Regulations: Adult Minimal Sedation Jason H. Goodchild, DMD DrJGoodchild@gmail.com October 2017
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Caveats 1. The regulations about to be presented are accurate and current as of today. 2. This could change tomorrow. 3. It is up to every licensed professional to keep themselves updated on the regulations to which they are responsible. 4. This presentation serves as a supplement to your regulations, it does not replace them and is not as comprehensive as them. Take Home Message: Read Your Regs!
Our Philosophy 1. In the next 45 minutes we will discuss regulations in general as they relate to SEDATION (very broad topic). 2. We will describe the relationship between laws, regulations and guidelines. 3. We will focus specifically on this Province (BC) and will do our best to answer questions on other States/Provinces. 4. As a reminder, the focus of this course is on MINIMAL ORAL SEDATION.
First, why do we have Regulations? To Protect the Public!
Things I ve Learned Read your Rules & Regulations, keep up to date Maintain BLS for you and your Team Get a focused Medical History Take baseline vitals (Pulse, BP, O 2 Sat%), and record at least three readings (pre-op, start of treatment, before discharge) Never leave sedation patients alone Pre-procedure dietary restrictions must be considered based on the sedative technique prescribed Pre-op & Post-op verbal and written instructions must be given to the patient, parent, escort, guardian, or care-giver Get a pulse oximeter! Use a time-oriented sedation record for documentation of monitoring parameters and drugs used Patient must satisfy discharge criteria for dismissal
Laws vs. Regulations vs. Guidelines LAWS Generally passed by the State Legislature and define the laws and rules pertaining to the practice of dentistry. RULES & REGULATIONS These are rules and directives made and maintained by the Dental Board or College. In British Columbia Minimal and Moderate Sedation (non-hospital) are described in the Standards & Guidelines. GUIDELINES These are general rules and principles. They give advice and guidance and are made by professional organizations like the Canadian Dental Association or other specialty organization (eg, ADA, AGD, ADSA, AAOMS, etc)
The most recent GUIDELINES from the ADA are from 2016. They are free to download at: http://www.ada.org/~ /media/ada/about% 20the%20ADA/Files/ anesthesia_use_guid elines.ashx
The most recent GUIDELINES from the CDSBC are from 2016. They are free to download at: http://www.cdsbc.org /~ASSETS/DOCUME NT/Minimal- Moderate-Sedation- Standards-2014-For- Web.pdf
Continuum of Sedation in BC Single Oral Sedative Nitrous Oxide & Oxygen Single Oral Sedative and Nitrous Oxide & Oxygen Moderate Sedation Minimal Sedation Further broken down into enteral and parenteral Deep Sedation General Anesthesia Adapted from CDSBC Standards and Guidelines
Usually Achieved by Minimal Sedation Oral/SL administration of a single enteral drug, up to the MRD Inhalation of N2O/O2 Both Moderate Sedation Oral administration of multiple sedative drugs, w/ or w/o N2O2/O2 Parenteral benzo (Level 1) Parenteral benzo + narcotic (Level 2) CDSBC Standards & Guidelines
Usually Achieved by Hrs Minimal Sedation 0 14 16 Oral/SL administration of a single enteral drug, up to the MRD Inhalation of N2O/O2 Both Hrs/Pts Moderate Sedation 40/20 60/20 150 cases Oral administration of multiple sedative drugs, w/ or w/o N2O2/O2 Parenteral benzo (Level 1) Parenteral benzo + narcotic (Level 2) CDSBC Standards & Guidelines
The most recent GUIDELINES from the ADA+C are from 2011
Alberta The Modalities Modality 1: Nitrous Oxide and Oxygen Sedation. Modality 2: Oral Administration of a Single Dose of a Single Sedative Drug (Benzodiazepines or Benzodiazepine-like drugs and Antihistamines only). Supplemental use of a single oral sedative drugs falls under Modality 3. Modality 3: Oral Administration of a Single Sedative Drug with Nitrous Oxide and Oxygen or Supplemental use of a Single Sedative Drug (upon review, permits are issued). Modality 4: Parenteral and Parenteral-like Sedation (Administration of Sedative Drugs other than Oral [intravenous, intramuscular, subcutaneous, submucosal or intranasal]) (upon review, permits are issued). * Single Drug IV (4S) * 2Drug IV with Fentanyl (4F)
The most recent GUIDELINES from the RCDSO are from 2012. They are free to download at: http://www.rcdso.org /Assets/DOCUMENT S/Professional_Practi ce/standard_of_prac tice/rcdso_standar d_of_practice Use_ of_sedation_and_ge neral_anesthesia.pdf
