| Archives
2002
January
|
Anthrax
Isn’t The Only Threat To Prompt
FDA Action
Reflecting the new urgency to be prepared for acts of
terrorism, the FDA updated its guidelines on the use of
potassium iodide (Pima syrup, SSKI, others) to reduce
the risk of thyroid cancer following exposure to radioactive
iodine through the air or contaminated food. Potassium
iodide blocks thyroid uptake of radioactive iodine. The
updated guidelines recommend a standard daily dose of
16 mg of potassium iodide (KI) for infants less than 1
month old, 32 mg for children ages 1 month to 3 years,
65 mg for children and teenagers, and 130 mg for adults,
including pregnant and lactating women, and teens over
150 pounds. For more on the FDA’s guidelines, point
your browser to www.fda.gov/cder/guidance/4825fnl.htm.
U.
S. Food and Drug Administration. “FDA’S guidance
on protection of children and adults against thyroid cancer
in case of nuclear accident.” 2001. www.fda.gov/bbs/topics/ANSWERS/2001/ANS01126.html
(11 Dec. 2001).
[TOP]
Watch
Out: These Shortcuts Can Lead To Medication Errors
Do you handwrite “U” for “units” or
“µg” for “micrograms?” Both
abbreviations are potential causes of medication errors,
according to JCAHO and the Institute for Safe Medication
Practices (ISMP). A handwritten “U” can be mistaken
for a “0”—which would increase a dose tenfold.
The Greek letter mu in “µg” can look like
an “m” and lead someone to read the dose as
milligrams. Instead, practitioners should write out “Units”
and use “mcg” for micrograms. Another dangerous
shortcut in writing or copying drug doses is using a decimal
point and trailing zeros for a whole number dose (e.g.,
writing “2.0” instead of simply “2”)
or not putting a zero in front of a decimal point when
the dose is less than one whole unit (e.g., writing “.2”
instead of “0.2”). Either practice increases
the chance that someone else might overlook the decimal
point—and give 10 times as much drug in error. For
examples of other potentially dangerous drug abbreviations
or dosage designations, visit the ISMP Web site (www.ismp.org).
Joint
Commission on Accreditation of Healthcare Organizations.
“Sentinel event alert: Medication errors related
to potentially dangerous abbreviations.” 2001. www.jcaho.org/edu_pub/sealert/sea23.html
(11 Oct. 2001). Institute for Safe Medication Practice.
“ISMP’s table of dangerous medical abbreviations.”
2001. www.ismp.org (16 Oct. 2001).
[TOP]
New
Antiretroviral Helps Fight Resistant
HIV Infection
Tenofovir disoproxil fumarate (Viread) has been approved
for use in combination with other antiretroviral medications
to treat HIV infection. Tenofovir, the first nucleotide
analogue, blocks HIV replication in the same manner as
nucleoside analogues such as zidovudine (Retrovir), but
is taken only once a day. (For more information on HIV
medications, see the article on page 31.) The drug was
studied in more than 700 patients who showed signs of
continued HIV replication despite antiretroviral therapy.
Those given a regimen containing tenofovir had significant
decreases in the quantity of HIV RNA in their blood, compared
to those on a standard regimen plus placebo. The use of
tenofovir in untreated patients is still under study;
the drug’s long-term efficacy is unknown. The most
frequent adverse events with tenofovir were mild to moderate
diarrhea, nausea, vomiting, and flatulence. Monitor patients
for the risk of severe and potentially fatal lactic acidosis
and hepatomegaly with steatosis—which have occurred
with nucleoside analogues alone or in combination with
antiretrovirals.
U.S.
Food and Drug Administration. “FDA approves Viread
for HIV-1 infection.” 2001. www.fda.gov/bbs/topics/answers/2001/ans01111.html
(12 Nov. 2001).
[TOP]
First
Contraceptive Skin Patch Is Applied Only Once Weekly
Women who use birth control have a new option—a transdermal
contraceptive patch that’s applied only once a week.
