| 1 | A bill to be entitled |
| 2 | An act relating to controlled substances; amending s. |
| 3 | 456.44, F.S.; revising the definition of the term |
| 4 | "addiction medicine specialist" to include a board- |
| 5 | certified psychiatrist, rather than a physiatrist; |
| 6 | providing that the management of pain in certain |
| 7 | patients requires consultation with or referral to a |
| 8 | psychiatrist, rather than a physiatrist; providing |
| 9 | that a prescription is deemed compliant with the |
| 10 | standards of practice and is valid for dispensing when |
| 11 | a pharmacy receives it; providing that the standards |
| 12 | of practice regarding the prescribing of controlled |
| 13 | substances do not apply to certain board-certified |
| 14 | psychiatrists and rheumatologists; amending ss. |
| 15 | 458.3265 and 459.0137, F.S.; requiring that a pain- |
| 16 | management clinic register with the Department of |
| 17 | Health unless the clinic is wholly owned and operated |
| 18 | by certain health care professionals, including a |
| 19 | board-certified psychiatrist or rheumatologist; |
| 20 | amending s. 465.015, F.S.; revising the requirements |
| 21 | for reporting the fraudulent obtaining of a controlled |
| 22 | substance; revising the required contents of the |
| 23 | report; amending s. 465.022, F.S.; requiring that the |
| 24 | Department of Health or the Board of Pharmacy deny an |
| 25 | initial or renewal application for a pharmacy permit |
| 26 | if an applicant or an affiliated person of record of |
| 27 | the applicant, including a health care practitioner, |
| 28 | has been convicted of, or entered a plea of guilty or |
| 29 | nolo contendere to, regardless of adjudication, |
| 30 | unlawfully providing a controlled substance or a |
| 31 | prescription for a controlled substance by |
| 32 | misrepresentation, fraud, forgery, deception, |
| 33 | subterfuge, or concealment of a material fact; |
| 34 | amending s. 465.023, F.S.; authorizing the department |
| 35 | or the board to revoke or suspend a pharmacy permit |
| 36 | and to fine, place on probation, or discipline a |
| 37 | pharmacy permittee if the permittee or any affiliated |
| 38 | person or agent of the permittee, including a health |
| 39 | care practitioner, has been convicted of, or entered a |
| 40 | plea of guilty or nolo contendere to, regardless of |
| 41 | adjudication, unlawfully providing a controlled |
| 42 | substance or a prescription for a controlled substance |
| 43 | by misrepresentation, fraud, forgery, deception, |
| 44 | subterfuge, or concealment of a material fact; |
| 45 | amending s. 499.003, F.S.; defining the term |
| 46 | "prescription" as it relates to the Florida Drug and |
| 47 | Cosmetic Act; creating s. 499.0032, F.S.; authorizing |
| 48 | a pharmacist to fill a prescription for drugs or |
| 49 | medicinal supplies which is transmitted or written by |
| 50 | a physician, dentist, veterinarian, or other |
| 51 | practitioner licensed to practice in another state |
| 52 | under certain circumstances; requiring the pharmacist |
| 53 | to obtain proof to a reasonable certainty of the |
| 54 | validity of the prescription under certain |
| 55 | circumstances; prohibiting the issuance of a |
| 56 | prescription order for a controlled substance on the |
| 57 | same prescription blank with another prescription |
| 58 | order for a controlled substance that is named or |
| 59 | described in a different schedule; prohibiting the |
| 60 | issuance of a prescription order for a controlled |
| 61 | substance on the same prescription blank as a |
| 62 | prescription order for a medicinal drug; providing |
| 63 | that a prescription obtained in violation of state |
| 64 | law, or obtained through misrepresentation, fraud, |
| 65 | forgery, deception, or subterfuge, is not a valid |
| 66 | prescription; amending s. 893.02, F.S.; redefining the |
| 67 | term "prescription" as it relates to the Florida |
| 68 | Comprehensive Drug Abuse Prevention and Control Act to |
| 69 | clarify that a prescription obtained in violation of |
| 70 | law is not a valid prescription; amending s. 893.055, |
| 71 | F.S.; requiring that a prescriber access information |
| 72 | in the prescription drug monitoring database before |
| 73 | prescribing certain controlled substances listed in s. |
| 74 | 893.03, F.S., under certain circumstances; amending s. |
| 75 | 893.13, F.S.; revising prohibited acts regarding the |
| 76 | distribution of controlled substances; providing an |
| 77 | effective date. |
| 78 |
|
| 79 | Be It Enacted by the Legislature of the State of Florida: |
| 80 |
|
| 81 | Section 1. Paragraph (a) of subsection (1) and subsection |
| 82 | (3) of section 456.44, Florida Statutes, are amended to read: |
| 83 | 456.44 Controlled substance prescribing.- |
| 84 | (1) DEFINITIONS.- |
| 85 | (a) "Addiction medicine specialist" means a board- |
| 86 | certified psychiatrist who holds physiatrist with a subspecialty |
| 87 | certification in addiction medicine or who is eligible for such |
| 88 | subspecialty certification in addiction medicine, an addiction |
| 89 | medicine physician who is certified or eligible for |
| 90 | certification by the American Society of Addiction Medicine, or |
| 91 | an osteopathic physician who holds a certificate of added |
