Dr. Lisse wrote --
> I can not see a difference really. Theophylline has been mentioned, and
> Carbamazepine. But first of all it's not the generic that makes the
> patient have an attack, its the compliance.
In response to the above comment, I would have to disagree (at least in
part). Generic equivalency does not ALWAYS relate to therapeutic
equivalency. This is especially true when the kinetics of a particular
drug (particularly the therapeutic window) are as "touchy" as say
carbamazepine or digoxin. There was a problem with generic substitution
of certain drugs (digoxin in particular) several years ago which caused a
minor stir. As health professionals, we dealt with the problem (poor
formulations) without stopping all generic substition. This was done by
including such things as acceptable deviations around the kinetic profile
of a drug which must be met to obtain the "generic equivalent" tag.
As the drug experts in the medical community it is our duty to identify
these issues early and make the appropriate adjustments. Mandatory
substitution MAY not be problem so long as it is not coupled with the
requirement to purchase the cheapest formulation without thought to its
therapeutic profile. Institutionally mandated generic substitution in
"private" hospitals has occurred in the states for some time with little,
if any, problems. We are allowed to "select" the generic brand to be used
based upon a combination of price and therapeutic value. We then try to
influence the prescribing practices of the medical staff through
Selection of a poor generic equivalent can affect the cost of that
patient's care dramatically which creates other economic problems. I
think the key to this discussion is professional judgement by someone
other than the prescribing physician. A written prescription in the State
of Texas for example is required to have two signature lines -- (1)
Product selection permitted; and (2) Dispense as Written.
When generic substitution is not clinically relevant, the physician is
encouraged to select the first option to reduce the cost paid by the
patient. The pharmacist then has the choice (with the patient's
permission) of which "brand" to dispense. In a controlled environment
such as a hospital, managed clinic, or governmental facility, the
physicians agree to allow generic substitution as a rule but still retain
the right to require a specific brand when they feel it clinically
relevant to that patient's care. This is generally questioned only when a
physician abuses this privilege which increases cost to the institution.
Their privileges as that institution can be revoked should they "not play
the game" for a win-win all around.
I can empathize with this issue, but the key is the education of the
medical professionals with which you work as to the "clinically relevant
issues" surrounding generic substitution. When used with a degree of
discretion, generic substitution (even required) can be used as a major
tool for cost reduction.
Douglas R. Smith, M.S., R.Ph.
Clinical Information Specialist
Department of Pharmacy
Baylor University Medical Center