BETHESDA, MD 30 Mar 2012—A lethal error in making injectable colchicine has resulted in federal criminal charges against a Texas pharmacy and its pharmacist-in-charge.
The error, according to an early public statement by the pharmacist-in-charge, was a "breach in protocol" that "apparently resulted in the batch being more potent than was indicated on the label."
The deaths occurred in Oregon and Washington, several states away from the pharmacy where the colchicine injection had been made.
Criminalization of an error in health care? In January, the National Coordinating Council for Medication Error Reporting and Prevention revised its eight-month-old position statement opposing the criminalization of errors in health care.
The revision gives more prominence to the sentence "Criminal acts and patient harm related to competency and/or licensure issues are not addressed in this statement as they are beyond the Council’s purview."
As to the criminal case in Texas, Council Chair Manisha Shah in an e-mail said the role of the group does not include commenting on individual events.
The error in Texas differs from the errors committed by Eric Cropp in Ohio and Julie Thao in Wisconsin, said Michael R. Cohen, president of the Institute for Safe Medication Practices.
Whereas the medication errors committed by those two hospital employees, who subsequently faced criminal charges, were system based, Cohen said, "in this other case, I don’t see it the same way."
Compounding versus manufacturing. From what he had read on the Internet, Cohen said the pharmacy, ApothéCure Inc., had apparently not been compounding preparations after receipt of or in anticipation of prescriptions.
"We have a problem in this country with people that aren’t given proper oversight by either FDA or the state boards—whether it’s sterile compounding or compounding in general," he said.
And although there is a national accrediting organization for compounding pharmacies, the Pharmacy Compounding Accreditation Board, ApothéCure has never been accredited by that group, according to Executive Director Joe Cabaleiro.
FDA’s current "compliance policy guidance" regarding pharmacy compounding states that the agency defers to state authorities when pharmacies commit "less significant" violations of the federal Food, Drug, and Cosmetic Act.
But the agency indicated it will "seriously consider enforcement action" when a pharmacy’s activities raise the types of concerns normally associated with a pharmaceutical manufacturer and also significantly violate the act’s provisions regarding new drugs, adulteration, or misbranding.
The Justice Department said it filed criminal charges against ApothéCure and corporate head Gary D. Osborn at the request of the FDA Office of Criminal Investigations.
ApothéCure and Osborn shipped allegedly misbranded drugs in interstate commerce, according to the Justice Department’s February 10 announcement.
The department said the charges stem from the pharmacy’s shipment in February 2007 of 72 vials of "compounded colchicine," some of which contained 640% of the amount declared on the label, to a medical facility in Oregon. Three patients died of colchicine toxicity after receiving injections of drug from that shipment.
Medical details on those patients were reported by Oregon and Washington investigators in Morbidity and Mortality Weekly Report in October 2007. The intended dose of colchicine for each patient had been 2 mg.
According to the Texas State Board of Pharmacy, ApothéCure personnel in January 2007 prepared 175 mL of colchicine solution at a concentration of 3.2 mg/mL, put 5-mL portions into 35 vials, and affixed labels stating the vials contained 1 mg of colchicine per 2 mL.
The labeled concentration was the same as that of the colchicine injection marketed by Bedford Laboratories in 2-mL vials.
About 15 days after ApothéCure personnel labeled the 35 vials, the state board said, the pharmacy "dispensed and delivered pursuant to an order for Colchicine 0.5 mg/ml for office use" about 34 of the vials to a physician in Oregon.
The state board in November 2010 reprimanded the pharmacist license of Osborn because he had failed to ensure that an error did not occur during the making of that compounded sterile preparation of colchicine.
ApothéCure was fined $125,000 and its license was put on probation for one year with the condition that the pharmacy develop and implement a continuous quality improvement program for preventing and handling dispensing errors.
At FDA. Compounding pharmacies do not have to register with FDA, and ApothéCure had not.
The federal Food, Drug, and Cosmetic Act allows any pharmacy not to register as a producer of drugs if the pharmacy regularly engages in dispensing prescription drugs or devices in response to prescriptions from appropriate practitioners. Other conditions also apply.
Pharmacies, such as Ameridose LLC and PharMEDium Services LLC, that do register with FDA must undergo routine inspections by the agency.
FDA issued its current compliance policy guidance on pharmacy compounding one month after the U.S. Supreme Court in 2002 ruled on the case commonly known as Thompson v. Western States Medical Center.
Essentially, the court’s decision eliminated the section of the Food and Drug Administration Modernization Act of 1997 that had sought to clarify the status of pharmacy compounding under federal law.
The case’s official name was Tommy G. Thompson, Secretary of Health and Human Services, et al., petitioners v. Western States Medical Center, et al.
ApothéCure was a member of the latter "et al."