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2002
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New
USP Report Sheds More Light On The Nature Of Med Errors
A new study from the United States Pharmacopeia's Center
for the Advancement of Patient Safety reveals that 105,603
medication errors were reported to its anonymous database
in 2001 and that incorrect drug administration techniques
continue to be a serious cause of patient injury. Nearly
370 healthcare facilities voluntarily reported the errors.
The vast majority of errors were corrected before harm
occurred, says the report. However, of the 2.4% of errors
(2,539) that did result in injury, 70 required a life-saving
intervention and 14 resulted in death. Errors in administration
techniques (e.g., improper dilution of IV products) were
nearly four times more likely to result in harm than other
types of error. In pediatrics, miscalculations in converting
a patient's weight from pounds to kilograms were common,
as was failure to record drug allergies. In the ED, more
than 58% of drug errors could be attributed to an improper
dose, an omission, or a prescribing error. The top five
drugs involved in harmful errors were heparin, insulin,
morphine, warfarin, and potassium chloride. Facilities
cited many contributing factors to errors, most commonly,
distractions (47%), increases in workload (24%), and staffing
issues (36%).
For
more on medication errors, see the article on page 52.
U.S. Pharmacopeia. "National patient safety study
documents medication errors in hospitals." 2002.
www.onlinepressroom.net/uspharm (5 Dec. 2002). U.S. Pharmacopeia.
"USP releases new study on medication errors at U.S.
hospitals." 2002. www .onlinepressroom.net/uspharm
(5 Dec. 2002).
With
Safety Issues Resolved, Abbokinase Is Available Again
The FDA has approved the reintroduction of the thrombolytic
urokinase (Abbokinase) following the manufacturer's resolution
of serious manufacturing deficiencies. In 1999, the FDA
ordered urokinase-which is derived from cultures of human
kidney cells-off the market because of concerns about
product contamination with infectious microorganisms.
The company has now demonstrated that it meets the FDA's
requirements for assuring the safety of the product. Urokinase
is approved only for the lysis of massive pulmonary emboli
and pulmonary emboli accompanied by unstable hemodynamics.
The "warnings" section of its labeling has been
strengthened to include post-marketing reports of anaphylaxis,
other infusion reactions, and the potential risk of cholesterol
embolization-a rare side effect that has been reported
with all types of thrombolytics.
Abbott
Laboratories. "Abbott Laboratories receives FDA approval
to reintroduce Abbokinase (urokinase)." 2002. www.abbokinase.com/news/press_release
.cfm?id=508 (23 Oct. 2002). U.S. Food and Drug Administration.
MedWatch. "Abbokinase (urokinase)." 2002. www.fda.gov/medwatch/SAFETY/2002/safety02.htm#abboki
(23 Oct. 2002).
New
Cancer Drug Gleevec Continues To Show Promise
Imatinib mesylate (Gleevec) is undergoing its third accelerated
FDA review. This one may result in the drug's approval
as a first-line treatment for newly diagnosed patients
in the chronic phase (the earliest stage) of Philadelphia-chromosome
positive (Ph+) chronic myeloid leukemia (CML). Pediatric
dosing in Ph+ CML is also under FDA review. In May 2001,
imatinib was approved for use in the later stages of the
disease or in the chronic phase after failure of interferon
therapy. Meanwhile, in an ongoing study of imatinib in
147 patients with advanced inoperable or metastatic gastrointestinal
stromal tumors (GIST), researchers reported that the drug
produced a partial response in more than half of patients,
with tumor size reductions of 50% - 96%. Early results
of this study had led the FDA to approve imatinib for
the treatment of advanced or metastatic GIST. Resistance
to the drug has been seen in 20 of the patients.
Based
on a press release from Novartis Oncology, August 22,
2002: FDA grants priority review for Gleevec (imatinib
mesylate) marketing application for first-line use in
early chronic myeloid leukemia (CML). Demetri, G. D.,
von Mehren, M., et al. (2002). Efficacy and safety of
imatinib mesylate in advanced gastrointestinal stromal
tumors. N Engl J Med, 347(7), 472.
