Rx & The Law
How Do We Protect The Patient From The Unforeseeable?
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.
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.
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?"
all diabetic drugs the risk of hypoglycemia is potentially dangerous. Counseling
about interactions, including foods, and side effects is important. Upjohn
"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
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."
article discusses general principles of law and risk management. It is not
intended as legal advice. Pharmacists should consult their own attorneys
insurance companies for specific advice. Pharmacists should be familiar with
the policies and procedures of their employers and insurance companies, and