Pharmacists And Prescribing Physicians Are Equally Liable

After reading the article in the required reading: “The medicine shoppe v. Loretta lynch, et al.: Pharmacists and prescribing physicians are equally liable.” Discuss the following:

1. Identify and discuss the duties and responsibilities of a pharmacist toward a patient.
2. Based upon your research and assessment of the case, did the pharmacist perform the required duties and uphold patient rights?
3. Is the pharmacy at fault? Why or why not?
4. What is the impact of the pharmacist’s actions on the patient and community?
5. What precautions can be taken to ensure these types of incidents by allied professionals don’t happen to others? Should there be more regulations in place?

Length: Submit a 3-page paper.

Petitioners challenged the DEA’s interpretation of “legitimate medical purpose” under the Controlled Substances

Act (“CSA”) and the “corresponding responsibility” standard under DEA Regulation 21 C.F.R. § 1306.04(a) (2014) on

the grounds that these standards exceed the United States Attorney General’s and the DEA’s statutory authority

under the CSA.7 On December 16, 2015, the Court denied The Medicine Shoppe’s petition for review without

comment, thereby leaving open the question of whether or not the United States Attorney General may expand the

professional duty of pharmacists to require they either endorse or overrule the medical judgment of the prescribing

physician. FULL TEXT

On November 3, 2011, the Dmg Enforcement Administration (“DEA”) conducted an inspection of The Medicine

Shoppe, a small family-owned pharmacy in San Antonio, Texas. DEA Diversion Investigators (“Dis”) seized

prescriptions filled by patients of a local physician who was under investigation for possible dmg diversion. On

October 7, 2013, the DEA Deputy Administrator issued an Order to Show Cause (“OTSC”) to revoke The Medicine

Shoppe’s controlled substances Certificate of Registration (“COR”) on the grounds that the pharmacy had filled

prescriptions written by the target physician that were not for a “legitimate medical purpose.”1 The DEA alleged

that The Medicine Shoppe’s pharmacists failed to exercise their “corresponding responsibility,” along with the

physician, “to assure that its prescription for controlled substances was issued for a legitimate medical purpose”

and “in the practitioner’s usual course of professional practice” under DEA regulation.

The Medicine Shoppe responded that the pharmacists had known the patients and the prescribing physician for

many years and had contacted the prescribing physician’s office to verify the prescriptions before filling them.2

The Medicine Shoppe argued that therefore it had complied with the requirements of their pharmacists’

professional licenses and absent clear evidence of diversion, the pharmacists were obliged to fill the

prescriptions.3

On October 2nd, 2014 the DEA revoked The Medicine Shoppe’s COR.4 The Medicine Shoppe then filed a Petition for

Review with the United States Court of Appeals for the District of Columbia Circuit, which has original jurisdiction

for appeals of DEA Orders under the Administrative Procedure Act (“APA”).5 The Medicine Shoppe appealed on the

grounds that imposing a “corresponding responsibility” on pharmacists to ensure that controlled substances are

prescribed for a “legitimate medical purpose’” requires them to make medical judgments beyond their education

and training.6 Moreover, should the DEA disagree with a physician’s medical judgment and the medical necessity

of a prescribed medication, pharmacists who now share a “corresponding responsibility,” along with the physician,

“to assure that its prescription for controlled substances was issued for a legitimate medical purpose” will be

subject to the same civil and criminal liability for the physician, despite authenticating the order with the

prescribing doctor, as required by state law.

 

https://search.proquest.com/docview/1782200966?accountid=28844

https://search.proquest.com/docview/1782200966?accountid=28844

 

Accordingly, Petitioners challenged the DEA’s interpretation of “legitimate medical purpose” under the Controlled

Substances Act (“CSA”) and the “corresponding responsibility” standard under DEA Regulation 21 C.F.R.

§1306.04(a) (2014) on the grounds that these standards exceed the United States Attorney General’s and the

DEA’s statutory authority under the CSA.7

On December 16, 2015, the Court denied The Medicine Shoppe’s petition for review without comment, thereby

leaving open the question of whether or not the United States Attorney General may expand the professional duty

of pharmacists to require they either endorse or overrule the medical judgment of the prescribing physician.

