 This is FDA Patient Safety News. In this edition, a new intranasal flu vaccine, a rapid test for invasive aspergillus infection, a caution about using Paxil in children, and fatal misconnections between blood pressure monitors and IV tubing. These stories and more on this edition of FDA Patient Safety News. Welcome to the program. For the U.S. Food and Drug Administration, I'm Mark Barnett. And I'm Anita Rainer. Let's start with some medical products FDA recently approved. 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 Incorporated. 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 in healthy adults ages 18 to 49. Just as with the injectable flu vaccine, children 5 to 8 years old need two doses, at least six weeks apart in their first year of influenza vaccination, and individuals 9 to 49 years old need one dose. In clinical trials, FluMist was evaluated in over 20,000 people, including over 10,000 healthy children 5 to 17 years old. The efficacy of the vaccine in preventing influenza was approximately 87% among children included in the trial. In healthy adults between the ages of 18 and 49, FluMist was effective in reducing the frequency of severe illnesses with fever and upper respiratory illnesses with fever, which may be caused by influenza infection. Mark, during past flu seasons we've sometimes had a problem with vaccine availability. Will this intranasal vaccine help that situation? Well, having an additional manufacturer licensed to produce flu vaccine could help to prevent shortages. But unlike the injectable flu vaccine, this is a live attenuated vaccine. It is a live attenuated vaccine, and that introduces some special cautions that are not applicable 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. So who else shouldn't get the vaccine? Well, several groups shouldn't get it. First of all, people with asthma or other reactive airway diseases shouldn't get it because the intranasal vaccine has not been shown to be safe and effective for them. Second, those under the age of five or over the age of 49, because again, safety and effectiveness haven't been established. Third, FluMist should not be given to people with chronic underlying medical conditions that might 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. 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 four weeks for the standard culture method of testing for aspergillus. The new test called Platelli Aspergillus EIA is manufactured by BioRed Laboratories. It works by detecting aspergillus galactomanin antigen in blood, which will 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 U.S. is estimated to be only a few thousand per year, once it occurs, affected patients have a mortality rate of 50 to 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 the test 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%. FDA recently approved two new chemotherapeutic agents to treat cancer. One drug is Iresa, 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 Iresa have shown no benefit from adding this drug to the standard platinum-based chemotherapy, and so Iresa 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 Bortesimib, 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, Iresa can cause fatal interstitial lung disease, and it may harm the fetus if it's 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, which is 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. 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 with 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, and so FDA's advice hasn't changed for these patients. How many cents out of every consumer dollar spent in the U.S. goes to buy products that are regulated by FDA? Is it less than 1 cent of every dollar spent? 1 cent? 5 cents? 10 cents? 25 cents? Believe it or not, an estimated 25 cents out of every consumer dollar spent in the U.S. is for products that FDA regulates. In addition to overseeing the safety and efficacy of new drugs and safeguarding the food supply, FDA also is responsible for products that run the gamut of modern life including the nation's blood supply, vaccines, feed and drugs for animals, cosmetics, medical devices of nearly every description, and consumer products that emit radiation like microwave ovens and TV sets. 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. How do these mixups occur? Basically because these systems use lure connectors. The mixups occurred because the tubing that led from the monitor's blood pressure cuff inflator had a male lure 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 needless IV tubing since the misconnection requires no manipulation of the tubing. But isn't the color of the blood pressure tubing different than the color of the IV tubing? Well, it turns out that you can't rely on that. ISMP reports on a case cited in the literature where a nurse accidentally connected the tubing from a blood pressure monitor to what looked like the white tube on the blood pressure 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. So what's being done about this problem? Well, some manufacturers are taking steps to address this problem. 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-lure connectors. And in some cases, biomedical engineering departments have alerted clinical managers about the problem. But as long as disposable blood pressure cuffs are available with female lure connectors, the tubing from the blood pressure monitor could be connected to an IV with potentially lethal results. Well, those are the steps that manufacturers are taking. Now, what's ISMP recommending that people do to prevent this problem? Well, their primary recommendation is to switch blood pressure equipment if necessary. What they're suggesting is to replace all blood pressure monitoring equipment to ensure that the tubing from the monitor is not compatible with lure connections. Until that happens, they recommend making it a practice to place blood pressure 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. 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% of patients with chronic illnesses are functionally illiterate. Almost a quarter of adult Americans read at or below the fifth grade level, but medical information leaflets are typically written at a tenth grade level or above. Three out of four patients discard the medication leaflet that's stapled to the prescription bag without reading it, and only half of all patients take their medications as directed. So Mark, what's the solution to the problem, to take special care with patients who have reading difficulties? That's easier said than done, because in fact, you can't always tell who has the difficulties. ISMP cautions healthcare practitioners that patients with reading problems may hide the fact, though their low literacy may not be obvious. They note that some of the most poised and articulate patients may actually have poor reading skills. So what should be done? Well, ISMP suggests that you gear your instructions as though everyone had a reading difficulty. 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 fifth grade reading level or below with clear captions and with 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. Well, give me an example of a yes or no kind of question. Well, if I were to ask you, do you understand how often to take this medicine? You might say yes and still you wouldn't understand possibly. But if I were to ask you, tell me how often you're supposed to take this medicine, I can check with your answer to be sure you really do understand. There's a new brochure available that helps consumers use medication 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 it 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 website to find out how to get free copies of the brochure or how to purchase bulk quantities. That's all for this edition of FDA Patient Safety News. Remember, you can get more information on all the stories you've seen here today by visiting our website. We also urge you to use the website to report problems you've encountered with medical products. That's how we learn about problems so we can alert others. We'll be back next month with another edition, so watch for us. Until then, for the U.S. Food and Drug Administration, I'm Anita Reiner. And I'm Mark Barnett. See you next time.