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The Official Publication of AAN - MA

All Nebulizer Medications are NOT Created Equally

Pharmacy compounding can lead to substandard respiratory drugs

PharmacistWhen you fill your prescription for a nebulizer medication, you just naturally believe you’re getting what your doctor ordered. But are you?

Unfortunately, the answer is not always. Using a legitimate provision under U.S. Food and Drug Administration (FDA) rules and regulations, some pharmacies are replacing the medication your doctor ordered for you with a so-called “generic” medication that was formulated by the pharmacy instead.

The rule—called “compounding”—allows pharmacies to formulate special medications for patients who would not benefit from drugs already on the market. It’s intended to deliver truly customized medications to individual patients who have no other option.

But some pharmacies are using this legitimate pathway to mass produce their own illegitimate versions of respiratory drugs that are on the market in FDA approved products. These pharmacy-compounded medications don’t go to just one patient with a special need, they go to thousands—indeed, perhaps millions—of unsuspecting patients who have little or no idea they are receiving a drug that has not been manufactured according to FDA standards.

Why it’s a problem

The first thing to note is these medications are not “generics” in the true sense of the word. Generic medications, or lower-cost pharmaceuticals, fall under the same FDA rules and regulations as brand name medications and are generally considered safe and effective. More than half of all pharmaceuticals dispensed are generic, according to the Generic Pharmaceutical Association.

But often pharmacies will refer to compounded medications as “generic” to convince patients they are just less-expensive versions of brand name drugs. This is not the case. In reality, these medications do not adhere to any FDA rules and regulations, because the whole idea behind pharmacy compounding is to allow pharmacies to make up special drugs for individual patients who cannot be treated with FDA approved medications. These compounded drugs do not have to meet high standards for safety, efficacy, or sterility; nor are they established as equivalent to FDA approved drugs. With no federal oversight, substandard packaging may mean the drug won’t be good as long as it should be, and the drug may not include all the necessary information (like dose, lot number, or even name of the manufacturer) on the label.

Even more troubling is the fact that pharmacy-compounded nebulizer medications have been linked to potentially serious problems. Some, for example, have been found to contain bacteria that causes pneumonia or preservatives that can lead to respiratory irritation. Concerns have also been raised about the leeching of cancer-causing substances into the medications from inks and glues used on the paper labels. There is no guarantee the drugs even contain the active ingredients needed to treat your respiratory problem—which could lead to a serious asthma attack from lack of proper treatment.

What’s being done

Patient support groups and health care professionals, including respiratory therapists from the American Association for Respiratory Care (AARC), have banded together in recent years to urge the FDA to crack down on the pharmacy compounding of respiratory medications already on the market. Working through a coalition called the Consumer Health Alliance for Safe Medication, or CHASM, they issued a Citizens Petition in 2005 requesting specific action on the part of the FDA.

The FDA responded by sending warning letters to three large pharmacies engaged in the practice, and the Medicare program also stepped in, issuing a new rule in the summer of 2007 saying it would no longer pay for these drugs. Private insurers followed suit, saying they would only pay for compounded medications as experimental drugs, a classification that includes additional restrictions.

Now the pharmacy industry is working to overturn these provisions, citing a new rule by United States Pharmacopeia (USP), the standards setting group for prescription and over-the-counter drugs and supplements, aimed at making the drugs more sterile. The International Academy of Compounding Pharmacists is using that rule to lobby for the reinstatement of Medicare payment for compounded nebulizer medications.

The USP may have good intentions with its new rule, but when all is said and done pharmacy compounded nebulizer medications still won’t have to adhere to the stricter FDA standards, so they will still be putting patients at risk. The AARC wants patients and families to understand the risks and how to avoid them. How can you tell if your respiratory medications are FDA approved drugs or pharmacy compounded versions? Look for these telltale signs:

Paper labels: FDA approved medications do not have paper labels, because these labels are printed with ink and use glue that could leech into the medication. FDA approved medications will have the labeling information embossed on the medication vial itself.

Plastic wings: Compounded medications are often contained in vials with plastic “wings” jutting off the sides of the vial. FDA approved medications do not have this feature.

Extra paperwork: Before a pharmacy can give you a compounded medication, they will need to have you or your physician sign paperwork approving the pharmacy to dispense the medication. A prescription for an FDA approved medication does not require any additional paperwork.

Suspect wording: Some compounded medications will carry a statement such as: “This medication was made specifically for you at your physician’s request.” This wording should raise a red flag and prompt investigation into the true nature of the medication. While your doctor may indeed have signed extra paperwork approving the special formulation, in most cases he is not aware of having done so because the paperwork was presented as a simple approval for refilling his original prescription.

Internet orders: The Internet is a big source of compounded medications, appealing to patients with claims of lower costs. Beware of any ads or e-mails claiming to deliver respiratory nebulizer medications at significant savings over standard pharmacy prices.

Home health agency/pharmacy links: Most of the patients who have been given pharmacy compounded medications either purchased or rented their nebulizer from a home health agency associated with a national or local pharmacy; following the rental or purchase, their name brand or generic drugs were switched to compounded medications produced by the pharmacy. Often the home health agency isn’t even aware of the switch.

How you can protect yourself

The good news is, ensuring your respiratory medications are FDA approved brand name or generic drugs is fairly easy. The best way is to ask your doctor to write, “Do Not Compound This Nebulizer Medication” on the prescription. Documenting your desire to receive only an FDA approved medication is your best defense against receiving—or unknowingly being switched to—an unapproved pharmacy compounded medication instead.

You can learn much more about pharmacy compounding of respiratory medications on the CHASM web site.

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