Canada: Confusion in Drug and Health Product Names

Originally published in FDLI Update, July/August 2006

Health Canada’s New "Look-Alike, Sound-Alike" Policy

Manufacturers who wish to sell drug and health products in Canada may need to revisit their branding strategies as a result of Health Canada’s new policy regarding the premarket regulatory approval process. The new policy, entitled "Drug Name Review: Look-alike Sound-alike Health Product Names,"1 is Health Canada’s response to concerns about the medical risks associated with "look-alike, soundalike" (LA/SA) names for drugs and other health products. Before this new policy was introduced, these concerns were generally dealt with informally on a case-by-case basis.2

LA/SA names refer to names that are similar when written or spoken. The concern is that such orthographic and phonetic similarities create confusion between two or more product names, which could lead to errors when prescribing, dispensing, or administering the products.

Health Canada’s new LA/SA Policy took effect January 1, 2006, with respect to brand or proprietary names for drugs—that is, Schedule C drugs (radiopharmaceuticals), Schedule D drugs (biologics), Schedule F drugs (prescription drugs), and prescribed drugs for human use.3 Over-the-counter drugs, natural health products,4 veterinary drugs, and medical devices are scheduled to become subject to the policy on July 1, 2006.

The Food and Drug Administration (FDA) reviews only proposed brand (proprietary) names of prescription drugs for LA/SA name risks; thus, Health Canada will be reviewing the names of a broader range of products than FDA.5

LA/SA Names

Name confusion is thought to account for one in every four medication errors. Statistics show that 12.5% of the 25,000 medication error reports received by FDA relate to names. Furthermore, a recent FDA study of 400 deaths caused by medication errors found that five percent of the deaths were attributed to brand (proprietary) name confusion and four percent to generic (nonproprietary) name confusion. 6 Because most of the drug names that exist in the United States are also used for Canadian products, it is reasonable to hypothesize that these statistics are applicable in Canada as well.

Of particular concern to Health Canada is the health risk associated with the following:

  • Similarities in brand (proprietary) names. Health Canada discourages products from having similar or identical brand names, especially when the products do not contain the same active ingredients.
  • Brand names that are similar to generic (nonproprietary) names. Health Canada is concerned when a brand name is confusingly similar to the proper or common name7 of a drug ingredient.
  • Product line extensions. Health Canada cautions drug companies against using similar names in their product line extensions. Specifically, Health Canada is concerned about the practice of adding a modifying prefix or suffix to the name of a product to distinguish it from the original product.

Table 1 lists examples of drug names that Health Canada has identified for their potential LA/SA confusion.8

Premarket Drug Name Review Process

Under the new LA/SA policy, Health Canada will review all proposed drug names included in a submission for marketing approval to ensure that 1) the name is unlikely to be confused with existing brand or generic names and thus cause medication errors, and 2) the brand name is not misleading (i.e., does not imply therapeutic claims).

The name review is separate from the assessment of the eligibility of the name for trademark registration. The Canadian Trademarks Office reviews a proposed trademark to determine whether, from a marketing perspective, it is confusingly similar to other trademarks (i.e., to protect trademarks from being used by others for financial gain), whereas Health Canada examines the product’s name from a safety perspective (i.e., to reduce medication errors).

To determine whether the similarity between the two names is problematic, Health Canada will consider a variety of factors including:

  • marketing status (prescription versus over-the-counter);
  • therapeutic category;
  • indications and directions for use;
  • clinical setting for dispensing or use (inpatient or outpatient hospital or clinic versus retail);
  • packaging and labeling;
  • strength of the products;
  • dosage form or routes of administration;
  • dose and dosing interval;
  • patient populations;
  • storage; and
  • potential for harm.

An initial review of the proposed drug name will take place within 90 days of the submission, and a second review will take place within 90 days of the drug’s anticipated approval date. Because the name review will take place concurrently with the rest of the product review, it is not expected to have any impact on the total drug review time.9

Table 1: Common Look-Alike, Sound-Alike Drug Names

Products that have similar brand names, but treat different conditions.

CelebrexTM
(treatment of inflammatory arthritis)

Celexa®
(treatment of depression)

Cerebyx®
(seizure control)

AccutaneTM
(treatment of acne)

AccuprilTM
(treatment of hypertension)

 

Sarafem®
(treatment of premenstrual dysphoric disorder)

Serophene®
(fertility aid)

Lamictal®
(treatment of bipolar disorder)

Lamisil®
(treatment of nail fungus)

Serzone®
(treatment of depression)

Seroquel®
(treatment of mania)

Losec®
(treatment of stomach acid production)

Lasix®
(diuretic)

Zantac®
(treatment of stomach acid production)

Zyrtec®
(allergy medication)

Product line extensions—names appear similar but treat different conditions.

Depakote®
(treatment of bipolar disorder)

Depakote® ER
(treatment of seizures)

 

The sponsors of the drug submission are encouraged to submit a prioritized list of up to two alternative names so that if Health Canada identifies the proposed name as potentially confusing, the department will consider the alternative names. Sponsors are also encouraged to submit a risk assessment and an evaluation of the product’s proposed name, supported with studies, data, and analysis. Health Canada recommends that sponsors consult with pharmacists and healthcare providers when preparing the name review analysis.

