Last week ended with two more news stories of compounding pharmacies producing and selling tainted products. Lowlite Investments, Inc., doing business as Olympia Pharmacy, has recalled all of its sterile products with an expiration date of September 25, 2013 or earlier.
According to the FDA release, "the recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance." As I’ve noted before in previous articles addressing the issues with compounding pharmacies, these companies are not using proper quality control on products. Over the last several months more than 50 people have died as a result of receiving medications made at the New England Compounding Center and countless others were sickened.
That’s only one of the centers found to be producing faulty medicines. Georgia, Florida, Tennessee, Massachusetts, the list goes on. A report by the Pew Charitable Trust details the depth and breadth of problems faced by compounding pharmacies across the United States. The report notes, "20 pharmacy compounding errors associated with 1022 adverse events, including 75 deaths, since 2001." The article goes on to outline by year, each incident, the product and the compounding error.
It’s alarming. And even though lawmakers are working now to come up with legislation giving the FDA greater oversight authority, we are still at risk. The second case last week was in New Mexico where recent problems were tracked back to a compounding pharmacy in Tennessee. The problem? Potentially ‘tainted anti-inflammatory injections’. These injections were sent out to clinics in 13 states. The drug in question, Methylprednisolone acetate, is used to treat inflammation, asthma, joint and upper respiratory issues. It is the same drug suspected of killing at least 55 people last year following an outbreak of fungal meningitis. (Washington Post, 5/30)
The drug didn’t come from the Framingham, MA pharmacy this time, but rather the Main Street Family Pharmacy of Newbern, TN. The same drug—different problems—different manufacturer. Fortunately no one was harmed from this batch in the New Mexico health clinic, but there were reports of people in other states who experienced skin abscesses at the injection site.
It seems as if none of these compounding pharmacies are safe. Even with all the news and FDA crackdowns. With the public concerns, loss of life, and other severe to moderate illnesses these people are still making medications in non-sterile conditions. They’re producing drugs that contain mold, glass bits and other horrendous things we might expect in a third world country. Not in the United States. Is it possible to assume these people are knowingly going to work each day in an environment that’s not clean enough to pass standards? Do the employees, managers, and CEOs know that they’re making unsafe, potentially harmful drugs that could be used by their own neighbors, families and people across the country?
It’s a powerless feeling when you begin to question the very safety of the people with whom you entrust your life. Ask your doctors and nurses if they’re using compounding pharmacy medications and ask where they come from. And, call your legislators today, to express your support for legislation to regulate compounding pharmacies.