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.