E-DRUG: Sharing info on Adverse Drug Reactions
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Dear E-druggers,
Small developing countries often don´t have sufficient human and financial resourses to implement a full pharmacovigilance-programme. Besides, IF they collect data on Adverse Drug Reactions, it would be most useful to exchange information with other countries on both regional and international level.
I´m aware that there are COMMERCIAL databases on ADR, but the fees these compagnies charge are often too high for the small budgets available for these purposes. Even the Uppsala Monitoring Centre that runs the WHO ADR database (Vigibase) charges high amounts for searches.
Ofcourse there are other platforms, like the FDA and EMEA and other platforms for ADR-registration in indusrialized countries, but the problem is that ADRs on many drugs (like artemisinin based combination-therapy) that are being used in Asia, South-America and Africa, are NOT available, simply because these are medicines that are not registred in these industrialized countries.
Can anybody help me to find non-commercial regional/international platforms/ADR-databases (in particular for Africa) that could help me to share/exchange information concerning ADRs?
I´m looking for:
Internet Based Platforms/Databases;
Contact adresses of key persons of regional/international platforms/pharmacovigilance programmes;
Etc.
Your help would of course be very much appreciated in these times of 'World Wide Information Availability', where in many cases poorer countries cannot profit from the availability of information.
Many thanks in advance!
Mechiel Weits, M.Sc, D. Pharm
Netherlands
mechiel@zonnet.nl
E-DRUG: Sharing info on Adverse Drug Reactions (2)
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Dear Mechiel,
You raise a very important issue which in my opinion is far from being
satisfactorily addressed.
What this world needs is a globally accessible database on ADRs free for
professional access.
EMEA, FDA and other national regulatory authority ADR databases are, in my
experience, still in their infancy (for standardisation, IT reasons); never
mind even implementing a global ADR database which can be presented in a
common format. Surely this should be a job for ICH and WHO?.
Why does WHO Uppsala charge a fee? Can they provide an answer to this
question? Does not WHO Uppsala offer a free service to developing countries?
Jonathan Harper; BSc, MD, MBA
Budapest, Hungary
"Jonathan Harper" <jrharper@axelero.hu>
E-DRUG: Sharing info on Adverse Drug Reactions (3)
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ICH E2 and M2 guidelines define standards for ADR expedited reporting, but
there is no agreement on how or who this info should be shared with at a
global level. EMEA has Eudravigilance - but this system is still a year at
least away from being fully implemented in the EU Member States for both
technical and administrative reasons.
I guess it is going to take another few years yet before we can expect to
see a real global IT system that handles ADRs and that professionals from
any country, irrespective of its development status, can use. This type of
system will also require national authorities in less developed countries to
implement at a national level.
It will happen, but when?
Jonathan Harper
Jonathan Harper; BSc, MD, MBA
Budapest, Hungary
"Jonathan Harper" <jrharper@axelero.hu>