According to 96% of health leaders polled in a 2021 study by Porter Research and Invistics, drug diversion within hospitals, pharmacies, and physician practices is still a major concern. This is despite the fact that health leaders are increasingly aware of the prevalence of substance use disorders (SUDs) in the public sphere. Because of this, it is essential that your pharmacy is well-prepared for a controlled substance drug diversion audit or investigation.
How to Prepare for a Drug Diversion Audit or Investigation
Trends in Recent Pharmacy-Related Fines
Over the past few years, there has been an increase in the number of fines and penalties imposed on pharmacies and other healthcare providers. These fines are often the result of violations of federal laws and regulations governing the distribution and dispensing of controlled substances.
One of the main reasons for these fines is a failure to comply with the regulations set forth by the Drug Enforcement Administration (DEA). The DEA is responsible for regulating the distribution and dispensing of controlled substances and ensuring that pharmacies and healthcare providers adhere to the rules.
Failing to Maintain Accurate Records
In some cases, pharmacies have been fined for failing to maintain accurate records of controlled substance transactions. This includes failing to properly document the receipt and distribution of controlled substances as well as failing to maintain accurate inventory records. The DEA takes these violations very seriously, as they are seen as a significant risk to public safety.
Improperly Managing CSOS Records
Another common reason for fines is a failure to properly manage Controlled Substance Ordering Systems (CSOS) records. CSOS is an electronic ordering system that allows healthcare providers to order controlled substances online. The system requires pharmacies and other healthcare providers to maintain accurate records of these orders, including the quantity and type of controlled substances ordered. Failure to properly manage CSOS records can result in significant fines and penalties, as well as the potential loss of DEA registration.
Overall, the trend in recent pharmacy-related fines is clear: the DEA is cracking down on pharmacies and other healthcare providers that fail to comply with federal regulations governing the distribution and dispensing of controlled substances. Pharmacies that want to avoid fines and penalties should make sure they are following all DEA rules and regulations, including maintaining accurate records of controlled substance transactions and properly managing CSOS records.
How Can Your Pharmacy Prepare Proactively?
Given the increased scrutiny, it is critical for pharmacies to take proactive steps to prepare for potential drug diversion audits or investigations. According to the ASHP Report, a comprehensive diversion prevention program includes:
- core administrative elements (e.g., legal and regulatory requirements, organization oversight, and accountability)
- system-level controls (e.g., human resources management, automation and technology, monitoring and surveillance, and investigation and reporting)
- individual-level controls (e.g., a chain of custody, storage, and security, internal pharmacy controls, prescribing and administration, returns, waste, and disposal).
Here are some best practices that pharmacies can adopt.
Regularly Review and Update Policies and Procedures
Pharmacies should regularly review and update their policies and procedures related to drug diversion prevention. This can help ensure that they are in compliance with current regulations and best practices. In addition, regular reviews can help identify areas where improvements can be made to prevent drug diversion.
Train Staff on Drug Diversion Prevention Techniques
Another important step that pharmacies can take to prepare for a drug diversion audit or investigation is to train their staff on drug diversion prevention techniques. This can include educating staff on the signs of drug diversion, implementing protocols for handling suspicious activity, and providing resources for reporting suspicious activity.
Maintain Accurate Records
Pharmacies should also maintain accurate records related to the dispensing of medications. This can include keeping detailed records of all medication dispensed, tracking inventory levels, and conducting regular audits of medication stock.
Secure Medications and Controlled Substances
Pharmacies should take steps to secure medications and controlled substances to prevent unauthorized access. This can include using secure storage containers, limiting access to medication storage areas, and implementing security cameras or other monitoring systems.
Establish a Response Plan
It is important to establish a response plan in the event that drug diversion is suspected. This plan should include procedures for reporting suspicious activity, conducting investigations, and taking corrective action as necessary.
Automation and Technology
Automated dispensing technology (ADT) assists with inventory control, documentation of removal, administration, and waste, billing, chain of custody tracking, and auditing. While the use of ADCs has become common in healthcare facilities, it is still important to make sure that adequate control, surveillance, and auditing processes are implemented.
How C2 Keep Can Help
C2Keep is proud to offer a reliable solution that can allow you to significantly reduce diversion risk by maintaining accurate records. No transaction data in our inventory management system can be deleted, only modified leaving an activity trail. C2 Keep’s solution can help you with the following processes:
Keep Track of Inventory
C2 Keep helps you save hours and eliminate headaches while completing inventory audits. With our solutions, your pharmacy can meet state and federal requirements more efficiently, track inventory activities with specific detail, tell a complete story of your inventory, and much more.
Create Compliant Reports
With C2 Keep, you can easily create compliant regulatory reports for your Corrective Action Plan (CAP), DEA biennial inventory reports in seconds, CAP ‘Total Inventory Reports’ for any timeframe, and 90-day-state-mandated audit reports in minutes.
Connect with Pharmacy Systems
Our system helps you reclaim up to 25 hours a month managing inventory with pharmacy system integrations. C2 Keep lets you maintain accurate perpetual inventory, track dispenses automatically so you never miss a transaction, and enjoy enhanced safety features that reduce errors.
Connect with Your Wholesalers
C2 Keep helps you avoid NDC substitution nightmares by only managing the inventory shipped to your pharmacy. This way, you can avoid missing or incorrectly recording orders. You can also conveniently attach and store DEA 222 forms and more with your orders, as well as track order numbers, invoices, and ship dates in one place.
Conclusion
Pharmacies face increasing scrutiny from regulatory agencies and law enforcement when it comes to drug diversion prevention. Fines for controlled substance drug diversion-related offenses can be significant and can have a serious impact on a pharmacy’s financial health.
At C2 Keep, we offer a service for straightforward and legal controlled substance inventory management to help you efficiently prepare for drug diversion audits. Moreover, because of C2 Keep’s automated inventory management procedures, you’ll have more time to look after your patients and grow your company. Contact us today to schedule a demo!
