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Drugs and Health Products

Draft Revised Guidance Document for Industry - Review of Drug Names for Look-alike Sound-alike (LASA) Attributes

Notice to the reader: The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.

Effective Date: February 19, 2013

Foreword

Guidance documents are meant to provide assistance on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada's mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternative approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternative approaches should be discussed in advance with the relevant program area to avoid possibly 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 document. 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 relevant sections of other applicable guidance documents and policies.

Table of Contents

1 Introduction

1.1 Policy Objective

The Review of Drug Names for Look-Alike Sound-Alike (LASA) Attributes Guidance has the following policy objective:

To provide market authorization holders more detailed direction on the process to be followed and information to be submitted to Health Canada regarding the potential for a proposed name to be confused with another product authorized for use in Canada with the aim of reducing medication errors.

1.2 Policy Statements

  • Health Canada has the regulatory authority to consider brand names when making a decision on whether or not to grant a Notice of Compliance (NOC) or Drug Identification Number (DIN) to a sponsor.
  • It is the responsibility of the sponsor to provide Health Canada with information to support the safety of a proposed brand name.
  • As a regulator, Health Canada will review the evidence submitted by the sponsor and may reject a brand name if in its judgement, the proposed name is misleading or has the potential to result in safety concerns if confused with the name (brand or non-proprietary name) of another product authorized for use in Canada.
  • Safety concerns are inclusive of issues that may arise due to lack of efficacy, i.e., the consequences of not receiving the intended drug to possible serious reactions, including death, resulting from receiving a product that was not intended for use.
  • Safety issues may still arise once a product is marketed and used by healthcare professionals, patients and consumers on a day-to-day basis in an uncontrolled environment (as opposed to a controlled clinical trial environment). If a potential health risk is identified, Health Canada will address the issue and work in collaboration with a sponsor to develop mitigation strategies. Sponsors may be asked to change a name if other risk mitigation strategies are not deemed sustainable.

1.3 Background

Health product names often look and sound alike. These similarities sometimes cause clinicians and patients to confuse one drug name for another. Confusion can occur at any stage of the drug use process in inpatient, outpatient, and self-care settings. Depending on when they occur, they can cause prescribing errors, transcription errors, dispensing errors, administration errors, and consumer health product selection errors. The end result of a name confusion error is that the patient gets the wrong product. Wrong product errors harm patients by depriving them of the benefit of the correct treatment and by subjecting them, unknowingly, to the risks and adverse effects of the mistakenly selected health product. Such errors can and do cause serious harm, up to and including death. One observational study in the US reported a wrong drug error rate in retail pharmacy of 0.13%.Footnote 1 Assuming that the error rate is similar in Canada, this translates to more than 672,000 errors annually, based on an annual Canadian dispensing volume of 517 million prescriptions.

Regulatory Authority

The Food and Drug Regulations require that a product name be provided in a drug submission as part of the information required to assess the safety and effectiveness of the product. These regulations allow the Health Products and Food Branch (HPFB) to adopt a pre-market requirement that the names of drugs not be confusable with one another. If confusion is considered likely and could result in safety concerns, then HPFB can refuse to issue an NOC (for new drugs only) or a Drug Identification Number (DIN, for new drugs and existing drugs) as per C.01.014 and C.08.004 of the Food and Drug Regulations.

The Food and Drug Regulations also provide authority to the regulator to address safety issues when identified post-market. If a potential health risk with a brand name is identified, Health Canada will work with the manufacturer to address the issue. Sponsors may be asked to change the brand name of the product if long term mitigation strategies are not considered sustainable. Health Canada may invoke C.08.006 or C.01.013 of the Food and Drug Regulations in situations where the sponsor is not willing to comply.

Pre-Authorization Authorities under the Food and Drug Regulations:

Health Canada has the regulatory authority to consider brand names when making a decision on whether or not to grant a Notice of Compliance (NOC) and issue a Drug Identification Number (DIN) to a sponsor. As per the Food and Drug Regulations:

  • C.01.014.1(2) sets out what must be included in an application for a DIN which includes:
    • (f) the brand name under which the drug is to be sold
  • C.01.014 to C.01.014.3 provides the requisite legal authority to refuse to issue a DIN to include situations where a specific drug has a similar name to another, thus placing users at risk.
  • C.08.002(2), requires a submission contain sufficient information and material to enable the Minister to assess the safety and effectiveness of a new drug, including the following relevant subsection:
    • (b) a statement of the brand name of the new drug or the identifying name or code proposed for the new drug sold;
  • C.08.002(3) permits the Minister to further require additional information or material that is considered necessary to assess the safety and effectiveness of the new drug.

Where Health Canada is not satisfied in its queries and it is evident that a potential safety risk exists, Health Canada is entitled to refuse to issue a NOC/DIN in accordance with subsections C.01.014 and C.08.004 of the Food and Drug Regulations.

Post-Authorization Authorities under the Food and Drug Regulations:

The regulator may invoke the following two sections of the Food and Drug Regulations if a potential health risk is identified post-market:

  • Suspension of NOC: C.08.006(2)(f) provides the authority to suspend (for a definite or indefinite period) the NOC based on new information obtained after the issuance of the NOC that the brand name of a drug is or has been shown to be misleading. Under the section, the suspension follows the failure of the manufacturer to correct this problem following written notice.
  • Stop Sale: C.01.013 provides the authority to direct a manufacturer to stop sale of a drug when it fails to submit evidence sufficient to establish the safety of a drug by a specific date.

Policy History

In January 2006, Health Canada's Guidance for Industry - Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names became effective. Footnote i This guidance stated Health Canada's expectations and sought to generate consistency in the information submitted by sponsors regarding the impact of a proposed name on the safe use of a health product. However, internal analysis of LASA-related submissions since the release of the 2006 guidance has revealed significant variation in the amount, type, and quality of the evidence submitted by sponsors. This analysis, along with requests from industry for greater direction and continuing public concern about medication incidents due to LASA names, suggested that there was an opportunity to improve public health by revisiting the 2006 guidance on LASA names.

The revised guidance is intended to provide Health Canada with objective information in a standardized format. The availability of more and better evidence about the likelihood of confusion will allow Health Canada to make more informed decisions about the acceptability of a name.

1.4 Scope and Application

General

This guidance applies to biologic and pharmaceutical drugs (prescription and non-prescription) for human use in which a brand name is proposed (innovator and generic).

Non-proprietary name:

This guidance does not apply to a proposed proper/common (non-proprietary) name of the medicinal (active) ingredient and the drug product in final dosage form as defined by section C.01.001 of the Food and Drug Regulations. Some examples include: Furosemide Tablets, Sodium Chloride Injection, Benzoyl Peroxide.

A generic drug where the manufacturer's name or an abbreviation of the manufacturer's name is combined with the proper/common (non-proprietary) name is considered a brand name and should be assessed by the sponsor using the criteria outlined in section 2.3, Initial Brand Name Review (e.g., Canada-Furosemide Tablets or Can-Furosemide Tablets where Canada is the manufacturer's name, Can is the abbreviation of the manufacturer's name and the product is furosemide).

Addition of a modifierFootnote ii to a non-proprietary name is considered a brand name and should be assessed by sponsors using the criteria outlined in section 2.3, Initial Brand Name Review and Appendix 2: Subsequent Submissions.

Alteration (e.g., truncation, abbreviation) of the non-proprietary name is considered unacceptable (e.g., Sod Chlor Injection).

Initial Brand Name Review

All brand names should be assessed by sponsors using the criteria outlined in section 2.3, Initial Brand Name Review. A LASA brand name assessment should not be initiated prior to evaluating the proposed brand name against this criteria as there may be circumstances that will prevent Health Canada from starting further review.

Look-alike Sound-alike Brand Name Assessments

Not all brand names will require a LASA brand name assessment. The information outlined below provides a list of inclusions and exclusions.

Biologic and Pharmaceutical Prescription Drugs

A LASA brand name assessment is required for all submission types for biologics and pharmaceutical prescription drugs wherein a brand name is being proposed or where a change to an existing brand name is being proposed (as per sections C.08.002 and C.01.014 of the Food and Drug Regulations). This excludes brand names that contain the proper or common name(s) in final dosage form in combination with the manufacturer name or an acceptable abbreviation of the manufacturer name. Some examples include: Canada-Furosemide Tablets, Can-Furosemide Tablets (where Canada is the manufacturer and the product is furosemide).

Non-prescription Drugs

A LASA brand name assessment is required for non-prescription drugs wherein a brand name is being proposed or where changes to an existing brand name are being proposed (as per sections C.08.002 and C.01.014 of the Food and Drug Regulations).

Prescription to non-prescription switch (and vice versa) submissions will require a LASA brand name assessment, even if the name is not being changed.

