Drug firm has history

Texas pharmacy implicated in 3 recent deaths was cited in 2004

By peter korn

The Portland Tribune, May 4, 2007, Updated Oct 30, 2009 (3 Reader comments)

The Oregon state medical examiner’s office has confiscated vials of bad colchicine that were mixed in lethal amounts.

L.E. Baskow / Portland Tribune

A Texas drug supplier that provided improperly mixed medication suspected in the deaths of two Portlanders and a Washington state resident also is under investigation for a 2004 incident involving three patients who developed serious complications from another drug.

In addition, records from the Texas State Board of Pharmacy show that on at least three other occasions the Dallas-based company, ApothéCure Inc., was investigated as a result of complaints that it illegally dispensed testosterone and growth hormones, once to a pregnant woman.

In each case, according to pharmacy board officials, the board failed to find enough evidence to discipline the company, but instead issued a letter of warning.

ApothéCure is under investigation by Oregon, Texas and federal authorities following the discovery last week that a batch of a drug called colchicine supplied to the Portland Center for Integrative Medicine was 10 times the potency stated on the label.

The center, in Southwest Portland, supplied the colchicine to two Portland patients and a third person in Yakima, Wash., all of whom subsequently died – in late March and early April.

All three patients received intravenous colchicine as treatment for chronic back and neck pain. The improperly mixed medicine was so potent that one injection was enough to kill each patient, according to state medical authorities.

Last week state health officials said they believed the bad medicine was in a single batch supplied to the center. The Oregon state medical examiner confiscated the remaining vials from the center.

On Monday, at the request of the Texas board of pharmacy, ApothéCure sent out a notice recalling all colchicine it had produced in the last year.

ApothéCure is not considered a drug manufacturer but a compounding pharmacy, a designation traditionally reserved for small pharmacies that mix medications not available from manufacturers.

Compounding pharmacies and the drugs they produce are not regulated by the federal Food and Drug Administration, but are overseen by state boards of pharmacy.

Larry Sasich, a pharmacist in Erie, Pa., who is a consultant for the nonprofit consumer watchdog group Public Citizen, said that he believes the latest revelations about ApothéCure’s history should lead to immediate action by the Texas pharmacy board.

“This shows the inadequacy of oversight of this industry by the federal government and state boards of pharmacy. This was in 2004 and here we are in 2007 and we have three people who are dead in Washington and Oregon and we don’t know what else has been going on out there,” Sasich said. “The responsible thing to do would be to close the pharmacy down and not allow it to do any compounding until there is adequate inspection.”

As authorities gear up their investigations of ApothéCure, the company’s history becomes especially relevant.

In 2004, the Pennsylvania Department of Health sent out a statewide alert after what appeared to be reactions in three Pennsylvania patients following intravenous injections of the drug phosphatidylcholine, supplied by ApothéCure.

According to the alert, the patients suffered nausea, vomiting and abnormally slow heart rate; two developed a condition that resulted in a loss of kidney function.

In response to the Pennsylvania alert, FDA officials and investigators from the Texas pharmacy board undertook an inspection of ApothéCure’s facility in Dallas.

The inspection revealed a number of deficiencies in the company’s operation, according to inspection reports. And at least one of those deficiencies might have a connection to the Portland and Washington deaths.

The August 2004 inspection cited the company for six violations ranging from refrigerators lacking adequate thermometers and temperature logs, to a lack of documentation of training for pharmacy personnel.

1 | 2 Next Page >>

Facebook	Digg	Del.icio.us
Newsvine	Stumbleupon	Reddit