BILL ANALYSIS
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|Hearing Date:June 14, 2010 |Bill No:AB |
| |977 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Gloria Negrete McLeod, Chair
Bill No: AB 977 Author: Skinner
As Amended:June 1, 2010 Fiscal: Yes
SUBJECT: Pharmacists: immunization protocols.
SUMMARY: Authorizes pharmacists to administer influenza
immunizations, pursuant to standardized protocols developed and
approved by the Medical Board of California (MBC), to any person 18
years or older, until January 1, 2015.
Existing law, the Business and Professions Code:
1) Provides for the practice of pharmacy and the licensing and
regulation of pharmacies and pharmacists by the Board of Pharmacy
(BOP) within the Department of Consumer Affairs (DCA.)
2) Defines "independent community pharmacy" as a pharmacy owned by a
person or entity who owns no more than four pharmacies in
California.
3) Authorizes pharmacists to administer, orally or topically, drugs
and biologicals pursuant to a prescriber's order.
4) Authorizes pharmacists to administer immunizations pursuant to a
protocol with a prescriber.
5) Authorizes pharmacists in a health care facility, and as part of
care provided by a health care facility, home health agency,
licensed clinic, health care service plan or physician, to
administer drugs and biologicals by injection pursuant to a
prescriber's order.
6) Requires pharmacists to submit proof of completion of 30 hours of
approved continuing pharmacy education prior to license renewal.
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Existing law, the Health and Safety Code:
1) The Health and Safety Code, allows a pharmacist to administer
influenza and pneumococcal immunizations pursuant to standing
orders and without patient-specific orders, in a skilled nursing
facility, for patients 50 years and older, if the following
criteria are met:
a) The skilled nursing facility medical director has approved the
immunization standing orders established by the facility.
b) The standing orders meet the recommendations of the Advisory
Committee on Immunization Practices (ACIP) of the Centers for
Disease Control (CDC).
This bill:
1)Sets forth findings and declarations detailing the safety of
vaccines and their efficacy in preventing sickness and death from
disease as follows: (1) The amount of people who actually receive
vaccines is less than recommended by CDC; (2) Californians' lack of
access to immunizations; (3) The ability of pharmacists in
preventive care; (4) The role of physicians in preventive care.
Details legislative intent to achieve greater access to
immunizations.
2)Allows a pharmacist associated with an independent community
pharmacy to initiate and administer influenza immunizations,
pursuant to standardized protocols developed and approved by the MBC
in consultation with public health officers, to any person 18 years
of age or older, until January 1, 2015.
3)Allows MBC to consult with the BOP in developing standardized
protocols and requires the standardized protocols to be consistent
with protocols developed by the ACIP of the CDC.
4)Requires a pharmacist, prior to initiating and administering
immunizations, to complete the American Pharmacists Association's
Pharmacy-Based Immunization Delivery Certificate Training Program or
another pharmacy-based immunization training certificate program
endorsed by the CDC or Accreditation Council for Pharmaceutical
Education.
5)Requires a pharmacist initiating and administering influenza
immunizations to complete three hours of immunization-related
continuing education coursework annually.
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6)Requires a pharmacist who fails to satisfy the continuing education
requirement, in addition to any other applicable disciplinary
action, to retake the American Pharmacists Association's
Pharmacy-Based Immunization Delivery Certificate Training Program,
or another pharmacy-based immunization training certificate program
endorsed by the CDC or Accreditation Council for Pharmaceutical
Education, and also complete the three hours of immunization-related
continuing education coursework prior to initiating and
administering any further immunizations.
7)Allows the three hours of immunization-related continuing education
to apply to the required 30 hours of continuing education for a
pharmacist's license renewal.
8)Requires a pharmacist initiating and administering influenza
immunizations to be certified in basic life support.
9)Requires a pharmacist to do all of the following at the time of
administering an influenza immunization:
a) Provide the patient or the patient's agent with the
appropriate Vaccine Information Statement (VIS), produced by the
CDC, for each immunization administered.
b) Provide documentation of administration of the immunization to
the patient and the patient's physician or primary care provider,
if one can be identified.
c) Provide documentation of administration of the immunization to
the appropriate immunization registry.
10)Requires a pharmacist to maintain an immunization administration
record for 10 years from the date of administration, which shall
include, but not be limited to the following:
a) The name of the vaccine.
b) The expiration date.
c) The date of administration.
d) The manufacturer and lot number.
e) The administration site and route.