Non-prescription drugs which require a LASA brand name assessment for review will not be eligible for submission as a Category IV Monograph or Labeling Standard and will instead need to be submitted as a DINA - Labeling Only submission

Sponsors will not be required to submit a LASA brand name assessment for review if the proposed brand name:

  1. contains the proper or common name(s) in final dosage form in combination with the manufacturer name or an acceptable abbreviation of the manufacturer. Some examples include: Canada - Benzoyl Peroxide, Can - Benzoyl Peroxide (where Canada is the manufacturer and the product is a benzoyl peroxide lotion);
  2. is exclusively descriptive per the proposed claim and medicinal ingredients. Some examples include: Sunscreen SPF 15, Sunscreen Lotion Face SPF 30, Lip Balm SPF 30, Moisturizing Lip Treatment SPF 15, Acne Relief Medication, Athletes Foot Treatment, Antiseptic Skin Cleanser, Diaper Rash Ointment, Medicated Skin Care Lotion, Throat Lozenges, Anti-Dandruff Shampoo, Allergy Medication, Cough and Cold Medication, Nasal Cold Sore Cream, Pain and Fever Relief Medication, Sleep Aid, Laxative: Stool Softener, Antacid Chewable Tablet etc.

Subsequent Submissions

Subsequent submissions in which the approved brand name and the medicinal ingredient or combination of medicinal ingredients remains the same (biologic, prescription and non-prescription pharmaceutical drugs), however one of the following attributes have been changed/added will require a rationale that the name will not be misleading or lead to potential safety concerns if confused with the name of another authorized product (see Appendix 2 - Subsequent Submissions):

  • Strength
  • Dose and dosing interval
  • Pharmaceutical form
  • Route of administration
  • Modifier
  • Formulation
  • Indication
  • Patient population
  • the clinical setting for dispensing or use (inpatient or outpatient hospital or clinic vs. retail pharmacy for use in home)

1.5 Process

General

Sponsors will be expected to perform a LASA brand name assessment in order to demonstrate the safety of a proposed name. Health Canada will review the information submitted. Failure to provide a LASA brand name assessment may result in a sponsor not receiving an NOC/DIN.

Health Canada will review only one brand name at a time. If the first brand name is not acceptable, sponsors will be asked to submit an alternate brand name.

Health Canada will review a sponsor's LASA brand name assessment as part of the drug submission within the performance standard outlined in Appendix 3 of the Management of Drug Submissions Guidance Document depending on the applicable submission type.Footnote iii Associated fees are provided in the "Guidance Document: Fees for the Review of Drug Submissions and Applications"Footnote iv.

As indicated above, non-prescription drugs which require a LASA brand name assessment are not eligible for submission as a Category IV Monograph or Labelling Standard and will need to be submitted as a DINA - Labelling Only submission type with the associated fees and review timelines. Sponsors are encouraged to consult the criteria outlined in section 2.3, Initial Brand Name Review and to contact the appropriate Regulatory Project Manager for consultation prior to filing.

For any product and at any time, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document in order to allow the Department to adequately review the safety, efficacy or quality of a drug (C.08.002 of the Food and Drug Regulations) to protect the public. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

Health Canada may reject a name if it considers, based on the information provided, or in its own review, that the name is likely to cause confusion with other health products, or is misleading with respect to the therapeutic effectiveness, composition or the safety of the product. Sponsors may formally appeal this decision according to Health Canada's "Guidance for Industry: Reconsideration of Final Decisions Issued for Human Drug Submissions"Footnote v.

If the brand name is deemed unacceptable, a Notice of Non-Compliance (NON) will be issued (C.01.014 and C.08.004 of the Food and Drug Regulations). However, if the proposed brand name is the only outstanding issue with the drug submission, the sponsor may choose to move forward with the use of the proper name (or common name, if there is no proper name) and the drug submission will be issued a NOC or DIN. If there is no proper or common name, an NON will be issued for the proposed product since an NOC cannot be issued without a proper or common name (C.01.004 of the Food and Drug Regulations).

The sponsor may propose a new name by submitting a LASA brand name assessment at a later date. This will be processed as an SNDS-Labelling Only (with associated fees).

Identification of Similar Brand Names

In the event that more than one submission proposes the same or similar brand name for different products, 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.

International Submissions

A LASA brand name assessment submitted to other International regulators is acceptable for Health Canada review as long as it can be demonstrated that LASA name candidates are identical, the medication use process of the proposed product is similar in Canada and the results of medication-use process simulations and Failure Mode and Effects Analysis (FMEA) are provided. If required, Health Canada may request additional information to assess the safety of the proposed name for the Canadian market.

Administrative Drug Submissions

Any submission that requires LASA brand name assessment to support a name change for the drug product is not considered administrative and should be submitted for processing as a Labelling Only submission.

Post-Market Safety Issues

Safety issues may still arise once a product is marketed and used by healthcare professionals, patients and consumers on a day-to-day basis in an uncontrolled environment (as opposed to a controlled clinical trial environment). If a potential health risk with a brand name is identified, Health Canada will work with the sponsor to address the issue. Sponsors may be asked to change the brand name of the product if long term mitigation strategies are not considered sustainable. Health Canada may invoke C.08.006 or C.01.013 of the Food and Drug Regulations in situations where the sponsor is not willing to comply.

All safety issues will be treated on a case-by-case basis. In situations where more than one manufacturer is implicated (e.g., look-alike sound-alike health product names), the manufacturer with the latest issued NOC will be contacted.

2 Guidance for Implementation

2.1 Development of a Revised Name Review Procedure

Sponsors will be responsible for carrying out the testing procedures to demonstrate that their submitted brand name is not likely to cause confusion with other health products that are authorised for use in Canada. Sponsors will report the findings from the required series of tests, which include database searches, simulations, and Failure Mode and Effects Analysis (FMEA). Health Canada will review the information submitted by the sponsor and make the decision to approve or reject the submitted name. This decision will form part of Health Canada's decision as to whether the product licensing requirements in the Food and Drug Regulations are met.

2.2 Brand Name Assessment Process

Testing of proposed brand names is intended to assess the likelihood that a new product could be confused with an existing product (sections C.08.002 and C.01.014 of the Food and Drug Regulations). A three-step approach to assessment of brand names for LASA confusability is proposed. These three steps at a minimum are to be conducted by the sponsor.

Search, Simulate, Synthesize.

The diagram below, Figure 1, outlines the three-step process to be conducted by the sponsor prior to Health Canada review.

Figure 1: Brand Name Assessment and Review Process

Brand Name Assessment and Review Process

Health Canada may reject a name if it considers, based on the information provided, or in its own review, that the name is likely to cause confusion with other products, or is misleading with respect to the therapeutic effectiveness, composition or the safety of the product.

2.3 Initial Brand Name Review

As a first step, Health Canada will review each proposed brand name using the criteria outlined below, regardless of whether a LASA brand name assessment is required. The criteria address naming practices that Health Canada view as misleading (per Section 9 of the Food and Drugs Act; C.08.006 of the Food and Drug Regulations). Sponsors should assess all brand names using this criteria.

An affirmative response to any of the questions one through eight will result in a proposed name failing the initial brand name review. In these circumstances, Health Canada will not initiate the review of the sponsor's LASA brand name assessment. Health Canada will contact the Sponsor to request an alternate brand name, accompanied by a LASA brand name assessment, if applicable. The sponsor may formally appeal this decision according to Health Canada's "Guidance for Industry: Reconsideration of Final Decisions Issued for Human Drug Submissions".

Table 1: Initial Brand Name Review Criteria
1. Does the name/modifier contain a promotional undertone with unsubstantiated unique effectiveness/composition, superiority claims, exaggerated product efficacy, broadening product indication or minimizing the risk of the product (e.g., making superiority claims such as 'CureAll')?
2. Does the name/modifier include or imply an ingredient that is not included in the drug product?
3. Is the name identical to an authorized product in Canada containing a different medicinal ingredient(s) (e.g., 'Podium' contains the medicinal ingredients 'XY' and a sponsor proposes the identical name 'Podium' for medicinal ingredient 'Z')?
4. Is the proper/common name abbreviated or truncated?
5. Does the proposed name contain a USAN (U.S. Adopted Name) or INN (International Nonproprietary Name) stem for the same or different pharmacological/chemical trait? Footnote viFootnote viiFootnote viii
6. Does the proposed brand name contain or suggest an exclusive composition of only one ingredient in a multi-ingredient product?
7. Does the name suggest an unsupported route of administration or dosage form (e.g., AcetaminophenOral® or AcetaminophenTablet® for a proposed acetaminophen suppository product)?
8. Does the name conflict with Schedule A of the Food and Drugs Act (e.g., DiabeticCareTM Acetaminophen Tablets)?

An affirmative response to any of questions nine through fourteen will raise concern that the proposed product name could result in confusion. In this case, Health Canada will continue with the review of the proposed brand name including the sponsor's LASA brand name assessment (if required). Concerns related to affirmative responses to any of these questions are to be addressed by the sponsor in the Synthesize step of the brand name assessment. If a LASA brand name assessment is not required, it is to be addressed within a rationale.