The Backdrop of Expanding DEA Enforcement

The DEA has declared prescription drug abuse to be the Nation’s fastest-growing dmg problem.8 It is of particular

concern because legally obtained substances can lead to addiction or death.9 One source of this problem is

medical offices acting as “pill mills” and brick and mortar pharmacies working together promoting the illegal sale

of pharmaceuticals.lu In response to this epidemic, the DEA has stepped up its enforcement efforts against

pharmacies suspected of diverting pharmaceutical medicines.11 In doing so, the DEA has broadened the legal

standard delineating licit from illicit dispensing of controlled substances.12

Controlled Substance Registration

The CSA and its implementing regulations “establish federal requirements regarding both illicit and licit controlled

substances.”13 A “controlled substance” is defined as “a drug or other substance, or immediate precursor, included

in Schedule I, II, III, IV, or V.”14 Under the framework of the CSA, enacted in 1970, “all controlled substance

transactions take place within a ‘closed system’ of distribution established by Congress.”15 Accordingly, the DEA

“requires all businesses that import, export, manufacture, or dispense controlled substances; all health care

practitioners entitled to give out, administer, or prescribe controlled pharmaceuticals; and all pharmacies

authorized to fill prescriptions, to register with the DEA.”16 The DEA has the unique dual responsibility to not only 1

) ensure the supply of pharmaceutical controlled substances for legitimate purposes, but also 2) prevent the

diversion of these substances to illicit users/abusers.1′ The DEA administers this provision of the CSA by issuing a

COR that authorizes a central individual or entity (s) (“Registrants”) to dispense controlled substances in

Schedules II thru V of the CSA.18 According to the most recent tally by the Department of Health and Human

Services Office of Inspector General (“OIG”), in March 2014 the DEA had 1.5 million active retail and wholesale

Registrants.19

The DEA actively monitors these Registrants through a system of scheduling, quotas, recordkeeping, reporting,

and security requirements.20 The DEA also uses criminal and regulatory tools to identify and determine who is

most likely involved in the illicit distribution of controlled substances.21 The DEA initiates criminal investigations

of those suspected of criminal violations of the CSA. Criminal prosecutions are coordinated with an Assistant

United States Attorney or state District Attorney. Criminal cases vary widely in resource requirements and

complexity.22

Administrative Inspection Warrants

Compliance inspections of pharmacies are carried out by the DEA Office of Diversion Control to ensure that the

pharmacies have sufficient measures in place to prevent the diversion of controlled substances.23

Noncompliance is determined primarily by investigating complaints about the dispensing practices of

pharmacies.24 The DEA’s compliance review system includes web sites that monitor the prescribing and

dispensing of controlled substances by physicians and pharmacies 2s For example, the DEA uses the Automated

Reports and Consolidated Order System (“ARCOS”) to identify high volume purchasers of narcotic controlled

substances.20 Signs of suspicious circumstances are termed “red flags.”27 Red flags can constitute evidence of

diversion from “legal and medically necessary uses towards uses that are illegal and typically not medically

authorized or necessary.”28 If red flags are detected but left unresolved, the DEA will issue an Administrative

Inspection Warrant (“AIW”). An AIW is an administrative search warrant that allows DEA Dis access to either a

medical practice or pharmacy for the purpose of conducting compliance audits.29

Pharmacists* Duty to Identify and Resolve Red Flags

 

 

Individual pharmacists are now required to do more than just “verify the validity and authenticity of a prescription,”

as has historically been the case under state and federal law as well as DEA decisional history.30 Pharmacists

must also “resolve all red flags” before filling the prescription.31

Under this new regime, A pharmacist who “knowingly fills an order that is not intended for a legitimate medical

purpose, as well as the physician issuing it, will be subject to the penalties provided for violations of the provisions

of law relating to controlled substances under the CSA.”32 “Knowingly” includes circumstances that are known or

should have been known to the pharmacist who may not “close [his or her] eyes and thereby avoid positive

knowledge of the real purpose of the prescription, upon verifying that a physician issued it.”33 Keeping oneself

unaware of facts that would render him or her liable in order to avoid civil or criminal liability is termed “willful

blindness,” “ignorance of the law,” or “contrived ignorance” and is not a defense under the law.34 Committing

multiple violations of a pharmacist’s “corresponding responsibility” can mean administrative or criminal

prosecution resulting in the revocation of a pharmacy’s COR, loss of the pharmacist’s professional license, and

possibly criminal prosecution under state or federal controlled substances statutes.35

Revoking Certificates of Registration and Orders to Show Cause

If the Registrant is believed to be non-compliant, the DEA may initiate an OTSC hearing as to why the Registrant’s

