New Opioid Rule Approved by BOD

As required by HB 21, the Board of Dentistry (BOD) recently finalized and approved Rule 64B5-17.0045, Standards for the Prescribing of Controlled Substances for the Treatment of Acute Pain. It will be effective in 50-70 days, and if you do not comply, you will be subject to discipline by the BOD.

This rule does several things as outlined below. Please pay special attention to the new requirements that must be included in the medical record. These requirements are in addition to what is already required by BOD rule and statute.

It defines acute pain 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: 

    • cancer.
    • 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 one year after diagnosis if the condition runs its normal course.
    • palliative care to provide relief of symptoms related to an incurable, progressive illness or injury.
    • a traumatic injury with an Injury Severity Score of 9 or greater.

Adopts the following standards for the prescribing of controlled substances for acute pain. Please note, these are the new standards for prescribing opioids and are in addition to the 3-day limit required by HB 21.

    1. 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.
    2. 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 dentist shall adjust medication therapy, if necessary, to the individual medical needs of each patient.
    3. Informed Consent and Agreement for Treatment. The dentist 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 also shall 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.
    4. Periodic Review. Based on the circumstances presented, the dentist 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 dentist’s evaluation of the patient’s progress. If treatment goals are not achieved, despite medication adjustments, the dentist shall re-evaluate the patient and determine the appropriateness of continued treatment. The dentist shall monitor patient compliance of medication usage and related treatment plans.
    5. Consultation. The dentist 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.
    6. Medical Records. The dentist is required to keep accurate and complete records to include, but not be limited to:
      a. the medical history and a physical examination, including history of drug abuse or dependence, if indicated
      b. diagnostic, therapeutic and laboratory results
      c. evaluations and consultations
      d. treatment objectives
      e. discussion of risks and benefits
      f. treatments
      g. medications (including date, type, dosage and quantity prescribed)
      h. instructions and agreements
      i. drug testing results, if indicated
      j. justification for deviation from the three-day prescription supply limit for a Schedule II opioid controlled substance for acute pain
      k. outline of problems encountered when attempting to consult the Prescription Drug Monitoring Database (PDMP), E-FORCSE, 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
      l. periodic reviews. Records must remain current, maintained in an accessible manner, readily available for review, and must be in full compliance with Rule 64B5-17.002, F.A.C, Section 456.057, F.S., Section 466.018, F.S., and Section 466.028(1)(m), F.S.