BILL ANALYSIS
AB 977
Page 1
Date of Hearing: April 21, 2009
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Mary Hayashi, Chair
AB 977 (Skinner) - As Amended: April 13, 2009
SUBJECT : Pharmacists: immunization administration.
SUMMARY : Authorizes pharmacists to administer flu and
pneumonia vaccines to persons over seven years, as specified.
Specifically, this bill :
1)Permits a pharmacist to initiate and administer influenza or
pneumococcal immunizations to any person seven years of age or
older once the pharmacist completes:
a) The American Pharmacists Association's Pharmacy-Based
Immunization Delivery Certificate Training Program or
another pharmacy-based immunization training certificate
program endorsed by the federal Centers for Disease Control
and Prevention (CDC) or the Accreditation Council for
Pharmaceutical Education; and,
b) Three hours of immunization-related continuing education
coursework annually.
2)Specifies that if a pharmacist fails to complete the three
hours of immunization-related continuing education coursework,
the pharmacist must retake the certificate training program
and the continuing education requirements prior to
administering any further immunizations.
3)Requires a pharmacist initiating and administering any
immunizations to be certified in basic life support.
4)Requires a pharmacist to obtain the consent of a parent or
guardian before administering an immunization to a patient
under 18 years.
5)Requires a pharmacist to do the following at the time of
immunization:
a) Provide the patient, or the patient's agent, with the
appropriate Vaccine Information Statement, produced by the
CDC, for each immunization administered;
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b) Provide the patient, or the patient's agent, and the
patient's physician or primary care provider with
documentation of administration of the immunization; and,
c) Provide documentation of administration of the
immunization to the California Immunization Registry.
6)Requires a pharmacist to maintain an immunization
administration record, which shall include, but not be limited
to:
a) The vaccine's name and expiration date;
b) The date of administration;
c) The manufacturer and lot number;
d) The administration site and route;
e) The Vaccine Information Statement date; and,
f) The name and title of the person administering.
7)Requires a pharmacist to maintain an immunization record for
the longer of either:
a) 10 years from the date of administration; or,
b) Three years beyond the patient's 18th birthday, if the
patient is younger than 18 years.
8)Permits any pharmacist initiating and administering vaccines
to initiate and administer epinephrine by injection for severe
allergic reactions.
9)Requires any adverse event to be reported to the Vaccine
Adverse Event Reporting System within the U.S. Department of
Health and Human Services (HHS).
10)Requires a pharmacist to assure proper vaccine temperature
during storage and handling.
11)Makes Legislative findings and declarations.
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EXISTING PHARMACY LAW :
1)Provides for the licensing and regulation of pharmacists by
the board.
2)Authorizes a pharmacist to administer immunizations pursuant
to a protocol with a prescriber.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author's office, "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 pharmacist 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 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."
Background . 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.
Currently, 49 states including California allow a pharmacist to
administer immunizations pursuant to a protocol with a
prescriber. A protocol typically identifies:
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The individual who has delegated activity
The pharmacist authorized to administer vaccine
Types of vaccines pharmacist is authorized to administer
Procedures, decision criteria, or the plan a pharmacist
should follow, including when to refer a patient
Procedure for emergency situations
Record keeping and documentation procedures
This bill would permit pharmacists to administer two vaccines
without a protocol. There is concern that this protocol is
essential for public health. The CDC currently recommends that
certain individuals should not be vaccinated for influenza
without first consulting a physician, and the pneumococcal
vaccine is usually not given to children five years old and
older.
Some argue that immunizations are a key entry point into the
doctor's office for children, especially teenagers. Permitting
pharmacists to provide immunizations would result in missed
opportunities to see a doctor and get other preventive care.
For adolescents, the age group targeted by this bill, the
booster vaccines are often the only reason they go to the
doctor, creating an opportunity to discuss other important
health care issues with the teen such as healthy eating,
prevention of substance abuse, and dating/partner violence.
Arguments in support . The California State Board of Pharmacy
writes, "The National Vital Statistics Report published by the
HHS reports that combined, influenza and pneumonia are the 8th
leading cause of death in people of all ages, and the 6th
leading cause of death in people over 65. Immunizations would
greatly benefit health to guard against these conditions.
"Pharmacists are on the front line of preventative care and
appointments are often not necessary to see a pharmacist.
Pharmacists are the most accessible healthcare provider, located
in over 6,000 pharmacies in over 1,100 zip codes throughout
California?. According to the California Healthcare Foundation,
12.1 million Californians are uninsured and may not have a
relationship with a physician.... Currently, pharmacists are
trained to screen, administer, and properly deal with the few
adverse events that may arise from vaccines as part of their
formal pharmacy education?. This proposal would increase access
to life saving vaccines."
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Arguments in opposition . The California Medical Association
writes, "While pharmacists are well-educated, licensed
professionals who have extensive knowledge about pharmaceuticals
and can be trained to give immunizations, this bill's dramatic
expansion of their authority to provide drugs to seriously ill
individuals without any medical oversight presents serious
patient safety and continuity of care issues that greatly
concern physicians."
Double referred . This bill is double-referred to the Assembly
Health Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
California State Board of Pharmacy (sponsor)
California Retailers Association
National Association of Chain Drug Stores
91 individual pharmacists
Opposition
California Academy of Family Physicians
California Medical Association
California Nurses Association
The American College of Obstetricians and Gynecologists,
District IX/CA
Analysis Prepared by : Sarah Huchel / B. & P. / (916) 319-3301