If there is one thing a pharmacist does not want to deal with, it is opening their doors one morning only to find diversion investigators from the DEA waiting to speak to them. When DEA investigators come calling, this usually means the pharmacy is about to be audited. Should this happen, investigators will be scrutinizing everything from the pharmacy’s inventory records to its compliance with federal regulations and the Controlled Substances Act. While it is possible an error or two found during the audit may mean severe penalties will not be issued, numerous errors or suspicious patterns involving prescriptions or other related matters could spell big trouble. If your pharmacy is being audited by the DEA, always make sure you have legal representation from experienced pharmacy compliance pharmacy audits DEA lawyers.
The Opioid Crisis
As the opioid crisis has exploded across the United States in recent years, the DEA has taken a much tougher stance against pharmacies it believes may be dispensing these medications illegally. Even if the mistakes made concerning this group of medications are honest mistakes, that will mean little to DEA investigators. Since it is a requirement your pharmacy be compliant with the Controlled Substances Act, the Food, Drug, and Cosmetic Act, and various parts of the Code of Federal Regulations, you could run the risk of being subjected to substantial federal penalties if problems are discovered during the audit.
Everything is Scrutinized
While you may think DEA investigators are only concerned about opioids, that is not true. In fact, they will be examining virtually all aspects of your pharmacy, from its physical security and electronic prescription procedures to inventory control procedures and much more. Thus, when these audits begin, it will be crucial you have as much supporting documentation as possible to show you are in compliance with various rules and regulations. Also, should investigators have questions about a certain area, you must be able to produce documents that can show you have done nothing wrong. If you cannot do this, the audit can quickly spiral out of control and lead to various charges being levied against you and your pharmacy.
Schedule II Controlled Substances
These drugs, which can include oxycodone, fentanyl, morphine, and amphetamines among others, are considered to be high-risk drugs by the DEA and are always closely scrutinized during an audit. Because of this, inventory error rates involving these drugs are virtually unacceptable, meaning you must have a strong compliance program in place to ensure no mistakes are made. Should DEA investigators believe you may be looking the other way regarding inventory issues, your pharmacy’s DEA registration could be revoked and you could be facing federal charges.
Unusual Patterns of Dispensing
Along with taking a close look at your pharmacy’s inventory procedures, DEA investigators who conduct an audit will also be very interested in examining what they perceive to be unusual dispensing patterns involving certain drugs. For example, if your pharmacy has a high number of customers who pay in cash, are on Medicaid, are being treated for chronic pain, or are new patients or are always in need of refills, these may be red flags to investigators. Because of this, you will need to have strong and compelling evidence that you are not guilty of wrongdoing. If you cannot provide this to investigators, your pharmacy may be subject to large fines, exclusion from participating in Medicaid, and having your pharmacy’s DEA registration taken away immediately. If you are being accused of any types of schemes involving unusual dispensing of controlled substances, never hesitate to contact knowledgeable pharmacy compliance pharmacy audits DEA lawyers at once to discuss your situation.
Relationships with Physicians
If your pharmacy does a large amount of business with a particular physician, DEA investigators may believe illegal activity such as kickbacks is taking place. Thus, if any evidence surfaces indicating payments you receive are linked to patient volume or the types of drugs being dispensed, the DEA will question legal aspects of your business relationship with a doctor or doctors. Since a conviction on charges of receiving kickbacks could land you in prison for many years, always discuss your situation in more detail with pharmacy compliance pharmacy audits DEA lawyers.
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