This document from the Supreme Court of the United States, Office of the Clerk, informs Mr. Norman J. Clement about the status of his case against the Drug Enforcement Administration.
It confirms that his petition for a writ of certiorari was filed on October 31, 2022, and officially placed on the court’s docket on November 7, 2022, under case number 22-6000.
The letter also indicates that a form related to the case is enclosed, and it instructs Mr. Clement to promptly serve opposing counsel and provide proof of this service to the Clerk’s office.
HOLDING THE JUDICIAL SYSTEM ACCOUNTABLE FOR WRONGDOING
This document is an Amicus Brief submitted by Clinical Pharmacist Jack Folson in response to a Drug Enforcement Administration (DEA) action against Pronto Pharmacy LLC., Tampa, Florida.
The brief argues that the DEA, guided by the opinion of a Pharmacist expert named Donald Sullivan, misunderstands and misrepresents the standard of care in specialty pharmacies, particularly concerning pain management and compounding practices.
Folson contends that common “Red Flags” for drug diversion cited by the DEA are often standard practices in a specialty pharmacy setting serving patients with chronic pain, and that the DEA’s focus is both misguided, potentially harming patients and misrepresenting legitimate pharmacy operations.
The brief aims to educate the court on the nuances of pharmacy practice and challenge the DEA’s accusations against Pronto Pharmacy.
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“..The PDMP: Raising Issues in Data
Study Guide: Donald Sullivan RPh., PhD., and the Folson Amicus Brief
BACKGROUND
As far as I can determine, as a practicing Pharmacist who is not an attorney, the Red Flags of Diversion gained the most traction in the Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195 cases.
However, in that case, the Pharmacies in question were regular chain drug stores, but Pronto Pharmacy is a specialty pharmacy specializing in pain management and compounding.
Therefore, they are in different classes. It’s like the difference between a general practitioner and a surgeon.
True, they are both doctors, but their level of training is not the same, and the selection of patients is not the same. A general practitioner might be able to stitch you up after a fall, but removing your gall bladder would be beyond his scope of practice. With that in mind, consider that Dr. Clement has advanced training in therapeutics, pain management, dentistry, and forensics, and more than 45 years of experience, and the typical CVS Pharmacist has less than 5 years of experience.
CVS’s business model focuses on high-speed production, while Pronto Pharmacy’s is focused on disease state management. Just like people might travel long distances to seek out a surgeon with a high level of training and a history of positive outcomes, the same would be true of Pronto Pharmacy.
You would be hard-pressed to find a CVS Pharmacist who could have the time to investigate chronic pain treatment modalities and how they impact severely compromised patients.
However, Dr. Clement has numerous sources of information that the typical Pharmacist would not be aware of. As a Clinical Pharmacist, I have seen some of his vast library of information and was suitably impressed. So, things that might be a “red flag” to the inexperienced Pharmacist are little more than a footnote for us. Many of our patients have been on service for many years, so the red flags may have been resolved years or even decades ago.
Therefore, an investigator who does not interview the patient, the Physician, or the Pharmacist might not capture the documentation. Often, the pertinent information is archived.
In the Holliday CVS case, one issue was the dispensing of narcotic prescriptions from prescribers with expired or revoked DEA registrations. This did not happen at Pronto Pharmacy.
At trial, the expert witness for the DEA, Dr. Donald Sullivan, contended that the Oxycodone and Hydrocodone were the highest available dosage forms. However, this is misleading in the world of pain management.
Many states require that the prescriptions for C-2 narcotics contain a maximal daily dose, and in the Holiday CVS case, the maximum daily dose for Oxycodone was 6 tablets of 30mg which is 180 mg per day. I have seen this dose in several states, and it is considered the top of the Oxycodone range for severe pain.
However, at Pronto Pharmacy, the maximum daily dose of Oxycodone was a mere 90 mg. The equivalent dose in Morphine Milligram Equivalents in hospitalized patients can top 210 mg daily in acute cases.
