Rx & The Law

The Pharmacy's Duty For Reducing Errors

by Kenneth R. Baker, B.S.Pharm., J.D.
Vice President, General Counse
Pharmacists Mutual Insurance Company

If a pharmacist makes a mistake on a prescription, the pharmacist may be held liable for the injuries caused by the error. Through the legal concept of vicarious liability, a pharmacy will be liable for damages caused by its employees if they are acting within the course and scope of their duties for the pharmacy. Does the pharmacy have a duty beyond this? Does the pharmacy have an independent duty to take steps to reduce errors by their employed pharmacists? According to the Alabama Supreme Court, the answer is "yes."

The Alabama case arose out of a pharmacist's mistake, which caused non-permanent injury to a patient. The patient filed a lawsuit against the pharmacy alleging the pharmacist was negligent. The patient (plaintiff) filed an additional count as part of the suit and asked for an extra monetary award to be paid by the pharmacy because it had not developed a system to assure that its pharmacists filled prescriptions correctly in the first place. The plaintiff's attorney argued that the pharmacy owed to its patients a duty to reduce the probability of prescription errors.

In the case of Harco Drugs v. Holloway, the pharmacist misread a Tamoxifen prescription and filled it with Tambocor. The jury found the pharmacist was negligent and that the pharmacy was responsible for the resulting injuries. The jury went further, finding the additional duty on the pharmacy as argued by the plaintiff's lawyer, and awarding the plaintiff punitive damages against the pharmacy owners.
The pharmacy appealed, but the Alabama Supreme Court agreed with the jury and upheld the punitive damages. In its decision the Court said: "We note that the jury was also informed of 233 incident reports that had been prepared by Harco employees during the three years preceding the incident. This evidence, in addition to evidence of complaints filed with the State Board of Pharmacy and the evidence of lawsuits filed alleging misfilled prescriptions, was relevant to show Harco’s knowledge of problems, and Harco’s having failed to initiate sufficient institutional controls over the manner in which prescriptions were filled."

By "institutional controls" the Court was clear that it was placing upon the pharmacy an additional duty, for which it could independently be held liable. That duty requires the pharmacy owner or chain to institute a system of risk management designed to reduce the number of errors in its pharmacies.
Several boards of pharmacy are now considering a similar position in order to stem what the boards see as an alarming rise in the number of complaints of pharmacy errors. When the number of errors reported have caused the boards to become concerned for the public's safety, some boards of pharmacy have required pharmacy owner or chains to institute a plan of quality assurance or risk management.

Risk management calls for a systematic approach to the practice of pharmacy. Human beings make errors, but a risk management system can be designed to reduce those errors. A true system of quality assurance goes beyond risk management to envelop the concept of quality measurement and continuous quality improvement. No system can eliminate errors, but pharmacy owners would be wise to begin exploring the implementation of a quality control program.

This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with the policies and procedures of their employers and insurance companies, and act accordingly.