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A
West Nile Vaccine Is Ready For Clinical Trial
A West Nile virus vaccine, developed by scientists at the National
Institute of Allergy and Infectious Diseases, has been tested successfully
in rhesus monkeys. The vaccine contains a live, but weakened virus
that was created by replacing proteins of the dengue type 4 virus
with corresponding West Nile virus proteins. (The dengue virus is
in the same family as the West Nile virus.) Two versions of the
vaccine were created-one with a more weakened virus than the other.
Monkeys who received either version and who were subsequently exposed
to the West Nile virus developed antibodies and successfully fought
the virus. Researchers say that the vaccine containing the weaker
version of the virus will be the first one used in human clinical
trials, set to begin by year's end. West Nile, which is spread to
people by mosquitoes, produces mild, flu-like symptoms and can cause
encephalitis.
National Institutes of Health. "Promising West
Nile virus vaccine protects monkeys." 2003. www.niaid.nih.gov/newsroom/releases/wnv.htm
(20 Aug. 2003).
A West
Nile Vaccine Is Ready For Clinical Trial
A West Nile virus vaccine, developed by scientists at the National
Institute of Allergy and Infectious Diseases, has been tested successfully
in rhesus monkeys. The vaccine contains a live, but weakened virus
that was created by replacing proteins of the dengue type 4 virus
with corresponding West Nile virus proteins. (The dengue virus is
in the same family as the West Nile virus.) Two versions of the
vaccine were created-one with a more weakened virus than the other.
Monkeys who received either version and who were subsequently exposed
to the West Nile virus developed antibodies and successfully fought
the virus. Researchers say that the vaccine containing the weaker
version of the virus will be the first one used in human clinical
trials, set to begin by year's end. West Nile, which is spread to
people by mosquitoes, produces mild, flu-like symptoms and can cause
encephalitis.
National Institutes of Health. "Promising West
Nile virus vaccine protects monkeys." 2003. www.niaid.nih.gov/newsroom/releases/wnv.htm
(20 Aug. 2003).
Statin
And Aspirin: A Package Deal
Pravigard PAC is pravastatin sodium (Pravachol) and buffered aspirin
tablets packaged together, for patient and prescriber convenience.
Pravastatin and buffered aspirin are both indicated to reduce the
occurrence of cardiovascular events, including heart attack and
stroke, in patients who have heart disease. The usual dose of Pravigard
PAC is one aspirin tablet with one Pravachol tablet once a day.
Pravigard PAC contains 30 tablets of each of the two drugs. The
buffered aspirin comes in 81 mg or 325 mg tablets, and the pravastatin
comes in 20 mg, 40 mg, or 80 mg tablets. This drug combination should
not be taken by patients with certain liver or kidney problems.
Also, it shouldn't be taken by pregnant patients, those who are
planning to become pregnant, or those under age 18.
Food and Drug Administration. "FDA approves
first co-packaged treatments to reduce occurrence of serious cardiovascular
and cerebrovascular events." 2003. www.fda.gov/bbs/topics/NEWS/2003/NEW00917.html
(1 July 2003). Bristol-Myers Squibb Company. "Bristol-Myers
Squibb receives FDA approval of Pravigard PAC (Buffered aspirin
and Pravastatin sodium) tablets." 2003. www.bms.com/news/press/data/fg_press
_release_3819.html (30 July 2003).
Problem
Rx
Is The Lipid-Lowering Med Causing These Symptoms?
A 59-year-old man with hyperlipidemia, hypertension, and diabetes
mellitus presents with muscle weakness and painful joints. He also
says he's been tiring easily. His blood pressure is 132/84. He's
in a sinus rhythm of 76 bpm, unchanged from previous tracings. This
patient has been on the statin simvastatin (Zocor), 20 mg PO daily
for two months. Can this lipid-lowering drug be the problem?
Yes, it could well be. While statins, as a rule, are safe and effective,
they do cause muscle toxicity in 0.1% of patients. Muscle symptoms
can occur at any time during the treatment. The risk of myopathy
varies among statins. The incidence of myopathy in patients taking
simvastatin in clinical trials (in which interacting drugs were
excluded) was 0.2% at 20 mg/day, 0.07% at 40 mg/day, and 0.3% at
80 mg/day. Other statins appear to have a lower risk of myopathy,
with pravastatin sodium (Pravachol) having the lowest risk. Significant
myopathy may also occur in patients taking statins with other drugs
such as cyclosporine (Neoral, Sandimmune) and gemfibrozil (Lopid).
Pravastatin is the only statin approved by the FDA for use with
cyclosporine. In this case, the patient was taken off the simvastatin
and had a total recovery. He was then given another lipid-lowering
drug, fenofibrate (Tricor), which he tolerated very well. Phillips,
P. S., Haas, R. J., et al. (2002). Statin-associated myopathy with
normal creatine kinase levels.
Ann Intern Med, 137(7), 581. THE AUTHOR LINDA M. PORTERFIELD,
RN, PhD, is a clinical pharmacologist and director of cardiovascular
research at Arrhythmia Consultants in Memphis. She works with her
husband, James Porterfield, MD, FACC, who is a cardiologist and
electrophysiologist.
Error
Watch
Is Your Patient A Diabetic? Watch That Insulin Dose!
In 2000 and 2001, there were a total of 4,764 insulin errors reported
to the USP's Medmarx database. Just over 6.5% of these errors caused
harm to the patient. That's more than double the historical average
of all drug errors reported to Medmarx that caused patient harm
(2.8%). Insulin errors can result from any number of factors. Certainly,
mixups can-and do-occur because of products with similar names.
But other factors can also lead to errors, including: * the "sliding-scale"
approach used by many hospitals, in which short-acting insulin is
administered, at scheduled times, with the dose dependent upon the
patient's blood glucose level at the time; * clinicians using "u"
as an abbreviation for "units;" and * the accessibility
of insulin as floor stock. Consider these two cases: In the first
case, a sliding scale order was written for regular insulin "4U"
when the patient's blood sugar was 240 - 300 mg/dL. The order was
misinterpreted and the patient was given 44 units of NPH (intermediate-acting)
insulin instead of regular (short-acting) insulin. When the error
was discovered, the patient was given three cups of juice and transferred
to the ICU for close monitoring. In the second case, a dialysis
technician inadvertently administered insulin instead of heparin
to a patient in the dialysis unit of a hospital. Insulin was kept
as floor stock in this unit. The patient suffered fatal neurological
damage due to decreased glucose levels. To prevent a similar tragedy
in the future, the facility removed insulin from floor stock and
instituted a policy requiring that all insulin doses carry patient-specific
labeling and be kept in patient-specific bins. To avoid an error
like the one in our first case, clinicians should spell out "units"
instead of abbreviating the word with a "u." Also, be
sure to use only regular insulin in sliding-scale protocols and
to use preprinted ordering sheets for insulin use, where possible.
Don't hesitate to call the doctor and clarify an order, and, no
matter what the situation, remember to always double-check the insulin
dosage before administering it to the patient.
THE AUTHORS JOHN P. SANTELL, MS, RPh, is director,
education program initiatives at the U.S. Pharmacopeia Center for
the Advancement of Patient Safety (CAPS). Rodney Hicks, RN, MSN,
MPA, is research coordinator at the Center. Marsha Protzel, RN,
BS, is quality control/quality analyst at the Center. |
