This amicus brief, submitted by expert pharmacist Jack Folson, argues against the DEA’s suspension of Pronto Pharmacy, a pain management and compounding pharmacy. Folson contends the DEA’s case relies on misinterpretations of “red flags” for opioid diversion, ignoring the nuances of specialty pharmacy practice and the specific needs of chronic pain patients.

He asserts that the DEA’s actions are based on insufficient evidence and disregard for established standards of care in pain management and compounding.

Folson highlights the DEA’s destruction of evidence and failure to consider patient histories and physician relationships. He emphasizes the importance of compounding in providing affordable and accessible medication for patients.

UNITED STATES DEPARTMENT OF JUSTICE

Drug Enforcement Administration

In the Matter of Pronto Pharmacy, LLC

Docket No. 19-42

AMICUS BRIEF

CONCERNING THE STANDARD OF PRACTICE IN PHARMACY, LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE

THE CALYX GROUP

Jack Folson, Jr

calyxgroup@yahoo.com 

28228 Warren Road

Westland, Michigan 48185

(908) 327-7322

(269) 659-0814 Facsimile

Expert in Pharmacy Practice: Hospital, Retail Chain, Retail Independent, Sterile Compounding, Non-Sterile Compounding, Former Director of Pharmacy. The respondent has retained me to review this case. In this case, the decision will have far-reaching deleterious effects on the professions of Medicine, Nursing, and other Mid-Level Practitioners and Pharmacists.

June 4, 2020

After reading the TRIAL TRANSCRIPT and ALJ DECISION, many glaring errors became apparent.  This document is intended to enlighten the court on the true nature of the STANDARD of CARE as it pertains to PHARMACY.  The practice of Pharmacy has many traditional and emerging roles, and a one-size-fits-all standard cannot apply.  This proves that certain facets are known as retail, institutional, healthcare organizations, etc.  Within these broad categories, there are subdivisions.  

What is clear here is that Pronto Pharmacy is a specialty pharmacy specializing in pain management and non-sterile compounding. Since Dr. Sullivan seems to have no experience in these fields, it is understandable that he does not grasp the fine nuances. Since I have experience in the above fields, I am submitting the following to enlighten the court. 

RED FLAGS OF DIVERSION

BACKGROUND

So unethical to ignore Australia’s 28 studies over 24 million people and that human beings are different here than they are anywhere else. It’s the biggest scam ever seen but it involves sadistic♿️torture so it’s also an attack and an assault and a genocide. pic.twitter.com/JX1Mg27pdw

— BilkedToTheBrink (@Bilked2TheBrink) January 19, 2025

As far as can be determined 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 that specializes 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, as well as more than 45 years of experience. The typical CVS Pharmacist has less than five 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 training level 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, the documentation might not be captured by an investigator who does not interview the patient, the Physician, or the Pharmacist.  Often, the pertinent information is archived.  

In the Holliday CVS case, one issue was dispensing narcotic prescriptions from prescribers with expired or revoked DEA registrations.  This did not happen at Pronto Pharmacy.  

January 15, 2025

This analytic review examines the clinical evidence regarding opioid use for chronic pain in the United States. The authors challenge common assumptions about opioid efficacy, dosage variability, mortality risk, and the development of opioid use disorder.

They analyze existing research, highlighting methodological flaws in past studies and proposing improved experimental designs.

Furthermore, the review explores the complexities of the opioid crisis, arguing that focusing solely on restricting clinical opioid prescribing overlooks the significant role of illicit opioids and broader societal factors.

Finally, the authors emphasize the need for a more comprehensive approach that addresses chronic pain management’s medical and social aspects.

HIGH DOSE OPIOIDS

At trial, the expert witness for the DEA, Mr. Sullivan, contended that Oxycodone and Hydrocodone were the highest available dosage form.  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 Holliday 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, which 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 of Morphine Milligrams Equivalents in hospitalized patients can top 210 mg per day in acute cases.  In certain cancer patients, the dose 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 toward disease state management, which correctly describes Pronto Pharmacy and its practice.

A similar example would be Vancomycin, an antibiotic with a narrow therapeutic index.  Typically, the dose in the hospital is 500 mg twice a day for three 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 that require this medication for about six weeks at home.

So, no. These are not excessively high doses in the patient population that is being treated.  Remember, these patients have been stabilized on these medications for years and continue to get the same doses from other pharmacies.  To single Pronto Pharmacy out of all the drug stores in America by way of an immediate suspension order without a hearing could be considered 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, to close 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 actions of the DEA are causing the things they are trying to avoid.  

According to the Office of the Inspector General’s report on the DEA, as prescription opioids have remained relatively flat, the increase in heroin use has been skyrocketing.  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 diversion business, 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 conclude.  Not only is there no evidence to the level of “more likely than not,” but the “preponderance of evidence” level has not been met.  

Lawhern’s Critique of Opioid Crisis Policies

The Opioid Crisis: A Critical Examination of Public Health Policy

Study Guide

I. Key Concepts & Arguments

• Over-prescription Myth: Lawhern challenges the prevailing narrative that over-prescribing by healthcare providers is the root cause of the opioid crisis. He cites studies like Brat et al. (2018) which demonstrate extremely low rates of misuse among opioid-naive patients following surgery.
• Addiction vs. Dependence: The author emphasizes the distinction between physical dependence, a natural physiological response to prolonged opioid use, and addiction, a complex behavioral disorder. He argues that conflating these terms has fueled unwarranted fear and restrictions on opioid prescribing.
• Role of Prescription Drugs: Lawhern contests the claim that prescription opioids are the primary driver of overdose deaths. He highlights the work of Jalal et al. (2018) which analyzed CDC data and found prescription drugs to be present in a minority of overdose fatalities.
• Flawed Guidelines: The study guide strongly criticizes opioid prescribing guidelines issued by organizations like the CDC, VA, and NICE. He argues that these guidelines are based on weak evidence, ignore individual patient variability (like genetic differences in opioid metabolism), and prioritize arbitrary dosage limits (MMEDD) over clinical judgment.
• Consequences of Restrictive Policies: The author details the harmful consequences of these flawed policies, including the denial of pain care to legitimate patients, the forced tapering of patients off opioids, and the prosecution of physicians based on unfounded accusations.

II. Short Answer Quiz

1. Explain the central argument of Richard Lawhern’s paper.
2. What evidence does Lawhern present to challenge the notion that over-prescribing by doctors is the root of the opioid crisis?
3. What is the difference between opioid dependence and opioid addiction? Why is this distinction important?
4. According to Lawhern, what is wrong with the Morphine Milligram Equivalent Daily Dose (MMEDD) as a metric for opioid prescribing?
5. What flaws does Lawhern identify in the opioid prescribing guidelines issued by the CDC and other organizations?
6. What is the STORM predictive risk model and what does it reveal about the factors that contribute to opioid overdose and suicide risk?
7. How does the work of Jalal et al. (2018) challenge the claim that prescription drugs are responsible for the majority of overdose deaths?
8. What are some of the negative consequences that Lawhern attributes to restrictive opioid prescribing policies?
9. What is Lawhern’s call to action at the end of his paper?
10. How does Lawhern’s background and experience inform his perspective on the opioid crisis?

III. Essay Questions

1. Critically evaluate the argument that opioid prescribing guidelines, while intended to address public health concerns, have resulted in unintended negative consequences for patients with chronic pain.
2. Discuss the ethical implications of restricting access to opioid analgesics for patients with legitimate pain conditions. Consider the balance between potential risks and benefits, patient autonomy, and the role of healthcare providers in pain management.
3. Analyze the role of media and public perception in shaping the narrative surrounding the opioid crisis. To what extent has misinformation contributed to the stigmatization of opioid analgesics and the criminalization of pain medicine?
4. Examine the historical context of the opioid crisis, including the role of pharmaceutical companies in promoting opioid painkillers. How have factors such as aggressive marketing, regulatory failures, and societal attitudes towards pain influenced the current situation?
5. Propose evidence-based policy recommendations to address the opioid crisis while ensuring access to appropriate pain care for patients. Consider alternative pain management strategies, harm reduction approaches, and strategies to combat illicit drug trafficking.

IV. Glossary of Key Terms

• Opioid Analgesics: Medications derived from opium or synthetically produced to relieve pain by interacting with opioid receptors in the brain and spinal cord.
• Chronic Pain: Pain that persists for an extended period, typically longer than three months, and can significantly impair quality of life.
• Opioid Dependence: A physiological adaptation to regular opioid use that results in withdrawal symptoms when the drug is stopped abruptly.
• Opioid Addiction: A chronic, relapsing brain disease characterized by compulsive drug-seeking and use despite harmful consequences. Also known as opioid use disorder (OUD).
• Overdose: A condition that occurs when an excessive amount of a drug is taken, overwhelming the body’s systems and potentially leading to life-threatening complications.
• Morphine Milligram Equivalent Daily Dose (MMEDD): A measure used to convert the dose of various opioids to a standard dose of morphine, facilitating comparisons across different medications. Lawhern argues against its use.
• Genetic Polymorphism: Variations in genes that affect individual responses to medications, including how the body metabolizes and processes drugs.
• STORM Predictive Risk Model: A statistical model developed by the VA that uses patient medical history to predict the risk of opioid overdose or suicide following opioid prescription.

