Guidance for Industry: Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names

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Policy and Promotion Division

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Guidance for Industry: Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names (PDF Version, 165 Kb)
Date: 2005-10-31

Table of Contents

• 1. Purpose
• 2. Background
• 3. Scope
• 4. Definitions
• 5. Policy
• 6. Procedures for Filing

Our file number: 04-117626-823

Release of the Revised Guidance Document: Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names

The purpose of this note is to inform you that, based on stakeholder feedback, a revised guidance entitled Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names has been posted on the Biologics and Genetic Therapies Directorate Website. It provides clarification to sponsors regarding the manner in which the Health Products and Food Branch (HPFB) foresees managing information and material related to proposed drug names for human use submitted by sponsors in accordance with the Food and Drugs Act and Regulations.

The proposed Drug Name Review: LA/SA Health Product Names guidance has been developed to implement the pre-market recommendations outlined in the Issue Analysis Summary: Look-alike Sound-alike (LA/SA)Health Product Names:The Development of a Comprehensive Policy Recommendation. Recommendations were developed to respond to a specific safety issue involving the potential for confusion between two approved biologics, as well as long-standing unresolved issues relating to LA/SA health product names.

For marketed health products, where name similarities may be an issue, please refer to the guidance, Marketed Health Product Name Assessment:Look-alike Sound-alike (LA/SA) Health Product Names.

If you have questions concerning this guidance, please contact:

Ms. Michèle Chadwick,

Policy and Promotion Division,
Centre for Policy and Regulatory Affairs,
Biologics and Genetic Therapies Directorate,
Health Canada,
Address Locator: 0702A,
Tunney's Pasture,
Ottawa, Ontario, K1A 0L2.

Email: Michele_Chadwick@hc-sc.gc.ca
Phone: (613) 946-5730
Fax: (613) 952-5364

Original signed by

Dr. Pierre Charest
Director General

Guidance for Industry

Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names

Published by authority of the
Minister of Health

• Draft Date2004/09/10
• Revision Date2005/10/25
• Effective Date2006/01/01

Health Products and Food Branch

^© Minister of Public Works and Government Services Canada 2004

Available in Canada through

Health Canada - Publications Brooke Claxton Building, A.L. #0913A Tunney's Pasture Ottawa, Ontario K1A 0K9

Tel: (613) 954-5995
Fax: (613) 941-5366

Également disponible en français sous le titre: Ligne directrice à l'intention de l'industrie: Examen de noms de médicaments : Noms des produits de santé à présentation et à consonance semblables (PSPCS)

Catalogue No.
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Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with the policies and governing statutes and regulations. They also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this guidance, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidances.

1. Purpose

The purpose of this guidance is to provide clarification to sponsors regarding the way in which the Health Products and Food Branch (HPFB) intends to manage and analyze information and material related to proposed drug names submitted by sponsors in accordance with the Food and Drugs Act and Regulations.

The benefits of a guidance document for Drug Name Review include:

• providing a framework for Health Canada to review the impact of a proposed name on the safe use of the drug;
• the identification of Health Canada's and submission sponsor's roles in the evaluation of a proposed drug name; and
• clarification to sponsors as to what information they should be submitting regarding the safety of a proposed name.

This guidance aims to articulate Health Canada's expectations and generate a level of consistency regarding the information submitted by sponsors regarding the impact of a proposed name on the safe use of a drug. A phased implementation of consistent use of this policy is planned where priority will be given to Schedule C, Schedule D (Biologics), Schedule F and prescribed drugs for human use^* before over-the-counter, natural health products, veterinary drugs and medical devices.

* Prescribed drugs are neither over-the-counter products nor are they listed on Schedule F. Examples include potassium chloride for injection and dextrose injection.

2. Background

Look-alike sound-alike (LA/SA) health product names refer to names of different health products that have orthographic similarities and/or similar phonetics (i.e.sound similar when written or spoken). These similarities may pose a risk to health by causing errors in prescribing, dispensing or in the administration of a product.

Various stakeholders, including the Canadian Medical Association (CMA), Canadian Pharmacists Association (CPhA), the Canadian Society of Hospital Pharmacists (CSHP) and the Institute for Safe Medication Practices-Canada (ISMP-Canada), have been concerned about LA/SA health product names for a number of years.

