Thursday, March 28, 2013

Compounding in the News

Image Source: Wikipedia
Entry: New England Compounding
         Center meningitis outbreak link
     Recently the field of compounding pharmacy was put in the national news spotlight. This was, for many people, the first time they had even heard of compounding pharmacy and what it entailed. Unfortunately, compounding pharmacy was not shown in a good light. For those of you not familiar with the New England Compounding Center and its involvment in a recent meningitis outbreak please see the link below the image. This link will take you to a Wikipedia page that gives the basic rundown of events that occurred without too much of a media bias.
     In October of 2012 there was an outbreak of fungal meningitis that affected patients in 23 different states. When the CDC began checking into possible causes of the meningitis outbreak they discovered all of the patients had received epidural steroid injections. The methylprednisolone acetate for injection had been produced at the NECC. The NECC immediately recalled this product and two others that may have been contaminated. As of March 2013, 48 patients had died from meningitis and over 700 people were injured or currently being treated for meningitis and other injection related infections.
     Like I said before, for many people in the public this was their first time learning about compounding pharmacies. The NECC has since closed its doors and is facing hundreds of lawsuits from families effected by their error and penalties from the US government. This tragedy was not only a huge blow against the NECC, but all pharmacists. It took away a level of trust the public has in our profession.
     Also, with the way the media presented the findings many people were terrified that any injection or any medication they received could kill them. True, all medications have their risks, but I really disagree with the media always using sensationalism and fear tactics to whip the public into a frenzy over any little thing. Simply by surfing around the internet and reading various message boards I see the paranoia and misinformation about this issue. Many people are asking, "Where was the FDA? Aren't they the ones supposed to be protecting us from the pharmaceutical companies?" Of course people demanded that compounding pharmacies now be inspected and subject to harsher laws. The NECC debacle lead to several other compounding pharmacies being shut down in Massachusetts and other states. This really scared me. I knew that soon every compounding pharmacy would be scrutinized and looked upon as a potential problem. The public would lose trust in pharmacy and the government would respond by driving independent compounding pharmacists out of business.
     I completely agree that compounding pharmacies should be held to high standards of safety as patients health and even lives are on the line. Unfortunately, the NECC was not operating as a compounding pharmacy in the true definition. In my next post I will get into the details of what constitutes "compounding" versus "manufacturing".  I think the NECC should be harshly punished to make an example for other pharmacies who may try to stray into the area of manufacturing.  I don't agree that more laws and regulations will necessarily prevent future tragedies of this nature. Case in point: the New England Compounding Center was violating tons of compounding pharmacy laws and this was not brought to light until they killed or injured hundreds of people.

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