Fungal Meningitis Outbreak Leads to Questions About Where Drugs Come From | Shapiro, Washburn & Sharp

What Happened: 

The recent outbreak of fungal meningitis has many people asking questions about the safety of compounding pharmacies and the origins of many of the medicines we put into our systems everyday. Something that many may not realize is just how hard it can be to track down the source of the drugs that you take on a daily basis.

So far the Centers for Disease Control and Prevention has said that the fungal meningitis outbreak has made 354 people sick in 19 states and caused 25 deaths. The outbreak was linked to a batch of injectable steroids that have since been recalled by the New England Compounding Center, a compounding pharmacy in Massachusetts.

UPDATE: Take a look at this 60 Minutes report talking about the sloppy and irresponsible actions taken at the New England Compounding  Center:

 

Compounders have recently played an important role in the medical field given the increasing occurrence of drug shortages. The pharmacies have been able to step in and provide some much needed supplies when the big manufacturers are down. Compounders are also useful as cheaper alternatives to the big name brands.

The recent rash of cases has pointed out a gap in the current FDA inspection regime. Though the FDA regularly inspects large pharmaceutical factories, it keeps out of inspecting compounding pharmacies, instead allowing states to handle that.

It’s hard to pin down exactly where medications come from. Learning the source of an injectable drug given in a hospital or clinic may be even harder. The fact is that many patients may not even know what a compounded drug is, let alone know where to begin to find out where it came from. Moreover, doctors aren’t accustomed to providing answers as few if any patients ever bother to ask.

Even many medical professionals are unaware of where the drugs they prescribe come from. This is because most drugs are purchased in large quantities from a central provider then distributed as necessary. Middlemen act as barriers between doctors and the manufacturers, providing yet another impediment to discovering the origin of drugs. Experts say that doctors may not be able to answer the question unless the specific vial of drugs contains information about the origins of the product.

Another possible source of information for concerned patients is the hospital’s procurement office or in-house pharmacy. Both departments are often in charge of ordering drugs and might have more contact with suppliers and other relevant information.

Despite the inconvenience, patients have a right to know where their medications come from and to refuse any compounded medications. Patients can ask to see a medication’s FDA-approved drug label if they are curious and want to be sure about the medicine’s safety. Something to watch for is that compounded drugs do not have to comply with the labeling requirements for a standard FDA-approved drug. This means that the risks of the drugs are typically not disclosed and instructions for safe use are usually not provided on compounded products.

While patients might not be able to inquire about their medications during an emergency operation, elective procedures, like the steroid injections in this case, allow patients plenty of time to find answers. Given the seriousness of the problem, there’s no reason why patients should hesitate in asking for a background on the drugs they take.

The North Carolina Injury Lawyer’s Perspective:

As experienced North Carolina dangerous drug attorneys, my colleagues and I have helped clients through many cases like this one. Sadly, thousands of people experience the pain of taking a medication prescribed by their doctor only to have it cause serious health problems later on. This happens far too often and the side effects can last a lifetime.

Helpful Info:

If you have been injured by a dangerous or defective drug, you may be able to hold the company that manufactured and marketed the drug accountable by filing claims for compensation. Read this article to begin learning about your legal rights and options when a faulty product leads to injuries.

Have Questions?

To learn more about how to proceed if you have been injured as a result of a prescription drug in North Carolina, please read the following FAQs.

 

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