Drug Safety and Effectiveness Network (DSEN) Newsletter - Summer 2012

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Summer 2012
Volume 3, Number 1

In This Issue:

Message from the DSEN Executive Director:

Dr. Robert Peterson

This spring has been very productive for the Drug Safety and Effectiveness Network and its researchers. With the development and adoption of a MCDA Query Prioritization process and, especially with the launch of the first wave of funding through the "Rapid Funding" mechanism, DSEN is now functional and actively reacting in a timely manner to our stakeholders' needs.

As you will note from the new "Publications" section of this Newsletter, DSEN researchers have been productive too, demonstrating that targeted research linking decision makers and researchers does not preclude academic performance.

At the CADTH Symposium 2012, DSEN organized a panel on the topic of "Coverage with Evidence Development in Canada" with very good attendance and participation. In the next few months, the DSEN Coordinating Office will be giving some thoughts to the "evidence development" phase of "Coverage with Evidence Development". We invite comments on this topic including recommendations on demonstration projects.

Lastly, 2012 will see further funding opportunities develop through DSEN, both Rapid Funding within the Network, as well as Catalyst Grants and Priority Announcements in partnership with CIHR Institutes.

Robert Peterson MD, PhD, MPH
Executive Director,
Drug Safety and Effectiveness Network

Events

Drug Safety and Effectiveness Network meeting (March 23rd, 2012)

In establishing the collaborative nature of the DSEN structure, the DSEN Coordinating Office has plans to hold regular meetings of the DSEN research community twice annually. This will facilitate knowledge translation and sharing of best practices amongst Collaborating Centres. It also provides an opportunity to invite other teams funded by DSEN and relevant stakeholders to expand on the network structure of the program. These recurring network meetings are essential to the function of the teams and the network as a whole. The DSEN Coordinating Office will make any effort to facilitate interactions between researchers and relevant stakeholders to facilitate good communication and clarify expectations.

DSEN held the second event of the series on March 23, 2012 in Ottawa to bring decision makers, DSEN funded researchers, and trainees together to gain common understanding and to enhance Network functioning. The main objectives of this meeting were:

  • To provide network-wide interaction between DSEN funded researchers and decision makers
  • To present and integrate expectations with results
  • To present and discuss the Query submission process
  • To help gain greater understanding of Network research capacity and how this can address DSEN Queries using available methodologies
  • To support trainees and provide them with exposure to the DSEN community
  • To update participants on recent developments and upcoming plans and activities including DSEN accountability under performance measurement criteria
  • To support a culture of reporting within the DSEN program

This second Network meeting was attended by 51 participants. After the welcome and introductions, Robert Peterson, DSEN Executive Director gave a brief overview of DSEN and its organizational structure. He also explained the objectives of the day. The morning session was dedicated to progress report presentations by research teams funded under the DSEN envelope. In the afternoon, a panel composed of DSEN researchers, and provincial and federal decision makers discussed their mutual expectations. Following the panel discussion and question session, three of the DSEN staff gave updates on important CIHR and DSEN program business (i.e., performance measurement, research results reporting, and new DSEN funding opportunities).

A third edition of this event is planned for the Fall, on October 19, 2012.

Drug Safety and Effectiveness Research National Curriculum (DSER NC)

As part of its mandate for capacity development DSEN has assumed a supporting role in the career development of a new generation of drug safety and effectiveness researchers by facilitating discussion aiming to develop a National Curriculum for training in the area. With funding by Health Canada, Dr. Lisa Dolovich has initiated work to develop a National Curriculum for Training in Drug Safety and Effectiveness Research. To date, much has been accomplished.

  • A National Curriculum Advisory Committee (NCAC) has been established and the first meeting was held March 30th, 2012. The NCAC is comprised of 12 researchers, professional associations, decision makers, academics, and others
  • A Working Group comprised of DSEN researchers has been established and a first meeting is being scheduled
  • A Survey to identify and prioritize the knowledge and skills necessary to produce a competent drug safety and effectiveness researcher has been drafted. The survey will be reviewed by the working group.
  • Meetings were held with experts in health care professionals curriculum development processes.

Following further work with stakeholders and interested parties, the Drug Safety and Effectiveness Research National Curriculum survey is expected to launch before April 2013.

Canadian Agency for Drugs and Technologies in Health (CADTH) 2012 Symposium — Evidence Matters: Outcomes, Efficiency, Impact

The CADTH 2012 Symposium was held in Ottawa on April 15th to 17th. CIHR/DSEN supported the Symposium which examined how health care decision-makers in Canada operate in an increasingly complex environment that has steadily intensified the challenge of adding value to the system while managing overall health care costs; and, how to fill the need for credible, independent, evidence based information.