The most recent GUIDELINES from the MDA are from 2016. They are free to download at: https://www.manitob adentist.ca/pdf/2017 /january/bylaw%20 FOR%20PHARMACO LOGICAL%20BEHAVI OUR%20MANAGEM ENT.pdf
Manitoba - Bylaw for Pharmacological Behavior Management Section 1 Anxiolysis Single Oral Sedative Agent No additional training Section 2 Conscious Sedation Single Oral Agent Ambulatory pts 13+ years or age (ASA 1-2) 6 hrs Ambulatory pts 13+ years or age (ASA 1-2) completed a hospital based internship program and 5 supervised cases Ambulatory pts 5-12 years of age (ASA 1-2) 6 hrs for adults plus another 6 hrs, 5 supervised cases Section 3 Conscious Sedation Nitrous Oxide Inhalation 6 hrs didactic instruction, 5 supervised cases (ASA 1-2) ASA 3 patients 12 month hospital internship, 5 supervised cases Section 4 Conscious Sedation Parenteral Administration of a sedative agent Section 5 Conscious Sedation Multiple Modalities Combination of Oral Sedatives or Nitrous Oxide with an Oral or Parenteral Agent Ambulatory pts 13+ years of age (ASA1-2), oral + nitrous 6 hrs for nitrous, 6 hrs for oral, and 6 hrs for the combination 18 hrs total Section 6 Deep Sedation and General Anesthesia
ASA CLASSIFICATION Class 1 Normal Healthy Class 2 Patient with mild systemic disease Class 3 Pt. w/ severe systemic disease that limits activity but is not incapacitating Class 4 Pt. w/ severe systemic disease that is a constant threat to life Class 5 Morbid pt. who is not expected to survive 24 hours with or without an operation Class 6 A declared brain dead pt. whose organs are being removed for donor purposes
Class 1 Class 2 Normal Healthy ASA CLASSIFICATION Patient with mild systemic disease According to the CDSBC and MDA: ASA 4 patients or above are not considered eligible candidates for elective outpatient sedation procedures. ADA+C: ASA 1-2 are ok, ASA 3 and above must be referred to a surgical facility Class 3 Pt. w/ severe systemic disease that limits activity but is not incapacitating Class 4 Pt. w/ severe systemic disease that is a constant threat to life ONTARIO DENTISTS: ASA4 patients can be Class 5 treated with operation Nitrous Oxide only, to provide min/mod sedation the dentist must be qualified for deep Class 6sedation or general anesthesia purposes MANITOBA DENTISTS: Although ASA3 patients can be treated in an outpatient setting in Manitoba, the training requirements for ASA 3 are significantly higher Morbid pt. who is not expected to survive 24 hours with or without an A declared brain dead pt. whose organs are being removed for donor
Manitoba s Interpretation of ASA Physical Status Classification
Regulations: Adult Minimal Sedation Some Definitions
Definitions Enteral (Alberta) any technique of administration in which the agent is absorbed through the GI tract or oral mucosa (ie, oral, rectal, sublingual) Enteral (BC) a technique of drug administration in which the agent is absorbed through the gastrointestinal (GI) tract or mucosa Examples of enteral administration include: oral sublingual (transmucosal)
Definitions Parenteral a technique of drug administration whereby the administration route is not through the digestive tract. Examples of parenteral administration include: intramuscular (IM) intravenous (IV) intranasal (IN) submucosal (SM) subcutaneous (SC) intraosseous (IO) Source: CDSBC Standards & Guidelines
Definitions Minimal Sedation (BC) a minimally depressed level of consciousness produced by a pharmacological method, in which the patient retains the ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected. Minimal Sedation (Alberta) - the patient with minimal sedation is able to maintain their own airway and to clear their airway should foreign material enter the larynx or pharynx. Respiration is normal The patient responds normally to tactile stimulation and verbal command Eye movements are normal Protective reflexes are intact Amnesia may or not be present
Definitions Reversal agents agents that act by interfering with a sedative medication s action(s). Reversal agents include flumazenil for benzodiazepines and naloxone for opioids. Supplemental dosing administration of an additional dose of the initial sedative drug. The supplemental dose should not exceed one-half of the initial dose, and should not be administered until the dentist has determined that the peak effect of the initial dosing has passed. The total aggregate dose must not exceed 1.5 times the MRD on the day of treatment. Supplemental dosing is discouraged, and if used, must be carried out with great caution. Time-oriented anaesthesia record documentation at appropriate time intervals of drugs, doses and physiological data obtained during patient monitoring.
