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.
