States are cracking down on specialty pharmacies, conducting surprise inspections and weighing proposals to require companies to obtain special permits to mix sterile drugs. The moves are in response to last fall’s deadly meningitis outbreak, which was linked to tainted steroid shots made by a Massachusetts pharmacy.
About a dozen states, including Maryland and Virginia, are considering legislation that would require stricter licensing requirements for specialty pharmacies, known as compounders.
In addition, New York regulators have issued a temporary ban on sales by Illinois-based Pharmedium Services, one of the largest compounding pharmacies in the country. That action is forcing several New York hospitals to mix or compound 5,000 doses a week to avoid running out of lifesaving medications — a labor-intensive and costly process that many hospitals are not equipped to perform, a spokesman for the Greater New York Hospital Association said.
A similar scenario could be looming in Iowa, where the pharmacy board is inspecting more than 600 out-of-state pharmacies that ship medications into Iowa. The inspections have led to charges against Pharmedium and four other specialty pharmacies. The board is accusing the companies of failing to comply with regulations that require compounders to have prescriptions for specific patients, among other violations.
If the charges are upheld, the compounders could lose their pharmacy licenses in Iowa and their ability to sell medications in other states could be hurt.
A disciplinary action in one state “would have to be addressed by every other board of pharmacy and could be grounds for discipline in another state,” said Lloyd Jessen, executive director of Iowa’s pharmacy board.
Nearly 70 percent of hospitals rely to some degree on specialty pharmacies for critical medications that control pain, induce labor, anesthetize surgical patients and provide intravenous nutrition, according to industry estimates.
The six-hospital Genesis Health System in Davenport, Iowa, could be compelled to mix medications in-house if it cannot buy them from Pharmedium, said Bill Schmidt, the system’s pharmacy director.
“That’s going to increase the workload in the pharmacy, and we’re already stretched thin,” he said. “When you have a patient admitted or someone who comes to the emergency room, you can’t say, ‘Hold on while we make this up for you.’ They needed it five minutes ago.”
Compounding pharmacies traditionally alter or mix drugs to meet a patient’s specific need. But in recent decades, some compounders, spurred in part by drug shortages, have begun producing large volumes of some of the highest-risk drugs, often without individual prescriptions. These medications often are shipped across state lines to hospitals and clinics, including veterinary clinics.
The now-shuttered Massachusetts company, New England Compounding Center (NECC), shipped more than 17,000 vials of steroid shots to 23 states. The meningitis outbreak has killed 50 people and sickened 722.
Compounding pharmacies are primarily regulated by state authorities, but enforcement is uneven. Wisconsin, for example, allows all pharmacies to self-
inspect. Compounders are not subject to the Food and Drug Administration’s strict safety standards for drugmakers, nor are their products approved by the agency.
The FDA is pressing Congress to allow the agency to regulate large compounders that operate more like drug manufacturers. The agency launched a surprise inspection campaign last month, targeting about 30 “high-risk” facilities that make sterile injectable products, such as the steroids in the NECC outbreak, and have a history of problems linked to illness and injury.
“Rather than wait for the decision on whether it’s going to be FDA or the states, in order for the [state pharmacy] license to have meaning, we’re going to make sure we do our best to protect you,” said Carmen Catizone, executive director of the National Association of Boards of Pharmacy, which represents the state regulators.
Iowa has been one of the most aggressive states in scrutinizing out-of-state pharmacies, including compounders. Agents for the Iowa pharmacy board have inspected about 50 facilities in Florida, New Jersey, Texas and Utah.
Those inspections led the Iowa board to charge five pharmacies, including Pharmedium. Iowa inspected Pharmedium’s Sugarland, Tex., facility in December. The board is accusing the company of shipping medications to hospitals without the required individual prescriptions and engaging in manufacturing, a violation of its pharmacy license.
In a statement, Pharmedium said it does not manufacture drugs. It also said “no inspection should have applied” because the company discontinued operations under its pharmacy license a month before the Texas inspection. The company continues to make and ship drugs under a wholesale license at the same facility, it said. The board’s inspection of that operation found no negative or deficient findings related to quality or patient safety, the company said.
But Pharmedium, which has four plants, acknowledged that its operations, like those of other large compounders, aren’t a perfect “fit” for regulation solely as a pharmacy, wholesaler or drug manufacturer. The company supports federal oversight of a new hybrid category — between a pharmacy and a manufacturer — and one set of standards.
Otherwise, proliferating — and possibly conflicting — state regulations could be a nightmare, company officials said.
“Who are we supposed to be in compliance with? The state we’re in or the state we’re shipping to?” Pharmedium President Rich Kruzynski said at a recent industry conference. “People are nervous because there is no one set of standards. . . . You may pass Iowa but fail California.”
The company is continuing to ship medications into Iowa while its case is pending.
Pharmedium declined to comment on the New York ban. In a cease-and-desist letter sent last year from New York’s pharmacy board to Pharmedium, authorities said New York permits compounded products to “be prepared and dispensed pursuant only to patient-specific prescriptions.”
Pharmedium was one of several companies highlighted in a Washington Post investigation about problems at manufacturing-style compounding pharmacies years before last fall’s outbreak. The Post reported that unsanitary conditions and human errors at Pharmedium plants had caused illnesses in at least 19 people.