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.