Mr. janeshwar

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  • Janeshwar Verma ITS, Ghaziabad
  • Janeshwar Verma ITS, Ghaziabad
  • Janeshwar Verma ITS, Ghaziabad
  • Janeshwar Verma ITS, Ghaziabad
  • Janeshwar Verma ITS, Ghaziabad
  • Janeshwar Verma ITS, Ghaziabad
  • Janeshwar Verma ITS, Ghaziabad
  • Janeshwar Verma ITS, Ghaziabad
  • Janeshwar Verma ITS, Ghaziabad
  • Janeshwar Verma ITS, Ghaziabad
  • Janeshwar Verma ITS, Ghaziabad
  • Janeshwar Verma ITS, Ghaziabad
  • Mr. janeshwar

    1. 1. PHARMACOVIGILANCE: CURRENT SCENARIO & FUTURE CHALLENGES IN INDIA JANESHWAR VERMA
    2. 2. PRESENTATION CONTENTS  Introduction  Why Pharmacovigilance  ADR Reporting procedure  Aim of Pharmacovigilance  Pharmacovigilance: Future challenges, Need & issues  Outcome of a successful program in Pharmacovigilance  Summery and Conclusion 2 JaneshwarVermaITS,Ghaziabad
    3. 3. INCREDIBLE INDIA 3 The zero and decimal system were developed. 38% Doctors in America are Indian 12% Scientist in America are Indian 36% NASA employees are Indian World’s largest democracy Clinical Research Hub Fourth largest exporter by volume of drugs USFDA office in Delhi, Mumbai & …. JaneshwarVermaITS,Ghaziabad
    4. 4. PHARMACOVIGILANCE The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO 2002). 4 Pharmakon vigilare Greek Latin Drug to be awake or alert, to keep watch JaneshwarVermaITS,Ghaziabad
    5. 5. 6 JaneshwarVermaITS,Ghaziabad
    6. 6. 7 WHY PHARMACOVIGILANCE?  Patients affected by preventable harm.  Top ten causes of mortality.  >10% of hospital admissions. JaneshwarVermaITS,Ghaziabad
    7. 7. 8 HISTORY OF PHARMACOVIGILANCE JaneshwarVermaITS,Ghaziabad
    8. 8. 9 BRIEF HISTORY OF PHARMACOVIGILANCE The Thalidomide Disaster JaneshwarVermaITS,Ghaziabad
    9. 9. 10 BRIEF HISTORY OF PHARMACOVIGILANCE JaneshwarVermaITS,Ghaziabad
    10. 10. 11 BRIEF HISTORY OF PHARMACOVIGILANCE JaneshwarVermaITS,Ghaziabad
    11. 11. INDIA ? 12 JaneshwarVermaITS,Ghaziabad
    12. 12. 13 BRIEF HISTORY OF PHARMACOVIGILANCE Pharmacovigilance in India JaneshwarVermaITS,Ghaziabad
    13. 13. PHARMACOVIGILANCE HIGHLIGHTS: GROWTH OF THE WHO GLOBAL ICSR DATABASE 14 individual case safety reports JaneshwarVermaITS,Ghaziabad
    14. 14. 15 JaneshwarVermaITS,Ghaziabad
    15. 15. WHAT TO REPORT? All suspected reactions Lack of effect Resistance Interaction Dependence and abuse 16 JaneshwarVermaITS,Ghaziabad
    16. 16. WHICH TO REPORT? Allopathic medicines including OTC Traditional Medicines Biologicals like vaccines and sera Herbals Blood products Medical devices 17 JaneshwarVermaITS,Ghaziabad
    17. 17. WHERE TO REPORT ? Patient Health Professional Regional Centre Manufacturer Hospital National Centre 18 JaneshwarVermaITS,Ghaziabad
    18. 18. MAJOR HEALTH PROFESSIONALS  Physicians  Dentists  Pharmacists  Nurses  Other health workers 19 JaneshwarVermaITS,Ghaziabad
    19. 19. WHEN IS AN ADR SERIOUS?  Death / life-threatening (real risk of dying)  Hospitalization (initial or prolonged)  Disability (significant, persistent or permanent)  Congenital anomaly  Requires intervention to prevent  Permanent impairment or damage 20 JaneshwarVermaITS,Ghaziabad
    20. 20. Reporting form 1. The patient 2. Adverse event 3. Suspected drug(s) 4. All other drugs used 5. Risk factors 6. Name and address of reporter  Reporting forms will be distributed.  Telephone, fax and email used to reporting ADR’s. 21 REPORTING OF ADVERSE DRUG REACTION JaneshwarVermaITS,Ghaziabad
