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Approved by the Board Approved at May 6-8, 2002 Board meeting
Service Area: Medical
Subject: Guidelines for Respiratory Care Practitioner Administration of Controlled Substances for Sedation and Analgesia
In accordance with Section 1023-40 of the 1976 Code of Laws of South Carolina, as amended, notice is hereby given that the South Carolina Board of Medical Examiners, upon recommendation of the Respiratory Care Committee, has adopted the following statement regarding the administration of controlled substances for sedation and analgesia as guidance for licensed respiratory care practitioners in the practice of respiratory care under the South Carolina Respiratory Care Practice Act. For disciplinary purposes in matters before the Board, compliance with this statement will not be considered a violation of the licensee's professional duty under Sections 40-47-630 (A), (6), (7), (10) of the amended Code.
GUIDELINES FOR RESPIRATORY CARE PRACTITIONER ADMINISTRATION OF CONTROLLED SUBSTANCES FOR SEDATION AND ANALGESIA
The South Carolina Department of Health and Environmental Control (DHEC) and the United States Drug Enforcement Association (DEA) have added Respiratory Care Practitioners to their list of licensed medical professionals who are authorized to administer controlled substances, provided the administration of the controlled substance has been ordered by a physician and such administration is related to a respiratory care procedure.
An ad-hoc physicians subcommittee of the Respiratory Care Committee was asked to provide a document that will offer guidance to the respiratory care community pertaining to the administration of controlled substances. The subcommittee was asked to give special emphasis on the following topics:
Definition of those procedures where the administration of a controlled substance by a
Respiratory Care Practitioner is appropriate;
Definition of routes of administration as it relates to the procedure(s);
Role of the Medical Director in the identification training and implementation of a controlled substance policy;
Emerging scopes of respiratory care practice that may influence the role of the respiratory care practitioner in the administration of control substance(s).
Based upon the report of the physicians subcommittee and the recommendation of the Respiratory Care Committee, the Board adopts the following statements regarding the administration of controlled substances for sedation and analgesia.
The scope of practice of Respiratory Care Practitioners is defined in the South Carolina Respiratory Care Practice Act (§ 40-47-500, et seq.) With cross-training, certain other procedures are now provided by respiratory care services in various hospitals throughout South Carolina. Some of these procedures may require the administration of a controlled substance and utilize Respiratory Care Practitioners in an assisting role. These procedures may include:
Bronchoscopy - diagnostic and therapeutic
Endoscopy - diagnostic and therapeutic
Oncology-nebulization of controlled substances for palliative care
Cardiac catherization and related procedures
Transport-adult and neonatal
National documents are available to assist in developing the role of the Respiratory Care Practitioner's in providing sedation and/or analgesia, including the American Association of Respiratory Care (AARC) document entitled, "Administration of Sedative and Analgesia Medications by Respiratory Care Practitioners,” revised 3/00; and "Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologist,” a report by the American Society of Anesthesiologist Task Force on Sedation and Analgesia by Non-Anesthesiologists, last amended on October 17, 2001.
A) Procedures where the administration of a controlled substance by a Respiratory Care Practitioner is appropriate
The role of the Respiratory Care Practitioner in assisting with diagnostic and therapeutic procedures including bronchoscopy, endoscopy, cardiac catherization, transport of ventilated patients and emergent intubation is expanding. Most of these procedures may require moderate sedation. The American Society of Anesthesiologist (ASA) Guidelines should be followed by all Respiratory Therapists when called upon to provide sedation and analgesia. Respiratory Care education programs approved by the Commission of Accreditation of Allied Health Education Program/Committee on Accreditation for Respiratory Care provide appropriate pharmacologic and technologic training to enable Respiratory Therapists who have successfully completed a formal training and competency assessment program, working under medical direction and under direct orders from a physician, to safely administer sedatives and analgesia (by whatever routes and in whatever doses of medication selected by the physician) by following the ASA Guidelines. Following successful completion of a formal education and competency assessment program, the Respiratory Therapist should:
Be knowledgeable about the techniques, medications, side effects, monitoring devices, response or untoward effects of medications, and documentation for any specific procedure.
Meet qualifications to be certified as competent, in accordance with her/his facility's and Respiratory Care Service's policy to administer sedatives and analgesics under medical supervision and the direct orders of the physician preforming the procedure, or the anesthesiologist in attendance.
The Report by the American Society of Anesthesiologist Task Force on Sedation and Analgesia by Non-Anesthesiologist, as amended October 17, 2001, specifically comments on the training of personnel recognizing that, although the literature is silent regarding the effectiveness of training on patient outcomes, education and training in the pharmacology of agents commonly used in sedation/analgesia improves the likelihood of satisfactory sedation and reduces the risk of adverse outcomes from either moderate or deep sedation. The Board agrees. Specific concerns may include:
(1) Potentiation of sedative-induced respiratory depression by concomitantly administered opioids;
(2) Inadequate time intervals between doses of sedative or analgesic agents resulting in a cumulative overdose; and
(3) Inadequate familiarity with the role of pharmacological antagonist for sedative and analgesic agents.
