LAFAYETTE, Ind. (AP) — Before federal agencies and state lawmakers engage in any crackdown on regulations for specialty and compounding pharmacies, those running such facilities have a message to share.
We're different, they say, from the Massachusetts manufacturer that produced 17,000 doses of a back pain steroid that is believed to have caused 19 deaths and sickened at least 247 people nationwide.
While Indiana pharmacists who run custom compounding businesses are fielding questions left and right from clients and others about the safety of their products, experts say cries about pharmaceutical regulation in light of the nationwide scare over a fungal meningitis outbreak may be misguided.
"The public fear is completely understandable, but people are taking it too far," John Herzig, medication safety project manager for the Purdue College of Pharmacy's Center for Medication Safety Advancement, told the Journal & Courier (http://on.jconline.com/RJ17RH ). "The whole health community knows that compounding pharmacies serve a real important service, and they do so much good."
New England Compounding Center, the Massachusetts company where health inspectors found fungus in at least one sealed vial of the steroid that is thought to have sickened many, is one of 7,500 compounding pharmacies nationwide that custom mix drugs. Most compounders make creams and oral medications.
In West Lafayette, Ben Rachwal of Custom Plus Pharmacy, specializes in making balms, creams and medicinal lollipops for his client base, which he told the Journal & Courier in June traditionally includes palliative care patients, women, children and animals.
The meningitis outbreak saddens Rachwal, whose business does not produce sterile compounds.
"It's really a shame. I feel terrible for the patients, and it has a potential to have a negative impact on our reputation," Rachwal said. "We follow very strict guidelines."
Less than half of the compounding community pharmacies in the United States provide sterile compounding — what pharmacists say would be used in the case of the steroid — according to the International Academy of Compounding Pharmacists. About 500 facilities in Indiana have permits to do sterile compounding.
Over-regulation of compound and specialty pharmacists in light of the meningitis scare may do more harm than good, Herzig said.
"These pharmacies serve a very real and necessary purpose," Herzig said. "My concern is if we over-regulate, we limit their ability to fill a necessary void, to make specific prescriptions for kids. If we put too many restrictions on them, it becomes cost prohibitive and they can't stay open."
Compounding pharmacies, which in Indiana are subject to the same state regulation and inspection as any other pharmacy, are safe, said Gregory Pachmayr, director of the Indiana Board of Pharmacy. The board will discuss compounding at its Nov. 5 meeting.
"The board's administrative rules are aimed at protecting the public, and compounding is safe when conducted within the confines of these rules and the law, and when it does not extend into the realm of manufacturing," Pachmayr said.
Karl Clearwater of Herbst Pharmacy in Kokomo said it is unfair to compare most compounding pharmacies with the Massachusetts firm.
"I have never in my life made that kind of dosage," Clearwater said. "I work with a baby out of (Riley Hospital for Children in Indianapolis) or a senior who won't swallow," as compared to "making something and shipping it to 20-plus states."
Specific laws regulate what distinguishes a compounding pharmacy from a drug manufacturer.
Although Butler University's Amy Peak, director of drug information services, said she had no firsthand knowledge of the Massachusetts facility, she said it seems it was walking a thin line between the two entities.
"Many compounding pharmacies don't get into the broad-scale things like this pharmacy has, because that's really pushing the legal limits," she said.
Clearwater said the entire pharmacy profession has been tarnished.
"I think every retail pharmacy has probably been touched, everywhere from local stores to chain stores," Clearwater said. "Talk about rocking something all the way down to your core. In medicine, you do no harm. That's why this really hurts."
Clearwater is more concerned with those who were infected with meningitis than how the incident might affect business.
"People have been asking questions, whether it's clients, family members, acquaintances," Clearwater said. "Anytime there's a national event, it creates fear. But I'm not looking at it in dollars and cents. With anyone I've talked to, that's not even on the table. We're looking at it as, 'What can I do to better my facilities and operation?' "
Herzig, the Purdue pharmacist, said fear could lead to a dangerous problem.
"This is not a great reason to not get your flu vaccine," Herzig said. "It will die down, but while we're in the midst of this, this might prevent people from getting medication they really need."
The meningitis outbreak reached Indiana. There are more than 30 reported cases and two people have died from the infection in the state, according to the Centers for Disease Control and Prevention.
Six Indiana health facilities received batches of the recalled back-pain medication.
Information from: Journal and Courier, http://www.jconline.com