In certain stages of cancer patients, where the disease has spread to other regions of the body, the dosages and dose frequency could be even higher. So, in the overall scheme of things, the current standard of care for these types of patients is to keep them at 90 mg per day or less if in chronic pain. Understandably, a professor of diversion would not know about the clinical ramifications of the specialist level of pain management.
However, he correctly stated that the practice of Pharmacy is moving more towards disease state management, which correctly describes Pronto Pharmacy and its practice.
Key Concepts and Themes:
- Standard of Pharmacy Practice: Understand the argument that a “one-size-fits-all” standard does not apply to all pharmacy types, particularly specialty pharmacies like Pronto Pharmacy (focused on pain management and compounding).
- Red Flags of Diversion: Analyze the traditional “red flags” identified by the DEA and the arguments presented against their strict application to Pronto Pharmacy’s unique circumstances and patient population.
- Specialty Pharmacy vs. Retail Pharmacy: Recognize the distinctions in business models, patient populations, pharmacist expertise, and services provided (disease state management vs. high-speed dispensing).
- Pain Management: Understand the complexities of chronic pain management, including high-dose opioids, opioid rotation, drug interactions, and the potential impact of overly restrictive policies on patient care.
- Compounding vs. Manufacturing: Differentiate between pharmacy compounding (tailored to individual patient needs) and drug manufacturing (mass production). Understand the relevant legal definitions and regulations.
- Anticipatory Compounding: Grasp the concept and legality of preparing limited quantities of compounded medications before receiving a prescription, based on historical prescribing patterns.
- The Role of the DEA: Analyze the author’s critique of the DEA’s investigation and the expert witness’s testimony, focusing on accusations of bias, incomplete understanding of pharmacy practice, and potential prosecutorial overreach.
- Patient Rights: Consider the arguments made regarding patients’ rights to pain management, freedom of choice in pharmacy, and the potential negative consequences of the DEA’s actions on patient access to care.
- The Significance of Cash Payments: Understand the various legitimate reasons why a patient might pay for prescriptions in cash, challenging the DEA’s assumption that it solely indicates diversion.
- The Impact of Pharmacy Benefit Managers (PBMs): Recognize the author’s criticism of PBM practices and their potential to disadvantage independent pharmacies.
A similar example would be for Vancomycin which is an antibiotic with a narrow therapeutic index. Typically, the dose in the hospital is 500 mg twice a day for 3 days. However, in Lyme Disease, the dose is titrated by peak and trough levels and can be as high as 2000 mg intravenously every 12 hours.
With careful titration and attention to the appropriate blood levels and presenting symptoms, a clinical pharmacist who is in charge of the therapy can ensure safe and effective outcomes for these patients who require this medication for about six weeks at home.
So, no. These are not excessively high doses in the patient population being treated. Remember, these patients have been stabilized on these medications for years and continue to get the same doses from other Pharmacies.
Single Pronto Pharmacy out of all the drug stores in America, and by way of immediate suspension order without a hearing, could be seen as Unconstitutional. His right to make a living (life, liberty, and pursuit of happiness) was taken away many months before the hearing began.
Just like in the CVS case in which Professor Doering testified that he could not foresee anything that would change his opinion, we see that Professor Sullivan, who is also a teacher, but not a practitioner in the specialty of pain management, also could not foresee anything that could enlighten him either. However, in neither case were the patients considered.
However, closing the avenues for patient care without considering the patients would be improper. Presently, because of the criminalization of pain management, suffering has increased and has led to an increase in Heroin use. Due to the dangers associated with heroin use, this, more than anything else in this case, is an immediate threat to public safety. To put it plainly, the DEA’s actions are causing what they are trying to avoid.
CLICK BELOW ON UNDER SIEGE
TRUTH UNDER SIEGE
According to the Office of the Inspector General’s report on the DEA, as prescription opioids have remained relatively flat, the use of heroin has skyrocketed. Death by fentanyl, which was once a rarity, is becoming a big player in the death of Americans due to opioids.
If Pronto Pharmacy were actually in the business of diversion, I would applaud the DEA’s effort to rid the profession of bad actors. However, in this case, there seem to be too many irregularities to reach that conclusion. Not only is there no evidence to the level of “more likely than not,” but the level of “preponderance of evidence” has not been met either.
