Would Tighter Regulation Of Compounding Pharmacies Have Averted The Meningitis Tragedy?

mortar and pestle 300x233 Would Tighter Regulation Of Compounding Pharmacies Have Averted The Meningitis Tragedy?To date, the ongoing meningitis outbreak from contaminated epidural steroid injections has left 23 people dead and hundreds infected with varying side effects. Before it’s over, up to 14,000 people could be affected.  The tragedy has put a spotlight on a little-known, or understood, problem within the pharmaceutical industry – that of the autonomy of individual compounding pharmacies who are not under the regulation of the FDA.  Let me explain.

Autonomy vs Tragedy? 

There are many tragic, individual, stories in the recent fungal meningitis outbreak.   Stories about people just receiving routine pain relief shots while recovering from back, or spinal, injuries.  Suddenly they had much more to contend with – life-changing side effects and even death. There’s no question that the particular compounding pharmacy – NECC out of Framingham, Massachusetts, is responsible for the fungus-contaminated batches of steroid injections they created.  But how did this happen? Aren’t pharmacies supposed to protect a person’s (and pet’s) life in administering drugs?

Compounding pharmacies are different when compared to traditional pharmacies.  A traditional pharmacy administers standard, manufacturer created doses of medication to people through their doctor’s prescription.  A compounding pharmacy creates an individualized dose from a doctor’s prescription that is tailored to the patient’s (or pet’s) specific needs.  Because they deal in creating individualized medication, compounding pharmacies have, to date, been successful in fighting the same FDA regulation that traditional pharmacies have. They are, instead, under their particular state’s regulation.

It is this autonomy of compounding pharmacies, however, that has lead to the meningitis tragedies across the United States – at least in the case of this one particular compounding pharmacy.  Instead of making up individualized injectable steroid formulas as needed, NECC apparently was making up bulk batches of the steroids (and other drugs) that then became contaminated with the rare fungal organism.

Many in support of the FDA regulation of compounding pharmacies see the meningitis outbreak as the worst-case scenario of why compounding pharmacies should be better regulated.  They feel that NECC was acting more like a drug manufacturer – creating drugs in large batches – rather than following the strict definitions of a compounding pharmacy.  Therefore, they should have been under different regulation than most compounding pharmacies.  Many feel that the meningitis outbreak illustrates what can happen when industry opposes government rules designed to protect both consumers and the environment.

According to a Huffington Post story [Behind the Meningitis Outbreak:  Pharmacies Fought FDA Regulation, October 2012], in 1997 Congress passed a law that gave the FDA more oversight control of these pharmacies.  In 2002, however, the compounding pharmacies sued the FDA and the U.S. Supreme Court repealed the 1997 law.

There have also been many complaints filed against compounding pharmacies such as blindness from non-sterile eye drops, as well as hospitalizations, and poisonings from compounding errors. In 2006, in response to these events, the compounding industry also put in place a compounding industry-run voluntary accreditation process for compounding pharmacies. According to Editorial Code and Data’s blog, there are over 400 compounding pharmacies in the U.S. Yet, as the ABC News story states, only 162 are accredited by the Pharmaceutical Accreditation Board (PCAB).

In 2007, members of the U.S. senate (Kennedy/Mass; Roberts/Kansas; Burr/N.C) introduced the Safe Compounding Drug Act to address the industry’s regulation gaps. The legislation never got out of the committee proposal stage.  Every time new legislation was proposed for compounding pharmacies, FDA regulation was overturned leaving it up to each state’s pharmacy boards to regulate.  According to an ABC News story [Compounding Pharmacies Defend Their Trade After Meningitis, October 22, 2012], NECC, the compounding pharmacy responsible for creating the contaminated steroid injections, was in violation of its own state’s licensing regulation.

To date, compounding pharmacies are still unregulated by the FDA.  Individual congressmen, however, have urged Congress to take further action to introduce new proposals for FDA regulation in the wake of the current meningitis outbreak.

What Can You Do to Stay Safe?

It might sound easy to simply stay away from compounding pharmacies and only use traditional pharmacies.  However, many people (and pets) have benefitted from the safe and individualized tailoring of drugs that most compounding pharmacies provide.  Some people – and animals – do not respond well to the general manufacturer’s doses, or forms, of medications.  A compounding pharmacy can customize a dose, even combine several drugs into one for ease of taking, or add flavor to them. This can be helpful in pets, children, and older people who may have trouble taking standard pills.  Some other benefits of using compounding pharmacies include preventing allergies to binders, dyes, and filler ingredients present in bulk manufactured drugs; also changing the form of a medication to a liquid, or cream, if a patient cannot swallow pills.

To stay safe using a compounding pharmacy, you should first research its reputation by determining any violations or lawsuits on record. Be sure it is accredited by the Pharmaceutical Accreditation Board (PCAB) and that the pharmacy conforms to their state’s accreditation guidelines.  To determine the accreditation of the compounding pharmacy you want to use you can search your state’s list of pharmacies here.

Stay Well,
Mark Rosenberg, M.D.
Natural Health News

Compounding Pharmacies Defend Their Trade After Meningitis, http://abcnews.go.com/Health/Drugs/compounding-pharmacists-defend-trade-meningitis/story?id=17503276#.UIWDqWdKzdM

Behind the Meningitis Outbreak:  Pharmacies Fought FDA Regulation, http://www.huffingtonpost.com/donald-cohen/pharmacies-fought-fda-reg_b_1974040.htm

Accredited Pharmacies, PCAB, http://www.pcab.org/accredited-pharmacies

Compounding Pharmacies In The United States www.marketsize.com/blog/index.php/2010/06/25/compounding-pharmacies-in-the-united-states/

photo credit: columbinerx.com

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