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At compounding pharmacies, drug safety is no guarantee

On Behalf of | Oct 10, 2019 | Medication Errors

As consumers in the American healthcare system, we trust our medical providers to keep us from harm. We also – perhaps less consciously – depend on the Food and Drug Administration (FDA) to ensure that the drugs we receive are safe. When you pick up a prescription from the pharmacy, the process that went into creating that drug probably doesn’t even cross your mind.

However, not all drug manufacturing facilities are created equal. While many drug manufacturers are subject to strict federal regulation, others – known as compounding pharmacies – fly under the radar. Such facilities have created a public health concern for Americans.

What are compounding pharmacies?

Compounding pharmacies make small-batch medications for specific patient requirements. Due to certain health conditions, many patients cannot take the medications available through bulk producers. For instance, patients with difficulty swallowing may require medication in liquid form. Other patients may require a smaller dosage of a medication that’s unavailable through regular avenues. In such cases, compounding pharmacies manufacture small amounts of medication for the required specifications.

While this may seem like a reasonable system, there are flaws. There is no federal oversight of compounding pharmacies – and insufficient state inspectors to go around. As a result, many compounding pharmacies have been able to get away with reckless practices that endanger lives.

Safety concerns

When the FDA oversees commercial drug manufacturers, the average failure rate of drugs is under 2%. For compounding pharmacies, however, the drug failure rate is 33%.

In one compounding pharmacy in Connecticut, spinal steroid injections were found to be contaminated with bacteria and fungus that was visible to the naked eye. These injections caused a meningitis outbreak that killed over 100 people.

Myriad investigations have found compounding pharmacies with sanitary concerns. One pharmacy stored open boxes of loose pills in the building’s bathroom, next to the toilet.

Recently in Texas, another compounding pharmacy was caught manufacturing medicine for eye injections, which contained both acetone and formaldehyde. Because such pharmacies have so little oversight – and are not required to report their problems to regulators – the issue was not discovered until six months had passed. In this time, nearly 70 patients had gone partially or completely blind from the contaminated drug.

Compounding pharmacies’ lack of oversight breeds carelessness and incentivizes corporate greed over human safety. It’s important for doctors and pharmacists to understand what they are prescribing. When injuries occur because of dangerous medications, there may be more than one party at fault: the manufacturer (for providing faulty medications), and the doctor (for not doing their due diligence in prescribing something that’s safe).

You shouldn’t have to suffer from someone else’s negligence regarding your health. If you experience health consequences from a medication, it’s worth discussing your case with an experienced medical malpractice attorney. You have the right to get compensation for your unfair hardship.


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