 This is FDA Patient Safety News. In this edition, a new combination vaccine for children, how to avoid errors when using transdermal medication patches, a warning on serious injuries when patients with implants get diathermy treatments, and new advice from the FDA on hormone replacement therapy. 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 by telling you about some medical products FDA recently cleared for marketing. You can find information on all FDA-cleared medical products on FDA's website. In a recent talk paper, FDA announced the approval of a new drug to treat the symptoms of ADHD or Attention Deficit Hyperactivity Disorder. It's called Stratera, and it's marketed by Eli Lillian Company. The generic name is Atomoxetine. According to the American Psychiatric Association, about three to seven percent of children and four percent of adults have ADHD. Unlike the drugs that have been commonly used to treat ADHD in the past, Stratera is not a stimulant. Because it doesn't appear to have a potential for abuse, it won't be classified as a controlled substance, although it will be available only by prescription. Stratera was studied in children, adolescents, and adults. Its safety and effectiveness were established in six double-blind placebo-controlled studies, which showed that it was superior to a placebo in improving patient symptoms. Side effects of Stratera include decreased appetite, gastric upset, nausea and vomiting, and fatigue. Some adult patients also experience sleep problems, dry mouth, dizziness, and sexual side effects. In another recent action, FDA approved a new combination vaccine that protects infants against diphtheria, tetanus, pertussis, polio, and hepatitis B infection. The vaccine is called Pediorix. Pediorix combines DTAP, hepatitis B, and IPV vaccines into one intramuscular injection. It's intended to be given three times at two, four, and six months of age. When these vaccines are administered separately in the same timeframe, infants receive nine injections. In a clinical trial, infants who were given the combination vaccine at two, four, and six months had similar immune responses to infants who were given separate vaccines. The most frequent adverse reactions to Pediorix were local injection site reactions, fever, and fussiness. Fever occurred more frequently after administration of Pediorix than with separately administered vaccines. Pediorix should not be administered to infants younger than six weeks. Therefore, it's not indicated for infants born to mothers who are infected with hepatitis B or whose hepatitis B status is unknown, since these infants should receive hepatitis B vaccines shortly after birth and complete their immunization according to a particular schedule. In a recent talk paper, FDA announced the clearance of a new rapid group B strep test for screening pregnant women. This test can provide results in as little as one hour as compared to 18 to 48 hours for culture testing. The new test is called the IDI strep B and it's made by Infectio Diagnostic Incorporated. Instead of using a standard culture method to grow the bacteria, the new test uses a special instrument to detect the DNA of group B strep in swab samples from the vagina and rectum. Group B strep is the leading cause of illness and death among newborns in the U.S. About 10 to 30% of pregnant women have group B strep, which can be transmitted to their newborns during birth if the women aren't given antibiotic treatment. Pregnant women are typically screened for group B strep two to four weeks before labor begins using the standard culture method. If the test is positive for group B strep, the woman is given four hours of antibiotic treatment during labor. Although culture results are reliable, they're available too late to be useful for women who have preterm labor or who haven't had prenatal care. This rapid test may be particularly useful for these women and it may help to avoid unnecessary antibiotic use. The IDI strep B test is the first non-culture test that meets the performance criteria recommended by CDC guidelines. That is at least 85% as sensitive as culture methods. Because of this, it can be used instead of the standard culture method. Transdermal patches are commonly used to administer hormone therapy, nicotine, and narcotic analgesia. Although these patches provide a useful alternative to oral medications, using them can lead to medication errors resulting in patient harm and even death. Some errors occur in applying and removing the patches. For example, when patients receive or apply more than one patch at a time. In one case, a man died after six fentanyl patches were applied to his skin at one time. Another common problem occurs when the old patch is not removed when the new patch is applied. That's particularly a problem with clear patches because they can be difficult to find when it's time to remove or replace them. The risk of errors increases when there are multiple caregivers, when nurses change shifts or when family members take turns helping patients with their medications because the caregivers may fail to communicate about where and when the last patch was placed and when the next one is due. Two-piece patches made up of an overlay and the medicated patch can also be confusing. The overlay secures the medicated patch to the patient's skin and is always supposed to be used with the medicated patch to facilitate absorption of the drug. But sometimes practitioners use tape to attach the patch instead of the overlay, and this can lead to a patient receiving no dose. Here are some strategies for avoiding these kinds of errors. First, when possible, avoid using clear patches. To prevent duplication of therapy, document the patch removal on the Patient Medication Administration Record as well as the application of each new patch. Be sure to include the site of application. This is critical if there are multiple caregivers involved in the patient's care. Monitor patients with two-piece patches to ensure that they're receiving active drug. In other words, be sure that the overlay is being used properly. This kind of error should be suspected if the therapy seems to be ineffective or if overlays are being returned to the pharmacy in the patient's medication cassette. Finally, remember that narcotic analgesic patches have the highest risk because they can depress