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f) The VIS date.
g) The name and title of the person administering.
11)Allows any pharmacist initiating and administering vaccines to
initiate and administer epinephrine by injection for severe allergic
reactions.
12)Requires any adverse event to be reported to the Vaccine Adverse
Event Reporting System within the United States Department of Health
and Human Services.
13)States that, upon receipt, a pharmacist is responsible for ensuring
that proper vaccine temperatures are maintained during subsequent
storage and handling to preserve the potency of the vaccine.
14)Requires the BOP and MBC to evaluate the effectiveness of allowing
pharmacists to initiate and administer influenza immunizations and
requires the BOP to report to the appropriate policy committees of
the Legislature by January 1, 2014.
FISCAL EFFECT: According to the January 21, 2010 Assembly Committee
on Appropriations analysis, this measure may result in a one-time
fee-supported special fund cost to the BOP and MBC likely in the range
of $50,000 to $100,000, combined, to establish the program in 2011.
The bill may also result in ongoing absorbable costs until 2015 to
provide program oversight. The bill may also result in fee-supported
special fund costs of approximately $50,000 to complete the evaluation
to be submitted to the Legislature.
COMMENTS:
1. Purpose. This bill is intended to remedy the difficulty
independent pharmacies have in administering vaccines by removing a
prescriber protocol. According to the Author, "In 1995, pharmacy
law allowed a pharmacist to administer immunizations pursuant to a
protocol with a physician. Since that time, pharmacists have
safely initiated and administered thousands of immunizations to
Californians. However, the full impact of pharmacists delivered
vaccines has not been realized. Many pharmacists are unable to
obtain a prescriber's signature on their vaccination protocol,
making them unable to administer vaccines. Even after extensive
education of physicians regarding the minimal liability incurred,
many remain apprehensive and choose not to sign immunization
protocols with pharmacists. Further, independent pharmacies are
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the hardest hit by the need for a prescriber protocol. These small
businesses often serve low-income, ethnically-diverse communities
in suburban and rural locations throughout California."
2. Background. Immunizations stand as a useful, cost-effective
measure in promoting public health and preventing the spread of
disease. According to the Institute of Medicine, more than 50,000
adults and 300 children die annually in the United States from
diseases or complications arising from diseases that are considered
vaccine-preventable. Studies show that immunizations assist in
preventing an estimated 14 million cases of vaccine-preventable
diseases and 33,000 cases of death.
Vaccines against influenza have been especially useful in
preventing the spread of that virus and have recently been at the
center of a larger national and international vaccination
conversation. While CDC recommends vaccination against influenza
for over 70% of the population, actual rates of immunization are
much lower. CDC estimates that 36,000 people die each year from
influenza or its complications. The H1N1 outbreak of 2009 resulted
in a CDC recommendation that everyone receive the vaccine. Yet
access to immunizations can be compounded by a growing uninsured
population in the state who may lack the ability to be seen in a
physician's office. In a report released earlier this year,
UCLA.'s Center for Health Policy Research found that the number of
uninsured adults and children in California grew by 28 percent
between 2007 and 2009.
Pharmacies and pharmacists are able to play a unique role in
contributing to higher access to immunizations. CDC's ACIP
recommendations for 2008 call for vaccinations to be provided in
alternative settings like pharmacies to help make progress toward
achieving national health objectives. According to an article in
the Journal of the American Pharmaceutical Association,
"Pharmacists and Immunizations," Gallup Polls have consistently
named the pharmacist among the most trusted professionals. People
in many communities, especially rural areas, look to their
community pharmacist for medical advice. This respect can be
pivotal in helping educate parents and other adults about the
importance of timely immunization. When parents and elderly
patients pick up prescriptions, pharmacists can take advantage of
their accessibility and reputation to ask them about their
immunization status and counsel them on the importance of
immunization. Pharmacies are located in many neighborhoods
throughout the state, have extended hours of operation and have
existing infrastructure to properly store vaccines.
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3. Arguments in Support. The Medical Board of California (MBC)
writes in support of this measure, noting that "the Board feels
that with the growing need for an increased availability of health
care providers who can administer influenza immunizations, it would
provide better access to care if the public could utilize their
pharmacists when searching for an influenza vaccine."
NOTE : Double-referral to the Senate Committee on Health (second.)
SUPPORT AND OPPOSITION:
Support:
Medical Board of California (MBC)
Opposition: None on file as of June 9, 2010.
Consultant:Sarah Mason