6.5 Controlled Substances, Pain Standards, the PDMP & Local Anesthesia by CRDHs

Controlled Substances and Pain Management

The acute pain supply limit — s. 456.44(5), F.S.

A prescription for a Schedule II controlled substance opioid for the treatment of acute pain may not exceed a 3-day supply. Up to a 7-day supply may be prescribed only where the prescriber determines it is medically necessary, adequately documents in the patient's medical record the acute medical condition and the lack of alternative treatments that would suffice, and indicates "ACUTE PAIN EXCEPTION" on the prescription.

Where the opioid is prescribed for pain other than acute pain, the prescriber must indicate "NONACUTE PAIN" on the prescription.

What is not acute pain — Rule 64B5-17.0045(1)(a)

The Board's own rule 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," and expressly excludes pain related to:

1. Cancer;
2. A terminal condition — a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered reversible without life-sustaining procedures, and will result in death within 1 year after diagnosis if it runs its normal course;
3. Palliative care to relieve symptoms of an incurable, progressive illness or injury; and
4. A traumatic injury with an Injury Severity Score of 9 or greater.

The fourth exclusion is the one most often dropped from summaries.

The prescribing standards — Rule 64B5-17.0045(2)

All dentists authorised to prescribe controlled substances must comply with seven standards. They "do not supersede the level of care, skill and treatment recognized in general law related to healthcare licensure":

• (a) Evaluation of the patient. A medical history and physical examination appropriate to the clinical condition must be conducted and documented, and the record must document one or more recognised medical indications for the controlled substance.
• (b) Treatment plan. A written plan indicating any further diagnostic evaluations or treatments planned, including non-opioid medications and therapies if indicated, with adjustment to individual needs after treatment begins.
• (c) Informed consent and agreement for treatment. Discussion of risks and benefits including the risk of abuse and addiction as well as physical dependence, with the patient or their surrogate or guardian, covering expected pain intensity, duration, options, use of pain medications, non-medication therapies, and common side effects. Special attention to patients at risk of misuse or diversion.
• (d) Periodic review of the course of treatment and any new information about the etiology of the pain, with reevaluation if treatment goals are not achieved and monitoring of patient compliance.
• (e) Consultation — referral as necessary; extra care, monitoring and documentation for patients with a history of substance abuse or a comorbid psychiatric disorder.
• (f) Medical records — twelve enumerated elements, including drug abuse or dependence history, diagnostic and laboratory results, evaluations and consultations, treatment objectives, discussion of risks and benefits, treatments, medications with date, type, dosage and quantity, instructions and agreements, drug testing results if indicated, justification for deviation from the 3-day prescription supply limit, an outline of problems encountered when attempting to consult the PDMP if it was non-operational or inaccessible, and periodic reviews. Records must remain current, accessible, readily available for review, and in full compliance with Rule 64B5-17.002 and ss. 456.057, 466.018, and 466.028(1)(m), F.S.
• (g) Compliance with the rule and all state and federal laws addressing prescribing and administration of controlled substances.

"Substance abuse" is defined in the rule as the use of any substances for non-therapeutic purposes or use of medication for purposes other than those for which it is prescribed.

The prescription drug monitoring program — s. 893.055, F.S.

Florida's PDMP is the Department of Health's electronic system for collecting controlled substance dispensing information. A prescriber or dispenser must consult the system to review a patient's controlled substance dispensing history before prescribing or dispensing a controlled substance to a patient age 16 or older.

Exclusions from the duty: nonopioid Schedule V controlled substances, and controlled substances prescribed to a patient who has been admitted to hospice.

If the system is unavailable — determined by the Department to be non-operational, or inaccessible because of a temporary technological or electrical failure — the prescriber is not required to consult it, but must document the reason in the patient's medical record and may not prescribe or dispense more than a 3-day supply to that patient. Rule 64B5-17.0045(2)(f)11. separately requires the record to outline problems encountered in attempting to consult the system.

Describing the duty as applying to "Schedules II through IV" understates it: the statute reaches controlled substances generally, subject only to the nonopioid Schedule V and hospice exclusions.

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Local Anesthesia by Certified Registered Dental Hygienists

The statutory conditions — s. 466.017(5)

"A dental hygienist under the direct supervision of a dentist may administer local anesthesia, including intraoral block anesthesia, soft tissue infiltration anesthesia, or both, to a nonsedated patient who is 18 years of age or older, if the following criteria are met."

Four hard limits sit in that single sentence: direct supervision, intraoral block and/or soft tissue infiltration only, nonsedated patient, and 18 years of age or older.

Criterion (a) — the course. Successful completion of a course in the administration of local anesthesia offered by a CODA-accredited dental or dental hygiene program or approved by the Board, comprising a minimum of 30 hours of didactic instruction and 30 hours of clinical experience, with instruction in: theory of pain control; selection of pain-control modalities; anatomy; neurophysiology; pharmacology of local anesthetics; pharmacology of vasoconstrictors; psychological aspects of pain control; systematic complications; techniques of maxillary anesthesia; techniques of mandibular anesthesia; infection control; and medical emergencies involving local anesthesia.

The 30/30 split is statutory — it appears in s. 466.017(5)(a), not in Rule 64B5-14.003.

Criterion (b) — evidence of current certification in basic or advanced cardiac life support.

Criterion (c) — a valid certificate issued under s. 466.017(6).

The certificate — s. 466.017(6)

The hygienist applies to the Department, remits an application fee, and submits proof of course completion. The Board certifies and the Department issues the certificate. Three details are examinable:

• The Board establishes a one-time application fee not to exceed $35;
• The certificate is not subject to renewal but is part of the hygienist's permanent record; and
• It must be prominently displayed at the location where the hygienist is authorised to administer local anesthesia.

On issuance, the hygienist is referred to as a Certified Registered Dental Hygienist (CRDH) — Rule 64B5-16.006(4)(a). That rule also explains the doctrinal mechanics: notwithstanding the ordinary rule that administering anesthetics other than topical is an irremediable task, "the administration of local anesthesia becomes a remediable and delegable task" once the hygienist holds the certificate. Section 466.024(1)(l) lists it among the tasks found by law to be remediable and delegable.

Reporting

A CRDH carries the independent 48-hour notice and 30-day report duty for adverse occurrences related to local anesthesia under s. 466.017(11) and Rule 64B5-14.006(4). See section 6.4.