Answer Key II. Short Answer Quiz Answers (Example)

1. Lawhern argues that the current approach to the “opioid crisis” is based on fundamental errors and that restrictive policies have resulted in the denial of pain care to legitimate patients and the unjust persecution of healthcare providers.
2. Lawhern cites the work of Brat et al., which found extremely low rates of opioid misuse among a large sample of post-surgical patients. He argues that this data refutes the claim that widespread overprescribing is the primary driver of the opioid crisis.
3. Opioid dependence refers to the body’s physical adaptation to opioids, leading to withdrawal symptoms upon discontinuation. Opioid addiction is a behavioral disorder characterized by compulsive drug-seeking and use. The distinction is crucial because conflating dependence with addiction fuels fear and leads to policies that harm patients who need opioids for pain relief.
4. Lawhern argues that MMEDD is an unreliable and misleading metric because it does not account for individual patient variability in opioid metabolism and response.
5. Lawhern criticizes guidelines for being based on weak evidence, ignoring genetic differences in opioid metabolism, and prioritizing arbitrary dosage limits over clinical judgment.
6. The STORM model uses patient data to predict overdose and suicide risk. It reveals that factors like mental health history, prior overdose, and hospitalizations are far stronger predictors than opioid prescribing itself.
7. Jalal et al.’s analysis of CDC data demonstrates that prescription drugs have consistently been present in a minority of overdose deaths, contradicting the claim that they are the primary driver.
8. Restrictive policies lead to denial of pain care, forced tapering, patient suffering, increased suicide risk, and unjust prosecution of doctors.
9. Lawhern calls for the withdrawal of flawed prescribing guidelines and an end to political interference in evidence-based pain management.
10. Lawhern’s experience as a data analyst and healthcare writer focused on pain and addiction policy provides him with a deep understanding of the issue and its complexities.

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 patient, prescriber, and pharmacy relationship is not present.  Although the presence of this is not proof of diversion, it has been highly touted as suspicious.  However, there are many reasons that this could be explained or cleared.  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, but 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, 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 they are more likely to obtain whatever they need wherever they find convenient.  Often, such a patient will 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 higher distances and avoid other specialists in the field.  Pronto Pharmacy is a compounding pharmacy which is a specialty.  Pronto Pharmacy is a pain management pharmacy that is a specialty.  A reasonable and prudent medical observer of the actions of the patients, prescribers, and pharmacists involved would see this relationship as a 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 many Pharmacies take most insurance, the cost to the patient is most 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 is the increasing number of American Nationals that are not counted and the illegal immigrants who, for the most part, do not have insurance, which 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 (PBM’s), 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 attacks 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 on the standard of care in Pharmacy practice: 

https://www.pharmacytimes.com/contributor/jeffrey-fudin/2017/10/opioid-red-flags-for-consideration-

“Of late, some community pharmacy chains have changed policies that have been developed around the pretext of patient safety. Such policies include the 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 improve safety or mitigate risk. There is sufficient data to support that placing such barriers, at least for patients requiring long-term opioids, may actually contribute to the heroin epidemic.”

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 without intractable pain and who are low-income or without insurance would travel.  As Director of Pharmacy in Home Infusion companies, I have personally needed to send delivery prescriptions for pain management medications as much as 4-hour drive away. This has been a common practice in the specialty of pain management for over 25 years. There is one company that I worked for that sent hemophilia patients various clotting factors nationwide.  To single out pain management as criminal while ignoring the vast number of therapies is the improper intrusion of government into a patient’s constitutionally guaranteed right to life, liberty, and the pursuit of happiness. 

The State of Florida is a big player in Mail-Order Pharmacy and, as such, provides medications (controlled and non-controlled) to patients in other states. This, in and of itself, should invalidate the red flag of distance since the Florida State Legislature and the Florida Board of Pharmacy condone and support this practice. Discriminating against Florida Pharmacies treating Florida patients is grotesque. 

In terms of documentation, I have personally seen patient interviews conducted between Dr. Clement and his patients in intractable pain. As an expert in the field of diversion and pain management, it is clear that without clear-cut guidelines from the DEA, FDA, JCAHO, or ISMP, the steps were reasonable and prudent. Other similarly practicing Pharmacists would concur with my conclusions.  

The DEA removed all of the documentation from Pronto Pharmacy and the backups but did not return them to Dr. Clement.  In fact, because of the negligence of the DEA some of the data was never retrievable, thus making it impossible for Dr. Clement to present the necessary notations on the prescription images, patient notes, patient profiles, and physician notes therein.  Then, he accused him of not having the proper documentation.  In some circles, this would be considered tampering with evidence.  This is very suspicious activity on the part of the DEA.   

EARLY FILLS

Narcotic prescriptions are not refillable and thus cannot be refilled early.  There has never been a C-2 narcotic refilled at Pronto Pharmacy.  That said, let’s look at early fills. Intractable pain is a very complex syndrome complete with changing dynamic clinical states.  These changes in morbidity can mean that a patient may be stabilized on a particular regimen and suddenly fall out of pain control and as such, need higher doses of pain medications.  The opposite is true also.  A patient may find that after reaching steady state blood levels, they could tolerate the pain for longer periods of time between medications.  

Drug interactions play an important role in these changes.  Therefore, for a patient to require an early fill of their medication is not uncommon, nor is a gap in treatment for several months.  The goal of therapy is the reduction of pain to tolerable levels.  Anxiety can often lead to increased pain sensation if a patient runs out of medication.  This is why patients, especially ones that have to travel far for their medications, often come in 2 – 7 days early from time to time.  Insurance companies have set up override codes for this very fact. Every Pharmacy system in America can track override codes.    

However, since the DEA destroyed the data in the Pronto Pharmacy computer, these codes, which are no more than 6 characters spread out over three different fields, cannot be presented.  The malfeasance of the DEA could be considered contributory negligence in this case.  Other places where such documentation could be found are on the front or back of the original prescriptions.  Not to mention the electronic patient profiles, all of which were available to the DEA but not presented at trial.

DRUG COCKTAILS

In this case, the DEA continually referred to combinations of medications as Drug Cocktails, which has no basis in clinical pharmacy or medicine.  It might be a street term, but since we, as Pharmacists, do not operate in the street, the use of that terminology is more akin to propaganda than actual medical practice.  Many patients with chronic pain have comorbidities and require medications to treat other issues.  To cherry-pick out two or three conditions and to assign criminality to them without the benefit of knowing what the patient’s condition rises to the height of absurdity and should be discounted.  

There is a plethora of double-blind, prospective, and retrospective studies that conclude that the combination of several combinations of oxycodone, hydrocodone, gabapentin, cyclobenzaprine, ibuprofen, ketoprofen, alprazolam, temazepam, oxazepam, baclofen, and others have increased efficacy in terms of pain management and the management of comorbidities commonly associated with inflammation, pain, and paralysis.  Competing step care protocols and empirical therapy exist in hospitals, home infusions, and community pharmacies. Therefore, criminalizing the ones being used in these cases without the benefit of the patient interview or prescriber input would raise serious doubts about this red flag.  The current information that the DEA uses to evaluate the use of opioids in the treatment of chronic pain is geared toward primary care practitioners and not specialists. 

January 15, 2025

Incompetence or Bad Faith? Opioids, Guidelines, and the Crisis

This paper argues that guidelines issued by the US CDC, VA, and similar organizations in Canada and the UK regarding opioid prescription are fundamentally flawed.  

The author contends these guidelines are based on false assumptions, leading to the unnecessary suffering of chronic pain patients and the unjust persecution of healthcare providers.  

Three significant studies are cited as evidence contradicting the claims made in the guidelines, demonstrating a significantly lower risk of addiction and overdose than previously asserted.  

The author calls for a complete retraction of these guidelines and an end to political interference in evidence-based medicine. 

Ultimately, the paper accuses these agencies of incompetence or bad faith in their handling of the opioid crisis.

Briefing Doc: Misconceptions and Misdirections in Opioid Crisis Policy

Main Themes: This document, written by Richard A. Lawhern, PhD, argues that the US, Canada, and the UK are fundamentally wrong in their approach to the “opioid crisis.” Lawhern critiques published guidelines restricting opioid prescriptions, asserting they are based on false assumptions and lack scientific evidence.

He emphasizes the devastating consequences for patients in pain and healthcare providers.

