REPORTED BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
“WE ARE PHARMACISTS NOT DRUG DEALERS”
“WE ARE NOT POWERLESS AND THROUGH OUR VIDEOS, WRITINGS, AND PHOTOGRAPHS WE WILL EXPOSE THE ABUSES AND TYRANNY OF UNITED STATES DRUG ENFORCEMENT AGENCY
JUST AS THE VIDEO WAS RECORDED BY THE CELL PHONE CAMERA OF YOUNG DARNELLA FRAZIER, BORE WITNESS TO THE MURDER OF GEORGE FLOYD THE BLOG youarewithinthenorms.com BARES WITNESS AND BOTH ALLOWS THE SYSTEM TO BE HELD ACCOUNTABLE”
UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NORTH CAROLINA EASTERN DIVISION
NO.
UNITED STATES OF AMERICA,
Plaintiff,
COMPLAINT
v.
FARMVILLE DISCOUNT DRUG, ) INC., and ROBERT L. CROCKER,
Defendants.
The United States of America, by and through the United States Attorney for the Eastern District of North Carolina, complains and alleges as follows:
Truth and Justice
The medical profession and science are under attack by a group of science deniers and law enforcement The Drug Enforcement Administration has no steady-state of enforcement. It appears they are led to apply arbitrary rules to justify selective enforcement tactics. Superimpose both Walmart brief and the Farmville DOJ/DEA Brief
PHARMACISTS’ ROLE IN THE OPIOID SUPPLY CHAIN
The role of the pharmacist in this regulatory framework is an important but limited one. Pharmacists do not prescribe opioids, and they cannot dispense them to anyone other than patients with prescriptions written by state-licensed and DEA-registered doctors. They apply their own professional judgment to the facts before them in light of their training, education, and experience. (1)
WHY WALMART FILED A PREEMPTIVE STRIKE AGAINST DEA/DOJ
” In its Complaint, Walmart Inc. (“Walmart”) explained why it, and the pharmacy industry more broadly, need declaratory relief clarifying the scope of its obligations under the Controlled Substances Act (“CSA”) and its regulations. The Drug Enforcement Administration (“DEA”) and its parent agency, the Department of Justice (“DOJ”), are seeking to distract from their own failures in combating the opioid crisis by shifting responsibility to pharmacists who fill prescriptions issued by state-licensed and DEA-registered doctors.” (18),(20),(21) “Unsupported by statute or regulation, The DOJ/DEA have invented a slew of purported obligations, all driving toward their broader position that pharmacists and pharmacies must rigorously second-guess doctors’ judgments before filling their prescriptions. At the same time, pharmacists and pharmacies face conflicting guidance and legal risk from state regulators, doctors, and patients who strenuously object to what they view as an invasion of the doctor-patient relationship and unauthorized practice of medicine.” (18) (31) (32)
AMERICAN MEDICAL ASSOCIATION AFFIRMED CDC NARCOTIC ANALGESIC AND ANXIETY GUIDELINES TO BE INCORRECT
ADDICTION, ABUSE, AND MISUSE
The distinction between tolerance and addiction should be emphasized; most opioid-tolerant patients do not exhibit signs of addiction. Once again, individual variability characterizes the development of addiction, making outcome prediction difficult [3], but some features are associated with increased risk for addiction: increasing dose requirement, younger age, preexisting mental health disorders, and prior substance abuse [4]. Significantly, aberrant behaviors have been observed in nearly a quarter of patients taking opioids for non-cancer low back pain in the U.S. [5]. The current widespread use of opioids for chronic non-cancer pain created a need for vigilance in identifying patients who are abusing (unlawful use or use despite harm to the user) or misusing (use other than as prescribed) opioid medication. (17)
INTRODUCTION OF THE DEA BIG LIE
1. For years, Defendants Farmville Discount Drug, Inc. and its owner and pharmacist-in-charge, Robert L. Crocker, repeatedly filled purported “prescriptions” in violation of the Controlled Substances Act. These “prescriptions” often involved highly-abused opioid painkillers such as oxycodone, hydrocodone, hydromorphone, and methadone, along with other drugs like diazepam (i.e., Valium), alprazolam (i.e., Xanax), and zolpidem (i.e., Ambien) that, when taken with opioids, heighten their potential for abuse and adverse events.
2. Farmville Discount Drug shirked its responsibility as the last line of defense between powerful drugs with high potential for abuse and the people seeking them. The warning signs were many, but Farmville Discount Drug ignored them.
