| 1 | A bill to be entitled |
| 2 | An act relating to pharmacy; amending s. 465.189, |
| 3 | F.S.; revising the types of vaccines that pharmacists |
| 4 | may administer; authorizing pharmacy interns to |
| 5 | administer certain vaccines under certain |
| 6 | circumstances; authorizing pharmacists and pharmacy |
| 7 | interns to administer an epinephrine autoinjection |
| 8 | under certain circumstances; revising protocol |
| 9 | requirements for vaccine administration and the duties |
| 10 | of supervising physicians under such protocols; |
| 11 | revising requirements for training programs, |
| 12 | certifications, and patient records related to vaccine |
| 13 | administration; amending s. 465.003, F.S.; conforming |
| 14 | terminology; providing an effective date. |
| 15 |
|
| 16 | Be It Enacted by the Legislature of the State of Florida: |
| 17 |
|
| 18 | Section 1. Section 465.189, Florida Statutes, is amended |
| 19 | to read: |
| 20 | 465.189 Administration of vaccines and epinephrine |
| 21 | autoinjection influenza virus immunizations.- |
| 22 | (1) A pharmacist, and a certified pharmacy intern working |
| 23 | under the pharmacist's supervision, Pharmacists may administer |
| 24 | the following influenza virus immunizations to adults within the |
| 25 | framework of an established protocol under a supervising |
| 26 | supervisory practitioner who is a physician licensed under |
| 27 | chapter 458 or chapter 459: |
| 28 | (a) Influenza vaccine to an adult 18 years of age or |
| 29 | older. |
| 30 | (b) Varicella zoster vaccine to an adult 60 years of age |
| 31 | or older. |
| 32 | (c) Pneumococcal vaccine to an adult 65 years of age or |
| 33 | older. |
| 34 | (d) Epinephrine using an autoinjector delivery system to |
| 35 | an adult 18 years of age or older who is suffering an |
| 36 | anaphylactic reaction. |
| 37 |
|
| 38 | The Each protocol must shall contain specific procedures for |
| 39 | addressing any unforeseen adverse allergic reaction to the |
| 40 | vaccine or epinephrine autoinjection influenza virus |
| 41 | immunizations. |
| 42 | (2) A pharmacist may not enter into a protocol unless he |
| 43 | or she maintains at least $200,000 of professional liability |
| 44 | insurance and has completed training on administration of the |
| 45 | vaccines and epinephrine autoinjection in influenza virus |
| 46 | immunizations as provided in this section. |
| 47 | (3) A pharmacist, or his or her intern, who administers a |
| 48 | vaccine or epinephrine autoinjection must administering |
| 49 | influenza virus immunizations shall maintain and make available |
| 50 | patient records using the same standards for confidentiality and |
| 51 | maintenance of such records as those that are imposed on health |
| 52 | care practitioners under s. 456.057. These records must shall be |
| 53 | maintained for a minimum of 5 years. |
| 54 | (4) The decision by a supervising physician supervisory |
| 55 | practitioner to enter into a protocol under this section is a |
| 56 | professional decision on the part of the physician practitioner, |
| 57 | and a person may not interfere with a supervising physician's |
| 58 | supervisory practitioner's decision to enter as to entering into |
| 59 | such a protocol. A pharmacist or his or her intern may not enter |
| 60 | into a protocol that is to be performed while acting as an |
| 61 | employee without the written approval of the owner of the |
| 62 | pharmacy. Pharmacists shall forward immunization records to the |
| 63 | department for inclusion in the state registry of immunization |
| 64 | information. |
| 65 | (5) Any pharmacist or pharmacy intern seeking to |
| 66 | administer a vaccine or epinephrine autoinjection influenza |
| 67 | virus immunizations to adults under this section must be |
| 68 | certified to administer the vaccine or epinephrine autoinjection |
| 69 | influenza virus immunizations pursuant to a certification |
| 70 | program approved by the Board of Pharmacy in consultation with |
| 71 | the Board of Medicine and the Board of Osteopathic Medicine. The |
| 72 | certification program shall, at a minimum, require that the |
| 73 | pharmacist or pharmacy intern attend at least 20 hours of |
| 74 | continuing education classes approved by the board. The program |
| 75 | shall have a curriculum of instruction concerning the safe and |
| 76 | effective administration of the vaccines and epinephrine |
| 77 | autoinjection listed in subsection (1) influenza virus |
| 78 | immunizations, including, but not limited to, potential adverse |
| 79 | allergic reactions to the vaccines or epinephrine autoinjection |
