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  • jwgilbreath

DEA Visits

Hello all!

I can tell you that the DEA has been active in the last month or so. There have been 4 hospitals and 1 retail site that I have been made aware of visited by DEA agents without cause. They did focus on the areas that I have touched on in some of my previous posts.

I highly recommend becoming familiar with the DEA Pharmacist's Manual. So much great information! Make sure you are looking at the most up to date version too.

As review for readiness (and I know I may be repeating myself but the more you focus the more likely you are to find problem areas)...make sure that before you let ANYONE into your pharmacy to verify their identification. This will help protect you from potential safety matters.

Before they step foot into your pharmacy, ensure that your inventories (I.e., initial and biennial) are in order. Remember, if a drug is NOT listed federally it should NOT be on the federally required inventories. If it is a state listed drug (ex. Gabapentin), have that drug listed with proper inventories in a separate file. Alll C2s must be separated from the 3-5s.

Have your POAs in a neat and orderly fashion. Personally I would have 1 drop file with 2 manila folders with 1 for active POAs and 1 for revoked ones.

Invoices should be separated as --- C2s totally in a separate file, 3 through 5s can be insterpsed with non-controls but they must be notated in a way that you can easily pull the info if needed. Personally, I would have 3-5s in their own separate file. When you or one of your employees receive the order, check in the order and---personally I would mark on the invoice in some way that indicates the product is actually in the shipment (ex. Check marks). Sign and date the invoice. This shows action was taken to ensure all items received:

Ensure you executed DEA form 222 forms are completed with all required information (ex. Ensure that the number of packages received and date received is on the executed forms if you are the purchaser). Personally I would not have ANY extraneous marks on the face of the 222. Only what is required. I realize if you are the requester this is a copy of the original (sense you sent the original to the supplier). I still think it's best to keep the face clean. If notes are needed on the 222, maybe consider on the back of the sheet or in a separate memo attached to the 222.

CSOS you have everything in order? Do you share your passcode with anybody? If you do you should STOP that! When items physically received, the CSOS record should be updated with number of packages received and date received. Personally, I would save a copy of the completed e222 on a local folder just in case of some issue with the electronic storage with the wholesaler.

If you are acting as the supplier (ex. Sending c2 controlled products to a reverse distributor) you receive the original, executed 222 from them. You must complete the section of number of packages sent and date sent. Verify that all items listed on the 222 are also present in the box and on the report created by the RD company. Personally, I would make the report with checks and sign and date (both you and the RD employee) showing that you both agree all present.

Voided 222 forms need to be filed and maintained much like executed 222s.

Make sure you have any theft and/or significant loss documentation. I realize when completing a DEA form 106 it does not prompt you to print but I would print and file. This will assist you IF the DEA agent asks questions about theft and loss. I would also have some way to document insignificant loss. It needs to be in a form that monitors for patterns. Patterns can mean theft!

If you are destroying controlled substances in the pharmacy (ex. A broken vial of lorazepam injection)...

Do you have the proper way to make product unretrievable? Have you documented the items on a DEA form 41?

if the DEA agent visits you he/she/they may complete an audit on a specific drug. You will have to pull data for them most likely the last biennial inventory, the "ins" from purchases, the "outs" for administrations/destructions/etc., and the current quantity. The data from this will be used to check your "closed system." If there are problems, this could lead to questions and possible findings.

If you are not there when the DEA shows up, is there someone that can find everything they are asking for? Who do you need to communicate with at the hospital if/when they do pop up?

Hopefully you find this at least somewhat helpful!

Jay G

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