The legal obligations of manufacturers, physicians, and pharmacists are examined in this case of a serious overdose.
Issue of the Case
When a patient is started on one dosage strength of a medication and then the strength of the medication is changed when a refill is authorized, does the pharmacist have a legal duty to call such a change to the attention of the patient, even when the patient has declined the offer of Omnibus Budget Reconciliation Act of 1990 (OBRA 90)–related counseling?
Facts of the Case
A patient in a Southern state underwent surgery for a total knee replacement and subsequently suffered a pulmonary embolism. To treat that condition, her doctor prescribed warfarin 1 mg with the instructions being to take 1 tablet 5 times per day “as directed.” She followed that regimen for 3 years. Exhausting the authorized refills, the patient contacted the prescriber’s office for refill authorization. When the nurse phoned in the prescription to the pharmacy, she indicated that the prescription was for warfarin 5 mg to be taken “as directed.”
The patient was extended the offer of counseling at pickup, as mandated by the state’s regulations affecting the OBRA- 90 mandates. She declined the offer, signing a form to document that decision. She continued to consume 5 tablets per day, and eventually ended up in the hospital with an epidural hematoma of the spinal cord.
Although the patient asserted that no information had been conveyed to her about the change in dosage strength and that she was merely told to sign the counseling form, the pharmacist who was on duty at the time claimed that she had indeed counseled the patient. However, the pharmacist could not recall the specifics of the counseling discussion. There was no testimony at the hearing on the motion regarding exactly who had checked the “decline counseling” box on the form.
Claiming that no information had been shared with her about the change in strength of the tablets, the patient filed a lawsuit against the prescribing physician and the pharmacy where she obtained the medication. The pharmacy asked the trial court to dismiss the claim against it, moving for summary judgment. Such a motion asks the judge to rule that, even viewing the evidence from a perspective most favorable to the other side, there is no genuine issue of material fact and judgment should be entered for the party making the motion. A summary judgment avoids a full trial.
The trial court judge granted the motion, ruling in favor of the pharmacy and dismissing the claims against it. The plaintiff appealed that dismissal of that portion of the case to the state supreme court.
The Court's Ruling
The state supreme court ruled in favor of the patient/plaintiff, reversing the decision of the trial court judge and reinstating the claims against the pharmacy.
The Court's Reasoning
In opposition to the pharmacy’s motion for summary judgment, the plaintiff had submitted an affidavit from a pharmacist licensed in the state indicating that it was the standard of care to advise patients about “change in certain medications and dosages.” This created a question that probably should go to a jury. Moreover, the difference of testimony about whether the counseling had taken place was also a question for a jury.
The final issue for the state’s highest court was whether the learned intermediary doctrine in state law applies to the facts of this case. This doctrine addresses the sorting out of liability “in light of the relationships between the parties involved in the prescribing, distribution, and use of prescription drugs.”
Succinctly stated, the rule is that the manufacturer of the medicine has an obligation to transmit to the prescriber information about the potential risks and benefits from use of the medication. It is then up to the practitioner to weigh the relative risks and benefits as part of the prescribing decision.
Following that, it is the responsibility of the prescriber to transmit to the patient any cautionary information about how to use the medication and what to be alert for as far as side effects or other adverse effects.
The court reviewed prior decisions that avoided imposing liability on pharmacists when such a mandate would require them to interfere with or infringe on the physician-patient relationship.
The court differentiated what was being sought here—emphasizing that the dosage had changed—from discussing potential risks and side effects.
The argument advanced by the patient was that the staff at the pharmacy should have alerted her to the fact that there had been a significant change in the dosage of a very dangerous medication, where a slight change can have magnified adverse consequences. The court concluded that the learned intermediary doctrine did not apply to this case and that the matter should be returned to the trial court.
Dr. Fink is professor of pharmacy law and policy and Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington.