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U.S. Department of Health and Human Services

Show #18, August 2003

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Show #18, August 2003

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 New Medical Products

August2003FDA Patient Safety News Homepage
First Intranasal Flu Vaccine (Video, print, and e-mail functions)
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FDA recently approved the first intranasal flu vaccine for marketing in the U.S. It's called FluMist, and it's manufactured by MedImmune Vaccines Inc. FluMist contains the three influenza virus strains recommended by the U.S. Public Health Service for the upcoming flu season.

FluMist is approved for use in healthy children and adolescents ages 5 to 17, and healthy adults ages 18-49. Just as with the injectable flu vaccine, children 5-8 years old need two doses at least 6 weeks apart in their first year of influenza vaccination, and individuals 9-49 years old need one dose.

In clinical trials, FluMist was evaluated in over 20,000 people, including over 10,000 healthy children 5-17 years old. The efficacy of the vaccine in preventing influenza was approximately 87 percent among children included in the trial. In healthy adults between the ages of 18-49, FluMist was effective in reducing the frequency of severe illnesses with fever, and upper respiratory illness with fever which may be caused by influenza infection.

During past flu seasons, there have sometimes been problems with vaccine availability. Having an additional licensed flu vaccine manufacturer could help to prevent shortages. Unlike the injectable flu vaccine, this is a live-attenuated vaccine, and that introduces some special cautions that don't apply to the injectable vaccine. As with other live virus vaccines, Flumist should not be given for any reason to immunosuppressed patients, including AIDS or cancer patients, and patients being treated with immunosuppressive drugs.

Several other groups shouldn't get this vaccine. For example, it’s not been shown to be safe and effective in people under the age of 5 or over the age of 49, or in people with asthma or other reactive airway diseases. And it shouldn’t be given to people with chronic underlying medical conditions that may predispose them to severe flu infections. For these people, the inactivated flu vaccine is indicated.

And finally, people should not receive FluMist, or any other flu vaccine, if they've had an allergic reaction to eggs or to a previous dose of any flu vaccine.

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August2003FDA Patient Safety News Homepage
Rapid Test for Aspergillus Infection (Video, print, and e-mail functions)
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FDA recently cleared for marketing the first rapid laboratory test for invasive aspergillus infection. Results from this new test are available in about three hours, compared to about 4 weeks for the standard culture method of testing for aspergillus.

The new test, called Platelia Aspergillus EIA, is manufactured by Bio-Rad Laboratories. It works by detecting Aspergillus galactomannan antigen in blood, which can be a good indicator of invasive infection.

Invasive aspergillosis occurs in leukemia patients, organ and bone marrow transplant patients, and patients whose immune systems are compromised by illness or chemotherapy. Although the number of invasive aspergillus cases in the United States is estimated to be only a few thousand per year, once it occurs, affected patients have a mortality rate of 50%-100%. Early diagnosis and treatment are important, and this test may help to identify infections more rapidly than in the past.

FDA's clearance was based on clinical studies that showed it could accurately identify the presence or absence of the aspergillus antigen. In these studies, the sensitivity of the rapid test was about 81%, and the specificity was about 89%.

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August2003FDA Patient Safety News Homepage
Two New Cancer Drugs (Video, print, and e-mail functions)
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FDA recently approved two new chemotherapeutic agents to treat cancer. One drug is Iressa, manufactured by AstraZeneca. Its generic name is gefitinib, and it's for patients with advanced non-small cell lung cancer, the most common form of lung cancer in the U.S.

The drug is intended for patients whose cancer has continued to progress despite treatment with existing chemotherapeutic agents. Clinical trials with Iressa have shown no benefit from adding this drug to standard, platinum-based chemotherapy, and so Iressa should be administered alone for those patients who don't respond to standard chemotherapy.

The second drug is Velcade, distributed by Millennium Pharmaceuticals. Its generic name is bortezomib, and it's the first in a new class of chemotherapeutic agents known as proteasome inhibitors. It's intended for multiple myeloma patients whose disease has relapsed after two prior treatments, and who've demonstrated resistance to their last treatment. So far, about 28 percent of patients treated with Velcade have shown a response.

Both of these drugs are intended to be used only when other chemotherapeutic agents have failed. Both can produce side effects, including those common to chemotherapeutic agents, such as nausea, vomiting and diarrhea. In addition, Iressa can cause fatal interstitial lung disease and may harm the fetus if administered to pregnant patients. Although both drugs have been shown to reduce tumor volume in some patients, clinical benefit has yet to be demonstrated.

These drugs were approved under FDA's Accelerated Approval program, designed to make new drugs for life-threatening conditions quickly available when they appear to provide a benefit over existing therapy. Under this program, these two chemotherapeutic agents were approved based on early clinical evidence. The manufacturers will be required to continue clinical testing to demonstrate that the drugs do indeed provide a therapeutic benefit to the patient. If they don't, the Accelerated Approval program also provides a mechanism for withdrawing the product from the market.

