Bill Text: FL S0768 | 2021 | Regular Session | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Administration of Vaccines

Spectrum: Slight Partisan Bill (? 2-1)

Status: (Passed) 2021-06-23 - Chapter No. 2021-127 [S0768 Detail]

Download: Florida-2021-S0768-Introduced.html

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       Florida Senate - 2021                                     SB 768
       
       
        
       By Senator Baxley
       
       
       
       
       
       12-00562A-21                                           2021768__
    1                        A bill to be entitled                      
    2         An act relating to immunizations; amending s. 381.003,
    3         F.S.; requiring certain persons licensed to practice
    4         pharmacy to report specified vaccination data to the
    5         Department of Health’s immunization registry, with
    6         exceptions; amending s. 465.189, F.S.; authorizing
    7         certain pharmacists and registered interns to
    8         administer specified immunizations and vaccines to
    9         children within a specified age range under certain
   10         circumstances; revising the specified immunizations or
   11         vaccines that such pharmacists and registered interns
   12         may administer; requiring authorized pharmacists and
   13         registered interns to obtain a certain medical consent
   14         form before administering a vaccine to a child younger
   15         than 18 years of age; specifying requirements for the
   16         consent form; requiring the parent or guardian of such
   17         child to provide a certain opt-out form to the
   18         pharmacist or registered intern to exclude the minor
   19         from the department’s immunization registry; requiring
   20         the pharmacist or registered intern to submit the opt
   21         out form to the department; requiring authorized
   22         pharmacists and registered interns to submit
   23         vaccination data to the department if an opt-out form
   24         is not provided; amending s. 465.003, F.S.; conforming
   25         a provision to changes made by the act; providing an
   26         effective date.
   27          
   28  Be It Enacted by the Legislature of the State of Florida:
   29  
   30         Section 1. Paragraph (e) of subsection (1) of section
   31  381.003, Florida Statutes, is amended to read:
   32         381.003 Communicable disease and AIDS prevention and
   33  control.—
   34         (1) The department shall conduct a communicable disease
   35  prevention and control program as part of fulfilling its public
   36  health mission. A communicable disease is any disease caused by
   37  transmission of a specific infectious agent, or its toxic
   38  products, from an infected person, an infected animal, or the
   39  environment to a susceptible host, either directly or
   40  indirectly. The communicable disease program must include, but
   41  need not be limited to:
   42         (e) Programs for the prevention and control of vaccine
   43  preventable diseases, including programs to immunize school
   44  children as required by s. 1003.22(3)-(11) and the development
   45  of an automated, electronic, and centralized database and
   46  registry of immunizations. The department shall ensure that all
   47  children in this state are immunized against vaccine-preventable
   48  diseases. The immunization registry must allow the department to
   49  enhance current immunization activities for the purpose of
   50  improving the immunization of all children in this state.
   51         1. Except as provided in subparagraph 2., the department
   52  shall include all children born in this state in the
   53  immunization registry by using the birth records from the Office
   54  of Vital Statistics. The department shall add other children to
   55  the registry as immunization services are provided.
   56         2. The parent or guardian of a child may refuse to have the
   57  child included in the immunization registry by signing a form
   58  obtained from the department, or from the health care
   59  practitioner or entity that provides the immunization, which
   60  indicates that the parent or guardian does not wish to have the
   61  child included in the immunization registry. Each consent to
   62  treatment form provided by a health care practitioner or by an
   63  entity that administers vaccinations or causes vaccinations to
   64  be administered to children from birth through 17 years of age
   65  must contain a notice stating that the parent or guardian of a
   66  child may refuse to have his or her child included in the
   67  immunization registry. The parent or guardian must provide such
   68  opt-out form to the health care practitioner or entity upon
   69  administration of the vaccination. Such health care practitioner
   70  or entity shall submit the form to the department. A parent or
   71  guardian may submit the opt-out form directly to the department.
   72  Any records or identifying information pertaining to the child
   73  shall be removed from the registry, if the parent or guardian
   74  has refused to have his or her child included in the
   75  immunization registry.
   76         3. A college or university student, from 18 years of age to
