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Controlled Substance Logs

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  • 1. Controlled Substance Logs
  • 2. What are controlled substances?
    • Substances of high abuse potential
    • Are outlined in the Controlled Substance Act of 1970 which reduced drug abuse by defined certain legal and illegal acts pertaining to these substances use
    • Established the Drug Enforcement Agency (DEA) to enforce the law
  • 3.  
  • 4.
    • The law was designed to provide an approved means for proper manufacture, distribution, dispensing and use of controlled substances through licensing of legitimate handlers of these drugs.
    • This is a “closed” system and has been very effective in reducing the diversion of these drugs into the illicit market
  • 5. 5 Classes (Schedules) of Controlled Substances
    • Schedules are based on their use or abuse potential
    • Schedule I –high abuse potential
    • research use only
    • LSD, heroin
    • DEA form C-222 required
    • no acceptable medical use
  • 6. 5 Classes (Schedules) of Controlled Substances
    • Schedule II – High abuse potential
    • Requires written prescription
    • No refills on script
    • DEA form C-222 required
    • Oxymorphone, Morphine,etc
    • Abuse may lead to severe addiction
  • 7. 5 Classes (Schedules) of Controlled Substances
    • Schedule III – Less than I & II abuse potential
      • oral or written script, up to 5 refills in 6 months
      • DEA registration number
      • Hycodan, anabolic steroids, etc
      • abuse may lead to moderate dependence
  • 8. 5 Classes (Schedules) of Controlled Substances
    • Schedule IV - low abuse potential
      • oral or written scripts with 5 refills in 6 months
      • DEA registration number
      • Diazapam, phenobarbital
      • Abuse may lead to limited dependence
  • 9. 5 Classes (Schedules) of Controlled Substances
    • Schedule V - low abuse potential
    • no DEA limits on dispensing
    • DEA registration number
    • Lomotil, Robitussin AC
    • lowest potential for abuse
  • 10.
    • All veterinarians who use these drugs must have a DEA license number
    • Records must be maintained on the acquisition and distribution of controlled substances
    • All controlled substance records must be “readily retrievable” if an inspector appears at the hospital
  • 11. Controlled Substance Compliance
    • A recording system must be set up to account for:
    • receipt of CS
    • inventory of CS
    • legal distribution of CS
    • signature sheet for anyone (staff) who can handle CS
    • scripts to local pharmacies
    • use of CS in hospital
  • 12. Ordering Controlled Substances
    • Any supplier who you will buy CS from must have a photocopy of the doctors current BNDD (Bureau of Narcotics and Dangerous Drugs) registration number on file.
    • DEA receives copies of all your CS order forms and invoices. Orders for excessive amounts or unusual items may trigger an audit
  • 13. Ordering schedule II drugs
    • Form 222, a triplicate form must be filled out and mailed to the supplier.
    • The supplier keeps a copy
    • A copy is sent to DEA
    • The 3 rd copy is returned to you with the order
  • 14. Receiving schedule II drugs
    • When a schedule II drug is received, the appropriate boxes on your copy of the form 222 need to be filled out with the number received and date of receipt.
    • Attach this form to your CS log copy of the invoice.
  • 15.
    • The audit trail of all CS must be clear, concise and readily retrievable.
    • You must keep good records of receipt, inventory and eventual legal distribution of all CS
  • 16.
    • When received, all controlled substances must be recorded and numbered in the unopened container log.
    • A separate log must be maintained for each drug and form of that drug. (ie.)
      • Phenobarbitol injectable
      • Phenobarbitol 60 mg tablets
  • 17.
    • Copies of all invoices for CS must be kept and readily available.
    • Schedule III, IV, and V must be labeled with a 1inch high red C in the lower right hand corner.
    • Schedule II must readily identifiable from III, IV and V
    • Can be kept in separate folders or mixed in the same one
  • 18.
    • All CS must be kept in a double locked box.
    • It is advisable to keep stock items in a safe and only open in use containers in the double lock box
    • If any need refrigeration, they must be in a special double lock box that affixes in the refrigerator or the refrigerator needs to be padlocked.
  • 19.  
  • 20.
    • 2 locked building doors DO NOT suffice
    • The safe or cabinet has to be bolted to the floor or wall
  • 21.
    • When taken out of stock, CS has to be logged in an open container log while at the same time being logged out of the unopened stock log
    • A signature and initial sheet for anyone who has access to and use of the drug logs needs to be kept in the front of one of your logs (usually the unopened stock log)
  • 22.
