Status of ADR
monitoring programme in Nepal
WHO programme for International Drug monitoring is an important
programme to record adverse reaction of drugs worldwide. The Uppsala Monitoring
Centre at Sweden
coordinates the activities. All the member countries send reports generated in
their country by an online system called Vigibase online. Nepal has expressed
its commitment to join as a member and as of September 2005, has got the status
of Associate member. Membership will be granted once Uppsala
monitoring centre (UMC) is satisfied that Nepal is doing ADR reporting
properly. His Majesty's Government, Ministry of Health and Population has
designated Department of Drug Administration (DDA), Kathmandu,
as a national center for ADR Monitoring.
The DDA has prepared an ADR reporting form for reporting
suspected ADRs. At the beginning, the reporting will mainly be for hospitalized
patients as there is no system yet to get information from outpatients. The
treating doctors will record any events of ADRs and the suspected drugs as well
as other information like patient information, concurrent medications, etc. and
report it to the DDA. All such information collected by the DDA will be entered
in the Vigibase system for evaluation. Since it is an online system, the action
is immediate and proper action can be taken for serious adverse effects if the
need arises.
The UMC, WHO collaborating center for International Drug
Monitoring conducted a training in the study of ADR and related problems, and
introduction to pharmacoepidemiology. The following plans for pharmacovigilance
activities in Nepal
for July, 2005- June 2006 were presented during the training:
1. Pharmacovigilance centre as national centre will be
established in Department of Drug Administration (DDA), Ministry of Health,
under Drug Information Section and also regional centres in eastern and western
Nepal
will be established.
2. Meetings will be conducted with six central hospitals
(tertiary level) and two teaching hospitals for ADR reporting and generation of
ADR reports.
3. ADR reporting form will be finalized.
4. ADR reporting form will be distributed to all interested
tertiary level hospitals and teaching hospitals.
5. Awareness training for pharmacovigiliance will be
conducted in teaching hospitals and tertiary level hospitals.
6. ADR data reported by prescribers from hospitals will be
entered into vigibase online.
7. The ADR data generated from vigibase online will be
utilized for the evaluation of product available in the Nepalese market on the
basis of risk/ benefit ratio.
8. Some of the serious side effects generated from
vigibase will be published in Drug Bulletin of Nepal (DBN). 
thank you for this post
ReplyDeletePlease provide copy of ADR reporting form of Nepal as an attachment.
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