What does it mean if your pharmacy has received a Letter of Admonition from the DEA?
For pharmacies, pharmacists, and pharmacy owners, a U.S. Drug Enforcement Administration (DEA) audit can have a whole host of consequences. These consequences vary widely in their severity, up to and including criminal prosecution with the potential for crippling fines and long-term federal imprisonment.
On the lower end of the scale is a Letter of Admonition. Typically, the DEA issues a Letter of Admonition when an audit uncovers evidence of a minor recordkeeping violation that does not warrant civil or criminal liability. But, while receiving a Letter of Admonition may not have any direct or immediate consequences, this does not mean that the letter can be ignored.
If your pharmacy receives a Letter of Admonition from the DEA, this means that DEA agents have found reason to believe that your pharmacy is not in full compliance with federal law, and this means that your pharmacy compliance program needs work. Even if the grounds stated in the letter are misguided, the simple fact that DEA agents believed your pharmacy was non-compliant is reason enough to make improvements. If the agents are correct that your pharmacy is not fully compliant, then you must address the issue promptly in order to avoid additional liability in a subsequent audit or investigation.
What is a DEA Letter of Admonition?
A DEA Letter of Admonition is roughly the equivalent of a formal reprimand. It provides notice that a compliance issue has been identified during a DEA audit, and it serves as a warning that the issue needs to be remedied before DEA auditors return. Short of a clean sheet, it is among the lowest forms of administrative action that the DEA can take after auditing or inspecting a registered pharmacy.
A Letter of Admonition does not impose any penalties, and it does not even directly require that follow-up action be taken. However, as mentioned above and discussed in greater detail below, pharmacies that receive these letters need to take them seriously and respond appropriately.
Why have I Received a Letter of Admonition from the DEA?
Generally, the DEA issues a Letter of Admonition when an audit uncovers evidence of a recordkeeping violation. Under the Controlled Substances Act (CSA), DEA regulations, and various other sources of federal authority, registered pharmacies are subject to extensive recordkeeping requirements. These requirements apply to matters including (but not limited to):
- Compliance program documentation and implementation
- Training of pharmacy personnel
- Prescription drug ordering
- Prescription drug inventory
- Prescription drug transfer and disposal
- Electronic and hardcopy prescriptions
- Relationships with referring physicians
- Evidence of medical necessity for refills
- Medicare, Medicaid, Tricare, and VA billing compliance
- DEA registration compliance
To be clear, not all recordkeeping violations will result in a Letter of Admonition. Some recordkeeping violations are more severe and can lead to more-serious administrative action (such as the issuance of an Order to Show Cause), or possibly even trigger a civil or criminal investigation. So, while pharmacy owners who receive a Letter of Admonition can breathe easy for the time being, they must promptly take the necessary steps to ensure that the DEA’s next audit does not uncover repeat or additional violations that could lead to greater repercussions.
What are the Consequences of Receiving a Letter of Admonition?
As we have discussed already, the direct consequences of receiving a Letter of Admonition following a DEA audit are virtually non-existent. The issuance of a Letter of Admonition is an administrative measure that is intended to provide the pharmacy with notice of an identified recordkeeping violation, and it does not carry any affirmative response obligations or administrative penalties. As a result, upon receiving a Letter of Admonition from the DEA, pharmacies can – and some pharmacies do – simply continue with their normal operations.
However, this tact is inadvisable. Unless the violation was truly a one-off human error and there is virtually no risk of repetition (which is virtually impossible), then the violation identified in the Letter of Admonition needs to be addressed. Depending on the nature of the violation and the reason(s) why it occurred, this could mean:
- Updating the pharmacy’s compliance policies and procedures;
- Providing additional training to personnel with recordkeeping responsibilities; or,
- Both of the above.
Additionally, it is important to note that receiving a Letter of Admonition does not amount to a clean bill of health with respect to the remainder of a pharmacy’s compliance efforts. Maybe DEA agents overlooked issues this time around, or perhaps their audit only focused on specific discrete issues. As a result, when confronted with one compliance violation, even if that violation is relatively minor, it may be prudent to conduct a comprehensive compliance assessment and determine whether any additional modifications, updates, or additions may be necessary.
