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Controlled Drug Management and Animal Activities: T he IACUC’s Problem or Not?

Controlled Drug Management and Animal Activities: T he IACUC’s Problem or Not?. Paul Mirles, RLATG, CPIA. What do the animal regulations say?. In accordance with the regulations the IACUC has the responsibility to:

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Controlled Drug Management and Animal Activities: T he IACUC’s Problem or Not?

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  1. Controlled Drug Management and Animal Activities: The IACUC’s Problem or Not? Paul Mirles, RLATG, CPIA

  2. What do the animal regulations say? In accordance with the regulations the IACUC has the responsibility to: • Conduct Semi-Annual inspections that include the examination of surgical areas, including anesthetic equipment, use of appropriate aseptic technique, and handling and use of controlled substances review of protocol-related.- “The Guide for the Care and Use of Laboratory Animals 8th edition” 2. Review all animal study protocols for the use of non-pharmaceutical grade chemicals and other substances.- “The Guide 8th edition” • Assure that professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during, and following actual research, teaching, testing, surgery, or experimentation were followed by the research facility; - “USDA Animal Welfare Act and Animal Regulations” 4. Review a description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; -”OLAW Public Health Services Policy on Humane Care and Use of Laboratory Animals”.

  3. According to the DEA • Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years. “DEA website” • These regulations may very from state to state and may often very between the State officials and the Federal Officials, on whom is responsible for the management of controlled substances and how to dispense them.

  4. What does your Institution Do • A quick survey on the list-serve was conducted to see who has the responsibility for managing the controlled substance for animal use. Here is the Summary of the responses:

  5. Occupational Health and Safety • Does your institution leave the responsibility of controlled drug management to your OHS? • 7 institutions, ranging from small to medium size programs, have their OHS department obtain a DEA license and are responsible for management of the controlled drugs. • What are the advantages of having OHS manage the controlled substances? • What are the disadvantages of having OHS manage the controlled substances?

  6. Attending Vet/Animal Care Facility • Does the Attending Vet/Animal Care Facility have the responsibility for the management of controlled substances? • 5 large institutions have the Attending vet/Animal Care Facility obtain the DEA license and assume responsibility for managing the controlled substances. • What are the advantages of having the Vet or the animal care facility managing the controlled substances? • What are the disadvantages of having the Vet or the animal care facility managing the controlled substances?

  7. PI labs • Does each PI have the responsibility to manage their own controlled substances? • 2 institutions leave the responsibility to the PI to obtain their own DEA license and have sole responsibility for the management of their own drugs. • What are the advantages of having the PI’s manage the controlled substances? • What are the disadvantages of having the PI’s manage the controlled substances?

  8. The IACUC • Does the IACUC have the responsibility for the management of the controlled drugs? • No responding institution considered the IACUC as the responsible party for managing the controlled substances. • What are the advantages of having the IACUC manage the controlled substances? • What are the disadvantages of having the IACUC manage the controlled substances?

  9. What is our role in the management of controlled substances? • However in all cases the IACUC was responsible for: • Reviewing all substances (Dosing, route of administration, PH, sterility and number of administrations) for each animal study protocol • Inspect all labs that use controlled substance for animal studies to ensure (expiration dates, quality, if substance are approved on the protocol, preparation , storage, handling and records.

  10. What do you think?

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