1
Case 4:20-cv-00018-FL Document 1 Filed 01/29/20 Page 1 of 25
Farmville Discount Drug filled prescriptions for dangerous, highly abused drug combinations for individuals who saw a doctor an hour away and lived an hour away. Farmville Discount Drug filled prescriptions for a prescriber that Crocker knew had been cut off by other pharmacies. Farmville Discount Drug-filled controlled-substance prescriptions for people who hopped from doctor to doctor or pharmacy to pharmacy. Farmville Discount Drug filled hundreds of opioid prescriptions for multiple members of the same family under highly suspicious circumstances.
FROM WALMART:
Case 4:20-cv-00817 Document 1 Filed 10/22/20 Page 1 of 54 PageID #: 1
Walmart Inc. (Walmart) seeks a judicial declaration to resolve a dispute with the U.S. Department of Justice (DOJ) and the U.S. Drug Enforcement Administration (DEA) about the obligations of pharmacists and pharmacies under the Controlled Substances Act (CSA).
“DOJ and DEA are placing pharmacists and pharmacies in an untenable position by threatening to hold them liable for violating DOJ’s unwritten expectations for handling opioid prescriptions—expectations that are directly at odds with state pharmacy and medical practice laws, the expert judgment of federal health agencies, and even DEA’s own public statements.
When a patient presents a pharmacist with an opioid prescription written by a doctor who is licensed by a state medical board and credentialed by DEA to prescribe controlled substances, the pharmacist must make a difficult decision.
The pharmacist can accept the doctor’s medical judgment and fill the opioid prescription, or second-guess the doctor’s judgment and refuse to fill it—a decision the pharmacist must make without the benefit of a medical license, examining the patient, or having access to medical records. “
The amici brief filed by the National Association of Chain Drug Stores and the American Pharmacists Association confirms that pharmacies and pharmacists likewise “need and deserve clarity regarding their obligations when filling prescriptions for controlled substances so that they can practice their profession without the threat of liability on all sides.” (ECF 39 at 1.) And the Association of American Physicians and Surgeons has also sought consent from the parties to file an amicus brief and will soon add its voice to the chorus asking this Court to help provide clarity. With both the industry and doctors crying out for guidance, Defendants’ straightforward obligation to defend their reading of the statute and regulations ought not to be deferred.
OR SEND
$150 DOLLARS TO CASH APP:$docnorm
FROM WALMART:
Case 4:20-cv-00817 Document 1 Filed 10/22/20 Page 1 of 54 PageID
Either decision puts the pharmacist and pharmacy at great risk. On the one hand, a pharmacist who fills a facially valid opioid prescription risks federal investigation, civil liability, or even criminal prosecution should DOJ and DEA claim in hindsight that a prescription the pharmacist believed was valid should not have been filled. On the other hand, a pharmacist who refuses to fill such prescription risks having her license stripped for the unauthorized practice of medicine, not to mention the potential harm to patients in need of their medicine.
TARGETTING BLACK PHARMACIST AND defining regulatory racism
Our group has been working with LUI as there is a nexus between police street brutality and State and Federal Regulatory Medical, Dental, Pharmacy Licensing, it’s called PREDATORY POLICING. PREDATORY POLICING in Professional Licensing and Regulation results in Regulatory Racism which affects the delivery of healthcare of all black- folks in America. Unfortunately, this type of racism is something hardly correlated or spoken about. Yet, both of these fights are intrinsically engrained in the US Culture of Systemic Racism.
These risks are not hypothetical. Walmart pharmacists have refused to fill hundreds of thousands of problematic opioid prescriptions, and Walmart has blocked thousands of concerning doctors from having their opioid prescriptions filled at any Walmart pharmacy. Because of this, Walmart and its pharmacists face state investigations and lawsuits for interfering in medical practice—that is, for going too far by refusing to fill opioid prescriptions. And DOJ now has stated it will sue Walmart for not going far enough by continuing to fill opioid prescriptions of certain licensed doctors—many of whom are still authorized by DEA to prescribe opioids to this day.
FARMVILLE DISCOUNT DRUG, INC., and ROBERT L. CROCKER, Defendants
The United States of America, by and through the United States Attorney for the Eastern District of North Carolina, complains and alleges as follows:
LEGAL BACKGROUND
The legal background of the DOJ’s has concocted a fraudulent misleading narrative is seen especially in paragraphs 12
“Schedule II controlled substances have a currently accepted medical use in the United States or a currently accepted medical use with severe restrictions”
People suffer pain and pain is real. Pain has been around and on this planet for quite some time. Pain is a medical issue, a normal complication that exists in nearly every species on earth and beyond. Pain and the treatment of pain, drug dependency, drug intoxication are medical public health issues and not criminal.
10. The CSA and its implementing regulations set forth a comprehensive regulatory regime for the manufacture, distribution, and dispensing of controlled substances. It is unlawful to manufacture, distribute, or dispense any controlled substance except in a manner authorized by the CSA or its implementing regulations.
11. Under the CSA, controlled substances are categorized into five schedules based on several factors, including whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and their likelihood of causing dependence when abused.