Table 1: Initial Brand Name Review Criteria (cont'd.)
9. Was the same/similar name used previously for a product that is no longer available on the market (i.e., discontinued)?
10. Does the name contain a confusable abbreviation? (See Appendix 2 for further information on abbreviations.)Footnote ix
11. Does the modifier contain a single letter or number? (See Appendix 2 for further information on the use of modifiers.)Footnote x
12. Might the modifier hinder the health professional/consumer in selecting the appropriate medication?
13. Does the brand name or part of the brand name represent or imply a medical and/or scientific term or acronym?
14. Has the name been approved in another country for a product with a different medicinal ingredient?

2.4 Multistep Testing of Proposed Brand Names

Sponsors are to subject proposed brand names to a multistep procedure that includes searching, simulations, and critical synthesis of findings, including failure mode and effects analysis, i.e., Search, Simulate, Synthesize. Testing of proposed brand names is intended to assess the likelihood of confusion between the proposed name and product names that are authorised for use in Canada.

2.4.1 Search

The purpose of the search step is to identify existing drug names that may have the potential for confusion with the proposed brand name. This step involves systematic searching of relevant drug name and medication error databases. The information retrieved during this step provides an initial list of drug names that merit further scrutiny during subsequent steps in the process.

Sponsors are to submit the proposed brand name as a query to a health product name search engine. The search engine will return a list of health product names, ranked in descending order of similarity to the query name, where similarity is measured by an objective computer algorithm. Search results submitted to Health Canada are to be based on the ALINE algorithms for orthographic, phonetic and combined orthographic-phonetic similarity. Footnote xi Any name with an ALINE score greater than or equal to 65% (in orthographic, phonetic or combined similarity) is to be included in the search results submitted to Health Canada.

Sponsors are to search the Drug Product Database (DPD) Footnote xii and the Licensed Natural Health Products Database (LNHPD). Footnote xiii Any commercial search engine can be used, however it must be capable of running the standard search protocol (i.e., the ALINE algorithm), as different search engines will retrieve different results. Using the standard protocol, the results should be the same, regardless of who runs the search.

In addition to all the names with ALINE scores equalling or exceeding 65%, the sponsor is to identify and record the five health product names with the highest orthographic similarity to the proposed brand name and the five health product names with the highest phonetic similarity to the proposed name. These names are to be identified and recorded even if their ALINE similarity score is less than 65%. These 'nearest neighbour' names will be used in Step 2 of the assessment process during screen-based tests of visual perception, auditory perception, and short term memory. It is important to note that the list of five phonetic and five orthographic nearest neighbours are to be submitted in addition to, not in place of, the list of all names with ALINE scores equalling or exceeding 65%.

If the proposed brand name is already marketed in another country, sponsors are to search the published literature, as well as medication error databases, and submit the results of those searches to Health Canada, with the goal being to identify any previously reported name confusion errors. This information will be gathered via a search of several sources, which can include internal sponsor databases, ISMP/ISMP Canada published reports and databases, MedMarx database, PubMed, and the International Pharmaceutical Abstracts.

If a name assessment was conducted and provided to an international regulator, sponsors are to provide a copy of the report as well as all follow-up information provided to the regulator and results of regulatory review.

In addition to searches of the DPD and LNHPD, Health Canada will conduct a search of the Drug Submission Tracking System (DSTS) to identify any brand names in the submission review process that could be candidates for confusion with the proposed name.

The information generated by the drug name search engine will be used in the Step 2 simulations, and its significance will be assessed during the third and final step, Synthesize. All raw data from the database search must be submitted to Health Canada.

2.4.2 Simulate

The purpose of simulation experiments is to assess the confusability of a name by inserting it into a variety of prescribing, transcribing, dispensing, administration, and self-selection tasks and documenting the resulting failures (i.e., the number and type of errors that occur). The LASA brand name assessment process involves two types of simulation: (1) screen-based simulations of simple perception and memory tasks, and (2) medication-use process simulations of prescribing, transcribing, etc. The screen-based and medication-use process simulations generate different lines of complementary evidence with respect to the likelihood of confusion involving a proposed brand name.

In order to create a context for planning and evaluating the simulations, sponsors are to prepare and submit a process map (as part of the LASA brand name assessment) that outlines where and how the proposed brand named drug will be used, based on its indications and who in the medication use system will potentially come into contact with the product. The human-computer interface occurs in many areas of the medication-use system--in healthcare facilities, community pharmacies, doctors' offices, and in the public domain. The process map needs to include, where applicable, the use of computers and electronic information. An example of a medication-use process map is presented in Figure 2, below. Additional examples can be found in Appendix 3.

Figure 2: Sample Medication-Use Process Map for NAME Y®, intravenous antineoplastic

Figure 2: Sample Medication-Use Process Map for NAME Y®, intravenous antineoplastic

The basic medication use processes are most simply outlined as:

Healthcare Practitioner
Consumer/Public
Prescribing
Self-Prescribing
Transcribing (Transcription)
Transcribing (Transcription)
Dispensing
Self-Selection
Administering (Administration)
Self-Administering (Self-Administration)
Monitoring
Self-Monitoring
 

The medication use system involves many processes--from the point of a product being considered for addition and use in a practitioner's armamentarium (or in a consumer's self-treatment) to final administration and subsequent monitoring of its effects.

Prescribing. Where a product is a prescription drug, prescribing could be performed by a medical doctor, dentist, podiatrist, nurse practitioner, or other healthcare professional with prescribing privileges.

Transcription occurs when a product is ordered verbally and the order is written down by someone else, such as a nurse or a pharmacist, or perhaps a ward clerk or a technician in a hospital setting. It can also occur when records are copied. In the case of the consumer, they can be considering a non-prescription drug, where transcribing could refer to copying the product name, as might be done when a consumer reads about a non-prescription product in a magazine or on the Internet, or hears about it on television program, and then makes a note to buy it or ask about it at a pharmacy or health food store. It can also occur when a patient is instructed or recommended to obtain a particular non-prescription medication and writes down the name they believe they heard. Transcription also takes place during medication reconciliation.

Dispensing can be performed by a pharmacist in a community pharmacy or hospital, by an assistant or nurse, or a doctor in his office. It can also relate to consumer self-selection.

Administration. Doctors, nurses and other healthcare professionals may be involved in administering a product, or a patient may self-administer.

Monitoring takes place after a product is administered and follow-up occurs.

All medication-use stages can come into play when an individual self-selects, self-treats and monitors their own treatment. Furthermore, although a patient may not be involved in the direct prescribing and handling of prescription drugs, they nevertheless receive the product and a transcribed document (drug label with name and directions) and then self-administer most drugs.

2.4.2.1 Screen-Based Simulations (PsycholinguisticFootnote xiv Testing)

This step involves screen-based tests of a proposed brand name in auditory perception, visual perception, and short-term memory tasks. The theoretical foundations for these experiments are well established, internationally accepted, and based on many years of experimental psychology and psycholinguistic research.Footnote 2 Footnote 3 Screen-based simulations are easy to control, efficient (i.e., capable of testing of many names and many people) and produce credible, objective results. These tests provide a simplified simulation of reality that focuses on confusability in the three cognitive domains most often implicated in name confusion errors: vision, hearing and short-term memory.

For example, in the visual perception task, a participant is asked to view a drug name presented on a computer screen and then to identify the name as quickly and accurately as possible. Errors occur when the name that is identified is not the same as the name that was presented. The level of control and consistency afforded by the screen-based simulations ensures that each participant has exactly the same experience. The efficiency of the test procedure allows large numbers of participants to view a large number of names at a relatively low cost, while producing objective data about confusability. This type of testing is equally applicable to professionals, auxiliary healthcare staff, and consumers.

Number and Type of Simulation Participants

The types of participants should reasonably reflect the population of users (e.g., physicians, nurses, pharmacists, and consumers) identified in the process map for the proposed drug. In accordance with the process map, the sponsor is to identify the principal participants in the medication-use process, including non-healthcare personnel and patients/consumers. Health Canada will require at least 25 people from each category of principal participants to participate in the screen-based simulations. It is expected that patients/consumers be included in all screen-based simulations, because patients must be able to correctly identify all of their medicines during the process of medication reconciliation.

Visual Perception

The purpose of the visual perception test is to determine the extent to which the written form of the proposed brand name is accurately recognized, and to identify what other names may be incorrectly substituted for the proposed name when it is misperceived. This experiment simulates the real world task where clinicians read a typewritten drug name and must identify it. A name is very briefly displayed to the participant on the computer screen, in a font style and size comparable to what would be seen on typical order entry screens. The task is to identify the name as quickly and as accurately as possible by (a) typing the name into a free-text response box and (b) by selecting it from a pick list of alternatives, where the alternatives consist of the proposed name and its 5 nearest orthographic neighbours. Because errors in visual perception are rare under perfect conditions, visual distortion or 'noise' may be added or the duration of exposure may be shortened to make the task more challenging. Errors occur when the name that is identified is not the name that was originally presented. The task produces an error (or accuracy) rate for each name, as well as a frequency-sorted list of the names that may be substituted for the target name when it is misperceived.

