I have been providing safe, effective oral sedation to patients with high anxiety since 2007 without any issues.  I have maintained the use of a pulse oximeter and had the appropriate emergency equipment available.  I DO NOT understand why an EKG is necessary for moderate oral sedation, and DO NOT agree with this burdensome requirement.  Additionally, the need for the dentist to be in the room during oral sedation is unnecessary when there are properly trained and certified assistants who can monitor the patient appropriately.

I am not providing IV sedation, however, I know oral surgeons who sedate their patients with more intense drugs than the ones I use who do not have EKGs for each patient.  Although I certainly understand the need to protect patients and doctors, this is a cruel choice and undermines the whole concept of minimally invasive oral sedation.  This really will only hurt patients who need care under sedation due to the inability to find dentists, under the new guidelines, to complete their general dentistry needs.  I implore you to change the requirement for having an EKG for moderately sedated patients and make it mandatory only for IV sedation where it is most useful.  The pulse oximeter is quite capable of determining the appropriate stats that require monitoring during traditional oral sedation--especially since the patient is able to breathe on his/her own and answer simple commands. 

PLEASE reconsider your decision, and remove the mandate for the EKG for moderate oral sedation and the requirement for the dentist to remain in the operatory.

Thank you!

     First I would like to agree with you on wanting to place regulations on oral/moderate sedation; public safety has to be the priority. I have practiced oral sedation since 2001. I have taken hundreds of hours of continuing ed in sedation and have received both the Felowship and Diplomat awards from The Dental Organization for Conscious Sedation. I have all the required emergency equipment so I feel my patients are safe. In all the years I have done oral sedation I have not had what I would classify as an emergency situation. I agree with most of the regulations you placed but have a concern with ywo. First, requiring EKG monitoring for oral sedation. While EKG monitoring is the gold stantard for IV I feel it is overkill for oral sedation. The pulse oximeter is very capable of providing the monitoring for oral sedaton. In oral sedation the patient is awake and responds to both verbal and physical stimuli. The pulse ox plus is what I have used for years. It allows great monitoring for my patients. Second, trained office personel should be able to monitor a patient while the dentist is checking a hygiene patient in the next room or operatory. Our assistants have to take training courses so they should be able to monitor oral sedation patients as long as the dentist is in the office and nearby. My assistants are extremely capable of this monitoring and I am always within 100ft or so. I hope you will take these comments under consideration.

I was trained to use sedation when I was in dental school. Demerol and Vistaryl were the drugs of choice than. The newer medications (Triazolam, Valium, Lorazepam) are much safer to use with less side effects.I have had very favorable results using these medications.

 The revisions are good - with two important exceptions: Moderate oral sedation will require (1) EKG monitoring and (2) the dentist will have to remain in the operatory.  EKG monitoring is standard of care for IV sedation, but overkill for oral sedation. I believe these two revisions that rare created for safe IV sedation are too far reaching for the slow onset and milder form of sedation that comes with oral sedation. With regular monitoring of patients vitals and utilization of capnography, any significant change will be seen right away. Furthermore, well trained staff can easily monitor oral sedation patients with the dentist within close proximity. We have been doing oral sedation safely for over 20 years and have appreciated the Boards handling of sedation but feel these two components are too far reaching and will not improve safety but will cause patients fees to increase significantly for a procedure that is hardly ever covered by dental insurance. Thank you for reading my thoughts, Greg Johnson, DDS

