Meeting Summary Report - Expert Advisory Committee on the Vigilance of Health Products (EAC-VHP) - October 19-20, 2011

Health Products and Food Branch (HPFB)

Location: Toronto, Ontario
Theme: Regional Collaboration and Opportunities in Pharmacovigilance

For more information contact the Committee Secretariat

Table of Contents

• Attendees
• Day 1
  • Opening Remarks and Welcome
  • Declaration of Affiliations and Interests
  • Pharmacovigilance Across Canada
  • Update From Last Meeting/Summary Basis of Decision
  • Overview of Health Canada's Ontario Region
  • Regulatory Modernization Overview
  • Advancing the Health Products and Food Branch's Strategic Plan (2012-2015)
  • Marketed Health Products Directorate Proposed Priorities (2012-2015)
  • Marketed Health Products Directorate Pilot Project
  • Regional Collaboration in Pharmacovigilance
  • Closing Remarks
• Day 2
  • Opening Remarks and Welcome
  • Committee Management
  • Opportunities in Pharmacovigilance Research
  • Pharmacovigilance
    • Pharmacovigilance: A Researcher's Perspective on Post-Market Surveillance
    • Comparing International Strategies for Active Pharmacovigilance: Lessons for Canada
  • Causality and Adverse Drug Reactions
  • e-Health and Adverse Reactions Reporting
  • Use of Administrative Health Care Database to Conduct Analyses
  • Next Steps, Closing Remarks and Adjournment of Meeting

Attendees

Members

Present: Robert Hamilton (Acting Chair - October 19), Colleen J. Metge (Acting Chair - October 20), Yola Moride (by teleconference), Bruce Ritchie (by teleconference), Patrick Cupido, Albert Eros, Linda Wilhelm, Durhane Wong-Reiger, Sarah Frise, Rishma Walji, Maureen Moores, Jane Smith, Janet Currie, K.P. Aujlay, Bruce Carleton, and Klaus-Gerhard Stitz

Regrets: Sylvia Hyland (Chair)

Health Council of Canada: John Abbott

Ontario Poison Centre at the Hospital for Sick Children (SickKids): Anne Gallo and Karen Fontana Chow

Ministry of Community Safety and Correctional Services (Ontario): Bert Lauwers

University of Toronto: David Juurlink, Jack Uetrecht, and Muhammad Mamdani

York University: Joel Lexchin and Mary Wiktorowicz

Government Officials: Paul Glover (by teleconference), Cindy Evans, Marc Berthiaume, Nashwa Irfan, Mary Raphael, Krista Apse, Jenifer Collette, Scott Jordan, Jacinthe Guindon, David K. Lee (by teleconference), Sandra Bruce, Ken Moore, Aaron Leung, Carol Della Penta (by teleconference), Julia Thorpe (by teleconference) and Brandon Northwood (by teleconference).

Secretariat: Dara Hakimzadeh, Véronique Martin (by teleconference) and Melinda Piecki (by teleconference).

Day 1

Opening Remarks and Welcome

The Associate Director General, Marketed Health Products Directorate (MHPD), Cindy Evans, called the meeting to order and the Health Products and Food Branch's Assistant Deputy Minister, Paul Glover and the committee's Acting Chair, Robert Hamilton, gave opening remarks.

Declaration of Affiliations and Interests

Members verbally declared if any of the items on the agenda were a conflict of interest based on their affiliations and interests. Based on the declarations, no conflicts of interest were present.

Pharmacovigilance across Canada

Presenter: John Abbott, Health Council of Canada
The purpose of this presentation was to provide a high-level overview of the key challenges in pharmacovigilance across Canada and provide a summary of what other nations are doing in comparison to Canada, based on the Council's report " Keeping an Eye on Prescription Drugs: Keeping Canadians Safe".

Update from Last Meeting/Summary Basis of Decision

Presenter: Cindy Evans, Marketed Health Products Directorate
Members were notified that Canada Vigilance Program acknowledgement letters sent to individuals reporting adverse reactions are being modified to include a link to Canada Vigilance Adverse Reaction Online Database. Updates expect to be completed by January.

An update of the "Mind the Gap" Research project aimed at reviewing the state of clinical pharmacology in Canada, and how it applies to the ethical development of safe and effective pharmaceuticals and biologics, labelling of therapies for infants, children and youth was shared with members.

Health Canada reminded members of the 60-day online consultation regarding changes to the Phase II of the Summary Basis of Decision (SBD) project. The project's intentions are to provide information about regulatory decisions for some pharmaceuticals, biological drugs and medical devices. Members were invited to participate and notifying colleagues (health professionals) to participate in the consultation which will finish in mid-December. Face to face meetings with stakeholders will be taking place in November. Since 2005, over 140 SBD documents have been posted on Health Canada Web site.

