| 1 | A bill to be entitled |
| 2 | An act relating to drugs; creating s. 831.311, F.S.; |
| 3 | prohibiting the sale, manufacture, alteration, delivery, |
| 4 | uttering, or possession of counterfeit-resistant |
| 5 | prescription blanks for controlled substances with the |
| 6 | intent to injure or defraud; providing penalties; amending |
| 7 | s. 893.04, F.S.; providing additional requirements for the |
| 8 | dispensing of a controlled substance listed in Schedule |
| 9 | II, Schedule III, or Schedule IV; specifying circumstances |
| 10 | under which a pharmacist who dispenses controlled |
| 11 | substances by mail is exempt from certain requirements |
| 12 | governing patient identification; providing requirements |
| 13 | and limitations for dispensing controlled substances upon |
| 14 | an oral prescription; creating s. 408.0611, F.S.; |
| 15 | providing legislative intent; providing definitions; |
| 16 | requiring the Agency for Health Care Administration to |
| 17 | create a clearinghouse of information on electronic |
| 18 | prescribing; requiring the agency to monitor and report on |
| 19 | the implementation of electronic prescribing; creating s. |
| 20 | 893.065, F.S.; requiring the department to develop and |
| 21 | adopt by rule the form and content for a counterfeit-proof |
| 22 | prescription blank for voluntary use by physicians in |
| 23 | prescribing a controlled substance listed in Schedule II, |
| 24 | Schedule III, or Schedule IV; providing that penalties |
| 25 | shall become effective only upon adoption of rules; |
| 26 | prescribing duties of law enforcement agencies and medical |
| 27 | examiners when a person dies of an apparent drug overdose; |
| 28 | providing an effective date. |
| 29 |
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| 30 | Be It Enacted by the Legislature of the State of Florida: |
| 31 |
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| 32 | Section 1. Section 831.311, Florida Statutes, is created |
| 33 | to read: |
| 34 | 831.311 Unlawful sale, manufacture, alteration, delivery, |
| 35 | uttering, or possession of counterfeit-resistant prescription |
| 36 | blanks for controlled substances.-- |
| 37 | (1) It is unlawful for any person having the intent to |
| 38 | injure or defraud any person or to facilitate any violation of |
| 39 | s. 893.13 to sell, manufacture, alter, deliver, utter, or |
| 40 | possess with intent to injure or defraud any person, or to |
| 41 | facilitate any violation of s. 893.13, any counterfeit-resistant |
| 42 | prescription blanks for controlled substances, the form and |
| 43 | content of which are adopted by rule of the Department of Health |
| 44 | pursuant to s. 893.065. |
| 45 | (2) Any person who violates this section commits a felony |
| 46 | of the third degree, punishable as provided in s. 775.082, s. |
| 47 | 775.083, or s. 775.084. |
| 48 | Section 2. Section 893.04, Florida Statutes, is amended to |
| 49 | read: |
| 50 | 893.04 Pharmacist and practitioner.-- |
| 51 | (1) A pharmacist, in good faith and in the course of |
| 52 | professional practice only, may dispense controlled substances |
| 53 | upon a written or oral prescription of a practitioner, under the |
| 54 | following conditions: |
| 55 | (a) Oral prescriptions must be promptly reduced to writing |
| 56 | by the pharmacist or recorded electronically if permitted by |
| 57 | federal law. |
| 58 | (b) The written prescription must be dated and signed by |
| 59 | the prescribing practitioner on the day when issued. |
| 60 | (c) There shall appear on the face of the prescription or |
| 61 | written record thereof for the controlled substance the |
| 62 | following information: |
| 63 | 1. The full name and address of the person for whom, or |
| 64 | the owner of the animal for which, the controlled substance is |
| 65 | dispensed. |
| 66 | 2. The full name and address of the prescribing |
| 67 | practitioner and the practitioner's federal controlled substance |
| 68 | registry number shall be printed thereon. |
| 69 | 3. If the prescription is for an animal, the species of |
| 70 | animal for which the controlled substance is prescribed. |
| 71 | 4. The name of the controlled substance prescribed and the |
| 72 | strength, quantity, and directions for use thereof. |
| 73 | 5. The number of the prescription, as recorded in the |
| 74 | prescription files of the pharmacy in which it is filled. |
| 75 | 6. The initials of the pharmacist filling the prescription |
| 76 | and the date filled. |
| 77 | (d) The prescription shall be retained on file by the |
| 78 | proprietor of the pharmacy in which it is filled for a period of |
| 79 | 2 years. |
| 80 | (e) Affixed to the original container in which a |
| 81 | controlled substance is delivered upon a prescription or |
| 82 | authorized refill thereof, as hereinafter provided, there shall |
| 83 | be a label bearing the following information: |
| 84 | 1. The name and address of the pharmacy from which such |
| 85 | controlled substance was dispensed. |
| 86 | 2. The date on which the prescription for such controlled |
| 87 | substance was filled. |
| 88 | 3. The number of such prescription, as recorded in the |
| 89 | prescription files of the pharmacy in which it is filled. |