As outlined in the Issue Analysis Summary: Look-alike Sound-alike (LA/SA) Health Product Names: The Development of a Comprehensive Policy Recommendation, which was revised after consulting with affected stakeholders, it was recommended that when filing a submission, sponsors provide a name analysis and have the option of providing a prioritized list of name choices.

Within HPFB, it was recommended that a complex computer application be acquired to screen for LA/SA health product names and those names that are flagged be reviewed for their potential to cause confusion. If reviewers cannot come to a decision regarding a name's potential for confusion or if there is a dispute with the sponsors, it is recommended that the name be considered further by an Interdirectorate Name Review Committee.

3. Scope

A phased implementation of the LA/SA policy is planned where priority will be given to Schedule C, Schedule D (Biologics), Schedule F and prescribed drugs^* for human use before over-the-counter, natural health products, veterinary drugs and medical devices.

^*Prescribed drugs are neither over-the-counter products nor are they listed on Schedule F. Examples include potassium chloride for injection and dextrose injection.

This guidance document applies to all drug submission types^{Footnote 1} received from the effective date of this guidance including:

• New Drug Submissions (NDS);
• Supplement to a New Drug Submission (SNDS) that include a change to the name of the drug ;
• Abbreviated New Drug Submission (ANDS) (ABNDS [acronym for veterinary drugs]);
• Supplement to an Abbreviated New Drug Submission (SANDS) (SABNDS [acronym for veterinary drugs]) that involve a change to the name of the drug ; and
• Applications for Drug Identification Numbers (DINA) (includes DINBs), or any administrative NDS, SNDS, ANDS (ABNDS for veterinary drugs), SANDS (SABNDS for veterinary drugs) or DINs that involves a change to the name of the drug.

In an effort to reduce the medication errors related to LA/SA health product name similarities, sponsors should carefully consider the potential for LA/SA similarities with products that are currently on the market. All proposed brand names submitted will be reviewed to ensure that they are unlikely to cause medication errors with brand names or generic names.This guidance will specify the way in which information and material regarding drug names submitted to Health Canada will be managed.

4. Definitions

Brand name (or proprietary drug name):

C.01.001.(1) of the Food and Drug Regulations states that a "brand name" means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French, (a) that is assigned to the drug by its manufacturer, (b) under which the drug is sold or advertised, and c) that is used to distinguish the drug.

The use of a brand name or proprietary name

is the choice of the sponsor. As stated in Section C.01.004. (1) of the Food and Drug Regulations, a drug is identified on its inner and outer label by the brand name (if there is one) followed by the proper name, if any. If there is no proper name, the common name is listed instead. For products with multiple ingredients, the product will have a brand name but no proper or common name for the product; only a proper name for each ingredient.

Chemical name:

The chemical name of a drug provides an unambiguous picture of a molecule so that a trained chemist can use it to draw its structure if required {i.e., 4-(4-Chlorophenyl)-1-[3-(4-flurobenzoyl) propyl]-piperidin-4-ol: 4-[4-p-Chlorophenyl]-4-hydroxypiperidino]-4-flurobutyrophenone is the chemical name for Haloperidol}.^{Footnote 2}

Common name:

C.01.001.(1) of the Food and Drug Regulations states that a "common name" means, with reference to a drug, the name in English or French by which the drug is (a) commonly known and (b) designated in scientific or technical journals, other than the publications referred to in Schedule B to the Act.

Generic name:

The generic or non-proprietary name describes the drug substance. International Nonproprietary Names are created to identify generic names as unique, universally applicable and accepted names. A generic name is the proper name of an ingredient, or the common name if the ingredient has no proper name.

Health product:

Health products include pharmaceuticals, biologicals, vaccines, medical devices, natural health products, radiopharmaceuticals and veterinary drug products.

International Nonproprietary Name (INN):

INNs identify a drug substance by a unique, universally applicable and accepted generic name. It is noted that chemicals that do not have a defined chemical composition or structure or that cannot adequately be described cannot be assigned INNs (i.e., mixtures of substances). An INN is the only internationally accepted generic name. In Canada, INNs are used exclusively, when they exist, in Schedule F.^{Footnote 3,Footnote 4}

Look-alike Sound-alike (LA/SA) Health Product Names:

Health products that have a similar written name or similar phonetics to those of another health product.

