In response to a growing problem in drug diversion in medical facilities, the Centers for Medicare & Medicaid Services (CMS) set the date of November 28, 2017, for long-term care (LTC) facilities—and other institutions—to implement new guidelines concerning the CMS Management of Controlled Substances management, storage, and distribution.
The guidelines, consisting of an amendment to the State Operation Manual (SOM), “Appendix PP Guidance to Surveyors for Long-Term Care Facilities,” include t
he following rules:
- The facility must have a system to account for controlled medications’ receipt and disposition in sufficient detail to enable an accurate reconciliation, and that the facility conduct a periodic reconciliation.
- These records must detail the name and strength of the medication, the quantity and date received, and the recipient’s name (the only exception is single-unit packages of medications that are not dispensed pursuant to a specific order).
- Records must be kept of personnel access, usage, and disposition of all controlled medications with sufficient detail to allow reconciliation (e.g., the MAR, proof-of-use sheets, or declining inventory sheets), including destruction, wastage, return to the pharmacy/manufacturer, or disposal in accordance with applicable state requirements;
- Periodic reconciliations of all records so as to minimize the time between the actual loss or potential diversion and the time of detection and follow-up to determine the extent of loss. In some circumstances, this reconciliation might be daily.
- If discrepancies are identified during the reconciliation, the pharmacist and the facility develop and implement recommendations for resolving them, and make referrals to law enforcement agencies as appropriate.
- Data from injectable, scheduled drug tracking should be regularly reviewed, and discrepancies or unusual access patterns investigated, including whether residents should be screened for exposure to blood-borne pathogens.
- Disposal methods for controlled medications must involve a secure and safe method to prevent diversion and/or accidental exposure.
- 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.
- The facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys, security codes or cards, or other technology such as fingerprints.
- During a medication pass, medications must be under the direct observation of the person administering the medications or locked in the medication storage area/cart.
- All drugs and biologicals used in the facility are to be labeled in accordance with professional standards, including expiration dates and with appropriate accessory and cautionary instructions.
In addition, the new rules contain specific guidelines for investigating cases of drug diversion or theft. CMS management of controlled substances is a hot topic and will effect all facilities.
Previously in the series:
– New CMS Controlled Substance Control Guidelines