In addition to the DSEN Coordinating Office booth, DSEN was represented on the following panels:

  1. Who Does What? Understanding Drug Safety Evidence at the Global and National Level. The panellists were Dr. Ebele Ola from Janssen, Dr. Amrit Ray from Janssen Research and Development, Kimby Barton from Health Canada, Diane Forbes from DSEN, and Dr. Sarah Frise from AstraZeneca.
  2. Coverage with Evidence Development in Canada with panellists Robert Peterson from DSEN, David K. Lee from Health Canada, Dr. Devidas Menon, from the University of Calgary, Lucie Robitaille from INESSS, and Nancy McColl, formerly from CEDAC.
  3. The Challenge of Integrating Patient Evidence and Values in HTA. Panellists: Elaine MacPhail from CADTH, Karen Facey from HTAi, Robert Peterson from CIHR, and Larry Broadfield from Cancer Care Nova Scotia.

Canadian Association for Population Therapeutics (CAPT) Annual Conference 2012: Effectiveness and Safety of Therapeutics: Dealing with Transparency, Minimizing Bias, and Improving Knowledge Translation to Concerned Stakeholders

In order to support its objective to facilitate knowledge translation of new evidence on post market drug safety and effectiveness to relevant stakeholders, DSEN was present at the 2012 Canadian Association for Population Therapeutics (CAPT) annual conference in Montreal (May 6-8).

Three DSEN related sessions were held:

  • CIHR/DSEN/CNODES co-hosted a symposium chaired by Mitchell Levine, highlighting CNODES and its projects with presentations from: Samy Suissa, Colin Dormuth, Michael Paterson, Laura Targownik, Kristian Filion, Lorraine Lipscombe, and Robert Platt.
  • CIHR/DSEN also hosted a separate academic session of oral presentations, chaired by Lucie Blais, for students and investigators conducting research in the area of drug safety and effectiveness.
  • DSEN was also represented by Diane Forbes on a panel titled: « Canada's Drug Effectiveness and Safety Network—How are Other Jurisdictions Managing Real World Safety and Effectiveness and Are There Lessons for Canada? » Other than DSEN, the panel provided perspectives on the government, pharmaceutical, and American experiences respectively.

All the sessions were well attended and stimulated interesting discussions.

DSEN Funding News

DSEN affiliated researchers receive funding for two queries through the new DSEN Rapid Funding tool.

DSEN funded two projects through the new Rapid Funding for DSEN Targeted Research program.

David Moher from the Ottawa Hospital Research Institute was allocated $99,460 for up to ten months for the query: Association between antidepressant therapies and their impact on bone mineral density change, risk of bone fractures and falls: a systematic review.

George Wells, from the Ottawa Heart Institute Research Corporation, received $96,329 for up to 7 months for the project: A Network Meta-Analysis of the Cardio-Cerebrovascular Risk Associated with the Anti-Parkinsonian Combination of levodopa/carbidopa/entacapone

DSEN funds six New Investigators through priority announcements for: Drug Safety and Effectiveness, and for Drug Safety and Effectiveness - Comparative Effectiveness

Six researchers received New Investigator awards for their projects submitted to two different streams of priority announcements. The awards, valued at up to $60,000 per annum for up to five years, have been granted to:

  • Lisa A. Hartling: Optimizing evidence synthesis for informed decision-making
  • Kristian B. Filion: The cardiovascular safety of Verenicline: A population-based cohort study
  • Andrea D. Furlan: My opioid manager: A point of care tool for patients with chronic non-cancer pain considering opioids
  • Corinne M. Hohl: Validation of a screening strategy for adverse drug reactions in the emergency department
  • Colin J. Ross: Drug Safety Pharmacogenetics Evaluation (Drug SAPHE) Initiative
  • Andrea C. Tricco: Knowledge synthesis methods across multi-disciplinary fields

Congratulations to the new DSEN awardees!

Current DSEN Funding Opportunities

More information about those funding opportunities can be found on the CIHR's website

Catalyst Grant: Post Market Drug Safety and Effectiveness (2012)
Application Deadline: October 17, 2012
Separate funding pools have been created for three relevant research areas. The following research areas are relevant within this funding opportunity.

  1. Haemolytic anaemia and immune globulin
  2. Disease-modifying anti-rheumatic drugs (DMARD) in patients with ankylosing spondylitis
  3. Community-based pharmacy drug intervention programs for smoking cessation

DSEN Priority Announcements:
DSEN Priority Announcements offer additional sources of funding for applications that are relevant to specific DSEN research priority areas. Applications are submitted through the open funding opportunity.

