Don’t confuse your automatic dispensing machine for a complete compliance solution.
Upon retiring from the Drug Enforcement Administration (DEA) three years ago, I contemplated how to use my extensive drug and law enforcement knowledge and skills to bridge the gap in controlled substance compliance between the healthcare industry and criminal justice organizations. From my perspective, finding solutions for opioid abuse shouldn’t fall solely on law enforcement. The entire supply chain has a collective social responsibility to do everything possible to stop the “diversion” of drugs into society. But what does that look like?
Since the beginning of the opioid epidemic, many DEA employees have left comfortable government jobs to work for the same pharmaceutical companies that are now under legal scrutiny for their role in the drug crisis. However, very few DEA investigative experts left government service to train and educate those in the part of the supply chain most impacted by this crisis—healthcare practitioners, especially in the veterinary industry. Is it fair that the billion-dollar pharmaceutical industry hired dozens of former DEA agents to satisfy DEA-compliance obligations, only to turn and point the finger at other ends of the supply chain, casting blame for non-compliance?
Today, many individuals and companies are calling themselves compliance “experts” to promote their products as DEA-compliance solutions.
In 2018, TITAN GROUP conducted onsite inspections for more than 75 veterinary hospitals and practices from New York to Hawaii. In many cases, we were informed that the facility had previously hired a “compliance expert” before us. Most of these individuals had a comprehensive understanding of compliance regulation from experience in pharmaceutical or veterinary practice management, but no practical experience in compliance law enforcement. For the lucky few, choosing the wrong compliance expert initially doubled their anticipated compliance costs. Those less fortunate were also facing extensive fines and legal recourse after being found noncompliant for issues that previously went unnoticed. Not to mention the cost to hire a new compliance expert.
Compliance requires more than just a comprehensive understanding of regulation. True expertise requires a working knowledge in multiple disciplines, the most important being an in-depth understanding of DEA regulations. To say that someone without real-life experience in compliance law enforcement can provide a total compliance solution is like saying a podiatrist can perform brain surgery, simply because he is a doctor. Certainly, a podiatrist could become a brain surgeon with a lot more training; however, if you need neurosurgery, you’re not going to choose a podiatrist simply because he is a “doctor.” You’d choose a neurosurgeon because neurosurgery is their area of expertise.
“To say that a professional lacking real-life experience in compliance law enforcement can provide a total compliance solution is similar to saying a podiatrist can perform brain surgery because they are a doctor.”
In addition to remediating internal and external solutions with regulators, a legitimate DEA compliance expert will also have expertise and a working knowledge in:
- Risk Management
- DEA Audits
- DEA Investigations
- Policy Development
One of the most frequently asked questions I hear from clients and prospects is, “I have a ‘box’ that automatically dispenses our drugs. Doesn’t that make my practice compliant?” The short answer is, no. An automated dispensing machine (ADM) is a great first step in securing your drug inventory. If used correctly, an ADM can help your practice become more efficient in capturing lost billing, but an ADM alone does not make you DEA compliant. It is only one component of a comprehensive controlled substance compliance solution.
Although ADMs can help prevent drug diversion, they are not a total compliance solution. Here’s an example: in Beverly, MA this past October, a technician responsible for loading ADM machines was charged with stealing nearly 18,000 pills and vials of medication—including opiates like Percocet, OxyContin and fentanyl—over a 13-month period. According to court documents, the technician was able to exploit a feature of the system by wrongly marking pills as “outdated” and removing them from the automated dispensing machine. A robust compliance system would have detected this crime. Which is why, when it comes to compliance, you must think “outside the box.”
Think of it this way: the salesperson who sold you the ADM probably had a solid understanding of their product and a good idea about of how their “box” should comply with current compliance standards. But was the salesperson also a DEA compliance expert? A former DEA agent or investigator? Had they ever been involved in a formal DEA inspection or audit? Did they have the proper background and training to direct you on security protocols for your controlled substance inventory? Again, the short answer is, probably, no. This is why it’s critically important to understand the difference between a compliance expert and a DEA compliance expert.
DEA COMPLIANCE EXPERTS
A DEA compliance expert, like the TITAN GROUP, will first evaluate your current protocols, then develop and engineer the appropriate individualized compliance program for your unique controlled substance inventory. TITAN will construct a “compliance box”—around your storage box—that will provide the proper security, training, education, legal assistance and peace of mind, so your company can stand up to a real DEA-compliance inspection. To learn more about TITAN’s complete suite of services click here.
If you’re shopping for an expert to evaluate how well your controlled-substance program stacks up against federal and state compliance regulations, would you trust your livelihood to just a compliance professional or a DEA compliance expert? Both have compliance experience, but only former DEA agents have real-life experience and perspective. A comprehensive understanding of compliance (even in combination with prior consulting experience) is very different than the expertise that comes with a retired DEA agent who has actually lived all facets of compliance.
When it comes to protecting your professional family, and your reputation, choose wisely. Your choice has the power to determine the future of your business.