A compounding pharmacy was presented with a prescription for chloroquine phosphate for a 7-year-old child who was traveling with her parents to Central America. Shortly after accepting the prescription from the mother, the pharmacist-on-duty noticed he did not have enough on hand to compound the entire order. Since it would take 48-72 hours to obtain it from his supplier and he had promised the prescription by the next day, he called another compounding pharmacy in the area to see if they had any chloroquine phosphate on hand that he could have. The owner of the second pharmacy noticed that he had two bottles on his shelf and offered to sell both at his cost. In lieu of using a courier, the owner of the second pharmacy simply dropped off the bottles on his way home from work. The pharmacist-on-duty noticed that one of the bottles he received was sealed but the other one had an "X" on it, denoting that it had already been opened. For some inexplicable reason, instead of using a combination of his own stock and the contents of the sealed bottle he had just purchased, the pharmacist elected to use his own stock and the contents of the opened bottle. In the end, it didn't matter.
Shortly after ingesting one of the compounded capsules of what was thought to be chloroquine phosphate, the child complained of "feeling funny" and passed out. Her father, a pediatric intensivist at a local hospital, recognized that his daughter was either having an allergic reaction to the medication or possibly something worse. He immediately put her in the car and took her to the emergency room of the hospital where he practiced. There, he ordered a number of lab tests including a toxic substances screen of her blood and urine and then transferred her to the intensive care unit (ICU) for supportive care with fluids, pressors, and a respirator. To everyone's surprise, both screens showed toxic, almost lethal, levels of clonidine, an antihypertensive agent. The child recovered over a period of a week and was discharged without sequelae. The balance of her prescription was sent to a forensic laboratory for assay. Not surprisingly, the capsules contained a combination of chloroquine phosphate and clonidine. The pharmacy that compounded the prescription immediately removed both bottles of the chloroquine phosphate it purchased from the second pharmacy and sent them for assay as well. The bottle that was used to compound the prescription (the bottle marked with the "X") contained a mixture of chloroquine phosphate and clonidine. The sealed bottle that was NOT used in the compounding contained pure clonidine. The most likely explanation was that the second compounding pharmacy purchased two sealed but mislabeled bottles of chloroquine phosphate from its supplier and used a portion of one of them for its own compounding purposes (interestingly, there were no reports of accidental clonidine poisonings associated with prescriptions coming from THAT pharmacy).
The father sued both the pharmacy that compounded the prescription and the manufacturer of purported chloroquine phosphate powder. A motion for summary judgment was granted to the pharmacy because the judge felt that even though the prescription was incorrectly filled, it was through no fault of the pharmacist. The manufacturer of the purported chloroquine phosphate, who had a long history of problems with the FDA, made a substantial settlement with the father. During discovery, when it was noted that a portion of the ingredients used to compound the prescription came from a second pharmacy, that pharmacy was added to the lawsuit as well. The theory that plaintiff's counsel pursued in the case of the second pharmacy was that since the owner decided to sell the product rather than lend it as is the long-standing custom in pharmacy practice, he was really functioning as a wholesaler (and an unlicensed one at that). Counsel for the second pharmacy, recognizing the bind they were in with regard to strict liability, also settled with the father. The takeaway point in this case is that it is always permissible, even laudable, for one pharmacist to come to the aid of another by lending a needed product when time is of the essence. However, selling the same product, even at acquisition cost, becomes a point of no return if the product is defective and results in a misadventure.
