Bill Summary – FastDemocracy

PRINTER'S NO.    1666
                  THE GENERAL ASSEMBLY OF PENNSYLVANIA
                       HOUSE BILL
                       No. 1535
                                              Session of
                                                2021
     INTRODUCED BY GROVE, WHEELAND, JAMES, PICKETT, HILL-EVANS,
        ZIMMERMAN, RYAN, KAUFFMAN, MENTZER, SAYLOR, LONGIETTI,
        BERNSTINE, FRITZ AND DELOZIER, JUNE 3, 2021
     REFERRED TO COMMITTEE ON PROFESSIONAL LICENSURE, JUNE 3, 2021
                                   AN ACT
 Amending the act of September 27, 1961 (P.L.1700, No.699),
    entitled "An act relating to the regulation of the practice
    of pharmacy, including the sales, use and distribution of
    drugs and devices at retail; and amending, revising,
    consolidating and repealing certain laws relating thereto,"
    further providing for authority to administer injectable
    medications, biologicals and immunizations.
    The General Assembly of the Commonwealth of Pennsylvania
 hereby enacts as follows:
    Section 1. Section 9.2 of the act of September 27, 1961
 (P.L.1700, No.699), known as the Pharmacy Act, is amended to
 read:
    Section 9.2.   Authority to Administer Injectable Medications,
 Biologicals and Immunizations.--[(a)   The board shall by
 regulation establish education and training standards and
 practice guidelines pursuant to which pharmacists shall be
 authorized to administer injectable medications, biologicals and
 immunizations to persons who are more than eighteen years of age
 and influenza immunizations by injectable or needle-free
 delivery methods to persons nine years of age and older. Such
 standards and guidelines shall include, but not be limited to,
 the following:
    (1)    Satisfactory completion of an academic and practical
 curriculum approved by the board that includes the current
 guidelines and recommendations of the Centers for Disease
 Control and Prevention in the Public Health Service of the
 United States Department of Health and Human Services, the
 American Council on Pharmaceutical Education or a similar health
 authority or professional body and includes, but is not limited
 to, disease epidemiology, vaccine characteristics, injection
 technique, emergency response to adverse events and related
 topics.
    (2)    Maintenance of a current cardiopulmonary resuscitation
 (CPR) certificate acceptable to the board.
    (3)    That the administration of injectable medications,
 biologicals and immunizations be in accordance with a definitive
 set of treatment guidelines established by a physician and the
 Centers for Disease Control and Prevention, Advisory Committee
 on Immunization Practices guidelines or another competent
 authority approved by the board.
    (4)    That a minimum of two hours of the thirty-hour
 requirement for continuing education for license renewal be
 dedicated to this area of practice.
    (5)    For individuals under eighteen years of age, that
 parental consent be obtained prior to administration.
 Administration of influenza immunizations by injectable or
 needle-free delivery methods shall be in accordance with the
 immunization schedule established by the Centers for Disease
 Control and Prevention.
    (6)    Maintenance of a level of professional liability
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 insurance coverage in the minimum amount of one million dollars
 ($1,000,000) per occurrence or claims made. Failure to maintain
 insurance coverage as required shall subject the licensees to
 disciplinary proceedings. The board shall accept as satisfactory
 evidence of insurance coverage any of the following:
    (i)    personally purchased liability insurance;
    (ii)    professional liability insurance coverage provided by
 the individual licensee's employer; or
    (iii)    similar insurance coverage acceptable to the board.
    (7)    Notification of the individual's primary care provider,
 if known, within forty-eight hours of administration.]
    (a.1)    The board shall by regulation establish education and
 training standards and practice guidelines pursuant to which
 pharmacists shall be authorized to administer:
    (1)    injectable medications, biologicals and immunizations to
 persons who are more than eighteen years of age; and
    (2)    the following immunizations by injectable or needle-free
 delivery methods to persons who are three years of age and
 older:
    (i)    A vaccine listed in the United States Centers for
 Disease Control and Prevention's recommended immunization
 schedule recommended by the Federal Advisory Committee on
 Immunization Practices; or
    (ii)    A vaccine recommended in the United States Centers for
 Disease Control and Prevention's Health Information for
 International Travel; or
    (iii)    A vaccine listed on the Food and Drug Administration's
 Vaccines Licensed for Use in the United States; or
    (iv)    A vaccine authorized through Emergency Use
 Authorization by the Food and Drug Administration.
