Orthodontists in Washington state were surprised earlier this year when the Dental Quality Assurance Commission (DQAC) adopted revisions to the dental anesthesia regulations that require every dentist who administers anesthetics to have a defibrillator for the office. The dentist and staff must be trained to use this equipment in an emergency. Basic life-support training certification is required of those working in the dental office, and new employees have 45 days to obtain the required certification. Offices administering anesthetic agents of any kind also must have suction equipment, a portable oxygen delivery system, and a blood pressure cuff and stethoscope. Emergency drugs, including a bronchodilator, glucose, aspirin, antihistaminic coronary artery vasodilator, and antianaphylactic agent must also be available and maintained.
For starters, you might think that, because orthodontists don't use anesthetics, the new defibrillator requirement would not apply to them. Well, not so fast. How many orthodontists place their own temporary anchorage devices (TADs) for better control of tooth movement? Yes, but the placement of a miniscrew requires only a topical anesthetic, and there is no risk to using topicals, is there?
As more orthodontists place miniscrews for anchorage, it is important to realize that all topicals are not the same. Normal topical anesthetic agents such as lidocaine and benzocaine are safe because, when used intraorally, they act only on the surface soft tissue, and very little is absorbed. However, when lidocaine and prilocaine or tetracaine are mixed together, the eutectic compound melting point decreases, and the resulting oil can rapidly penetrate tissues to a depth of 2 to 3 mm, producing more profound local anesthesia. Placing these compounded anesthetics on abraded, mucous, or soft tissues causes much more rapid absorption and possible systemic toxicity. According to the US Food and Drug Administration (FDA),1 the compounding of drugs or topical anesthetics is legal without FDA approval if produced on a customized basis as prescribed by attending professionals. In 2006, the FDA issued a public health advisory alert about the potential life-threatening side effects of compounded topical anesthetics.2 According to this alert, exposure to high concentrations of local anesthetics can lead to serious adverse reactions, including anesthetic overdose, seizure, irregular heartbeat, and even death.
Yes, there are risks associated with compounded topical anesthetics.
The only compound topical anesthetic manufactured for intraoral use is Oraqix (Dentsply Pharmaceuticals, York, Pa), which was approved by the FDA for root planing procedures in dentistry.3 However, Oraqix might be inadequate for the placement of TADs, according to practitioners. Examples of compound topicals that have been recommended for TAD placement are TAC 20% alternate (Professional Arts Pharmacy, Lafayette, La) and Profound PET (Stevens Pharmacy, Costa Mesa, Calif).3 “No studies have measured the quantity of systemic absorption occurring with compound topical anesthetics for orthodontic uses based on the type and thickness of gingival tissues, surface area, and duration of application,” cautioned Zahrowski.4 “To my knowledge, there are no reports of any toxicity from compound topical anesthetics used intraorally. But with the lack of FDA approval and until more tests are done on these anesthetics, precautions should be seriously considered when using these anesthetics.” For more detailed information on the history of these compound anesthetics and their toxicity when misused, see the guest editorial by Baumgaertel5 in this issue.
How are the orthodontists in Washington state handling the revised regulations from the DQAC? Have they all purchased defibrillators, or have they stopped using TADs?
Upon request by the dental community at the DQAC hearing, it was decided to repeal the proposed rule, consider allowing offices to share defibrillators and allow exemptions for dental offices that use only topical anesthetics.
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