National Association of Pharmacy Regulatory Authorities (NAPRA): Final record of decisions April 5, 2022

Health Canada, Health Products and Food Branch (HPFB)
Bilateral Meeting Program
Virtual
April 5, 2022 1:00 p.m. to 2:30 p.m.

On this page

• Participants
• Meeting minutes
• Next meeting

Participants

NAPRA participants

• Sarah Marshall, Manager, Professional and Regulatory Affairs, NAPRA Co-chair
• Greg Eberhart, Registrar, Alberta College of Pharmacy
• Suzanne Solven, Registrar, College of Pharmacists of British Columbia
• Lieutenant-Colonel Sean Meredith, Canadian Armed Forces Pharmacy Services
• Rani Chatterjee-Mehta, Deputy Registrar, College of Pharmacists of Manitoba
• Cathy Purvis, New Brunswick College of Pharmacists
• Bev Zwicker, Registrar, CEO, Nova Scotia College of Pharmacists
• Judy Chong, Ontario College of Pharmacists
• Susan James, Acting Registrar, Ontario College of Pharmacists
• Michelle Wyand, Registrar, Prince Edward Island College of Pharmacy
• Michel Caron, Pharmacist/Advisor-analyst, Ordre des pharmaciens du Québec
• Jeana Wendel, Registrar, Saskatchewan College of Pharmacy Professionals
• Stephanie Connolly, Director, Professional Licensing and Regulatory Affairs, Government of Yukon
• Barbara Harvey, Registrar – Health Professions, Government of Nunavut
• Theresa Schopf, Manager, Programs and Services, NAPRA
• Elizabeth Kozyra, Pharmacy Practice Specialist, NAPRA
• Sarah ter Huurne, Pharmacy Practice Advisor, NAPRA

Health Canada participants

• John Patrick Stewart, Director General, Pharmaceutical Drugs Directorate (PDD) (Co-chair)
• Kelly Robinson, Director General, Marketed Health Products Directorate (MHPD) (Co-chair)
• Rita Beregszaszy, Bureau of Policy, Science and International Programs (BPSIP), PDD
• Janet Brunette, Office of Performance, Planning and Review Services (OPPRS), PDD
• Mary Coughlin, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), PDD
• Émile Geoffroy, OPPRS, PDD
• Colin Gunning, MHPD
• Debra Haltrecht, Policy, Planning and International Affairs Directorate (PPIAD)
• Tracey Hazelwood, MHPD
• Melissa Hunt, Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS), PDD
• Marc Legrand, BPSIP, PDD
• Laura Johnson, OPPRS, PDD
• Heather L. Macdonald, BPSIP, PDD
• Martin McLean, BGIVD, PDD
• Andre Molgat, Resource Management and Operations Directorate (RMOD)
• Rania Mouchantaf, MHPD
• Sabrina Nour, MHPD
• Brian Parker, BPSIP, PDD
• Marc Poitras, MHPD
• Bruno Rodrigue, PPIAD
• Chris Rose, Bureau of Pharmaceutical Sciences (BPS), PDD
• Michelle Ross, MHPD
• Aara Sidenius, PPIAD
• Jeffrey Skene, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), PDD
• Elizabeth Smith-Kawasaki, BPSIP, PDD
• Evelyn Soo, BGIVD, PDD
• Emma Spreekmeester, BPS, PDD
• Mona Walsh, OPPRS, PDD
• Donna Watt, OPPRS, PDD
• Kristen Zorn, BPSIP, PDD

Observer

• Derrick Barnes, Food and Drugs Act Liaison Office (FDALO)

Meeting minutes

Welcome and introductions

John Patrick Stewart, Director General, Pharmaceutical Drugs Directorate (PDD) co-chair welcomed everyone to the bilateral meeting between the National Association of Pharmacy Regulatory Authorities (NAPRA) and Health Canada. He thanked participants for the flexibility to continue with the virtual format and for taking the time to participate in the meeting. Dr. Stewart introduced Kelly Robinson, Director General of the Marketed Health Products Directorate (MHPD), as Health Canada co-chair of the meeting. As Adele Fifield, NAPRA Executive Director, was not able to attend the meeting, Sarah Marshall, Manager, Professional and Regulatory Affairs took on the role of NAPRA co-chair.