While applaud the Board of Dentistry's effort to make sedation safer in dental offices, I am dismayed that a valuable tool has been removed from my practice to provide a positive experience for my patients. We have routinely prescribed Atarax for young patients, to be taken in the comfort of the home.  We prescribe the amount for the appointment, so an overdose is unlikely and in the event of an inadvertant pharmacological filling error.  it is recognized that the medication has an unprecedented margin of safety.  We use no other drugs in our office.  We do use Nitrous Oxide and our patients are alert and responsive throughout the procedure.  For older children we prescribe Valium to be taken at home prior to the appointment.  Again, prescribing the amount only for that appointment. I think most would agree that a 5 mg tablet of Valium would be safe for a child in the 7-12 age group.  Since we have been in compliance with the "emergency regulations", we have discovered that parents are not willing to pay the extra fees involved for the "sedation" that we must charge for the administration, ordering, record keeping, etc.. Also they are not willing to come in an extra hour in advance of the appointment.  There is no insurance code that fits this procedure, therefore there is no insurance reimbursement. The prescriptions were covered by insurance.  And we are left with the difficulty of treating these children and the emotional aftermath of the appointments.  Pediatric dental offices are overwhelmed with children who have difficulties, for whatever reason, in obtaining dental care.  The burgeoning population of autistic children, who require Valium, just for a prophylaxis and examination is staggering.  To have this safe and effective medication removed from our armamentarium, has been a huge disaster for our patients.

In review of the untoward situations that have occured with children in the dental offices, it is important to note that most involved the administration of oral Chloral Hydrate, BY the dentist, IN the dental office.  I would suggest that my administering Atarax and Valium in my office would not change this type of occurence.  The problem is more about the kind of medication not where it is administered.  So I would propose that the schedule of the type of drugs be limited for prescribing at home, rather than a blanket  prohibition of safe and effective medications, which can be administered at home by parents. Sincfor

I'm not sure if I read the new proposed regulations correctly, but seriously are you expecting EKG monitoring for giving a patient a few oral pills to mildly sedate them?  No EKG monitoring is required for a bartender to serve 3 drinks, which is the equivalent of what we are giving our patients for light sedation.  Please use common sense for our regulations.

I am writing to express my great concern regarding the recently developed regulations for sedation in dental treatment.  These regulations are unnecessarily burdensome on dentists who want to practice sedation dentistry for the comfort of their patients.  The regulations will drive up the cost of dental care significantly, they will decrease the number of dentists who offer sedation treatment, and they will result in more dangerous treatment for patients.  Following is an explanation of my contentions:

1. The regulations require dentists to purchase an EKG for monitoring patients during even mild to moderate sedation.  This machine could cost in the area of $5,000, and its output would be a waste, because it would not be constantly monitored during treatment, thereby making much of its data meaningless.  

2. The regulations would also require dentists to be in the room for the entire time of the sedation treatment.  If this does not change, then dentists will have to charge far more for sedation appointments than currently.  Right now an assistant or hygienist who has been trained can monitor the sedation, with the dentist still in the building and able to respond to any irrgularities.  Requiring the dentist to be in the room the entire time will make the cost of treatment far greater, thereby decreasing the number of patients that can afford it.

3. It appears that the board must be afraid that sedation dentistry poses a serious threat to the health of Virginia patients.  However, in reality, mild-moderate sedation makes treatment of patients far safer, especially if they are nervous or have heart problems. It keeps them calm and relaxed, and they also heal better after sedation treatment.  

4. It is also unfortunate that the regulations do not distinguish between deep sedation and mild-moderate sedation.  I believe the regulations are unduly harsh for the mild level of sedation that is induced parenterally.

5. The American Dental Association has spend considerable time developing guidelines regarding appropriate use of mild-moderate sedation in dentistry.  They do not require the use of an EKG machne, and they do not require the dentist to be in the room constantly.  Perhaps we should follow their lead.

6. There is no state in our country whose dental sedation regulations are as severe as Virginia's.  This is over-regulation, the patients would lose out if the regulations are not changed.

For the reasons above, I hope that the Virginia Board of Dentistry will reconsider its current regulations and do what is truly in the best interests of our patients and oru profession.

Sincerely,

William Griffin, DDS

Newport News, VA

Dear Board Members and others:

I have practiced Oral Conscious Sedation in Virginia since 2003.  I have performed over 500 cases without incident.  The new regulations address several issues that were necessary such as permitting which is great.

But there are two serious problems with the new regulations:

 (1) ECG monitoring is required for mild to moderate oral sedation. This is Overkill for mild to moderate oral conscious sedation.  It is needed for deep sedation.  There needs to be some verbage that differentiates the two.  The intended level of sedation for oral sedation does not have any adverse effect on cardiac function.  If anything, it has a positive impact.

