To ensure compliance with regulations, it is necessary to implement clear policies and procedures with compliance guidelines. What may appear to be a minor issue on the surface can result in repercussions, including severe penalties. Consider the following red flags that may result in non-compliance during a pharmacy audit by the DEA.
Prescriptions Paid by Cash
While it is not illegal for a patient to pay for a prescription with cash, it is an activity that’s considered a red flag. This is especially the case when there is a large number of patients using cash as a method of payment. There is no formula for calculating what would be considered too many patients paying by cash. DEA investigators will take many factors into consideration and make an assessment accordingly. If most of your clients pay by cash, that will more than likely be considered a red flag.
Non-Existent Policies on Opioid Dispensing
Due to the opioid crisis, much attention is paid to opioid policies and practices within pharmacies. As a result, DEA investigators want to ensure regulatory compliance by pharmacies, which includes having written policies on how opioids are dispensed. Failure to provide this information will likely be considered a problem. You must also have practices in place to prevent the theft and abuse of opioids.
There are some instances when DEA investigators will assume that a pharmacy is unable to comply with requirements based on specific circumstances, such as limited staffing. If a pharmacy is operating with a staff that is smaller in size than other pharmacies dispensing a similar quantity of prescriptions, the investigator may consider the issue problematic.
Outdated DEA Registration Records
Updated DEA registration records are a requirement. A certificate demonstrating that your pharmacy is approved by the DEA must be posted in compliance with guidelines. Failure to maintain valid registration or post it appropriately in the facility will be an issue.
No Policy on Diversion Control
The DEA prioritizes diversion control. All pharmacies are required to have diversion practices that comply with federal law. This is a requirement for drugs that are often abused. Failure to demonstrate practices that support diversion control will likely be a problem during a DEA audit.
Insufficient Staff Training
There is an expectation that all staff in a pharmacy will receive proper compliance training. Problems will arise if you conducted training and failed to document it appropriately. Maintaining accurate training logs is critical. Investigators will make the assumption that there is a failure to comply with training requirements. This is considered the responsibility of the Pharmacist in Charge.
Poor Record-Keeping Practices
Failure to maintain organized records will be a significant issue during a DEA audit. The purpose of having good records is to demonstrate your compliance with regulations. If specific records are requested and you are unable to locate them, this will be viewed as insufficient and possibly an issue of non-compliance. It is often viewed as an indication that you are unable to properly manage a pharmacy in accordance with requirements.
Issuing Refills Frequently
While there is no problem with issuing refills that are necessary for medical purposes, this is not something that should be done without caution. In the event that you have issued refills to the same customers repeatedly, it will likely raise eyebrows among DEA investigators.
Limited Communication with Prescribing Physicians
Pharmacists must communicate with prescribing physicians on a regular basis. In the event that there is no indication that frequent communication occurs, DEA Diversion Investigators will consider it problematic. Ongoing communication is necessary to validate prescriptions for drugs.
These are just a few of many potential red flags that should be resolved if they exist in your pharmacy. If you have been notified of a DEA audit, contact us for assistance. Our experienced defense lawyers can provide the guidance you need. If you have not been contacted by the DEA, we can help you avoid issues in the future.