International Medication Safety Network. Links with Pharmacovigilance Centres Analysis of Data in Canada

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1 International Medication Safety Network Links with Pharmacovigilance Centres Analysis of Data in Canada 3 rd Annual Meeting The Joint Commission Headquarter Oakbrook, Illinois, USA November 11, 2008 Sylvia Hyland Institute for Safe Medication Practices Canada Institute for Safe Medication Practices Canada 2007

2 Presentation Outline Canadian Medication Incident Reporting and Prevention System (CMIRPS) Expert Advisory Committee on the Vigilance of Health Products Example collaborative analysis of pharmacovigilance data

3 Canadian Medication Incident Reporting and Prevention System Collaborative initiative among: Canadian Institute for Health Information Health Canada ISMP Canada ISMP Canada responsibilities include interdisciplinary analysis that considers practice concerns, clinical significance, systems issues, and potential preventive measures. Individual Practitioner Reporting Program ( Develop a national strategy for consumer reporting

4 Expert Advisory Committee Vigilance of Health Products Purpose: Provide Health Canada with informed advice on improving post-market surveillance activities related to health products. Membership includes researchers, academia, health professionals, consumers and industry. Co-chaired by ISMP Canada

5 Expert Advisory Committee Vigilance of Health Products Current priorities include: Post-market surveillance strategy and coordination Review of distribution and reach of risk communications to the public, media and health professionals including: Advisories Warnings Adverse Reaction Newsletter Develop partnerships for Risk Communications Develop measures of effectiveness

6 Example Collaborative Analysis of Pharmacovigilance Data Signal detection related to fentanyl patch medication incidents ISMP (US) bulletins ISMP Canada bulletins International Medication Safety Network (IMSN) meeting in Ireland Reports of adverse drug reactions to Health Canada Agreement among Health Canada and ISMP Canada to assess and analyze fentanyl patch pharmacovigilance data together

7 Example Collaborative Analysis of Pharmacovigilance Data Development of analysis plan based upon: CMIRPS core data set of information elements ISMP Canada Medication Incident Analysis and Learning Framework developed for CMIRPS Learning from ISMP Canada and ISMP (US) bulletins First-level analysis by team from Health

8 Example Collaborative Analysis of Pharmacovigilance Data Meetings with ISMP Canada to review data analysis findings and prepare Canadian Adverse Reaction Newsletter submission Expert review and editorial review Final review and acceptance by Health Canada and ISMP Canada for publication

9 Summary of Findings: Fentanyl patch and fatal adverse reactions reported Health Canada received 105 reports of adverse reactions suspected of being associated with fentanyl patch wherein a fatal outcome was reported Time period: Jan 1992 December 2007

10 Summary of Findings: Fentanyl patch and fatal adverse reactions reported 33/105 : cause of death unrelated to patch (e.g. patient was on patch and therefore the product was listed on the adverse reaction report) 20/105 : insufficient information for analysis 25/105 : intentional drug abuse 4/105 : intentional overdose or suicide 23/105 : preventable harm from medication use (medication incidents)

11 Summary of Findings: Factors Related to Preventable Harm (medication incidents) Dose initiation and titration errors Concomitant use with CNS depressants Known drug interaction Application errors Use errors