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Let past experience with chloral hydrate syrup for conscious sedation guide safe use of VERSED Syrup

From the November 18, 1998 issue

PROBLEM: Like chloral hydrate liquid, Roche Laboratories' new VERSED (midazolam) Syrup may be used for conscious sedation in pediatric patients prior to diagnostic, therapeutic or endoscopic procedures. Versed is also an effective anxiolytic and amnesic. We know from past experience with chloral hydrate that medication errors with Versed Syrup are possible given similar circumstances. For example, technical support personnel often administer oral conscious sedation even though they are not properly trained (Assuring safe use of chloral hydrate syrup, ISMP Medication Safety Alert! June 5, 1996). An ambiguous physician order to give "chloral hydrate 5 cc prn sedation" or ". prn agitation," rather than a specific mg amount and maximum dose, has led to a number of events where multiple doses of chloral hydrate were given from floor stock supplies. By the time the child fell asleep, the amount given was a massive overdose leading to respiratory arrest. In some cases, to save time, chloral hydrate has been prescribed for use at home prior to travel to the practice site. Once a parent gave an accidental overdose when a community pharmacist dispensed 120 mL instead of 12 mL. The child suffered respiratory arrest and died before reaching the hospital.

SAFE PRACTICE RECOMMENDATION: Consider updating your institution's JC-required policy for conscious sedation to promote safe Versed Syrup use. We suggest that the following precautions, in addition to package insert recommendations, be employed:

  • The drug must never be prescribed by volume (e.g., "5 mL," "one teaspoonful," etc.). Orders for Versed Syrup must include the specific milligram amount needed, as well as the mg/kg formula upon which the dose was based. This makes the dose clear and allows independent dose calculation by pharmacists and nurses.
  • Wherever possible, orders for Versed Syrup should be dispensed by the pharmacy for each patient in labeled unit dose oral syringes. Providing the product in bulk packages as floor stock is less safe. If floor stock is dispensed, special oral syringes accompanying the Versed container, or oral syringes sent by pharmacy, should be used to measure and label doses. Parenteral syringes and medication cups should not be used. We have asked Roche to look into supplying Versed Syrup in unit packaging to assist in drug control and lessen the chance of an accidental overdose.
  • Pharmacists should not dispense prescriptions for patient use in the home. Official labeling for Versed notes that the syrup is intended for use only in monitored settings, never the home.
  • As noted in the product's boxed warning, only health care professionals who are trained in conscious sedation procedures, and authorized to administer conscious sedation, should administer Versed Syrup. Careful monitoring by direct visual observation is necessary and age/size appropriate resuscitation equipment must be readily available. Flumazenil (ROMAZICON) may be used for suspected Versed overdose.
  • The available package size for Versed is 118 mL of 2 mg/mL syrup. The dose is 0.25 mg/kg to 1 mg/kg with a maximum of 20 mg pre-procedure. The safety of repeat doses is unknown. The product is accompanied by 4 special oral syringes to facilitate dosing and prevent accidental injection of the drug IV. Additional syringes will be needed to use the contents of the bottle given the volume, concentration and usual dose.
  • Although labeled for pediatric use, oral Versed has been used in adults. Patients should not drive or handle hazardous equipment for 24-hours after conscious sedation or until the drug effects have subsided.
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