COVID-19 has continued to be a major priority since the last PDD/NAPRA bilateral meeting on September 22, 2020. As part of the government's response to the pandemic, Health Canada introduced innovative and agile regulatory measures through the use of Interim Orders. These measures expedited the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards. Following the expiry of many of the Interim Orders in the fall of 2021, Health Canada brought forward transition regulations that have allowed many of the flexibilities to remain in place on a longer-term basis.

There have been a few changes in senior management since the last PDD/NAPRA bilateral meeting in September 2020. Nancy Hamzawi has been appointed as Assistant Deputy Minister of the Health Products and Food Branch (HPFB). Natalie Page is the new Director General of the Natural and Non-prescription Health Products Directorate (NNHPD). Dr. Stewart noted that colleagues from the Food and Drugs Liaison Office at Health Canada (FDALO) were in attendance at the meeting. FDALO strives to make the regulatory process open, understandable and accessible to Canadians. It is a neutral body charged with fostering effective communication between Health Canada and external parties interested in the administration of the Food and Drugs Act (FDA). FDALO provides impartial dispute resolution services to help resolve complaints and inquiries between external stakeholders and regulatory staff at Health Canada who administer the FDA.

Kelly Robinson, Director General for the Marketed Health Products Directorate (MHPD) noted that the meeting represents an excellent opportunity for NAPRA and Health Canada to interact and to discuss current topics of mutual interest. She indicated that the critical role that NAPRA plays in supporting the health of Canadians and helping Health Canada deliver on its mandate is appreciated. Health Canada values NAPRA's participation in these meetings as an expression of commitment to ongoing engagement with the Department. For NAPRA and for Health Canada, patient safety is a fundamental cornerstone of health care. MHPD is looking forward to the next engagement sessions in Spring 2022 to further the conversation around Risk Management Plans and other risk minimization measures.

Sarah Marshall, NAPRA co-chair, thanked Health Canada for hosting the meeting and for giving NAPRA the opportunity to discuss various important items and to receive updates. She indicated that NAPRA appreciated that both MHPD and PDD were in attendance at this meeting as it helps to have these cross-directorate discussions.

Review of agenda

There were no changes to the agenda.

Approval of meeting notes of the September 22, 2020 meeting notes / action Items

The meeting notes from the September 22, 2020 meeting were approved and the action item has been completed.

Risk Management Plans (RMPs)

NAPRA indicated that Risk Management Plans (RMPs) have been an ongoing discussion with Health Canada and an agreement that is satisfactory to NAPRA has not been reached. The association noted that when RMPs affect the practice of health professionals and the usual distribution systems for medications, they can bypass the checks and balances of the existing health system that have been put into place in order to keep patients safe. NAPRA indicated that bypassing these systems can increase the risk of adverse events or negative outcomes, create potential privacy concerns, and limit patient access to appropriate therapy. NAPRA indicated that it understands that Health Canada's intention is to mitigate risks but added that it is possible to unintentionally create privacy, safety and access issues.

Rania Mouchantaf, Acting Director, Marketed Pharmaceuticals Bureau, Marketed Health Products Directorate, addressed this item. For a drug to receive and maintain marketing authorization in Canada, its benefits must outweigh its risks. As part of weighing the risks and benefits of a drug in deciding whether it should be authorized for sale in Canada, or to continue to be sold, Health Canada may consider the proposed RMPs and risk mitigation measures in making that decision. NAPRA and Health Canada share a common goal in seeking to help improve the health of all Canadians and ensuring access to safe and effective drugs. In order to meet these goals, Health Canada has adopted a proactive-life-cycle management approach.