COR should not be revoked, suspended, or application for one denied.36 This authority is derived from an

amendment to the CSA in 1984, which “gives the United States Attorney General the power to revoke the federal

registrations of physicians and pharmacists for the purpose of addressing the severe problem of diversion of

dmgs of legitimate origin into the illicit market.”3′ If the DEA deems the violation to be egregious enough to pose

an “imminent threat to public health or safety,” the DEA may issue an immediate suspension order that summarily

revokes the Registrant’s authorization to prescribe or dispense controlled substances.08 OTSC hearings and

immediate suspension orders are collectively known as “Registrant Actions.”39 Since the DEA grants a COR to a

pharmacy and not the pharmacist, this legal action refers to the practices of the store, although the actual parties

being scrutinized are the pharmacy owners and the registered pharmacists operating it.40

Once the DEA Administrator issues an OTSC, the Registrant may either allow the DEA Administrator to issue a

Final Decision and Order modifying or revoking the pharmacy’s COR or request an OTSC due process hearing.41 If

the Registrant wants a hearing, a DEA Administrative Law Judge (“ALJ”) hears evidence presented by DEA Counsel

and the Registrant. The ALJ will make findings as to whether or not a preponderance of the evidence submitted

shows the Registrant’s continued registration is “inconsistent with the public interest.”42 The ALJ will then issue

his or her Findings of Fact, Conclusions of Law and a Recommended Decision to the DEA Administrator. The DEA

Administrator may agree or disagree with the recommendation of the ALJ and will render his or her final Decision

and Order adopting, modifying or rejecting the ALJ’s Findings of Fact, Conclusions of Law and a Recommended

Decision.43

Pharmacists “Corresponding Responsibility”

The DEA Administrator’s decision to allow a pharmacy to continue dispensing controlled substances depends, in

part, on whether it has acted responsibly in filling prescriptions. DEA regulations require pharmacists have a

“corresponding responsibility,” along with the physician, “to assure that a prescription for a controlled substance

“was issued for a legitimate medical purpose” and “in the practitioner’s [physician’s] usual course of professional

practice.”44 An order purporting to be a prescription issued not in the usual course of professional treatment or a

legitimate medical purpose 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.45 In

other words, the DEA make pharmacists as equally responsible as the prescribing doctor that medications the

pharmacy dispenses are necessary for treating a patient’s medical condition.46

Controlled Substances Must Be for a “Legitimate Medical Purpose”

Although the “legitimate medical purpose” standard has existed for more that 90 years, the phrase is not defined in

the CSA, and this omission invites conjecture about its meaning.4” For the most part, “legitimate medical purpose”

 

 

has been construed by the federal courts and DEA decisional history to require that dispensing controlled

substances be done “in accordance with a standard of medical practice recognized and accepted in the United

States.”48 However, the United States Attorney General and state legislatures have repeatedly been at odds when

the DEA has interpreted its statutory authority under the CSA in a way that enables it to control healthcare policy49

For example, at issue in The Medicine Shoppe case was whether the DEA may interpret this phrase to decide

medical standards of care and require pharmacists to judge whether prescribed medications are necessary to treat

a patient’s medical condition.50

Federal Pre-emption v. State Police Powers

Since medical standards of care are traditionally determined by the states, a tension has developed between

federal and state enforcement in discerning whether a practice is for a “legitimate medical purpose” or “illegitimate

nonmedical purpose.”61 More particularly at issue in The Medicine Shoppe case is whether the United States

Attorney General may expand the professional duty of pharmacists to require that they either endorse or overrule

the medical judgment of the prescribing physician. Under Texas state law, and the law of most other states,

pharmacists have the duty to “exercise sound professional judgment with respect to the accuracy and authenticity

of any prescription drug order dispensed. If the pharmacist questions the accuracy or authenticity of a prescription

drug order, the pharmacist shall verify the order with the practitioner before dispensing.”52 “A prescription drug

order may not be dispensed or delivered if the pharmacist has reason to suspect that the prescription drug order

may have been authorized in the absence of a valid patient-practitioner relationship, or otherwise in violation of the

practitioner’s standard of practice [.]”S3 Historically, the DEA’s interpretation of pharmacists’ duty under the CSA is

to require they verify the validity and authenticity of the prescription with the prescriber and to deny the order if it

appears suspicious.64

However, the DEA contends that it has the authority to expand the professional duty of pharmacists to require they

either endorse or overrule the medical judgment of the prescribing physician even if contrary to state law. The

United State’s Attorney General interprets the CSA’s preemption provision, 21 U.S.C. 903, as clearly demonstrating

that “Congress expressly intended that there would be a dual system of Federal-State regulation of controlled

substances,” which reflects that this field of regulation was to be shared by the federal and state governments.55

This provision reiterates what is inherent in the Supremacy Clause of the United States Constitution – that no state

may enact a law relating to controlled substances that present a “positive conflict” with the CSA. The DEA cites the

preceding language of the CSA as its authority to make a determination, independent of state regulators, whether

the Registrant’s continued authority to handle controlled substances would follow the public interest.56 Yet,

expanding this interpretation in a way that grants the United States Department of Justice the power to determine

medical necessity has consistently put the federal government at odds with the states’ ability to regulate the use

and dispensing of controlled substances.