Dentists Educational Requirements CDSBC Standards & Guidelines Single Oral Sedative Drug: The dentist must have achieve training from either their undergraduate dental program or an appropriate postgraduate course. Dentists currently registered with CDSBC may administer a single oral sedation drug for the purpose of minimal sedation. Nitrous Oxide/Oxygen: The dentist must have achieve training from either their undergraduate dental program or an appropriate postgraduate course. At a minimum, this must include 14 hours of combined didactic/clinical training. Nitrous Oxide/Oxygen With a Single Oral Sedative Drug: The dentist will typically obtain training in a continuing education course. At a minimum, the course must include 16 hours of combined didactic/clinical training.
Minimal Sedation Registration: Dentists administering minimal sedation do not need to register their qualifications with CDSBC but must meet the educational requirements as set out in these Standards To administer minimal sedation, the dentist must maintain certification in BLS for health care providers (CPR-HCP) or an appropriate equivalent as determined by the Sedation and General Anaesthetic Services Committee. ACLS required for moderate sedation
Equipment Requirements The following equipment must be immediately available during sedation: 1. A ventilation apparatus or bag valve mask (e.g., Ambu bag) suitable for the patient being treated (both in treatment and in recovery areas); 2. An emergency medication kit or cart (Minimal -- Appendix C; Moderate -- Appendix D); 3. Oxygen and suction equipment; and 4. A manual defibrillator and/or AED is highly recommended for minimal sedation and is required for both oral (enteral) moderate sedation and parenteral moderate sedation
Equipment Requirements Appendix C: Emergency Medications Required for Minimal Sedation
Equipment Requirements Minimum Requirements for Inhalation Equipment Used during Sedation 1. Inhalation equipment must have the capacity to deliver 100% oxygen and never more than 70% nitrous oxide concentration at a flow rate appropriate for the patient s size; 2. Nitrous oxide/oxygen equipment must have a fail-safe system; and 3. Nitrous oxide/oxygen equipment must have an appropriate scavenging system. Any nitrous oxide machine capable of delivering a nitrous level greater than 70% MUST be retired.
Equipment Requirements Equipment Maintenance Requirements 1. Nitrous oxide machines must be inspected annually or more frequently as recommended by the manufacturer, whichever is more frequent; 2. Physiological monitoring devices must be inspected and maintained on an annual basis or in accordance with the manufacturer s guidelines, whichever is more frequent; and 3. A logbook of all equipment inspections and maintenance must be kept on the premises.
Clinical Standards for Minimal and Moderate Sedation Medical History Present and part illnesses Hospital admissions Current medications (incl. doses) Rx drugs Non-Rx drugs Herbals Allergies to drugs A functional inquiry Appropriate physical evaluation Sample MHx in Appendix E of CDSBC Standards & Guidelines
Personnel Requirements for Minimal Sedation The only persons who may administer oral sedative agents to patients are: 1. Dentist 2. Registered Nurse (RN) acting under the direction of the Dentist 3. For pediatric patients, a parent/guardian. Must be given in the presence of the dentist/rn CDA s MUST NEVER give medication directly to patients. An appropriately trained staff person must be with the patient at all times during treatment.
