Record of Decisions - October 5, 2009, National Association of Pharmacy Regulatory Authorities (NAPRA)

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Contact: Office of Business Transformation

Health Canada - Health Products and Food Branch (HPFB) Bilateral Meeting Program

Record of Decisions: NAPRA (National Association of Pharmacy Regulatory Authorities)

Location: 1600 Scott Street, Holland Cross, Tower B, 2^nd Floor, Boardroom 2048, Ottawa, Ontario

Date: Monday, October 5, 2009

Start Time: 1:30 p.m.

End Time: 2:45 p.m.

Participants

NAPRA

Carole Bouchard, Executive Director, NAPRA, Co-Chair

Susan Groves, Canadian Forces Pharmacy Service, Department of National Defence

Marshall Moleschi, Registrar, College of Pharmacists of British Columbia

Deanna Williams, Registrar, Ontario College of Pharmacists

Via Teleconference

Michel Caron, Ordre des pharmaciens du Québec

Gary Meek, Assistant Registrar, New Brunswick Pharmaceutical Society

Health Canada Participants

Supriya Sharma, Director General, Therapeutic Products Directorate (TPD), Co-Chair

Michael Vandergrift, Director General, Policy, Planning and International Affairs Directorate (PPIAD)

Kimby Barton, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), TPD

Barbara Benning, Director General's Office (DGO), TPD

Jacques Bouchard, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD

Elizabeth Dussault, Office of Controlled Substances (OCS), Healthy Environments and Consumer Safety Branch (HECS)

Joanne Garrah, PPIAD

Gail Gervais, Liaison Unit, Office of Business Transformation (OBT), TPD

Adam Gibson, DGO, TPD

Natasha Kuran, BGIVD, TPD

Denise Quesnel, Liaison Unit, OBT, TPD

Marilyn Schwartz, Submission and Information Policy Division (SIPD), TPD

Roy Thaller, HPFB-Inspectorate

Brigitte Zirger, Bureau of Policy, Science and International Programs (BPSIP), TPD

Observers

Kathryn Jarrett-Ekholm, BPSIP, TPD

Edward Gertler, Strategic Policy Branch (SPB)

Holly Hutchings, PPIAD

Alain Loranger, Office of Consumer and Public Involvement (OCAPI)

Susan Marthaler, BPSIP, TPD

1. Welcome and Introductions

Barbara Benning, Senior Executive Director, Therapeutic Products Directorate welcomed the attendees.

Carole Bouchard, Executive Director, National Association of Pharmacy Regulatory Authorities, thanked Health Canada for the opportunity to meet.

A roundtable of introductions followed.

2. Review of Agenda

Some items were moved up on the agenda in order to accommodate various schedules, and NAPRA requested an update on the Cough and Cold file which was added to the Roundtable part. The agenda was then approved.

3. Review of Previous Meeting Notes/April 24, 2009/Action Items

Action Item 4: Electronic Prescribing

NAPRA to compile a list of implementation-related questions for submission to HPFB and HECSB. The list is not available. NAPRA will be meeting with members at the end of October, and use this opportunity to discuss and compile a list of questions for Health Canada.

Health Canada representatives to assess Health Canada's role in the development of guidance on e-prescribing and think about the types of risks associated with its implementation.

Michael Vandergrift, Director General, Policy, Planning and International Affairs Directorate (PPIAD), addressed this issue. He mentioned that there are concerns related to electronic prescriptions, including the potential for fraud and the integrity of the prescription. Once received, Health Canada will review the list of regulatory/compliance-related questions and consider the best mechanism for addressing the issues raised - a guidance or Q and A document are a few options. Health Canada will seek involvement and expertise from NAPRA, if required.

Update: NAPRA may be able to provide the list of questions to Health Canada only in January 2010.

Action Item 5: E-Ordering of Controlled Substances

Mrs. Kula was to provide NAPRA with information on the intent of the definition of Pharmacists in the Regulations that sit under the Controlled Drugs and Substances Act.

Elizabeth Dussault, HECS, requested further clarification on what exactly NAPRA would like to know about the intent of the definition of Pharmacists in the Regulations. Carole Bouchard, NAPRA, explained that NAPRA wanted an understanding of why the definitions are different in the regulations and what was the intent of the difference. HECS will look into the intent of definitions, and Carol Bouchard, NAPRA, will communicate with Ms. Kula.

Elizabeth Dussault, also mentioned that The Office of Controlled Substances (OCS) is planning to review the 1999 Interim Guidelines on the Electronic Ordering of Controlled Substances. The OCS will be circulating a letter to stakeholders requesting input on the Interim Guidelines.

Actions: OCS, HECS will look at the intent of definitions.

NAPRA will communicate with Jocelyn Kula.

OCS, HECS will be circulating a letter to stakeholders requesting input on the Interim Guidelines.

4. Health Canada/Public/Stakeholders Services

NAPRA finds that it has become more difficult over the years to identify which group or person is responsible for any given matters, regionally and nationally. In addition, once the group or the person is found, it seems that there is a lack of resources to provide timely and accurate information on topics under the responsibility of Health Canada. This is particularly noted in the regions. NAPRA then provided concrete examples where better communications with Health Canada would have been beneficial for all parties involved.