Auditory Perception

The purpose of the auditory perception test is to determine the extent to which the spoken form of the proposed name is accurately recognised and to identify what other names may be incorrectly substituted for the proposed name when it is misperceived. This experiment simulates the real world task where clinicians hear a health product name spoken in person or over the phone (or on voice mail) and must identify the spoken name. A name is played for the participant over headphones. The task is to identify the name as quickly and as accurately as possible by (a) typing the name into a free-text response box and (b) by selecting it from a pick list of alternatives, where the alternatives consist of the target name and its 5 nearest phonetic neighbours. Because errors in auditory perception are rare under perfectly quiet conditions, multi-speaker noise is added to the task to make it more difficult and realistic. Errors occur when the name that is identified is not the name that was originally spoken. The task produces an error (or accuracy) rate for each name, as well as a frequency-sorted list of the names that may be substituted for the target name when it is misperceived.

Short-Term Memory

The purpose of the memory test is to document the extent to which a proposed name is prone to short-term memory errors and to identify what other names may be incorrectly substituted for the proposed name when it is recalled incorrectly. The memory task simulates the real world situation wherein a person reads a prescription in one setting (e.g., on a computer screen or written prescription or chart) and then needs to go to another setting (e.g., to a computer or to shelf stock) and select or retrieve the product. Errors occur when the product that is retrieved or selected is not the one that was on the original order. In the experiment, a typewritten drug name is briefly presented to the participant on a computer screen. The participant completes a brief mental arithmetic task meant to simulate real-world distraction. The participant then identifies the target name, first by typing it into a free-text response box and then by selecting it from a pick list of alternatives, where the alternatives consist of the target name and its 5 nearest phonetic neighbours. The task produces an error (or accuracy) rate for each name, as well as a frequency-sorted list of the names that may be substituted for the target name when it is misremembered.

Additional Information

Experimental software to run psycholinguistic tests (e.g., SuperLab, E-Prime) is commercially available. Software code has been developed by Health Canada and will be made available to sponsors to allow use of commercially available software to run the specific psycholinguistic tasks required under the proposed new LASA guidance.

As stimulus materials, each task will include the proposed brand name (i.e., the 'test name') along with 50 additional 'filler names'. The filler names are included so that the same participants can complete all three tests (visual perception, auditory perception, and short-term memory) without knowing which name is the focus of the study and without easily being able to learn or memorize the names as they proceed from one task to the next. To further safeguard against practice effects, the order of the tasks should be changed for each subject and the order of presentation of names within each task should be randomized for each subject.

Upon request, Health Canada will provide to the sponsor a list of 50 filler names, and the five phonetic and five orthographic nearest neighbours for each filler name, for use in the screen-based tests of perception and memory.

All of the raw data from the screen-based simulations are to be submitted to Health Canada. During the Synthesize step of the LASA brand name assessment process, the results of screen-based simulations are to be summarized, evaluated and incorporated into the Sponsor's final assessment of the proposed name.

2.4.2.2 Medication-Use Process Simulations

In medication-use process simulations, healthcare professionals, ancillary staff, and consumers participate in simulated scenarios. Using the documented medication-use process map, the newly proposed name is communicated and processed in much the same way as it would be in real-world circumstances. The number of different drug use scenarios will vary depending upon the type of product being tested. For example, an injectable drug used only in the operating room setting would have far fewer scenarios than an oral prescription drug.

Although the submitted process map(s) are to be comprehensive, simulations do not need to involve all mapped pathways. Key pathways are to be identified according to the most common use settings and circumstances. The basic mechanisms of human and system error are the same across scenarios, thus it should be possible to obtain useful information about the potential for error with a smaller number of carefully chosen scenarios that correspond to the most likely circumstances where the new product will be used. Nonetheless, it is clearly important for the simulations to capture the main modes of communication--spoken, handwritten, faxed, electronically submitted--and to involve key members of the healthcare team (e.g., physician, ward clerk, nurse, receptionist, pharmacist, technician) as well as the consumer or patient.

The number of scenarios tested will depend on the submitted medication-use process map(s) and the identification of key usage pathways for the product. Sponsors will be required to submit the findings from at least 5 medication-use process simulations. These can be single replications of at least 5 scenarios, or multiple replications of single scenarios.

Simulation testing is done using real-life participants--doctors, nurses, nurse practitioners, pharmacists, pharmacy assistants/technicians, secretaries, patients--in scenarios that simulate interaction and communication points between individuals. These communication points involve the brand name being prescribed, transcribed, dispensed, administered, or self-selected, i.e., written, typed, and spoken. For example, a telephone message is left on an answering machine by a doctor (a generalist, a specialist, or both, depending on the drug). A nurse then picks up that message, mimicking a verbal order using the proposed brand name. Additionally, the proposed name is written by a doctor and faxed to a central location, simulating a prescription, which is then picked up and read by a pharmacist. For non-prescription items, a pharmacist leaves a message on a telephone answering system, which is then picked up by a patient, who listens to the name and then selects it from a list of possible products. Drug-specific scenarios are developed that are relevant to the product's intended use. The scenarios can be played out by multiple individuals, but each individual must only 'process' the proposed name once to avoid familiarity and learning. When the simulations are completed, the participants are debriefed according to a structured protocol and are required to answer a standard set of questions about the proposed brand name. (See Appendix 4 for more details on medication-use process simulation.) Participants in the simulations are to be practicing clinicians, and consumers who have taken a prescription/non-prescription product within the previous year. Participants should be representatives of both French and English speaking populations.

The primary purpose of the name simulation studies is to gather qualitative data about possible risks of confusion involving a proposed brand name. The simulations are used as a mechanism to elicit expert experience and opinion about the risk of confusion posed by a proposed name when that name is used in a realistic clinical scenario. The results of these studies identify the potential hazards, errors, and failure modes related to the use of the name. The information gathered during the name simulation studies is collated and assessed in the last step of the name review process, Synthesize.

Copies of scenarios, scripts, messages, results, and participant response sheets are to be included in the submission.

2.4.3 Synthesize

The search results together with the simulations generate complementary lines of evidence necessary to help make a decision about the likelihood of confusion with the proposed name. In the final step, sponsors are to complete a failure mode and effects analysis (FMEA) and synthesize the information gathered throughout the name testing process. All raw data are also to be provided with the final submission.

Sponsors are to prepare a table that lists all the drug names that were identified across the search and the simulation tests that could be confused with the proposed brand name. After having listed the names, the sponsor will provide a rationale as to why the names will be included or excluded in the FMEA, e.g., the name is of a disinfectant or veterinary product.

2.4.3.1 Failure Mode and Effects Analysis

Sponsors are to put their proposed product name through an FMEA process and demonstrate that the proposed name has no significant failure modes, or at least none so significant as to prevent the name from being approved.

FMEA is a proactive technique to identify process and product problems before they occur. It involves the analysis of a product or process by domain experts. In the case of healthcare, these may be practicing physicians, pharmacists, nurses, other health professionals, as well as consumers who have taken at least one prescription/non-prescription product within the previous year. The FMEA team includes active practitioners in the field of use for the product. These 'experts' seek to identify all potential things that can go wrong with a process or product (i.e., its failure modes). The patient perspective is again valuable at this point. Even though the patient/consumer may not be considered an 'expert', the patient experience requires them to recognize and understand the health products they themselves are taking, especially in the context of medication reconciliation.

An FMEA of a drug name typically involves having a panel of experienced clinicians and ancillary healthcare staff read, write, and listen to a proposed brand name. These experienced individuals are process-proficient and can identify what could go wrong with that name, considering possible abbreviations, misspellings, misunderstandings, the product's generic and familiar names, storage issues, usage issues, etc. Their evaluations are based on mental simulation of usage and on professional, practical, and consumer experience and judgement. Panellists also generate a list of names and words that they think are confusingly similar to the proposed brand name.

In the context of this guidance, rather than rely only on the mental simulation of the product's use by the FMEA panel members, the panel will use submitted medication-use process map(s), which plot(s) the drug's passage through the healthcare system--from procurement and distribution activities to ordering/prescribing, selection, manipulation (if required), dispensing, administration, patient monitoring, etc. Furthermore, all the drug names identified as potentially confusable in the Search and Simulate steps, and those generated by the panellists, are to be considered in the FMEA. Data from the simulation studies (described in Sections 2.4.2.1 and 2.4.2.2, above) are also reviewed and discussed by the panel, incorporating the findings into their discussions of the mapped medication-use process. These components are complementary.

The FMEA is to include comparisons of overlapping characteristics of the confusable drug names with the profile of the proposed product. The following product profile criteria, or non-name attributes, are to be considered in completing the analysis: marketing status (Rx or non-prescription), therapeutic category, medicinal ingredient, indication(s), clinical setting for dispensing or self-selection, strength, dosage form, route of administration, proposed dose, dosing interval/frequency and storage (e.g., refrigerated or room temperature). Additional examples of attributes to take into consideration in determining the degree of similarity are provided in Appendix 5.

Each of the transaction points are discussed by the panel of experts to identify failure modes. Each of the failure modes is then graded by how easily it might be avoided and by the severity of the potential consequences should the failure mode occur.

