Florida Senate - 2020                        COMMITTEE AMENDMENT
       Bill No. CS for SB 1094
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

       The Committee on Appropriations (Diaz) recommended the
    1         Senate Amendment (with title amendment)
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Subsection (2) of section 381.0031, Florida
    6  Statutes, is amended to read:
    7         381.0031 Epidemiological research; report of diseases of
    8  public health significance to department.—
    9         (2) Any practitioner licensed in this state to practice
   10  medicine, osteopathic medicine, chiropractic medicine,
   11  naturopathy, or veterinary medicine; any licensed pharmacist
   12  authorized under a collaborative pharmacy practice agreement, as
   13  defined in s. 465.1865, to perform or order and evaluate
   14  laboratory and clinical tests; any hospital licensed under part
   15  I of chapter 395; or any laboratory appropriately certified by
   16  the Centers for Medicare and Medicaid Services under the federal
   17  Clinical Laboratory Improvement Amendments and the federal rules
   18  adopted thereunder which diagnoses or suspects the existence of
   19  a disease of public health significance shall immediately report
   20  the fact to the Department of Health.
   21         Section 2. Subsection (13) of section 465.003, Florida
   22  Statutes, is amended to read:
   23         465.003 Definitions.—As used in this chapter, the term:
   24         (13) “Practice of the profession of pharmacy” includes
   25  compounding, dispensing, and consulting concerning contents,
   26  therapeutic values, and uses of any medicinal drug; consulting
   27  concerning therapeutic values and interactions of patent or
   28  proprietary preparations, whether pursuant to prescriptions or
   29  in the absence and entirely independent of such prescriptions or
   30  orders; and conducting other pharmaceutical services. For
   31  purposes of this subsection, the term “other pharmaceutical
   32  services” means the monitoring of the patient’s drug therapy and
   33  assisting the patient in the management of his or her drug
   34  therapy; reviewing and making recommendations regarding, and
   35  includes review of the patient’s drug therapy and health care
   36  status in communication with the patient’s prescribing health
   37  care provider as licensed under chapter 458, chapter 459,
   38  chapter 461, or chapter 466, or a similar statutory provision in
   39  another jurisdiction, or such provider’s agent or such other
   40  persons as specifically authorized by the patient; and
   41  initiating, modifying, or discontinuing drug therapy for a
   42  chronic health condition under a collaborative pharmacy practice
   43  agreement, regarding the drug therapy. However, Nothing in this
   44  subsection may be interpreted to permit an alteration of a
   45  prescriber’s directions, the diagnosis or treatment of any
   46  disease, the initiation of any drug therapy, the practice of
   47  medicine, or the practice of osteopathic medicine, unless
   48  otherwise permitted by law or specifically authorized by s.
   49  465.1865. The term “Practice of the profession of pharmacy” also
   50  includes any other act, service, operation, research, or
   51  transaction incidental to, or forming a part of, any of the
   52  foregoing acts, requiring, involving, or employing the science
   53  or art of any branch of the pharmaceutical profession, study, or
   54  training, and shall expressly permit a pharmacist to transmit
   55  information from persons authorized to prescribe medicinal drugs
   56  to their patients. The practice of the profession of pharmacy
   57  also includes the administration of vaccines to adults pursuant
   58  to s. 465.189 and the preparation of prepackaged drug products
   59  in facilities holding Class III institutional pharmacy permits.
   60  The term also includes ordering and evaluating any laboratory or
   61  clinical testing; conducting patient assessments; and modifying,
   62  discontinuing, or administering medicinal drugs pursuant to s.
   63  465.0125 by a consultant pharmacist.
   64         Section 3. Section 465.0125, Florida Statutes, is amended
   65  to read:
   66         465.0125 Consultant pharmacist license; application,
   67  renewal, fees; responsibilities; rules.—
   68         (1) The department shall issue or renew a consultant
   69  pharmacist license upon receipt of an initial or renewal
   70  application that which conforms to the requirements for
   71  consultant pharmacist initial licensure or renewal as adopted
   72  promulgated by the board by rule and a fee set by the board not
   73  to exceed $250. To be licensed as a consultant pharmacist, a
   74  pharmacist must complete additional training as required by the
   75  board.
