Broadcast
#13 - March 2003
New
Products Bulletin Board
New Non-Stimulant
ADHD Drug
View a video of this segment...
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/bbs/topics/ANSWERS/2002/ANS01177.html
New Pediatric
Combination Vaccine
View a video of this segment...
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/cber/products/dtapsmi121302.htm
Rapid
Group B Strep Test for Pregnant Women
View a video of this segment...
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/bbs/topics/ANSWERS/2002/ANS01172.html
New Device Clearance: IDI-Strep B Assay
http://www.fda.gov/cdrh/mda/docs/k022504.html
Protecting
Your Patients
Errors
Using Transdermal Patches
View a video of this segment...
Transdermal 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/cder/drug/MedErrors/transdermal.pdf
Warning
on Diathermy and Implanted Leads
View a video of this segment...
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/cdrh/safety/121902.html
http://www.fda.gov/cdrh/safety/121902.pdf
Journal
Scan
Insulin Mixups
View a video of this segment...
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 View a video of this segment...
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/default.htm
Patients
are Asking
New
Labeling and Advice on Hormone Therapies for Postmenopausal Women
View a video of this segment...
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/cder/drug/infopage/estrogens_progestins/default.htm
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FDA
Quick Quiz
View a video of this segment...
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
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Updated 4/1/2003 |