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Assume that you are working in a community
pharmacy that you own and are fully licensed as a pharmacist by your state
Board of Pharmacy (or the government's licensing organization), as is your
pharmacy. The medications you dispense to your patients are purchased only
from companies that are licensed manufacturers by the FDA. All in all, it's
just a normal day in the neighborhood.
Very recently, however, a chain-store business
catering to farm and agricultural needs opened a new shop next door. Being the
friendly (or maybe just curious) pharmacist that you are, you take it upon
yourself to meet the new neighbors. While conversing with the manager, you
learn that they have a thriving practice of distributing drugs to customers
who have a veterinarian's prescription for their animals. This leads you to
wonder why is it that you and your pharmacy have to be licensed to sell
prescription drugs, but the guy next door is not a pharmacist and his store is
not licensed as a pharmacy. Your conundrum looms even larger when you realize
that you are both distributing the same drugs, often from the same
manufacturers. Sure, some of his drugs are labeled for animal use only and
your drugs are approved for human use, but for all you know, they may still
come from the same manufacturing line. If you think about it for a minute, the
only significant difference between your patients and his ultimate consumers
are the number of legs each employs to stand up on. But what really gets your
goat (pun intended) is that folks can buy the same drugs next door at much,
much cheaper prices than you can even buy them at. Is that not a serious
situation that calls for action on your part?
Being the upstanding citizen that you are (or just
a troublemaker whose heart is nevertheless in the right place), you call the
Board of Pharmacy to share your concerns, highlighting that you are being
treated differently and are unfairly discriminated against because you have to
be licensed, but the other guy does not. If you luck out and get to talk to a
live human being, chances are that all you are going to get from this
conversation is the bureaucrat's promise that the board will look into the
matter.
A few months later, you learn from the pharmacy
grapevine that the state is going to charge your neighbor with unlawful
operation of a pharmacy without a license. If the state wins, the store next
door will be shuttered and the owners might be charged with criminal
wrongdoing. This result would make you happy (you muckraker). If the state
loses, however, you may be annoyed, but it has not cost you anything and you
still get to have the same friendly neighbor who in all likelihood will never
know that you instigated the investigation.
Now, it's time to decide: Who is going to win this
lawsuit? The big bad agricultural vultures stealing money you should have in
your pocket or the knight in shining armor representing your state government?
Before deciding, be forewarned that this is going to be a close call that will
depend on how legislative statutes are interpreted, as well as how the rule
of lenity is applied. It's okay if you think the question is unfair
because you have never even heard of lenity, let alone know that there is a
rule about it. Believe it or not, this whole scenario comes out of a real case.
1
Facts
Over the past 20 years, the defendant United Pharmacal sold federal legend
drugs (what the rest of the world knows as prescription-only drugs) to
consumers who have prescriptions from veterinarians for treatment of their
animals. The company does not sell or dispense drugs for human use. As
expected, it has engaged in these practices without a license from
Missouri
's Board of Pharmacy, and it does not employ a licensed pharmacist. It is
interesting and, in fact, pivotal to the outcome to note that in both 1994 and
1997, the Board of Pharmacy investigated United Pharmacal for selling animal
legend drugs without a pharmacy license, each time taking no action. In 2000,
a board staff member undertook a third investigation of the organization (no
doubt with encouragement from the local pharmacy community) and, without
explanation for the change, concluded that its conduct comes within the
definition of the "practice of pharmacy," in violation of the Missouri
Pharmacy Practices Act.2
Proceedings
Based on this investigation, the pharmacy board issued a "Cease and Desist
Warning," declaring that the company's practice of selling prescription-only
animal drugs constituted the practice of pharmacy without a license. The
letter ordered United Pharmacal to stop selling animal-legend drugs to
consumers without a pharmacy license and informed the company that violating
the act also constituted a crime under the state laws.
The company did not take this notice lightly. It
filed a motion with a local trial court, asking for a declaratory ruling that
the board does not have authority to regulate veterinary drugs.3
The trial court found, however, that selling animal-only prescription legend
drugs violates Missouri law and that the Board of Pharmacy does indeed have
jurisdiction to regulate the unauthorized practice of pharmacy. The company
appealed to the state's Supreme Court, seeking dismissal of the lawsuit.
