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.
   21  Be It Enacted by the Legislature of the State of Florida:
   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.—
   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.
  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.
  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).
  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.