As Passed by the Senate                       1            

123rd General Assembly                                             4            

   Regular Session                            Sub. S. B. No.  248  5            

      1999-2000                                                    6            


      SENATORS DRAKE-ARMBRUSTER-SPADA-HAGAN-PRENTISS-MUMPER        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;                                                    

      (4)  Performing drug regimen reviews with individuals by     55           

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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.                                                           

      (E)  "Drug" means:                                           104          

                                                          3      


                                                                 
      (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          

order for drugs or combinations or mixtures of drugs to be used    156          

                                                          4      


                                                                 
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)  Until three years and eight months after the effective  173          

date of this amendment, an advanced practice nurse approved under  175          

section 4723.56 of the Revised Code to prescribe drugs and         176          

therapeutic devices;                                               177          

      (3)  A clinical nurse specialist, certified nurse-midwife,   180          

or certified nurse practitioner who holds a certificate to         181          

prescribe issued under section 4723.48 of the Revised Code;                     

      (4)  An optometrist licensed under Chapter 4725. of the      184          

Revised Code to practice optometry under a therapeutic             186          

pharmaceutical agents certificate;                                              

      (5)  A physician authorized under Chapter 4731. of the       189          

Revised Code to practice medicine and surgery, osteopathic         190          

medicine and surgery, or podiatry;                                              

      (6)  A veterinarian licensed under Chapter 4741. of the      192          

Revised Code.                                                      193          

      (J)  "Sale" and "sell" include delivery, transfer, barter,   195          

exchange, or gift, or offer therefor, and each such transaction    196          

made by any person, whether as principal proprietor, agent, or     197          

employee.                                                          198          

      (K)  "Wholesale sale" and "sale at wholesale" mean any sale  200          

in which the purpose of the purchaser is to resell the article     201          

purchased or received by the purchaser.                            202          

      (L)  "Retail sale" and "sale at retail" mean any sale other  204          

than a wholesale sale or sale at wholesale.                        205          

                                                          5      


                                                                 
      (M)  "Retail seller" means any person that sells any         207          

dangerous drug to consumers without assuming control over and      208          

responsibility for its administration.  Mere advice or             209          

instructions regarding administration do not constitute control    210          

or establish responsibility.                                       211          

      (N)  "Price information" means the price charged for a       213          

prescription for a particular drug product and, in an easily       214          

understandable manner, all of the following:                       215          

      (1)  The proprietary name of the drug product;               217          

      (2)  The established (generic) name of the drug product;     219          

      (3)  The strength of the drug product if the product         221          

contains a single active ingredient or if the drug product         222          

contains more than one active ingredient and a relevant strength   223          

can be associated with the product without indicating each active  224          

ingredient.  The established name and quantity of each active      225          

ingredient are required if such a relevant strength cannot be so   226          

associated with a drug product containing more than one            227          

ingredient.                                                        228          

      (4)  The dosage form;                                        230          

      (5)  The price charged for a specific quantity of the drug   232          

product.  The stated price shall include all charges to the        233          

consumer, including, but not limited to, the cost of the drug      234          

product, professional fees, handling fees, if any, and a           235          

statement identifying professional services routinely furnished    236          

by the pharmacy.  Any mailing fees and delivery fees may be        237          

stated separately without repetition.  The information shall not   238          

be false or misleading.                                            239          

      (O)  "Wholesale distributor of dangerous drugs" means a      241          

person engaged in the sale of dangerous drugs at wholesale and     242          

includes any agent or employee of such a person authorized by the  244          

person to engage in the sale of dangerous drugs at wholesale.      245          

      (P)  "Manufacturer of dangerous drugs" means a person,       247          

other than a pharmacist, who manufactures dangerous drugs and who  248          

is engaged in the sale of those dangerous drugs within this        249          

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state.                                                             250          

      (Q)  "Terminal distributor of dangerous drugs" means a       252          

person who is engaged in the sale of dangerous drugs at retail,    254          

or any person, other than a wholesale distributor or a             255          

pharmacist, who has possession, custody, or control of dangerous   257          

drugs for any purpose other than for that person's own use and     259          

consumption, and includes pharmacies, hospitals, nursing homes,    260          

and laboratories and all other persons who procure dangerous       261          

drugs for sale or other distribution by or under the supervision   262          

of a pharmacist or licensed health professional authorized to      263          

prescribe drugs.                                                                