What Should a Pharmacy Do After Receiving a Letter of Admonition?
We have largely covered this topic in the prior sections, above, but the importance of taking affirmative steps in response to a DEA Letter of Admonition cannot be overstated. There are a few reasons why:
- First, as previously mentioned, if your pharmacy is not in compliance with all pertinent federal laws and regulations in any respect, coming into full compliance needs to be a top priority.
- Second, failing to address a compliance issue that has been identified by DEA agents can enhance your pharmacy’s risk in a subsequent audit. When DEA auditors return, they will be looking to see that all prior issues have been addressed; and, if they have not been addressed, this will not be looked upon favorably.
- Third, a Letter of Admonition goes on file at the DEA. In other words, it does not simply go away. Having any type of past disciplinary action on file increases the chances of facing a subsequent audit or inspection, and compiling a history of even relatively-minor violations can lead to enhanced enforcement action in the future.
So, upon receiving a Letter of Admonition from the DEA, what should you do? Here are some specific recommendations from our federal pharmacy defense attorneys and former DEA agents:
1. Conduct a Comprehensive Compliance Assessment (or Internal Audit)
In order to determine what updates or improvements to your pharmacy’s compliance program are necessary, you need to conduct a comprehensive compliance assessment (also referred to as an internal audit) focused on identifying any and all compliance deficiencies. Again, just because the DEA did not raise an issue during its most-recent audit, this does not necessarily mean that the issue does not exist. As a pharmacy owner, you must have a comprehensive understanding of the effectiveness of your pharmacy’s compliance program, and you must promptly remedy any issues that have the potential to trigger more forceful enforcement action in the future.
2. Update Your Pharmacy’s Compliance Program
Once you have thoroughly assessed your pharmacy’s compliance needs, then you can transition your focus to updating your pharmacy’s compliance program. When it comes to making updates, no shortcuts should be taken, as any efforts to cut costs now are almost certain to lead to much more expensive compliance issues in the future. Working with your pharmacy’s compliance counsel, you should comprehensively identify all areas where updates, improvements, or additions are needed, and then you should develop and execute a systematic plan for making all necessary revisions to your pharmacy’s documented policies and procedures.
3. Provide Updated Training for All Pertinent Pharmacy Personnel
Upon adopting updated compliance documentation, your next step is to implement the updates through adequate training. Training should be provided to all pharmacy personnel who are impacted by the updates, with particular emphasis on any employees who made mistakes that led to the issuance of the Letter of Admonition. In order to be able to demonstrate full compliance to the DEA if and when it becomes necessary to do so, your pharmacy’s training efforts should be thoroughly documented, as should all employees’ successful completion of pertinent training programs.
4. Establish a Monitoring Program to Identify Future Recordkeeping Violations
As part of your pharmacy’s compliance program, it will be important to adopt policies and procedures for monitoring your pharmacy’s compliance on an ongoing basis. If another recordkeeping violation (or other violation) occurs, you need to catch it before DEA agents identify it during an audit. An effective monitoring program will involve protocols designed to systematically identify violations—either in real-time or as a result of regular reviews of patient, drug, and billing records.
5. Develop a Proactive Plan for Responding to a Subsequent DEA Inquiry
Finally, your pharmacy’s updated compliance program should also include a plan for proactively responding to a subsequent DEA inquiry. DEA audits and inspections are facts of life for registered pharmacies; and, now that your pharmacy has a Letter of Admonition on file, you need to be absolutely certain that you are prepared next time DEA agents show up at your pharmacy’s door.
Contact the Pharmacy Compliance Lawyers and Consultants at Oberheiden P.C.
If you would like more information about the steps involved in developing and implementing an effective pharmacy compliance program, we encourage you to get in touch. To speak with one of our pharmacy compliance lawyers or consultants in confidence, call us at 888-680-1745 or request a free consultation online today.