Safeguards in place, but risk exists with compounded drugs

By Mike Helenthal | Jun 9, 2016

LAKELAND – The practice of mixing patient-specific medicines, known as compounding, has become big business in the pharmaceutical industry, but it’s not without risk, as evidenced by a lawsuit being considered in Florida courts against a lab accused of mixing a fatal mix of pain medicine. 

The estate of an Ohio man who was mistakenly given a fatal dose of pain medicine was granted approval by the Florida 2nd District Court of Appeal last week to sue the Pennsylvania compounding pharmacy that allegedly made the error.

The man who died was allegedly being treated for back pain via a pain pump in his spinal canal.

According to, while vacationing in the state in 2012, the man was referred by his Ohio doctor to Florida-based Charlotte Pain Management Center, which used Professional Compounding Pharmacists of Western Pennsylvania to compound the hydromorphone being prescribed. The man died soon after it was administered, and it was later discovered the dose was three times what had been prescribed.

Nancy Harris, a registered nurse for Charlotte Pain Management Center, told the Florida Record the center’s experience with pharmaceutical compounding has been mostly a positive one, and it is used only when it’s thought to help a patient.

“It’s a little on the expensive side, but if our doctors they think it could help a patient, they prescribe it," Harris said.

She said the center’s experience has been that doctors are able to be more precise with the medicines they prescribe, which means patients are being given the exact amount they need and no more.

Harris said there is also another level of protection, which is closer scrutiny of an overseeing pharmacist who is compounding certified.

“They are able to work directly with the patients to ensure they’re getting what the doctor is prescribing,” she said.

But like any prescribed medication, there can be mistakes and unintended side effects.

“It’s like any other prescription – there are risks and errors can be made,” Don Williams, president of Compounding Pharmacists of Western Pennsylvania, told the Florida Record. “But there are also lawsuits for issues with manufactured drugs.”

Williams said that compounding is still a very small slice of the pharmaceutical market, but in most instances helps patients.

“It gives more capabilities to pharmacies and more options to patients,” he said. “There are times when you don’t have an optimal manufactured drug, and compounding fills the gap. It’s individualized medicine. It has to be a triad relationship where they are all working for the patient’s care.”

He said his company goes to great lengths to follow the rules and regulations, and to ensure its medications are safe for patients.

While compounding has been an individual pharmacist’s niche for a long time, Carmen Catizone, executive director of the National Association of Boards of Pharmacy, told the Florida Record that it’s only become a big business in the past 10 years.

Catizone’s association is a collection of state pharmaceutical regulating agencies.

He said compounders have to be licensed with a state to do business there, and that all states now have rigorous requirements to distribute drugs under that system. He said the FDA has also aggressively pursued compounding companies with inadequate facilities or illegal billing practices.

“Up until just a few years ago, a lot of the rules were only loosely followed,” he said. “It’s gotten much better, but it’s still not where it needs to be.”

He said there are still unscrupulous manufacturers who can’t meet the rigid requirements and try to circumvent the legitimate process.

“We have to weed out more of them,” Williams said.

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Charlotte Pain Management Center Florida 2nd District Court of Appeal

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