Clinical Best Practices – Controlled Substances Reconciliation

Several nursing home surveys on a monthly basis identify failures to appropriately reconcile narcotics or controlled substances. Generally speaking, controlled substance reconciliation is based on the individual providers policies and procedures, however, there are best practices that can be followed to quickly identify drug diversion.

Frequency

The frequency of reconciliation is likely based on the program. For example, Assisted Living Programs may administer fewer controlled substances and have a lower number of staff with access to controlled substances, which may reduce the need to reconcile narcotics as frequently. However, circumstances in nursing homes including routine changing of staff that have access to controlled substances, higher inventory numbers, as well as number of residents receiving controlled substances, leads to a need to reconcile controlled substances more often.  

According to an AAPACN article Preventing and Detecting Drug Diversions: Quick Tips for Success, the best practice related to frequency is for two staff members, typically the outgoing and oncoming nurse each shift. The article states that if the nurse leaves before counting and the oncoming nurse identifies that a medication card is missing, both nurses are then under suspicion for the missing controlled substances.

Procedures

Previously, sufficient controlled substance reconciliation included one person verifying the number of pills in the container while the other person verified the number on the controlled substance logs. However, as practice has evolved and drug diversion has increased in prevalence, DIAL has cited in deficiencies that nursing homes failed to reconcile narcotics appropriately based on this practice. In the 2567s, DIAL cites that each person completing reconciliation should verify the number of pills in the containers match the number of pills documented on the log. This includes both individuals visually inspecting the pills and the number identified on the log.

According to the CMS Medication Storage and Labeling CE Pathway, surveyors are reviewing the following related to controlled substances:

• All Schedule II-V controlled medications (excluding single-unit packaging in minimal quantities that can readily be detected if missing) were maintained within a separately locked permanently affixed compartment. *Note this includes controlled substances that require refrigeration.
• Sufficiently detailed records of receipt and disposition of controlled medications were maintained to enable an accurate reconciliation.
• All medication records were in order and an account of all controlled medications was maintained and periodically reconciled.
• Disposal methods for controlled medications involve a secure and safe method to prevent diversion and/or accident exposure.

The interpretative guidance in F755 in appendix PP also includes the following requirements:

• If controlled substances are included in an emergency medication supply, the policies and procedures must address the reconciliation of this supply. *Note this likely includes verifying a locked tag number and promptly sending the emergency medication supply back to the pharmacy for replacement of the medication(s) when used.
• If discrepancies are identified during the reconciliation, the pharmacist and the nursing home develop and implement recommendations for resolving them, and make referrals to law enforcement agencies as appropriate.
• Liquid controlled medications are often dispensed in multi-dose containers which indicate approximate volume. The containers may also be opaque to protect the medication from light. It should be noted that absolute accuracy in tracking volume and use of liquid controlled medications may not be possible. The actual volume in these containers may be slightly over or under the manufacturer’s stated volume depending on the shape and material of the container and the formulation of the medication such as thick liquid suspensions.
  • The standard of practice for documenting usage of liquid controlled medications is to record the starting volume from the label, record each dose administered, subtract the dose administered from the previously recorded volume, and record the remaining amount. Manufacturer’s instructions may list the estimated volume variance (such as 30 ml plus or minus 2.5 mL).

In addition, DIAL has cited several deficiencies for staff failing to sign out both the controlled substance record and the MAR. In several instances the staff administering medications only sign out the MAR or the controlled substance record. Note that both the controlled substance log and the MAR must be signed each time a medication is administered.