Government
Seeks To Combat Phony Weight Loss Claims
Ads making false or misleading claims for weight loss
pills, devices, or programs have proliferated over the
last decade, according to a recent report by the Federal
Trade Commission (FTC). The problem's so bad, the FTC
held a public workshop last month to solicit new approaches
to combat the trend. Almost half of the ads examined in
the report claimed that consumers could lose weight without
diet and exercise. Nearly 40% made at least one false
or misleading claim, such as the unrealistic promise of
losing 8 to 10 pounds per week over an extended period
of time. In contrast, weight loss experts recommend that
people lose weight gradually by setting realistic goals-for
example, losing 1 pound per week. And they stress that
the hard part-cutting calories and boosting exercise and
physical activity-is essential to any program.
The
full report is on the FTC Web site, at www .ftc.gov/dietfit.
A consumer guide to losing weight is available at www.consumer.gov/weightloss.
Federal Trade Commission. "Report on weight-loss
advertising: An analysis of current trends." 2002.
www.ftc.gov/opa/2002/09/weightlossrpt.htm (2 Oct. 2002).
First
In A New Class Of Drugs For Treating Hypertension
A new type of cardiovascular agent-eplerenone (Inspra)-has
been approved for treating patients with high blood pressure.
Eplerenone is designed to selectively block receptors
of aldosterone, a hormone that has been implicated in
the development and progression of hypertension. Eplerenone
was shown to be effective as monotherapy and in combination
with other antihypertensive drugs in more than 3,000 patients.
The most common adverse events were dizziness (in 3% of
patients), and fatigue, flu-like symptoms, diarrhea, and
cough (each reported in 2% of patients). Eplerenone should
not be used in patients with significant potassium elevations,
renal insufficiency, or diabetes associated with microalbuminuria;
nor should it be used in patients taking potassium supplements
or potassium-sparing diuretics. The drug is currently
being studied for use in heart failure.
Pharmacia
Corp. "FDA approves Inspra, an aldosterone blocker
for the treatment of hypertension." www.pharmacia.com/newsroom/script_press.asp?id=349
(1 Oct. 2002).
OTC
TALK
Teach Patients To Read Their Cold Remedy Labels With winter
here, many of your patients are likely to be reaching
for OTC cough/cold products that contain various combinations
of drugs. You can help them choose selectively, matching
ingredients to specific symptoms. As you know, some cough/cold
preparations contain analgesic/antipyretics such as acetaminophen,
aspirin, or ibuprofen. Advise patients and parents to
check the labels. It's all too easy to accidentally "double-up"
on doses of, say, acetaminophen, by taking it separately
and then getting more in the cough/cold product. Products
containing aspirin shouldn't be used in children. Patients
may need to think carefully about decongestants, too.
While they may know that decongestants like pseudoephedrine
relieve that "stuffy" feeling in their nose
and head, they may not know that these drugs work by constricting
blood vessels, which may cause hypertension in some patients.
Antihistamines are included in some cough and cold formulas
to dry the mucous membranes of the nasal passage, throat,
and eyes. Some, such as chlorpheniramine and diphenhydramine,
however, can cause drowsiness, urinary retention, and
constipation. Antitussives such as dextromethorphan can
help reduce a patient's coughing, but it can also make
patients drowsy. Finally, some products contain an expectorant
such as guaifenesin to loosen phlegm and thin mucus. However,
drinking lots of fluids can be just as helpful. Advise
patients to choose a product with the minimal number of
ingredients they need. Also, remind them to consult their
healthcare provider or pharmacist when buying a cough/cold
remedy for a child or someone who's pregnant.
Sources:
1. U.S. National Library of Medicine. Medline Plus. "Drug
information." 2002. www.nlm.nih.gov/medlineplus (12
Nov. 2002). 2. Columbia University College of Physicians
& Surgeons Complete Home Medical Guide. "Proper
use of medications." 2002. http://cpmcnet.columbia.edu/texts/guide/hmg34_0008.html
(12 Nov. 2002). THE AUTHOR JAMES M. WOOTEN, PharmD, a
member of the RN editorial board, is an assistant professor
of medicine at the University of Missouri School of Medicine,
in Kansas City, Mo.
