Pharmacy Law: Legal Standard for Physicians Applied to Pharmacists

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington, Kentucky.

A pharmacist is engaged in an expanded scope of practice that includes medication therapy management (MTM) activities traditionally performed by physicians, and a patient alleges that damages were suffered due to a deviation from standards of care. Should the performance of the pharmacist be evaluated in light of a pharmacist-derived standard or a physician-derived standard?

Facts of the Case

A patient who had suffered several strokes was on anticoagulation therapy using Coumadin. A Vietnam veteran, he had been treated at a Veterans Affairs (VA) Medical Center for nearly 30 years. For the 6 years prior to the incident giving rise to this lawsuit, his anticoagulation therapy was managed by a pharmacist at the VA clinic.

The pharmacist monitored the patient’s lab work, including the international normalized ratio (INR)—a reflection of time required for the patient’s blood to clot. This patient’s target therapeutic INR was 2.0 to 3.0. If it fell below that range it reflected an increased chance of clotting, while a reading above the range presented an increased chance of bleeding. The patient’s medical record reflected that when he was scheduled for dental surgery, the pharmacist indicated he should withhold use of the Coumadin and use Lovenox, an injectable anticoagulant that acts quickly when the INR is low.

On a subsequent visit, the patient’s INR was low—in fact, the lowest it had been since the pharmacist had been managing his therapy. Use of Coumadin was recommended with a return visit 3 weeks later due to a planned out-of-town trip by the patient. Five days later the patient suffered a massive stroke, which left him in a near-vegetative state. One key issue in the case was the patient care notes made by the pharmacist in the patient’s medical record—were they complete and what did the pharmacist recall about what the patient had said about his availability to return for follow-up care?

The patient’s daughter, a nurse, took him to her home to care for him. Acting as guardian for him, she filed a claim against the United States under the Federal Tort Claims Act, the statute governing such matters when the US government is the defendant.

Following filing of the matter in court, each side moved for partial summary judgment. In essence, each side felt that a portion of the issues in the lawsuit presented no “genuine issue of material fact” and that, as a result, a judgment on those specified issues should be entered in their favor by the judge because no trial was needed. The process for handling such motions includes the judge looking to the party making the motion to establish that there is no genuine issue concerning any material fact. When considering the motion, the judge views the issues in a light most favorable to the nonmoving party. If the judge feels the moving party has shown that no material issue exists, the burden then is transferred to the nonmoving party to convince the judge that there is indeed an issue of material fact. If the judge concludes that no material issue of fact exists, he can enter a summary judgment (judgment without trial) on the matter.

The Court’s Ruling

Reviewing the case record, the judge concluded that there was a material fact at issue regarding whether the pharmacist’s violation of the applicable standard of care was the direct or proximate cause of the patient’s injuries. Accordingly, the motions for summary judgment made by both sides in the case were denied.

The Court’s Reasoning

The judge in the US District Court handling this case reviewed a number of factors to ascertain whether issues of material fact existed on one or both sides of the case—did the pharmacist violate the applicable standard of due care, were the actions of the pharmacist the direct or proximate cause of the injuries, and a number of varied issues related to the measure of damages included in the claims. In the course of addressing the first of those issues, the court made liberal reference to how physicians would have managed such a patient challenge, thereby adopting the approach that pharmacists who engage in MTM will be expected to perform at the same standard of care as a physician doing the same tasks.

This case is another indication that there is no substitute for accurate, thorough documentation of what transpired between pharmacist and patient. Better documentation by the pharmacist in this case regarding the decision making on various factors related to use or nonuse of medications may well have served a very valuable role in defense of the claims. â–