Personnel Requirements for Minimal Sedation The minimal sedation team MUST be comprised of at least two individuals: 1. An appropriately trained dentist with current BLS or equivalent 2. An appropriately trained staff member with current BLS or equivalent Dentist Responsibilities During Minimal Sedation Must ensure that the assistant is adequately trained Must administer the sedation Must ensure the patient is monitored and supported Must recognize and treat adverse patient responses
Personnel Requirements for Minimal Sedation Professional responsibilities of the sedation/operative assistants include: 1. Assisting in determining the patient s level of consciousness; 2. Assisting in monitoring physiologic parameters; 3. Assisting in protecting the airway by keeping it free of secretions, blood and debris; 4. Recording appropriate findings/parameters; 5. Assisting the dentist in supporting the patient if the level of sedation becomes deeper than intended; 6. Assisting in emergency procedures; and 7. Supervising and monitoring the patient as directed by the dentist.
Supplemental dosing during minimal enteral sedation with or without nitrous oxide and oxygen This practice is discouraged and must be carried out cautiously. In this circumstance, the total aggregate dose, both initial and supplemental, must not exceed 1.5 times MRD on the day of treatment. If supplemental dosing is administered, the patient s oxygenation, ventilation, and circulation must be monitored continually.
Inhalational administration of nitrous oxide and oxygen Nitrous oxide/oxygen minimal sedation must be administered by an appropriately trained dentist. If inhaled nitrous oxide and oxygen is administered, the patient s oxygenation, ventilation, and circulation must be monitored as clinically indicated.
Inhalational administration of nitrous oxide and oxygen An appropriately trained staff member, under the order and supervision of an appropriately trained dentist, may monitor a patient receiving nitrous oxide provided that: 1. Appropriate dosage levels have been previously determined and recorded by the dentist in the patient record; 2. Nitrous oxide/oxygen minimal sedation has been initiated for the patient by the dentist; and 3. The dentist is present at all times in the office and immediately available in the event of an emergency.
Monitoring A dentist or, at the dentist s direction, an appropriately trained staff member, must remain in the operatory to monitor the patient continuously until the patient meets the criteria for discharge. The appropriately trained staff member must be familiar with monitoring techniques and equipment.
Monitoring Monitoring observations must include: 1. Oxygenation Colour of mucosa and/or skin must be continually evaluated. Measurement of oxygen saturation by pulse oximetry is required for patients 12 years of age and under. Measurement of oxygen saturation by pulse oximetry is highly recommended for all other patients. 2. Ventilation The dentist and/or appropriately trained staff member must continually confirm chest excursions. The dentist and/or appropriately trained staff member must continually monitor respirations. 3. Circulation Blood pressure and heart rate should be evaluated as clinically indicated.
ALL Guidelines Agree on These Definitions: Minimal sedation: A drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected (Anxiolysis). Usually associated with a single oral sedative drug and/or nitrous oxideoxygen.
Moderate sedation: A drug induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Usually associated with multiple oral drugs combined with or without nitrous oxide/oxygen, or parenteral sedation. NOT what this course certifies you for.
Conscious sedation: A minimally and moderately depressed level of consciousness that retains the patient s ability to independently and continuously maintain an airway and respond appropriately to physical stimulation and verbal command. This course certifies you for the minimal part of this definition.
Deep sedation: A controlled state of depressed consciousness accompanied by partial loss of protective reflexes including the inability to respond purposefully to verbal command, produced by a pharmacologic or nonpharmacologic method or a combination thereof. NOT what this course certifies you for.
General anaesthesia: A controlled state of unconsciousness accompanied by loss of protective reflexes, including inability to maintain an airway independently and respond purposefully to physical stimulation or verbal command. This state therefore applies to any technique which has depressed the patient beyond deep sedation. NOT what this course certifies you for.
ALL guidelines agree on these standards: 1. Guidelines for Teaching Sedation; 2. Guidelines for Doing Sedation (Education, Training and Continuing Education); 3. Guidelines for Helping with Sedation (Staff education, competencies); 4. Guidelines for Where Sedation is being done (Equipment); 5. Guidelines for Keeping Sedation Safe (Monitoring, Record Keeping, Emergency Preparedness, Reversal). These vary depending on the level of sedation intended to be provided.
So what do you need to know in B.C. when providing MINIMAL sedation? First, you need to know your definition and intent: Minimal Sedation: A drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected (Anxiolysis). Usually associated with a single oral sedative drug and/or nitrous oxide-oxygen.
