ARCHIVED — Vol. 147, No. 25 — June 22, 2013

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Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use)

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: Today, millions of Canadians rely on non-prescription and prescription drugs to maintain and improve their health. Although drugs can offer significant benefits, they also come with risks and uncertainties. In Canada and internationally, studies and health literacy research indicate that over-crowded and confusing drug labels, unclear instructions, and similarities between packages and names contribute to medication errors. Examples include accidental overdose, taking or giving the wrong drug, and not knowing how to take the drug properly. Although the reduction of medication errors is a system-wide and shared responsibility involving industry, health professionals, patients and caregivers, Health Canada has an important and early role in product and label review. The existing Food and Drug Regulations do not yet take into account ways to better reflect current knowledge of medication use and ways to minimize opportunities for confusion with labels, packages or names. Other international regulators have identified similar issues and have taken steps to improve drug safety; this proposal aims for alignment with international best practices.

Description: Whereas the current Food and Drug Regulations (Regulations) contain requirements for industry regarding drug labelling and packaging, the proposed amendments further emphasize the importance of plain language labelling. The regulatory proposal consists of five targeted amendments (and consequential adjustments) to the current Regulations: one general requirement for clear, understandable, plain language labels; and four pre-market requirements (i.e. contact information on labels to report problems, standard table format for non-prescription drug labels, submission of label and package mock-ups, and look-alike/sound-alike [LASA] name assessments). The scope of the proposal is human drugs, specifically non-prescription and prescription, pharmaceutical and biologic drugs. The proposed amendments are focused on outcomes and not overly detailed, which would provide industry flexibility about how to implement the changes, and Health Canada guidance and operations would be able to adjust to innovations over time.

Cost-benefit statement: These Regulations would provide a net benefit to Canadians with a net present value of $72.4 million. The quantified benefits relate primarily to the cost savings to the health care system and the economic value of the reduced risk of death due to preventable medication errors.

One-for-One” Rule and small business lens: Due to the nature of the proposed Regulations, incremental cost, if any, would be attributed to compliance. Given that the “One-for-One” Rule only considers administrative burden, it does not apply to this proposal. The small business lens does not apply to this proposal, as few if any market authorization holders would meet the small business definition.

Domestic and international coordination and cooperation: Health Canada’s proposed amendments have been designed to align with international best practices and trading partners, and also support the collaborative efforts of the Regulatory Cooperation Council.

Background

Drug safety and the communication of information to support the safe and effective use of drugs is a complex issue involving many stakeholders in the health system. Drug labels, including affixed and supplementary information such as a package inserts and patient leaflets, are one of the primary vehicles for communicating important information to health professionals, patients and consumers about the safe and proper use of drugs. Evidence has demonstrated that the design of drug labels, packages and names, including format and colour, contribute to the safe and appropriate use of a drug and are important aids in identification, selection and administration.

For health professionals, the information on labels is used to assist them in prescribing or dispensing drugs to patients and to counsel patients on the appropriate use of a medication. For consumers, this information needs to support the proper selection and use of the drug, as well as to help inform their decisions when there is no interaction with a health professional.

In Canada and internationally, studies and health literacy research indicate that over-crowded and confusing drug labels, unclear instructions, and similarities between packages and names contribute to medication errors. Examples include accidental overdose, taking or giving the wrong drug, and not knowing how to take the drug properly.

As a regulator, Health Canada (the Department) assesses drugs and their labels in a pre- and post-market environment. This work is an important step along the continuum of information that is disseminated through the health care system, and is achieved through a combination of mandatory label requirements, guidance and review practices.

In response to the high rate of medication errors observed in the health system, and recognizing the role of the label, significant work has been undertaken in Canada and internationally to identify opportunities to improve the clarity and accessibility of drug labels. In 2011, the Department conducted consultations to seek input on options to improve the product information intended for consumers. The Department also developed guidance for industry and conducted consultations on the submission requirements for drug labels and the assessment of drug names.

Since the late 1990s, regulatory bodies in the United States and Europe have created or amended the authority to improve drug labels, packages and names. These changes have focused on standardizing non-prescription drug labels with a Drug Facts table in the United States; improvements to prescription drug labelling; assessment of names, labels and packages for confusion; processes for seeking and assessing evidence of user comprehension of labels; and ability to require changes to labels in response to new safety information. The U.S. Food and Drug Administration (FDA) also established the Safe Use Initiative in 2009, a collaborative project to help improve medication safety and reduce preventable harm. These jurisdictions have also published guidance on labelling; packaging and naming, as well as readability and medication errors.

In Australia, the Therapeutic Goods Administration (TGA) conducted consultations in 2012 on proposals to improve medicine labels and packages, including proposals similar to the FDA’s Drug Facts table; look alike/sound alike (LASA) assessment of drug labels, packages and names; as well as the prominence of active ingredient names and space on labels of dispensed prescription drugs. The TGA also has a best practices guideline, as well as regulatory guidelines for prescription and non-prescription drugs.

Issue

Today, millions of Canadians rely on non-prescription and prescription drugs to maintain and improve their health. Although drugs can offer significant benefits, they also come with risks and uncertainties. Too often, people experience avoidable harm as a result of confusing drug labels, packages and names.

