Florida Senate - 2020                        COMMITTEE AMENDMENT
       Bill No. SB 714
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

       The Committee on Health Policy (Hutson) recommended the
    1         Senate Amendment (with title amendment)
    3         Delete lines 70 - 148
    4  and insert:
    5  treatment of influenza pursuant to s. 465.1895, and the
    6  preparation of prepackaged drug products in facilities holding
    7  Class III institutional pharmacy permits.
    8         Section 3. Section 465.1895, Florida Statutes, is created
    9  to read:
   10         465.1895Testing for and treatment of influenza.—
   11         (1)A pharmacist may test for and treat influenza if all of
   12  the following criteria are met:
   13         (a)The pharmacist has entered into a written protocol with
   14  a supervising physician licensed under chapter 458 or chapter
   15  459, and such protocol complies with the requirements in
   16  subsection (5) and the Board of Medicine’s rules.
   17         (b)The pharmacist uses an instrument and a waived test, as
   18  that term is defined in 42 C.F.R. s. 493.2.
   19         (c)The pharmacist uses a testing system that:
   20         1.Provides automated readings in order to reduce user
   21  subjectivity or interpretation of results.
   22         2.Is capable of directly or indirectly interfacing with
   23  electronic medical records systems.
   24         3.Is capable of electronically reporting daily
   25  deidentified test results to the appropriate agencies.
   26         4.Uses an instrument that incorporates both internal and
   27  external controls and external calibration that show the reagent
   28  and assay procedure is performing properly. External controls
   29  must be used in accordance with local, state, and federal
   30  regulations and accreditation requirements.
   31         (d)The pharmacist is certified to test for and treat
   32  influenza pursuant to a certification program approved by the
   33  Board of Medicine, in consultation with the board and the Board
   34  of Osteopathic Medicine. The certification program must be
   35  developed and implemented within 90 days after the date upon
   36  which this section becomes effective and must require that the
   37  pharmacist attend, on a one-time basis, 8 hours of continuing
   38  education courses approved by the Board of Medicine. The
   39  continuing education curriculum must be provided by an
   40  organization of instruction approved by the Accreditation
   41  Council for Pharmacy Education and must include, at a minimum,
   42  point-of-care testing for influenza and the safe and effective
   43  treatment of influenza.
   44         (e) The pharmacist collects from the patient a full history
   45  of the patient’s past and present medical conditions on a form
   46  adopted by the Board of Medicine in rule which allows the
   47  patient to check off medical conditions from a list and add
   48  other conditions that are not listed. The history must be
   49  maintained as part of the patient’s records in accordance with
   50  subsection (3).
   51         (f) The pharmacy in which a pharmacist tests for and treats
   52  influenza prominently displays signage indicating that any
   53  patient tested and treated at the pharmacy is advised to seek
   54  followup care from his or her primary care physician or, if the
   55  patient has no primary care physician, from the pharmacist’s
   56  supervising physician.
   57         (g) The pharmacist who tests for or treats influenza
   58  provides the patient with the name and contact information for
   59  the pharmacist’s supervising physician and a pamphlet or
   60  brochure that meets criteria established by the Board of
   61  Medicine in rule informing the patient that:
   62         1. If the test indicates that the patient has influenza,
   63  the patient is advised to seek followup care from the patient’s
   64  primary care physician or, if the patient has no primary care
   65  physician, from the pharmacist’s supervising physician; and
   66         2. If the pharmacist treats the patient for influenza, the
   67  pharmacist and the pharmacy where the testing and treating
   68  occurred are liable for damages the patient suffers as a result
   69  of an adverse reaction to the treatment.
   70         (h) The pharmacist’s treatment is limited to medications
   71  designed to treat influenza which are approved by the Board of
   72  Medicine and which the Board of Medicine shall review annually.
   73         (i) The pharmacist, prior to treating the patient, reviews
   74  the patient’s current prescriptions and recent prescription
   75  history to check for relative contraindications involving the
   76  pharmacist’s intended treatment.
   77         (2)A pharmacist may not enter into a written protocol
   78  under this section unless he or she maintains at least $250,000
   79  of professional liability insurance and is certified as required
   80  in paragraph (1)(d).
   81         (3)A pharmacist who tests for and treats influenza shall
   82  maintain and make available patient records using the same
   83  standards for confidentiality and maintenance of such records as
   84  those that are imposed on health care practitioners under s.
   85  456.057. Each patient’s records maintained under this subsection
   86  must include confirmation that the requirements of paragraphs
   87  (1)(e) and (1)(g) were fulfilled. Such records shall be
   88  maintained for at least 5 years.
   89         (4)The decision by a supervising physician licensed under
   90  chapter 458 or chapter 459 to enter into a written protocol
   91  under this section is a professional decision on the part of the
   92  physician and a person may not interfere with a physician’s
   93  decision regarding entering into such a protocol. A pharmacist
   94  may not enter into a written protocol that is to be performed
   95  while acting as an employee without the written approval of the
   96  owner of the pharmacy.
   97         (5)The Board of Medicine, in consultation with the board
   98  and the Board of Osteopathic Medicine, shall adopt rules
   99  establishing requirements for the written protocol within 90
  100  days after the date upon which this section becomes effective.
