Pharmacy DEA Audits
Is Your Pharmacy Being Audited by the DEA? If So, Here’s What You Need to Know.
It is Tuesday morning. You just opened your pharmacy, and the first orders are coming in. Suddenly, two women enter your pharmacy, show their badges, and ask to speak with the pharmacist. They are Diversion Investigators with the U.S. Drug Enforcement Administration (DEA). Your pharmacy is being audited.
Will you pass the audit? Is your pharmacy compliant with all DEA regulations and the Controlled Substances Act (CSA)? What will happen if your inventory shows a discrepancy? What error rate is tolerable? What is the worst that can happen? Can the DEA revoke your registration? As the pharmacy’s owner, could you face personal civil or criminal liability?
Why is the DEA Auditing Your Pharmacy?
First and foremost, the job of DEA Diversion Investigators is to ensure that pharmacies are in strict compliance with all applicable laws and regulations. This includes, but is not limited to, the Controlled Substances Act (21 U.S.C. 801-971), the Combat Methamphetamine Epidemic Act of 2005 (CMEA), the Food, Drug, and Cosmetic Act (FDCA), and the pertinent provisions of the Code of Federal Regulations (21 C.F.R. Parts 1300 et seq.). So, during an audit of your pharmacy, the DEA’s Diversion Investigators will be closely scrutinizing all aspects of your business, from your pharmacy’s physical security to its electronic prescription compliance procedures.
However, with the nation’s opioid epidemic continuing to be a top DEA priority, the primary focus of the audit will undisputedly lie in examining your pharmacy’s prescriptions for drugs containing of benzodiazepine and other commonly-abused drugs such as oxycodone, hydrocodone, hydromorphone, morphine, codeine, clonazepam, alprazolam, lorazepam, diazepam, and carisoprodol. Since this is the DEA’s top compliance concern, it needs to be one of your top compliance concerns as well. However, while this is the case, it does not mean that you can afford to let your compliance efforts slide in other areas. If an audit reveals any regulatory or statutory violation, you could be at risk for substantial federal penalties.
7 Common Issues During DEA Audits
As we mentioned above, during DEA audits, pharmacy owners can expect to face questions related to all facets of their business operations. While this list is by no means exhaustive, here are some of the most-common issues we see when our attorneys and former agents represent clients in DEA pharmacy investigations:
1. Violations Related to Schedule II Controlled Substances
Schedule II controlled substances are considered high-risk drugs for diversion due to their illicit street value and propensity for abuse. During a pharmacy audit, DEA Diversion Inspectors will spend a significant of time focused on the pharmacy’s practices related to schedule II narcotics and stimulants such as morphine, hydromorphone, methadone, meperidine, oxycodone, fentanyl, amphetamine, methamphetamine, and methylphenidate.
DEA-registered pharmacies simply cannot afford to have material inventory error rates in this category, which also includes cocaine, amobarbital, glutethimide, and pentobarbital. Any perceived issues related to the dispensing of schedule II controlled substances will be the subject of intensive review, and the DEA (along with the U.S. Department of Justice (DOJ)) aggressively pursues pharmacy owners and pharmacists suspected of either (i) intentionally diverting schedule II drugs, (ii) turning a blind eye to possible diversion, or (iii) failing to take the necessary steps to develop an adequate compliance program.
2. Violations Related to Schedule III Controlled Substances
Schedule III controlled substances include combinations containing less than 15 milligrams of hydrocodone per dosage unit (Vicodin), drugs containing not more than 90 milligrams of codeine per dosage unit (Tylenol with codeine), buprenorphine products (Suboxone and Subutex), as well as non-narcotics like benzphetamine, phendimetrazine, ketamine, and anabolic steroids.
Since many schedule III controlled substances are also at high-risk for abuse, DEA Diversion Investigators heavily scrutinize pharmacy’s prescription and dispensing practices related to these drugs as well. For example, a pharmacy that fills an abnormally high number of prescriptions for schedule III drugs could be at risk for allegations that it either (i) is facilitating diversion in conjunction with an overprescribing physician, or (ii) has not implemented adequate controls to for these prescriptions to internally raise red flags. In these types of scenarios, it is not a defense for a pharmacy to claim that it was simply filling the prescriptions it received. Pharmacies have affirmative an affirmative obligation to investigate questionable prescription practices, and they can face severe consequences for failing to do so. This is why you may need a DEA audit defense lawyer!
