Bill Analysis

Legislative Service Commission

LSC Analysis of Senate Bill

Am. S.B. 58

127th General Assembly

(As Reported by H. Health)

 

Sens.      Coughlin, Mumper, Gardner, D. Miller, Clancy, Cafaro, Carey, Niehaus, Schaffer, Schuler, Spada

Reps.     Flowers, Yuko, Fende, Brown, Letson, Otterman, DeBose, B. Williams, Uecker, Huffman, White

BILL SUMMARY

·        Adds immunizations for meningitis, diphtheria, and pertussis to the immunizations pharmacists are permitted to administer to adults.

·        Lowers the minimum age to 14 (from 18) for individuals to receive influenza immunizations from pharmacists.

·        Permits pharmacy interns working under the direct supervision of a pharmacist to administer influenza immunizations to adults.

·        Permits pharmacists to administer epinephrine and diphenhydramine to individuals in emergency situations resulting from adverse reactions to the immunizations administered by a pharmacist or pharmacy intern.

·        Reduces the number of votes needed for the State Board of Pharmacy to approve and confirm a finding or order resulting from an investigation or hearing undertaken by one or more of the Board members.

CONTENT AND OPERATION

Administration of immunizations by a pharmacist

(R.C. 4729.01 and 4729.41(A)(1))

Current law allows pharmacists to administer immunizations for influenza, pneumonia, tetanus, hepatitis A, and hepatitis B.  The immunizations may be administered only to adults.[1]

In addition to the currently authorized immunizations, the bill permits pharmacists to administer immunizations for meningitis, diphtheria, and pertussis, to individuals 18 years of age or older.  For the remaining adult immunizations, the bill specifies that the immunizations may be administered to individuals 18 years of age or older.

In the case of immunizations for influenza, the bill lowers the minimum age at which an individual may receive the immunization from a pharmacist to 14.  To provide the immunization to an individual between the ages of 14 and 18, however, permission must be obtained from the individual's parent or legal guardian.

Administration of influenza immunizations by a pharmacy intern

(R.C. 4729.01 and 4729.41(A)(2))

The State Board of Pharmacy licenses individuals seeking to practice as pharmacy interns while actively pursuing an educational program in preparation for licensure as a pharmacist.  Pharmacy interns may practice pharmacy only under the personal supervision of a pharmacist.  (R.C. 4729.11 and 4729.28, not in the bill.)

The bill allows pharmacy interns to administer influenza immunizations to individuals age 18 or older.  The pharmacy intern must be working under the direct supervision of a pharmacist.

Adverse reactions

(R.C. 4729.41(A)(3))

As part of engaging in the administration of immunizations or supervising a pharmacy intern's administration of immunizations, the bill authorizes a pharmacist to administer epinephrine or diphenhydramine,[2] or both, to individuals in emergency situations resulting from adverse reactions to the immunizations administered by the pharmacist or pharmacy intern.

Requirements for the administration of immunizations

(R.C. 4729.41(B), (C), and (D)(2))

To be authorized to engage in the administration of immunizations, current law requires pharmacists to complete an approved course in the administration of immunizations[3] and to receive and maintain certification to perform basic life-support procedures.[4]  Current law also requires pharmacists to practice in accordance with a definitive set of treatment guidelines specified in a protocol established by a physician and approved by the Board.

For a pharmacy intern to be authorized under the bill to administer influenza immunizations to adults, the pharmacy intern must meet the same training and protocol requirements that pharmacists must meet.  The bill expressly prohibits pharmacy interns from administering influenza immunizations without meeting those requirements.

Patient observation

(R.C. 4729.41(C)(1))

Under current law, the protocol for administration of immunizations by pharmacists must include a requirement that the pharmacist observe an individual who has been immunized to determine whether the individual has an adverse reaction to the immunization.[5]  In like manner, the bill requires pharmacy interns to observe adults for adverse reactions when they administer influenza immunizations.

