As a law enforcement officer, I spent my career protecting the public from various threats. Today, I feel compelled to address a growing danger many may not be aware of: the risks associated with compounded medicines.
While these drugs can serve important medical needs, they also pose significant dangers, including the potential for exposing the public to counterfeit medicines or counterfeit ingredients used to make compounded medicines.
Moreover, I heard that some in Congress want to allow Medicare to cover compounded medicines. Quite frankly, this is a terrible idea because it would exacerbate these risks, ultimately jeopardizing patient safety.
Compounded medicines are custom-made drugs prepared by compounding pharmacists to meet the specific needs of individual patients.
These medications are not FDA-approved, meaning they do not undergo the rigorous testing for safety, effectiveness, and quality that brand-name drugs do. While compounding can be beneficial for patients with unique needs like allergies, it also opens the door to significant risks to patient safety.
Due to the lack of oversight, poorly compounded medicines have resulted in severe adverse reactions and even death of patients. These non-FDA-approved drugs put patients at risk of contamination from unsanitary conditions, incorrect dosages, and substandard ingredients. Unfortunately, we saw this tragically play out in 2012 when a fungal meningitis outbreak linked to contaminated steroid injections from a compounding pharmacy caused more than 60 deaths and hundreds of illnesses.
And in 2019, patients suffered eye injuries from non-sterile compounded eye injections made in a Florida outsourcing facility.
The lack of regulation and oversight also creates opportunities for counterfeit medicines to enter the market. Counterfeit drugs, which can be harmful or deadly, may contain incorrect ingredients, improper dosages, or harmful substances. The FDA has issued numerous warnings about counterfeit and poorly compounded drugs, including those for popular medications like semaglutide and tirzepatide.
We have seen for years the toll counterfeit opioid pills made with fentanyl have had on our communities. Opening the door to more counterfeit drugs in our communities is not the answer.
I witnessed the devastating effects of counterfeit drugs throughout my years in law enforcement. During my tenure, I was involved in several investigations to seize counterfeit drugs manufactured in unsanitary conditions and distributed through illegal channels run by organized crime syndicates that are driven solely by profits with no regard for the public’s health and safety.
Patients who unknowingly received these counterfeit drugs experienced treatment failures, adverse reactions, or worsening medical conditions.
The proliferation of counterfeit drugs undermines trust in the healthcare system and puts countless lives at risk. Allowing Medicare to cover compounded medicines may seem like a way to increase access to treatments, but it would have unintended consequences.
By covering compounded drugs, Medicare would effectively endorse treatments that lack FDA approval and oversight, which could increase Florida seniors’ exposure to counterfeit, substandard or adulterated compounded drugs.
Furthermore, expanding Medicare coverage could strain the already limited resources of regulatory agencies like the FDA. With more compounded medicines on the market, the FDA would face greater challenges in monitoring and ensuring the safety of these drugs. This could result in more cases of contamination, incorrect dosages, and counterfeit medications slipping through the cracks.
Maintaining strict oversight of compounded medicines is crucial to protecting patient safety. Regulatory agencies must have the resources and authority to enforce high standards for compounding practices. Additionally, healthcare providers and patients should be educated about the risks associated with compounded drugs and encouraged to use FDA-approved drugs whenever possible.
While compounded medicines can serve important medical needs, they also pose significant threats we cannot ignore. Expanding Medicare coverage of compounded medicines would only exacerbate these dangers, putting patient safety at greater risk. As a retired law enforcement officer, I urge policymakers to prioritize patient safety and maintain strict oversight of compounded medicines. Our health and lives depend on it.
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Mark Baughman is a 35-year law enforcement veteran whose career in Florida included serving in the Drug Enforcement Administration.
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