  101  At a minimum, the written protocol shall include:
  102         (a)The terms and conditions required in s. 465.189(7).
  103         (b)Specific categories of patients for whom the
  104  supervising physician authorizes the pharmacist to test for and
  105  treat influenza.
  106         (c)The supervising physician’s instructions for the
  107  treatment of influenza based on the patient’s age, symptoms, and
  108  test results, including negative results.
  109         (d)A process and schedule for the supervising physician to
  110  review the pharmacist’s actions under the written protocol.
  111         (e)A process and schedule for the pharmacist to notify the
  112  supervising physician of the patient’s condition, tests
  113  administered, test results, and course of treatment.
  114         (6)When the patient has a primary care provider, a
  115  pharmacist who provides testing for or treatment of influenza
  116  under this section shall notify the patient’s primary care
  117  provider within 2 business days after providing any such testing
  118  or treatment.
  119         (7) If a pharmacist tests for and treats influenza for a
  120  patient under this section, the pharmacist or his or her
  121  designee must follow up with the patient 3 days later to
  122  determine whether the patient’s condition has improved, and if
  123  the patient informs the pharmacist that his or her condition has
  124  not improved, the pharmacist shall do all of the following:
  125         (a) Recommend that the patient seek treatment from the
  126  patient’s primary care physician or, if the patient has no
  127  primary care physician, from the pharmacist’s supervising
  128  physician.
  129         (b) Inform the patient’s primary care physician that the
  130  patient’s condition failed to improve 3 days after treatment or,
  131  if the patient has no primary care physician, the pharmacist
  132  shall so inform the pharmacist’s supervising physician.
  133         (c)Document in the patient’s record maintained under
  134  subsection (3) whether the followup required under this
  135  subsection occurred or whether attempts to contact the patient
  136  were unsuccessful.
  137         (8) A pharmacist may not test for or treat influenza under
  138  this section for a patient who:
  139         (a)Is younger than 18 years of age;
  140         (b) Is older than 75 years of age;
  141         (c) Refuses to provide a medical history under paragraph
  142  (1)(e); or
  143         (d)Provides a medical history under paragraph (1)(e)
  144  indicating a history of conditions relating to heart disease,
  145  bronchial disorders, pneumonia, chronic obstructive pulmonary
  146  disease, asthma, or any other medical conditions as determined
  147  by the Board of Medicine in rule on an annual basis.
  148         (9) A supervising physician who enters into a written
  149  protocol with a pharmacist under this section must be a primary
  150  care physician who is actively practicing in the community in
  151  which the pharmacist tests and treats under this section
  152  according to Board of Medicine rule. A supervising physician may
  153  not enter into such a protocol with pharmacists employed at more
  154  than four pharmacy locations.
  155         (10) Implementation of this section is contingent upon the
  156  enactment of an appropriation within the General Appropriations
  157  Act which is sufficient to fund the Board of Medicine’s efforts
  158  to carry out its duties as required under this section.
  160  ================= T I T L E  A M E N D M E N T ================
  161  And the title is amended as follows:
  162         Delete lines 3 - 18
  163  and insert:
  164         of influenza; amending s. 381.0031, F.S.; requiring
  165         specified licensed pharmacists to report certain
  166         information to the Department of Health; amending s.
  167         465.003, F.S.; revising the definition of the term
  168         “practice of the profession of pharmacy”; creating s.
  169         465.1895, F.S.; authorizing pharmacists to test for
  170         and treat influenza and providing requirements
  171         relating thereto; requiring the written protocol
  172         between a pharmacist and a supervising physician to
  173         contain certain information, terms, and conditions;
  174         requiring the Board of Medicine, in consultation with
  175         the Board of Pharmacy and the Board of Osteopathic
  176         Medicine, to develop a specified certification program
  177         for pharmacists within a specified timeframe;
  178         requiring a pharmacist to collect a medical history
  179         before testing and treating a patient; requiring a
  180         pharmacy in which a pharmacist tests for and treats
  181         influenza to display and distribute specified
  182         information; providing limitations on the medications
  183         a pharmacist may administer to treat influenza;
  184         requiring pharmacists to review certain information
  185         for a specified purpose before testing and treating
  186         patients; requiring a pharmacist who tests for and
  187         treats influenza to maintain professional liability
  188         insurance in a specified amount; providing
  189         recordkeeping requirements for pharmacists who test
  190         for and treat influenza; providing that a person may
  191         not interfere with a physician’s professional decision
  192         to enter into a written protocol with a pharmacist;
  193         providing that a pharmacist may not enter into a
  194         written protocol under certain circumstances;
  195         requiring the Board of Medicine, in consultation with
  196         the Board of Pharmacy and the Board of Osteopathic
  197         Medicine, to adopt rules within a specified timeframe;
  198         requiring pharmacists to notify a patient’s primary
  199         care provider and follow up with the treated patient
  200         within specified timeframes; prohibiting a pharmacist
  201         from testing or treating patients under certain
  202         circumstances; specifying circumstances under which a
  203         physician may supervise a pharmacist under a written
  204         protocol; providing a contingency on implementation;
  205         providing an effective date.