Key Points:

• Misattribution of the Opioid Crisis: Lawhern contends that the focus on over-prescribing by healthcare providers is misplaced. He cites studies by Brat et al and Jalal et al to demonstrate that addiction and overdose rates among patients treated with prescription opioids are significantly lower than claimed and that prescription drugs constitute a relatively small percentage of drug overdose deaths.
• Flawed Guidelines: Lawhern criticizes the US CDC, VA, and similar organizations in Canada and the UK for publishing guidelines that are not evidence-based. He highlights their reliance on Morphine Milligram Equivalent Daily Dose (MMEDD), a metric he deems unreliable, and their failure to consider the role of genetic variations in opioid metabolism.
• Disregarding Patient Needs: Lawhern underscores the devastating impact of these restrictive guidelines on patients with chronic pain who are being denied effective pain management. He argues that the focus on preventing addiction has led to the neglect of the needs of millions of patients.
• Criminalization of Medicine: Lawhern criticizes the role of law enforcement agencies like the DEA in persecuting doctors based on unfounded accusations of over-prescribing. He contends that this criminalization of medicine is detrimental to both patients and healthcare providers.

Important Quotes:

• “Everything the US government thinks it knows about the opioid crisis is wrong.” This encapsulates Lawhern’s core argument that the prevailing narrative surrounding the opioid crisis is fundamentally flawed.
• “Someone should tell us: how does such a low risk factor justify under-treating the pain of 999 patients out of 1,000? And how might a clinician reliably predict which of a thousand patients in pain might be vulnerable to substance use disorder?” This quote highlights the disproportionate focus on preventing addiction at the expense of providing adequate pain relief to the vast majority of patients.
• “It is now clear that the opioid crisis is not doctors’ or pharmaceutical companies’ fault.” Lawhern directly challenges the common narrative blaming healthcare providers and pharmaceutical companies for the opioid crisis.
• “It is time for government agencies in multiple countries to publicly repudiate and withdraw their published opioid prescribing guidelines and end political interference in the practice of evidence-based medicine.” This is Lawhern’s call to action, urging a radical shift in policy and a return to evidence-based medicine.

Conclusion: Lawhern’s document serves as a potent critique of current approaches to the opioid crisis. He advocates for a reassessment of the role of prescription opioids in pain management, urging policymakers to prioritize patient needs and adopt a more nuanced, evidence-based approach. He highlights the urgent need for change to address the suffering of patients denied pain relief and the persecution of healthcare providers.

Folson Brief 2020:

CDC Guideline for Prescribing Opioids for Chronic Pain — the United States, 2016

https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fmmwr%2Fvolumes%2F65%2Frr%2Frr6501e1er.htm 

Feds issue new warning to doctors: Don’t skimp too much on opioid pain pills 

https://www.usatoday.com/story/news/health/2019/04/24/opioid-pain-pills-crackdown-doctors-prescriptions-cdc-fda/3562373002/

This has left too many patients not getting the pain relief that they deserve.  In fact, pain relief is a fundamental human right according to the International Treaty on Human Rights that the United States is a signatory to. 

Pain management: a fundamental human right.

https://www.ncbi.nlm.nih.gov/pubmed/17578977

One of the most exciting developments in pain management is opioid rotation.  In this technique, short-acting opioids are rotated or alternated in patients with developed tolerance. Analgesic tolerance is defined pharmacologically as a reduced potency of the analgesic effects of opioids after repeated administration or the need for higher doses to maintain the same effect.  Tolerance is such a factor that State Legislatures nationwide and Congress are grappling with the clinical ramifications of their directives. For example, The Intractable Pain Treatment Act of Texas indicates that there is overwhelming evidence that all types of pain, either of malignant or nonmalignant origin, are underrated, and reluctance to use narcotics for selected patients with nonmalignant painful medical conditions stems from the mistaken belief that they will become narcotic “addicts.” Data from the medical literature do not support such a contention.  Since Dr. Sullivan is not practicing in the field of pain management or hospital or long-term care, it is not unexpected that these new treatment modalities are not on his radar. 

Opioid rotation for cancer pain – American Cancer Society Journal https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/(SICI)1097-0142(19991101)86:9%3C1856::AID-CNCR30%3E3.0.CO;2-G

Other Examples:

• 2009 Clinical Guidelines from the American Pain Society and the American Academy of Pain Medicine on the use of chronic opioid therapy in chronic noncancer pain: what are the key messages for clinical practice?https://www.ncbi.nlm.nih.gov/pubmed/19776687
• Negative mood mediates the effect of poor sleep on pain among chronic pain patients.https://www.researchgate.net/publication/43148187_Negative_Mood_Mediates_the_Effect_of_Poor_Sleep_on_Pain_Among_Chronic_Pain_Patients
• The Intractable Pain Treatment Act of Texas https://europepmc.org/abstract/med/1348377
• Opioid Cumulative Daily Morphine Milligram Equivalents (MME) Limit – MME Decrease – Alabama Medicaid. https://medicaid.alabama.gov/alert_detail.aspx?ID=13378 

CASH PAYMENTS

As was stated before, suspicion of diversion is not an actual diversion.  However, as a diversion expert, I am aware that some people attempt to obtain narcotics from Pharmacies fraudulently, and one thing that tips a Pharmacist off is that the patient attempts to purchase the medication using cash.  This is particularly concerning when it is known that the patient has insurance available.  But there are many reasons that this so-called “red flag” may be investigated and cleared.  By checking the PDMP data, it is possible to see that a patient has previously obtained the medication in question by using insurance.  If this is found to be true, the patient may be trying to divert, especially in the face of other red flags such as distance, early fill, unreasonable therapy, and the like.  However, in this case, the DEA did not produce the historical PDMP data at trial, so it is impossible to say that this condition of ignoring past payment methods existed for any of the patients in question.  

This is crucial information. There are so many legitimate reasons that a patient would pay cash that were not addressed at trial.  The patient in question could not have insurance at all.  The patient could have a lapse in coverage.  The patient might have insurance that is provided by their employer and they might not want the employer to know that they have chronic pain.  Examples of that might be truck drivers or medical personnel or heavy equipment operators.  

The local pharmacies might not accept their insurance.  Pronto Pharmacy could not have a contract with the patient’s insurance.  This item was proven at trial.  If there is no PBM contract, there is no insurance contract.  It is common knowledge that Pronto Pharmacy’s business model includes the principle of not accepting insurance company contracts.  

It is also proven at trial that no law, Federal, State, or Local, requires contracting with a PBM for a Pharmacy.  I used to be the Supervising Pharmacist of a place called Cash Rx Plus Pharmacy in New York City, which did not take insurance either. Many Pharmacies take a few insurances and not others.  With the shrinking margins that are forced upon community pharmacies nationwide, many are cherry-picking which insurance companies to contract with.  Some are avoiding them altogether.  This is an increasing trend in the marketplace.  

The USD or United States Dollar, which is the fiat currency of THE UNITED STATES OF AMERICA, has a statement on every denomination.  It says, “THIS NOTE IS LEGAL TENDER FOR ALL DEBTS PUBLIC AND PRIVATE.” According to 31 U.S. Code § 5103, United States coins and currency (including Federal reserve notes and circulating notes of Federal reserve banks and national banks) are legal tenders for all debts, public charges, taxes, and dues. Foreign gold or silver coins are not legal tender for debts. The prevailing sentiment on this is that all United States money, as identified above, is a valid and legal offer of payment for debts when tendered to a creditor. There is. However, no Federal statute mandates that a private business, a person or an organization must accept currency or coins as payment for goods and services. Private businesses are free to develop their policies on whether or not to accept cash unless a State law says otherwise. For example, a bus line may prohibit payment of fares in pennies or dollar bills. In addition, movie theaters, convenience stores, and gas stations may refuse to accept large denomination currency (usually notes above $20) as a matter of policy.

Currently, no law in this country contravenes 31 U.S. Code § 5103.  Therefore, if a patient offers to pay in cash, it might seem suspicious but does not necessarily raise the level of actual diversion.  This is important because any patient has the right to expect that the Pharmacy will act within the law in this matter, and in light of their freedom of choice and fundamental human rights, suspicion may be present but does not require that the patients themselves be subject to this requirement.  

If a Pharmacist does not reasonably believe that the medication will be diverted, there is no reason not to accept cash.  Currently, the PDMP system at present cannot distinguish between cash, credit, debit or healthcare payment cards.  All of these things come up on the system as cash.  With the growing cost of medications, the payment of copayments, as well as full prices by credit or debit cards, is increasing.  Healthcare payment cards are often the form that employers use to decrease their overall healthcare costs by limiting the benefits to their employees.  The employer matches contributions to the funds made through payroll deductions with specific limitations, which are in fact, insurance in a broad sense.  It removes the bureaucracy of insurance companies and PBMs and switches from the overall cost of healthcare.  

