Compounding pharmacies put patients at risk

Opinion: October 23, 2012 at 12:00a.m.

By Sarah L. SELLERS AND LYNN R. GOLDMAN

McClatchy-Tribune

According to the Centers for Disease Control and Prevention, 231 people now suffer from meningitis and 15 have died as a result of taking contaminated steroids mixed up by a single Massachusetts-based compounding pharmacy, and more cases may still be reported. Investigators believe the steroid, which was ordered for back pain patients, was contaminated with a slow-growing fungus that caused the meningitis.

The company in question, the New England Compounding Center, has already surrendered its license but not before the tainted drug was shipped to 23 different states. Florida, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia have all reported cases tied to the contaminated steroid. Policymakers must step in and take action now - or these cases will be just the leading edge of an epidemic of illness and death caused by drugs that are largely unregulated, unproven and given mostly to unsuspecting patients.

We believe the time has come to rein in an industry that has flourished in recent years, selling not only substandard drugs and tainted medicines but also unapproved substances that represent little more than a modern day equivalent to snake oil.

Traditional practice

Compounded drugs made according to traditional practice serve an important purpose for sensitive patients who cannot take the usual products approved by the Food and Drug Administration. In such cases, compounding has fallen outside the FDA’s purview with oversight generally deferred to State Boards of Pharmacy.

But today an estimated 3,000 to 4,000 compounding pharmacies have set up shop nationwide, some of which dispense more than 100 non-approved prescriptions per day. When compounded drugs are shipped directly to clinics or hospitals, doctors and patients are robbed of their ability to choose a drug that passes muster with the FDA.

Indeed, the people affected by the current meningitis outbreak had no idea they had been given a drug that was not approved for safety, efficacy, potency or purity. And, in many cases, the doctors in these cases did not realize they were prescribing unapproved drugs.

Investigators have said the steroid made by the New England Compounding Center harbored two different kinds of fungus, a contaminant that can lead to meningitis, particularly when administered to the spine. In fact, such problems can occur easily when staff are not adequately trained or supervised, when facilities are inadequate or when compounding companies rely on non-sterile raw materials to mix up drugs.

Making matters worse, compounding pharmacies are not required to report adverse events to the FDA so most of the risk associated with the use of these drugs remains hidden. Yet a review of the scientific literature reveals a long list of cases that document the dangers of compounding, including an outbreak of meningitis in California that killed three people and hospitalized eight and an estimated 4,000 cancer patients put at risk because a Missouri compounding pharmacy shipped out diluted chemotherapy drugs.

To protect the public from unsafe or tainted drugs, large-scale compounding pharmacies must be required to meet federal manufacturing standards and register with the FDA. Drugs prepared for intravenous or spinal injection, or inhalation, must be sterile regardless of the scale of their manufacture. We cannot expect state regulatory agencies to step up to the plate in these cases. These pharmacies are allowed to ship their wares all over the country and a bad batch can potentially threaten thousands of people. Sub-potent, super-potent and contaminated medications should not be allowed to fall through the federal regulatory system because of a loophole.

Adverse events

In addition, compounding pharmacies must be required to report adverse events to State Boards of Pharmacy or to the FDA. Without such a requirement, detecting drug-induced illness is not possible, except in circumstances where it is relatively easy to both identify an illness and associate that illness with a drug exposure.

Finally, compounding pharmacies must ensure physicians and patients are warned of the regulatory status of products and their potential risks in advance of prescription authorizations in order to inform medical decision-making. In some cases, patients may be lured by marketing tactics into thinking they need a “tailor-made” compound but they should do so only with a full understanding of the potential risk involved.

Sarah L. Sellers is the president of Q-Vigilance, LLC, a consulting firm that helps drug manufacturers meet safety and quality standards. Lynn R. Goldman is the dean of the George Washington University School of Public Health and Health Services and a former official with the Environmental Protection Agency’s Office of Chemical Safety and Pollution Prevention.