Bill Text: OH HB373 | 2011-2012 | 129th General Assembly | Introduced

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Bill Title: 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.

Spectrum: Moderate Partisan Bill (Republican 8-1)

Status: (Introduced - Dead) 2011-11-09 - To Health & Aging [HB373 Detail]

Download: Ohio-2011-HB373-Introduced.html

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As Introduced

129th General Assembly Regular Session 2011-2012

H. B. No. 373

Representatives Johnson, Gonzales 

Cosponsors: Representatives Bubp, Buchy, Hackett, McClain, Reece, Stebelton, Terhar 

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A BILL

To amend sections 4729.37 and 4729.38 and to enact

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section 4729.382 of the Revised Code to prohibit a

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pharmacist from substituting another drug for a

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tamper resistant opioid analgesic drug unless the

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substituted drug is also tamper resistant or

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consent is obtained from the prescribing health

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professional.

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BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

Section 1. That sections 4729.37 and 4729.38 be amended and	8
section 4729.382 of the Revised Code be enacted to read as	9
follows:	10

Sec. 4729.37.  A copy of an original prescription may only be	11
filled in accordance with the rules and regulations adopted by the	12
state board of pharmacy.	13

Prescriptions received electronically or by word of mouth,	14
telephone, telegraph, or other means of communication shall be	15
recorded in writing by the pharmacist and the record so made by	16
the pharmacist shall constitute the original prescription to be	17
filled by the pharmacist. All prescriptions	18

Both of the following shall be preserved on file at the	19
pharmacy for a period of three years, subject to inspection by the	20
proper officers of the law:	21

(1) All prescriptions;

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(2) All written and signed consents received under section	23
4729.382 of the Revised Code.	24

Sec. 4729.38.  (A) Unless instructed otherwise by the person	25
receiving the drug pursuant to the prescription, a pharmacist	26
filling a prescription for a drug prescribed by its brand name may	27
select a generically equivalent drug, as defined in section	28
3715.01 of the Revised Code, subject to the following conditions:	29

(1) The pharmacist shall not select a generically equivalent	30
drug if the prescriber handwrites "dispense as written," or	31
"D.A.W.," on the written prescription, or, when ordering a	32
prescription electronically or orally, the prescriber specifies	33
that the prescribed drug is medically necessary. These	34
designations shall not be preprinted or stamped on the	35
prescription. Division (A)(1) of this section does not preclude a	36
reminder of the procedure required to prohibit the selection of a	37
generically equivalent drug from being preprinted on the	38
prescription.	39

(2) If the prescribed drug is an opioid analgesic drug as	40
defined in division (A) of section 4729.382 of the Revised Code,	41
the pharmacist shall not select a generically equivalent drug	42
except as provided in section 4729.382 of the Revised Code.	43

(3) The pharmacist shall not select a generically equivalent	44
drug unless its price to the patient is less than or equal to the	45
price of the prescribed drug.	46

(3)(4) The pharmacist, or the pharmacist's agent, assistant,	47
or employee shall inform the patient or the patient's agent if a	48
generically equivalent drug is available at a lower or equal cost,	49
and of the person's right to refuse the drug selected. Division	50
(A)(3) of this section does not apply to any:	51

(a) Prescription that is billed to any agency, division, or	52
department of this state which will reimburse the pharmacy;	53

(b) Prescriptions for patients of a hospital, nursing home,	54
or similar patient care facility.	55

(B) Unless the prescriber instructs otherwise, the label for	56
every drug dispensed shall include the drug's brand name, if any,	57
or its generic name and the name of the distributor, using	58
abbreviations if necessary. When dispensing at retail a	59
generically equivalent drug for the brand name drug prescribed,	60
the pharmacist shall indicate on the drug's label or container	61
that a generic substitution was made. The labeling requirements	62
established by this division are in addition to all other labeling	63
requirements of Chapter 3715. of the Revised Code.	64

(C) A pharmacist who selects a generically equivalent drug	65
pursuant to this section assumes no greater liability for	66
selecting the dispensed drug than would be incurred in filling a	67
prescription for a drug prescribed by its brand name.	68

(D) The failure of a prescriber to restrict a prescription by	69
specifying "dispense as written," or "D.A.W.," pursuant to	70
division (A)(1) of this section shall not constitute evidence of	71
the prescriber's negligence unless the prescriber had reasonable	72
cause to believe that the health condition of the patient for whom	73
the drug was intended warranted the prescription of a specific	74
brand name drug and no other. No prescriber shall be liable for	75
civil damages or in any criminal prosecution arising from the	76
interchange of a generically equivalent drug for a prescribed	77
brand name drug by a pharmacist, unless the prescribed brand name	78
drug would have reasonably caused the same loss, damage, injury,	79
or death.	80

Sec. 4729.382.  (A) As used in this section, "opioid	81
analgesic drug" means a drug in the opioid analgesic drug class,	82
whether in immediate or extended release form and whether or not	83
combined with another drug.	84

(B)(1) The state board of pharmacy shall create a list of	85
opioid analgesic drugs incorporating tamper resistance	86
technologies that includes both of the following:	87

(a) Each opioid analgesic drug incorporating tamper	88
resistance technologies for which a drug manufacturer or	89
distributor has submitted satisfactory evidence, as determined by	90
the board, of both of the following:	91

(i) That the drug incorporates a tamper resistance	92
technology;	93

(ii) That the drug has been approved by the United States	94
food and drug administration pursuant to an application that	95
includes at least one human tampering or abuse potential study or	96
a laboratory study. The study must be one that compared the tamper	97
or abuse resistance properties of the drug to one or more opioid	98
analgesic drugs that have been approved by the United States food	99
and drug administration and served as a positive control for the	100
experiment.	101

(b) A determination by the board as to which drugs included	102
on the list under division (B)(1)(a) of this section have	103
substantially similar tamper resistance properties. This	104
determination shall be based solely on studies submitted by the	105
drug manufacturer to the United States food and drug	106
administration as described in division (B)(1)(a)(ii) of this	107
section.	108

(2) When a drug is initially considered for inclusion on the	109
list created under division (B)(1) of this section, the board	110
shall not require that the drug bear on its labeling, as approved	111
by the United States food and drug administration, a claim	112
regarding the reduction of tampering, abuse, or abuse potential.	113

(3) The board shall publish the list created under division	114
(B)(1) on receiving from a drug manufacturer or distributor	115
evidence that satisfies the criteria in divisions (B)(1)(a)(i) and	116
(ii) of this section. The board shall update and republish the	117
list every time it receives such evidence from a drug manufacturer	118
or distributor.	119

(C) If a prescribed drug is on the list published under	120
division (B)(3) of this section, a pharmacist shall not substitute	121
a brand or generic drug for the prescribed drug without one of the	122
following:	123

(1) A determination by the board, as indicated on the list,	124
that the drug to be substituted has substantially similar tamper	125
resistance properties to the prescribed drug;	126

(2) Receipt by the pharmacist of written and signed consent	127
to the substitution from the prescriber.	128

Section 2.  That existing sections 4729.37 and 4729.38 of the	129
Revised Code are hereby repealed.	130