A04904
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
511
Session of
2021
INTRODUCED BY J. WARD, FONTANA, ARGALL, COLLETT, VOGEL, MARTIN,
PHILLIPS-HILL, PITTMAN, YUDICHAK, HUTCHINSON, MENSCH, BAKER
AND BROWNE, APRIL 13, 2021
REFERRED TO CONSUMER PROTECTION AND PROFESSIONAL LICENSURE,
APRIL 13, 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.
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; and abrogating
inconsistent regulations.
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
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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.
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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
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
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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.
(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
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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.
(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
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(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
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.
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(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.
Section 1. Section 9.2(a) introductory paragraph and (5) and
(b) of the act of September 27, 1961 (P.L.1700, No.699), known
as the Pharmacy Act, are amended and the section is amended by
adding subsections 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 and COVID-19 immunizations by injectable or
needle-free delivery methods to persons [nine] five years of age
and older. Such standards and guidelines shall include, but not
be limited to, the following:
* * *
(5) For individuals under eighteen years of age, that
parental consent be obtained prior to administration.
Administration of influenza and COVID-19 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.
* * *
(b) [A] Except as provided under subsection (e), a
pharmacist's authority to administer injectable medications,
biologicals and immunizations shall not be delegated to any
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other person. A pharmacy intern who has completed a course of
education and training which meets the requirements of
subsection (a)(1) and (2) may administer injectable medications,
biologicals and immunizations to persons who are more than
eighteen years of age and influenza and COVID-19 immunizations
by injectable or needle-free delivery methods to persons [nine]
five 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
or a physician, physician assistant or certified registered
nurse practitioner.
(c) A supervising pharmacist shall report the
administration of immunizations under this section to the
immunization registry maintained by the Department of Health
within seventy-two hours of immunization administration and to
the individual's primary care provider in accordance with
subsection (a)(7). Nothing in this subsection shall be construed
to prohibit a supervising pharmacist from delegating the
reporting of immunization administration to a pharmacy intern.
(d) A pharmacist or pharmacy intern who administers an
influenza or COVID-19 immunization to an individual under
eighteen years of age shall inform the parent or adult caregiver
of the importance of a well-child visit with a pediatrician or
other licensed primary care provider and refer the patient as
appropriate.
(e) A pharmacist who holds the authority to administer
injectable medications, biologicals and immunizations may
delegate the authority to administer influenza and COVID-19
immunizations to a certified registered nurse practitioner,
physician assistant, registered nurse or licensed practical
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nurse.
Section 2. The provisions of 49 Pa. Code ยงยง 27.12(c)(1) and
27.403(b) are abrogated insofar as they are inconsistent with
the amendment or addition of section 9.2(a) introductory
paragraph and (5), (b), (c) and (d) of the act.
Section 3. This act shall take effect immediately.
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