Although the reduction of medication errors is a system-wide and shared responsibility involving industry, health professionals, patients and caregivers, the Department has an important role in product and label review, which contributes to the safe and effective use of drugs.

The current Food and Drug Regulations (the Regulations) outline requirements for industry, including for labelling and packaging. Part A of the Regulations currently includes general requirements for labelling and requirements for security packaging; however, requirements related to improving labels to aid in proper use and comprehension do not yet exist. Part C of the Regulations provides (in Divisions 1 and 8) a number of general and specific requirements for drugs. Embedded in these divisions are drug name, labelling and packaging submission requirements that companies must meet. The current structure also includes a few limited requirements once the product is on the market.

The existing Regulations do not yet take into account ways to better reflect current knowledge of medication use and minimize opportunities for confusion with labels, packages or names.

Objectives

The objectives of this proposal are to improve the safe and effective use of drugs and reduce the number of medication errors resulting from confusing drug names, labels and packages; and to reduce compliance costs to the extent possible by enabling the changes to be implemented with the natural cycle of label revisions. These objectives would be achieved through targeted amendments to the Food and Drug Regulations for drug names, labels and packages, which would also align Canada with international best practices.

More specifically, the proposed regulatory amendments are intended to

  • introduce general requirements for plain language labelling to explicitly link readability of the label to certain elements such as colour contrast, font size, and layout of text;
  • standardize the format for non-prescription drug labels in a table to help users locate important information; and
  • specify requirements for manufacturers to provide mock-ups of labels and packages, so that information filed with submissions accurately represents the information that consumers and health professionals would see; to provide evidence that a drug would not be confused with another drug because of similar names; and to require contact information on labels so that users can report a problem (e.g. medication error that led to taking the wrong drug or the wrong dose or at the wrong time).

Description

The proposed regulatory amendments to the Food and Drug Regulations address drug names, labels and packages, and are targeted within the current structure under Part A and Part C (Divisions 1 and 8) of the current Regulations. The proposal includes five core requirements, as well as associated adjustments to ensure consistent terminology, clarification of scope, and proper section linkages across divisions of the Regulations. The scope of the proposal is human drugs, specifically non-prescription and prescription, pharmaceutical and biological.

General plain language requirement

The proposed new requirement would emphasize the need for labels of drugs for human use in dosage form to be in plain language, and that the format or presentation of labels should not impede comprehension (e.g. poor layout or design, or distracting or confusing graphics or information). The existing section (A.01.016) that requires clear, prominent, readily discernible information on labels would be retained for veterinary drugs.

Pre-market requirements

In order to ensure that labels and packages are clear and easy to understand, this proposal would introduce new requirements during the pre-market submission process, including the following:

  • Contact information on labels to report problems: This proposal would provide users with a clear and transparent mechanism to contact someone who is responsible for the product in Canada, should they experience a problem (e.g. medication error that led to taking the wrong drug or the wrong dose or at the wrong time) or have a question or concern. Drug labels must already provide the name and address of the manufacturer, and this proposal would introduce more modern and flexible options such as a toll-free number, email address, or Web site.
  • Standard table format for non-prescription drug labels: This proposal is about the layout or format of information that manufacturers are already required to include on labels. This proposal would require certain information to be in a table format, in order to help users locate important information. The information in the table would be required in both English and French. The existing content requirements that would be included in such a table are “adequate directions for use,” which typically includes indications or uses, recommended single and daily dose, route of administration, storage conditions, warnings and precautions; a list of the medicinal (or active) ingredients and non-medicinal (or inactive) ingredients; and the proposed new requirement above for contact information to enable users to report problems. The objective of grouping information in a manner that is distinct from other information is to help users locate and read critical information about a product and make informed decisions. Distinguishable information facilitates readability, thereby enhancing safe and effective use of drugs.
  • Submission of mock-ups of labels and packages: The Food and Drug Regulations currently only require manufacturers to submit written text or drafts of every label for pre-market review, and final labels are only submitted once a product is already on the market. This proposal would revise the current submission requirements to require manufacturers to submit scaled mock-ups of the label and package, as an accurate representation of what would be available on the market. This proposal would ensure that the Department receives and reviews a mock-up of drug packages and labels, including an accurate representation of colour, scale, content and format, graphics and design. Operationally, this would continue to be an iterative process, through which the Department works with manufacturers through the submission review and achieves agreement on what the final packages and labels would look like. The proposal would also repeal the requirement to submit final labels after the drug is available for sale, as the accurate mock-up or representation of final packages and labels would be agreed upon at the time Health Canada authorizes the product. Any significant changes to the label following authorization would have to be reviewed in accordance with existing submission requirements.
  • Submission of an assessment that a drug would not be confused with another drug because of similar names: This proposal would codify current policy in regulation — i.e. it would formalize the authority for this submission information and the current operational approach and guidance. For drug names, manufacturers would be required to submit an assessment that the brand name of their drug would not be likely to be mistaken for the brand, common or proper name of a different authorized drug; the Department provides guidance and tools for how to conduct such an assessment.

Regulatory and non-regulatory options considered

The Department has assessed regulatory and non-regulatory options (detailed below), and has taken into account Government initiatives for international regulatory cooperation and for red tape reduction, the small business lens, and the appropriate level of oversight. In summary, Canadians would benefit from the proposed amendments, which have been designed to offer high levels of protection while streamlining processes for companies, aligning with key trading partners, and supporting timely and transparent approval and change processes.

