H. Abdullah and H. Wu

17 Pages·2011·0.37 MB·English

Pharmacy Jurisprudence

For pharmacists in states with a pharmacy law
continuing education (CE) requirement.

Index:

2 The DEA Opines on “Corresponding Responsibility” of
Pharmacists

Accreditations (Pharmacy): This continuing pharmacy education
activity has been approved by the Ohio State Board of Pharmacy for
Ohio Board-approved jurisprudence and accredited by ACPE for
law-related continuing education for pharmacists and technicians.

Credit(s): 1.0 contact hours (0.1 C.E.U.)
Release Date: August 17, 2011
Expiration Date: May 13, 2013
Cost: $15.00

Select CE® is accredited by the Accreditation Council for Pharmacy
Education as a provider of continuing pharmacy education.

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Programs in this booklet are acceptable for mandatory law CE in states of AZ, CT, MA,
NJ, OH, and UT, and in all other states which recognize ACPE accreditation.
Program Title: The DEA Opines on “Corresponding Responsibility” of
Pharmacists

Target Audience: All Pharmacists and Pharmacy Technicians

Release Date: August 17, 2011

Expiration Date: May 13, 2013

Ohio State Board of
Pharmacy Program No.: 036-350-11-003-H03

ACPE Program No.: 487-000-11-003-H03-P knowledge-based activity

487-000-11-003-H03-T knowledge-based activity

Accreditations: This continuing education activity is approved by the Ohio State
Board of Pharmacy for 1.0 contact hours, or 0.10 C.E.U.‘s, of continuing pharmacy
education in Board-approved jurisprudence. This program is also accredited by ACPE
for pharmacists and pharmacy technicians under our trade name Select CE®.

Select CE® is accredited by the Accreditation Council for Pharmacy
Education as a provider of continuing pharmacy education.

Media: Enduring print material and interactive test-taking at www.selectce.org.

Fee Information: $15.00

Estimated Time to Complete the Activity: 60 minutes

Procedures: To receive a Statement of Credit, read this program, complete the post-test
questions and evaluation on the Answer Sheet, and either:

i) mail the Answer Sheet and the program fee of $15.00 to us. You will receive a
Statement of Credit mailed to you within 2 weeks. Checks or money orders are
encouraged. Mail to: Pharmacy Jurisprudence, P.O. Box 21186, Columbus, Ohio 43221-
0186. Refunds are generally not provided.

or

ii) use our online test-taking website www.selectce.org. Follow the instructions on the
website, using any major credit card to pay the $15 program fee. Upon passing the test,
you will receive immediate confirmation via email, and your official Statement of Credit
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© Pharmacy Jurisprudence, L.L.C. and Select CE® 2011 All rights reserved. Page 2
provided, unless you mistakenly make too many online payments or some such other
online snafu.

A minimum score of 70% is required to earn a Statement of Credit.

Faculty: Patricia A. Nussle, R.Ph., J.D., is the founder of Pharmacy Jurisprudence and
Select CE. She is also a healthcare attorney who has written and published continuing
education programs in pharmacy law and nursing law for over 200,000 healthcare
professionals since 2001.

Disclosure of Commercialism, Unlabeled Uses, Bias, Conflicts of Interest: Prior to
the delivery of the content, we will disclose any commercial support, and we do so here:
No commercial support was requested or accepted for developing or presenting this
program. All development, printing, and mailing costs, as well as accreditation
services and fees, come solely from your program fees. No unlabeled uses of drugs
are discussed in this program. Faculty Patricia A. Nussle, Pharmacy Jurisprudence and
Select CE have no real, apparent, or potential conflicts of interest or financial
relationships to disclose, other than that Patricia A. Nussle is the owner of Pharmacy
Jurisprudence and Select CE, and she warrants that she presents this information fairly
and without bias.

Objective: At the conclusion of this program, pharmacists should be able to list factors
found in ―corresponding responsibility‖ failures according to the DEA.

Objective: At the conclusion of this program, pharmacy technicians should be able to
list factors found in ―corresponding responsibility‖ failures according to the DEA.

Important Note: Colleagues, this is a continuing education program. It is not legal
advice. Do not rely on this CPE program as legal authority. If you do have a legal
problem or question, please consult an attorney experienced in pharmacy law matters to
discuss your specific situation.

Questions? Call us at [phone], or email us at [email protected].

Thank you! We truly enjoy serving you.

© Pharmacy Jurisprudence, L.L.C. and Select CE® 2011 All rights reserved. Page 3
The DEA Opines on “Corresponding Responsibility” of Pharmacists

Summary

Under federal law and under nearly each state‘s law, pharmacists have a
―corresponding responsibility‖ with the prescriber for the proper
prescribing and dispensing of controlled substance medications.

