LEECHBURG – The practice of mixing patient-specific medicines has been around for a long time, but only in recent years has it become big business. The president of the Compounding Pharmacists of Western Pennsylvania warns that the practice is not without risks, however. 

“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 Pennsylvania Record.  “But there are also lawsuits for issues with manufactured drugs.”

"Compounding,” as it's known in the pharmaceutical industry,  gives doctors the ability to bypass manufactured medicines and prescribe an exact mix of medications tailored for a specific patient.

It can be a lucrative practice for pharmacists, and increasingly for large corporations, as the exclusive nature of a compounded drug makes it more expensive.

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.”

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

Despite that caution, a Florida appeals court recently granted an Ohio man’s estate the right to sue CPWP after the man died in 2012 after he was mistakenly being given a fatal dose of pain medicine.

According to modernmedicine.com, the man was referred by his Ohio doctor to Florida-based Charlotte Pain Management Center, which used Professional CPWP 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.

And last year, the Food and Drug Administration closed down Florida-based Franck’s Compounding Lab for allegedly manufacturing contaminated drugs.

Williams said industry rules have tightened significantly since the U.S. Food and Drug Administration passed the Drug Quality and Security Act in 2013 in response to a New England compounding company’s mistake that caused 84 patient deaths and 800 to become sick.

That law also led to a spate of state-sponsored compounding oversight and rule-tightening.

“It ended up leading to some positives changes, like having minimal standards and guidelines, and an accreditation process," Williams said. 

The cost of adhering to the regulations and an increase in liability insurance premiums also drove out many of the smaller compounding pharmacists, he said.

“Insurers definitely want to know if you will be compounding prescriptions, and your risk and premiums can go up,” he said.

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

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

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 Pennsylvania Record it’s only become big business in the past 10 years.

Cartizone’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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