House of Representatives Staff Analysis, PCS for HB 1063, Administration of Vaccines

Summary

A House of Representatives staff analysis dated March 15, 2021 of the proposed committee substitute for HB 1063, Administration of Vaccines, sponsored by the Professions & Public Health Subcommittee. The analysis states that current law lets pharmacists and registered interns give adults only vaccines on the CDC adult immunization schedule as of February 1, 2015, CDC travel vaccines as of July 1, 2015, and vaccines approved by the Board of Pharmacy. It states that the bill would let qualified Florida-licensed pharmacists and pharmacy interns administer any CDC-recommended or FDA-licensed vaccine to an adult, allow influenza vaccines for individuals age 7 and older, and repeal the 2015 limitation. Background sections cover the Advisory Committee on Immunization Practices and state pharmacist age limits. The analysis gives an effective date of July 1, 2021.

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                                    HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #:     PCS for HB 1063 Administration of Vaccines
SPONSOR(S): Professions & Public Health Subcommittee
TIED BILLS:       IDEN./SIM. BILLS:

  REFERENCE                                                        ACTION                   ANALYST                STAFF DIRECTOR or
                                                                                                                   BUDGET/POLICY CHIEF

  Orig. Comm.: Professions & Public Health                                                  Morris                 McElroy
     Subcommittee

                                                         SUMMARY ANALYSIS
Current law authorizes pharmacists and registered interns who meet certain educational requirements to
administer vaccines to adults within an established protocol with a supervising physician. A pharmacist may
administer:

         Immunizations or vaccines listed on the U.S. Centers for Disease Control and Prevention (CDC) Adult
          Immunization Schedule as of February 1, 2015;
         Vaccines recommended by the CDC for international travel as of July 1, 2015;
         Immunizations or vaccines approved by the Board of Pharmacy in rule; and
         Immunizations or vaccines approved by the Board of Pharmacy in response to a state of emergency
          declared by the Governor.

PCS/HB 1063 authorizes qualified Florida-licensed pharmacists or registered pharmacy interns to administer
any CDC-recommended vaccine or vaccine licensed for use in the United States by the U.S. Food and Drug
Administration (FDA) to an adult. The PCS allows the Board of Pharmacy to authorize by rule additional
immunizations or vaccines, as they are recommended by the CDC or licensed by the FDA, that a qualified
pharmacist or registered pharmacy intern may administer. The PCS also authorizes pharmacists to provide
influenza vaccines to individuals age 7 and older.

The PCS also repeals the specific statutory limitation to the 2015 CDC-recommended vaccines.

The PCS has an insignificant, negative fiscal impact on the Department of Health, which can be absorbed
within existing resources. The PCS has no fiscal impact on local governments.

The PCS provides an effective date of July 1, 2021.




This document does not reflect the intent or official position of the bill sponsor or House of Representatives .
STORAGE NAME: pcs1063.PPH
DATE: 3/15/2021
                                                        FULL ANALYSIS

                                                I. SUBSTANTIVE ANALYSIS

    A. EFFECT OF PROPOSED CHANGES:
         Present Situation

         Vaccinations

                 CDC Immunizations Recommendations

         The Advisory Committee on Immunization Practices (ACIP) is comprised of medical and public health
         experts who develop recommendations on the use of vaccines in the United States.1 The ACIP works
         with professional organizations, such as the American Academy of Pediatrics, the American Academy
         of Family Physicians, the American College of Obstetricians and Gynecologists, and the American
         College of Physicians to develop annual childhood and adult immunization schedules.2 The Centers for
         Disease Control and Prevention (CDC) reviews the ACIP’s recommendations; and once approved, they
         are published as the CDC’s official recommendations for immunizations of the U.S. population.3 The
         current recommended immunization schedule for those ages 18 and under includes:4

              Hepatitis B                                                  Rotavirus
              Diphtheria, tetanus, & acellular pertussis                   Haemophilus influenza type b
              Pneumococcal conjugate                                       Inactivated poliovirus
              Influenza                                                    Measles, mumps, rubella (MMR)
              Varicella                                                    Hepatitis A
              Meningococcal                                                Human papillomavirus
              Meningococcal B                                              Pneumococcal polysaccharide
              Tetanus, diphtheria, and acellular pertussis

         The current recommended immunization schedule for adults includes:5

              Influenza (annually)                                         Varicella (if born in 1980 or later)
              Measles, mumps, rubella (if born in 1957 or                  Tetanus, diphtheria, pertussis (booster
               later)                                                        every 10 years)
              Zoster                                                       Human papillomavirus
              Pneumococcal polysaccharide                                  Pneumococcal conjugate
              Haemophilus influenza type b                                 Hepatitis A
              Hepatitis B                                                  Meningococcal A, C, W, Y
              Meningococcal B