 (2) The dentist cannot leave the operatory during mild to moderate oral conscious sedation.  This is also overkill.  My staff is trained to stay with the patient at all times, while constantly monitoring them.  This is all that is necessary for mild to moderate sedation.

Two other issues that I think need to be considered are:

1. The ADA had a lot of discussion on the sedation protocols several years ago, and came up with a policy after months of discussion with all of the leading experts in the field.  Why is Virginia coming up with regulations that differ from the ADA, when they clearly have not researched the topic to the extent of the ADA or had any national experts give recommendations.
2. The new regulations do not pass the litmus test.  Specifically, patients that are scared and nervous inherently have elevated blood pressure and a greater predisposition to cardiac and/or medical issues.  Sedation lowers the chance these patients will have a problem.  These regulations will allow fewer patients access to sedation services, which will increase the incidence of cardiac and medical emergencies in general dentist’s offices throughout Virginia.

Please reconsider the new regulations, specifically in regards to the points above.  The citizens of Virginia will be the ones hurt the most if these changes go into effect.

Sincerely,

Brad Spano, DDS

After reviewing the proposed Sedation requirements for the state of Virginia and discussing the proposal in detail with colleagues, we are in agreement that the regulations have a few problems that need to be addressed.

1. ECG monitoring for Moderate Sedation is not necassary to provide proper monitoring for moderate sedation. According to the Academy of Pediatric Dentistry, American Academy of Pediatrics and American Dental Association the following is recommended during moderate sedation (different from Deep Sedation):

During the Procedure
The practitioner shall document the name, route, site, time of administration, and dosage of all drugs administered. There shall be continuous monitoring of oxygen saturation and heart rate and intermittent recording of respiratory rate and blood pressure; these should be recorded in a time-based record. Restraining devices should be checked to prevent airway obstruction or chest restriction. If a restraint device is used, a hand or foot should be kept exposed. The child’s head position should be checked frequently to ensure airway patency. A
functioning suction apparatus must be present. (from the guielines of the AAPD)

ECG monitoring should not be required prior to, during, or after moderate sedation procedures.

2. Continuous monitoring of the patient for moderate sedation should not be required prior to starting the dental procedure.

Most of the time the reason patients are recieving medications for sedation is because of precooperative behavior or uncooperative behavior. The medications are given after baseline vitals are measured and checked and then it takes time for the medications to take effect and peak in order to start the procedure... the patients will not sit in a room and leave monitors on for the 30-45 minutes prior to starting the precedure with the dentist in the room watching the patient bounce off the walls. The area should be quiet, with the parents, and nonstimulating prior to starting the dental procedure, without the dentist in the room. Office personel should be able to monitor the patient prior to starting the procedure with the dentist. When the patient becomes drowsy by the medications, then monitors can be placed and the dentist can start continuous monitoring for the procedure and able to discharge the patient when appropriate according to the guidelines. 

Please consider all recommendations suggested in the comment section when finalizing the sedation regulations and distinguish between Deep and Moderate sedation monitoring requirements. Eliminate the requirement for ECG monitoring equipment and continuous monitoring by the dentist.

Thank you!  Corey J. Sheppard, D.D.S.

I have read and agree with the posted comments regarding the new regulations.  I hope that the logic requiring the use of an EKG will be seriously reconsidered.

After reviewing the proposed Sedation requirements for the state of Virginia and discussing the proposal in detail with colleagues, we are in agreement that the regulations have a few problems that need to be addressed.

