Meningitis outbreak sheds light on compounding drugs and lack of regulation

The growing meningitis outbreak, which has be linked to spiral injections for back pain, has shed light on improper regulation of a certain kind of drug production – one that has had a distressing history, New York Times reported.

Instead of being developed at a major drug company, the contaminated steroid drug was created by a compounding pharmacy in Framingham, Mass.  These kinds of pharmacies do not receive approval from the Food and Drug Administration when creating their drugs, according to the New York Times.

When federal inspectors examined a sealed vial of the drug at the New England pharmacy, foreign particles could be seen floating in the drug by the naked eye.  Upon further analysis, the particles were revealed to be a fungus.  Federal health officials said that a total of 17,676 vials of this tainted drug have been shipped to 75 clinics in 23 states.

So far, five people have died  and many more are continuing to get sick.  Such a terrible outbreak has many people wondering how clinics could utilize unapproved drugs for something so sensitive as an epidural injection.

According to the New York Times, some physicians say that using compounding pharmacies helps them to procure speciality drugs that they wouldn’t be able to find otherwise.  However, Dr. Arthur S. Watanabe told the New York Times that the steroid injection was indeed available at some major drug companies.

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Compounding is typically considered to be the art of tailoring a specific pharmaceutical to fit the unique needs of a single patient – not a large group of people. Typically done in hospital pharmacies, compounding falls between state and federal regulations, and no legal status has yet to been assigned to compounded drugs.  While compounding pharmacies are supposedly tolerated and overseen by the FDA, a recent court case ruled that the FDA does not have the authority to regulate these kinds of agencies.

Due to the lack of regulations, many health officials try to stay clear of these kinds of drug makers because of the possibility for contamination.  In fact, an outbreak like this has happened before in 2002, when contaminated vials traced back to South Carolina compounding pharmacy led to five illnesses and one death.

This New England pharmacy has also had its fair share of problems before, according to the New York Times.  A representative for the Massachusetts Department of Public Health said that the pharmacy has received three previous complaints in regards to a compound used in eye surgery, and its sterilizing process has also been questioned.  The FDA had also sent numerous warnings to the pharmacy, cautioning them to not open sterile vials of the cancer drug Avastin and repackage them as an eye disease treatment.  Another warning concerned the pharmacy selling a pain cream that could be toxic if rubbed into the skin too much.

In light of recent events, many physicians are calling for more regulation of this industry, given its potential to reach so many people.  Joe Cabaleiro, executive director of the Pharmacy Compounding Accrediation Board told the New York Times that the New England center has never applied for accreditation, which would characterize the pharmacy as meeting industry standards.  However, applying for accreditation is only voluntary, and only 162 out of around 3,000 compounding pharmacies have applied.

Click for more form the New York Times.