Product Information (Labelling)

Having access to clear, accurate and understandable drug information is critical for health professionals and consumers to allow them to make informed decisions about drug therapies. The following provides an overview of product information so that stakeholders can provide input on the strategies that Health Canada is currently considering to improve how information about drugs is communicated.
 
Product information can include the product name, the product monographs, prescribing information, packaging labels (label on the immediate or outer container of drug), package leaflets (package inserts), file cards, fact sheets, dear health care professional letters, patient leaflets, patient diaries or other material containing drug product specific information.

For a discussion of strategies Health Canada is considering for improving the communication of accurate and up-to-date new safety information, please see the discussion paper on Post-Market Risk Communications for Drug Products.

Although maintaining and improving health and safety is a responsibility that is shared between governments (federal and provincial/territorial), industry, health professionals and their respective associations, Market Authorization Holders (usually the product manufacturers) are primarily responsible to develop the necessary information for the safe use of their product which is being sold to Canadians.

The Issue

For the purposes of this paper, product information (known as 'labelling' in the Food and Drugs Act) will refer to the product monograph and the materials included in the packaging or supplied to the consumer/patient at the time of purchase. This material includes the drug name, the label on the package (immediate or outer container of the drug), and package leaflets.

Product information communicates important information about a drug such as: what the drug name is, what the drug does and how it works; who should (or should not) use the drug; how much of the drug should be used and the dosing schedule; adverse events that have been associated with the use of the drug; and what kind of monitoring should be done when the drug is used (such as blood tests).

Various other types of information about drugs are available to health professionals, patients, and the public through the internet, fact sheets/pamphlets provided by pharmacies, and private publications. It has been noted that some of this information may not always be consistent with Health Canada-authorized product monographs.

The safe use of health products can be affected by the way in which they are named, packaged or labelled.  Confusion arising from health product naming, packaging or labelling is a significant cause of medication incidents and will be the subject of a subsequent discussion paper.

Health Canada needs to decide how to include product information in a progressive licensing model, for example:

• how should requirements for product information be reflected in regulations;
• whether additional product information activities should be undertaken by Health Canada;
• whether new regulatory authorities and /or processes are needed to require manufacturers to revise product information when new information becomes available; and
• how to disseminate product information.

Current Practices

Health Canada reviews and approves drug product information such as the name, labels, package leaflets, and product monographs/prescribing information prior to authorization for sale.

The product monograph is a factual, scientific document about the drug that describes the properties, claims, indications, and conditions for the use of the drug. It also contains any other information that may be required for the optimal use of the product. It does not contain promotional material. The information in the product monograph is more detailed than the information found on the package label.

Currently, product monographs are made available by Health Canada to all interested parties directly upon request and there are efforts underway to make product monographs available on the Health Canada Web site to all interested parties.

When products are purchased in their original packaging, package leaflets contain consumer-oriented, product-specific information and are provided with products purchased in their original packaging. However, when products are dispensed by a pharmacist (such as prescription drugs) the information provided at point-of-sale may not be consistent with Health Canada- authorized information. The nature and extent of the discrepancies however, is unclear at this time and there are no regulatory requirements that require pharmacies to provide Health Canada-authorized information to patients (the practice of pharmacy is regulated by the provinces and territories).

Under the current Food and Drug Regulations, manufacturers must submit labels and other product information to Health Canada as part of the overall application it submits for review prior to obtaining authorization to market a drug. When a new emerging potential risk is identified, Health Canada is limited in its ability to require a manufacturer to change the drug name, the contents of a label or product monograph after the product has received a Notice of Compliance, although it requests that manufacturers do so. This process can be time-consuming as there are no regulations in place to facilitate and guide the changes.

Other Countries' Practices

In the United States, manufacturers are required to submit proposed labels and product information for review as part of a drug submission. Currently there are no requirements for manufacturers to revise product information after marketing, although this is frequently done by the manufacturer after new information has become available or after a request from the Food and Drug Administration. There are calls for increased authorities for the FDA to be able to compel changes to product information. FDA approved product information is available in a publication known as the Physician's Desk Reference, and on the FDA Web site.

In Europe, manufacturers must also provide proposed labels and package leaflets with drug submissions. Any revisions to product information may be initiated by the manufacturer or regulatory authority. Regulatory authorities can also require manufacturers to update their products' labelling when new information becomes available and may suspend a marketing approval if the label and package leaflet do not comply with stated requirements. Drug specific information for health professionals and consumers is available on the European Medicines Agency Web site.

For some years the United Kingdom has implemented a risk management program for new drugs known as the Black Triangle Scheme, a program that identifies new products with a black triangle symbol. The purpose is to communicate to professionals and patients that the regulatory agency in the UK is intensively monitoring the product and wishes to receive all reports of suspected adverse reactions associated with these products. The symbol can also be used to identify products that are already licensed under certain conditions, such as when a product contains a new combination of active ingredients.

The Australian Therapeutic Goods Administration has the authority to require product labelling changes including the addition of contraindications, warnings, precautions and adverse reaction information to the Product Information and Consumer Medicines Information documents, which are designed for health professionals and consumers respectively.

Potential Strategies and Impacts

Health Canada is considering the following product information strategies:

• Updating requirements for product information in the Food and Drug Regulations so that they are consistent with a life-cycle approach;
• Including requirements specific to product monographs in the Food and Drug Regulations;
• Enhancing the availability of product monographs to health professionals and consumers (for example through the Health Canada Web site which is currently underway); 
• Including requirements regarding name changes, the revision of labels, product monographs, and package leaflets in the Food and DrugRegulations to address safety issues or to ensure that new risk information is included in a timely manner;
• Establishing new procedures for the timely updating of information included in labels and product monographs;
• Implementing a program similar to the 'Black Triangle' scheme in the United Kingdom to identify drugs of interest and/or maintaining a list of such drugs; and,
• Ensuring Canadians are receiving accurate and timely information (including at point of sale) to enable informed decision making.  This may be accomplished through work with health professionals, provincial/territorial governments, vendors, chain drug stores and patient groups etc.

Potential impacts of such changes could include increased availability of product information, quicker changes to product information, and greater awareness among stakeholders about product information and where to obtain it. An investment of resources would need to be made by Health Canada to ensure that product information is revised in a timely manner and those changes communicated to stakeholders.

Links

The following material originates with an organization not subject to the Official Languages Act and is available on this site in the language in which it was written.

FDA, Index to Drug Specific Information

EMEA, Index of European Public Assessment Reports

Health Canada, Guidance for Industry: Product Monograph

Contact information for the Progressive Licensing Project.