12. Schedule II controlled substances have a currently accepted medical use in the United States, or a currently accepted medical use with severe restrictions; however, these substances also have a high potential for abuse, which may lead to severe psychological or physical dependence. See 21 U.S.C. § 812(b)(2). Examples of Schedule II controlled substances include opioid-based painkillers such as oxycodone, hydrocodone, and methadone.
13. Schedule III controlled substances have a potential for moderate physical dependence or high psychological dependence, but less abuse potential than Schedule II substances. See 21 U.S.C. § 812(b)(3). Examples of Schedule III controlled substances include buprenorphine or products containing less than 90 milligrams of codeine.
14. Schedule IV controlled substances may lead to physical or psychological dependence when abused, but the potential for abuse is less than Schedule III substances. See 21 U.S.C. § 812(b)(4). Examples of Schedule IV controlled substances include alprazolam (brand name Xanax), diazepam (brand name Valium), and lorazepam (brand name Ativan).
15. To prevent the diversion of controlled substances, the CSA imposes requirements for the distribution and dispensing of these drugs. Among others, all
pharmacies wishing to distribute or dispense controlled substances first must register with DEA. See 21 U.S.C. § 822(a). Once registered, a pharmacy, as well as its agents and employees, are only permitted to distribute or dispense controlled substances to the extent authorized by their registration and in conformity with the CSA. See 21 U.S.C. § 822(b).
16. The CSA defines dispensing to mean delivering a controlled substance to an ultimate user (e.g., a patient) by, or pursuant to a lawful order of, a practitioner (i.e., a prescription). See 21 U.S.C. § 802(10). Distributing means delivering a controlled substance other than by dispensing or administering. See id. § 802(11).
17. The rules governing the issuance and filing of prescriptions are set forth in 21 U.S.C. § 829 and 21 C.F.R. Part 1306.
HOWEVER WALMART:
II. PHARMACISTS’ ROLE IN THE OPIOID SUPPLY CHAIN.
42. The role of the pharmacist in this regulatory framework is an important but limited one. Pharmacists do not prescribe opioids, and they cannot dispense them to anyone other than patients with prescriptions written by state-licensed and DEA-registered doctors. They apply their own professional judgment to the facts before them in light of their training, education, and experience.
FARMVILLE
18. Section 829 sets forth, among other things, the circumstances when a controlled substance may be dispensed pursuant to an oral or written prescription. Under 21 C.F.R. § 1306.04(a), a prescription for a controlled substance is valid only if it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Along with the medical practitioner issuing the prescription, a pharmacist considering whether to fill the prescription bears a “corresponding responsibility” to ensure “the proper prescribing and dispensing of controlled substances.” Id. Any “person knowingly filling such a purported prescription . . . shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” Id. “Person” is defined to include an individual, a corporation, a partnership, an association, and any other legal entity. 21 C.F.R. §§ 1300.01, 1306.02.
HOWEVER WALMART
43. The rules governing the dispensing of controlled substances, including prescription opioids, are set out in part in 21 C.F.R. § 1306.04(a). That section provides:
A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
44. As that regulation makes clear, it is the “prescribing practitioner” (the doctor) who bears primary responsibility for ensuring that controlled substances are properly prescribed (“for a legitimate medical purpose” and “in the usual course” of a practitioner’s professional practice).
45. That allocation of responsibility makes sense. The patient’s doctor is the one who has been licensed by the state medical board to practice medicine, has been authorized by DEA to prescribe controlled substances, can examine the patient and access her complete medical history, and is best positioned by virtue of the doctor-patient relationship to accurately assess the patient’s treatment needs and any accompanying risks.
HOWEVER WALMART
46. By contrast, pharmacists are not doctors. Pharmacists cannot examine or diagnose a patient who has received a prescription for opioid medication. They cannot obtain or review the
FARMVILLE
19. Under 21 C.F.R. § 1306.06, a pharmacist may only fill a controlled- substance prescription while “acting in the usual course of his professional practice.” Among other things, acting in the usual course of pharmacy practice includes compliance with all relevant state laws and regulations. In North Carolina, a pharmacist “shall not fill or refill a prescription order if, in the exercise of professional judgment, there is or reasonably may be a question regarding the order’s accuracy, validity, authenticity, or safety for the patient.” 21 N.C. Admin. Code 46.1801(b) (emphasis added).
HOWEVER WALMART
47. Nevertheless, pharmacists have an important role to play when filling prescriptions. As the DEA regulation proceeds to explain, pharmacists have a “corresponding responsibility” and may not “knowingly” fill a prescription that was not “issued for a legitimate medical purpose by a [prescriber] acting in the usual course of his professional practice.” Id. A subsequent regulatory provision adds that “[a] prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice.” Id. § 1306.06.