    21. 21. 22 AIM OF PHARMACOVIGILANCE JaneshwarVermaITS,Ghaziabad
    22. 22.  Improve patient care and safety  Improve public health and safety  Early detection of unknown safety problems  Identification of risk factors  Quantifying risks 23 AIMS OF PHARMACOVIGILANCE Janeshwar Verma ITS, Ghaziabad
    23. 23.  Assessment of benefit, harm & effectiveness  Promote understanding, education in PV.  Encouraging safe, rational, and effective use  Preventing patients from being affected unnecessarily 24 AIMS OF PHARMACOVIGILANCE Janeshwar Verma ITS, Ghaziabad
    24. 24. PARTNERS IN PHARMACOVIGILANCE Partners in the practice of drug safety monitoring. Government Industry Hospitals and academia Medical and pharmaceutical associations Health professionals Patients Consumers Media WHO 25 JaneshwarVermaITS,Ghaziabad
    25. 25. INDIA TODAY  PV is still in its infancy in INDIA  Major advancement are in western countries  More clinical research conducted in India  Immense need to understand the importance of PV 26 JaneshwarVermaITS,Ghaziabad
    26. 26. PHARMACOVIGILANCE, CHALLENGES, NEEDS & ISSUES 27 JaneshwarVermaITS,Ghaziabad
    27. 27.  Population that is predominantly rural.  Use of traditional medicines.  Poor reporting.  Lake of physician and consumer awareness.  Inadequate post marketing surveillance.  Surfeit no. of licensed drug manufactures (>6,000)  Surfeit no. of branded formulations (>60,000). 28 JaneshwarVermaITS,Ghaziabad PHARMACOVIGILANCE CHALLENGES, NEEDS AND ISSUES
    28. 28. Need to move toward more active Pharmacovigilance  PSURs (Periodic Safety Update Reports)  Post marketing studies  Risk Management plans (periodicity driven by risk)  Improved communication Need to Strengthen Safety Reporting Requirements for:  Medical Devices,  Food Supplements and  Herbal products. 29 JaneshwarVermaITS,Ghaziabad PHARMACOVIGILANCE CHALLENGES, NEEDS AND ISSUES
    29. 29. Each country should:  Establish a PV system and collect information  Training of HCPs and Health Authorities.  Promote Product Safety Awareness.  Encourage all HCPs to report suspected ADRs. 30 JaneshwarVermaITS,Ghaziabad PHARMACOVIGILANCE CHALLENGES, NEEDS AND ISSUES
    30. 30. OUTCOME OF A SUCCESSFUL PROGRAM IN PHARMACOVIGILANCE 31 JaneshwarVermaITS,Ghaziabad
    31. 31. OUTCOME OF A SUCCESSFUL PROGRAM IN PHARMACOVIGILANCE  Assessment of benefit, harm, effectiveness & risk.  Improve patient care and safety.  Improve public health and safety.  Promote understanding, education & training in PV.  Effective communication to the public. 32 JaneshwarVermaITS,Ghaziabad
    32. 32. SUMMARY & CONCLUSION 33 JaneshwarVermaITS,Ghaziabad
    33. 33. To minimize the harm, medicine should have good: Efficacy: Evaluated from clinical trials. Quality: Established standards by GMP. Safety : By toxicology, clinical trials. In all, Pharmacovigilance will promote: Systematic and rational use of medicines Boost confidence for safety. 34 JaneshwarVermaITS,Ghaziabad SUMMARY & CONCLUSIONS
    34. 34. KEY MESSAGES  The NPvP launched to improve the current state  Its basic purpose is to analyze ADR data  Healthcare team actively participate in the program  They should start reporting AE  Help to ensure that children’s safety 35 JaneshwarVermaITS,Ghaziabad
    35. 35. THANK YOU 36 ‘People who are vigilant do not die; people who are negligent are as if dead’. Shakyamuni Buddha JaneshwarVermaITS,Ghaziabad

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