1. ECG monitoring for Moderate Sedation is not necassary to provide proper monitoring for moderate sedation. According to the Academy of Pediatric Dentistry, American Academy of Pediatrics and American Dental Association the following is recommended during moderate sedation (different from Deep Sedation):

During the Procedure
The practitioner shall document the name, route, site, time of administration, and dosage of all drugs administered. There shall be continuous monitoring of oxygen saturation and heart rate and intermittent recording of respiratory rate and blood pressure; these should be recorded in a time-based record. Restraining devices should be checked to prevent airway obstruction or chest restriction. If a restraint device is used, a hand or foot should be kept exposed. The child’s head position should be checked frequently to ensure airway patency. A
functioning suction apparatus must be present. (from the guielines of the AAPD)

ECG monitoring should not be required prior to, during, or after moderate sedation procedures.

2. Continuous monitoring of the patient for moderate sedation should not be required prior to starting the dental procedure.

Most of the time the reason patients are recieving medications for sedation is because of precooperative behavior or uncooperative behavior. The medications are given after baseline vitals are measured and checked and then it takes time for the medications to take effect and peak in order to start the procedure... the patients will not sit in a room and leave monitors on for the 30-45 minutes prior to starting the precedure with the dentist in the room watching the patient bounce off the walls. The area should be quiet, with the parents, and nonstimulating prior to starting the dental procedure, without the dentist in the room. Office personel should be able to monitor the patient prior to starting the procedure with the dentist. When the patient becomes drowsy by the medications, then monitors can be placed and the dentist can start continuous monitoring for the procedure and able to discharge the patient when appropriate according to the guidelines. 

Please consider all recommendations suggested in the comment section when finalizing the sedation regulations and distinguish between Deep and Moderate sedation monitoring requirements. Eliminate the requirement for ECG monitoring equipment and continuous monitoring by the dentist.

Thank you for your consideration, 

Shepherd Sittason D.D.S.

I have been providing conscious sedation since 2007 and have been cnstantly amazed at how much  patients love this option for dental treatment.  It provides a reasonably priced option that is both safe and manageable.  I believe the new regulations requiring EKG monitoring as well as the dentist being in the room for the entire appointment will make this option for care unreasonable for most general dentists.

Since most dentists do not provide IV or IO medications,even if we detected an arrythmia, we would be unable to provide the proper medications to treat the underlying problem.  In light of this, it appears the EKG requirement offers little added saftety to the patient.

As for the dentist being in the room for the entire appointment, most dental offices are small by nature and the dentist will never be more than 20 feet away from the patient if an emergency should arise.

On behalf of the Virginia Society of Anesthesiologists, we respectfully offer the following comments in connection with the Notice of Intended Regulatory Action (NOIRA) filed September 5, 2012 regarding the Regulations Governing the Practice Sedation and Anesthesia Permits for Dentists. 

            Certified Registered Nurse Anesthetists (CRNAs) are subject to joint regulation by the Boards of Medicine and Nursing.  Paragraph D of 18VAC90-30-120 provides as follows:

D. A certified registered nurse anesthetist shall practice in accordance with the functions and standards defined by the American Association of Nurse Anesthetists (Scope and Standards for Nurse Anesthesia Practice, Revised 2005) and under the medical direction and supervision of a doctor of medicine or a doctor of osteopathic medicine or the medical direction and supervision of a dentist in accordance with rules and regulations promulgated by the Board of Dentistry. (Emphasis added).

It should be noted that all medical doctors receive training in anesthesia.  Even a doctor who is not an anesthesiologist receives critical care training, including advanced resuscitation techniques.  Moreover, Virginia regulation, 18VAC85-20-320, requires doctors providing office-based anesthesia to abide by a number of requirements, including:

• Perform a pre-anesthetic evaluation and examination or ensure that it has been performed;
• Develop the anesthesia plan or ensure that it has been developed;
• Ensure that the anesthesia plan has been discussed and informed consent obtained;
• Ensure patient assessment and monitoring through the pre-, peri-, and post-procedure phases, addressing not only physical and functional status, but also physiological and cognitive status;
• Ensure provision of indicated post-anesthesia care; and
• Remain physically present or immediately available, as appropriate, to manage complications and emergencies until discharge criteria have been met. (Emphasis added).

Additionally, 18VAC85-20-330 requires that “doctors who utilize office-based anesthesia shall ensure that all medical personnel assisting in providing patient care are appropriately trained, qualified and supervised….” (Emphasis added).

