Durham VA Seeks to Improve Labeling of Investigational Drugs to Improve Safety

by U.S. Medicine

June 7, 2012

DURHAM, NC — Research into investigational drugs focuses on clinical safety and effectiveness after use and must assume that the correct drug was administered in the correct dose.

Inadequate or confusing labeling and packaging sometimes can make that difficult, however. To remedy that problem, the investigational drug team at the Durham VA Medical Center took a long, hard look at their storage and handling practices and, immediately, recognized opportunities to improve patient safety.

Jamie Brown, PharmD, BCPS, drug information and investigational drug specialist at the North Carolina facility

“We hadn’t experienced a lot of problems with medication errors,” Jamie Brown, PharmD, BCPS, drug information and investigational drug specialist at the North Carolina facility told US Medicine. “There was real potential for mistakes, though, so we developed safety mechanisms that reduced the opportunity for errors.”

When he started out as an investigational drug pharmacist five years ago, Brown found that, while there were “abundant regulatory requirements on the function and responsibilities of the investigational drug pharmacist from the FDA, The Joint Commission and the VA, there was a lack of information available on medication and patient safety from a perspective of reducing medication errors.”  

“Sponsors traditionally focus on clinical safety and efficacy,” added Brown. “They may not think as much about safe labeling, packaging and storage, so it was important for us to recognize the issue and find ways to mitigate the risks.”

“An individual investigational drug pharmacist has little or no control over an investigational drug’s labeling and packaging, which makes it even more important to implement practices to promote medication safety. We can do that, no matter how an investigational drug is packaged,” he added.

In the review of investigational drug practices, the Durham VAMC identified potential safety concerns. Labeling was particularly problematic. The use of abbreviations and “license plate”-style nomenclature made  easy drug identification difficult. The standard format includes an abbreviation of the sponsoring company’s name, followed by several digits.

Matthew Grissinger, RPh, FASCP, director of Error Reporting Programs at the Institute for Safe Medication Practices (ISMP), wrote in an article in Pharmacy and Therapeutics that, because many research pharmacies participate in multiple studies with the same sponsor, this format contributes to confusion. 1

In addition, the length of the letter-and-number combinations in sponsor-created names often force pharmacy computer systems to shorten the medication code name to fit the allotted field. Problems may be compounded by changing names for medications during studies, as sometimes happens when a sponsor merges with another pharmaceutical company or as the generic name comes into greater use, Grissinger noted.

Durham VA Seeks to Improve Labeling of Investigational Drugs to Improve Safety

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.

Drug_Safety_drugillustration.jpgThere 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.

Durham VA Seeks to Improve Labeling of Investigational Drugs to Improve Safety

Reporting to Sponsors

The Durham team developed a mechanism for reporting concerns to study sponsors, too. “We communicate any problems with ongoing studies, but we expect limited changes in the short term. Sponsors have been readily accepting of feedback. If there is enough recognition of issues, it can lead to systematic changes to improve safety over time,” Brown said.

The team reports any errors that do occur to multiple parties. First, a note goes in the file that describes the incident and the corrective-action plan to prevent a recurrence. Then, the institutional-review board is notified, and it assesses the risk vs. benefit of the new protocol. The sponsor also is alerted and report filed with the ISMP Medication Errors Reporting Program.

Having identified many areas for improvement in investigational-drug safety, Brown’s on a personal campaign to share with others in the medical community the safe practices his team adopted to reduce medication errors. He recently presented the team’s findings and new procedures at the American Society of Health System Pharmacists Midyear Meeting in New Orleans.

“I received a very positive response to the presentation,” he said. “Patient safety is a priority for other medical centers, as well. What we’re doing here is not ground-breaking; the ideas are not that novel. What’s different is that we’re promoting universal best practices that apply to investigational drugs as well as pharmacy.”

  1. Grissinger M. Reducing the Potential for Mistakes With Investigational Drugs. PT. 2011 March;35(3):120-121,138.

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