Florida Senate - 2020                      CS for CS for SB 1094
       By the Committees on Appropriations; and Health Policy; and
       Senator Diaz
       576-04564-20                                          20201094c2
    1                        A bill to be entitled                      
    2         An act relating to the practice of pharmacy; amending
    3         s. 381.0031, F.S.; requiring certain licensed
    4         pharmacists to report specified information relating
    5         to public health to the Department of Health; amending
    6         s. 465.003, F.S.; revising the definition of the term
    7         “practice of the profession of pharmacy”; amending s.
    8         465.0125, F.S.; requiring a pharmacist to complete
    9         additional training to be licensed as a consultant
   10         pharmacist; authorizing a consultant pharmacist to
   11         perform specified services under certain circumstances
   12         and within the scope of a written collaborative
   13         practice agreement with certain health care
   14         practitioners; providing requirements for the
   15         agreement; prohibiting a consultant pharmacist from
   16         modifying or discontinuing medicinal drugs prescribed
   17         by a health care practitioner without a written
   18         collaborative practice agreement; revising the
   19         responsibilities of a consultant pharmacist; requiring
   20         written collaborative practice agreements to be made
   21         available upon request from or upon inspection by the
   22         Department of Health; prohibiting a consultant
   23         pharmacist from diagnosing any disease or condition;
   24         defining the term “health care facility”; creating s.
   25         465.1865, F.S.; defining the terms “collaborative
   26         pharmacy practice agreement” and “chronic health
   27         condition”; specifying criteria a pharmacist must meet
   28         to provide services under a collaborative pharmacy
   29         practice agreement; providing requirements for
   30         collaborative pharmacy practice agreements; providing
   31         for the renewal of such agreements; requiring
   32         collaborating pharmacists and physicians to maintain a
   33         copy of the collaborative pharmacy practice agreements
   34         at their practices and make such agreements available
   35         upon request or inspection; requiring pharmacists to
   36         submit a copy of the signed collaborative pharmacy
   37         practice agreement to the Board of Pharmacy before
   38         implementing it; prohibiting pharmacists from engaging
   39         in specified activities without a collaborative
   40         pharmacy practice agreement; prohibiting pharmacists
   41         from entering into collaborative pharmacy practice
   42         agreements under certain circumstances; prohibiting
   43         collaborating physicians from delegating to
   44         pharmacists the authority to initiate or prescribe a
   45         controlled substance; providing continuing education
   46         requirements for pharmacists practicing under
   47         collaborative pharmacy practice agreements; requiring
   48         the Board of Medicine in consultation with the Board
   49         of Osteopathic Medicine and the Board of Pharmacy to
   50         adopt rules; providing an effective date.
   52  Be It Enacted by the Legislature of the State of Florida:
   54         Section 1. Subsection (2) of section 381.0031, Florida
   55  Statutes, is amended to read:
   56         381.0031 Epidemiological research; report of diseases of
   57  public health significance to department.—
   58         (2) Any practitioner licensed in this state to practice
   59  medicine, osteopathic medicine, chiropractic medicine,
   60  naturopathy, or veterinary medicine; any licensed pharmacist
   61  authorized under a collaborative pharmacy practice agreement, as
   62  defined in s. 465.1865, to perform or order and evaluate
   63  laboratory and clinical tests; any hospital licensed under part
   64  I of chapter 395; or any laboratory appropriately certified by
   65  the Centers for Medicare and Medicaid Services under the federal
   66  Clinical Laboratory Improvement Amendments and the federal rules
   67  adopted thereunder which diagnoses or suspects the existence of
   68  a disease of public health significance shall immediately report
   69  the fact to the Department of Health.
