Drug Monitoring
Expensive
Daily Observer
‘Hey
Mac’ used to be a convenient way of addressing a stranger to ask directions,
but now even this simple and convenient manner of speech faces extinction in
the maw of the acronym.
HEW
(acronymic for the Department of Health, Education, and Welfare) has now
decided that
The
guidelines, published in the Federal Register on
Of
course Federal policy states that the substitute drugs will be of quality and
bioavailability equal to that which the physician prescribed. The FDA (Food and Drug Administration) is
supposed to supervise this. They do not
have enough inspectors in the field, nor the laboratory space available to
maintain this commitment.
Actually,
the formulation of a medication is quite complex and the final product contains
inactive excipients, such as fillers, binders,
lubricants, disintegrants, dispersants, coatings, as well
as a small quantity of the drug itself.
The
pressure under which a final product is forged into a tablet is also a vital
consideration, since obviously, talc can be compressed to an insoluble pellet
which will merely go in one end and come out, quite intact, from the other.
As
patients run out on drugs that have been formulated by the members of the
pharmaceutical industry, the generic product can be put on the market. There is no limit to the number of generic
suppliers that may crop up to supply the government with its “cheap”
equivalents.
To
maintain an inspection force to police the new drug companies may exceed the
expense of buying the more expensive product.
The
best way to determine whether or not a drug is properly compounded is to test
the concentrations of the end product in the blood stream. It is this procedure that the government
sleuths will depend upon to track down the inadequate products.
However,
even with the best formulations there is a wide individual variability in
absorption of a given medication so that the doctors are becoming increasingly
aware that the best way to monitor drug dosage is to periodically check its
concentration in the serum.
Techniques
are available for this, and the effective serum levels are known for many of
the important drugs used. Thus, digoxin for the heart, or Dilantin
for epilepsy can now be administered more scientifically than ever before
without the physician having to depend on clinical signs of toxicity to warn of
over-dosage.
But
here the government will be forced into another quandary. The analysis of blood for drug concentration
is far from inexpensive.
If
physicians find that their Medicare and Medicaid patients are receiving the so
called generic equivalents of drugs they prescribed, they might be doubly
cautious and order chemical surveillance of blood levels on a continuing basis
to monitor dosage. Thus, out the window
go the savings that the governmental agencies projected when their penchant for
frugality drove them tinkering with the practice of medicine.
There
is no way out of the quandary.
Everything
is expensive. Life is expensive and
health is expensive. To take a budgetary
view of the sanctity of life will eventually raise questions about priorities
with respect to the sanctity of life, and the volcanic eruptions from the
ensuing debate will shake the ethical foundations of our civilization.