MULTIPLE PRESCRIBERS
Although the case glossed over this red flag, a patient going to multiple prescribers to obtain high-dose opioid medications is a well-established red flag of diversion.
The basis of this is that the relationship between the patient, prescriber, and pharmacy is not present. Although this is not proof of diversion, it has been highly touted as suspicious.
However, there are many reasons that this could be explained or clarified.
On the PDMP dataset, if a patient goes to a clinic and sees several prescribers in that clinic, it will show up as multiple prescribers.
However, on closer examination, the fact that the prescribers are at the same address could be determined. If the prescriber has multiple offices and the patient is seen at different offices, or the information is entered into the computer incorrectly, the PDMP data could appear to be that of drug-seeking behavior or merely that of convenience for the patient or the prescriber.
What is glaring in this case is that every patient noted in the allegation only got medications from one specific prescriber for that individual patient. So, this firmly establishes for each patient the prescriber, patient, and pharmacy relationship and should be the firm foundation that this case should be based upon. This is important for several reasons because when relationships are formed it causes variations in behavior that do not happen without a relationship.
If a pharmacy acts only as a source of medication for a particular patient, then that patient is more likely to obtain whatever they need wherever they find convenience. Such a patient will often seek out the lowest cost. On other occasions, that type of patient will be concerned specifically with service.
However, when there is a relationship such as with a specialist, that patient will reasonably travel longer distances and avoid other specialists in the field.
1.Pronto Pharmacy is a compounding pharmacy, which is a specialty.
2. Pronto Pharmacy is a specialty pain management pharmacy.
A reasonable and prudent medical observer of the actions of the patients, prescribers, and pharmacists involved would see this relationship as normal specialty practice.
DISTANCE
The red flag of distance serves as a point of discussion in pharmacy. If a patient travels so far that they pass several Pharmacies to get to a specific Pharmacy, many issues may be in play. One is the cost. Since many patients have insurance and pharmacies take most insurance, the cost to the patient is likely the same.
However, more than 8.5 % of Americans are without insurance now, and 13.5 % were at the time of the Affordable Care Act, according to the Census Bureau
(https://khn.org/news/number-of-americans-without-insurance-rises-in-2018/ ).
Coupled with that are the increasing number of American Nationals that are not counted, and the illegal immigrants who, for the most part, do not have insurance, would make this red flag an unreliable indicator of actual diversion.
In fact, in light of the current trend of insurance companies bolstered by Pharmacy Benefit Managers (PBMs), this is likely to become increasingly irrelevant if it is not already.
The business practices of these near-monopolies are akin to those of Standard Oil before it was broken up by the Sherman Antitrust Act ( https://en.wikipedia.org/wiki/Standard_Oil ).
The PBM’s attack smaller retail Pharmacies with substandard reimbursement while paying their larger Pharmacy chain operations a premium for the same medications on the same day (https://communityoncology.org/march-30-what-cvs-is-doing-to-mom-and-pop-pharmacies-in-the-us-will-make-your-blood-boil/ ).
This effectively leads to small retail Pharmacies being forced to charge larger copayments and the chains being able to charge lower copayments. Kickbacks and Rebates between wholesalers, insurers, and PBM, which are hidden in convoluted pricing schemes, all the while under the secrecy of “Trade Secrets,” threaten to undermine the patient’s overall Freedom of Choice (42 CFR sec 431.51).
According to the Pharmacy trade publication, which is one authority in the standard of care in Pharmacy practice:
“Of late, some community pharmacy chains have changed policies developed around the pretext of patient safety. Such policies include a limited-day supply of opioids for acute pain. However, this may present a bitter inconvenience for patients who legitimately require opioids for a major acute injury and also maximizes the profitability associated with multiple copays and dispensing fees for drugs that cost pennies. To our knowledge, there is no evidence to support that limited supplies for legitimate patients to improve safety or mitigate risk.
There is sufficient data to support that placing such barriers, at least for patients requiring long-term opioids, may contribute to the heroin epidemic.”
