Fwd: HOT CONTROVERSIES FROM REDFLAGSDAILY.COM, OCTOBER 23, 2003

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Fri, 24 Oct 2003 12:03:01 -0700

HOT CONTROVERSIES FROM REDFLAGSDAILY.COM, OCTOBER 23, 2003

 

" Nicholas Regush "

 

 

THURSDAY, OCTOBER 23, 2003

 

REDFLAGSDAILY.COM

 

GO TO THE SPECIAL EXTRA! PAGE

 

GO TO FLASH! NEWS

 

HOT CONTROVERSIES

 

COMPOUNDING PHARMACISTS

 

Here is an ARTICLE that drew our attention today.

 

The article reports on a U.S. Senate hearing that focused attention on

compounding. This is when pharmacists " combine, mix, or alter ingredients in a

medication. "

 

The concern is that some pharmacies are abusing this age-old and important

practice of tailoring medications to individual needs. How? Mainly by acting as

manufacturers of high-volume sale items, rather than preparing products for

select patients who require altered forms of drugs.

 

Several years ago, when I was at ABC News, I investigated what seemed like scam

pharmacy operations that were buying bulk ingredients from wholesalers and

essentially setting up their own manufacturing plants. This is not what I

consider to be " compounding. " Anyone who does is mixing apples with aardvarks.

It was — and is — basically an industry that got around FDA requirements for

drug manufacturing. In a three-month period, I managed to locate a large number

of so-called " pharmacies " that were spewing out large volumes of everything from

inhalant drugs to time-release capsules. In some cases, there were improper

sterilization procedures being used, and in one case, a cashier at a pharmacy

was actually involved in making drugs (with no experience of any sort).

 

We had experts check out some of the inhalants and found that some samples

tested for unusually high potency — enough to produce heart rhythm disturbances.

 

We also had labs check out time-release capsules for heart drugs and found that

patients using these drugs would get a big load of the drug at the outset,

rather than small amounts over time.

 

In a few cases, we discovered that large volumes of poorly made products were

being shipped to nursing homes.

 

There’s a rather simple message here: If a pharmacy is reasonably providing

altered forms of medication as a service to its patients, that’s one thing, but

it is quite another to compound (manufacture) large volumes of drugs already

available on the market. What’s the point of this, except to make money? Who

needs this kind of risk?

 

The rotten apples in the barrel (and there are a lot of them) are giving the

genuine compounding pharmacists a bad name.

 

Yeah, yeah, tell me about the evil conventional drug manufacturers and how they

bilk the public. Of course they do, but do we need yet another level of greed

operating and without proper regulation? I think not.

 

-Nicholas Regush

 

 

 

 

 

http://www.reuters.com/newsArticle.jhtml?type=healthNews & storyID=3680289

 

Pharmacy Mixing Practices Draw Scrutiny

Thu October 23, 2003 06:13 PM ET

 

By Lisa Richwine

 

WASHINGTON (Reuters) - Pharmacists have provided weak and contaminated medicines

to patients as part of a practice designed for tailoring drugs to meet special

needs, witnesses told a U.S. Senate hearing on Thursday.

Senators said they were considering whether legislation was needed to ensure

better monitoring of " drug compounding, " in which pharmacists combine, mix or

alter ingredients in a medication for particular patients.

For example, a pharmacist might crush a tablet and create a liquid for an

elderly patient or a child who cannot swallow pills, or provide a formulation

without a dye or preservative to someone allergic to those ingredients.

In the vast majority of cases, compounding provides patients with safe and

effective products that are not otherwise available, said Dr. Steven Galson,

acting director of the Food and Drug Administration's Center for Drug Evaluation

and Research. But the FDA has uncovered cases in which patients received

medicines that were too weak or were tainted with bacteria, he said.

" We don't think these are representative, but they clearly do occur, " Galson

told the Senate Health, Education, Labor and Pensions Committee.

ABUSE OF THE PRACTICE

Also, some pharmacists have abused the practice by undertaking large-scale drug

manufacturing and calling it compounding, Galson said.

Pharmacists are not required to provide reports of harm linked to compounded

products to the FDA. But the agency has become aware of 200 " adverse events "

involving 71 compounded products since about 1990, including three deaths and 13

hospitalizations following injection of a drug contaminated with bacteria, said

Janet Heinrich, an investigator for the congressional General Accounting Office.

Daniel Herbert, president-elect of the American Pharmacists Association, said

the organization was developing strategies " to assure that patients get the

compounded medications they need, at the level of quality they should expect. "

Among the ideas under consideration is whether pharmacists involved in complex

compounding should complete a special certification process, he said.

Oversight of compounding activities from state pharmacy boards and the FDA

appears limited, Missouri Republican Sen. Kit Bond said. Lawmakers are

considering whether the FDA needs additional authority, including the power to

require adverse event reporting for compounded products.

" I would hope this is a wake-up call to all of us that this system is not

working, " Bond said.

 

 

 

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