Psychiatr News October 20, 2006
Volume 41, Number 20, page 27
© 2006 American Psychiatric Association
IOM Recommendations Fall Short
Recommendations in an Institute of Medicine (IOM) report on reforming the
U.S. Food and Drug Administration's (FDA) drug safety process may be a good
start (see page 1), but
the IOM's report does not go far enough, a group of experts in brain,
behavior, and neuropsychopharmacology concluded last month.
In a statement issued by the American College of Neuropsychopharmacology
(ACNP) in response to the report, Charles O'Brien, M.D., Ph.D., vice chair of
the Department of Psychiatry at the University of Pennsylvania and chair of
ACNP's Human Research Committee, and Donald Klein, M.D., a professor of
psychiatry at Columbia University, said, "The current postmarketing
surveillance process only accidentally detects rare but serious harmful
effects of prescription medications, including legal off-label use of drugs
prescribed for illnesses that were not studied in premarketing trials, as well
as toxic drug interactions."
While applauding the IOM's call for expanding the FDA's legislated
authority to mandate postmarketing studies, O'Brien and Klein said,
"[T]his is not enough. In order to adequately detect late, rare, and
off-label toxicities, a new cross-linked computerized database should be
created."
A week before the release of the IOM report, ACNP convened a panel of
experts at a forum examining the FDA's tracking of adverse drug events related
to medications already on the market. The panel, noting recent high-profile
cases of serious adverse events that were not detected in the clinical-trials
stage of drug development, explored ways to improve pharmacovigilance.
The ACNP panel asserted the need for a computerized surveillance system
that integrates medical, laboratory, and pharmacy records. A computerized
database linked to a person's medical records "will reduce medical
errors and help physicians identify side effects that weren't detected during
clinical trials, which are often too short and too small to identify rare or
late events."
Under the current system, 51 percent of drugs have significant label
changes due to major safety issues discovered after the drug goes on the
market. Nearly 20 percent of drugs go on to receive black-box warnings, and 3
percent to 4 percent are ultimately withdrawn from the market for safety
reasons.
The group outlined three specific areas to explore. One was the
implementation of "provisional approval" from the FDA in which
drugs are allowed to come to market sooner but their marketing is highly
restricted.
"This type of program will enable the people who need the drugs the
most to get them, while encouraging industry to continue to collect data and
monitor side effects," said O'Brien.
Second, the computerized drug-surveillance system needs to integrate
medical records and pharmacy records so that side effects can be quickly
identified and researched. A cross-linked computerized surveillance system
similar to that being suggested by the ACNP is already in use in the
Netherlands. Known as the PHARMO Institute, the system integrates input from
practitioner, hospital, pharmacy, and laboratory records. Another example of
integrated databases is the General Practice Research Database in the United
Kingdom.
Finally, the ACNP panel recommended that the organization itself should
consider establishing fellowships in pharmacoepidemiology to promote the field
and facilitate training of a new generation of scientists dedicated to
pharmacovigilance. The group agreed that individuals with solid methodological
expertise will be essential to collecting data and using the data wisely.
More information on the ACNP is posted at
<www.acnp.org>.
Information on the Netherlands' PHARMO Institute and the U.K.'s GPRD is posted
at, respectively,
<www.pharmo.nl/>
and
<www.gprd.com/home/>.
Related Article:
-
FDA Overhaul Needed to Ensure Drug Safety, IOM Says
- Jim Rosack
Psychiatr News 2006 41: 1-27.
[Full Text]
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