The Challenges of Pharmacovigilance Presented by:- Dr. ROCHAK SONI ICRI (DELHI).
Content: <ul><li>Pharmacovigilance </li></ul><ul><li>Need for Pharmacovigilance </li></ul><ul><li>Challenges of Pharmacovi...
WHO definition of Pharmacovigilance The science and activities relating to the detection, assessment, understanding and pr...
Need for pharmacovigilance   <ul><li>Limitation of preclinical safety data </li></ul><ul><li>Changing pharmaceutical marke...
Challenges of pharmacovigilience <ul><li>Detection of ADRs </li></ul><ul><li>Assessment  </li></ul><ul><li>Other challenge...
Detection of ADRs :- The education of doctors, pharmacists, industry and patients about drug safety and the importance of ...
Size and severity of the ADR problem  Patient safety signals .     <ul><li>39 prospective studies from US hospitals </li><...
Drug Authority Dr.ROCHAK SONI Experience report Drug experience report Drug Information Drug Information Patient Health pr...
Managing a signal  A first signal Increasing information and knowledge Public  Information 1 Public  Information 2 Media c...
Activities essential  to pharmacovigilance: <ul><li>Suspected ADR signal detection and formation of hypotheses </li></ul><...
Assessment of  Problems in withdrawal & regulation    Dr.ROCHAK SONI
Example of a decision problem to be solved [1] ... <ul><li>Cisapride - heart rhythm disorders </li></ul><ul><li>1986:  dou...
Example of a decision problem to be solved [2] ... <ul><li>Piroxicam is the most GI toxic of the NSAIDS in several compara...
Discussion point <ul><li>How often is drug withdrawal really necessary? </li></ul><ul><li>Does withdrawal harm more people...
Other Challenges of pharmacovigilience Dr.ROCHAK SONI
Sponsors related challenges  <ul><li>Timely reporting from all the sponsor is challengeable  </li></ul><ul><li>Different s...
For generic manufactures:- <ul><li>Reporting the same molecules of others manufactures whenever the information is receive...
Industry related challenges <ul><li>To maintain the standardization of processes and data within organization </li></ul><u...
Challenges of pharmacovigilence in india Dr.ROCHAK SONI
Dr.ROCHAK SONI
Dr.ROCHAK SONI
Dr.ROCHAK SONI
Where does fault lie? <ul><li>Adequate sharing of information between stockholder is poor </li></ul><ul><li>No rapport wit...
It is said that  pharmacovigilance is not easy and its errors and problems tend to be repeated .[ 1 ] True, we have seen t...
NEED TO DO <ul><li>There are much more active approaches needed for education of HPs and public in all countries </li></ul...
Managing a signal: the future Increasing information and knowledge also negative response Public  Information 1 Public  In...
Cont.-Patient involvement <ul><li>Patients need more general information about drugs and their effectiveness and risk </li...
Conclusions <ul><li>Think less about drug safety: more about patient safety </li></ul><ul><li>Think less about regulating ...
Conclusions <ul><li>‘ ..Drug safety information must serve the health of the public. Such information should be ethically ...
Questions? Dr.ROCHAK SONI
Dr.ROCHAK SONI
mail id-:  [email_address] <ul><li>Contact no-: +918010808158 </li></ul>Dr.ROCHAK SONI
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Rochak presentation....current challenges of pharmacovegilence

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Rochak presentation....current challenges of pharmacovegilence

