WHEN MONEY CHANGES HANDS, EVEN A WELL-MEANT GESTURE CAN BACKFIRE

   
Fortunately, this doesn’t happen often but when it does, it has implications far beyond the actual misadventure.  Suffice it to say, it was quite an eye-opener for me as the consultant on the case.  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.  The pharmacist did not have enough drug on hand to compound the entire order and since it would take 48 to 72 hours to obtain it from his regular supplier, he contacted another compounding pharmacy in the area to see if they could help him out.  The owner of the second pharmacy noticed that he had two bottles on his shelf and offered to sell both of them at his cost and drop them off on his way home from work.  The pharmacist at the first pharmacy noticed that one of the bottles was sealed but the other one had an “X” on it, denoting that it had already been opened.  For some inexplicable reason, he combined his own stock with the opened bottle rather than with the sealed bottle.  In the end, it did not really matter.

Shortly after ingesting one of the compounded capsules, the child complained of “feeling funny” and passed out.  Her father, a pediatric intensivist at a local hospital recognized the seriousness of the situation, and immediately took her to the emergency room of the hospital where he practiced, and ordered a number of lab tests including a toxic substances screen of both her blood and urine.  The girl was then transferred to the ICU where she was supported with pressors, fluids, and a respirator.  To everyone’s shock, both screens came back positive for near-lethal levels clonidine, a commonly-prescribed medication for hypertension and a variety of other disorders.  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, all the capsules that were part of her prescription contained a combination of chloroquine phosphate and clonidine.  The pharmacy that compounded the prescription did likewise with the two bottles they had obtained from the second pharmacy.  The bottle that was marked with the “X” (the one that was used to compound the prescription) was actually a mixture of chloroquine phosphate and clonidine.  The sealed bottle that was NOT used actually contained pure clonidine.  The most likely explanation was that the second pharmacy purchased two mislabeled bottles of chloroquine phosphate from its supplier, used one of them in its own compounding (interestingly, there were no reports of accidental clonidine poisonings associated with THAT pharmacy), and re-adulterated the bottle with its own chloroquine phosphate.

The father sued the first pharmacy as well as the manufacturer of the purported chloroquine phosphate powder.  Surprisingly, the judge dismissed the case against that pharmacy because he felt that even though the prescription was incorrectly filled, it was through no fault of theirs.  The manufacturer of the purported chloroquine phosphate had a long history of problems with the FDA and made a substantial  settlement with the father.  When discovery revealed that the product used to compound the prescription actually originated from another pharmacy rather than from a licensed wholesaler or manufacturer, the second pharmacy was added to the suit.  That pharmacy owner also settled with the father in order to avoid a trial. 

Takeaway Points

Pharmacists should always remember that it is permissible, even laudable, for one pharmacist to come to the aid of another by lending a needed product when time is of the essence.  Unfortunately, this is not what happened.  Even though I’m sure the owner of the second pharmacy meant well, by selling the drug to the first pharmacy, even at his cost, he became a de facto wholesaler, and an unlicensed one at that.  The fact that he sold an open container made the situation that much worse.  Pharmacists must be cognizant of where they fit in the supply chain at all times.

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