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    (a.2)    The standards and guidelines to be established by the
 board shall include, but not be limited to, the following:
    (1)    Satisfactory completion of an academic and practical
 curriculum approved by the board that includes the current
 guidelines and recommendations of the Centers for Disease
 Control and Prevention in the Public Health Service of the
 United States Department of Health and Human Services, the
 Accreditation Council for Pharmacy Education or a similar health
 authority or professional body and includes, but is not limited
 to, disease epidemiology, vaccine characteristics, injection
 technique, emergency response to adverse events and related
 topics.
    (2)    Registration with the board or certification as a
 certified pharmacy technician from either the Pharmacy
 Technician Certification Board or National Healthcareer
 Association and satisfactory completion of a practical training
 program that is approved by the Accreditation Council for
 Pharmacy Education or a similar health authority and a minimum
 of two hours of approved immunization-related continuing
 pharmacy education. The practical training program must include,
 but is not limited to, hands-on injection technique and the
 recognition and treatment of emergency reactions to vaccines.
    (3)    Acceptable proof of education and training standards as
 evidenced by the immunization credentials or a license of an
 individual who, at the time of filing an application is licensed
 as a pharmacist and has immunization credentials or a license,
 if applicable, in another state or territory of the United
 States.
    (4)    Maintenance of a current cardiopulmonary resuscitation
 (CPR) certificate acceptable to the board.
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    (5)    That the administration of injectable medications,
 biologicals and immunizations be in accordance with a definitive
 set of treatment guidelines established by a physician and the
 Centers for Disease Control and Prevention, Advisory Committee
 on Immunization Practices guidelines or another competent
 authority approved by the board.
    (6)    That a minimum of two hours of the thirty-hour
 requirement for continuing education for license renewal be
 dedicated to this area of practice.
    (7)    For individuals under eighteen years of age, that
 parental consent be obtained prior to administration.
 Administration of influenza immunizations by injectable or
 needle-free delivery methods shall be in accordance with the
 immunization schedule established by the Centers for Disease
 Control and Prevention, the Advisory Committee on Immunization
 Practices or another competent authority.
    (8)    Maintenance of a level of professional liability
 insurance coverage in the minimum amount of one million dollars
 ($1,000,000) per occurrence or claims made. Failure to maintain
 insurance coverage as required shall subject the licensees to
 disciplinary proceedings. The board shall accept as satisfactory
 evidence of insurance coverage any of the following:
    (i)    personally purchased liability insurance;
    (ii)    professional liability insurance coverage provided by
 the individual licensee's employer; or
    (iii)    similar insurance coverage acceptable to the board.
    (9)    Notification of the individual's primary care provider,
 if known, within forty-eight hours of administration.
    (b)    A pharmacist's authority to administer injectable
 medications, biologicals and immunizations [shall not] may be
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 delegated to [any other person] a pharmacy technician or
 pharmacy intern trained in accordance with this section. A
 pharmacy intern who has completed a course of education and
 training which meets the requirements of subsection [(a)(1) and
 (2)] (a.2)(1) and (4) and a pharmacy technician who meets the
 requirements of subsection (a.2)(2) and (4) may administer
 injectable medications, biologicals and immunizations to persons
 who are more than eighteen years of age and [influenza] the
 immunizations listed in subsection (a.1)(2) by injectable or
 needle-free delivery methods to persons [nine] who are three
 years of age and older only under the direct, immediate and
 personal supervision of a pharmacist holding the authority to
 administer injectable medications, biologicals and
 immunizations.
    (c)   A supervising pharmacist shall report the administration
 of vaccines under this section to the immunization registry
 maintained by the Department of Health within seventy-two hours
 of vaccine administration and to the patient's primary care
 physician in accordance with subsection (a.2)(9).
    (d)   A pharmacist, pharmacy intern and pharmacy technician
 who administers an immunization to a person under eighteen years
 of age in accordance with this section shall inform the parent
 or adult caregiver on the importance of a well-child visit with
 a pediatrician or other licensed primary care provider and refer
 the patient as appropriate.
    (e)   Nothing in this section shall be construed to prohibit a
 supervising pharmacist from delegating the reporting of vaccine
 administration in subsection (c) to a pharmacy technician or
 pharmacy intern.
    Section 2.    This act shall take effect in 60 days.
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Statutes/Laws affected: 
Printer's No. 1666: P.L.1700, No.699