E-drug: Re: New drug info resource (cont'd)
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Dear Colleagues,
I am responding with significantly less enthusiasm than Andy Gray that
Medscape has combined two databases from FristDataBank and the American
Society of Health-System Pharmacists (ASHP), specifically in regard to the
quality of the patient drug information available on the Medscape Web site.
The ninth line in the Medscape DrugInfo Patient Handout for cisapride (U.S.
brand name Propulsid) reads: "This medication can rarely cause irregular
heartbeat and dizziness/fainting." This should be compared to the first
sentence in the Food and Drug Administration (FDA) approved patient
information leaflet for the drug: "PROPULSID � may cause serious irregular
heartbeats that may cause death
(www.janssen.com/products/pi_files/propulsMG.pdf available May 13, 2000)."
Janssen first proposed the language for the cisapride patient information
leaflet in June 1998, including the explicit warning about the risk of
death with the drug.
We believe that it is Janssen's and the FDA's expectation that the FDA
approved information for cisapride would be distributed to patients by
pharmacists. Unfortunately, it appears that too many patients have been
receiving unregulated leaflets, produced by commercial information vendors,
similar in quality to that of the information available on the Medscape Web
site, rather than the FDA approved information.
Cisapride has been withdrawn from the U.S. market and will be off pharmacy
shelves by mid-summer. The FDA has reports of 80 deaths associated with
the use of the drug through the end of 1999
(www.fda.gov/bbs/topics/ANSWERS/ANS01007.html). In a letter to the FDA
Commissioner Jane Henney on April 11, we urged the immediate withdrawal of
the drug after we had identified another 23 deaths associated with the use
of the drug occurring in the first quarter of 2000
(www.citizen.org/hrg/PUBLICATIONS/1519.htm). For E-Druggers not familiar
with the U.S. adverse event reporting system, it is generally estimated
that for each event reported 10 events go unreported.
Commercial information vendors agreed to voluntary guidelines in 1996
defining useful and scientifically accurate written drug information for
patients. Voluntary standards have a tradition of failure. The Medscape
cisapride leaflet is one example.
The results of an eight state survey, sponsored by the FDA, on the quality
of written drug information distributed to patients was presented at a
public meeting in March of this year. The conclusion of those who
conducted the survey was the quality of the information given to patients
is "variable." The results of this survey and the transcript of the
meeting can be found at www.fda.gov/cder/ddmac/research.htm.
Our comments on the results of the survey are considerably more pointed.
Written drug information intended for patients that is incomplete,
inaccurate, or out-of-date that does not communicate risk in a context
meaningful to patients is misleading and thus potentially dangerous when
patients logically assume that written information given to them by
pharmacists is all they need to know to use the drug safely. Our comments
on the survey can be found at
http://www.citizen.org/hrg/PUBLICATIONS/1512.htm.
Pharmacists must be much more critical than they have been in the past
about the quality of written information that is distributed to patients.
Best regards,
Larry
Larry D. Sasich, Pharm.D., M.P.H., FASHP
Public Citizen's Health Research Group
1600 20th Street, NW
Washington, DC 20009
Voice: 202-588-7782
FAX: 202-588-7793
E-Mail: lsasich@citizen.org
Web Site: www.citizen.org/hrg
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