What is this corresponding responsibility? It arises from the Drug
Enforcement Administration (―DEA‖) regulations which state that "[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."1

DEA‘s regulation applies only to controlled substances prescriptions. As
a federal regulation it is applicable to prescriptions in all 50 states. Yet,
some state boards of pharmacy have expanded this rule so that it applies
to all prescriptions, not just controlled substance prescriptions. This is
true for Ohio2, but Massachusetts, New Jersey, California3 and most
other states follow the DEA and limit the pharmacist‘s corresponding
responsibility to controlled substance prescriptions only.

A pharmacist‘s corresponding responsibility is so important that a state
board of pharmacy recently stated:

[Corresponding responsibility] is axiomatic in the pharmacy
profession. This means that a pharmacist must review every
prescription for legitimacy and must then make a professional
judgment on whether or not to fill the prescription. Every
pharmacist is accountable to this Board and to society for what
he knew or should have known due to professional training,

1 21 CFR 1306.04(a)
2 OAC 4729-5-30
3 MGL c94C: section 19(a); N.J.A.C. 8:65 (Chapter 65 of Title 8, Controlled Dangerous
Substances, was recodified as Chapter 45H of Title 13, effective March 17, 2011); Cal.
Admin. Code tit. 16, § 1761

© Pharmacy Jurisprudence, L.L.C. and Select CE® 2011 All rights reserved. Page 4
experience, licensure, and continuing pharmacy education in
pharmacy law.4

And yet, in the same case in which the board of pharmacy made its
above proclamation, the state appeals court stated:

There is sparse Ohio case law regarding the scope of a
pharmacist‘s ―corresponding responsibility‖ to properly dispense
prescription medicine; however federal courts have developed
substantial case law in the context of criminal prosecutions under
the federal Controlled Substances Act5….

and the state court went on to apply federal court interpretations of a
pharmacist‘s corresponding responsibility.

Because ―corresponding responsibility‖ is so important to daily
pharmacy practice, and yet the case law applying this responsibility in
the states tends to be sparse, we present this continuing education
Question 1:

Courts have examined ―corresponding responsibility‖ as used in
the pharmacy profession:

a) Sparsely in state courts, such as Ohio‘s;
b) Substantially in federal courts in regards to controlled
substance prescriptions;
c) Both of the above are true.
program. The goal is to help pharmacists, as well as all healthcare
providers and especially our pharmacy technicians, better understand this
important legal rule under which pharmacists must operate every day.

4 http://www.sconet.state.oh.us/rod/docs/pdf/5/2010/2010-ohio-701.pdf at ¶ 37 and 38.
5 http://www.sconet.state.oh.us/rod/docs/pdf/5/2010/2010-ohio-701.pdf at ¶ 52.

© Pharmacy Jurisprudence, L.L.C. and Select CE® 2011 All rights reserved. Page 5
The DEA Opines on Pharmacists’ “Corresponding Responsibility”6

The Drug Enforcement Administration (―DEA‖) is charged with
enforcing our nation‘s laws respecting narcotics and controlled
substances. The DEA has more than 5,200 Special Agents and a budget
of over $2.6 billion to enforce the federal controlled substance laws.7

Of special interest to pharmacists and technicians, the DEA recently
published a decision that considers the scope of a pharmacist‘s
―corresponding responsibility‖ under federal law found at 21 C.F.R. §
1306.04(a). The case is an affirmance of a suspension order, and can be
found at (Docket No. 09-48) (75 Fed. Reg. 66149 (Oct. 27, 2010), but for
purposes of this program we will call the case and the retail pharmacy
involved simply ―The Pharmacy‖.

As background, the Code of Federal Regulations § 1306.04 provides that
while ―the responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner . . . a
corresponding responsibility rests with the pharmacist who fills the
prescription.‖ 21 C.F.R. §1306.04. The regulation further states, ―the
person knowingly filling such a purported prescription, as well as the
person issuing it [is] subject to the penalties provided for violations of
the provisions of law relating to controlled substances.‖ The DEA
interprets this regulation to mean that a pharmacist is prohibited from
filling a prescription for controlled substances ―when he either knows of
or has reason to know that the prescription was not written for a
legitimate purpose.‖ 8 75 Fed. Reg. at 66163. Further, the DEA has
further stated that ―when prescriptions are clearly not issued for
legitimate medical purposes, a pharmacist may not intentionally close his
eyes and thereby avoid [actual] knowledge of the real purpose of the
prescription.‖ Id.

