E-DRUG: Two drug systems in the U.S. (7)
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Dear e-druggers,
I completely understand the European position regarding drug development
and use. In the US, drug regulation is really nebulous because of the
union of the State and big PHARMA. The preparation of any medication for
patient use by pharmacists and physicians is a matter for individual
state (not federal) regulation and intervention. And the states have
never done a very good job. In fact, the professions here do not
routinely self-regulate even though we say we have self-governance via
the State Boards of Medicine and Pharmacy. Thus, the impact of
federalism in the US Constitution; the issue of drug preparation relates
not only to commercial speech (First Amendment), but to treaty formation
and the Commerce Clause (Article 8). In Germany, for example, the
situation is very different because even though Germany is a federal
republic, its governing structure (and therefore function) is different.
See Arthur Daemmrich's book, Pharmacopolitics (Chapel Hill, NC:
University of North Carolina Press, 2004) for more explanation and
synthesis. The health professions in the US need to resume
responsibility for their medication-use recommendations, or else step
aside for a direct plebiscite from a safety-weary public.
It is interesting to note the influence of Big PHARMA in the writing of
the standards for drug discovery, access, and financing. I do not know
whether compounded medications will be reimbursed by the Medicare
scheme. Moreover, as Professor David Newton has suggested to me on
several occasions, compounding-related morbidity and mortality are
dwarfed in comparison to that caused by mass-produced pharmaceutical
use! Compounding pharmacies have taken steps to self-regulate via a
registry system similar to the Joint Commission on Accreditation of
Healthcare Organizations; an international society exists to aid
pharmacists involved in compounding at www.iacprx.org. Public Citizen
has published an interesting report "The Medicare Drug War: Drug
Companies and HMOs Led an Army of Nearly 1,000 Lobbyists to Promote
Misguided Legislation" at www.citizen.org.
Regards,
Richard
Richard H. Parrish II, Ph.D., R.Ph.
Assistant Professor
Department of Pharmacy Practice
Bernard J. Dunn School of Pharmacy
Shenandoah University
Faculty Senate Secretary - 2004-5
1775 North Sector Court
Winchester, VA 22601 USA
tel: +1 540 678 4392
fax: +1 540 665 1283
email: RParrish@su.edu