Option 1: Status quo

The status quo would maintain current regulatory authority for drug labels and packages. This option was rejected for several reasons. Research has shown that medication harm is a significant source of preventable injury and that over-crowded labels, unclear instructions and confusing names are factors that can make drug labels difficult to read, can lead to product confusion and can ultimately contribute to serious patient harm. This option would not address the gaps in the current regulatory framework, which have not been adequately mitigated by non-regulatory options such as guidance. Specifically, this option would not codify the requirement in regulations for manufacturers to submit assessments of names for potential confusion with other products, or to submit a mock-up of the final label and package with an accurate visual representation of the proposed market label. Further, this option does not reflect international regulatory alignment and continues to lead to inconsistencies across industry.

Option 2: Voluntary improvement through updated guidance

This option considered continuing to regulate labelling and packaging under the current Regulations (status quo) and achieving voluntary improvements through updated guidance to allow for the introduction of new policy objectives and to provide direction to industry to better meet labelling and packaging objectives.

While updated guidance would be the appropriate mechanism to provide direction, establish details and flexibility, important safety requirements would not be mandatory and would continue to lead to inconsistency across the industry. This option would not address the gaps in the currently outdated regulatory framework, where previous experiences have demonstrated that voluntary approaches would not achieve the intended outcomes in a timely manner. Further, this option would provide only a limited opportunity to align internationally and benefit from the regulatory work done in other jurisdictions to advance plain language labelling and better packaging. As a result, this option was rejected.

Option 3: Amending the Food and Drug Regulations — Proposed option

This option would amend the Food and Drug Regulations in order to add requirements that address the highlighted gaps, including a general plain language labelling requirement, a new requirement for contact information on labels to report problems, a new requirement to standardize format elements of the label for non-prescription drugs, a requirement to submit mock-ups of labels and packages, and new codified submission requirements to support the assessment of names for clarity and potential for confusion. This option was chosen because it represents the most efficient and effective approach for addressing the existing gaps in the current Regulations. The Regulations would be supported by non-regulatory mechanisms such as guidance, best practices and collaborative approaches with other stakeholders that have a role to play in the development and dissemination of important drug safety information.

Through selecting this option, Health Canada would achieve the intended outcomes for patients, consumers and health care professionals by having the appropriate level of oversight and requirements through regulation. This option has been developed in consultation with stakeholders and based on best practices from other regulators. Further, this option is consistent with regulatory reform initiatives to reduce burdens and encourage operational efficiencies.

Benefits and costs

The regulatory proposal consists of five targeted amendments within the current regulatory structure (refer to the “Description” section above for further detail). This cost-benefit analysis focuses on the pre-market submission requirements of the proposal to determine the economic impact on stakeholders relative to the current regulatory environment.

The Department has designed this proposal to focus on areas where improvements can be made, to align with international best practices, and to provide flexibility for future innovation with as little burden as possible. A six-month and a three-year transition period would allow the industry to properly plan and adjust to the new regulatory requirements within the natural cycle of label revisions. The phased transition period is described in greater detail in the “Implementation, enforcement and service standards” section.

As the key elements of the proposal are already in place in other countries, are a matter of policy in Canada, and have been consulted on, the industry is quite familiar with these elements, and many companies may have already implemented them for products in other jurisdictions.

The total net present value benefit of the proposed amendments would be approximately $72.4 million for 10 years, between 2013 and 2022. The complete cost-benefit analysis is available upon request.

Cost-benefit statement

Quantified impacts (in dollars)

 

Base Year

Final Year

Total (PV)

Average Annual

Benefits

Canadians and the health care system

  • Cost saving to health care system

$1.9M

$1.9M

$13.3M

$1.9M

  • Economic value of reducing risk of deaths due to medication errors

  $8.9M

  $8.9M

 $62.6M

 $8.9M

Total benefits

$10.8M

$10.8M

$75.9M

$10.8M

Cost

Industry — Compliance cost (to adjust OTC label and package design)

  $1.2M

     $0

 $3.5M

$0.5M

Net benefits

$9.6M

$10.8M

$72.4M


Qualitative impacts

  • Reduction in preventable medication errors that are currently being caused from confusion or mix-ups due to a drug’s name, label or package.
  • Reduction in the number of emergency department visits and number of hospitalization and the length of stays.
  • Reduction in cases of morbidity and mortality as a result of drug-related adverse events.
  • Reduction in the dispensing error rate in community pharmacies. Studies have suggested it could be as high as 22%, of which 3% were potentially harmful.
  • Possible reduction in number of tort cases relating to medication errors before court.
  • Improvement of drug names, labels and packages to reduce opportunities for confusion.
  • Improvement of over-the-counter (OTC) product selection and use.
  • Improvement of the drug information tool that Canadians rely on when they are most vulnerable — e.g. parents with sick children; seniors with deteriorating eye sights or memory; health care professionals under stressful situations.
  • More efficient consumer search and compare mechanisms to distinguish among products with similar ingredients, names and uses.
Benefits
Reduction in avoidable medication errors

Avoided medication errors and hospital visits would benefit both Canadians and the health care system. According to the Canadian Institute of Health Information (CIHI), Canadians made approximately 15.8 million trips to the emergency departments in 2011, with an estimated 1.9 million trips relating to preventable medication errors. Based on available data, an emergency visit would incur an estimated median wait-time of two hours for patients and caregivers and an average cost to the emergency department of $218 per visit, with an estimated annual cost of $527 million to the Canadian economy.

