These are just a few of the recent headlines regarding the disturbing deaths of children and other patients undergoing dental procedures under "sedation and anesthesia" in office-based settings. In recent years, the Texas Society of Anesthesiologists (TSA) and the American Society of Anesthesiologists (ASA) have witnessed an increase in media and advocacy activity involving dental anesthesia and sedation. This activity is mostly centered on recent pediatric deaths in dental offices. Associations including ASA, the American Dental Association, the American Academy of Pediatrics, the American Association of Oral and Maxillofacial Surgeons, and the American Academy of Pediatric Dentists have recently updated their applicable policy documents on the issue.

It is unclear whether these complications are becoming more frequent, however what is clear is that large numbers of these procedures are being done in Texas and around the country. It is possible that the number of deaths are not increasing, however, the public, as a whole, and the policy makers are certainly becoming more aware and are very concerned about "patients dying in dentists' offices"! It should also be noted also that these incidents have not been limited to dentists and have at times even included physician anesthesiologists as providers of the anesthesia in the dental offices. This is a serious subject and one that organizations from anesthesiology, pediatrics, and dentistry are trying to address. This article will review the policy enhancements by these organizations, physician anesthesiologists' role, potential challenges we should consider, and, of course, what the future may hold.

Policy Enhancements

Pain relief services in the dental office are not a new development. Pain relief for a dental procedure is as expected as the free toothbrush at the end of a cleaning. Throughout the years, state legislators and dental boards have addressed within their laws and rules educational/training/office requirements for dentists to administer sedation/anesthesia. The TSA has been asked to weigh in when the Texas State Board of Dental Examiners (TSBDE) considered amending their regulations on the subject. At present, TSBDE requires a permit for Nitrous Oxide/Oxygen Inhalation sedation, minimal sedation, moderate enteral sedation, moderate parenteral sedation, and deep sedation or general anesthesia.

While detailing requirements in law for anesthesia/sedation administration is not new, what has been new is the increase in media attention on the number of patient complications in these settings. From Alaska and Hawaii to Florida, hardly a state has not witnessed a media report highlighting a serious patient complication in a dental chair. Unfortunately, our pediatric patients seem to be some of the most vulnerable.

• American Dental Association

  The American Dental Association (ADA) has offered guidelines to dentists concerning the administration and teaching of anesthesia/sedation since the early 1970's. In the most recent update of those guidelines (2016), the language addressed, among other things, end-tidal CO2 monitoring; the independence of depth of sedation and route of sedation; body mass index (BMI) as part of a pre-procedural workup; and the removal of pediatric patients from the guidelines.

• The minimal sedation language no longer allows supplemental dosing. The previous language provided in part "during minimal sedation, supplemental dosing is a single additional dose of the initial dose of the initial drug that may be necessary for prolonged procedures. The supplemental dose should not exceed one-half of the initial dose and should not be administered until the dentist has determined the clinical half-life of the initial dosing has passed. The total aggregate dose must not exceed 1.5x the maximum recommended dose (MRD) on the day of treatment."¹ Under the updated language, moderate sedation guidelines would apply were a patient administered enteral drugs that exceeded the MRD during a single appointment.

• An important update from previous versions includes that the moderate sedation language no longer differentiates between moderate enteral and moderate parenteral sedation. The fact that the language recognized depth of sedation is independent of the route of administration was well received. Additionally, the equipment requirements were improved to provide "The equipment necessary for monitoring end-tidal CO2 and auscultation of breath sounds must be immediately available."² Patient history and evaluation requirements were updated to include language providing that ASA III/IV patients must consult with a primary care physician or consulting medical specialist. Finally, the guidelines language for moderate sedation included language providing that part of the pre-procedural workup should include assessment of Body Mass Index (BMI).

• The guidelines also updated the language concerning pediatric patients. The recommendations no longer define a child as one 12 years of age and under. Instead, the updated language does not offer an age limitation. As with the previous language the updated language defers to the American Academy of Pediatrics/American Academy of Pediatric Dentistry Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures.

• American Academy of Pediatric Dentistry and American Academy of Pediatrics

• In June 2016, the American Academy of Pediatrics (AAP) and the American Academy of Pediatric Dentistry (AAPD) released their Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016.³

• Similar to the ADA guidelines, the AAP/AAPD guidelines do not distinguish between level of sedation and route of administration, they recommend a consultation with physician anesthesiologists or appropriate subspecialists for ASA III and IV patients, and recommend capnography for moderate sedation and require capnography for deep sedation. The AAP/AAPD guidelines clearly warn "Children younger than 6 years (particularly those younger than 6 months) may be at greatest risk of an adverse event."⁴

• American Society of Anesthesiologists

• In October 2017, the American Society of Anesthesiologists House of Delegates approved the ASA Statement on Sedation & Anesthesia Administration in Dental Office-Based Settings.⁵ The document addresses training & education, monitoring & equipment, patient selection & case selection, resuscitative measures & protocols, and data reporting & transparency. Importantly, within the patient selection and case selection section, the ASA document addresses patients age six (6) and under. Specifically, the document encourages that because such patients are at enhanced risk of respiratory and related complications, the same standard of care and monitoring for moderate sedation should be applied as for deep sedation and general anesthesia, i.e. a distinct and separate qualified anesthesia provider not otherwise involved in the procedure.

• The ASA language further advises that because ASA Physical Status III and above patients are at higher risk of adverse events, they should be evaluated by a physician anesthesiologist or primary care physician before the procedure. The ASA language also warns "Prolonged and extensive procedures with longer periods of sedation and anesthesia care are of concern in the office-based setting and qualified anesthesia providers, in consultation with such patients, should consider more suitable facilities for the procedure."⁶

There were several other commonalities between the ASA, AAP, AAPD, and ADA documents. Readers are encouraged to review these recommendations.

