By Michael R. Cohen, R.Ph.
Ameridose LLC, a compounding pharmacy that shares ownership with New England Compounding Center (NECC), the pharmacy behind the meningitis outbreak, has begun a national voluntary recall of all products.
In a 3:30 p.m. FDA-arranged conference call this afternoon, the Agency said that they found a “lack of sterility assurance” during recent inspections at the facility. They did not say they found any unsterile products or identified impurities in any Ameridose products and said have been no known infections in patients. FDA has cited Ameridose in the past for quality issues but that is also true for many major pharmaceutical manufacturers and other compounders.
Ameridose, licensed in Massachusetts as a compounding pharmacy and also registered with the FDA as a manufacturer, had already stopped dispensing drugs on October 10, 2012 in the wake of the investigation at its sister company, NECC. But until today, products that had already been dispensed remained in use. Hospitals were told to quarantine all products from Ameridose.
Ameridose is one of the largest compounding pharmacies in the US, and has been a major hospital supplier of injectable medications that make up for the vast number of drug shortages that have been plaguing US hospitals for the past two years.
Drug shortages often occur for quality reasons, because of difficulty in obtaining raw ingredients, or because certain products are no longer considered profitable. While the shortage situation has improved somewhat over the past year, hospitals are still finding it difficult or impossible to obtain certain critically necessary drugs. Thus, they rely heavily on companies like Ameridose.
Currently, sodium bicarbonate injection, which is used in treating victims of cardiac arrest, and succinylcholine injection, which is given to patients breathing through a tube and on a respirator, are two medications that are unavailable. Others were also named during today’s call.
FDA admitted concern today that the recall will only worsen the shortage situation since a large number of doses are currently in stock and being used by US hospitals. Drug shortages are often linked to under treatment of patients, medication errors, and side effects from alternative therapies.
FDA said they are working with drug companies to expedite some products and also considering importing some drugs from other countries. This can’t come soon enough. Already this afternoon I’ve spoken to several pharmacists who believe the recall will have dire consequences for patients, especially those who need the two drugs mentioned above.