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Re: E-DRUG: Mandatory generic prescribing vs trade mark rights

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
Dallas, Texas
(214) 820-2961

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