Overview of Health Canada's Ontario Region

Presenters: Sandra Bruce and Ken Moore, Regions and Programs Branch

The purpose of this presentation was to give members an overview of the region's role related to compliance and enforcement as well as pharmacovigilance activities in Ontario and Nunavut.

Some of the key activities of the Canada Vigilance Program in Ontario include:

• Provides a point-of-contact for the national Canada Vigilance post-market surveillance program for adverse reaction reporting in the region;
• Collects reports by health professionals and consumers in Ontario and Nunavut;
• Reviews reports for completeness and forwards them to national office for further analysis;
• Provides guidance to health professionals and consumers on adverse reaction reporting in order to maximize quality of reports;
• Improves awareness of the Canada Vigilance Program through presentations and exhibits at meetings, conferences, and other forums.

Highlights of discussion following the presentation

• Members had questions for the regional office on four key topics: adverse drug reaction trends, outreach opportunities, provincial mandatory reporting (Drug Substitution Policy for Brand-Name Products), and the implications of increased prescribing rights among traditional and newer types of health professionals.

Regulatory Modernization Overview

Presenter: David K. Lee, Policy Planning and International Affairs Directorate

Health Canada is continuing to develop a series of proposals to modernize drug safety regulations in Canada and held regulatory technical discussions with a vast range of stakeholders such as patient/consumer groups, industry, health professionals and academics.

Highlights of discussion following the presentation

• Members questioned whether regulation changes would achieve the same sort of results that could be gained by legislation.
• Transparency was identified as a key component of regulatory modernization.
• Discussion surrounding appropriate fee levels and gaps compared to other international regulators.

Advancing the Health Products and Food Branch's Strategic Plan (2012-2015)

Presenter: Krista Apse, Policy, Planning and International Affairs Directorate

A draft strategic framework for the Branch over the next three years, including activities and key outputs for modernizing the regulatory framework, meeting operational excellence and investing in staff and technology was shared with the Committee.

Marketed Health Products Directorate Proposed Priorities (2012-2015)

Presenter: Cindy Evans, Marketed Health Products Directorate

The main goal of this presentation was to provide information on the Directorate's priorities which are linked to the Health Products and Food Branch's Strategic Plan.

Highlights of discussion following the presentation

• Members reiterated the importance of a life-cycle approach for continuous surveillance and transparency (publicly accessible information about clinical trials).
• Concerns about the potential impact of shorter drug approval timelines on post-market surveillance.
• The benefits and drawbacks of technology should be considered equally in the process.

Marketed Health Products Directorate Pilot Project

Presentation #1

Presenter: Scott Jordan, Marketed Health Products Directorate

An overview of a collaborative project between the Marketed Health Products Directorate and the Ontario Poison Centre in Ontario was described to members. The purpose of the project is to determine the usefulness, for pharmacovigilance purposes, of data collected by Canadian poison control centres. The status of the three year project, the anticipated evaluation process and potential benefits to Health Canada were highlighted.

This outline was complemented by the following presentation by Ontario's Poison Centre.

Presentation #2

Presenters: Anne Gallo and Karen Fontana Chow, Ontario Poison Centre

The presentation included an overview of the role of the poison centre and a brief description of the type of information the centre collects. An early status report of the first and second year of the project was shared with members as well as the overall potential benefits of this work.

Highlights of discussion following both presentations

• Members were interested to know that currently there are five recognised poison centres in the country. These centres collaborate with each other to share expertise and data.
• Privacy issues were raised as a concern among members. The project leads outlined that the centres are not sharing any demographic or personal information and that once the project enters the third year it will have to go through a research ethics board at the hospital to ensure that privacy is maintained.
• Other suggestions from members included seeing if poison centres could collaborate with  Telehealth Ontario because they may be collecting similar data.

Regional Collaboration in Pharmacovigilance

Presenter: Bert Lauwers, Deputy Chief Coroner - Investigations

Information on the process for death investigations and inquests was shared with the committee. Dr. Lauwers also discussed suicide rates in Ontario and talked about the recommendations stemming from the Carlin Inquest.

Highlights of discussion following the presentation

• Members were particularly interested in the Coroner's data related to opioid use in Ontario and his observations related to the Carlin Inquest.
• Discussion following presentation mainly focused on data sharing and noted a need for more collaboration between signal detection and data collections.

Closing Remarks

The Chair thanked the speakers and adjourned the meeting for the day.

Day 2

Opening Remarks and Welcome

The Acting Chair, Colleen Metge gave opening remarks and introduced presenters and observers.

Committee Management

Presenters: Cindy Evans, Marketed Health Product Directorate; and via teleconference: Carol Della Penta and Julie Thorpe, Public Affairs, Consultation and Communications Branch (PACCB)

The Committee was informed by PACCB of Health Canada's new policy for External Advisory Bodies and its effect on the committee's Terms of Reference. Members were also reminded of the membership renewal process and opportunities to be peer reviewers to assist the Canadian Adverse Reaction Newsletter's editorial team.