Health Canada has observed repeated occurrences, in the post-market setting, of serious unexpected adverse drugs reactions (ADRs), including life-threatening harms, leading to drug withdrawals. These occurrences have demonstrated the importance of moving the practice of pharmacovigilance to a more proactive strategy. Modern pharmacovigilance seeks to anticipate, prevent and mitigate harm. RMPs outline a structured process for identifying, monitoring and minimizing risk throughout a product's life cycle. In this way, RMPs do not just prevent adverse events, they promote public health and one way to promote public health is to allow access. NAPRA clarified that it is not opposed to the proactive approach described by Health Canada, but when RMPs interfere with the practice of health professionals and bypass the usual checks and balances of the system, it can cause safety, access and privacy issues for the public.

Controlled distribution programs

NAPRA indicated that certain RMPs have included controlled distribution programs that either: require physician-only dispensing; require health professionals to obtain "authorization" from the manufacturer to prescribe or dispense; or, require patients to register with the manufacturer to receive the medication. MHPD responded that only a small proportion of new drugs authorized on the Canadian market require additional Risk Management Measures (RMMs) beyond safety information in the labelling, and an even smaller proportion of those have required controlled distribution programs. MHPD indicated that the decision to implement such a program and to determine the best risk minimization measures is complex and is considered carefully. NAPRA reiterated that nonetheless, these measures have had unintended consequences on patient safety, access and privacy.

Health Canada's role is not just to protect but to promote public health and to empower patients and health care professionals to get the information that they need at the right time. MHPD is aligning with international practices with respect to Risk Management Plans. Health Canada recognizes the challenges that have been shared by NAPRA and committed to better consider how to implement RMMs so that they meet the desired behaviours and objectives without introducing barriers to access or a creating burden on the health care system.

NAPRA thanked Health Canada for implementing sophisticated approval processes in order to provide more timely access to medications. The association added that a broad perspective from various regions across the country is foundational to identifying and minimizing harms and monitoring to address them. MHPD responded that Health Canada has health care professionals on staff that come from a variety of backgrounds, including pharmacists as well as physicians. MHPD indicated that it engages stakeholders through the advisory committees which have representatives from across the country. NAPRA also noted it is important for Health Canada to consider regulators, who focus on the public interest, as partners rather than advocacy associations, who are accountable to and influenced by their members.

MHPD indicated that it would be valuable to hear what NAPRA considers to be the best way to engage its members to obtain feedback. While a submission is under review, there are tight timelines and confidentiality issues that Health Canada needs to consider when engaging with stakeholders. Health Canada is interested in hearing any proposals and solutions from NAPRA with regards to options for consultation.

In authorising health products and making decisions on appropriate RMMs, the safety and well-being of Canadians is Health Canada's mandate and of paramount concern. Health Canada recognizes that continued collaboration among various stakeholders is essential to ensuring that RMMs are designed and implemented in a manner that is effective and acceptable to end-users, and that they fit into existing health care settings. To achieve this, Health Canada will be hosting an engagement session with NAPRA and other stakeholders in May 2022. NAPRA requested that additional representatives from different provinces and territories also be invited to attend. MHPD agreed to look at opportunities to bring additional representatives from across the country.

Agile licensing for drugs

Debra Haltrecht, Director, Office of Legislative and Regulatory Modernization (OLRM), Policy, Planning and International Affairs Directorate (PPIAD) presented this item. The Agile Licensing for Drugs initiative is a key component of Health Canada's Regulatory Innovation Agenda. From July 31, 2021 to October 28, 2021, Health Canada consulted on proposed targeted amendments to the Food and Drug Regulations and Medical Devices Regulations through a Notice of Intent published in Canada Gazette, Part I. As the first phase on this initiative, these proposed amendments are based on agile regulatory tools tested through the COVID-19 response and others aimed at addressing long-standing industry irritants.

The Notice of Intent set out the proposed amendments for four different areas: terms and conditions for drugs and medical devices; Risk Management Plans (RMPs) for drugs; rolling submissions for drugs; and modernizing requirements for biologic drugs that fall under Part C, Division 4 of the Food and Drug Regulations. Health Canada is considering adding a couple of other regulatory amendments relating to irritants that have been raised by industry. The first is related to repealing a particular provision in Division 1 of the Food and Drug Regulations that requires manufacturers to indicate the name of a standard when it is applicable on the inner and outer labels. The second is technical where Health Canada is considering an amendment to another provision under Division 1 that requires drugs that are claiming a manufacturer's standard to meet the highest degree of purity and the least variation in potency of any pharmacopoeia in which they appear under Schedule B in the Food and Drugs Act. This is new since the Notice of Intent was published in 2021.

