Rx & The Law

How Do We Protect The Patient From The Unforeseeable?

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

Occasionally when developing risk management techniques that will protect us from liability, we forget the ultimate goal of risk management is to protect those who rely on us as professionals. In the 1994 Tennessee Supreme Court case of Pittman v. Upjohn, neither the physician nor the pharmacy were found legally liable for the death of the adult grandson of the patient. The Court ruled it was not legally foreseeable to the pharmacy or the physician that the adult grandson would accidentally take his grandmother’s Micronase®. However the young man sustained permanent brain damage requiring constant care. Regardless of legal liability, could the physician or the pharmacist have taken steps that would have prevented this tragedy?

In 1988 Bessie Richards was diagnosed as having adult-onset diabetes and received a prescription for Micronase. The directions on the prescription label were "Take one tablet daily before breakfast." Neither the physician nor the pharmacist gave any written information about the drug, nor did either counsel Bessie. At Bessie’s request, the prescription was filled in a non-safety cap bottle.

Six months later, Mrs. Richard’s grandson, Don Pittman, 26 years old, was visiting her house. Don complained to his grandmother that he thought he had the flu and hurt all over. Bessie told Don there were some aspirin on top of the refrigerator. Don apparently took some of the Micronase. Over the next two days Mr. Pittman got worse and eventually went into a hypoglycemic coma. It was discovered he had taken six of the Micronase over the two day period.

Pharmacists, like most people who choose a career in one of the health professions, are caring people. An incident such as this has a devastating effect on the pharmacist as well as the family of the injured party. What steps could you take in your pharmacy to protect against this type of case?

As pharmacists we deal with potentially dangerous drugs that can injure as well as cure. We cannot protect our patients against all bad outcomes. We cannot take responsibility for everything bad that happens. There are no steps we can take to guarantee an event like in Pittman v. Upjohn never happens. We can, however, take steps to protect our patients.

While all patients should be counseled, at least with new prescriptions, certain drugs require more information and more time. Patients need to know what they are taking and why. The Indian Health Service recommends an initial question during counseling of "What did your doctor tell you this is for?"

With all diabetic drugs the risk of hypoglycemia is potentially dangerous. Counseling about interactions, including foods, and side effects is important. Upjohn literature states:

"Information for the Patients: Patients should be informed of the potential risks and advantages of Micronase and of alternative modes of therapy. They also should be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of urine and/or blood glucose."

The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. Primary and secondary failure also should be explained.

The physician may have already explained these things. In order for the pharmacists to make the best use of his or her time, the Indian Health Service recommends a second question to test what the patient already knows. In this case, asking the patient "What side effects and precautions did the doctor go over with you on this medication?" will discover what areas the pharmacist does not need to spend time on.

In addition, the pharmacist might strongly suggest to all patients that medication be kept in a safe place away from other medications other members of the family might take. In the Pittman case, the grandson was an adult, but there are many sad cases where the child is under five years. Perhaps, even when a patient routinely requests non-safety caps, we may want to suggest that if any young children ever visit they may want to reconsider that decision. A few moments of inconvenience each day may save a child. One Kansas pharmacist who had that experience, now makes that suggestion to every patient.

The Court in the Pittman case left no doubt that had the facts been different, the pharmacy would have been liable. The Court said "the pharmacy, as well as the physician, owed [the patient] the duty to warn" of the "symptoms and dangers of complications that might arise from the use of Micronase."

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.