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EMF Studies

17 October 2012

The Meningitis Catastrophe and Compounding Pharmacies

Update: 2 November 2012 (source: People’s Pharmacy):  At last count, close to 400 people have been infected with fungal meningitis and more than two dozen have died. Others have developed infections in their shoulders, elbows, knees and hips because of steroid injections into such joints. The New England Compounding Center of Massachusetts responsible for the contaminated vials of methylprednisolone has been closed and is now under investigation.

This entire tragic event has led to closer scrutiny of large compounding pharmacies. A sister company of the New England Compounding Center, Ameridose, has also been closed for inspection. In addition, Massachusetts authorities have shut down an unrelated pharmacy called Infusion Resource because of concerns about sterility. Florida regulators have suspended operations at a compounding pharmacy in their state as well because of a number of violations.

At the time of publication of this post, as many as 14,000 patients may have been exposed to spinal steroid injections (methylprednisolone) containing the fungi aspergillus and exserohilum which has caused a terrible meningitis outbreak in the United States.  Sixteen persons have died and the toll is likely to rise over the next several weeks. Over 17,000 vials of the spinal steroid were shipped to doctors' offices, clinics and surgical centers in 23 states. Following are extracts from this article, published on 8 October 2012 by the People’s Pharmacy, which is a balanced and very informative site on pharmaceutical medications and other, more natural, health remedies. The article raises the issue of oversight of the compounding industry. The U.S. Supreme Court has restricted the ability of the Food and Drug Administration to monitor compounding pharmacies, leaving the door open to catastrophes such as this one. 

The Meningitis Catastrophe and Compounding

Before drug companies took over the world of pharmaceuticals, pharmacists actually used to make many of the medicines they sold to customers. It was routine for a pharmacist in the 1940s and 1950s to make remedies to treat diarrhea, coughs or fungal infections like athlete's foot. In fact, there was no distinction back then between a standard pharmacy and a "compounding" pharmacy. All pharmacists were trained in the art of making medicine.

These days most chain pharmacists (and pharmacy technicians) are so busy with insurance hassles, drive thru windows, and a huge volume of prescriptions to fill that they don't have the time or resources to actually compound a lot of pills, creams and emulsions. As a result, a cottage industry has grown up in the United States involving compounding pharmacies. They create bio-identical hormones to deal with menopausal symptoms and a variety of other products that are tailored to specific patients' needs.

[Pharmaceutical compounding (done in compounding pharmacies) is the creation of a particular pharmaceutical product to fit the unique needs of a patient. To do this, compounding pharmacists combine or process appropriate ingredients utilizing various tools. This may be done for medically necessary reasons, such as to change the form of the medication from a solid pill to a liquid, to avoid a non-essential ingredient that the patient is allergic to, or to obtain the exact dose needed. It may also be done for voluntary reasons, such as adding favorite flavors to a medication: Source Wikipedia.]

When such pharmacies make a small number of products for people in their community, the consequences of a compounding error are likely to be limited to only those few products. But over the last few decades we have seen the growth of larger compounding facilities that sell products to a much wider audience. Some advertise on the Internet or even send sales representatives to doctors' offices promoting special formulations. Some of these products have not been approved by the Food and Drug Administration. Others are copies of commercially available products and are sold at a steep discount. This makes them attractive to physicians who get to charge a fee for injecting a particular product. With drug shortages creating havoc for hospitals and clinics around the country, compounding pharmacies sometimes fill the void.

And this leads us to the terrible meningitis outbreak caused by fungal contamination of injectable methylprednisolone. At the time of this writing it is estimated that as many as 13,000 patients could have been exposed to spinal steroid injections containing the fungi aspergillus and exserohilum. Over 100 people in nine states have become ill and eight are dead. The toll is likely to rise over the next several days and weeks. Over 17,000 vials of the spinal steroid were shipped to doctors' offices, clinics and surgical centers in 23 states.

How could this happen? Compounding pharmacies are not regulated the way drug companies are. Even if they have lots of employees and advertise on the web, they do not get the same oversight a pharmaceutical manufacturer might. Kevin Outterson, an associate professor of law at Boston University, was quoted in the New York Times as saying, "The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts."

That is a sad commentary on the oversight of this cottage industry. The Supreme Court has restricted the ability of the FDA to monitor compounding pharmacies. States are limited in their ability to inspect these production facilities the way the FDA does and regulate what drugs are compounded and in what quantities. So there is a kind of legal limbo that has evolved in which some compounding pharmacies may slip between the cracks. If the FDA doesn't have the authority to oversee their manufacturing processes and the state they operate in does not have the resources to do so adequately, consumers are pretty much on their own.

This does not mean that we should give up on local compounding pharmacies. A community pharmacy that serves its customers with care and caution is a valuable resource. Pharmacists can create liquid medicine or drug-containing gummy candy that is tasty and easier for a child to take than a large pill. Pharmacists can formulate special doses to help people discontinue antidepressant medications that would otherwise cause unpleasant withdrawal symptoms. Injectable drugs, on the other hand, need special care. And large compounding pharmacies that advertise on the Internet may not always get the oversight you deserve. Perhaps it is time for patients and physicians to insist that the FDA take a more active role in monitoring drug manufacturing here at home as well as abroad.

Patients will also need to be more vigilant when interacting with the pharmacist. These days they are overworked and overextended. In our book, Top Screwups Doctors Make and How to Avoid Them we document that as many as 1 out of 5 prescriptions may have an error or deviate from the physicians' written orders (Journal of the American Pharmacists Association, March-April, 2009). Although most errors are not life-threatening, far too many can lead to harm.

Top 10 Pharmacist Screwups:

• Not counseling patients
• Dispensing the wrong drug
• Dispensing the wrong dose
• Ignoring drug interactions
• Not standing up to doctors (when a mistake is made)
• Trusting all generic drugs
• Relying on inadequate labels and leaflets
• Not reporting errors
• Switching drugs without patient approval
• Not supervising techs carefully

Be proactive! Ask your pharmacist for specific instructions on how to take your medicine (with food or on an empty stomach). It can make a big difference when it comes to drug effectiveness. Find out about food and beverage interactions. Make sure your pharmacist explains carefully the most common and most dangerous side effects of your medicine. WRITE THEM DOWN! Do not rely on that little slip of paper that may be included in your bag. It will likely get lost easily. Ask your pharmacist to double check for drug incompatibility with any other medicines you are taking. And finally, make sure you have received the right medicine in the right dose and the instructions match those your doctor gave you. Do not just grab and go the next time you pick up your prescription!

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