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S. B. No. 114 As IntroducedAs Introduced
| 127th General Assembly | | Regular Session | | 2007-2008 |
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Cosponsors:
Senators Gardner, Cafaro
A BILL
To amend sections 4729.38 and 4729.99 and to enact section 4729.382 of the Revised Code regarding substitution of drugs intended to treat epilepsy.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That sections 4729.38 and 4729.99 be amended and section 4729.382 of the Revised Code be enacted to read as follows:
Sec. 4729.38. (A) Unless instructed otherwise by the
person receiving the drug pursuant to the prescription, a
pharmacist filling a prescription for a drug prescribed by its
brand name may select a generically equivalent drug, as defined
in section 3715.01 of the Revised Code, subject to the following
conditions: (1) The pharmacist shall not select a generically
equivalent drug if the prescriber handwrites "dispense as
written," or "D.A.W.," on the written prescription, or,
when
ordering a prescription electronically or orally, the prescriber
specifies that the
prescribed drug is medically necessary. These designations shall
not be preprinted or stamped on the prescription. Division
(A)(1) of this section does not preclude a reminder of the
procedure required to prohibit the selection of a generically
equivalent drug from being preprinted on the prescription. (2) The pharmacist shall not select a generically
equivalent drug unless its price to the patient is
less than or equal to the price of the prescribed drug. (3) The pharmacist, or the pharmacist's agent, assistant,
or employee shall inform the patient or the patient's agent
if a generically
equivalent drug is available at a lower or equal cost, and of the
person's right to
refuse the drug selected. Division (A)(3) of
this
section does not apply to any: (a) Prescription that is billed to any agency, division,
or department of this state which will reimburse the pharmacy; (b) Prescriptions for patients of a hospital, nursing
home, or similar patient care facility.
(4) If the drug is prescribed to treat epilepsy, the pharmacist receives the statement required by section 4729.382 of the Revised Code. (B) Unless the prescriber instructs otherwise, the label
for every drug dispensed shall include the drug's brand name, if
any, or its generic name and the name of the distributor, using
abbreviations if necessary. When dispensing at retail a
generically equivalent drug for the
brand name drug prescribed, the pharmacist shall indicate on the drug's
label
or container that a generic substitution was made. The labeling requirements
established by this division are in addition to all other labeling
requirements of Chapter 3715. of the Revised Code. (C) A pharmacist who selects a generically equivalent drug
pursuant to this section assumes no greater liability for
selecting the dispensed drug than would be incurred in filling a
prescription for a drug prescribed by its brand name. (D) The failure of a prescriber to restrict a prescription
by specifying "dispense as written," or "D.A.W.,"
pursuant to
division (A)(1) of this section shall not constitute evidence of
the prescriber's negligence unless the prescriber had reasonable
cause to believe that the health condition of the patient for
whom the drug was intended warranted the prescription of a
specific brand name drug and no other. No prescriber
shall be liable for civil damages or in any criminal prosecution
arising from the interchange of a generically equivalent drug for
a prescribed brand name drug by a pharmacist, unless the
prescribed brand name drug would have reasonably caused the same
loss, damage, injury, or death.
Sec. 4729.382. (A) As used in this section:
(1) "Epilepsy drug" means a drug prescribed for the treatment of epilepsy or a drug prescribed to treat or prevent seizures.
(2) "Epilepsy" means a neurological condition characterized by recurrent seizures.
(3) "Seizure" means a brief disturbance in the electrical activity of the brain.
(4) "Interchange" means the substitution of a generically equivalent drug for the prescribed drug, or substitution of a different drug for the drug prescribed, including any of the following:
(a) The substitution of a generic brand of the drug for the brand prescribed;
(b) The substitution of one generic brand of the drug for another generic brand;
(c) The substitution of one formulation of the drug for another;
(d) The substitution of one therapeutic drug treatment for another.
(B) A pharmacist shall not knowingly interchange a prescribed epilepsy drug without notifying the prescriber and receiving a signed statement consenting to the interchange from the prescriber and either the patient or the patient's parent, legal guardian, or spouse.
Sec. 4729.99. (A) Whoever violates section 4729.16,
division (A) or (B) of section 4729.38, or section 4729.382 or 4729.57 of the
Revised Code is guilty of a minor misdemeanor. Each day's
violation constitutes a separate offense. (B) Whoever violates section 4729.27, 4729.28, or 4729.36
of the Revised Code is guilty of a misdemeanor of the third
degree. Each day's violation constitutes a separate offense. If
the offender previously has been convicted of or pleaded guilty to a
violation of this
chapter, that person is guilty of a misdemeanor of the second
degree. (C) Whoever violates section 4729.32, 4729.33, or 4729.34
of the Revised Code is guilty of a misdemeanor. (D) Whoever violates division (A), (B), (D), or (E) of
section 4729.51 of the Revised Code is guilty of a misdemeanor of
the first degree. (E)(1) Whoever violates section 4729.37, division (C)(2) of
section 4729.51, division (J) of section 4729.54, or section
4729.61 of the Revised Code is guilty of a felony of the
fifth degree. If the offender previously has been convicted of or
pleaded guilty to a violation of this chapter or a violation of
Chapter 2925. or 3719. of the Revised Code, that person is guilty of a felony
of the fourth degree. (2) If an offender is convicted of or pleads guilty to a
violation of section 4729.37, division (C) of section 4729.51,
division (J) of section 4729.54, or section 4729.61 of the
Revised Code, if the violation involves the sale, offer to
sell, or possession of a schedule I or II controlled
substance, with the exception of marihuana, and if the court imposing
sentence upon the offender finds that the offender as a result
of the violation is a major drug offender, as defined in section
2929.01 of
the Revised Code, and is guilty of a specification of the type described in
section 2941.1410 of the Revised Code, the court, in
lieu of the prison term authorized or required by division (E)(1) of
this section and sections 2929.13 and 2929.14 of the Revised
Code and in addition to any other sanction imposed for the offense
under sections 2929.11 to 2929.18 of the Revised
Code, shall impose upon the offender, in accordance with division
(D)(3)(a) of section 2929.14 of the Revised
Code, the mandatory prison term specified in that
division and may
impose an additional prison term under division
(D)(3)(b) of that section. (3) Notwithstanding any contrary provision of section 3719.21
of the Revised Code, the clerk of court shall pay any
fine imposed for a violation of section 4729.37, division (C) of
section 4729.51,
division (J) of section 4729.54, or section 4729.61 of the
Revised Code pursuant to division (A)
of section
2929.18 of the Revised Code in accordance with
and subject
to the requirements of division (F) of section 2925.03
of the
Revised Code. The agency that receives the
fine shall use
the fine as specified in division (F) of section 2925.03
of the
Revised Code. (F) Whoever violates section 4729.531 of the Revised Code
or any rule adopted thereunder or section 4729.532 of the Revised
Code is guilty of a misdemeanor of the first degree. (G) Whoever violates division (C)(1) of
section 4729.51
of the Revised Code is guilty of a felony of the
fourth
degree. If the offender has previously been convicted of or
pleaded guilty to a
violation of
this chapter, or of a violation of Chapter 2925. or 3719. of the
Revised Code, that person is guilty of a felony of the
third degree. (H) Whoever violates division (C)(3) of section 4729.51
of the Revised Code is guilty of a misdemeanor of the first
degree. If the offender has previously been convicted of or pleaded guilty
to a violation of this chapter, or of a violation of Chapter 2925. or
3719. of the Revised Code, that person is guilty of a felony of
the fifth degree.
Section 2. That existing sections 4729.38 and 4729.99 of the Revised Code are hereby repealed.
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