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To amend sections 4729.01 and 4729.39 of the Revised | 1 |
Code to revise the laws governing pharmacist | 2 |
consult agreements and to authorize a pharmacist | 3 |
to prescribe and administer drugs under a consult | 4 |
agreement. | 5 |
Section 1. That sections 4729.01 and 4729.39 of the Revised | 6 |
Code be amended to read as follows: | 7 |
Sec. 4729.01. As used in this chapter: | 8 |
(A) "Pharmacy," except when used in a context that refers to | 9 |
the practice of pharmacy, means any area, room, rooms, place of | 10 |
business, department, or portion of any of the foregoing where the | 11 |
practice of pharmacy is conducted. | 12 |
(B) "Practice of pharmacy" means providing pharmacist care | 13 |
requiring specialized knowledge, judgment, and skill derived from | 14 |
the principles of biological, chemical, behavioral, social, | 15 |
pharmaceutical, and clinical sciences. As used in this division, | 16 |
"pharmacist care" includes the following: | 17 |
(1) Interpreting prescriptions; | 18 |
(2) Dispensing drugs and drug therapy related devices; | 19 |
(3) Compounding drugs; | 20 |
(4) Counseling individuals with regard to their drug therapy, | 21 |
recommending drug therapy related devices, and assisting in the | 22 |
selection of drugs and appliances for treatment of common diseases | 23 |
and injuries and providing instruction in the proper use of the | 24 |
drugs and appliances; | 25 |
(5) Performing drug regimen reviews with individuals by | 26 |
discussing all of the drugs that the individual is taking and | 27 |
explaining the interactions of the drugs; | 28 |
(6) Performing drug utilization reviews with licensed health | 29 |
professionals authorized to prescribe drugs when the pharmacist | 30 |
determines that an individual with a prescription has a drug | 31 |
regimen that warrants additional discussion with the prescriber; | 32 |
(7) Advising an individual and the health care professionals | 33 |
treating an individual with regard to the individual's drug | 34 |
therapy; | 35 |
(8) Acting pursuant to a consult agreement with | 36 |
one or more physicians authorized under Chapter 4731. of the | 37 |
Revised Code to practice medicine and surgery or osteopathic | 38 |
medicine and surgery, if an agreement has been established | 39 |
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(9) Engaging in the administration of immunizations to the | 41 |
extent authorized by section 4729.41 of the Revised Code. | 42 |
(C) "Compounding" means the preparation, mixing, assembling, | 43 |
packaging, and labeling of one or more drugs in any of the | 44 |
following circumstances: | 45 |
(1) Pursuant to a prescription issued by a licensed health | 46 |
professional authorized to prescribe drugs; | 47 |
(2) Pursuant to the modification of a prescription made in | 48 |
accordance with a consult agreement; | 49 |
(3) As an incident to research, teaching activities, or | 50 |
chemical analysis; | 51 |
(4) In anticipation of orders for drugs pursuant to | 52 |
prescriptions, based on routine, regularly observed dispensing | 53 |
patterns; | 54 |
(5) Pursuant to a request made by a licensed health | 55 |
professional authorized to prescribe drugs for a drug that is to | 56 |
be used by the professional for the purpose of direct | 57 |
administration to patients in the course of the professional's | 58 |
practice, if all of the following apply: | 59 |
(a) At the time the request is made, the drug is not | 60 |
commercially available regardless of the reason that the drug is | 61 |
not available, including the absence of a manufacturer for the | 62 |
drug or the lack of a readily available supply of the drug from a | 63 |
manufacturer. | 64 |
(b) A limited quantity of the drug is compounded and provided | 65 |
to the professional. | 66 |
(c) The drug is compounded and provided to the professional | 67 |
as an occasional exception to the normal practice of dispensing | 68 |
drugs pursuant to patient-specific prescriptions. | 69 |
(D) "Consult agreement" means an agreement | 70 |
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(E) "Drug" means: | 75 |
(1) Any article recognized in the United States pharmacopoeia | 76 |
and national formulary, or any supplement to them, intended for | 77 |
use in the diagnosis, cure, mitigation, treatment, or prevention | 78 |
of disease in humans or animals; | 79 |
(2) Any other article intended for use in the diagnosis, | 80 |
cure, mitigation, treatment, or prevention of disease in humans or | 81 |
animals; | 82 |
(3) Any article, other than food, intended to affect the | 83 |
structure or any function of the body of humans or animals; | 84 |
(4) Any article intended for use as a component of any | 85 |
article specified in division (E)(1), (2), or (3) of this section; | 86 |
but does not include devices or their components, parts, or | 87 |
accessories. | 88 |
(F) "Dangerous drug" means any of the following: | 89 |
(1) Any drug to which either of the following applies: | 90 |
(a) Under the "Federal Food, Drug, and Cosmetic Act," 52 | 91 |
Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is | 92 |
required to bear a label containing the legend "Caution: Federal | 93 |
law prohibits dispensing without prescription" or "Caution: | 94 |
Federal law restricts this drug to use by or on the order of a | 95 |