Conflicting Applications of the “Legitimate Medical Purpose” Standard

Chronic Pain Management

In United States v. Moore, the United States Supreme Court upheld the conviction of a physician alleged to have

“knowingly or intentionally, dispensed or distributed [methadone] by prescription, and who did so other than in

good faith in the usual course of a professional practice and in accordance with a standard of medical practice

generally recognized and accepted in the United States.”57

However, the Court clarified that the CSA extends only to issues related to a practitioner’s federal registration and

“extends no further.”58 In so doing, the Moore Court limited the DEA’s authority to regulate transactions within “the

legitimate distribution chain.”59 Therefore, the holding in Moore did not interpret the CSA to “authorize the DEA to

set standards of care, but rather reserves those questions for the States.”60 Nor did the Court extend the ruling to

impose an independent duty or “corresponding responsibility” for the medical necessity of the prescribed

medications on pharmacists.61 The Court observed that these were medical standards of care that have

traditionally been relegated to the states and applied to the prescribing practitioner.62 Therefore, scrutiny of

pharmacy practice by the DEA had historically been limited to issues concerning the manner in which controlled

 

 

substances are stored and distributed.63

Medical Marijuana

However, the authority of the United States Attorney General to set healthcare policy under the doctrine of

preemption was embraced by the United States Supreme Court in Gonzales v. Raich (previously Ashcroft v. Raich).

In Raich, the Court held that the United States Congress may criminalize the production and use of medical

marijuana even where the states approve its use as medically necessary and for a “legitimate medical purpose.”64

Here, the Court acknowledged Congressional intent to criminalize the possession and use of marijuana for all

purposes as a Schedule I controlled substance.65 Consequently, federal law and the United States Attorney

General’s enforcement of the CSA preempt state law under the Commerce Clause of the United States Constitution

when Congress has manifested its clear intention to do so.66

Death with Dignity

Yet a year later, the Court in Gonzales v. Oregon expressly limited the DEA’s role in evaluating the medical

usefulness of a prescription drug. The Gonzales Court held that “the states, not the DEA, have the authority to

determine what orders have been issued for a ‘legitimate medical purpose.’”0′ The Court said that the authority

delegated by the United States Attorney General permits the DEA to deny, suspend, or revoke a registration that

would be “inconsistent with the public interest.”68 In determining consistency with the public interest, the Attorney

General must consider five factors, including the state’s recommendation, compliance with state, federal, and local

law regarding controlled substances, and public health and safety.69 The CSA explicitly contemplates a role for

the states in regulating controlled substances. However, the Gonzales Court found substantial limitations in the

implementation of the CSA by the DEA in this regard.i0 Justice Kennedy, writing for the Court, stated:

The CSA and this Court’s case law amply support the conclusion that Congress regulates medical practice insofar

as it bars doctors from using their prescriptionwriting powers as a means to engage in illicit drug dealing and

trafficking as conventionally understood. Beyond this, the Act manifests no intent to regulate the practice of

medicine generally, which is understandable given federalism’s structure and limitations. The CSA’s structure and

operation presume and rely upon a functioning medical profession regulated under the States’ police powers. The

Federal Government can set uniform standards for regulating health and safety. In connection with the CSA,

however, the only provision in which Congress set general, uniform medical practice standards, 42 U.S.C.

§2990bb2a, strengthens the understanding of the CSA as a statute combating recreational drug abuse and also

indicates that when Congress wants to regulate medical practice in the given scheme, it does so by explicit

statutory language.71

Consequently, the Gonzales Court adhered to a policy of “continuing to give deference to the opinions of the state

licensing authorities.”72 By ruling for the state of Oregon, the Supreme Court is requiring that states, through their

legislatures, professional licensing boards, and citizen initiatives, will continue to decide what uses of medications

are for a legitimate medical purpose.70

Furthermore, the Gonzales Court and its progeny reveal a reluctance to grant the DEA the absolute authority to

impose upon pharmacists civil or criminal liability arising from a “corresponding responsibility with physicians that

controlled substances are intended for a legitimate medical purpose” unless there is direct evidence that the

pharmacist had actual knowledge that the prescribing physician is diverting drugs. That means that the

pharmacist knew that the doctor has “knowingly or intentionally, dispensed or distributed by prescription, other

than in good faith in the usual course of professional practice and in accordance with a standard of medical

practice recognized and accepted in the United States.”74 Therefore, “[a]cts of prescribing or dispensing of

controlled substances that are done within the course of the registrant’s professional practice are, for purposes of

the Controlled Substances Act, lawful. It matters not that such acts might constitute terrible medicine or

malpractice. They may reflect the grossest form of medical misconduct or negligence. They are nevertheless

legal.”71 Moreover, “[i]n making a medical judgment concerning the right treatment for an individual patient,

physicians require a certain latitude of available options,”76 Hence, “[w]hat constitutes Bona fide medical practice

must be determined upon consideration of the evidence and attending circumstances.”7′ However, under the guise