FARMVILLE
20. In assessing a prescription’s legitimacy, a pharmacist looks to see whether it presents “red flags,” or warning signs that create a reasonable suspicion that the prescription is not legitimate. “Red flags” may include the amount or combination of controlled substances prescribed; the abuse potential of those controlled substances; the temporal proximity to other prescriptions filled for the patient; the prescriber issuing the prescription in light of that prescriber’s location, prescribing history with the patient, or general prescribing practices; or circumstances unique to the individual presenting the prescription.
21. When a “red flag” is present, a pharmacist must conduct further and sufficient inquiry to determine whether the controlled-substance prescription is legitimate. A pharmacist who fills a prescription in the face of one or more red flags without taking sufficient steps to resolve the red flags exceeds their authorization to dispense controlled substances under the CSA, and subjects the pharmacist and the pharmacy to civil penalties.
HOWEVER WALMART:
Case 4:20-cv-00817 Document 1 Filed 10/22/20 Page 17 of 54 PageID #: 17
48. Under these regulations, a pharmacist cannot, for example, fill a prescription if the doctor lacks an active DEA registration, if the pharmacist recognizes the doctor’s signature as forged, if the prescription has been photocopied or tampered with, or if it is lacking basic requirements like the patient’s date of birth.
49. When a patient presents a facially valid prescription from an actively licensed and DEA-registered doctor, refusing to fill the prescription raises special concerns because it is overriding a licensed medical provider’s professional judgment about the care and treatment of that medical provider’s particular patient. Patient advocates, medical and pharmaceutical boards, and even government agencies have cautioned pharmacists against disrupting the normal course of medical care in this manner. That holds true for prescription opioids, which “should not [be]
– 16 –
Case 4:20-cv-00817 Document 1 Filed 10/22/20 Page 17 of 54 PageID #: 17
abruptly discontinue[d] … in a patient who is physically dependent.” FDA, FDA Drug Safety Communication (Apr. 9, 2019), available at https://www.fda.gov/drugs/drug-safety-and- availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and- requires-label-changes.
50. The DEA regulations provide no categorical rules and little practical advice on how or when a pharmacist should go about making these decisions. Neither § 1306.04(a) nor the CSA mentions any specific indicators that a prescription is or may not be valid. Nor do they specify when such indicators (or any combination of them) would prohibit a pharmacist from filling the prescription or suggest that a pharmacist is supposed to investigate or resolve questions about the prescription before proceeding.
51. Regulators have exacerbated this uncertainty by providing contradictory guidance to pharmacists. DEA has recently advised pharmacists not to fill prescriptions that are “doubtful, questionable, or suspicious.” DEA, The Pharmacist’s Manual 42 (2020). But state regulators and others in the medical community—those who are supposed to have the final say on which prescriptions are legitimate—object to any interference in the doctor-patient relationship. State boards of medicine and pharmacy—which have the power to revoke pharmacists’ licenses and to take legal action against pharmacies—have condemned pharmacists and pharmacies for taking medical decisions into their own hands by refusing to fill prescriptions from actively licensed doctors.
52. For example, the Executive Director of the Tennessee Pharmacy Board has stated that pharmacists should dispense medication whenever the prescribing doctor maintains a valid DEA registration and an unencumbered medical license, even if the pharmacist views the prescription as suspicious. Members of the Idaho Board of Pharmacy have agreed; in their view,
– 17 –
Case 4:20-cv-00817 Document 1 Filed 10/22/20 Page 18 of 54 PageID #: 18
even a doctor’s arrest on suspicion of narcotics trafficking should not cause pharmacists to decline all of the doctor’s prescriptions. Such a blanket judgment, the Idaho Board has said, precludes the professional judgment required to discharge a pharmacist’s duties. These state regulators recognize that doctors, not pharmacists, are responsible for the decision to prescribe.
ELIMINATE DISCUSSION OF THE DISEASE STATE BY PROSECUTING THE PILL
Eliminate the ability to treat pain by eliminating pharmacies and pharmacists and criminimizing the medications used to treat pain. For example, in every indictment, US Attorney Generals have redefined the purposes of narcotic analgesic medications, such as oxycodone, to be a dangerously addictive drug that causes death. The DOJ/DEA has cleverly controlled the narrative by reclassifying the medication’s mechanism of action, therapeutic indications, understanding of its pharmacological effect by spinning criminality. The DOJ/DEA has intentionally gone out of its way to willfully and deliberately omit from their narratives the disease states and the conditions of the patient.
For example, oxycodone is targeted by DEA/DOJ as a dangerous drug. In fact, we know as pharmacists all drug medications are dangerous, especially when taken beyond their therapeutic dose levels. If controlling death has been what the US Attorney’s office has been looking for, then they would be hard-pressed to explain the role of chemotherapy and long-term use of Cox inhibitors, which causes the death of many persons, even when given therapeutic doses.
