Bad medicine: Local drug compounder says more regulation isn’t the answer
By Denise Crosby firstname.lastname@example.org November 2, 2012 1:16PM
Erin Berthold from Geneva, sterilizes and puts on a gown before going into the sterile room at The Compounder in Aurora on Wednesday, October 24, 2012. | Brian Powers~Sun-Times Media
Updated: December 5, 2012 6:06AM
Compared to the big labs, like the Massachusetts compounding pharmacy at the epicenter of the deadly meningitis outbreak, Larry Frieders’ Aurora business is just a mom-and-pop place — literally.
He and wife Patricia, both pharmacists, began their first medicine shop back in 1983. And today, their compounding business — aptly named The Compounder — now boasts two additional employees, their kids Joel and Lydia Lesniak.
Just how small is their operation? Whereas some of these big pharmacies might send out 2,000 to 5,000 vials in individual orders a month, The Compounder sends out 20 to 25.
Still, Frieders and other local pharmacists who customize their own medications to fit individual needs are carefully tuned in to any and all news surrounding the New England Compounding Pharmacy in Framingham, Mass., which is linked to a national meningitis outbreak that has killed dozens and sickened hundreds more.
The culprit could have been anything from moldy tile ceilings to dirt on a worker’s clothes.
“I don’t know what happened there, whether it was nefarious or accidental,” said Frieders. “It is almost impossible to tell how sterile vials get contaminated ... you can never be 100 percent sure.”
We all should know more about these compounding pharmacies, since physicians are increasingly getting material from them because they can sell drugs at a lower cost than major manufacturers.
In a nutshell: Compounding pharmacists customize medications to fit an individual’s needs. Doctors order these medications when the manufactured drug has been taken off the market because of slow sales or because it is ineffective. Frieders says that could mean everything from a dosage being too large to a patient having an allergic reaction to certain ingredients.
At The Compounder, for example, his family makes medicines for children in a particular flavor. Or they will make eye drops without preservatives for someone who is sensitive to a certain ingredient. They even take orders from veterinarians — such as medicines flavored with beef or chicken, so your pet will more easily swallow the dosage.
Frieders has “nothing but respect” for the bigger labs, adding that small operations like his can learn from how the bigger labs do things. But in a lot of ways, it’s good to be small because it means more oversight. “Each and every vial that goes out the doors” (of The Compounder) is tested,” he said.
Contamination could happen with any drug, manufactured or compounded. Yet the vast majority are perfectly safe, Frieders said. And the call for more oversight is a knee-jerk reaction that simply is not the answer to the problem.
“I would agree to more regulation if you define what that means,” he said. “Does it mean more inspections? Then how often is enough? I could pass an inspection one day, then sneeze into a vial the next day, and did that new regulation do any good?”
Also, he noted, adding more rules only adds to the cost — which would be passed along to customers.
Federal health inspectors say that over the past year, staffers at the New England pharmacy documented dozens of cases of mold and bacteria growing in rooms that were supposed to be sterile. The Food and Drug Administration inspectors said even though the mold and bacterial contamination there exceeded the company’s own safety levels, there is no evidence the pharmacy investigated or corrected the problem.
Frieders insisted that testing is going on all the time at The Compounder, sometimes as much as three times a day. “And we do other things that are not required,” he added, such as sometimes holding back drugs for a few months “just to see if there is any degrading over time.”
Frieders says the floors and walls of their outer chamber room — which should contain low levels of airborne particles and surface contamination — are scrubbed daily, with the entire area getting cleaned weekly. Twice a year, air samples are sent to an outside lab; and The Compounder does its own internal testing once a month.
The Illinois State Board of Pharmacy Department of Regulation is responsible for oversight of these compounding pharmacies, and Frieders sees no need for the federal government to get involved.
“We have plenty of gun laws, yet people are still shooting each other,” he noted. “I don’t know what new regulations are going to make things safer.”