The analysis is to also address the following questions:

  1. Are any of the drugs that could be confused with the proposed brand name:
    1. a high alert drug or a drug with a narrow therapeutic indexFootnote xv
    2. a pharmacological opposite
    3. a product with significant contraindications or warnings and precautions,
    4. a product with known drug interactions or allergies
    5. a product with a high prescribing frequency
  2. Omitting the drug
    1. What are the consequences of omitting the intended drug?
    2. What would be the consequences in special patient populations, e.g., patients who are pregnant, elderly, nursing, or have compromised liver or kidney function?
    3. How long could a patient go without the intended treatment before being adversely affected?
  3. Wrong drug therapy
    1. What are the consequences of being exposed to the wrong drug (i.e., all the confusable drug names identified in Search and Simulate steps and by the FMEA panel)?
    2. Are allergies to the medication common?
    3. What number of doses would need to be administered to cause harm?
    4. What would be the consequences in special patient populations, e.g., patients who are pregnant, elderly, nursing, or have compromised liver or kidney function?
  4. Combined drug therapy
    1. What are the consequences of combined drug therapy?
    2. Is there a potential to exacerbate adverse reactions due to differing drug profiles?

A summary report is prepared, which highlights the major identified vulnerabilities of the name (if any), based on the panel's input. An example of an FMEA approach is shown in Appendix 6.

2.4.3.2 Synthesize

A report summarizing all the findings from the LASA brand name assessment, i.e., the Search and Simulate steps and the FMEA, must be submitted to Health Canada. Furthermore, a cumulated list of all the names generated from every component of the assessment process, i.e., the Search and Simulate steps and the FMEA, must be submitted.

A final rationale for the approval of the proposed name for marketing in Canada is to be presented. Where certain findings are excluded, an explanation must be provided as to why they do not present an obstacle to approval.

2.5 Decide

The final phase involves Health Canada making a decision about the acceptability of the proposed name. The decision takes into consideration the results of Health Canada's Drug Submission Tracking System search and review of the sponsor's detailed LASA brand name assessment.

This guidance is intended to provide Health Canada with objective information in a consistent format. The intent is that the availability of better evidence about potential confusions will allow Health Canada to make more informed decisions, thereby protecting the public from the consequences of LASA medication errors.

As a regulator, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a drug (C.08.002 and C.01.014 of the Food and Drug Regulations). Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

Health Canada may reject a name if it considers, based on the information provided or in its own review, that the name is likely to cause confusion with other health products, or is misleading with respect to the therapeutic effectiveness, composition or the safety of the product.

Safety issues may still arise once a product is marketed and used by healthcare professionals, patients and consumers on a day-to-day basis in an uncontrolled environment (as opposed to a controlled clinical trial environment). If a potential health risk with a brand name is identified, Health Canada will work with the sponsor to address the issue. Sponsors may be asked to change the brand name of the product if long term mitigation strategies are not considered sustainable. Health Canada may invoke C.08.006 or C.01.013 of the Food and Drug Regulations in situations where the sponsor is not willing to comply.

Reference

Footnotes

Footnote 1

Hicks RW, Becker SC, Cousins DD, eds. MEDMARX data report. A report on the relationship of drug names and medication errors in response to the Institute of Medicine's call for action [Internet]. Rockville (MD): Center for the Advancement of Patient Safety, US Pharmacopeia; 2008 [cited 2011 Feb 15]. Available from:www.scribd.com/doc/26028426/MedMarx-Report-2008

Return to footnote 1 referrer

Footnote 2

Garnham A. Psycholinguistics: Central topics. New York: Methuen; 1987.

Return to footnote 2 referrer

Footnote 3

Gernsbacher MA, ed. Handbook of psycholinguistics. San Diego, CA: Academic Press; 1994.

Return to footnote 3 referrer

Additional Reading

Emmerton LM, Rizk MFS. Look-alike and sound-alike medicines: risks and 'solutions'. Int J Clin Pharm. 2012;34:4-8.

Gregg V. Word frequency, recognition, and recall. In: Brown J, ed. Recall and Recognition. New York, NY: John Wiley & Sons; 1976.

Lambert BL, Chang K-Y, Gupta P. Effects of frequency and similarity neighborhoods on pharmacists' visual perception of drug names. Soc Sci Med. 2003;57:1939-1955.

Lambert BL, Lin S-J, Toh S, et al. Auditory perception of drug names. Annual Congress of the National Patient Safety Foundation. Washington, DC; 2007.

Lambert BL, Lin S-J, Toh S, et al. Frequency and neighborhood effects on auditory perception of drug names in noise [abstract # 3aNS3]. J Acoust Soc Am. 2005;118(3Pt2):1955.

Lambert BL, Yu C, Thirumalai M. A system for multi-attribute drug product comparison. J Med Syst. 2004;28(1):29-54.

Savin HB. Word-frequency effect and errors in the perception of speech. J Acoust Soc Am. 1963;35:200-206.

Whitlow JW, Cebollero A. The nature of word frequency effects in perceptual identification. J Exp Psychol Learn Mem Cogn. 1989;15(4):643-656.

Appendix 1: Definitions

Authorized Product: A product that has been approved by Health Canada.

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.

Sponsors must declare the entire product name as it will appear on the final labelling in box 8 of the 3011 form.

Failure Mode and Effects Analysis (FMEA): A team-based systematic and proactive approach for identifying the ways that a process or design can fail, why it might fail, the effects of that failure and how it can be made safer. FMEA focuses on how and when a system will fail, not if it will fail. (ISMP Canada).

Generic Name: The generic (also known as non-proprietary and established name) describes the drug substance. International Non-proprietary 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.

High-Alert Medications: A drug known to present serious risk of harm due to its pharmacological properties (e.g., paralytic drugs, opioid analgesics, concentrated electrolytes). These medications have a high risk of causing injury when they are misused. Footnote xvi

Most medications have a moderate margin of safety, yet a small number of drugs have a high risk of causing injury when they are misused. These are called 'high-alert medications' to draw attention to this characteristic, and so all involved in their use will handle them with the care and respect they require. Errors may or may not be more common with the use of these drugs compared to others. However, the consequences of the errors are more devastating and their use requires enhanced precautions. These medications often need to be packaged differently, stored differently, prescribed differently, dispensed differently and administered differently than most other medications. Note: Definition adapted from the Institute for Safe Medication Practices (ISMP).

Immediate Container: C.01.001 of the Food and Drug Regulations states that an immediate container is the receptacle that is in direct contact with a drug.

International Nonproprietary Name (INN): The INN identifies 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).Footnote xviiFootnote xviii

LabelFootnote xix- Section 2 of the Food and Drugs Act states that the label includes any legend, word or

mark attached to, included in, belonging to, or accompanying any food, drug, cosmetic, device or package.

Label (Inner) - A.01.010 of the Food and Drug Regulations states that the inner label is the label on or affixed to an immediate container of a food or drug.

Label (Outer) - A.01.010 of the Food and Drug Regulations states that the outer label is the label on or affixed to the outside package of a drug. For example, the label on a box containing a bottled drug.

Look-Alike Sound-Alike (LASA) Health Product Names: Health products that have a similar written name or similar phonetics to those of another health product.

Medication Incident: Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Medication incidents may be related to professional practice, drug products, procedures, and systems, and include prescribing, order communication, product labelling/ packaging/nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.Footnote xxSimilar Term: Medication Error.

Medication-Use System: The Institute of Medicine describes medication-use system as the system that encompasses the continuum of (1) prescribing by the clinician (or self-prescribing), followed by transcribing; (2) preparing and dispensing by the pharmacist; (3) administering by the provider or consumer (self-care); and (4) monitoring for therapeutic and adverse effects (by nurse, surrogate, or self). Each of these steps includes critical control points at which decisions and actions can contribute to safety or errors.

Near Miss or Close Call: An event that could have resulted in unwanted consequences, but did not because either by chance or through timely intervention the event did not reach the patient.Footnote xx Similar Terms: Near Hit or Good Catch.

Non-prescription Drug: a drug available without a prescription. This includes drugs that

  1. may be sold to the general public without the intervention of a health care professional (consumer-available non-prescription drug, e.g., acetylsalicylic acid [ASA]);
  2. may not be sold to the general public without the intervention of a health care professional, usually a pharmacist (e.g., nitroglycerin, insulin, injectable epinephrine for anti-allergic purposes); and
  3. are sold directly to health professionals and intended for professional use. (e.g., contrast media, anaesthetics). (Labelling of Pharmaceutical Drugs for Human Use - Draft Guidance for Industry 2010).

Non-Proprietary Name:

Chemical Name: The Chemical name of a drug which 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]-piperidinn-4-ol: 4-[4-p-Chlorophenyl]-4-hydroxypiperidino]-4-flurobutyrophenone is the chemical name for Haloperidol}. Footnote xxi

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 publication referred to in Schedule B to the Act.

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 aproper name for each ingredient. Example of a proper name - Acetaminophen, Azithromycin Capsules.

Package: In the context of this document, the term package includes anything in which any food, drug, cosmetic or device is wholly or partly contained, placed of packed, from Section 2 of the Food and Drugs Act. Note: The terms 'package' and 'packaging' are used synonymously for the purposes of this document, and mean package as defined here.

