Florida Senate - 2020                                     SB 714
       By Senator Hutson
       7-00934-20                                             2020714__
    1                        A bill to be entitled                      
    2         An act relating to the testing for and treatment of
    3         influenza and streptococcus; amending s. 381.0031,
    4         F.S.; requiring specified licensed pharmacists to
    5         report certain information to the Department of
    6         Health; amending s. 465.003, F.S.; revising the
    7         definition of the term “practice of the profession of
    8         pharmacy”; creating s. 465.1895, F.S.; authorizing
    9         pharmacists to test for and treat influenza and
   10         streptococcus and providing requirements relating
   11         thereto; requiring that the written protocol between a
   12         pharmacist and supervising physician contain certain
   13         information, terms, and conditions; requiring the
   14         Board of Pharmacy to adopt rules within a specified
   15         time period; requiring that a pharmacist notify a
   16         patient’s primary care provider within a specified
   17         time period after providing any such testing or
   18         treatment; providing an effective date.
   20  Be It Enacted by the Legislature of the State of Florida:
   22         Section 1. Subsection (2) of section 381.0031, Florida
   23  Statutes, is amended to read:
   24         381.0031 Epidemiological research; report of diseases of
   25  public health significance to department.—
   26         (2) Any practitioner licensed in this state to practice
   27  medicine, osteopathic medicine, chiropractic medicine,
   28  naturopathy, or veterinary medicine; any licensed pharmacist
   29  authorized pursuant to a written protocol to order and evaluate
   30  laboratory and clinical tests; any hospital licensed under part
   31  I of chapter 395; or any laboratory appropriately certified by
   32  the Centers for Medicare and Medicaid Services under the federal
   33  Clinical Laboratory Improvement Amendments, and the federal
   34  rules adopted thereunder, which diagnoses or suspects the
   35  existence of a disease of public health significance shall
   36  immediately report the fact to the Department of Health.
   37         Section 2. Subsection (13) of section 465.003, Florida
   38  Statutes, is amended to read:
   39         465.003 Definitions.—As used in this chapter, the term:
   40         (13) “Practice of the profession of pharmacy” includes
   41  compounding, dispensing, and consulting concerning contents,
   42  therapeutic values, and uses of any medicinal drug; consulting
   43  concerning therapeutic values and interactions of patent or
   44  proprietary preparations, whether pursuant to prescriptions or
   45  in the absence and entirely independent of such prescriptions or
   46  orders; and conducting other pharmaceutical services. For
   47  purposes of this subsection, “other pharmaceutical services”
   48  means the monitoring of the patient’s drug therapy and assisting
   49  the patient in the management of his or her drug therapy, and
   50  includes review of the patient’s drug therapy and communication
   51  with the patient’s prescribing health care provider as licensed
   52  under chapter 458, chapter 459, chapter 461, or chapter 466, or
   53  similar statutory provision in another jurisdiction, or such
   54  provider’s agent or such other persons as specifically
   55  authorized by the patient, regarding the drug therapy. However,
   56  nothing in this subsection may be interpreted to permit an
   57  alteration of a prescriber’s directions, the diagnosis or
   58  treatment of any disease, the initiation of any drug therapy,
   59  the practice of medicine, or the practice of osteopathic
   60  medicine, unless otherwise permitted by law. “Practice of the
   61  profession of pharmacy” also includes any other act, service,
   62  operation, research, or transaction incidental to, or forming a
   63  part of, any of the foregoing acts, requiring, involving, or
   64  employing the science or art of any branch of the pharmaceutical
   65  profession, study, or training, and shall expressly permit a
   66  pharmacist to transmit information from persons authorized to
   67  prescribe medicinal drugs to their patients. The practice of the
   68  profession of pharmacy also includes the administration of
   69  vaccines to adults pursuant to s. 465.189, the testing for and
   70  treatment of influenza and streptococcus pursuant to s.
   71  465.1895, and the preparation of prepackaged drug products in
   72  facilities holding Class III institutional pharmacy permits.
