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Compounded drugs are dangerous concoctions, critics say.

Nostalgia may sustain the idea of a friendly neighborhood druggist preparing a personal bottle of cough syrup for Mrs. Smith when she requires it--but through rose-colored glasses is no way to look at today's compounded drugs.

Pharmacists may legally compound customized prescription medication from scratch--common examples include hormone products, antibiotics, steroids, anesthetics, and drugs to treat glaucoma, asthma, iron-deficiency anemia, and erectile dysfunction. This is routine practice when special formulations aren't available commercially. For instance, if a patient is allergic to an ingredient in a mass-produced drug, his or her doctor can write a prescription for the drug without that ingredient and a pharmacist will prepare the compound.

But consumers may not realize that a compounded drug isn't necessarily a therapeutic twin of the original, minus whatever troublesome trait was eliminated. By 2004, the FDA had collected at least 200 reports of adverse reactions to compounded drugs, and an agency study that year showed that one-third of compounded drugs failed to meet basic standards of quality.

Accounts of deaths and injuries have been mounting. In 2001, three California patients died of meningitis after getting contaminated steroid shots made by a compounder. In Nevada, erectile dysfunction drugs from a compounder sent several men to the emergency room with priapism. Last year, patients and their families sued a Fredericksburg, Virginia, hospital and the compounding pharmacy that made a contaminated drug that doctors used in heart bypass surgery. Four patients died and seven suffered injuries.

The nine lawsuits filed in the Virginia incident (most settled confidentially) represent just a few of the suits seeking compensation for injuries caused by compounded drugs. And as safety concerns grow, the FDA is taking a closer look at the compounding industry.

Currently, the FDA allows compounding but does not regulate it because it has authority only over pharmaceutical manufacturers. State boards of pharmacy are responsible for regulating hospital pharmacies and smaller pharmacies that do simple compounding, as well as separate compounding companies that specialize in making more complex drug variations. Compounded drugs aren't subject to pre- or postmarket testing, and compounders may buy chemicals in bulk from overseas sources that don't necessarily adhere to FDA-sanctioned Current Good Manufacturing Practice (CGMP).

Compounded drugs are made in bulk now, too, and some hospitals contract with compounders to save the cost of mixing their own compounds. Compounding companies can advertise special drugs tailored to the user, and some even send representatives to doctors' offices.

In 2004, trade groups estimated that compounders filled as many as 30 million prescriptions per year. Last year, the National Association of Boards of Pharmacy estimated that compounds account for 1 percent to 5 percent of all prescriptions. The International Academy of Compounding Pharmacists lists more than 1,800 members.

Error risk

Medical journal articles have warned that errors in mixing, calculation, and selection of ingredients can occur in compounding, and unsanitary techniques can lead to bacterial contamination. Patients may get inadequate information about the ingredients used in their drug and its safety risks. And no one is checking that the amount of active medication included is accurate--except the compounders, who say they ensure this themselves.

Some people get compounded drugs without a prescription--for instance, for cosmetic treatments. Some spas distribute anesthetic creams made by compounders, and at least two women have died of lidocaine poisoning after they followed the spas' directions for using these creams before hair-removal treatments.

And as compounders flood the market with bulk drugs, manufacturers of commercial, FDA-regulated drugs are expressing concern about both economic harm and patient injury.

Wrongful death and negligence claims have been filed across the country against compounding pharmacies and the doctors and hospitals that use them. It's a relatively untested area of litigation, generally confined to state courts, as the FDA's jurisdiction is unclear.

"These compounders basically whip out whatever the cocktail is that may or may not be effective, but it's not a manufactured and routinely regulated drug as in national pharmaceutical litigation," said John Harnishfeger of Washington, D.C., who is preparing a case for a patient who received a compounded drug during cataract surgery. The suit against the compounding pharmacy that distributed the product to hospitals alleges that the contaminated product, which was later recalled, caused a bacterial infection. The patient was blinded and eventually had to have his eye removed.

"You don't have the levels of marketing and testing that you might have with a major pharmaceutical company," Harnishfeger said.

Other cases allege that compounders have misled consumers about the nature of their products. Stanley Karon, an attorney in Richfield, Minnesota, settled a suit after a client was burned by a skin-lightening product made by a compounder. The suit alleged that the product was defective and unreasonably dangerous and that its manufacturer and distributor had failed to register it as a drug with the FDA.

The manufacturer was a foreign company that was "unrealistic" about potential risks of its product, Karon said: "They advertised and claimed in the lawsuit that it was a cosmetic, when in fact it was a drug that required significant testing prior to sale, which they did not perform." Three weeks after he settled the case, the FDA contacted the California company that distributed the product and charged it with having sold drugs under the guise of cosmetics. (Doe v. Roe Corp., confidential docket no. (D. Minn. June 22, 2004).)

Rewriting the rules

Given the potential for compounded drugs to cause serious injury and even death, many consumer advocates are pressing for better regulation of the conapounding industry. A 2003 Government Accountability Office (GAO) report found that the four states studied--Missouri, North Carolina, Vermont, and Wyoming--had adopted new regulations about compounding or made provisions for more extensive testing of compounded drugs. The report noted that industry organizations were drafting standards for compounded drugs that states could adopt as law.

The GAO concluded, however, that "while these actions may help improve oversight, the ability of states to oversee and ensure the quality and safety of compounded drugs may be affected by state-specific factors such as the resources available for inspections and enforcement." (Prescription Drugs: State and Federal Oversight of Drug Compounding by Pharmacies, No. GAO-04-195T (Oct. 23, 2003).)

