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
- 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.