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Report finds lax oversight of specialty pharmacies
Thursday - 4/18/2013, 10:18am EDT
AP Health Writer
WASHINGTON (AP) -- Congressional investigators say pharmacy boards in nearly all 50 states lack the information and expertise to oversee specialty pharmacies like the one that triggered a deadly meningitis outbreak last year.
A report released Monday by House Democrats shows that most states do not track or routinely inspect compounding pharmacies. Staffers surveyed officials in 50 states about their oversight of pharmacies and then compiled the responses.
The findings come as lawmakers debate how to prevent another outbreak like that caused by the New England Compounding Center, a Massachusetts compounding pharmacy. Contaminated injections distributed by the company last year have killed more than 50 people and sickened hundreds more.
Compounding pharmacies, which mix customized medications based on doctors' prescriptions, have traditionally been overseen by state pharmacy boards. But the growth of larger compounding pharmacies like the NECC, which mass-produced and distributed thousands of vials of drugs across the U.S., has prompted calls for more federal oversight.
The report from Democrats on the House Energy and Commerce Committee argues that state regulators are not adequately policing the space, and that the Food and Drug Administration should be given direct authority over the pharmacies.
"In states from coast to coast, compounding pharmacies are going untracked, unregulated, and under-inspected, exposing patients everywhere to tainted drugs, disease and death," said Rep. Ed Markey, D-Mass, in a statement. Markey represents the congressional district where NECC is located.
Of the 49 states that responded to the inquiry, only officials from Missouri and Mississippi could provide the exact number of compounding pharmacies in their state. Missouri and Mississippi were also the only two states that require permits or licenses for pharmacies that perform compounding.
None of the states indicated that they track whether pharmacies sell compounded drugs across state lines or in large quantities. That kind of mass production was a key issue in the case of NECC, which shipped more than 17,600 doses of its pain injection to 23 states.
Investigators found that many states do not keep any inspection records of compounding pharmacies. Twenty-two states, or 44 percent, said they do not keep histories of problems like contamination, cleanliness and drug potency. Other states said they use a combination of inspection reports, complaints and "staff recollections," to track problematic pharmacies.
On average, most pharmacy boards have five inspectors responsible for visiting all the pharmacies in the state. Budgets vary greatly from state to state, with Nevada providing $3,000 in funding for each pharmacy in the state and Indiana providing with less than $200 per pharmacy. Only 19 states train inspectors to recognize problems with sterile compounding, which is considered the riskiest type of compounding because it requires highly sanitary conditions and complicated production techniques.
"This report clearly indicates what we've known for quite some time -- that there is no clear, functioning, or uniform process for all 50 states to manage and oversee compounding pharmacies," said Rep. John Dingell, D-Mich., in a statement. Dingell's office helped conduct the survey.
The findings will likely come into play on Tuesday, when a House investigative committee holds its second hearing on the meningitis outbreak. Republicans on that committee have argued that the FDA could have shut down the NECC using its existing powers. Lobbyists for the compounding industry generally share that view, and have fought proposals to give the federal government more authority over compounding for decades.
Last week House Democrats released dozens of documents from the International Academy of Compounding Pharmacists, the industry's leading trade group. The documents include internal memos to members suggesting how they deal with FDA inspectors, in particular: "when a pharmacist should NOT provide certain information to the FDA," and "when pharmacists should draw the line and discontinue the visit and call their attorney."
Democrats on the House Energy & Commerce Committee suggested the CEO of the trade group should testify at Tuesday's hearing. However, Democratic staffers said late last week they had not received a response on that request from Republicans, who control the chamber.
FDA Commissioner Margaret Hamburg is schedule to testify.
Late Monday, the FDA warned health care providers that products from two Dallas-based compounding pharmacies were made "under conditions that could create a high potential for contamination." The agency warned against using sterile drug products made by ApotheCure Inc. and freeze-dried-power drug products made by NuVision Pharmacy.
The FDA said the two pharmacies had issued voluntary recalls for the products. The warning comes amid an ongoing inspection of the pharmacies' facilities, the FDA said.
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