Florida Senate - 2019                                     SB 706
       By Senator Bean
       4-00744A-19                                            2019706__
    1                        A bill to be entitled                      
    2         An act relating to institutional pharmacies; amending
    3         s. 465.003, F.S.; revising the definition of the term
    4         “institutional formulary system”; amending s. 465.019,
    5         F.S.; authorizing the use of an institutional
    6         formulary system in a Class I institutional pharmacy;
    7         specifying requirements for the policies and
    8         procedures of an institutional formulary system in a
    9         Class I institutional pharmacy; providing an effective
   10         date.
   12  Be It Enacted by the Legislature of the State of Florida:
   14         Section 1. Subsection (7) of section 465.003, Florida
   15  Statutes, is amended to read:
   16         465.003 Definitions.—As used in this chapter, the term:
   17         (7) “Institutional formulary system” means a method whereby
   18  the medical staff evaluates, appraises, and selects those
   19  medicinal drugs or proprietary preparations that, which in the
   20  clinical judgment of the medical staff, staff’s clinical
   21  judgment are most useful in patient care, and which are
   22  available for dispensing by a practicing pharmacist for a Class
   23  I institutional pharmacy, or a practicing pharmacist in a Class
   24  II institutional pharmacy or a Class III institutional pharmacy,
   25  as those terms are defined in s. 465.019(2).
   26         Section 2. Subsection (6) of section 465.019, Florida
   27  Statutes, is amended, subsection (7) is added to that section,
   28  and paragraph (a) of subsection (2) of that section is
   29  republished, to read:
   30         465.019 Institutional pharmacies; permits.—
   31         (2) The following classes of institutional pharmacies are
   32  established:
   33         (a) “Class I institutional pharmacies” are those
   34  institutional pharmacies in which all medicinal drugs are
   35  administered from individual prescription containers to the
   36  individual patient and in which medicinal drugs are not
   37  dispensed on the premises, except that nursing homes licensed
   38  under part II of chapter 400 may purchase medical oxygen for
   39  administration to residents. No medicinal drugs may be dispensed
   40  in a Class I institutional pharmacy.
   41         (6) In a Class I institutional pharmacy, a Class II
   42  institutional pharmacy, or a Class III institutional pharmacy,
   43  an institutional formulary system may be adopted with approval
   44  of the medical staff for the purpose of identifying those
   45  medicinal drugs, proprietary preparations, biologics,
   46  biosimilars, and biosimilar interchangeables that may be
   47  dispensed by a practicing pharmacist for a Class I institutional
   48  pharmacy, or dispensed by a practicing pharmacist in a Class II
   49  institutional pharmacy or a Class III institutional pharmacy,
   50  who is employed by the institutional pharmacy the pharmacists
   51  employed in such institution. A facility that has with a Class I
   52  institutional pharmacy permit, a Class II institutional pharmacy
   53  permit, or a Class III institutional pharmacy permit which is
   54  operating under the formulary system shall establish policies
   55  and procedures for the development of the system, in accordance
   56  with the joint standards of the American Hospital Association
   57  and American Society of Hospital Pharmacists, for the use
   58  utilization of an institutional a hospital formulary system,
   59  which must formulary shall be approved by the medical staff.
   60         (7)The policies and procedures for an institutional
   61  formulary system in a Class I institutional pharmacy must:
   62         (a)Be approved by the medical staff.
   63         (b)Openly provide detailed methods and criteria for the
   64  selection and objective evaluation of all available
   65  pharmaceuticals.
   66         (c)Include policies for the development, maintenance,
   67  approval, dissemination, and notification to prescribers of the
   68  drug formulary and for continuous and comprehensive review of
   69  formulary drugs.
   70         (d)Provide for regular monitoring of compliance with the
   71  policies and procedures and of clinical outcomes in
   72  circumstances in which a substitution of drugs has occurred.
   73         (e)Provide a mechanism to inform the prescriber prior to
   74  any substitution of drugs by using a method of communication
   75  designated by the prescriber for such purpose. The method of
   76  communication designated by the prescriber must be noted in the
   77  patient’s chart.
   78         (f)Establish a process that allows any individual
   79  prescriber to opt out of the formulary system.
   80         (g)Establish a process that allows any individual
   81  prescriber to opt out of the formulary system only with respect
   82  to a particular patient.
   83         (h)Include policies stating that practitioners will not be
   84  penalized for prescribing nonformulary drug products that are
   85  medically necessary.
   86         (i)Be consistent with applicable state and federal laws
   87  and with rules of the department and board.
   88         Section 3. This act shall take effect July 1, 2019.