At the same time as the Notice of Intent, Health Canada conducted a cost-benefit survey for industry and implicated stakeholders for the package. PPIAD noted that the feedback that was received from NAPRA and other stakeholders was appreciated. In general, stakeholders were supportive of the intent of the amendments but it was clear that everyone, including NAPRA, wanted more detail on the regulations as well as their implementation. As this is a foundational regulation that underpins Health Canada's regulatory framework, PPIAD indicated that it is important to take the time to analyse the feedback that is informing the development of the regulations as well as the implementation. As a result of this feedback, PPIAD has delayed the original target of the publication in Canada Gazette, Part I from Spring to Fall 2022. It is anticipated that draft guidance material will be published at the same time in order to provide more detail as to how it will be implemented.

Canada vigilance adverse reaction online database

Michelle Ross, Associate Director, Health Products Surveillance and Epidemiology Bureau, Marketed Health Products Directorate (MHPD), provided a presentation on the Canada Vigilance Adverse Reaction Online Database. Health Canada is developing a new interactive, web-based tool (termed a "dashboard") for this database. The dashboard is intended to make the data easier to search and displays results in a more user-friendly format, while maintaining the functionality of the existing database. MHPD requested NAPRA's assistance to perform user testing of this dashboard in order to ensure that it meets the needs of stakeholders. Participation would involve performing three to five tasks and should take less than 30 minutes. MHPD will provide additional information prior to the start of user testing which is anticipated to begin in May 2022. Anyone interested in participating can send an e-mail to the following Health Canada address: CVInterfaceFeedback.CommentairesInterfaceCV@hc-sc.gc.ca

Hospital mandatory reporting

MHPD is also developing a second dashboard based on data from hospital mandatory reporting of serious adverse drug reactions and medical device incidents. Currently, this data is communicated to Canadian hospitals through MHPD's regular newsletter and outreach activities. Statistics in this new dashboard will include: the number of reports that have been submitted over time; reports submitted by hospital size and regional location; the number of serious of reports; and top suspect groups reported. MHPD's goal is to publish this information in Summer 2022. Plans for this dashboard will be communicated to hospitals via regular newsletter. The data for hospital mandatory reporting will be taken from the Canada Vigilance Database. Both of the new dashboards will allow users to search using different fields. For example, the Canada Vigilance dashboard could be used to restrict information just to hospital mandatory reports. Statistics related to hospital reports could be obtained on both of the dashboards.

Transparency initiatives - Finding information on prescription pharmaceuticals - Health Canada databases and websites

Laura Johnson, Manager, External Transparency Unit, Office of Planning, Performance and Review Services, PDD presented an overview of Health Canada's transparency initiatives. The Health Products and Food Branch has increased the information published on Health Canada's website about prescription pharmaceuticals. These initiatives include: Public Release of Clinical Information; the Drug and Health Product Register, including Consumer Information, Regulatory Decision Summary and Summary Basis of Decision documents; Submissions Under Review and Generic Submissions Under Review Lists; lists of applications and authorized products for COVID-19; and the Clinical Trials Database.

PRCI

Andre Molgat, Head of Operations, Public Release of Clinical Information (PRCI), Resource Management and Operations Directorate (RMOD) provided an update on PRCI. The objective of this initiative is to make anonymized clinical information used to support therapeutic product applications (drugs, biologics and medical devices) publicly available for non-commercial purposes following the completion of Health Canada's regulatory review process. Information is disclosed both proactively and on request.

This initiative is underpinned by regulatory amendments that were made in 2019 to the Food and Drug Regulations and the Medical Device Regulations to clarify that clinical data would no longer be considered to be confidential business information. Access to anonymized clinical information is made public through the PRCI Web Portal. The portal includes information on drug submissions and in March 2022, RMOD began proactively releasing medical device data. Since 2019, all past decisions have been accessible by request. COVID-19 related information was added in 2020. This initiative provides comprehensive clinical data. The only protections that are put on this data is that personal information is protected through anonymization in a way that tries to maintain as much of the utility of the data as possible. There are limited redactions to confidential business information as a result of the 2019 regulatory clarifications.

