Dear
DSaRM Advisory Committee Members:
It
is my pleasure to welcome you to the second day of the two-day (September 18th
and 19th) Drug Safety and Risk Management Advisory Committee
meeting. During these deliberations, our
attention is focused on ways to reduce the incidence of medication errors. On September 19th, you will be
hearing from a series of speakers who will elaborate on a number of proprietary
drug name screening methods including:
· Computer analyses
(orthographic, phonetic)
· Expert Committees
· Focus Groups
· Simulated Practice
Environment
· Field Testing
Many
of you participated in the FDA/ISMP/PhRMA public meeting that was held on June
26th in
On
September 19th, we will be asking you to take the next step. We will ask you to consider the advantages
and disadvantages of taking a risk-based approach to testing proprietary drug
names; identify critical design elements of each method to be included in good
naming practices; describe circumstances when a field test should be required
and to indicate whether any one method could stand alone; and to describe
circumstances, if any, when it would be appropriate to approve a proprietary
drug name contingent on a risk-management program.
We
appreciate your efforts in this area.
Ensuring the safe use of drugs and appropriately managing the risks of
medications is pivotal to protecting patients and improving the public
health. We are looking forward to
continuing to work with you on issues of public health significance relating to
drug safety.
Sincerely
yours,
/s/
Victor
F.C. Raczkowski, M.D., M.S.
Director
Office
of Drug Safety
Enclosures