Development of a monitoring program for substances controlled by the health system

It is essential to have a robust controlled substance monitoring program to identify and mitigate drug diversion in a timely manner.

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

Drug diversion can potentially be performed by anyone and from anywhere. Therefore, it is critical that the organization have a robust controlled substance monitoring program in place to mitigate and identify drug diversion early on.

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

Documentation is essential for all actions performed on controlled substances. Implement the CSOS (Electronic Substance Ordering System) process.

A reverse counting process after each controlled substance transaction will help prevent miscounting of controlled substances during dispensing.

Creation of your own controlled substances monitoring team

The team should include at least the pharmacy manager, the responsible pharmacist, the director of nursing care and the risk manager.

Monitoring

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

If electronic health records (EMARs) and ADM are integrated, the system may be able to generate a drug removal report that does not match doses. These discrepancies should be investigated as soon as possible.

If there is no integration, drug removals will need to be manually verified with the EMAR. Be sure to keep a record of the documentation of these discrepancies.

Layout

Disposal should be done through a waste container which inactivates the controlled substance, if available. If not, it can be flushed down the toilet / sink, if permitted by state law. All wasteful activities should be done with a witness.

Signaling deviation

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

Methods of prevention

Human resources should perform background checks and verify the pharmacist’s license before hiring. All drug handling personnel should be educated on the nature and extent of the diversion of controlled substances problem.

Diversion methods include garbage theft, reuse of a fentanyl patch, drug removal for an already discharged patient, tampering or substitution, common characteristics of drug diversionaries, and the signs and symptoms of possible diversion and addiction .

Warehousing

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

  • Controlled substances are safely stored in the ADM or in a double-locked location unless under the control of an authorized person.
  • Controlled substances that are under the control of an authorized person are not placed where their vision could be obstructed or where a distraction could prevent direct observation at all times.
  • Access to the storage areas of controlled substances is reduced to a minimum and limited to authorized personnel.
  • A locked box is placed in the ADM refrigerator to store controlled substances. This locked box has a double lock which needs 2 keys to open it. The keys are stored in the ADM cabinet, accessible only by authorized personnel.
  • Controlled substances introduced by a resident that cannot be returned home are inventoried by 2 licensed health workers, stored in a locked restricted area and destroyed after a period of 6 months.

Surveillance methods

The pharmacy manager or designated pharmacist:

  • Perform the monthly inventory of ADM and controlled substance stocks from the pharmacy.
  • Perform record receipt and delivery checks.
  • Cross-referenced controlled substance ADM removal with administration registration.
  • Monitor ADM discrepancies.
  • If possible, complete a full annual inventory of all controlled substances.

The nursing department:

  • All activities related to loss / waste / return of controlled substances are activities for 2 people.
  • Any discrepancy in the controlled substance count, the nurse should immediately work to resolve the discrepancy.
  • In the event of a discrepancy, an accident report is drawn up with an investigation into the incident and the form is sent to the pharmacy manager.

The Pharmacy and Therapy Committee:

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

References

  1. Wood D. Drug Diversion. Aust Prescr. 2015; 38 (5): 164-166. doi: 10.18773 / Austprescr. 2015.058
  2. CPS. The prevention of controlled diversion of substances is a key element in the compliance of pharmacies and hospitals. CPS.

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