   70         Section 2. Subsection (13) of section 465.003, Florida
   71  Statutes, is amended to read:
   72         465.003 Definitions.—As used in this chapter, the term:
   73         (13) “Practice of the profession of pharmacy” includes
   74  compounding, dispensing, and consulting concerning contents,
   75  therapeutic values, and uses of any medicinal drug; consulting
   76  concerning therapeutic values and interactions of patent or
   77  proprietary preparations, whether pursuant to prescriptions or
   78  in the absence and entirely independent of such prescriptions or
   79  orders; and conducting other pharmaceutical services. For
   80  purposes of this subsection, the term “other pharmaceutical
   81  services” means the monitoring of the patient’s drug therapy and
   82  assisting the patient in the management of his or her drug
   83  therapy; reviewing and making recommendations regarding, and
   84  includes review of the patient’s drug therapy and health care
   85  status in communication with the patient’s prescribing health
   86  care provider as licensed under chapter 458, chapter 459,
   87  chapter 461, or chapter 466, or a similar statutory provision in
   88  another jurisdiction, or such provider’s agent or such other
   89  persons as specifically authorized by the patient; and
   90  initiating, modifying, or discontinuing drug therapy for a
   91  chronic health condition under a collaborative pharmacy practice
   92  agreement, regarding the drug therapy. However, Nothing in this
   93  subsection may be interpreted to permit an alteration of a
   94  prescriber’s directions, the diagnosis or treatment of any
   95  disease, the initiation of any drug therapy, the practice of
   96  medicine, or the practice of osteopathic medicine, unless
   97  otherwise permitted by law or specifically authorized by s.
   98  465.1865. The term “Practice of the profession of pharmacy” also
   99  includes any other act, service, operation, research, or
  100  transaction incidental to, or forming a part of, any of the
  101  foregoing acts, requiring, involving, or employing the science
  102  or art of any branch of the pharmaceutical profession, study, or
  103  training, and shall expressly permit a pharmacist to transmit
  104  information from persons authorized to prescribe medicinal drugs
  105  to their patients. The practice of the profession of pharmacy
  106  also includes the administration of vaccines to adults pursuant
  107  to s. 465.189 and the preparation of prepackaged drug products
  108  in facilities holding Class III institutional pharmacy permits.
  109  The term also includes ordering and evaluating any laboratory or
  110  clinical testing; conducting patient assessments; and modifying,
  111  discontinuing, or administering medicinal drugs pursuant to s.
  112  465.0125 by a consultant pharmacist.
  113         Section 3. Section 465.0125, Florida Statutes, is amended
  114  to read:
  115         465.0125 Consultant pharmacist license; application,
  116  renewal, fees; responsibilities; rules.—
  117         (1) The department shall issue or renew a consultant
  118  pharmacist license upon receipt of an initial or renewal
  119  application that which conforms to the requirements for
  120  consultant pharmacist initial licensure or renewal as adopted
  121  promulgated by the board by rule and a fee set by the board not
  122  to exceed $250. To be licensed as a consultant pharmacist, a
  123  pharmacist must complete additional training as required by the
  124  board.
  125         (a)A consultant pharmacist may provide medication
  126  management services in a health care facility within the
  127  framework of a written collaborative practice agreement between
  128  the pharmacist and a health care facility medical director or a
  129  physician licensed under chapter 458 or chapter 459, a podiatric
  130  physician licensed under chapter 461, or a dentist licensed
  131  under chapter 466 who is authorized to prescribe medicinal
  132  drugs. A consultant pharmacist may provide medication management
  133  services, conduct patient assessments, and order and evaluate
  134  laboratory or clinical testing only for patients of the health
  135  care practitioner with whom the consultant pharmacist has a
  136  written collaborative practice agreement.
  137         (b)A written collaborative practice agreement must outline
  138  the circumstances under which the consultant pharmacist may:
  139         1.Order and evaluate any laboratory or clinical tests to
  140  promote and evaluate patient health and wellness, and monitor
  141  drug therapy and treatment outcomes.
  142         2.Conduct patient assessments as appropriate to evaluate
  143  and monitor drug therapy.
  144         3.Modify or discontinue medicinal drugs as outlined in the
  145  agreed-upon patient-specific order or preapproved treatment
  146  protocol under the direction of a physician. However, a
  147  consultant pharmacist may not modify or discontinue medicinal
  148  drugs prescribed by a health care practitioner who does not have
  149  a written collaborative practice agreement with the consultant
  150  pharmacist.