Currently, Health Canada will not undertake its own risk assessment or evaluation of the drug’s proposed name to determine whether a LA/SA name issue exists. Instead, Health Canada will rely on the information provided by the sponsor. Although Health Canada plans to implement a computer application that screens health product names for potential LA/SA confusion, currently, the application is still being developed. In the United States, FDA carries out an independent name review of the proposed drug name using an expert panel review, handwriting and verbal analyses, computer-assisted analysis, labeling and packaging analysis, and overall risk evaluation.10

If sponsors have not submitted alternative proposed drug names with a drug submission or if all the names have been rejected, the drug submission will be placed on "name hold" until a proposed alternative name is acceptable to Health Canada.11 Sponsors have the right to appeal Health Canada’s LA/SA name review decisions, in accordance with Health Canada’s general appeal procedure for drug submissions.12

Postmarket Drug Name Review

Although Health Canada will not review the names of products already on the market, the department will monitor the names of these products, as well as the names of products that underwent a name review but for which a name safety issue was not identified during the premarket approval process. Health Canada is investigating the possibility of developing a more formal process for monitoring and reviewing marketed products for safety issues.

The current postmarket review procedures are outlined in the policy entitled "Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names."13

When LA/SA drug and health product names are identified as a concern postmarketing, the product manufacturers will be given an opportunity to suggest a strategy that will mitigate identified risks. For example, the manufacturer may suggest issuing fact sheets, sending "Dear Healthcare Professional" letters, or changing the packaging or labeling of the product. If the suggestions are not acceptable to Health Canada as a viable way to reduce the risks associated with the LA/SA name issue, the manufacturer may be required to change the name of the health product.14

Health Canada acknowledges that significant brand equity and identity may have developed in a marketed health product by the time a LA/SA name issue is identified. If a manufacturer is required to change the name of a marketed product, the manufacturer may incur an economic loss due to costs associated with product recalls and loss of brand recognition. The health and safety of Canadians is of foremost importance to Health Canada, however. Thus, as a last resort, a name may need to be changed or modified to avoid errors.15

Conclusion

Health Canada’s new LA/SA policy represents an additional tool for ensuring the safety of drugs and other health products used by Canadians. The policy also represents a regulatory hurdle that manufacturers need to be aware of while developing their marketing and branding strategies.

Footnotes

1. Health Canada, Guidance for Industry, Drug Name Review: Look-alike Sound-alike Health Product Names (Oct. 31, 2005), available at http://www.hcsc. gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/brgtherap/ lasa_premkt-noms_semblables_precomm_e.pdf

2. Health Canada, Issue Analysis Summary: Look-alike Sound-alike Health Product Names: The Development of a Comprehensive Policy Recommendation for Look-alike Sound-alike Health Product Names (Mar. 23, 2004) [hereinafter Health Canada, Issue Analysis Summary], available at http://www.hc-sc.gc. ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/brgtherap/ lasa-pspcs_ias-ra_e.pdf.

3. Prescribed drugs are neither over-the-counter products nor listed in Schedule F. Examples include potassium chloride and dextrose injections.

4. These include herbal products, vitamins, and minerals, as well as a variety of consumer products that contain these substances. For example, many toothpastes and antiperspirants are classified as natural health products because they contain mineral compositions (fluoride, aluminum).

5. See Health Canada, Issue Analysis Summary, supra note 2.

6. Id.

7. A proper name is the name by which the drug is designated in scientific or technical journals. A drug ingredient is given a common name when there is no proper name.

8. The examples were retrieved from Health Canada, Look-alike Sound-alike (LA/SA) Health Product Names: Comments and Responses to the Related Draft Guidances 6 (Aug. 3, 2005), available at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfbdgpsa/ pdf/brgtherap/lasa_comm_rep-noms_conson_ sembl_comm_rep_e.pdf and Health Canada, Look-alike Sound-alike Health Product Names, What Are Look-Alike Sound-Alike (LA/SA) Health Product Names? (Aug. 14, 2003), available at http://www. hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/brgtherap/ lasa-pspcs_factsheet-faitsaillant_e.pdf.

9. Health Canada, Look-alike Sound-alike (LA/SA) Health Product Names: Comments and Responses to the Issue as Presented in the Issue Analysis Summary 21 (Mar. 24, 2004) [hereinafter Health Canada, Comments and Responses to Issue Analysis Summary], available at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/ hpfb-dgpsa/pdf/brgtherap/lasa-pspcs_com_response- reponse_e.pdf.

10. Health Canada, Issue Analysis Summary, supra note 2, at App. A.

11. Id. at 18.

12. Health Canada, Guidance for Industry, Reconsideration of Final Decisions Issued for Human Drug Submissions (effective Mar. 1, 2006), available at http://www. hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/ decisions_hum_drug_drogue_e.pdf.

13. Health Canada, Draft Guidance for Industry, Marketed Health Product Name Assessment: Look-alike Soundalike (LA/SA) Health Product Names (Nov. 10, 2005), available at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/ hpfb-dgpsa/pdf/brgtherap/lasa-pspcs_post_market- comm_guidance-directive_2_e.pdf.

14. Id. at 7.

15. Health Canada, Comments and Responses to Issue Analysis Summary, supra note 9, at 22.

Update 2006, Issue 4 With Permission from FDLI, www.fdli.org

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions