led the study. She said the reason the syndrome was detected in this study is that previous research has been conducted only in men.
Researchers found that half the women in the study were not getting enough blood to their hearts and that a third were likely to have a heart attack or some other serious problem—more than three times the normal risk.
In light of the study results, cardiologists should be more reluctant to dismiss the concerns of women with chest pains and no apparent blockages, and be more willing to order additional tests, said Elizabeth G. Nabel MD, director of the National Heart, Lung and Blood Institute, Bethesda, MD.
Microvascular syndrome can be detected with alternative techniques such as nuclear single-photon emission computed tomography (SPECT), which can identify about a third of patients with the condition. A more effective way is provocative coronary testing, a stress test in which an adenosine injection mimics the effects of exercising on a treadmill. According to Dr. Bairey Merz, this test is much more effective than the treadmill test itself.
Once the condition is detected, it can be treated with drugs such as beta blockers and ACE inhibitors to lower blood pressure, statins to lower cholesterol levels and the dietary supplement L-arginine. But because the recognition of the syndrome is so new, Dr. Bairey Merz added that research about effective treatments has yet to be done.
(Source: Los Angeles Times)
