From the August 2006 issue

Although DIASTAT (diazepam rectal gel) has been available for a number of years, the DIASTAT ACUDIAL delivery system was approved late last year for the treatment of both prolonged and cluster seizures.  Since its introduction, a number of errors with using the device have occurred because the device was not properly dialed and locked. Some of these errors have led to respiratory depression and required emergent intervention.

In one case, a 4-year-old girl with complex seizure disorder was prescribed Diastat AcuDial 5 mg. The pharmacy, however, dispensed an unlocked 10 mg Diastat AcuDial rectal syringe.  Luckily, her parents had been educated to check that the dose was locked in at 5 mg and reported this dispensing mishap to the pediatric neurologist and pharmacy before administering it to their daughter. A second case involved a young boy weighing 8 kg also with complex partial seizure disorder. Unfortunately, unlike the case above, the parents of this patient were not provided education on what to check for when using Diastat AcuDial.  The pharmacy dispensed an unlocked 10 mg Diastat AcuDial rectal syringe and the parents administered the entire contents to their son. The child developed respiratory depression, was transported to the emergency room and thankfully recovered.

The Diastat AcuDial delivery system has been designed as a 10 mg and a 20 mg rectal syringe to deliver minimum dosages of 5 mg or 10 mg respectively with dosage increments of 2.5 mg. Many of the errors we have received have been related to the pharmacy failing to lock the dose or locking the incorrect dose.

Diastat AcuDial comes with two unlocked rectal syringes per package with the maximum (i.e., 10 mg or 20 mg) dose appearing in the dose display window of the device.  Before the product is dispensed, both syringes must be dialed, set, and locked to the prescribed dose by the pharmacy, even when the maximum dose is prescribed. Once set and locked, the prescribed dose will appear in the dose display window and the locking ring, designated with a green ready band, will be engaged (see figure). It is important to check that the dose has been dialed correctly and locked for BOTH syringes. Patients and caregivers (most patients will be children) should be educated by prescribers and pharmacists on how to use the device, including confirming that: the prescribed dose is visible in the display window; the green ready band is visible; and the smaller rectal tip size is used if the patient is a child. More information and details on the pharmacist’s role in dispensing Diastat AcuDial can be found at
www.diastat.com/HTML-INF/Diazepam_Rx/Diastat_Dispensing.htm.

We thank Kimberly Tallian, PharmD, FCSHP, FASHP, University of California, San Diego Medical Center, for her significant contributions to this article.