Opinion: A Reaction to DEA's Efforts to Target Pharmacies with 'Unusual' Opioid Prescription Rates

In response to “Sessions: DEA to Target Pharmacies, Prescribers in Crackdown”¹ as published in The Hill, it should be obvious to responsible medical clinicians that Sessions and colleagues are naïve to the complex and biopsychosocial, medical, and pharmaceutical paradigms that are actually driving the opioid epidemic.

The article states that in 2016 there were “at least 66,000 deaths from overdoses reported, including 42,249 deaths from opioids. Opioid overdose deaths now kill more Americans every year than breast cancer, according to the latest statistics from the CDC.”²

What the article does not tell you is what percentage of the 42,240 deaths are from illegally-obtained prescription versus nonprescription opioids. It avoids elucidating that legitimate, written prescriptions have rapidly declined since 2009; that although heroin use has been on the rise since 2002, it has more than doubled since 2013; that many if not most recent heroin deaths included in these stats are not from prescription drugs but are from illegally imported nonpharmaceutical grade nonprescription fentanyl derivatives; that daily morphine equivalent doses have drastically declined by more than 70% between 2010 and 2015 (and most probably have declined more by 2018); that of 351 total opioid deaths in New Hampshire in 2015, 28 died of heroin as a single-drug overdose and that fentanyl derivatives (most probably imports) were a factor in 253 of the overdose deaths.^2,3,4

These facts are not likely to appear in any political outlets because they do not serve politicians well, are inconsistent with the narrative, and they do not support law enforcement efforts targeting those legitimately prescribing or dispensing opioids when appropriate.

Patients in Pain or a System in Pain?

The algorithms in use by the DEA are less than transparent. However, from the data that is observable as disclosed in OIG's analysis of HHS Medicare Part D data, it looks like there are about 90,000 individuals who are outliers in the Medicare Part D Prescriber data.

One might presume these numbers reflect misuse or abuse, but one could just as easily conclude that high dose users are the sickest of the sick and are served by physicians whose practices concentrate on serving this complex population. It also looks like CMS has not enforced the requirement that insurers provide intensive support to complex patients and their physicians through the application of medical necessity criteria as part of drug utilization review (DUR).^12,13 As part of the DUR systems, CMS requires plan sponsors to have methods to identify beneficiaries who are potentially overusing specific drugs or groups of drugs, including opioids. If this is the case, these numbers may reflect the failure to close the care coordination loop between CMS, insurers, and physicians rather than mis-prescribing.

The Criminalization of American Medicine: What Have We Done?

It has often been said that the definition of insanity is doing something over and over again and expecting a different result. This is certainly the case with American drug policy, a policy that continues to emphasize a punitive approach to solving a complex societal problem.⁵ While the regulation of prescription drugs in the United States can result in positive micro and macro health outcomes, the most recent effort by the Justice Department to reduce overdose via data mining without regard to individual patient care, is yet another example of how the cure is worse than the disease itself.

According to The Hill article, Sessions said he has "assigned experienced prosecutors in opioid hot spot districts to focus solely on investigating and prosecuting opioid-related health care fraud. I have sent these prosecutors to where they are especially needed—including Kentucky."

One author (JF) has spent a lot of time is Kentucky over the last several weeks and has met many concerned health care providers, most of whom would be better served if money was spent on proper medical education and payment for various opioid and nonopioid medication alternatives that are more costly than immediate-release generic opioids. These providers would benefit from money spent on access to multidisciplinary approaches when treating patients, and provider status for pharmacists to be included in and paid for clinic visits. Consider that abruptly stopping or significantly reducing doses of legitimate prescriptions only serves to fuel a fire that sends patients to the streets for heroin or to suicide.

Prescription pain medication, properly prescribed and dispensed, unlike illicit opioids, has and should continue to occupy a place in palliative care. Despite the fact that the majority of overdoses are caused not by prescription opioids but rather the use of illicit drugs such as heroin,⁶ the DEA has instead decided to focus its efforts on a “nationwide investigation of pharmacies and drug prescribers that are issuing 'unusual or disproportionate' numbers of opioid prescriptions” in an effort to “make more arrests, secure more convictions—and ultimately help us reduce the number of prescription drugs available for Americans to get addicted to or overdose from these dangerous drugs.”

