[e-drug] Samples of counterfeit drugs (cont)

[Nancy Blum <nlb@usp.org>]

E-drug: Samples of counterfeit drugs (cont)
---------------------------------------------

I agree with Richard that quality cannot be "tested in" to a product 
- it must be manufactured from good quality bulk materials and under 
acceptable GMPs.  However, I do not agree with the suggested terms 
"overstandard" and "understandard".  If we are talking about the 
amount of the active ingredient, it would be more specific to say 
"subpotent" if the amount is less than the label claim and 
over-potent  if the content is greater than label claim.  I am afraid 
that the term "over standard" will imply the product may be "better" 
than internationally accepted standards.  This is certainly not the 
case -a product that delivers more of the active ingredient than is 
specified on the label can be equally or more dangerous than a 
subpotent or fake product.
   This is particularly true if the patient is a child or a pregnant woman.
When we are talking about global problems, it is very important we 
use specific, easily-translated terminology.  If we can come to some 
general agreement on a definition of terms, we are at a starting 
point for global cooperation on making improvements.



Nancy Blum, M.P.H., M.A.
Director, Global Assistance Initiatives
U.S.Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD  20852

(301) 816-8161
(301) 816-8374 FAX
nlb@usp.org
www.usp.org
--
To send a message to E-Drug, write to: e-drug@usa.healthnet.org
To subscribe or unsubscribe, write to: majordomo@usa.healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@usa.healthnet.org
Information and archives: http://www.healthnet.org/programs/edrug.html