   76         (a)A consultant pharmacist may provide medication
   77  management services in a health care facility within the
   78  framework of a written collaborative practice agreement between
   79  the pharmacist and a health care facility medical director or a
   80  physician licensed under chapter 458 or chapter 459, a podiatric
   81  physician licensed under chapter 461, or a dentist licensed
   82  under chapter 466 who is authorized to prescribe medicinal
   83  drugs. A consultant pharmacist may provide medication management
   84  services, conduct patient assessments, and order and evaluate
   85  laboratory or clinical testing only for patients of the health
   86  care practitioner with whom the consultant pharmacist has a
   87  written collaborative practice agreement.
   88         (b)A written collaborative practice agreement must outline
   89  the circumstances under which the consultant pharmacist may:
   90         1.Order and evaluate any laboratory or clinical tests to
   91  promote and evaluate patient health and wellness, and monitor
   92  drug therapy and treatment outcomes.
   93         2.Conduct patient assessments as appropriate to evaluate
   94  and monitor drug therapy.
   95         3.Modify or discontinue medicinal drugs as outlined in the
   96  agreed-upon patient-specific order or preapproved treatment
   97  protocol under the direction of a physician. However, a
   98  consultant pharmacist may not modify or discontinue medicinal
   99  drugs prescribed by a health care practitioner who does not have
  100  a written collaborative practice agreement with the consultant
  101  pharmacist.
  102         4.Administer medicinal drugs.
  103         (c)A The consultant pharmacist shall maintain be
  104  responsible for maintaining all drug, patient care, and quality
  105  assurance records as required by law and, with the collaborating
  106  practitioner, maintain written collaborative practice agreements
  107  that must be available upon request from or upon inspection by
  108  the department.
  109         (d)This subsection does not authorize a consultant
  110  pharmacist to diagnose any disease or condition.
  111         (e)For purposes of this subsection, the term “health care
  112  facility” means an ambulatory surgical center or hospital
  113  licensed under chapter 395, an alcohol or chemical dependency
  114  treatment center licensed under chapter 397, an inpatient
  115  hospice licensed under part IV of chapter 400, a nursing home
  116  licensed under part II of chapter 400, an ambulatory care center
  117  as defined in s. 408.07, or a nursing home component licensed
  118  under chapter 400 within a continuing care facility licensed
  119  under chapter 651 for establishing drug handling procedures for
  120  the safe handling and storage of drugs. The consultant
  121  pharmacist may also be responsible for ordering and evaluating
  122  any laboratory or clinical testing when, in the judgment of the
  123  consultant pharmacist, such activity is necessary for the proper
  124  performance of the consultant pharmacist’s responsibilities.
  125  Such laboratory or clinical testing may be ordered only with
  126  regard to patients residing in a nursing home facility, and then
  127  only when authorized by the medical director of the nursing home
  128  facility. The consultant pharmacist must have completed such
  129  additional training and demonstrate such additional
  130  qualifications in the practice of institutional pharmacy as
  131  shall be required by the board in addition to licensure as a
  132  registered pharmacist.
  133         (2) Notwithstanding the provisions of subsection (1), a
  134  consultant pharmacist or a doctor of pharmacy licensed in this
  135  state may also be responsible for ordering and evaluating any
  136  laboratory or clinical testing for persons under the care of a
  137  licensed home health agency when, in the judgment of the
  138  consultant pharmacist or doctor of pharmacy, such activity is
  139  necessary for the proper performance of his or her
  140  responsibilities and only when authorized by a practitioner
  141  licensed under chapter 458, chapter 459, chapter 461, or chapter
  142  466. In order for the consultant pharmacist or doctor of
  143  pharmacy to qualify and accept this authority, he or she must
  144  receive 3 hours of continuing education relating to laboratory
  145  and clinical testing as established by the board.
