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Should a biologic have a brand name and a non-proprietary name?
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What are international non-proprietary names (inns)?
Dec 15, 2023 · International Non-proprietary Names (INNs) are the standardized, generic names assigned to drugs by the World Health Organization (WHO). These unique, non-branded names aim to: Prevent confusion: INNs avoid the potential for confusion caused by brand names, which can vary depending on the country and manufacturer.
- Overview
- Foreword
- Table of Contents
- 1 Introduction
- 2 Guidance for Implementation
- Appendix 1 - Definitions
- Appendix 2 - Modifiers/Abbreviations
- Appendix 3 - Medication-Use Process Maps
- Appendix 4 - Medication-Use Process Simulation
- Appendix 5 - Additional Attributes to Assist in Determining the Degree of Similarity
Full implementation of this guidance document will commence twelve months after registration of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) in Canada Gazette Part II.
Release Date: July 2, 2014
Pub. 140304
Cat. H164-184/2014E-PDF
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.
•1 Introduction
•1.1 Policy Objective
•1.2 Policy Statements
•1.3 Background
•1.4 Scope and Application
•1.5 Process
1.1 Policy Objective
To provide market authorization holders direction on the process to be followed and information to be submitted to Health Canada regarding the potential for a proposed name to be misleading or confused with another product authorized for use in Canada with the aim of preventing 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. 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. 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 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 as a last resort if other risk mitigation strategies are not deemed sustainable.
1.3 Background
Medication incidents occur for a variety of reasons including confusion between health products with similar names. These similarities sometimes cause healthcare professionals and patients to confuse one health product 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 self-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. Regulatory Authority The Food and Drug Regulations require that a product name and an assessment of the brand name be provided in a drug submission as part of the information required to evaluate the safety and effectiveness of the product. The assessment is to determine that the names of drugs will not be confusable with one another. If confusion with the proposed brand name is considered likely and could result in safety concerns, then the Health Products and Food Branch (HPFB) can refuse to issue an NOC (for new drugs only) or a Drug Identification Number (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 as a last resort 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 and issue a Drug Identification Number 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 (o) in the case of a drug for human use, an assessment as to whether there is a likelihood that the drug will be mistaken for any of the following products due to a resemblance between the brand name that is proposed to be used in respect of the drug and the brand name, common name or proper name of any of those products: a drug in respect of which a drug identification number has been assigned, a radiopharmaceutical, as defined in section C.03.201, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01 and a kit, as defined in section C.03.205, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01. 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; (o) in the case of a new drug for human use, an assessment as to whether there is a likelihood that the new drug will be mistaken for any of the following products due to a resemblance between the brand name that is proposed to be used in respect of the new drug and the brand name, common name or proper name of any of those products: a drug in respect of which a drug identification number has been assigned, a radiopharmaceutical, as defined in section C.03.201, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01 and a kit, as defined in section C.03.205, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01. 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 with the proposed brand name, Health Canada is entitled to refuse to issue a NOC/DIN in accordance with subsections C.01.014.2 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 1 The 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. This 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.
2.1 Brand Name Assessment Process
Assessment of proposed brand names is intended to determine if the name is misleading or could be confused with an existing product authorised for use in Canada (sections C.08.002(2)(o), C.08.002.1(2)(a), C.08.003(3.1)(b) and C.01.014.1(2)(o) of the Food and Drug Regulations). Sponsors will be responsible for carrying out the initial brand name review and LASA testing procedures (where applicable) outlined in this guidance to demonstrate that their submitted brand name is not likely to be misleading or cause confusion with other health products that are authorised for use in Canada. Health Canada will review the information submitted and make the decision to approve or reject the proposed brand name. The diagram below, Figure 1, outlines the process to be followed in completing a brand name assessment.