So what do you need to know in B.C. when providing MINIMAL sedation? Second, you, your staff and your facility need to be qualified: The dentist is responsible for providing and maintaining the armamentarium necessary for the provision of sedation, including equipment for emergency resuscitation and life support. Dentists administering minimal sedation do not need to register their qualifications with CDSBC but must meet the educational requirements. (Beyond Minimal MUST register)
Qualifications in B.C. to provide MINIMAL sedation? Successfully complete a sedation course/program acceptable to CDSBC (obtained in dental school or through post-graduate training or continuing education) that is designed to produce competency in the specific modality of sedation utilized (i.e., this course qualifies you to provide MINIMAL sedation). The dentist must maintain certification in BLS for health care providers (CPR-HCP) or an appropriate equivalent as determined by the Sedation and General Anaesthetic Services Committee.
Qualifications in B.C. to provide MINIMAL sedation? There is more information in section 4.3 of these guidelines (4 pages long) but in general: Single Oral Sedative Drug: The dentist must have obtained training from either their undergraduate dental program or an appropriate postgraduate course. Dentists currently registered with CDSBC may administer a single oral sedative drug for the purpose of minimal sedation. Nitrous Oxide/Oxygen: 14 hours of combined didactic/clinical training. Nitrous Oxide/Oxygen With a Single Oral Sedative Drug: 16 hours of combined didactic/clinical training.
Equipment Requirements in B.C. to provide MINIMAL sedation? A ventilation apparatus or bag valve mask (e.g., Ambu bag) suitable for the patient being treated (both in treatment and in recovery areas); An emergency medication kit or cart (9 drugs); Oxygen and suction equipment; A manual defibrillator and/or AED is highly recommended. (it is required for deeper levels of sedation)
Equipment Requirements in B.C. to provide MINIMAL sedation? Inhalation equipment must have the capacity to deliver 100% oxygen and never more than 70% nitrous oxide concentration at a flow rate appropriate for the patient s size; Nitrous oxide/oxygen equipment must have a fail-safe system; Nitrous oxide/oxygen equipment must have an appropriate scavenging system. (Alberta) Must have alarm settings and an audio component on monitoring equipment must be used at all times A nitrous monitor to measure ambient nitrous oxide in the operatory is recommended; or The use of nitrous oxide dosimeters used bi-annually, or where there is a concern about ambient nitrous oxide in the office is recommended.
Equipment Requirements in B.C. to provide MINIMAL sedation? Nitrous oxide machines must be inspected annually or more frequently as recommended by the manufacturer, whichever is more frequent; Physiological monitoring devices must be inspected and maintained on an annual basis or in accordance with the manufacturer s guidelines, whichever is more frequent; A logbook of all equipment inspections and maintenance must be kept on the premises.
Reversal BC - While a reversal agent should not be used routinely, if a reversal agent is administered before discharge criteria have been met, the patient MUST be monitored until recovery is assured. The duration of action of the reversal agent MUST be taken into account. Alberta Should a reversal agent be required, the patient must remain in the office for at least 75 minutes after the reversal agent has been administered to assess level of consciousness and vital signs up to and including the period of time the effects of each dose of the reversal agent is expected to last Reversal agents must not be used to expedite patient discharge Reversal agents are for emergency use only The use of a reversal agent is a reportable event
Reportable Events BC Cases resulting in the need for resuscitation Cases resulting in the need for transfer of a patient to a hospital Death Alberta When a reversal agent is used When a patient s response to sedation results in depression beyond the level of sedation intended Incidents involving emergency interventions outside the office (eg, 911 called whether or not transferred to the hospital) Transfers of the patient or the care of the patient to another care provider within 10 days of the sedation, regardless of whether or not the patient was admitted Unexpected treatment by another care provider within 10 days of the sedation procedure Death Missing or non-locatable drugs
Drug Requirements in B.C. to provide MINIMAL sedation? Health Canada categorizes benzodiazepines, opioids and ketamine as targeted substances and, as such, they must be managed in a way that both keeps them secure from loss/theft and permits auditing. 1. Housed in a securely mounted and locked cabinet. 2. Keys must be kept in a secure, separate location, with limited, authorized access. 3. At the end of any day on which the locked cabinet is opened, a count and reconciliation of each targeted substance must be completed by 2 individuals.
