US Pharm. 2015;40(2):55-57.

Imagine the following scenario. A pharmacy contracts with a long-term care facility (LTCF) to provide medications and consultation services to the residents of the facility. An order entry error is made at the pharmacy and the patient does not receive a drug prescribed by the patient’s physician in a timely manner. Is the pharmacy liable for damages the patient incurs, or is the pharmacy so far removed from the medication delivery system that it is immune from any liability? According to a recent decision from the Ohio Court of Appeals, the pharmacy and the pharmacist responsible for dispensing the medication and consultations are also responsible for the harm sustained by the patient.1

Facts of the Case

The patient was admitted to a LTCF on March 28, 2011, with a diagnosis of deep venous thrombosis (DVT) and pulmonary embolism (PE). At that time, the patient was receiving warfarin 3.5 mg dispensed as 2.5-mg and 1-mg tablets. Upon admission to the LTCF, she was assigned a new physician. On April 9, that doctor ordered warfarin 5 mg to be given for 2 days and 4 mg daily thereafter. In addition, international normalized ratio (INR) draws were ordered for each Tuesday.

A new pharmacy (Omnicare) became the pharmacy provider to the LTCF during this period. The pharmacy created “physician order sheets” dated May 1 and June 1 that listed pending prescriptions for warfarin 2.5 mg, 1 mg, and 4 mg. The pharmacy records showed dispensing of 30 doses of 1 and 2.5 mg tablets of warfarin on March 28, and two doses of 5 mg were shipped on April 10. The prescription for 4-mg was entered into the pharmacy computer system, but the 4 mg dose was never shipped to the facility. The pharmacy’s consulting pharmacist to the facility noted the unavailability of 4-mg tablets and reported this to the nursing staff of the facility, but no further action was taken.

An April 12th report showed that the patient’s INR was 1.3, well below the target range for patients with DVTs. The consulting pharmacist noted the absence of weekly INR laboratory reports in May and June. The pharmacist took no further action.

The patient was transferred to a hospital on June 14 where she was diagnosed with extensive bilateral DVTs and acute PE. She died on July 2 from acute respiratory failure secondary to PE.

Lawsuit

A complaint was lodged against the dispensing and consulting pharmacists and the pharmacy, alleging that the 4-mg dose ordered on April 9 was never delivered and that the consulting pharmacist failed to properly conduct monthly medication regimen reviews. It was claimed that the patient died as a result of the defendants’ failure to provide services as agreed.

Trial Court Proceedings

The pharmacy asked the court to dismiss the lawsuit on the grounds that the pharmacy and the consulting and dispensing pharmacists’ duties were owed to the LTCF and not directly to the patient. The trial court granted the pharmacy’s motion for summary judgment on the grounds that the pharmacy’s agreement with the LTCF did not establish a duty of care to the patient and that there was no common-law duty on the part of the pharmacists to oversee and guarantee delivery of medication to the patient. Of particular note, the trial court refused to consider the affidavit of the plaintiff’s expert witness attesting to the duty of the pharmacy and the pharmacists to care for the patient’s needs.

Court of Appeals Decision

On appeal, the plaintiff argued that the pharmacy and pharmacists owed a common-law duty to the patient based on the foreseeability of the risks involved. She also appealed dismissal of the expert witness’s report.

Dealing first with the opinion of the expert witness, a licensed pharmacist with over 30 years of experience, the Court of Appeals ruled that the trial court erred in refusing to consider this report. The court determined that the witness was fully qualified to testify as to the duties of the pharmacy and pharmacist involved with the patient’s care. Based upon that opinion, the court noted that “a consultant pharmacist is part of a long-term care patient’s healthcare team, and acts to monitor all aspects of drug therapy, including but not limited to assuring the accurate acquiring, receiving, dispensing, administering, and storage of all drugs and biologicals to meet the needs of each patient. A consultant pharmacist also ensures that long-term care patients are receiving and being administered his/her prescribed medications and that said patients are receiving the intended benefits from his/her medications.”

The court also noted that the expert witness opined that the dispensing pharmacist breached the standard of care required of her to discontinue the patient’s pre-April 9th prescription order for the administration of the 3.5-mg daily dosage of warfarin and dispense the 4-mg daily dosage of warfarin as prescribed by the physician.

