The Drug Enforcement Administration (DEA) office of diversion uses so-called “red flag” indicators to determine which pharmacies should be placed under closer scrutiny and undergo undercover visits. Understanding these DEA red flags is crucial, as the higher the number of them, the greater the likelihood of scrutiny.
Notably, there is nothing illegal about most red flags. However, possessing even some of them will typically cause your pharmacy to face increased scrutiny from the DEA or other federal agencies. At the Hedding Law Firm, we have extensive experience dealing with the DEA in criminal and administrative matters, providing legal counsel and representation to pharmacies facing compliance issues.
Our team of experienced attorneys is well-versed in pharmacy compliance and DEA regulations, and we are committed to helping pharmacies navigate these complex issues.
In recent years, pharmacies have come under increasing scrutiny from the DEA, wholesalers, and manufacturers. Pharmacists, once viewed solely as dispensers of medications and caretakers of patient health, are now recognized as crucial gatekeepers against prescription drug diversion and abuse. This shift in perception underscores the integral role pharmacists play in the healthcare system.
Understanding DEA red flags and pharmacists' responsibilities is not only crucial but also empowering for success in modern pharmaceutical practice. The regulatory landscape has shifted, and the expectations placed on pharmacy owners and their staff have also changed. This knowledge enables you to navigate these changes effectively, providing a sense of control and confidence in your operations.
What are DEA Red Flags?
The DEA has long identified certain "red flags" that may suggest a prescription is not issued for a legitimate medical purpose or is being diverted. These red flags are not just suggestions; they serve as factors that may trigger enforcement action or administrative penalties.
Pharmacies that ignore these warning signs may face DEA investigations, audits, license suspension, or even criminal liability. DEA audits focus on ensuring compliance with the Controlled Substances Act (CSA) and its regulations.
Non-compliance can lead to significant consequences, including fines, legal action, and the potential loss of DEA registration. The loss of DEA registration, in particular, can severely impact your pharmacy's operations.
By addressing common areas of non-compliance, pharmacies can strengthen their compliance programs, minimize risks, and prepare effectively for DEA audits. Establishing a culture of accurate record-keeping, along with robust security measures, is a crucial step in DEA compliance.
What are Common DEA Red Flags?
Let's review a list below that would be considered "red flags" by the Drug Enforcement Administration for a pharmacy audit:
- High volume of controlled substances dispensed. Pharmacies consistently dispensing high volumes of opioids, benzodiazepines, stimulants, or other Schedule II medications raise immediate concerns if they exceed those of similarly situated pharmacies.
- Cash payments for controlled substances. A high percentage of patients paying cash, as opposed to using insurance, for controlled substances can indicate attempts to bypass insurer scrutiny or reimbursement limits.
- Geographic issues. Patients traveling significant distances, particularly across city or county lines, to fill prescriptions is a classic red flag. This often suggests "doctor shopping" or that the prescriber is part of a problematic prescribing network.
- Pattern prescribing or identical prescriptions. Prescriptions that are essentially identical, in terms of drugs, quantities, and dosages, from the same prescriber to multiple patients may indicate that prescriptions are not tailored to individual medical needs.
- Lack of prescriber-patient relationship. Prescriptions written by providers in a different specialty, such as a dentist prescribing long-term opioids, or with no clear treatment rationale, can be investigated.
- Drug cocktails. The combination of opioids, benzodiazepines, and muscle relaxants, often referred to as the 'Holy Trinity,' is a strong indicator of potential misuse or diversion. This combination of drugs, when prescribed together, can significantly increase the risk of overdose and is therefore closely monitored by the DEA.
The Controlled Substances Act (CSA) imposes a corresponding responsibility on pharmacists to ensure that controlled substances are dispensed only for a legitimate medical purpose. This duty exists in conjunction with the prescriber's obligation and requires the pharmacist to exercise professional judgment.
The law is clear: both the prescriber and the pharmacist can be held accountable for improper dispensing. This means that both parties must be diligent in their roles to prevent potential misuse or diversion of controlled substances.
Pharmacy Non-Compliance Issues
Let's review some of the more common pharmacy non-compliance issues, such as the following:
- Inaccurate Controlled Substance Records. Federal law mandates pharmacies to maintain detailed and precise records for all controlled substances received, dispensed, or destroyed. Recordkeeping errors include failure to document prescriptions properly, missing or improperly completed DEA Form 222s, and absence of biennial inventory records.
- Lack of Written Policies. Opioid prescription practices are closely scrutinized during DEA audits. Pharmacies must not only have appropriate safeguards in place to prevent theft and misuse of opioid medications, but also have written policies that outline their pharmacy's procedures and protocols.
- Lack of Documentation. Pharmacies must have adequate measures in place to validate all narcotics prescriptions. The pharmacy must confirm that the prescription is medically necessary, and it must take certain other steps in order to mitigate the chances of the drug ending up in the hands of a dependent user.
- Inventory Discrepancies. The DEA expects the actual inventory on hand to match the documented quantities. Any discrepancy, no matter how small, can raise concerns about potential diversion. Common causes of inventory discrepancies include miscounts during inventory checks, failure to update inventory after returns or transfers, and loss of controlled substances due to theft or human error.
- Improper Handling and Storage. Controlled substances must be stored in a manner that minimizes the risk of diversion and theft. Examples of improper handling or storage include leaving controlled substances unsecured or unattended, allowing unauthorized personnel access to controlled substances, and failing to document the destruction or disposal of expired drugs.
- Dispensing Violations. Common dispensing violations include filling prescriptions that are incomplete, fraudulent, or electronically altered, dispensing quantities that exceed state or federal limits, and failing to verify the legitimacy of high-risk or suspicious prescriptions. One particular red flag DEA looks for is the dispensing of inordinate quantities of high-risk drugs (such as OxyContin), whether it's large amounts in single prescriptions or multiple prescriptions for these drugs.
- Dispensing Certain High-Risk Drugs. Notably, certain drugs are well-known as being particularly sought-after among drug abusers and dependent patients. Dispensing a high volume of these drugs, such as Oxy 30g, will raise questions during a DEA pharmacy audit.
Consult with a Federal Lawyer
The consequences of DEA non-compliance are not to be taken lightly. Depending on the severity of the violations, potential penalties include civil fines ranging from thousands to millions of dollars. Pharmacies may face the suspension or revocation of their DEA registration, which would prevent them from dispensing controlled substances.
Serious violations could even lead to criminal charges and imprisonment for pharmacy owners or employees found guilty of such offenses. The urgency and seriousness of these potential consequences cannot be overstated.
Serious violations could lead to criminal charges and imprisonment for pharmacy owners or employees found guilty. Responding to allegations of non-compliance can be a daunting prospect for pharmacy owners who may already be overwhelmed with operational responsibilities.
Our federal criminal defense attorneys are experienced in DEA cases. We can provide invaluable assistance by reviewing and analyzing DEA audit findings or allegations, identifying and addressing compliance gaps, negotiating with DEA officials to resolve minor violations and reduce penalties, and representing pharmacies in administrative hearings or criminal proceedings.
For more information, contact the Hedding Law Firm, located in Los Angeles, California.
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