Final Record of Decisions - June 26, 2015, Meeting with National Association of Pharmacy Regulatory Authorities (NAPRA)

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

1600 Scott Street, Holland Cross Conference Centre, Ground Floor, Ottawa, Ontario

June 26, 2015 (10:00 a.m. to 11:30 a.m.)

NAPRA Participants

  • Carole Bouchard, Executive Director, National Association of Pharmacy Regulatory Authorities (NAPRA), Co-Chair
  • Greg Eberhart, Registrar, Alberta College of Pharmacists
  • Commander Sylvain Grenier, Canadian Forces Pharmacy Services
  • Ron Guse, Registrar, College of Pharmacists of Manitoba
  • Ray Joubert, Registrar, Saskatchewan College of Pharmacists
  • Sam Lanctin, Registrar, New Brunswick College of Pharmacists
  • Sarah Marshall, Manager, Professional and Regulatory Affairs, NAPRA
  • Marshall Moleschi, Registrar, Ontario College of Pharmacists
  • Bob Nakagawa, Registrar, College of Pharmacists of British Columbia
  • Susan Wedlake, Registrar, Nova Scotia College of Pharmacists
  • Michelle Wyand, Registrar, Prince Edward Island College of Pharmacists

Health Canada Participants

  • Celia Lourenco, Bureau of Gastroenterology, Infection and Viral Diesases (BGIVD), TPD, Co-chair
  • Janet Brunette, Office of Performance, Planning and Review Services (OPPRS), TPD
  • Debjani Chakravarty - Health Products and Food Branch Inspectorate
  • Daphne Jurgens, Marketed Health Products Directorate
  • Madeleine Marshall, Bureau of Policy, Science and International Programs (BPSIP), TPD
  • Eric Ormsby, BPSIP, TPD
  • Hugh Scheuerman, OPPRS, TPD
  • Sophie Sommerer, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), TPD
  • Tasha Yovetich, BPSIP, TPD
  • Donna Watt, OPPRS, TPD

Health Canada Observers

  • Ratna Bose, Natural and Non-prescription Health Products Directorate
  • Genevieve Moore, Food and Drugs Act Liaison Office (FDALO)

1. Welcome and Introductions

Celia Lourenco, Director, Bureau of Gastroenterology, Infection and Viral Diseases, Therapeutic Products Directorate (TPD) welcomed everyone to the meeting and a roundtable of introductions followed. There have been a number of staffing changes at Health Canada since the last bilateral meeting with NAPRA. Simon Kennedy is the new Deputy Minister and Anil Arora is Associate Deputy Minister. In TPD, the Executive Medical Director, John Patrick Stewart is now Director General of the Marketed Health Products Directorate and Cindy Evans is currently on assignment in the Director General's Office as Senior Executive Director.

HPFB has made significant progress on a number of key initiatives over the past year such as the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law).

2. Review of Agenda

An item was added to the agenda by Carole Bouchard, NAPRA, on the topic of compounding standards.

3. Approval of Meeting Notes of June 27, 2014 / Previous Action Items

A change was requested on page 5 (Item 6) of the June 27, 2014 Record of Decisions.

Action: Bilateral Meeting Program Secretariat to update the Record of Decisions.

Update: The June 27, 2014 Record of Decisions was updated with the change and a copy was forwarded to NAPRA on July 14, 2015.

Item 10. Roundtable: Sophie Sommerer, Associate Director, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), TPD to provide NAPRA with more detailed information on the possible scheduling change of "injectable" formulations of dimenhydrinate from an ethical product to a prescription product, so that they may provide input as requested.

Update: On hold pending analysis and decisions as to next steps on ethical products and to be discussed at agenda item 5 Guidances and Policy Update.

Health Canada noted that products are still being added to the list of ethicals for emergencies. NAPRA indicated that a scheduling structure framework for ethicals is needed to deal with the over 1,000 products in this category that have no formal scheduling status.

