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H. B. No. 373 As IntroducedAs Introduced
129th General Assembly | Regular Session | 2011-2012 |
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Representatives Johnson, Gonzales
Cosponsors:
Representatives Bubp, Buchy, Hackett, McClain, Reece, Stebelton, Terhar
A BILL
To amend sections 4729.37 and 4729.38 and to enact
section 4729.382 of the Revised Code to prohibit a
pharmacist from substituting another drug for a
tamper resistant opioid analgesic drug unless the
substituted drug is also tamper resistant or
consent is obtained from the prescribing health
professional.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That sections 4729.37 and 4729.38 be amended and
section 4729.382 of the Revised Code be enacted to read as
follows:
Sec. 4729.37. A copy of an original prescription may only be
filled in accordance with the rules and regulations adopted by the
state board of pharmacy.
Prescriptions received electronically or by word of mouth,
telephone, telegraph, or other means of communication shall be
recorded in writing by the pharmacist and the record so made by
the pharmacist shall constitute the original prescription to be
filled by the pharmacist. All prescriptions
Both of the following shall be preserved on file at the
pharmacy for a period of three years, subject to inspection by the
proper officers of the law:
(2) All written and signed consents received under section
4729.382 of the Revised Code.
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) If the prescribed drug is an opioid analgesic drug as
defined in division (A) of section 4729.382 of the Revised Code,
the pharmacist shall not select a generically equivalent drug
except as provided in section 4729.382 of the Revised Code.
(3) 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)(4) 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.
(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, "opioid
analgesic drug" means a drug in the opioid analgesic drug class,
whether in immediate or extended release form and whether or not
combined with another drug.
(B)(1) The state board of pharmacy shall create a list of
opioid analgesic drugs incorporating tamper resistance
technologies that includes both of the following:
(a) Each opioid analgesic drug incorporating tamper
resistance technologies for which a drug manufacturer or
distributor has submitted satisfactory evidence, as determined by
the board, of both of the following:
(i) That the drug incorporates a tamper resistance
technology;
(ii) That the drug has been approved by the United States
food and drug administration pursuant to an application that
includes at least one human tampering or abuse potential study or
a laboratory study. The study must be one that compared the tamper
or abuse resistance properties of the drug to one or more opioid
analgesic drugs that have been approved by the United States food
and drug administration and served as a positive control for the
experiment.
(b) A determination by the board as to which drugs included
on the list under division (B)(1)(a) of this section have
substantially similar tamper resistance properties. This
determination shall be based solely on studies submitted by the
drug manufacturer to the United States food and drug
administration as described in division (B)(1)(a)(ii) of this
section.
(2) When a drug is initially considered for inclusion on the
list created under division (B)(1) of this section, the board
shall not require that the drug bear on its labeling, as approved
by the United States food and drug administration, a claim
regarding the reduction of tampering, abuse, or abuse potential.
(3) The board shall publish the list created under division
(B)(1) on receiving from a drug manufacturer or distributor
evidence that satisfies the criteria in divisions (B)(1)(a)(i) and
(ii) of this section. The board shall update and republish the
list every time it receives such evidence from a drug manufacturer
or distributor.
(C) If a prescribed drug is on the list published under
division (B)(3) of this section, a pharmacist shall not substitute
a brand or generic drug for the prescribed drug without one of the
following:
(1) A determination by the board, as indicated on the list,
that the drug to be substituted has substantially similar tamper
resistance properties to the prescribed drug;
(2) Receipt by the pharmacist of written and signed consent
to the substitution from the prescriber.
Section 2. That existing sections 4729.37 and 4729.38 of the
Revised Code are hereby repealed.
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