Current Pharmacovigilance Practice And Improving Methods

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Pharmacovigilance, New Methods for adverse drug reactions

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Current Pharmacovigilance Practice And Improving Methods

  1. 1. Avinash S. Khairnar , PhD (Pharmacology), MBA (HR), M. Pharm (Pharmacology), IDCRC, PGDPRA, PGDIPR, PGDHRM, DIM, Telmed, IMM Asst. Prof. (Pharmaceutical Medicine), MUHS, UDIRT [email_address] , +91 99225 09025 Current Pharmacovigilance Practice in India and Improving Methods 2nd Annual Pharmacovigilance 2011, 19 Aug 2011
  2. 2. Contents <ul><li>History of PVG in India </li></ul><ul><li>Current PVG Practice </li></ul><ul><li>Improving Methods: A Practical Approach </li></ul>
  3. 3. A story from 1798 - 1961 “ A Phocomelus of the Eighteenth Century As Seen by Francisco Goya “- Journal of Clinical Pediatrics Louvre Museum, Paris By Francisco Goya y Lucientes
  4. 4. DISASTER THALIDOMIDE 1961- Thalidomide Catastrophe
  5. 5. <ul><li>WHO Pilot Research Project for International Drug Monitoring </li></ul>
  6. 6. WHO Programme for International Drug Monitoring
  7. 7. History of PVG in India <ul><li>“ Infancy in India” </li></ul><ul><li>1986 Formal Adverse Drug Reactions Monitoring System Started </li></ul><ul><li>12 Regional Centers </li></ul><ul><li>India – WHO </li></ul>
  8. 8. Main Objective…. <ul><li>TO Monitor ADRs of Marketed Drugs </li></ul>
  9. 9. Failure….. <ul><li>Lack of Awareness of Prescribers </li></ul><ul><li>Lack of Funding from Government </li></ul>
  10. 10. Nov. 2004…. <ul><li>CDSCO Established NPP with WHO Sponsorship and World Bank Funding </li></ul>
  11. 11. National PVG Programme Structure E Regional N Regional W Regional W Regional NE Zonal SW Zonal National PVig Center
  12. 12. Objectives <ul><li>To Foster Reporting Culture </li></ul><ul><li>To Involve large number of health care professionals in the system of information </li></ul><ul><li>To be benchmark for global drug monitoring </li></ul>
  13. 13. <ul><li>2007-08 Stopped due to funding problem </li></ul>
  14. 14. Problem Faced During NPP ? <ul><li>Appointing Staff </li></ul><ul><li>Attrition of Staff </li></ul><ul><li>No Job Securities for PVG Officer </li></ul><ul><li>Assessment of form as per Standard Requirement </li></ul><ul><li>Staff Training from CDSCO </li></ul>
  15. 15. Problem Faced During NPP ? <ul><li>Reporting to Vigiflow </li></ul><ul><li>Quality of the report </li></ul><ul><li>No Signal Detection </li></ul><ul><li>Vaccine vigilance ??? </li></ul><ul><li>Traditional Medicines </li></ul><ul><li>No Reporting from Industry </li></ul>
  16. 16. Now: 2011: Current Practice <ul><li>Started 6 months before </li></ul>
  17. 17. Adapted from, cdsco.nic.in
  18. 18. 5 YEAR ROADMAP OF PHARMACOVIGILANCE PROGRAMME OF INDIA (Year 2010—2015 ) Adapted from, cdsco.nic.in
  19. 19. Five Phases of Pharmacovigilance
  20. 20. Collaboration with World Health Organization-Uppsala Monitoring Centre (UMC) <ul><li>To establish a ‘ Centre of Excellence ’ for Pharmacovigilance in India </li></ul><ul><li>Training of the staff at the PvPI national coordinating centre </li></ul><ul><li>Usage of UMC’s Vigiflow software (for medicines) and Paniflow (for vaccines) at no cost to PvPI. </li></ul><ul><li>Access to Vigibase, which contains worldwide medicines safety data </li></ul>
  21. 21. Programme Systems and Procedures <ul><li>In the FY 2010-11, 40 ADR monitoring centers will be enrolled </li></ul><ul><li>An additional 60 centers will be enrolled in the FY 2011-12 </li></ul><ul><li>An incremental addition of 100 each respectively for FY 2012-13 and 2013-14 will be done, resulting in 300 enrolled centers </li></ul><ul><li>Centers provided technical, administrative, & financial support by the respective Zonal /Sub Zonal Offices </li></ul>
  22. 23. Improving Methods <ul><li>Based on Reliability </li></ul><ul><li>Easy for Collection of data </li></ul><ul><li>Collect Quality Data </li></ul><ul><li>Generate Signals </li></ul><ul><li>Informative </li></ul>
  23. 24. Practical Approach: Improving Methods <ul><li>Intensive Event Monitoring </li></ul><ul><li>Consumer Reporting </li></ul><ul><li>Use of Triggers </li></ul><ul><li>ADRs Monitoring With Abnormal Laboratory Values </li></ul>