Product Characteristics: The physical characteristics of the product itself (i.e., dosage form, strength, medicinal ingredient) and environment in which the product is used, including but not limited to the established name, label, labelling, container, facility, storage conditions, who prescribes and administers the product, patient population, and other conditions of use.

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): USAN identifies non-proprietary 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 vi

Real World Safe Use: Term used to describe the use of a product by healthcare professionals, patients and consumers on a day-to-day basis in an uncontrolled environment (as opposed to a controlled clinical trial environment).

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.

Appendix 2: Subsequent Submissions

Subsequent submissions in which the approved brand name and the medicinal ingredient or combination of medicinal ingredients remains the same (biologic, prescription and non-prescription pharmaceutical drugs), however one of the following attributes have been changed/added will require a rationale that the name will not be misleading, lead to potential safety concerns if confused with the name of another authorized product.

  • Strength
  • Dose and dosing interval
  • Pharmaceutical form
  • Route of administration
  • Modifier
  • Formulation
  • Indication
  • Patient population
  • the clinical setting for dispensing or use (inpatient or outpatient hospital or clinic vs. retail pharmacy for use in home)

Sponsors should consider the following factors when assessing the name:

  • Other products within the sponsor's own line or from another company with the same or similar (look-alike and/or sound-alike) brand name;
  • Indications for each relevant product;
  • Any safety (inclusive of lack of efficacy) issues that may arise from use of the brand name for the new product, should it be confused with other products with the same or similar brand name, based on consideration of the safety profile of the medicinal ingredients;
  • Specific populations of patients/consumers where differences exist between products with the same brand name e.g., children, pregnant women, elderly people, those with renal or hepatic impairment;
  • Differences in interaction with other medicines;
  • Differences in indications, contraindications, warnings, drug dose and frequency, strength;
  • Differences in effects of and management of overdose;
  • Differences in the mode and speed of action between medicinal ingredients in products sharing the same brand name;
  • Use of different suffixes/prefixes etc. and how these may differentiate between products, addressing issues such as strength, population, therapeutic area, etc.;
  • Details of the label including:
    • Overall colour and design;
    • Package design shape and size;
    • Placement and prominence of medicinal ingredient and usage information;
    • Form(s) of product;
    • Ability to differentiate between products sharing the same brand name.

Modifiers/Abbreviations:

The use of modifiers/abbreviations in a name can create opportunities for error and misinterpretation. The use of modifiers may be necessary in some cases, especially when it assists the health professional/consumer to select the appropriate medication (e.g., distinguishing an extended release dosage form from an immediate release dosage form). Health Canada will review proposed modifiers/abbreviations from the point of view of safety and confusability. Sponsors are to provide a rationale for the necessity of a modifier/abbreviation, its potential for safe use and any available studies that corroborate the intended meaning of the proposed modifier.

Acceptable modifiers/abbreviations should meet the following minimum criteria:

  • Modifiers should reinforce in a clear manner existing information on the label and thus aid the health professional/consumer to select the appropriate medication.
  • The modifier should provide useful and easily identifiable information to the health professional/consumer.
  • The modifier should not be ambiguous or otherwise have the potential to be misinterpreted by health professionals/consumers and thus result in medication incidents. For example, abbreviations that indicate dosing schedules should be avoided. (QD may be read or interpreted as QID, OD may be interpreted as either Oculus Dexter [Latin, meaning 'right eye'] or Once Daily).
  • Generic versions should contain the same modifier to the brand name version or innovator product to distinguish the different indications or dosing considerations.
  • Consideration should be given to the potential risk or benefit to the patient in the case of using the modifier versus an alternate brand name.
  • Consideration should be given to the consequences of the accidental omission of the modifier in the brand name in prescribing, dispensing and administration. For example, if there are identical strengths, a medication incident is more likely to occur.
  • Drug name abbreviations are not acceptable (e.g., MTX for methotrexate, PE for phenylephrine)

Refer to the Institute for Safe Medication PracticesFootnote xxii and the National Coordinating Council on Medication Error Reporting and PreventionFootnote xxiii for a list of recognized high risk error-prone abbreviations that are to be avoided. As well, refer to Health Canada's Guidance for Industry - Labelling of Pharmaceutical Drugs for Human Use.Footnote xxiv

For any product and at any time, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a drug. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

Health Canada may reject a name if it considers, based on the information provided, or in its own review, that the name is likely to cause harm resulting from confusion with other health products, or is misleading with respect to the therapeutic effectiveness, composition or the safety of the product.

Safety issues may still arise once a product is marketed and used by healthcare professionals, patients and consumers on a day-to-day basis in an uncontrolled environment (as opposed to a controlled clinical trial environment). If a potential health risk is identified, Health Canada will address the issue and work in collaboration with sponsor to develop mitigation strategies, including issuing risk communications. Sponsors may be asked to change a name if other risk mitigation strategies are not deemed sustainable.

Appendix 3 - Medication-Use Process Maps

Medication-use process maps outline where and how a drug will be used, based on its indications and who in the medication use system will potentially come into contact with it. Three examples for different products and contexts are provided. These diagrams identify the principal participants in the medication-use process, including non-healthcare or ancillary personnel and patients/consumers. The maps plot the passage of the drug through the healthcare system--from procurement and distribution activities to ordering/prescribing, selection, manipulation (if required), dispensing, administration, and patient monitoring.

Figure 2: Sample Medication-Use Process Map for NAME Y®, intravenous antineoplastic

Figure 2: Sample Medication-Use Process Map for NAME Y®, intravenous antineoplastic

Figure 3: Sample Medication-Use Process Map for NAME X®, non-prescription allergy treatment tablet

Figure 2: Sample Medication-Use Process Map for NAME Y®, intravenous antineoplastic

Figure 4: Sample Medication-Use Process Map for NAME Z®, oral prescription drug

Figure 4: Sample Medication-Use Process Map for NAME Z

Appendix 4: Medication-Use Process Simulation

In medication-use process simulation, proposed brand names for a single product are tested for their safety as they pass through various channels before being used by the patient, e.g., from the time a name is written by a prescriber then faxed to a pharmacy and finally delivered to a patient. Simulations should follow the medication-use process map developed for a particular product. The intention is not to determine whether a name is liked, but rather to do the following:

  1. to evaluate its performance--its safety and clarity--when spoken, written, faxed and read; and
  2. to identify how distinctive each name is compared to other drug product names and compared to other general products and terms.

One process example is shown below. (Note that for select drugs certain patient populations may have underlying conditions and may be taking other drugs that could contribute to confusion or add confounding elements.)

Table 2: Sample Medication-Use Process in the Primary Care Physician Setting
PATHWAYS
(PCP Setting)
Written
(handwritten & typed)
Spoken Drug name under evaluation

Table 1 footnotes

Table 1 footnote 1

Abbreviations: PCP = Primary care physician, PC = Primary care, PA = Pharmacy assistant

Return to table 1 footnote * referrer

PCPTable 1 footnote * recommends or prescribes product to Patient PCP 1 to Patient 1
PCP 2 to Patient 2
(written to simulate in office process; prescription writing)
PCP 1 to Patient 3
PCP 2 to Patient 4
(simulates phone call if patient calls, and interpretation of the name when recommended or prescribed at visit)
NAME
PCP to PCTable 1 footnote * Nurse
(include PCP to nurse for non-prescription drugs, in case nurse fields call from patient)
PCP 1 to PC Nurse 1
(written)
PCP 2 to PC Nurse 2 NAME
PCP to PC Secretary PCP 2 to PCP Secretary 1
(written;
simulates chart transcription)
PCP 1 to PC Secretary 2
(simulates transcription)
NAME
PCP to Pharmacist PCP 1 to Pharmacist 1
(written)
PCP 1 to Pharmacist 2 NAME
PCP to Pharmacy Technician or Pharmacy Assistant PCP 1 to Pharmacy Technician1
(written, e.g., renewal of prescription or reading of PCP's note to patient)
PCP 1 to PA* 1
(e.g., renewal of prescription)
NAME
PC Nurse or Secretary to Patient PC Nurse 3 to Patient 5 PC Secretary 3 to Patient 6 NAME

The number of scenarios tested will depend on the submitted medication-use process map(s) and the identification of key usage pathways for the product. Sponsors will be required to submit the findings from at least 5 medication-use process simulations. These can be single replications of at least 5 scenarios, or multiple replications of single scenarios.

Each participant processes only one transaction to avoid learning the drug name which would bias the results. However, one participant may leave a verbal and a written communication and each communication may be picked up by more than one participant. The number of scenarios can be greater than the number of participants. For example, one 'prescriber' can write and verbally transmit a number of drug names, which can be picked up for interpretation by any number of nurses, patients, other prescribers, secretaries, pharmacists, and pharmacy technicians, as long as each individual processes the name only once.

Healthcare professionals are provided with the test name. They then handwrite and fax the name or type and fax it to a predetermined fax line, or leave a voicemail on a predetermined phone line for retrieval. This is done from participants' usual practice sites, where there are daily routines, standard equipment, and usual background activities and noises. Recipients retrieve the name for interpretation from the fax or by listening to the voicemail (simulating the spoken communication of the name).

