State Enacts Statute Prohibiting Pharmacists From Commenting on Efficacy of Therapy

ISSUE OF THE CASE

The legislature of a Midwestern state enacted a statute with potentially negative implications for pharmacists and pharmacies. A pharmacist in the state went to federal court seeking an injunction prohibiting the board of pharmacy from enforcing that statute. Should the court rule in favor of the pharmacist or permit the board to proceed with enforcement action as authorized by the statute?

Image credit: BillionPhotos.com | stock.adobe.com

FACTS OF THE CASE

The state legislature enacted a statute during the COVID-19 pandemic that became effective in August 2022. This legislation made an amendment to the state’s pharmacy practice act to prohibit the board of pharmacy from taking enforcement action against pharmacies that distributed ivermectin tablets or hydroxychloroquine sulfate tablets to manage the disease pursuant to an authorized practitioner’s request.

The statute included a provision directed at individual pharmacists rather than the pharmacies where they practiced. The statute authorized the board to initiate disciplinary action against a pharmacist as follows: “A pharmacist shall not contact the prescribing physician or the patient to dispute the efficacy of ivermectin tablets or hydroxychloroquine sulfate tablets for human use unless the physician or patient inquires of the pharmacist about the efficacy of ivermectin tablets or hydroxychloroquine sulfate tablets.”

A pharmacist practicing in one of the metropolitan areas of the state filed an action in a federal district court requesting that the court prohibit the board from taking enforcement actions pursuant to that provision. Among the arguments advanced by the pharmacy practitioner was that pharmacists are permitted, and even encouraged, to contact prescribers on their own initiative to share their professional insights, including discussing the efficacy of any and all medications. Her position was that as a US citizen, she has constitutionally protected freedom of speech. Moreover, this legislatively imposed limitation on her communications with prescribers or patients was directed at specific content of her speech. That, in the view of the pharmacist, made the legislation inconsistent with her free speech rights under the First Amendment. A key issue of the case was whether the pharmacist had standing to legally pursue the matter.

THE RULING

In legal terminology, “standing” refers to the fact that the person’s legal interests would be adversely affected by the legislation being challenged.If it is decided that there is sufficient potential harm from the legislation to adversely affect the person filing the suit, then the lawsuit filed by that person may be taken up by the courts because the individual has standing.

The judge of the federal district court ruled that the pharmacist did indeed have standing and, as a result, could maintain the legal action challenging the statute.

THE COURT’S REASONING

The judge concluded that the legislation unconstitutionally restricts the speech of this pharmacist as well as other pharmacists based on their viewpoint. The court pointed out that under this statute,

“a pharmacist who violates the statute—for example, by on her own initiative alerting a doctor or patient that the FDA has not approved either drug to treat a particular disease—may face disciplinary action, including potential loss of her license. On the other hand, a pharmacist who on her own initiative contacts a doctor or patient to tout the efficacy of either drug for a purpose FDA has not approved faces no such sanction.”

The pharmacist had requested that the judge issue a preliminary injunction that maintains the status quo, prohibiting the board from acting on such matters. This prohibition would remain in place until the court can conduct a full proceeding on the issue. Concluding that the legislation and the action authorized to be taken by the board “unconstitutionally restricts this pharmacist’s and other pharmacists’ speech on the basis of their viewpoints,” the judge entered the order for a preliminary injunction. The board was prohibited “from reviewing, investigating, prosecuting, adjudicating, or enforcing violations of the sentence in the statute directed at pharmacists as individuals.”

The court relied heavily on the Code of Ethics for Pharmacists adopted by the American Pharmacists Association. Initially, the court pointed out that the pharmacist’s responsibilities “include dispensing prescription medications and counseling patients on the safe use of such medications based on her professional expertise.” The pharmacist had stated that she believed that “counseling patients and doctors to the best of her professional judgment is required as a matter of professional ethics, even when that means contacting the patient or doctor to dispute the efficacy of a given medication.”

There is an interesting twist to this legal matter. Most frequently, pharmacy-related cases are heard in federal courts based on diversity of citizenship because the parties are citizens of different states. In this matter, however, the federal court had jurisdiction based on the issue involving a federal question, meaning the issue arises under a federal statute or regulation, or as here, under the US Constitution.

About the Author

Joseph L, Fink III, JD, DSC, (HON), BSPHARM, FAPHA, is a professor emeritus of pharmacy law and policy and the former Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.

Reference

Stock v Gray, 2601218 (WD Mo Mar 2023). Accessed August 3, 2023. https://casetext.com/case/stock-v-gray