Bill Text: FL S0708 | 2020 | Regular Session | Comm Sub
Bill Title: Automated Pharmacy Systems
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Introduced - Dead) 2020-03-12 - Laid on Table, refer to CS/CS/HB 59 [S0708 Detail]
Download: Florida-2020-S0708-Comm_Sub.html
Florida Senate - 2020 CS for CS for SB 708 By the Committees on Rules; and Health Policy; and Senator Hutson 595-04241-20 2020708c2 1 A bill to be entitled 2 An act relating to automated pharmacy systems; 3 amending s. 465.0235, F.S.; authorizing a community 4 pharmacy to use an automated pharmacy system under 5 certain circumstances; requiring such community 6 pharmacies to adopt, annually review, and maintain a 7 record of, for a specified time period, certain 8 policies and procedures; providing that certain 9 medicinal drugs stored in an automated pharmacy system 10 for outpatient dispensing are part of the inventory of 11 the pharmacy providing services through such system; 12 authorizing, rather than requiring, the Board of 13 Pharmacy to adopt specified rules; deleting an 14 obsolete date; providing an effective date. 15 16 Be It Enacted by the Legislature of the State of Florida: 17 18 Section 1. Section 465.0235, Florida Statutes, is amended 19 to read: 20 465.0235 Automated pharmacy systems used by long-term care 21 facilities, hospices, or state correctional institutions or for 22 outpatient dispensing.— 23 (1) A pharmacy may provide pharmacy services to a long-term 24 care facility or hospice licensed under chapter 400 or chapter 25 429 or a state correctional institution operated under chapter 26 944 through the use of an automated pharmacy system that need 27 not be located at the same location as the pharmacy. 28 (2) A community pharmacy, as defined in s. 465.003(11), 29 which is licensed in this state may provide pharmacy services 30 for outpatient dispensing through the use of an automated 31 pharmacy system that need not be located at the same location as 32 the community pharmacy if all of the following criteria are met: 33 (a) The automated pharmacy system is under the supervision 34 and control of the community pharmacy. 35 (b) The automated pharmacy system is housed in an indoor 36 environment area and in a location that increases patients’ 37 access to their prescriptions, including, but not limited to, 38 medical facilities, places of business where essential goods and 39 commodities are sold, rural areas of the state, large employer 40 workplaces, and locations where access to a community pharmacy 41 is limited. 42 (c) The community pharmacy providing services through the 43 automated pharmacy system notifies the board of the location of 44 the automated pharmacy system and any changes in such location. 45 (d) The automated pharmacy system has a mechanism that 46 provides live, real-time patient counseling by a pharmacist, as 47 defined in s. 465.003(10) and who is licensed in this state, 48 before the dispensing of any medicinal drug. 49 (e) The automated pharmacy system does not contain or 50 dispense any controlled substance listed in s. 893.03 or 21 51 U.S.C. s. 812. 52 (f) The community pharmacy maintains a record of the 53 medicinal drugs dispensed which includes the identity of the 54 pharmacist responsible for verifying the accuracy of the dosage 55 and directions and providing patient counseling. 56 (g) The automated pharmacy system ensures the 57 confidentiality of personal health information. 58 (h) The community pharmacy maintains written policies and 59 procedures to ensure the proper, safe, and secure functioning of 60 the automated pharmacy system. The community pharmacy shall 61 annually review the policies and procedures and maintain a 62 record of them for a minimum of 4 years. The annual review must 63 be documented in the community pharmacy’s records and must be 64 made available to the board upon request. The policies and 65 procedures must, at a minimum, address all of the following: 66 1. Maintaining in good working order the automated pharmacy 67 system and any accompanying electronic verification process. 68 2. Ensuring the integrity of the automated pharmacy 69 system’s drug identifier database and its ability to identify 70 the person responsible for making database entries. 71 3. Ensuring the accurate filling, stocking, and 72 verification of the automated pharmacy system. 73 4. Ensuring sanitary operation of the automated pharmacy 74 system and prevention of cross-contamination of cells, 75 cartridges, containers, cassettes, or packages. 76 5. Testing the accuracy of the system and any accompanying 77 electronic verification process. The automated pharmacy system 78 and accompanying electronic verification process must, at a 79 minimum, be tested before the first use of the system, upon 80 restarting the system, and after a modification of the system or 81 electronic verification process which alters the filling or 82 electronic verification process. 83 6. Training persons authorized to access, stock, restock, 84 or use the system. 85 7. Conducting routine and preventative maintenance of the 86 automated pharmacy system, including calibration, if applicable. 87 8. Removing expired, adulterated, misbranded, or recalled 88 drugs from the automated pharmacy system. 89 9. Preventing unauthorized persons from accessing the 90 automated pharmacy system, including assigning, discontinuing, 91 or modifying security access. 92 10. Identifying and recording persons responsible for 93 stocking and filling the automated pharmacy system. 94 11. Ensuring compliance with state and federal law, 95 including, but not limited to, all applicable labeling, storage, 96 and security requirements. 97 12. Maintaining an ongoing quality assurance program that 98 monitors performance of the automated pharmacy system and any 99 accompanying electronic verification process to ensure proper 100 and accurate functioning, including tracking and documenting 101 system errors. A community pharmacy must maintain such 102 documentation for a minimum of 4 years and must produce it to 103 the board upon request. 104 (3)(2)Medicinal drugs stored in bulk or unit of use in an 105 automated pharmacy system servicing a long-term care facility, 106 hospice, or correctional institution, or for outpatient 107 dispensing, are part of the inventory of the pharmacy providing 108 pharmacy services to that facility, hospice, or institution, or 109 for outpatient dispensing, and medicinal drugs delivered by the 110 automated pharmacy system are considered to have been dispensed 111 by that pharmacy. 112 (4)(3)The operation of an automated pharmacy system must 113 be under the supervision of aFlorida-licensedpharmacist 114 licensed in this state. To qualify as a supervisor for an 115 automated pharmacy system, the pharmacist need not be physically 116 present at the site of the automated pharmacy system and may 117 supervise the system electronically. TheFlorida-licensed118 pharmacist shall be required to develop and implement policies 119 and procedures designed to verify that the medicinal drugs 120 delivered by the automated pharmacydispensingsystem are 121 accurate and valid and that the machine is properly restocked. 122 (5)(4)The Legislature does not intend for this section to 123 limit the current practice of pharmacy in this state. This 124 section is intended to allow automated pharmacy systems to 125 enhance the ability of a pharmacist to provide pharmacy services 126 in locations that do not employ a full-time pharmacist. This 127 section does not limit or replace the use of a consultant 128 pharmacist. 129 (6)(5)The board mayshalladopt rules governing the use of 130anautomated pharmacy systems. If adopted, such rulessystem by131January 1, 2005,whichmust include all of the following 132specify: 133 (a) Recordkeeping requirements.;134 (b) Security requirements.; and135 (c) Labeling requirements that permit the use of unit-dose 136 medications if the facility, hospice, or institution maintains 137 medication-administration records that include directions for 138 use of the medication and the automated pharmacy system 139 identifies all of the following: 140 1. The dispensing pharmacy.;141 2. The prescription number.;142 3. The name of the patient.; and143 4. The name of the prescribing practitioner. 144 Section 2. This act shall take effect July 1, 2020.