|
Archives
2003
May
April
March
February
January
2002
December
November
October
September
August
July
June
May
April
March
February
January
|
A Quality Of Life
Advance For Chemotherapy Patients
A new type of antiemetic called aprepitant (Emend) gives cancer patients
extended protection against nausea and vomiting caused by chemotherapy,
including high-dose cisplatin. Standard protection has centered around 5-HT3
antagonists such as ondansetron (Zofran) and granisetron (Kytril), which are
approved to prevent nausea and vomiting in the first 24 hours after
chemotherapy (acute phase). Aprepitant is the first agent approved for
preventing nausea and vomiting in both the acute phase and the delayed phase,
25 - 120 hours after chemotherapy. Aprepitant has a unique mechanism of action,
selectively blocking P/neurokinin 1 (NK1) receptors in the brain, which appear
to play a role in chemotherapy-induced nausea and vomiting. Aprepitant is taken
for three days as part of a regimen that includes a 5-HT3 antagonist and a
corticosteroid such as dexamethasone (Decadron). Aprepitant may affect plasma
concentrations of certain medications, including some chemotherapy agents,
warfarin (Coumadin), and oral contraceptives. Closely monitor prothrombin time
in patients on warfarin, especially in days seven to 10 after the first dose of
aprepitant.
U. S. Food and Drug
Administration. "FDA approves new drug to combat nausea and vomiting for
cancer patients getting chemotherapy." 2003.
www.fda.gov/bbs/topics/news/2003/new00886.html Merck & Co. "Emend
(aprepitant)." 2003. www.emend.com (10 Apr. 2003).
New Class Of Drug
Against HIV Gets Accelerated Approval
The FDA has approved a new class of drug for use in combination with other
agents to treat advanced HIV-1 infection. Enfuvirtide (Fuzeon) is indicated in
adults and children ages 6 and up who have ongoing evidence of viral
replication in spite of treatment with other antiretroviral agents. Enfuvirtide
is the first "fusion inhibitor," so called because it blocks the
fusion of viral and cellular membranes and thus interferes with the entry of
HIV-1 into healthy CD4 cells. Studies of its long-term effects are ongoing.
Patients will need to be taught to watch for symptoms of pneumonia, which was
more frequent in subjects who had enfuvirtide added to their anti-HIV regimen
than in those who did not. In trials, nearly all patients had at least one
local infusion site reaction and 17% had a reaction that lasted for more than
seven days. Serious systemic allergic reactions may occur. Complete details on
the new drug are available at www.fuzeon.com.
U.S. Food and Drug
Administration. "FDA approves first drug in new class of HIV treatments
for HIV infected adults and children with advanced disease." 2003.
www.fda.gov/bbs/topics/NEWS/2003/NEW00879.html (17 Mar. 2003).
Antibiotic
Labeling Must Warn Of Risk Of Bacterial Resistance
The FDA has announced that by February 6, 2004, labeling for systemic
antibiotics must carry statements telling providers about the risk of resistant
bacteria developing if these drugs are used inappropriately, and advising them
to counsel patients about this risk. The reminders-including one right under
the headline of the product name-will caution that the antibiotic is to be used
only for infections that are proven or strongly believed to be caused by
bacteria. Providers will also be reminded to consider culture and antibiotic
sensitivity information when available. Patients are to be advised that their
antibiotic is effective only against bacterial, not viral, infections and that
they need to take it exactly as directed. Explain that skipping or not
completing the prescribed regimen reduces the effectiveness of the antibiotic
and raises the chance of bacteria developing resistance.
U. S. Food and Drug
Administration. "FDA publishes final rule to require labeling about
antibiotic resistance." 2003.
www.fda.gov/bbs/topics/news/2003/new00869.html (10 Feb. 2003).
Gleevec's Use Is
Expanded In Chronic Myeloid Leukemia
Imatinib mesylate (Gleevec) has been approved for first-line treatment of
adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid
leukemia (CML). The drug was initially approved in May 2001-after an
accelerated three-month FDA review-for patients with advanced stages of CML and
as a second-line agent for patients in the chronic phase following the failure
of interferon-alpha therapy. Imatinib is now approved as a first- or
second-line agent for patients in any stage of CML. Imatinib targets an enzyme
that produces the rapid growth of white blood cells in CML. In a trial
comparing it with a combination of interferon-alpha and cytosine arabinoside
(Ara-C) in 1,106 patients with chronic phase CML, those on imatinib had
significantly less cancerous cells in their blood and bone marrow. Imatinib
also appears to have reduced disease progression at one year. The most common
adverse effects include nausea, vomiting, edema, muscle cramps, fatigue, skin
rash, and headache.
U. S. Food and Drug
Administration. "Gleevec approved for first line treatment of chronic
myeloid leukemia (CML)." www.fda.gov/bbs/topics/news/2002/new00860.html (7
Jan. 2003). O'Brien, S. G., Guilhot, F., et al. (2003). Imatinib compared with
interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic
myeloid leukemia. N Engl J Med, 348(11), 994.
Help Reduce Adverse Events In
Elderly Outpatients
About 40% of elderly outpatients use five or more medications per week-a factor
that increases their risk of having an adverse drug event (ADE). But many ADEs
are avoidable, according to a recent study. Researchers examined the records of
27,617 elderly patients for a 12-month period and identified 1,523 ADEs, 421 of
which were deemed preventable. Though most avoidable errors had no long-term
effects, five patients died. Preventable errors most often occurred in the
prescribing (58%) and monitoring stages (60%) of care. (In tracking a single
ADE, it was possible to spot the error at more than one stage and to identify
more than one error in a single stage.) Preventable errors also occurred when
patients did not follow directions (21%). This, say the researchers,
underscores the importance of careful patient instruction.