Called Ortho Evra, the 13 4-inch-square patch releases
the progestin norelgestromin and ethinyl estradiol estrogen
through the skin and into the bloodstream. Women should
apply the patch to the lower abdomen, buttocks, outer
upper arm, or upper body (but not the breasts), wear it
for one week, then replace it with a new patch on the
same day of each week, for three consecutive weeks. No
patch is worn during the fourth week. In studies involving
4,578 women, the patch appeared to be less effective than
oral contraceptives (OCs) in women weighing more than
198 pounds. About 5% of women had at least one patch detach
from the skin, and about 2% discontinued the patch due
to skin irritation. As with OCs, adverse effects with
Ortho Evra include an increased risk of thromboembolism,
MI, and stroke.
Smoking
increases these risks, particularly for women who are
over 35 years old. Women with a history of thrombophlebitis
or thromboembolism, heart attack, stroke, or certain cancers,
or those who are or may be pregnant, should not use the
patch.
U.S.
Food and Drug Administration. “FDA approves first
hormonal contraceptive skin patch.” 2001. www.fda.gov/bbs/topics/answers/2001/ans01119.html
(26 Nov. 2001). Based on a news release from Ortho-McNeil
Pharmaceutical, November 20, 2001: The first birth control
patch receives FDA approval. www.orthoevra.com/newsroom/pressRelease10192001.html.
[TOP]
Drug
Maker Acts To Prevent Accutane-Related Birth Defects
The manufacturer of isotretinoin (Accutane) has introduced
a stricter risk management program to help ensure that
women don’t become pregnant while taking the drug,
and that those who are pregnant don’t get a prescription.
Isotretinoin is effective against the most serious form
of acne but has caused birth defects and fetal death.
The new program, called SMART (System to Manage Accutane-Related
Teratogenicity), enhances the previously existing prescriber
and patient education components and introduces a mechanism
to further prevent mis-prescribing. Pharmacists won’t
fill an isotretinoin prescription for a woman unless a
special yellow, self-adhesive “Accutane Qualification
Sticker” has been affixed to it, indicating that
the patient has had negative pregnancy tests and was counseled
about the drug’s risks. This “qualified”
prescription is required each month for all female patients,
regardless of whether they’re sexually active. Female
patients must also sign a special consent form about isotretinoin
and birth defects, and be invited to enroll in a confidential
survey that will assess whether the risk management program
is working.
U.S.
Food and Drug Administration. “FDA announces changes
to the risk management program to prevent birth defects
caused by Accutane.” 2001. www.fda.gov/bbs/topics/answers/2001/ans01113.html
(2 Nov. 2001).
[TOP]
Pain
Clinic
Helping Patients Speak Up About Pain Q A 74-year-old
patient who’s had chronic inoperable back pain
for 10 years is taking controlled-release oxycodone (OxyContin)
20 mg bid. She’s nevertheless become less active
and more isolated because of the pain, but hasn’t
told the doctor. What’s the best way to begin a dialogue
with her about her pain? A Begin by telling the patient
that she shouldn’t suffer in silence. Explain
that you and the doctor depend on her to describe her
pain, since she’s the one experiencing it. Elicit
details with questions such as these: • Where
exactly do you feel pain? What makes it get worse? How
bad is it right now on a scale of 1 (no pain) to 10 (extremely
painful)? • What does your pain feel like? (Is
it sharp? Stabbing? Dull?) • How much relief
does the medicine you’re taking provide? • Is
your pain keeping you from being active? Do you feel unable
to cope? Be sure to tell the patient that in the future,
if her medication fails to relieve her pain, she should
take a moment to record her pain symptoms in a “pain
diary.” Tell her that doing so will help her to remember
what the symptoms were like and assist the healthcare
team in identifying the best remedy for her symptoms.
Source:
American Pain Foundation. “Pain action guide.”
2001. www.painfoundation.org./page_paguide.asp (20 Dec.
2001).
THE AUTHOR MARY J. SCHOLZ, RN, PhD, is a nurse clinician
and behavioral medicine specialist at Northwest Psychophysiology,
an affiliate of Northwest Neuroscience Institute in Seattle.
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