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

The purpose of the draft revised guidance document is to provide guidance to market authorization holders on the testing procedures to be used and the information to be submitted to Health Canada to demonstrate that a proposed drug name is not likely to be confused with another health product authorized for use in Canada.  This guidance document is applicable to biologics and pharmaceuticals (prescription and non-prescription) for human use in which a brand name is proposed (innovator and generic).

Background

Health product names often look and sound alike. These similarities sometimes cause clinicians and patients to confuse one drug name for another.

In January 2006, Health Canada's Guidance for Industry - Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names became effective. This guidance stated Health Canada's expectations and sought to generate consistency in the information submitted by market authorization holders regarding the impact of a proposed name on the safe use of a health product. 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 market authorization holders. 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 revising the 2006 guidance on LASA brand name assessment.

Objective

The revised guidance is intended 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.

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.

Consultation Document

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

How to Get Involved

This consultation is open from Feb 19 to April 19, 2013.

Stakeholders are invited to provide input on the Draft revised Guidancefor Industry: Review of Drug Names for Look-alike Sound-alike (LASA) Attributes using the Comment Template.

Please submit your comments via e-mail, fax or by mail.

Patient Safety Section
Therapeutic Effectiveness and Policy Bureau
Marketed Health Products Directorate
Health Canada
200 Tunney's Pasture Driveway
Address Locator 0701L
Ottawa, Ontario   K1A 0K9
Fax: (613) 948-7996
E-mail: patientsafety_securitepatients@hc-sc.gc.ca

Reporting to Canadians

For additional information, contact the Patient Safety Section, Marketed Health Products Directorate.