Pharmacovigilance

1. Pharmacovigilance Dr . Jannatul Ferdoush Assistant Professor Department Of Pharmacology

2. O bjectives: Importance & needs of pharmacovigilance . Monitoring Adverse drug reaction. Adverse drug reaction reporting.

3. What is Pharmacovigilance? The science and activities relating to the detection , assessment, understanding a nd prevention of adverse effects or any other drug-related problem .

4. Insufficient evidence of safety from clinical trials 1959-61 thalidomide disaster ( 4000-100000 case) Why do we need pharmacovigilance?

5. Cont’d… Medicines are supposed to save lives Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. Lepakhin V. Geneva 2005 Promoting rational use of medicines and adherence.

6. Cont’d… Among the Leading cause of death-

7. Cont’d… ADRs are expensive !! Cost of ADRs in the US: Cost of drug related morbidity and mortality exceeded $ 177.4 billion in 2000 ( Ernst FR & Grizzle AJ, 2001: J American Pharm. Assoc ) ADR related cost to the country exceeds the cost of the medications themselves.

8. Cont’d… Ethics: To know of something that is harmful to another person who does not know, and not telling, is unethical. No medicine is risk free, vigilant assessment of the risks and benefits of medicine promote safety.

9. Aims of pharmacovigilance To improve patient care and safety To improve public health and safety To contribute to the assessment of benefit, harm, effectiveness and risk of medicine .

10. Adverse drug reactions[ADRs] monitoring Monitoring centre: - WHO collaborating centre for international drug monitoring , Uppsala Monitoring Centre, Sweden . - Established in1968. In Bangladesh: - Directorate General of Drug Administration.

11. Cont’d… Monitoring of ADRs: - Clinical trial monitoring - Prescription event monitoring - Yellow card system

12. ADRs reporting: Who to report: - All health care professionals. What to report: - Any suspected ADRs.

13. Cont’d… How to report: - ADRs form - Assessment tool: Naranjo scale Where to report: - National body

14. Pharmacovigilance is Essential

15. Thank You!