David B. Brushwood, BSPharm, JD
A federal judge in Ohio who oversees the National Prescription Opiate Litigation (NPOL) has recently issued a ruling with significant implications for pharmacists and pharmacies. The ruling requires pharmacists to document refusals of opioid prescriptions based on so-called “red flags.” Pharmacy companies are required to share these documented refusals with pharmacists at all of their practice sites. Pharmacists are required to consider their colleagues’ documented prior refusals during their screen of subsequent opioid prescriptions.
Background
The NPOL is a conglomerate of lawsuits filed by states, counties, municipalities, tribes, and other government entities against opioid manufacturers, drug wholesalers, and pharmacies. The NPOL has been divided into separate tracks, and the pharmacy defendants have been split out into Track Three.
The plaintiffs have alleged that the defendant pharmacies created a public nuisance through the failure of their pharmacists to identify and resolve “red flags” signaling opioid prescription invalidity. The pharmacies allegedly did not implement policies and procedures that would have prevented the creation of a public nuisance by their pharmacists.
The rationale of the NPOL is not complicated. The general idea is that pharmacists abdicated their responsibility for the screening of opioid prescriptions, resulting in harm to the public that must be remedied through an abatement in the form of money damages paid by the pharmacy defendants to the plaintiffs.
The pharmacies asserted many arguments in their defense. They contended, among other things, that the term “red flags” is a vague phrase coined by DEA with no legal authority. The laws governing controlled substances do not use this term. There is no clear government guidance as to what factors constitute “red flags,” how “red flags” are to be identified and managed by a pharmacist, or how the resolution of “red flags” is to be documented. Despite these arguments, the pharmacy defendants were held liable at trial, and they have entered into a global settlement agreement with the plaintiffs.
Prior to the settlement, the federal judge in Ohio issued an injunction requiring the defendants to implement specific policies and procedures. The defendants filed a motion to delay the injunction, pending appeal of the case. The pharmacies contend that the injunction includes provisions that are not set out in the global settlement. These provisions relate to the required documentation of opioid prescription refusals by pharmacists.
Rationale
The judge noted that the court’s injunction order reflected evidence at trial showing that “pharmacists who refuse to fill a prescription often fail to document their refusal, and the pharmacy defendant fails to notify other of its pharmacists and stores of the refusal. The result is that other pharmacists do not know of the refusal, which could be critical information if the patient tries to present their red-flag prescription again.” The judge explained that his injunction order “requires the pharmacy defendants to institute policies and procedures requiring pharmacists to document any refusals to fill, and to consider prior refusals during their prescription validation process.” The judge expressed regret that “these common-sense provisions were not included in the national settlement provisions.” Regarding the policies and procedures for documentation, the judge noted it is “likely the defendants will apply them nationally.”
The motion to delay the injunction was denied.
Takeaways
The responsibility recognized by the judge in this case is novel. There is no existing professional standard for documentation by pharmacists of prescription refusals. Pharmacy software may not provide the opportunity to record comments related to prescriptions or patients for whom medications are not provided.
Several important questions must be addressed: Where should this documentation of refusal be made? How extensive must the documentation be? To what extent is a subsequent pharmacist obliged to consider comments previously made by a professional colleague?
The judge has invented a standardless responsibility. The pharmacy profession must now develop standards for compliance. These standards must ensure that documentation by pharmacists who refuse opioid prescriptions is complete, concise, accurate, and respectful. ■