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  • jwgilbreath

Regulatory Body Visit (#2)

Hello All!


Let's continue the discussion of how to be ready for a regulatory body visiting your sites. The regulatory body will expect proper handling of storage and acceptance of products into stock.


--We discussed proper storage of invoices for ordering medications previously. On a future post, I will go more in depth about invoices and uses of DEA form 222s or CSOS. For the purpose of this post, though, we will consider that you will order controlled substances from your wholesaler or other supplier and you must receive and store them properly.


--Is the storage of your controlled substances correct based on your states requirements? There are often very specific requirements for storage such as does your state require storage in a safe? What about a locked cabinet? What about a cinder block vault?


--How is your facility keeping up with the "numbers" of products you have on hand. There are generally 2 types of options: paper copy perpetual inventories or electronic processes such as an automated vault. As an aside some states absolutely REQUIRE some form of perpetual inventory but the DEA does not. It is still absolutely a best practice and I could not recommend it enough for you to maintain one.


--Paper perpetual inventories are used often in smaller facilities that do not use automation. The process of use is simple but there is more chance of errors due to addition and subtraction problems. Ensuring accuracy of the inventories is very important to help ensure reduced chance of diversions and loss.


--Does your facility use an automated vault in the pharmacy for controlled substances? Automated vaults are very useful for use in pharmacies as they can operate as an electronic perpetual inventories. Remember, proper acceptance into the automated vaults from your wholesaler or other supplier is of great importance.


Ensure all controlled substances are set to blind count to assist in the overall diversion prevention positives of using blind counts. The reports from the machine are exceedingly important to monitor movement of medications from inside the pharmacy to outside the pharmacy. Daily review of reports for descrepancies is exceedingly useful in monitoring for diversions and errors.


--Do you maintain controlled substances in automated dispensing cabinets (ADCs) on the units or locked cabinets?


--For ADC users, are you fully compliant with your state regarding licensing related to those machines? Are specific registrations required?


If you are a retail pharmacist that maintains an ADC at a nursing home, is your registration correct for DEA?


--Is your pharmacy reviewing activity of the ADC? You need to be watching problems within the processes such failed wasting of products on units, improper wasting, improper documentation related to items removed from the ADCs, etc.


--If your facility does not use ADCs are you monitoring the Controlled Substance Administration Records (CSARs). CSARs are basically perpetual inventories for the medical units. They are used to track overall movement on the unts.


--We have discussed many things above about receiving, storing, and handling controlled substances. Monitoring for movement of the medications throughout the facility (whether you use ADCs or not) is very important. This brings up a very important topic that is a basic expectation of the DEA....CLOSED SYSTEM for handling controlled substances.


--The DEA expects that if/when they review your processes are in a "closed system." Closed systems help your facility know step by step exactly where your medications are located in the system. If you do not have a closed system in place, you will run a risk of theft/diversion and significant levels of loss of controlled substances.


--What can you do to ensure you have a closed system? To fully know your system you must be able to follow the movements of medications from receiving to administration or destruction. You could choose a medication and go step by step to ensure the end result balances. If it does not why does it not? Is there some change that would be required? Consider repeating this process regulatory to monitor your process regularly.


Keep a watch for future post!

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