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 Recalls and Safety Alerts

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Caution on Pediatric Use of Paxil (Video, print, and e-mail functions)
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FDA is reviewing reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents being treated with Paxil for major depressive disorder. Although our evaluation of these reports is still underway, FDA is recommending that Paxil not be used to treat depression in patients younger than 18. At this time, there's no evidence that Paxil is effective for this indication and it's currently not approved by FDA for any use in children.

Despite these new possible safety concerns, patients should not abruptly discontinue the use of Paxil. Any changes in these patients' drug regimen must take place under medical supervision.

In adults, Paxil is approved for several indications, including obsessive compulsive disorder, major depressive disorder and panic disorder. For adults, there's no evidence that Paxil is associated with an increased risk of suicidal thinking, so FDA's advice hasn't changed for these patients.

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 Preventing Medical Errors

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Dangerous Misconnections Between BP Monitors and IV Ports (Video, print, and e-mail functions)
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The Institute for Safe Medication Practices has reported on a number of cases where the tubing from a patient's blood pressure monitor was mistakenly connected to the IV port. These misconnections have been fatal when the air that was supposed to inflate the blood pressure cuff instead entered the patient's vascular system and created an air embolism. ISMP points out that although these kinds of mixups may be rare, the hazard exists at many hospitals.

The mix-ups occurred because the tubing that led from the monitor's blood pressure cuff inflator had a male Luer connector that fit into a female connector on the cuff. ISMP says that these misconnections are more likely to occur at the Y-site of needleless IV tubing, since the misconnection requires no manipulation of the tubing.

Although the color of the tubing on the blood pressure cuff is different than the color of the IV tubing, ISMP points out that you can’t rely on that. They cite one case in the literature where a nurse accidentally connected the tubing from a BP monitor to what looked like the white tube on the BP cuff. But in fact, the drug propofol, which is white and opaque, had been infusing through the patient's IV line, making it look like the white tube on the cuff, and that's how the mistake occurred.

Some manufacturers are taking steps to try to prevent these errors. Some of them have warned their customers about the problem, or provided warning labels for the monitors and tubing. And some plan to require dedicated tubing with non-Luer connectors. And in some cases biomedical engineering departments have alerted clinical managers about the problem. But as long as disposable BP cuffs are available with female Luer connectors, tubing from the BP monitor could be connected to an IV, with potentially lethal results.

ISMP’s primary recommendation is to switch blood pressure equipment, if necessary. What they're suggesting is to replace all BP monitoring equipment to ensure that the tubing from the monitor is not compatible with Luer connections. Until that happens, they recommend making it a practice to place BP cuffs on a different arm than the IV site, and to remove IV catheters as soon as they're no longer needed. They say that using labels on the tubing can help, but they warn not to rely on labeling alone to solve the problem.

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August2003FDA Patient Safety News Homepage
Patients with Reading Problems (Video, print, and e-mail functions)
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In a recent Medication Safety Alert, the Institute for Safe Medication Practices cautions that many patients, more of them than you might think, have difficulty reading. Quoting from a 1999 report from the AMA's Council on Scientific Affairs, they list some eye-opening facts.

For example, more than 40 percent of patients with chronic illnesses are functionally illiterate. Almost a quarter of adult Americans read at or below the 5th grade level, but medical information leaflets are typically written at a 10th grade level or above. Three out of four patients discard the medication leaflet stapled to the prescription bag without reading it. And only half of all patients take their medications as directed.

ISMP points out that you can't always tell who has the problem. Patients who have difficulty reading may hide the fact, so their low literacy may not be obvious. They note that some of the most poised and articulate patients may have poor reading skills.

The ISMP suggests that you assume that everyone could have a reading problem, and gear your instructions accordingly. They point out that even people who read well still want to have simple, straightforward instructions. Here are some of their suggestions:

First, when counseling patients about their medications, offer small amounts of information at one time and stay away from medical terminology. Use simple, everyday language to tell patients what they truly need to know about their medication. Instead of stressing the medical facts, stress what you want them to do.

Second, ISMP recommends providing written materials at the 5th grade reading level or below, with clear captions and pictures if possible.

And finally, verify that the patient understands. Instead of asking yes or no questions, ask patients to show and tell you in their own words how they would take their medicine, so you can spot problems. If you ask the patient, “Do you understand how often to take this medicine?”, he or she might answer “yes” even though they didn't understand. But if you say “Tell me how often you're supposed to take this medicine,” you can confirm that they actually understand.

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 Advice for Patients

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New Consumer Brochure on Safe Medication Use (Video, print, and e-mail functions)
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There's a new brochure available that helps consumers use medications safely. It's called “Your Medicine: Play it Safe,” and it's been issued by the Agency for Healthcare Research and Quality, along with the National Council on Patient Information and Education.

It teaches people the importance of communication between patient and healthcare provider, and covers such things as knowing what the medication is for, asking questions, taking a full course of antibiotic treatment, and keeping medication records. Go to our web site to find out how to get free copies of the brochure, or how to purchase bulk quantities.

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