| 80 | influenza virus immunizations. |
| 81 | (6) The written protocol between the pharmacist and |
| 82 | supervising physician must include particular terms and |
| 83 | conditions imposed by the supervising physician upon the |
| 84 | pharmacist relating to the administration of a vaccine or |
| 85 | epinephrine autoinjection influenza virus immunizations by the |
| 86 | pharmacist or his or her intern. The written protocol must shall |
| 87 | include, at a minimum, specific categories and conditions among |
| 88 | patients for whom the supervising physician authorizes the |
| 89 | pharmacist or pharmacy intern to administer a vaccine or |
| 90 | epinephrine autoinjection influenza virus immunizations. The |
| 91 | terms, scope, and conditions set forth in the written protocol |
| 92 | between the pharmacist and the supervising physician must be |
| 93 | appropriate to the pharmacist's or pharmacy intern's training |
| 94 | and certification for the vaccine or epinephrine autoinjection |
| 95 | immunization. A pharmacist or his or her intern Pharmacists who |
| 96 | is have been delegated the authority to administer a vaccine or |
| 97 | epinephrine autoinjection influenza virus immunizations by the |
| 98 | supervising physician must shall provide evidence of current |
| 99 | certification by the Board of Pharmacy to the supervising |
| 100 | physician. A supervising physician must physicians shall review |
| 101 | the administration of the vaccine or epinephrine autoinjection |
| 102 | influenza virus immunizations by the pharmacist or his or her |
| 103 | intern pharmacists under such physician's supervision pursuant |
| 104 | to the written protocol, and this review shall take place as |
| 105 | outlined in the written protocol. The process and schedule for |
| 106 | the review shall be outlined in the written protocol between the |
| 107 | pharmacist and the supervising physician. |
| 108 | (7) The pharmacist shall submit to the Board of Pharmacy a |
| 109 | copy of his or her protocol or written agreement to administer |
| 110 | the vaccine or epinephrine autoinjection influenza virus |
| 111 | immunizations. |
| 112 | Section 2. Subsection (13) of section 465.003, Florida |
| 113 | Statutes, is amended to read: |
| 114 | 465.003 Definitions.-As used in this chapter, the term: |
| 115 | (13) "Practice of the profession of pharmacy" includes |
| 116 | compounding, dispensing, and consulting concerning contents, |
| 117 | therapeutic values, and uses of any medicinal drug; consulting |
| 118 | concerning therapeutic values and interactions of patent or |
| 119 | proprietary preparations, whether pursuant to prescriptions or |
| 120 | in the absence and entirely independent of such prescriptions or |
| 121 | orders; and other pharmaceutical services. For purposes of this |
| 122 | subsection, "other pharmaceutical services" means the monitoring |
| 123 | of the patient's drug therapy and assisting the patient in the |
| 124 | management of his or her drug therapy, and includes review of |
| 125 | the patient's drug therapy and communication with the patient's |
| 126 | prescribing health care provider as licensed under chapter 458, |
| 127 | chapter 459, chapter 461, or chapter 466, or similar statutory |
| 128 | provision in another jurisdiction, or such provider's agent or |
| 129 | such other persons as specifically authorized by the patient, |
| 130 | regarding the drug therapy. However, nothing in this subsection |
| 131 | does not may be interpreted to permit an alteration of a |
| 132 | prescriber's directions, the diagnosis or treatment of any |
| 133 | disease, the initiation of any drug therapy, the practice of |
| 134 | medicine, or the practice of osteopathic medicine, unless |
| 135 | otherwise permitted by law. The term "practice of the profession |
| 136 | of pharmacy" also includes any other act, service, operation, |
| 137 | research, or transaction incidental to, or forming a part of, |
| 138 | any of the foregoing acts, requiring, involving, or employing |
| 139 | the science or art of any branch of the pharmaceutical |
| 140 | profession, study, or training, and shall expressly permit a |
| 141 | pharmacist to transmit information from persons authorized to |
| 142 | prescribe medicinal drugs to their patients. The term practice |
| 143 | of the profession of pharmacy also includes the administration |
| 144 | of certain vaccines and epinephrine autoinjection influenza |
| 145 | virus immunizations to adults pursuant to s. 465.189. |
| 146 | Section 3. This act shall take effect July 1, 2012. |