4. Health Canada Interpretation of the Term "written" prescription

NAPRA requested that it be copied on Health Canada responses to correspondence of a regulatory nature related to the practice of pharmacy. It is NAPRA's understanding that prescriptions can be stored electronically. NAPRA requested clarification as to whether a pharmacist needs to create a written copy when a verbal prescription is received. Eric Ormsby, Manager, Office of Science, Bureau of Policy, Science and International Programs, TPD responded that verbal prescriptions can be recorded in any format as long as there is a record, whether electronic or written, to capture the prescriptions. In the future, Health Canada will engage NAPRA on any enquires or issues regarding federal requirements related to the practice of pharmacy.

NAPRA requested information on whether Health Canada would consider communicating this interpretation to other stakeholders such as third party payors. NAPRA indicated that it is important that third party payors be made aware of the new interpretation of federal requirements, but also that they be notified that provincial/territorial record-keeping requirements may not align with federal requirements. Third party payers such as non-insured health benefits currently rely on NAPRA's interpretation. The association noted that there is a difference between electronic prescriptions and prescriptions sent electronically. Health Canada acknowledged that if there are differences between federal and provincial regulations, the provincial and territorial governments have primary jurisdiction over the administration and delivery of health care services and may therefore impose additional requirements.

Action: Eric Ormsby, Bureau of Policy, Science and International Programs to look into the possibility of posting a notice on written prescriptions along with a Question and Answer document and to share this information with NAPRA prior to posting, if possible.

Action: NAPRA to send TPD any potential scenarios for the impact of clawbacks on retail pharmacy.

5. Guidances and Policies Update

Eric Ormsby, Manager, Office of Science, Bureau of Policy, Science and International Programs, TPD updated that the only switch that will be coming into effect is Mometasone furoate on August 12, 2015.

The consultation period has ended for the Product Monograph Guidance Document Parts I and II and the Bureau of Policy, Science and International Programs is in the process of reviewing the more than 500 comments that were received. It is expected that the guidance document will be ready in Fall 2015.

In terms of review of some ethical drugs, Erythrosine plaque disclosing agent is no longer considered to be an ethical and is now over-the-counter. A proposal to move injectable hyoscine butylbromide for human use to prescription status (to be consistent with veterinary use) is expected to be released in the Fall of 2015. The hyoscine butylbromide tablets will remain ethical.

NAPRA noted that it adds drugs to the National Drug Schedules after it receives notification that Health Canada has updated the Prescription Drug List.

In Saskatchewan, pharmacists have authority to prescribe for self-care or minor ailments. Therefore, NAPRA requested information on which drugs are in the stream for switching. Health Canada responded that this information is currently treated as confidential.

6. Restriction of Access to Products by Pharmaceutical Manufacturers that Causes an Increased Risk to Patients

NAPRA expressed concern that a letter was sent by a pharmaceutical company indicating that there is a new "centralized pharmacy distribution system in each province" for a particular product. Only one particular pharmacy in the province is authorized by the pharmaceutical company to dispense the product to the patient. Therefore, physicians need to direct the patient to this pharmacy. Once the prescription has been received by this pharmacy, the prescription can then be sent to a pharmacy of the patient's choice. NAPRA indicated that this would seem to: not facilitate timely and equitable patient access to medication, would increase the risk to patients, contravene personal health information legislation, and contravene the Food and Drugs Act regarding distribution of drugs and good manufacturing practices. NAPRA requested a review by Health Canada to identify if this type of drug distribution by an Establishment Licence holder is consistent with the regulations of the Food and Drugs Act. NAPRA also noted that it is a challenge when one a location has both an establishment license and a pharmacy license.

Debjani Chakravarty, A/Section Head, Establishment Licensing, Billing and Invoicing Unit, Health Products and Food Branch Inspectorate addressed this item. The pharmaceutical company in question currently holds a valid Drug Establishment Licence for the activities of importation and distribution. An establishment that holds a valid Establishment Licence must remain in compliance with the Food and Drugs Regulations. The prescription options mentioned appear to relate to the practice of pharmacy and is beyond the scope of Division I. Division 1a does not indicate how the product should be distributed. The Establishment Licence would only be affected if not in compliance with Division 1 or Division 2. It would depend on particulars of the distribution model as to whether there could be any potential violations to the Food and Drug Regulations. A more in depth assessment via compliance verification activities or an inspection may be required. Health Canada also suggested that NAPRA explore other avenues such as Industry Canada's Competition Bureau.

