Bill Text: GA HB681 | 2009-2010 | Regular Session | Introduced
Bill Title: Prescription drugs; substitution of generic drugs; change certain provisions
Spectrum: Moderate Partisan Bill (Republican 5-1)
Status: (Introduced - Dead) 2009-03-05 - House Second Readers [HB681 Detail]
Download: Georgia-2009-HB681-Introduced.html
09 LC 35
1284
House
Bill 681
By:
Representatives Byrd of the
20th,
Lunsford of the
110th,
Shipp of the
58th,
Hill of the
21st,
Cheokas of the
134th,
and others
A
BILL TO BE ENTITLED
AN ACT
AN ACT
To
amend Article 5 of Chapter 4 of Title 26 of the Official Code of Georgia
Annotated, relating to prescription drugs, so as to change certain provisions
relating to the substitution of generic drugs; to provide legislative findings;
to eliminate redundant language relating to the practice of medicine; to
prohibit the substitution of anti-epileptic drugs except under certain
conditions; to provide for related matters; to repeal conflicting laws; and for
other purposes.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
SECTION
1.
The
General Assembly finds that epileptic children and adults are entering clinics
and emergency rooms with life-threatening seizures due to the undisclosed
substitution of generic drugs for their prescribed drugs. While the Food and
Drug Administration is investigating whether an extended release generic drug
provides less active drug effects than the comparable brand name, leading to
increased risk of severe and life-threatening seizures, Georgia continues to
authorize the substitution of generic drugs without patient or physician
consent. This undisclosed generic drug substitution has resulted in medical
complications, severe injuries, seizure-related automobile accidents, and even
death of epileptic patients, including many epileptic children. Experts in
epilepsy and its treatment have routinely advised against switching among
different versions of the same drug without physician guidance, monitoring, and
oversight. The General Assembly further finds that the potential for increased
profits to pharmacies or cost savings to medical insurance companies resulting
from the use of generic drugs does not outweigh the substantial risk of
permitting drug substitution without informed consent. No one should have to
risk a seizure because of a flawed formulation of their medication.
SECTION
2.
Article
5 of Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating
to prescription drugs, is amended by revising Code Section 26-4-81, relating to
substitution of generic drugs for brand name drugs, as follows:
"26-4-81.
(a)
In accordance with this Code section
and except as
otherwise provided in Code Section
26-4-81.1, a pharmacist may substitute a
drug with the same generic name in the same strength, quantity, dose, and dosage
form as the prescribed brand name drug product which is, in the pharmacist's
reasonable professional opinion, pharmaceutically equivalent.
(b)
If a practitioner of the healing arts prescribes a drug by its generic name, the
pharmacist shall dispense the lowest retail priced drug product which is in
stock and which is, in the pharmacist's reasonable professional opinion,
pharmaceutically equivalent.
(c)
Substitutions as provided for in subsections (a) and (b) of this Code section
are authorized for the express purpose of making available to the consumer the
lowest retail priced drug product which is in stock and which is, in the
pharmacist's reasonable professional opinion, both therapeutically equivalent
and pharmaceutically equivalent.
(d)
Whenever a substitution is made, the pharmacist shall record on the original
prescription the fact that there has been a substitution and the identity of the
dispensed drug product and its manufacturer. Such prescription shall be made
available for inspection by the board or its representative in accordance with
the rules of the board.
(e)
The substitution of any drug by a registered pharmacist pursuant to this Code
section does not constitute the practice of medicine.
(f)
A patient for whom a prescription drug order is intended may instruct a
pharmacist not to substitute a generic name drug in lieu of a brand name
drug.
(g)
A practitioner of the healing arts may instruct the pharmacist not to substitute
a generic name drug in lieu of a brand name drug by including the words 'brand
necessary' in the body of the prescription. When a prescription is a hard copy
prescription drug order, such indication of brand necessary must be in the
practitioner's own handwriting and shall not be printed, applied by rubber
stamp, or any such similar means.
(h)
The substitution of any drug by a registered pharmacist pursuant to this Code
section does not constitute the practice of
medicine."
SECTION
3.
Said
article is further amended by adding a new Code section to read as
follows:
"26-4-81.1.
(a)
As used in this Code section, the term:
(1)
'Anti-epileptic drug' means:
(A)
Any drug prescribed for the treatment of epilepsy; and
(B)
A drug used to treat or prevent seizures.
(2)
'Epilepsy' means a neurological condition characterized by recurrent
seizures.
(3)
'Interchange' means the substitution of one version of a drug for another,
including a generic version for the prescribed brand version, a brand version
for the prescribed generic version, a generic version by one manufacturer for a
generic version by another manufacturer, a different formulation of the
prescribed version, and a different drug for the product
prescribed.
(4)
'Seizure' means an acute clinical change secondary to a brief disturbance in the
electrical activity of the brain.
(b)
A pharmacist shall not interchange an anti-epileptic drug or formulation of an
anti-epileptic drug without prior approval from the prescribing
physician."
SECTION
4.
All
laws and parts of laws in conflict with this Act are repealed.