Product line extension:

A product line extension results when a drug is named by using the brand name of another drug with the addition of a modifying prefix or suffix that is intended to distinguish the new product from the original. In some cases, this practice has arisen as a marketing strategy to take advantage of familiarity of an original product name.^{Footnote 5}

Proper name:

C.01.001.(1) of the Food and Drug Regulations states that a "proper name" means, with reference to a drug, the name in English or French (I) assigned to the drug in section C.01.002, (ii) that appears in bold-face type for the drug in these Regulations and, where the drug is dispensed in a form other than that described in this Part the name of the dispensing form, (iii) specified in the Canadian licence in the case of drugs included in SCHEDULE C or SCHEDULE D to the Act, or (iv) assigned in any of the publications mentioned in SCHEDULE B to the Act in the case of drugs not included in subparagraphs (I), (ii) or (iii) of this paragraph. For products with multiple ingredients, there is no proper name for the product but there is a proper name for each ingredient.

Trade-mark:

Section 2 of the Trade-marks Act states that a trade-mark is (a) a mark that is used by a person for the purpose of distinguishing or so as to distinguish wares or services manufactured, sold, leased, hired or performed by him from those manufactured, sold leased, hired or performed by others, (b) a certification mark, c) a distinguishing guise, or (d) a proposed trade mark.

Trade-name:

Section 2 of the Trade-marks Act states that a trade name is the name under which any business is carried on, whether or not it is the name of a corporation, a partnership or individual.

United States Adopted Name (USAN):

USANs identifies nonproprietary names for drugs by establishing simple, logical nomenclature based on pharmacological and/or chemical relationship. The USAN committee develops the names, taking into account practical considerations, such as the existence of trademarks, international harmonization of drug nomenclature, the development of new classes of drugs, and the fact that the intended uses of substances for which names are being selected may change.^{Footnote 6}

5. Policy

The Food and Drug Regulations require that a drug's name be provided in a drug submission as part of the information required to assess the safety and effectiveness of a product (refer to sections C.08.002 and C.01.014 of the Food and Drug Regulations). These regulations allow HPFB to adopt a pre-market requirement that the names of drugs not be confusing with one another [see subsection C.08.002.(1), C.08.002.(2), C.08.002.(3) and C.01.014.1(2) of the Food and Drug Regulations]. If confusion is considered likely and could result in safety concerns, then HPFB can refuse to issue a DIN (new drugs and drugs other than new drugs) and/or a Notice of Compliance (NOC) [new drugs only], as applicable.

HPFB will review all proposed drug names as part of the drug review process. If a potentially confusing name is identified during the review, it may be disallowed. If a proposed drug name is rejected, and the sponsor has chosen to submit a prioritized list of name choices (maximum of two), the subsequent name on this list will be assessed.

If the name is the only outstanding issue of a submission, the proposed product will be issued a NOC or NON, as applicable. For instance, if it is the brand name that is at issue, an NOC will be issued without the brand name*. However, if there is a outstanding issue with the proper name (or common name if there is no proper name), a NON will be issued for the proposed product since an NOC cannot be issued without a proper name or common name, as applicable.

* Sponsors could then follow up with an administrative submission in order to obtain approval of a proposed brand name.

Specific naming practices related to LA/SA health product names that increase the possibility of medication errors are discouraged. They include the following:

1. Similarities in brand names (including the same brand name)
   Products having similar or the same brand names are discouraged especially when the products do not contain the same active ingredient(s).
   
   Related to similar brand names, the practise of using abbreviations or suffixes in brand names is discouraged as it is perceived to increase the chance of confusion and/or error. Ideally, a proprietary name should consist of only one word and should avoid qualifications by letters or numbers. However, if qualifications/abbreviations are to be included in the name, appropriate justification for their inclusion should be provided (i.e. the use of abbreviations could be acceptable if there is a need to distinguish different routes of administration for the same medicinal product, e.g. IV: intravenous, IM: intramuscular, SC: subcutaneous).
   
   
2. Brand names similar to generic names
   Health Canada discourages the use of similarities between brand names and generic names for products that contain different medicinal ingredients as they may result in medication errors and may impede the development of new non-proprietary names (INN or USAN names).
   
   
3. Product line extensions
   A product line extension results when a drug is named by using the brand name of another drug with the addition of a modifying prefix or suffix that is intended to distinguish the new product from the original. Most concerning to Health Canada are those product line extensions that contain a drug product with a different medicinal ingredient or combination of medicinal ingredients from the established parent drug product. As Health Canada's principal consideration is to ensure that drugs are taken safely and correctly, if a sponsor would like to proceed with a product line extension, they must provide a rationale stating why it is unlikely the proposed name will not give rise to safety and/or efficacy concerns. Health Canada may reject the name if it considers that the name may cause confusion, may be misleading or unsafe.

