STATE BOARD OF PHARMACY;  77 SOUTH HIGH STREET, ROOM 1702;  COLUMBUS, OHIO 43215-6126

Tel:  614/466-4143         Fax:  614/752-4836          Eml:  exec@bop.state.oh.us          Web:  www.state.oh.us/pharmacy

 

 

 

PHARMACISTS ADMINISTERING ADULT IMMUNIZATIONS

(09/19/2003)

 

 

 

ORC ‑ Ohio Revised Code      OAC ‑ Ohio Administrative Code

 

 

 

Section 4729.01  Definitions.  [ORC: 06/26/2003]

 

As used in this chapter:

(A)  *  *  *

(B)  "Practice of pharmacy" means providing pharmacist care requiring specialized knowledge, judg­ment, and skill derived from the principles of biological, chemical, behavioral, social, pharmaceutical, and clinical sciences. As used in this division, "pharmacist care" includes the following:

(1)  Interpreting prescriptions;

(2)  Compounding or dispensing drugs and dispensing drug therapy related devices;

(3)  Counseling individuals with regard to their drug therapy, recommending drug therapy related devices, and assisting in the selection of drugs and appliances for treatment of common diseases and injuries and providing instruction in the proper use of the drugs and appliances;

(4)  Performing drug regimen reviews with individuals by discussing all of the drugs that the indi­vidual is taking and explaining the interactions of the drugs;

(5)  Performing drug utilization reviews with licensed health professionals authorized to prescribe drugs when the pharmacist determines that an individual with a prescription has a drug regimen that warrants additional discussion with the prescriber;

(6)  Advising an individual and the health care professionals treating an individual with regard to the indi­vidual's drug therapy;

(7)  Acting pursuant to a consult agreement with a physician authorized under Chapter 4731. of the Re­vised Code to practice medicine and surgery or osteopathic medicine and surgery, if an agreement has been established with the physician;

(8)  Administering the adult immunizations specified in section 4729.41 of the Re­vised Code, if the pharmacist has met the requirements of that section.

*    *    *

 

Rule 4729-5-01  Definitions.  [ORC: 02/01/2003]

 

As used in Chapter 4729. of the Revised Code:

*    *    *

(G)  "Pharmacist" means an individual who holds a current pharmacist identification card pursuant to section 4729.08 or 4729.09 of the Revised Code; or, pursuant to section 4729.12 of the Revised Code.

*    *    *

(N)  "Positive identification" means a method of identifying an individual who pre­scribes, administers, or dispenses a dangerous drug.  Such method must include a physical means of identification such as, but not limited to, the following:

(1)  A manual signature on a hard-copy record;

(2)  A magnetic card reader;

(3)  A bar code reader;

(4)  A thumbprint reader or other biometric method; or

(5)  A daily printout of every transaction that is verified and manually signed within twenty-four hours by the individual who prescribed, administered, or dispensed the dangerous drug.  The printout must be maintained for three years and made available on request to those individuals authorized by law to review such records.

A magnetic card reader or a bar code reader system of identification must also include a private per­sonal identi­fier, such as a password, for entry into a mechanical or automated system.

 

Section 4729.41  Pharmacists administering adult immunizations.  [ORC: 06/26/2003]

 

(A)  A pharmacist licensed under this chapter who meets the requirements of division (B) of this section may administer adult immunizations for any of the following:

(1)  Influenza;

(2)  Pneumonia;

(3)  Tetanus;

(4)  Hepatitis A;

(5)  Hepatitis B.

(B)  To be authorized to administer the adult immunizations specified in division (A) of this section, a pharmacist shall do all of the following:

(1)  Successfully complete a course in the administration of adult immunizations that has been approved by the state board of pharmacy as meeting the standards established for such courses by the centers for disease control and prevention in the public health service of the United States department of health and human services;

(2)  Receive and maintain certification to perform basic life-support procedures by successfully completing a basic life-support training course certified by the American red cross or American heart association;

(3)  Practice in accordance with a definitive set of treatment guidelines specified in a protocol established by a physician and approved by the state board of pharmacy. The protocol shall include provisions requir­ing that the pharmacist do both of the following:

(a)  Observe an individual who has been immunized by the pharmacist to determine whether the individual has an adverse reaction to the immunization. the length of time and location of the observation shall be specified in rules adopted by the state board of pharmacy under division (D) of this section.

(b)  Not later than thirty days after administering an adult immunization to an individual, notify the individual's family physician or, if the individual has no family physician, the board of health of the health district in which the individual resides.

(C)  No pharmacist shall do either of the following:

(1)  Engage in the administration of adult immunizations by injection unless the require­ments of division (B) of this section have been met;

(2)  Delegate to any person the pharmacist's authority to administer adult immunizations.

(D)  The state board of pharmacy shall adopt rules to implement this section, including rules for approval of courses in administration of adult immunizations and approval of protocols to be followed by pharmacists in administering adult immunizations. Prior to adopting the rules regarding approval of protocols, the state board of pharmacy shall consult with the state medical board and the board of nursing. The rules shall be adopted in accordance with Chapter 119. of the Revised Code.