Drug Requirements in B.C. to provide MINIMAL sedation? Health Canada categorizes benzodiazepines, opioids and ketamine as targeted substances and, as such, they must be managed in a way that both keeps them secure from loss/theft and permits auditing. 4. A logbook of the count reconciliation must be kept in the office at all times, in a secure location, separate from the drug cabinet. 5. Any identified loss or theft of a targeted substance must be reported to Health Canada within 10 days of its discovery (complete Health Canada loss and theft report form online).
Documentation Requirements in B.C. to provide MINIMAL sedation? An adequate, clearly recorded current medical history: 1. Present and past illnesses; 2. Hospital admissions; 3. Current medications and/or non-prescription drugs and/or herbal supplements, as well as dose; 4. Allergies (in particular to drugs); 5. A functional inquiry and an appropriate physical evaluation completed for each patient prior to the administration of any form of sedation; 6. A determination of the patient s American Society of Anesthesiologists (ASA) Physical Status Classification (ASA). 7. BMI (Alberta)
Documentation Requirements in B.C. to provide MINIMAL sedation? Pre-operative preparation checklist MUST be completed to include: 1. Review of procedure 2. Informed consent 3. Dietary restrictions (NPO) 4. Pre-operative written instructions 5. Baseline vitals 6. Focused physical evaluation (eg, airway)
Documentation Requirements in B.C. to provide MINIMAL sedation? Peri-operative documentation MUST include: An appropriate anaesthetic record identifying all drugs administered (including local anaesthetics), dosages used and the patient s monitored physiological parameters, especially the patient s blood pressure and heart rate as clinically indicated.
Documentation Requirements in B.C. to provide MINIMAL sedation? Post-operative documentation MUST include: 1. Oxygen and suction equipment must be immediately available during recovery. 2. Monitoring observations must include: oxygenation, ventilation and circulation. 3. The dentist must determine and document that the level of consciousness, oxygenation, ventilation and circulation are satisfactory prior to discharge. 4. Post-operative verbal and written instructions must be given to the patient, parent, escort, guardian or caregiver.
Remember that in in B.C.... The only persons who may administer oral sedative agents to patients are: Dentists or RNs (never CDAs). The minimal sedation team MUST be comprised of at least two individuals: Dentists and an appropriately trained staff member, who has current certification in BLS for health care providers (CPR-HCP) or an appropriate equivalent. The guidelines speak further about the integrated responsibilities of the sedation team in section 9.2.
Remember that in in B.C.... In the majority of cases, oral sedative drugs must be administered in the dental office. In cases where the dentist believes the patient s anxiety is such that sedation is necessary to allow transport to the dental office, an oral sedative drug may be prescribed to be taken outside the office: 1. A limit of one type of sedative drug must be prescribed at any one time. 2. The dose of the sedative drug must not exceed MRD. 3. Clear written instructions must be given to the patient or guardian explaining how to take the sedative drug and listing the expected effects from the drug. 4. The patient must be instructed not to drive a vehicle and must be accompanied to and from the office by a responsible adult.
Remember that in in Manitoba Drug and dosage parameters accepted by the MDA
Remember that in in B.C.... Children MUST NEVER be sedated outside the dental office.
Remember that in in B.C.... Supplemental dosing during minimal enteral sedation with or without nitrous oxide and oxygen is discouraged and must be carried out cautiously. In this circumstance, the total aggregate dose, both initial and supplemental, must not exceed 1.5 times MRD on the day of treatment. If supplemental dosing is administered, the patient s oxygenation, ventilation, and circulation must be monitored continually.
Appendices we have provided you: Pre-Sedation Checklist Post-Sedation Instructions Informed Consent for Dental Sedation Procedures Informed Consent for Anxiolysis Discharge Criteria Checklist Intraoperative Sedation Record Health History Form Emergency Kit Set Up and Directions Procedures for N2O Sedation Clinical Assessment and Guidelines
The reality is... YOU are responsible for reading and knowing your regulations and keeping up to date!
DrJGoodchild@gmail.com