  146         (3) The board shall adopt promulgate rules necessary to
  147  implement and administer this section.
  148         Section 4. Section 465.1865, Florida Statutes, is created
  149  to read:
  150         465.1865Collaborative pharmacy practice for chronic health
  151  conditions.—
  152         (1)For purposes of this section, the term:
  153         (a)“Collaborative pharmacy practice agreement” means a
  154  written agreement between a pharmacist who meets the
  155  qualifications of this section and a physician licensed under
  156  chapter 458 or chapter 459 in which a collaborating physician
  157  authorizes a pharmacist to provide specified patient care
  158  services to the collaborating physician′s patients.
  159         (b)“Chronic health condition” means:
  160         1.Arthritis;
  161         2. Asthma;
  162         3.Chronic obstructive pulmonary diseases;
  163         4.Type 2 diabetes;
  164         5.Human immunodeficiency virus or acquired immune
  165  deficiency syndrome; or
  166         6.Obesity.
  167         (2)To provide services under a collaborative pharmacy
  168  practice agreement, a pharmacist must be certified according to
  169  rules of the Board of Medicine that he or she:
  170         (a)Holds an active and unencumbered license to practice
  171  pharmacy in the state.
  172         (b)Has earned a degree of doctor of pharmacy or has
  173  completed 5 years of experience as a licensed pharmacist.
  174         (c)Has completed an initial 20-hour course approved by the
  175  Board of Medicine in consultation with the Board of Osteopathic
  176  Medicine and the Board of Pharmacy which includes, at a minimum,
  177  instruction on all of the following:
  178         1.Performance of patient assessments.
  179         2.Ordering, performing, and interpreting clinical and
  180  laboratory tests related to collaborative pharmacy practice.
  181         3.Evaluating and managing diseases and health conditions
  182  in collaboration with other health care practitioners.
  183         4.Any other area required by Board of Medicine rule,
  184  adopted in consultation with the Board of Osteopathic Medicine
  185  and the Board of Pharmacy.
  186         (d)Maintains at least $250,000 of professional liability
  187  insurance coverage. However, a pharmacist who maintains
  188  professional liability insurance coverage of at least $250,000
  189  under a written protocol with a supervising physician for the
  190  testing for and treatment of minor nonchronic health conditions
  191  satisfies this requirement.
  192         (e)Has established a system to maintain records of all
  193  patients receiving services under a collaborative pharmacy
  194  practice agreement for a period of 5 years.
  195         (3)The terms and conditions of the collaborative pharmacy
  196  practice agreement must be appropriate to the pharmacist′s
  197  education and training and the services delegated to the
  198  pharmacist must be within the collaborating physician′s scope of
  199  practice. A copy of the certification issued under subsection
  200  (2) must be included as an attachment to the collaborative
  201  pharmacy practice agreement.
  202         (a)A collaborative pharmacy practice agreement must
  203  include the following:
  204         1.Name of the collaborating physician′s patient or
  205  patients for whom a pharmacist may provide services.
  206         2.Each chronic health condition to be collaboratively
  207  managed.
  208         3.Specific medicinal drug or drugs to be managed by the
  209  pharmacist.
  210         4.Circumstances under which the pharmacist may order or
  211  perform and evaluate laboratory or clinical tests.
  212         5.Conditions and events upon which the pharmacist must
  213  notify the collaborating physician and the manner and timeframe
  214  in which such notification must occur.
  215         6.Beginning and ending dates for the collaborative
  216  pharmacy practice agreement and termination procedures,
  217  including procedures for patient notification and medical
  218  records transfers.
  219         7.A statement that the collaborative pharmacy practice
  220  agreement may be terminated, in writing, by either party at any
  221  time.
  222         (b)A collaborative pharmacy practice agreement must be
  223  renewed at least every 2 years.
  224         (c)The pharmacist, along with the collaborating physician,
  225  must maintain on file the collaborative pharmacy practice
  226  agreement at his or her practice location and must make such
  227  agreements available upon request or inspection.
