Electronic media in prescription drug labelling guidance: Guidelines

Links and barcodes

Guideline 1: Take into account the overall legibility of the prescription drug label when deciding on the location and the format of the link, and incorporate the link in a way that maximizes user accessibility.

The FDR requires that the format of a label, including the manner in which its text and any graphics are displayed on it, does not impede the comprehension of information that is required to appear on the label. This regulation is intended to improve the safe use of drugs by making drug labels easier to read and understand. You must consider the overall design of the label, including the placement of any key text or graphics, when incorporating a link to an electronic platform such as a URL or 2D barcode.

You should also make an effort to facilitate access to the platform so that as many users as possible can benefit. Links that are novel, overly complex or lacking context could impede access for some users. You should consider these strategies to maximize user accessibility:

If there is sufficient space on the label, offer users more than one way to access the electronic platform. For example, a 2D barcode should ideally be accompanied by a URL so that consumers can type the URL into an internet browser if they lack a device to scan the 2D barcode.
Select a user-friendly URL, using words rather than a series of numbers or random alphanumeric characters. A shorter URL may also be easier to enter into a browser.
If space permits, include a short statement near the link to explain its purpose and provide instructions for use.

Advertising

Guideline 2: Ensure that the design and content of the platform do not violate federal advertising laws

Distributing prescription drug information electronically can expose you to the risk of advertising violations, even when this information is intended for non-promotional purposes. For example, prescription drug information (beyond name, price and quantity) which is accessible to the general public could be considered promotional and in violation of federal advertising laws. You should take appropriate measures to prevent potential compliance issues.

When designing a platform intended for patients or health care providers, you should incorporate a robust 'gating' mechanism (a virtual barrier that requires user authentication) on the platform to prevent public access. A "noindex" meta tag should also be used for every page behind a gating mechanism to prevent public access through search engine results.

You should also consider other potential risks unique to electronic media such as the use of metadata in Search Engine Optimization (SEO) or Search Engine Marketing (SEM). Metadata for non-gated pages should not contain direct or implied product claims that would contravene the regulations.

You must also ensure that all materials (in all media formats) distributed through an electronic platform comply with federal advertising laws, even if the platform is gated. Whenever such materials contain a reference to a drug product, you must assess whether the information is promotional and whether it contravenes federal advertising laws.

You should consult the policy described in The Distinction Between Advertising and Other Activities to help determine whether information is promotional or not. In general, information on a platform (which is intended for patients and health care providers) will be considered non-promotional if it:

does not expand upon or conflict with the drug's PM
is limited to the drug for which the platform was designed
is gated by a robust mechanism to ensure access is limited to patients who have been prescribed the drug

Given the complexities associated with digital advertising, we strongly encourage you to submit your electronic platforms for review to an independent advertising preclearance agency prior to launching a platform. This will help ensure the platform is adequately protected from potential advertising violations.

Content and sources

Guideline 3: Ensure that drug information on a platform is consistent with the approved Product Monograph, and that non-drug information is derived from trusted, high-quality sources

Any information on an electronic platform is considered to meet the definition of a label under the FDA if it:

speaks directly to topics covered by the label of the drug in question, and
is linked to a drug's label, including the inner and outer label, package insert or PM

Because the PM serves as the standard against which all labelling information is compared, drug information on an electronic platform must be consistent with the most up-to-date version of the approved Canadian PM. Like physical labels, electronic labels must be for assessment and receive authorization prior to distribution. We will assess electronic labels as part of established regulatory drug review processes.

While we review electronic labels on electronic platforms as part of our regulatory review process, non-labelling materials (that are non-promotional in nature) are generally beyond our regulatory oversight. Nonetheless, patients and health care providers will rely on the accuracy of non-drug information distributed through such platforms. As such, you should ensure that this information, which could be disease or other health information, is derived from reputable and up-to-date scientific sources. When appropriate, references should be included to demonstrate the reliability of this information. You should also be careful not to express this information in a way that creates a false or misleading impression about the drug.

Separation of information

Guideline 4: Separate Health Canada approved electronic labels from other types of information on the platform

Electronic platforms may contain both information that would be classified as a label as well as non-labelling materials, such as disease or general health information. In order to help end-users distinguish between approved labels and other types of information, and to facilitate the submission and review of labelling materials, you should avoid blending these two types of information on the platform and should clearly separate them (for example, place them on different areas or webpages of a website). Avoid using statements such as "Health Canada approved" when organizing various content on a platform. These statements may be considered in violation of Section C.01.007 of the FDR, as described in the guidance document for Labelling of Pharmaceutical Drugs for Human Use.

Plain language labelling

Guideline 5: Present information in a way that is clear, understandable and accessible

The 2014 Plain Language Labelling (PLL) Regulations were enacted to improve the safe use of drugs by requiring labels that are clear, understandable and expressed in plain language. While these Regulations generally implicate physical labels, you should apply similar standards to electronic labels.

The application of PLL requirements to physical labels has required consideration of print-specific features such as:

type style and size
use of white space
colour and contrast

Electronic platforms can be a more complex medium. Unlike printed materials, electronic platforms can include dynamic elements such as audio and video content. While such features can offer new and effective ways of educating users, the nature of this medium also gives rise to potential accessibility barriers. People who may be particularly vulnerable to such barriers include:

those with disabilities
those who are unfamiliar with the technologies necessary to benefit from this medium

In the absence of Health Canada guidance on this topic, you should observe established and internationally recognized digital accessibility standards, such as the World Wide Web Consortium's (WC3) Web Content Accessibility Guidelines (WCAG). WCAG compliance can:

improve accessibility to electronic content
address many of the considerations necessary to achieve clear and understandable electronic labels

You should continue to express any electronic information in plain language.

Protection of personal information

Guideline 6: Protect any personal information collected through the platform

Any personal information collected by interacting with an electronic platform is subject to the Personal Information Protection and Electronic Documents Act (PIPEDA), the federal privacy law for private-sector organizations. PIPEDA sets the ground rules for how businesses should handle personal information in the course of commercial activity. There are a number of requirements associated with PIPEDA. In general, organizations must obtain an individual's consent when they collect, use or disclose that individual's personal information. In addition, personal information can only be used for the purposes for which it was collected.

Maintenance

Guideline 7: Maintain full control over the platform

You are responsible for ensuring that your electronic platform is compliant with all federal requirements. As such, you should maintain complete control over the platform including any information linked to it. This means ensuring that the platform does not link to third-party platforms that:

are beyond your control
may be or become non-compliant

In some cases, you may choose to contract the services of a third party to host your platform. Contracting a third party to host the platform does not change your regulatory obligations, regardless of the platform's host or location, and regardless of any agreements between you and the third party.

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Date modified:: 2021-05-18

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