Dallas compounding pharmacy’s super-strength meds behind 3 deaths
A Dallas compounding pharmacy called Apothécure mixed and sold a medication that was 640 times the normal strength for the gout drug and shipped it to Portland, WA. 3 people died from taking the super-strength medication. Federal investigators quickly found the common thread behind the three victims’ sudden deaths: a Dallas compounding pharmacy called Apothécure.
This past April, the owner of Apothécure, Gary Osborn, pleaded guilty in relation to the three deaths from the super-strength gout drug. You might be surprised, but the charge was only a misdemeanor. It involved the mislabeling of the drug. Mislabeling of drugs is a federal offense, so the FDA did have authority to step in on this instance. (Source: David Schechter, WFAA.com, 10/9/12)
About Compounding Pharmacies in the United States
Around 7,500 compounding pharmacies exist in the United States. That’s up from just about 5,000 only three years ago. The industry has burgeoned due to needs for unavailable and custom-mixed medications partially created by drug shortages caused by high-profile medication recalls.
Most of these compounding pharmacies are small, locally owned “mom and pop” type businesses. Compounding is actually a centuries-old pharmaceutical tradition. Since 1950 though, it has been a specialized industry in the United States.
Technically, compounding pharmacies don’t “manufacture” new or novel drugs. They custom-mix drugs from manufactured brand drugs and bulk ingredients to create tailor-made medications in specific dosages, with new flavors, without allergens, or to re-create drugs that brand manufacturers have taken off the market due to lack of profitability, often once the patent has expired. Compounding pharmacies aren’t supposed to widely “market” their creations either.
The Current Lack of Adequate Oversight of Compounding Pharmacies
Because the compounding pharmacies supposedly do not manufacture new or novel drugs, they aren’t subject to FDA regulation and their compounded drugs don’t require FDA approval. State pharmacy and health boards oversee the compounding pharmacies and their activities. These 50 state boards simply don’t have the budget, manpower, or in-depth knowledge required to adequately oversee the 7,500 compounding pharmacies operating in the United States today.
So sometimes things slip through the cracks. An injectable steroid drug intended to mediate lower back pain, for instance, gets contaminated with fungus that leads to deadly meningitis. Or a drug gets mixed at 640 times the usual strength and deadens the pain of patients who take it, permanently.
Now that deaths from compounding pharmacy errors have captured headlines nationwide, consumers and lawmakers are starting to take notice and ask questions about the massive gap in regulatory authority that leaves the industry prone to such errors. Whether questions will lead to action is another matter.
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