DEA REDEFINES MEDICAL AND PHARMACEUTICAL PROTOCOLS WHO CONTROLS THE NARRATIVE?
The United States Department of Justice (DOJ), United States Drug Enforcement Administration (DEA) has fostered an overall attitude that there are treatments for some and prison for others. Both Federal Government entities have further hyped media, the public, and Congress with exaggerations of the phrases pill mills, cocktails, holy trinity, and red flags, to which pharmacists have a corresponding responsibility to determine whether prescriptions are illegitimate, without first consulting the physician.***
WHO CONTROLS THE NARCOTIC ANALGESIC (OPIOID) NARRATIVE ???
More concerning, over 20 years the DEA has created troubling guidelines enforced upon the pharmacists which disrupt the physician-patient relationship. The laws and rules the DEA has created, further force pharmacists to operate outside the licensure and the scope of the profession of pharmacy.
More significantly, at any point, a DEA Diversion Investigator can arbitrarily target, sanction, or have a pharmacist arrested and/or a pharmacy’s Control Substance License suspended. This is based solely on DEA Diversion Investigators’ profound ignorance of medical/pharmaceutical procedures, bias, and/or their failure to investigate.
THE BIG red flag LIE
SEE LINK: THE DEA HUGH RED FLAG LIE WHICH DESTROYED ROBERT L. CROCKER’S YEARS OF HARD WORK: https://www.witn.com/content/news/OPIOID-RED-FLAGS–Farmville-pharmacist-fined-600K-must-surrender-license–567532001.html
EXPOSING THE DEA’S FRAUDULENT RED FLAG ANALYSIS
On August 9, 2019, DEA Diversion Investigator Richard Albert prepared a warrant that “opinion based on a red flag that Pronto Pharmacy LLC, in Tampa Florida engaged in manufacturing-controlled substances. This is an assumption that a crime was committed within the Pronto Pharmacy. Pronto Pharmacy is a licensed pharmaceutical company by law that can compound medications. (37)
JUDGEMENT BY THE MILE MARKER!! QUESTION TO UNITED STATES COURT OF APPEALS DC?
There is perhaps some person who works for this court who is also a caregiver to a loved one suffering from a condition that requires specialized medical care. Let’s say that person lives in Reston Virginia and their loved one is being seen at the John Hopkins Medical Center in Baltimore, Maryland at what point on the mile marker according to DEA Law Enforcement, guidelines does their medical care become suspicious? What statutory requirements are violated?
NO STATISCAL GUIDELINES
The DEA has no statistical guidelines or law to support or establish boundary levels, which are indicative of criminal acts when filling any Control prescription written for patients by a physician who has performed a thorough physical examination, diagnoses supported by medical/dental radiographs, and treatment plan.
As further written December 29, 2020, by the Wall Street Journal Editorial Board in a stark rebuke of the United States Department of Justice (DOJ) lawsuit filed in federal court in Delaware claims that: The Walmart DOJ complaint also includes:
” more than 190 mentions of “red flags” about suspicious opioid prescriptions. It claims Walmart often didn’t adequately resolve them and sometimes knowingly filled illegitimate prescriptions despite the warnings. But Walmart notes in its lawsuit that the Controlled Substances Act “and its implementing regulations do not include the concept of red flags, let alone identify any particular factors as a red flag.”
“The feds try to side-step this problem by claiming that, under the Controlled Substances Act and regulations, “the pharmacist’s conduct must adhere to the usual course of his or her professional practice as a pharmacist.” The complaint argues that catching and resolving “red flags” for opioid prescriptions is “a well-recognized responsibility of a pharmacist in the professional practice of pharmacy,” so “failing to fulfill this responsibility” is a violation of the federal law.”
However, the Wall Street Journal Editorial Board further points out:
” All of this raises constitutional issues based on a lack of legal standing. A negligence claim like the one alleged here is supposed to have a specific party claiming a specific injury caused by someone specific. Those are typically claims by one private party against another. The government can sue for violations of law, not because someone was negligent. The government’s claims of Controlled Substances Act violations are so general that they seem contrived to add some violation of the law.(1)
” In effect, DOJ is asking the federal court to overrule state law in favor of informal federal guidance and a vague notion of pharmaceutical best practices.
RED FLAGS OF DIVERSION
In recent enforcement actions it has filed across the country, accusing pharmacists and pharmacies of unlawfully dispensing medicines, the U.S. Department of Justice (DOJ) has aggressively attempted to sidestep § 1306.04’s knowledge requirement. Citing pharmacists’ “corresponding responsibility,” DOJ has argued that pharmacists are liable for filling prescriptions that allegedly present so-called “red flags”—factors that do not necessarily bear on a prescription’s facial validity but that, in DOJ’s opinion, suggest the prescriber may have written it for an illegitimate purpose.