In cases where self-selection is a use scenario, message recipients may be asked to identify the name they see or read within a printed list of names or from a photo array, where a number of different and possibly confusable products, usually from the same therapeutic category, are presented. The photo array can be made to mimic a shelf-selection exercise. A mock-up of the target product is inserted into the inventory on a regular store or pharmacy shelf and a picture is taken. The participant is presented with the picture of the shelf after reading or hearing the product name and identifies (e.g., draws a circle around) what they believe to be the target product in the picture.

Participants are sent all of their materials along with a timeline of when to complete each portion of the simulation process. The voicemail and fax records can be checked by the simulation organizer to ensure that participants are following the agreed upon timetable. Where respondents do not complete the scheduled task by the agreed upon time, follow-up phone calls are made to remind them of their obligations. Findings are not affected by a few drop-outs because they are not included in the presented sample sizes or in the findings. Large numbers of respondents can be enlisted to minimize skewing and to represent a broad user experience.

Once they complete the transmission or reception of drug names, participants must complete a questionnaire about the name(s) they have processed. (See Sample Follow-Up Questions under data Collection within the Summary of Findings.)

All details of the simulation and questionnaire responses are to be tabulated and reported.

Summary of Findings

Data Collection

  1. Performance of the 'Look' of the Name
    All interpretations of written names are listed, correct and incorrect.
  2. Performance of the 'Sound' of the Name
    All interpretations of heard names are listed, correct and incorrect.
  3. Sample Follow-Up Questions
    • Does this name look like any other drug name?
    • Does this name look like any other medical term or laboratory test?
    • Does this name look like any other general product (non-medical)?
    • Does this name sound like any other drug name?
    • Does this name sound like any other medical term or laboratory test?
    • Does this name sound like any other general product (non-medical)?
Table 3: Findings for NAME
Factor Yes Responses Findings and Comments
Does this name look like any other drug name? 5/15 There was a high risk of confusion with other drug names. Yet the only other drug names that respondents think look like NAME are AAA and NAME.
Does this name look like any other medical term or laboratory test? 1/15 There is low risk of confusion for other medical terms or laboratory tests, as the only mention was BBB.
Does this name look like any other general product (non-medical)? 1/15 There was a low risk of confusion for general products, with the one respondent thinking of CCC.
Does this name sound like any other drug name? 4/15 The risk of confusion is moderate for sounding like other drugs, associations again include AAA and NAME.
Does this name sound like any other medical term or laboratory test? 0/15 There was a no risk of confusion with other medical terms or laboratory tests.
Does this name sound like any other general product (non-medical)? 1/15 The risk of confusion is low, the only general product association mentioned was DDD.
Table 4: Perceived Confidence and Safety of NAME

Scale: 1-10, where 10 indicates very confident/safe & 1 indicates not confident/safe.
Factor Mean Rating Findings High Scorer Comments Low Scorer Comments
Pronunciation will be correctly understood via telephone or voicemail 8.1 High score indicates that there is low risk of medication errors when verbally saying/interpreting the name.
  • easy to say/pronounce
  • pronounced just as it's spelled
  • sounds unique
  • phonetically pleasing
  • short
  • not complicated
  • difficult to understand when pronounced
  • may be mispronounced
  • 'aaa' may be heard as 'aai' or 'aga'
  • unsure of spelling
  • difficult name
  • too similar to BBB
Will be legible when faxed or written 8.5 High score indicates that there is a low risk of errors when reading the faxed or written name.
  • spelled as it sounds
  • unique spelling
  • not similar to anything else
  • clear/easy to write
  • easy to read
  • difficult to spell
  • not sure of spelling
  • 'aaa' may be confused with 'aai' or 'aga'
Is safe, will not cause medication errors or confusion 8.4 High score indicates that this name is perceived as very safe.
  • sounds unique
  • not likely to be confused with anything else
  • easy to say/spell which will lead to no errors
  • too similar to other drugs
  • unclear sounding
  • hard to pronounce
Table 5: Interpretation of Name in Simulation Process: NAME
Manner Correct Errors
Received via handwritten fax 1/2 AAA
Retrieved via voicemail 6/8 BBB, CCC
Received via typed fax 2/2 No errors
Total correct interpretations and commentary 9/12 (75%)
Voicemail appears to pose the greatest problem as the verbal pronunciation can be interpreted in a couple of different ways, especially for a name that has not been seen before. The middle 'o' in the name was often confused as an 'i'. Exposure to the name via detailing and marketing may decrease this misinterpretation as the overall perception of the name in terms of saying and spelling it scores well.

Appendix 5: Additional Attributes to Assist in Determining the Degree of Similarity

Below, are additional examples of attributes to take into consideration in determining the degree of similarity of the proposed name during the FMEA process:

  • Identical Prefix
  • Identical Infix
  • Identical Suffix
  • Similar length of the name
  • Similar spelling
  • Upstrokes (capital and lower case e.g. 'P', 'd') in similar locations
  • Downstrokes (e.g.,'q', 'y') in similar locations
  • Cross-strokes (e.g., 'x', 't') in similar locations
  • Dotted letters (e.g.,'i') in similar locations
  • Ambiguity introduced when scripting letters (e.g., 'P' may appear as 'B', 'D', or 'R'; lower case 'r' may appear as 'e', 'v' or 'I'; lower case 'a' may appear as any vowel; lower case 'x' may appear as lower case 't', 'f' or 'y' etc.)
  • Similar number of words/groups of characters in a name (A "word" is considered as any group of characters separated by a space)
  • Similar number of syllables
  • Similar stresses (e.g., Trycel and Triafil have similar stresses: TRY-cel and TRIA-fil; try-CEL and tria-FIL)
  • Placement of vowel sounds is similar (e.g., 'e' may sound like 'a' or 'i'; 'i' may sound like 'a' or 'e'; 'a' may sound like 'e' or 'i' etc.)
  • Placement of consonant sounds is similar (e.g., 'n' may sound like 'm', 'dn', 'gn', 'kn', 'mn', 'pn'; 't' may sound like 'd', 'b' or 'pt' etc.)
  • First letter and/or sound (but made with the same letter) is identical
  • Last letter is identical
  • Same letters but in different order (e.g., Termix and Trevisc - the "er" and "re" can be interpreted as the same and do not provide protection from name confusion)

Appendix 6: Failure Mode and Effects Analysis (FMEA) Footnote xxv

Sample FMEA Process for Confusability of Health Product Names

Step 1: Select a topic to be analyzed and assemble a team.

The topic of the FMEA is Proposed Brand Name Confusability.The team includes representation from actively practicing healthcare practitioners and ancillary healthcare or non-healthcare staff, who would be involved in the product's use (e.g., nurses, pharmacists, pharmacy assistants, secretaries, clerks) and consumers who self-medicate or who have been prescribed a drug within the past year. The FMEA team includes active practitioners in the field of use for the product.

Step 2: Diagram the process to be analyzed.

Use the medication-use process map(s) developed for the product as part of the Simulate step (section 2.4.2).

The FMEA panel reviews the drug use process map(s), assesses their adequacy in describing the product's use, and, if necessary, adds additional transaction points, based on their expertise and experience with similar drugs or settings.

Step 3: Brainstorm potential failure modes within the process and identify their effects. What could go wrong?

The primary failure mode to be considered is the possibility that at any stage of the medication-use process the product name or other attributes could result in confusion potentially leading to an error. The effects resulting from name confusability, or confusion caused or contributed by non-name attributes are identified and discussed by the team.

The team must answer the following questions, considering the proposed name and the potentially confusable names, both identified through the Search and Simulate steps and generated by the FMEA team members.Footnote xxvi Rating of harm can be expressed using the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) taxonomy of harm, A to I.Footnote xxvii

  1. Are any of the drugs that could be confused with the proposed brand name:
    1. a high alert drug or a drug with a narrow therapeutic indexFootnote xv
    2. a pharmacological opposite
    3. a product with significant contraindications or warnings and precautions,
    4. a product with known drug interaction or allergies
    5. a product with a high prescribing frequency
  2. Omitting the drug
    1. What are the consequences of omitting the intended drug?
    2. What would be the consequences in special patient populations, e.g., patients who are very young, pregnant, elderly, nursing, or have compromised liver or kidney function?
    3. How long could a patient go without the intended treatment before being adversely affected?
  3. Wrong drug therapy
    1. What are the consequences of being exposed to the wrong drug (i.e., all the confusable drug names identified in Search and Simulate steps and by the FMEA panel)?
    2. Are allergies to the medication common?
    3. What number of doses would need to be administered to cause harm?
    4. What would be the consequences in special patient populations, e.g., patients who are very young, pregnant, elderly, nursing, or have compromised liver or kidney function?
  4. Combined drug therapy
    1. What are the consequences of combined drug therapy?
    2. Is there a potential to exacerbate adverse reactions?

Step 4: Identify the causes of the potential failure modes. Why could things go wrong?

