Duty to warn: The importance of the pharmacist in everyday practice

Speaking of ethics, Socrates said, “It is no small matter, it is how we ought to live.” Once in a while something reminds us of the importance of pharmacists in everyday practice. The Indiana case of Kolozsvari v. Doe[i] is such a reminder.

In brief, the story is this. Christine was told she had to have a colonoscopy. Christine’s doctor prescribed the pre-prep laxative OsmoPrep, sodium phosphate-based tablets. Sodium phosphate products such as OsmoPrep, now designated REMS drugs, pose a risk of renal failure. This risk may be heightened when combined with factors that stress the kidneys.

Adding to the risk is the concurrent use of ACE inhibitors, such as lisinopril, which Christine took for her blood pressure. OsmoPrep carries a warning “regarding the drug’s potential for causing kidney damage as a result of possible interactions with lisinopril.”¹ The computer in Christine’s pharmacy provided such a warning when her prescription was filled.

See also: The good of every patient

Patient asked

After taking the OsmoPrep, Christine found that her colonoscopy had to be rescheduled, which meant that she had to take a second dose of the laxative. She told her doctor’s office “. . . she had experienced some tingling in her fingers and forearms and asked whether these sensations might be related to the OsmoPrep.” ¹ Someone from the doctor’s office “told her that these were not caused by the OsmoPrep.”¹

Christine took the second OsmoPrep prescription to the pharmacy and asked again about these symptoms. “The technician consulted with [the pharmacist] who said that OsmoPrep did not cause the tingling sensation.”¹

After the second round of OsmoPrep, Christine was admitted to the emergency room with symptoms of kidney failure. The court said, “The damage to her kidneys requires that Christine undergo dialysis for the rest of her life or receive a kidney transplant, and she has been placed on a transplant waiting list.”

See also: Special knowledge may give rise to special duties to warn

Failure to warn

The only question for the court at this phase of the case was whether the pharmacist and pharmacy could be sued for failure to warn Christine and/or her physician of the risk of taking the drugs. The court ruled in the affirmative, saying, “We hold that [the pharmacy and the pharmacist] had a duty of care to Christine either to warn Christine of the side effects of OsmoPrep or to withhold the medication in accordance with [Indiana Law].”¹ The Court did not rule on what caused the kidney failure; that was for the trial jury to determine.

We are looking at this case only as a reminder of the live-saving professional and ethical role pharmacists can exercise for its patients. It reminds us of the importance of the role of the pharmacist.

Reference

1. Kolozsvari v. Doe, Ind App, 943 N.E.2d 823 (2011). The facts cited are from the Court opinion. Since this was a motion for summary judgment, the facts were stated in favor of the nonmoving party, in this case the plaintiff Kolozsvari. There was no conclusion in the case as to whether the OsmoPrep caused or led to the kidney failure. This would have to be proved in the trial that followed this opinion. The question here was only one of duty, not ultimate liability. Since this was a motion for summary judgment, the defenses of the pharmacy and pharmacist were not considered in this opinion but would be presented in the trial.

See also: Making ethics work: Manage your counseling time