         New vaccines are considered for addition to the schedule after licensure by the United States Food and
         Drug Administration.6 Not all newly licensed vaccines are added to the schedule. Some licensed
         vaccines are only recommended for people who are traveling to areas where other vaccine preventable

1 Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices (ACIP), General Committee-Related

Information, available at https://www.cdc.gov/vaccines/acip/committee/index.html (last visited March 8, 2021).
2 Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices (ACIP), ACIP Recommendations,

available at https://www.cdc.gov/vaccines/acip/recommendations.html (last visited March 8, 2021).
3 Id.
4 Centers for Disease Control and Prevention, Recommended Child and Adolescent Immunization Schedule for Ages 18 Years and

Younger, United States, 2021, available at https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html (last visited March 8,
2021). The schedule provides the recommended age, as well as the administration intervals for vaccines that require multiple doses.
Some vaccines are recommended only for populations with special situations that put these individuals at higher risk.
5 Centers for Disease Control and Prevention, Recommended Adult Immunization Schedule for Ages 19 Years or Older, United States,

2021, available at https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html (last visited March 8, 2021). The schedule provides the
recommended age, as well as the administration intervals for vaccines that require multiple doses. Some vaccines are recommended
only for populations with special situations that put these individuals at higher risk.
6 College of Physicians of Philadelphia, The History of Vaccines: The Development of the Immunization Schedule, available at

http://www.historyofvaccines.org/content/articles/development-immunization-schedule (last visited March 8, 2021).
STORAGE NAME: pcs1063.PPH                                                                                                     PAGE: 2
DATE: 3/15/2021
         diseases occur, such as yellow fever, cholera, dengue, Japanese encephalitis, plague, rabies,
         smallpox, and typhoid.7

                 CDC Health Information for International Travel

        CDC’s Health Information for International Travel, commonly called the Yellow Book (Book), is
        published biannually by the CDC as a reference for those who advise international travelers about
        health risks.8 The Book includes the CDC’s most current travel health guidelines, including pre-travel
        vaccine recommendations and destination-specific health advice. The Book is authored by subject-
        matter experts both within and outside the CDC and the guidelines in the Book are evidence-based and
        supported by best practices.9

         Vaccinations are recommended by the CDC to protect international travelers from illness and prevent
         the importation of infectious diseases across international borders. The Book recommends that persons
         traveling internationally should be up to date on all CDC-recommended vaccines.10 Additionally, the
         Book may recommend additional vaccinations based on traveler’s destination and other factors.
         Examples of additional vaccines required for travelers based on the country of entry is yellow fever,
         meningococcal, and polio.11 An example of a vaccine the CDC recommends travelers obtain to protect
         their health, even if they aren’t required for entry into the country, is the typhoid vaccine.12

         Practice of Pharmacy

                 Licensure

         Pharmacy is the third largest health profession behind nursing and medicine.13 The Board of Pharmacy
         (Board), in conjunction with the Department of Health (DOH), regulates the practice of pharmacists
         pursuant to ch. 465, F.S.14 To be licensed as a pharmacist, a person must:15

                 Complete an application and remit an examination fee;
                 Be at least 18 years of age;
                 Hold a degree from an accredited and approved school or college of pharmacy;16
                 Have completed a Board-approved internship; and
                 Successfully complete the Board-approved examination.

         A pharmacist must complete at least 30 hours of Board-approved continuing education during each
         biennial renewal period.17 Pharmacists who are certified to administer vaccines or epinephrine
         autoinjections must complete a 3-hour continuing education course on the safe and effective
         administration of vaccines and epinephrine injections as a part of the biennial licensure renewal.18


7 Id. For a complete list of FDA-licensed vaccines, see U.S. Food & Drug Administration, Vaccines Licensed for Use in the United

States, (last rev. Jan. 16, 2020), available at https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-
states (last visited February 4, 2020).
8 Centers for Disease Control and Prevention. CDC Yellow Book 2020: Health Information for International Travel, available at

https://wwwnc.cdc.gov/travel/page/yellowbook-home (last visited March 8, 2021).
9 Id.
10 Id.
11 Centers for Disease Control and Prevention, Travelers’ Health Most Frequently Asked Questions, available at

https://wwwnc.cdc.gov/travel/page/faq (last visited March 8, 2021).
12 Id.
13 American Association of Colleges of Pharmacy, About AACP, available at https://www.aacp.org/about-aacp (last visited March 8,

