THERE IS A NEW LEGAL DOCUMENT that:
- Was created without public input, but has negatively impacted the essential care received by millions of patients across our nation?
- Has a secret component that has fractured critical pharmacy operations and prevented patients from receiving legitimate prescribed medications?
- Generates data “for the benefit of the DEA” and the State Attorneys General to single out physicians who may have done nothing more than attempting to help patients being hurt by this very document?
- Like a corrupt monopoly, created layers upon layers of bureaucracy which are made impenetrable to breach?
- Puts this machinery in place to fight the alleged harm being created by prescription pain medication, a false narrative based on false data?
How does this fifty-four-page document up-end a critical part of our health care system with almost no one knowing? The following revelations should set everyone on the path to immediate action!
WHO AND WHAT WAS INVOLVED?
In July of 2022, the National Association of Attorneys General announced that they had negotiated a settlement with the three main distributors/wholesalers of controlled substances: AmerisourceBergen, Cardinal Health, and McKesson. The settlement was signed by 41 of the 50 states. The monetary part of this settlement is not the critical component; the damage to our healthcare system is being done by the Injunction.
HOW DOES THE INJUNCTION ACHIEVE A STRANGLEHOLD ON BOTH PHARMACIES AND PHYSICIANS?
- It creates “SECRET THRESHOLDS” for pharmacies.
- this legal direction results in catastrophic confusion for both pharmacies and their customers as neither can be informed how much of a pain medication, they are receiving every month. Patients often cannot find a pharmacy that has their medication in stock. (Note: These Threshold limits are applied in addition to the DEA yearly cut in production quotas)
- It requires the Distributors to rain terror on its pharmacies:
- the Distributors must decide what is a “suspicious order,” and then if identified, they must halt that order from being delivered. (see “Definitions Addendum” for “red flags” and “suspicious orders.”)
- based on the interpretation by the Distributor, it can stop ALL ORDERS of controlled substances to that pharmacy, often putting it out of business.
- Distributors are now required to report both “suspicious orders” and all “red flags” not just to the DEA, but to the state’s Attorney General.
- It adds layers of bureaucracy to enable data mining for the DEA. It does this through a new position called a Monitor, as well as a Clearinghouse and Clearinghouse Advisory Panel. This new hierarchy:
- creates customized reports to search for “suspicious physicians.”
- specifically recognizes the DEA as a central “stakeholder,” and creates reports for DEA’s “benefit.”
- acknowledges reports are “incomplete” due to the nine states not being party to the settlement, and yet continues to use this data punitively.
- has, for their obvious benefit, written a clause stating that none of the above entities are liable for data breaches and data integrity, including immunity from consequences to individuals for incomplete data.
WHAT HAS BEEN THE IMPACT ON PHARMACISTS AND PHYSICIANS?
- Pharmacists are increasingly feeling pressured to deny prescriptions for fear of having themselves or their pharmacy scrutinized and unfairly persecuted.
- Some pharmacists have stated that the new requirements are causing increased stress and worry that, because of this added workload, dispensing errors will increase.
- Physicians who are now aware that any prescription they write might end up on their Attorney General’s desk, or that data mining may mark them as a “suspicious physician,” are increasingly making the choice to stop prescribing controlled substances altogether.
- Physicians, often mandated by their employer, have forced taper patients whom they think might put them in the cross hairs of these new requirements.
- Physician morale is dropping as they see their “physician-patient relationship” dramatically eroded.
WHAT HAS THE IMPACT BEEN ON PATIENTS?
- Patients with legitimate prescriptions are unable to obtain critical medications from their pharmacy with predictable consequences:
- being forced, with risk of being accused of “pharmacy shopping,” to reach out to multiple pharmacies to locate their medication in stock.
- waiting for their physician to resend the prescription, a requirement that adds to the gauntlet the patient must endure.
- Patients are losing their quality of life. This is true, not just for the millions of chronic pain patients, but for patients in acute pain, and those receiving behavioral health medications which fall into the category of controlled substances. Patients who are forced to live with uncontrolled pain or a severe mental health disorder:
- lose their ability to function and are suddenly unable to care for themselves, or as a caregiver, they can no longer provide this critical assistance to family members.
- are physically and emotionally no longer able to manage physician appointments and become “lost to follow up.” This causes loss of preventative health screening and raises the burden of preventable conditions, such as hypertension and diabetes, on our health care system.
- patients have opted not to have needed surgery as they are being told they will only get Tylenol or an extremely short post-operative time with adequate pain medications.
- patients who were working are now unable to work, or must cut back their hours.
- Most concerning of all, there are patients who lose access to their medications to such a degree that they find themselves in unrelenting pain. A growing number of these patients end up taking their own lives.
CONCLUSION:
With this settlement, the State Attorneys General have decided to ignore every piece of evidence available that clearly shows prescription medications are not, and were never, the cause of the “opioid crisis.” This injunction shows, beyond any question, that they are determined to plow forward on a false narrative. It makes no difference to the Attorneys General, that there are innocent people harmed or dying in the process. Physicians, pharmacists, and patients are just collateral damage.