Pharmacists are well trained and aware of their ―corresponding
responsibility.‖ They must only fill valid prescriptions for controlled
substances issued by a legitimate practitioner for a legitimate medical

6 Taken from John Gilbert and Karla Palmer on their law firm‘s blog at
http://www.fdalawblog.net/fda_law_blog_hyman_phelps
7 http://www.justice.gov/dea/history.htm
8 From 75 Fed Reg 66149 to 66165, which can be found at
http://edocket.access.gpo.gov/2010/pdf/2010-27096.pdf.

© Pharmacy Jurisprudence, L.L.C. and Select CE® 2011 All rights reserved. Page 6
purpose. Nevertheless, the standard for what exactly is – and,
specifically, what exactly is the extent of -- a pharmacist‘s
―corresponding responsibility‖ has been a troublesome concept.
Admittedly, the pharmacist in The Pharmacy matter allegedly engaged in
misconduct, and the case involved one bad doctor (who the Deputy
Administrator called a ―drug dealer‖). And, although this may be a case
where over-the-top facts indeed make bad law, pharmacists and those
who write controlled substance prescriptions should be mindful of The
Question 2:

The Drug Enforcement Administration (―DEA‖):

a) was created by Executive Order of President Carter;
b) has enforcement ability over laws respecting narcotics and
controlled substances;
c) has enforcement ability over laws respecting all prescriptions.

Question 3:

Under federal regulations:

a) the responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner . . . a
corresponding responsibility rests with the pharmacist who fills the
prescription;
b) the person knowingly filling such a purported prescription, as well
as the person issuing it [is] subject to the penalties provided for
violations of the provisions of law relating to controlled substances;
c) both of the above are true.
Pharmacy opinion because in it the DEA has taken significant strides to
clarify the scope of a pharmacist‘s corresponding responsibility.

First, faced with pharmacist‘s assertion that the ―corresponding
responsibility‖ standard is vague, ―unknown‖ and ―ambiguous,‖ the DEA
stated that the standard is constitutional: Federal courts have had ―little

© Pharmacy Jurisprudence, L.L.C. and Select CE® 2011 All rights reserved. Page 7
problem‖ applying the DEA regulation, which gives ―fair notice that
certain conduct is proscribed.‖ Id.

The DEA next addressed certain ―red flags‖ that should have given the
respondent pharmacist a ―reason to know‖ that the prescriptions patients
presented to him were not legitimate. Importantly, the DEA did not
focus on whether the pharmacist in The Pharmacy had ―actual
knowledge‖ that the prescriptions were not issued for a legitimate
medical purpose, but instead whether the pharmacist had ―reason to
know [they] were not issued for a legitimate medical purpose by a
practitioner acting in the usual course of professional practice.‖ Id. at
66163.

DEA’s Ten Red Flags

The DEA hired an expert to select and review 10% of the prescriptions
seized in a DEA raid on The Pharmacy. The expert chose the
prescriptions of fifty-five (55) patients filled by the pharmacist at The
Pharmacy between September 13 and February 9 of the following year.
Id. at 66158. In reviewing the pharmacist‘s conduct, the DEA‘s expert
testified and the DEA Administrator found that the pharmacist ignored
several signs that the prescriptions written by a certain physician were
not legitimate. These red flags include the following:

(1) “ample evidence” showing that the pharmacist
repeatedly dispensed “cocktailed” prescriptions for
oxycodone, hydrocodone, alprazolam, and carisoprodol and
finding that this combination of prescriptions is ―well known in
the pharmacy profession as being used by patients abusing
prescription drugs.‖ Indeed, the government‘s expert stated
that ―pharmacists refer the combination of ‗the benzodiazepine,
the narcotic * * * pain killer, and the sleeping pill‘‘ as ‗‗[t]he
triple,‘‘ and that when Soma (carisoprodol) is added, the
combination is known as the ‗‗homerun.‘‘ Noting that the
prescriber was writing two prescriptions for schedule II
narcotics, the government‘s expert testified that he ―had never
seen two schedule II narcotics prescribed together, other than
for treatment of cancer or hospice patients.‖ Id at 66158. In
his report to the DEA, the expert noted that there were three
patients who ‗‗received three narcotic pain killers on the same

© Pharmacy Jurisprudence, L.L.C. and Select CE® 2011 All rights reserved. Page 8
day‘‘ and that ‗‗[t]here is no logical reason why the patient
would be on two or three narcotic pain killers at the same
time.‘‘ Continuing, he explained that this is ‗‗a major red
flag‘‘ which is strongly suggestive of abuse and that ‗‗[n]o
reasonable pharmacist would fill two or three of these
prescriptions on the same day.‘‘ (discussing M.C., who on the
same day received prescriptions for Percocet 10/325, Norco
10/325, and oxycodone 30 mg.). Id at 66159.