The bill requires a pharmacist or pharmacy intern observing an individual who has been immunized to comply with the standards specified in rules adopted by the Board for the approval of protocols.  The bill also adds a provision requiring the protocol to specify procedures to be followed by a pharmacist in administering epinephrine, diphenhydramine, or both, to an individual who has an adverse reaction to an immunization administered by the pharmacist or a pharmacy intern.

Physician notification

(R.C. 4729.41(C)(2))

Current law requires the protocol for administration of immunizations by a pharmacist to include a requirement that the pharmacist notify an individual's family physician within 30 days after administering an immunization.  If there is no family physician, the pharmacist must notify the board of health serving the health district in which the individual resides.

For influenza immunizations administered to individuals age 18 or older, the bill eliminates the notification requirement.  Pharmacy interns are likewise not required to provide notification for the influenza immunizations they administer to adults.  When a pharmacist administers an influenza immunization to an individual between the ages of 14 and 18, however, the pharmacist must provide the notification in the same manner that applies when the pharmacist administers the other immunizations authorized by current law and the bill.

With respect to the notification of boards of health, the bill includes a provision to accommodate notifications that are made in health districts with an alternative entity performing the duties of a board of health.

Parental consent for influenza immunizations to minors

(R.C. 4729.41(C)(3))

In the case of immunizations administered by pharmacists to individuals age 14 or older but younger than 18, the bill adds a provision requiring that the protocol for administration of immunizations include a requirement that permission be obtained from the individual's parent or legal guardian.  It may be obtained by the pharmacist or a pharmacy intern.

Delegation

Current law prohibits a pharmacist from delegating to another person the pharmacist's authority to administer immunizations.  The bill further prohibits a pharmacist from delegating to another person the pharmacist's authority to supervise the administration of immunizations.

State Board of Pharmacy rules

The bill retains current law requiring the State Board of Pharmacy to adopt rules regarding the approval of courses in administration of immunizations and approval of protocols to be followed by pharmacists in administering immunizations.  In addition to extending these rules to the administration of adult influenza immunizations by pharmacy interns, the bill requires that the Board adopt rules to provide for the following:

(1)  Procedures to be followed by pharmacists and pharmacy interns in obtaining from the individual's parent or legal guardian permission for a pharmacist to administer influenza immunizations to an individual age 14 or older but younger than 18;

(2)  Protocols that identify the locations at which a pharmacist or a pharmacy intern may engage in the administration of immunizations.

Order or finding of State Board of Pharmacy

(R.C. 4729.17)

Under current law, any investigation, inquiry, or hearing that the State Board of Pharmacy is authorized to hold or undertake may be held or undertaken by or before any one or more members of the Board.  The finding or order of the member or members is deemed to be the order of the Board when approved and confirmed by a majority of the Board.  The Board consists of nine members, with five members constituting a quorum.[6]

In place of the requirement for a vote by a majority of the Board, the bill provides that the finding or order resulting from an investigation, inquiry, or hearing held or undertaken by one or more Board members is deemed to be the Board's order when approved and confirmed by a majority of the Board members present and voting at a meeting at which there is a quorum.

HISTORY

ACTION

DATE

 

 

Introduced

02-20-07

Reported, S. Health, Human Services & Aging

03-08-07

Passed Senate (33-0)

03-20-07

Reported, H. Health

05-10-07

 

 

 

s0058-rh-127.doc/kl



[1] Current law does not specify the age at which a person becomes an adult for purposes of the provisions authorizing a pharmacist to administer adult immunizations; however R.C. 3109.01 provides that a person "is of full age for all purposes" at age 18.

[2] Benadryl is a brand name form of diphenhydramine.

[3] The course must be approved by the State Board of Pharmacy as meeting standards established for such courses by the Centers for Disease Control and Prevention.

[4] The certification must be obtained through a course certified by the American Red Cross or American Heart Association.

[5] The length of time and location of the observation is to be specified in rules adopted by the State Board of Pharmacy.

[6] The Board member serving as president does not vote except in the case of a tie (R.C. 4729.02, 4729.03, and 4729.05, not in the bill).