| 92 | qualification in Addiction Medicine through the American |
| 93 | Osteopathic Association. |
| 94 | (3) STANDARDS OF PRACTICE.-The standards of practice in |
| 95 | this section do not supersede the level of care, skill, and |
| 96 | treatment recognized in general law related to health care |
| 97 | licensure. |
| 98 | (a) A complete medical history and a physical examination |
| 99 | must be conducted before beginning any treatment and must be |
| 100 | documented in the medical record. The exact components of the |
| 101 | physical examination shall be left to the judgment of the |
| 102 | clinician who is expected to perform a physical examination |
| 103 | proportionate to the diagnosis that justifies a treatment. The |
| 104 | medical record must, at a minimum, document the nature and |
| 105 | intensity of the pain, current and past treatments for pain, |
| 106 | underlying or coexisting diseases or conditions, the effect of |
| 107 | the pain on physical and psychological function, a review of |
| 108 | previous medical records, previous diagnostic studies, and |
| 109 | history of alcohol and substance abuse. The medical record must |
| 110 | shall also document the presence of one or more recognized |
| 111 | medical indications for the use of a controlled substance. Each |
| 112 | registrant must develop a written plan for assessing each |
| 113 | patient's risk of aberrant drug-related behavior, which may |
| 114 | include patient drug testing. Registrants must assess each |
| 115 | patient's risk for aberrant drug-related behavior and monitor |
| 116 | that risk on an ongoing basis in accordance with the plan. |
| 117 | (b) Each registrant must develop a written individualized |
| 118 | treatment plan for each patient. The treatment plan must shall |
| 119 | state objectives that will be used to determine treatment |
| 120 | success, such as pain relief and improved physical and |
| 121 | psychosocial function, and must shall indicate if any further |
| 122 | diagnostic evaluations or other treatments are planned. After |
| 123 | treatment begins, the physician shall adjust drug therapy to the |
| 124 | individual medical needs of each patient. Other treatment |
| 125 | modalities, including a rehabilitation program, shall be |
| 126 | considered depending on the etiology of the pain and the extent |
| 127 | to which the pain is associated with physical and psychosocial |
| 128 | impairment. The interdisciplinary nature of the treatment plan |
| 129 | shall be documented. |
| 130 | (c) The physician shall discuss the risks and benefits of |
| 131 | the use of controlled substances, including the risks of abuse |
| 132 | and addiction, as well as physical dependence and its |
| 133 | consequences, with the patient, persons designated by the |
| 134 | patient, or the patient's surrogate or guardian if the patient |
| 135 | is incompetent. The physician shall use a written controlled |
| 136 | substance agreement between the physician and the patient |
| 137 | outlining the patient's responsibilities, including, but not |
| 138 | limited to: |
| 139 | 1. Number and frequency of prescriptions and refills for |
| 140 | controlled substances substance prescriptions and refills. |
| 141 | 2. Patient compliance and reasons for which drug therapy |
| 142 | may be discontinued, such as a violation of the agreement. |
| 143 | 3. An agreement that controlled substances for the |
| 144 | treatment of chronic nonmalignant pain shall be prescribed by a |
| 145 | single treating physician unless otherwise authorized by the |
| 146 | treating physician and documented in the medical record. |
| 147 | (d) The patient shall be seen by the physician at regular |
| 148 | intervals, not to exceed 3 months, to assess the efficacy of |
| 149 | treatment, ensure that controlled-substance controlled substance |
| 150 | therapy remains indicated, evaluate the patient's progress |
| 151 | toward treatment objectives, consider adverse drug effects, and |
| 152 | review the etiology of the pain. Continuation or modification of |
| 153 | therapy depends shall depend on the physician's evaluation of |
| 154 | the patient's progress. If treatment goals are not being |
| 155 | achieved, despite medication adjustments, the physician shall |
| 156 | reevaluate the appropriateness of continued treatment. The |
| 157 | physician shall monitor patient compliance in medication usage, |
| 158 | related treatment plans, controlled substance agreements, and |
| 159 | indications of substance abuse or diversion at a minimum of 3- |
| 160 | month intervals. |
| 161 | (e) The physician shall refer the patient as necessary for |
| 162 | additional evaluation and treatment in order to achieve |
| 163 | treatment objectives. Special attention shall be given to those |
| 164 | patients who are at risk for misusing their medications and |
| 165 | those whose living arrangements pose a risk for medication |
| 166 | misuse or diversion. The management of pain in patients with a |
| 167 | history of substance abuse or with a comorbid psychiatric |
| 168 | disorder requires extra care, monitoring, and documentation and |
| 169 | requires consultation with or referral to an addictionologist or |
| 170 | psychiatrist physiatrist. |
| 171 | (f) A physician registered under this section must |
