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To amend sections 4729.37 and 4729.38 and to enact | 1 |
section 4729.382 of the Revised Code to prohibit a | 2 |
pharmacist from substituting another drug for a | 3 |
tamper resistant opioid analgesic drug unless the | 4 |
substituted drug is also tamper resistant or | 5 |
consent is obtained from the prescribing health | 6 |
professional. | 7 |
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. | 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; | 22 |
(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 |
| 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 |