On Wednesday, July 29, 2020, the U.S. Department of Justice’s Drug Enforcement Administration (DEA) proposed a new rule that clarifies that the submission of DEA Form 106 (Report of Theft or Loss of Controlled Substances) shall be submitted electronically through the DEA Diversion Control Division’s secure network within fifteen (15) days of discovery and must be “complete and accurate.” The current rule requires DEA registrants to notify the local DEA office in writing via hard copy or electronically of any theft or significant loss of any controlled substance within one (1) business day of discovery; the proposed rule does NOT change this requirement.
Unfortunately, the proposed rule does not define or further clarify “significant loss” or “date of discovery,” which means that organizations are still left to interpret those terms themselves. The proposed rule better aligns the DEA Form 106 submission process to that of the DEA Form 107 (Report of Theft or Loss of Listed Chemicals), which is also required to be submitted electronically (through the DEA Diversion Control Division’s secure network) within 15 days.
It is becoming more and more evident that drug diversion and pharmacy compliance programs should be priority areas for compliance and audit programs. Government enforcement around diversion is on the rise, and organizations should focus on prevention and detection controls such as:
- Implementing safeguards to prohibit the ordering of controlled substances by unauthorized individuals. For example, limiting the ordering of controlled substances to a DEA registrant or those with power of attorney.
- Use of a perpetual inventory and a blind-count process when adding or removing controlled substances. If a perpetual inventory is in place, a weekly/monthly inventory should be performed. Otherwise, a daily inventory should be performed (and when low stock is maintained). At a minimum, as required by the DEA, a biennial inventory must be conducted.
- Restricting access to controlled substance inventory and monitoring those who have access. For example, the review of an outlier report (e.g., higher amounts of dispense, waste or canceled dispenses), overrides, discrepancies (e.g., discrepancy discovered by a blind count), or a buddy waste report (that is, users who commonly witness each other’s waste).
- Monitoring of theft, waste and misuse. For example, random auditing of waste from high-risk (e.g., operating rooms) and high-volume areas and the reconciliation of dispensation for high-volume areas with the administration/waste record.
- Development of a drug diversion prevention program, which includes collaboration across key departments such as pharmacy, clinical operations, legal, audit and compliance. Upon confirmation of a diversion, report it to the DEA and the organization’s applicable boards (e.g., pharmacy, nursing, anesthesia) as required.
Pharmacy compliance and drug diversion prevention programs should keep abreast of leading practices related to regulatory requirements, drug ownership, clinical practices and monitoring, inventory management, and investigations and response procedures.