Under DOJ’s theory, the presence of one or more “red flags” not only proves that a prescription is illegitimate but that a pharmacist who fills it
must be doing so “knowingly.” (see Amicus Curiae Brief National Association Chain Drug Stores, US Supreme Court Case No. 20-1410, Ruan vs. the United States of America)
The “red flags” advanced by DOJ include patients seeking to fill “[n]ew prescriptions for controlled sub- stances a patient has never received before”;(2) certain combinations of prescribed drugs; 3 providing physician-ordered refills when “one to three days of supply
remained”;(4) late filing of prescriptions;5 dispensing the same medications “for the same patients over long periods of time”;6 prescriptions for doses above “90 [morphine milligram equivalents]/ day”;(7) and prescriptions for more than one “immediate-release opioid[ ] …sufficiently close in time that the supplies would have overlapped.”(8) Even though in many circumstances these supposed “red flags” have legitimate explanations (medical or otherwise), DOJ has gone so far as to argue that the presence of one or more of these elements is “near conclusive[ ] evidence of a prescription’s invalidity.”(9)
According to DOJ, when faced with a prescription presenting one or more “red flags,” a pharmacist must identify each issue, take steps to resolve it, and document in writing how it was resolved—no matter how many times the same patient has presented the prescription. Until and unless each “red flag” is resolved, DOJ says, a pharmacist must second-guess the prescription’s appropriateness, override the prescriber’s medical judgment, and refuse to fill it—or else face the threat of liability.
corresponding responsibility violates patient’s healthcare rights and is unconstitutional
The law permits the pharmacist to violate the patient’s Fourth Amendment Rights to seek medical based on the pharmacist’s bias. The pharmacist then withholds treatment based on their bias and on a subjective presumption of wrongdoing. Neither, does this law require the pharmacist to put their reasonings into writing as part of the [p]atients’ medical record as to why their medication treatment is being withheld? Critically, proper recording of the patient medical care record information is an absolute must requirement of corresponding responsibility of every prescribing practitioner.
Drug Enforcement Agency (DEA) in its regulations (21 CFR 1306.04) which states:
“A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of Section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” (1)
Thus, in interpreting the regulations, a pharmacist’s position is nearly identical to the practitioner who issued the prescription, though the pharmacist did not examine the patient or review their medical records.
Therefore, the pharmacist filling a controlled substance prescription should proceed with caution and use their professional judgment to determine if a prescription for a controlled substance was issued for a legitimate medical purpose during the course of his or her usual professional practice
However, this law has further led to abuses of patient rights and has wrong empowered and encouraged pharmacists to intimidate patients, confiscate and destroy legitimately written authorized pain control prescriptions, and then calls the prescriber to request the practitioner to lower their dosage or to prescribe and alternative pain treatments. Such actions amount to the pharmacist giving a diagnosis or a second opinion which is outside the scope of a pharmacist’s training and licensure.
FACTUAL ALLEGATIONS IN FARMVILLE
22. As a retail pharmacy, FARMVILLE DISCOUNT DRUG purchases,
stores, and dispenses controlled substances. At all relevant times, FARMVILLE
DISCOUNT DRUG and CROCKER were subject to the registration and dispensing
requirements of Part C of the CSA, including 21 U.S.C. § 829.
I. Defendants Systematically Ignored Red Flags When Filling Controlled-Substance Prescriptions.
23. From on or about December 1, 2014, through at least as late as July 2019, Defendants knowingly filled prescriptions for controlled substances that presented significant red flags with respect to their medical legitimacy and/or with respect to whether they were written by a practitioner in the usual course of professional treatment. Defendants ignored and otherwise failed to take sufficient steps to resolve these red flags before filling the prescriptions.
Red Flag No. 1: Geographic Distance
24. A person traveling an unusually long distance from their home address and/or their prescriber’s office to fill a prescription, including traveling past multiple other pharmacies, can be a red flag that the prescription was not written for a legitimate medical purpose or in the usual course of professional practice.
25. Defendants repeatedly dispensed controlled substances, including opioids, to multiple people whose residential address and/or prescriber address were
7
Case 4:20-cv-00018-FL Document 1 Filed 01/29/20 Page 7 of 25
more than fifty (50) miles from FARMVILLE DISCOUNT DRUG. It would have taken these individuals more than one hour to drive from their homes or from the distant prescriber’s office to FARMVILLE DISCOUNT DRUG, passing dozens of pharmacies along the way.
