The Rosenfeld laboratory was researching the efficacy in rodents of certain new synthetic opioids when a nationwide shortage of buprenorphine hydrochloride occurred. Buprenorphine was being used as a negative experimental control because previous research demonstrated that the drug was not effective in alleviating the induced neuropathic pain that was being studied. “Not a problem,” said Lonny Lyons, one of the post-docs in the lab, “we have USP buprenorphine reference standard from some earlier work and we’ll just use it instead of the commercial drug.” But when the request for the change reached the attending veterinarian for concurrence via the Veterinary Verification and Consultation (VVC) method, the veterinarian said she was not able to concur with the request because the literature provided by the vendor of the reference standard said that it was not intended to be used as a drug.

Still undaunted, the lab requested that it be allowed to use its recently outdated commercial buprenorphine hydrochloride, and they provided the IACUC with literature citations that claimed most drugs can be used well past their expiration dates without a loss of efficacy. Accompanying the request was a note from Dr. Rosenfeld explaining that she could not substitute a different negative control drug in the middle of her research. The veterinarian referred the request to the full committee which was meeting in a few days. At that meeting she said that upon reflection, she did not think that either the outdated buprenorphine or the buprenorphine reference standard would create an animal welfare issue, but she was reluctant to verify the use of either of those products without IACUC input. She added that she had tried borrowing in-date buprenorphine from nearby colleagues, but her attempts were unsuccessful.

Do you think that the IACUC should agree with the use of the outdated drug, the reference standard, or take an entirely different approach? Was the VVC method being used appropriately?