3. Violations Related to Schedule IV Controlled Substances
Schedule IV controlled substances include the narcotic propoxyphene as well as alprazolam, clonazepam, clorazepate, diazepam, lorazepam, midazolam, temazepam, and triazolam. The DEA often considers schedule IV substances dangerous supplements to schedule II or schedule III narcotics (with combined drugs referred to as “cocktails”).
Here, too, pharmacies need to be extremely careful. Even isolated incidents can raise DEA Diversion Investigators’ eyebrows, and high error rates can lead to a presumption of intentional misconduct. If mistakes have been made, they will need to be addressed proactively, but this must be done carefully in order to avoid raising additional questions during the audit.
4. Suspicious Dispensing Patterns
In addition to independently assessing pharmacies’ compliance with regard to controlled substances on schedules II, III, and IV (and sometimes schedule V), during an audit the DEA will also analyze any suspicious dispensing patterns. For example, the Diversion Investigators may request statistics of the number of cash-paying patients, Medicaid patients, chronic pain patients, patients with frequent refills, new patients, and the like.
When it comes to dispensing medications, as we mentioned above, pharmacies’ obligations extend far beyond simply filling doctors’ prescriptions. Right now, the DEA views pharmacies as part of the problem with regard to the nation’s opioid epidemic, and it expects them to become part of the solution. As a result, even inadvertent compliance can lead to substantial fines, loss of DEA registration, and Medicaid exclusion, among other penalties. If the DEA suspects that you may be diverting prescription drugs intentionally, it won’t hesitate to go to the DOJ with the evidence prosecutors need to seek an indictment on criminal charges.
5. Relationship with Physicians
Increasingly, we have seen instances of DEA Diversion Investigators asking pharmacy owners and physicians in charge (PICs) about pharmacies’ relationships with specific physicians. For example, in one recent audit, investigators disclosed that a certain physician who previously referred narcotic prescriptions to our client had recently been indicted for alleged violations of the Controlled Substances Act. With regard to our client, the investigators’ questions centered around to what extent the prescriptions from this physician met the test of medical necessity and, more generally, what steps our client took to validate the correctness, appropriateness, and necessity for each controlled substance prescription.
In addition to these types of questions, pharmacies can also face questions regarding their financial relationships with prescribing physicians. While there are lawful ways for pharmacists to contract with third-party physicians (i.e. under various safe harbors of the Anti-Kickback Statute), in general, any evidence of payments or other benefits being tied to the volume of prescriptions or patient referrals is going to raise questions as to the legality of the relationship.
6. The Pharmacy’s Business Model
During pharmacy audits, the DEA will often also scrutinize why individuals use the audited pharmacy and why physicians refer their patients there. Any questioning in this area is also designed to assess whether the pharmacy may be complicit in the unlawful diversion of schedule II, III, or IV controlled substances. For example, if patients travel a significant distance to use the pharmacy (particularly when there are closer pharmacies nearby), or if a particular physician consistently sends a specific type of prescription to the pharmacy, this will likely be viewed as a red flag for possible drug diversion.
7. Inadequate Compliance Controls or Documentation
Finally, during a pharmacy audit, DEA Diversion Investigators will also examine the overall sufficiency of the pharmacy’s compliance program. This includes not only actual compliance, but also documentation of the pharmacy’s compliance efforts (which, technically, is itself a part of compliance). Here, too, even unintentional shortcomings can lead to significant ramifications; and, if there are enough shortcomings to suggest that the pharmacy’s owners should have known better or have intentionally turned a blind eye to compliance, then the consequences can become even more severe.
When auditing pharmacies’ compliance efforts, DEA Diversion Investigators will focus their examination on seven key aspects of compliance:
- Prescription Drug Inventory
- Packaging and Transfer of Prescription Drugs
- Security to Prevent Loss or Theft
- Pharmacy Record-Keeping Practices
- Prescription Management and Fraud Monitoring
- Drug Ordering
- Drug Dispensing and Diversion Prevention
However, this list, too, is not comprehensive. DEA-registered pharmacies have a host of compliance obligations, and certain types of pharmacies (i.e. compounding pharmacies and specialty pharmacies) face even greater compliance burdens. If your pharmacy is being audited, in order to avoid unnecessary consequences, you should speak with a pharmacy and compliance defense lawyer promptly.
Speak with a Pharmacy Compliance and DEA Audit Defense Lawyer at Oberheiden P.C.
Is your pharmacy being audited by the DEA? To speak with a pharmacy and compliance defense lawyer in confidence, call 214-692-2171 or request a free case assessment online now.