Using Controlled Substances in Research, Teaching, and Veterinary Care at UAB

Transcription

1 Using Controlled Substances in Research, Teaching, and Veterinary Care at UAB I. The DEA and Controlled Substances II. The Federal Drug Enforcement Administration (DEA) is authorized to prevent, detect, and investigate the diversion of legally manufactured controlled substances (CS). The DEA also determines which substances are classified as controlled substances. About Controlled Substances CS Definition The DEA's definition of controlled substances states that these substances: Other CS Uses are chemicals whose manufacture, possession, and use will be regulated by the DEA, can be addictive as well have medicinal properties, could include illegal drugs as well prescription medicines, and can be mind-altering. The DEA also states that controlled substances can be used as or in: Analgesics (pain control) Euthanasia (induce death) Anabolic Steroids (athletic enhancement) Anesthetics and Sedation CS Are NOT While many would agree these are bad for us, the DEA states that they are NOT considered controlled substances. Caffeine - chocolate, tea, coffee, many sodas, energy drinks Tobacco products - cigarettes, snuff, chewing tobacco, cigars And alcohol in any form - beer, wine, whiskey, etc. UAB, the DEA, and You The DEA and UAB UAB is licensed to use controlled substances for research, teaching, and/or veterinary care by the DEA. The DEA, UAB, OH&S, and the Controlled Substances Program The Department of Occupational Health and Safety (OH&S) has been chosen to administer a Controlled Substances Program to aid researchers and others in obtaining controlled substances. This means that you do not have to obtain your own license through the DEA. OH&S, through the CS Program, is required by the DEA to monitor the use and management of controlled substances in all non-hospital (non-clinical) areas. Using Controlled Substances Page 1 Last Updated: 05/10/2012

2 Your Responsibilities and Our Expectations of You: You should: 1. use only those controlled substances that are authorized through the Controlled Substances Program; and 2. adhere to proper storage, record keeping, and disposal requirements. Schedule Factors Controlled substances are classified into Schedules I through V. The DEA assigns substances their schedule numbers based on a variety of factors. This includes their: Schedules I-V abuse potential, pharmacological effect, medical value, likelihood of physical or psychological dependence, and current pattern of abuse and other risk factors. Here are a few examples: Schedule I Heroin, LSD, Ecstasy, Marijuana Higher potential for abuse and no recognized medical value Schedule II Methamphetamine, Cocaine, Oxycodone (Percocet) Schedule III Schedule IV Schedule V Hydrocodone, Anabolic Steroids, Tylenol with Codeine Chloral Hydrate, Barbital Donnagel with Paregoric, Robitussin with Codeine, Opium preparations Lower potential for abuse Identification A controlled substance s container must be labeled with the letter "C" and the Roman numerals I through V to indicate the Schedule. DEA Number The DEA website is an important tool that you will use often. On the website, the DEA lists all controlled substances and their 4-digit assigned number. It also states whether the substances are considered narcotics and other names the substance may be known as. Using Controlled Substances Page 2 Last Updated: 05/10/2012

3 As a person authorized to purchase, possess, or use controlled substances at UAB for research, veterinary care, or teaching, you will need to become familiar with this website and the information there. Questions This next part is an interactive exercise. You will need to go the link and obtain/print a PDF file. Then go to the DEA's website. Search for the missing information on the PDF file. Make sure that you write it down. Answer the series of questions below concerning the information. Good luck! NOTE: You can skip these questions, but you will see them again in the assessment. Which of the following groups of controlled substances does NOT contain any narcotics? Buprenorphine, Ketamine, Pentobarbital Diazepam, Ketamine, Buprenorphine Diazepam, Ketamine, Pentobarbial What is the DEA number for Ketamine? Which controlled substance is listed as a Schedule IV? Ketamine Diazepam Buprenorphine Pentobarbital What are other name(s) for Diazepam? Nembutal or Suboxone Ketaset Valium or Diastat Answers are at the end of this document. List Chemicals There are chemicals that are regulated because they are used as key ingredients to manufacture controlled substances. For example, hydrochloric acid in large amounts can be used to produce cocaine and many other illegal drugs. These chemicals are subject to similar regulations and protected like Schedules I - V controlled substances. Using Controlled Substances Page 3 Last Updated: 05/10/2012

