Florida Senate - 2020                              CS for SB 714
       By the Committee on Health Policy; and Senator Hutson
       588-03836-20                                           2020714c1
    1                        A bill to be entitled                      
    2         An act relating to the testing for and treatment of
    3         influenza; amending s. 381.0031, F.S.; requiring
    4         specified licensed pharmacists to report certain
    5         information to the Department of Health; amending s.
    6         465.003, F.S.; revising the definition of the term
    7         “practice of the profession of pharmacy”; creating s.
    8         465.1895, F.S.; authorizing pharmacists to test for
    9         and treat influenza and providing requirements
   10         relating thereto; requiring the written protocol
   11         between a pharmacist and a supervising physician to
   12         contain certain information, terms, and conditions;
   13         requiring the Board of Medicine, in consultation with
   14         the Board of Pharmacy and the Board of Osteopathic
   15         Medicine, to develop a specified certification program
   16         for pharmacists within a specified timeframe;
   17         requiring a pharmacist to collect a medical history
   18         before testing and treating a patient; requiring a
   19         pharmacy in which a pharmacist tests for and treats
   20         influenza to display and distribute specified
   21         information; providing limitations on the medications
   22         a pharmacist may administer to treat influenza;
   23         requiring pharmacists to review certain information
   24         for a specified purpose before testing and treating
   25         patients; requiring a pharmacist who tests for and
   26         treats influenza to maintain professional liability
   27         insurance in a specified amount; providing
   28         recordkeeping requirements for pharmacists who test
   29         for and treat influenza; providing that a person may
   30         not interfere with a physician’s professional decision
   31         to enter into a written protocol with a pharmacist;
   32         providing that a pharmacist may not enter into a
   33         written protocol under certain circumstances;
   34         requiring the Board of Medicine, in consultation with
   35         the Board of Pharmacy and the Board of Osteopathic
   36         Medicine, to adopt rules within a specified timeframe;
   37         requiring pharmacists to notify a patient’s primary
   38         care provider and follow up with the treated patient
   39         within specified timeframes; prohibiting a pharmacist
   40         from testing or treating patients under certain
   41         circumstances; specifying circumstances under which a
   42         physician may supervise a pharmacist under a written
   43         protocol; providing a contingency on implementation;
   44         providing an effective date.
   46  Be It Enacted by the Legislature of the State of Florida:
   48         Section 1. Subsection (2) of section 381.0031, Florida
   49  Statutes, is amended to read:
   50         381.0031 Epidemiological research; report of diseases of
   51  public health significance to department.—
   52         (2) Any practitioner licensed in this state to practice
   53  medicine, osteopathic medicine, chiropractic medicine,
   54  naturopathy, or veterinary medicine; any licensed pharmacist
   55  authorized pursuant to a written protocol to order and evaluate
   56  laboratory and clinical tests; any hospital licensed under part
   57  I of chapter 395; or any laboratory appropriately certified by
   58  the Centers for Medicare and Medicaid Services under the federal
   59  Clinical Laboratory Improvement Amendments, and the federal
   60  rules adopted thereunder, which diagnoses or suspects the
   61  existence of a disease of public health significance shall
   62  immediately report the fact to the Department of Health.
   63         Section 2. Subsection (13) of section 465.003, Florida
   64  Statutes, is amended to read:
   65         465.003 Definitions.—As used in this chapter, the term:
   66         (13) “Practice of the profession of pharmacy” includes
   67  compounding, dispensing, and consulting concerning contents,
   68  therapeutic values, and uses of any medicinal drug; consulting
   69  concerning therapeutic values and interactions of patent or
   70  proprietary preparations, whether pursuant to prescriptions or
   71  in the absence and entirely independent of such prescriptions or
   72  orders; and conducting other pharmaceutical services. For
   73  purposes of this subsection, “other pharmaceutical services”
