As Passed by the House 1 123rd General Assembly 4 Regular Session Am. Sub. S. B. No. 248 5 1999-2000 6 SENATORS DRAKE-ARMBRUSTER-SPADA-HAGAN-PRENTISS-MUMPER- 7 REPRESENTATIVES VAN VYVEN-BRADING-TERWILLEGER-WIDENER 8 _________________________________________________________________ 10 A B I L L To amend section 4729.01 and to enact section 12 4729.41 of the Revised Code to establish 13 standards for the administration of certain adult immunizations by pharmacists. 14 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO: 16 Section 1. That section 4729.01 be amended and section 18 4729.41 of the Revised Code be enacted to read as follows: 19 Sec. 4729.01. As used in this chapter: 28 (A) "Pharmacy," except when used in a context that refers 30 to the practice of pharmacy, means any area, room, rooms, place 31 of business, department, or portion of any of the foregoing where 33 the practice of pharmacy is conducted. 34 (B) "Practice of pharmacy" means providing pharmacist care 36 requiring specialized knowledge, judgment, and skill derived from 38 the principles of biological, chemical, behavioral, social, 39 pharmaceutical, and clinical sciences. As used in this division, 40 "pharmacist care" includes the following: (1) Interpreting prescriptions; 42 (2) Compounding or dispensing drugs and dispensing drug 44 therapy related devices; 45 (3) Counseling individuals with regard to their drug 47 therapy, recommending drug therapy related devices, and assisting 49 in the selection of drugs and appliances for treatment of common 50 diseases and injuries and providing instruction in the proper use 52 of the drugs and appliances; 2 (4) Performing drug regimen reviews with individuals by 55 discussing all of the drugs that the individual is taking and explaining the interactions of the drugs; 56 (5) Performing drug utilization reviews with licensed 58 health professionals authorized to prescribe drugs when the 59 pharmacist determines that an individual with a prescription has 60 a drug regimen that warrants additional discussion with the 61 prescriber; 62 (6) Advising an individual and the health care 64 professionals treating an individual with regard to the 65 individual's drug therapy; 66 (7) Acting pursuant to a consult agreement with a 68 physician authorized under Chapter 4731. of the Revised Code to 72 practice medicine and surgery or osteopathic medicine and 73 surgery, if an agreement has been established with the physician; 74 (8) ADMINISTERING BY INJECTION THE ADULT IMMUNIZATIONS 76 SPECIFIED IN SECTION 4729.41 OF THE REVISED CODE, IF THE 77 PHARMACIST HAS MET THE REQUIREMENTS OF THAT SECTION. 78 (C) "Compounding" means the preparation, mixing, 81 assembling, packaging, and labeling of one or more drugs in any 82 of the following circumstances: 83 (1) Pursuant to a prescription issued by a licensed health 86 professional authorized to prescribe drugs; (2) Pursuant to the modification of a prescription made in 88 accordance with a consult agreement; 89 (3) As an incident to research, teaching activities, or 92 chemical analysis; (4) In anticipation of prescription drug orders based on 95 routine, regularly observed dispensing patterns. (D) "Consult agreement" means an agreement to manage an 97 individual's drug therapy that has been entered into by a 99 pharmacist and a physician authorized under Chapter 4731. of the 100 Revised Code to practice medicine and surgery or osteopathic 102 medicine and surgery. 3 (E) "Drug" means: 104 (1) Any article recognized in the United States 106 pharmacopoeia and national formulary, or any supplement to them, 108 intended for use in the diagnosis, cure, mitigation, treatment, 109 or prevention of disease in humans or animals; 110 (2) Any other article intended for use in the diagnosis, 112 cure, mitigation, treatment, or prevention of disease in humans 114 or animals; (3) Any article, other than food, intended to affect the 116 structure or any function of the body of humans or animals; 118 (4) Any article intended for use as a component of any 120 article specified in division (C)(1), (2), or (3) of this 121 section; but does not include devices or their components, parts, 122 or accessories. 123 (F) "Dangerous drug" means any of the following: 125 (1) Any drug to which either of the following applies: 127 (a) Under the "Federal Food, Drug, and Cosmetic Act," 52 130 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is 131 required to bear a label containing the legend "Caution: Federal 133 law prohibits dispensing without prescription" or "Caution: 134 Federal law restricts this drug to use by or on the order of a 135 licensed veterinarian" or any similar restrictive statement, or 136 the drug may be dispensed only upon a prescription; 137 (b) Under Chapter 3715. or 3719. of the Revised Code, the 139 drug may be dispensed only upon a prescription. 