NAPRA requested information on situations when a company was shown to have an infraction, what kind of oversight would there be from Health Canada. The HPFB Inspectorate noted that when a complaint is received, it is given to the HPFB Inspectorate compliance unit.

It is NAPRA's understanding that for establishment licences, companies can only distribute to certain entities. The HPFB Inspectorate responded that the company who holds the DIN would be defined as the distributor, who can provide directly to a pharmacy. NAPRA noted that if the wholesaler was found to be selling directly to the patient, it might be in violation.

NAPRA requested that it work with Health Canada on this topic as the extra process that the patients need to go through to obtain access is a barrier. The association added that patient records are being released to an organization that does not have the right to possess them.

Action: Debjani Chakravarty, HPFB Inspectorate to take the issue back to colleagues for further input/details.

Action: NAPRA to send more detailed information on pharmaceutical manufacturers restricting access to products to Étienne Ouimette of the HPFB Inspectorate.

Action: Debjani Chakravarty, Health Products and Food Branch Inspectorate, to provide NAPRA with the generic e-mail account for the HPFB Inspectorate's compliance unit.

7. Therapeutic Products Directorate / Marketed Health Products Directorate Transparency Initiatives

Tasha Yovetich, Senior Policy Analyst, Policy Division, Bureau of Policy, Science and International Programs, TPD presented this item. On March 13, 2015, a Notice to Stakeholders was sent to DIN holders, medical device licence holders and major trade associations to announce new transparency initiatives being implemented under the Department's Regulatory Transparency and Openness Framework. As described in the Notice, Health Canada will begin to publish a list of Submissions Under Review (this applies to prescription pharmaceuticals and biologics, for human use), and Regulatory Decision Summaries (applies to Class IV medical devices, prescription pharmaceuticals and biologics, for human use), in a phased approach.

Regulatory Decision Summaries

Regulatory Decision Summaries explain the rationale for Health Canada's decision for certain drugs and medical devices. Health Canada has committed to posting positive decisions for new drug submissions, supplemental new drug submissions for new uses, and new class IV medical device applications decisions made after April 1, 2015. Health Canada indicated that pacemakers are an example of a Class IV medical device. Class IV is being examined because it represents the highest risk. Medical Device regulations are very different from those of pharmaceuticals. Final negative decisions for new drug submissions for new active substances are expected to be posted in 2016.

Submissions Under Review

Starting in July, 2015, the list of submissions under review will include all new drug submissions for new active substances for both pharmaceuticals and biologics that are accepted into review. The Submissions Under Review posting will include the medicinal ingredient(s) and the therapeutic class for the new drug but not the proposed brand name or the manufacturer's name. Beginning in April 2016, the proposed plan is to expand the list to include all new drug submissions.

NAPRA requested information on whether switches would be included in the posting of Submissions Under Review.

Action: Tasha Yovetich, Bureau of Policy, Science and International Programs, TPD to take back to colleagues as to whether switches would be included in the posting of Submissions Under Review.

NAPRA requested information on how the media obtains information. Health Canada responded that it contacts the sponsor and asks if the company would be willing to disclose. The European Medicines Agency (EMA) has a similar process with a more comprehensive list. Up to now, Health Canada has treated information received from manufacturers as confidential.

Summary Safety Reviews and other HPFB Initiatives

Daphne Jurgens, Senior Advisor, Therapeutic Effectiveness and Policy Bureau, Marketed Health Products Directorate updated on other initiatives that HPFB has implemented to increase transparency about health product safety:

  1. Summary Safety Reviews - Since April 2014, HPFB has been publishing summaries of completed drug safety reviews. More than 30 Summary Safety Reviews have been published to date. Drug Summary Safety Reviews are 2-4 page documents summarizing the assessment done by Health Canada of potential changes to the risks and benefits of a drug after it has been marketed. The full Safety Review can be requested from Health Canada. NAPRA requested information on the criteria required for which drugs are chosen for safety reviews. Health Canada indicated that safety reviews can be initiated for a variety of reasons, including reports of adverse reactions or information received from a foreign regulatory agency indicating a potential concern with a drug.