   74  means the monitoring of the patient’s drug therapy and assisting
   75  the patient in the management of his or her drug therapy, and
   76  includes review of the patient’s drug therapy and communication
   77  with the patient’s prescribing health care provider as licensed
   78  under chapter 458, chapter 459, chapter 461, or chapter 466, or
   79  similar statutory provision in another jurisdiction, or such
   80  provider’s agent or such other persons as specifically
   81  authorized by the patient, regarding the drug therapy. However,
   82  nothing in this subsection may be interpreted to permit an
   83  alteration of a prescriber’s directions, the diagnosis or
   84  treatment of any disease, the initiation of any drug therapy,
   85  the practice of medicine, or the practice of osteopathic
   86  medicine, unless otherwise permitted by law. “Practice of the
   87  profession of pharmacy” also includes any other act, service,
   88  operation, research, or transaction incidental to, or forming a
   89  part of, any of the foregoing acts, requiring, involving, or
   90  employing the science or art of any branch of the pharmaceutical
   91  profession, study, or training, and shall expressly permit a
   92  pharmacist to transmit information from persons authorized to
   93  prescribe medicinal drugs to their patients. The practice of the
   94  profession of pharmacy also includes the administration of
   95  vaccines to adults pursuant to s. 465.189, the testing for and
   96  treatment of influenza pursuant to s. 465.1895, and the
   97  preparation of prepackaged drug products in facilities holding
   98  Class III institutional pharmacy permits.
   99         Section 3. Section 465.1895, Florida Statutes, is created
  100  to read:
  101         465.1895Testing for and treatment of influenza.—
  102         (1)A pharmacist may test for and treat influenza if all of
  103  the following criteria are met:
  104         (a)The pharmacist has entered into a written protocol with
  105  a supervising physician licensed under chapter 458 or chapter
  106  459, and such protocol complies with the requirements in
  107  subsection (5) and the Board of Medicine’s rules.
  108         (b)The pharmacist uses an instrument and a waived test, as
  109  that term is defined in 42 C.F.R. s. 493.2.
  110         (c)The pharmacist uses a testing system that:
  111         1.Provides automated readings in order to reduce user
  112  subjectivity or interpretation of results.
  113         2.Is capable of directly or indirectly interfacing with
  114  electronic medical records systems.
  115         3.Is capable of electronically reporting daily
  116  deidentified test results to the appropriate agencies.
  117         4.Uses an instrument that incorporates both internal and
  118  external controls and external calibration that show the reagent
  119  and assay procedure is performing properly. External controls
  120  must be used in accordance with local, state, and federal
  121  regulations and accreditation requirements.
  122         (d)The pharmacist is certified to test for and treat
  123  influenza pursuant to a certification program approved by the
  124  Board of Medicine, in consultation with the board and the Board
  125  of Osteopathic Medicine. The certification program must be
  126  developed and implemented within 90 days after the date upon
  127  which this section becomes effective and must require that the
  128  pharmacist attend, on a one-time basis, 8 hours of continuing
  129  education courses approved by the Board of Medicine. The
  130  continuing education curriculum must be provided by an
  131  organization that is approved by the Accreditation Council for
  132  Pharmacy Education to provide instructional services and must
  133  include, at a minimum, point-of-care testing for influenza and
  134  the safe and effective treatment of influenza.
  135         (e) The pharmacist collects from the patient a full history
  136  of the patient’s past and present medical conditions on a form
  137  adopted by the Board of Medicine by rule which allows the
  138  patient to check off medical conditions from a list and add
  139  other conditions that are not listed. The history must be
  140  maintained as part of the patient’s records in accordance with
  141  subsection (3).
  142         (f) The pharmacy in which a pharmacist tests for and treats
  143  influenza prominently displays signage indicating that any
  144  patient tested and treated at the pharmacy is advised to seek
  145  followup care from his or her primary care physician or, if the
  146  patient has no primary care physician, from the pharmacist’s
  147  supervising physician.
  148         (g) The pharmacist who tests for or treats influenza
  149  provides the patient with the name and contact information for
  150  the pharmacist’s supervising physician and a pamphlet or
  151  brochure that meets criteria established by the Board of
  152  Medicine by rule informing the patient that:
  153         1. If the test indicates that the patient has influenza,
  154  the patient is advised to seek followup care from the patient’s
  155  primary care physician or, if the patient has no primary care
  156  physician, from the pharmacist’s supervising physician; and
  157         2. If the pharmacist treats the patient for influenza, the
  158  pharmacist and the pharmacy where the testing and treating
  159  occurred are liable for damages the patient suffers as a result
  160  of an adverse reaction to the treatment.
  161         (h) The pharmacist’s treatment is limited to medications
  162  designed to treat influenza which are approved by the Board of
  163  Medicine and which the Board of Medicine shall review annually.
  164         (i) The pharmacist, prior to treating the patient, reviews
  165  the patient’s current prescriptions and recent prescription
  166  history to check for relative contraindications involving the
  167  pharmacist’s intended treatment.