140 (2) Any drug that contains a schedule V controlled 142 substance and that is exempt from Chapter 3719. of the Revised 143 Code or to which that chapter does not apply; 144 (3) Any drug intended for administration by injection into 146 the human body other than through a natural orifice of the human 147 body. 148 (G) "Federal drug abuse control laws" has the same meaning 150 as in section 3719.01 of the Revised Code. 151 (H) "Prescription" means a written, electronic, or oral 155 4 order for drugs or combinations or mixtures of drugs to be used 156 by a particular individual or for treating a particular animal, 157 issued by a licensed health professional authorized to prescribe 159 drugs. (I) "Licensed health professional authorized to prescribe 162 drugs" or "prescriber" means an individual who is authorized by 164 law to prescribe drugs or dangerous drugs or drug therapy related 166 devices in the course of the individual's professional practice, 167 including only the following: 168 (1) A dentist licensed under Chapter 4715. of the Revised 171 Code; (2) Untilthree years and eight months after the effective173date of this amendmentJANUARY 17, 2000, an advanced practice 175 nurse approved under section 4723.56 of the Revised Code to 178 prescribe drugs and therapeutic devices; 179 (3) A clinical nurse specialist, certified nurse-midwife, 182 or certified nurse practitioner who holds a certificate to 183 prescribe issued under section 4723.48 of the Revised Code; (4) An optometrist licensed under Chapter 4725. of the 186 Revised Code to practice optometry under a therapeutic 188 pharmaceutical agents certificate; (5) A physician authorized under Chapter 4731. of the 191 Revised Code to practice medicine and surgery, osteopathic 192 medicine and surgery, or podiatry; (6) A veterinarian licensed under Chapter 4741. of the 194 Revised Code. 195 (J) "Sale" and "sell" include delivery, transfer, barter, 197 exchange, or gift, or offer therefor, and each such transaction 198 made by any person, whether as principal proprietor, agent, or 199 employee. 200 (K) "Wholesale sale" and "sale at wholesale" mean any sale 202 in which the purpose of the purchaser is to resell the article 203 purchased or received by the purchaser. 204 (L) "Retail sale" and "sale at retail" mean any sale other 206 5 than a wholesale sale or sale at wholesale. 207 (M) "Retail seller" means any person that sells any 209 dangerous drug to consumers without assuming control over and 210 responsibility for its administration. Mere advice or 211 instructions regarding administration do not constitute control 212 or establish responsibility. 213 (N) "Price information" means the price charged for a 215 prescription for a particular drug product and, in an easily 216 understandable manner, all of the following: 217 (1) The proprietary name of the drug product; 219 (2) The established (generic) name of the drug product; 221 (3) The strength of the drug product if the product 223 contains a single active ingredient or if the drug product 224 contains more than one active ingredient and a relevant strength 225 can be associated with the product without indicating each active 226 ingredient. The established name and quantity of each active 227 ingredient are required if such a relevant strength cannot be so 228 associated with a drug product containing more than one 229 ingredient. 230 (4) The dosage form; 232 (5) The price charged for a specific quantity of the drug 234 product. The stated price shall include all charges to the 235 consumer, including, but not limited to, the cost of the drug 236 product, professional fees, handling fees, if any, and a 237 statement identifying professional services routinely furnished 238 by the pharmacy. Any mailing fees and delivery fees may be 239 stated separately without repetition. The information shall not 240 be false or misleading. 241 (O) "Wholesale distributor of dangerous drugs" means a 243 person engaged in the sale of dangerous drugs at wholesale and 244 includes any agent or employee of such a person authorized by the 246 person to engage in the sale of dangerous drugs at wholesale. 247 (P) "Manufacturer of dangerous drugs" means a person, 249 other than a pharmacist, who manufactures dangerous drugs and who 250 6 is engaged in the sale of those dangerous drugs within this 251 state. 