Other costs associated with preventable medication errors include but are not limited to preventable prolongation of hospital stays or avoidable hospital admissions; as well as the economic cost of morbidity and mortality, where as many as 2 131 (see footnote 1) annual deaths in Canada could be attributed to preventable medication errors. The proposed amendments are expected to help reduce these quantifiable costs.

Costs

As the general plain language labelling requirement is intended to provide clarity and boundary for the interpretation of various definitions within the context of plain language, this analysis focuses on the proposed pre-market requirements, and associated costs.

Contact information on labels to report problems

Industry is already required to provide their name and address on labels, and has generally gone beyond the minimum by providing additional contact information such as email address on its labels voluntarily (and aligning with requirements from the United States). Therefore, no incremental cost to both internal and external stakeholders is expected as a result of the proposed amendment. In addition, the flexible approach is intended to accommodate changes in the future for any technological advances as well as research.

Standard table format for non-prescription drug labels

This proposed amendment is strictly related to the format of information and would not change label content requirements for non-prescription drug labels. In Canada, there are slightly over 3 000 over-the-counter (OTC) drug products for human use available, which are regulated under the Food and Drug Regulations. At present, reviewers use a number of tools to conduct label reviews, including the draft guidance document Labelling of Pharmaceutical Drugs for Human Use, the Guidance for Industry: Product Monograph, the U.S. Food and Drug Administration Guidance for Industry — Labeling OTC Human Drug Products Using a Column Format, as well as Nonprescription Drugs: Labelling Standards.

In the United States, the FDA has required all OTC drug products to have a standardized “Drug Facts” table since 1999. The United States was the first to introduce the standard drug information panel and its industry was the first being asked to meet the then new requirements.

The U.S. FDA estimated the one-time compliance cost for its industry to be about $57.5 million for approximately 100 000 OTC drug products affected at that time. This was comprised of $19.4 million for label redesign and $38.1 million for packaging change. In 2012 dollars, the original amount of $19.4 million (1999) would be equivalent to approximately $47 million once the discount rate of 7% is applied.

The Department rarely receives submissions for new non-prescription drugs. For the switch from prescription to non-prescription status, the average is one submission per year. Nevertheless, nearly one-third of label submissions for non-prescription drugs received by Health Canada already include a standard drug information panel currently. With the proposed amendment, the Department would be aligning with requirements and processes in place internationally.

Given the historical precedence of the Drug Facts table in the United States and the global nature of the business, the incremental cost for this proposal on a per-product basis should be much less in magnitude since the industry has already transitioned to a standard format in the United States, and almost one-third of Canadian submissions already include a standard table panel.

Because the Canadian proposal would not require any new information requirements for the standard drug panel, or be overly prescriptive in regulation regarding the format, the Department does not expect any changes in label or package size as a result.

Based on the U.S. economic assessment model, (see footnote 2) the one-time compliance cost to the industry is estimated to be about $3.5 million over a three-year transition period. The total net present value benefit of the proposed amendments would be approximately $72.4 million for 10 years, between 2013 and 2022.

Submission of label and package mock-ups before versus after regulatory approvals

At present, the Department receives written text or drafts of the label at the time of submission, and the mock-ups of the final version (also known as “trade dress”) following regulatory approvals. From an incremental cost perspective, the regulatory proposal would not theoretically require additional work on the part of the sponsor. Rather, it would change the timing, and possibly reduce some of the procedural steps during review — i.e. the mock-ups would occur prior to the relevant submission approval rather than afterward. Thus, it would eliminate the need for the submission of draft text and another (duplicative) submission of final versions after marketing. The change would align Canada with the practice of other regulators, such as the European Medicines Agency (EMA).

LASA name assessments

To estimate the burden related to LASA name assessments, it is important to note that the Canadian Look-alike Sound-alike policy has been in effect since 2006, when the Department first published the guidance for industry on Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names. Thus, the proposal in this case merely codifies the process in regulation to ensure uniformity.

Lessons learned over the past seven years of LASA experiences have recently been used to revise the guidance, and industry has been anticipating these updates following consultations that took place February to April 2013.

“One-for-One” Rule

Due to the nature of the proposed Regulations, incremental cost, if any, would be attributed to compliance. Given the “One-for-One” Rule only considers administrative burden, it does not apply to this proposal.

Small business lens

The small business lens applies to regulatory proposals that impact small business and that have nationwide cost impacts of over $1 million annually. The Treasury Board Secretariat defines small business as any business, including its affiliates, that has fewer than 100 employees or between $30,000 and $5 million in annual gross revenues. This definition is based on commonly used definitions for what is considered a “small” business in Canada.

In this case, only market authorization holders (MAHs) of human prescription and non-prescription (OTC) drugs would be affected by the proposal. Due to their revenue generation and capital-intense characteristics, few if any of the MAHs would meet the small business definition.