 

 

of treatment, a physician cannot prescribe, and a pharmacy cannot sell drugs to a dealer nor distribute drugs

intended to cater to cravings of an addict.’8 Congress did not intend for doctors to become drug pushers. This

general principle does not diminish the difficulty in the application of the legal standards set forth for the proper

prescribing and dispensing of controlled substances.’9

Lethal Injection

Because sodium thiopental is a Schedule III drug, the CSA requires a qualified medical practitioner to write a

prescription for the drug before it may be dispensed.80 As lethal injection has become the near exclusive method

of execution in this country, challenges to capital punishment will migrate from federal U.S. Constitutional

amendment VIII challenges involving cruel and unusual punishment to whether the drugs used have been

dispensed and administered for a “legitimate medical purpose.”81 Based on this position, the DEA can no longer

consistently hold that it should not regulate the drugs used in lethal injections.82

Clear Examples of Illicit Purposes

Decisions in the Fifth Circuit and Sixth Circuit have provided some, but not much guidance to pharmacists as to

how they define “legitimate medical purpose,” but mostly these decisions tell stakeholders what is not considered

a legitimate medical purpose. In United States v. Rosen, the Court of Appeals observed that “[a] majority of cases

[in which physicians were alleged to have dispensed controlled substances without a legitimate medical purpose]

have dealt with facts which were so blatant that a statement of clear-cut criteria in a form useful in other cases

would have been superfluous to the decision.”83 The Rosen Court did, however, “glean from reported cases certain

recurring concomitance of condemned behavior to include conclusive evidence of wrongdoing such as providing

multiple prescriptions to individuals in fictitious names to avoid detection; trading drugs for sexual favors or

money; or, physicians who sell prescriptions to drug dealers or abusers; and evidence of illicit sales.”84

In United States v. August, the Court of Appeals for the Sixth Circuit stated that “there are no specific guidelines

concerning what is required to support a conclusion that an accused acted outside the usual course of

professional practice…. [Rather, the courts] “must engage in a case-by-case analysis of evidence to determine

whether a reasonable inference of guilt may be drawn from specific facts.”85 The August Court’s holding

essentially declared that the judiciary was no more qualified than the DEA to say what a “legitimate medical

purpose” is, but could say in particularly blatant cases what it is not by including a few condemned behaviors that

are so flagrant as to warrant concern. For example, ( 1 ) an inordinately large quantity of controlled substances

was prescribed;86 (2) large numbers of prescriptions were issued;8′ (3) no physical examination was given;88 (4)

the physician warned the patient to fill prescriptions at different drug stores;89 (5) the physician issued

prescriptions for a patient known to be delivering the dmgs to others;90 (6) the physician prescribed controlled

dmgs at intervals inconsistent with legitimate medical treatment;91 (7) the physician involved used street slang

rather than medical terminology for the dmgs prescribed;92 (8) there was no logical relationship between the

dmgs prescribed and treatment of the condition allegedly existing; and (9) the physician wrote more than one

prescription on occasions to spread them out.93

The Medicine Shoppe v, Loretta Lynch, et, aL

Factual Background

As noted above, The Medicine Shoppe Pharmacy is a small, familyowned, franchised pharmacy located in San

Antonio, Texas. In October 2011, the DEA executed an AIW in connection with its investigation of a local physician.

Neither the Pharmacist-In-Charge (“PIC”) nor the pharmacy itself had ever been the subject of a complaint.94

On October 7, 2013, two years after the AIW was executed, the DEA Deputy Administrator issued an OTSC to revoke

The Medicine Shoppe’s COR. The grounds for the OTSC were that the pharmacy, two years prior, filled

prescriptions written by the physician under investigation and that these prescriptions should not have been filled

because they presented unresolved red flags. According to the DEA, the prescriptions presented red flags because,

among other things, they were written for the “holy trinity dmg cocktail” of hydrocodone, Xanax and Soma (a

muscle relaxant), and were suspicious for that reason.95 The Medicine Shoppe responded that its pharmacists