| 172 | maintain accurate, current, and complete records that are |
| 173 | accessible and readily available for review and comply with the |
| 174 | requirements of this section, the applicable practice act, and |
| 175 | applicable board rules. The medical records must include, but |
| 176 | are not limited to: |
| 177 | 1. The complete medical history and a physical |
| 178 | examination, including history of drug abuse or dependence. |
| 179 | 2. Diagnostic, therapeutic, and laboratory results. |
| 180 | 3. Evaluations and consultations. |
| 181 | 4. Treatment objectives. |
| 182 | 5. Discussion of risks and benefits. |
| 183 | 6. Treatments. |
| 184 | 7. Medications, including date, type, dosage, and quantity |
| 185 | prescribed. |
| 186 | 8. Instructions and agreements. |
| 187 | 9. Periodic reviews. |
| 188 | 10. Results of any drug testing. |
| 189 | 11. A photocopy of the patient's government-issued photo |
| 190 | identification. |
| 191 | 12. If a written prescription for a controlled substance |
| 192 | is given to the patient, a duplicate of the prescription. |
| 193 | 13. The physician's full name presented in a legible |
| 194 | manner. |
| 195 | (g) Patients with signs or symptoms of substance abuse |
| 196 | shall be immediately referred to a board-certified pain |
| 197 | management physician, an addiction medicine specialist, or a |
| 198 | mental health addiction facility as it pertains to drug abuse or |
| 199 | addiction unless the physician is board-certified or board- |
| 200 | eligible in pain management. Throughout the period of time |
| 201 | before receiving the consultant's report, a prescribing |
| 202 | physician shall clearly and completely document medical |
| 203 | justification for continued treatment with controlled substances |
| 204 | and those steps taken to ensure medically appropriate use of |
| 205 | controlled substances by the patient. Upon receipt of the |
| 206 | consultant's written report, the prescribing physician shall |
| 207 | incorporate the consultant's recommendations for continuing, |
| 208 | modifying, or discontinuing the controlled-substance controlled |
| 209 | substance therapy. The resulting changes in treatment shall be |
| 210 | specifically documented in the patient's medical record. |
| 211 | Evidence or behavioral indications of diversion shall be |
| 212 | followed by discontinuation of the controlled-substance |
| 213 | controlled substance therapy, and the patient shall be |
| 214 | discharged, and all results of testing and actions taken by the |
| 215 | physician shall be documented in the patient's medical record. |
| 216 | (h) When a pharmacy subject to this section receives a |
| 217 | prescription, the prescription is deemed compliant with the |
| 218 | standards of practice under this section and, therefore, valid |
| 219 | for dispensing. |
| 220 |
|
| 221 | This subsection does not apply to a board-certified |
| 222 | anesthesiologist, physiatrist, psychiatrist, rheumatologist, or |
| 223 | neurologist, or to a board-certified physician who has surgical |
| 224 | privileges at a hospital or ambulatory surgery center and |
| 225 | primarily provides surgical services. This subsection does not |
| 226 | apply to a board-certified medical specialist who has also |
| 227 | completed a fellowship in pain medicine approved by the |
| 228 | Accreditation Council for Graduate Medical Education or the |
| 229 | American Osteopathic Association, or who is board certified in |
| 230 | pain medicine by a board approved by the American Board of |
| 231 | Medical Specialties or the American Osteopathic Association and |
| 232 | performs interventional pain procedures of the type routinely |
| 233 | billed using surgical codes. |
| 234 | Section 2. Paragraph (a) of subsection (1) of section |
| 235 | 458.3265, Florida Statutes, is amended to read: |
| 236 | 458.3265 Pain-management clinics.- |
| 237 | (1) REGISTRATION.- |
| 238 | (a)1. As used in this section, the term: |
| 239 | a. "Chronic nonmalignant pain" means pain unrelated to |
| 240 | cancer or rheumatoid arthritis which persists beyond the usual |
| 241 | course of disease or beyond the injury that is the cause of the |
| 242 | pain or which persists more than 90 days after surgery. |
| 243 | b. "Pain-management clinic" or "clinic" means any publicly |
| 244 | or privately owned facility: |
| 245 | (I) That advertises in any medium for any type of pain- |
| 246 | management services; or |
| 247 | (II) Where in any month a majority of patients are |
| 248 | prescribed opioids, benzodiazepines, barbiturates, or |
| 249 | carisoprodol for the treatment of chronic nonmalignant pain. |
| 250 | 2. Each pain-management clinic must register with the |
| 251 | department unless: |
| 252 | a. The That clinic is licensed as a facility pursuant to |
| 253 | chapter 395; |
| 254 | b. The majority of the physicians who provide services in |
| 255 | the clinic primarily provide primarily surgical services; |
| 256 | c. The clinic is owned by a publicly held corporation |
| 257 | whose shares are traded on a national exchange or on the over- |
| 258 | the-counter market and whose total assets at the end of the |
| 259 | corporation's most recent fiscal quarter exceeded $50 million; |
| 260 | d. The clinic is affiliated with an accredited medical |