  1. 1. The Challenges of Pharmacovigilance Presented by:- Dr. ROCHAK SONI ICRI (DELHI).
  2. 2. Content: <ul><li>Pharmacovigilance </li></ul><ul><li>Need for Pharmacovigilance </li></ul><ul><li>Challenges of Pharmacovigilance overall </li></ul><ul><li>Challenges of pharmacovigilence in india </li></ul><ul><li>Need to do </li></ul><ul><li>Conclusion </li></ul>Dr.ROCHAK SONI
  3. 3. WHO definition of Pharmacovigilance The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem Dr.ROCHAK SONI
  4. 4. Need for pharmacovigilance <ul><li>Limitation of preclinical safety data </li></ul><ul><li>Changing pharmaceutical marketing strategies </li></ul><ul><li>- direct consumer advertising </li></ul><ul><li>Changing physician and patient preferences </li></ul><ul><li>- increase use of drug to improve QoF </li></ul><ul><li>Easy accessibility </li></ul>Dr.ROCHAK SONI
  5. 5. Challenges of pharmacovigilience <ul><li>Detection of ADRs </li></ul><ul><li>Assessment </li></ul><ul><li>Other challenges:- </li></ul><ul><li>a) sponsor related </li></ul><ul><li>b) industry related </li></ul>Dr.ROCHAK SONI
  6. 6. Detection of ADRs :- The education of doctors, pharmacists, industry and patients about drug safety and the importance of ADR reporting can certainly be listed among the greatest challenges. Dr.ROCHAK SONI
  7. 7. Size and severity of the ADR problem Patient safety signals . <ul><li>39 prospective studies from US hospitals </li></ul><ul><li>Overall incidence of serious ADRs = 6.7% </li></ul><ul><li>Overall incidence of fatal ADRs = 0.32% </li></ul><ul><ul><li>(106 000 individuals) </li></ul></ul><ul><li>4th - 6th leading cause of death </li></ul>Dr.ROCHAK SONI
  8. 8. Drug Authority Dr.ROCHAK SONI Experience report Drug experience report Drug Information Drug Information Patient Health professional Drug info/ADR reporting Centre
  9. 9. Managing a signal A first signal Increasing information and knowledge Public Information 1 Public Information 2 Media coverage Also negative response SCARE Dr.ROCHAK SONI
  10. 10. Activities essential to pharmacovigilance: <ul><li>Suspected ADR signal detection and formation of hypotheses </li></ul><ul><li>Analysis of all issues around the signal, particularly confirmation of hypothesis, estimation of the size of the risk and whether susceptible patients exist </li></ul><ul><li>Communication of information to health professionals and patients in a useful way. And possible regulatory action. </li></ul><ul><li>Consequence evaluation. </li></ul>Dr.ROCHAK SONI
  11. 11. Assessment of Problems in withdrawal & regulation Dr.ROCHAK SONI
  12. 12. Example of a decision problem to be solved [1] ... <ul><li>Cisapride - heart rhythm disorders </li></ul><ul><li>1986: double blind study “cisapride produced tachycardia” </li></ul><ul><li>1992 WHO Signal published in Br Med J on serious arrhythmia </li></ul><ul><li>1995 case report published, Lancet “QT prolongation and tachycardia” </li></ul><ul><ul><li>Dear Doctor letter in USA by manufacturer </li></ul></ul><ul><li>Should cisapride still be marketed? </li></ul>Dr.ROCHAK SONI
  13. 13. Example of a decision problem to be solved [2] ... <ul><li>Piroxicam is the most GI toxic of the NSAIDS in several comparative studies </li></ul><ul><ul><li>GI toxicity is a major cause of morbidity </li></ul></ul><ul><ul><li>Should piroxicam replace rofecoxib in Venezuela? </li></ul></ul>Dr.ROCHAK SONI
  14. 14. Discussion point <ul><li>How often is drug withdrawal really necessary? </li></ul><ul><li>Does withdrawal harm more people than it helps? (example-micturin- it cause cardic arrhythmias but people still want it to maintain there QoF) </li></ul><ul><li>How can we reduce the time from signal to useful and properly used information </li></ul>Dr.ROCHAK SONI
  15. 15. Other Challenges of pharmacovigilience Dr.ROCHAK SONI
  16. 16. Sponsors related challenges <ul><li>Timely reporting from all the sponsor is challengeable </li></ul><ul><li>Different safety reporting software –repeat work and time </li></ul><ul><li>Data shared between sponsor is very slow </li></ul><ul><li>Difficult to obtain data from other sponsors </li></ul>Dr.ROCHAK SONI
  17. 17. For generic manufactures:- <ul><li>Reporting the same molecules of others manufactures whenever the information is received or call </li></ul><ul><li>Aggregate safety report/ signal detection- </li></ul><ul><li>Assessment of safety operation across all case reported for the active moiety from all manufactures </li></ul><ul><li>Difficult to obtain data from other manufactures </li></ul>Dr.ROCHAK SONI
  18. 18. Industry related challenges <ul><li>To maintain the standardization of processes and data within organization </li></ul><ul><li>To maintain harmonization </li></ul><ul><li>Delay in making better decisions </li></ul><ul><li>If manufacturing process is different it may lead to different effect and also side effect </li></ul>Dr.ROCHAK SONI
  19. 19. Challenges of pharmacovigilence in india Dr.ROCHAK SONI
  20. 20. Dr.ROCHAK SONI
  21. 21. Dr.ROCHAK SONI
  22. 22. Dr.ROCHAK SONI
  23. 23. Where does fault lie? <ul><li>Adequate sharing of information between stockholder is poor </li></ul><ul><li>No rapport with practising physician and peripheral centers </li></ul><ul><li>Lack of documentation </li></ul>Dr.ROCHAK SONI
  24. 24. It is said that pharmacovigilance is not easy and its errors and problems tend to be repeated .[ 1 ] True, we have seen that before. We have had our share of errors and problems. We should now hope that the new programme will have a smooth sailing. It will help us improve the patient safety significantly . Dr.ROCHAK SONI
  25. 25. NEED TO DO <ul><li>There are much more active approaches needed for education of HPs and public in all countries </li></ul><ul><ul><li>- more active use of the media </li></ul></ul><ul><ul><li>-much more interest in patient safety issues </li></ul></ul><ul><li>There is a great need to know the basis for regulatory decisions </li></ul><ul><li>Medication errors </li></ul><ul><ul><ul><ul><li>Root –cause analysis </li></ul></ul></ul></ul>Dr.ROCHAK SONI
  26. 26. Managing a signal: the future Increasing information and knowledge also negative response Public Information 1 Public Information 2 Media coverage Pre-marketing risk management What do HPs and patients think and want A first signal Dr.ROCHAK SONI
  27. 27. Cont.-Patient involvement <ul><li>Patients need more general information about drugs and their effectiveness and risk </li></ul><ul><li>VERY IMPORTANT </li></ul><ul><ul><li>We need much more information about what risks patients are prepared to take for what benefit to them. Until we know this we will continue to ‘second-guess’ about what is acceptable or no t </li></ul></ul>Dr.ROCHAK SONI
  28. 28. Conclusions <ul><li>Think less about drug safety: more about patient safety </li></ul><ul><li>Think less about regulating (incl. Withdrawal) more about useful information output </li></ul><ul><li>Think more about impact and consequences of decisions and non-decisions </li></ul>Dr.ROCHAK SONI
  29. 29. Conclusions <ul><li>‘ ..Drug safety information must serve the health of the public. Such information should be ethically and effectively communicated in terms of both content and method. Facts, hypotheses and conclusions should be distinguished, uncertainty acknowledged, and information provided in ways that meet both general and individual needs...’ </li></ul><ul><li>Erice Declaration, 1998. </li></ul>Dr.ROCHAK SONI
  30. 30. Questions? Dr.ROCHAK SONI
  31. 31. Dr.ROCHAK SONI
  32. 32. mail id-: [email_address] <ul><li>Contact no-: +918010808158 </li></ul>Dr.ROCHAK SONI

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