2021).
14 Sections 465.004 and 465.005, F.S.
15 Section 465.007, F.S. DOH may also issue a license by endorsement to a pharmacist who is licensed in another state upon meeting

the applicable requirements set forth in law and rule. See s. 465.0075, F.S.
16 If the applicant has graduated from a 4-year undergraduate pharmacy program of a school or college of pharmacy located outside

the United States, the applicant must demonstrate proficiency in English, pass the board-approved Foreign Pharmacy Graduate
Equivalency Examination, and complete a minimum of 500 hours in a supervised work activity program within Florida under the
supervision of a DOH-licensed pharmacist
17 Section 465.009, F.S.
18 Section 465.009(6), F.S.

STORAGE NAME: pcs1063.PPH                                                                                                     PAGE: 3
DATE: 3/15/2021
         Pharmacists who administer long-acting antipsychotic medications must complete an approved 8-hour
         continuing education course as a part of the continuing education for biennial licensure renewal.19

                  Scope of Practice

         In Florida, the practice of the profession of pharmacy includes:20

                 Compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of
                  a medicinal drug;
                 Consulting concerning therapeutic values and interactions of patent or proprietary preparations;
                 Monitoring a patient’s drug therapy and assisting the patient in the management of his or her
                  drug therapy, including the review of the patient’s drug therapy and communication with the
                  patient’s prescribing health care provider or other persons specifically authorized by the patient,
                  regarding the drug therapy;
                 Transmitting information from prescribers to their patients;
                 Administering vaccines to adults;21
                 Administering epinephrine injections;22 and
                 Administering antipsychotic medications by injection.23

                  Pharmacy Interns

         To become a pharmacy intern, a person must be certified by the Board as enrolled in an intern program
         at an accredited school or college of pharmacy or as a graduate of an accredited school or college of
         pharmacy and not yet licensed as a pharmacist in Florida.24 The Board’s rules outline the registration
         process for pharmacy interns and the internship program requirements for U.S. pharmacy students or
         graduates and foreign pharmacy graduates.25

         A pharmacist is responsible for any delegated act performed by a registered pharmacy intern employed
         or supervised by the pharmacist.26

                  Pharmacist Vaccine Administration

         A pharmacist, or registered pharmacy intern under the supervision of a certified pharmacist, may
         administer immunizations and vaccines to adults within an established protocol under a licensed
         supervising physician.27 The protocol between the pharmacist and the supervising physician dictates
         which types of patients to whom the pharmacist may administer allowable vaccines.28 The terms,
         scope, and conditions set forth in the protocol must be appropriate to the pharmacist’s training and
         certification. A supervising physician must review the administration of vaccines by the pharmacist.29

         To be certified to administer vaccines, a pharmacist or registered pharmacy intern must successfully
         complete a Board-approved vaccine administration certification program. The certification program
         requires a pharmacist or registered intern to complete 20 hours of Board-approved continuing
         education that addresses:30

                 Mechanisms of action for vaccines, contraindications, drug interactions, and monitoring after
                  vaccine administration;

19 Section 465.1893, F.S.
20 Section 465.003(13), F.S.
21 See s. 465.189, F.S.
22 Id.
23 Section 465.1893, F.S.
24 Section 465.013, F.S.
25 Rule 64B16-26.2032, F.A.C. (U.S. pharmacy students/graduates); Rule 64B16-26.2033, F.A.C. (foreign pharmacy graduates).
26 Rule 64B16-27.430, F.A.C.
27 Section 468.189(1), F.S.
28 Section 465.189(7), F.S.
29 Id.
30 Rule 64B16-26.1031, F.A.C.

STORAGE NAME: pcs1063.PPH                                                                                                PAGE: 4
DATE: 3/15/2021
                 Immunization schedules;
                 Immunization screening questions, provision of risk/benefit information, informed consent,
                  recordkeeping, and electronic reporting into the statewide immunization registry maintained by
                  DOH;
                 Vaccine storage and handling;
                 Bio-hazardous waste disposal and sterile technique;
                 Entering, negotiating, and performing pursuant to physician oversight protocols;
                 Community immunization resources and programs;
                 Identifying, managing and responding to adverse incidents including but not limited to potential
                  allergic reactions associated with vaccine administration;
                 Procedures and policies for reporting adverse incidents to the Vaccine Adverse Event Reporting
                  System;
                 Reimbursement procedures and vaccine coverage by federal, state, and local governmental
                  jurisdictions and private third party payers;
                 Administration techniques;
                 Administration of epinephrine using an autoinjector delivery system;
                 The February 1, 2015, CDC Recommended Adult Immunization Schedule;
                 The immunizations or vaccines recommended for international travel as of July 1, 2015, found in
                  the CDC Health Information for International Travel (2014 Edition);
                 State of emergency administration of immunizations or vaccines;
                 Review of the current law permitting a pharmacist to administer vaccinations and epinephrine;
                  and
                 CPR training.