licensed veterinarian" or any similar restrictive statement, or | 96 |
the drug may be dispensed only upon a prescription; | 97 |
(b) Under Chapter 3715. or 3719. of the Revised Code, the | 98 |
drug may be dispensed only upon a prescription. | 99 |
(2) Any drug that contains a schedule V controlled substance | 100 |
and that is exempt from Chapter 3719. of the Revised Code or to | 101 |
which that chapter does not apply; | 102 |
(3) Any drug intended for administration by injection into | 103 |
the human body other than through a natural orifice of the human | 104 |
body. | 105 |
(G) "Federal drug abuse control laws" has the same meaning as | 106 |
in section 3719.01 of the Revised Code. | 107 |
(H) "Prescription" means a written, electronic, or oral order | 108 |
for drugs or combinations or mixtures of drugs to be used by a | 109 |
particular individual or for treating a particular animal, issued | 110 |
by a licensed health professional authorized to prescribe drugs. | 111 |
(I) "Licensed health professional authorized to prescribe | 112 |
drugs" or "prescriber" means an individual who is authorized by | 113 |
law to prescribe drugs or dangerous drugs or drug therapy related | 114 |
devices in the course of the individual's professional practice, | 115 |
including only the following: | 116 |
(1) A dentist licensed under Chapter 4715. of the Revised | 117 |
Code; | 118 |
(2) A clinical nurse specialist, certified nurse-midwife, or | 119 |
certified nurse practitioner who holds a certificate to prescribe | 120 |
issued under section 4723.48 of the Revised Code; | 121 |
(3) An optometrist licensed under Chapter 4725. of the | 122 |
Revised Code to practice optometry under a therapeutic | 123 |
pharmaceutical agents certificate; | 124 |
(4) A pharmacist licensed under this chapter acting under a | 125 |
consult agreement; | 126 |
(5) A physician authorized under Chapter 4731. of the Revised | 127 |
Code to practice medicine and surgery, osteopathic medicine and | 128 |
surgery, or podiatric medicine and surgery; | 129 |
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prescribe issued under Chapter 4730. of the Revised Code; | 131 |
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Revised Code. | 133 |
(J) "Sale" and "sell" include delivery, transfer, barter, | 134 |
exchange, or gift, or offer therefor, and each such transaction | 135 |
made by any person, whether as principal proprietor, agent, or | 136 |
employee. | 137 |
(K) "Wholesale sale" and "sale at wholesale" mean any sale in | 138 |
which the purpose of the purchaser is to resell the article | 139 |
purchased or received by the purchaser. | 140 |
(L) "Retail sale" and "sale at retail" mean any sale other | 141 |
than a wholesale sale or sale at wholesale. | 142 |
(M) "Retail seller" means any person that sells any dangerous | 143 |
drug to consumers without assuming control over and responsibility | 144 |
for its administration. Mere advice or instructions regarding | 145 |
administration do not constitute control or establish | 146 |
responsibility. | 147 |
(N) "Price information" means the price charged for a | 148 |
prescription for a particular drug product and, in an easily | 149 |
understandable manner, all of the following: | 150 |
(1) The proprietary name of the drug product; | 151 |
(2) The established (generic) name of the drug product; | 152 |
(3) The strength of the drug product if the product contains | 153 |
a single active ingredient or if the drug product contains more | 154 |
than one active ingredient and a relevant strength can be | 155 |
associated with the product without indicating each active | 156 |
ingredient. The established name and quantity of each active | 157 |
ingredient are required if such a relevant strength cannot be so | 158 |
associated with a drug product containing more than one | 159 |
ingredient. | 160 |
(4) The dosage form; | 161 |
(5) The price charged for a specific quantity of the drug | 162 |
product. The stated price shall include all charges to the | 163 |
consumer, including, but not limited to, the cost of the drug | 164 |
product, professional fees, handling fees, if any, and a statement | 165 |
identifying professional services routinely furnished by the | 166 |
pharmacy. Any mailing fees and delivery fees may be stated | 167 |
separately without repetition. The information shall not be false | 168 |
or misleading. | 169 |
(O) "Wholesale distributor of dangerous drugs" means a person | 170 |
engaged in the sale of dangerous drugs at wholesale and includes | 171 |
any agent or employee of such a person authorized by the person to | 172 |
engage in the sale of dangerous drugs at wholesale. | 173 |
(P) "Manufacturer of dangerous drugs" means a person, other | 174 |
than a pharmacist, who manufactures dangerous drugs and who is | 175 |
engaged in the sale of those dangerous drugs within this state. | 176 |
(Q) "Terminal distributor of dangerous drugs" means a person | 177 |
who is engaged in the sale of dangerous drugs at retail, or any | 178 |
person, other than a wholesale distributor or a pharmacist, who | 179 |
has possession, custody, or control of dangerous drugs for any | 180 |
purpose other than for that person's own use and consumption, and | 181 |
includes pharmacies, hospitals, nursing homes, and laboratories | 182 |
and all other persons who procure dangerous drugs for sale or | 183 |