   73         Section 3. Section 465.1895, Florida Statutes, is created
   74  to read:
   75         465.1895Testing for and treatment of influenza and
   76  streptococcus.—
   77         (1)A pharmacist may test for and treat influenza and
   78  streptococcus if all of the following criteria are met:
   79         (a)The pharmacist has entered into a written protocol with
   80  a supervising physician licensed under chapter 458 or chapter
   81  459, and such protocol complies with the requirements in
   82  subsection (5) and board rules.
   83         (b)The pharmacist uses an instrument and a waived test, as
   84  that term is defined in 42 C.F.R. s. 493.2.
   85         (c)The pharmacist uses a testing system that:
   86         1.Provides automated readings in order to reduce user
   87  subjectivity or interpretation of results.
   88         2.Is capable of directly or indirectly interfacing with
   89  electronic medical records systems.
   90         3.Is capable of electronically reporting daily
   91  deidentified test results to the appropriate agencies.
   92         4.Uses an instrument that incorporates both internal and
   93  external controls and external calibration that show the reagent
   94  and assay procedure is performing properly. External controls
   95  must be used in accordance with local, state, and federal
   96  regulations and accreditation requirements.
   97         (d)The pharmacist is certified to test for and treat
   98  influenza and streptococcus pursuant to a certification program
   99  approved by the board, in consultation with the Board of
  100  Medicine and the Board of Osteopathic Medicine, within 90 days
  101  after the date upon which this section becomes effective. The
  102  certification program must require that the pharmacist attend,
  103  on a one-time basis, 8 hours of continuing education courses
  104  approved by the board. The continuing education curriculum must
  105  be provided by an organization of instruction approved by the
  106  Accreditation Council for Pharmacy Education and must include,
  107  at a minimum, point-of-care testing for influenza and
  108  streptococcus and the safe and effective treatment of influenza
  109  and streptococcus.
  110         (2)A pharmacist may not enter into a written protocol
  111  under this section unless he or she maintains at least $200,000
  112  of professional liability insurance and is certified as required
  113  in paragraph (1)(d).
  114         (3)A pharmacist who tests for and treats influenza and
  115  streptococcus shall maintain and make available patient records
  116  using the same standards for confidentiality and maintenance of
  117  such records as those that are imposed on health care
  118  practitioners under s. 456.057. Such records shall be maintained
  119  for at least 5 years.
  120         (4)The decision by a supervising physician licensed under
  121  chapter 458 or chapter 459 to enter into a written protocol
  122  under this section is a professional decision on the part of the
  123  physician and a person may not interfere with a physician’s
  124  decision regarding entering into such a protocol. A pharmacist
  125  may not enter into a written protocol that is to be performed
  126  while acting as an employee without the written approval of the
  127  owner of the pharmacy.
  128         (5)The board shall adopt rules establishing requirements
  129  for the written protocol within 90 days after the date upon
  130  which this section becomes effective. At a minimum, the written
  131  protocol shall include:
  132         (a)The terms and conditions required in s. 465.189(7).
  133         (b)Specific categories of patients for whom the
  134  supervising physician authorizes the pharmacist to test for and
  135  treat influenza and streptococcus.
  136         (c)The supervising physician’s instructions for the
  137  treatment of influenza and streptococcus based on the patient’s
  138  age, symptoms, and test results, including negative results.
  139         (d)A process and schedule for the supervising physician to
  140  review the pharmacist’s actions under the written protocol.
  141         (e)A process and schedule for the pharmacist to notify the
  142  supervising physician of the patient’s condition, tests
  143  administered, test results, and course of treatment.
  144         (6)When the patient has a primary care provider, a
  145  pharmacist who provides testing for or treatment of influenza
  146  and streptococcus under this section shall notify the patient’s
  147  primary care provider within 2 business days after providing any
  148  such testing or treatment.
  149         Section 4. This act shall take effect upon becoming a law.