Roy Thaller, Acting Manager, Drug GMP Inspection Unit, Health Products and Food Branch Inspectorate, HPFB, indicated that Health Canada acknowledges NAPRA's difficulty in knowing which Health Canada organization or group to contact for information and/or to resolve issues. In response, Health Canada is willing to deliver a presentation at a future NAPRA meeting that would review the current organizational structure for Health Canada, and set out the responsibilities for subjects of interest to NAPRA, both in the National Capital Region and in the Regions. The goal of this presentation would be to provide NAPRA with a better understanding of who to contact in seeking input into or resolution of a given issue.

In the interim however, the Health Products and Food Branch Inspectorate and the Office of Controlled Substances have prepared a table of organization units, which was distributed, to contact for information regarding the areas of interest identified by NAPRA.

For enquiries, Health Canada uses a general email, not a searchable Web site. Due to multi-facets of some issues, sometimes several Bureaux are involved. By using the general email, questions are directed to the right people.

Mr. Thaller mentioned that the regions should contact their operational centres, which will redirect calls accordingly. When cases are more complicated, people are asked to follow up with an email or fax, and provided as much detailed information as possible. As staff of the Office of Controlled Substances works mainly in Ottawa, people are to contact the Ottawa office. Enquiries regarding controlled substances and precursor chemicals should be directed to the Office of Controlled Substances in Ottawa.

5. Modernization of the Food and Drugs Act and its Regulations

Michael Vandergrift provided a brief update. He mentioned that the government remains committed to modernize important legislation for food, drugs and cosmetics. A new act has not been introduced at this time, and the decision to introduce and the timing of introduction of new legislation is at the discretion of the government.

Mr. Vandergrift also mentioned that it was Health Canada's intention to work with external reference groups, and hopes to have sufficient basis to guide Parliament.

Marshall Moleschi, Registrar, College of Pharmacists of British Columbia, mentioned that the Regulatory bodies would be able to help Health Canada, as a sounding board. Mr. Vandergrift thanked him for his offer.

6. E-Health / E-Prescribing Pilots in Ontario

Deanna Williams, Registrar, Ontario College of Pharmacists shared the latest information on these projects activities and challenges. She provided examples of the Georgian Bay and the Sault Ste-Marie Models. There are positive feedbacks for both models. The pilots will continue until the end of December. She talked about the easy access to the Diabetes Registry. She also shared information on remote dispensing kiosks pilot projects in place in Ontario. Some of the challenges include confidentially of the patients, ensuring a controlled environment, authenticity of the script.

7. Acetaminophen

Natasha Kuran, Nonprescription Drug Evaluation Division, TPD, provided the information on this item. She indicated that Health Canada attended the Federal Drug Administration (FDA) townhall meetings and remains in contact with its regulatory counterparts as they continue to work on the acetaminophen issue. TPD consulted on a draft Acetaminophen Labelling Standard in January 2009 and anticipates that the final version will be posted by Fall 2009. The new standard outlines the permitted ingredients, doses, and indications for use for these products, as well as the directions for use and ingredient-specific warning statements which are required to appear on the product labels. Of note, this labelling standard now reflects strengthened safety labelling regarding acetaminophen overdosing, the risks to infant health posed by codeine use in nursing mothers and provides weight-based dosing information for children.

The final labelling standard will replace the applicable portions of the December 2, 1994 Analgesics Labelling Standard. It is anticipated that products will have updated labelling on shelves by Fall 2010 to include the strengthened labelling requirements identified in the final labelling standard.

At the same time, Health Canada will continue to monitor the activities of the United States and other regulatory jurisdictions regarding acetaminophen. Health Canada intends to assess the information used by the United States in a Canadian context, and may consider whether regulatory amendments would be required as a result. Health Canada will ensure that stakeholders are consulted in the process should it move forward with any additional amendments to acetaminophen regulation.

8. Round Table

• a) Cough and Cold
  Adam Gibson, Senior Advisor, Director General's Office, TPD, mentioned that there is a questionnaire and related report concerning the effectiveness of the outreach strategy that is being prepared. An outline of this report and feedback will be presented to NAPRA when it is completed and a Health Canada representative from the Office of Consumer Involvement and Public Consultation can contact NAPRA to give them some initial details. He added that the evaluation was on-going.
• b) Contact Information to Establish Good Stakeholders Relationships
  Adam Gibson, DGO, TPD, addressed this item on behalf of Danielle Brûlé-Brown, Director of the Office of Risk Management. He mentioned that Ms. Brûlé-Brown is interested to know the contact name at NAPRA in order to have someone who is accessible when the need arises and also to improve stakeholder relationships. Carole Bouchard mentioned that any requests for NAPRA should be sent directly to her attention at the NAPRA office.

9. Adjournment:

Meeting adjourned at 2:45 p.m.

10. Next Meeting:

Monday, April 19th, 2010 (1:30 p.m.)
1600 Scott Avenue, Holland Cross
Tower B, Boardroom 2048

Original signed by Barbara J. Sabourin for

Dr. Supriya Sharma
Director General
Therapeutic Products Directorate