DEA: No Guidance for Opioid Wholesalers

The DEA expects opioid supply-chain wholesalers to report “suspicious” orders without the necessary information which is collected, but not shared, by the DEA itself. Below is a statement given by an opioid wholesaler to the House of Represenatives in May 2018 that explains the problem:

WRITTEN STATEMENT OF JAMES CHRISTOPHER SMITH FORMER PRESIDENT AND CHIEF EXECUTIVE OFFICER, H.D.SMITH LLC BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS COMMITTEE ON ENERGY AND COMMERCE U.S. HOUSE OF REPRESENTATIVES PRESENTED MAY 8, 2018″

H.D.Smith was only one part of a complex supply chain, and we could not see all the information up and down the chain that could flag a potential problem.  

As a wholesale distributor, H.D.Smith could not second-guess physicians’ prescribing decisions, and could not itself assess the medical needs of the patients of those prescribing physicians.

This is exactly the problem with asking wholesalers, distributors, and pharmacies to report “suspicious” opioid orders and prescriptions. At such a high level, these entities have no way of knowing anything about the individual patients, their doctors, their diagnoses, or their medication doses.

There are difficult policy and medical decisions that are needed to balance access against diversion and we did the very best we could with the limited information to which we had access.

H.D.Smith was a wholesaler. We purchased prescription and generic medicines directly from manufacturers, and distributed them to the licensed pharmacies that ordered them for patients with prescriptions.

As a wholesale distributor, H.D.Smith did not interact directly with patients, nor were we in a position to make or second-guess clinical decisions.

Yet, this is exactly what they are being asked to do: make or second-guess clinical decisions that should be made (in private) between a doctor and their patient.

We also had no way of knowing whether or to what extent our customers were purchasing medicines, including opioids, from other distributors, unless this information was voluntarily disclosed.

As the DEA’s expectations changed, in May of 2008, we implemented an electronic controlled substance order monitoring program(the “CSOMP”), and provided extensive training to our personnel in how best to reliably utilize that system, just as we trained our sales representatives to be alert to any signs of diversion or irregularities at the individual pharmacies we served

H.D.Smith changed our reporting practices upon learning from the DEA that we were over-reporting and that orders were not “suspicious” simply because they were flagged for initial review by the company’s electronic anti-diversion CSOMP.

So, the DEA was compalining that this wholesaler was reporting too many orders as “suspicious” and, instead of doing their job and tracking them down, they merely asked the wholesaler not to report so many.

After this time, H.D.Smith reported orders to the DEA only if we determined after further review and due diligence that the order was indeed “suspicious” and should be rejected.

H.D.Smith also reported a number of physicians and pharmacies to the DEA when concerns arose. 

DEA’s complaints that H.D.Smith was reporting too many orders as suspicious because they exceeded the ordering limitations imposed on a particular customer.

We experienced some frustration in working with the DEA, however; during some periods of time, the DEA rebuffed the industry and refused to give guidance to help distributors in their efforts to detect suspicious orders.

Additionally, the Prescription Drug Monitoring Programs (PDMPs) in many states require physicians and pharmacists to provide patient and prescription information to state-run databases about the prescriptions they write or fill for opioids.

In West Virginia in particular, the DEA and other federal and State law enforcement agencies have immediate and unlimited access to this database, as do various professional licensing boards, but notably distributors do not.

Thus, in addition to the ARCOS data that is automatically reported by manufacturers and distributors to the DEA, the DEA has access all the way down to

  • prescriber-specific,
  • pharmacy-specific, and
  • patient-specific

data on each and every opioid prescription written and filled and the patient to whom each opioid was dispensed.

Wholesale drug distributors, however, cannot access this data.

Without help from the DEA, and particularly guidance about the reporting of suspicious orders, distributors cannot make complete assessments about pharmacies’ purchasing habits, and are, therefore, limited in their ability to detect suspicious orders.

1 thought on “DEA: No Guidance for Opioid Wholesalers

  1. Kathy C

    That was why this was so confounding. Most physicians and pain patients were aware that every dosage was tracked. They were already aware of the addiction potential for these drugs. Yet as the media, back in the early 2000″s covered “addiction” and numerous articles warned about “addiction” the number of pill sold to wholesalers increased. Each year since then scrutiny on patients and physicians, was encouraged in pharma ads and propaganda. This was to protect the industry, and allowed them to profit while avoiding any accountability.

