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Pharmacovigilance at Trauma Center, AIIMS

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Pharmacovigilance at Trauma Center, AIIMS

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Pharmacovigilance at Trauma Center, AIIMS

  1. 1. Dr.Sharad H. Gajuryal MHATrainee, AIIMS Pharmacovigilance: Pillar for Patient Safety
  2. 2. Introduction Pharmacovigilance = Greek words Pharmacon= “Drug” Vigilare =“To keep alert "
  3. 3. According to WHO it is the science relating to detection, assessment, understanding and prevention of adverse drug reaction or any drugs related problem. ADR???
  4. 4. Adverse drug reaction A response to a drug that is noxious and unintended which occurs at a dose normally used in man for prophylaxis, diagnosis or therapy of disease.
  5. 5. Adverse Event Vs Adverse Reaction
  6. 6. Pharmacovigilance is not only confined to Modern medicine but also includes Herbal medicines, blood products and vaccines too.
  7. 7. Aim of Pharmacovigilance To improve patient care and safety in relation to use of medication To improve public health and safety in relation to use of medicine Contribute to assessment of benefit, harm, effectivemess and risk of medicines ,encouraging their safe and rational use. Promote understanding, Educational and clinical Training in Pharmacovigilance.
  8. 8. Guides regulators on whether the drug should beGuides regulators on whether the drug should be continue in market,continue in market, be restricted in usages, orbe restricted in usages, or in worst possiblein worst possible scenario,withdrawn from the marketscenario,withdrawn from the market
  9. 9. DRUGS RECENTLY BANNED IN INDIA? Pioglitazone-can cause heart failure and increases risk of bladder cancer. Dienxit- Deanxit  is a harmful combination Analgin-causing a sharp fall in white blood cells, a potentially fatal condition, called agranulocytosis Others-Sibutramin, Gatifloxacin,Nimuslide
  10. 10. History and Evolution 1937 –Sulphanilamide +Diethylglycol Disaster Death of 105 individuals Diethyleneglycol was incriminated Drug and Cosmetic Act, 1938 under which pharmaceutical product manufacturers would have to show scientific evidences of the safety of the drugs before releasing them for sale.
  11. 11. 1959-1961 –Thalidomide Disaster (Max. Seen in Germany) Linked to a congenital abnormality phocomelia In 1962, It was discontinued. The Kefauver-Harris amendment was approved, under which scientific evidences of efficacy and safety of drugs required before drug test/trail in humans.
  12. 12. Thalidomide effect
  13. 13. WHO's Programme for International Drug Monitoring was started in 1968 as a means of pooling existing data on adverse drug reactions .
  14. 14. At the end of 2010, 134 countries were part of the WHO Pharmacovigilance Programme. This Program is coordinated by WHO together with its collaborating centre in Uppsala, Sweden. The collaborating center is responsible for maintaining the global ADR database, Vigibase. At present the database contains more than four million ADR reports Till Date -149 countries
  15. 15. Process in Pharmacovigilance Collect and Record Adverse Event/ Adverse Drug Reaction Causality Assesment and analysis of ADR Collate and Code in Database Compute Risk benefit and Suggest regulatory action Communicate for safe use of drugs among stakeholders.
  16. 16. Pharmacovigilance in INDIA 150 Adverse Monitoring Center & NCC (Indian Pharmacopoeia commission)
  17. 17. Patient Safety and Performance Improvement Program @JPNATC
  18. 18. PS & PIP-
  19. 19. Pharmacovigilance at JPNATC Objectives: To Monitor Adverse Drug Reaction seen in JPNATC Patients To Create awareness among HCP about the importance of ADR Reporting To monitor Benefit risk profile of Medicines To Support National Pharmacovigilance Center for formulation of safety related regulatory decision for Medicine.
  20. 20. Pharmacovigilance at JPNATC Initiated along with Patient Safety Program at JPNATC Feb 10th : Meeting conducted at Pharmacology department Main Hospital AIIMS. The following Stake holders were present at the meeting. 1. HOD,Pharmacology Department, 2. Add. MS JPNATC, 3. Faculty Incharge IT. 4. HOD,Microbiology 5. Residents Hospital Administration
  21. 21. Minutes of Meeting To Initiate Pharmacovigilance program in JPNATC . 1 Phd Student and two Research Assistant to be appointed for Pharmacovigilance program. Adverse Drug Reaction form to be digitalized in coordination with faculty I/C IT and to be incorporated in E- Hospital
  22. 22. Appropriate Training session to be designed to enhance knowledge of ADR reporting among Health care professionals of JPNATC. Orientation classes to Health care professional for guidance to Report ADR
  23. 23. 13th March,2015 : Orientation class regarding pharmacovigilance was given to Nursing Staffs .
  24. 24. KAP Survey Total 25 Participants (Nurses , DNS, ANS ,Grade I and Grade II) 20 set of question Designation Frequency (n=25) Percentage ANS 10 25% DNS 3 12% Grade I 8 32% Grade II 7 28%
  25. 25. Result KNOWELDGE & AWARENESS 12 Questions Pre-Test Mean Result =5.4 Post-Test Mean Result=9.5
  26. 26. Conclusion Pharmacovigilance program is a helpful tool for protecting consumers (Patients) from harmful effects of medicines. ADR Should be considered as professional obligation Every HCP should be aware of existing pharmacovigilance mechanism in their country . It’s the efficient way to boost the confidence for safety.
  27. 27. Dying from a disease is sometime unavoidable, Dying from a medicine is unacceptable ! -Lepakhin V. Geneva

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