(2) no individualization of dosing by the prescribing
physician. As to the prescriptions for schedule III
hydrocodone/apap drugs, the government‘s expert noted that
‗‗100% (89/89) were for the highest strength available, which
is 10 mg. of hydrocodone.‘‘ Id at 66159. Observing that it was
‗‗clinically impossible that all the patients in the sample would
always need the highest possible dose of hydrocodone with
acetaminophen,‘‘ the expert thus concluded that there was ‗‗no
individualization of dosing based on pain in these patients,
which should have been a major red flag for any pharmacist.‘‘
Id. Moreover, ‗‗[a]ny pharmacist would have known that this
was a problem and a strong indicator of a doctor operating a
controlled substance prescribing mill.‘‘ Id. And the expert
observed that ‗‗[m]any of the narcotic prescriptions had the
words ‗severe LBP‘ on them,‘‘ which ‗‗most likely stands for
‗Severe Low Back Pain.‘ ‘‘ Explaining that ‗‗[l]ower back
pain is viewed in the medical field as the ‗biggest scam to
obtain controlled substances‘ because it is the hardest to
disprove due to the lack of definitive clinical measures,‘‘ he
reported that ‗‗[i]t is very unusual that all these patients had the
same diagnosis and they all had to be on the maximum doses of
these controlled substances including Soma.‘‘ Id at 66159.

(3) filling multiple prescriptions for the strongest
formulations of hydrocodone and alprazolam. With respect to
the Xanax (alprazolam) prescriptions, ‗‗one of the most highly
abused benzodiazepines on the market‘‘ and a drug ‗‗in high
demand on the street,‘‘ the government‘s expert observed that
all sixty prescriptions were for the maximum strength of the
drug. Id at 66159. Moreover, ninety-three percent of the
prescriptions ‗‗exceeded the FDA approved maximum daily

© Pharmacy Jurisprudence, L.L.C. and Select CE® 2011 All rights reserved. Page 9
dosage of 4 mg. per day‘‘ and thirty-two percent ‗‗exceeded the
FDA approved dosing schedule of three times a day.‘‘ Id. At
the hearing, the government expert explained that Xanax 2 mg
is generally only prescribed to patients with post-traumatic
stress disorder. Id. at 66159.

(4) requests for early dispensing of refills. There were
several instances of refill-too-soon cited by the government
expert as indicia of the pharmacist‘s failure to fulfill his
corresponding responsibility. These instances were early
refills for patient L.B., who on December 28 received a Xanax
prescription two weeks early; and S.K., who, on September 13
received a prescription for 240 tablets of oxycodone 15 mg.,
with eight tablets to be taken per day (thus being a thirty-day
supply), and who, one week later, obtained an additional 168
tablets of the same drug. Moreover, patient M.P. filled two
prescriptions for Percocet 5/325 on the same day, and patient
L.A.T. filled two prescriptions for oxycodone on the same day.
Id. at 66159.

(5) refilling prescriptions of patients or doctors located 100
miles away from the pharmacy. The allegations against The
Pharmacy cited the pharmacist for filling prescriptions for
controlled substances to persons who were travelling
substantial distances to obtain the drugs. More specifically, the
Immediate Suspension Order alleged that on October 2, L.D.C.,
a resident of Portsmouth, Ohio obtained from a physician
practicing in Wheelersburg, Ohio, prescriptions for 90 tablets
of oxycodone 30 mg and 60 tablets of carisoprodol (a non-
controlled but highly abused drug which metabolizes into
meprobamate, a Schedule IV depressant), and that she then
travelled ‗‗approximately 100 miles from Wheelersburg to
Columbus‘‘ and filled the prescriptions at The Pharmacy. The
Order alleged that the next morning, L.D.C. ‗‗was found dead
at her residence * * * with a prescription vial identifying [the
pharmacist] as the dispensing pharmacy and several scattered
oxycodone tablets * * * next to her body,‘‘ and that the
Coroner‘s Office had preliminarily determined that she ‗‗died
from the * * * ‗probable toxic effects of drugs (oxycodone,
carisoprodol and others).‘ ‘‘ Id. at 66150.

© Pharmacy Jurisprudence, L.L.C. and Select CE® 2011 All rights reserved. Page 10