Supreme Court Ruling
The seven justices who ruled unanimously found that the Board of Pharmacy does
not have the authority to regulate prescription-only drugs intended for
use in animals (other than humans, of course). The decision came down to a
determination that the governing statutes are ambiguous and could be read to
favor either side's arguments.4 The Board of Pharmacy claimed
that the statutes should be read broadly to encompass the sale of all
prescription drugs, because they do not specifically exempt veterinary drugs,
and the dictionary defines "drug" to include substances to treat disease in
"man or other animal." However, in support of the animal-feed store's claims,
the court acknowledged that the language in the statute concerning
"consultation with patients and other health care practitioners" can be
construed as being limited to human patients, as the dictionary defines a
"patient" as "a sick individual... awaiting or under the care of a physician
or surgeon." In addition, another provision exempts veterinarians from
regulation when dispensing their own medications. The high court judges
concluded that this exemption would be unnecessary if the statute does not
apply to veterinary drugs. The justices ruled that because there was no
language in the statutes that explicitly grants the board authority to
regulate the sale of prescription-only drugs for animal use, it was improper
to read such a legislative intent into the act. Furthermore, the court felt no
compulsion to defer to the board's recent change in interpreting its statutory
authority. As to why they voted this way, the opinion states:
When it investigated United Pharmacal's
practices twice in the 1990s, the board apparently concluded the company was
not engaged in the practice of pharmacy, as it took no action to regulate the
company's practice. The board's statutory scope of authority has not changed
since, and the board has not articulated why it changed its interpretation of
its statutory authority. Administrative agencies such as the board are
legislative creations that possess only those powers expressly conferred or
necessarily implied by statute. Because it is uncertain that [the statutes]
regulate United Pharmacal's activity, it is equally uncertain that the board
legally could license United Pharmacal or regulate that license.1
The court also noted that violations of the
statutes constitute a class C felony. This, six of the seven judges thought,
required application of a little known or used legal doctrine: the "rule of
lenity." The court stated that because criminal charges could be rendered, the
rule required the court to construe the statutes so that the sale of
veterinary drugs is not considered the "practice of pharmacy."
One judge also agreed with the majority opinion
that those engaged in the retail sale of veterinary drugs are not subject to
regulation by the board, but she did not believe it was necessary to employ
the lenity rule. This justice wrote:
The rule of lenity applies only in criminal
cases and is not appropriately applied in this case, in which the Court has
been asked to determine generally whether an administrative agency has
authority to regulate the retail dispensing of veterinary drugs, not whether
someone can be sanctioned or held criminally accountable for a violation of
the relevant statutes… Application of laws that are largely remedial in
character, such as this, normally is determined by ascertaining whether a
particular provision should be given a broad or narrow construction, not by
applying the rule of lenity.1
Thus, the judge agreed with the majority opinion
on the outcome because, in her opinion, the same result would have occurred
without reference to the lenity rule.
Analysis
So what is the rule of lenity and how can you make use of it? Lenity is
defined as "the condition or quality of being lenient." Leniency, mildness,
mercy, and mercifulness as a consequence of being lenient or tolerant are
terms commonly associated with lenity.5
In
America
, a person who is charged with violating a statute must have committed actions
that are specifically addressed in the law. For the most part, application of
this standard is easy. But what happens when a statute is ambiguous as to
whether an individual's conduct is in compliance or unlawful? For example,
"vagrancy" laws have been used in the past to arrest and detain persons the
police believed had committed or were about to commit crimes.6 A
person could be arrested for vagrancy by having no permanent address or for
moving aimlessly through the streets. In a U.S. Supreme Court case, the
justices found that a statute declaring vagrancy as a crime was
unconstitutional because it was too vague to be reasonably understood.7
The court emphasized that a person cannot avoid engaging in criminal conduct
if prior to engaging in it, he or she cannot determine that the conduct is
forbidden by law. The general rule is that an ambiguity should be resolved in
favor of the defendant. Applying this notion, a judge should choose the more
lenient interpretation in determining the intent of a statute.8
Now that you know what lenity is and how and when
it should be applied, what good is that to a pharmacist? First of all, let us
all hope that none of us will ever be charged with criminal misconduct. That
said, history shows that pharmacists are charged with violating controlled
substance laws on more than just the rare occasion. To illustrate, imagine you
receive a prescription for oxycodone HCL with acetaminophen, a schedule II
drug.9 Using a heightened level of scrutiny, as should always
happen with prescriptions for addictive narcotic drugs, you find the number of
the prescribing physician in the phone book, call it for verification, and the
person on the other end tells you that the name on the prescription is a
patient of the doctor and the prescription is valid. Moments after you give
the medication to the patient, the storm troopers rush the counter and drag
you away under arrest for knowingly distributing a narcotic without a
valid prescription. While in jail waiting to be arraigned for this heinous
crime, you learn from your cell mates (a bunch of folks who understand drug
use at least as well as any pharmacist) that the doctor who prescribed the
drug lost his license several weeks earlier. That is sobering news that you
wish you had known earlier that week. After you are charged with this criminal
activity, the Board of Pharmacy seeks revocation of your pharmacist and
controlled substance licenses.