At least 12 states have adopted the 2004 U.S. Pharmacopeia standard, "Pharmaceutical Compounding--Sterile Preparations," known as USP 797. However, many hospitals have found it too expensive to upgrade pharmacy equipment to meet the standard, which may have caused even more reliance on outsourcing to compounding companies.

Plaintiff attorney Stephanie Grana of Richmond, Virginia--who represented the families of victims injured by the compounded heart drug at Mary Washington Hospital in Fredericksburg--said the compounder in the case and its parent company both claimed they could document their compliance with USP 797.

"We argued that they said they were meeting what was required, but they weren't because there were endotoxins found" in the compounded product, said Grana, noting that the FDA later recalled the injectable solution. "They hadn't met their own advertising, their own promises as to what the sterility would be."

The case was state-focused, and "we didn't argue that they were outside of FDA approval," Grana said. Even so, shutting down the compounder was difficult.

"Virginia [regulators] couldn't go to the facility in Maryland, because [they] had no authority there, so the Maryland Board of Pharmacy had to go in, along with the FDA," she said. The Maryland board found what Grana called "a laundry list of violations" in September 2005 and closed the facility until February 2006.

The FDA has lately stepped up its involvement in compounding cases. Last year, the agency sent three letters in August warning compounders about mass-producing unapproved inhalation drugs and six letters in December warning compounders against making new drugs and misbranding them by failing to provide labels stating adequate directions for, or potential consequences of, their use. It also warned five compounders at the end of the year to stop making topical anesthetic creams.

Those warning letters stated the FDA's position: "Traditional pharmacy compounding typically involves pharmacies preparing drugs that are not commercially available.... This kind of compounding follows a physician's decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs. FDA normally permits such traditional pharmacy compounding, and the agency's action is not targeting this practice. By contrast, FDA is concerned that the five firms receiving warning letters are behaving like drug manufacturers, not traditional compounding pharmacies, because they produce standardized versions of topical anesthetic creams for general distribution."

The FDA maintains that the Food, Drug, and Cosmetic Act (FDCA) establishes agency jurisdiction over "new drugs," including compounded drugs. Although a 1997 law exempted compounders from key provisions of the FDCA, the FDA cites cases in the Fifth and Third circuits that said the act does not expressly exempt compounded drugs or compounding pharmacies. (Profs. &Patients for Customized Care v. Shalala, 56 E3d 592, 593 n. 3 (5th Cir. 1995); Wedgewood Village Pharm. v. United States, 421 F.3d 263, 269 (3d Cir. 2005).)

The FDA maintains that the compounded drugs in these cases are "new drugs" within the meaning of the act because they aren't "generally recognized among experts ... as safe and effective."

After a 2002 Supreme Court decision nullified part of the law for putting unconstitutional restrictions on compounders' commercial speech, the validity of the entire compounding section was in question. (Thompson v. W. State Med. Ctr., 535 U.S. 357, 360-61 (2002).) Later that year, the FDA issued guidelines for when it would consider taking enforcement action against drug compounders.

The 2002 Compliance Policy Guide lists the factors that would determine whether a pharmacy's compounding "extends beyond the traditional practice of pharmacy and more closely resembles drug manufacturing"--including whether a firm compounds drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drugs.

Compounders continue to argue that they are regulated solely by the states. Last year, a group of 10 state-licensed compounding pharmacists challenged the FDA's authority to regulate compounded drugs, and a Texas district court judge ruled that these products, when created for an individual patient with a prescription from a licensed practitioner, are implicitly exempt from the FDCA's definition of a new drug. (Med. Ctr. Pharm. v. Gonzales, No. MO-04-CV-130 (W.D. Tex. Aug. 30, 2006).)

Congress may be ready to step in and resolve the debate. Sen. Edward Kennedy (D-Mass.) has drafted the Safe Drug Compounding Act of 2007, which would give the FDA authority to regulate what type of compounded medicines pharmacists can prepare and doctors can prescribe.

"The problem has escalated and Congress is taking notice. Compounding pharmacies are way out of control and thumbing their noses at the FDA," said Eammon Hobbes, president and CEO of New York-based AngioDynamics, a medical device manufacturer that makes and sells Sotradecol--one of two FDA-approved treatments for varicose veins. Compounded agents currently dominate the sclerotherapy market.

"Some compounding pharmacies--over 79 we know of--are making windfall profit basically competing with the pharmaceutical companies and selling drugs really cheap," said Hobbes.

He said that when his company entered the market he was amazed to find that many doctors treating varicose veins buy a bulk substitute for the approved drug from compounding pharmacies at a much lower cost. "This is a sterile injectable, not a pill, so the chance of it causing patient harm is very high" because of the risk of contamination, he said. "It's amazing to consider that a physician would consider using a local compounding pharmacy concoction in order to net a $15 to $30 additional profit per procedure."

Compounding, he said, could damage the physician-patient relationship and "hurt everyone's business: theirs and ours."

Competition from compounders has had a significant impact on his company's sales--in a $70 million market, AngioDynamics makes a little over $2 million a year. But Hobbes noted that inadequately regulated compounding has ramifications both for makers of FDA-approved drugs and for patients.

Compounded drugs "are not inspected, they're not regulated by the FDA, there's no protection for patients, there's no adverse event reporting requirement, and there's no patient awareness," he said. "We don't know how many patients get hurt by compounded drugs every year until they die."
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Title Annotation:news & trends
Author:Porter, Rebecca
Date:May 1, 2007
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