Florida Administrative Code
64 - DEPARTMENT OF HEALTH
64B8 - Board of Medicine
Chapter 64B8-9 - STANDARDS OF PRACTICE FOR MEDICAL DOCTORS
Section 64B8-9.013 - Standards for the Prescribing of Controlled Substances for the Treatment of Acute Pain
Universal Citation: FL Admin Code R 64B8-9.013
Current through Reg. 50, No. 187; September 24, 2024
The standards of practice in this rule do not supersede the level of care, skill and treatment recognized in general law related to healthcare licensure. All physicians and physician assistants who are authorized to prescribe controlled substances shall comply with the following:
(1) Definitions.
(a) Acute Pain. For the purpose of this rule,
"acute pain" is defined as the normal, predicted, physiological, and
time-limited response to an adverse chemical, thermal, or mechanical stimulus
associated with surgery, trauma, or acute illness. The term does not include
pain related to:
1. Cancer.
2. A terminal condition. For purposes of this
subparagraph, the term "terminal condition" means a progressive disease or
medical or surgical condition that causes significant functional impairment, is
not considered to be reversible without the administration of life-sustaining
procedures, and will result in death within 1 year after diagnosis if the
condition runs its normal course.
3. Palliative care to provide relief of
symptoms related to an incurable, progressive illness or injury.
4. A traumatic injury with an Injury Severity
Score of 9 or greater.
(b) Prescription Drug Monitoring Program
(PDMP) or "the system." For the purpose of this rule, the prescription drug
monitoring system is defined as the Florida Department of Health's electronic
system to collect and store controlled substance dispensing information as set
forth in section 893.055, F.S.
(c) Substance Abuse. For the purpose of this
rule, "substance abuse" is defined as the use of any substances for
non-therapeutic purposes or use of medication for purposes other than those for
which it is prescribed.
(2) Standards. The nature and extent of the requirements set forth below will vary depending on the practice setting and circumstances presented to the clinician. The Board has adopted the following standards for the prescribing of controlled substances for acute pain:
(a) Evaluation of the Patient. A medical
history and physical examination appropriate for the patient's clinical
condition must be conducted and documented in the medical record. The medical
record also shall document the presence of one or more recognized medical
indications for the use of a controlled substance.
(b) Treatment Plan. The written treatment
plan shall indicate if any further diagnostic evaluations or other treatments
are planned including non-opioid medications and therapies if indicated. After
treatment begins, the physician shall adjust medication therapy, if necessary,
to the individual medical needs of each patient.
(c) Informed Consent and Agreement for
Treatment. The physician shall discuss the risks and benefits of the use of
controlled substances including the risk of abuse and addiction as well as
physical dependence with the patient, persons designated by the patient, or
with the patient's surrogate or guardian if the patient is incompetent. The
discussion shall also include expected pain intensity, duration, options, use
of pain medications, non-medication therapies, and common side effects. Special
attention must be given to those pain patients who are at risk of misuse or
diversion of their medications.
(d)
Periodic Review. Based on the circumstances presented, the physician shall
review the course of treatment and any new information about the etiology of
the pain. Continuation or modification of therapy shall depend on the
physician's evaluation of the patient's progress. If treatment goals are not
achieved, despite medication adjustments, the physician shall reevaluate the
patient and determine the appropriateness of continued treatment. The physician
shall monitor patient compliance of medication usage and related treatment
plans.
(e) Consultation. The
physician shall refer the patient as necessary for additional evaluation and
treatment in order to achieve treatment objectives. The management of pain in
patients with a history of substance abuse or with a comorbid psychiatric
disorder requires extra care, monitoring, and documentation, and may require
consultation with or referral to an expert in the management of such
patients.
(f) Medical Records. The
physician is required to keep accurate and complete records to include, but not
be limited to:
1. The medical history and a
physical examination, including history of drug abuse or dependence, if
indicated;
2. Diagnostic,
therapeutic, and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. Discussion of risks and
benefits;
6. Treatments;
7. Medications (including date, type, dosage,
and quantity prescribed);
8.
Instructions and agreements;
9.
Drug testing results if indicated;
10. Justification for deviation from the
3-day prescription supply limit for a Schedule II opioid controlled substance
for acute pain;
11. Outline of
problems encountered when attempting to consult the Prescription Drug
Monitoring Program (PDMP) or its successor, if the system was non-operational
or the clinician, or his or her designee, is unable to access the PDMP due to a
temporary technological or electrical failure; and
12. Periodic reviews. Records must remain
current, maintained in an accessible manner, readily available for review, and
must be in full compliance with rule
64B8-9.003, F.A.C., section
456.057, F.S., and section
458.331(1)(m),
F.S.
(g) Compliance with
Laws and Rules. Physicians and physician assistants shall at all times, remain
in compliance with this rule and all state and federal laws and regulations
addressing the prescribing and administration of controlled
substances.
Rulemaking Authority 456.44(4), 458.309(1), 458.331(1)(v) FS. Law Implemented 456.44, 458.326, 458.331(1)(g), (t), (v) FS.
New 12-21-99, Amended 11-10-02, 10-19-03, 10-17-10, 2-21-19.
Disclaimer: These regulations may not be the most recent version. Florida may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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