| 261 | school at which training is provided for medical students, |
| 262 | residents, or fellows; |
| 263 | e. The clinic does not prescribe controlled substances for |
| 264 | the treatment of pain; |
| 265 | f. The clinic is owned by a corporate entity exempt from |
| 266 | federal taxation under 26 U.S.C. s. 501(c)(3); |
| 267 | g. The clinic is wholly owned and operated by one or more |
| 268 | board-certified anesthesiologists, physiatrists, psychiatrists, |
| 269 | rheumatologists, or neurologists; or |
| 270 | h. The clinic is wholly owned and operated by one or more |
| 271 | board-certified medical specialists who have also completed |
| 272 | fellowships in pain medicine approved by the Accreditation |
| 273 | Council for Graduate Medical Education, or who are also board- |
| 274 | certified in pain medicine by a board approved by the American |
| 275 | Board of Medical Specialties and perform interventional pain |
| 276 | procedures of the type routinely billed using surgical codes. |
| 277 | Section 3. Paragraph (a) of subsection (1) of section |
| 278 | 459.0137, Florida Statutes, is amended to read: |
| 279 | 459.0137 Pain-management clinics.- |
| 280 | (1) REGISTRATION.- |
| 281 | (a)1. As used in this section, the term: |
| 282 | a. "Chronic nonmalignant pain" means pain unrelated to |
| 283 | cancer or rheumatoid arthritis which persists beyond the usual |
| 284 | course of disease or beyond the injury that is the cause of the |
| 285 | pain or which persists more than 90 days after surgery. |
| 286 | b. "Pain-management clinic" or "clinic" means any publicly |
| 287 | or privately owned facility: |
| 288 | (I) That advertises in any medium for any type of pain- |
| 289 | management services; or |
| 290 | (II) Where in any month a majority of patients are |
| 291 | prescribed opioids, benzodiazepines, barbiturates, or |
| 292 | carisoprodol for the treatment of chronic nonmalignant pain. |
| 293 | 2. Each pain-management clinic must register with the |
| 294 | department unless: |
| 295 | a. The That clinic is licensed as a facility pursuant to |
| 296 | chapter 395; |
| 297 | b. The majority of the physicians who provide services in |
| 298 | the clinic primarily provide primarily surgical services; |
| 299 | c. The clinic is owned by a publicly held corporation |
| 300 | whose shares are traded on a national exchange or on the over- |
| 301 | the-counter market and whose total assets at the end of the |
| 302 | corporation's most recent fiscal quarter exceeded $50 million; |
| 303 | d. The clinic is affiliated with an accredited medical |
| 304 | school at which training is provided for medical students, |
| 305 | residents, or fellows; |
| 306 | e. The clinic does not prescribe controlled substances for |
| 307 | the treatment of pain; |
| 308 | f. The clinic is owned by a corporate entity exempt from |
| 309 | federal taxation under 26 U.S.C. s. 501(c)(3); |
| 310 | g. The clinic is wholly owned and operated by one or more |
| 311 | board-certified anesthesiologists, physiatrists, psychiatrists, |
| 312 | rheumatologists, or neurologists; or |
| 313 | h. The clinic is wholly owned and operated by one or more |
| 314 | board-certified medical specialists who have also completed |
| 315 | fellowships in pain medicine approved by the Accreditation |
| 316 | Council for Graduate Medical Education or the American |
| 317 | Osteopathic Association, or who are also board-certified in pain |
| 318 | medicine by a board approved by the American Board of Medical |
| 319 | Specialties or the American Osteopathic Association and perform |
| 320 | interventional pain procedures of the type routinely billed |
| 321 | using surgical codes. |
| 322 | Section 4. Subsection (3) of section 465.015, Florida |
| 323 | Statutes, is amended to read: |
| 324 | 465.015 Violations and penalties.- |
| 325 | (3)(a) It is unlawful for any pharmacist to knowingly fail |
| 326 | to report any instance in which the pharmacist knows or believes |
| 327 | that a person obtained or attempted to obtain, through a |
| 328 | fraudulent method or representation, a controlled substance as |
| 329 | defined in s. 893.02 from the pharmacy at which the pharmacist |
| 330 | practices pharmacy. The pharmacist shall report to the sheriff |
| 331 | or other chief law enforcement agency of the county where the |
| 332 | pharmacy is located within 24 hours after learning of the fraud |
| 333 | or attempted fraud any instance in which a person obtained or |
| 334 | attempted to obtain a controlled substance, as defined in s. |
| 335 | 893.02, or at the close of business on the next business day, |
| 336 | whichever occurs is later, that the pharmacist knew or believed |
| 337 | was obtained or attempted to be obtained through fraudulent |
| 338 | methods or representations from the pharmacy at which the |
| 339 | pharmacist practiced pharmacy. Any pharmacist who knowingly |
| 340 | fails to make such a report within 24 hours after learning of |
| 341 | the fraud or attempted fraud or at the close of business on the |
| 342 | next business day, whichever occurs is later, commits a |
| 343 | misdemeanor of the first degree, punishable as provided in s. |
| 344 | 775.082 or s. 775.083. |
| 345 | (b) A sufficient report of the fraudulent obtaining of a |
