HB 59 — Automated Pharmacy Systems

F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/HB 59 2020 A bill to be entitled An act relating to automated pharmacy systems;

providing that certain medicinal drugs stored in ansuch automated pharmacy system for outpatient dispensing are part of the inventory of the pharmacy providing services through such system;

requiring communitythe pharmaciesBoard of Pharmacy to adopt certainrules; policies and procedures;

authorizing, rather than requiring, the Board of Pharmacy to adopt specified rules;

deleting an obsolete date;

465.0235 Automated pharmacy systems used by long-term care facilities, hospices, or state correctional institutions, or for outpatient dispensing.— (1) A pharmacy may provide pharmacy services to a long- term care facility or hospice licensed under chapter 400 or chapter 429 or a state correctional institution operated under chapter 944 through the use of an automated pharmacy system that Pageneed 1not ofbe 6located CODING:at the same location as the pharmacy.

(2) A community pharmacy, as defined in s.

465.003 and licensed in this state, may provide pharmacy services for Page 1 of 4 CODING:

hb0059-02-c2hb0059-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/HB 59 2020 outpatient dispensing through the use of an automated pharmacy system that need not be located at the same location as the pharmacy.community pharmacy if:

(2) A community pharmacy, as defined in s.

465.003 and licensed in this state, may provide pharmacy services for outpatient dispensing through the use of an automated pharmacy system that need not be located at the same location as the community pharmacy if:

(b) The automatedcommunity pharmacy systemproviding isservices housedthrough inthe anautomated indoorpharmacy environmentsystem areanotifies andthe inboard a location to increase patients' access to their prescriptions, including, but not limited to, medical facilities, places of businessthe wherelocation essential goods and commodities are sold, rural areas of the state,automated largepharmacy employersystem workplaces, and locationsany wherechanges accessin tosuch alocation. community pharmacy is limited.

(c) The community pharmacy providing services through the automated pharmacy system notifiesis under the boardsupervision ofand thecontrol location of thea automatedpharmacist, pharmacyas systemdefined and any changes in suchs. location.

(d)465.003 Theand automatedlicensed pharmacyin systemthis hasstate, awho mechanismis thatavailable providesand live,accessible real-timefor patient counseling bybefore athe pharmacist,dispensing asof definedany inmedicinal s.drug.

465.003(d) andThe licensedautomated inpharmacy thissystem state,does beforenot thecontain dispensingor ofdispense any medicinalcontrolled drug.substance listed in s.

(e) The automated pharmacy system does not contain or dispense any controlled substance listed in s.

Page(e) 2The community pharmacy maintains a record of 6the CODING:medicinal drugs dispensed, including the identity of the pharmacist responsible for verifying the accuracy of the dosage and directions and providing patient counseling.

(f) The automated pharmacy system ensures the confidentiality of personal health information.

(3)(2) Medicinal drugs stored in bulk or unit of use in an automated pharmacy system servicing a long-term care facility, hospice, or correctional institution, or for outpatient dispensing, are part of the inventory of the pharmacy providing Page 2 of 4 CODING:

hb0059-02-c2hb0059-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/HB 59 2020 (f) The community pharmacy maintainsservices ato recordthat offacility, thehospice, medicinalor drugsinstitution, dispensed,or includingfor theoutpatient identitydispensing, ofand themedicinal pharmacistdrugs responsibledelivered forby verifying the accuracyautomated ofpharmacy thesystem dosageare andconsidered directionsto andhave providingbeen patientdispensed counseling.by that pharmacy.

(g) The automated pharmacy system ensures the confidentiality of personal health information.

(h) The community pharmacy maintains written policies and procedures to ensure the proper, safe, and secure functioning of the automated pharmacy system.

The community pharmacy shall annually review the policies and procedures and maintain a record of such policies and procedures for a minimum of 4 years.

The annual review must be documented in the community pharmacy's records and must be made available to the board upon request.

The policies and procedures must, at a minimum, address all of the following:

1.

Maintaining the automated pharmacy system and any accompanying electronic verification process in good working order.

2.

Ensuring the integrity of the automated pharmacy system's drug identifier database and its ability to identify the person responsible for making database entries.

3.

Ensuring the accurate filling, stocking, restocking, and verification of the automated pharmacy system.

4.

Ensuring the sanitary operation of the automated pharmacy system and the prevention of cross-contamination of Page 3 of 6 CODING:

Words stricken are deletions;

words underlined are additions.

hb0059-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 59 2020 cells, cartridges, containers, cassettes, or packages.

5.

Testing the accuracy of the automated pharmacy system and any accompanying electronic verification process.

The automated pharmacy system and accompanying electronic verification process must, at a minimum, be tested before the first use of the system, upon restarting the system, and after a modification of the system or electronic verification process which alters the filling, stocking, or restocking of the system or the electronic verification process.

6.