Innovations-Magazine-February-2024 - 5

REGULATORY PERSPECTIVES
pronouncements of then-President Donald
J. Trump. During the week of August 13,
2021, 88,000 prescriptions for ivermectin
were presented, compared to an average of
3,600 weekly prescriptions before 2021.
The court also noted that " telehealth
companies now have dedicated pages
for ivermectin that advertise the ease of
obtaining a prescription for the drug. "
As noted, " these prescriptions are off-label,
and many patients refuse to divulge what
the prescriptions are for. "
Justifying the threat to the plaintiff and
other similarly situated Missouri pharmacists,
the court reviewed the functions of the Board
and the authority it held to administratively
sanction a licensee. Potential sanctions
included censure, reprimand, suspension, and
revocation of licensure. Further, the court
noted that the issue of pharmacists being
presented with, filling, and dispensing such
prescriptions were not isolated circumstances
and will likely be ongoing and continuous.
The defendants argued that the second
sentence is not viewpoint discrimination
because it regulates conduct, not speech.
The court found this argument to be
unpersuasive. In rejecting this argument,
the court emphasized that the:
" statute does not prohibit initiating
contact with the patients or doctors
(a regulation of conduct). Nor does
it prohibit initiating contact with
patients or doctors to speak on any
matter at all (a content-neutral regulation
of speech). Nor does it prohibit initiating
contact with patients or doctors to talk
about a particular subject matter, such
as any discussion of either drug (a
content-based regulation of speech).
Rather, the provision bans initiating
contact only if the contact is to
express the viewpoint that the drugs
are not effective for human use. "
Next, the defendants argued that
the law is not a ban on a viewpoint
doubting effectiveness, but rather a ban
on pharmacists engaging in arguments
When " may, " " should, "
or " must " a pharmacist
exercise professional
judgment and have a duty
to warn as part of filling and
dispensing a prescription?
statute. However, to date, the preliminary
injunction appears to be in effect,
disallowing enforcement of the specified
section of the statutory amendment.
While this statutory amendment and
the legal arguments under the First
Amendment may be politically charged,
about the effectiveness of these drugs
generally. They argued that disputing the
drugs can involve either promoting or
discouraging their use. The court found
this position to be even less persuasive
than the conduct vs. speech argument. It
held that such a position " defies common
sense. " As noted, pharmacists inquire
about prescriptions to alert the prescriber
about side effects, contraindications, or
drug interactions. Pharmacists do not
call doctors or patients to applaud the
prescriber and congratulate the patient.
" This being the case, Defendants' claim that
the legislature has enacted a law barring
a pharmacist from calling a doctor or
patient to tout a drug is hard to swallow. "
Focusing on the word " dispute " and its
common meaning to doubt or question
the validity of something, the court
summarized the statutory prohibitions
to be limited to communications that
question or criticize the effectiveness of
the drug. Such restrictions clearly violate
the First Amendment. Significant case
law states that " government may not
discriminate against speech based on the
ideas or opinions it conveys. " As such, the
court found in favor of the plaintiff and
entered an order granting a preliminary
injunction on the enforcement of the
second sentence of the Missouri statute,
cited as MRS §338.055.7 (2022).
The state of Missouri has the option of
continuing the litigation on the merits and
the legislature may decide to amend the
bigger questions may be at stake. When
" may, " " should, " or " must " a pharmacist
exercise professional judgment and
have a duty to warn as part of filling
and dispensing a prescription? Or
perhaps, may the pharmacist refuse
to fill such a prescription? Of what
importance is the fact that such a
prescription is for an off-label use? How
and when do pharmacists distinguish
between questioning and disputing
the prescription? How does the law
distinguish between speech and conduct?
As the " last chance " between a patient
and ingestion of a drug, the pharmacist
plays a critical role using knowledge,
skills, and abilities in the implementation
and maintenance of a drug regimen.
With COVID-19 no longer frontpage
news, the prescriptions for
hydroxychloroquine and ivermectin may
not be as prevalent, but these bigger
questions remain. Stay tuned.
Stock v. Gray, 2023 U.S. Dist.
LEXIS 48300.
This article was written by Dale J. Atkinson,
Esq, with The Atkinson Firm. Please note, the
opinions and views expressed by The Atkinson
Firm do not necessarily reflect the official views,
opinions, or policies of NABP or any member
board unless expressly stated.
FEBRUARY 2024 | 3
Innovations-Magazine-February-2024

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