Red Flag No. 2: Doctor Shopping
26. A person’s history of obtaining controlled substances from multiple prescribers is also a red flag that a controlled-substance prescription may not have been written for a legitimate medical purpose or in the usual course of professional treatment. For example, a physician may stop writing prescriptions for a person if the physician believes the person is abusing substances, requiring the person to seek out prescriptions from other physicians. Alternatively, a patient could move regularly from doctor to doctor to make it more difficult for anyone prescriber to identify drug-seeking behavior.
27. Seeking prescriptions from multiple prescribers is colloquially referred to as “doctor shopping.” Defendants had tools available to review a person’s prescription history, including prescriber information, through North Carolina’s Controlled Substance Reporting System. Defendants nevertheless repeatedly dispensed opioids and other controlled substances to doctor-shopping individuals, including people who had received controlled-substance prescriptions from eleven or more prescribers in the previous five years, and to at least one person who had received controlled-substance prescriptions from nineteen separate prescribers during the previous five years.
8
Case 4:20-cv-00018-FL Document 1 Filed 01/29/20 Page 8 of 25
Red Flag No. 3: Pharmacy Shopping
28. A person’s history of filling and attempting to fill prescriptions at multiple pharmacies is also a red flag that a controlled-substance prescription may not have been written for a legitimate medical purpose or in the usual course of professional treatment. For example, pharmacies may stop filling for a prescriber whose prescribing practices themselves raise red flags, thereby requiring drug seekers to move from pharmacy to pharmacy to fill their prescriptions written by questionable prescribers. Alternatively, pharmacy staff may recognize a person’s drug-seeking behavior based on his or her prescription history and may stop filling for that person, requiring the person to seek to fill a prescription at another pharmacy.
29. Filling prescriptions at multiple pharmacies is colloquially referred to as “pharmacy shopping.” Defendants had tools available to review an individual’s prescription history, including the name of the pharmacy filling other prescriptions, through North Carolina’s Controlled Substance Reporting System. Defendants nonetheless repeatedly dispensed opioids and other controlled substances to pharmacy-shopping individuals, including to people who had filled controlled- substances at more than ten different pharmacies over a five-year period.
Red Flag No. 4: Family Members & Individuals Residing at Same Address
30. The presentation of prescriptions for similar controlled substances by members of the same family or by individuals residing at the same address is also a red flag that the prescriptions may not have been written for a legitimate medical
9
Case 4:20-cv-00018-FL Document 1 Filed 01/29/20 Page 9 of 25
purpose or in the usual course of professional treatment. Defendants repeatedly dispensed controlled substances, including many of the same drugs, to individuals of the same family and individuals sharing a common address.
Red Flag No. 5: Pattern Prescribing
31. A single prescriber who repeatedly issues prescriptions for the same drug or drug combinations to multiple people also raises a red flag that the prescriptions may not have been written for a legitimate medical purpose or in the usual course of professional treatment. This practice is colloquially referred to as “pattern prescribing.” Defendants repeatedly dispensed the same drug and/or similar drug combinations prescribed by the same practitioner for multiple individuals (i.e., pattern prescribing), including for individuals residing at the same address.
Red Flag No. 6: Suspicious Drug Combinations
32. Another red flag consists of prescriptions issued for combinations of drugs that are highly unlikely to serve a legitimate medical purpose and/or are known cocktails favored by drug abusers. For example, certain combinations of opioids and other controlled substances, such as benzodiazepines, muscle relaxers, sedatives, and/or stimulants, can enhance the effects of the substances, but also increase the risk of adverse events, such as overdose, to the user. Defendants repeatedly dispensed combinations of controlled substances whose medical legitimacy was suspect, including prescribing high doses of opioids combined with other opioids, benzodiazepines, muscle relaxers, or sedatives.
10
Case 4:20-cv-00018-FL Document 1 Filed 01/29/20 Page 10 of 25
Red Flag No. 7: Early Fills of Schedule II and Schedule IV Drugs
33. A person’s attempt to fill a prescription early—i.e., before their current supply of drugs from a previous prescription is exhausted—is also a red flag that a controlled-substance prescription may not have been written for a legitimate medical purpose or in the usual course of professional treatment. A review of dispensing data suggests that Defendants repeatedly dispensed controlled substances early. For example, on more than 150 occasions, and for multiple individuals, Defendants appear to have dispensed Schedule II and Schedule IV controlled substances more than five days early, and on some occasions, more than twenty days early.
II. Many Individuals Presented Multiple Red Flags
34. In many cases, the foregoing red flags were not presented to Defendants in an isolated fashion. Rather, Defendants ignored numerous red flags presented by the same person or prescription. The following examples illustrate the extent to which Defendants repeatedly failed to resolve multiple red flags in filling prescriptions for powerful and often abused controlled substances.
Individuals A and B
35. FARMVILLE DISCOUNT DRUG filled eighty-one (81) controlled-substance prescriptions for Individual A between 2015 and 2018.