 

Rule 4729-5-27  Recordkeeping.  [OAC: 02/01/2002]

 

*    *    *

(K)  Records shall be maintained for three years on all adult immunizations administered pursuant to section 4729.41 of the Revised Code and must include at least the following information:

(1)  Full name and address of the patient;

(2)  Patient’s date of birth or age;

(3)  Patient’s gender;

(4)  Patient’s applicable allergy information;

(5)  Date of administration by the pharmacist;

(6)  Name, strength, and dose of the adult immunization administered;

(7)  Lot number and expiration date of the immunization;

(8)  Route of administration;

(9)  Location of the injection site;

(10)  Positive identification of the administering pharmacist;

(11)  Documentation of patient informed consent.

(L)  A pharmacist who administers adult immunizations pursuant to section 4729.41 of the Revised Code shall maintain and immediately make available, upon the request of the state board of pharmacy, the following records:

(1)  Documentation of the successful completion of a board-approved course in the admini­stration of adult immunizations;

(2)  Documentation of the certification to perform basic life-support procedures pursuant to division (B)(2) of section 4729.41 of the Revised Code.

 

Rule 4729-5-28  Computerized recordkeeping systems.  [OAC: 07/01/2001]

 

If a computerized recordkeeping system is being used as an alternate recordkeeping system pursuant to rule 4729-5-27 of the Administrative Code, the following requirements must be met:

*    *    *

(I)  The system must be capable of providing immediate retrieval (via CRT display and hard-copy print­out or other mutually agreeable transfer medium) of patient information for all adult immunizations administered pursuant to section 4729.41 of the Revised Code within the previous twelve months and retrieval within three working days, excluding weekends and holidays, of all adult immunizations ad­ministered within the previous thirty-six months.  This infor­mation shall include at least the following:

(1)  Full name and address of the patient;

(2)  Patient’s date of birth;

(3)  Patient’s gender;

(4)  Patient’s applicable allergy information;

(5)  Date of administration by the pharmacist;

(6)  Name, strength, and dose of the adult immunization administered;

(7)  Lot number and expiration date of the immunization;

(8)  Route of administration;

(9)  Location of the injection site;

(10)  Positive identification of the administering pharmacist;

(11)  Documentation of patient informed consent.

 

Rule 4729-5-36  Course requirements in the administration of adult immunizations. 

[OAC: 07/01/2001]

 

(A)  A course in the administration of adult immunizations developed pursuant to division (B)(1) of sec­tion 4729.41 of the Revised Code shall meet at least the following require­ments:

(1)  The instructor shall be a licensed health care professional and have the appropriate education and experience to teach a course in the administration of adult immunizations.

(2)  The content must meet the standards established for such courses by the centers for disease control and prevention in the public health service of the United States department of health and human services.

(3)  The course must be a minimum of five hours in length and include at least the following:

(a)  A review of immunology that includes a discus­sion of the body’s immune system reaction to the immunizations.

(b)  A review of each immunization listed in divi­sion (A) of section 4729.41 of the Revised Code that includes the following:

(i)  Disease states associated with the immunization;

(ii)  Type or nature of activity of the immunization;

(iii)  Appropriate administration schedules;

(iv)  Appropriate routes of administration;

(v)  Appropriate injection sites;

(vi)  Appropriate dosages;

(vii)  Appropriate monitoring of the patient for adverse reactions;

(viii)  Appropriate patient populations;

(ix)  Precautions and contraindications;

(x)  Proper storage requirements for the immunization.

(c)  A review of sterile technique in injectable dosage preparation and administration.

(d)  A minimum of one hour of instruction and physical participation in administration techniques.

(e)  A review of the proper disposal procedures for contaminated needles and immuni­zations.

(f)  A review of the proper procedures for accidental needle sticks.

(4)  The course must provide a method to evaluate the successful mastery of the content.

(B)  All courses in adult immunizations must be submitted to the state board of pharmacy for approval.  The courses may be reviewed with the state medical board and the board of nursing, as appropriate.  Any subse­quent revisions to the course, after the initial approval, must be submitted to the state board of pharmacy for approval.

 

Rule 4729-5-37  Protocols for the administration of adult immunizations.  [OAC: 07/01/2001]

 

(A)  To be considered an approved protocol pursuant to division (B)(3) of section 4729.41 of the Re­vised Code, the physician-established protocol for the administration of adult immunizations must include at least the following:

(1)  For each immunization listed in division (a) of section 4729.41 of the Revised Code:

(a)  Name and strength;

(b)  Precautions and contraindications;

(c)  Intended audience or patient population;

(d)  Appropriate dosage;

(e)  Appropriate administration schedules;

(f)  Appropriate routes of administration;

(g)  Appropriate injection sites.

(2)  The length of time the pharmacist must observe an individual for adverse effects, which shall be based on appropriate standards of care established by the physician.  The location of the observation shall be in the general vicinity of the administering pharma­cist to allow for on-going evaluation.

(3)  A method to address emergency situations including, but not limited to, adverse reactions, anaphy­lactic reactions, and accidental needle sticks.

(4)  A method to notify an individual’s physician or the applicable board of health within thirty days after administering an immunization.

(B)  All physician-established protocols must be signed and dated by the physician prior to implemen­tation and maintained by the administering pharmacist.  The pharmacist must renew the protocol annually with the physician.

(C)  Upon the request of the state board of pharmacy, a pharmacist shall immediately provide the pro­tocols for adult immunizations pursuant to division (B)(3) of section 4729.41 of the Revised Code.  The state board of pharmacy, after review, may approve the protocol or return it to the phar­macist for revi­sion without approval.  If a pro­tocol has been returned for revision without approval, it may not be implemented until the board has approved it.  The state board of pharmacy may review the protocols with the state medical board and the board of nursing, as appropriate.

 

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