Gurwitz, J. H., Field, T. S., et
al. (2003). Incidence and preventability of adverse drug events among older
persons in the ambulatory setting. JAMA, 289(9), 1107.
Modified Rapamune
Regimen Improves New Kidney Function
A study of kidney transplant patients has shown that early withdrawal of
cyclosporine from a regimen that includes sirolimus (Rapamune) can
significantly improve renal function and blood pressure without increasing the
risk of organ rejection. Labeling for sirolimus now includes this new regimen,
but it's recommended only for patients who are at low-to-moderate immunologic
risk of organ rejection. Patients should be started on the standard three-drug
immunosuppressive regimen-sirolimus, cyclosporine (Sandimmune, Neoral), and
corticosteroids-but have cyclosporine withdrawn two to four months after the
transplant. The sirolimus dose is then increased to recommended serum
concentrations. In the study, graft survival at three years was 91% with the
modified regimen vs. 85% in those who stayed on cyclosporine.
Wyeth Pharmaceuticals. "FDA
approves new indication for Rapamune." 2003. www.wyeth
.com/news/pressed_and_released/pr04_11 _2003_16_04_31.asp (18 Apr. 2003). U. S.
Food and Drug Administration. "FDA approves new Rapamune labeling likely
to improve transplanted kidney function." 2003.
www.fda.gov/bbs/topics/answers/2003/ans01211.html (18 Apr. 2003).
Pain Clinic
Which Triptan Is Best For Your Migraine Patient?
Q Your patient tells you that while her current triptan is
effective in treating her migraine attacks, her headaches return fairly often.
She asks whether a different triptan would help more. What can you tell her?
A Tell her that
another triptan may, indeed, work better for her. A recent review of the
research found that migraine recurrence rates varied by the triptan used,
ranging from 17% - 40%. It appears that the longer a triptan's half-life and
the higher its potency for certain receptors in the brain, the lower the
recurrence rate. Of the seven available triptans, the review found that
frovatriptan succinate (Frova) 2.5 mg, naratriptan HCl (Amerge) 2.5 mg, and
eletriptan hydrobromide (Relpax) 40 mg had the lowest recurrence rates.
Eletriptan was approved late last year. In a large, placebo-controlled study,
eletriptan 40 mg was compared to sumatriptan succinate (Imitrex) 100 mg.
Researchers found that more eletriptan patients reported having mild or no pain
at two hours (67% vs. 59%, respectively) and fewer of them had a recurrence
(31% vs. 37%). When it comes to your patient, tell her that a recurrence can
happen with any triptan, but the likelihood of that happening can vary by the
particular triptan she's taking. Ultimately, only her own "trial" can
tell which is best for her.
Geraud, G., Keywood, C., &
Senard, J. M. (2003). Migraine headache recurrence: Relationship to clinical,
pharmacological, and pharmacokinetic properties of triptans. Headache, 43(4),
376. Mathews, N. T., Schoenen, J., et al. (2003). Comparative efficacy of
eletriptan 40 mg versus sumatriptan 100 mg. Headache, 43(4), 214. 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.
Error Watch
This is the first in a series of bimonthly columns that RN will offer on
preventing drug errors. It will feature actual cases reported to the Center for
the Advancement of Patient Safety (CAPS) at the U. S. Pharmacopeia, along with
analysis and recommendations by CAPS staff.
A Series Of Slips Led To This
Drug Mix-up
Borrowing drugs, not confirming a verbal request, and not knowing a weekend
protocol paved the way for this "Serzone/ Seroquel" mix-up reported
anonymously to the U. S. Pharmacopeia's Medication Errors Reporting (MER)
Program.* A patient's dose of the antidepressant nefazodone HCl (Serzone) was
being gradually reduced. On a Friday, a 200 mg tablet was dispensed, along with
two 100 mg tablets to be used as the tapered doses for the weekend, when the
pharmacy was closed. The patient was inadvertently given the two 100s on
Friday, leaving the weekend nurse with only the (unscored) 200 mg tablet.
Forgetting that extra Serzone was kept in the night cabinet on weekends, the
nurse asked a colleague to borrow a 100 mg Serzone tablet from another unit.
The colleague thought she said "Seroquel"-which is the antipsychotic
agent quetiapine fumarate. Seroquel (in 100 mg tablets) is what she borrowed,
and that's what the patient got for two days. Come Monday, the colleague called
the pharmacy to get more Seroquel for the patient-and the error was caught. The
patient suffered no harm, but the drug could have caused seizures and excessive
orthostatic hypertension, among other reactions. This mishap teaches the
importance of several safety measures, such as having a "no
borrowing" policy, posting reminders on procedures when the pharmacy is
closed, alerting staff to easily confused drug names, and rechecking verbal
requests for medications.
*MER is presented in cooperation
with the Institute for Safe Medication Practices. THE AUTHORS DIANE D. COUSINS,
RPh, is vice president of the Center for the Advancement of Patient Safety
(CAPS) at the U. S. Pharmacopeia. MARSHA PROTZEL, RN, BS, is quality
control/quality assurance analyst at the center.
|
