As Introduced

130th General Assembly Regular Session 2013-2014

S. B. No. 240

Senator Burke 

Cosponsors: Senators Manning, Patton 

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A BILL

To amend sections 4729.01 and 4729.39 of the Revised

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Code to revise the laws governing pharmacist

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consult agreements and to authorize a pharmacist

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to prescribe and administer drugs under a consult

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agreement.

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

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:

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(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;

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(2) Dispensing drugs and drug therapy related devices;

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(3) Compounding drugs;

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(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 a physician	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 with	39
the physician;	40

(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 to manage an	70
individual's drug therapy that has been entered into by a	71
pharmacist and a physician authorized under Chapter 4731. of the	72
Revised Code to practice medicine and surgery or osteopathic	73
medicine and surgeryunder section 4729.39 of the Revised Code.	74

(E) "Drug" means:

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(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:

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(1) Any drug to which either of the following applies:

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(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

(5)(6) A physician assistant who holds a certificate to	130
prescribe issued under Chapter 4730. of the Revised Code;	131

(6)(7) A veterinarian licensed under Chapter 4741. of the	132
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;

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(2) The established (generic) name of the drug product;

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(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;

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(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) A pharmacistOne or more pharmacists may	207
enter into a consult agreement with a physicianone or more	208
physicians authorized under Chapter 4731. of the Revised Code to	209
practice medicine and surgery or osteopathic medicine and surgery.	210
UnderWith respect to consult agreements, all of the following	211
apply:	212

(1) Under a consult agreement, a pharmacist is authorized to	213
manage an individual's drug therapydo both of the following, but	214
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;

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(b) Order blood tests.

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(B) All of the following apply to a consult agreement that	219
authorizes a pharmacist to manage the drug therapy of an	220
individual who is not a patient of a hospital, as defined in	221
section 3727.01 of the Revised Code, or a resident in a long-term	222
care facility, as defined in section 3729.01 of the Revised Code:	223

(1) A separate consult agreement must be entered into for	224
each individual whose drug therapy is to be managed by a	225
pharmacist. A consult agreement applies only to the particular	226
diagnosis for which a physician prescribed an individual's drug	227
therapy. If a different diagnosis is made for the individual, the	228
pharmacist and physician must enter into a new or additional	229
consult agreement.	230

(2) Management of an individual's drug therapy by a	231
pharmacist under a consult agreement may include monitoring and	232
modifying a prescription that has been issued for the individual.	233
Except as provided in section 4729.38 of the Revised Code for the	234
selection of generically equivalent drugs, management of an	235
individual's drug therapy by a pharmacist under a consult	236
agreement shall not include dispensing a drug that has not been	237
prescribed by the physician.	238

(3) Each consult agreement shall be in writing, except that a	239
consult agreement may be entered into verbally if it is	240
immediately reduced to writing.	241

(4) A physician entering into a consult agreement shall	242
specify in the agreement the extent to which the pharmacist is	243
authorized to manage the drug therapy of the individual specified	244
in the agreement.	245

(5) A physician entering into a consult agreement may specify	246
one other physician who has agreed to serve as an alternate	247
physician in the event that the primary physician is unavailable	248
to consult directly with the pharmacist. The pharmacist may	249
specify one other pharmacist who has agreed to serve as an	250
alternate pharmacist in the event that the primary pharmacist is	251
unavailable to consult directly with the physician.	252

(6) A consult agreement may not be implemented until it has	253
been signed by the primary pharmacist, the primary physician, and	254
the individual whose drug therapy will be managed or another	255
person who has the authority to provide consent to treatment on	256
behalf of the individual. Once the agreement is signed by all	257
required parties, the physician shall include in the individual's	258
medical record the fact that a consult agreement has been entered	259
into with a pharmacist.	260

(7) Prior to commencing any action to manage an individual's	261
drug therapy under a consult agreement, the pharmacist shall make	262
reasonable attempts to contact and confer with the physician who	263
entered into the consult agreement with the pharmacist. A	264
pharmacist may commence an action to manage an individual's drug	265
therapy prior to conferring with the physician or the physician's	266
alternate, but shall immediately cease the action that was	267
commenced if the pharmacist has not conferred with either	268
physician within forty-eight hours.	269

A pharmacist acting under a consult agreement shall maintain	270
a record of each action taken to manage an individual's drug	271
therapy. The pharmacist shall send to the individual's physician a	272
written report of all actions taken to manage the individual's	273
drug therapy at intervals the physician shall specify when	274
entering into the agreement. The physician shall include the	275
pharmacist's report in the medical records the physician maintains	276
for the individual.	277

(8)(2) A consult agreement may be terminated by either the	278
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

(9) Except as described in division (B)(5) of this section,	291
the authority of a pharmacist to manage an individual's drug	292
therapy under a consult agreement does not permit the pharmacist	293
to manage drug therapy prescribed by any other physician.	294

(C) All of the following apply to a consult agreement that	295
authorizes a pharmacist to manage the drug therapy of an	296
individual who is a patient of a hospital, as defined in section	297
3727.01 of the Revised Code, or a resident in a long-term care	298
facility, as defined in section 3729.01 of the Revised Code:	299

(1) Before a consult agreement may be entered into and	300
implemented, a hospital or long-term care facility shall adopt a	301
policy for consult agreements. For any period of time during which	302
a pharmacist or physician acting under a consult agreement is not	303
physically present and available at the hospital or facility, the	304
policy shall require that another pharmacist and physician be	305
available at the hospital or facility.	306

(2) The(3) A consult agreement shall be made in writing and	307
shall comply with the hospital's or facility's policy on consult	308
agreements.	309

(3)(4) The content of thea consult agreement shall be	310
communicated to theeach individual whose drug therapy will beis	311
managed in a manner consistent with the hospital's or facility's	312
policy on consult agreementsunder the agreement.	313

(4)(5) A pharmacist acting under a consult agreement shall	314
maintain in the individual's medical record a record of each	315
action taken for each individual whose drug therapy is managed	316
under the agreement.	317

(5)(6) Communication between a pharmacist and physician	318
acting under thea consult agreement shall take place at regular	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

(6)(7) A consult agreement may be terminated by the	323
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

(7) The authority of a pharmacist acting under a(8) A	330
consult agreement does not permit thea pharmacist to act under	331
the agreement in a hospital long-term care facility at which the	332
pharmacist is not authorized to practicemanage drug therapy	333
prescribed by a physician who has not entered into the agreement.	334

(D)(9) A pharmacist may prescribe or administer dangerous	335
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