Florida Senate - 2018 SB 458 By Senator Bean 4-00631-18 2018458__ 1 A bill to be entitled 2 An act relating to controlled substance prescribing; 3 amending s. 456.44, F.S.; limiting an initial 4 prescription for a controlled substance that is an 5 opioid to a 7-day supply; limiting a refill or 6 subsequent prescription for a controlled substance 7 that is an opioid to a 30-day supply; providing 8 exceptions to supply limits for certain patients; 9 requiring a prescriber of certain controlled 10 substances to access a patient’s drug history in the 11 prescription drug monitoring program’s database before 12 prescribing the drug and at least every 90 days 13 thereafter if the prescriber continues to treat that 14 condition with any such controlled substances; 15 requiring a health care practitioner who is authorized 16 to prescribe controlled substances to complete a 17 continuing education course as a condition of initial 18 licensure and biennial licensure renewal; providing an 19 effective date. 20 21 Be It Enacted by the Legislature of the State of Florida: 22 23 Section 1. Subsection (3) of section 456.44, Florida 24 Statutes, is amended, and subsections (4), (5), and (6) are 25 added to that section, to read: 26 456.44 Controlled substance prescribing.— 27 (3) STANDARDS OF PRACTICE FOR THE TREATMENT OF CHRONIC 28 NONMALIGNANT PAIN.—The standards of practice in this section do 29 not supersede the level of care, skill, and treatment recognized 30 in general law related to health care licensure. 31 (a) A complete medical history and a physical examination 32 must be conducted before beginning any treatment and must be 33 documented in the medical record. The exact components of the 34 physical examination shall be left to the judgment of the 35 registrant who is expected to perform a physical examination 36 proportionate to the diagnosis that justifies a treatment. The 37 medical record must, at a minimum, document the nature and 38 intensity of the pain, current and past treatments for pain, 39 underlying or coexisting diseases or conditions, the effect of 40 the pain on physical and psychological function, a review of 41 previous medical records, previous diagnostic studies, and 42 history of alcohol and substance abuse. The medical record shall 43 also document the presence of one or more recognized medical 44 indications for the use of a controlled substance. Each 45 registrant must develop a written plan for assessing each 46 patient’s risk of aberrant drug-related behavior, which may 47 include patient drug testing. Registrants must assess each 48 patient’s risk for aberrant drug-related behavior and monitor 49 that risk on an ongoing basis in accordance with the plan. 50 (b) Each registrant must develop a written individualized 51 treatment plan for each patient. The treatment plan shall state 52 objectives that will be used to determine treatment success, 53 such as pain relief and improved physical and psychosocial 54 function, and shall indicate if any further diagnostic 55 evaluations or other treatments are planned. After treatment 56 begins, the registrant shall adjust drug therapy to the 57 individual medical needs of each patient. Other treatment 58 modalities, including a rehabilitation program, shall be 59 considered depending on the etiology of the pain and the extent 60 to which the pain is associated with physical and psychosocial 61 impairment. The interdisciplinary nature of the treatment plan 62 shall be documented. 63 (c) The registrant shall discuss the risks and benefits of 64 the use of controlled substances, including the risks of abuse 65 and addiction, as well as physical dependence and its 66 consequences, with the patient, persons designated by the 67 patient, or the patient’s surrogate or guardian if the patient 68 is incompetent. The registrant shall use a written controlled 69 substance agreement between the registrant and the patient 70 outlining the patient’s responsibilities, including, but not 71 limited to: 72 1. Number and frequency of controlled substance 73 prescriptions and refills. 74 2. Patient compliance and reasons for which drug therapy 75 may be discontinued, such as a violation of the agreement. 76 3. An agreement that controlled substances for the 77 treatment of chronic nonmalignant pain shall be prescribed by a 78 single treating registrant unless otherwise authorized by the 79 treating registrant and documented in the medical record. 80 (d) The patient shall be seen by the registrant at regular 81 intervals, not to exceed 3 months, to assess the efficacy of 82 treatment, ensure that controlled substance therapy remains 83 indicated, evaluate the patient’s progress toward treatment 84 objectives, consider adverse drug effects, and review the 85 etiology of the pain. Continuation or modification of therapy 86 shall depend on the registrant’s evaluation of the patient’s 87 progress. If treatment goals are not being achieved, despite 88 medication adjustments, the registrant shall reevaluate the 89 appropriateness of continued treatment. The registrant shall 90 monitor patient compliance in medication usage, related 91 treatment plans, controlled substance agreements, and 92 indications of substance abuse or diversion at a minimum of 3 93 month intervals. 94 (e) The registrant shall refer the patient as necessary for 95 additional evaluation and treatment in order to achieve 96 treatment objectives. Special attention shall be given to those 97 patients who are at risk for misusing their medications and 98 those whose living arrangements pose a risk for medication 99 misuse or diversion. The management of pain in patients with a 100 history of substance abuse or with a comorbid psychiatric 101 disorder requires extra care, monitoring, and documentation and 102 requires consultation with or referral to an addiction medicine 103 specialist or a psychiatrist. 