[e-drug] Two drug systems in the U.S. (5)

E-DRUG: Two drug systems in the U.S. (5)
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Dear e-druggers~

The Utah case finding is informative, however, for those interested in the legal complexities of this issue I would also suggest reading the federal court opinion in the Wedgewood Pharmacy case (which affirms FDA's guidance on compounding as a reasonable interpretation of the federal Food Drug and Cosmetic Act (FFDCA)), Supreme Court Justice Stephen Breyer's dissent in the Western States case mentioned in Richard Parrish's post (addresses global public health concerns associated with compounding not confined to the First Amendment issue) and the brief for the petitioners by Daniel Troy and Alex Azar, II also submitted in the Western States Supreme Court Case (which address FDA's application of the FFDCA to the compounding problem). I have found these documents merit consideration with regards to the legalities of compounding.

Justice Stephen Breyer's dissent makes the logical point that providing exemptions from the FFDCA for compounding under FDAMA "inherently creates risks simply by placing untested drugs in the hands of consumers". The dissenting opinion is joined by The Chief Justice, Justice Stevens, and Justice Ginsburg, and further notes the absence of a clear line that will "distinguish (1) sales of compounded drugs to those who clearly need them from (2) sales of compounded drugs to those for whom a specially tailored but untested drug is a convenience but not a medical necessity".

Sarah Sellers, PharmD MPH
ssellers@jhsph.edu

E-DRUG: Two drug systems in the U.S. (6)
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For a West European this story is completely incomprehensible.
Is there really no pharmaceutical inspectorate in the US Ministry of Health?
Is there no professional supervision?

I might be too naove - but is the USA really some sort of banana republic?

Best wishes from a Dutch physician,

Dr.L.Offerhaus
offerhausl@euronet.nl

E-DRUG: Two drug systems in the U.S. (9)
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[copied as fair use. WB]

Dear E-druggers,

With all due respect, may I offer this news article that describes another
problem?

Stevan Gressitt
gressitt@uninets.net

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Bangor Daily News

By Meg Haskell, e-mail Meg mhaskell@bangordailynews.net
Last updated: Tuesday, October 5, 2004
New law cancels drug benefit
Valium, Xanax among Rx cuts

BANGOR - Without federal legislative intervention, thousands of Maine
seniors enrolled in MaineCare, Maine's Medicaid program, will lose coverage
for medications they may rely on to control anxiety, seizures, panic attacks
and insomnia.

A provision buried in the 700-page Medicare Modernization Act of 2004
excludes the important and widely prescribed group of psychoactive drugs
known collectively as benzodiazepines - Xanax, Valium, Halcion, Klonopin,
Librium and others - from coverage under the much-touted national
prescription drug benefit.

In January 2006, when Americans with both Medicare and Medicaid coverage
will start having their medications paid for by Medicare, benzodiazepines
will not be included. The switch will affect about 8,000 Mainers, including
many in nursing homes and other residential facilities.

The drugs are not especially expensive - a 30-day supply generally costs
about $30 to $40 - but because so many recipients are low-income seniors,
the impact of the benzodiazepine exclusion on them is the focus of growing
national concern. It is largely through the efforts of a Maine-based
organization that the fine-print provision has been brought to light.

The Maine Benzodiazepine Study Group was formed three years ago to study the
use, abuse and misuse of benzodiazepines. The position of the group, made up
of physicians, substance abuse treatment providers, consumer health
advocates and others, is that benzodiazepines are medically valuable but
overprescribed, with the result that they too often wind up on the street, a
favorite of recreational drug users and addicts alike.

Group members also are alert to common side effects of the drugs, especially
in the elderly. These may include drowsiness, depression, memory loss,
confusion and physical weakness. Studies indicate that people taking
benzodiazepines are more likely to experience falls, car accidents and other
potentially serious mishaps. Taken in combination with alcohol or other
medications, benzodiazepines can cause life-threatening cardiac and
respiratory conditions and other problems.

The drugs also are habit-forming, making it difficult, time-consuming and
sometimes impossible to wean a patient to another treatment.

Despite their drawbacks, though, many health care providers and consumers
say benzodiazepines are effective at treating the conditions they're
designed to remedy and, when carefully monitored, can improve daily life for
patients as well as their caretakers.

The study group's mission is to educate physicians and consumers about the
appropriate use of benzodiazepines and to promote the use of effective
alternatives when possible.

But the new federal exclusion is "throwing the baby out with the bath
water," according to one presenter at the organization's second annual
conference in Bangor on Monday. Robert Hayes, president of the New
York-based Medicare Rights Center, called the benzodiazepine exclusion "a
looming debacle" that will profoundly affect millions of Americans,
especially the low-income elderly, unless it is derailed by congressional
intervention.

Hayes said the Maine study group "has been a major catalyst in raising the
issue" in other states and among the health care provider community.

Clearly no fan of the Medicare Modernization Act, Hayes said the Bush
administration's omnibus legislation contains "something to offend just
about everybody." He conceded, however, that the benzodiazepine exclusion is
"seemingly inadvertent" and "a mistake of public policy" that came about as
a result of the bill's rapid progress through the House and Senate. Medicare
bill drafters looked to existing Medicaid provisions that allow individual
states to exclude a number of drugs from their coverage, including
weight-loss drugs, over-the-counter drugs, and benzodiazepines, Hayes
explained. In the interest of cost control and simplicity, he said, a flawed
decision was made to eliminate the substances from the Medicare list,
without a clear understanding of what was at stake.

Benzodiazepines were on Medicaid's optional list because of their recognized
potential for abuse, but 43 states - including Maine - include them on their
list of approved drugs for Medicaid. Hayes said there is growing support in
Congress for correcting the problem but it will take a focused legislative
effort and strong leadership to undo the error, something that's unlikely to
occur either before the November presidential election or in the "lame duck"
session between November and January.

Roseanne Pawelec, a spokeswoman at the regional office of the Centers for
Medicaid and Medicare Services in Boston, said last week she is unaware of
any specific proposals to change the provisions of the Medicare
Modernization Act. While states' concern over the benzodiazepine exclusion
is growing, the Maine study group has been most vocal in drawing attention
to the issue, she said. The Centers for Medicaid and Medicare Services will
encourage state Medicaid programs to pay for any medications not covered by
the Medicare benefit, Pawelec said, including benzodiazepines for the
low-income elderly.

Monday's meeting also included a presentation on the relationship between
prescription drug abuse and crime in Maine and a discussion on the state's
new prescription monitoring program.

On Tuesday, the last day of the conference, the agenda was expected to be
devoted to state and federal efforts to regulate the disposal of unused
medications in order to protect the environment as well as to keep
prescription medications away from substance abusers.

More information on the Maine Benzodiazepine Study Group, including the
Medicare exclusion, can be found on the Internet at
www.noemaine.org/benzo/benzo.htm