Dispensing Alert! Dial, Set, and Lock that Dose

The DIASTAT ACUDIAL (diazepam rectal gel) delivery system is approved for the acute treatment of patients 2 years and older who are on stable antiepileptic medications and experience bouts of increased seizure activity. Since the product’s introduction, the Institute for Safe Medication Practices has received a number of reports of errors using the device because it was not properly dialed and locked by the pharmacist prior to dispensing. 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 they reported this dispensing mishap to the pediatric neurologist and pharmacy before administering the medication to their daughter.

A second case involved a young boy weighing 8 kg who had complex partial seizure disorder. Unfortunately, unlike the case above, the parents were not educated 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 department, and thankfully recovered.

More recently, the parent of a disabled adult with a seizure disorder reported that her daughter received a Diastat AcuDial rectal syringe that had been locked at an incorrect dose. The patient’s prescribed dose was 15 mg, but the pharmacist mistakenly locked the dose at 20 mg. The patient’s parent did not discover the error until after she had administered the dose. The patient was lethargic and slept for over 15 hours following administration.

The Diastat AcuDial delivery system is available as a 10-mg or 20-mg rectal syringe designed to deliver minimum dosages of 5 mg or 12.5 mg, respectively, with dosage increments of 2.5 mg. Each package comes with 2 unlocked rectal syringes per package. Before the product is dispensed, both syringes must be dialed, set, and locked to the prescribed dose by the pharmacist, 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. To aid the pharmacist in locking the prescribed dose, each Diastat AcuDial package comes with a pharmacist instruction card (the instructions are also available online at www.diastat.com/hcps/ pharmacists/dial-set-lock-instructions).

Ensure that each pharmacist is taught how to dial, set, and lock the dose for the Diastat AcuDial rectal syringe. Consider building an alert into the pharmacy computer system to notify the pharmacist that the dose must be dialed and locked. To check that the correct dose has been selected, incorporate an independent double check with a second pharmacist or pharmacy technician before the dose is locked. It is important to check that the dose has been dialed correctly and locked for both syringes. At the point of sale, have the patient or caregiver check each syringe to ensure that the correct dose has been locked. Also, patients and caregivers should be taught how to use the device, including confirming that (1) the prescribed dose is visible in the display window, (2) the green ready band is visible, and (3) 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/hcps/pharmacists.

Dr. Gaunt is a medication safety analyst and the editor of ISMP Medication Safety Alert! Community/Ambulatory Care Edition.