Shutdown spurs hunt for medication sources
Hospitals and the government are devising plans to ensure an uninterrupted supply of critical medications after the disclosure of numerous problems with sterility procedures at Ameridose LLC, a major drug supplier that suspended operations after the national meningitis outbreak.
Ameridose — a sister company of the Framingham phamacy that produced contaminated steroids blamed for hundreds of cases of meningitis and more than 30 deaths — is slated to remain closed until Monday, but its reopening date is now in question. A spokesman for the state Department of Public Health said in an e-mail the date is "under review."
"I get tired of holding my breath – now it's just like even if it ever opened again, I'm not sure I'm comfortable putting my eggs back in that basket," said Margaret Clapp, chief pharmacy officer at Massachusetts General Hospital. "This is kind of a new day, so we are working to rethink what our strategy and our capability is going to be here."
Clapp said the Partners HealthCare system, which includes Mass. General, has begun to examine the possibility of creating a central compounding facility that would seek approval from the US Food and Drug Administration to prepare medications for the hospitals within the state's largest health care system.
Dr. Margaret A. Hamburg, commissioner of the FDA, said Wednesday in testimony before a congressional committee that six Ameridose products were already on the FDA's shortage list before the company shut down. One drug in particular, sodium bicarbonate injection, a standard hospital medication often used in emergency procedures, is now so hard to obtain that she said the FDA is looking atallowing "temporary importation" from foreign drug companies.
None of Ameridose's drugs have been linked to infections, but on Oct. 10, the company agreed to suspend operations as it underwent inspection by officials, who were concerned because of its shared ownership with New England Compounding Center, the pharmacy tied to the outbreak. Now, Ameridose has recalled all of its more than 2,000 products from hospitals nationwide, and most of Ameridose's employees have been laid off.
And on Monday, the FDA released a lengthy inspection report listing 15 issues at the company's Westborough facility, ranging from failure to investigate complaints about ineffective drugs to problems with equipment and procedures intended to insure drugs are sterile.
The report, called a 483, is what investigators use to alert a company about issues that may be in violation of federal law. Although the FDA has declined to comment on the severity of the findings, Steven Richter, president and scientific director of Microtest Laboratories in Agawam and a former FDA microbiologist, said that he was appalled by the problems described.
"These are all critical observations, because it's an aseptic processing facility," Richter said. "You can't run a facility like this."
In a statement, an Ameridose spokesman said that the company was preparing a full response to the FDA.
"Ameridose is committed to addressing all observations in order to enhance our existing systems," the statement said.
In light of the uncertainty surrounding the company, Clapp said Partners is thinking broadly. Creating a central drug-making facility would take significant time and funding, so in the short-term, Clapp said she hopes state regulators will loosen regulations so that, for example, Mass. General's pharmacy could provide drugs for other hospitals in the system.
Clapp plans to buy robotic equipment and expand into recently renovated space that could help the pharmacy, which has already added several employees and evening, overnight, and weekend shifts, to increase capacity.
At Mass. General, she said it has been especially difficult to keep up with demand for patient-controlled pain medication and epidurals — medications for injection near the spine — because creating the individual doses is time-consuming.
"We're in what I would call an everyday crisis status quo – the everyday crisis part is because we're just keeping up," Clapp said.
In its newsletter this week, the Massachusetts Hospital Association said hospitals are grappling with shortages of succinylcholine, a drug doctors use when they intubate patients who need help breathing.
In a statement, the hospital association said solutions being explored "include the state allowing a hospital pharmacy to ship compounded drugs – that are made following appropriate quality and safety standards – to other hospitals within its own health system, or to modify state regulations so that the time in which a medication can be used is extended while still ensuring the medications meet quality and safety standards."
David Kibbe, a spokesman for the state Department of Public Health, said the agency is working together with clinical experts, hospitals, and pharmacies to address drug shortages.
Rob Brogna, a spokesman for UMass Memorial Medical Center, said the hospital bought only a small number of products from Ameridose, and has found other certified suppliers of those drugs.
"We have had a Critical Shortage Taskforce in place for some time, as the closure of Ameridose exacerbates an already difficult national problem," Brogna said in an e-mail.
Even hospitals that did not use Ameridose are monitoring possible shortages. Jerry Berger, a spokesman for Beth Israel Deaconess Medical Center, said that its Boston campuses did not use Ameridose, but are closely monitoring their supply chain for the possible ripple effects from hospitals that have had to turn to alternate suppliers.
Ameridose alerted state officials of its layoffs in a letter made public Tuesday.
In that letter, dated Friday, Nov. 9, the company's director of human resources wrote, "While we continue to expect to resume operations, we have now determined that because of continued inspection by state and federal authorities it may be necessary to resume operations at a reduced level."
The letter states that 676 Ameridose employees were laid off last Friday, and that an additional 31 Ameridose employees would be laid off at the end of November.