Tips for Improving Controlled Substance Safety

Prioritizing controlled substance safety is essential for today’s healthcare professionals. The opioid crisis has been ongoing for years, prompting government agencies and healthcare organizations to take action to reduce its impact. According to the U.S. Centers For Disease Control and Prevention (CDC),  deaths related to opioid overdoses decreased from 114,000 in 2023 to 87,000 in 2024. While this progress is promising, more must be done and pharmacists are in a unique position to make a meaningful impact.

Government agencies can put regulations in place, but it is ultimately up to pharmacists and other healthcare professionals to interpret, implement, and enforce them. In this article, we’ll explore best practices to strengthen diversion prevention efforts and ensure safe handling of controlled substances. Key strategies include recognizing red flags, securing inventory and records, and ensuring proper transfer and disposal. While these steps can be challenging to manage manually, digital tools like C2 Keep make it easier to safeguard communities from opioid misuse while fostering a culture of opioid stewardship.

Red Flag Identification

The first line of defense when it comes to controlled substance safety is being able to recognize the “red flags” associated with diversion. Even though it may be unlikely a suspicious activity is actually linked to diversion, taking each instance seriously will ensure safer practice when a diversion does occur.

Under the Controlled Substances Act (CSA), all dispensers are responsible for identifying and responding to potential red flags. Common red flags include:

• Unusual Ordering Ratios: A high ratio of controlled substances to non-controlled substances.
• Order Volume Trends: Increased orders of controlled substances without a corresponding increase in non-controlled medications.
• Unusual Formulations: Requests for high-risk formulations outside of standard patterns.
• Out-of Area Patients: Large numbers of patients from outside the local ZIP code.
• Cash payments: A disproportionate number of cash transactions for controlled substances.

Dispensers must also be aware of red flags their wholesalers monitor them for through the Controlled Substances Monitoring Program (CSMP). In addition to the red flags mentioned above, this includes:

• Prescriber Activity: Unusual prescribing patterns from a pharmacy’s top prescribers.
• Regulatory History: Any disciplinary actions against a pharmacy or its staff in the last five years.
• Termination From Other Distributors: Past termination from other distributors due to compliance concerns.

Staying vigilant against both patient-level and wholesaler-level red flags is key to ensuring controlled substance safety.

Secure Inventory and Data

Another critical aspect of controlled substance safety is securing both physical inventory and the records linked to it. Controlled substances must, by law, be stored in locked cabinets with appropriate security measures. Any loss or diversion must be reported to the DEA using Form 106 within one business day.

However, protecting physical inventory alone is not enough. Paper logbooks and manual records are prone to manipulation and human error. For example, a staff member could remove controlled substances and adjust logs to make the numbers appear accurate. Handwritten notes may also be misinterpreted, leading to discrepancies that make diversion harder to detect.

To reduce these risks:

• Store controlled substances in locked, access-controlled cabinets.
• Ensure all records are legible, accurate, and secure.
• Implement accountability measures, such as requiring two staff members to be present during dispensing and logging.
• Consider digital inventory solutions that automate recordkeeping, minimize human error, and improve efficiency.

By enhancing controlled substance safety efforts with secure storage with reliable record management, pharmacies can significantly strengthen their diversion prevention effectiveness.

Proper Transfer and Disposal

The safe transfer and disposal of controlled substances is another essential element of compliance. Under the CSA, dispensers may use third parties for packaging and logistics, but they remain responsible for the transfer itself. For Schedule II substances, a DEA-222 form or its electronic equivalent must be issued. Other transfers may include returning stock to the original supplier or transferring inventory in the event of a pharmacy closure or acquisition.

For disposal, DEA registrants have several approved options:

• On-Site Destruction: In accordance with 21 CFR 1317.90 and 1317.95.
• Reverse-Distributor: Using a DEA-registered reverse distributor to manage destruction.
• Recall or Return: Returning to the supplier, manufacturer, or an authorized registrant.
• Special Agent: Requesting assistance from a DEA agent in charge at the practitioner’s location.

Just as with inventory, disposal activities must be properly documented. Tracking these processes manually with spreadsheets or logbooks is often time-consuming and error-prone. A comprehensive digital solution can simplify compliance, making it easier to differentiate between transfers, disposals, and other controlled substance activities.

Conclusion

Controlled substance safety has never been more critical. Federal initiatives such as the CSA, CSMP, and Drug Supply Chain Security Act (DSCSA) provide the framework to protect communities from misuse, but it is up to healthcare professionals to take action. By identifying red flags, securing inventory and records, and ensuring proper transfer and disposal, healthcare professionals can strengthen controlled substance safety and protect the patients they serve.

Technology plays a growing role in this mission. Modern tools are helping providers stay compliant, reduce risk, and contribute to ending the opioid crisis.

C2 Keep: Your Partner in Controlled Substance Safety

C2 Keep is a cloud-based, fully integrated compliance and management platform built to simplify controlled substance workflows for independent pharmacies and other healthcare practices. With seamless perpetual inventory management and automated reporting, C2 Keep reduces manual work and minimizes errors.

Healthcare professionals use C2 Keep to track activities such as back-counts, compounded medications, transfers, and disposals all in one secure system. With over 1,500 daily users nationwide, C2 Keep gives its users confidence in their compliance efforts while freeing them up to focus on patient care.

Interested in learning more? Schedule a 30-minute demo with our founder and CEO, Roland Achenjang, to see how C2 Keep can help your practice strengthen compliance and prioritize controlled substance safety.