| 1 | The Health Care Regulation Committee recommends the following: |
| 2 |
|
| 3 | Council/Committee Substitute |
| 4 | Remove the entire bill and insert: |
| 5 | A bill to be entitled |
| 6 | An act relating to pharmacy practice; amending s. 465.003, |
| 7 | F.S.; revising the term "practice of the profession of |
| 8 | pharmacy" to include the administering of influenza virus |
| 9 | immunizations to adults by a pharmacist within an |
| 10 | established protocol under a supervisory practitioner who |
| 11 | is a licensed physician or pursuant to a written agreement |
| 12 | between the pharmacist and a county health department; |
| 13 | providing requirements for the protocol; requiring |
| 14 | professional liability insurance, training and |
| 15 | certification in immunization, and employer approval prior |
| 16 | to entering into a protocol; providing requirements for |
| 17 | the certification program; providing an effective date. |
| 18 |
|
| 19 | Be It Enacted by the Legislature of the State of Florida: |
| 20 |
|
| 21 | Section 1. 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 other pharmaceutical services. For purposes of this |
| 31 | subsection, "other pharmaceutical services" means the monitoring |
| 32 | of the patient's drug therapy and assisting the patient in the |
| 33 | management of his or her drug therapy, and includes review of |
| 34 | the patient's drug therapy and communication with the patient's |
| 35 | prescribing health care provider as licensed under chapter 458, |
| 36 | chapter 459, chapter 461, or chapter 466, or similar statutory |
| 37 | provision in another jurisdiction, or such provider's agent or |
| 38 | such other persons as specifically authorized by the patient, |
| 39 | regarding the drug therapy. However, nothing in this subsection |
| 40 | may be interpreted to permit an alteration of a prescriber's |
| 41 | directions, the diagnosis or treatment of any disease, the |
| 42 | initiation of any drug therapy, the practice of medicine, or the |
| 43 | practice of osteopathic medicine, unless otherwise permitted by |
| 44 | law. "Practice of the profession of pharmacy" also includes any |
| 45 | other act, service, operation, research, or transaction |
| 46 | incidental to, or forming a part of, any of the foregoing acts, |
| 47 | requiring, involving, or employing the science or art of any |
| 48 | branch of the pharmaceutical profession, study, or training, and |
| 49 | shall expressly permit a pharmacist to transmit information from |
| 50 | persons authorized to prescribe medicinal drugs to their |
| 51 | patients. "Practice of the profession of pharmacy" also includes |
| 52 | the administering to adults of influenza virus immunizations by |
| 53 | a pharmacist within the framework of an established protocol |
| 54 | under a supervisory practitioner who is a physician licensed |
| 55 | under chapter 458 or chapter 459 or pursuant to a written |
| 56 | agreement between the pharmacist and a county health department. |
| 57 | Each protocol must contain specific procedures to address any |
| 58 | unforeseen allergic reaction to an immunization and must require |
| 59 | that the patient has had a physical examination by his or her |
| 60 | licensed primary physician within the 6 months preceding the |
| 61 | date of immunization. A pharmacist may not enter into a protocol |
| 62 | unless he or she maintains at least $200,000 of professional |
| 63 | liability insurance and not until the pharmacist has completed |
| 64 | training in immunizations as provided in this subsection. The |
| 65 | decision by a supervisory practitioner to enter into such a |
| 66 | protocol is a professional decision of the practitioner, and a |
| 67 | person may not interfere with a supervisory practitioner's |
| 68 | decision as to whether to enter into such a protocol. A |
| 69 | pharmacist may not enter into a protocol that is to be performed |
| 70 | while acting as an employee without the written approval of the |
| 71 | owner of the pharmacy. Any pharmacist seeking to immunize |
| 72 | patients under this subsection must be certified to administer |
| 73 | immunizations pursuant to a certification program approved by |
| 74 | the Board of Pharmacy upon consultation with the Board of |
| 75 | Medicine. The certification program must, at a minimum, require |
| 76 | that a pharmacist attend at least 20 hours of continuing |
| 77 | education classes approved by the Board of Pharmacy. The program |
| 78 | must have a curriculum of instruction concerning the safe and |
| 79 | effective administration of immunizations, including, but not |
| 80 | limited to, potential allergic reactions to immunizations. |
| 81 | Section 2. This act shall take effect July 1, 2005. |