| 346 | controlled substance substances under this subsection must |
| 347 | contain, at a minimum, a copy of the prescription used or |
| 348 | presented and a narrative, including all information available |
| 349 | to the pharmacist concerning the transaction, such as the name |
| 350 | and telephone number of the prescribing physician; the name, |
| 351 | description, and any personal identification information |
| 352 | pertaining to the person who presented the prescription; and all |
| 353 | other material information, such as photographic or video |
| 354 | surveillance of the transaction. Any sheriff or chief law |
| 355 | enforcement officer of a jurisdiction, or the agent of any such |
| 356 | person, who receives a report from a pharmacist under this |
| 357 | subsection must receive and document such report. If the sheriff |
| 358 | or chief law enforcement officer of a jurisdiction, or the agent |
| 359 | of any such person, refuses to take the pharmacist's report, the |
| 360 | pharmacist shall be deemed to have complied with this subsection |
| 361 | if the pharmacist documents such refusal. |
| 362 | Section 5. Subsection (5) of section 465.022, Florida |
| 363 | Statutes, is amended to read: |
| 364 | 465.022 Pharmacies; general requirements; fees.- |
| 365 | (5) The department or board shall deny an application for |
| 366 | a pharmacy permit if the applicant or an affiliated person, |
| 367 | partner, officer, director, or prescription department manager, |
| 368 | health care practitioner, or consultant pharmacist of record of |
| 369 | the applicant: |
| 370 | (a) Has obtained a permit by misrepresentation or fraud. |
| 371 | (b) Has attempted to procure, or has procured, a permit |
| 372 | for any other person by making, or causing to be made, any false |
| 373 | representation. |
| 374 | (c) Has been convicted of, or entered a plea of guilty or |
| 375 | nolo contendere to, regardless of adjudication, a crime in any |
| 376 | jurisdiction which relates to the practice of, or the ability to |
| 377 | practice, the profession of pharmacy. |
| 378 | (d) Has been convicted of, or entered a plea of guilty or |
| 379 | nolo contendere to, regardless of adjudication, a crime in any |
| 380 | jurisdiction which relates to health care fraud. |
| 381 | (e) Has been convicted of, or entered a plea of guilty or |
| 382 | nolo contendere to, regardless of adjudication, a felony under |
| 383 | chapter 409, chapter 817, or chapter 893, or a similar felony |
| 384 | offense committed in another state or jurisdiction, since July |
| 385 | 1, 2009. |
| 386 | (f) Has been convicted of, or entered a plea of guilty or |
| 387 | nolo contendere to, regardless of adjudication, a felony under |
| 388 | 21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396 since July 1, |
| 389 | 2009. |
| 390 | (g) Has been terminated for cause from the Florida |
| 391 | Medicaid program pursuant to s. 409.913, unless the applicant |
| 392 | has been in good standing with the Florida Medicaid program for |
| 393 | the most recent 5-year period. |
| 394 | (h) Has been terminated for cause, pursuant to the appeals |
| 395 | procedures established by the state, from any other state |
| 396 | Medicaid program, unless the applicant has been in good standing |
| 397 | with a state Medicaid program for the most recent 5-year period |
| 398 | and the termination occurred at least 20 years before the date |
| 399 | of the application. |
| 400 | (i) Is currently listed on the List of Excluded |
| 401 | Individuals and Entities that is maintained by the United States |
| 402 | Department of Health and Human Services Office of Inspector |
| 403 | General General's List of Excluded Individuals and Entities. |
| 404 | (j) Has dispensed any medicinal drug based upon a |
| 405 | communication that purports to be a prescription as defined by |
| 406 | s. 465.003(14) or s. 893.02 when the pharmacist knows or has |
| 407 | reason to believe that the purported prescription is not based |
| 408 | upon a valid practitioner-patient relationship that includes a |
| 409 | documented patient evaluation, including history and a physical |
| 410 | examination adequate to establish the diagnosis for which any |
| 411 | drug is prescribed and any other requirement established by |
| 412 | board rule under chapter 458, chapter 459, chapter 461, chapter |
| 413 | 463, chapter 464, or chapter 466. |
| 414 | (k) Has been convicted of, or entered a plea of guilty or |
| 415 | nolo contendere to, regardless of adjudication, a felony under |
| 416 | s. 893.13(7)(b). |
| 417 |
|
| 418 | For felonies in which the defendant entered a plea of guilty or |
| 419 | nolo contendere in an agreement with the court to enter a |
| 420 | pretrial intervention or drug diversion program, the department |
| 421 | shall deny the application if, upon final resolution of the |
| 422 | case, the licensee has failed to successfully complete the |
| 423 | program. |
| 424 | Section 6. Subsection (1) of section 465.023, Florida |
| 425 | Statutes, is amended to read: |
| 426 | 465.023 Pharmacy permittee; disciplinary action.- |
| 427 | (1) The department or the board may revoke or suspend the |
| 428 | permit of any pharmacy permittee, and may fine, place on |
| 429 | probation, or otherwise discipline any pharmacy permittee if the |