COMPOUNDING VS MANUFACTURING

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, was legislatively negotiated to strike “a balance between two potentially competing policy interests—inducing pioneering development of pharmaceutical formulations and methods and facilitating the efficient transition to a market with low-cost, generic copies of those pioneering inventions at the close of a patent term.” The Hatch-Waxman Act was, at least according to two economists, the first change in patent terms since 1861.  So, one of the pillars of the generic drug push by Congress was to ensure that patients had low-cost alternatives to brand-name drugs.  

Compounding has been a primary facet of the practice of Pharmacy since the beginning of the profession.  Prior to that, it was only done legally by physicians or their assistants.  In the United States, compounding pharmacies are licensed and regulated by their respective states, like all other pharmacies. National standards have been created by the Pharmacy Compounding Accreditation Board (PCAB).  However, accreditation is not mandatory, and inspections for compliance occur only every three years for particular facets of compounding.  As mentioned, some confusion has arisen when the traditionally patient-specific nature of compounding gets blurred by making the multi-product “batches,” such as in anticipation of similar orders.  Notably, the Food and Drug Administration (FDA) has always had the authority to regulate “manufacturing,” – which is when drug products are not made or modified to be tailored in some way to the individual patient – regardless of whether this is done at a factory or at a pharmacy.  And conversely, truly legitimate/traditional compounding does not cease to be so merely by having a high frequency or occurrence – indeed, progressing towards more prevalent drug product customization is an appealing aspect of personalized medicine. https://en.wikipedia.org/wiki/Compounding 

Since I have experience in Manufacturing (Schering-Key) as well as sterile compounding (Director of Pharmacy of several Home Infusion Pharmacies) along with non-sterile compounding (more than 30 years in Retail Pharmacy) very few Pharmacists nationwide have my level of experience and as such I could be thought of as an authority on the subjects.  It was apparent that the Administrative Law Judge (Mr. Dowd), the Diversion Expert (Mr. Alpert), the Prosecutor (Mr. Beerbower), as well as the Expert Witness (Mr. Sullivan) are not likely to understand the level of care and clinical issues in this case better than myself.  Additionally, since I have extra training in reading and understanding the law, although I am not an Attorney, I could be considered a Lawyer (a person learned in the law) as defined in Black’s Law Dictionary 3^rd Edition.  However, I do not delude myself into thinking that my knowledge of the law is all encompassing or greater than that of a Lawful Man acting in the course of the profession of Pharmacy.  But I do maintain that my interpretation of all these sometimes apparently conflicting laws and regulations is understandable to me.  

Reassessing the Opioid Crisis

Early Period (Undated – likely decades ago):

• Misconceptions about opioid pain relievers arise, leading to a negative public perception.
• The American Medical Association (AMA) estimates a 3%-19% addiction rate for patients prescribed opioid medications.

2016:

• The US Centers for Disease Control and Prevention (CDC) publishes opioid prescribing guidelines, which are later criticized for containing significant errors and potentially contributing to the denial of effective pain relief to patients.

2017:

• Elizabeth M. Oliva and colleagues at the US Veterans Administration (VA) develop the STORM predictive risk model. This model accurately predicts overdose or suicide risk in patients treated with opioids for pain, highlighting factors like mental health history and prior overdose attempts as stronger predictors than opioid prescribing itself.

2018:

• Gabriel A. Brat et al. publish a study analyzing data from 37 million commercially insured patients. Their research indicates a very low rate (0.6%) of opioid misuse (defined as dependence, abuse, or overdose) within six years following surgery in opioid-naïve patients. This challenges the prevailing narrative about high addiction rates associated with opioid prescriptions.
• Howre Jalal et al. publish a study in the journal Science, analyzing data from over 600,000 accidental drug overdose deaths between 1978 and 2016. Their findings reveal that prescription drugs have never accounted for more than 22% of all overdose deaths, contradicting claims that prescription opioids are the primary driver of the overdose crisis.

Post-2018:

• The trend identified by Jalal et al. continues, with prescription drugs contributing to an even smaller percentage of overdose deaths (around 12% in 2022).
• The “Opioid Crisis” continues, with the CDC, VA, and law enforcement agencies like the DEA facing criticism for their handling of the situation. Critics argue that their policies and actions have resulted in the persecution of doctors and the denial of necessary pain care to patients.
• The National Institute for Health and Care Excellence (NICE) in the UK publishes guidelines that recommend against starting opioid treatment for chronic pain based on opinions rather than robust clinical evidence.
• Canadian guidelines for opioid therapy in chronic non-cancer pain are released, recommending a dose restriction below 90 mg morphine equivalent per day. These guidelines, like their US counterparts, are criticized for relying on the disputed concept of Morphine Milligram Equivalent Daily Dose (MMEDD).
• Richard A. Lawhern, PhD, a healthcare writer and data analyst, publishes a critical review of the opioid crisis response by the CDC, VA, and law enforcement, arguing that their actions are based on flawed assumptions and have caused significant harm.

Current Day (2024 and beyond):

• The debate over the “Opioid Crisis” continues, with advocates pushing for changes in policy and a more evidence-based approach to pain management.

Cast of Characters

Richard A. Lawhern, PhD: A healthcare writer and data analyst with extensive experience in public health policy related to opioid analgesics. He is a vocal critic of the CDC, VA, and law enforcement’s response to the “Opioid Crisis,” arguing that their policies are based on faulty science and have caused significant harm to patients in pain and their healthcare providers.

Gabriel A. Brat: Lead author of a 2018 study that analyzed data from 37 million commercially insured patients. His research challenged the prevailing narrative about high addiction rates associated with opioid prescriptions, showing a significantly lower rate of opioid misuse following surgery.

Elizabeth M. Oliva: A researcher at the US Veterans Administration who, along with her colleagues, developed the STORM predictive risk model in 2017. This model accurately predicts the risk of overdose or suicide in patients treated with opioids for pain, emphasizing factors like mental health history as stronger predictors than opioid prescribing itself.

Howre Jalal: Lead author of a 2018 study published in the journal Science. His research, analyzing data from over 600,000 accidental drug overdose deaths, revealed that prescription drugs have never been the primary driver of the overdose crisis.

Nora Volkow, MD: Director of the US National Institute on Drug Abuse (NIDA). While not directly mentioned in the provided text, her work on addiction is referenced to support the argument that addiction is a rare outcome of opioid prescribing.

Organizations:

• United States Centers for Disease Control and Prevention (CDC): A US government agency responsible for public health. The CDC’s 2016 opioid prescribing guidelines are central to the controversy discussed in the text.
• US Veterans Administration (VA): A government-run healthcare system for US military veterans. The VA’s opioid prescribing practices and the development of the STORM risk model are significant points of discussion.
• Drug Enforcement Administration (DEA): A US federal law enforcement agency responsible for combating drug trafficking and abuse. The DEA’s role in enforcing opioid regulations and its perceived role in the “Opioid Crisis” are highlighted.
• American Medical Association (AMA): A professional organization for physicians in the US. The AMA’s earlier estimate of addiction rates associated with opioid prescribing is contrasted with newer research findings.
• National Institute for Health and Care Excellence (NICE): A UK organization that provides guidance and advice on health and social care. NICE’s guidelines on opioid prescribing are mentioned for their restrictive approach and lack of supporting evidence.

DEFINITION OF MANUFACTURING: 

21 U.S. Code § 802 

(15) The term “manufacture” means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice. The term “manufacturer” means a person who manufactures a drug or other substance. 

DEFINITION OF COMPOUNDING:

Section 503A of the Federal Food, Drug, and Cosmetic Act SEC. 503A. 

PHARMACY COMPOUNDING.

(a) In General.–Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient if the drug product meets the requirements of this section, and if the compounding–

(1) is by–

(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or

(B) a licensed physician, on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or

(2) (A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and

(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between–

(i) the licensed pharmacist or licensed physician; and

(ii) (I) such individual patient for whom the prescription order will be provided; or

(II) the physician or other licensed practitioner who will write such prescription order.

Mr. Sullivan indicated that compounding should be narrowly drawn at trial.  This flies in the face of 200 years of Pharmacy Practice standards.  What he defines as when it is proper to compound is based upon his opinion and that of the manufacturers.  However, Pharmacists nationwide would not agree.  If patients cannot afford their medication, their clinical outcomes are less than optimal.  Price can be a major factor in compliance, so when Pronto Pharmacy minimizes the impact of price, they are acting within the spirit of the law that created generics in the first place. Because the batches are small it could be inferred that the danger is also decreased.  Manufacturers’ errors lead to nationwide recalls (Cimetidine), but small batch compounding can only affect a few people, and therefore safer for the public.  When I started in the profession all Pharmacies were required to have compounding supplies as a condition of registration in every state in the union.  However, as the manufacturers gained more of a stranglehold on the government with their bribes and corruption, compounding in Pharmacy began to diminish.  We found that as insurance penetration into the profession increased the reimbursement for compounding decreased.  But Congress and the State Boards of Pharmacy have not totally abandoned the profession and compounding still has its place as a pillar of Pharmacy.  Without compounding there will be no intravenous admixtures, specialized solutions to complex problems or innovation.  

