E-DRUG: Adverse Drug Reaction (ADR) Reporting by patients (cont)
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To change the focus a little away from patient reporting of ADRs onto how
drug regulatory authorities deal with drug safety I would like to bring to
the attention of E Druggers a very good editorial that appeared in JAMA
1998;279:1571-3. In this article by Moore, Psaty and Furberg they outline
four specific tasks that drug regulators should do if they want to truly
protect the public from the risks of marketed drugs: estimating the number
and cause of serious injuries and deaths; identifying new serious adverse
reactions; monitoring the effect of previous safety alerts; and operating
an early warning system. Most of the resources of regulatory authorities
are devoted to the second of these tasks, but even here there are problems.
The regulators rely on spontaneous reporting of adverse reactions, i.e.,
doctors and pharmacists seeing a reaction, diagnosing it correctly and then
taking the time to fill out a report and send it in. However, only about
1% of all reactions are ever reported which means that the risks of some
drugs might be seriously underestimated. Also if there is a long time lag
between ingesting the drug and the adverse effect, as is the case with DES
exposure in utero and the development of vaginal cancer in a female child
20 years later, then the system is likely to fail.
In the other three essential areas the problems are even greater. Are
preventable drug-related injuries occuring because of inadequate initial
testing, a breakdown in postmarket surveillance, physician prescribing
errors or a lack of patient compliance? Regulators don't know because they
don't collect any information on these subjects. Do doctors heed warnings
that regulators issue about newly detected adverse reactions? Once again
there is a big blank in our knowledge. Better than a spontaneous system of
reporting, would be an active surveillance plan to look for sensitive
indicators of possible problems such as birth defects or heart arrhythmias
(irregular beating of the heart). But regulators generally don't fund
these sort of studies.
Joel Lexchin
Joel Lexchin MD
121 Walmer Rd.
Toronto, Ontario
CANADA M5R 2X8
Phone: (416)-964-7186
Fax: (416)-923-9515
e mail: joel.lexchin@utoronto.ca
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