1	Ordering Controlled Substances Through the Animal Resource Center Nanette R. Kleinman, DVM, DACLAM Associate Director ARC September 28, 2004
2	Definitions Controlled Substance A drug or chemical whose use is controlled by law Scheduled Drug DEA classifies drugs by Schedule I,II,III,IV,V The schedules represent abuse potential and danger with Schedule I being the most closely controlled Prescription Drug A drug requiring authorized prescription for dispensing (not necessarily controlled)
3	Controlled Substance Schedules Schedule I – high abuse potential, no recognized medical use E.g., Heroin, LSD, marijuana Schedule II – high abuse potential, medical use E.g., morphine and other narcotics excluding heroin and codeine, pentobarbital, amphetamine, phencyclidine Schedule III – moderate abuse potential, medical use E.g., ketamine, anabolic steroids, Tylenol with codeine Schedule IV – low abuse potential, medical use E.g., valium and other tranquillizers, chloral hydrate, phenobarbital Schedule V – lowest abuse potential, medical use E.g., low dose codeine containing analgesics
4	Controlled Substances Covered by the Controlled Substances Act of 1970 Chemicals, drugs and other substances identified by the United States Department of Justice, Drug Enforcement Agency (DEA) as having a high potential for abuse. Regulations designed to limit abuse cover Ordering – Storage – Use Recordkeeping – Disposal The DEA license and the Ohio Board of Pharmacy license for CWRU purchases is held by the Director of the Animal Resource Center (ARC).
5	Controlled Substances which may be ordered through the ARC Controlled substances which are to be used in laboratory animals in a procedure covered by an active IACUC protocol. E.g., anesthetics, analgesics, tranquillizers
6	Ordering Policy Some controlled substances are be purchased through the ARC Individually registered researchers may order, possess, account for, and administer controlled drugs under their own registration Researchers, who use controlled substances in the following applications must obtain their own DEA licensure As test materials in nonanimal experimentation Use of controlled drugs outside of an approved IACUC protocol The ARC does not order or manage controlled drugs that are used solely in vitro test materials All controlled substances must be ordered through E-procurement and not through the P- card mechanism All noncontrolled prescription drugs must also be ordered through E-procurement
7	Ordering Schedule III, IV and V Substances Through E-Procurement List Identity Formulation Amount Vendor Separate E-Procurement order required for each controlled substance No other items may be listed on the order used for controlled substances Must be submitted by the Principal Investigator (PI) The order must indicate the name of the person responsible for pick up Orders will be processed for Schedules III, IV and V without further documentation A copy of the requisition and purchase order is faxed by the purchasing department to the ARC
8	Ordering Schedule I and II Substances Through E- Procurement List Identity Formulation Amount Vendor Separate order is required for each controlled substance requested No other items may be listed on the order for the controlled substance. Must be submitted by the Principal Investigator (PI) Purchasing verify price, stock, handling fees description, size, unit and quantity for Schedule I and II Purchasing may amend the order if required
9	DEA 222 Form Required for ordering controlled substances in Schedules I and II. Must be signed only by the holder of the DEA license for CWRU. Blank forms are maintained in locked storage Removal of blank forms must be witnessed by a second person. Forms are completed by the ARC Administrative Manager and signed by the ARC Director. Forms sealed in a confidential envelope by the ARC Administrative Manager and placed in the drop off box for direct delivery to the Purchasing Office.
