Pharmacy Scrutiny Shrinking
As this Austin American-Statesman article illustrates, pharmacies that compound prescription drugs do so with practically zero oversight. Slack Davis Sanger currently represents a young boy who suffered temporary blindness because his pharmacy made an enormous error when it compounded his prescription. The steroid the little boy has to take three times per day contained more than 700% of the prescribed dose.
While people naturally want to trust their pharmacy to give them the right medicine, when that trust is violated, people can die. Sadly, these days the only way to persuade pharmacies to adopt safer policies is for injured customers to take a stand by filing a lawsuit.
As Pharmacies Face Scrutiny, State’s Oversight Drops
By Eric Dexheimer, Austin American-Statesman
In 2008, the Texas State Board of Pharmacy warned that there needed to be more testing of compounded drugs – prescription medications mixed and prepared by individual pharmacies, typically with much less oversight than government regulators demand of drug manufacturers.
A year earlier, Texas legislators had for the first time given the agency $50,000 a year to pay for random testing, which it had begun. But “we believe that the agency should be conducting more tests,” the board’s administrators wrote in the request for their 2010-2011 budget. “Any problem with these products could have dramatic and potentially life-threatening effects on the patient.”
Instead, thanks to budget cuts, over the past three years the number of pharmacies whose products the state tests for contamination, sterility and potency to ensure patient safety has plummeted.
In 2010, the agency conducted tests on medications compounded at 65 Texas pharmacies. The following year, the number dropped to 30. By the end of fiscal year 2012, in August, the number had plunged to only 21 – less than a third from only two years earlier. Money the agency spent on the testing program slid 72 percent over that time.
Testing fewer than two dozen pharmacies is “absolutely not” sufficient to protect patients, said state Sen. Leticia Van de Putte, D-San Antonio, a licensed pharmacist who sponsored the bill authorizing state regulators to test mixed drug samples. “You just hope to God nothing goes wrong.”
The pharmaceutical compounding industry has come under sudden scrutiny after federal investigators linked an injectable steroid medicine prepared by the New England Compounding Center to 29 meningitis deaths and 377 cases of sickness across 19 states. While U.S. Food and Drug Administration records show the company sent the drug – injected in the spine to relieve back pain – to medical facilities in Texas, the state has reported only a single case of illness tied to it.
The U.S. Centers for Disease Control identified a fungus found in vials of the drug as the likely culprit. Subsequent inspections found unsanitary conditions at the Framingham, Mass., pharmacy and regulators ordered the facility shuttered.
Last week, state regulators closed a second pharmacy and promised more rigorous oversight.
Texas’ compound-testing program has withered during a time when the number of state pharmacies has grown steadily, to about 6,300, and despite the fact that in a given year state regulators found up to a third of the samples tested did not contain the potencies identified on their labels. Pharmaceutical standards permit variations of 10 percent in either direction, so the compounds identified by the state’s testing were too weak or too strong by at least 11 percent, said Gay Dodson, the pharmacy board’s executive director.
Some medicines were off by more, she said. But, Dodson added, she could not identify the facilities or the drugs: A 2009 Texas law prohibits release of the information unless the pharmacy is disciplined, or the board determines the public’s health is at risk – a situation that has not arisen.
Pharmacists compound medicine when specific patients need special doses or combinations of drugs not available from manufacturers. The process can range from combining two ointments, to mixing several powerful drugs under sterile conditions.
The FDA closely regulates manufacturers, requiring regular product testing and inspections. But the oversight of compounding pharmacies has largely fallen to the states. Most perform comparatively less regulation even as the industry has expanded.
Instead of requiring a patient prescription to make a custom medicine, for example, newer state laws permit compounding pharmacies to produce large batches of mixed drugs for hospitals and clinics in anticipation of patients’ needs. New England Compounding sent as many as 500 doses at a time of its specially produced steroid to individual Texas hospitals, FDA records show, prompting some to question if the company was more manufacturer than pharmacy.
Not all pharmacies compound medicine. Yet like most states, Texas does not require a separate registration for those that do, so officials here concede they don’t know how many of the facilities mix drugs. The Missouri City, Texas-based International Academy of Compounding Pharmacists estimates that about half of the country’s 56,000 pharmacies do basic medicine mixing, with about 3,000 nationwide performing sophisticated sterile compounding.
