| 1 | A bill to be entitled |
| 2 | An act relating to monitoring controlled substance |
| 3 | prescriptions; creating s. 893.055, F.S.; providing a |
| 4 | definition; requiring the Department of Health to |
| 5 | establish, initially within specified counties, a |
| 6 | comprehensive electronic system to monitor the dispensing |
| 7 | of specified controlled substances; requiring the |
| 8 | department to phase in implementation statewide; requiring |
| 9 | the dispensing of such controlled substances to be |
| 10 | reported to the department through the system; providing |
| 11 | exceptions; providing for rulemaking concerning data to be |
| 12 | reported and for reporting formats; providing that costs |
| 13 | for required reporting by dispenser may not be material or |
| 14 | extraordinary; providing that specified costs are not |
| 15 | material or extraordinary; authorizing transmission of |
| 16 | data to certain persons or agencies; providing for data |
| 17 | retention; requiring that data transmissions comply with |
| 18 | privacy and security laws; providing penalties for |
| 19 | violations; requiring that the department and regulatory |
| 20 | boards adopt rules; requiring the department to obtain |
| 21 | financial assistance through grants; providing an |
| 22 | effective date. |
| 23 |
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| 24 | Be It Enacted by the Legislature of the State of Florida: |
| 25 |
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| 26 | Section 1. Section 893.055, Florida Statutes, is created |
| 27 | to read: |
| 28 | 893.055 Electronic monitoring system for dispensing of |
| 29 | controlled substances listed in Schedules II, III, and IV.-- |
| 30 | (1) As used in this section, the term "pharmacy" means any |
| 31 | pharmacy subject to licensure or regulation by the department |
| 32 | under chapter 465 that dispenses or delivers a controlled |
| 33 | substance listed in Schedule II, Schedule III, or Schedule IV to |
| 34 | a patient in this state. |
| 35 | (2) By June 30, 2009, the department shall design and |
| 36 | establish an electronic system consistent with standards of the |
| 37 | American Society for Automation in Pharmacy to monitor the |
| 38 | prescribing and dispensing of controlled substances listed in |
| 39 | Schedule II, Schedule III, or Schedule IV by health care |
| 40 | practitioners and the dispensing of such controlled substances |
| 41 | to an individual by a pharmacy permitted or registered by the |
| 42 | Board of Pharmacy. Initially, the system shall be implemented in |
| 43 | Broward County and Palm Beach County only. The department shall |
| 44 | implement expansion of the program to include the remaining |
| 45 | counties of the state in accordance with a plan to be developed |
| 46 | by the department. |
| 47 | (3) Each time a controlled substance listed in Schedule |
| 48 | II, Schedule III, or Schedule IV is dispensed to an individual |
| 49 | in the county, the controlled substance must be reported to the |
| 50 | department through the system as soon thereafter as possible but |
| 51 | not more than 35 days after the date the controlled substance is |
| 52 | dispensed. A pharmacy or dispensing practitioner may meet the |
| 53 | reporting requirements of this section by providing to the |
| 54 | department, in a format approved by the department as provided |
| 55 | in subsection (6), each controlled substance listed in Schedule |
| 56 | II, Schedule III, or Schedule IV that it dispenses. |
| 57 | (4) This section does not apply to controlled substances: |
| 58 | (a) Administered by a health care practitioner directly to |
| 59 | a patient. |
| 60 | (b) Dispensed by a health care practitioner authorized to |
| 61 | prescribe controlled substances directly to a patient and |
| 62 | limited to an amount adequate to treat the patient for a period |
| 63 | of not more than 72 hours. |
| 64 | (c) Dispensed by a health care practitioner or a |
| 65 | pharmacist to an inpatient of a facility that holds an |
| 66 | institutional pharmacy permit. |
| 67 | (d) Ordered from an institutional pharmacy permitted under |
| 68 | s. 465.019 in accordance with the institutional policy for such |
| 69 | controlled substances. |
| 70 | (e) Dispensed by a pharmacist or administered by a health |
| 71 | care practitioner to a patient or resident receiving care from a |
| 72 | hospital, nursing home, assisted living facility, home health |
| 73 | agency, hospice, or intermediate care facility for the |
| 74 | developmentally disabled that is licensed in this state. |
| 75 | (5) The data required to be reported under this section |
| 76 | shall be determined by the department by rule but may include |
| 77 | any data required under s. 893.04. |
| 78 | (6) A practitioner or pharmacist who dispenses a |
| 79 | controlled substance under this section must submit the |
| 80 | information required by this section in a written or electronic |
| 81 | or other format approved by rule of the department. The cost to |
| 82 | the dispenser in submitting the information required by this |
| 83 | section may not be material or extraordinary. Costs not |
| 84 | considered to be material or extraordinary include, but are not |
| 85 | limited to, regular postage, compact discs, zip-drive storage, |
| 86 | regular electronic mail, magnetic tapes, diskettes, and |
| 87 | facsimile charges. The information submitted to the department |
| 88 | under this section may be transmitted to any person or agency |
| 89 | authorized to receive it under chapter 119, and that person or |
| 90 | agency may maintain the information received for up to 24 months |
| 91 | before purging the information from its records. All |
| 92 | transmissions required by this subsection must comply with |
| 93 | relevant privacy and security laws of the state and the Federal |
| 94 | Government. However, any authorized agency receiving such |
| 95 | information may maintain it for longer than 24 months if the |
| 96 | information is pertinent to an ongoing investigation or |
| 97 | prosecution. |
| 98 | (7) Any person who knowingly fails to report the |
| 99 | dispensing of a controlled substance as required by this section |
| 100 | commits a misdemeanor of the first degree, punishable as |
| 101 | provided in s. 775.082 or s. 775.083. |
| 102 | (8) The department and the regulatory boards for the |
| 103 | health care practitioners subject to this section shall adopt |
| 104 | rules pursuant to ss. 120.536(1) and 120.54 to administer this |
| 105 | section. |
| 106 | (9) All costs incurred by the department in administering |
| 107 | the prescription monitoring system shall be paid through a grant |
| 108 | applied for by the county or the state. The department and local |
| 109 | government will cooperate in seeking grant funds at no cost to |
| 110 | the department. |
| 111 | Section 2. This act shall take effect July 1, 2008. |