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Staying Compliant Under Tightening DEA Regulations

Blog Post

Staying Compliant Under Tightening DEA Regulations

By Madelyn Vanwyk

Pharmacy teams stand at a crossroads as advancements in technology and rigorous new regulations reshape the approach to drug diversion prevention. This year, two significant trends are shaping the landscape of drug diversion in healthcare settings: advanced technology integration and increased regulatory scrutiny. Below, we’ll examine these trends in detail and explore how insights from industry experts and best practices can empower pharmacy leaders to address diversion more effectively.

The Rise of Technology Integration to Combat Diversion

The increasing adoption of advanced technology is improving how pharmacies detect and prevent drug diversion. According to the 2025 Diversion Trends Report, 53% of hospital staff involved in diversion surveillance currently use software to track documentation discrepancies, monitor employee behavior, and investigate incidents. Looking ahead, 40% of respondents plan to invest further in diversion prevention technology within the next year.

How Analytics Improve Detection

By combining analytics with automation, advanced diversion prevention platforms eliminate the inefficiencies of manual processes, allowing instant detection of patterns associated with diversion activities and giving staff more time to focus on other critical tasks. Advanced analytics harnesses large volumes of pharmacy data, including dispensing records, inventory levels, and employee access logs. Benefits include:

  • Pattern Recognition: Spot unusual drug usage trends, such as excessive quantities ordered or mismatches in inventory records.
  • Real-Time Alerts: Automated systems that notify teams immediately of potential diversion incidents.
  • Behavior Monitoring: Track employee activities to flag suspicious practices, such as repeated overrides on controlled substances or patterns of improper waste.

For example, during a webinar titled “Open Q&A with Former DEA Investigator Susannah Herkert,” Susannah Herkert noted that discrepancies in controlled substance dispensing or frequent overrides could flag diversion concerns. Diversion monitoring software detects these specific red flags, empowering leadership to investigate immediately. This level of precision increases protection and demonstrates a robust commitment to compliance during audits.

Tools that Make a Difference

Technology solutions such as RFID-powered shelf liners, automated dispensing cabinets (ADCs), and machine learning-driven inventory systems are among the most impactful additions to hospital operations. These tools streamline compliance efforts by ensuring comprehensive, data-backed tracking of controlled substances. Importantly, proper waste documentation, particularly for commonly diverted substances like fentanyl, was identified as a top area for improvement during the webinar discussions.

Increased Regulatory Scrutiny Means Higher Stakes

Regulatory agencies, including the Drug Enforcement Administration (DEA), have intensified their oversight in efforts to address the opioid crisis. Healthcare facilities must adopt a proactive stance to mitigate risk and maintain compliance in this high-stakes environment.

Top Areas of DEA Focus

Today, pharmacy teams face closer monitoring in areas such as:

  • Frequent Unannounced Audits: DEA teams are increasingly performing on-site inspections to evaluate records and compliance.
  • Immediate Suspension Orders (ISOs): Facilities unable to account for controlled substances may face ISOs that suspend operations during investigations.
  • Financial Penalties: The cost of diversion can be staggering, with reports from the U.S. Department of Justice National Drug Intelligence Center (NDIC) show an average fine of $565,000 per detected case.

Collaboration and Policy as Safeguards

The importance of collaboration among operational teams cannot be overstated. According to Herkert, ensuring a corporate-wide culture of compliance—from pharmacy and nursing to HR and security—is fundamental to meeting DEA requirements. Leadership should foster “progressive discipline,” holding all team members accountable for discrepancies, while also investing time in educating hospital staff on DEA reporting guidelines.

Mock inspections emerged as another recommendation from the webinar. Practicing audits internally prepares the team for real DEA inspections by ensuring all records are readily retrievable, discrepancies are resolved, and compliance policies are enforced consistently. These proactive audits are indispensable since, as Herkert emphasized, the DEA does not offer on-site remediation. An incomplete or inaccurate record can lead to fines of up to $18,750 per violation. This underscores the importance of maintaining meticulous records, implementing compliance programs, and adopting advanced technology. Such measures allow critical data to be easily accessible during investigations, allowing for effective inventory monitoring while significantly reducing liability and financial costs.

Best Practices for Preventing Drug Diversion

Preventing drug diversion requires a systematic approach that combines the right tools and processes. Below are strategies to strengthen hospital diversion programs based on insights from experts and industry best practices:

1. Conduct Routine Audits

Regular audits of controlled substance inventories help identify variances and discrepancies early. Herkert emphasized that unresolved discrepancies are not automatic DEA violations but must be thoroughly investigated and documented with clear follow-up actions. Facilities should establish standard operating procedures for these processes.

2. Proper Waste Management

Improper waste disposal remains a leading avenue for diversion, as highlighted in the webinar. Waste must be rendered “non-retrievable” to prevent theft or misuse. Chemical remediation methods are common, but hospitals should routinely audit staff compliance with waste protocols. For example, partial bottles or vials found in sharps containers violate regulations, exposing organizations to compliance risks. 

3. Enforce Separation of Duties

Dividing responsibilities among staff members handling ordering, receiving, and storing controlled substances reduces internal diversion risks. Separation of duties creates transparency and accountability throughout the medication management lifecycle.

4. Implement Technology Solutions

Leveraging advanced tools, like ControlCheck, helps close gaps in manual monitoring processes. Tools like this one provide detailed, real-time visibility into potential diversion activity, mitigating the risk of errors.

5. Educate and Train Staff

Comprehensive employee training programs should go beyond the basics to include interview techniques, investigation procedures, and the importance of addressing discrepancies. According to webinar insights, facilities where leadership reinforces education not only gain compliance advantages but also foster a culture of accountability.

6. Maintain a Diversion Response Plan

Herkert underscored the importance of formal diversion response plans. These plans should provide step-by-step guidelines for investigating incidents, including when to report to the DEA and state boards. Clear documentation and timely reporting are crucial components of effective diversion management.

A Strategic Path Forward

The integration of advanced auditing technology and the influence of regulatory oversight are reshaping how we approach the pervasive challenge of drug diversion. Pharmacy teams committed to leveraging advanced analytics, adhering to best practices, and fostering collaboration can not only mitigate risks but also strengthen their organization’s reputation and trustworthiness.

By staying ahead of these trends and investing in proactive strategies, you can prioritize the safety of patients, the compliance of your operations, and the growth of your institution.