Publication

It has now been one year since Health Canada released a new policy to review drug and other health product names as part of its pre-market regulatory approval process.  The policy, which takes the form of a guidance document entitled Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names,[1] ("the Drug Name Review guidance") is Health Canada's response to safety concerns regarding "look-alike, sound-alike" health product names, and enables Health Canada to approve or disapprove the brand name of any health product on the basis of confusion. 

The Drug Name Review guidance is currently in effect for all drug submission types with respect to brand (proprietary) names for prescribed drugs for human use.[2]   The policy is not yet, however, in effect for over-the-counter drugs, natural health products, veterinary drugs and medical devices, despite earlier reports that these product were to become subject to the policy as of July 1, 2006.

It is important for health product manufacturers to note that Health Canada's name review is separate and distinct from the assessment of the eligibility of the name for trade-mark registration by the Canadian Trade-marks Office.  This bulletin is intended to serve as a reminder to drug manufacturers that their health product marketing and branding strategies can no longer be developed with consideration to trade-mark issues alone - consideration must be given to the effect of Health Canada's Drug Name Review policy.

"Look-Alike, Sound-Alike" Health Product Names

The Drug Name Review guidance defines "look-alike, sound-alike" ("LA/SA") health product names as names which have orthographic and/or phonetic similarity; in other words, names which sound similar when written or spoken.  The concern is that these similarities may pose a health risk by creating confusion, and consequently causing errors in the prescription, dispensing or administration of a drug or other health product.

The Drug Name Review guidance specifically discourages naming practices related to LA/SA health product names that increases the possibility of medication errors, including: (a) similarities in brand names (including the same brand name);[3] (b) similarities in brand names and generic names;[4] and (c) the addition of a modifying prefix or suffix to an existing brand name in the case of a product line extension.[5]

Health Canada has advised that submissions for prescribed drugs are now being reviewed in accordance with the procedures as described in the Drug Name Review guidance, but declined to comment as to whether any submission decisions based on a LA/SA name issue have been made.  Health Canada has advised that decisions made based on a LA/SA name issue are not public information and would be subject to a request made under the Access to Information Act.   Although it was admitted that there have been discussions in respect of making LA/SA decisions public, Health Canada advises that there are no immediate plans to implement such a system.

According to the Drug Name Review guidance, sections C.08.002(1), (2), and (3) and section C. 01.014.1(2) of the Food and Drug Regulations permit Health Canada to adopt a pre-market requirement that the names of health products not be confusing with one another.   Under the new policy, Health Canada will review all proposed drug names included in a submission for marketing approval to ensure that the name is not confusingly similar with an existing brand or generic name, and to ensure that the proposed name does not misleadingly imply therapeutic claims.

The Drug Name Review guidance sets out a variety factors which HPFB will consider when assessing the possibility of confusion between LA/SA names, which include:

a)      the marketing status of the product (prescription versus over-the-counter);

b)      the therapeutic category;

c)      the indication(s) and directions for use;

d)      the clinical setting for dispensing or use (inpatient or outpatient hospital or clinic vs. retail pharmacy for use in home);

e)      the packaging and labelling;

f)        the strength;

g)      the dosage form or routes of administration;

h)      the proposed dose and dosing interval;

i)        the similarity of target patient populations and storage (i.e., location on shelf); and

j)        the potential for harm.[6]

If, after all of the factors are assessed as a whole, it is concluded that the proposed name creates a safety risk, Health Canada can refuse to issue a DIN and/or a NOC.  If the brand name is the only outstanding issue on a submission, a NOC will be issued without indication of the brand name, and the sponsor can then follow up with an administrative submission in order to obtain approval of a  new brand name.  However, if there is an outstanding issue regarding the proposed proper name or common name of the drug, then a NON will be issued for the proposed product. The sponsor of the drug submission has a right to appeal a LA/SA name review decision in accordance with Health Canada's general appeal procedure for drug submissions.

The Drug Name Review guidance sets out the information that should be submitted by the sponsor to facilitate the name review process.  Firstly, the sponsor should submit a prioritized list of alternate name choices (maximum of 2) for consideration by Health Canada in the event that the proposed name is identified as being potentially confusing.  Secondly, sponsors are encouraged to submit a risk assessment and evaluation of the product's proposed brand name supported with studies, data and analysis.  

Finally, the Drug Name Review guidance provides that a target review period of 90-days has been set for the initial review of the proposed name.  Following the provision of preliminary feedback to the sponsor, Health Canada will complete a second, abbreviated review within 90-days of the anticipated date of approval, which focuses specifically on brand names that received approval from the time of the first review until approval of the submission in issue.  Because the name review process will take place concurrently with the remainder of the product review, it is not expected to impact the total drug review time.[7]

Currently, Health Canada does not have a formal process for the monitoring and review of marketed health products.  However, Health Canada has issued a draft guidance document, entitled Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names ("the Marketed Health Product Name Assessment guidance), to address the potential or actual safety issues that may arise after a drug has reached the market.

The Marketed Health Product Name Assessment guidance provides that a market authorization holder ("MAH"), in accordance with its responsibility under the Food and Drugs Act, is expected to proactively monitor health product name similarities between its product(s) and other marketed products, and, where its product name has caused or could potentially cause a medication error, to propose an appropriate mitigating intervention.[8]

Until Health Canada has developed a policy for responding to post-market safety issues, the Marketed Health Product Name Assessment guidance provides that, when LA/SA health product names are identified as problematic post-marketing, the MAH will be notified and be provided with the opportunity to suggest possible strategies that will mitigate risks.  Health Canada will work with the MAH collaboratively to devise a reasonable strategy to mitigate risk.  In situations were there is no agreement on an acceptable mitigating strategy, Health Canada may require the MAH to change the product name.

Health Canada now has an established policy for minimizing the risk of medication errors related to LA/SA health product names, at least in respect of prescribed drugs for human use, and therefore has an additional tool for ensuring patient safety in Canada.  However, these changes have a significant impact on health product manufacturers and must be considered when developing branding strategies and conducting trade-mark searches for drugs and other health products to be sold in Canada.

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