HealthJuly 19, 2024|UpdatedOctober 02, 2024

Drug diversion prevention: The cost of non-compliance

Compliance with DEA regulations in handling controlled substances safeguards healthcare facilities, protecting patients and staff from drug diversion risks.

The potential repercussions of non-compliance, such as hefty fines, legal sanctions, loss of licensure, and damage to reputation, can have devastating financial and operational impacts on organizations. 

The cost of non-compliance

In several high-profile cases, non-compliance with DEA regulations at healthcare facilities led to staggering multimillion-dollar fines. In one case involving Pikeville Medical Center in 2022, the health system’s non-compliance eventually resulted in over four million dollars in settlements. Another notable example was in 2020 when Vega Alta Community Health was improperly registered as a retail pharmacy with the DEA. Failure to properly register, and other incidents of non-compliance such as an unsecured cabinet or incomplete biennial inventories, resulted in thousands of dollars in civil penalties. For drug diversion specifically, non-compliance with DEA guidelines on documentation requirements and investigation processes can carry similar financial risk. 

Beyond direct financial ramifications, a health system in violation of controlled substances regulations may also face a non-prosecutorial agreement that involves a corrective action plan. Further, through a patient care lens, non-compliance with DEA-controlled substance regulations poses significant risks to patient safety and jeopardizes patient trust. When healthcare facilities fail to adhere to these regulations, controlled substances may be diverted or misused, leading to patients not receiving appropriate medication or receiving incorrect dosages. Tampering with controlled substances for the purposes of diversion may also result in the transmission of blood-borne pathogens among patients. Without proper compliance measures, a lack of accountability and oversight can heighten the risk of medication errors, theft, and tampering.

Steps to ensure compliance in your health system

To avoid penalties and help safeguard your health system, organizations should consider establishing a dedicated team or task force to oversee procedures and best practices for compliance and drug diversion prevention. It is recommended to reference the Code of Federal Regulations (CFR) and DEA website, along with guidance documents and manuals from national and local regulatory bodies as applicable to your health system. The DEA's Practitioner Manual is a great resource for health systems to reference for maintaining compliance with federal regulations. Beyond federal requirements, many states have additional controlled substance recordkeeping and accountability requirements that can often be found on the state’s Board of Pharmacy website. Additionally, utilizing, and reassessing current practices, tools, and records is an essential preventative measure. For example, designated staff members should regularly check data analytics to flag concerns or optimize existing processes and tools a health system has in place. Sentri7 Drug Diversion supports many of these efforts to analyze data and behavior patterns of clinicians who handle controlled substances. 

SOLUTIONS

Sentri7 Drug Diversion

Quickly uncover potential diversion from purchase to patient with predictive analytics and actionable dashboards.
Reconciles drug transactions using AI to rapidly and accurately identify patterns of behavior consistent with drug diversion.

Compliance leaders may also connect with local DEA Diversion Control offices to address any inquiries and additional support needs. When it comes to DEA reporting requirements for drug diversion compliance in the evolving landscape of controlled substances, staying vigilant is critical to prevent outcomes such as fines, loss of licensure, damage to reputation, and, most importantly, harm to patients or staff. 

Looking for additional resources on drug diversion best practices? Check out these recent articles. 

Sentri7 Drug Diversion Solutions
Gordon Watkins
Specialized Consulting Manager
Dr. Gordon Watkins has over 8 years of experience in institutional pharmacy clinical practice and operations, most specifically in implementing and optimizing pharmacy technology solutions.
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