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To amend sections 4729.01, 4729.17, and 4729.41 of | 1 |
the Revised Code to modify the authority of | 2 |
pharmacists to administer immunizations and to | 3 |
make changes in certain voting procedures of the | 4 |
State Board of Pharmacy. | 5 |
Section 1. That sections 4729.01, 4729.17, and 4729.41 of the | 6 |
Revised 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 a physician | 36 |
authorized under Chapter 4731. of the Revised Code to practice | 37 |
medicine and surgery or osteopathic medicine and surgery, if an | 38 |
agreement has been established with the physician; | 39 |
(9) | 40 |
immunizations | 41 |
4729.41 of the Revised Code | 42 |
43 |
(C) "Compounding" means the preparation, mixing, assembling, | 44 |
packaging, and labeling of one or more drugs in any of the | 45 |
following circumstances: | 46 |
(1) Pursuant to a prescription issued by a licensed health | 47 |
professional authorized to prescribe drugs; | 48 |
(2) Pursuant to the modification of a prescription made in | 49 |
accordance with a consult agreement; | 50 |
(3) As an incident to research, teaching activities, or | 51 |
chemical analysis; | 52 |
(4) In anticipation of orders for drugs pursuant to | 53 |
prescriptions, based on routine, regularly observed dispensing | 54 |
patterns; | 55 |
(5) Pursuant to a request made by a licensed health | 56 |
professional authorized to prescribe drugs for a drug that is to | 57 |
be used by the professional for the purpose of direct | 58 |
administration to patients in the course of the professional's | 59 |
practice, if all of the following apply: | 60 |
(a) At the time the request is made, the drug is not | 61 |
commercially available regardless of the reason that the drug is | 62 |
not available, including the absence of a manufacturer for the | 63 |
drug or the lack of a readily available supply of the drug from a | 64 |
manufacturer. | 65 |
(b) A limited quantity of the drug is compounded and provided | 66 |
to the professional. | 67 |
(c) The drug is compounded and provided to the professional | 68 |
as an occasional exception to the normal practice of dispensing | 69 |
drugs pursuant to patient-specific prescriptions. | 70 |
(D) "Consult agreement" means an agreement to manage an | 71 |
individual's drug therapy that has been entered into by a | 72 |
pharmacist and a physician authorized under Chapter 4731. of the | 73 |
Revised Code to practice medicine and surgery or osteopathic | 74 |
medicine and surgery. | 75 |
(E) "Drug" means: | 76 |
(1) Any article recognized in the United States pharmacopoeia | 77 |
and national formulary, or any supplement to them, intended for | 78 |
use in the diagnosis, cure, mitigation, treatment, or prevention | 79 |
of disease in humans or animals; | 80 |
(2) Any other article intended for use in the diagnosis, | 81 |
cure, mitigation, treatment, or prevention of disease in humans or | 82 |
animals; | 83 |
(3) Any article, other than food, intended to affect the | 84 |
structure or any function of the body of humans or animals; | 85 |
(4) Any article intended for use as a component of any | 86 |
article specified in division (E)(1), (2), or (3) of this section; | 87 |
but does not include devices or their components, parts, or | 88 |
accessories. | 89 |
(F) "Dangerous drug" means any of the following: | 90 |
(1) Any drug to which either of the following applies: | 91 |
(a) Under the "Federal Food, Drug, and Cosmetic Act," 52 | 92 |
Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is | 93 |
required to bear a label containing the legend "Caution: Federal | 94 |
law prohibits dispensing without prescription" or "Caution: | 95 |
Federal law restricts this drug to use by or on the order of a | 96 |
licensed veterinarian" or any similar restrictive statement, or | 97 |
the drug may be dispensed only upon a prescription; | 98 |
(b) Under Chapter 3715. or 3719. of the Revised Code, the | 99 |
drug may be dispensed only upon a prescription. | 100 |
(2) Any drug that contains a schedule V controlled substance | 101 |
and that is exempt from Chapter 3719. of the Revised Code or to | 102 |
which that chapter does not apply; | 103 |
(3) Any drug intended for administration by injection into | 104 |
the human body other than through a natural orifice of the human | 105 |
body. | 106 |
(G) "Federal drug abuse control laws" has the same meaning as | 107 |
in section 3719.01 of the Revised Code. | 108 |
(H) "Prescription" means a written, electronic, or oral order | 109 |
for drugs or combinations or mixtures of drugs to be used by a | 110 |
particular individual or for treating a particular animal, issued | 111 |
by a licensed health professional authorized to prescribe drugs. | 112 |
(I) "Licensed health professional authorized to prescribe | 113 |
drugs" or "prescriber" means an individual who is authorized by | 114 |
law to prescribe drugs or dangerous drugs or drug therapy related | 115 |
devices in the course of the individual's professional practice, | 116 |
including only the following: | 117 |
(1) A dentist licensed under Chapter 4715. of the Revised | 118 |
Code; | 119 |
(2) A clinical nurse specialist, certified nurse-midwife, or | 120 |
certified nurse practitioner who holds a certificate to prescribe | 121 |
issued under section 4723.48 of the Revised Code; | 122 |
(3) An optometrist licensed under Chapter 4725. of the | 123 |
Revised Code to practice optometry under a therapeutic | 124 |