In this case all the things that are required for compounding instead of manufacturing are present.  Each prescription for a compound is for a specific patient.  There is a Physician – Pharmacist relationship.  There is a Patient – Pharmacist relationship.  In the anticipatory compounding reasonable, limited quantities are being compounded and the necessary prescriptions do show up in reasonable time frames.  All over the country, anticipatory compounding is done, and a typical limit is about 3 weeks but may actually loom as high as 3 months in some cases.  This is the standard of care in compounding Pharmacy.  Mr. Sullivan does not realize this is further proof of his lack of experience, and thus, he is not an expert in this realm.  Diversion Expert Alpert admitted at trial that he has no understanding of compounding.   The DEA did not produce even one piece of evidence that shows mastery of the subject of compounding. 

ANTICIPATORY COMPOUNDING OF CONTROLLED SUBSTANCES

The DEA contended that Pronto Pharmacy illegally manufactured controlled substances.  However, without mastery of the laws concerning compounding, their contention fails on its face.  Let’s look at the pertinent statutes:

21 U.S. Code § 841.Prohibited acts

(a)Unlawful acts Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally—

(1)to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense a controlled substance

Taken by itself, I could see their point.  However, there are exceptions in play.

This information is available on the DEA, Findlaw, and elsewhere.  Since the wording in this part is particularly voluminous, and Pronto Pharmacy had a valid DEA license at the time that was without blemish and not expired, this is the only pertinent part that might be under question.

21 USC § 1301.13 Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents, and signature; coincident activities

(iii) Dispensing or Instructing (includes… Retail Pharmacy…) A Pharmacist may manufacture aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion not exceeding 20 percent of the complete solution, compound or mixture,

Business Activity – (iv) Dispensing or instructing (includes Practitioner, Hospital/Clinic, Retail Pharmacy, Central Fill Pharmacy, Teaching institution)

Controlled substances Schedules ll-V

DEA Application Forms New – 224 Renewal – 224a

Application Fee $731 

REGISTRATION PERIOD 3 years

Coincident Activities allowed May to conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute.  A Pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form consisting of a narcotic controlled substance in Schedule ll – V in a proportion not exceeding 20% of the complete solution, compound or mixture. A Retail Pharmacy may perform central fill activities.

As can be seen, when the DEA contended that Pronto Pharmacy needed to be registered as a manufacturer, the law says otherwise.  Compounding of controlled substances takes place in every state of the union and has since the beginning. If the prohibition is against a certain substance, the law could be changed, such as it was in the case of heroin, laudanum, opium, and so many others.  The law could have been changed long before if it were meant to restrict C-2 medications.  The reporting of the C-2 medications in question to PDMP was proper, according to the silence on the part of the DEA who brought this case.  The question of exceeding the 20% maximum was not a point of contention in the case and therefore is not in question here.

Removing anticipatory compounding from Pharmacy Practice would have many far-reaching negative consequences for patient care and an exponential increase in unnecessary waste.  After all, to pierce anticipatory compounding would too broadly define the issue.  It would include antibiotics, antipsychotics, neuroleptics, vitamins, tablets, capsules, pills, troches, solutions, emulsions, creams, lotions, macerations, decoctions, ointments, suppositories, and all the other dosage forms that exist.  It is highly unlikely that the Legislature would have as its intent such an egregious threat to public safety or such burdensome costs to be placed on the American people.  The FDA regulates compounding and manufacturing.  The DEA is in charge of administering and enforcing the Controlled Substances Act.  The State Boards of Pharmacy regulate compounding.  Therefore, a practicing pharmacist must be abreast of sometimes overlapping jurisdictions and possibly contradictory information.  

Before starting this case, the DEA could have looked at the PDMP data and surmised that these patients were stabilized on pain management therapies.  Even if they didn’t fully understand the effects of enzyme induction, drug interactions, tolerance, or comorbidity protocols, there is ample information to help them figure these things out in the public space.  However, they did not focus their gaze on possible treatment of patients but rather on suspicion and innuendo.   

A reasonable and prudent individual might conclude that discovering the truth was not the goal in this investigation.

RESPECTFULLY SUBMITTED

Jack Folson, Jr – Clinical Pharmacist

Owner – THE CALYX GROUP

28228 Warren Road

Westland, Michigan 48185

908-327-7322

Expert in Pharmacy Practice

CERTIFICATE OF SERVICE

I HEREBY CERTIFY that on June 9, 2020, a true and correct copy of the foregoing was electronically filed via ECF and/or served via e-mail upon the following:

John E. Beerbower, Esq. Diversion & Regulatory Litigation Section Drug Enforcement Administration Office of Chief Counsel 8701 Morrissette Drive Springfield, VA 22152 John.E.Beerbower@usdoj.gov DEA.Registration.Litigation@usdoj.gov		Dale R. Sisco // Dominic A. Isgro  SISCO- LAW  1110 N. Florida Avenue Tampa, FL  33602 (813) 224-0555 (813) 221-9736 FAX dsisco@sisco-law.com  Florida Bar No. 559679 disgro@sisco-law.com  Florida Bar No. 113318 Attorneys for the Respondent
Hearing Clerk  Office of Administrative Law Judges Drug Enforcement Administration 8701 Morrissette Drive Springfield, VA 22152 ECF-DEA@usdoj.gov

BACKGROUND

As far as can be determined 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 that specializes 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, as well as more than 45 years of experience. The typical CVS Pharmacist has less than five 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 training level 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 in service for many years, so the red flags may have been resolved years or even decades ago.  Therefore, the documentation of the same might not be captured by an investigator who does not interview the patient, the Physician, or the Pharmacist.  Often, the pertinent information is archived.  

In the Holliday CVS case, one issue was dispensing narcotic prescriptions from prescribers with expired or revoked DEA registrations.  This did not happen at Pronto Pharmacy.  

HIGH DOSE OPIOIDS       

At trial, the expert witness for the DEA, Dr. Donald Sullivan, contended that Oxycodone and Hydrocodone were the highest available dosage form.  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 Holliday CVS case, the maximum daily dose for Oxycodone was six 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.  

Conclusion

These are but a few indicators that the search for truth did not exist during this procedure.  Everything presented here is common knowledge and available to the DEA and was available before the proceedings. 

It seems that prosecutorial myopathy was in play here.  But, because the DEA has an agenda that is based upon incomplete information and a desire to combat the so-called “Opioid Epidemic” and has had its feet held to the fire by the Office of the Inspector General’s Report on the DEA https://oig.justice.gov/reports/2019/e1905.pdf their focus on diversion could be seen as overzealous. 

Unfortunately, this misguided witch hunt has made individual practitioners the scapegoat.  The biggest issue is that suspicion of diversion is not necessarily actual diversion.  

Before starting this case, the DEA could have interviewed the prescribers and learned about the individual patient’s needs. However, they did not.

Had they done so, and wrongdoing was found, they could have censured the prescriber and notified the Pharmacists in the state to avoid the prescriber’s narcotic prescriptions. If no wrongdoing had been found, the DEA could have concentrated its resources in other areas. 

Even still, because of the DEA’s fear of retribution, most prescribers took a too-conservative approach. Indeed, the CDC and the FDA agree that these standards may be too constricting for a majority of pain patients.

Briefing Doc: The DEA, Opioid Crisis, and Physician Persecution

Main Themes:

• Misplaced blame in the opioid crisis: The source strongly argues that the DEA is to blame for the opioid crisis due to its incompetence and focus on persecuting physicians rather than addressing the root causes, like the influx of illicit fentanyl.
• Unjust prosecution of physicians: The source presents multiple cases of physicians being unjustly targeted and prosecuted by the DEA, leading to severe consequences like imprisonment, loss of licenses, and financial ruin.
• Harm to patients: The source emphasizes that the DEA’s actions have created a climate of fear among healthcare providers, leading to undertreatment of legitimate pain patients and pushing them towards dangerous alternatives.

Most Important Ideas/Facts:

1. DEA’s role in the opioid crisis:

• The source claims the DEA has ultimate control over legal narcotics manufacturing in the US, but has failed to prevent theft and loss, which is the true source of the crisis.
• Quote: “What has been responsible for the drug crisis is the tremendous number of narcotics being stolen or lost, NOT the prescriptions written by doctors.”
• The DEA’s focus on prosecuting physicians is likened to “getting the low-hanging fruit” and diverting attention from its own failures.
• Quote: “The Drug Enforcement Administration, the agency that most directly oversees access to opioids, deserves much of the blame for these deaths…Because of its incompetence, the opioid crisis has gone from bad to worse.”

