Texas’ Oversight of Compounded Drugs Falling Off

Budget cuts have reduced the number of pharmacies in Texas whose compounded drugs are tested in a state program that’s aimed at ensuring patient safety, a newspaper reported Sunday.

The Austin American-Statesman said the Texas State Board of Pharmacy warned four years ago that there should be more testing of the drugs, which are prescription medications mixed and prepared by individual pharmacies. But since 2010, the number of pharmacies subjected to tests has dropped from 65 to 21, the newspaper said, citing three years of budget cuts.

Testing fewer than two dozen pharmacies is “absolutely not” sufficient to protect patients, said state Sen. Leticia Van de Putte, a licensed pharmacist who sponsored the bill authorizing the testing program, rare among states. “You hope to God nothing goes wrong.”

The safety and oversight of compounded drugs has come under federal scrutiny after regulators linked an injectable steroid prepared by a Massachusetts company to a deadly meningitis outbreak.

The Texas testing program became law in 2005. Two years later, legislators authorized $50,000 a year for random testing.

In their 2010-2011 budget request, the board’s administrators said more testing was necessary because “any problem with these products could have dramatic and potentially life-threatening effects on patients.”

But the request fell victim to budget cuts that reduced the number of tested pharmacies from 65 in 2010 to 30 in 2011 and 21 by the end of the 2012 fiscal year in August.

The testing program has fallen off at the same time the number of pharmacies in the state has grown to about 6,300 and despite the fact that, in a given year, state regulators have found up to a third of the samples tested didn’t contain the potencies listed on their labels, the American-Statesman said.

The pharmacy board declined to identify the facilities or the drugs at issue, citing a state law barring the public disclosure of such information unless a pharmacy is disciplined or the board determines the public health is at risk.

Paul Holder, the board’s assistant director of enforcement, said errors resulting from compounding are “extremely uncommon.”

However, the newspaper said drugs mixed by a Dallas pharmacy a year before the testing program was implemented were linked to three deaths – two in Oregon and one in Washington. The pharmacy, while not admitting guilt, agreed to pay a $125,000 fine and install better quality control procedures to settle with the board.