Florida Senate - 2012                        COMMITTEE AMENDMENT
       Bill No. SB 850
       
       
       
       
       
       
                                Barcode 366132                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                   Comm: RE            .                                
                  01/26/2012           .                                
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       The Committee on Health Regulation (Jones) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 465.189, Florida Statutes, is amended to
    6  read:
    7         465.189 Administration of vaccines and epinephrine
    8  autoinjection influenza virus immunizations.—
    9         (1) A pharmacist Pharmacists may administer the following
   10  influenza virus immunizations to adults within the framework of
   11  an established protocol under a supervising supervisory
   12  practitioner who is a physician licensed under chapter 458 or
   13  chapter 459:
   14         (a) Influenza vaccine to an adult 18 years of age or older.
   15         (b) Shingles vaccine to an adult 60 years of age or older.
   16         (c) Pneumococcal vaccine to an adult 65 years of age or
   17  older.
   18         (d) Epinephrine using an autoinjector delivery system to an
   19  adult 18 years of age or older who is suffering an anaphylactic
   20  reaction.
   21  
   22  The Each protocol must shall contain specific procedures for
   23  addressing any unforeseen adverse allergic reaction to the
   24  vaccine or epinephrine autoinjection influenza virus
   25  immunizations.
   26         (2) A pharmacist may not enter into a protocol unless he or
   27  she maintains at least $200,000 of professional liability
   28  insurance and has completed training on administration of the
   29  vaccines and epinephrine autoinjection in influenza virus
   30  immunizations as provided in this section.
   31         (3) A pharmacist who administers a vaccine or epinephrine
   32  autoinjection must administering influenza virus immunizations
   33  shall maintain and make available patient records using the same
   34  standards for confidentiality and maintenance of such records as
   35  those that are imposed on health care practitioners under s.
   36  456.057. These records must shall be maintained for a minimum of
   37  5 years.
   38         (4) The decision by a supervising physician supervisory
   39  practitioner to enter into a protocol under this section is a
   40  professional decision on the part of the physician practitioner,
   41  and a person may not interfere with a supervising physician’s
   42  supervisory practitioner’s decision to enter as to entering into
   43  such a protocol. A pharmacist may not enter into a protocol that
   44  is to be performed while acting as an employee without the
   45  written approval of the owner of the pharmacy. Pharmacists shall
   46  forward immunization records to the department for inclusion in
   47  the state registry of immunization information.
   48         (5) Any pharmacist seeking to administer a vaccine or
   49  epinephrine autoinjection influenza virus immunizations to
   50  adults under this section must be certified to administer the
   51  vaccine or epinephrine autoinjection influenza virus
   52  immunizations pursuant to a certification program approved by
   53  the Board of Pharmacy in consultation with the Board of Medicine
   54  and the Board of Osteopathic Medicine. The certification program
   55  shall, at a minimum, require that the pharmacist attend at least
   56  20 hours of continuing education classes approved by the board.
   57  The program shall have a curriculum of instruction concerning
   58  the safe and effective administration of the vaccines and
   59  epinephrine autoinjection listed in subsection (1) influenza
   60  virus immunizations, including, but not limited to, potential
   61  adverse allergic reactions to the vaccines or epinephrine
   62  autoinjection influenza virus immunizations.
   63         (6) The written protocol between the pharmacist and
   64  supervising physician must include particular terms and
   65  conditions imposed by the supervising physician upon the
   66  pharmacist relating to the administration of a vaccine or
   67  epinephrine autoinjection influenza virus immunizations by the
   68  pharmacist. The written protocol must shall include, at a
   69  minimum, specific categories and conditions among patients for
   70  whom the supervising physician authorizes the pharmacist to
   71  administer a vaccine or epinephrine autoinjection influenza
   72  virus immunizations. The terms, scope, and conditions set forth
   73  in the written protocol between the pharmacist and the
   74  supervising physician must be appropriate to the pharmacist’s
   75  training and certification for the vaccine or epinephrine
   76  autoinjection immunization. A pharmacist Pharmacists who is have
   77  been delegated the authority to administer a vaccine or
   78  epinephrine autoinjection influenza virus immunizations by the
   79  supervising physician must shall provide evidence of current
   80  certification by the Board of Pharmacy to the supervising
   81  physician. A supervising physician must physicians shall review
   82  the administration of the vaccine or epinephrine autoinjection
   83  influenza virus immunizations by the pharmacist pharmacists
   84  under such physician’s supervision pursuant to the written
   85  protocol, and this review shall take place as outlined in the
   86  written protocol. The process and schedule for the review shall
   87  be outlined in the written protocol between the pharmacist and
   88  the supervising physician.
   89         (7) The pharmacist shall submit to the Board of Pharmacy a
   90  copy of his or her protocol or written agreement to administer
   91  the vaccine or epinephrine autoinjection influenza virus
   92  immunizations.
   93         Section 2. Subsection (13) of section 465.003, Florida
   94  Statutes, is amended to read:
   95         465.003 Definitions.—As used in this chapter, the term:
   96         (13) “Practice of the profession of pharmacy” includes
   97  compounding, dispensing, and consulting concerning contents,
   98  therapeutic values, and uses of any medicinal drug; consulting
   99  concerning therapeutic values and interactions of patent or
  100  proprietary preparations, whether pursuant to prescriptions or
  101  in the absence and entirely independent of such prescriptions or
  102  orders; and other pharmaceutical services. For purposes of this
  103  subsection, “other pharmaceutical services” means the monitoring
  104  of the patient’s drug therapy and assisting the patient in the
  105  management of his or her drug therapy, and includes review of
  106  the patient’s drug therapy and communication with the patient’s
  107  prescribing health care provider as licensed under chapter 458,
  108  chapter 459, chapter 461, or chapter 466, or similar statutory
  109  provision in another jurisdiction, or such provider’s agent or
  110  such other persons as specifically authorized by the patient,
  111  regarding the drug therapy. However, nothing in this subsection
  112  does not may be interpreted to permit an alteration of a
  113  prescriber’s directions, the diagnosis or treatment of any
  114  disease, the initiation of any drug therapy, the practice of
  115  medicine, or the practice of osteopathic medicine, unless
  116  otherwise permitted by law. The term “practice of the profession
  117  of pharmacy” also includes any other act, service, operation,
  118  research, or transaction incidental to, or forming a part of,
  119  any of the foregoing acts, requiring, involving, or employing
  120  the science or art of any branch of the pharmaceutical
  121  profession, study, or training, and shall expressly permit a
  122  pharmacist to transmit information from persons authorized to
  123  prescribe medicinal drugs to their patients. The term practice
  124  of the profession of pharmacy also includes the administration
  125  of certain vaccines and epinephrine autoinjection influenza
  126  virus immunizations to adults pursuant to s. 465.189.
  127         Section 3. This act shall take effect July 1, 2012.
  128  
  129  ================= T I T L E  A M E N D M E N T ================
  130         And the title is amended as follows:
  131         Delete everything before the enacting clause
  132  and insert:
  133                        A bill to be entitled                      
  134         An act relating to pharmacy; amending s. 465.189,
  135         F.S.; revising the types of vaccines that pharmacists
  136         may administer; authorizing pharmacists to administer
  137         an epinephrine autoinjection under certain
  138         circumstances; revising protocol requirements for
  139         vaccine administration and the duties of supervising
  140         physicians under such protocols; revising requirements
  141         for training programs, certifications, and patient
  142         records related to vaccine administration; amending s.
  143         465.003, F.S.; conforming terminology; providing an
  144         effective date.