Failure to Conduct DUR Is Basis for Negligence Suit

Issue of the Case

Do the provisions in the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) regarding drug utilization review (DUR) by pharmacists create a basis for a lawsuit when damages result from the review not having been done?

What are the legal expectations for a pharmacist regarding DURs?

Facts of the Case

A pharmacist at a chain pharmacy in a Southern state dispensed amitriptyline to a young woman. Nineteen days later, a pharmacist at
the same pharmacy prepared a morphine prescription for that same patient. It was picked up 2 days after that. Six days later, the patient died from an alleged fatal adverse interaction between the 2 medications she was prescribed.

The deceased woman’s mother filed a lawsuit against the pharmacy. The lawsuit alleged that the pharmacy knew or should have known that the 2 medications could be fatal when mixed. The lawsuit also alleged that, based on that knowledge, the pharmacy staff members had a legal duty to do the following but failed to do so: call the prescriber to inquire about the appropriateness of prescribing amitriptyline and morphine simultaneously, create and follow guidelines to ensure that prescriptions do not have adverse reactions to each other, disclose material facts about the prescription, monitor the patient’s drug history, refuse to dispense the morphine after dispensing the amitriptyline, and warn about the possible adverse effects of mixing the 2 medications. The plaintiff alleged that all these obligations arose from enactment of provisions in OBRA ’90.

The pharmacy chain made a motion with the US district court where the case was being handled to dismiss the lawsuit for failure to state a legally cognizable claim. Attorneys for the chain argued that the pharmacy “had no statutory or common law duty to monitor the patient’s prescriptions or prevent her from combining adverse medications.”

The Ruling

The court ruled there was indeed a legal duty created by a state statute to monitor medication use for potential drug-drug interactions.

The Court's Reasoning

The court split the motion in 2, focusing first on whether there was a statutory basis for these expectations in OBRA ’90 before looking at other common or statutory law origins as possible sources of the requirements.

The conclusion reached by the judge in the case was that the wording of the federal statute “did not require the defendants to review the deceased’s drug profile” as was asserted.

Rather, the wording of the OBRA ’90 legislation dictated that states were required “to adopt expanded standards of pharmaceutical care for Medicaid patients as a condition on receipt of federal Medicaid funds.”

The court viewed the wording in the federal statute as “guidance to states, not private actors, on how to comply with OBRA’s mandate.”

The judge concluded that “OBRA ’90 does not create a private right of action through which [the] plaintiff could assert her claims.”

As a result, the claims based on violation of OBRA ’90 provisions were dismissed with prejudice, meaning permanently.

The attorneys for the pharmacy chain had argued that the pharmacy owed the patient “no duty whatsoever under the law of the state to review her drug profile, warn of adverse effects, or refrain from filling her prescriptions because those duties rest with the prescribing physician.”

However, the court reviewed relevant provisions in state regulations and statute, and said: “A pharmacist shall review the patient record and each prescription drug order presented for dispensing for the purpose of promoting therapeutic appropriateness by identifying...drug-drug interactions... Upon recognizing any of the above situations, the pharmacist shall take appropriate steps to avoid or resolve the situation or problem, which shall, if necessary, include consultation with the prescribing practitioner.”

This led the judge to conclude that “although [the chain’s] pharmacists may not have had a duty to the patient under the common law of the state, the court finds that the legislature clearly imposed a statutory duty on pharmacists under particular circumstances, specifically including the duty to monitor potential drug-drug interactions.”

The pharmacy chain’s attorneys also cited an earlier case from the state dealing with what the court described as the “narrow issue of a pharmacist’s duty to warn of a drug’s potential [adverse] effects.”

However, the judge distinguished that court ruling from this case because it focused on adverse effects and not drug-drug interactions, so that argument was rebuffed.

The outcome was that the defensive arguments advanced on behalf of the pharmacy chain that were rooted in the wording of the federal OBRA ’90 statute were rejected, so that basis for the lawsuit could not be used by the plaintiff.

On the other hand, the wording of state-level regulations and statutes did provide a clear basis for the lawsuit to proceed. Accordingly, the court denied the pharmacy chain’s motion to dismiss the suit.

Joseph L. Fink III, JD, DSc (Hon) FAPhA, BSPharm, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.