Wednesday, April 23, 2014
The recall of all products manufactured by a Massachusetts drug company has created a critical shortage of several commonly used, life-saving injectable medications, according to the U.S. Food and Drug Administration.
Many hospital pharmacies, including in Maine, are being forced to compound their own medications or use other drugs, sometimes less effective ones, to treat patients.
"We are doing the manufacturing in-house now and it's definitely put a crimp on the system," said Tim McCall, pharmacy director for Maine Coast Memorial Hospital in Ellsworth.
Don Watson, pharmacy manager for clinical services at Maine Medical Center in Portland, said the recall has exacerbated a national shortage that has been a problem for the past two years.
"It's a moving target to make sure patients are getting the most appropriate medication," he said. "There are days when we say, 'Where are we going to get drugs for these patients?'"
Ameridose of Westborough, Mass., voluntarily recalled all of its products and suspended operations last month in response to an investigation by the FDA and Massachusetts' board of pharmacy.
Authorities began looking into the company because of its ties to the New England Compounding Center of Framingham, Mass., whose products were responsible for an outbreak of fungal meningitis that has caused 29 deaths and hundreds of infections.
No products made by Ameridose have been found to be contaminated, but all have been recalled as a precaution because the company could not verify that sterility practices were followed, according to the FDA. The company stopped producing on Oct. 10 and will be shut down at least until Nov. 19 while the FDA continues to investigate.
With Ameridose no longer manufacturing products, the FDA says some commonly used drugs are in short supply:
• Sodium bicarbonate, which is sometimes used to treat acidosis or in conjunction with CPR.
• Succinylcholine, a muscle relaxer that is often used to facilitate insertion of a breathing tube.
• Atropine sulfate, which is used to stimulate heart rates.
• Bupivacaine hydrochloride, an anesthetic.
• Lidocaine hydrochloride, an anesthetic.
• Furosemide, a diuretic often administered to patients with hypertension and congestive heart failure.
The FDA has asked other manufacturers to increase production of those medications. If U.S. manufacturers cannot meet patient needs, the FDA has said it will explore importing drugs.
The Maine Board of Pharmacy asked Ameridose on Thursday to voluntarily surrender its license to operate here. The board also suspended New England Compounding Center's license in the state.
It's still not clear how many Maine facilities are customers of Ameridose. John Martins, a spokesman for Maine's Department of Health and Human Services, said the state hasn't played a role in the latest recall and didn't have information on how many Maine hospitals or practices did business with Ameridose.
Becky Schnur, a spokeswoman for the Maine Hospital Association, said she didn't know which Maine hospitals have been affected. An FDA spokeswoman said the federal agency did not have a list of Ameridose customers.
Representatives from Ameridose have not returned multiple calls for comment. The company's website indicates that all customers were sent a letter dated Oct. 31 instructing them to quarantine all products they received from Ameridose.
The FDA said Ameridose customers are not being asked to notify patients who might have received the company's medications because no contamination has been found.
Some Maine hospitals said they have received Ameridose products in the past, but none characterized the company as a major supplier.
McCall at Maine Coast Memorial in Ellsworth said he had to pull only four Ameridose products, and none were on the shortage list. He said his staff is now doing its compounding in-house.
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