252 (Q) "Terminal distributor of dangerous drugs" means a 254 person who is engaged in the sale of dangerous drugs at retail, 256 or any person, other than a wholesale distributor or a 257 pharmacist, who has possession, custody, or control of dangerous 259 drugs for any purpose other than for that person's own use and 261 consumption, and includes pharmacies, hospitals, nursing homes, 262 and laboratories and all other persons who procure dangerous 263 drugs for sale or other distribution by or under the supervision 264 of a pharmacist or licensed health professional authorized to 265 prescribe drugs. (R) "Promote to the public" means disseminating a 267 representation to the public in any manner or by any means, other 268 than by labeling, for the purpose of inducing, or that is likely 269 to induce, directly or indirectly, the purchase of a dangerous 270 drug at retail. 271 (S) "Person" includes any individual, partnership, 273 association, limited liability company, or corporation, the 274 state, any political subdivision of the state, and any district, 275 department, or agency of the state or its political subdivisions. 276 (T) "Finished dosage form" has the same meaning as in 278 section 3715.01 of the Revised Code. 279 (U) "Generically equivalent drug" has the same meaning as 281 in section 3715.01 of the Revised Code. 282 (V) "Animal shelter" means a facility operated by a humane 284 society or any society organized under Chapter 1717. of the 285 Revised Code or a dog pound operated pursuant to Chapter 955. of 286 the Revised Code. 287 (W) "Food" has the same meaning as in section 3715.01 of 290 the Revised Code. Sec. 4729.41. (A) A PHARMACIST LICENSED UNDER THIS 293 CHAPTER WHO MEETS THE REQUIREMENTS OF DIVISION (B) OF THIS 294 SECTION MAY ADMINISTER, BY INJECTION, ADULT IMMUNIZATIONS FOR ANY 295 7 OF THE FOLLOWING: 296 (1) INFLUENZA; 298 (2) PNEUMONIA; 300 (3) TETANUS; 302 (4) HEPATITIS A; 304 (5) HEPATITIS B. 306 (B) TO BE AUTHORIZED TO ADMINISTER THE ADULT IMMUNIZATIONS 308 SPECIFIED IN DIVISION (A) OF THIS SECTION, A PHARMACIST SHALL DO 309 ALL OF THE FOLLOWING: 310 (1) SUCCESSFULLY COMPLETE A COURSE IN THE ADMINISTRATION 312 OF ADULT IMMUNIZATIONS THAT HAS BEEN APPROVED BY THE STATE BOARD 313 OF PHARMACY AS MEETING THE STANDARDS ESTABLISHED FOR SUCH COURSES 314 BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION IN THE PUBLIC 315 HEALTH SERVICE OF THE UNITED STATES DEPARTMENT OF HEALTH AND 316 HUMAN SERVICES; (2) RECEIVE AND MAINTAIN CERTIFICATION TO PERFORM BASIC 318 LIFE-SUPPORT PROCEDURES BY SUCCESSFULLY COMPLETING A BASIC 319 LIFE-SUPPORT TRAINING COURSE CERTIFIED BY THE AMERICAN RED CROSS 320 OR AMERICAN HEART ASSOCIATION; 321 (3) PRACTICE IN ACCORDANCE WITH A DEFINITIVE SET OF 323 TREATMENT GUIDELINES SPECIFIED IN A PROTOCOL ESTABLISHED BY A 324 PHYSICIAN AND APPROVED BY THE STATE BOARD OF PHARMACY. THE 326 PROTOCOL SHALL INCLUDE PROVISIONS REQUIRING THAT THE PHARMACIST 327 DO BOTH OF THE FOLLOWING: 328 (a) OBSERVE AN INDIVIDUAL WHO HAS BEEN IMMUNIZED BY THE 330 PHARMACIST TO DETERMINE WHETHER THE INDIVIDUAL HAS AN ADVERSE 331 REACTION TO THE IMMUNIZATION. THE LENGTH OF TIME AND LOCATION OF 333 THE OBSERVATION SHALL BE SPECIFIED IN RULES ADOPTED BY THE STATE 334 BOARD OF PHARMACY UNDER DIVISION (D) OF THIS SECTION. (b) NOT LATER THAN THIRTY DAYS AFTER ADMINISTERING AN 336 ADULT IMMUNIZATION TO AN INDIVIDUAL, NOTIFY THE INDIVIDUAL'S 337 FAMILY PHYSICIAN OR, IF THE INDIVIDUAL HAS NO FAMILY PHYSICIAN, 338 THE BOARD OF HEALTH OF THE HEALTH DISTRICT IN WHICH THE 339 INDIVIDUAL RESIDES. 8 (C) NO PHARMACIST SHALL DO EITHER OF THE FOLLOWING: 341 (1) ENGAGE IN THE ADMINISTRATION OF ADULT IMMUNIZATIONS BY 343 INJECTION UNLESS THE REQUIREMENTS OF DIVISION (B) OF THIS SECTION 344 HAVE BEEN MET; 345 (2) DELEGATE TO ANY PERSON THE PHARMACIST'S AUTHORITY TO 348 ADMINISTER ADULT IMMUNIZATIONS. (D) THE STATE BOARD OF PHARMACY SHALL ADOPT RULES TO 351 IMPLEMENT THIS SECTION, INCLUDING RULES FOR APPROVAL OF COURSES IN ADMINISTRATION OF ADULT IMMUNIZATIONS AND APPROVAL OF 352 PROTOCOLS TO BE FOLLOWED BY PHARMACISTS IN ADMINISTERING ADULT 353 IMMUNIZATIONS. PRIOR TO ADOPTING THE RULES REGARDING APPROVAL OF 354 PROTOCOLS, THE STATE BOARD OF PHARMACY SHALL CONSULT WITH THE 355 STATE MEDICAL BOARD AND THE BOARD OF NURSING. THE RULES SHALL BE ADOPTED IN ACCORDANCE WITH CHAPTER 119. OF THE 357 REVISED CODE. 358 Section 2. That existing section 4729.01 of the Revised 360 Code is hereby repealed. 361