E-drug: Re: Standardized Pill Imprint Codes USP
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Gordon Schiff's message raises several questions. I do not intend to
discuss all of them here. I am pessimistic regarding establishing a
pill imprint system, both in US and internationally.
*Standardised *Pill Imprint *Codes *USP
*Standardised requires a standard and an organisation to develop
and maintain it. To be effective, the standard must be recognised
and used by the most of the countries/institutions that are (or ought
to be) affected by the standard. I am not very optimistic regarding
neither the standard, the organisation nor the recognising/usage. A
very relevant example in this connection is the ATC classification
system for medicines. Even being a WHO-supported standard, this
is not yet used in relevant connections in WHO (Essential Medicines
Model List is one example), and not yet used by US, UK, France,
Germany, or Japan. US does not even have any official drug
classification system (Veteran Administration and American Society
of Health System Pharmacists both have 'private' US systems).
Ignoring the lacking will, there are many practical problems
establishing such a standard. In US there are marketed about ten
different strengths of warfarin alone. There are many
pharmaceutical formulations for pills, for diltiazem tablets there are
at least three different formulations. And not to mention the
innumerable variety of FDCs, Fixed Dosage Combinations.
It is possible to imagine a code without establishing a standard. It
would then be necessary to have an organisation to register/give
out codes, to assign the codes to the medicines, and to answer
questions regarding codes. This has to be financed by someone.
And the manufacturers have to join the system, which I doubt if
they do volontarily.
There are, to my knowledge, only two areas (USA and the Nordic
countries) that have unique identifying codes on all medicine
packages (National Drug Code and Nordisk varenummer).
Identifying code on the package is not absolutely necessary for pill
imprint coding, but the regulations/politics would probably be
comparable for the two issues.
*Codes
There is an inverse relationship between the degree of coding and
the human readability. I can not imagine that a 10 digit code will be
sufficient to show (without decoding) the generic switching
example mentioned.
*USP
International trade and travel is increasing enormously. The
pharmaceutical industry is extremely internationalised.
USA/USP/FDA is probably one of the few 'organisations' that have
strength to demand pill imprint, and to maintain the necessary
organisation. I doubt if US have the will to do it nationally.
Gordon Schiff also mentions 'available to consumers and
practitioners' and 'identify 100% of the pills on the market'. This is
not obtainable with any 'simple standard'.
Pill imprint codes is a very large matter even within one nation.
Internationally it is such a big and complex project that I think it is
neither worth the effort, nor possible to accomplish.
Stein Lyftingsmo
Hospital Pharmacy of Elverum, Norway
e-mail: lyftings@online.no
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