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E-DRUG Drug Alers
The following ideas for a drug-alert system were developed two years ago
and distributed in a small circle of acquantances. It might be a
contribution to the current discussion on white- and blacklisting.
At a SOCEPTA/DURG-AFRO regional meeting held in Malawi some 4 (!) years
ago the issue of sub-standard drugs being marketed in the region came
up. After discussion it was agreed that the possibility of establishing
some form of information exchange on this should be investigated.
However there has not yet been any follow up to put this into operation.
Recently Rob and I started discussing how we could initiate some kind of
network system for exchanging such information making use of the
increasingly available electronic information systems , especially the
Internet and perhaps e-drug - ie. an electronic Drug Alert System.
Basically the objective would be to facilitate access to useful and
practical information on drugs which had been found upon
testing/examination to be substandard and thereby alert interested
individuals or agencies that may be liable to procure/use such items.
The target audience would be basically anyone worldwide who handles
drugs (especially imported items) and who would need to be sure of drug
quality and composition. This could include Ministries of Health, drug
regulatory authorities, quality control laboratories, medical
stores/procurement agencies, retail and wholesale pharmacies, others??
etc. The language (initially at least) would be English.
'Sub-standard' would cover any aspect of unacceptable quality including
for example, expired items, incorrect composition/fake drugs, poor
formulation, inadequate packaging and labelling, etc. This could be
revealed as a result of quality control testing or perhaps, where there
are obvious problems, upon visual examination (especially if back-up lab
facilities are not available). Information on registration application
rejections and batch withdrawals might also be exchanged and
(possibly??) information on poor supplier performance (although this is
probably more of a grey area).
Some issues would need careful examination prior to proceeding with
setting up a workable and sustainable system. These would include:
1. System administration: presumably there would need to be some central
point (ie. a moderator/facilitator/system administrator) to whom all
relevant information would be first be sent for
vetting/confirmation/approval as necessary prior to being sent out. It
would be important to ensure (legal implications??) that information
being circulated was fair and accurate and capable of being
substantiated (if necessary) in some way. Perhaps ideally the person
would be a pharmacist working with a drug regulatory authority or
quality control laboratory. It would also be nice if the system was run
as an African initiative
2. Confidentiality: we assume that many countries will have
confidentiality rules applicable to drug testing, drug registration
procedures, etc. It would be necessary for these to be waived or relaxed
in some way for the information to be circulated beyond the currently
authorized recipients. Also we wonder if the target audience should be
restricted in any way - eg. to those registered in some way as members
of the network - using an email address for identification - or whether
it should be (ideally?) completely open. Of course then the drug
companies themselves would have access but maybe that is not a bad thing
- provided the information was completely reliable. There may be other,
eg. political and security angles to such information exchange which we
should consider??
3. Subscriptions: we presume there must be some costs involved in
establishing and running such a system. These would need to be covered
somehow - perhaps one of the agencies involved in the promotion/ensuring
of ethical drug use and marketing might be approached for support, eg.
HAI, WHO (??) others ?? Alternatively interested recipients of the
information could be asked to pay a modest annual subscription. The
latter option has its own problems, eg. the information exchange would
no longer be free, payment of subscriptions is notorious unreliable and
would be subject to foreign exchange difficulties in some countries and
there would need to be an accounting/financial management aspect to the
system which would have its own associated costs.
4. Publicity/promotion: once all the above issues had been
satisfactorily resolved and a workable/sustainable system developed,
there would need to be a suitable promotional campaign to inform all
interested parties of the existence, purpose and operation of the Drug
Alert System and get everyone on-board. Of course email could be used
but not everyone has access to this yet and there would be need for
other forms of promotion, eg. printed materials such as journals (eg.
Essential Drugs Monitor?? - although we are not sure about the
practicality/suitability of overt WHO involvement/promotion, INRUD
journal, etc), circulars to known potentially interested
individuals/agencies, etc, verbal promotion in pharmaceutical fora, etc.
We really believe that the establishment of an efficient system of
worldwide exchange of information on sub-standard drugs (and medical
supplies) is not only vital but should be feasible and of potentially
immense practical benefit to many involved in the pharmaceutical field
(particularly in those countries with a weak or inefficient drug
regulatory system). If it worked well the result would be the gradual
elimination of substandard drugs and unethical companies from the
market. This would have potentially enormous economic and social
benefits and would above all help to protect individual patients from
the hazards of use of such items.
With best regards
Chris Forshaw
Rob Verhage
[Moderators Comments This seems to be the most detailed proposal yet for how
such a network could be established. The mention of DURG-AFRO and SOCEPTA
are interesting. These are professional organizations. Could such a network
for information sharing be set up through such organizations? Possibly with
external funding support? Richard Laing Co-Moderator]
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