Consultation

Since 2001, the Department has conducted engagement activities and various consultations related to drug names, labels and packages. This proposal builds on the feedback received in those consultations, as well as incorporates best practices from and discussions with international counterparts. A summary of the consultations and feedback received is reflected below.

Overall, stakeholders have generally agreed with the issue, objective and key principles of the plain language labelling proposals, including the targeted regulatory approach. The issue of preventable medication errors is recognized as being a complex and system-wide concern, and it is acknowledged as an issue relevant to both prescription and non-prescription drugs.

When considering effective implementation of the proposals, stakeholders have noted the importance of Health Canada’s review capacity and consistency. Discussions regarding implementation and transition planning have suggested a stepwise and burden-reducing approach, supported by education and awareness activities.

Technical discussions on regulatory modernization for therapeutic products (January 2011)

These sessions included a broad range of stakeholders, representing the perspective of the regulator, industry, health professionals, consumer and patient groups, academics, international partners and other government departments.

The discussion topic on labelling generated strong support from all stakeholders for requiring clear, accurate and easily understandable labelling, and standardization of labelling and packaging was suggested as a means to reduce medication errors. The main concern noted was any “unique-to-Canada” requirements or overly prescriptive requirements.

Discussions with international counterparts (2012)

Health Canada has also undertaken discussions with international counterparts including Europe’s EMA, Australia’s TGA and the U.S. FDA. Lessons learned include the benefit of receiving colour mock-ups; the insights that can be gained through user testing or comprehension studies; the common format of a Drug Facts table assisting users in identifying important information and aiding in proper use; the factors to consider for LASA drug name, labels and packages; and the situations that may warrant formal requests to change a label or package. International counterparts have also provided insight into challenges they have faced regarding implementation, including recommending two- to three-year transition periods as opposed to coming into force on the date registered.

Plain language labelling (December 2012)

In advance of developing proposals for publication in the Canada Gazette, Part Ⅰ, Health Canada held consultations with a broad range of stakeholders, including patient and consumer groups, patient safety associations, health professional groups, and industry associations. Stakeholders expressed general agreement with the issue, objective and key principles of the proposals and supported flexible, non-prescriptive regulations that would not have to be regularly amended over time as products evolve.

Through the consultations, industry expressed that it faces several challenges, including small container sizes, a need to label products in both English and French, and, given the globally integrated nature of the drug industry, the challenges in meeting unique regulations in each international jurisdiction. Consequently, Health Canada consistently heard that international alignment, a phased approach to accommodate the natural life cycle of a product, and details of associated guidance and consultations would be critical in order to meet the proposed new requirements for label and package mock-ups, LASA name assessments, common table format for non-prescription drug labels, accessibility, and discretionary abilities for Health Canada when there is a health or safety concern.

Feedback on the specific proposals is summarized as follows:

  • Label and package mock-ups: It was confirmed that the requirement to submit a scaled mock-up of the label and package is standard practice internationally during the pre-market assessment of products for market authorization. The main concerns discussed relate to operational implementation of this requirement, such as when mock-ups would have to be submitted during the review period.
  • LASA name assessments: Stakeholders agreed with the importance of drug name selection and the role a name can play in choosing a product. Although industry acknowledged that name assessments are not a new concept in Canada or internationally, there was interest in learning further details and comments about the importance of a consistent approach across product lines (e.g. products available in a selfselection environment). Note: A LASA webcast was hosted in February 2013, and the Department is also currently analyzing comments received from the consultation (February to April 2013) on the revised guidance to industry on LASA name assessments.
  • Common format for non-prescription drug label panels: There was general agreement that standardizing certain aspects of labels helps improve comprehension and safe use. There was support for the proposal as it would align with international approaches (e.g. U.S. Drug Facts table and Australian proposal for Medicine Information Box) and therefore facilitate label reviews.
  • Accessibility: Access to approved and up-to-date information was recognized as a complex and multi-jurisdictional issue, where pharmacies have in place systems that provide drug information from third-party vendors; in this matter, stakeholders recognized that issues of accessibility are beyond the scope of this regulatory proposal and would require further collaborative efforts between Health Canada, pharmacies, and the associations which represent pharmacies.
  • Discretionary authorities for Health Canada (i.e. to request further information such as user testing or comprehension studies and to request changes to labels or packages): There was general support for Health Canada having additional tools or authorities in warranted situations (e.g. when a product is switching from prescription to non-prescription status, when it is important to ensure that consumers use the medication properly, when there are reports of medication errors resulting from confusing names, or when safety-related label changes made in another country should also be made in Canada). These authorities would be similar to those in other jurisdictions.

Regulatory cooperation

The existing Regulations do not yet take into account ways to better reflect current knowledge of medication use and minimize opportunities for confusion with labels, packages or names. Other regulators have taken similar steps to improve drug safety, and this proposal aims to align Canadian practices with international best practices, while also considering the Canadian context and the least burdensome approach for transition and implementation. The proposed amendments would better align Canadian requirements with those of the United States, Europe or Australia, as follows:

Regulatory proposal

United States

Europe

Australia

Plain language labelling

ü

ü

ü

Submission of mock-ups

ü


(on request)

ü

X

LASA name assessment

ü

ü

X (see footnote 3)

Standard table format for OTCs

ü

X

X (see footnote 4)

Contact information to report harm

ü

X

X

The proposals would also support and build on the Government initiative of the Regulatory Cooperation Council (RCC), which has already resulted in work with the U.S. FDA on Common Monographs for over-the-counter drugs, and an example that can be seen in Canadian stores was through permitting the U.S. Drug Facts tables on sunscreens labels in Canada.

