In our September 2003 issue of Rx IP Update, we reported that Health Canada presently reviews drug names on an informal basis, but that consultations regarding proposed amendments to the review process may take place as early as this Fall.
Recently, a Look-alike/Sound-alike (LA/SA) Working Group, made up of representatives from the Health Products and Food Branch (HPFB), including members of the Therapeutic Products Directorate, was tasked with reviewing and analyzing the issues associated with LA/SA health product names and recommending an appropriate course of action. On October 17, 2003, the Working Group released a draft Issue Analysis Summary entitled “Look-alike Sound-alike (LA/SA) Health Product Names: The Development of a Comprehensive Policy Recommendation.”1
By way of background, the document describes the current review process and need for a long term strategy as follows:
Currently, LA/SA drug name issues are handled on a case-by-case basis. Since there is no consistent or formal process within the Branch to review LA/SA aspects of product names, the name review is somewhat arbitrary and depends on initiative, memory, intuition and judgment of staff. Current computer systems are not set up to flag identical or similar names. Furthermore, the subjective nature of similarities between drug names compounds the problem, since names that are similar to one person may not be to another. In addition, the general perception is that there is questionable authority as to whether the Food and Drugs Act can be used to require a name change. When a LA/SA drug is identified either pre- or post-market, the sponsor is notified and encouraged to consider changing their product name. Alternatively, they are questioned regarding any proposed remedial measures they can suggest to reduce the potential for medication errors. When such issues have been brought to the manufacturer's attention, HPFB success has been mixed. As a result, there is a general consensus that a long term strategy needs to be developed, in co-operation with stakeholders, to deal with LA/SA drug names.
The LA/SA Working Group’s conclusions regarding Health Canada’s authority and powers relating to pre- and post-market monitoring of drug names are as follows:
Pre-market: In summary, the LA/SA WG believes that the Food and Drug Regulations allow HPFB to adopt a pre-market requirement that the names of drugs not be confusing with one another [see subsection C.08.002.(1), C.08.002.(2), C.08.002.(3) and C.01.014.1(2) of the Food and Drug Regulations]. If confusion with another drug name was considered likely and confusion could result in safety concerns, then HPFB could refuse to issue a DIN (new drugs and drugs other than new drugs) and/or NOC (new drugs only), as applicable.
Post-market: Section C.01.013. of the Food and Drug Regulations requires that, upon request, a manufacturer must submit sufficient evidence by a specified date to establish the safety and effectiveness of a drug for the purposes recommended. When sufficient evidence is not provided, further sales of the drug can be suspended.Upon becoming aware of a safety concern associated with LA/SA name confusion following issuance of an NOC and/or DIN for a drug, the LA/SA WG is of the opinion that HPFB can use C.01.013. to require the manufacturer to establish the safety of the drug under its recommended uses in light of a safety concern identified in relation to its name. If sufficient evidence is not provided, HPFB could consider suspending sales of the drug by way of the C.01.013 process.
The following recommendations are endorsed by the LA/SA Working Group as the best options for reviewing LA/SA names:
Pre-market: A complex computer application should be acquired to screen for LA/SA health product names. Those names that are flagged should be reviewed and if the reviewer cannot come to a decision, it is considered further by an Interdirectorate Name Review Committee. Prior to filing a submission, a sponsor would be required to show that a proposed health product name does not have LA/SA name similarities. Furthermore, the sponsor would have the option of providing a prioritized list of name choices.
Post-market: Potential LA/SA health products should be monitored and, if sufficient risk of harm due to potential medication errors is identified, appropriate market intervention should be initiated (e.g. Fact Sheets, Dear Health Care Professional Letters, name or labelling change to one of the products etc.).
The Proposal is presented as a draft for comment only. On October 20 and 21, 2003, an Invitational National Workshop was held to discuss these issues. A post-workshop report will be released shortly. We will report on developments on this initiative, including a copy of the post-workshop report, in future issues of Rx IP Update.
1 Health Canada has also recently released a fact sheet relating to Look-alike Sound-alike Health Product Names.
Nancy P. Pei, Toronto