Knowledge Synthesis Grant : Fall 2012 Priority Announcement (PA) :
Application Deadline: 2012-10-01
Drug Safety and Effectiveness Network
DSEN will provide funding for applications that advance knowledge translation in support of decision making and that are determined to be relevant to evidence informed decision making on the real world safety and effectiveness of prescription drugs and one of the following research priority areas described below:

  1. Scoping reviews:
    • leading to the development of integrated KT frameworks, models and/or tools to assist knowledge creators and users to address gaps in evidence on the real world use of prescription drugs by Canadians
    • identifying barriers to KT to knowledge users and decision makers in the Canadian health care system
    • examining how decision makers in the health care system use prescription drug research
    • describing strategies to increase decision makers' use of research
  2. Syntheses:
    • Leading to the development of frameworks, tools, guidelines and/or models that advance existing KT approaches which support decision making

New Investigator Salary Award: Fall 2012 Priority Announcement:
Application Deadline: 2012-09-17
Drug Safety and Effectiveness

Fellowship: Fall 2012 Priority Announcement:
Application Deadline: 2012-10-01
Drug Safety and Effectiveness

Doctoral Research Award: Fall 2012 Priority Announcement:
Application Deadline: 2012-10-15
Drug Safety and Effectiveness

Governance

Announcements

The DSEN Coordinating Office would like to thank Dr. Ian Graham and Mr. Bob Nakagawa for their contributions to the DSEN Steering Committee (DSEN SC).

Dr. Ian Graham has stepped down as DSEN SC Chair. Following five years as Vice-President of the CIHR Knowledge Translation and Public Outreach Portfolio he has returned to his position at the University of Ottawa. Dr. Jane E. Aubin, Chief Scientific Officer and Vice-President Research and Knowledge Translation Portfolio will assume the Chair of the DSEN SC.

Bob Nakagawa, ADM of Pharmaceutical Services for the British Columbia Ministry of Health has accepted a position as Registrar of the College of Pharmacists of British Columbia. The DSEN Coordinating Office has begun the process of seeking a new nomination to the DSEN SC to represent the Provinces and Territories.

Prioritization of DSEN Queries

The DSEN CO has completed the procedures for an efficient, transparent and timely response to DSEN Queries. Before being promoted to the DSEN Research Agenda, each Query will undergo a two-step prioritization process consisting of an assessment of the scientific feasibility of the project, followed by the prioritization of the Query by the DSEN Steering Committee (DSEN SC), using a Multi-Criteria-Decision-Analysis approach (MCDA). This approach, which allows comparison of Queries based on multiple attributes will provide transparent and reproducible information to the DSEN SC on which to decide about the prioritization of DSEN Queries. Details of the MCDA process will be available shortly on DSEN’s website.

Drug Safety and Effectiveness Network Steering Committee

The DSEN Steering Committee (DSEN SC) met in Ottawa on January 20, 2012. The DSEN SC supported the application of the MCDA query prioritization tool for one year in its present form, in order to validate the results of the first application.

The next scheduled meeting of the Steering Committee will be held in Ottawa on November 23, 2012.

Publications by DSEN Funded Researchers

  • The Pharmacoepidemiology of Antipsychotics for Adults With Schizophrenia in Canada, 2005 to 2009
    Pringsheim T, Lam D, Tano DS, Patten SB.
    Can J Psychiatry. 2011 Oct;56(10):630-4.
  • Treatment Recommendations for Extrapyramidal Side Effects Associated With Second-Generation Antipsychotic Use in Children and Youth
    Pringsheim T, Doja A, Belanger S, Patten S, The Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in Children
    (CAMESA) guideline group
    Paediatr Child Health. 2011Nov; 16(9):590-8
  • The Pharmacoepidemiology of Antipsychotic Medications for Canadian Children and Adolescents: 2005-2009
    Pringsheim T, Lam D, Patten SB.
    J Child Adolesc Psychopharmacol. 2011 Dec;21(6):537-43. Epub 2011 Dec 2.
  • Influence of relative age on diagnosis and treatment of attention-deficit / hyperactivity disorder in children
    Morrow RL, Garland EJ, Wright JM, Maclure M, Taylor S, Dormuth CR.
    CMAJ. 2012 Apr 17;184(7):755-62. Epub 2012 Mar 5.
  • The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: nested case-control study
    Azoulay L, Yin H, Filion KB, Assayag J, Pollak MN, Suissa S.
    BMJ. 2012; 344; e6345
  • Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality
    Suissa S, Dell’aniello S, Ernst P.
    Thorax. 2012 Jun 8. [Epub ahead of print]
  • The use of atypical antipsychotics and the risk of breast cancer.
    Azoulay L, Yin H, Renoux C, Suissa S.
    Breast Cancer Res Treat. 2011 Sep;129(2):541-8. doi: 10.1007/s10549-011-1506-2. Epub 2011 Apr

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