10	Ordering Schedule I and II Substances Purchasing notifies ARC when a DEA 222 form is required ARC completes the DEA 222 form for DEA line items only exactly as it appears on the amended E-Procurement order All copies of the DEA 222 form are returned to Purchasing Purchasing completes needed items A copy of DEA form and copy of the requisition and order is faxed to ARC
11	Receiving/Disbursement All controlled substances (Schedules I through IV) ordered using the ARC DEA license are shipped directly to the ARC. The ARC verifies PI has current documentation for all previous orders ARC contacts PI or the responsible person on the order ARC verifies that the drug use is covered by an active IACUC protocol All forms from previous orders must be completed before controlled substances are dispensed
12	Receiving/Disbursement The controlled substance is disbursed ONLY the PI or the responsible person in the presence of a second witness. A log sheet to document the use of the drug is provided with each ordered The log sheet must be returned before subsequent orders are processed
13	Receiving/Disbursement The ARC records the following information: Date of disbursement Identity and quantity of drug disbursed Expiration date of disbursed drugs Identity of the receiver, lab/office location and contact telephone number Relevant IACUC protocol number Lab location where drugs will be maintained under locked storage Names of the witnesses
14	Storage, Use and Recordkeeping Controlled substances must be stored in a locked storage drawer, cabinet or safe Access must be limited to authorized users Controlled drugs are not transferable between laboratories Log sheets should be stored together with the controlled substance
15	Storage, Use and Recordkeeping Each time the controlled substance is used the log sheet enter the following information: Date the drug is dispensed/administered Amount of drug dispensed Amount remaining in the container (via subtraction) ID of animal(s) receiving the drug and amount given per animal Relevant IACUC protocol Name of person using the drug (full name printed and signature)
16	Tracking The ARC performs quarterly tracking of all disbursed controlled substances. PIs holding controlled substances which have passed their expiration date will be contacted to return remaining unused drug and log sheets to the ARC. Any remaining controlled substance without an expiration date will be recalled after 5 years of the delivery date has elapsed. The ARC retains completed log sheets for 3 years after the expiration date of the disbursed drug.
17	Audit The ARC conducts random unannounced audits of controlled drug storage/use sites and recordkeeping for labs using controlled substances ordered through the ARC. The CWRU IACUC may inspect ARC and researcher laboratory records and storage security for all controlled drugs during semi-annual inspections of animal care and use facilities or unannounced visits. Any discrepancy of >5% should be reported to the ARC Office.
18	Disposal of unused/expired controlled substances Researchers may return drugs dispensed by the ARC to the ARC ARC will handle disposition of partial bottles of controlled substances that are out-of-date or that are no longer needed. Any controlled substance without an expiration date should be disposed of within 5 years delivery if not used The ARC does not dispose of controlled substances for other License Holders
19	Loss of controlled substances Significant loss or disappearance of controlled drugs (>5%) purchased and/or dispensed by the ARC must be reported at once to the ARC Administrator.
20	Request of small quantities of controlled drugs for immediate use The ARC stocks small quantities of controlled drugs commonly used in research animals, as well euthanasia solutions. CWRU researchers may request limited amounts of controlled drugs to be used for “immediate use” from ARC Veterinary Technicians as needed to anesthetize, relieve pain or distress, or to euthanize animals in the performance of experiments in research protocols. Researchers who wish to acquire larger quantities of controlled drugs to be used for periods longer than “immediate use,” should place an order via E-Procurement to CWRU Purchasing.
21	Rodent Anesthesia Cocktail The ARC provides premixed Rodent Anesthesia Cocktail for rats, guinea pigs and rabbits Ketamine HCl 150 mg (100 mg/ml)[3 parts] Xylazine HCl 30 mg (20 mg/ml)[3 parts] Acepromazine 5 mg (10 mg/ml)[1 part] And 1:4 diluted cocktail for use in mice. Log sheets are dispensed with orders which will not be used completely within 24 hours. Expiration date is 3 months after mixing. Rodent cocktail which is mixed by investigative personnel from separately purchased ingredients must Be stored in a tinted or foil wrapped injection vial Label the date of mixing on the vial Use a log sheet to track use of the cocktail and discard all unused cocktail after 3 months
22	Fatal Plus/Euthasol Fatal Plus and Euthasol are dispensed by the ARC in 12cc syringes. No log sheet is required if the drug will be used (and any excess discarded) on the day it is received. Investigators wishing to purchase more than ½ bottle of Fatal Plus or Euthasol will be directed to obtain it through the Purchasing Department.
23	Documentation Thank you for completing the Controlled Substances training module. To document your training please complete and submit the required test Take Test