1. Physician persecution:

• The source cites HIPAA regulations and the healthcare fraud law (18 U.S.C. §1347) as tools used to unfairly target physicians.
• Quote: “Buried in the bowels of the HIPAA regulation text was a rotten compilation of laws, including the health care fraud regulations (18 U.S.C. §1347).”
• It lists numerous examples of physicians who have faced severe consequences, including Dr. Steven Henson (life in prison), Dr. Bockoff, Dr. Couch, Dr. Ruiz, Dr. Joel Smithers (40 years in prison), and Dr. Richard Paulus.
• Quote: “Our best and brightest in the medical profession are being detained and imprisoned.”
• The source alleges a racial bias in targeting, with physicians of color disproportionately targeted and receiving harsher sentences.

1. Impact on patients:

• The source argues that the DEA’s actions have created a climate of fear among healthcare providers, leading many to avoid prescribing opioids altogether.
• Quote: “Doctors increasingly face scrutiny and legal risks when prescribing opioids… This has created a climate of fear among healthcare providers, many of whom avoid prescribing pain medication altogether to protect their careers.”
• This results in undertreatment of legitimate pain patients, who are left to suffer unnecessarily and often turn to dangerous alternatives.
• Quote: “As a result, countless patients with legitimate pain needs go untreated, suffering unnecessarily because doctors are afraid to provide appropriate care.”

Calls to Action:

• The source urges for reform of the DEA, including the possibility of “getting rid of it entirely.”
• It advocates for Attorney General Pam Bondi to “clean house” at the DEA and stop the unjust prosecution of physicians.
• It encourages support for legal defense funds for targeted physicians.

Overall:

The source presents a strong and impassioned argument against the DEA’s handling of the opioid crisis. It blames the agency for the crisis itself, accuses it of unjustly targeting physicians, and highlights the devastating consequences for patients with legitimate pain needs. The source calls for urgent reform and action to address these issues.

The DEA: A Force for Good or Fueling the Opioid Crisis?

Source: Excerpts from “Pasted Text” (likely an online article or blog post)

I. The DEA Under Fire

• This section establishes the central argument of the source material: the DEA is unjustly targeting physicians, fueling the opioid crisis through its incompetence, and needs to be reformed or abolished.
• It highlights the climate of fear among healthcare providers due to scrutiny from the DEA and other regulatory bodies.
• It introduces the concept of the DEA benefiting financially from drug-related deaths and seizures.

II. The Impact of HIPAA and the Rise of Physician Prosecutions

• This section explores the 1996 Health Information Portability and Accountability Act (HIPAA) and how it unintentionally paved the way for increased prosecutions of physicians.
• It criticizes the DEA’s tactics, including the use of intimidation and asset seizure, and accuses them of operating outside the rule of law.

III. The Ruan vs. United States Case and the DEA’s Disregard

• This section examines the landmark Supreme Court ruling in Ruan vs. United States, which established the importance of considering a physician’s good faith efforts in prescribing controlled substances.
• It criticizes the DEA for ignoring the Ruan ruling and continuing to target physicians based on subjective interpretations of medical practice.

IV. The Human Cost of the DEA’s Actions

• This section focuses on the devastating consequences of the DEA’s policies on patients with legitimate pain needs.
• It highlights the increase in veteran suicides and the suffering of countless patients who are denied access to essential pain medication.
• It features anecdotal accounts of physicians like Dr. Muhamad Aly Rifai, who are targeted and penalized by the DEA despite providing quality care.

V. The Real Culprit: Illicit Fentanyl and the DEA’s Incompetence

• This section argues that the opioid crisis is primarily driven by the proliferation of illicit fentanyl, not prescription opioids.
• It criticizes the DEA for failing to address the fentanyl problem effectively and suggests they benefit from the increased drug-related deaths.
• It highlights the case of Dr. Lesly Pompy, who was acquitted of unlawful prescribing charges, demonstrating the DEA’s overreach.

VI. Calls for Reform and the Need for Accountability

• This section calls for reform of the DEA, emphasizing the need for an overhaul or even the abolition of the agency.
• It cites legal experts like Leo Beletsky, who place blame for the opioid crisis on the DEA’s incompetence.
• It advocates for a shift in focus towards targeting illicit fentanyl and protecting patients with legitimate pain needs.

VII. Unjust Prosecutions and the Erosion of Physician Trust

• This section continues to expose the injustice faced by physicians accused of healthcare fraud, showcasing the cases of Dr. L. Joseph Parker, Dr. Steven Henson, and Dr. Richard Paulus.
• It highlights the devastating impact of these prosecutions on patients who lose access to trusted healthcare providers.
• It calls for a return to trial by jury as a safeguard against prosecutorial overreach and emphasizes the need for experienced legal representation for physicians facing unfounded accusations.

VIII. A Call to Action

• The final section urges readers to donate to legal defense funds for targeted physicians and underscores the importance of fighting against the suppression of knowledge.
• It leaves the reader with a sense of urgency and a call to stand up for physicians and patients caught in the crossfire of the opioid crisis.
• _______________________________________________________________________________________________________________

Factors Contributing to the US Opioid Crisis

The sources provided point to a complex interplay of factors contributing to the opioid crisis, with a particular emphasis on the role of the Drug Enforcement Administration (DEA) and its policies.

Here are some key contributing factors:

●

Restrictive Drug Policies and Fear Among Healthcare Providers: The sources highlight how the opioid crisis has led to stringent policies and increased scrutiny of doctors prescribing opioids. This environment of fear has led many healthcare providers to avoid prescribing pain medications altogether, even for patients with legitimate needs. This, in turn, has resulted in untreated pain and suffering for many patients.

●

DEA’s Role in Fueling the Crisis: The sources strongly criticize the DEA, arguing that its actions have exacerbated the opioid crisis. They claim that the DEA’s focus on prescribers is misdirected and that the agency’s incompetence in controlling the flow of narcotics has allowed the problem to worsen. Sources specifically point to the DEA’s slow response to the dangers of fentanyl, allegedly motivated by the agency’s desire for increased budgets and seizures.

●

Shift in Focus from Illicit Substances to Prescribed Medications: The sources argue that the focus on prescribed opioids has shifted attention away from the real culprit behind opioid-related deaths: illicit substances like fentanyl. They contend that people are not dying from properly prescribed and supervised opioid use; instead, they are dying from dangerous street drugs.

●

Unjust Prosecutions of Physicians: The sources describe the DEA’s approach as a “war on doctors,” with accusations of unjust prosecutions and intimidation tactics. They claim that doctors are being targeted and imprisoned for practicing medicine responsibly, and that the DEA’s actions are driven by a desire for seizures and financial gain rather than public health.

The sources provide a specific example of Dr. Lesly Pompy, who was acquitted of unlawful prescribing and other charges. This acquittal is presented as evidence of the DEA’s overreach and tendency to unjustly target physicians.

The sources advocate for reform, suggesting that the DEA should be overhauled or even abolished. They call for a shift in focus toward addressing the flow of illicit substances like fentanyl and away from targeting physicians who are prescribing medications responsibly.

The sources present a strong argument against the DEA and its role in the opioid crisis. They emphasize the negative consequences of restrictive policies that have created fear among healthcare providers, leading to untreated pain for patients in need.

The DEA’s actions have had a significant impact on healthcare providers and patients, primarily by creating a climate of fear that discourages the prescription of opioids, even for patients with legitimate pain needs.

●

Increased Scrutiny and Legal Risks for Healthcare Providers: The DEA has increased its scrutiny of healthcare providers who prescribe opioids, leading to fines, license suspensions, and even criminal charges for some providers. This has created a climate of fear among healthcare providers, many of whom avoid prescribing pain medications altogether to protect their careers.

●

Under-Treatment of Pain and Patient Suffering: As a result of the DEA’s actions, countless patients with legitimate pain needs are going untreated and suffering unnecessarily. Doctors are afraid to provide appropriate care for fear of legal repercussions.

●

Focus on Prescribers Instead of Illicit Drug Supply: While the DEA has focused on prescribers, the majority of opioid-related deaths are caused by fentanyl and other illicit drugs. The war on opioids should focus on illicit substances, not the regulated medications that chronic pain patients need to maintain quality of life.

●

Unintended Consequences of Opioid Safety Initiative: The Opioid Safety Initiative, aimed at curbing opioid misuse and addiction, has had unintended negative effects, including increased vulnerability of some patients suffering from severe chronic pain. Some patients, suddenly tapered or taken off their pain medications, have died due to the physical deterioration of their health caused by under-treated or untreated pain.