Cape Town South Africa DISTANCE TRAVELED
https://videopress.com/embed/QpGjraAF?preloadContent=metadata&hd=1
THANK YOU PHARMACIST ADOU OF CLICK’S PHARMACY FOR NOT JUDGING ME BY THE MILE MARKER IN CAPE TOWN, SOUTH AFRICA
It would be reasonable for a patient to travel outside of their local area when faced with such discrimination by Chain Pharmacies such as CVS, Walgreens, Rite-Aid, and others if they have chronic pain. With their combined market share, it would be almost impossible for such a patient to be treated properly at all times.
Because Pronto Pharmacy is a specialty pharmacy that specializes in pain management and compounding it is reasonable for their clientele to travel distances that normal Pharmacy patients do not.
Conclusion:
The amicus brief strongly advocates for Pronto Pharmacy, arguing that the DEA’s action is based on a fundamental misunderstanding of specialty pharmacy practice, particularly in pain management and compounding.
Folson challenges the DEA’s interpretation of diversion “Red flags,” raises serious concerns about the fairness and thoroughness of the investigation, and emphasizes the potential negative consequences for patients with chronic pain.
The brief highlights the importance of considering the nuances of different pharmacy models and the need for the DEA to fully understand the clinical realities of pain management and compounding practices.
The arguments presented suggest a significant conflict between the DEA’s focus on combating opioid diversion and the standard of care in specialized pharmacy settings.
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THE NORMS
This document was an amicus brief submitted by Jack Folson, an expert in pharmacy practice, concerning the case between the Drug Enforcement Administration (DEA) and Pronto Pharmacy. Folson argues that the court should consider the specialized nature of pharmacy practice, particularly in pain management and compounding, when evaluating Pronto Pharmacy’s actions. He contends that the DEA’s understanding of pharmacy standards, influenced by cases involving standard chain pharmacies, does not appropriately apply to a specialty pharmacy like Pronto. The brief aims to enlighten the court about the complexities of pain management, compounding, and the potential negative consequences of the DEA’s actions on patient care and the pharmacy profession.
Pharmacy Compounding and the DEA
1. What are “Red Flags of Diversion” in the context of pharmacy practice?
“Red Flags of Diversion” are indicators that might suggest potential diversion of prescription medications from their intended use. These flags were established in the Holliday CVS case, which involved a typical chain pharmacy, not a specialty pharmacy like Pronto Pharmacy. Examples of these red flags include:
- High Dose Opioids: Dispensing seemingly excessively large quantities of opioids.
- Multiple Prescribers: A patient receiving prescriptions for the same or similar controlled substances from multiple prescribers.
- Distance: Patients traveling unusually long distances to a specific pharmacy, bypassing closer options.
- Early Fills: Patients consistently requesting refills of controlled substances before their prescribed supply should have been exhausted.
- Drug Cocktails: Dispensing combinations of drugs that, while potentially appropriate for legitimate medical use, could also indicate diversion.
- Cash Payments: Patients paying for controlled substances in cash, particularly when they have insurance that could cover the cost.
It’s crucial to note that these are potential indicators, not definitive proof of diversion. A thorough investigation should be conducted to determine the legitimacy of prescriptions and patient need before taking any action.
2. How does Pronto Pharmacy differ from a chain pharmacy like CVS?
Pronto Pharmacy is a specialty pharmacy focusing on pain management and compounding. This specialization requires a higher level of training and expertise than typically found in chain pharmacies like CVS.
- Expertise: Pronto Pharmacy pharmacists, like Dr. Clement, have advanced training and experience in pain management and compounding, allowing them to address complex patient needs that a general pharmacist may not be equipped to handle.
- Patient Focus: Pronto Pharmacy focuses on disease state management, working closely with patients and prescribers to create individualized treatment plans. Chain pharmacies prioritize high-volume dispensing, often limiting their ability to provide personalized care.
- Specialty Services: Pronto Pharmacy offers compounding services, creating customized medications to meet specific patient needs. This service is not readily available in most chain pharmacies.