      (R)  "Promote to the public" means disseminating a           265          

representation to the public in any manner or by any means, other  266          

than by labeling, for the purpose of inducing, or that is likely   267          

to induce, directly or indirectly, the purchase of a dangerous     268          

drug at retail.                                                    269          

      (S)  "Person" includes any individual, partnership,          271          

association, limited liability company, or corporation, the        272          

state, any political subdivision of the state, and any district,   273          

department, or agency of the state or its political subdivisions.  274          

      (T)  "Finished dosage form" has the same meaning as in       276          

section 3715.01 of the Revised Code.                               277          

      (U)  "Generically equivalent drug" has the same meaning as   279          

in section 3715.01 of the Revised Code.                            280          

      (V)  "Animal shelter" means a facility operated by a humane  282          

society or any society organized under Chapter 1717. of the        283          

Revised Code or a dog pound operated pursuant to Chapter 955. of   284          

the Revised Code.                                                  285          

      (W)  "Food" has the same meaning as in section 3715.01 of    288          

the Revised Code.                                                               

      Sec. 4729.41.  (A)  A PHARMACIST LICENSED UNDER THIS         291          

CHAPTER WHO MEETS THE REQUIREMENTS OF DIVISION (B) OF THIS         292          

SECTION MAY ADMINISTER, BY INJECTION, ADULT IMMUNIZATIONS FOR ANY  293          

OF THE FOLLOWING:                                                  294          

                                                          7      


                                                                 
      (1)  INFLUENZA;                                              296          

      (2)  PNEUMONIA;                                              298          

      (3)  TETANUS;                                                300          

      (4)  HEPATITIS A;                                            302          

      (5)  HEPATITIS B.                                            304          

      (B)  TO BE AUTHORIZED TO ADMINISTER THE ADULT IMMUNIZATIONS  306          

SPECIFIED IN DIVISION (A) OF THIS SECTION, A PHARMACIST SHALL DO   307          

ALL OF THE FOLLOWING:                                              308          

      (1)  SUCCESSFULLY COMPLETE A COURSE IN THE ADMINISTRATION    310          

OF ADULT IMMUNIZATIONS THAT HAS BEEN APPROVED BY THE STATE BOARD   311          

OF PHARMACY AS MEETING THE STANDARDS ESTABLISHED FOR SUCH COURSES  312          

BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION IN THE PUBLIC    313          

HEALTH SERVICE OF THE UNITED STATES DEPARTMENT OF HEALTH AND       314          

HUMAN SERVICES;                                                                 

      (2)  RECEIVE AND MAINTAIN CERTIFICATION TO PERFORM BASIC     316          

LIFE-SUPPORT PROCEDURES BY SUCCESSFULLY COMPLETING A BASIC         317          

LIFE-SUPPORT TRAINING COURSE CERTIFIED BY THE AMERICAN RED CROSS   318          

OR AMERICAN HEART ASSOCIATION;                                     319          

      (3)  PRACTICE IN ACCORDANCE WITH A DEFINITIVE SET OF         321          

TREATMENT GUIDELINES SPECIFIED IN A PROTOCOL ESTABLISHED BY A      322          

PHYSICIAN AND APPROVED BY THE STATE BOARD OF PHARMACY.  THE        324          

PROTOCOL MUST INCLUDE A PROVISION REQUIRING THAT THE PHARMACIST,   325          

NOT LATER THAN THIRTY DAYS AFTER ADMINISTERING AN ADULT            326          

IMMUNIZATION TO AN INDIVIDUAL, NOTIFY THE INDIVIDUAL'S FAMILY                   

PHYSICIAN OR, IF THE INDIVIDUAL HAS NO FAMILY PHYSICIAN, THE       327          

BOARD OF HEALTH OF THE HEALTH DISTRICT IN WHICH THE INDIVIDUAL     328          

RESIDES.                                                                        

      (C)  NO PHARMACIST SHALL DO EITHER OF THE FOLLOWING:         330          

      (1)  ENGAGE IN THE ADMINISTRATION OF ADULT IMMUNIZATIONS BY  332          

INJECTION UNLESS THE REQUIREMENTS OF DIVISION (B) OF THIS SECTION  333          

HAVE BEEN MET;                                                     334          

      (2)  DELEGATE TO ANY PERSON THE PHARMACIST'S AUTHORITY TO    337          

ADMINISTER ADULT IMMUNIZATIONS.                                                 

      (D)  THE STATE BOARD OF PHARMACY SHALL ADOPT RULES AS        339          

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NECESSARY TO IMPLEMENT THIS SECTION, INCLUDING RULES FOR APPROVAL  340          

OF COURSES IN ADMINISTRATION OF ADULT IMMUNIZATIONS AND APPROVAL   341          

OF PROTOCOLS TO BE FOLLOWED BY PHARMACISTS IN ADMINISTERING ADULT  342          

IMMUNIZATIONS.  THE RULES SHALL BE ADOPTED IN ACCORDANCE WITH      343          

CHAPTER 119. OF THE REVISED CODE.                                  344          

      Section 2.  That existing section 4729.01 of the Revised     346          

Code is hereby repealed.                                           347