Sunday, January 6, 2013

ADR monitoring in Nepal

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).


  1. Please provide copy of ADR reporting form of Nepal as an attachment.
    Prof.(Dr.P Prema Khosla