E-DRUG: Problem suppliers (cont'd)

e-drug
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E-DRUG Problem drugs

I think Dzul's suggestion of "event reporting" is a good one. There
needs to be some sort of international sharing of information.
Information reported to National Authorities unfortunately remains
within the bounds of the particular authority and is not shared more
widely - be it in the form of lists, events ... In some developing
countries a Regulatory Authority may not be in existence. If there
is no sharing of information of this nature then more than a few
people's lives may be at risk.

This issue should not be about protecting national pride or
particular manufacturers. It should be about the sharing of
information for the common good of patients. A reputable company
with GMP in place may have one or two recalls. If information is
shared properly, one should be able to see the reason for the recall
or particular batch related problem from the report. Companies
who for one or other reason produce substandard products on a
regular basis deserve to have their reputation sullied.

If we must protect the interests of substandard manufacturers by
not mentioning their names, then information could be shared on a
per product basis. There should preferably be a standard format for
sharing information too.

Leesette Turner

Leesette Turner
snail: PO Box 21638, Kloof Street, 8008, SA
tel: (+27)083-261-3299
tel/fax: (+27-21-)4651158

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E-DRUG Criteria for Problem suppliers

As a follow up to Leesette's suggestion can we look at the 5
categories below in trying to evolve a MINIMUM standard reporting format
about "problem drug events" as a form of info sharing.

Name of Drugs (and accompanying detailed documentation, eg. product
name, batch number, manufacturer's name/number,
supplier/agent/distributor information, etc)

Description of Event (i.e, the problem encountered, with indication of the
time/date of the event as a matter of reference)

Any confirmation of the problem (especially with respect to Lab. QC)

Any action taken to rectify ther problem (and outcome if possible)

Any advisory note (to others)

Regards,
Dzul
National Poison Centre
Malaysia
Dzulkifli Abdul Razak <dzul@prn.usm.my>

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