• Dennis Wichern

A DEA Agent Explains How to Fight the Opioid Crisis and Mitigate DEA Risk

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42,000. That’s the number of CDC reported overdose deaths in 2016 due to opioids.

Ten percent. That’s the percentage of the estimated 2.1 million opioid substance abusers receiving treatment help and even fewer afforded medication-assisted treatment (MAT) for their struggles.

Three percent or around 40,000. That’s the number of physicians out of a total of 1.3 million across the U.S. qualified by the Substance Abuse and Mental Health Services Administration (SAMHSA) to treat opioid dependence with buprenorphine in various medical office settings.

Eight hours. That’s the amount of time it takes to be qualified to treat substance abusers with MAT after completing a SAMHSA training class.

2018. That’s the year you no longer fear MAT or DEA.

Now, stick with me as I explain why this is important, how we got here, and how to navigate MAT risk- free to help combat opioid dependency — from a lifelong DEA agent.

SAMHSA oversees MAT for opioid dependence, while DEA supports their efforts through the regulation and oversight of controlled narcotic substances approved by the Food and Drug Administration (FDA). Sublingual buprenorphine was first approved for clinical use in 2002 by the FDA and in combination with counseling and behavioral therapies, allows qualified physicians the ability to treat those with opioid dependence in an office-based setting known as “office-based opioid treatment.”

Buprenorphine combined with naloxone, buprenorphine alone and long-acting implantable buprenorphine; methadone; and naltrexone have all been approved by the FDA for use in MAT.

Back in 2004, SAMHSA published TIP 40 titled, “Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction: Treatment Improvement Protocol (TIP) Series 40,” which indicated that patients seeking treatment for opioid dependence were first inducted with buprenorphine medication in a physician’s office to determine the appropriate dose before a prescription was written. Most providers back then maintained an inventory of buprenorphine in their offices for dispensing and induction.

In keeping with requirements under the Controlled Substances Act (CSA), the DEA began conducting buprenorphine recordkeeping inspections of MAT providers starting around 2006. Many of these providers failed the inspections due to a lack of education and understanding regarding recordkeeping requirements for buprenorphine dispensing.

As you could imagine, these inspections went over as well as a patient’s first colonoscopy.

Those who failed the inspections were given innocuous Memorandums of Agreements or Letters of Admonition by DEA and instructed on proper recordkeeping requirements. Nonetheless, these buprenorphine inspections struck fear in many providers and frequently caused a negative view of DEA and MAT.

Let’s fast forward to 2018 when the recently released and updated treatment protocols from SAMHSA have streamlined and simplified the induction process for MAT providers. SAMHSA’s recent publication, “Medications for Opioid Use Disorder For Healthcare and Addiction Professionals, Policymakers, Patients, and Families – Treatment Improvement Protocol 63” states “Office-Based Induction Providers can perform office-based induction by ordering and storing induction doses in the office or by prescribing medication and instructing patients to bring it to the office on the day of induction.”

Think simple and smart, not hard. A prescription is simple and speaks for itself. Ordering, storing and dispensing controlled substances, along with a litany of recordkeeping requirements is hard, cumbersome, and slow.

Let’s keep it simple and virtually risk-free. Prescribe only and do not maintain any controlled substance. Period. This is my risk mitigation tip #1.

DEA’s only door into your medical practice is through controlled substances. If you can operate without maintaining controlled substances, by prescribing only, you effectively close the door from DEA ever inspecting your office.

My risk mitigation tip #2 is to follow a national MAT guideline like SAMHSA TIP 40, SAMHSA TIP 63 or ASAM’s 2015 National Practice Guideline.

Lastly, if you do have to maintain controlled substances ensure that your records are complete — think checkbook register. Records should include an initial inventory, biennial inventory, closing inventory, the maintenance of receiving records (minimum two-year federal retention; your state could be longer), distribution records, theft and loss reports if any, and drug destruction records if any.

Now, let’s all help save a life and a nation from opioid addiction.

Dennis Wichern is a retired DEA Agent who now works to mitigate controlled substance risk for providers and hospital organizations worldwide.

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