4 They are separated into two categories: List I Chemicals that are: direct precursors or catalysts, critical to manufacturing controlled substances, and regulated. List II Chemicals that: are solvents and other common chemicals, are often used in industry and science, could be used for large scale manufacture of controlled substances, and have controls that are subject to high threshold amounts that generally do not apply to the average campus user. Precursor Chemicals Precursor chemicals are compounds that are required in the synthesis or extraction of drug production. These are regulated similar to Schedules I-V and are List I chemicals. An example of this is Pseudoephedrine - a precursor used in the illegal manufacture of Methamphetamine, a powerful stimulant. Pseudoephedrine is an ingredient in many popular cold and sinus medications. Here are two examples: Sudafed and Mucinex D III. The CSUA DEA Registration Before you can obtain or use controlled substances, you must apply for a Controlled Substance Use Authorization (CSUA). The CSUA is an authorization to purchase, possess, or use controlled substances at UAB for research, veterinary care, or teaching. The authorization contains specific information about how your laboratory is to use the Schedule, List, or Precursor Chemicals. When applying for the CSUA, you must declare: why you need the controlled substances, what each one will be used for, where and how you will store and secure them, and who will handle or use them under your authorization number. (These are considered authorized personnel.) Authorized Personnel Each authorized person listed on the CSUA will need to: complete the Personnel Screening Data Sheet (PSDS), have a background check on file with UAB, successfully complete this course with a score of 85% or higher, and adhere to the procedures and program elements as identified by the Controlled Substances Program Manager. Using Controlled Substances Page 4 Last Updated: 05/10/2012

5 IV. More on the CSUA The CSUA application requires approval from your Department Chairman as well as the Controlled Substances Program Manager. CSUA's must be renewed and approved annually. The Principal Investigator may apply for, modify, or renew a CSUA. However, if modifications are made, those must be reviewed and approved as well. Storage and Security The Storage Units Controlled substances must be stored according to the schedule number and locked in a secure place or within an Authorized User's sight at all times. Schedules I II controlled substances must be stored in a safe or steel cabinet equivalent. Schedules III - V controlled substances must be stored in a locked drawer or cabinet. The drawers must be inaccessible from upper or lower drawers in the stack. Some types of controlled substances (i.e., Pentobarbital / Nembutal) must be stored in a metal cabinet. Outside the Storage Units Wheeled storage units are NOT allowed for controlled substances! Padlocks and hinges must have the mounting screws or bolts of the hasp inaccessible when the door is closed, and the lock is fastened. Inside the Storage Units No matter what type of storage device you are using, the DEA has specific rules for how things are stored inside the device. Separate, secure storage of controlled substances and separate documentation of Schedules I and II and Schedules III-V is a requirement of the DEA. However, if you must have both in the same secure storage area, you must: store the Schedule I-II CS and the matching documentation together; and store the Schedule III-V CS the matching documentation together. The Schedules I-II should be separated from the Schedules III-V CS by a shelf or stored in separate drawers. Access to Keys/Combinations Only authorized personnel listed on the CSUA should have access to the controlled substances and the documentation. If other staff members need access, you must first submit a modification of the CSUA and have it approved before issuing a key/combination to the person. Using Controlled Substances Page 5 Last Updated: 05/10/2012

6 You are allowed to make multiple key copies or assign combinations to the authorized personnel listed on the CSUA only after approval. Storage key(s) must be in the physical custody of authorized personnel at all times. Never leave storage keys in a drawer, on a desk, or hanging on a wall. Additional Controls Controlled substances must NEVER leave the University of Alabama at Birmingham. They must be kept under your control on campus at all times. At the end of work or if you are finished using them, the unused controlled substances must be returned to locked storage units. Your Responsibilities It is your responsibility to provide effective controls so as to: guard against theft or diversion, prevent illegal drug use, and protect the public from harm that may result from controlled substances under your care. This includes the use of controlled substances at any time for: research animals, veterinary care, in vitro research (such as cell culture, patch clamping, or tissue processing), and chemical research (including synthesis and reaction). Sharing is NOT Allowed Sharing controlled substances within facilities or with other facilities, including nearby laboratories, is NOT allowed. You must use only the controlled substances within your area, and only for the purposes described in your CSUA. If you are collaborating with another researcher, he/she is NOT allowed to use your controlled substances. Do Not When managing controlled substances: 1. Do NOT share storage facilities. You must have your own unique storage unit for your chemicals. If you are in a lab with shared space, each researcher must maintain their own, separate, storage units. 2. Do NOT transfer a controlled substance from its original container for storage purposes. It must be labeled at all times with the original information from the manufacturer. 3. Do NOT store other chemicals or supplies in the same storage unit as your controlled substances. 4. Do NOT store controlled substances in a corridor. They must be kept under lock and key in an area inaccessible to the public. Using Controlled Substances Page 6 Last Updated: 05/10/2012

