Even
though there is no immediate concern here in Australia, there is
an ever increasing pressure exerted on our Therapeutic Goods Administration
(TGA) to bring all forms of manufacture on to a common line. A recent
example of this was the push in the complementary medicines field,
where it was legitimately argued that there was a tremendous variance
in the potency of herbal and nutritional products offered for sale.
While there were some glaring examples, the end result was a sharp
increase in the cost of complementary medicines offset by a uniformly
regulated market, promoting long term confidence.
Orthodox medicine saw this as a sensible and logical progression,
but alternate medicine practitioners saw this as a loss of a traditional
right which had worked for the benefit of their patients for centuries.
Would
this not be the way pharmacists would view the situation, if legislation
prised them away from a process that also has its origins in pharmacy
tradition, and has operated with a high degree of patient safety
down the centuries?
There
is a wide variance in the approach by Australian pharmacists to
the process of compounding.
Some pharmacists are turning patients away because they feel the
cost of compounding cannot be recovered in a patient fee (the
Auspharmlist is currently expounding on this fact).
Other pharmacists are specialising in compounding, enthusiastic
in the fact that they are bringing traditional skills to bear
on a patient medication problem.
Others still are adopting a hybrid process where they compound
a limited range of substances, but would be happy if they were
not repeated.
In
my previous articles, I have raised the profile for compounding
as being a legitimate specialty for a pharmacist to develop, and
a specialty that could fit under the umbrella of a consultant
pharmacist.
If readers would like to access my previous articles and read
them in context, you will note that I promoted the concept of
a consultant pharmacist writing the prescription and compounding
notes, for a dispensary technician to actually prepare. The stimulus
for the prescription could be a medical practitioner seeking to
help his patient be compliant, thus requiring a different form
of a medication already available. It could also originate from
the consultant pharmacist in the first instance, adapting or originating
a novel form of medication for patient benefit, which these days
could be derived from allopathic medicine or herbal medicine.
While
I was researching material for this article I became interested
in some aspects of the Trade Practices Review, which is underway
currently in Australia.
The ACCC wants an expansion of penalties for cartel type behaviour.
Big business has countered that it will accept a range of penalties,
provided they apply uniformly for businesses of all sizes.
In other words, they want the corner grocer to go to gaol if he
corners the market in baked beans and is able to influence the
market retail price adversely.
The concept is ludicrous, because it is only big business, with
the ability to concentrate a market, that can actually achieve
this.
However, if they succeed in having the legislation accepted, they
have another tool to tie up a small business in legal proceedings,
the costs of which could eventually force closure. You only have
to see the extremes that have been prosecuted for recent trade
mark infringements, to notice a definite paranoia within big business
and their attitude towards small business.
So
don't run away with the thought that the compounding of medicines
cannot be legislated for in exactly the same way. By stifling
the innovation and initiative of a small business, be it a pharmacy
or any other type, you eliminate future competition from the marketplace.
The
FDA in the US is prosecuting its case on two points:
*
It is claimed that when a product is compounded, it produces a
new and unapproved drug.
*
Because the compounded product is unapproved, it is therefore
not registered and cannot be advertised.
The
American Pharmacist's Association has entered the debate by filing
an "amicus curiae" (friend of the court) brief
to counter the FDA arguments and to illustrate the benefits of
pharmacists being able to compound.
The APhA brief sets out to explain in a clear and concise manner
the fundamental differences between compounding and manufacturing.
It gives specific instances of compounding, including the preparation
of sterile products in hospitals (cytotoxics, TPN's, eye drops,
pediatric preparations etc.) and how these preparations are patient
specific.
It also argues that compounding is a core element of pharmacy
practice, taught within universities and regulated by the states.
Further, in the past, pharmacies had been specifically excluded
from any form of restrictive compounding legislation, and that
existing legislation included a definition of a pharmacy which
stated.."shall be held to mean, and include, every store
or shop or other place where physicians' prescriptions are compounded."
The
FDA action does not make sense, and is therefore political in
nature, a tactic fueled by big business lobbying interests.
Only
an active pharmacy lobby can counter the above problems, but individual
pharmacists need to put their house in order, so that a finger
cannot be pointed at a later date.
For
instance, if compounding is a core element of pharmacy in Australia,
make sure it is stated in your business plan and the vision statement
it contains.
Mention it as part of your marketing mix and general advertising,
and ensure that you are properly set up to dispense i.e. you do
in fact have the legislated equipment on the premises.
Look to forming alliances in the purchase of galenicals. The lack
of a galenical, or its unavailability in a small pack size, must
surely indicate that there is a niche market out there for someone
to be involved in repackaging.
Be creative and set up an Internet alliance of compounding pharmacists,
so that these problems can be resolved on an industry-wide basis.
Share information.
The compounding skills of the apprenticeship era of pharmacy have
all but faded away, and where there was once a large and formal
body of information, it is now hard to find.
This is probably the most singular inhibitor for a pharmacist,
in that there may be a willingness to compound, if the basic information
is available.
The original prestige and popularity that patients bestowed on
"their" pharmacist, was largely because of the fact
that they made medicines and compounded specifically for the individual
patient.
Even within the same business structure it was not unusual for
a patient to seek out a specific pharmacist and request his/her
exclusive services in preparing their compounded prescription.
These
rewards are already available for pharmacists who have not abrogated
their professional role in favour of the "too hard"
basket.
Compounding forms a valid skill role for a consultant pharmacist
to be involved in.
And when you are asked to justify your "core elements",
if the TGA or some other body wants to take away your compounding
rights, what will your arguments be?
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