  151         4.Administer medicinal drugs.
  152         (c)A The consultant pharmacist shall maintain be
  153  responsible for maintaining all drug, patient care, and quality
  154  assurance records as required by law and, with the collaborating
  155  practitioner, maintain written collaborative practice agreements
  156  that must be available upon request from or upon inspection by
  157  the department.
  158         (d)This subsection does not authorize a consultant
  159  pharmacist to diagnose any disease or condition.
  160         (e)For purposes of this subsection, the term “health care
  161  facility” means an ambulatory surgical center or hospital
  162  licensed under chapter 395, an alcohol or chemical dependency
  163  treatment center licensed under chapter 397, an inpatient
  164  hospice licensed under part IV of chapter 400, a nursing home
  165  licensed under part II of chapter 400, an ambulatory care center
  166  as defined in s. 408.07, or a nursing home component licensed
  167  under chapter 400 within a continuing care facility licensed
  168  under chapter 651 for establishing drug handling procedures for
  169  the safe handling and storage of drugs. The consultant
  170  pharmacist may also be responsible for ordering and evaluating
  171  any laboratory or clinical testing when, in the judgment of the
  172  consultant pharmacist, such activity is necessary for the proper
  173  performance of the consultant pharmacist’s responsibilities.
  174  Such laboratory or clinical testing may be ordered only with
  175  regard to patients residing in a nursing home facility, and then
  176  only when authorized by the medical director of the nursing home
  177  facility. The consultant pharmacist must have completed such
  178  additional training and demonstrate such additional
  179  qualifications in the practice of institutional pharmacy as
  180  shall be required by the board in addition to licensure as a
  181  registered pharmacist.
  182         (2) Notwithstanding the provisions of subsection (1), a
  183  consultant pharmacist or a doctor of pharmacy licensed in this
  184  state may also be responsible for ordering and evaluating any
  185  laboratory or clinical testing for persons under the care of a
  186  licensed home health agency when, in the judgment of the
  187  consultant pharmacist or doctor of pharmacy, such activity is
  188  necessary for the proper performance of his or her
  189  responsibilities and only when authorized by a practitioner
  190  licensed under chapter 458, chapter 459, chapter 461, or chapter
  191  466. In order for the consultant pharmacist or doctor of
  192  pharmacy to qualify and accept this authority, he or she must
  193  receive 3 hours of continuing education relating to laboratory
  194  and clinical testing as established by the board.
  195         (3) The board shall adopt promulgate rules necessary to
  196  implement and administer this section.
  197         Section 4. Section 465.1865, Florida Statutes, is created
  198  to read:
  199         465.1865Collaborative pharmacy practice for chronic health
  200  conditions.—
  201         (1)For purposes of this section, the term:
  202         (a)“Collaborative pharmacy practice agreement” means a
  203  written agreement between a pharmacist who meets the
  204  qualifications of this section and a physician licensed under
  205  chapter 458 or chapter 459 in which a collaborating physician
  206  authorizes a pharmacist to provide specified patient care
  207  services to the collaborating physician′s patients.
  208         (b)“Chronic health condition” means:
  209         1.Arthritis;
  210         2. Asthma;
  211         3.Chronic obstructive pulmonary diseases;
  212         4.Type 2 diabetes;
  213         5.Human immunodeficiency virus or acquired immune
  214  deficiency syndrome; or
  215         6.Obesity.
  216         (2)To provide services under a collaborative pharmacy
  217  practice agreement, a pharmacist must be certified according to
  218  rules of the Board of Medicine that he or she:
  219         (a)Holds an active and unencumbered license to practice
  220  pharmacy in the state.
  221         (b)Has earned a degree of doctor of pharmacy or has
  222  completed 5 years of experience as a licensed pharmacist.
  223         (c)Has completed an initial 20-hour course approved by the
  224  Board of Medicine in consultation with the Board of Osteopathic
  225  Medicine and the Board of Pharmacy which includes, at a minimum,
  226  instruction on all of the following:
  227         1.Performance of patient assessments.
