Developing a Health-System Controlled Substance Monitoring Program

It is vital to have a robust controlled substance monitoring program to promptly identify and mitigate drug diversion.

Drug diversion is the theft of drugs or any criminal act involving prescription drugs—and is not just restricted to controlled substances. Drug diversion affects our patients, hospital, and community by causing lack of adequate pain control, impaired driving, and it places the hospital at risk of civil/regulatory liability.1

Drug diversion can potentially be done by anyone and from anywhere. Therefore, it is vital that the organization has a robust controlled substance monitoring program to mitigate and promptly identify the drug diversion.

The hospital leadership may create a delineation of duties involving controlled substances.2 The tasks of ordering, receiving, dispensing, and refilling of the automatic dispensing machine (ADM) can be performed by separate employees, if possible.

Documentation is vital for all actions performed regarding controlled substances. Implement the electronic controlled substance ordering system (CSOS) process.

A reverse-count process after every controlled substance transaction will aid in preventing miscounts of controlled substances drugs while dispensing.

Creating Your Controlled Substance Monitoring Team

The team should at a minimum include the director of pharmacy, pharmacist-in-charge, director of nursing, and risk manager.

Monitoring

At a minimum, a complete inventory of all controlled substances in the building (pharmacy stock and ADM stock) should be performed and discrepancies promptly investigated. Enable a discrepancy report with the ADM to ensure that all CS discrepancies are monitored and resolved on a daily basis.

If the electronic medical administration records (EMAR) and the ADM are integrated, the system may be able to generate a report of mismatching medication removals versus administrations. These discrepancies should be investigated as soon as possible.

If there is no integration, the medication removals will need to be manually cross-checked with the EMAR. Be sure to maintain a documentation log of these discrepancies.

Disposal

Disposal should be done through a wasting container that inactivates the controlled substance, if available. If not, it may be flushed down the toilet/sink, if allowable by state regulation. All wasting activities should be done with a witness.

Reporting diversion

Perform an investigation with your controlled substance monitoring team, which includes ADM reports, EMAR records, and witness interviews. If loss is identified, the director of pharmacy will need to complete and submit a DEA 106 form in addition to the state applicable form.

Prevention methods

Human resources should perform background checks and verify pharmacist licensure prior to hiring. All staff who handle medications should be educated regarding the nature and the scope of the problem of controlled substances diversion.

Methods of diversion include theft of waste, reusing a fentanyl patch, removing medication for a patient already discharged, tampering or substitution, common characteristics of drug diverters, and signs and symptoms of possible diversion and addiction.

Storage

The pharmacy team must ensure that controlled substances are stored and dispensed in a DEA-compliant method:

  • Controlled substances are securely stored either in the ADM or in a double-locked location unless in control of an authorized individual.
  • Controlled substances that are in the control of an authorized individual are not placed where their view may be obstructed or where a distraction may prevent direct observation at all times.
  • Access to the controlled substances storage areas is minimized and limited to authorized staff.
  • A locked box is placed in the ADM refrigerator to store controlled substances. This locked box has a double lock that needs 2 keys to open it. The keys are stored in the ADM cabinet, which can only be accessed by authorized personnel.
  • Controlled substances brought in by a resident that cannot be returned home are inventoried by 2 authorized health care staff, and stored in a locked, limited access area and destroyed after a period of 6 months.

Surveillance methods

The pharmacy director or pharmacist designee:

  • Perform monthly inventory of ADM and pharmacy-controlled substance stock.
  • Perform audits of receipt and dispensing records.
  • Cross-reference controlled substance ADM removal with record of administration.
  • Monitor for ADM discrepancies.
  • If possible, complete an annual complete inventory of all controlled substances.

The nursing department:

  • All activities concerning loss/wasting/returning of controlled substances are 2-person activities.
  • Any discrepancy in the controlled substance count, the nurse must immediately work to resolve the discrepancy.
  • In the event of a discrepancy, an incident report is completed with an investigation of what happened, and the form is sent to the director of pharmacy.

Pharmacy and therapeutics committee will:

  • Receive analyzed reports of the outcome of department of pharmacy/nursing monthly and weekly surveillance activities of controlled substances.
  • Track, trend, and analyze data related to missing/lost/stolen controlled substances.
  • Participate in investigations concerning controlled substances.

References

  1. Wood D. Drug diversion. Aust Prescr. 2015;38(5):164-166. doi:10.18773/austprescr.2015.058
  2. CPS. Controlled Substance diversion prevention is a key element in pharmacy and hospital compliance. CPS.