Van de Putte said she would introduce a bill in the next legislative session mandating a better tracking system in Texas.
Unlike nearly every other state, Texas has an existing compounding pharmacy testing program. Passed into law in 2005, it was not funded until 2007. Industry representatives stress that druggists have been compounding medicines on their own for hundreds of years, and that errors are rare. “They’re extremely uncommon,” confirmed Paul Holder, assistant director of enforcement for the Texas Board of Pharmacy.
Yet medication compounded at Texas pharmacies also has caused serious harm. A year before the state implemented its testing program, three people – two in Oregon and one in Washington – died after being injected with drugs mixed at a Dallas pharmacy.
Subsequent tests of the medicine prepared by ApotheCure revealed it was “super-potent, containing 640 percent of the level of colchicine declared on the label,” according to federal records. A gout medicine, colchicine has been used off-label to treat back pain. Prosecution of the case has dragged. When state and federal regulators first asked to review the company’s records, ApotheCure refused, and the Texas pharmacy board filed a lawsuit forcing the company to comply. In November 2010, ApotheCure, while denying wrongdoing, agreed to pay a $125,000 fine to the state pharmacy board and install better quality control procedures.
This past April – four years after the deaths – ApotheCure pharmacist Gary Osborn pleaded guilty to misdemeanor violations of federal laws for shipping misbranded medicine. A separate lawsuit brought by the state of Texas alleging violations of the state’s Food, Drug and Cosmetic Act is scheduled to go to trial later this month, said a spokesman for Greg Abbott, the Texas attorney general. Meanwhile, ApotheCure has remained in business.
Another Texas pharmacy narrowly averted a compounding-error tragedy. In 2008, 17 babies at Corpus Christi’s Christus Spohn Hospital received intravenous doses of heparin, an anticoagulant drug, that were 100 times stronger than recommended. The mistake, discovered by nurses who quickly administered a drug to counter the heparin’s effects, was traced to the hospital pharmacy, which had incorrectly mixed the medicine. “At least five patients may have experienced bleeding,” according to state records.
Three months later, the hospital paid a $1,200 fine to the pharmacy board and agreed to institute new quality-control policies in its pharmacy.
The decline in the scope of the Texas’s compounding- pharmacy testing program parallels an overall contraction of the state’s oversight of pharmacies and pharmacists exacerbated by the state’s budget crisis.
Over the past decade, the number of pharmacies across the state has grown by about 1,200. During the same period, the number of the Texas State Board of Pharmacy inspectors charged with ensuring the facilities meet state quality standards has remained at six. (The agency has had a seventh inspector, but the position currently is unfilled.) The Austin-based inspector’s territory alone ranges southeast to Galveston and west to Junction.
Holder said the agency’s goal is to inspect every pharmacy once every two years; each inspector is expected to evaluate 400 facilities a year – an average of about two per day. But even if they meet that goal, the agency still falls short of its goal by more than 1,000 pharmacies each year.
“If you do the math, it doesn’t work,” Holder said.
Budget cuts of 5 percent and 2.5 percent in 2010-11, and 10 percent in 2012-13, “have had a dramatic impact on TSBP’s ability to properly do our job of protecting the public,” Dodson wrote two months ago in the agency’s 2014-15 legislative request.
Van de Putte added that state lawmakers’ concern last session over proliferating pill mills – clinics that overprescribe narcotic pain medications – also diverted scarce resources. “The Legislature was very clear on where the agency needed to concentrate its efforts,” she said.
Yet even when accounting for the short-staffing, the state’s method of overseeing compound pharmacies is spotty. If the Texas pharmacy board receives a complaint about a specific pharmacy, inspectors can, but don’t always, demand a test of a compound. They also can, but don’t always, require the facility to submit compound samples for testing if a pharmacy fails one of several checkoffs during a regular inspection.
Even then, inspectors generally only test compounds if the facility happens to have a sample of the mixed drug handy. “If a pharmacy doesn’t already have something prepared, we don’t want to ask them to make it because we know they’ll be careful” while inspectors watch, Holder said.
“It’s really kind of hit-and-miss,” he added.
Dodson vowed her agency will be more aggressive conducting compounded drug tests this year: “I think every state now is saying, ‘We don’t want to be the next Massachusetts.'”
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