   77  23 years of age, who obtains a vaccination from a college or
   78  university student health center or clinic in the state may
   79  refuse to be included in the immunization registry by signing a
   80  form obtained from the department, health center, or clinic
   81  which indicates that the student does not wish to be included in
   82  the immunization registry. The student must provide such opt-out
   83  form to the health center or clinic upon administration of the
   84  vaccination. Such health center or clinic shall submit the form
   85  to the department. A student may submit the opt-out form
   86  directly to the department. Any records or identifying
   87  information pertaining to the student shall be removed from the
   88  registry if the student has refused to be included in the
   89  immunization registry.
   90         4. The immunization registry shall allow for immunization
   91  records to be electronically available to entities that are
   92  required by law to have such records, including, but not limited
   93  to, schools and licensed child care facilities.
   94         5. A health care practitioner licensed under chapter 458,
   95  chapter 459, or chapter 464, or chapter 465 in this state who
   96  administers vaccinations or causes vaccinations to be
   97  administered to children from birth through 17 years of age is
   98  required to report vaccination data to the immunization
   99  registry, unless a parent or guardian of a child has refused to
  100  have the child included in the immunization registry by meeting
  101  the requirements of subparagraph 2. A health care practitioner
  102  licensed under chapter 458, chapter 459, or chapter 464, or
  103  chapter 465 in this state who administers vaccinations or causes
  104  vaccinations to be administered to college or university
  105  students from 18 years of age to 23 years of age at a college or
  106  university student health center or clinic is required to report
  107  vaccination data to the immunization registry, unless the
  108  student has refused to be included in the immunization registry
  109  by meeting the requirements of subparagraph 3. Vaccination data
  110  for students in other age ranges may be submitted to the
  111  immunization registry only if the student consents to inclusion
  112  in the immunization registry. The upload of data from existing
  113  automated systems is an acceptable method for updating
  114  immunization information in the immunization registry. The
  115  information in the immunization registry must include the
  116  child’s name, date of birth, address, and any other unique
  117  identifier necessary to correctly identify the child; the
  118  immunization record, including the date, type of administered
  119  vaccine, and vaccine lot number; and the presence or absence of
  120  any adverse reaction or contraindication related to the
  121  immunization. Information received by the department for the
  122  immunization registry retains its status as confidential medical
  123  information and the department must maintain the confidentiality
  124  of that information as otherwise required by law. A health care
  125  practitioner or other agency that obtains information from the
  126  immunization registry must maintain the confidentiality of any
  127  medical records in accordance with s. 456.057 or as otherwise
  128  required by law.
  129         Section 2. Present subsections (2) through (8) of section
  130  465.189, Florida Statutes, are redesignated as subsections (3)
  131  through (9), respectively, a new subsection (2) is added to that
  132  section, and subsection (1) and present subsection (6) are
  133  amended, to read:
  134         465.189 Administration of vaccines and epinephrine
  135  autoinjection.—
  136         (1) In accordance with guidelines of the United States
  137  Centers for Disease Control and Prevention for each recommended
  138  immunization or vaccine, a pharmacist, or a registered intern
  139  under the supervision of a pharmacist who is certified under
  140  subsection (7)(6), may administer the following immunizations or
  141  vaccines to a person 6 years of age or older an adult within the
  142  framework of an established protocol under a supervising
  143  physician licensed under chapter 458 or chapter 459:
  144         (a) Immunizations or vaccines listed in the Adult
  145  Immunization Schedule as of February 1, 2015, by the United
  146  States Centers for Disease Control and Prevention. The board may
  147  authorize, by rule, additional immunizations or vaccines as they
  148  are added to the Adult Immunization Schedule.
  149         (b) Immunizations or vaccines listed in the Child and
  150  Adolescent Immunization Schedule by the United States Centers
  151  for Disease Control and Prevention.
  152         (c) Immunizations or vaccines recommended by the United
  153  States Centers for Disease Control and Prevention for
  154  international travel as of July 1, 2015. The board may
  155  authorize, by rule, additional immunizations or vaccines as they
  156  are recommended by the United States Centers for Disease Control
  157  and Prevention for international travel.
  158         (d)(c) Immunizations or vaccines approved by the board in