            The VSA is concerned with proposed changes to 18 VAC 60-20-110 (Requirements for a permit to administer deep sedation/general anesthesia).   Section E of this regulation, which is all new language, states:

A dentist not qualified to administer deep sedation and general anesthesia shall only use the services of a dentist with a current deep sedation/general anesthesia permit or an anesthesiologist to administer deep sedation or general anesthesia in a dental office. In a licensed outpatient surgery center, a dentist not qualified to administer deep sedation or general anesthesia shall use either a permitted dentist, an anesthesiologist, or a certified registered nurse anesthetist to administer deep sedation or general anesthesia.  (Emphasis added).  

The last sentence suggests that CRNAs do not have to be supervised in the outpatient surgery setting, which is clearly contrary to Virginia law. 

            The VSA supports current regulations contained in Regulations of the Board of Dentistry dealing with Anesthesia, Sedation and Analgesia, 18VAC60-20-107 et seq.  In particular, we support the educational requirements provided in 18VAC60-20-110 setting forth the training requirements to administer deep sedation/general anesthesia.  We further support the provision set forth in 18VAC60-20-110-B that permits a dentist who has fulfilled the training requirements in subsection A to employ the services of a CRNA.  That level of training for the dentist gives true and appropriate meaning to the principle of medical direction and supervision of a CRNA as is required by Virginia law and regulation.  A practitioner who does not have appropriate anesthesia and critical care training and experience cannot provide adequate medical direction and supervision to a CRNA.

We hope that any proposed revision to the regulations is consistent with this important principle and complies with applicable law and regulation.  In particular, we ask the Board to amend 18 VAC 60-20-110 Section E to make clear that CRNAs can only operate under the medical direction and supervision of a doctor of medicine, a doctor of osteopathic medicine or a dentist, even in the outpatient surgery context.

            The VSA respectfully submits that the interests of patients are best served by having skilled physicians or dentists supervising CRNAs.  This position has been amply borne out by decades of actual experience.

As a dentist who has been using both IV and oral sedation in my office since 1993, I have to voice my concern about the request to mandate EKG usage for all moderate sedation cases. The only time I have ever had to call 911 was because I did NOT sedate a patient who developed an anxiety induced angina episode during local anesthesia.   The safety is beyond question, and with the routine use of pulse oximetry, and reversal agents for opioids and benzodiazapines, over effect can be quickly controlled.  The concept of mandating the dentist to be in the operatory at all times will have a cost increase effect which will likely make sedaation unaffordable for many patients, who will in ten avoid treatment to their own detriment. As well trained staff can safely monitor patients, and alert of any concerns with vital signs , it seems to be overkill with these newly proposed regulations. I am certain that many of the prescription drugs provided by physicians, are used either accidtly or otherwise, to create effects similar to or beyond what is considered Moderate conscious sedation in a dental office, yet withNO monitoring whatsoever .

Please reconsider the implementation of these new regulations .

     I have been doing mild to moderate conscious oral sedation dentistry for over eight years and have had no problems with the current recommended technique of monitoring the patient with the pulse oximeter.  The recent change in the regulations that will go into effect April 1st, 2013, is not something that has been recommended by the American Dental Association, which has reviewed moderate oral sedation extensively.  I therefore feel that these changes are much more than are needed.  Virginia is the only state which will require these stricter changes and they will decrease the access to dental care for those patients that need to be sedated in order to help them get through their dental treatment.  I ask that you reonsider these regulation changes and have them withdrawn before the activation date of April 1st 2013.                               The requirement to have the dentist present in the room with the patient the entire time the patient is sedated in the office is also an unnecessary requirement.  During the initial and post-op phase of the sedation appointment, or when the dentist needs to check a hygiene patient, the sedated patient can be adequately monitored by a qualified and trained dental assistant or hygienist.  In most dental offices the doctor can be sumoned in a few seconds to address any concerns that might arise.  This requirement is also overkill and should be revoked as soon as possible.