Dear Virginia Board of Dentistry, 

The concern of Virginia oral sedation dentists centers around the dosage restrictions being proposed for minimal sedation. Dentists would be limited to the MRD of a single sedative with or without nitrous. This dosage restriction was obviously copied from the American Dental Association's October 2016 sedation guidelines, which were the result of a great deal of controversy from dentists and stakeholders. The 2007 to 2015 iterations of the ADA guidelines contained a minimal sedation provision that allowed for up to 1.5x the MRD of a single sedative with or without nitrous, but the Virginia Board of Dentistry never bothered to adopt that provision during those eight years. No patients were harmed during that time with either minimal or moderate oral sedation by dentists who had formal training required by the board since 2005 (18 to 24 hours + ACLS + 4 hours q 2 years of renewal CE). And yet, one has to wonder what the political motivations are behind the current push to adopt this grossly over-restrictive proposal now.

It should be noted that some states have adopted an “unrestricted” minimal sedation concept that is consistent with the American Society of Anesthesiology’s own guidelines whereby the intended and resulting level of sedation governs. This has been implemented in Colorado, Illinois, Massachusetts, Minnesota, Nebraska, New York, Oregon, Rhode Island, South Carolina, Utah, Virginia (until now), and Washington when those dental boards revised their sedation rules over the past several years. I will elaborate below:

It should be noted that the full definition of "MRD" is "manufacturer's maximum recommended dose for at-home unmonitored use."

1. Manufacturer's: The common misconception here is that the MRD is set by the US FDA. It is not. In fact, the FDA's dosage limits appear on a chart called the MRTD, or maximum recommended therapeutic dose, which is actually MUCH higher than the MRD…higher than any of us would ever recommend or administer.
2. At-home: The MRD applies to at-home self-administration, not a dental or other healthcare office.
3. Unmonitored: This is most important. The MRD contemplates that the patient is unmonitored. Even during minimal sedation, this would not be standard of care. DOCS teaches that, even during minimal sedation, the patient would be monitored with pulse oximetry, an assistant would be present to assist the dentist with monitoring, the operatory would be equipped with standard of care equipment, and the appropriate unexpired emergency drugs would be readily available.
   1. Patients react differently to different drugs and a dentist must be able to adapt the drugs administered to the patient’s particular circumstances.
   2. Certain drugs may work better in combination with other agents, reducing the overall volume of sedatives required or permitting the time that a patient is under sedation to be reduced. For example, hydroxyzine administered together with a traditional short-half-life benzodiazepine sedative will permit more effective sedation at lower overall sedative volumes and will, in addition, help to reduce saliva volumes and gagging during procedures and increase sedative effectiveness in patients who are smokers.
   3. The ability to incrementally dose sedatives allows sedative levels to be kept to the minimum amount necessary. If a sedative can only be administered up to the MRD, dentists will have little option but to administer a bolus MRD just to achieve minimal sedation.
   4. The provision in the ADA guidelines dealing with supervision of sedated patients by Qualified Anesthesia Monitors, and the requirements for available facilities, including reversal agents, provide protection for patients.
   5. Allowing dentists to incrementally administer sedatives also protects patients by permitting the dentist to administer the minimum amount of medication required at each appointment, which may vary for each patient and on each day that that patient is sedated.
   6. NOTE:  DOCS adheres to a policy that the MRD should never be exceeded for pediatric patients (in Virginia, <13yo) under any circumstances. Patients under age 5yo should be referred to hospital-based dentistry, if necessary. 

The problem with dosage restrictions for minimal sedation is that they handcuff both the dentist and the patient. One size simply does not fit all. Sometimes 0.25mg of triazolam is enough to get Patient A into minimal sedation. Sometimes more than 0.5mg is necessary for Patient B to achieve minimal sedation.

A misconception about the DOCS incremental protocols is that they are intended to induce moderate or even deep sedation. This is simply not true. The incremental protocols are primarily intended to induce AND MAINTAIN minimal sedation. They were primarily created to assist dentists with long appointments for patients who have neglected their dental care for years or even decades. This is both safer and more cost-effective for the patient.

As such, DOCS training and the incremental protocols are intended to foster access to care...safe and effective dental care.

RECOMMENDATION:

While we agree that a maximum dose limitation is required, an overall maximum of the MRD of a single sedative may be too low for many otherwise healthy (ASA I and some ASA II) patients. An alternative suggestion would be to tie the dosages for the various widely-used sedatives to the patient’s body weight, such as:

1. Total overall prescribed dose of triazolam in mg (to a maximum of 2.0 mg) = body weight in lbs/100 (drug quotient factor for triazolam). This is only for ADULT patients (≥18yo) AND is rounded down AND is cut in half for medically-complex patients or patients over the age of 64;
   1. E.g. 180 lb patient (180 lb/100 qf) = 1.8 = 1.75 mg triazolam.
2. Total Overall Prescribed dose of lorazepam in mg (to a maximum of 8.0mg) = body weight in lbs/25 (drug quotient factor for lorazepam). This is only for ADULT patients (≥18yo) AND is rounded down AND is cut in half for medically-complex patients or patients over the age of 64. 
   1. E.g. 180 lb patient (180 lb/25 qf) = 7.2 = 7 mg triazolam.

Minimal Sedation is a vital component of modern general dentistry and the availability of affordable sedation options is absolutely necessary for a significant portion of the general public to be able to access dental services and maintain their oral health.

The goal of the Board must, therefore, be to establish a system which allows reasonable and cost-effective access to Minimal Sedation services for the patients who need them, while preserving reasonable standards of training for the dentist and dental auxiliaries to provide the safest services with reasonable requirements for the facilities in which the services are provided.

Thank you as always for your time and consideration. 

Respectfully submitted, 

John P. Bitting, Esq.

Regulatory and CE Counsel

DOCS Education

106 Lenora Street

Seattle, WA 98121

(206) 412-0089

(800) 727-4907 fax

John@DOCSeducation.com