“HOW TO SURVIVE A DEA INSPECTION SERIES: WHAT $16,864.00 and $72,683.00 MEANS” ?

Recently, I checked to see if the cost of civil fines when up due to inflation Well, it did! Why I’m writing this article. The Diversion Control Division (“Diversion”) of the Drug Enforcement Administration (“DEA”) are now doing more inspections of independent pharmacies.

What are they looking for during an inspection? DEA required records, the security of controlled substances, and your due diligence in determining the validity of a controlled substance prescription which includes the pharmacist’s corresponding responsibilities.

At this point, you would be asking yourself, “Are my DEA records organized?” or “What would happen if my DEA records were not organized?”. Well, let’s take out a calculator and multiple the number of violations times $16,864.00 per violation. The best shock treatment for a pharmacy owner is to make him aware of the DEA regulation on “failure to maintain complete and accurate records” which is found in the Controlled Substances Act of 1970 (“CSA”). The find is very clear, and it isn’t clear until the registrant of a pharmacy gets a letter from the United States Attorney General’s Office making them aware that they are the subject of a federal civil action. Meaning? The pharmacy business checkbook is going on a strict diet.

Let’s talk security of controlled substances. Do you have an alarm system with multiple CCTV cameras to record the theft by a pharmacy staff member? Not enough CCTV cameras? The allegation is that the “pharmacy did not maintain a stringent security program to prevent theft or loss of controlled substances”. If the DEA Diversion says you don’t have a stringent security program, an administrative or civil action will take place. The cost beside the services of an attorney is $16,864.00 per blind spot.

Now that I got your attention, I’m giving you this free advice. DEA has now linked the use of heroin with the abuse of opioids such as Oxycodone and Hydromorphone with deaths relating to drug abuse. It appears that their target is the prescriber but in many cases the pharmacy that dispense such controlled substances is also on their cross-hairs. If you don’t dispense these drugs the chances of you being their target are lessened than those that do dispense those drugs.

They call that Due Diligence because the pharmacist has a corresponding responsibility to determine the necessity for a controlled substance prescription. The pharmacy on the other hand needs to take the fault for the error of the pharmacist. As part of their due diligence review, DEA Diversion will do an audit of controlled substances in all schedules. This generally is followed by the review of your controlled substance prescriptions. The civil fine for prescriptions is $72,683.00 per prescription.

So, what can go wrong with your controlled substance prescriptions? Well, first you need to understand that all information that is noted on the DEA regulation 21CFR1306.05 must be written on the controlled substance paper or electronic prescription. No patient address or the X number for opioid dependent patients, multiple the violation times $72,683.00 per violation.

There are several things that DEA Diversion has been looking for and let me explain it.

-         The filling of controlled substance prescriptions earlier than two days. This one they are always right. So, you decide to fill a prescription seven days early. Now you got the patient being given the same amount twice on the same day. This is a very serious violation that DEA and the Board of Pharmacy will take their actions against the pharmacy owner and the pharmacist who filled the prescription.

-         Dispensing an amphetamine and a benzodiazepine to the same patient. These prescriptions are causing many pharmacies headaches. Very easy civil fine of $72,683.00 per violation.

-         Exceeding the 90 morphine milligram equivalent for dispensing opioids especially for pain. Here all they must show is that you didn’t do a PMP profile, and that the pharmacist has not communicated with the prescriber to determine the necessity for the IR and ER opioid for the patient. Besides the civil fine of $72,683.00 per violation, DEA Diversion may want a consent agreement with the pharmacy.  

Why DEA Diversion personnel targeted your pharmacy will depend on what controlled substances your pharmacy is purchasing from their suppliers, whose prescriptions you are filling for controlled substances, and what steps you take to prevent the theft or loss of controlled substances.  

Remember $16,864.00 for controlled substance records/security violations, and $72,683.00 for controlled substance prescription violations! Is your pharmacy ready for a DEA Diversion inspection and audit of your controlled substances?

Carlos M. Aquino

Compliance Consultant & Founder

 PharmDiversion LLC ?

Direct: (610) 487-4663

Email: [email protected]

www.pharmadiversion.com