The primary cause for potential name confusion in this FMEA is the LASA/confusable drug name, as identified in the previous steps of the name review, Search and Simulate.

In addition to name confusability, and considering the findings of the psycholinguistic tests and the real world simulations, the FMEA must assess the amount of overlap in non-name attributes of the proposed name and product and any potentially confusable existing names and products. These, at minimum, include marketing status (Rx or non-prescription), therapeutic category, medicinal ingredient(s), indication(s), clinical setting for dispensing/administration/use, strength, dosage form, route of administration, proposed dose, dosing interval/frequency, and storage (e.g., refrigerated or room temperature).

Step 5: Redesign the process/product to address the potential failure modes.

Reviewing the severity and detectability indicators, the team must identify the failure modes with the highest indicators. How to affect or mitigate these failure modes can then be considered in light of the proposed name and the product's non-name attributes. The goals are to prevent errors, to make errors more visible (preferably before reaching the user/patient), and to mitigate harm to the user/patient. The FMEA panel should focus their recommendations on mitigation strategies that are within the sponsor's control.

It should be kept in mind that reliance on human memory and cognition are not true 'fixes', as they are dependent on individuals working under ideal circumstances with optimal resources and alertness.

Appendix 7: Acknowledgements

Health Canada gratefully acknowledges the individuals listed below in alphabetical order, who were instrumental in the development of the Proposed Revisions to Health Canada's Guidance for Industry - Drug Name Review: Look-Alike Sound-Alike (LASA) Health Product Names.

  • Luna Al-Khalili, Marketed Health Products Directorate, Health Canada
  • Christopher Antonio, Biologics and Genetic Therapies Directorate, Health Canada
  • Carol Holquist, Division of Medication Error Prevention and Analysis, FDA
  • Janet Kramer, Therapeutic Products Directorate, Health Canada
  • Valentina Jelincic, ISMP Canada
  • Bruce Lambert, Ph.D., President, BLL Consulting, Inc., River Forest, IL
  • Sally Pepper, Marketed Health Products Directorate, Health Canada
  • Mai Pham, Therapeutic Products Directorate, Health Canada
  • Marilyn Schwartz, Therapeutic Products Directorate, Health Canada
  • John Senders, Professor Emeritus, Faculty of Applied Sciences, University of Toronto
  • Alima Tapsoba, Therapeutic Products Directorate, Health Canada
  • Kellie Taylor, Division of Medication Error Prevention and Analysis, FDA
  • David U, ISMP Canada, Co-chair
  • Myriam Wallet, Therapeutic Products Directorate, Health Canada
  • Kevin Wood, Natural Health Products Directorate, Health Canada
  • Margaret Zimmermann, Marketed Health Products Directorate, Health Canada, Co-chair

Footnotes

Footnote 1

Health Products and Food Branch, Health Canada. Guidance for industry. Drug name review: look-alike sound-alike (LA/SA) health product names [Internet]. Ottawa (ON): Minister of Public Works and Government Services Canada; 2005 [cited 2011 Apr 29]. Available from: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb- dgpsa/pdf/brgtherap/lasa_premkt-noms_semblables_precomm-eng.pdf

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Footnote 2

Generic versions of products should contain the same modifier to the brand name version or innovator product to distinguish the different indications or dosing considerations.

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Footnote 3

Health Products and Food Branch, Health Canada. Guidance for industry.Management of drug submissions [Internet]. Ottawa (ON): Minister of Public Works and Government Services Canada; 2011: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/mands_gespd-eng.pdf [cited 2012 Feb 20]

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Footnote 4

Guidance Document: Fees for the Review of Drug Submissions and Applications: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/fee_frais_guide-eng.php (cited: 2012 Aug 10)

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Footnote 5

Guidance for Industry: Reconsideration of Final Decisions Issued for Human Drug Submissions: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/decisions_hum_drug_drogue-eng.pdf (cited: 2012 Aug 10)

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Footnote 6

USAN Stem List: http://www.ama-assn.org/resources/doc/usan/stem-list-cumulative.pdf [cited 2012 Feb 15]

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Footnote 7

INN Stem List: http://apps.who.int/medicinedocs/index/assoc/s14141e/s14141e.pdf [cited 2012 Feb 15]

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Footnote 8

World health Organization. Guidance on the establishment of new INN stems: http://www.who.int/medicines/services/inn/stems_policy_explanation.pdf [cited 2012 Feb 15]

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Footnote 9

The use of colloquial abbreviations in a name may be misinterpreted. See abbreviations recognized as error-prone and potentially dangerous by the Institute for Safe Medication Practices (www.ISMP.org/tools/errorproneabbreviations.pdf [cited 2012 Feb 15]).

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Footnote 10

This would not be considered sufficient differentiation between two products of differing formulations and these single letters and digits are easily lost or confused with strength or dosage.

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Footnote 11

The measures of similarity are built into the FDA's Phonetic and Orthographic Computer Analysis (POCA) software program, which has been released freely to the public and is available from commercial search vendors. http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-3170.pdf

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Footnote 12

Available from: http://webprod5.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp [cited 2012 Feb 15]

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Footnote 13

Available from: http://webprod3.hc-sc.gc.ca/lnhpd-bdpsnh/ [cited 2012 Feb 15]

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Footnote 14

Psycholinguistics: The study of mental representations and processes related to composing, comprehending, speaking, hearing and remembering language.

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Footnote 15

Most medications have a moderate margin of safety, yet a small number of drugs have a high risk of causing injury when they are misused. These are called 'high-alert medications' 4,5. i to draw attention to this characteristic, and so all involved in their use will handle them with the care and respect they require. Errors may or may not be more common with the use of these drugs compared to others. However, the consequences of the errors are more devastating and their use requires enhanced precautions. These medications often need to be packaged differently, stored differently, prescribed differently, dispensed differently and administered differently than most other medications. Note: Definition adapted from the Institute for Safe Medication Practices (ISMP) (http://www.ismp.org/faq.asp#Question_5 [cited 2012 Feb 15]).

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Footnote 16

ISMP's List of High-Alert Medications is available from: www.ismp.org/Tools/highalertmedications.pdf. The ISMP List of High-Alert Medications in Community/Ambulatory Healthcare is available from: http://www.ismp.org/communityRx/tools/highAlert-community.pdf [cited 2012 Feb 15]

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Footnote 17

Lebelle M.J. Drug names and medication errors: Who is responsible? Can Med Assoc J. 1993;149(7):941-943.

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Footnote 18

Guidelines on the Use of International Nonproprietary Names (INNs) for Pharmaceutical Substances, 1997, Programme of International Nonproprietary Names, Division of Drug Management and Policies, World Health Organization, WHO/Pharm S/NOM 1570.

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Footnote 19

The terms label and labelling are used synonymously in this document and refer to inner and outer label as defined above.

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Footnote 20

Developed by the collaborating parties of the Canadian Medication Incident Reporting and Prevention System. 2001. Collaborating parties for the development and implementation of the Canadian Medication Incident Reporting and Prevention System (CMIRPS) are: Institute for Safe Medication Practices Canada, Canadian Institute for Health Information and Health Canada.

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Footnote 21

Lebelle M.J. Drug names and mis-medications - A Canadian perspective. Bureau of Drug Research, Drugs Directorate, Health Protection Branch, Presented at the Second PMA/PTMG Conference on Trademarks, Washington DC, May 2-4, 1994.

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Footnote 22

ISMP's List of Error-Prone Abbreviations, Symbols, and Dose Designations: www.ISMP.org/tools/errorproneabbreviations.pdf [cited 2012 Feb 15]

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Footnote 23

National Coordinating Council on Medication Error Reporting and Prevention: www.nccmerp.org [cited 2012 Feb 15]

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Footnote 24

Available from: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_ebauche_label_guide-eng.php [cited 2012 Feb 16].

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Footnote 25

The Institute for Safe Medication Practices Canada has published an FMEA manual focused on process analysis, the Canadian Failure Mode and Effects Analysis Framework. Proactively Assessing Risk in Healthcare. 2007. Other sources of information and FMEA tools are available on-line from Resource Engineering, Inc. (http://www.qualitytrainingportal.com/resources/fmea/index.htm) and the American Society for Quality (http://asq.org/learn-about-quality/process-analysis-tools/overview/fmea.html) [cited 2012 Feb 15].

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Footnote 26

Additional notes regarding safety:
Labelling - type size, contrast, trade dress; including directions. Does the user know the indications/dosage form/product/dose? - This would add to confusion and potential severity. Stress of user may add to possible confusion
Areas of use and patient circumstances can add to places where drug name confusion could occur. Severity of effects will also vary
Consumer-selected products - Are indication and diagnosis for treatment known? Potential for error due to user stress and fatigue
Identify the 'at risk' population, e.g., paediatric, geriatric, pregnant

Return to footnote xxvi referrer

Footnote 27

National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). NCC MERP Taxonomy of Medication Errors. 1998. Section 30, Patient Outcome. Available from: www.nccmerp.org/pdf/taxo2001-07-31.pdf [cited 20 Feb 2012].

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