Best Practices for the Management of Controlled Substances in Your Setting

When handling controlled substances, procedures may vary depending on your practice and organization. However, there are basic responsibilities that may be universally helpful.
 
For example, it is a best practice to implement organizational policies for managing the controlled substances used for various procedures and/or to treat pain in general.

Note: The Controlled Substance Act requires that records are complete and accurate for all quantities of controlled substances manufactured, imported, exported, received, delivered, distributed, dispensed, or otherwise disposed of (A DEA Resource Guide, 2020).

Basic Responsibilities include:

• Complete controlled substance checks on a every shift/staff change
• Physically witness the discarding of a controlled substance and document appropriately
• Keep controlled substances locked unless in use
• Use lock boxes when the setting is appropriate (hospice settings, home health)
• Rotate individuals handling controlled substances (discrepancies can be found when different individuals handle the medications)
• Thoroughly investigate any discrepancies in real time; make every effort to resolve the discrepancy at the time it is discovered
• If unable to resolve a discrepancy, follow your organizational policy and procedure on handling discrepancies and/or report it to the appropriate personnel or authorities (DEA) if criteria are met (see below) as soon as possible
• Unused controlled substances should be returned rather than disposed of if possible
• Controlled substances should be administered immediately after removal
• Controlled substances should be administered to a single patient (one patient at a time)

Disposing of a controlled substance:

• It is a best practice that the disposal process includes at least two individuals to observe, witness and record the disposing of unused medication
• Dispose of controlled substances at the time of the removal
• Document in real time
• Do not carry the medication with you for intended disposal at a later date or time
• Never document that you witnessed a disposal if you did not actually visualize the process
• Never sign after the fact that you witnessed a disposal of a controlled substance
• Dispose of the control substance in the appropriate location (irretrievable location)
• When using multi dose vials, the best practice is to draw up the remaining/unused medication at the time in a separate syringe or dispose of the entire vial in the appropriate location/bin

DEA Reporting Requirements - When and How to Report:

• Significant loss of a controlled substance(s)
• Theft of a controlled substance(s)
• Unexplained loss of a controlled substance(s)
• Significant loss or theft must be reported within one business day of discovery
• You must use the DEA form 106 to file a report

 
(Refer to the sites below for more information on reporting and a copy of DEA form 106) 
DEA Form 106 (usdoj.gov)
DEA Contact Us - Search Utility (usdoj.gov)
https://www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0812.htm
Contact Us (dea.gov)
Significant Theft or Loss Reporting of Controlled Substances (usdoj.gov)
 
Suspicious behaviors that may indicate diversion:

• Patient(s) complaining that pain is not relieved (look for patterns in terms of clinicians)
• Patient(s) complaining that they experienced pain/were awake during a procedure requiring sedation (look for consistencies with shifts, personnel, medications)
• One clinician volunteering and/or insisting on overseeing controlled substances
• Inconsistent dosing among clinicians for similar procedures
• Removing medications for more than one patient at a time
• Patterns in behaviors when removing or disposing of medications
• Purposely choosing larger doses to require a disposal
• Holding onto medications to dispose of later
• Not disposing at the time of removal (making excuses as to why the disposal was delayed)
• Pulling controlled substances earlier than required
• Placing medications in one’s pocket during transport/transfer

Recordkeeping in any setting:

• Maintain complete and accurate records of controlled substances
• Clearly identify operating procedures for your practice (define policies and procedures)
• Witness and document the receiving of controlled substances (best practice is to have an area designated for managing controlled substances)
• Match and attach invoices when receiving the medications
• Consider conducting biennial inventory during your required annual inventory, or every six months (DEA requires biennial inventory be conducted every two years)
• Schedule II opioid records MUST be kept separate from schedule III-IV controlled substances
• Implement consistent reconciliation; best practice is weekly at a minimum
• Have controlled substance records filed in an organized and readily available manner
• Document any discrepancies (keep a chronological log for future reference)
• Record retention of controlled substances is a minimum of two years

 
To help minimize the risk of a controlled substance incident in your organization, properly educate and communicate the importance of following procedures and protocols. Be aware of inconsistencies and stress the importance of communicating questionable behaviors to the designated person in your organization for further evaluation.

References:
https://www.dea.gov/drug-information/csa
https://www.dea.gov/sites/default/files/2020-04/Drugs%20of%20Abuse%202020-Web%20Version-508%20compliant-4-24-20_0.pdf
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3875106/
http://www.rn.org/courses/coursematerial-10004.pdf
https://www.ncbon.com/myfiles/downloads/course-bulletin-offerings-articles/bulletin-article-winter-2019-protect-your-nursing-license.pdf