If your pharmacy receives the Letter of Admonition from the Drug Enforcement Authority (DEA), you may be rightfully alarmed. The DEA audit has a range of consequences for pharmacy owners, pharmacists and pharmacies. The consequences have a range of severity levels, all the way up to long-term federal imprisonment and large fines.
What Is a Letter of Admonition?
The Letter of Admonition is sent by the DEA if their audit determines your pharmacy or pharmacist has a minor violation of record-keeping procedures. This letter doesn’t lead to civil or criminal liability. However, you can’t ignore it. The DEA agents found good reason to believe your pharmacy isn’t complying with the law, and your compliance program needs work. This is clear evidence that you need to make improvements, and the time to do it is now. If you don’t promptly address the matter, the next audit could result in more severe consequences.
Why Pharmacies Receive a Letter of Admonition
The Letter of Admonition is like a formal reprimand. It gives you formal notice of compliance faults. Those faults must be addressed before the auditors return to your pharmacy. It’s the lowest form of action taken by the DEA. It doesn’t require you to take action, but it’s in your best interest to do so. The Letter of Admonition will have a reason why, such as a violation of program documentation requirements, improper training of personnel, or poor record-keeping. The record-keeping issue could relate to ordering, inventory, disposal, transfers of prescriptions, electronic and hard-copy records, relationships with referring physicians or evidence of necessity for refills. You could also receive the letter for issues related to Medicare, Medicaid or VA billing practices.
Consequences of a Letter of Admonition
There is no obligation for you to respond to a Letter of Admonition. There are no legal or administrative penalties associated with the letter. However, a more severe violation of policies could result in a civil or criminal charge by the DEA. It’s important to fix the issue. Ignoring the warning letter could result in more severe actions in the future.
What to Do After Receiving a Letter of Admonition
There are several steps to take after receiving the letter. First, you should update your polices and procedures. Making updates to these steps will show that DEA that you take their letter seriously. Changing your policies will also be important if you were to face more serious charges.
Second, address the issue stated in the letter. Although ignoring the Letter of Admonition is an option, it’s not a good one to take. Problems with compliance, training or record-keeping don’t fix themselves. Bad employee habits may even get passed on to the next new hires, which could worsen the situation.
Third, the Letter of Admonition goes into your DEA file. This could lead to issues with certifications and audits in the future. If you lose your DEA license, you’ll be unable to operate as a pharmacy. Being in poor standing with the DEA could also impact the livelihoods of your employees.
Fourth, you should also conduct an internal audit. This could be done by a team, an experienced manager or another designated person in your agency. You may even want to bring in a third-party to do this for you. You should set this up as an ongoing process so that deficiencies are found in a prompt manner and addressed as quickly as possible.
Finally, set up a monitoring program and develop a proactive plan to respond to future audits and DEA inquiries. An efficient monitoring program identifies violations almost instantly. If monitoring uncovers a repeat violation, it allows your pharmacy to make changes to training, policies or procedures in the moment. An individual who causes repeated violations may need additional training. Documenting it shows that you’re taking action.
After receiving a Letter of Admonition from the DEA, it’s imperative to take action and address the reasons for non-compliance or violations in your pharmacy. You may also desire to be proactive and make updates to your policies, training and procedures in order to avoid the receipt of this letter.
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