International alignment improves the efficiency of the regulatory system, while also enhancing the level of oversight of the drug products that Canadians use. The proposed amendments would help minimize regulatory differences with key partners through a flexible regulatory structure (e.g. outcome-based requirement for common format of non-prescription drug label panels) and through a phased transition period.

Rationale

Improving the safe and effective use of drugs and reducing the number of medication errors resulting from confusing drug names, labels and packages would be achieved through this proposal and associated updates to guidance and operational implementation. The proposed approach is intended to benefit patients, consumers and health care professionals by having the appropriate level of oversight and requirements in regulation. This approach was chosen because it provided the most targeted means of addressing existing gaps in the current Regulations as they related to labelling and packaging risks and preventable harm. The proposed Regulations would be supported by non-regulatory instruments such as guidance, best practices and collaborative approaches with other stakeholders that have a role to play in the development and dissemination of important drug safety information. Overall, the total net present value benefit of the proposed amendments would be approximately $72.4 million over 10 years, between 2013 and 2022.

Implementation, enforcement and service standards

Health Canada is proposing a phased coming into force of the amendments following final approval, with a six-month transition period for prescription drugs and a three-year transitional period for non-prescription drugs respecting certain provisions. This delayed implementation period is intended to provide time for industry to plan for and adjust to the new regulatory requirements, and provide Health Canada time to update its processes and train staff. The existing Regulations would remain in force until the date of coming into force of the proposed amendments.

Guidance documents created by Health Canada would be available to aid regulated parties in coming into compliance. For submission-related processes, Health Canada would adhere to existing service standards as provided in the Guidance for Industry: Management of Drug Submissions.

This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and the Food and Drug Regulations enforced by the Health Products and Food Branch Inspectorate.

Contact

Danielle Lozon
Policy, Planning and International Affairs Directorate (PPIAD)
Health Products and Food Branch (HPFB)
Health Canada
Address Locator: 3105A
Holland Cross, Tower B, 5th Floor
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Fax: 613-941-7104
Email: LRM_MLR_consultations@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), proposes to make the annexed Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use).

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice and be addressed to Danielle Lozon, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Health Canada, Address Locator: 3105A, Holland Cross, Tower B, 5th Floor, 1600 Scott Street, Ottawa, Ontario, K1A 0K9 (fax: 613-941-7104; email: LRM_MLR_consultations@hc-sc.gc.ca).

Ottawa, June 6, 2013

JURICA ČAPKUN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (LABELLING, PACKAGING AND BRAND NAMES OF DRUGS FOR HUMAN USE) AMENDMENTS

1. The portion of section A.01.016 of the Food and Drug Regulations (see footnote 5) before paragraph (a) is replaced by the following:

A.01.016. All information that is required by these Regulations to appear on a label of a food or a drug, other than a drug for human use in dosage form, shall be

2. The Regulations are amended by adding the following after section A.01.016:

A.01.017. Every label of a drug for human use in dosage form shall meet the following conditions:

  • (a) the information that is required by these Regulations to appear on the label shall be
    • (i) prominently displayed on it,
    • (ii) readily discernible to the purchaser or consumer under the customary conditions of purchase and use, and
    • (iii) expressed in plain language; and
  • (b) the format of the label, including the manner in which all of its text and any graphics are displayed on it, shall not impede comprehension of the information referred to in paragraph (a).

3. (1) Subparagraphs C.01.004(1)(c)(iii) and (iv) of the Regulations are replaced by the following:

  • (iii) adequate directions for use of the drug, except in the case of a drug to which subsection C.01.004.02(1) applies,
  • (iv) a quantitative list of the medicinal ingredients of the drug by their proper names or, if they have no proper names, by their common names, except in the case of a drug to which subsection C.01.004.02(1) applies,

(2) Subsections C.01.004(1.1) to (1.5) of the Regulations are repealed.

(3) The portion of subsection C.01.004(2) of the Regulations before paragraph (a) is replaced by the following:

(2) In addition to the requirements of subsection (1), the outer label of a drug shall display the following information:

4. The Regulations are amended by adding the following after section C.01.004:

C.01.004.01 (1) Every label of a drug for human use in dosage form shall display the following:

  • (a) a telephone number, email address, website address, postal address or any other information that enables communication with a contact person in Canada; and
  • (b) a statement to the effect that any injury to a person’s health that is suspected of being associated with the use of the drug may be reported to the contact person.

(2) Subsection (1) does not apply to

  • (a) the labels of a drug as defined in section C.03.001 or C.04.001; or
  • (b) the inner and outer labels of a drug to which section C.01.004.02 applies.