6. Procedures for filing

Please refer to the document Guidance to Industry: Management of Drug Submissions and the latest version of the Guidance to Industry: Management of Regulatory Submissions (veterinary drugs only) that provides clarification as to how the HPFB manages information and material submitted by sponsors in accordance with the Food and Drugs Act and Regulations.

Proposed proprietary drug names submitted with an NDS, SNDS, ANDS ( or ABSNDS), SANDS (or SABNDS), DIN and any administrative submissions that involve a change to the name of a drug will be reviewed when the submission is filed. Once the submission is received, Health Canada will complete an initial review of the name within a 90* day target. At this time, Health Canada feedback would have to be preliminary in nature because it is possible that another product (or products) may be approved between the time of the initial name review and final approval (NOC and/or DIN) of the product in question. As a result, a second but abbreviated review of the proposed proprietary name is necessary and will be completed within 90 days of the anticipated day of approval that focuses specifically on proprietary names that were approved by HPFB from the time of first review until approval of the said submission. If in the unlikely event that more than one submission proposes the same or similar proprietary name for different products, the sponsors will be advised of the concerns about the potential for confusion and HPFB will work to facilitate a satisfactory solution for all parties involved. In the event that this does not occur, Health Canada will proceed with the approval of all submissions. However, when the first drug submission is approved, the other sponsors will be asked to change the name before it can be approved.

* As Labelling Standards, Category IV Monographs and administrative submissions have a 45 day review target, these name reviews will need to be prioritized in the name review workload.

To facilitate the name review process, sponsors should submit the following:

• a proposed proprietary name and, if desired, a prioritized list of alternate name choices (up to a maximum of 2 alternate names); and
• a risk assessment and evaluation of the product's proposed brand name supported with studies, data and analysis.

As the science for the assessment of drug names is developing, it is unclear which assessment technique is the best at predicting risk of LA/SA drug name errors. As such, a risk assessment can include but is not limited to: search for similar proprietary and nonproprietary names (drug/medical reference search), computer analysis (orthographic/phonetic), prescription testing studies (verbal and handwritten studies), review of medication error literature and/or a systematic assessment of the name [possibility of medication error including contributing factors (i.e., dosage form or route of administration)] and process flow (i.e., Who purchases? Where stored? Who prescribes?, Ordering process? Where used? Reordering?).

HPFB will consistently review proposed drug names, initially screening the proposed product for similarities with the names of products that are currently on the market or have been submitted to HPFB for approval. Proposed names that are flagged will be scrutinized more carefully for specific similarities identified. Whether or not a proposed name is flagged, a general name review will be performed and HPFB will consider the risk assessment and evaluation of the proposed product's name provided by the sponsor.

Specifically, in determining whether the degree of similarity in names is problematic, the following contributing factors will be taken into consideration during the review, as applicable:

• the marketing status (Rx or OTC);
• therapeutic category ;
• indication(s) and directions for use ;
• the clinical setting for dispensing or use (inpatient or outpatient hospital or clinic vs. retail pharmacy for use in home);
• the packaging and labelling ;
• the strength ;
• the dosage form or routes of administration;
• the proposed dose and dosing interval;
• similar patient populations; and
• storage.

In determining whether the degree of similarity in names is problematic for self-care health products, the following contributing factors would be taken into consideration during the review, as applicable:

• the marketing status (OTC use) and setting for use;
• the therapeutic category and the indications;
• the packaging and labelling ;
• the location on the shelf; and
• similar patient populations.

Other considerations such as the proposed dose and dosing interval, dosage form, routes of administration and strength would not tend to be as significant considerations for self-care health products as for Rx drugs.

When comparing the proposed name with another, the potential for harm will be assessed. For instance, the consequences of the patient missing the pharmacological action of the intended drug and the pharmacological actions and toxicities of the unintended drug will often be considered.

Generally, if one or more of the factors listed above are different enough that the potential for confusion can be minimized, there may be less of a concern with the name since the chance of a medication error is smaller. After assessing all factors as a whole, Health Canada will decide if the proposed name creates a potential safety risk.