●

DEA’s Role in Fueling the Opioid Crisis: The DEA has been criticized for its role in fueling the opioid crisis.  The DEA has ultimate control over how many legal narcotics are manufactured in the U.S. and regulates every aspect of narcotics. Critics argue that the DEA’s focus on prescribers has diverted attention from the vast quantities of narcotics that are stolen or lost. Critics also point to the DEA’s slow response to the rise of dangerous street analog drugs like acetylfentanyl, suggesting that the agency benefits from increased drug abuse and deaths due to larger budgets, seizures, and forfeitures.

●

DEA’s Incompetence and Unjust Prosecutions: The DEA has been accused of incompetence, unjust prosecutions, and ignoring Supreme Court rulings. Critics argue that the DEA targets low-hanging fruit by going after prescribers instead of tackling the more complex problem of illicit drug trafficking. They also point to cases where exemplary physicians have been targeted and unjustly prosecuted, leading to imprisonment, loss of licenses, and seizure of assets.

●

Call for DEA Reform or Abolition: Some critics call for overhauling the DEA or even abolishing it entirely. They argue that the DEA’s actions have done more harm than good and that the agency needs to be reformed or replaced to effectively address the opioid crisis.

The sources highlight a complex issue with significant consequences for both healthcare providers and patients. The DEA’s actions have created a challenging environment for pain management, leading to under-treatment of pain and unnecessary suffering for patients while placing healthcare providers at risk of legal action. Critics argue that the DEA’s focus on prescribers has been misguided and that the agency needs to be reformed or abolished to effectively address the root causes of the opioid crisis.

Legal and Ethical Issues Surrounding Opioid Prescription Practices

The sources highlight several legal and ethical issues surrounding opioid prescription practices, particularly focusing on the actions of the Drug Enforcement Administration (DEA) and Department of Justice (DOJ):

●

Overzealous Prosecution and Intimidation of Physicians: The sources argue that the DOJ and DEA aggressively prosecute physicians for opioid prescriptions, creating a climate of fear that deters doctors from adequately treating patients with legitimate pain needs. This has resulted in many patients suffering unnecessarily and even dying due to inadequate pain management. The sources specifically criticize the use of HIPAA regulations, intended for patient privacy, as a tool for prosecuting physicians. They also point to the targeting of specific demographics within the medical profession, such as older physicians, those in private practice, foreign medical graduates, and physicians of color.

●

DEA’s Role in the Opioid Crisis: The sources claim that the DEA’s actions have exacerbated the opioid crisis by focusing on prescribers rather than the sources of illicit fentanyl and the theft or loss of legally manufactured narcotics. They allege that the DEA has neglected its responsibility to regulate the manufacturing and distribution of narcotics, leading to increased availability of illicit substances. The sources also point to the DEA’s financial incentives to maintain the drug crisis as a justification for increased budgets and asset seizures.

●

Disregard for Medical Expertise and Patient Needs: The sources criticize the DEA for creating its own “medical science” and ignoring the individual needs of patients. They argue that the DEA’s focus on statistics and a rigid “norm” for prescribing practices fails to consider the legitimate medical needs of patients with chronic pain. This disregard for medical expertise and patient autonomy creates a system where patients are denied effective pain management and forced to seek dangerous alternatives on the black market.

●

Unjust Asset Seizures and Erosion of Due Process: The sources accuse the DEA of using intimidation tactics and unjustly seizing the assets of healthcare providers. They describe a system where physicians are subjected to house arrest, imprisonment, and the loss of their professional licenses without due process. The sources call for reform of the DEA, suggesting either an overhaul of the agency or its complete elimination.

●

Focus on Funding over Public Health: The sources suggest that the DEA’s focus is on generating revenue through asset seizures and prosecutions rather than addressing the root causes of the opioid crisis. They argue that the DEA’s actions benefit the agency financially while harming patients and healthcare providers. The sources advocate for a shift in focus from prosecuting prescribers to targeting illicit fentanyl manufacturers and traffickers.

The sources present a strong critique of the DEA and DOJ, arguing that their actions have created an environment of fear and mistrust in the medical community, leading to inadequate pain management for patients and exacerbating the opioid crisis. They call for reform of the DEA and a more nuanced approach to opioid prescription practices that prioritizes patient care and medical expertise.

REFERENCES:

Pronto Pharmacy and the DEA: Compounding, Diversion, and Due Process

FAQ: 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 bypass closer options.
• Early Fills: Patients consistently request refills of controlled substances before their prescribed supply has been exhausted.
• Drug Cocktails: Dispensing combinations of drugs that, while potentially appropriate for legitimate medical use, could also indicate diversion.
• Cash Payments: Patients pay 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. Before taking any action, a thorough investigation should be conducted to determine the legitimacy of prescriptions and patient needs.

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 significantly negatively impact 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.
• Stifled Innovation: Limiting anticipatory compounding could discourage innovation in personalized medicine, as pharmacies would hesitate to develop new compounded formulations without guaranteed demand.

Pronto Pharmacy Case Study: Law and Practice

Understanding Pharmacy Law and Practice: A Study Guide

Quiz

Instructions: Answer each question in 2-3 sentences.

1. What type of pharmacy is Pronto Pharmacy and how does it differ from chain pharmacies like CVS?
2. What are the potential shortcomings of using “red flags” as sole indicators of prescription drug diversion?
3. Explain why the “distance” red flag might be unreliable in the context of Pronto Pharmacy.
4. According to Jack Folson, why is the term “drug cocktails” problematic in this case?
5. What are some of the legitimate reasons a patient might pay for their prescriptions with cash?
6. Differentiate between “compounding” and “manufacturing” in the pharmaceutical context.
7. What legal authority does a pharmacist have to compound medications, particularly those containing controlled substances?
8. How does the concept of “anticipatory compounding” apply to Pronto Pharmacy’s practices?
9. What criticisms does Jack Folson make regarding the DEA’s investigation and prosecution of Pronto Pharmacy?
10. What alternative actions could the DEA have taken prior to initiating legal action against Pronto Pharmacy?

Answer Key

1. Pronto Pharmacy is a specialty pharmacy specializing in pain management and non-sterile compounding. Unlike chain pharmacies like CVS, Pronto focuses on disease state management and personalized patient care for complex conditions, rather than high-volume dispensing.
2. “Red flags” are often based on generalized assumptions and may not account for individual patient circumstances or the nuances of specialized medical practices. Relying solely on red flags without proper investigation can lead to misjudgments and potentially harm patients who legitimately require certain medications.
3. The “distance” red flag is unreliable in Pronto Pharmacy’s case because it is a specialty pharmacy attracting patients with specific needs who may travel long distances to receive specialized care. Additionally, factors like insurance limitations and discriminatory practices by chain pharmacies can motivate patients to seek alternative options.
4. The term “drug cocktails” is problematic because it carries negative connotations and lacks a basis in clinical pharmacy or medicine. It oversimplifies the complex needs of patients with chronic pain who may require multiple medications to manage their pain and associated comorbidities.
5. Patients might pay cash for various legitimate reasons, including lack of insurance, a lapse in coverage, privacy concerns related to their employment, or the pharmacy not accepting their specific insurance plan. It’s important to note that using cash does not automatically equate to diversion.
6. Compounding involves preparing customized medications tailored to individual patient needs based on a prescription, while manufacturing refers to large-scale production of standardized drug products for general distribution.
7. Pharmacists are legally authorized to compound medications, including those containing controlled substances, as long as they adhere to state and federal regulations. The law permits compounding for individual patients based on valid prescriptions and within specified limits for controlled substances.
8. Anticipatory compounding allows pharmacists to prepare limited quantities of compounded medications in anticipation of receiving valid prescriptions based on an established history with a patient or prescriber. This practice promotes efficiency and timely access to necessary medications for patients with ongoing needs.
9. Jack Folson criticizes the DEA for failing to conduct a thorough investigation before taking action against Pronto Pharmacy. He argues that they neglected to interview prescribers, understand the complexities of pain management, and consider alternative explanations for Pronto Pharmacy’s practices, leading to a mischaracterization of their actions.
10. The DEA could have investigated individual prescribers, analyzed PDMP data to assess patient medication histories, and consulted with pain management specialists to gain a better understanding of the legitimate needs of chronic pain patients before pursuing legal action against Pronto Pharmacy.

Essay Questions

1. Analyze Jack Folson’s argument that “suspicion of diversion is not necessarily actual diversion.” Discuss the ethical and legal implications of relying solely on “red flags” to identify potential diversion.
2. Evaluate the potential impact of restricting or eliminating anticipatory compounding on patient care, particularly for individuals with chronic pain or complex medical conditions.
3. Compare and contrast the roles of the DEA, FDA, and State Boards of Pharmacy in regulating the compounding and dispensing of medications, including controlled substances. Analyze the potential for conflicting regulations or jurisdictional overlaps.
4. Discuss the challenges specialty pharmacies like Pronto Pharmacy face in navigating the complexities of insurance, pharmacy benefit managers (PBMs), and patient affordability. How can regulatory frameworks better support access to necessary medications while ensuring patient safety?
5. Explore the evolving role of pharmacists in disease state management and patient-centered care. How can pharmacists collaborate effectively with prescribers and other healthcare professionals to optimize medication therapy for patients with chronic pain or other complex conditions?