5. The Regulations are amended by adding the following before section C.01.004.1:

C.01.004.02 (1) In addition to the requirements of section C.01.004, the inner and outer labels of a drug for human use in dosage form shall clearly and prominently display, either one bilingual table, placed on any panel, that contains only the following information in both English and French or one unilingual table in English and one unilingual table in French, each of which is placed on any panel, that contains only the following information:

  • (a) adequate directions for use of the drug;
  • (b) a quantitative list of the drug’s medicinal ingredients by their proper names or, if they have no proper names, by their common names;
  • (c) the drug’s non-medicinal ingredients listed in alphabetical order or in descending order of predominance by their proportion in the drug, preceded by words that clearly distinguish them from the medicinal ingredients; and
  • (d) the information referred to in subsection C.01.004.01(1).

(2) If a package is too small to accommodate an outer label that displays one bilingual table that lists all of the drug’s non-medicinal ingredients or two unilingual tables, each of which lists all of the drug’s non-medicinal ingredients, the list of non-medicinal ingredients shall be displayed in both English and French on a tag, tape or card that is attached to the package.

(3) If pharmaceutical ink, a fragrance or a flavour has been added to the drug, the following expressions may be included in the list of non-medicinal ingredients to indicate that such ingredients have been added to the drug, instead of listing those ingredients or combinations of them individually:

  • (a) in the case where a bilingual table referred to in subsection (1) is displayed, the expressions “flavour/saveur”, “fragrance/parfum” and “pharmaceutical ink/encre pharmaceutique”; or
  • (b) in the case where two unilingual tables referred to in subsection (1) are displayed, the expressions
    • (i) “encre pharmaceutique”, “parfum” and “saveur” in the French-language table; and
    • (ii) “flavour”, “fragrance” and “pharmaceutical ink”, in the English-language table.

(4) If the composition of the drug varies from one lot to another,

  • (a) in the case where a bilingual table referred to in subsection (1) is displayed, the table shall include a reference to all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol “+/–” or “±” or the expression “or/ou” or “may contain/peut contenir”; or
  • (b) in the case where two unilingual tables referred to in subsection (1) are displayed,
    • (i) the French-language table shall list all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol “+/–” or “±” or the expression “ou” or “peut contenir”, and
    • (ii) the English-language table shall list all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol “+/–” or “±” or the expression “or” or “may contain”.

(5) For the purposes of paragraph (3)(a) and (4)(a), the French terms in the expressions may appear first.

(6) Subsections (1) to (5) do not apply to

  • (a) prescription drugs;
  • (b) drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner; and
  • (c) drugs that are represented as being solely for use as a disinfectant on hard non-porous surfaces.

6. Section C.01.010 of the Regulations is replaced by the following:

C.01.010. If it is necessary to provide adequate directions for the safe use of a parenteral drug or prescription drug that is used in the treatment or prevention of any disease, disorder or abnormal physical state mentioned in Schedule A to the Act, the disease, disorder or abnormal physical state may be mentioned on its labels, including package inserts, and, in that respect, the drug is exempt from subsections 3(1) and (2) of the Act.

7. (1) The portion of subsection C.01.014.1(2) of the Regulations before paragraph (a) is replaced by the following:

(2) An application under subsection (1) shall be made to the Director in writing and shall include the following information and material:

(2) Paragraph C.01.014.1(2)(g) of the Regulations is replaced by the following:

  • (g) an indication of whether the drug is for human use or veterinary use;

(3) Paragraphs C.01.014.1(2)(m) and (n) of the Regulations are replaced by the following:

  • (m) in the case of a drug for veterinary use, the written text of every label to be used in connection with the drug, including package inserts and any document that is provided on request and that sets out supplementary information on the use of the drug;
  • (m.1) in the case of a drug for human use, mock-ups of every label to be used in connection with the drug — including package inserts and any document that is provided on request and that sets out supplementary information on the use of the drug — and mock-ups of the drug’s packages;
  • (n) the name and title of the person who signed the application and the date of signature; and
  • (o) in the case of a drug for human use, an assessment as to whether there is a likelihood that the drug will be mistaken for any of the following products due to a resemblance between the brand name of the drug and the brand name, common name or proper name of any of those products:
    • (i) a drug in respect of which a drug identification number has been assigned, and
    • (ii) a radiopharmaceutical, as defined in section C.03.201, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01.

8. Section C.01.014.3 of the Regulations is replaced by the following:

C.01.014.3 The manufacturer or importer, as the case may be, or a person authorized by the manufacturer or importer, shall, within 30 days after the day on which the sale of a drug begins in Canada, date and sign the document referred to in subsection C.01.014.2(1) and return it with a statement set out on it that the information recorded in it is correct and with an indication of the date on which the drug was first sold in Canada.

9. Subparagraph C.01.062(5)(e)(ii) of the Regulations is replaced by the following:

  • (ii) all labels to be used in connection with the drug, including package inserts, make proper claims in respect of the drug,

10. (1) Subsection C.08.002(1) of the English version of the Regulations is amended by adding “and” at the end of paragraph (b) and by replacing paragraph (c) with the following:

  • (c) the notice of compliance in respect of the submission has not been suspended under section C.08.006.

(2) Paragraph C.08.002(1)(d) of the Regulations is repealed.