  24. 25. Intensive Drug Event Monitoring <ul><li>Method of Active Pharmacovigilance </li></ul>
  25. 26. Practical Difficulties <ul><li>Fear of personal and organizational liability </li></ul><ul><li>Labor-intensive </li></ul><ul><li>Complex, and time-consuming reporting processes </li></ul><ul><li>Minimal feedback provided to reporters </li></ul><ul><li>No incentives, rewards, or motivation to report </li></ul><ul><li>High rate of underreporting </li></ul>
  26. 27. Where is Problem? Barriers Barriers Agree Disagree Non-Awareness of the Pharmacovigilance System (Intensive Event Monitoring) 29 (80. 55 %) 8 (22.2 %) Lack of time to fill in a report 22 (61.11 %) 14 (38.88 %) Lack of time to communicate / discuss with the pharmacovigilance officer or pharmacologist about the ADR 26 (72.22 %) 10 (27.77 %) A single report may affect the ADR database 15 (41.66 %) 21 (58.33 %) Lack of time to actively look for an ADR while at work 17 (47.22 %) 19 (52.77 %) Don’t feel the need to report 12 (33.33 %) 24 (66.66 %) Not able to perform causality analysis 30 (83.33 %) 6 (16.66 %) Position /level in the practice is the barrier in the ADR reporting 22 (61.11 %) 14 (38.88 %) Fear that if ADR reported that generate the extra work 16 (44.44 %) 20 (55.55 %)
  27. 28. Working Model <ul><li>Part A: Routinely used method for the intensive event monitoring </li></ul><ul><li>Assessed according the Individual Case Safety Report (ICSR), WHO </li></ul><ul><li>Note Down Barriers </li></ul><ul><li>Part B: ruled out the causes of underreporting as observed in part A </li></ul><ul><li>Fear of personal and organizational liability : The trained medical professional communicated with not only physician but also with the nurses, registrar, and resident medical officer of the respected unit and explained the importance of the adverse event reporting. </li></ul>
  28. 29. <ul><li>Labor-intensive, complex, and time-consuming reporting processes: The process made simple by helping out to participants (physicians, nurses, registrars, and resident medical officer) as the making simple way for filing the ADR form. Assistance provided to participants at the initial stage until they become independent. So that the participants have the easier process rather than the complex and time consuming. </li></ul>
  29. 30. <ul><li>Feedback provided to reporters: The constant feedback was provided at the every week regarding the number of AE reported by the concerned department. Information about the seriousness, causality, severity, expectedness of the ADR provided to the participants. </li></ul><ul><li>No incentives, rewards, or motivation to report: Importance of the voluntary reporting and the importance of the AE reporting to the India was explained to the participants. </li></ul>
  30. 31. Our Research Improvement
  31. 32. ADR Report Before Educational Intervention After Educational Intervention ‘ P’ Value (n) (31) % 100% (n) (500) % 100% A. Patient Information 1. Patient Identifier Initiales 5 16 303 60 0.0040* 2. Age at time of event: 12 38 409 81.8 0.0283* 3. Date of Birth: 3 9.67 250 50 0.0022* 4. Sex 5 16 368 73.6 0.0004* 5. Weight_____ Kgs 1 3.2 167 33.3 0.0024* B. Suspected Adverse Reaction 1. Date of reaction started (dd/mm/yy) 13 41.93 289 57.8 0.4211 2. Date of recovery (dd/mm/yy): 1 3.2 109 21.8 0.026* 3. Describe reaction or Problem 9 29 379 75.8 0.0131* <ul><li>4. Name of Reaction </li></ul>21 67.74 445 89 0.3928 C. Suspected medication(s) 1. Name (brand and / or generic name) 24 77.41 419 83.8 0.8893 <ul><ul><li>Dose used </li></ul></ul>5 16 210 42 0.057 <ul><ul><li>Route used </li></ul></ul>8 25.80 311 62.2 0.027* <ul><ul><li>Frequency </li></ul></ul>9 29.00 326 65.2 0.0351* <ul><ul><li>Date started </li></ul></ul>7 22.58 315 63 0.0154* <ul><ul><li>Date stopped </li></ul></ul>2 6.45 217 43.4 0.014* <ul><ul><li>Reason for Use </li></ul></ul>3 9.67 312 62.4 0.0002* <ul><ul><li>Treatment of ADR Completed </li></ul></ul>3 9.67 168 33.6 0.0381* <ul><ul><li>Causality </li></ul></ul>Nil Nil 187 37.4 <0.0001*
  32. 33. Voluntary Reporting….