In the criminal trial, your exceptionally clever
lawyer asks the judge to apply the rule of lenity to determine that you could
not have possibly known that the doctor was not authorized to practice
medicine, as that term is used by the statute you have been charged with
violating. All criminal allegations are dismissed, and you are free to go back
to work except for just one thing. The Board of Pharmacy's proceeding seeks to
revoke your licenses. You figure that lenity thing worked before, so let's try
it again. But this time, the concept is not followed and you lose your
pharmacist license. What went wrong? The Board of Pharmacy allegations are
administrative, not criminal. The rule of lenity is not available in
administrative hearings.10 (Think O.J. Simpson, not guilty of
criminal charges but liable for wrongful death in a civil claim.) Of course,
there are other ways to avoid punishment for doing what you thought was right
at the time. Just don't expect that every allegation against you should be
dropped because some other judge in a different proceeding gave you leniency.
For practice, ask your spouse or other loved ones to cut you a break using the
rule of lenity when you do something especially stupid and know you are going
to be in trouble. Claim that the rules are not clear and you had no idea that
you were violating the rules. Offer to throw yourself on the mercy of the
family court and see what happens. But do not try this tactic more than once
or twice in a lifetime.
References
1. United Pharmacal Company of
Missouri
v.
Missouri
Board of Pharmacy, Slip Op No SC87316 (December 19, 2006),
Missouri
Supreme Court,
2006
Mo.
LEXIS 149.
2. RSMo (2000) 338.010.1 and 338.220.
3. This was actually the second time that the case came to this court. In the
first case, the Supreme Court of Missouri first ruled that the case had been
filed in the wrong county and remanded the matter to a trial court in the
correct county. United Pharmacal Company of Missouri, Inc. v. Missouri
Board of Pharmacy, 159 S.W.3d 361, 363 (
Mo.
banc 2005). That holding is not germane to the issues addressed in the
present holding.
4. Section 338.010, defining the "practice of pharmacy," provides in relevant
part: 1. The "practice of pharmacy" shall mean the interpretation and
evaluation of prescription orders; the compounding, dispensing and labeling of
drugs and devices pursuant to prescription orders; the participation in drug
selection according to state law and participation in drug utilization
reviews; the proper and safe storage of drugs and devices and the maintenance
of proper records thereof; consultation with patients and other health care
practitioners about the safe and effective use of drugs and devices; and the
offering or performing of those acts, services, operations, or transactions
necessary in the conduct, operation, management and control of a pharmacy. No
person shall engage in the practice of pharmacy unless he is licensed under
the provisions of this chapter. …This chapter shall also not be construed to
prohibit or interfere with any legally registered practitioner of medicine,
dentistry, podiatry, or veterinary medicine, or the practice of optometry in
accordance with and as provided in sections 195.070 and 336.220, RSMo, in the
compounding or dispensing of his own prescriptions.
Section 338.210, defining "pharmacy," provides in part: Pharmacy refers to any
location where the practice of pharmacy occurs or such activities are offered
or provided by a pharmacist or another acting under the supervision and
authority of a pharmacist, including every premise or other place: where the
practice of pharmacy is offered or conducted; where drugs, chemicals,
medicines, prescriptions, or poisons are compounded, prepared, dispensed, or
sold or offered for sale at retail; where the words "pharmacist,"
"apothecary," "drugstore," "drugs," and any other symbols, words, or phrases
of similar meaning or understanding are used in any form to advertise retail
products or services; where patient records or other information is maintained
for the purpose of engaging or offering to engage in the practice of pharmacy
or to comply with any relevant laws regulating the acquisition, possession,
handling, transfer, sale, or destruction of drugs, chemicals, medicines,
prescriptions, or poisons.
5. See www.answers.com/topic/lenity. Accessed December 31, 2006.
6. See www.answers.com/topic/within-the-statute. Accessed January 4, 2007.
7. Papachristou v.
Jacksonville
, 405
U.S. 156, 92
S. Ct. 839, 31 L. Ed.
2d 110 (1972).
8. See Note 6, supra.
9. Percocet, Endo Pharmaceuticals, see
www.endo.com/healthcare/products/percocet.html. Accessed January 5, 2007.
10. In re: Kostas, Food and Drug Administration [Docket No. 92N-0429] [
Federal Register: June 25, 1998;64(122)] [pages 34,652-34,655],
Constantine I. Kostas; Denial of Hearing; Final Debarment Order,
www.fda.gov/ora/compliance_ref/debar/dbarfedreg/kostas98.txt. Accessed
December 31, 2006.
To comment on this article, contact
editor@uspharmacist.com.
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