| 90 | 4. The name of the prescribing practitioner. |
| 91 | 5. The name of the patient for whom, or of the owner and |
| 92 | species of the animal for which, the controlled substance is |
| 93 | prescribed. |
| 94 | 6. The directions for the use of the controlled substance |
| 95 | prescribed in the prescription. |
| 96 | 7. A clear, concise warning that it is a crime to transfer |
| 97 | the controlled substance to any person other than the patient |
| 98 | for whom prescribed. |
| 99 | (f) A prescription for a controlled substance listed in |
| 100 | Schedule II may be dispensed only upon a written prescription of |
| 101 | a practitioner, except that in an emergency situation, as |
| 102 | defined by regulation of the Department of Health, such |
| 103 | controlled substance may be dispensed upon oral prescription but |
| 104 | is limited to a 72-hour supply. A No prescription for a |
| 105 | controlled substance listed in Schedule II may not be refilled. |
| 106 | (g) A No prescription for a controlled substance listed in |
| 107 | Schedule Schedules III, Schedule IV, or Schedule V may not be |
| 108 | filled or refilled more than five times within a period of 6 |
| 109 | months after the date on which the prescription was written |
| 110 | unless the prescription is renewed by a practitioner. |
| 111 | (2)(a) A pharmacist may not dispense a controlled |
| 112 | substance listed in Schedule II, Schedule III, or Schedule IV to |
| 113 | any patient or patient's agent without first determining, in the |
| 114 | exercise of her or his professional judgment, that the order is |
| 115 | valid. The pharmacist may dispense the controlled substance, in |
| 116 | the exercise of her or his professional judgment, when the |
| 117 | pharmacist or pharmacist's agent has obtained satisfactory |
| 118 | patient information from the patient or the patient's agent. |
| 119 | (b) Any pharmacist who dispenses by mail a controlled |
| 120 | substance listed in Schedule II, Schedule III, or Schedule IV is |
| 121 | exempt from the requirement to obtain suitable identification |
| 122 | for the prescription dispensed by mail if the pharmacist has |
| 123 | obtained the patient's identification through the patient's |
| 124 | prescription benefit plan. |
| 125 | (c) Any controlled substance listed in Schedule III or |
| 126 | Schedule IV may be dispensed by a pharmacist upon an oral |
| 127 | prescription if, before filling the prescription, the pharmacist |
| 128 | reduces it to writing or records the prescription electronically |
| 129 | if permitted by federal law. Such prescriptions must contain the |
| 130 | date of the oral authorization. |
| 131 | (d) Each written prescription prescribed by a practitioner |
| 132 | in this state for a controlled substance listed in Schedule II, |
| 133 | Schedule III, or Schedule IV must include both a written and a |
| 134 | numerical notation of the quantity on the face of the |
| 135 | prescription and a notation of the date, with the abbreviated |
| 136 | month written out on the face of the prescription. A pharmacist |
| 137 | may, upon verification by the prescriber, document any |
| 138 | information required by this paragraph. |
| 139 | (e) A pharmacist may not dispense more than a 30-day |
| 140 | supply of a controlled substance listed in Schedule III upon an |
| 141 | oral prescription issued in this state. |
| 142 | (f) A pharmacist may not knowingly fill a prescription |
| 143 | that has been forged for a controlled substance listed in |
| 144 | Schedule II, Schedule III, or Schedule IV. |
| 145 | (3)(2) Notwithstanding the provisions of subsection (1), a |
| 146 | pharmacist may dispense a one-time emergency refill of up to a |
| 147 | 72-hour supply of the prescribed medication for any medicinal |
| 148 | drug other than a medicinal drug listed in Schedule II, in |
| 149 | compliance with the provisions of s. 465.0275. |
| 150 | (4)(3) The legal owner of any stock of controlled |
| 151 | substances in a pharmacy, upon discontinuance of dealing in |
| 152 | controlled substances, may sell said stock to a manufacturer, |
| 153 | wholesaler, or pharmacy. Such controlled substances may be sold |
| 154 | only upon an order form, when such an order form is required for |
| 155 | sale by the drug abuse laws of the United States or this state, |
| 156 | or regulations pursuant thereto. |
| 157 | Section 3. Section 408.0611, Florida Statutes, is created |
| 158 | to read: |
| 159 | 408.0611 Electronic prescribing clearinghouse.-- |
| 160 | (1) It is the intent of the Legislature to promote the |
| 161 | implementation of electronic prescribing by health care |
| 162 | practitioners, health care facilities, and pharmacies in order |
| 163 | to prevent prescription drug abuse, improve patient safety, and |
| 164 | reduce unnecessary prescriptions. To that end, it is the intent |
| 165 | of the Legislature to create a clearinghouse of information on |
| 166 | electronic prescribing to convey the process and advantages of |
| 167 | electronic prescribing; to provide information regarding the |
| 168 | availability of electronic prescribing products, including no- |
| 169 | cost or low-cost products; and to regularly convene stakeholders |
| 170 | to assess and accelerate the implementation of electronic |
