E-drug: Standardized Pill Imprint Codes USP
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I have been working on the goal of rationalizing the imprint codes
on solid oral dosage pills to permit the consumer and health care
provider to easily identify their medications-drug name and dosage.
How many times have patients or professionals needed an easy
way to answer the question "What is this pill" --emergency
poisoning situation, patient with pills in handkerchief or pill
organizer, avoiding duplication of therapy (health plan switches to
generic version of same medication, patient could see both have the
same code number and thus know it is same medicine).
Codes should be easily "decoded" on Internet or even touch tone
phone, instead of current somersaults needed to identify based on
size, shapes, and markings chosen in uncoordinated and
unstandardized fashion by the manufacturer.
Codes need to be unambiguous, nonredundant, uniform,
authoritatively generated, non-sense randomly assigned (ie 10mg
wouldn't be a good 4 digit code), and with enough combinations to
accommodate needed numbers of drugs (4 digit probably OK, gives
~ 1 million combinations, or perhaps 5). The current system flunks
on virtually all counts. Identidex and Identidrug, currently best US
reference books/products to help identify pills, are generally not
available to consumers and practitioners and are needlessly complex
and fail to identify 100% of pills on the market.
We have been working with USP and FDA over the years to pursue
this simple standard. A resolution to explore the advisablity and
feasablity of such a system was passed by USP in both 1990 and
2000. PHARMA and big manufacturers have opposed, but most of
their arguments ought not be serious obstacles (ie. retooling
costs--if phased in over 5-10 years production tools are routinely
replaced anyway; regulatory changes that would be needed for
product changes--could be worked out in a streamlined fashion with
FDA)
My questions to those on this listserve are 3
1. Is anyone else interested in this issue and willing to be in contact
with me to help move forward?
2. Is anyone aware of specific initiatives in countries other than US.
WHO at one point was quite interested in this idea, that could lead
to an international standard. Any information on EU or other
organizations that are considering this issue?
3. Does any have any experience or literature (the work of WO
Robertson is the main literature in the US) documenting problems
arising from lack of such a uniform standardized coding system
from their own country or experience. (or any other thoughts on
this subject)?
Gordon Schiff MD
Director Clinical Quality Research
Dept of Medicine
Cook County Hospital
Chicago IL, USA
Chair Safe Medication Use Task Force on Standardized Imprint
Codes (former Chair of Consumer Interest/Patient Education
Advisory Panel)
United Stated Pharmacopoeia Inc
Rockville MD, USA
gdschiff@aol.com
W 312 633 6905
Pager 312 740 4398
Fax 312 633 3684
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