| 430 | permittee, or any affiliated person, partner, officer, health |
| 431 | care practitioner, director, or agent of the permittee, |
| 432 | including a person fingerprinted under s. 465.022(3), has: |
| 433 | (a) Obtained a permit by misrepresentation or fraud or |
| 434 | through an error of the department or the board; |
| 435 | (b) Attempted to procure, or has procured, a permit for |
| 436 | any other person by making, or causing to be made, any false |
| 437 | representation; |
| 438 | (c) Violated any of the requirements of this chapter or |
| 439 | any of the rules of the Board of Pharmacy; of chapter 499, known |
| 440 | as the "Florida Drug and Cosmetic Act"; of 21 U.S.C. ss. 301- |
| 441 | 392, known as the "Federal Food, Drug, and Cosmetic Act"; of 21 |
| 442 | U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse |
| 443 | Prevention and Control Act; or of chapter 893; |
| 444 | (d) Been convicted or found guilty, regardless of |
| 445 | adjudication, of a felony or any other crime involving moral |
| 446 | turpitude in any of the courts of this state, of any other |
| 447 | state, or of the United States; |
| 448 | (e) Been convicted or disciplined by a regulatory agency |
| 449 | of the Federal Government or a regulatory agency of another |
| 450 | state for any offense that would constitute a violation of this |
| 451 | chapter; |
| 452 | (f) Been convicted of, or entered a plea of guilty or nolo |
| 453 | contendere to, regardless of adjudication, a crime in any |
| 454 | jurisdiction which relates to the practice of, or the ability to |
| 455 | practice, the profession of pharmacy; |
| 456 | (g) Been convicted of, or entered a plea of guilty or nolo |
| 457 | contendere to, regardless of adjudication, a crime in any |
| 458 | jurisdiction which relates to health care fraud; or |
| 459 | (h) Dispensed any medicinal drug based upon a |
| 460 | communication that purports to be a prescription as defined by |
| 461 | s. 465.003(14) or s. 893.02 when the pharmacist knows or has |
| 462 | reason to believe that the purported prescription is not based |
| 463 | upon a valid practitioner-patient relationship that includes a |
| 464 | documented patient evaluation, including history and a physical |
| 465 | examination adequate to establish the diagnosis for which any |
| 466 | drug is prescribed and any other requirement established by |
| 467 | board rule under chapter 458, chapter 459, chapter 461, chapter |
| 468 | 463, chapter 464, or chapter 466; or. |
| 469 | (i) Been convicted of, or entered a plea of guilty or nolo |
| 470 | contendere to, regardless of adjudication, a felony under s. |
| 471 | 893.13(7)(b). |
| 472 | Section 7. Subsection (56) is added to section 499.003, |
| 473 | Florida Statutes, to read: |
| 474 | 499.003 Definitions of terms used in this part.-As used in |
| 475 | this part, the term: |
| 476 | (56) "Prescription" means an order for drugs or medicinal |
| 477 | supplies written, signed, or transmitted by word of mouth, |
| 478 | telephone, telegram, or other means of communication by a duly |
| 479 | licensed practitioner licensed in this state to prescribe such |
| 480 | drugs or medicinal supplies, issued in good faith and in the |
| 481 | course of professional practice, intended to be filled, |
| 482 | compounded, or dispensed by another person licensed in this |
| 483 | state to do so, and meeting the requirements of s. 893.04. The |
| 484 | term also includes an order for drugs or medicinal supplies so |
| 485 | transmitted or written by a physician, dentist, veterinarian, or |
| 486 | other practitioner licensed to practice in another state. |
| 487 | Section 8. Section 499.0032, Florida Statutes, is created |
| 488 | to read: |
| 489 | 499.0032 Prescriptions.-A pharmacist licensed in this |
| 490 | state may fill a prescription for drugs or medicinal supplies |
| 491 | which is transmitted or written by a physician, dentist, |
| 492 | veterinarian, or other practitioner licensed to practice in |
| 493 | another state if the pharmacist determines, in the exercise of |
| 494 | his or her professional judgment, that the order was issued |
| 495 | pursuant to a valid patient-physician relationship, that it is |
| 496 | authentic, and that the drugs or medicinal supplies so ordered |
| 497 | are considered necessary for the continuation of treatment of a |
| 498 | chronic or recurrent illness. However, if the physician writing |
| 499 | the prescription is not known to the pharmacist, the pharmacist |
| 500 | shall obtain proof to a reasonable certainty of the validity of |
| 501 | the prescription. A prescription order for a controlled |
| 502 | substance may not be issued on the same prescription blank with |
| 503 | another prescription order for a controlled substance that is |
| 504 | named or described in a different schedule. A prescription order |
| 505 | for a controlled substance may not be issued on the same |
| 506 | prescription blank as a prescription order for a medicinal drug, |
| 507 | as defined in s. 465.003(8), which does not fall within the |
| 508 | definition of a controlled substance as defined in s. 893.02. A |
| 509 | prescription obtained in violation of state law, or obtained |
| 510 | through misrepresentation, fraud, forgery, deception, or |