7 V. Documenting and More Record Keeping Record keeping is an important aspect of the controlled substances program. Documentation of all activities, personnel, and equipment is both "good practice" as well as evidence that each laboratory complies with the terms of the Departmental DEA registration. You are required to maintain all documentation in binders - one for Schedule I-II controlled substances and another for Schedule III-V. These binders will be known as your "Usage Log Binders." Each binder must be kept with the controlled substances associated with it under lock and key unless being used. The Usage Log Binder must be made immediately available at the time of an inspection or an audit. Usage Log Binder Contents In your Usage Log Binder, you should keep a variety of records: 1. CSUA approval (listing all Authorized Personnel), 2. Usage Log forms including copies where CS was used up or returned to CS Program Manager for disposal, 3. biennial inventory, 4. all disposal or return documents, 5. training records, and 6. supplemented documents or copies of 222 forms. Using and Documenting CS You must log the amount you are physically using at all times in the Usage Log Form approved by the CS Program. This means that the amount of controlled substance in the laboratory must equal the amount recorded on the Usage Log form. These forms must be kept in the same storage unit as the controlled substances. On the end of the form you must record either the complete use, or the return of the controlled substances to the CS Program Manager for proper disposal. Retain a copy of the log sheet and send one to the CS Program Manager. These forms must be retained for three years from the date of either complete use or disposal. Ordering and Receiving Ordering and receiving are not covered in this training course. These will be covered in live classes or with job aids. Check the OH&S website for more information. What we do expect you to know is that ordering and receiving will be managed through the OH&S Controlled Substances Program. Using Controlled Substances Page 7 Last Updated: 05/10/2012

8 Transfers, Imports, and Exports You must never share, or hand over, your controlled substances to another person. This means that even if another Principal Investigator and his/her staff shares the same laboratory space with you, you must not share controlled substances with them. Do not obtain or receive controlled substances from anyone other than the CS Program Staff - even if you have the same controlled substances in your own inventory. Importing, exporting, transferring, shipping, relocating, passing down, or removing controlled substances is NOT ALLOWED at UAB. This includes relocating your inventory to another facility or passing them on to the next person in the lab. You are only approved to use or possess controlled substances for the purposes described in your CSUA. Biennial Inventory In addition to documentation on a Usage Log form, you are also required to conduct a complete inventory of your controlled substances every two years. When your biennial inventory is due, the CS Program Manager will send you an notification with a specific date and instructions for completing the form. If the biennial inventory is not received after three attempts, the CSUA will be suspended, and any orders will be stopped. Your inventory status must be declared even if there are zero controlled substances in stock. As long as you have an approved CSUA on file, you must participate in the biennial inventory process. VI. If you no longer need controlled substances, make sure to the CS Program Manager with the date you wish your CSUA to be deactivated. When you do this, note that there can be NO remaining items in inventory. Disposal Disposal and Chain of Custody It is unlawful for anyone to dispose of controlled substances without DEA approval and submittal of the proper form. If you have controlled substances that requires disposal, begin with documenting on the Usage Log form. This form must be retained for 3 years from the date you indicated its disposal or return to the CS Program Manager. Expired and unwanted controlled substances cannot be thrown away in the regular trash, and therefore must be returned to the CS Program Manager and documented on the inventory as waste. The only exception to this rule is that empty controlled substances bottles or vials can be discarded at your facility. Make sure to open the container to ensure that it is completely empty. Deface the label and discard in regular trash. Using Controlled Substances Page 8 Last Updated: 05/10/2012

9 If you have controlled substances to return; notify the CS Program Manager, and we will pick up the controlled substances, and complete the required chain of custody form. VII. Diversion and Loss Reporting Audits/Inspections In addition, routine audits and inspections of your work area will be conducted on a regular basis. To prevent diversion and loss, these audits may be random and unannounced. During an audit you may be asked to make available all your documentation and access to all of your controlled substances. The adequacy of your security measures may be assessed as well. You are also advised to perform a self-assessment of your work area to ensure you are in compliance. Discrepancies Discrepancies in Usage Logs forms or disposal records may trigger an internal investigation by campus authorities. Make sure to report any problems immediately to the CS Program Manager. This is especially important since federal law requires that the CS Program Manager notify the DEA within 24 hours of a loss or theft. Diversion Diversion is the act of using a controlled substance obtained legitimately for illegitimate purposes. Most regulations are established to prevent diversion. Therefore, it is your responsibility to report any suspicious activity to CS Program Manager as soon as possible. You may remain anonymous if you wish. VIII. Questions and the Assessment Questions? If you have comments, questions, or concerns please take the opportunity to contact: The Controlled Substances Program Manager Bob Collum (bcollum@uab.edu) or Phone: (205) The Assessment This concludes the course. You should now take the assessment. 85% or higher is considered passing. You have three attempts to successfully complete the assessment. Failing all three attempts means that you fail the course and must start over. Good luck! Using Controlled Substances Page 9 Last Updated: 05/10/2012

10 Questions and Answers Which of the following groups of controlled substances does NOT contain any narcotics? Diazepam, Ketamine, Pentobarbial What is the DEA number for Ketamine? 7285 Which controlled substance is listed as a Schedule IV? Diazepam What are other name(s) for Diazepam? Valium or Diastat Using Controlled Substances Page 10 Last Updated: 05/10/2012