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

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.

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