    • Any scripts given to clients to take to local pharmacies need to be copied and kept in a file so that they can be tracked.
    • Suggestion, make 2 copies, 1 for the patient record and 1 for the DEA file
    • In NYS, we have to use specific state prescription pads that void themselves if tampered with or photocopied
  • 23.
    • In the open use CS log, all use has to be documented with:
      • Date
      • Patient/client name
      • Patient/client ID number
      • Amount used
      • New balance left in the container
      • Initials of staff member who drew up or counted out the drug
  • 24.
    • Frequent audits of your CS should be done. Depending on the size of the facility.
      • Daily
      • Every shift
      • Etc
  • 25.
    • A biennial drug inventory is mandatory by DEA regulations.
    • Keep all CS records 5 years + since the statute of limitations is 5 years.
    • A separate inventory of Ketamine on hand must be recorded and stored with the biennial drug inventory records. This is due to severe Ketamine drug abuse issues
  • 26.
    • Go to CS log transparencies
      • Signature sheet
      • Unopened log
      • Opened log
      • Biennial inventory
  • 27.
    • Tramadol - (a pain medication) not currently controlled, may soon be changed to controlled because of the increasing abuse of the drug
  • 28.
    • Any and all employees that have access to CS must be screened. This includes Drs, techs, assistants, receptionists, kennel staff and possibly groomers.
    • Anyone convicted of a felony can not have access to or handle CS
  • 29. Outdated Controlled Substances
    • It is illegal to use outdated CS since it is considered adulterated.
    • It CAN NOT BE THROW AWAY
    • It should, with the appropriate documentation be:
      • Returned to the supplier
      • Given to a reverse distributor
      • Given to a disposal agency
      • Obtain DEA on site destruction permission
  • 30.
    • Best is to return to supplier if possible. The supplier fills out all the necessary DEA paperwork and gets the authorization. You then send it back with the paperwork keeping your copy of the paperwork
    • No cost to the veterinarian
  • 31.
    • Contracting with a reverse distributor who also fills out all the paperwork with DEA and then picks up the CS from you to destroy.
    • No cost to the veterinarian
    • Hard to find them
  • 32.
    • Disposal agency also fills out all the DEA paperwork and picks up from you
    • Fee for the service
  • 33.
    • If none of those are an option, you can fill out the appropriate paperwork DEA forms DOH-2340 and DOH-166 or if schedule II a Form 222 also and submit to your regional DEA office for authorization to do an on sight ( at the practice) disposal.
    • Download forms from: www.nyhealth.gov/professionals/narcotic/ and mail to appropriate area office of the Bureau of Narcotic Enforcement
    • Not available in all areas of the country
  • 34.
    • Go to Bureau of narcotics destruction forms
  • 35.
    • If outdated CS is returned or destroyed, it must be logged out of stock
    • Justification for the use of all CS must be clearly demonstrated in the patient’s medical record.
    • There has to be a valid Client/patient/doctor relationship
  • 36.
    • Any loss or theft of CS must be reported to DEA
    • If a DEA inspector shows up at the practice and shows proper ID and has a warrant or subpoena, you must immediately show them all the CS records except for financial records
  • 37.
    • Penalties, up to and including revocation of the veterinarian’s BNDD number can be assessed.
    • Without the ability to purchase controlled substances practice is very limited
  • 38. Additional New York State Regulations
    • In order to control CS abuse NYS requires all pharmacies, human and veterinary, to upload by the 15 of the following month a record of all the CS that has been dispensed from the practice in the past month.
    • The Health Dept’s supercomputer checks to see if people are getting multiple scripts for CS from different doctors or if doctors are writing abnormally large amounts of CS scripts. Which will trigger an investigation
  • 39.
    • Article 33 of the Public Health Law and Part 80 of Title 10 regulations require pharmacies to electronically submit information to the New York State Department of Health (NYSDOH) from all prescriptions dispensed for controlled substances. Such information must be submitted not later than the 15th of the month following the month in which the controlled substance was dispensed.
  • 40.
    • Go to upload word document
  • 41. FYI
    • You can not fill prescriptions for any medications for other practitioners unless you are a licensed pharmacist employed in a registered pharmacy
    • Compounding of substances without a special license as a compounding pharmacy is illegal
  • 42. FYI
    • You can not order compounded substances from a compounding pharmacy and re-dispense them to your patients. This is distributing. You can only order them for in hospital use.
    • You must script out compounded substances for a specific patient and have them filled through a compounding pharmacy. Marking up the price is illegal.
  • 43.  

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