By Jack Folson – Clinical Pharmacist
Not to overstate the problem but the DEA is attacking healthcare providers with artificial metrics. The so-called RED FLAGS OF DIVERSION are part of an algorithm that the DEA uses to assign criminality to oftentimes legitimate medical treatments. Most practitioners believe that the DEA is purposely turning a blind eye to emerging techniques and even the American Medical Association has weighed in on this shortcoming of the DEA’s approach to diversion control.
In fact, as opioid-induced deaths have skyrocketed the deaths attributable to prescribed opioids have actually decreased while death due to illicit drugs such as heroin, cocaine, and fentanyl which comes across our borders from other countries continues to rise. In fact, the term opioid epidemic no longer applies to prescription medications.
What is particularly troubling is the intent for the DEA to increase their intrusion into the Doctor-Patient-Pharmacist relationship without a clear understanding of all the parameters involved. In fact, patient care is totally lost in their conversation. Upon searching the cases tried in DEA court one notices a glaring deficit. Nowhere is the patients’ conditions a factor that is elucidated.
Common-Law jurisdiction requires an actual injured party of which they never present. Maritime Jurisdiction requires that there be a contract in force in which all the parameters are known by both parties but this fails because the DEA never publishes the names of suspect prescriber before they attack the pharmacies, nor do they publish the actual definitions that they use to assign criminality to their red flags of diversion.
SAVINGS FOR UNINSURED PATIENTS
They use the spurious standard of “standard of care” which is very much open to interpretation but if they come after a provider what they say is the standard of care does not represent the standard of care that is published in the medical literature. They have become nothing more than a political organization that has lost its way.
Furthermore, the selection process of who to go after seems to be aimed at those that are the least able to defend themselves from the regulatory overreach.
Let’s look at a few scenarios.
1. Long Distance
If you see a prescriber in one area and live in another area and see a pharmacy in yet another area you could trip the RED FLAG of distance. The funny thing is that the DEA never gives a definition of how far the distance is that is acceptable for them. Furthermore, the Constitutionally guaranteed right of choice is trampled upon with impunity.
This means that if you are on vacation in one part of the state and go to the hospital in that same area but hold onto your prescription until you get home and your pharmacy fills that prescription the DEA might indict your pharmacist.
Another common issue is for a patient who lives in one area but works in another and sees their doctor close to where they work and fill the prescription near home. This could be a big problem for you, your doctor, and your pharmacist.
Can you see how this might cause a lot of confusion and pain for a person who is suffering from pain, anxiety, depression, or other conditions?
2. Multiple Short Acting Opiod Prescriptions
Although the medical literature is quite available to show that one treatment that is very effective in minimizing the escalation of opioid dosing in patients that have intractable pain after they have developed enzyme induction that leads to tolerance of the normal treatment the DEA seems to be unaware of this clinical reality.
In fact, the “expert” witnesses that the DEA employs in their witch hunt of healthcare professionals always testify that they can not see any reason to use the alternating short-acting opioid protocol because they themselves have never heard of it. However, they are not pain management specialists and as such would not be expected to understand this often end-of-life protocol that is commonly used.
EXAMPLE OF SCHEDULE-II PRESCRIPTION FOR OXYCODONE
3. Cash
Even though more than 50% of Americans do not have health insurance that pays for certain pain medications the DEA assigns the RED FLAG of CASH to any opioid or benzodiazepine prescription that is paid for by cash. Cash in their estimation includes credit and debit cards. So if your insurance company will not pay for preexisting conditions and you have arthritis that requires an opioid for treatment you can find yourself in the midst of controversy concerning the DEA.
4. Doctor Shopping
Let’s say that you go to a clinic system that includes several prescribers and each time you go there is a different prescriber handling your treatment. Even though your prescribers have a shared protocol and are on the same page as to your treatment if you go from one location to the other you might feel the ire of the DEA because you are labeled as a DOCTOR SHOPPER. If a pharmacy fills your prescription they might be indicted.
5. Multiple People on the Same Day
Let’s say that you and your cousin live in the same house. Both of you have a medical condition that is hereditary, but you need the same pain or anti-anxiety medications, but you are both indigent. So, you plan your trips to the Doctor and Pharmacy on the same days to save on transportation costs. The DEA has now criminalized this behavior. If a pharmacy fills both of the medications that you need that pharmacy might get indicted.
6. Compounding
Let’s say you need a narcotic medication every month for whatever reason and your copay for the commercially available dosage form is too high for you to afford. But you find a pharmacy that is willing to compound the medication into a cheaper version specifically for you. Well, under the law compounding for such medication is allowed as long as the dosage form does not contain more than 20% active ingredient.
The pro-manufacturer bias of the DEA assigns criminality to that solution to your problem unless you are given a dose that is individualized. But here’s the thing. The law allows for this solution, but the DEA does not want the pharmacy to save you that money because they are in bed with Big Pharma. Even though the wording of the law says may they concoct an artificial and extrajudicial standard of must or shall which is not in the law to the detriment of the patients, prescribers, and dispensers of these medications.
People Are Talking
In a recent article in the online news organization “Filter”
The Drug Enforcement Administration (DEA) is looking to expand its anti-diversion surveillance infrastructure by being able to search and analyze myriad patient behaviors for the vast majority of controlled and scheduled drug prescriptions—all accompanied by a rapid process for legally unveiling personally-identifying information.
The implications of such massive invasion of privacy should not be allowed in light of the fact that the DEA can not be trusted with the information that they currently have.
FOR NOW YOU ARE WITHIN THE NORMS
Footnotes:
Pharmaceutical Compounding Versus Manufacturing: Renewed Interest in an Old Question
2012-12-11 14:41:28
James A. Jorgenson, RPh, MS, FASHP
“By substituting opioids and using lower doses than expected according to the equivalency conversion tables, it is possible in the majority of cases to reduce or relieve the symptoms of opioid toxicity in those patients who were highly tolerant to previous opioids while improving analgesia and, as a consequence, the opioid responsiveness. Cancer 1999;86:1856–66. © 1999 American Cancer Society.”
Cancer – Original Article – Opioid Rotation for Cancer Pain Rationale and Clinical Aspects
First published: 20 November 2000
“Opioid switching and opioid rotation, at different stages of therapy, represent two clinical strategies used to optimize opioid response for patients with moderate-to-severe pain.”
Review Article – Opioid switching and rotation in primary care: implementation and clinical utility
Pages 2133-2150 | Accepted 16 Jun 2009, Published online: 14 Jul 2009
https://www.tandfonline.com/doi/abs/10.1185/03007990903120158
“The reality is that Portugal’s drug situation has improved significantly in several key areas. Most notably, HIV infections and drug-related deaths have decreased, while the dramatic rise in use feared by some has failed to materialise. “
Transform Drug Policy Foundation Journal
Drug decriminalisation in Portugal: setting the record straight.
What Does “Rat Park” Teach Us About Addiction?
June 10, 2019
The implications of such massive invasion of privacy should not be allowed in light of the fact that the DEA can not be trusted with the information that they currently have.
BACKGROUND
Jack Folson is a renowned Expert in Pharmacy Practice: Hospital, Retail Chain, Retail Independent, Sterile Compounding, Non-Sterile Compounding, Former Director of Pharmacy,
- June 9, 2020, by Jack Folson, DONALD SULLIVAN Ph.D. AND THE FOLSON AMICUS BRIEF, STORY BEHIND THE ECONOMIC LYNCHING OF BLACK OWNED PHARMACY BUSINESSES BY THE DRUG ENFORCEMENT AGENCY (DEA) IN AMERICA
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