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PHARMACOVIGILANCE Systems in NEPAL

PHARMACOVIGILANCE Systems in NEPAL. PROF. N.R. BISWAS ,MD, DM, DNB, DSc Prof. of Clinical Pharmacology & Therapeutics , BPKIHS, Dharan, NEPAL And Govt. of India Advisor to BPKIHS, Dharan, NEPAL. Brief History. In Nepal, Pharmacovigilance ( ADR reporting ) started in 2003 .

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PHARMACOVIGILANCE Systems in NEPAL

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  1. PHARMACOVIGILANCE Systems in NEPAL PROF. N.R. BISWAS ,MD, DM, DNB, DSc Prof. of Clinical Pharmacology & Therapeutics , BPKIHS, Dharan, NEPAL And Govt. of India Advisor to BPKIHS, Dharan, NEPAL

  2. Brief History • In Nepal, Pharmacovigilance ( ADR reporting ) started in 2003. • It was mainly due to initiation by Prof. Kumud. K. Kafle of Institute of Medicine , Kathmandu, Nepal

  3. The Department of Drug Administration (DDA),MoHP ( Ministry of Health and Population ) is the focal point of Pharmacovigilance in Nepal.

  4. The (5) regional centers of Pharmacovigilance in Nepal • (1) BPKIHS, Dharan • (2) Institute of Medicine (IOM), Kathmandu • (3) Manipal College of Medical Sciences (MCOMS), Phokhra • (4) Nepal Medical College (NMC) ,Kathmandu • (5) KIST Medical College, Kathmandu

  5. Total number of ADR cases reported to Department of Drug Administration

  6. Pharmacovigilance Centre,Clinical Pharmacology Department, Institute of Medicine , katmandu80 cases of adverse drug reactions reported from OPDs and wards of Tribhuban University Teaching Hospital, Katmandu (Nov, 2006 – May, 2010)

  7. Type of ADRs and Number of Cases

  8. OTHER ACTIVITIES The department of Clinical Pharmacology , Institute of Medicine , Katmandu also provides following services 1. Drug information unit • Question-answering services to the prescribers of TUTH • Publication of four issues IN A YEAR of Drug and Therapeutics Letter

  9. 2.Drug Monitoring and Toxicology Laboratory • Service provided since 1987 • Total number of services utilized (July, 2009 – March, 2010) - 757

  10. Future Plannig--- • The focal point should encourage regional centers to report cases • Regional centers should collect/encourage spontaneous reporting of cases in their institutions • The focal point should identify more regional centers

  11. PHARMACOVIGILANCE at BPKIHS, DHARAN • Dept of Clinical Pharmacology and Therapeutics is the in –charge of Regional Pharmacovigilance Centre. • It is registered as Regional Pharmacovigilance Centre at International Pharmacovigilance Centre, UPPSALA , Sweden , through Dept. of Drug Authority , Katmandu , Nepal.

  12. ACTIVITIES of the Department • Collection and monitoring ADR data from various clinical departments • Teaching Pharmacovigilance to undergraduate ( MBBS and BDS) students so that the students can be familiar with ADRs. • Conducting research on Rational Use of Drugs at BPKIHS and providing feedback to respective departments to prevent ADR

  13. INCIDENCE of ADRs in different Disciplines

  14. TYPES of ADRs encountered at BPKIHS

  15. TYPES of ADRs encountered at BPKIHS ( contd.)

  16. FUTURE PLAN at BPKIHS • To do ADR reporting more effective , the Residents and Clinical Faculties will be trained by delivering lectures on ADR . • To include zonal hospitals of Eastern Nepal and to train them on how to report ADRs.

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