A
Vaccine For Two STDs May Be On The Horizon
Clinical researchers are reporting progress in the development
of vaccines against two common STDs-human papillomavirus
and herpes. An interim report on a human papillomavirus
type 16 (HPV-16) vaccine generated a great deal of attention
this past fall. HPV-16 is associated with 50% of cervical
cancers. The three-dose vaccine reduced the incidence
of both HPV-16 infection (0 cases vs. 41 with placebo)
and HPV-16 related cervical intraepithelial neoplasia
(0 cases vs. nine with placebo)-suggesting a vaccine efficacy
of 100%. In addition, the effectiveness of a vaccine against
genital herpes was demonstrated for the first time in
two trials, though only in a subgroup of patients who
received the vaccine. A herpes simplex virus type 2 (HSV-2)
vaccine produced clinically significant protection in
about 73% of women who were seronegative at baseline for
both HSV-2 and herpes simplex virus type 1 (HSV-1). However,
the vaccine was not significantly effective in men nor
in women who were seronegative for HSV-2 but seropositive
for HSV-1 at baseline. An FDA-approvable vaccine for either
STD, say researchers, is still several years away.
Koutsky,
L. A., Ault, K. A., et al. (2002). A controlled trial
of a human papillomavirus type 16 vaccine. N Engl J Med,
347(21), 1645. Stanberry, L. R., Spotswood, S. L., et
al. (2002). Glycoprotein-D-adjuvant vaccine to prevent
genital herpes. N Engl J Med, 347(21),1652.
Acne
Drug Gets New Warnings-And Some Competition, Too
Labeling for isotretinoin (Accutane) has been updated
with new warnings and precautions based on post-marketing
safety reports. The new labeling warns of a rare but potential
risk of aggressive and violent behavior in patients taking
the drug, though no mechanism of action has been established.
Also, the labeling warns of osteoporosis and other bone-loss
related effects. In addition, the labeling contains clinical
trial reports of back pain and arthralgias in pediatric
patients, and precautions about prescribing the drug to
patients on phenytoin or systemic corticosteroids. Finally,
providers are advised to follow the recommendations for
dosing and duration of therapy and to remind patients
to take the drug with a meal. Meanwhile, with Accutane's
patent expired, Bertek Pharmaceuticals has announced its
plans to market isotretinoin under the brand name Amnesteem.
U.S.
Food and Drug Administration. MedWatch. "Accutane
(isotretinoin)." 2002. www.fda.gov/medwatch/safety/2002/safety02.htm#accuta
(6 Nov. 2002). Bertek Pharmaceuticals. "Mylan Laboratories
Inc. announces first ANDA approval for isotretinoin."
2002. www.bertek.com/company/frameset_newsroom.html (21
Nov. 2002)
Drug
Roundup
* Oral and injectable forms of levofloxacin (Levaquin)
were approved for the treatment of nosocomial pneumonia,
based on data showing that levofloxacin 750 mg (IV followed
by oral for seven - 15 days) was comparable in efficacy
to a regimen of IV imipenem/cilastatin (Primaxin) plus
oral ciprofloxacin (Cipro). * Metaglip, a new two-in-one
pill for patients with Type 2 diabetes, combines glipizide
(Glucotrol) and metformin HCl (Glucophage). It's approved
for use as an initial drug therapy or as a second-line
agent for patients not responding to either metformin
or a sulfonylurea agent alone. * Rabeprazole sodium (Aciphex),
a proton-pump inhibitor, received approval as a seven-day
treatment-in combination with amoxicillin and clarithromycin-for
patients with H. pylori infection and duodenal ulcer.
* New warnings were added to labeling for valdecoxib (Bextra)
following reports of rare life-threatening risks related
to skin reactions, including Stevens-Johnson syndrome,
and anaphylactoid reactions. Tell patients who start the
drug and get a rash to stop taking it immediately. It
shouldn't be used in patients allergic to products containing
sulfa.
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