In Texas, of note for the membership of this organization and under the context of this increased awareness, there have been two recent activities. In 2017, as part of the mandated Texas Legislative Sunset Review Process the Texas State Board of Dental Examiners (and the Dental Practice Act) was up for scheduled review and renewal and a strong voice for patient safety and public health emerged within the body charged with this activity. Dr. Charles Schwertner, an orthopedic surgeon as well as a Texas Senator on the Commission quickly became the advocate for reform at the TSBDE especially with regards to office-based anesthesia for dental procedures (regardless of provider).

The leadership of the TSA (and others) mobilized early in the legislative session to work with Dr. Schwertner and his staff to add language in the legislation regarding more office inspections (as with other based office based surgery), increased education and training, better reporting and more public transparency. The information in written and oral testimony was largely obtained from our own guidelines, statements, and standards developed at the ASA level. Not totally unexpected, all of our recommendations did not make it into the final rewrite and to insure better patient care still need to be addressed.

But the important formation of an Anesthesia Advisory Committee to the TSBDE was finalized in the bill and, just as importantly, a physician anesthesiologist was included by statute in this entity. Certainly, complications with surgery and anesthesia can and do occur but the public expects consistent high standards of patient safety regardless of the setting. These standards should not be tempered to save money nor should corners be cut to augment profits.

The other activity that occurred during this same time period related to this problem involved TSA members at the ASA national level. Somewhat as a result of the public awareness and outcry, ASA leadership determined that a public statement with endorsement by the members was necessary. Members of the Committee on Quality Management and Departmental Administration were assigned to an ad hoc task force to produce for Board and House approval an official statement for dissemination via the webpage.

Three TSA/ASA members and three California ASA members as well as the current ASA Liaison to the American Dental Association worked for several months to produce the now accepted Statement on Sedation and Anesthesia in Dental Office-based Settings. For the first time, our members and others have a resource that clearly states our values regarding the safe practice of anesthesia outside the hospital in dental offices regardless of the provider of the sedation/anesthesia.

Physician Anesthesiologists' Role

The public awareness of anesthesia-related complications in dental settings has increased (and possibly the actual numbers of incidents), causing a wave of media-related activity. The topic has gone beyond local media and has now reached national level attention. In July 2017, Megyn Kelly reported on these types of adverse events on her program, Sunday Night with Megyn Kelly. Karen Sibert, M.D., FASA, CSA President, was interviewed as part of the story. Professional organizations and some state dental boards have updated their policies. These administrative agencies have been proposing a range of updates to their regulations to incorporate both policy recommendations of national organizations as well as those local recommendations from dentists in the state.

As the experts in anesthesia, it is important to make oneself available to dental boards on this incredibly important subject. Texas has been working through its updates in this space but there are several other states where our members are also practicing. In the event a state dental board is considering updating or has already proposed changes to their dental regulations concerning anesthesia/sedation, physician anesthesiologists are encouraged to participate in those discussions, share ASA policy,⁷ and ensure those policymakers are aware of the latest patient safety recommendations that are in place in medicine.

Potential Challenges We Should Consider

It is important to remember that, within dentistry, the subject is not limited to general dentists. Dental anesthesiologists, pediatric dentists, oral and maxillofacial surgeons also have their unique practice settings and patient populations to take into account. Physician anesthesiologists throughout the state provide anesthesia and sedation services for all dental office settings and for those patients undergoing dental surgeries in hospitals. The dental practice act and dental regulations are completely separate from the medical practice act and the medical board. The medical education, training, and background required to become a board certified physician anesthesiologist is not the same as is required to secure a dental anesthesia/sedation permit in Texas. Our goal is always the protection of the patient. With that, it is important to consider the challenges we will encounter from others that have been offering sedation/anesthesia services at all ranges of the continuum. We should also be mindful of the challenges we may present should we expect the same level of education and training of dentists as for our own medical specialty.

What the Future May Hold

Patients, the media, lawmakers, policymakers, and healthcare providers are demanding more of those offering anesthesia/sedation services to dental patients. As the anesthesia/sedation experts, we have an opportunity to share our recommendations to the dental community to promote patient safety. This may also be an opportunity to work with dentistry on other areas to protect and promote patient care in our communities.

References:

1. Guidelines for the Use of Sedation and General Anesthesia by Dentists Adopted by the ADA House of Delegates, October 2016. Available at: https://www.ada.org/~/media/ADA/Education%20and%20Careers/Files/ADA_Sedation_Use_Guidelines.pdf?la=en
2. Id.
3. Coté CJ, Wilson S, AMERICAN ACADEMY OF PEDIATRICS, AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016; 138(1): e20161212
4. Id.
5. Available at: http://www.asahq.org/quality-and-practice-management/standards-guidelines-and-related-resources/statement-on-sedation-and-anesthesia-administration-in-dental-office-based-settings
6. Id.
7. Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018
   Standards for Basic Anesthetic Monitoring
   ASA Physical Status Classification System
   Statement on Practice Recommendations for Pediatric Anesthesia
   Advisory on Granting Privileges for Deep Sedation to Non Anesthesiologist Physicians
   Statement on Sedation and Anesthesia Administration in Dental Office Based Settings
   Guidelines for Office Based Anesthesia
   Statement on Anesthesia Care Team
   Statement of Granting Privileges for Administration of Moderate Sedation to Practitioners
   Statement on Qualifications of Anesthesia Providers in the Office Based Setting