respiration. In a previous broadcast, we alerted you to the danger of using diathermy to treat patients who may have metallic leads from neurostimulator devices implanted in their bodies. Two patients with these implanted devices died when they later received diathermy treatments because of the excessive heat generated in the tissue surrounding the metal leads. We're now expanding the warning to include any implanted metallic lead in the patient's body. Among the many implanted devices that may use metallic leads are cardiac pacemakers and defibrillators, cochlear implants, bone growth stimulators, and deep-brain spinal cord and other nerve stimulators. The warning covers microwave or radiofrequency diathermy, also called shortwave diathermy. These are widely used by physicians, dentists, physical therapists, chiropractors, and sports therapists. The warning does not include ultrasound diathermy. FDA's public health notification states that the danger can occur even when the diathermy device is in a non-heating mode, which you might not expect. Also, the danger exists even when the implanted device isn't turned on. And the danger is still there after the implant has been removed from the patient's body as long as the metal leads are left in, and that often happens. The notification urges healthcare professionals who implant devices with metallic leads to explain to the patient what diathermy is and stress that they should not receive shortwave or microwave diathermy. And it urges healthcare professionals who administer shortwave or microwave diathermy to always ask the patient about possible implants. If the patient has an implanted lead, diathermy should not be used even if the implant is turned off. If the patient says that he or she has had an implant that's been removed, don't use diathermy unless you're absolutely certain that any metallic leads have also been removed. In a recent medication safety alert, the Institute for Safe Medication Practices warned that the growing number of insulin combination products is increasing the opportunity for errors. ISMP describes several mix-ups between Humalog Mix 7525 and Humalin 7030. And it mentions the possibility of similar mix-ups between Novolog Mix 7030 and Novolin 7030. These kinds of mix-ups could cause episodes of hypoglycemia in patients. Part of the problem is that the names of these products are so similar and that the labeling and packaging are also similar. ISMP suggests several ways to help avoid these mix-ups. For example, consider designing a pre-printed order form for insulin that lists all the specific insulin products available in your facility, along with their ingredients and component ratios. If the product is dispensed in a vial, the pharmacy should label the vial for a specific patient, rather than supplying it as a floor stock item and then have a system for retrieving discontinued insulin vials. Place reminders about potential confusion in computer systems and storage locations. When a new insulin product is introduced in the facility, put a sticker on it to distinguish it from the older products. And consider conducting a daily review of current medication orders from the pharmacy computer system. In other news, the CDC recently published new hand hygiene guidelines as part of their MMWR recommendations and reports. These guidelines provide specific recommendations on how to improve hand hygiene practices and reduce transmission of pathogenic microorganisms. For example, in addition to traditional hand washing with soap and water, CDC now recommends using alcohol-based hand rubs. The guideline says that these hand rubs significantly reduce the number of microorganisms on the skin, they're fast-acting, and they can cause less skin irritation than traditional hand washing. The rubs also take less time. CDC estimates that over an eight-hour shift an ICU nurse could save an hour by using an alcohol-based hand rub. And data show that healthcare personnel may be more inclined to use alcohol-based hand rubs because they're more convenient. CDC is not recommending alcohol hand rub products to the exclusion of traditional soap and water hand washing. The major change is that CDC is now recommending the alcohol hand products for routine use and not just when soap and water aren't available. The document still recommends a soap and water hand wash before eating and after using the bathroom. CDC is distributing materials like posters to help promote hand hygiene within healthcare facilities. You can find the CDC guideline on our website. True or false? The letters FDA stand for Federal Drug Administration. False. FDA stands for Food and Drug Administration, but foods and drugs aren't the only things FDA is responsible for. It also regulates blood products, vaccines, cosmetics, veterinary drugs, medical devices, and radiation products like microwave ovens. Now for the part of the program called Patients Are Asking, that helps you answer questions about medical products and procedures that are on people's minds. This time we're talking about treating post-menopausal women with estrogen or estrogen plus progestin products. By now, most people have heard about data from the Landmark Women's Health Initiative study that raised concerns about the risks of using these products, and many women are asking about this. Recent results from this study showed that post-menopausal women taking estrogen plus progestin have an increased risk of heart attacks, stroke, breast cancer, and blood clots. FDA is working with manufacturers of estrogen and estrogen plus progestin products to incorporate this new information in professional and patient labeling. FDA's labeling changes include a new boxed warning that highlights the increased risks of MI, stroke, breast cancer, and venous thromboembolism, and it emphasizes that these products should not be used to prevent cardiovascular disease. The revised labeling also clarifies treatment indications for these products. Our website contains more complete information for women and their doctors about these drug labeling changes, including copies of revised labeling, questions and answers on estrogen and estrogen progestin therapy, and a fact sheet providing advice to women on these products. 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 in your 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.