The PRCI Web Portal is organized by drugs or devices and contains over 200 entries that are fully searchable by brand name or manufacturer. All of the data is published under the submission control number or application number associated with the drug submission or device application. The user is required to agree to Terms of Use which indicate that the data must not be used for commercial purposes. The information is primarily comprehensive clinical study reports, the associated supporting documents, the statistical analysis plan, the protocol, and the summaries and overviews that are in Module 2 of drug submissions. About half of the requests come from academia. The publications support some larger academic projects that are looking at certain research questions. The portal has received over 300,000 visits which indicates that the public is interested in this information. Of the requests, about half a dozen come from pharmacists throughout Canada that have made specific requests for products. The products can be requested through the Request public release of clinical information – Drugs link.

The Drug and Health Product Register that was created in 2015 is now evolving into the new Drug and Health Product Portal. Information will migrate from the Register to the Portal over time by means of a phased approach. The goal is to provide easy access to consumer information about drugs, natural health products and medical device incidents. The intention of publishing Regulatory Decision Summary (RDS) and Summary Basis of Decision (SBD) documents is to increase the transparency of regulatory review processes for certain health products. To compare RDSs and SBDs, RDSs are shorter (about 1 page long) and are intended to provide an overview of the rationale for Health Canada's decision. SBDs go into the detail about the scientific and benefit/risk analysis that factored into Health Canada's decision to approve a novel product. They are about 15-20 pages long and are published for the products of highest interest. Summary Safety Reviews (SSRs) outline Health Canada's assessment, findings, and action taken (if any) following the review of a potential safety issue.

NAPRA indicated that the new searchability of the Prescription Drug List within the Drug and Health Product Register is a significant improvement. NAPRA suggested merging the Drug Product Database and the Drug and Health Product Portal and Register so there is one place that contains all of the drug product database information plus all of the regulatory summaries. PDD responded that links between the two systems are being strengthened in order to become a one-stop shop. There are consultation plans in the works for the future.

There have been a number of consultations related to RDSs and SBDs. The goals are to raise awareness of the existence of these documents, to increase the participation of non-industry stakeholders and to obtain feedback as to how the documents can be improved. PDD is hoping to engage with NAPRA and other stakeholders on this topic in Fall 2022.

The COVID-19 vaccines and treatments portal was established as a central hub of information related to vaccines and treatments for COVID-19 that is updated regularly. This portal enables patients and practitioners to obtain links to all of the different information on the approved vaccines and therapies that have been authorized for sale in Canada.

NAPRA noted that pharmacists are critical to support its initiatives to combat misinformation. The association indicated that the RDSs and SBDs are helpful and useful tools and that arming pharmacists with these summaries is critical. NAPRA commented that, for some medications, there is specific targeted misinformation in circulation and added that it would be helpful to have a specific Health Canada commentary available to counter the misinformation. For example, misinformation might arise from a small randomized trial that might not reflect the same data as a larger study.

NAPRA requested information on the reason for the recent changes to Health Canada's Drug Product Database (DPD). The association indicated that, on the Health Canada Website, it appears that Health Canada is moving away from the American Hospital Formulary System in terms of the classification of drugs. NAPRA noted that the American Hospital Formulary System is used routinely in hospitals and when people develop practice guidelines, they may use these categories. Some of NAPRA's members are working on regulations around pharmacist prescribing and were considering referring to these categories of drugs when identifying which drugs a pharmacist could prescribe, rather than a list of individual drugs. This may be difficult if the categories were removed from the DPD.

Action: Laura Johnson, Office of Policy, Planning and Review Services, PDD, indicated that she would pass the information on to the Resource Management and Operations Directorate (RMOD) as it administers the DPD.

Action complete: RMOD has contacted NAPRA directly to continue this conversation.