Because the primary complications of sedation/analgesia are related to respiratory or cardiovascular depression, the individual responsible for monitoring the patient should be trained in the recognition of complications associated with sedation/analgesia. Because sedation/analgesia constitute a continuum, practitioners administering moderate sedation should be able to rescue patients who enter a state of deep sedation, while those intending to administer deep sedation should be able to rescue patients who enter a state of general anesthesia. Therefore, at least one qualified individual trained in basic life support skills (CPR, bag-valve-mask ventilation) should be present in the procedure room during both moderate and deep sedation. In addition, the immediate availability (1 - 5 minutes away) of an individual with advanced life support skills (e.g., tracheal intubation, defibrillation, use of resuscitation medication) for moderate sedation and in the procedure room itself for deep sedation should be ensured.Accordingly, the Board recommends that:
a) Individuals responsible for patients receiving sedation/analgesia should understand the pharmacology of the agents that are administered, as well as the role of pharmacologic antagonist for opioids and benzodiazepines.
b) Individuals monitoring patients receiving sedation/analgesia should be able to recognize the associated complications.
At least one individual capable of establishing a patent airway and positive pressure ventilation, as well as a means of summoning additional assistance, should be present whenever sedation/analgesia are administered. It is recommended that an individual with advanced life support skills be immediately available (within five minutes) for moderate sedation and within the procedure room for deep sedation.
It is apparent that if Respiratory Care Practitioners are to provide sedation/analgesia, they must receive a specific educational experience in the pharmacology and potential side effects of these medications and the appropriate mechanisms or drugs to deal with those side effects. In most of the procedures that may require the administration of a controlled substance and utilize Respiratory Care Practitioners in an expanded capacity (i.e., bronchoscopy, endoscopy, cardiac catheterization and emergent intubation), a physician will be present for the duration of the procedure. It would be an acceptable practice for a Respiratory Care Practitioner to administer sedatives and/or analgesics by whatever route felt necessary by the physician, under the direct supervision of the physician performing the procedure.
Respiratory Care Practitioners are involved in intrahospital and interhospital transport of adult, pediatric and neonatal patients. Many of these patients are intubated and mechanically ventilated during transport. In situations in which there is a competent airway in place and appropriate mechanical ventilation requires the use of sedatives and/or analgesic medications, it may be appropriate for the Respiratory Care Practitioner to provide medications under the direct order of the responsible physician.
It should be clear that the most appropriate professional to provide any medication by the aerosol route is the Respiratory Care Practitioner. While the delivery of aerosolized morphine for treatment of dyspnea in oncology patients may or may not be effective, if this drug is to be delivered by this route, it should be delivered by a professional trained in the appropriate delivery of an aerosolized medication. Concerns about the adequacy of currently available nebulizers and the real problem of residual volume within the nebulizer at the completion of an aerosolized treatment should be directed to DHEC for their assistance in the development of guidelines regarding policy for wasting of this residual medication.
B) Routes of administration as it relates to the procedure(s)
The routes of administration could include oral, rectal, transcutaneous (transdermal), intramuscular, intravenous or aerosol nebulization. For most procedures in which a Respiratory Care Practitioner may be assisting a physician, the route of administration of a sedating or analgesic agent will be provided intravenously. The physician and their facility should select and approve the appropriate route of administration of sedative/analgesic medications to be provided by Respiratory Care Practitioners.
Respiratory Care Practitioners should not provide sedative/analgesic medications in the home care environment.
C) Role of the Medical Director in the identification, training, and implementation of a controlled substance policy
The role of the Medical Director in the identification, training, and implementation of a controlled substance policy is of major importance. The Medical Director should be involved in the development of the education experience necessary for the Respiratory Care Practitioner to use sedatives and/or analgesic medications and in the development of the assessment tool to determine competency in the use of these medications. The assistance of a Pharm D, if available within the facility or institution, is recommended.
1. S.C. DHEC and U.S. DEA have added Respiratory Care Practitioner's to their list of licensed medical professionals who are authorized to administer controlled substances, if such administration is related to a respiratory care procedure.
2. The S.C. Respiratory Care Practice Act defines "Respiratory Care or Respiratory Therapy" as the allied health profession or specialty which provides educational, therapeutic, or diagnostic procedures utilized in the prevention, detection, and management of deficiencies or abnormalities, or both, of the cardiopulmonary systems.
3. The role of Respiratory Care Services in S.C. is institution or facility specific. Some facilities have expanded the role of Respiratory Care Practitioner's to include endoscopy and cardiac catheterization labs.
4. The administration of sedative/analgesic controlled substances by Respiratory Care Practitioners will require a formal educational experience and competency assessment tool approved by the Respiratory Care Committee. Annual assessment of competency should be mandatory.
5. The administration of sedative/analgesic controlled substances by Respiratory Care Practitioners should be in accordance with the "Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologist" of the ASA.
Nebulized morphine for the relief of dyspnea should be discouraged in view of current nebulizer technology and lack of scientifically proven efficacy. If nebulized morphine is utilized by a facility a Respiratory Care Practitioner may provide that service.
7. There is no role for the Respiratory Care Practitioner to administer sedative/analgesic medications in the home care environment inasmuch as that environment lacks any appropriate safeguards, as discussed herein.
Although a licensee who conducts himself in accordance with this policy will avoid disciplinary action by the Board of Medical Examiners. A licensee may still face civil liability under some circumstances and should, therefore, consult private counsel where doubt exists as to what actions are appropriate.