How well do you know your customer?
What is a legitimate pain clinic? The answer to that question will be different depending on your perspective. For example, if you are a medical professional the term often refers to a medical practice that specializes in treatment for patients that suffer from chronic pain. If you are a compliance officer employed by a DEA-registered drug distributor or manufacturer the term “pain clinic” may cause you to have many sleepless nights. And if you are an investigator with a law enforcement agency a pain clinic may represent a target of opportunity.
Make no mistake about it pain management is real and millions of Americans suffer from chronic pain. The pharma industry has dedicated billions of dollars to research, manufacture and market drugs that will allow people who suffer from chronic pain to lead productive lives and enjoy a better quality of life. Unfortunately, the misuse and abuse of prescription drugs is also very real and ruins lives.
We have all heard the statistics, prescription drug misuse and abuse is second only to the abuse of marijuana in the United States. Although the majority of pain clinics are legitimate, many are not. The unscrupulous that prey on others hardships and addictions have caused the terms “pain clinic” or “pain management clinic” to invoke negative connotations to law enforcement and those involved with regulating the prescription drug industry.
South Florida is the unofficial hub for rogue pain clinics. Recently, the DEA, in coordination with several state and local law enforcement agencies culminated “Operation Pill Nation”. This year long investigation targeted over forty pain clinics (pill mills) operating in South Florida and resulted in 22 arrests and the seizure of $2.2 million in cash and 70 vehicles. The enforcement operation highlighted the vexing issues that the pharma industry, law enforcement, and the medical community are confronted with as it pertains to how society defines pain management.
The differences between legitimate pain management clinics and rogue pain clinics can be very distinctive. Some indicators of a rogue clinic may include;
• Operating as cash only businesses not accepting insurance or credit cards
• Having lines of people sometimes out in the parking lot or in the street waiting to be seen
• Employing armed security personnel to deter potential robberies (cash and drugs)
Securing huge profits is the priority of these businesses, not the health or well being of the patients that are almost always prescribed powerful addictive pain medications. I would not classify the people who frequent these rogue clinics as patients but rather as customers. Their intent is almost always to secure powerful prescription drugs which are often transported to other parts of the U.S. and sold illicitly, as opposed to patients seeking legitimate pain management or treatment for chronic pain.
Prior to the rogue pain clinic epidemic the internet was a major source of the illicit distribution of prescription drugs. The passage of the Ryan Haight Act legislation in 2008 made it illegal for a doctor to prescribe medication to a patient without at least one face to face meeting. The legislation greatly reduced rogue internet pharmacies operating in the United States, creating a vacuum for those illicitly seeking prescription drugs, and ultimately that vacuum was filled by rogue pain clinics. Because “Pill Mills” employ physicians on site and are often disguised as independent pain management centers, the pharma industry as well as law enforcement authorities are faced with the difficult task of determining what is legitimate and what is illegitimate.
The Controlled Substances Act (CSA) requires that DEA-registered manufacturers and distributors assure that all purchased and dispensed controlled substances and regulated chemical products are for legitimate use. The dilemma of discerning legitimate from illegitimate use and therefore avoiding possible regulatory action and or fines has proven to be a daunting task. To remain in compliance with the CSA, it is critical that a stringent due diligence/know your customer policy be implemented and followed, not only by the compliance personnel but the sales representatives as well. If the sales staff is educated and “buys in” to the company due diligence policies, they can be very effective in determining if contracting with a specific customer is in the best interests of their employer. Drug distributors may find it onerous and cost prohibitive to hire investigators full time to conduct due diligence investigations and will often hire consultants who specialize in these investigations.
Until such time that federal and or state legislation is enacted that restricts the criminal nature of these rogue pain clinics they will continue to operate with impunity. Ultimately, it is the burden and responsibility of DEA-registered pharmaceutical manufacturers and distributors to know the business operations of their customers, thus protecting public health and safety from the illicit distribution of prescription drugs.