On The Docket
David B. Brushwood, BSPharm, JD
Some corporate pharmacy policies forbid pharmacists from honoring opioid prescriptions that exceed specified limits for dose and/or duration, but these policies may interfere with a chronic pain patient’s access to needed opioid medications.
In a recent lawsuit based on alleged violations of the Americans with Disabilities Act, a federal court refused to dismiss a patient’s claim that a corporate pharmacy’s policies regarding opioid dispensing had denied her “the benefit of access to the professional judgment of a prescriber and pharmacist acting in consultation.”
Background
The patient alleged that the pharmacy corporation had “misinterpreted guidance from the Center for Disease Control and Prevention (CDC) by instituting formal and informal policies which discourage or prohibit its pharmacists from filling opioid prescriptions above a certain dose and duration threshold.”
The patient referenced the conclusion of several national medical organizations that the corporation’s policies had “wrongly imposed limits on opioid prescriptions.” The patient also cited a CDC press release “expressing concern that its guideline was being misapplied and misconstrued as hard and fast limits.”
The patient alleged that her opioid prescriptions had been refused at 6 of the corporation’s pharmacies. She alleged that one pharmacist told her that “since the CDC guidelines were released,” the corporation “was changing their policy concerning filling opioid prescriptions.” Another pharmacy manager allegedly told the patient that “[b]ecause of the CDC guidelines, the DEA is looking at us too closely. It is too much of a liability and risk to fill it.”
The pharmacy corporation filed a motion to dismiss the patient’s lawsuit.
Rationale
The corporation claimed that the patient had not shown the existence of a corporate policy creating a “hard-and-fast dose duration limit set at 90 [morphine milligram equivalent]/day and seven days.”
The court disagreed with the corporation’s claim, ruling that the patient’s allegations were sufficient.
The court said “a prescriber’s thoughtful, individualized determination of the proper prescription along with a pharmacist’s attendant scrutiny of its provenance and legitimacy, both crucial exercises of professional judgment, are precluded by a hard-and-fast limit on the dose and duration of opioid prescriptions.”
The court continued to say that “while [the corporation] has every reason to scrutinize large opioid prescriptions, it cannot do so in a way that cuts the judgment of the doctor and the pharmacist out of the picture through a blanket corporate policy, as alleged. That professional judgment is essential to the benefit and service pharmacists provide, and an essential part of [the patient’s] healthcare.”
As a possible solution, the court suggested that: “Crafting some reasonable process of prior approval, appeal of denials, and/or additional scrutiny, a process which constitutes a viable path of access for patients who genuinely need large opioid prescriptions, is a reasonable request.”
The pharmacy corporation’s motion to dismiss the patient’s lawsuit was denied.
Discussion
The importance of this court ruling is that it recognizes the potential for pharmacy liability for declining opioid prescriptions, in contrast to many other cases that have recognized potential liability for honoring opioid prescriptions.
In this case, the court clarified that pharmacies are not stuck in a “lose-lose” situation. The court described a process through which pharmacies can meet both their responsibility to provide medication to those who need it and their responsibility to deny medication to those who do not need it. The court respected the value and necessity of opioid prescription screening at pharmacies. However, the court insisted that pharmacist professional judgment not be constrained by hard-and-fast corporate policies.
The formula suggested by the court describes a corporate role in the development and management of a system to evaluate and preapprove opioid prescriptions for chronic pain patients, to review complaints from patients whose opioid prescriptions have been denied, and to provide a flexible set of criteria through which pharmacists apply their professional judgment in the evaluation of opioid prescriptions. The pharmacist’s role, within this system, would be to evaluate individual prescriptions. ■