Opportunities in Pharmacovigilance Research

Presenter: David Juurlink, University of Toronto

Dr. Juurlink shared his insights into data holdings and the use of observational studies (administrative data) in researching adverse drug reactions with specific case study data related to opioids, antibiotics, antidiabetics and bisphosphonates.

Highlights of discussion following the presentation

• Currently, the Institute for Clinical Evaluation Sciences uses data from: hospitals, emergency departments, prescriptions (individuals older than 65 or on social assistance), disease-specific registries and coroner's data.
• A member noted that in the European Union (EU) there is a capacity for non-industry observational studies on drug safety. The presenter noted that observational studies are relatively cheap, but a registry linking these studies would be expensive and it would be a question of who would pay to set up such a system.

Pharmacovigilance

Presentation #1 - Pharmacovigilance: A Researcher's Perspective on Post-Market Surveillance

Presenter: Joel Lexchin, York University

Dr. Lexchin presented information on why a post-market surveillance system is important, examined views of the current system from provincial drug plan officials and suggested the system can be improved with better access to data, better reporting, increased resources, a focus on effectiveness, and improved transparency and communication. His presentation was based on recommendations found in the Health Council of Canada's report " Keeping an Eye on Prescription Drugs: Keeping Canadians Safe", which he wrote with a team of researchers, including Dr. Wiktorowicz.

Presentation #1 - Comparing International Strategies for Active Pharmacovigilance: Lessons for Canada

Presenter: Mary Wiktorowicz, York University.

Dr. Wiktorowicz informed the committee of different international systems for active pharmacovigilance research. She looked at systems in New Zealand (regulator-embedded model), United Kingdom (regulator-supported model) and the United States (regulator-directed model).

Highlights of discussion following these presentations

• It was suggested by the presenters that provincial health care plans' electronic health care and pharmacy reports are a resource for observational studies and that provincial health care systems, Health Canada and research epidemiologists could cooperate to share active surveillance epidemiologic data through mechanisms such as the  Drug Safety and Effectiveness Network.
• Top suggestions related to improving transparency included: access to clinical trial information (de-identified data provided by industry), access to Health Canada's decision making (such as, improved stakeholder understanding of how Health Canada uses the information it collects), and a better understanding of the effectiveness of Health Canada's risk communications.

Causality and Adverse Drug Reactions

Presenter: Jack Uetrecht, University of Toronto

The objective of the presentation was to share the nuances of determining causality with idiosyncratic (unique) drug reactions (IDRs). Dr. Uetrecht presented case studies to highlight the difficulty in estimating causality in patients.

Highlights of discussion following the presentation

• Presenter highlighted the fact that most serious IDRs go unreported (less than 10%) and of the ones that are reported there tends to be insufficient data to determine causality or severity. He noted that pharmaceutical companies do not have the authority to obtain follow up clinical information from consumers and that due to the amount of signals increasing the quality of data for IDRs is a challenge.
• Encouraged Health Canada to examine opportunities to fund training for health professionals in signal detection.

E-Health and Adverse Reaction Reporting

Presenter: Mary Raphael, Marketed Health Products Safety and Effectiveness Information Bureau

The objective of this presentation was to provide members with an update on Health Canada's activities related to leveraging Electronic Medical Records (EMRs) and Electronic Health Records (EHRs) for adverse reaction reporting. Topic discussed during the presentation included the benefits of integrating adverse reaction reports into EMRs and EHRs, key players at the federal (such as, Federal Health Care Partnership), provincial/territorial and non-governmental level (Canada Health Infoway) and the Directorate's introductory next steps to engaging with those involved.

Highlights of discussion following the presentation

• Discussion of EMRs highlighted the fact that adverse reaction surveillance electronically should not be an additional burden to physicians and will require integration into the systems being developed provincially.
• Privacy issues related to health data were mentioned.

Use of Administrative Health Care Databases to Conduct Analyses

Presenter: Muhammad Mamdani, University of Toronto

Dr. Mamdani started his presentation by outlining the conflicting perspectives that researchers and policy-makers have in terms of end goals, research questions, timelines, focus of validity and metrics. He also outlined the challenges of using administrative data for answering clinical questions, approaches to maximizing validity and the challenges with numeric literacy within the research community. In terms of opportunities for using administrative data, he noted that rapid research is an area that should be considered (such as, he works with the Ontario Drug Policy Research Network and the fastest turn-around time for a study they completed was four hours).

Highlights of discussion following the presentation

• Committee noted that Ontario has legislated access to give the data to researchers, while this is not the case in other provinces.
• There was overall support around having focused, quick turn-around research for surveillance, but the understanding that not all research questions can be answered.

Next Steps, Closing Remarks and Adjournment of Meeting

The next meeting is tentatively scheduled for the fall, 2012. It will be held in Ottawa, Ontario. The theme of the meeting has yet to be confirmed.

Meeting adjourned.