104 (f) A registrant must maintain accurate, current, and 105 complete records that are accessible and readily available for 106 review and comply with the requirements of this section, the 107 applicable practice act, and applicable board rules. The medical 108 records must include, but are not limited to: 109 1. The complete medical history and a physical examination, 110 including history of drug abuse or dependence. 111 2. Diagnostic, therapeutic, and laboratory results. 112 3. Evaluations and consultations. 113 4. Treatment objectives. 114 5. Discussion of risks and benefits. 115 6. Treatments. 116 7. Medications, including date, type, dosage, and quantity 117 prescribed. 118 8. Instructions and agreements. 119 9. Periodic reviews. 120 10. Results of any drug testing. 121 11. A photocopy of the patient’s government-issued photo 122 identification. 123 12. If a written prescription for a controlled substance is 124 given to the patient, a duplicate of the prescription. 125 13. The registrant’s full name presented in a legible 126 manner. 127 (g) A registrant shall immediately refer patients with 128 signs or symptoms of substance abuse to a board-certified pain 129 management physician, an addiction medicine specialist, or a 130 mental health addiction facility as it pertains to drug abuse or 131 addiction unless the registrant is a physician who is board 132 certified or board-eligible in pain management. Throughout the 133 period of time before receiving the consultant’s report, a 134 prescribing registrant shall clearly and completely document 135 medical justification for continued treatment with controlled 136 substances and those steps taken to ensure medically appropriate 137 use of controlled substances by the patient. Upon receipt of the 138 consultant’s written report, the prescribing registrant shall 139 incorporate the consultant’s recommendations for continuing, 140 modifying, or discontinuing controlled substance therapy. The 141 resulting changes in treatment shall be specifically documented 142 in the patient’s medical record. Evidence or behavioral 143 indications of diversion shall be followed by discontinuation of 144 controlled substance therapy, and the patient shall be 145 discharged, and all results of testing and actions taken by the 146 registrant shall be documented in the patient’s medical record. 147 148 This subsection does not apply to a board-eligible or board 149 certified anesthesiologist, physiatrist, rheumatologist, or 150 neurologist, or to a board-certified physician who has surgical 151 privileges at a hospital or ambulatory surgery center and 152 primarily provides surgical services. This subsection does not 153 apply to a board-eligible or board-certified medical specialist 154 who has also completed a fellowship in pain medicine approved by 155 the Accreditation Council for Graduate Medical Education or the 156 American Osteopathic Association, or who is board eligible or 157 board certified in pain medicine by the American Board of Pain 158 Medicine, the American Board of Interventional Pain Physicians, 159 the American Association of Physician Specialists, or a board 160 approved by the American Board of Medical Specialties or the 161 American Osteopathic Association and performs interventional 162 pain procedures of the type routinely billed using surgical 163 codes. This subsection does not apply to a registrant who 164 prescribes medically necessary controlled substances for a 165 patient during an inpatient stay in a hospital licensed under 166 chapter 395. 167 (4) LIMITATIONS ON OPIOID PRESCRIPTIONS.—An initial 168 prescription for a controlled substance that is an opioid 169 prescribed to treat acute pain is limited to a 7-day supply. A 170 refill or a subsequent prescription for a controlled substance 171 that is an opioid to treat the same condition is limited to a 172 30-day supply, unless the patient is in hospice care, is being 173 treated for cancer, or is being treated for chronic nonmalignant 174 pain pursuant to subsection (3). 175 (5) CONSULTING THE PRESCRIPTION DRUG MONITORING PROGRAM’S 176 DATABASE.—Before prescribing a controlled substance listed in 177 Schedule II, Schedule III, or Schedule IV in s. 893.03, to a 178 patient 16 years or older, a prescriber as defined in s. 893.055 179 or his or her designee must access the patient’s prescription 180 drug history in the prescription drug monitoring program’s 181 database. At a minimum, this inquiry is required before an 182 initial prescription for a patient’s condition and at least 183 every 90 days thereafter if the prescriber continues to treat 184 that condition with a controlled substance listed in one of 185 these schedules. 186 (6) CONTINUING MEDICAL EDUCATION.—A health care 187 practitioner who is authorized under federal and state law to 188 prescribe controlled substances must complete a 2-hour 189 continuing education course on the current standards for 190 prescribing controlled substances and the risks associated with 191 prescribing controlled substances for chronic and acute pain. 192 Beginning on January 1, 2019, completion of this course is 193 required as a condition of initial licensure and biennial 194 licensure renewal. The course may be offered in a distance 195 learning format and must be included within the number of 196 continuing education hours required by law for the licensee’s 197 profession. 198 Section 2. This act shall take effect July 1, 2018.