Although it is unclear what constitutes “unusual or disproportionate,” such phrases are particularly disturbing when we realize that the regulation of medical practice is a traditional state function, not a federal one. Further, what continues to get lost in the shuffle is the increasing negative impact that drug enforcement policy is having on the treatment of pain, evidenced by involuntary tapers, patient abandonment, and practitioner flight.^7,8,9

Eventually, our nation will recognize that instead of protecting people, we have harmed them, and perhaps one day soon our elected officials will ask themselves the same question that Lieutenant Colonel Nicholson asked himself when he realized that he had harmed his own people by building a bridge on the River Kwai: "What have I done?"¹⁰ Reducing harmful drug use and unlawful distribution remains an important goal, but so does the treatment of pain, and solving one problem at the expense of the other will end up harming all of us.

President Trump’s vision that “we can be the generation that ends the opioid epidemic” is quite presumptuous considering the hundreds of years that various countries have fought political and real opium wars starting with in China in the early 1800s. To really make a difference, we should not be engaging in war on health care providers, instead, money should be spent supporting them and alternatives to prescription opioids that are as safe, effective, and covered by insurance.

In the end, perhaps Sessions should heed the advice of Nelson Mandela that “education is the most powerful weapon which you can use to change the world,”not political rhetoric and alternative facts to advance a harmful agenda.

This opinion article was written by:

Jeffrey Fudin, PharmD, DAAPM, FCCP, FASHP, FFSMB

Chief Executive Officer and Chief Medical Officer, Remitigate LLC

Adjunct Associate Professor, Western New England University College of Pharmacy

Adjunct Associate Professor of Pharmacy Practice & Pain Management, Albany College of Pharmacy & Health Sciences

Stephen Ziegler, PhD, JD

Professor Emeritus of Public Policy

Purdue University, Fort Wayne

Mayday Pain & Society Fellow and

Terri Lewis, PhD, NCC

Adjunct Professor Rehabilitation

Southern Illinois University-Carbondale

Assistant Professor Rehabilitation

National Changhua University of Education, Taiwan, ROC

References

1.

Bowden J. Sessions: DEA to target pharmacies, prescribers in crackdown http://thehill. January 30, 2018. Available at: com/homenews/administration/371412-sessions-dea-to-target-pharmacies-prescribers-in-crackdown?utm_campaign=KHN:%20First%20Edition&utm_source=hs_email&utm_medium=email&utm_content=60338186&_hsenc=p2ANqtz-8sLqVCJJviSQdOry4Zedo1LNKyPGu4-0TYuVpXlVLJxZibVwFmnEHrQIy4TRG0Ej8Gd3qmPZE1Qna58W58H38u0N6f3jOjDC6S_Xd_mzqogMM5ff8&_hsmi=60338186

2.

http://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs2014/NSDUH-DetTabs2014.htm#tab7-44a National Survey on Drug and Health (NSDUH) Tables 7.44A&B

3.

Guy GP, et al. MMWR Morb Mortal Wkly Rep. 2017;66:697—704.

4.

Costantini C, et al. “Death by Fentanyl”. Documentary, aired December 3, 2016. (NH State Medical Examiner data)

5.

Ziegler, SJ. (2013). Governmental Intervention in Prescribing: Reducing Harm and Medico-legal Iatrogenesis, PWJ. 1(3), 36-40.

6.

Schatman ME & Ziegler SJ. Pain management, prescription opioid mortality, and the CDC: is the devil in the data? J Pain Research. 2017, 10: 2489—2495.

7.

Addiction psychiatrist questions involuntary tapering of opioids (https://youtu.be/pRmPizYuZFM), last accessed February 2, 2018.

8.

Ziegler SJ Patient Abandonment in the Name of Opioid Safety. Pain Med. 2013, 14 (3):323-324.

9.

Why I am Closing My Pain Practice? https://www.painnewsnetwork.org/stories/2018/1/17/why-i-am-closing-my-pain-practice

10.

The Bridge on the River Kwai - "What have I done?"https://youtu.be/TlvKydE0EVA

11.

https://www.oig.hhs.gov/oei/reports/oei-02-17-00250.asp

12.

Prescription Opioids: Medicare Needs to Expand Oversight Efforts to Reduce the Risk of Harm GAO-18-15: Published: Oct 6, 2017. Publicly Released: Nov 6, 2017. https://www.gao.gov/products/GAO-18-15