pharmaceutical agents certificate; | 125 |
(4) A physician authorized under Chapter 4731. of the Revised | 126 |
Code to practice medicine and surgery, osteopathic medicine and | 127 |
surgery, or podiatry; | 128 |
(5) A physician assistant who holds a certificate to | 129 |
prescribe issued under Chapter 4730. of the Revised Code; | 130 |
(6) A veterinarian licensed under Chapter 4741. of the | 131 |
Revised Code. | 132 |
(J) "Sale" and "sell" include delivery, transfer, barter, | 133 |
exchange, or gift, or offer therefor, and each such transaction | 134 |
made by any person, whether as principal proprietor, agent, or | 135 |
employee. | 136 |
(K) "Wholesale sale" and "sale at wholesale" mean any sale in | 137 |
which the purpose of the purchaser is to resell the article | 138 |
purchased or received by the purchaser. | 139 |
(L) "Retail sale" and "sale at retail" mean any sale other | 140 |
than a wholesale sale or sale at wholesale. | 141 |
(M) "Retail seller" means any person that sells any dangerous | 142 |
drug to consumers without assuming control over and responsibility | 143 |
for its administration. Mere advice or instructions regarding | 144 |
administration do not constitute control or establish | 145 |
responsibility. | 146 |
(N) "Price information" means the price charged for a | 147 |
prescription for a particular drug product and, in an easily | 148 |
understandable manner, all of the following: | 149 |
(1) The proprietary name of the drug product; | 150 |
(2) The established (generic) name of the drug product; | 151 |
(3) The strength of the drug product if the product contains | 152 |
a single active ingredient or if the drug product contains more | 153 |
than one active ingredient and a relevant strength can be | 154 |
associated with the product without indicating each active | 155 |
ingredient. The established name and quantity of each active | 156 |
ingredient are required if such a relevant strength cannot be so | 157 |
associated with a drug product containing more than one | 158 |
ingredient. | 159 |
(4) The dosage form; | 160 |
(5) The price charged for a specific quantity of the drug | 161 |
product. The stated price shall include all charges to the | 162 |
consumer, including, but not limited to, the cost of the drug | 163 |
product, professional fees, handling fees, if any, and a statement | 164 |
identifying professional services routinely furnished by the | 165 |
pharmacy. Any mailing fees and delivery fees may be stated | 166 |
separately without repetition. The information shall not be false | 167 |
or misleading. | 168 |
(O) "Wholesale distributor of dangerous drugs" means a person | 169 |
engaged in the sale of dangerous drugs at wholesale and includes | 170 |
any agent or employee of such a person authorized by the person to | 171 |
engage in the sale of dangerous drugs at wholesale. | 172 |
(P) "Manufacturer of dangerous drugs" means a person, other | 173 |
than a pharmacist, who manufactures dangerous drugs and who is | 174 |
engaged in the sale of those dangerous drugs within this state. | 175 |
(Q) "Terminal distributor of dangerous drugs" means a person | 176 |
who is engaged in the sale of dangerous drugs at retail, or any | 177 |
person, other than a wholesale distributor or a pharmacist, who | 178 |
has possession, custody, or control of dangerous drugs for any | 179 |
purpose other than for that person's own use and consumption, and | 180 |
includes pharmacies, hospitals, nursing homes, and laboratories | 181 |
and all other persons who procure dangerous drugs for sale or | 182 |
other distribution by or under the supervision of a pharmacist or | 183 |
licensed health professional authorized to prescribe drugs. | 184 |
(R) "Promote to the public" means disseminating a | 185 |
representation to the public in any manner or by any means, other | 186 |
than by labeling, for the purpose of inducing, or that is likely | 187 |
to induce, directly or indirectly, the purchase of a dangerous | 188 |
drug at retail. | 189 |
(S) "Person" includes any individual, partnership, | 190 |
association, limited liability company, or corporation, the state, | 191 |
any political subdivision of the state, and any district, | 192 |
department, or agency of the state or its political subdivisions. | 193 |
(T) "Finished dosage form" has the same meaning as in section | 194 |
3715.01 of the Revised Code. | 195 |
(U) "Generically equivalent drug" has the same meaning as in | 196 |
section 3715.01 of the Revised Code. | 197 |
(V) "Animal shelter" means a facility operated by a humane | 198 |
society or any society organized under Chapter 1717. of the | 199 |
Revised Code or a dog pound operated pursuant to Chapter 955. of | 200 |
the Revised Code. | 201 |
(W) "Food" has the same meaning as in section 3715.01 of the | 202 |
Revised Code. | 203 |
Sec. 4729.17. Any investigation, inquiry, or hearing, which | 204 |
the state board of pharmacy is empowered to hold or undertake may | 205 |
be held or undertaken by or before any member or members of the | 206 |
board and the finding or order of such member or members shall be | 207 |
deemed to be the order of said board when approved and confirmed | 208 |
by a majority of the board members present and voting at a meeting | 209 |
of the board at which there is a quorum. | 210 |
Sec. 4729.41. (A)(1) A pharmacist licensed under this chapter | 211 |
who meets the requirements of division (B) of this section may | 212 |
