Managing a dispensary or pharmacy involves more than just keeping shelves stocked. It's about ensuring compliance, safety, and the highest standards of care. With the DEA closely monitoring the use of controlled substances, it's essential to have a solid management plan in place.
Here's how to navigate the complexities of DEA regulations while running a dispensary or pharmacy effectively.
Ordering and Procurement: The First Line of Defense
- The Right Way to Order: Using an electronic Controlled Substance Ordering System (CSOS) is the gold standard for ordering controlled substances, ensuring every order is accurately accounted for. For those still using paper DEA Form 222s, meticulous record-keeping and secure storage are non-negotiable.
- Authorized Personnel Only: Limit the task of ordering controlled substances to a select few who are authorized and trained, ensuring a separation of duties throughout the procurement process.
- Audit and Verify: Regular audits and verifications of orders against inventory are crucial to prevent discrepancies and ensure that every substance can be accounted for.
Safe Storage: Guarding the Vault
- Inventory Management: A perpetual inventory system, complemented by blind counts, ensures that your controlled substances are always accounted for.
- Secure Access: Utilize biometric scanners for vault access, limiting entry to authorized personnel and keeping a detailed log of who accessed what and when.
- Surveillance and Security: Cameras and restricted personal belongings in storage areas add an extra layer of security, deterring potential diversion.
Dispensing: Precision and Caution
- End-of-Shift Inventories: Regular inventories ensure that all controlled substances are accounted for, with special storage solutions like secured lock boxes for specific medication types.
- Double Verification: Always have two individuals, one of whom is licensed, conduct counts before transporting substances to ensure accuracy and accountability.
Returns, Wasting, and Disposal: Closing the Loop
- Verified Returns: Ensure that all returns are checked for integrity, and dispose of controlled substances according to legal requirements, with documentation every step of the way.
- Secure Disposal: Partner with a DEA-approved reverse logistics processor to handle returns and recalls, maintaining a strict chain of custody throughout.
Enhancing Physical and Procedural Security
- Controlled Access: Electronic systems should monitor entry into all critical areas, with regular audits to ensure compliance.
- Surveillance: Camera monitoring extends to all access points and sensitive areas, providing a visual deterrent and a record of activities.
Special Considerations: Surgical Areas and Prescribing
- Surgical Vigilance: Secure and reconcile controlled substances in surgical settings, ensuring that unused medications are properly accounted for and wasted.
- Responsible Prescribing: Leverage electronic systems for prescribing, using secure and tracked methods for all controlled substance orders.
Organizational Commitment: A Team Effort
- Interdisciplinary Leadership: Establish a dedicated team, including a designated diversion officer, to oversee and guide the anti-diversion program, ensuring a cohesive and comprehensive approach.
- Regular Reviews: Monthly analyses of controlled substance data, alongside a standardized process for investigating potential diversion, ensure that any issues are quickly identified and addressed.
- Reporting and Response: Prompt reporting of any thefts, losses, or suspected diversion to the DEA is essential, alongside a thorough response plan that includes patient safety assessments and coordination with enforcement agencies.
The Bottom Line
Managing DEA compliance in a veterinary dispensary or pharmacy demands diligence, detailed procedures, and a team committed to upholding the highest standards of care and legal responsibility. By following these guidelines, you can ensure that your practice not only meets but exceeds the requirements, providing safe and effective care for your patients.
Want to learn more? Get in touch with TITAN Group to learn more about what effective DEA compliance looks like in the modern world.