Due to these differences, red flags established in the Holliday CVS case may not apply to Pronto Pharmacy in the same way.
3. Why might the DEA’s reliance on “Red Flags of Diversion” be problematic in the case of Pronto Pharmacy?
Applying generalized “Red Flags of Diversion” to a specialized practice like Pronto Pharmacy can lead to misinterpretations and potentially unjust accusations of diversion.
- Lack of Context: “Red Flags” need to be evaluated within the context of a patient’s medical history, diagnosis, and treatment plan. A high dose of opioids, for example, may be entirely appropriate for a patient with intractable pain.
- Specialty Considerations: Factors like distance traveled and cash payments may be less indicative of diversion in a specialty pharmacy that attracts patients from a wider geographical area and may not contract with insurance companies.
- Ignoring Expertise: Pronto Pharmacy pharmacists possess specialized knowledge in pain management and compounding. Their assessment of patient needs and prescribing patterns should be considered with greater weight than generalized red flags.
4. What is pharmaceutical compounding, and how is it regulated?
Pharmaceutical compounding is the art and science of preparing personalized medications for patients based on a prescriber’s order. It involves combining, mixing, or altering ingredients to create a medication tailored to an individual’s specific needs.
- Regulation: In the United States, compounding pharmacies are regulated by their respective state boards of pharmacy. National standards are set by the Pharmacy Compounding Accreditation Board (PCAB), although accreditation is not mandatory. The FDA has the authority to regulate manufacturing, which involves producing medications on a larger scale that are not tailored to individual patients.
5. What is “anticipatory compounding,” and is it legal?
Anticipatory compounding is the practice of preparing limited quantities of compounded medications in advance of receiving valid prescription orders. This is done based on a history of receiving similar prescriptions, allowing the pharmacy to provide timely service to patients.
- Legality: Section 503A of the Federal Food, Drug, and Cosmetic Act outlines conditions under which anticipatory compounding is permissible, including requirements for a valid prescriber-patient-pharmacist relationship and limitations on the quantities compounded.
6. Does Pronto Pharmacy’s compounding practice constitute illegal manufacturing of controlled substances?
The DEA contended that Pronto Pharmacy was engaged in illegal manufacturing of controlled substances due to its compounding practices. However, this argument appears to misunderstand the legal distinctions between compounding and manufacturing.
- Compounding vs. Manufacturing: Compounding involves preparing customized medications for individual patients based on valid prescriptions. Manufacturing refers to the large-scale production of medications not tailored to specific individuals.
- Legal Allowance: 21 USC § 1301.13 explicitly allows pharmacists to manufacture solutions or solid dosage forms containing a narcotic controlled substance in a proportion not exceeding 20% of the total compound. This provision supports the legality of Pronto Pharmacy’s compounding practices.
7. What concerns are raised about the DEA’s investigation and handling of the Pronto Pharmacy case?
Several concerns arise regarding the fairness and thoroughness of the DEA’s investigation and prosecution of Pronto Pharmacy.
- Lack of Due Diligence: The DEA seemingly failed to conduct a thorough investigation, including interviewing prescribers and reviewing patient medical records, to understand the legitimate medical needs of Pronto Pharmacy’s patients.
- Overreliance on Red Flags: The DEA appears to have relied too heavily on generalized red flags without considering the context of Pronto Pharmacy’s specialized practice and the individual circumstances of its patients.
- Destruction of Evidence: The DEA’s removal and failure to return all of Pronto Pharmacy’s documentation, including crucial electronic data, raises concerns about potential evidence tampering and hindering Dr. Clement’s ability to mount a proper defense.
8. What potential negative consequences could arise from limiting or eliminating anticipatory compounding in pharmacy practice?
Eliminating anticipatory compounding would have significant negative impacts on both patient care and the efficient operation of pharmacies.
- Delayed Access to Medications: Patients would experience delays in receiving essential medications, particularly those with complex medical needs requiring customized compounded preparations.
- Increased Waste: Pharmacies would be forced to discard compounded medications prepared in advance if corresponding prescriptions were not received within a short timeframe, leading to substantial financial losses and medication waste.
