| 1 | The Health & Families Council recommends the following: |
| 2 |
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| 3 | Council/Committee Substitute |
| 4 | Remove the entire bill and insert: |
| 5 | A bill to be entitled |
| 6 | An act relating to pharmacy common databases; amending s. |
| 7 | 465.026, F.S.; deleting a provision authorizing certain |
| 8 | community pharmacies to transfer prescriptions for |
| 9 | Schedule II medicinal drugs under certain conditions; |
| 10 | creating s. 465.0266, F.S.; authorizing the dispensing of |
| 11 | a prescription contained in a common database under |
| 12 | specified conditions; providing requirements for a policy |
| 13 | and procedures manual that governs pharmacies, |
| 14 | pharmacists, and pharmacy employees participating in a |
| 15 | pharmacy common database; providing for the rights and |
| 16 | obligations of pharmacists dispensing prescriptions; |
| 17 | providing an effective date. |
| 18 |
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| 19 | Be It Enacted by the Legislature of the State of Florida: |
| 20 |
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| 21 | Section 1. Subsection (7) of section 465.026, Florida |
| 22 | Statutes, is amended to read: |
| 23 | 465.026 Filling of certain prescriptions.--Nothing |
| 24 | contained in this chapter shall be construed to prohibit a |
| 25 | pharmacist licensed in this state from filling or refilling a |
| 26 | valid prescription which is on file in a pharmacy located in |
| 27 | this state or in another state and has been transferred from one |
| 28 | pharmacy to another by any means, including any electronic |
| 29 | means, under the following conditions: |
| 30 | (7) A community pharmacy licensed under this chapter which |
| 31 | only receives and transfers prescriptions for dispensing by |
| 32 | another pharmacy may transfer a prescription for a medicinal |
| 33 | drug listed in Schedule II under chapter 893. The pharmacy |
| 34 | receiving the prescription may ship, mail, or deliver into this |
| 35 | state, in any manner, the dispensed Schedule II medicinal drug |
| 36 | under the following conditions: |
| 37 | (a) The pharmacy receiving and dispensing the transferred |
| 38 | prescription maintains at all times a valid, unexpired license, |
| 39 | permit, or registration to operate the pharmacy in compliance |
| 40 | with the laws of the state in which the pharmacy is located and |
| 41 | from which the medicinal drugs are dispensed; |
| 42 | (b) The community pharmacy and the receiving pharmacy are |
| 43 | owned and operated by the same person and share a centralized |
| 44 | database; and |
| 45 | (c) The community pharmacy assures its compliance with the |
| 46 | federal laws and subsections (1)-(5). |
| 47 | Section 2. Section 465.0266, Florida Statues, is created |
| 48 | to read: |
| 49 | 465.0266 Common database.--Nothing contained in this |
| 50 | chapter shall be construed to prohibit the dispensing by a |
| 51 | pharmacist licensed in this state or another state of a |
| 52 | prescription contained in a common database, and such dispensing |
| 53 | shall not constitute a transfer as defined in s. 465.026(1)?(6), |
| 54 | provided that the following conditions are met: |
| 55 | (1) All pharmacies involved in the transactions pursuant |
| 56 | to which the prescription is dispensed are under common |
| 57 | ownership and utilize a common database. |
| 58 | (2) All pharmacies involved in the transactions pursuant |
| 59 | to which the prescription is dispensed and all pharmacists |
| 60 | engaging in dispensing functions are properly licensed, |
| 61 | permitted, or registered in this state or another state. |
| 62 | (3) The common database maintains a record of all |
| 63 | pharmacists involved in the process of dispensing a |
| 64 | prescription. |
| 65 | (4) The owner of the common database maintains a policy |
| 66 | and procedures manual that governs its participating pharmacies, |
| 67 | pharmacists, and pharmacy employees and that is available to the |
| 68 | board or its agent upon request. The policy and procedures |
| 69 | manual shall include the following information: |
| 70 | (a) A best practices model detailing how each pharmacy and |
| 71 | each pharmacist accessing the common database will comply with |
| 72 | applicable federal and state laws, rules, and regulations. |
| 73 | (b) The procedure for maintaining appropriate records for |
| 74 | regulatory oversight for tracking a prescription during each |
| 75 | stage of the filling and dispensing process, identifying the |
| 76 | pharmacists involved in filling and dispensing the prescription |
| 77 | and counseling the patient, and responding to any requests for |
| 78 | information made by the board under s. 465.0156. |
| 79 | (c) The policy and procedure for providing adequate |
| 80 | security to protect the confidentiality and integrity of patient |
| 81 | information. |
| 82 | (d) A quality assurance program designed to objectively |
| 83 | and systematically monitor, evaluate, and improve the quality |
| 84 | and appropriateness of patient care through the use of the |
| 85 | common database. |
| 86 |
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| 87 | Any pharmacist dispensing a prescription has at all times the |
| 88 | right and obligation to exercise his or her independent |
| 89 | professional judgment. Notwithstanding other provisions in this |
| 90 | section, no pharmacist licensed in this state participating in |
| 91 | the dispensing of a prescription pursuant to this section shall |
| 92 | be responsible for the acts and omissions of another person |
| 93 | participating in the dispensing process provided such person is |
| 94 | not under the direct supervision and control of the pharmacist |
| 95 | licensed in this state. |
| 96 | Section 3. This act shall take effect July 1, 2006. |