  33. 34. Consumer Reporting: An Emerging Method <ul><li>The patient involvement in such programs is seen only in some countries. </li></ul><ul><li>Adverse Event Reporting System (AERS) contains roughly 2.5 million health-care professional or lay-person-derived adverse event reports (Trontell., 2004). </li></ul>
  34. 35. <ul><li>Patients will be given the right to report suspected ADRs, without the intervention of a health professional, to the Medicines and Healthcare products Regulatory Agency (MHRA) (Boseley S. 2004). </li></ul><ul><li>The user friendly yellow form has been filed by the consumers (IOM, 2005). </li></ul>
  35. 36. <ul><li>Patients report adverse drug reactions (ADRs) more promptly than health care professionals and one of the challenges is to enable patients to report in a way that is effective for them (Sarah Davis, 2007). </li></ul>
  36. 37. Our Research Patients Reporting Of AE Thirteen (13) out of the 300 (4.33 %) patients were communicated their adverse event to their physician The patient reported it to the physician 13/300 4.33 %
  37. 38. Patients Awareness About Reason Of Their ADR Six out of 300 (2%) patients were aware about the reason of the ADR Patients who know the probable reason 6/300 2 % This patient thought that his ADR was due to wrong dose administration of given medications
  38. 39. Use of Triggers <ul><li>The concept of a “trigger” (or clue) to identify adverse events in the medical record was introduced by Jick in 1974 (Resar RK, et al., 2003). </li></ul><ul><li>Studies using the trigger method have borne this out, (Rozich JD et al., 2003; Resar RK et al., 2003; Resar RK et al., 2006; Sharek PJ et al., 2003) identifying AE rates as much as 50 times higher than hospital-based occurrence reporting strategies (Resar RK et al., 2006). </li></ul>
  39. 40. Adverse drug events (ADEs) identified in the pediatric ward using the trigger tool from 1500 charts: Triggers Number of Positive Triggers No. of ADEs DPT *and Generalized tonic convulsion 49 21 AKT* and hepatoxicity 32 12 Seizures and Antiepileptic 31 16 Antibiotic and Rash 21 10 Diarrhea and Antibiotics 21 13 Gastritis and Antimalerial 29 09 Bleeding and Anticoagulant 21 03 Fat Deposition and Steroids 14 04 Total 218 88 (40.36%)
  40. 41. ADRs Monitoring With Abnormal Laboratory Values <ul><li>Linking laboratory and medication data might be useful for evaluating compliance to laboratory monitoring which is recommended for many drugs for early detection of adverse drug reactions (Classen DC et al., 1991, Dormann H et al., 2000). </li></ul>
  41. 42. Consumers, Health Care Professionals Peripheral Centers, Regional Centers, Zonal Centers, National Centers Pharma. Industry Regulatory Authority Proposed Structure: Inverted Pyramid
  42. 43. <ul><li>Your </li></ul><ul><li>5 Minutes </li></ul><ul><li>Can Help Us To </li></ul><ul><li>Ensure </li></ul><ul><li>Safer </li></ul><ul><li>Medications </li></ul>CDSCO
  43. 45. Thank You

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