  228         (d) A pharmacist who enters into a collaborative pharmacy
  229  practice agreement must submit a copy of the signed agreement to
  230  the Board of Pharmacy before the agreement may be implemented.
  231         (4)A pharmacist may not:
  232         (a)Modify or discontinue medicinal drugs prescribed by a
  233  health care practitioner with whom he or she does not have a
  234  collaborative pharmacy practice agreement.
  235         (b)Enter into a collaborative pharmacy practice agreement
  236  while acting as an employee without the written approval of the
  237  owner of the pharmacy.
  238         (5)A physician may not delegate to a pharmacist the
  239  authority to initiate or prescribe a controlled substance as
  240  described in s. 893.03 or 21 U.S.C. s. 812.
  241         (6)In addition to the continuing education requirements
  242  under s. 465.009, a pharmacist who practices under a
  243  collaborative pharmacy practice agreement must, for each
  244  biennial licensure renewal, complete an 8-hour continuing
  245  education course approved by the Board of Medicine in
  246  consultation with the Board of Osteopathic Medicine and the
  247  Board of Pharmacy which addresses issues related to the chronic
  248  conditions to be collaboratively managed. Such pharmacist must
  249  submit confirmation of having completed such course when
  250  applying for licensure renewal. A pharmacist who fails to comply
  251  with this subsection shall be prohibited from practicing under a
  252  collaborative pharmacy practice agreement under this section.
  253         (7)The Board of Medicine in consultation with the Board of
  254  Osteopathic Medicine and the Board of Pharmacy shall adopt rules
  255  pursuant to ss. 120.536(1) and 120.54 to implement this section.
  256         Section 5. This act shall take effect July 1, 2020.
  258  ================= T I T L E  A M E N D M E N T ================
  259  And the title is amended as follows:
  260         Delete everything before the enacting clause
  261  and insert:
  262                        A bill to be entitled                      
  263         An act relating to the practice of pharmacy; amending
  264         s. 381.0031, F.S.; requiring specified licensed
  265         pharmacists to report certain information relating to
  266         public health to the Department of Health; amending s.
  267         465.003, F.S.; revising the definition of the term
  268         “practice of the profession of pharmacy”; amending s.
  269         465.0125, F.S.; requiring a pharmacist to complete
  270         additional training to be licensed as a consultant
  271         pharmacist; authorizing a consultant pharmacist to
  272         perform specified services under certain conditions;
  273         prohibiting a consultant pharmacist from modifying or
  274         discontinuing medicinal drugs prescribed by a health
  275         care practitioner under certain conditions; revising
  276         the responsibilities of a consultant pharmacist;
  277         requiring a consultant pharmacist and a collaborating
  278         practitioner to maintain collaborative practice
  279         agreements; requiring collaborative practice
  280         agreements to be made available upon request from or
  281         upon inspection by the Department of Health;
  282         prohibiting a consultant pharmacist from diagnosing
  283         any disease or condition; defining the term “health
  284         care facility”; creating s. 465.1865, F.S.; defining
  285         terms; providing requirements for pharmacists to
  286         provide services under a collaborative pharmacy
  287         practice agreement; requiring the terms and conditions
  288         of such agreement to be appropriate to the training of
  289         the pharmacist and the scope of practice of the
  290         physician; requiring notification to the Board of
  291         Pharmacy upon practicing under a collaborative
  292         pharmacy practice agreement; requiring pharmacists to
  293         submit a copy of the signed collaborative pharmacy
  294         practice agreement to the Board of Pharmacy; providing
  295         for the maintenance of patient records for a certain
  296         timeframe; providing for renewal of such agreement;
  297         requiring a pharmacist and the collaborating physician
  298         to maintain on file and make available the
  299         collaborative pharmacy practice agreement; prohibiting
  300         certain actions relating to such agreement; requiring
  301         specified continuing education for a pharmacist who
  302         practices under a collaborative pharmacy practice
  303         agreement; requiring the Board of Medicine in
  304         consultation with the Board of Osteopathic Medicine
  305         and the Board of Pharmacy to adopt rules; providing an
  306         effective date.