         A pharmacist must also pass an examination and demonstrate vaccine administration technique.31
         Pharmacists who are certified to administer vaccines must maintain at least $200,000 of professional
         liability insurance.32 A pharmacist is permitted to administer epinephrine to treat any allergic reaction
         resulting from a vaccine.

         Current law restricts the vaccines a pharmacist may administer to adults to those vaccines listed in the
         February 1, 2015, CDC Recommended Adult Immunization Schedule, which is the same as the 2021
         list of recommended vaccines (see pg. 3), except that the CDC has added the Meningococcal B
         vaccine to the list.33

         The Board may authorize, by rule, additional vaccines a pharmacist may administer.34 The Board may
         authorize pharmacists to administer vaccines in response to a declared state of emergency.35 There
         are 14,579 Florida-licensed pharmacists and 3,579 pharmacy interns who are certified to administer
         vaccines.36

         Pharmacist Vaccination and Age Restrictions

         In August of 2020, the U.S. Department of Health and Human Services amended the Declaration under
         the Public Readiness and Emergency Preparedness Act to authorize pharmacists and registered or
         licensed pharmacy interns acting under the supervision of a pharmacist to administer vaccines to
         individuals aged three to 18 years.37

31 Id.
32 Section 465.189(3), F.S.
33 Centers for Disease Control and Prevention, Recommended Adult Immunization Schedule, United States - 2015, available at

https://www.cdc.gov/vaccines/schedules/downloads/past/2015-adult.pdf (last visited March 8, 2021). The schedule provides the
recommended age, as well as the administration intervals for vaccines that require multiple doses. Some vaccines are recommended
only for populations with special situations that put these individuals at higher risk. See also supra note 5.
34 Section 465.189, F.S..
35 Section 465.189(1)(c), F.S.
36 E-mail correspondence with DOH, dated March 8, 2021 on file with the Professions and Public Health Subcommittee.
37 U.S. Department of Health and Human Services, Third Amendment to Declaration Under the Public Readiness and Emergency

Preparedness Act for Medical Countermeasures Against COVID-19, https://www.hhs.gov/sites/default/files/third-amendment-
declaration.pdf (last visited March 8, 2021).
STORAGE NAME: pcs1063.PPH                                                                                                    PAGE: 5
DATE: 3/15/2021
         Currently, all 50 states authorize pharmacists to administer vaccinations; however, that authority may
         vary by, among other things, the age of the patients that a pharmacist may vaccinate.38 Four states,
         including Florida, limit pharmacist vaccinations to adult patients.39 Twenty six states allow pharmacists
         to administer vaccines to individuals of any age.40 The remaining states have minimum age restrictions
         that range from 12 years to 2 years.41

         Authority to administer influenza vaccines to minors differ by state. For example, some states, such as
         Arizona, allow pharmacists to administer influenza vaccines to children age 3 and over, while other
         states, such as West Virginia, only allow pharmacists to administer influenza vaccines to those age 11
         and older. Three states, including Florida, do not authorize pharmacists to administer influenza
         vaccines to minors, 19 states have age restrictions, and 28 others allow pharmacists to give influenza
         vaccines to children of any age. Sixteen states require a prescription for an influenza vaccine. 42

         Effect of Proposed Changes

         PCS/HB 1063 revises the list of immunizations that qualified pharmacists and registered pharmacy
         interns can provide to adults. Currently, pharmacists may only administer those vaccines listed in 2015
         CDC-recommended immunization for adults and the 2015 CDC-recommended immunizations for
         international travels. The PCS authorizes pharmacists to administer those vaccines or immunizations
         listed in the 2021 CDC Recommended Immunization Schedule for adults and the CDC’s Health
         Information for International Travel. Therefore, pharmacists may administer the Meningococcal B
         vaccine, which is on the current recommended immunization schedule but was not on the 2015
         recommended schedule.