Figure 1: Brand Name Assessment and Review Process
Sponsor Initial Brand Name Review: Screen proposed name according to general safety criteria. Decide on the initial acceptability of the proposed brand name for continuation with brand name assessment. Pass or Fail (misleading name) Review scope inclusions/exclusions to determine if a LASA brand name assessment is required. LASA Brand Name Assessment Step 1: Search Search proposed name against the Drug Product Database (DPD) and the Licensed Natural Health Products Database (LNHPD) Identify any name with similarity score of 50% or above Search published literature for error reports Step 2: Simulate Develop use process map(s) for proposed name Conduct medication-use process simulations encompassing prescribing, transcribing, selection, dispensing and administration Step 3: Synthesize Document names that have been identified as confusing during steps 1 and 2 Inclusion of names in FMEA process Conduct FMEA Document results Prepare final report with rationale and recommendation for approval Health Canada Review Step 1: Initial Brand Name Review Screen proposed name according to general safety criteria Decide on the initial acceptability of the proposed brand name for continuation with step 2 of the Health Canada review. Accept or Reject Step 2: Review Search proposed name against DPD, LNHPD and the Drug Submission Tracking System (DSTS) Review sponsor's detailed LASA brand name assessment Request additional information, if needed Decide on the acceptability of the proposed brand name. Accept or Reject
2.2 Initial Brand Name Review
All brand names must undergo an initial brand name review. Sponsors should review each proposed brand name using the criteria outlined below. These criteria address naming practices that Health Canada views as misleading (per Section 9 of the Food and Drugs Act; A.01.017 and C.08.006 of the Food and Drug Regulations). A proposed brand name must pass the initial brand name review to be considered for approval. An affirmative response to any of the questions one through seven will result in a proposed name failing the initial brand name review. In these circumstances, Health Canada will contact the Sponsor to request an alternate brand name, accompanied by a LASA brand name assessment, if applicable. Initial Brand Name Review Criteria Does the name/modifier suggest/imply an 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')? Does the name/modifier include or imply an ingredient that is not included in the drug product? 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')? Does the proposed name contain a letter sequence/stem that is in the same position designated by USAN (U.S. Adopted Name) or INN (International Nonproprietary Name) for the same or different pharmacological/chemical traitFootnote 6,Footnote 7,Footnote 8 Does the proposed brand name contain or suggest an exclusive composition of only one ingredient in a multi-ingredient product? Does the name suggest an unsupported route of administration or dosage form? Does the name conflict with Schedule A of the Food and Drugs Act (e.g., DiabeticCareTM Acetaminophen Tablets)? Below is a list of additional factors that are given consideration by Health Canada when making a decision about the acceptability of a proposed brand name. Although these factors will not lead to an automatic rejection of the proposed name, they will require the sponsor to provide a rationale supporting why this approach can be used without the risk of being misleading or resulting in confusion. Was the same/similar name used previously for a product that is no longer available on the market (i.e., discontinued)? Does the name contain a confusable abbreviation?Footnote 9 (e.g. QD may be read or interpreted as QID, OD may be interpreted as either Oculus Dexter [Latin, meaning 'right eye'] or Once Daily) (See Appendix 2 for further information on abbreviations.) Does the modifier contain a single letter or number?Footnote 10 (See Appendix 2 for further information on the use of modifiers.) Might the modifier hinder the health professional/consumer in selecting the appropriate medication? (See Appendix 2 for further information on the use of modifiers.) Does the brand name or part of the brand name represent or imply a medical and/or scientific term or acronym? Does the proposed name contain a letter sequence/stem that is in a different position designated by USAN or INN for the same or different pharmacological/chemical traitFootnote 11,Footnote 12,Footnote 13? Is the proper/common name abbreviated or truncated? Are you aware if the name has been approved in another country for a product with a different medicinal ingredient?
Authorized Product: \tA product that has been approved by Health Canada.
Brand Name (or proprietary drug name): \tC.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,
1.that is assigned to the drug by its manufacturer,
2.under which the drug is sold or advertised, and
3.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 Drug Submission Application Form (Health Canada3011).
The use of modifiers/abbreviations in a name can create opportunities for error and misinterpretation. 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, where permissible with respect to copyright/trademark law.
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. Two examples for different products and contexts are provided. These diagrams identify the principal participants in the medication-use process, including non-healthcare or ...
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.)
A minimum of 100 Canadian healthcare professionals must participate in the medication-use simulations unless a strong case can be made for a smaller number due to the specialised nature of the product and its intended users. 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.
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
Feb 14, 2019 · All biologic drugs, including biosimilars, reference biologics and innovator biologics, would receive a unique, meaningless 4-letter suffix appended to the non-proprietary name. Products sharing the same non-proprietary name would be distinguished by the suffix.
The Crossword Dictionary explains the answers for the crossword clue 'Non-proprietary (drug)'. If more than one Crossword Definition exists for a clue they will all be shown below. Links to Crossword Dictionary entries can be found when searching for clues using the Crossword Solver - Non-proprietary (drug)
Following internal and external stakeholder consultations and analysis of related issues, Health Canada has decided that biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix.
