Post-Marketing Pharmacosurveillance in Canada

A background paper prepared for the Working Conference on Strengthening the Evaluation of Real World Drug Safety and Effectiveness, September 13-15, 2005

Bruce Carleton, BPharm Pharm D
Vicki Foerster, MD MSc CCFP
Leanne Warren, BA
M. Anne Smith, BSc, MSc
August 31, 2005

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Table of Contents

Report Summary

1.0 Introduction

2.0 Objectives

3.0 Initiatives

3.1 Drug Regulatory Authority Frameworks

3.1.1 Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
3.1.2 Notice of Compliance with Conditions (NOC/c)
3.1.3 Research at the Pharmaceutical Outcomes and Policy Innovations Programme

3.2 Health Plan and Drug Plan Frameworks

3.2.1 Administrative database studies: grant-funded or funded by drug plans
3.2.2 Alberta Biologics Registry (the RAPPORT project)
3.2.3 Modeling trends and regional variation in asthma care (POPi)
3.2.4 New Brunswick monitoring of antibiotic consumption
3.2.5 NIHB project on diabetes and cardiovascular drugs
3.2.6 Secondary reviews and policy research related to administrative databases

3.3 Drug Manufacturer Frameworks

3.3.1 Clozapine patient registries

3.4 Clinician / Clinical Group / Disease Collaborative Frameworks

3.4.1 BC Centre of Excellence for HIV/AIDS
3.4.2 BC Chronic Disease Management (CDM) projects
3.4.3 Canadian Cardiovascular Outcomes Research Team (CCORT)
3.4.4 Children's Oncology Group (COG)
3.4.5 The MOXXI Project
3.4.6 New drugs for multiple sclerosis
3.4.7 Patient survey on hypertensive management (a POPi initiative)
3.4.8 Pharmacy Medication Monitoring Program (PMMP)

4.0 Conclusions

Appendix I

A. Canadian Outcome Databases

A1. Management of databases
A2. Core data elements
A3. Strengths and limitations
A4. Access to outcome databases
A5. Application of outcome databases in post-market surveillance

B. Canadian Product Utilization Databases

B1. Management of databases
B2. Core data elements
B3. Strengths and limitations
B4. Application of IMS Health databases in post-market surveillance

C. Canadian Provincial Linked Databases

C1. Management of databases
C2. Core data elements
C3. Strengths and limitations of provincial health databases
C4. Access to provincial health databases
C5. Application of provincial health databases in post-market surveillance