         The PCS also authorizes a pharmacist to administer any vaccine that has been licensed for use in the
         United States by the U.S. Food and Drug Administration (FDA) and allows the Board to authorize by
         rule additional vaccines that may be administered as they are recommended by the CDC or licensed by
         the FDA. This allows a pharmacist to administer vaccines for yellow fever, cholera, dengue, Japanese
         encephalitis, plague, rabies, smallpox, and typhoid, which are not in the CDC-recommended schedule
         but have been approved by the FDA. The PCS expands the authority of qualified pharmacists and
         pharmacy interns to administer the influenza vaccines to allow them to administer the vaccine to
         individuals age 7 and older.

         The PCS provides an effective date of July 1, 2021.

    B. SECTION DIRECTORY:
         Section 1 Amends s. 465.189, F.S., relating to administration of vaccines and epinephrine
                   autoinjection.

38 Yvette C. Terrie, BSPharm, RPH, Vaccinations: The Expanding Role of Pharmacists, PHARMACY TIMES, Jan. 15, 2010, available at

https://www.pharmacytimes.com/publications/issue/2010/january2010/featurefocusvaccinations-0110 (last visited March 8, 2021).
39 National Alliance of State Pharmacy Associations, Pharmacist Administered Vaccines (Sept. 18, 2020), https://naspa.us/wp-

content/uploads/2020/08/IZ-Authority-9_2020.pdf (last visited March 8, 2021). The states that limit pharmacist vaccinations to adults are
Connecticut, Delaware, Florida, and Vermont.
40 Id. The twenty six states that allow pharmacists to vaccinate individuals of any age are: Alabama, Alaska, California, Colorado,

Georgia, Idaho, Indiana, Iowa, Louisiana, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, Nevada, New Mexico,
Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
41 Id. Minimum age limits: Hawaii and West Virginia is 11 years; Illinois is 10 years; Massachusetts, Maryland, Pennsylvania, and

Rhode Island is 9 years; Arkansas, Maine, Montana, New Jersey, Ohio, and Wyoming is 7 years; Kansas, Minnesota, and North
Carolina is 6 years; North Dakota is 5 years; Arizona is 3 years; and New York is 2 years.
42 Id at p. 11. The three states that do not allow pharmacists to administer influenza vaccines to minors are Connecticut, Florida, and

Vermont. The states with age limits re: Hawaii and West Virginia is 11 years; Illinois is 10 years; Massachusetts, Maryland,
Pennsylvania, and Rhode Island is 9 years; Arkansas, Maine, Montana, New Jersey, Ohio, and Wyoming is 7 years; Kansas,
Minnesota, and North Carolina is 6 years; North Dakota is 5 years; Arizona is 3 years; and New York is 2 years. The twenty eight states
that allow pharmacists to give influenza vaccines to children of any age are: Alabama, Alaska, California, Colorado, Delaware (with an
adult dose), Georgia, Idaho, Indiana, Iowa, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New
Mexico, Nevada, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
The sixteen states that require a prescription for an influenza vaccine are: California, Georgia, Hawaii, Idaho, Indiana, Iowa, Kentucky,
Louisiana, Missouri, Oregon, South Carolina, Texas, Virginia, West Virginia, and Wisconsin.
STORAGE NAME: pcs1063.PPH                                                                                                       PAGE: 6
DATE: 3/15/2021
       Section 2 Provides an effective date of July 1, 2021.



                        II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

   A. FISCAL IMPACT ON STATE GOVERNMENT:

       1. Revenues:
           None.

       2. Expenditures:
           The PCS may have an insignificant, negative fiscal impact on DOH, as the Board of Pharmacy will
           need to amend its rules.

   B. FISCAL IMPACT ON LOCAL GOVERNMENTS:

       1. Revenues:
           None.

       2. Expenditures:
           None.

   C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
       Those between the ages of 7 and 18 may obtain influenza vaccinations from a qualified pharmacist,
       which may reduce costs associated with travel and physician office visits.

   D. FISCAL COMMENTS:
       None.


                                               III. COMMENTS

   A. CONSTITUTIONAL ISSUES:

       1. Applicability of Municipality/County Mandates Provision:
          Not applicable. The PCS does not appear to affect county or municipal governments.

       2. Other:
          None.

   B. RULE-MAKING AUTHORITY:
       Rule-making authority is not needed to implement the provisions of the PCS.

   C. DRAFTING ISSUES OR OTHER COMMENTS:
       None.


                            IV. AMENDMENTS/ COMMITTEE SUBSTITUTE CHANGES




STORAGE NAME: pcs1063.PPH                                                                            PAGE: 7
DATE: 3/15/2021


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