  228         2.Ordering, performing, and interpreting clinical and
  229  laboratory tests related to collaborative pharmacy practice.
  230         3.Evaluating and managing diseases and health conditions
  231  in collaboration with other health care practitioners.
  232         4.Any other area required by Board of Medicine rule,
  233  adopted in consultation with the Board of Osteopathic Medicine
  234  and the Board of Pharmacy.
  235         (d)Maintains at least $250,000 of professional liability
  236  insurance coverage. However, a pharmacist who maintains
  237  professional liability insurance coverage of at least $250,000
  238  under a written protocol with a supervising physician for the
  239  testing for and treatment of minor nonchronic health conditions
  240  satisfies this requirement.
  241         (e)Has established a system to maintain records of all
  242  patients receiving services under a collaborative pharmacy
  243  practice agreement for a period of 5 years.
  244         (3)The terms and conditions of the collaborative pharmacy
  245  practice agreement must be appropriate to the pharmacist′s
  246  education and training and the services delegated to the
  247  pharmacist must be within the collaborating physician′s scope of
  248  practice. A copy of the certification issued under subsection
  249  (2) must be included as an attachment to the collaborative
  250  pharmacy practice agreement.
  251         (a)A collaborative pharmacy practice agreement must
  252  include the following:
  253         1.Name of the collaborating physician′s patient or
  254  patients for whom a pharmacist may provide services.
  255         2.Each chronic health condition to be collaboratively
  256  managed.
  257         3.Specific medicinal drug or drugs to be managed by the
  258  pharmacist.
  259         4.Circumstances under which the pharmacist may order or
  260  perform and evaluate laboratory or clinical tests.
  261         5.Conditions and events upon which the pharmacist must
  262  notify the collaborating physician and the manner and timeframe
  263  in which such notification must occur.
  264         6.Beginning and ending dates for the collaborative
  265  pharmacy practice agreement and termination procedures,
  266  including procedures for patient notification and medical
  267  records transfers.
  268         7.A statement that the collaborative pharmacy practice
  269  agreement may be terminated, in writing, by either party at any
  270  time.
  271         (b)A collaborative pharmacy practice agreement must be
  272  renewed at least every 2 years.
  273         (c)The pharmacist, along with the collaborating physician,
  274  must maintain on file the collaborative pharmacy practice
  275  agreement at his or her practice location and must make such
  276  agreements available upon request or inspection.
  277         (d) A pharmacist who enters into a collaborative pharmacy
  278  practice agreement must submit a copy of the signed agreement to
  279  the Board of Pharmacy before the agreement may be implemented.
  280         (4)A pharmacist may not:
  281         (a)Modify or discontinue medicinal drugs prescribed by a
  282  health care practitioner with whom he or she does not have a
  283  collaborative pharmacy practice agreement.
  284         (b)Enter into a collaborative pharmacy practice agreement
  285  while acting as an employee without the written approval of the
  286  owner of the pharmacy.
  287         (5)A physician may not delegate to a pharmacist the
  288  authority to initiate or prescribe a controlled substance as
  289  described in s. 893.03 or 21 U.S.C. s. 812.
  290         (6)In addition to the continuing education requirements
  291  under s. 465.009, a pharmacist who practices under a
  292  collaborative pharmacy practice agreement must, for each
  293  biennial licensure renewal, complete an 8-hour continuing
  294  education course approved by the Board of Medicine in
  295  consultation with the Board of Osteopathic Medicine and the
  296  Board of Pharmacy which addresses issues related to the chronic
  297  conditions to be collaboratively managed. Such pharmacist must
  298  submit confirmation of having completed such course when
  299  applying for licensure renewal. A pharmacist who fails to comply
  300  with this subsection shall be prohibited from practicing under a
  301  collaborative pharmacy practice agreement under this section.
  302         (7)The Board of Medicine in consultation with the Board of
  303  Osteopathic Medicine and the Board of Pharmacy shall adopt rules
  304  pursuant to ss. 120.536(1) and 120.54 to implement this section.
  305         Section 5. This act shall take effect July 1, 2020.