Printer-friendly versionInformational Sheet: The IACUC has provided a set of guidance documents (Policies, Guidelines, and Informational Sheets) for use when planning animal procedures at the University of Iowa. Informational Sheets provide information about frequently asked questions and represents guidance for best practices. Deviation from the recommendation(s) does not require specific justification.
Purpose: The purpose of this document is to provide labs with adequate information needed to add Buprenorphine Extended-Release (formerly) Sustained-Release to an animal protocol, obtain a prescription, order, store, and use the drug for research animals. It is also to provide labs with information about extended-release buprenorphine options, including the use of FDA-approved versus compounded versions.
Buprenorphine Extended-Release (Bup ER) is a patented compounded opioid that provides up to 48 hours of analgesia and is only available by prescription from a veterinarian. See the IACUC Guidelines on Analgesia for dosing information.
How to add Bup ER to an animal protocol:
If Buprenorphine ER is the only DEA controlled drug that you will be using on your protocol, you will need to answer the DEA controlled substance question in the Special Circumstances and Hazards section as “YES”. You will be prompted to name the person whose license you will be using. Because this is a prescription, you are not required to have a DEA license; however this question must be answered to complete and submit your protocol. Please list ‘OAR Veterinarian’ as the license holder in this case.
If you are using other DEA controlled substances as well as Buprenorphine ER, no additional information is required as you will answer YES and provide the license holder for use of those other substances.
How to obtain a prescription for Bup ER:
Go to the Drug Order section of the OAR website and click ‘Buprenorphine-ER Prescription Request Form’, which processes your request through Workflow using your HawkID. Fill out the information as accurately as possible, using the HawkID of the Principal Investigator for the protocol. It may take up to 7 business days for your prescription to be submitted to the manufacturer.
How to order Bup ER:
Once you receive confirmation that your prescription has been submitted, contact the manufacturer Wedgewood Pharmacy (formerly ZooPharm) to set up an account and/or place your order. Wedgewood Pharmacy may be contacted by phone (877-357-6613) or on the website (https://www.wedgewoodpharmacy.com/contact-us.html). If refills are available for your prescription and you already have an account, log-in to your account to order. Bup ER costs $150-190 per 5cc/ml vial, depending upon concentration, and shipping is approximately $35. One vial is sufficient for approximately 80 mice or 16 rats.
Storage of Bup ER:
Bup ER is shelf stable until the labeled expiration (typically 6 months to 1 year after compounding) unless you are otherwise informed by your veterinarian. The label may state a recommendation for disposal after the seal is punctured. Research labs are not required to adhere to this recommendation. While prudent to keep Bup ER locked up for safety and security reasons, as a prescription drug it is not required that you do so. If you do however lock it up, do not store it in the same lock box as other DEA controlled drugs. You will need a different storage location such as a locked drawer or cabinet.
Use of Bup ER:
- Do NOT dilute Bup-ER as it affects the rate of release. Dilution of Bup-ER is not permitted.
- MUST be given as a subcutaneous injection
- Bup-ER is viscous and may require larger needle sizes (22-23 gauge) for administration and may most easily be administered under anesthesia.
- Consult with an OAR Veterinarian regarding concerns of dosing and administration
- Administration of small volumes may be aided by drawing up air into the syringe prior to the dose or using low-dead space syringes.
Recent FDA guidance GFI #256 Compounding Animal Drugs from Bulk Drug Substances has been implemented that impacts the use of Buprenorphine ER (formerly Buprenorphine SR). Per the guidance, compounded drugs that have an FDA-approved equivalent must have a medical rationale describing the clinical difference between them. This indicates that justification must be provided in order to procure Bup ER as there is an FDA-approved extended-release buprenorphine product for mice and rats called Ethiqa XR.
All labs should review their use of extended-release buprenorphine and consider use of the FDA-approved Ethiqa XR for future studies. For further prescriptions of Buprenorphine ER/SR, a medical rationale will be required and reviewed by the prescribing veterinarian, who will make final decision to write the prescription.
Below is a chart comparing the two Buprenorphine extended-release products:
|
|
Ethiqa XR |
Buprenorphine ER/SR |
|
FDA Approval Status |
FDA-Approved |
Compounded
|
|
Analgesia Length |
Up to 72 hrs |
48-72 hrs |
|
Dosage |
Mouse: 3.25 mg/kg SQ Rat: 0.65 mg/kg SQ |
Mouse: 0.5-2 mg/kg SQ Rat: 1-1.2 mg/kg SQ |
|
Concentration |
1.3 mg/mL |
0.5, 1, and 3 mg/mL |
|
Volume |
3 mL |
5 mL |
|
Shelf Life Unopened |
24 months |
Varies by lot; typically 10-12 months from date of purchase |
|
Shelf Life after Piercing Rubber Seal |
90 days |
30 days |
|
Cost per vial* |
$415 |
$150-190 |
|
How to Obtain |
Investigators can purchase on their own with their individual DEA license through multiple suppliers/distributors |
Prescription must be written by a veterinarian and drug ordered through Wedgewood Pharmacy |
* As of 6/9/23. Price subject to change.
Please note that Ethiqa XR is considered a controlled substance and since it is acquired directly by the researcher, is managed as any other controlled substance in regards to storage, inventory, and disposal.
More information about Ethiqa XR, including suppliers/distributors, can be found here: https://ethiqaxr.com/
Last Reviewed by the IACUC 10/11/2023