In addition, the expert witness testified that the consulting pharmacist breached her duty to the patient to carefully check the patient’s medical chart at least monthly to ensure that she was receiving her warfarin and that she received therapeutic benefits from her warfarin therapy. As a result of this breach of duty, according to the expert witness, the consulting pharmacist did not discover irregularities in the patient’s care and did not report to the director of nursing or the physician that the patient was not receiving her medications or laboratory testing, which directly contributed to her hospitalization and ultimate death.

The trial court refused to consider the expert witness’s testimony on the basis that he was not a physician and therefore not qualified to testify as to the patient’s cause of death. The Court of Appeals disagreed and found that he did not opine as to the cause of death but that he only attested that the failure to take the prescribed warfarin would have been consistent with the development of blood clots and PE.

As to the issue of whether or not the contract between the pharmacy and the LTCF created a duty of due care either to the facility or directly to the patient, the Court of Appeals ruled that the pharmacy patient’s lack of “privity” was of no consequence in this case. Here, according to the Court of Appeals, the court found that there is a duty of care between a professional and a foreseeable third-party to a contract. The court stated that even if it considered that the pharmacy undertook for consideration to render services only to the LTCF, those services were necessary for the protection of its residents. Therefore, the pharmacy is liable under negligence law to each resident for physical harm resulting from its failure to exercise reasonable care to protect a resident if a) the failure to exercise reasonable care increases the risk of harm; or b) the pharmacy has undertaken to perform a duty owed by the facility to a patient; or c) the harm is suffered because of the reliance of the facility on the pharmacy’s undertaking of a duty to the patient.

In this case, the pharmacy voluntarily undertook the facility’s duty to provide pharmacy services to the patient and therefore had a duty to exercise reasonable care in providing the services that it agreed to provide to the patient under the contract with the LTCF. Furthermore, the Court of Appeals determined that the pharmacy owed a common-law duty to exercise reasonable care to the patient in the dispensing of medications.

Analysis

Normally, when one party contracts for services to another party, the duties are outlined in the agreement and bind the parties to each other for performance of services called for in the contract. Persons who are not “in privity,” or parties to the contract, generally cannot claim a breach of duty for the failure of the parties to the contract to perform called-for services. An exception exists to this general rule when injury to a third party is foreseeable based upon the agreement executed by the two parties to the contract. In this case, the pharmacy contracted with the LTCF to provide medications and consulting pharmacist services. The pharmacy contended that based upon general contract law, its duties extended only to the LTCF. The trial court agreed and dismissed the case. The Court of Appeals noted the exception to the general rule and held that the pharmacy did indeed owe duties of due care to the patients of the facility. Based upon the plaintiff’s expert witness opinion, the Court of Appeals accepted the argument that the standard of care between a pharmacy and an LTCF extends to the patients of the facility.

The Court of Appeals also established that irrespective of the contractual arrangement between the pharmacy and the LTCF, the pharmacy owed a common-law duty of care directly to the patient and that this duty was negligently breached by failing to deliver the warfarin dosage ordered by the physician to the patient. Therefore, the trial court’s dismissal of the case was reversed and the Court of Appeals remanded the case for further proceedings.

This case, if followed in other jurisdictions, establishes a prece-dent that pharmacies and the consulting pharmacist employed by the pharmacy may be liable to patients of LTCFs if patients suffered damages as the result of pharmacy errors. Take note that the pharmacy and the individual pharmacist were both found negligent.

A pharmacist employed by a pharmacy that services patients in an LTCF to provide dispensing and/or consulting activities should take special care to see that all services are provided in a professional manner, making certain that patients receive prescribed medications and any laboratory tests ordered in concert with the medications provided. Employed pharmacists should confirm that they are covered by the employer’s malpractice insurance policy to avoid having to pay judgments rendered against an individual pharmacist. Otherwise, the pharmacist should have his or her own malpractice insurance policy. In any event, the insurance policy’s payment limits must be of sufficient magnitude to pay for any judgment rendered against the individual pharmacist.

REFERENCES

1. Moore v. Covenant Care Ohio, Inc. (Slip Op. No. L-13-1259, Sept. 19, 2014), 2014 Ohio App. Lexis 4012. https:// www.supremecourt.ohio.gov/rod/docs/pdf/6/2014/2014-ohio-4113.pdf. Accessed January 14, 2015.

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