No Expire Dates

Brown said the typical small white labels on investigational drug bottles made providing sufficient detail challenging, while the small fonts used required close examination to avoid confusion. At the same time, labels frequently failed to include the drug’s expiration date, which created potential trouble in long-term studies.

There also was an issue with the large volume of investigational drugs kept on hand. On the pharmacy side, lower volumes of medication are typical.

“But we get comfortable with larger quantities with investigational drugs, and that may desensitize us,” noted Brown. “As a result, we may not recognize overdoses as readily or register that a patient has too much of an investigational drug.”

Grissinger noted that this problem is particularly pronounced with parenteral drugs. The vial sizes provided may require a pharmacist to use multiple vials to prepare one dose. “Thus, recognition of a possible overdose is less apparent during the preparation of investigational drugs than it would be during preparation of other drugs, where the use of dozens of vials for a single dose would clearly signal an error.”

The team now uses a multi-step process to improve safety. First, all investigational drugs undergo a thorough safety evaluation. “We look for similar packaging and labeling and new studies that use the same or similar active ingredients. Also, we identify those that have similar sounding or looking drugs,” Brown said. In these cases, the team physically separates drugs that could easily be confused.

Inadequate distinction and separation between study drugs caused by overcrowding on storage shelves increases the opportunity for a medication errors, such as drug misidentification or confirmation bias with look-alike/sound-alike investigational medications.

“If the investigational-drug service establishes that a study has oversupply, we remove the excess and physically separate it into another dedicated investigational-drug storage area,” added Brown. To keep the separation clear, the Durham team does not actively fill investigational drugs in the investigational-drug overflow storage area. It also alerts the study sponsor to concerns related to oversupply. 

Proper labeling is the next priority.

• Additional descriptive information is added to auxiliary labels and products. The expanded information may include strength, concentration and lot number, as well as make information present on the primary label easier to read.
• For small bottles that cannot accommodate more descriptive labels, the team now uses bins for storage, then appropriately labels the bins.
• Some drugs, when permitted by the sponsor and appropriate to the medication, are repackaged in unit doses to minimize potential errors.
• Prescription labels are added to most drug bottles to comply with state dispensing standards.  

For each investigational drug, the Durham team creates standard-dispensing instructions. Templated ordering and dosing nomograms reduce the chance of error, according to Brown. All pharmacists involved in investigational-drug studies go through an orientation program that educates them on the team’s and specific drugs’ protocols and emphasizes the importance of practices that promote patient safety.