213 |
(a) Administer immunizations for influenza to individuals | 214 |
fourteen years of age or older; | 215 |
(b) Administer immunizations to individuals eighteen years of | 216 |
age or older for any of the following: | 217 |
| 218 |
| 219 |
| 220 |
| 221 |
| 222 |
(v) Meningitis; | 223 |
(vi) Diphtheria; | 224 |
(vii) Pertussis. | 225 |
(2) A pharmacy intern licensed under this chapter who meets | 226 |
the requirements of division (B) of this section and is working | 227 |
under the direct supervision of a pharmacist who meets the | 228 |
requirements of that division may administer immunizations for | 229 |
influenza to individuals eighteen years of age or older. | 230 |
(3) As part of engaging in the administration of | 231 |
immunizations or supervising a pharmacy intern's administration of | 232 |
immunizations, a pharmacist may administer epinephrine or | 233 |
diphenhydramine, or both, to individuals in emergency situations | 234 |
resulting from adverse reactions to the immunizations administered | 235 |
by the pharmacist or pharmacy intern. | 236 |
(B) | 237 |
to | 238 |
as specified in division (A) of this section, | 239 |
pharmacy intern shall do all of the following: | 240 |
(1) Successfully complete a course in the administration of | 241 |
242 | |
pharmacy as meeting the standards established for such courses by | 243 |
the centers for disease control and prevention in the public | 244 |
health service of the United States department of health and human | 245 |
services; | 246 |
(2) Receive and maintain certification to perform basic | 247 |
life-support procedures by successfully completing a basic | 248 |
life-support training course certified by the American red cross | 249 |
or American heart association; | 250 |
(3) Practice in accordance with a definitive set of treatment | 251 |
guidelines specified in a protocol established by a physician and | 252 |
approved by the state board of pharmacy. | 253 |
(C) The protocol required by division (B)(3) of this section | 254 |
shall include provisions | 255 |
implementation of the following requirements: | 256 |
| 257 |
The pharmacist or pharmacy intern who administers an immunization | 258 |
shall observe the individual who receives the immunization to | 259 |
determine whether the individual has an adverse reaction to the | 260 |
immunization. The length of time and location of the observation | 261 |
shall | 262 |
the state
board of pharmacy under division | 263 |
for the approval of protocols. The protocol shall specify | 264 |
procedures to be followed by a pharmacist when administering | 265 |
epinephrine, diphenhydramine, or both, to an individual who has an | 266 |
adverse reaction to an immunization administered by the pharmacist | 267 |
or a pharmacy intern. | 268 |
| 269 |
immunization to an individual,(2) For each immunization | 270 |
administered to an individual by a pharmacist, other than an | 271 |
immunization for influenza administered to an individual eighteen | 272 |
years of age or older, the pharmacist shall notify the | 273 |
individual's family physician or, if the individual has no family | 274 |
physician, the board of health of the health district in which the | 275 |
individual resides or the authority having the duties of a board | 276 |
of health for that district under section 3709.05 of the Revised | 277 |
Code. The notice shall be given not later than thirty days after | 278 |
the immunization is administered. | 279 |
(3) For each immunization for influenza administered by a | 280 |
pharmacist to an individual who is fourteen years of age or older | 281 |
but younger than eighteen years of age, the pharmacist or a | 282 |
pharmacy intern shall obtain permission from the individual's | 283 |
parent or legal guardian in accordance with the procedures | 284 |
specified in rules adopted under division (E) of this section. | 285 |
| 286 |
| 287 |
288 | |
have been met; | 289 |
| 290 |
291 | |
immunizations. | 292 |
(2) No pharmacy intern shall engage in the administration of | 293 |
immunizations for influenza unless the requirements of division | 294 |
(B) of this section have been met. | 295 |
| 296 |
implement this section | 297 |
shall be adopted in accordance with Chapter 119. of the Revised | 298 |
Code and shall include provisions for the following: | 299 |
(a) Approval of courses in
administration of | 300 |
immunizations | 301 |
(b) Approval of protocols to be followed by pharmacists and | 302 |
pharmacy interns in | 303 |
administration of immunizations, including protocols that contain | 304 |
provisions specifying the locations at which a pharmacist or | 305 |
pharmacy intern may engage in the administration of immunizations; | 306 |
(c) Procedures to be followed by pharmacists and pharmacy | 307 |
interns in obtaining from the individual's parent or legal | 308 |
guardian permission to administer influenza immunizations to an | 309 |
individual younger than eighteen years of age pursuant to division | 310 |
(A)(1)(a) of this section.
| 311 |
(2) Prior to adopting | 312 |
protocols to be followed by pharmacists and pharmacy interns in | 313 |
engaging in the administration of immunizations, the state board | 314 |
of pharmacy shall consult with the state medical board and the | 315 |
board of nursing. | 316 |
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Section 2. That existing sections 4729.01, 4729.17, and | 318 |
4729.41 of the Revised Code are hereby repealed. | 319 |