  168         (2)A pharmacist may not enter into a written protocol
  169  under this section unless he or she maintains at least $250,000
  170  of professional liability insurance and is certified as required
  171  in paragraph (1)(d).
  172         (3)A pharmacist who tests for and treats influenza shall
  173  maintain and make available patient records using the same
  174  standards for confidentiality and maintenance of such records as
  175  those that are imposed on health care practitioners under s.
  176  456.057. Each patient’s records maintained under this subsection
  177  must include confirmation that the requirements of paragraphs
  178  (1)(e) and (1)(g) were fulfilled. Such records shall be
  179  maintained for at least 5 years.
  180         (4)The decision by a supervising physician licensed under
  181  chapter 458 or chapter 459 to enter into a written protocol
  182  under this section is a professional decision on the part of the
  183  physician and a person may not interfere with a physician’s
  184  decision regarding entering into such a protocol. A pharmacist
  185  may not enter into a written protocol that is to be performed
  186  while acting as an employee without the written approval of the
  187  owner of the pharmacy.
  188         (5)The Board of Medicine, in consultation with the board
  189  and the Board of Osteopathic Medicine, shall adopt rules
  190  establishing requirements for the written protocol within 90
  191  days after the date upon which this section becomes effective.
  192  At a minimum, the written protocol shall include:
  193         (a)The terms and conditions required in s. 465.189(7).
  194         (b)Specific categories of patients for whom the
  195  supervising physician authorizes the pharmacist to test for and
  196  treat influenza.
  197         (c)The supervising physician’s instructions for the
  198  treatment of influenza based on the patient’s age, symptoms, and
  199  test results, including negative results.
  200         (d)A process and schedule for the supervising physician to
  201  review the pharmacist’s actions under the written protocol.
  202         (e)A process and schedule for the pharmacist to notify the
  203  supervising physician of the patient’s condition, tests
  204  administered, test results, and course of treatment.
  205         (6)When the patient has a primary care provider, a
  206  pharmacist who provides testing for or treatment of influenza
  207  under this section shall notify the patient’s primary care
  208  provider within 2 business days after providing any such testing
  209  or treatment.
  210         (7) If a pharmacist tests for and treats influenza for a
  211  patient under this section, the pharmacist or his or her
  212  designee must follow up with the patient 3 days later to
  213  determine whether the patient’s condition has improved, and if
  214  the patient informs the pharmacist that his or her condition has
  215  not improved, the pharmacist shall do all of the following:
  216         (a) Recommend that the patient seek treatment from the
  217  patient’s primary care physician or, if the patient has no
  218  primary care physician, from the pharmacist’s supervising
  219  physician.
  220         (b) Inform the patient’s primary care physician that the
  221  patient’s condition failed to improve 3 days after treatment or,
  222  if the patient has no primary care physician, the pharmacist
  223  shall so inform the pharmacist’s supervising physician.
  224         (c)Document in the patient’s record maintained under
  225  subsection (3) whether the followup required under this
  226  subsection occurred or whether attempts to contact the patient
  227  were unsuccessful.
  228         (8) A pharmacist may not test for or treat influenza under
  229  this section for a patient who:
  230         (a)Is younger than 18 years of age;
  231         (b) Is older than 75 years of age;
  232         (c) Refuses to provide a medical history under paragraph
  233  (1)(e); or
  234         (d)Provides a medical history under paragraph (1)(e)
  235  indicating a history of conditions relating to heart disease,
  236  bronchial disorders, pneumonia, chronic obstructive pulmonary
  237  disease, asthma, or any other medical conditions as determined
  238  by the Board of Medicine by rule on an annual basis.
  239         (9) A supervising physician who enters into a written
  240  protocol with a pharmacist under this section must be a primary
  241  care physician who is actively practicing in the community in
  242  which the pharmacist tests and treats under this section
  243  according to Board of Medicine rule. A supervising physician may
  244  not enter into such a protocol with pharmacists employed at more
  245  than four pharmacy locations.
  246         (10) Implementation of this section is contingent upon the
  247  enactment of an appropriation within the General Appropriations
  248  Act which is sufficient to fund the Board of Medicine’s efforts
  249  to carry out its duties as required under this section.
  250         Section 4. This act shall take effect upon becoming a law.