USA Today expose slams compounding

Saturday, April 30, 2005

WASHINGTON -- Compounding pharmacies landed in the middle of the national spotlight in March after a critical review of the safety of the practice wound up on the front page of USA Today.
The article, "Safety concerns grow over pharmacy-mixed drugs," questioned whether compounding pharmacies were "mass-producing drugs without FDA oversight, sometimes making contaminated, ineffective or too potent products."
One of the article's opening paragraphs read: "Because the state-regulated pharmacies are not held to the same quality and safety rules as FDA-regulated drug companies, they don't have to test their ingredients. And --in the overwhelming majority of states -- they don't have to check the final products for potency or sterility. Nor are they required to report problems with their drugs."
The article cited Med 4 Home's 2003 drug recall after state regulators found bacterial contamination as a "potency and sterility concern." It also mentioned a Puerto Rican pharmacy where the FDA found that the amount in the vials did not match what the labels said they contained.
Opponents of the practice said these problems arise because compounding pharmacies are not required to meet the same safety standards as drug manufacturers. A coalition of doctors and consumer advocates took this complaint to the FDA in March. They filed a petition that would require pharmacy-compounded respiratory drugs to be labels "not FDA-approved."
Officials at the FDA said the agency had not addressed the petition by press time. It has 180 days to address all petitions.
FDA officials did agree, however, that the safety of compounded medications is a concern for the agency.
"We have done some small sampling surveys to get a feel for what the quality of compounded products are, and we have identified as part of those surveys some potency and other quality problems associated with compounded products," said Jane Axelrad, director of the office of regulatory policy for the CDER.
Concern over the copying of commercially available drugs and compounding on a grand scale are also concerns being addressed by the FDA, said David Horowitz, director of the office of compliance for the CDER.
Despite the fears, the FDA chooses to allow some forms of compounding and leaves much of the oversight of the activity to the state boards of pharmacy, said Axelrad, a fact missing in the USA Today article.
Also missing from the article was mention of new measures aimed at improving operating standards at compounding pharmacies, including USP 797 and the creations of compounding accreditation criteria. (See story page XX)
"Ten years ago there was very little testing going on, but today it is routine," said Dr. Loyd V. Allen Jr., editor in chief of the International Journal of Pharmaceutical Compounding. "There have been a lot of recent initiatives that people are not aware of, as is evident by the [USA Today] story."
Mickey Letson, owner of The Letco Companies, which supplies compounding pharmacies, provided much of the rebuttal to the story's to claims of malpractice.
"There has not been one recorded death associated with nebulizer medications, to my knowledge, of the hundred or millions of doses that have been compounded," Letson was quoted as saying.
Letson argues that the article overlooked similar issues of potency and safety at the drug manufacturing level.
"It was a fairly one-sided article," he said. "[The reporter] slanted it very badly that it was potentially dangerous to take a compounded product, yet she couldn't quote any but one incident that anything had ever happened and no one has ever been hurt. She just continued to beat on the unsafetyness."