    They ran ad campaigns about responsible prescribing, as they marketed “alternatives.” TV personalities had reality TV shows, on “intervention” to advertise expensive “Malibu ” treatment clinics. It was all a marketing campaign and smokescreen. The DEA”s hand were tied, they were not allowed to act on the data they collected, instead they were directed to go after the “addicted” and not the industry wholesalers. https://www.theguardian.com/us-news/2018/may/22/rudy-giuliani-opioid-epidemic-oxycontin-purdue-pharma The same names come up in the headlines today, part of a sophisticated scheme, to undermine federal regulators, and hamstring the DEA.

    This was all about protecting corporate profits, while obscuring the despair and hopelessness driving addiction. Our corporate media, dependent on pharma advertising, avoided telling the story. It was better for their advertisers, and owners, who were invested in these profitable corporations to direct the anger at sick people, and the “addicted.” As the death rates rose and more people overdosed, they chose to direct attention at the addicted. The riveting stories of grandmas passed out while their grandchildren looked on, did not “spread awareness” they targeted the addicted for hate. It was really clear, that when the ACA rolled out with no laws requiring addiction treatment, that the corporations, and politicians who wrote the ACA had no intent to deal with this “crisis.”

    The lies and propaganda continue the DEA is still going after patients and physicians, instead of the huge corporations involved. For over 20 years the media ran misleading stories about addiction, as they advertised for treatment centers with no accountability. When the addicted and their families, shelled out thousands of dollars for “treatment” at fly by night treatment centers. often repeatedly, and the family member still died, no agency held them accountable. After all “drug are bad” so any kind of “treatment” was better than nothing. A few deaths were small price to pay, compared to the horrors of drug addiction. A free for all of marketing and misinformation, using misreported “science” told the public there were “two sides,” even though the science and facts are clear on treating addiction. Some people want to believe in punishment or faith based approaches, even though facts tell is that there will be more deaths. This deliberately created confusion is profitable. It also perpetuates the denial.

    Today on The Doctors” a corporate marketing, TV show, which peddles pharma, their most profitable advertiser, along with plastic surgery and sensationalized “health news,” They advertised “Incarcerating the addicted.” Corporate media is amplifying misleading and dangerous themes about “addiction.” A highly polarized TV Physician, who claimed he is an “addiction specialist” and sent a number of reality show participants so their deaths, is now back. It is no accident they are going to prop up his ideas on TV. He is calling for incarcerating the addicted, and homeless, amplifying dangerous authoritarian ideas promoted by the administration. “.[5] In May 2013, Pinsky announced that season six was the final season, explaining that he had grown weary of the criticism leveled at him after celebrities that he treated had relapsed into addiction and died.[6][7] ”
    https://en.wikipedia.org/wiki/Celebrity_Rehab_with_Dr._Drew

    If we start with the 1996 Oxycontin marketing campaign, and coincidentally, the end of most regulations on health marketing. One thing is certain, it has been profitable, for the big corporations, and a few celebrities. Casting doubt is profitable, and there is a lot of money pushing ideological responses to addiction and pain. In New Mexico, there was a problem with heroin before 1996. Instead of providing actual treatment, they promoted the faith based approach. It was sold to people of faith, and it was portrayed as less expensive than an evidence based approach. Like other areas, it ensured generational drug abuse. Blaming patients took attention away the despair and economic circumstances, that led to addiction.

    https://www.nickiswift.com/26338/sketchy-things-dr-drew-everyone-ignores/

    Big Investors https://www.ecommercetimes.com/story/commerce/1612.html
    Dr Drew’s scaremongering targeting the homeless.
    https://www.breitbart.com/health/2019/07/19/dr-drew-pinsky-bubonic-plague-outbreak-imminent-in-los-angeles/

    We live in dangerous times when lies and propaganda are amplified by attention seeking self described experts. it is difficult to separate the marketing, and propaganda from meaningful facts. Inciting fear and violence against the vulnerable has gone mainstream.

    Liked by 1 person

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