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Vol 1,Is 3 ( ay/ une 2005)
Family Medicine Clinical Pharmacy Forum is a brief bi-monthly publication from the Family
Medicine clinical pharmacists distributed to faculty and residents of the Department of Family
Medicine. O ur intent is to provide timely information on broad-based issues of
pharmacotherapy,as well as regulatory and practiced-based issues affecting you as a
f e
prescriber. I you have suggestions for things you would lik to see in the newsletter,please
contact one of us.
Pharm acothearpy Is .
s ues
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Authored by:
Mi E rns D.
chael .E t,Pharm . ;BCPS
J tefens er,
enna S f m ei Pharm . D.
2
Regulatory Issues.
Drug W ithdrawal. After concluding that the overall risk versus benefit profile is
unfavorable, FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra™
(valdecoxib) from the market. For more information, see:
http: //www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Bextra
Contrary to rumors, there are NO immediate plans to bring Vioxx™ back on the market.
It is true that the FDA subcommittee voted that it *could*be brought back (with stricter
labeling), but Merck has not announced any official plans.
Pseudoephedrine. Effective 5/21/05, most pseudoephedrine-containing products sold
in Iowa will be handled as Schedule V controlled substances. This new law affects
pseudoephedrine provided as a single-agent product and any combination product
that contains any amount of pseudoephedrine. As with other controlled substances,
these products must be stored within pharmacy and all patient care areas under lock
and key, and a perpetual inventory of supplies kept on hand must be maintained.
Outpatient prescriptions for any pseudoephedrine-containing products will also be
treated like other controlled substances in Schedules III, IV and V;the prescriber must
supply his/her DEA registration number on the prescription and the number of refills will
be limited to five (or six months). The new law limits the amount that can be purchased
without a prescription to 7500 mg (total) within a 30-day period. Purchasers must be 18
years of age and provide a government-issued photo ID (e.g., a driver’s license).
Reminyl™ (galantamine), for Alzheimer’s disease, has been renamed Razadyne™.
Multiple C- Rx’ Apparently the new DEA interpretation of not allowing multiple C-II
II s.
Rx’s to be written on the same day (with instructions to not fill until a certain date) is
causing a big uproar. The actual law has not changed, only the DEA interpretation.
Many state boards say that it is still legal to do so. I called the Iowa Board of Pharmacy
Examiners for clarification, and they told me that you can only write a future fill date on
one C-II Rx and it should be within a 15-day window of when to fill it. In other words, if
you see a patient for a visit and notice that they will run out of their C-II in a few days,
you can write a new Rx (with today’s date) and instruct that it not be filled until a
certain date (the Board recommends this be within a 15 day window). You should
continue to rewrite C-II Rx’s on a monthly basis and not post-date or provide multiple
Rx’s with future fill dates. The Board advises me that the DEA may be revisiting this later.
Research.
Enrollment continues in the Collaborative Management of Hypertension Study. If you
have a newly diagnosed hypertensive patient or a patient on treatment and not at BP
Authored by:
Michael E. Ernst, Pharm.D.; BCPS
Jenna Steffensmeier, Pharm.D.
3
goal, please have one of the nurses contact Karen Kluesner at 430-7335. Fliers are
posted in the patient care areas.
Clinical Pearl.
A recent drug information question I received was: “Does androstenedione affect
testosterone levels?”
Yes, oral androstenedione supplementation has been shown to down-regulate
endogenous testosterone production through its reduction in circulating LH levels and
et,
subsequent increases in estrone and estradiol levels. In the Andro proj 15 men (mean
age 43) receiving androstenedione 100 mg BID were found to have testosterone levels
that decreased 16% after 1 month of use. Enhancements in adaptation to resistance
training were no different than placebo for body composition or muscular strength.
ect. Arch Intern Med 2000;160:3093-14.
Broeder CE, et al. The Andro proj
(from a flier brought back from Mexico by Dr. Michael Maharry)
Authored by:
Michael E. Ernst, Pharm.D.; BCPS
Jenna Steffensmeier, Pharm.D.