    The Branch also publishes a list of the safety reviews that have been initiated (for drugs and natural health products) so that Canadians can see which potential risk issues are being evaluated. This list is updated quarterly.
  2. Launch of the Health Product InfoWatch - this monthly publication expands on and replaces the Canadian Adverse Reaction Newsletter (CARN) and continues to provide information on potential safety issues.
  3. Publication of a list of drugs with paediatric information in the labelling - This list includes drugs that have authorized indications for use in children and/or drugs that have warnings/ precautions/contraindications for use in children.
  4. Launch of the Drug and Health Product Register (DHPR) - Consumers and health professionals can access practical health product safety information including what a drug is used for, safety warnings, common side effects and adverse reactions.

NAPRA indicated that the Drug and Health Product Register is a great tool and requested information on what other ways the Register could be useful to NAPRA. Health Canada responded that the scope is going to expand to include links to Summary Safety Reviews with the intent of bringing all areas of information into one source.

On June 23, 2015, Rona Ambrose, Minister of Health, announced the Regulatory Transparency and Openness Framework and Action Plan 2015-2018. The intent of the action plan is to encourage dialogue in order to increase transparency.

8. Plain Language Labelling Initiative

Madeleine Marshall, Unit Manager, Bureau of Policy, Science, and International Programs (BPSIP), TPD introduced this item. The new Plain Language Labelling regulatory requirements came into force on June 13, 2015 for prescription drugs and those administered or obtained through a health professional. The regulations will come into force for non-prescription products on June 13, 2017.

The purpose of the regulatory requirements was to reduce preventable drug harms and support the safe and effective use of drugs by making improvements to ensure health product labels are clear, accurate, easily understandable, and minimizing opportunities for confusion with labels, packages or names. The new Plain Language Labelling regulatory requirements apply only to biologics, pharmaceuticals and radiopharmaceuticals and not to veterinary drugs or natural health products.

The amendments to the regulations introduced five new requirements:

  1. a general plain language requirement,
  2. requirements for manufacturers to provide evidence that drug names will not be confused with other authorized products,
  3. a requirement to include contact information on all labels for users to report problems or adverse reactions,
  4. a requirement for the standardization of the format for non-prescription drug labels in a table to help users find and understand important information, and
  5. a requirement for manufacturers to submit full colour scaled mock-ups of labels (instead of written text of every label) and packages as accurate representations of what will be available on the market.

Action: Madeleine Marshall, Bureau of Policy, Science and International Programs BPSIP, TPD to respond to NAPRA's question as to how plain language labelling will affect line extensions.

9. Federal Regulatory Oversight for Commercial Compounding/ Manufacturing

Carole Bouchard of NAPRA presented this topic. NAPRA has been developing model standards for compounding in order to update the association's current guidelines. NAPRA's Board of Directors has approved the content and the Model Standards are expected to be released in Fall 2015. The Health Canada Website indicates that the Department is developing a new regulatory framework to address commercial compounding. As the work that NAPRA is doing is linked into this, NAPRA highlighted the importance that Health Canada completes this framework quickly. The association had provided comments during Health Canada's stakeholder consultation for the Commercial Compounding Proposal and some members of NAPRA had participated on the sub-working group to the Ad-Hoc ADM FTP Working Group on Admixing and Compounding.

NAPRA's Registrars for the provincial pharmacy regulatory authorities have expressed their concerns that the new framework on commercial compounding has not moved further ahead and that if it is not completed, it may, in their opinion, have the potential to leave some commercial compounding activities non-regulated. A reference was made to Dr. Thiessen's report, which also noted significant concerns about possible implications of not having a new framework on commercial compounding. The association would like to reiterate that it has made this topic a priority. NAPRA indicated it will be writing to the Department to convey again its concerns with the lack of progress on the federal commercial compounding framework.

Prior to the meeting, TPD provided NAPRA with a contact at the Policy, Planning and International Affairs Directorate, HPFB who will be able to provide more information on compounding.

10. Roundtable

There were no roundtable items.

11. Closing and Adjournment

Celia Lourenco thanked everyone for participating.

The meeting was adjourned at 11:30 a.m.

12. Next Meeting - Spring/Summer 2016

Original signed by
Barbara J Sabourin
Director General
Therapeutic Products Directorate

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