| 171 | prescribing. |
| 172 | (2) As used in this section, the term: |
| 173 | (a) "Electronic prescribing" means, at a minimum, the |
| 174 | electronic review of the patient's medication history, the |
| 175 | electronic generation of the patient's prescription, and the |
| 176 | electronic transmission of the patient's prescription to a |
| 177 | pharmacy. |
| 178 | (b) "Health care practitioner" means an individual |
| 179 | authorized by law to prescribe drugs. |
| 180 | (3) The agency shall work in collaboration with private- |
| 181 | sector electronic prescribing initiatives and relevant |
| 182 | stakeholders to create a clearinghouse of information on |
| 183 | electronic prescribing for health care practitioners, health |
| 184 | care facilities, and pharmacies. These stakeholders shall |
| 185 | include organizations that represent health care practitioners; |
| 186 | organizations that represent health care facilities; |
| 187 | organizations that represent pharmacies; organizations that |
| 188 | operate electronic prescribing networks; organizations that |
| 189 | create electronic prescribing products; and regional health |
| 190 | information organizations. Specifically, the agency shall, by |
| 191 | October 1, 2007: |
| 192 | (a) Provide on its website: |
| 193 | 1. Information regarding the process of electronic |
| 194 | prescribing and the availability of electronic prescribing |
| 195 | products, including no-cost or low-cost products; |
| 196 | 2. Information regarding the advantages of electronic |
| 197 | prescribing, including using medication history data to prevent |
| 198 | drug interactions, prevent allergic reactions, and deter doctor |
| 199 | and pharmacy shopping for controlled substances; |
| 200 | 3. Links to federal and private-sector websites that |
| 201 | provide guidance on selecting an appropriate electronic |
| 202 | prescribing product; and |
| 203 | 4. Links to state, federal, and private-sector incentive |
| 204 | programs for the implementation of electronic prescribing. |
| 205 | (b) Convene quarterly meetings of the stakeholders to |
| 206 | assess and accelerate the implementation of electronic |
| 207 | prescribing. |
| 208 | (4) Pursuant to s. 408.061, the agency shall monitor the |
| 209 | implementation of electronic prescribing by health care |
| 210 | practitioners, health care facilities, and pharmacies. By |
| 211 | January 31 of each year, the agency shall report on the progress |
| 212 | of implementation of electronic prescribing to the Governor and |
| 213 | the Legislature. Information reported pursuant to this |
| 214 | subsection shall include federal and private-sector electronic |
| 215 | prescribing initiatives and, to the extent that data is readily |
| 216 | available from organizations that operate electronic prescribing |
| 217 | networks, the number of health care practitioners using |
| 218 | electronic prescribing and the number of prescriptions |
| 219 | electronically transmitted. |
| 220 | Section 4. Section 893.065, Florida Statutes, is created |
| 221 | to read: |
| 222 | 893.065 Counterfeit-resistant prescription blanks for |
| 223 | controlled substances listed in Schedule II, Schedule III, or |
| 224 | Schedule IV.--The Department of Health shall develop and adopt |
| 225 | by rule the form and content for a counterfeit-resistant |
| 226 | prescription blank which may be used by practitioners for the |
| 227 | purpose of prescribing a controlled substance listed in Schedule |
| 228 | II, Schedule III, or Schedule IV. The Department of Health may |
| 229 | require the prescription blanks to be printed on distinctive, |
| 230 | watermarked paper and to bear the preprinted name, address, and |
| 231 | category of professional licensure of the practitioner and that |
| 232 | practitioner's federal registry number for controlled |
| 233 | substances. The prescription blanks may not be transferred. |
| 234 | Section 5. The penalties created in s. 831.311(2), Florida |
| 235 | Statutes, by this act shall be effective only upon the adoption |
| 236 | of the rules required pursuant to s. 893.065, Florida Statutes, |
| 237 | as created by this act. |
| 238 | Section 6. If a person dies of an apparent drug overdose: |
| 239 | (1) A law enforcement agency shall prepare a report |
| 240 | identifying each prescribed controlled substance listed in |
| 241 | Schedule II, Schedule III, or Schedule IV of s. 893.03, Florida |
| 242 | Statutes, which is found on or near the deceased or among the |
| 243 | deceased's possessions. The report must identify the person who |
| 244 | prescribed the controlled substance, if known or ascertainable. |
| 245 | Thereafter, the law enforcement agency shall submit a copy of |
| 246 | the report to the medical examiner. |
| 247 | (2) A medical examiner who is preparing a report pursuant |
| 248 | to s. 406.11, Florida Statutes, shall include in the report |
| 249 | information identifying each prescribed controlled substance |
| 250 | listed in Schedule II, Schedule III, or Schedule IV of s. |
| 251 | 893.03, Florida Statutes, that was found in, on, or near the |
| 252 | deceased or among the deceased's possessions. |
| 253 | Section 7. This act shall take effect July 1, 2007. |