The Upjohn company distributes triazolam (Halcion) in the U.S. They make no claims of its usefulness as a dental sedative, nor has it been tested for use with children. The UpJohn company made it very clear to me in a letter that its use for dental sedation and with children is investigational in nature and not supported or encouraged by the company.


The Food and Drug Administration does not recognize triazolam's use for either dental or pediatric sedation. A practitioner must recognize that should there be a problem, the lack of FDA approval would create problems from a medical-legal standpoint. Lack of FDA approval does not, however, prevent our using the drug for sedation.

Recordkeeping requirements

The Drug Enforcement Administration, a division of the U.S. Department of Justice, has a booklet that is available from any DEA office entitled, Physician's Manual, An Informational Outline of the Controlled Substances Act of 1970. This manual spells out the requirements of recordkeeping, storage, inventory, security, etc. required for prescribing and dispensing a controlled substance. triazolam is a schedule IV substance.

Schedule IV substances "have an abuse potential less than those listed in Schedule III and include such drugs as barbital, phenobarbital ... chloral hydrate ... Meprobamate ... diazepam (Valium) ... alprazolam (Xanax) ... triazolam (triazolam) ... lorazepam (Ativan) ... medazolam (Versed) ... "

To administer, prescribe or dispense any controlled substance a physician (dentist) must be registered with the DEA. "The registration must be renewed every three years and the certificate of registration must be maintained at the registered location."

"It is necessary for dentists to keep records of drugs purchased, distributed and dispensed. Having this closed system, a controlled substance can be traced from the time it is manufactured to the time it is dispensed to the ultimate user."

"All controlled substance records must be filed in a readily retrievable manner from all other business documents, retained for two years and made available for inspection by DEA. Controlled substance records maintained as part of the patient file will require that this file be made available for inspection by DEA."

"A physician (dentist) who dispenses controlled substances is required to keep a record of each transaction." "(Dispense means to deliver a controlled substance in some type of bottle, box or other container to a patient. Under these acts the definition of dispense also includes the administering of a controlled substance.)"

"A physician (dentist) who regularly engages in administering controlled substances in Schedule II, III, IV and V is required to keep records if patients are charged for these drugs either separately or together with other professional services. When a physician dispenses a controlled substance and administers this substance occasionally or regularly from the same inventory, the physician (dentist) must keep a record of all transactions." "Administer means to instill a drug into the body of a patient."

Inventory requirements

"A physician (dentist) who dispenses or regularly engages in administering controlled substances and is required to keep records as stated above must take an inventory every two years of all stocks of the substances on hand." An inventory of all stocks must be on hand on the date when the use of controlled substances began. "In the event no controlled substances are on hand at the initial inventory, a zero inventory should be recorded."

'The inventory record must:

1. List the name, address and DEA registration number of the registrant.

2. Indicate the date and time the inventory is taken. i.e., opening or close of business.

3. Be signed by the person or persons responsible for taking the inventory.

4. Be maintained at the location appearing on the registration certificate for at least two years.

5. Keep records of schedule II drugs separate from all other controlled substance records."

"All inventories and records of controlled substances in Schedule IV must be maintained separately or must be in such form that they are readily retrievable from the ordinary professional and business records of the physician (dentist)."


"A physician (dentist) who has controlled substances stored in an office or clinic must keep these drugs in a securely locked, substantially constructed cabinet or safe. "

"It is recommended that the controlled substance stock be kept to a minimum." In my office, the triazolam is kept locked in a key locker which is permanently attached to an office wall. Inventory sheets are kept in a book with patient record forms. This sheet shows date, patient name, age, weight and has space for comments. The inventory total is changed with each drug administration so as to provide a running total of the drug inventory. When restocking the drug supply, a copy of the prescription is attached to the inventory sheet.

Patient records

Patient records are kept for all treatments. They include blood pressure records, pulse rates and pulse oximeter readings. These records are taken and recorded preoperatively and at 15 minute increments from the the drug administration until the case is completed. In addition, the patient reports their level of apprehension preoperatively at 30 minutes, at the start of the procedure (60 minutes), midway through the procedure, and at the close of the procedure. The patient's medical status (ASA rating) is recorded along with their age, sex, weight, amounts of drug administered, name date and whether this is the first administration of this sedative.

Our sedation records are necessary for several reasons. First, they establish a baseline and would be one of the first indicators of a potential problem. If any of the parameters measured start to change, we should immediately be alerted to this possibility and start corrective action. Second, the stress of an emergency makes time sequencing difficult for the practitioner. It becomes all but impossible to recall vital signs and the times they were recorded. Complete records can provide clues about the case and possible solutions to our problem as it progresses. (At what point did we lose verbal contact? How long has the patient been at this level? Did the change come on rapidly or have vital signs been slowly changing for some time?) Lastly, in the event of legal action, complete and accurate records are a must for one's defense.

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