E-drug: Adverse Drug Reaction (ADR) Reporting by patients (cont)
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Dear Markus,
Having worked two years as head of the national centre for adverse drug
reaction monitoring in Norway and still following the issues of safety of
drugs closely because I find it very important and interesting , I would
like to participate briefly in the discussion.
At Norway's national centre only reports from prescribers are now received.
When I worked there, we also received reports from patients, but only
sporadic as we did not encourage it, unfortunately (due to lack of
resources).
A serious disadvantage of most of the existing national centres is the low
number of reports received which makes it difficult to even identify
signals. The low reporting is often due to lack of feedback to reporting
prescriber and thus lack of interest in reporting. Some countries (Sweden,
France) have therefore set up regional centres which at least improves
communication with the prescribers, makes it easier to conduct studies etc.
This has resulted in substantial increase in reporting in these countries.
In Norway efforts to set up such regional centres have so far failed due to
resistance from the national centre which looks at this as
a possible break of confidentiality (they think the regional centres will
punish doctors who have given drugs which have caused ADRs!!) It is at
present a heated public debate going on.
Now, decentralisation is one way of increasing reporting, but it does
little to encourage reporting by patients if the centres do not accept such
reports (I am not sure if the two countries mentioned do, but I think they
don't). I think it is important to lower the threshold for reporting by
allowing non-prescribers to report, but as Leo said, you will receive a lot
of non-important reports and it will take a lot of time to investigate
them. My experience was that doctors often do not see a complaint from a
patient as an ADR and therefore do not report it. It also happens that he
first checks with the manufacturer which is likely to find another cause
than his own drug! Other professionals, e.g. pharmacists and clinical
pharmacologists would be more aware of the drugs'potential for
adverse reactions and be more willing to report/investigate it. Another
reason to allow others to report would be to increase reporting of e.g.
herbal remedies as patients often do not report to his/her physician taking
such OTC products.
I think the first step would not be to have patients report directly to
some centre, may be with the exception of places like KILEN where they are
concerned with habitforming drugs only. I would suggest to start as they
have done in UK by allowing pharmacists to report. I think that would give
the necessary filter and ensure that all data are available. In fact
reports from pharmacists have often been of better quality than from
physicians. Many issues of the Pharmaceutical Journal have reported on the
result so far, I suggest you contact the Royal Pharmaceutical Society
(http://www.rpsgb.org.uk/).
Good luck!
Best wishes from a rather hot Botswana where I occasionally sit down to
follow and participate in your debates!
Kirsten
Kirsten Myhr, MScPharm, MPH
Permanent address: Oslo, Norway
myhr@online.no
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