Compounding pharmacists come under attack

Compounding pharmacies were put on the defensive recently after a group of health organizations asked federal regulators to crack down on how the pharmacies market their products.

The group accused some compounders of running what amounts to a cottage industry of unregulated drug manufacturing that sells to physicians and patients with little Food & Drug Administration oversight. They want tighter labeling that alerts doctors and patients to drugs' compounded status.

Pharmacies responded that they are already regulated by both states and the federal government and that their industry is making major moves to increase the public's confidence in compounded drug products. The controversy centers mostly on nebulized inhaler drugs for asthma and other lung ailments, which physicians often order from compounding pharmacies in order to obtain dosage forms or drug combinations not available on the market. Compounding pharmacies fill some 30 million prescriptions per year, the majority of them for respiratory diseases, the FDA estimates.

"These pharmacy manufacturers are producing these drugs without any kind of disclosure to the patient of what the risks are. They're talking only about the benefits, which haven't even been established," charged Nancy Sanders, president of the Allergy & Asthma Network Mothers of Asthmatics. AANMA is a member of CHASM-the Consumer Health Alliance for Safe Medication. CHASM, which receives financial backing from several makers of inhaled respiratory drugs, filed a petition demanding that the FDA begin requiring compounded drugs to carry labels warning that the drugs are compounded in a pharmacy and thus are not approved by the FDA and have not been tested for safety, efficacy, or sterility.

CHASM cited several instances in which batches of compounded drugs failed to meet their claimed potency levels when tested. One survey performed by the FDA and cited by CHASM found a 34% failure rate for potency and purity in a limited sample of compounded drugs. The group also pointed to 200 adverse event reports collected by the FDA, which it said grossly underestimate the actual number of persons harmed after using compounded medications.

"Pharmacies aren't registered with the FDA, so the FDA doesn't know where a lot of this stuff is going on," said Sarah Sellers, Pharm.D., executive director of the Center for Pharmaceutical Safety and a consultant to CHASM.

That was not the case for Med-Mart Pulmonary Services, a medical supply and compounding pharmacy company in Novato, Calif. The firm was cited by the FDA in September 2002 for essentially acting as a manufacturer because it was producing medications far in excess of what was required by individual physicians' prescriptions. Eric Brennan, senior director of quality and regulatory affairs at the company, now called Pacific Pulmonary Services, said that his firm routinely tests its products for potency and sterility in accordance with state law.

Brennan said that his company agreed with clearly labeling products as compounded in order to differentiate them from manufactured drugs. But forcing them to carry a warning that they have not been tested for potency or sterility would be unfair, since they are tested, he said. "I'm sure that there are some out there that are not making sure their doses are safe and effective," he said in an interview. "But we are doing that testing."

Only some states have laws on the books mandating some form of sterility and potency testing, and proper enforcement is still another matter, said L. D. King, executive director of the International Academy of Compounding Pharmacists. Some state boards are strained for resources, and inspections come only once a year or less often," he said.

King's group and seven others, including the National Association of State Boards of Pharmacy, are developing a set of accreditation standards for compounding pharmacies that are meant to serve as a kind of "good-housekeeping" seal. The standards are being finalized and should be available to pharmacies by early 2006.

The group hopes the standards will head off calls to crack down on compounding pharmacies, whether for safety concerns or because they are competing with more heavily regulated drug manufacturers. "If there are concerns, use an accredited pharmacy. They will all be inspected," King said.