| 511 | subterfuge is not a valid prescription. |
| 512 | Section 9. Subsection (22) of section 893.02, Florida |
| 513 | Statutes, is amended to read: |
| 514 | 893.02 Definitions.-The following words and phrases as |
| 515 | used in this chapter shall have the following meanings, unless |
| 516 | the context otherwise requires: |
| 517 | (22) "Prescription" means and includes an order for drugs |
| 518 | or medicinal supplies written, signed, or transmitted by word of |
| 519 | mouth, telephone, telegram, or other means of communication by a |
| 520 | duly licensed practitioner licensed by the laws of the state to |
| 521 | prescribe such drugs or medicinal supplies, issued in good faith |
| 522 | and in the course of professional practice, intended to be |
| 523 | filled, compounded, or dispensed by another person licensed by |
| 524 | the laws of the state to do so, and meeting the requirements of |
| 525 | s. 893.04. The term also includes an order for drugs or |
| 526 | medicinal supplies so transmitted or written by a physician, |
| 527 | dentist, veterinarian, or other practitioner licensed to |
| 528 | practice in a state other than Florida, but only if the |
| 529 | pharmacist called upon to fill such an order determines, in the |
| 530 | exercise of his or her professional judgment, that the order was |
| 531 | issued pursuant to a valid patient-physician relationship, that |
| 532 | it is authentic, and that the drugs or medicinal supplies so |
| 533 | ordered are considered necessary for the continuation of |
| 534 | treatment of a chronic or recurrent illness. However, if the |
| 535 | physician writing the prescription is not known to the |
| 536 | pharmacist, the pharmacist shall obtain proof to a reasonable |
| 537 | certainty of the validity of said prescription. A prescription |
| 538 | order for a controlled substance shall not be issued on the same |
| 539 | prescription blank with another prescription order for a |
| 540 | controlled substance which is named or described in a different |
| 541 | schedule, nor shall any prescription order for a controlled |
| 542 | substance be issued on the same prescription blank as a |
| 543 | prescription order for a medicinal drug, as defined in s. |
| 544 | 465.003(8), which does not fall within the definition of a |
| 545 | controlled substance as defined in this act. A prescription |
| 546 | obtained in violation of state law or through misrepresentation, |
| 547 | fraud, forgery, deception, or subterfuge is not a valid |
| 548 | prescription. |
| 549 | Section 10. Paragraph (b) of subsection (7) of section |
| 550 | 893.055, Florida Statutes, is amended to read: |
| 551 | 893.055 Prescription drug monitoring program.- |
| 552 | (7) |
| 553 | (b)1. A pharmacy, prescriber, or dispenser shall have |
| 554 | access to information in the prescription drug monitoring |
| 555 | program's database which relates to a patient of that pharmacy, |
| 556 | prescriber, or dispenser in a manner established by the |
| 557 | department as needed for the purpose of reviewing the patient's |
| 558 | controlled substance prescription history. Before prescribing a |
| 559 | controlled substance listed in Schedule II, Schedule III, or |
| 560 | Schedule IV in s. 893.03, a prescriber must access information |
| 561 | in the prescription drug monitoring database for the purpose of |
| 562 | reviewing the patient's controlled substance prescription |
| 563 | history and must indicate on the face of the prescription that |
| 564 | such review was completed. |
| 565 | 2. A dispensing pharmacist who: |
| 566 | a. Believes, or reasonably should believe, that a patient |
| 567 | has been prescribed a controlled substance listed in Schedule |
| 568 | II, Schedule III, or Schedule IV in s. 893.03 by a prescriber |
| 569 | who has not reviewed the prescription drug monitoring database |
| 570 | for the purpose of reviewing the patient's controlled substance |
| 571 | prescription history; or |
| 572 | b. Does not have any prior dispensing history or |
| 573 | relationship with the patient for whom the controlled substance |
| 574 | prescription was written, |
| 575 |
|
| 576 | must access information in the prescription drug monitoring |
| 577 | database for the purpose of reviewing the patient's controlled |
| 578 | substance prescription history and may not dispense the |
| 579 | controlled substance prescription if there is any clear pattern |
| 580 | of doctor-shopping or fraudulent activity by the patient |
| 581 | presenting the prescription. Notwithstanding any other provision |
| 582 | of law, the dispensing pharmacist is not obligated to review the |
| 583 | prescription drug monitoring database before dispensing any |
| 584 | prescription for any hospice patient or established patient of |
| 585 | the pharmacy. A pharmacist may orally confirm a prescriber's |
| 586 | compliance with this paragraph and document such confirmation on |
| 587 | the prescription. |
| 588 | 3. Other access to the program's database shall be limited |
| 589 | to the program program's manager and to the designated program |
| 590 | and support staff, who may act only at the direction of the |
| 591 | program manager or, in the absence of the program manager, as |
| 592 | authorized. Access by the program manager or such designated |
