| 1 | A bill to be entitled |
| 2 | An act relating to controlled substances; creating s. |
| 3 | 893.055, F.S.; providing definitions; requiring the Agency |
| 4 | for Health Care Administration to establish a statewide, |
| 5 | comprehensive electronic system to monitor the prescribing |
| 6 | and dispensing of controlled substances listed in Schedule |
| 7 | II, Schedule III, or Schedule IV; providing reporting |
| 8 | requirements; requiring the agency to notify certain |
| 9 | dispensers and prescribers of the implementation date for |
| 10 | the reporting of controlled substances; specifying |
| 11 | circumstances under which a pharmacy or practitioner is |
| 12 | exempt from participating in the system; requiring |
| 13 | prescribing or dispensing pharmacists and practitioners to |
| 14 | submit information in a certain format; providing a |
| 15 | penalty; requiring that the department and regulatory |
| 16 | boards adopt rules; requiring that all costs incurred by |
| 17 | the agency be paid through federal, private, or grant |
| 18 | funding sources; providing an effective date. |
| 19 |
|
| 20 | Be It Enacted by the Legislature of the State of Florida: |
| 21 |
|
| 22 | Section 1. Section 893.055, Florida Statutes, is created |
| 23 | to read: |
| 24 | 893.055 Electronic-monitoring system for prescription of |
| 25 | controlled substances listed in Schedule II, Schedule III, or |
| 26 | Schedule IV.-- |
| 27 | (1) As used in this section, the term: |
| 28 | (a) "Agency" means the Agency for Health Care |
| 29 | Administration. |
| 30 | (b) "Department" means the Department of Health. |
| 31 | (c) "Pharmacy" means any pharmacy that is subject to |
| 32 | licensure or regulation by the department pursuant to chapter |
| 33 | 465 and that dispenses or delivers a controlled substance |
| 34 | included in Schedule II, Schedule III, or Schedule IV in s. |
| 35 | 893.03 to a patient in this state. |
| 36 | (2) By June 30, 2010, the agency shall design and |
| 37 | establish an electronic system consistent with standards of the |
| 38 | American Society for Automation in Pharmacy to monitor the |
| 39 | prescribing of controlled substances listed in Schedule II, |
| 40 | Schedule III, or Schedule IV in s. 893.03 by health care |
| 41 | practitioners and the dispensing of such controlled substances |
| 42 | to an individual by a dispensing practitioner pursuant to |
| 43 | chapter 465 or a pharmacy permitted or registered by the Board |
| 44 | of Pharmacy pursuant to chapter 465. |
| 45 | (3) Each time a controlled substance listed in Schedule |
| 46 | II, Schedule III, or Schedule IV is dispensed to an individual, |
| 47 | the controlled substance must be reported to the agency through |
| 48 | the system as soon thereafter as possible, but not more than 15 |
| 49 | days after the date the controlled substance is dispensed. A |
| 50 | pharmacy or dispensing practitioner may meet the reporting |
| 51 | requirements of this section by providing to the agency in |
| 52 | written or any electronic or magnetic format, including, but not |
| 53 | limited to, electronic submission via the Internet or magnetic |
| 54 | disc or tape, each controlled substance listed in Schedule II, |
| 55 | Schedule III, or Schedule IV which it dispenses. |
| 56 | (4) The agency shall notify each dispenser and prescriber |
| 57 | subject to the reporting requirements in this section of the |
| 58 | implementation date for the reporting requirements as set forth |
| 59 | in the rules of the agency. |
| 60 | (5) This section does not apply to controlled substances: |
| 61 | (a) Administered by a health care practitioner directly to |
| 62 | a patient. |
| 63 | (b) Dispensed by a health care practitioner authorized to |
| 64 | prescribe controlled substances directly to a patient and |
| 65 | limited to an amount adequate to treat the patient for a period |
| 66 | of not more than 72 hours. |
| 67 | (c) Dispensed by a health care practitioner or a |
| 68 | pharmacist to an inpatient of a facility that holds an |
| 69 | institutional pharmacy permit. |
| 70 | (d) Ordered from an institutional pharmacy permitted under |
| 71 | s. 465.019 in accordance with the institutional policy for such |
| 72 | controlled substances or drugs. |
| 73 | (e) Dispensed by a pharmacist or administered by a health |
| 74 | care practitioner to a patient or resident receiving care from a |
| 75 | hospital, nursing home, assisted living facility, home health |
| 76 | agency, hospice, or intermediate care facility for the |
| 77 | developmentally disabled which is licensed in this state. |
| 78 | (6) The data required to be reported under this section |
| 79 | shall be determined by the department by rule and may include, |
| 80 | but is not limited to, any data required under s. 893.04. |
| 81 | (7) A practitioner or pharmacist who dispenses a |
| 82 | controlled substance listed in Schedule II, Schedule III, or |
| 83 | Schedule IV in s. 893.03 must submit the information required by |
| 84 | this section in an electronic or other format approved by rule |
| 85 | of the agency. The cost to the dispenser in submitting the |
| 86 | information required by this section may not be material or |
| 87 | extraordinary. Costs not considered to be material or |
| 88 | extraordinary include, but are not limited to, regular postage, |
| 89 | compact discs, zip-drive storage, regular electronic mail, |
| 90 | magnetic tapes, diskettes, and facsimile charges. The |
| 91 | information submitted to the agency under this section may be |
| 92 | transmitted to any person or agency authorized to receive it |
| 93 | pursuant to chapter 119, and that person or agency may maintain |
| 94 | the information received for up to 24 months before purging the |
| 95 | information from its records. All transmissions required by this |
| 96 | subsection must comply with relevant privacy and security laws |
| 97 | of the state and federal government. However, any authorized |
| 98 | agency receiving such information may maintain it for longer |
| 99 | than 24 months if the information is pertinent to an ongoing |
| 100 | investigation or prosecution. |
| 101 | (8) Any person who knowingly fails to report the |
| 102 | dispensing of a controlled substance listed in Schedule II, |
| 103 | Schedule III, or Schedule IV as required by this section commits |
| 104 | a misdemeanor of the first degree, punishable as provided in s. |
| 105 | 775.082 or s. 775.083. |
| 106 | (9) The department and the regulatory boards for the |
| 107 | health care practitioners subject to this section shall adopt |
| 108 | rules to administer this section. |
| 109 | (10) All costs incurred by the agency in administering the |
| 110 | prescription-monitoring system shall be through federal, |
| 111 | private, or grant funding applied for by the state. The agency |
| 112 | and state government shall cooperate in seeking grant funds at |
| 113 | no cost to the agency. |
| 114 | Section 2. This act shall take effect July 1, 2009. |