In the dynamic healthcare industry, clinicians must adapt to rapid changes while ensuring precise record-keeping to support quality measures and manage controlled substances effectively.
Adherence to Drug Enforcement Administration (DEA) regulations supports more than compliance; it is also essential for the integrity of healthcare systems and assuring the safety of patients and staff. Effective record-keeping is a key pillar of DEA compliance, offering a tangible trail that validates adherence to regulations and best practices. Guidelines from industry organizations like the American Society of Health-System Pharmacists (ASHP) continue to recognize documentation as a crucial element of controlled substance handling and, by extension, drug diversion prevention practices.
Regarding onsite DEA inspections, maintaining organized and readily retrievable documents is essential in efficiently demonstrating transparent closed-loop accountability of controlled substances to a DEA diversion investigator. These records are invaluable tools for tracking and ensuring compliance across various aspects of controlled substance management, spanning procurement, inventory control, distribution, dispensing, and disposal. By diligently documenting each stage of a medication’s lifecycle, healthcare facilities can benefit twofold—ensuring compliance with regulations and reducing the administrative burden of busy clinicians and staff.
Types of data inputs to ensure compliance
For example, one of the fundamental requirements for DEA compliance is the maintenance of accurate and up-to-date inventory records for all controlled substances within the healthcare facility. The federal Controlled Substances Act mandates a complete and accurate inventory every two years, although some systems may find more frequent inventories beneficial. An inventory is typically a complete and accurate list of all quantities of stocks and dosage forms of controlled substances in the registrant’s possession.
A health system should always have these records easily accessible for copying and inspection by the DEA Diversion Control Division. These inventory records must contain the detailed information required by the Controlled Substances Act and should be maintained for the required retention period.
In addition to aiding compliance with DEA reporting requirements for drug diversion, records can account for any transfers or discrepancies discovered during routine inventory audits. Accurate inventory records serve multiple purposes, both identifying potential irregularities or patterns and enabling prompt resolution to mitigate the risk of drug diversion.
While the DEA specifies required record retention periods at a federal level, it is vitally important to research the required record storage periods at the local or state level, which can be more stringent. These requirements can often be found on your State Board of Pharmacy Website or in your state’s Controlled Substance Act. The DEA's Practitioner Manual can also be a helpful resource to reference.