FDA Patient Safety News: Show #13, March 2003

New Non-Stimulant ADHD Drug

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 Strattera, and it's marketed by Eli Lilly and 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, Strattera 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.

Strattera 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 Strattera include decreased appetite, gastric upset, nausea and vomiting, and fatigue. Some adult patients also experienced sleep problems, dry mouth, dizziness and sexual side effects.

Additional Information:

FDA Talk Paper: FDA Approves Non-Stimulant ADHD Drug.
http://www.fda.gov/ohrms/dockets/dockets/06p0209/06P-0209-EC3-Attach-1.pdf


New Pediatric Combination Vaccine

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 Pediarix™.

Pediarix™ combines DTaP, Hepatitis B and IPV vaccines into one intramuscular injection. It's intended to be given three times, at 2, 4, and 6 months of age. When these vaccines are administered separately in the same time frame, infants receive 9 injections.

In a clinical trial, infants who were given the combination vaccine at 2, 4, and 6 months had similar immune responses to infants who were given separate vaccines. The most frequent adverse reactions to Pediarix™ were local injection site reactions, fever, and fussiness. Fever occurred more frequently after administration of Pediarix™ than with separately administered vaccines.

Pediarix™ should not be administered to infants younger than 6 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 vaccine shortly after birth and complete their immunization according to a particular schedule.

Additional Information:

Product Approval Information – Licensing Action.
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm103183.htm


Rapid Group B Strep Test for Pregnant Women

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 Assay and it's made by Infectio Diagnostic, Inc. 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 a leading cause of illness and death among newborns in the U.S. About 10 to 30 percent 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 pre-term labor or who haven't had prenatal care. This rapid test may be particularly useful for these women, and may help avoid unnecessary antibiotic use.

The IDI-Strep B test is the first non-culture test that meets the performance criteria recommended by CDC guidelines--at least 85% as sensitive as culture methods. Because of this, it can be used instead of the standard culture method.

Additional Information:

FDA Talk Paper.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm083015.htm


Rapid Group B Strep Test for Pregnant Women

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 Assay and it's made by Infectio Diagnostic, Inc. 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 a leading cause of illness and death among newborns in the U.S. About 10 to 30 percent 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 pre-term labor or who haven't had prenatal care. This rapid test may be particularly useful for these women, and may help avoid unnecessary antibiotic use.

The IDI-Strep B test is the first non-culture test that meets the performance criteria recommended by CDC guidelines--at least 85% as sensitive as culture methods. Because of this, it can be used instead of the standard culture method.

Additional Information:

New Device Clearance: IDI-Strep B Assay.
http://www.accessdata.fda.gov/cdrh_docs/pdf2/k022504.pdf


Errors Using Transdermal Patches

patches are commonly used to administer hormonal therapy, nicotine, and narcotic analgesia. Although transdermal 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 it’s always supposed to be used with the medicated patch to facilitate absorption of the drug. But sometimes practitioners attach the overlay directly to the patient's skin and tape the medication patch on top of the overlay;this can lead to a patient receiving no dose.

Here are some strategies for avoiding these kinds of errors:

* 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 they are 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.

Additional Information:

Drug Topics: April 1, 2002. FDA Safety Page - Transdermal Patches: High Risk for Error?
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm048721.htm


Warning on Diathermy and Implanted Leads

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 any form of microwave diathermy or radiofrequency diathermy (which is 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 notes that the danger can occur even when the diathermy device is in the non-heating mode, which you might not expect. Also, the danger exists even when the implanted device isn’t turned on. And it’s still there after the implant has been removed from the patient’s body, as long as the metal leads are left in—which often happens.

The Notification urges health care 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 health care 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.

Additional Information:

FDA Public Health Notification: Diathermy Interactions with Implanted Leads and Implanted Systems with Leads.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM062167


Insulin Mixups

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 mixups between Humalog Mix 75/25 and Humulin 70/30. And it mentions the possibility of similar mixups between Novolog Mix 70/30 and Novolin 70/30. These kinds of mixups 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 mixups. For example, consider designing a preprinted 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.

Additional Information:

ISMP Medication Safety Alert (November 27, 2002): Proliferation of insulin combination products increases opportunity for errors.
http://www.ismp.org/MSAarticles/products.htm


CDC Recommendations on Hand Hygiene

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 handwashing with soap and water, CDC now recommends using alcohol-based handrubs. The guideline says that these handrubs significantly reduce the number of microorganisms on the skin, they are fast acting, and 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 handrub. And data show that health care personnel may be more inclined to use alcohol-based handrubs 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 health care facilities. You can find the link to the CDC guideline below.

Additional Information:

Centers for Disease Control and Prevention: Hand Hygiene in Healthcare Settings.
http://www.cdc.gov/handhygiene/


New Labeling and Advice on Hormone Therapies for Postmenopausal Women

This time we're talking about treating postmenopausal 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 postmenopausal women taking estrogen plus progestin have an increased risk of heart attack, 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 web site 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.

Additional Information:

Drug Information: Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women.
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm135318.htm



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