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Best Practices: Preparing for a Controlled Substances Drug Diversion

According to over 90% of health leaders polled in a 2021 study, 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 onsite visits, 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.

Failure to comply with the regulations set forth by the Drug Enforcement Administration (DEA) can have a significant impact on your pharmacy operation. 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

Most cases against the pharmacies are due to the fact that did not maintain or failed 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 perpetual inventory records. The DEA takes these violations extremely serious, as they are 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. Pharmacies and other healthcare providers must maintain accurate records of these orders, including the quantity and type of controlled substances ordered. Failure to properly manage CSOS records can result in fines and penalties, as well as the possibility of the loss of your DEA registration.


Recent trends-fines and penalties

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 can avoid fines and penalties by making sure they are following all DEA rules and regulations, including maintaining accurate records of controlled substance transactions and properly managing CSOS records as well as the corresponding responsibilities.


How Can Your Pharmacy Prepare Proactively?

Pharmacies must take proactive steps to prepare for potential drug diversion audits or investigations. According to the experts, a comprehensive diversion prevention program includes:

· Core administrative oversight for example legal and regulatory requirements, organization oversight, and accountability

· System-level controls to include employee management, automation and technology, monitoring and surveillance, and investigation and proper reporting

· Individual-level controls to include 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.


Monthly Review and Update of all Policies and Procedures and self-audits

Pharmacies should regularly review and update their policies and procedures related to drug diversion prevention. This can help ensure that you are in compliance with current regulations and best practices. In addition, regular monthly reviews can help identify areas where improvements can be made to prevent drug diversion and help you steer away from any PBM audits.


Employee training on Drug Diversion Prevention

An important step that pharmacies can take to prepare for a drug diversion audit or investigation is to train their staff on drug diversion and prevention. This can include educating staff on the signs of drug diversion, implementing systems for handling suspicious orders and activity, providing resources for reporting suspicious activity and monthly review on all policies and procedures regarding the sale of controlled medication.


Maintaining Accurate Records

Pharmacies must also maintain accurate records related to the dispensing of medications. This can include keeping detailed records of all medication dispensed, inventory records, and conducting regular analytics and reporting of medication stocked.


Secure Medications and Controlled Substances

Pharmacies must take steps to secure medications and controlled substances to prevent diversion. This can include using safe storage ,authorized access to medication storage, and implementing security cameras or other monitoring systems as well as online resources to securely monitor purchase and dispensing.


Establish compliance policies and procedures

It is important to establish a compliance policy and procedures 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. Maintaining an audit trail and proof of compliance can be an important factor in situations where diversion may have occurred at your pharmacy.



TabulaRx – The most advanced system

TabulaRx is the most advanced system to maintain records and analyze your controlled drug inventory in compliance with state and federal regulations. TabulaRx 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.

Schedule a demo today at www.RxConnexion.com.



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