Kimberly Kindy, Lena H. Sun and Alice Crites
Washington Post
Shoddy practices and unsanitary conditions at three large-scale specialty pharmacies have been tied to deaths and illnesses over the past decade, revealing that the serious safety lapsesat a Massachusetts pharmacy linked to last fall’s deadly meningitis outbreak were not an isolated occurrence, records and interviews show.
The series of safety failures happened long before national attention focused on the New England Compounding Center, whose contaminated steroid shots were linked to 45 deaths and 651 illnesses.
A Washington Post analysis found that state and federal authorities did little to systematically inspect and correct hazards posed by specialty pharmacies, which custom-mix medications for individual patients, hospitals and clinics. In the lightly regulated industry, pharmacies were rarely punished even when their mistakes had lethal consequences.
The Post reviewed hundreds of records, including lawsuits and Food and Drug Administration documents, and interviewed dozens of government and industry officials. The review found serious problems at three of 15 large-scale compounding pharmacies that dominate the industry. These multimillion-dollar companies mass-produce medications and ship them across state lines, often without individual patient prescriptions.
Three of the firms, in addition to the NECC, have experienced significant safety problems over the past decade that were tied to at least 39 illnesses. Two companies’ missteps were linked to at least six deaths. The problems included medications that were too potent or laced with bacteria.
One of the three firms identified by The Post — the California-based Central Admixture Pharmacy Services — is under investigation at its Massachusetts facility by the FDA, according to industry and government officials.
Executives at CAPS, a pioneer and among the largest manufacturing-style compounders, declined to comment on the investigation, which has not been previously disclosed. Federal officials would not discuss the probe, which was triggered by their ongoing investigation of the NECC and a sister company, Ameridose.
Illinois-based PharMEDium Services and Texas-based ApotheCure also had serious deficiencies, records show.
Officials at CAPS, PharMEDium and ApotheCure said their companies produce high-quality products and are continuously upgrading operations to make them safe.
But when regulators have visited the firms after patient illnesses or deaths, they have sometimes found alarming conditions.
“The things they saw, they would chill your bones,” said cardiologist John Armitage, regarding the FDA’s 2005 investigation of several CAPS facilities after some of his patients died or became gravely ill.
Today, compounders supply about 40 percent of all intravenous medications used in hospitals, up from 16 percent a decade ago, according to industry estimates. They make some of the highest-risk drugs available, including steroid injections like the ones linked to the meningitis outbreak. Yet they are not required to follow the safety rules that apply to commercial drugmakers.
