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  • Protocol Review
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Achieving the desired outcome

Lab Animal volume 47, pages 139–140 (2018)Cite this article

The scenario states that buprenorphine is administered to rodents as a negative control in a study evaluating the efficacy of certain new synthetic opioids; however, a nationwide shortage of buprenorphine has occurred. The IACUC is faced with the challenge of trying to decide if it is acceptable for Dr. Rosenfeld to use outdated buprenorphine or a buprenorphine reference standard to complete her study. The IACUC’s policy on veterinary verification and consultation (VVC) is not provided in this scenario, but it seems unlikely that the policy would address the use of either a reference standard or an expired drug, so the Attending Veterinarian was correct in referring the request to the full committee.

An understanding of what a drug reference standard is would be helpful to the IACUC in evaluating this problem. “A reference standard is a substance prepared for use as the standard in an assay, identification, or purity test and should have a quality appropriate for its use1.” As noted in the scenario, reference standards are not intended to be used as a drug. The United States Pharmacopeia (USP) states, “USP Reference Standards are not for use in humans or animals as drugs or medical devices. They are intended for test and assay use only as per their associated USP compendial application(s)2.” Given this information, the use of the buprenorphine reference standard in Dr. Rosenfeld’s study would not be an acceptable solution. Furthermore, the drug reference standard may yield results that differ from those obtained using the commercial buprenorphine product.

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References

  1. Maguire, J.A., W. Jiang, and L.X. Yu. 2017. Chapter 40- Modern pharmaceutical regulations: quality assessment for drug products. Published in Developing Solid Oral Dosage Forms (2nd Edition). Editors: Y. Qiu, Y. Chen, G.G.Z. Zhang, L. Yu, and R.V. Mantri. Academic Press, Tokyo, pp. 1095-1126. https://www.sciencedirect.com/topics/medicine-and-dentistry/drug-reference-standard

  2. United States Pharmacopeial Convention. Position statement found on-line at: http://www.usp.org/sites/default/files/usp/document/our-work/reference-standards/qa-policy-statement-usp-rs-uses-and-applications.pdf (2017).

  3. Office of Laboratory Animal Welfare, National Institutes of Health. Frequently asked questions: PHS Policy on humane care and use of laboratory animals. F.5. https://grants.nih.gov/grants/OLAW/faqs.htm#663 (2017).

  4. Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals. 8th edn., pp. 6–7 (National Academies Press, Washington, DC, 2011).

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  5. Office of Laboratory Animal Welfare, National Institutes of Health. Frequently asked questions: PHS Policy on humane care and use of laboratory animals. G.10. https://grants.nih.gov/grants/olaw/faqs.htm#3284 (2017).

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Authors and Affiliations

  1. Oak Ridge National Laboratory, Oak Ridge, Tennessee, USA

    Joan T. Richerson & Dana Glass-Mattie

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  1. Joan T. Richerson
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  2. Dana Glass-Mattie
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Correspondence to Joan T. Richerson.

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Richerson, J.T., Glass-Mattie, D. Achieving the desired outcome. Lab Anim 47, 139–140 (2018). https://doi.org/10.1038/s41684-018-0068-x

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