It is imperative to ask ourselves who gets to determine the quality of life of millions of patients in pain. The State Attorneys General must be held accountable for the catastrophe they have created.
Outstanding article. We should all be terrified.
Indeed.
When I read the section P of the settlement injunction ( good for 10 Years)
It reminded me of some totalitarian document
What can be done? It seems even if one sends an email or letter complaining, it does no good. There is so much that has happened already that should have made a difference to stopping this crusade against pain patients, yet nothing changes. I don’t even think that if there were more suicides it would change and that is probably what is going to happen.
We must speak truth to power,
But also to ineptness, greed, totalitarian solutions to individual problems,
And:
RESTORE THE SACRED PHYSICIAN PATIENT RELATIONSHIP
What can be done? It seems even if one sends an email or letter complaining, it does no good. There is so much that has happened already that should have made a difference to stopping this crusade against pain patients, yet nothing changes. I don’t even think that if there were more suicides it would change and that is probably what is going to happen.
Yes, outlining a course of action would be helpful. I have wondered if a class-action lawsuit against specific perpetrators of this astounding overreach is the way to go. HIPAA is being violated, as are patients’ rights under ADA. There’s more violations than that and also harms to physicians, pharmacists, etc.
It’s hard to know where to start and where to focus. Journalists have covered some of this with no policy change result. That avenue seems a dead end.
How can we identify a sympathetic law firm with the requisite size and health care
field expertise to look at this mess and identify the path to demanding accountability and change?
Please update the information on Ms Irving,
A courageous whistleblower who WAS the national risk management director for Kaiser-Permanente.
She was INVOLUNTARILY WEANED from her life-saving medications, by Kaiser.
How’s that for irony?
There are nurses, and there are Nurse Influencers,
Pat is the latter
Thanks for this critically informative article. Too many (most) continue to believe the large uptick in pain medication shortages on pharmacies’ shelves is only due to DEA production quotas. Thanks for being the “first” to alert the pain community of the magnitude of the harm this nationwide settlement has wrought. Thanks for continuing to educate on this critical issue!
All I can say is WOW!
Spot on. To say it’s not fair, is the understatement of the century.
The discrimination we face, for having medical conditions associated with CP, is unforgiving. Noone, and I mean noone wants to be in the situation where pain meds are needed for quality of life. But, so many do need them. We are being punished daily for the Chinese Fentanyl border crisis that has nothing to do with legitimate treatment of legitimate pain patients.
Some state and federal agencies are now becoming aware of the horrific effects of these settlement terms on American healthcare. The DEA has used this document to extend and enhance their existing authority into unprecedented levels – with no transparency and NO REDRESS. There is NO oversight, and no one is tracking the escalating harms to patients nationwide.
Among other things, the injunctive relief section of the settlement document requires that the new CSMP teams must be staffed by people with “appropriate experience regarding compliance with the laws and regulations concerning controlled substances, in particular laws and regulations requiring effective controls against the potential diversion of controlled substances.” In other words: you must hire former DEA for these roles.
While DEA helped to destroy medication access through this settlement they also carved out VERY lucrative job prospects for themselves and their colleagues – making at last 4-5 times in salary what they made at their GS pay levels at DEA.
DEA looked after their own, but sentenced the entire country to abrupt medication disruptions and worse: blacklisting of providers (by pharmacies and distributors) who have done nothing wrong – even by DEA standards – other than appropriately treating their patients for pain, addiction, anxiety, ADHD, seizures, and more.
And I believe they assumed no one would suspect the DEA/state AGs were behind it with this settlement, because most people will think that the persistent “medication shortage problem” in the USA would be the cause.
But it is not. This settlement/injunctive relief terms are causing medical crises all over, INCLUDING the throttling of distribution of Suboxone and Buprenorphine for those struggling with OUD. The very thing this settlement was supposed to fund.
People are noticing, and we are engaging our healthcare agencies. This settlement document has gone WAY TOO FAR.
Corporations’ primary goal is to make money for stockholders (actually “executives”). So these harms are irrelevant unless they generate monetary loss. Remedy: )Class action Wrongful Death Suits. 2)Class Action suits for violatons of Americans with Disabilities Act.
Co-conspirators are the Attorneys General. Bad publicity and loss of votes in re-election campaigns is their weak spot. Remedy: incessant complaints to media and elected officials re: the harms caused. Public Awareness will stifle their re-election or ascention-to-governor plans.
Rich Kirkpatrick, MD, Longview, WA
The DEA is making up for its corruption as outlined in the book “American Cartel where the DEA was complicit in letting the pill.mills operate. Part if the difficulty is there are a number of people who’s son or daughter developed addiction through prescription opioids (usually illicit use – not a legitimate physician prescription) and they are a loud lobby, too.