Therapeutic Agents (Anesthesia/Analgesia) Policy
Introduction
For this policy, therapeutic agents are defined as substances used to control/minimize pain and/or distress or used to produce euthanasia. The guidelines in this policy are derived from various USDA and PHS regulations designed to guarantee that the agents used have reproducible effects and thus effectively minimize pain and/or distress and from regulations relative to drugs that have addicting/abuse potential in humans when used inappropriately.
General requirements
Therapeutic agents are not to be used beyond their expiration date. Pharmaceutical-grade therapeutic agents are to be used whenever they are available, even for terminal procedures. Non-pharmaceutical-grade therapeutic agents can be used in research animals only if their use on a particular protocol has been prospectively reviewed and approved by the IACUC. The IACUC will review such use based upon scientific justification and the non-availability of an acceptable veterinary or human pharmaceutical-grade compound. Many experimental agents are not under these constraints as many are not available in pharmaceutical grade and do not have an expiration date.
Volatile anesthetics must be used in a hood or with a functioning vapor scavenging device. Contact with skin and mucous membranes (either of research animals or of laboratory personnel) will cause inflammation and should be avoided. A physical barrier, such as a wire mesh screen, must be used to prevent contact between the research subject and the agent used.
Controlled substances are to be stored and used in accordance with state and federal laws. The general policies are summarized in the section on controlled substances.
Controlled substances
Controlled substances are drugs which are regulated by the Drug Enforcement Administration (DEA) because of potential for abuse. Federal regulations require that each state board of pharmacy oversee use of controlled substances within a given state and mandate that state policies be as strict or stricter than federal policies. The following sections outline procedures that must be followed when using controlled substances.
License
Controlled substances must be used under auspices of a person licensed by the Drug Enforcement Agency and the State Board of Pharmacy. Investigators in some areas of campus hold individual licenses, while some colleges and/or departments operate under a single controlled substance license. For example, the College of Medicine operates under a single controlled substance license located at the Ohio State Medical Center.
Storage
When not in use, controlled substances and their associated usage logs must be stored in a securely locked, substantially constructed cabinet, drawer, or lock-box. The key to the controlled substances cabinet should be kept in a separate location. Controlled substances that have been diluted prior to use (ex. ketamine/xylazine mixtures) must be stored in the controlled substances cabinet overnight but may be kept in the laboratory during the day provided that the door to the lab is locked when no one is present in the laboratory. Non-controlled substances used for anesthesia or analgesia, such as xylazine, isofluorane or halothane, do not need to be kept in the controlled substances cabinet. However, the laboratory should consider storing these agents in such a way that the drugs are not visible or accessible to the casual laboratory visitor.
Labeling
All controlled substances should be labeled with the name and date of expiration. Containers with controlled substances that have been diluted prior to use should be labeled with the names and expiration dates of the controlled substance and the diluent. Controlled substances for parenteral use must be diluted and/or transferred aseptically (i.e. diluted with sterile saline or water into a sterile vile using sterile equipment). Diluted solutions may be kept for a maximum of 30 days or until a precipitate forms in the vial.
Records
In accordance with Federal and State pharmaceutical regulations, the laboratory must document controlled substance accountability. All actions taken with a controlled substance, including receiving, using, diluting/combining, transferring or disposing of expired and waste drugs must be recorded. This record or usage log should contain the name and expiration date of the control substance, the action taken, the action date, the volume involved in the action, the volume remaining in the container, and the responsible person’s initials.
Records of controlled substances usage should be maintained separately from surgical and/or post-operative records. Surgical and post-operative records should contain the amount of controlled substances given to individual animals. Surgical and post-operative records should include the administration of diluted controlled substances (such as ketamine/xylazine).
Disposal
Controlled substances should be disposed of when their usage is no longer necessary or when they have reached their expiration date. Policies and regulations of the Pharmacy of the Medical Center for disposing of expired or unused controlled substances should be followed by Investigators at the College of Medicine. Investigators holding individual controlled substance licenses should follow the following procedure. Investigators should write the Assistant Executive Director, Ohio State Board of Pharmacy, 77 South High Street, Room 1702, Columbus, OH 43215-6126. The letter should contain a list of expired or unused controlled substances needing disposal. Upon receipt of a response from the Ohio State Board of Pharmacy for disposal, the investigator may dispose of the controlled substances.
Further questions/information:
Ohio State Board of Pharmacy
77 South High St., Room 1702
Columbus, OH 43215-6126
Phone: 614-466-4143
General Licensing Information: licensing@bop.state.oh.us