| 593 | staff is for prescription drug program management only or for |
| 594 | management of the program's database and its system in support |
| 595 | of the requirements of this section and in furtherance of the |
| 596 | prescription drug monitoring program. Confidential and exempt |
| 597 | information in the database shall be released only as provided |
| 598 | in paragraph (c) and s. 893.0551. The program manager, the |
| 599 | designated program and support staff who act at the direction of |
| 600 | or in the absence of the program manager, and any individual who |
| 601 | has similar access regarding the management of the database from |
| 602 | the prescription drug monitoring program shall submit |
| 603 | fingerprints to the department for background screening. The |
| 604 | department shall follow the procedure established by the |
| 605 | Department of Law Enforcement to request a statewide criminal |
| 606 | history record check and to request that the Department of Law |
| 607 | Enforcement forward the fingerprints to the Federal Bureau of |
| 608 | Investigation for a national criminal history record check. |
| 609 | Section 11. Paragraph (a) of subsection (7) of section |
| 610 | 893.13, Florida Statutes, is amended to read: |
| 611 | 893.13 Prohibited acts; penalties.- |
| 612 | (7)(a) A person may not: |
| 613 | 1. Distribute or dispense a controlled substance in |
| 614 | violation of this chapter. |
| 615 | 2. Refuse or fail to make, keep, or furnish any record, |
| 616 | notification, order form, statement, invoice, or information |
| 617 | required under this chapter. |
| 618 | 3. Refuse entry into any premises for any inspection or |
| 619 | refuse to allow any inspection authorized by this chapter. |
| 620 | 4. Distribute a controlled substance named or described in |
| 621 | s. 893.03(1) or (2) except pursuant to an order form as required |
| 622 | by s. 893.06. |
| 623 | 5. Keep or maintain any store, shop, warehouse, dwelling, |
| 624 | building, vehicle, boat, aircraft, or other structure or place |
| 625 | which is resorted to by persons using controlled substances in |
| 626 | violation of this chapter for the purpose of using these |
| 627 | substances, or which is used for keeping or selling them in |
| 628 | violation of this chapter. |
| 629 | 6. Use to his or her own personal advantage, or reveal, |
| 630 | any information obtained in enforcement of this chapter except |
| 631 | in a prosecution or administrative hearing for a violation of |
| 632 | this chapter. |
| 633 | 7. Possess a prescription form which has not been |
| 634 | completed and signed by the practitioner whose name appears |
| 635 | printed thereon, unless the person is that practitioner, is an |
| 636 | agent or employee of that practitioner, is a pharmacist, or is a |
| 637 | supplier of prescription forms who is authorized by that |
| 638 | practitioner to possess those forms. |
| 639 | 8. Fail to affirmatively disclose to Withhold information |
| 640 | from a practitioner or pharmacist from whom the person acquires |
| 641 | or obtains, or attempts to acquire or seeks to obtain, a |
| 642 | controlled substance or a prescription for a controlled |
| 643 | substance that the person acquired or obtained making the |
| 644 | request has received a controlled substance or a prescription |
| 645 | for a controlled substance of like therapeutic use from another |
| 646 | practitioner within the previous 30 days, the name of the |
| 647 | prescribing practitioner from whom such previous prescription |
| 648 | was sought, the quantity, and the dosage. |
| 649 | 9. Acquire or obtain, or attempt to acquire or obtain, |
| 650 | possession of a controlled substance by misrepresentation, |
| 651 | fraud, forgery, deception, or subterfuge. |
| 652 | 10. Affix any false or forged label to a package or |
| 653 | receptacle containing a controlled substance. |
| 654 | 11. Furnish false or fraudulent material information in, |
| 655 | or omit any material information from, any report or other |
| 656 | document required to be kept or filed under this chapter or any |
| 657 | record required to be kept by this chapter. |
| 658 | 12. Store anhydrous ammonia in a container that is not |
| 659 | approved by the United States Department of Transportation to |
| 660 | hold anhydrous ammonia or is not constructed in accordance with |
| 661 | sound engineering, agricultural, or commercial practices. |
| 662 | 13. With the intent to obtain a controlled substance or |
| 663 | combination of controlled substances that are not medically |
| 664 | necessary for the person or an amount of a controlled substance |
| 665 | or substances that is not medically necessary for the person, |
| 666 | obtain or attempt to obtain from a practitioner a controlled |
| 667 | substance or a prescription for a controlled substance by |
| 668 | misrepresentation, fraud, forgery, deception, subterfuge, or |
| 669 | concealment of a material fact. For purposes of this |
| 670 | subparagraph, a material fact includes whether the person has an |
| 671 | existing prescription for a controlled substance issued for the |
| 672 | same period of time by another practitioner or as described in |
| 673 | subparagraph 8. |
| 674 | Section 12. This act shall take effect October 1, 2012. |