NAPRA requested information as to whether studies done by the manufacturer that have negative results that do not support their drug submission are published as part of public release of clinical information. RMOD responded that the scope of what is published on the portal is everything that was submitted in a New Drug Submission (NDS) or a Supplement to a New Drug Submission (SNDS) post-licensure that supported safety and efficacy data in Module 5 Clinical Data. It is a regulatory transparency initiative to show the public everything that was reviewed to render that decision. NAPRA asked that RMOD consider publishing negative data in the future to make it accessible to researchers and the public. RMOD indicated that there are different points in time in a therapeutic product lifecycle where there are opportunities for transparency and clinical trial registries are expected to provide transparency on all trials in the future. NAPRA asked, when a search is performed for a drug, if it would be possible to access a link to a dashboard for that drug.

Action: Kelly Robinson, MHPD, to look into the suggestion.

Round table

Policy updates

Rita Beregszaszy, Director of the Bureau of Policy, Science and International Programs, PDD presented this item. PDD provided NAPRA with an extensive list of written updates on various key policy and regulatory projects which included: agile licensing for drugs and medical devices; clinical trials modernization; the Special Access Program; electronic labelling; antimicrobial resistance (AMR); the draft revised guidance document "Data requirements for switching medicinal ingredients from prescription to non-prescription status"; exceptions to the Prescription Drug List (PDL); Post Notice of Compliance (NOC) Changes Quality Document; change to performance standard for Post-DIN changes (PDCs) for prescription pharmaceuticals; and the Generics Modernisation Plan. The focus of the updates was in areas where there has been recent outreach in consultation and where there might be future opportunities. Milestones such as the publication of documents and final regulatory packages moving forward were also included.

XML Product Monograph (PM)

Health Canada is working on various projects such as converting Product Monographs into HTML so that they are readily accessible. To obtain patient information for a specific health product, a pharmacist would be able to electronically access Part III of the Product Monograph through their computer systems and provide it to their patients so that Canadians have access to Canadian labelling information rather than information from a U.S. database. The group that is responsible for the XML Product Monograph is planning to reach out to pharmacist organizations and to NAPRA in order to answer questions regarding the work that is being done to make PMs more accessible.

NAPRA indicated that this information is valuable and supportive of pharmacists and their primary role of drug therapy management. The association asked whether "how to" video clips could be produced in order to make health care providers aware of these tools along with how to access them and navigate them. MHPD supported the idea of "how to" videos and noted that it has been considering recording webinars to raise awareness of the tools that are available. NAPRA indicated that it is willing to support Health Canada for this initiative, especially with regards to working against misinformation.

Drug shortages

In order to avoid any future drug shortages, NAPRA indicated that it is interesting in anticipating and mitigating any supply issues and noted that it would appreciate being included in Health Canada discussions on the topic. NAPRA expressed concern regarding possible situations where there is extreme demand and insufficient supply of pharmaceuticals. PDD responded that the Regulatory Operations and Regions Branch (ROEB) leads the file on drug shortages and suggested that NAPRA contact Linsey Hollett (Lindsey.Hollett@hc-sc.gc.ca), Director General of the Health Product Compliance Directorate in ROEB. PDD supports regulatory flexibilities and submissions to bridge when there are shortages. PDD also oversees the Special Access Program which is sometimes used to deal with drug shortages. There has also been discussion at the International Coalition of Medicines Regulatory Authorities (ICMRA) around the flexibilities that were afforded during COVID-19 to address drug shortages. Products were brought in to bridge gaps in supply from other jurisdictions where bridging studies would normally have been required. There are ongoing discussions globally about which flexibilities make sense during COVID-19 and which ones should be continued.

Closing and adjournment

Sarah Marshall, NAPRA co-chair, thanked Health Canada for providing responses to the association's questions and noted that it was looking forward to the follow up meetings with Health Canada. Health Canada co-chairs John Patrick Stewart, PDD, and Kelly Robinson, MHPD, thanked everyone for their participation and for a useful discussion. MHPD indicated that it is also looking forward to the follow up meetings and, in particular, to engaging with NAPRA around Risk Management Plans in May 2022.

The meeting was adjourned at 2:30 p.m.

Next meeting

Spring 2023

Signed by:

Director General
Pharmaceutical Drugs Directorate