other distribution by or under the supervision of a pharmacist or | 184 |
licensed health professional authorized to prescribe drugs. | 185 |
(R) "Promote to the public" means disseminating a | 186 |
representation to the public in any manner or by any means, other | 187 |
than by labeling, for the purpose of inducing, or that is likely | 188 |
to induce, directly or indirectly, the purchase of a dangerous | 189 |
drug at retail. | 190 |
(S) "Person" includes any individual, partnership, | 191 |
association, limited liability company, or corporation, the state, | 192 |
any political subdivision of the state, and any district, | 193 |
department, or agency of the state or its political subdivisions. | 194 |
(T) "Finished dosage form" has the same meaning as in section | 195 |
3715.01 of the Revised Code. | 196 |
(U) "Generically equivalent drug" has the same meaning as in | 197 |
section 3715.01 of the Revised Code. | 198 |
(V) "Animal shelter" means a facility operated by a humane | 199 |
society or any society organized under Chapter 1717. of the | 200 |
Revised Code or a dog pound operated pursuant to Chapter 955. of | 201 |
the Revised Code. | 202 |
(W) "Food" has the same meaning as in section 3715.01 of the | 203 |
Revised Code. | 204 |
(X) "Pain management clinic" has the same meaning as in | 205 |
section 4731.054 of the Revised Code. | 206 |
Sec. 4729.39. (A) | 207 |
enter into a consult agreement with | 208 |
physicians authorized under Chapter 4731. of the Revised Code to | 209 |
practice medicine and surgery or osteopathic medicine and surgery. | 210 |
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apply: | 212 |
(1) Under a consult agreement, a pharmacist is authorized to | 213 |
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only to the extent specified in the agreement, this section, and | 215 |
the rules adopted under this section: | 216 |
(a) Manage an individual's drug therapy; | 217 |
(b) Order blood tests. | 218 |
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pharmacist or physician who entered into the agreement. By | 279 |
withdrawing consent, the individual whose drug therapy is being | 280 |
managed or the individual who consented to the treatment on behalf | 281 |
of the individual may terminate a consult agreement. The | 282 |
pharmacist or physician who receives the individual's withdrawal | 283 |
of consent shall provide written notice to the opposite party. A | 284 |
pharmacist or physician who terminates a consult agreement shall | 285 |
provide written notice to the opposite party and to the individual | 286 |
who consented to treatment under the agreement. The termination of | 287 |
a consult agreement shall be recorded by the pharmacist and | 288 |
physician in the records they maintain on the individual being | 289 |
treated. | 290 |
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communicated to | 311 |
managed
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maintain | 315 |
action taken for each individual whose drug therapy is managed | 316 |
under the agreement. | 317 |
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acting under | 319 |
intervals specified by the primary physician acting under the | 320 |
agreement. The agreement may include a requirement that a | 321 |
pharmacist send a consult report to each consulting physician. | 322 |
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individual, a person authorized to act on behalf of the | 324 |
individual, the primary physician acting under the agreement, or | 325 |
the primary pharmacist acting under the agreement. When a consult | 326 |
agreement is terminated, all parties to the agreement shall be | 327 |
notified and the termination shall be recorded in the individual's | 328 |
medical record. | 329 |
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consult agreement does not permit | 331 |
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prescribed by a physician who has not entered into the agreement. | 334 |
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drugs under a consult agreement, subject to the terms of the | 336 |
agreement and in accordance with rules adopted under this section. | 337 |
A physician who has entered into a consult agreement may limit the | 338 |
categories of drugs a pharmacist may prescribe or administer under | 339 |
the agreement. | 340 |
(B) The state board of pharmacy, in consultation with the | 341 |
state medical board, shall adopt rules to be followed by | 342 |
pharmacists, and the state medical board, in consultation with the | 343 |
state board of pharmacy, shall adopt rules to be followed by | 344 |
physicians, that establish standards and procedures for entering | 345 |
into a consult agreement and managing an individual's drug therapy | 346 |
under a consult agreement. The boards shall specify in the rules | 347 |
any categories of drugs or types of diseases for which a consult | 348 |
agreement may not be established. Either board may adopt any other | 349 |
rules it considers necessary for the implementation and | 350 |
administration of this section. All rules adopted under this | 351 |
division shall be adopted in accordance with Chapter 119. of the | 352 |
Revised Code. | 353 |
Section 2. That existing sections 4729.01 and 4729.39 of the | 354 |
Revised Code are hereby repealed. | 355 |