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Pharmacovigilance

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Pharmacovigilance

  1. 1. Dr. Jannatul Ferdoush Assistant Professor Department Of Pharmacology
  2. 2. Objectives: Importance & needs of pharmacovigilance. Monitoring Adverse drug reaction. Adverse drug reaction reporting.
  3. 3. What is Pharmacovigilance? The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug- related problem.
  4. 4.  Insufficient evidence of safety from clinical trials 1959-61 thalidomide disaster ( 4000-100000 case) Why do we need pharmacovigilance?
  5. 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. 6. Cont’d… Among the Leading cause of death-
  7. 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. 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. 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. 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. 11. Cont’d…  Monitoring of ADRs: - Clinical trial monitoring - Prescription event monitoring - Yellow card system
  12. 12. ADRs reporting:  Who to report: - All health care professionals.  What to report: - Any suspected ADRs.
  13. 13. Cont’d…  How to report: - ADRs form - Assessment tool: Naranjo scale  Where to report: - National body
  14. 14. Pharmacovigilance is Essential
  15. 15. Thank You!
  • poojithamudiraj

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