For any pharmacy, pharmacist, or pharmacy owner, a DEA audit can have a lot of consequences. There are a number of consequences – and the severity of them can vary widely. It’s possible for you to face criminal prosecution, and also fines, and even long-term imprisonment. On the lower end of the scale of potential punishments is a Letter of Admonition. This is issued by the DEA – typically, when they do an audit – and uncover minor record keeping violations that don’t warrant a civil or criminal liability. Even though getting a letter of admonition doesn’t have any direct consequences – it shouldn’t be ignored.
If your pharmacy gets a Letter of Admonition from the DEA, it means the DEA has found cause to believe that your pharmacy isn’t in full compliance with the law. This means you really need to get your pharmacy compliance program revised, and correctly implemented. Even if the facts stated in the letter are incorrect, the simple fact the DEA believes your pharmacy is non-compliant means you have room for improvement. If the agents are correct that your pharmacy wasn’t compliant – then you have to address these issues promptly in order to avoid potential liability in new audits or investigations.
What’s a DEA Letter of Admonition
DEA letters of admonitions are essentially reprimands. They are a notice that a compliance issue was found during a DEA audit. It’s a warning that you have to rectify issues. It is among the least severe of administrative actions the DEA can take, after auditing, or inspecting, a pharmacy. There are no penalties necessarily, with Letters of Admonitions. It doesn’t even require that there be any follow up actions. Pharmacies that get these letters need to take them with immense seriousness – and take actions in case the DEA does a follow up audit.
The DEA usually issues a letter of admonition when it uncovers record keeping issues. Based on the law, registered pharmacies have an immense burden placed on them when it comes to record keeping. The requirements, regarding record keeping, apply to matters such as:
Not all record keeping violations result in Letters of Admonition. Some violations are more severe, and can lead to administrative actions. For example, more serious issues can lead to civil/criminal investigations. If you get a Letter of Admonition, you can relax – knowing that things are ok for now – but you have to take actions. You have to ensure that the NEXT DEA AUDIT doesn’t uncover repeat violations.
What are the consequences of getting a DEA letter of admonition?
There are no direct consequences of getting a letter of admonition from the DEA. The main thing is that the DEA is now looking at you. There is no response obligation, or penalties associated with the letter of admonition. As a result, most pharmacies – who get a letter of admonition, continue operating normally. This is not advisable. Unless your violation was a one-off error, and there is no risk of repetition, then the violation must be addressed. Depending on the nature of your violation, this could mean things such as:
It’s important to realize that letters of admonitions don’t mean that the other aspects of your pharmacy are fine. It could be that DEA agents overlooked other issues, or perhaps their audit was only focused on specific issues. Even if the violation is only minor, it can be wise to conduct a comprehensive compliance audit – and determine whether other updates/additions might be needed.
After your pharmacy gets a letter of admonition, there are a number of things you should do.
First – if your pharmacy isn’t in compliance with all the federal laws, your priority should be to come into full compliance. Failing to the address the compliance issue which was noted in the letter of admonition could result in additional risks during subsequent audits. When the DEA agents return, they will FIRST look to see if the prior issues were addressed. If the issues haven’t been addressed, this will be detrimental. It’s important to remember that the letter of admonition goes on file at the DEA. In other words – it’s not going away. It’s going to be part of your permanent record, and if there are further subsequent audits which find shortcomings – this letter can be used against you – since now, there is a history of violations.
What should I do after getting a letter of admonition from the DEA?
There’s a number of things you can do and should do.
Conduct a compliance audit: It might be relevant to conduct a comprehensive compliance audit, which is focused on all deficiencies in your pharmacy. Just because ALL of the issues your pharmacy might have in this DEA audit weren’t discovered – doesn’t mean none exist. As a pharmacy owner, you have to do a comprehensive review of your pharmacy compliance program, and remedy any shortcomings.
Update your compliance program: Once you’ve assessed your compliance needs, you can then transition to focus on updating your pharmacy’s compliance program entirely. You should hire a DEA defense attorney who understands what the federal guidelines are so you can make your compliance program up to date.
Train your pharmacy personnel: You should train your pharmacy personnel after you’ve updated your compliance program. Training must be provided to all pharmacy personnel. It’s important that all of this training be documented, so you can demonstrate your willingness to be in full compliance with the DEA.
Setup a program to identify future violations: As part of your compliance program, its important to create a framework to monitor your pharmacy’s compliance. If other record keeping violations occur, you must catch them before the DEA identifies it during the audit. Monitoring programs that involve protocols, can be helpful.
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