36. During this time, Individual A lived in New Bern, North Carolina at an address approximately sixty (60) miles from FARMVILLE DISCOUNT DRUG. All 81 prescriptions were written by a prescriber located in New Bern, North Carolina, approximately fifty-three (53) miles from FARMVILLE DISCOUNT DRUG.
11
Case 4:20-cv-00018-FL Document 1 Filed 01/29/20 Page 11 of 25
37. In the eighteen months before coming to FARMVILLE DISCOUNT DRUG, Individual A had filled controlled-substance prescriptions at four separate pharmacies. But beginning in 2015, Individual A began regularly filling prescriptions at FARMVILLE DISCOUNT DRUG and continued to do so for nearly three and a half years.
38. Approximately 77% of the prescriptions Individual A filled at FARMVILLE DISCOUNT DRUG were for 30-mg oxycodone tablets, the highest strength immediate-release oxycodone tablet available. At one point, FARMVILLE DISCOUNT DRUG dispensed four thirty-day supplies of 30-mg oxycodone tablets (720 tablets) for Individual A in just sixty-six (66) days. Specifically, FARMVILLE DISCOUNT DRUG dispensed 180 tablets of 30-mg oxycodone to Individual A on December 5, 2016; another 180 tablets on December 15, 2016; another 180 tablets on January 12, 2017; and another 180 tablets on February 9, 2017.
39. FARMVILLE DISCOUNT DRUG often dispensed oxycodone to Individual A in combination with other opioids (such as 5-mg or 10-mg methadone) or muscle relaxers (such as 350-mg carisoprodol). For three months in a row, FARMVILLE DISCOUNT DRUG filled thirty-day supplies of all three drugs on the same day—180 tablets of 30-mg oxycodone, 30 tablets of 10-mg methadone, and 60 tablets of 350-mg carisoprodol. Taken together, these drugs increased the euphoric effects of each other and the potential for abuse. However, because of the combined depressant effects of these drugs on the central nervous system, the combination also produced a heightened risk of death or overdose. For example, although the Centers
12
Case 4:20-cv-00018-FL Document 1 Filed 01/29/20 Page 12 of 25
for Disease Control and Prevention (“CDC”) urge caution when an individual receives an opioid dosage greater than 90 morphine milligram equivalents (MME) per day, Individual A received more than 300 MME per day from the oxycodone and methadone in these prescriptions before adding the potentiating (and central-nervous-system depressing) effects of carisoprodol.
40. FARMVILLE DISCOUNT DRUG also filled thirty-four (34) prescriptions for Individual B between May 2017 and October 2018. Individual B shares the same last name as Individual A and resided at the same address as Individual A for some period of time—the address that was approximately sixty (60) miles from FARMVILLE DISCOUNT DRUG. Individual B sometimes resided at a different address; however, that address was also approximately forty-six (46) miles from FARMVILLE DISCOUNT DRUG and would have required approximately one hour to drive from the address to FARMVILLE DISCOUNT DRUG.
41. In addition, all of the prescriptions Individual B filled at FARMVILLE DISCOUNT DRUG were written by the same prescriber located in New Bern, North Carolina, who issued Individual A’s prescriptions.
42. Thirty-three (33) of the thirty-four (34) prescriptions that FARMVILLE DISCOUNT DRUG filled for Individual B were for 30-mg oxycodone tablets—the same drug and strength that Individual A was receiving. During the period when both Individual A and Individual B were receiving 30-mg oxycodone from FARMVILLE DISCOUNT DRUG, Individual A received 3,108 tablets of 30-mg
CONCLUSION
There are many problems with DOJ’s “red flags” theory. It has no basis in the CSA or its implementing regulations, or even in the DEA’s Pharmacist’s Manual. It imprudently dismisses the individualized, case-by-case approach that pharmacists take when filling prescriptions in favor of a categorical approach to culpability. And it traps pharmacists in an untenable position—either face liability under the CSA for filling a facially valid prescription that raises a “red flag,” or face state-based professional liability and even civil suits, for refusing to fill such a prescription.
But the critical point here is that § 1306.04 provides protection for pharmacists that the Court should not inadvertently eliminate: a pharmacist may only be held liable if the pharmacist “knowingly fill[s]” a “purported” prescription.
In other words, unless a pharmacist subjectively knows that a facially legitimate prescription has been prescribed for illegitimate reasons, the pharmacist should not face potential liability for dispensing medication based on that prescription.
Strict adherence to this knowledge element is critical to ensuring that pharmacists acting in good faith are not punished for filling facially valid prescriptions written by licensed and registered prescribers— a punishment that, if rendered, would chill other pharmacists from performing their duties.
FOR NOW, YOU ARE WITHIN
THE NORMS
