AMR Bulletin - Fall 2003
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Table of Contents
News
Background
Current Status
AMR Guidance Document
Risk Assessment Policy Framework
Risk Profile on Specific Drug-Bug-Commodity
Combination
VICH Expert Working Group on Antimicrobial
Resistance
AMR Policy Development Process
Consultation with Stakeholders
New AMR information posted on VDD's Web
site
Out and About
Next Steps
News
Background
VDD has been coordinating or participants in several initiatives to address
the growing concerns regarding the use of antimicrobial agents in food-producing
animals and the development of antimicrobial resistance. The AMR Advisory
Committee recommendations have been the subject of consultations. In February,
2003, VDD held a consultation meeting with provincial/territorial authorities
to discuss multi-jurisdictional issues around AMR including the regulation
and distribution of antimicrobial drugs. In May, 2003, another round of
consultations was held with stakeholders on the development of a risk
management strategy on AMR with a focus on the recommendations of the
Advisory Committee. Several policy options were proposed and stakeholders
perspectives were presented at this consultation. VDD has received comments
from a broad cross-section of stakeholders on the impact of implementing
Health Canada's proposed options.
Current Status:
AMR Guidance Document
On the basis of the current status of scientific knowledge on AMR and
considering several international guidance documents, VDD has drafted
guidelines for assessing the microbiological safety of new veterinary
antimicrobial drugs. Comments on this document have been received from
drug sponsors. Consultation with stakeholders is being planned for this
Fall/Winter, 2003.
Risk Assessment Policy Framework
The interdepartmental AMR Policy Committee has recently finalized a draft
risk assessment policy framework document for the conduct of AMR risk
assessments. This document will soon be posted on our web site for consultation.
Risk Profile on Specific Drug-Bug-Commodity Combination
The interdepartmental AMR Science Committee has identified specific drug-bug-commodity
combination and is currently developing a risk profile to position the
risk issue in a public health context and to initiate the risk analysis
process.
VICH Expert Working Group on Antimicrobial Resistance
Dr. Lateef Adewoye represented the Government of Canada at the fourth
session of the VICH Expert Working Group on Antimicrobial Resistance in
London, England (September 25-26, 2003). The guidance document on "Pre-approval
information for registration of new veterinary medicinal products for
food-producing animals with respect to antimicrobial resistance"
(GL27) was signed off at Step 5 of the VICH process. The VICH Steering
Committee met in Washington at the beginning of October to discuss the
draft guidance document. It is expected that the guidance document will
be signed-off for implementation at Step 6 and will be posted on VDDs
Web site for consultation with stakeholders following approval by the
Steering Committee.
AMR Policy Development Process
High priority is placed on the issue of AMR and many stakeholders have
expressed concerns about policy gaps. A variety of initiatives have been
and are currently being implemented to facilitate the development of policy
on antimicrobial resistance.
Consultation with Stakeholders
VDD held a consultation meeting with stakeholders on May 21-23, 2003.
The theme of the consultation was the development of a risk management
strategy on AMR with a focus on issues around the recommendations of the
AMR Advisory Committee. Discussions were held on the ramifications of
the regulation and distribution of antimicrobial drugs, the management
of antimicrobial resistance risks, antimicrobial growth promotants, AMR
surveillance, prudent use of antimicrobial drugs, research and education.
Stakeholders have been largely supportive of Health Canada's efforts to
address the AMR issue and to develop strategy/policy on animal uses of
antimicrobial agents. While there are many areas of consensus, especially
with respect to the need for a national integrated surveillance system,
there are areas where stakeholders opinions are diverse, such as whether
or not to make antimicrobials available by prescription only. These comments
are currently being analyzed as part of the assessment of impact of policy
options.
New AMR information posted on VDD's Web site
Out and About
Dr. Lateef Adewoye presented an update on antimicrobial resistance on
July 8, 2003 at the Animal Nutrition Association of Canada (ANAC) 74th
Annual Meeting and Convention in Whistler, BC.
Next Steps
- Establishment of Expert Panel on AMR (Fall/Winter, 2003)
- Risk analysis of existing veterinary antimicrobial drugs (Ongoing
activities)
- Consultation with MAPAQ on the prescription status regulation of drugs
in Quebec (October, 2003)
- Consultation with stakeholders on Guidelines for assessing the microbiological
safety of Veterinary New Drug Submissions (Fall/Winter, 2003)
- Development of Health Canada's Final Response to the AMR Report (Winter
2003/2004)
- Policy framework on AMR (for consultation in Spring, 2004)
You may contact us at
E-mail: vetdrugs-medsvet@hc-sc.gc.ca
General Information Number: (613) 954-5687
Fax: (613) 957-3861
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