  159  response to a state of emergency declared by the Governor
  160  pursuant to s. 252.36.
  161  
  162  A registered intern who administers an immunization or vaccine
  163  under this subsection must be supervised by a certified
  164  pharmacist at a ratio of one pharmacist to one registered
  165  intern.
  166         (2) To administer an immunization or vaccine to a child
  167  younger than 18 years of age, a pharmacist or registered intern
  168  certified under subsection (7) must first obtain a medical
  169  consent form signed by a person who has the power to consent to
  170  medical care or treatment on behalf of the child in accordance
  171  with s. 743.0645. The medical consent form must contain a notice
  172  stating that the parent or guardian of such child may refuse to
  173  have the child included in the immunization registry under s.
  174  381.003. If a parent or guardian does not want the child
  175  included in the immunization registry, he or she must provide to
  176  the pharmacist or registered intern a completed opt-out form
  177  approved by the department upon administration of the vaccine.
  178  The pharmacist or registered intern shall submit the opt-out
  179  form to the department. If a parent or guardian of a child
  180  younger than 18 years of age does not provide an opt-out form,
  181  the pharmacist or registered intern must report the vaccination
  182  data for such child to the department in accordance with s.
  183  381.003.
  184         (7)(6) Any pharmacist or registered intern seeking to
  185  administer vaccines to adults under this section must be
  186  certified to administer such vaccines pursuant to a
  187  certification program approved by the Board of Pharmacy in
  188  consultation with the Board of Medicine and the Board of
  189  Osteopathic Medicine. The certification program shall, at a
  190  minimum, require that the pharmacist attend at least 20 hours of
  191  continuing education classes approved by the board and the
  192  registered intern complete at least 20 hours of coursework
  193  approved by the board. The program shall have a curriculum of
  194  instruction concerning the safe and effective administration of
  195  such vaccines, including, but not limited to, potential allergic
  196  reactions to such vaccines.
  197         Section 3. Subsection (13) of section 465.003, Florida
  198  Statutes, is amended to read:
  199         465.003 Definitions.—As used in this chapter, the term:
  200         (13) “Practice of the profession of pharmacy” includes
  201  compounding, dispensing, and consulting concerning contents,
  202  therapeutic values, and uses of any medicinal drug; consulting
  203  concerning therapeutic values and interactions of patent or
  204  proprietary preparations, whether pursuant to prescriptions or
  205  in the absence and entirely independent of such prescriptions or
  206  orders; and conducting other pharmaceutical services. For
  207  purposes of this subsection, the term “other pharmaceutical
  208  services” means monitoring the patient’s drug therapy and
  209  assisting the patient in the management of his or her drug
  210  therapy, and includes reviewing, and making recommendations
  211  regarding, the patient’s drug therapy and health care status in
  212  communication with the patient’s prescribing health care
  213  provider as licensed under chapter 458, chapter 459, chapter
  214  461, or chapter 466, or a similar statutory provision in another
  215  jurisdiction, or such provider’s agent or such other persons as
  216  specifically authorized by the patient; and initiating,
  217  modifying, or discontinuing drug therapy for a chronic health
  218  condition under a collaborative pharmacy practice agreement.
  219  This subsection may not be interpreted to permit an alteration
  220  of a prescriber’s directions, the diagnosis or treatment of any
  221  disease, the initiation of any drug therapy, the practice of
  222  medicine, or the practice of osteopathic medicine, unless
  223  otherwise permitted by law or specifically authorized by s.
  224  465.1865 or s. 465.1895. The term “practice of the profession of
  225  pharmacy” also includes any other act, service, operation,
  226  research, or transaction incidental to, or forming a part of,
  227  any of the foregoing acts, requiring, involving, or employing
  228  the science or art of any branch of the pharmaceutical
  229  profession, study, or training, and shall expressly permit a
  230  pharmacist to transmit information from persons authorized to
  231  prescribe medicinal drugs to their patients. The practice of the
  232  profession of pharmacy also includes the administration of
  233  vaccines to persons 6 years of age or older adults pursuant to
  234  s. 465.189, the testing or screening for and treatment of minor,
  235  nonchronic health conditions pursuant to s. 465.1895, and the
  236  preparation of prepackaged drug products in facilities holding
  237  Class III institutional pharmacy permits. The term also includes
  238  the ordering and evaluating of any laboratory or clinical
  239  testing; conducting patient assessments; and modifying,
  240  discontinuing, or administering medicinal drugs pursuant to s.
  241  465.0125 by a consultant pharmacist.
  242         Section 4. This act shall take effect July 1, 2021.