DEA Inspection Guide: Proactive Steps to Prevent Drug Diversion

In the complex world of controlled substances management, being prepared for a DEA inspection is crucial. For fire departments, EMS professionals, first responders, and ambulance services understanding the intricacies of these inspections can help mitigate risks and ensure compliance. A multi-layered approach encompassing processes, practices, culture, security, and strategy is essential to prevent diversion effectively.

What to Expect During a DEA Inspection

The DEA’s Diversion Control Division is dedicated to preventing, detecting, and investigating the diversion of controlled substances from legitimate sources. Inspections are a key component of this mission. Here’s what you can expect if your organization is subject to a DEA inspection:

Why the DEA Might Visit

DEA inspections can be triggered by various events:

• Scheduled Inspections: Regular checks to ensure ongoing compliance.
• Theft/Loss: Inspection following reports of stolen or lost controlled substances.
• Patient Complaint: Investigation into a complaint about the handling of controlled substances.
• Suspicious Order Report: Follow-up on reports of unusual or suspicious orders.
• DEA Registrant Request: Inspections requested by the registrant themselves for various reasons.

The On-site Process

DEA inspections typically involve several steps:

1. Notice of Inspection: Often unannounced, with two or more DEA personnel presenting a “Notice of Inspection.”
2. Initial Meeting: The inspectors will meet with management and the controlled substance handler.
3. Facility Tour: Inspectors will tour areas where controlled substances are kept.
4. Review Procedures: Inspection of Standard Operating Procedures related to controlled substances.
5. Document Request: Inspectors will request various documents such as Power of Attorney forms, Key Control Logs, Spill Logs, Inventories, and more.
6. Physical Count: A physical count of controlled substances on hand will be conducted.

Primary Purpose

The primary purpose of the inspection is to ensure compliance with the Controlled Substances Act. This involves checking:

• Reporting: Ensuring accurate and timely reporting of controlled substances.
• Drug Disposal/Destruction: Proper methods for disposing of or destroying controlled substances.
• Licensing: Validity and scope of licenses.
• Records & Inventories: Complete and accurate maintenance of records and inventories.
• Security: Adequate security measures to prevent diversion.

Key Elements of Compliance

To be prepared for a DEA inspection, fire departments, EMS professionals, and other related organizations should focus on these key areas:

Security Requirements

Ensure that controlled substances are stored securely and access is restricted to authorized personnel. This may include physical security measures such as locks and alarms, as well as procedural controls like access logs.

Recordkeeping Requirements

Maintaining accurate and complete records is critical. This includes:

• Biennial Inventory: The most recent biennial inventory of controlled substances.
• Reconciliations: Regular reconciliation of inventory records.
• Receiving Records: Documentation of all controlled substances received.
• DEA-222 Forms: Properly executed DEA-222 forms for Schedule II substances.
• Invoices and Distribution Records: Detailed records of controlled substance distributions.
• Dispensing Records: Accurate records of all dispensed controlled substances.
• Disposal and Destruction Records: Documentation of substances that have been disposed of or destroyed.
• Theft/Loss Reports: Detailed reports of any theft or loss incidents.

Compliance with Established Schedules

Ensure that controlled substances are handled according to their specific schedule requirements. For example, Schedule II substances must be maintained separately from all other records and stored at the registered location.

Strategies to Prevent Diversion

A single approach will not mitigate all risks of diversion. A multi-layered strategy is recommended:

Process Improvements

Implement robust Standard Operating Procedures (SOPs) for handling controlled substances. Regularly review and update these procedures to adapt to new risks and regulatory changes.

Cultural Initiatives

Foster a culture of compliance within your organization. Educate staff about the importance of adhering to regulations and the consequences of diversion. Encourage open communication and reporting of suspicious activities.

Security Enhancements

Invest in advanced security technologies such as biometric access controls, surveillance systems, and alarm systems. Regularly audit security measures to identify and address potential vulnerabilities.

Conclusion

Preparing for a DEA inspection involves more than just meeting regulatory requirements. It requires a proactive approach to prevent diversion and ensure the safety and integrity of controlled substances. By adopting a multi-layered strategy that addresses processes, practices, culture, security, and strategy, fire departments, EMS professionals, first responders, and ambulance services can better prepare for inspections and mitigate the risks associated with controlled substances.

Further Reading/Reference Material

This slide deck, published by the Drug Enforcement Administration, provides further context and was used to create this blog post.