(3) Paragraph C.08.002(2)(j) is replaced by the following:

  • (j) in the case of a new drug for veterinary use, a draft of every label to be used in connection with the new drug, including package inserts and any document that is provided on request and that sets out supplementary information on the use of the new drug;
  • (j.1) in the case of a new drug for human use, mock-ups of every label to be used in connection with the new drug — including package inserts and any document that is provided on request and that sets out supplementary information on the use of the new drug — and mock-ups of the new drug’s packages;

(4) Subsection C.08.002(2) of the Regulations is amended by striking out “and” at the end of paragraph (m) and by replacing paragraph (n) with the following:

  • (n) in the case of a new drug intended for administration to food-producing animals, the withdrawal period of the new drug; and
  • (o) in the case of a new drug for human use, an assessment as to whether there is a likelihood that the new drug will be mistaken for any of the following products due to a resemblance between the brand name of the new drug and the brand name, common name or proper name of any of those products:
    • (i) a drug in respect of which a drug identification number has been assigned, and
    • (ii) a radiopharmaceutical, as defined in section C.03.201, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01.

11. Subparagraph C.08.002.01(2)(b)(i) of the Regulations is replaced by the following:

  • (i) the information and material described in paragraphs C.08.002(2)(a) to (f), (i) to (m) and (o),

12. Subparagraphs C.08.002.1(2)(a)(i) and (ii) of the Regulations are replaced by the following:

  • (i) paragraphs C.08.002(2)(a) to (f), (j) to (l) and (o), in the case of an abbreviated new drug submission, and
  • (ii) paragraphs C.08.002(2)(a) to (f), (j) to (l) and (o), and subparagraphs C.08.002.01(2)(b)(ix) and (x), in the case of an abbreviated extraordinary use new drug submission;

13. (1) Subsection C.08.003(1) of the English version of the Regulations is amended by adding “and” at the end of paragraph (b) and by replacing paragraph (c) with the following:

  • (c) the notice of compliance in respect of the supplement has not been suspended under section C. 08.006.

(2) Paragraph C.08.003(1)(d) of the Regulations is repealed.

(3) Paragraph C.08.003(2)(g) of the Regulations is replaced by the following:

  • (g) the labels to be used in connection with the new drug or the new drug’s packages;

TRANSITIONAL PROVISIONS

14. For the purposes of sections 16, 19, 21 and 23, “submission” means any of the following:

  • (a) a new drug submission that is filed under section C.08.002 of the Food and Drug Regulations;
  • (b) an extraordinary use new drug submission that is filed under section C.08.002.01 of those Regulations;
  • (c) an abbreviated new drug submission that is filed under section C.08.002.1 of those Regulations; or
  • (d) an abbreviated extraordinary use new drug submission that is filed under section C.08.002.1 of those Regulations.

15. Subsection C.01.014.1(2) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to an application for a drug identification number that is made under subsection C.01.014.1(1) of those Regulations before the day on which section 1 comes into force.

16. Subsection C.08.002(2), subparagraph C.08.002.01(2)(b)(i) or paragraph C.08.002.1(2)(a) of the Food and Drug Regulations, as the case may be, as that provision read immediately before the day on which section 1 comes into force, applies to a submission that is filed before the day on which section 1 comes into force.

17. In sections 18 to 23, “drug” means a drug for human use in dosage form other than a drug that belongs to one of the following classes:

  • (a) prescription drugs; or
  • (b) drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner.

18. Paragraph C.01.014.1(2)(m) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to an application for a drug identification number in respect of a drug that is made under subsection C.01.014.1(1) of those Regulations during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

19. Paragraph C.08.002(2)(j) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to a submission in respect of a drug that is filed during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

20. If a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations is issued for a drug in respect of an application referred to in section 18 or a submission referred to in section 19, section C.01.014.3 of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

21. If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations, for a drug in respect of a submission referred to in section 19, paragraph C.08.002(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

22. Paragraphs C.01.014.1(2)(m.1) and (o) of the Food and Drug Regulations, as enacted by subsection 7(3), do not apply to an application for a drug identification number in respect of a drug that is made under C.01.014.1(1) of those Regulations during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

23. Paragraphs C.08.002(2)(j.1) and (o) of the Food and Drug Regulations, as enacted by section 10, do not apply to a submission in respect of a drug that is filed during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

COMING INTO FORCE

24. (1) These Regulations, other than sections 3 and 5, come into force on the day that is 6 months after the day on which they are registered.

(2) Sections 3 and 5 come into force on the day that is three years after the day on which these Regulations are registered.

[25-1-o]

Footnote 1
The estimation is based on the estimated number of deaths attributed to medical errors multiplied by percentage considered preventable multiplied by percentage relating to medication errors (Baker and Norton).

Footnote 2
There were a number of cost-benefit analyses carried out by the U.S. FDA that were published in the Federal Register. For the purpose of this exercise, it was based on the information published in the Federal Register, Vol. 64, No. 51, March 17, 1999, under “Rules and Regulations.” The present value and the difference in number of the products available on the market and other factors were taken into consideration. See the cost-benefit analysis for more details.

Footnote 3
Proposals under consultation and consideration in Australia.

Footnote 4
Proposals under consultation and consideration in Australia.

Footnote 5
C.R.C., c. 870

Footnote a
S.C. 2012, c. 19, s. 414(2)

Footnote b
R.S., c. F-27