Glossary of Key Terms

Term Definition Amicus BriefA legal document filed by a non-party to a case that provides information or expertise relevant to the issues before the court.

Red Flags of Diversion Indicators or patterns of behavior that may suggest potential diversion of prescription drugs for illicit purposes.PDMPPrescription Drug Monitoring Program: an electronic database that tracks prescription drug dispensing and identifies potential diversion or misuse.

Disease State Management: A collaborative approach to healthcare that focuses on managing chronic conditions to improve patient outcomes and reduce healthcare costs.

Compounding: Preparing customized medications tailored to individual patient needs based on a prescription.

Manufacturing: The large-scale production of standardized drug products for general distribution.Anticipatory CompoundingCompounding limited quantities of medications in anticipation of receiving valid prescriptions based on an established history with a patient or prescriber.Controlled Substances ActFederal law regulates the manufacture, distribution, dispensing, and possession of controlled substances (drugs with a potential for abuse or addiction).

DEADrug Enforcement Administration: the federal agency responsible for enforcing the Controlled Substances Act.FDA Food and Drug Administration: the federal agency responsible for regulating food, drugs, and medical device safety and effectiveness.

State Boards of Pharmacy: State-level agencies that regulate pharmacy practice, including licensing pharmacists and pharmacies, setting standards for compounding and dispensing, and investigating violations of pharmacy law.

Prosecutorial Myopathy is a term describing a prosecutor’s excessive zeal or bias in pursuing a conviction, potentially leading to disregarding evidence or ethical considerations.

Pronto Pharmacy Amicus Brief: A Case of Diversion

Timeline of Events

Unfortunately, the provided source does not provide a detailed timeline. The document is an amicus brief, focusing on arguing against the DEA’s decision and highlighting the expertise of Jack Folson Jr. rather than providing a chronological account of events.

However, we can piece together a rough timeline based on the information provided:

• Undisclosed Past: Dr. Clement, the pharmacist at Pronto Pharmacy, established his practice specializing in pain management and compounding. He has built a reputation and clientele over many years.
• Undisclosed Past—Present: Pronto Pharmacy operates with a business model that does not accept insurance company contracts. Due to the specialized services offered, patients pay in cash and often travel long distances to obtain medication.
• Undisclosed Past (likely years): Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195 cases establish legal precedents regarding “Red Flags of Diversion,” a concept central to the DEA’s case against Pronto Pharmacy.
• Undisclosed Date: DEA conducts an investigation of Pronto Pharmacy, possibly seizing documentation and computer data.
• Undisclosed Date: DEA issues an immediate suspension order against Pronto Pharmacy, effectively halting its operations.
• Undisclosed Date: A trial takes place where DEA presents its case against Pronto Pharmacy, alleging illegal distribution of controlled substances based on perceived “Red Flags of Diversion.”
• Undisclosed Date: Dr. Donald Sullivan, a diversion expert, testifies on behalf of the DEA, while Jack Folson Jr. provides expert testimony defending Pronto Pharmacy and Dr. Clement.
• June 4, 2020: Jack Folson Jr. completes his amicus brief, criticizing the DEA’s actions, the prosecution’s arguments, and the expert witness’s lack of understanding of specialized pain management practices.
• June 9, 2020: The amicus brief is electronically filed and served to relevant parties, including the DEA, the respondent’s attorneys, and the hearing clerk.

Cast of Characters

1. Dr. Clement:

• Pharmacist and owner of Pronto Pharmacy in Tampa, Florida.
• Specializes in pain management and non-sterile compounding.
• Has advanced training in therapeutics, pain management, Dentistry, and Forensics.
• Possesses over 45 years of experience in pharmacy practice.

2. Jack Folson Jr.:

• Clinical pharmacist and owner of The Calyx Group.
• Retained by Pronto Pharmacy as an expert in pharmacy practice to review the case.
• Has experience in hospital, retail chain, retail independent, sterile compounding, and non-sterile compounding pharmacy settings.
• Served as a former Director of Pharmacy.
• Author of the amicus brief.

3. Dr. Donald Sullivan:

• Expert witness for the DEA at the trial.
• Presents arguments based on “Red Flags of Diversion.”
• Lacks experience in pain management and compounding, leading to criticisms of his understanding of Pronto Pharmacy’s practices.

4. Mr. Alpert:

• DEA Diversion Expert involved in the case.
• Admitted at trial to having no understanding of compounding.

5. John E. Beerbower, Esq.:

• Attorney representing the DEA in the case against Pronto Pharmacy.
• Works for the Diversion & Regulatory Litigation Section of the DEA Office of Chief Counsel.

6. Dale R. Sisco & Dominic A. Isgro:

• Attorneys representing Pronto Pharmacy (the respondent).
• Work for Sisco-Law in Tampa, Florida.

7. Mr. Dowd:

• Administrative Law Judge presiding over the case against Pronto Pharmacy.

8. Professor Doering:

• Expert witness who testified in the Holiday CVS case, setting precedent for “Red Flags of Diversion.”
• Not directly involved in the Pronto Pharmacy case, but his previous testimony is referenced.

Note: This cast of characters is based solely on the provided source. Other individuals may have been involved in the case, but their names and roles were not mentioned in the amicus brief.

Folson’s Amicus Brief: Pronto Pharmacy Case

Briefing Document: Review of Jack Folson’s Amicus Brief in Support of Pronto Pharmacy

Case: United States Department of Justice Drug Enforcement Administration vs. Pronto Pharmacy, LLC Tampa, Florida

Document: Amicus Brief by Jack Folson, Jr., Clinical Pharmacist and Owner of The Calyx Group

Date: June 4, 2020

Main Argument: Jack Folson argues that the DEA’s actions against Pronto Pharmacy, a specialty pharmacy specializing in pain management and compounding, are based on a misapplication of “red flags of diversion” and a lack of understanding of the nuances of pain management practices.

Key Themes and Facts:

• Specialty Practice vs. General Pharmacy: Folson emphasizes the distinction between Pronto Pharmacy’s specialized practice and chain pharmacies like CVS. He argues that applying the same “red flags” used in the Holiday CVS case to Pronto Pharmacy is inappropriate, as the latter operates with a different level of expertise and patient selection criteria.

Quote: “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.”

• Misinterpretation of “Red Flags”: Folson systematically addresses each “red flag” raised by the DEA, explaining why they do not necessarily indicate diversion in the context of Pronto Pharmacy’s practice. For instance, he argues that:
• High Dose Opioids: Dosage levels considered “high” in general pharmacy settings are within the standard of care for chronic pain management.
• Quote: “So, no. These are not excessively high doses in the patient population that is being treated. Remember, these patients have been stabilized on these medications for years and continue to get the same doses from other pharmacies.”
• Distance Traveled: Patients may travel further to access specialized care, especially given the complexities of insurance coverage and PBM practices.
• Cash Payments: Pronto Pharmacy’s business model does not involve insurance contracts, making cash payments a more common practice.
• Early Fills & Drug Cocktails: Fluctuations in pain levels and the need to manage comorbidities necessitate adjustments to medication regimens, leading to “early fills” and the use of multiple medications.
• Compounding vs. Manufacturing: Folson argues that Pronto Pharmacy’s compounding practices are legal and within the accepted standards of care, refuting the DEA’s claim of illegal manufacturing. He cites the relevant legal statutes and his own extensive experience in both compounding and manufacturing to support his argument.
• Due Diligence and Patient Care: Folson criticizes the DEA for failing to conduct thorough investigations, such as interviewing prescribers and patients, which could have provided a clearer understanding of Pronto Pharmacy’s practices. He emphasizes that the DEA’s actions ultimately harm patients by limiting access to necessary pain management treatments.

Quote: “Before starting this case, the DEA could have interviewed the prescribers and learned about the individual patient’s needs. However, they did not. Had they done so, and wrongdoing was found, they could have censured the prescriber and notified the Pharmacists in the state to avoid the prescriber’s narcotic prescriptions.”

Conclusion:

Folson’s amicus brief presents a strong defense of Pronto Pharmacy, highlighting the DEA’s misapplication of general pharmacy “red flags” to a specialty practice.

He emphasizes the nuances of pain management and compounding practices, arguing that the DEA’s actions are not only detrimental to Pronto Pharmacy but also to patients in need of specialized care.

His expertise and detailed analysis provide a compelling argument in favor of Pronto Pharmacy’s legitimacy and the importance of considering the context of “red flags” before taking action against pharmacies.