United States Adopted Names Council
Meeting summary
Friday, July 13, 2007
United States Pharmacopeial Convention
The summer, 2007 meeting of the United States Adopted Names (USAN) Council was held Friday, July 13, 2007 at the United States Pharmacopeial Convention, Inc. (USP) in Rockville, MD. The topics discussed at this meeting included general USAN activities and policy, and issues relating to drug nomenclature and name requests.
The members of the USAN Council were in attendance, as well as the members of the USAN Program staff housed at the American Medical Association (AMA). Additional observers were present from the AMA, USP and the World Health Organization (WHO) International Nonproprietary Names (INN) Program. Also briefly in attendance were representatives from the Institute for Safe Medication Practices (ISMP) on hand to give a presentation on medication error issues.
The following items were discussed:
USAN activities
The negotiations update showed a steady flow of new submissions and a slight increase in USAN modified (USANM) submissions due to the new application policy, which became effective March 15, 2007 and is posted on the USAN Web site.
USAN policy
Stems: A list of new stems was presented at the meeting and approved by the USAN Council.
The scope of USAN was discussed.
USAN Web site
The USAN Web site has undergone updates including the posting of revised and consolidated naming guidelines and instructions, new USAN application policy, new USAN stem policy, American Chemical Society (ACS) Nomenclature Committee report posting, a request for comments or suggestions under staff contacts, and revised contact lens naming guidelines.
USAN Council and Review Board membership
With the opening of a new Council position for member-at-large, the sponsoring organizations are asked for their nominations. The Council and Review Board will undergo the annual nominations and appointment process. This selection and nomination process will be completed before the January, 2008 USAN Council meeting.
USAN negotiations
33 negotiations discussed: 6 INN revisions, 6 biologics, 11 multiple round and 10 new negotiations
WHO-INN nomenclature and USAN-sponsored negotiations
A total of 77 INN applications were discussed. Of that amount there were 41 USAN-sponsored INN applications.
Names were selected for 67 substances.
Names were deferred for 8 entities and no INN assigned for 2.
There were minor changes for 21 applications.
There were 4 deferred requests-1 deferred by manufacturer, 3 deferred by INN Expert Group.
WHO-INN biotechnology meeting and the discussion on biosimilars
The WHO-INN biotechnology meeting took place in April, 2007. It was a review of INN policy regarding biological products. This was generated by the worldwide discussion occurring on biosimilars. The recommendation is that there will be no change in the INN policy to name glycosylated proteins, thus INN will keep the system of having a common name and identifier. Other items of discussion at this meeting included monoclonal antibodies, cell therapy products, and the gene therapy naming scheme.
Medication error issues
Representatives from ISMP discussed hydromorphone versus morphine problems and recommendations as to USAN Council action sought.
Possible confusion with the use of acetaminophen and paracetamol discussed and recommendations as to USAN Council action sought.
USP activity presentation
USP staff presented their current activities regarding Food Chemicals Codex, the Dietary Supplement Compendium, the concern by USP for standards of drug manufacturing outside of the United States (Standards for Articles Legally Marketed Outside of the United States (SALMOUS)), the salt nomenclature policy, USP naming of biologics, and the Substance Registry System.
The USP Medication Errors Reporting Program covering Dec. 1, 2006 - April 30,
2007 was discussed. The medication error program helps to point
out possible errors due to naming problems, but most seem to be due to
educational issues.
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