The fungal meningitis outbreak across the U.S. linked to contaminated steroid shots could not have come at a worse time for Pill Box Pharmacy owner Sam Costello.
Costello is concerned that an outbreak linked to 23 deaths and 308 illnesses, including four joint infections, from shots manufactured at the New England Compounding Center in Framingham, Mass., will hurt his business.
Costello, whose pharmacies are at Alabama 67 in Priceville and Danville Road Southwest, offers non-sterile compounding — the preparation of specialized medications. He is spending about $40,000 to prepare a sterile prescription compounding unit during the next two to three months to provide injections, ear drops and other medications.
“We need to make sure we’re doing everything and beyond that we should do,” Costello said. “I know physicians and patients will have doubts after seeing what happened in New England, but the primary thing is to earn that trust back from the patients and physicians.”
Nineteen Alabama residents have received the steroid product manufactured in Framingham during procedures in Tennessee and Florida. Other unrelated NECC medications were recalled last week at Decatur Morgan Hospital Parkway Campus, Cullman Regional Medical Center and Huntsville Hospital.
The Centers for Disease Control, Food and Drug Administration and pharmacy boards in six states are investigating the outbreak.
Compounding is the mixing of prescribed medicine for patients who require varying strengths of medication, a different dosage form or suffer from allergies.
Compounding pharmacies have grown in popularity during the past few years because of an ongoing shortage of critical manufactured medications, according to the International Academy of Compounding Pharmacists.
The IACP estimates about 56,000 community-based pharmacies exist in the U.S., more than half providing some level of compounding to patients and physicians. Up to 3 percent of all U.S. prescriptions are compounded.
Massachusetts Gov. Deval Patrick pushed to revoke the licenses of the New England Compounding Center and three pharmacists there Tuesday after an unannounced inspection was done at a compounding pharmacy linked to the outbreak.
Inspectors found visible black specks of fungus in steroids and a leaking boiler near a room that was supposed to be sterile. Officials would not give the name of the pharmacy and said inspection results were being reviewed.
IACP spokesman David Ball said he is not aware of specific violations of state and federal laws by the NECC.
Compounding pharmacies are subject to governmental oversight by the state boards of pharmacy, FDA and Drug Enforcement Administration. They must adhere to stringent U.S. Pharmacopeia standards.
Nearly 14,000 patients received the steroid injections, which NECC produced in bulk at its facility, without a prescription.
Stephan Beek, director of marketing for the Professional Compounding Centers of America, said it’s rare for compounded drugs to be contaminated at local pharmacies because technicians have more time to focus on individual prescriptions.
“Those pharmacies are typically part of the community, and because of that, they’re very focused on safety because that’s their livelihood,” he said. “They know the patients coming through the door and the physicians they’re working with.”
To prepare a sterile compounding unit, Costello must install a positive air-flow control system, paint walls and ensure the ceiling and floors have no cracks to trap impurities.
The room will be sterilized several times a day, and testing must be sent to independent labs. Technicians will wear gloves, gowns and face masks to prevent contamination.
During a preliminary investigation, Massachusetts officials discovered NECC shipped out the steroid shots before its own tests came back determining whether the injections were sterile.
“It appears that if that testing was done, it should have been picked up in a suitable amount of time to prevent the outbreak from happening,” Costello said. “That’s what we want to do, but the bad publicity is out there now, and my answer now is we’re going to do it right.”
Mike Preuitt, co-owner and pharmacist at Gilchrist Pharmacy in Hartselle, offers non-sterile compounding.
Preuitt, who was trained through a compounding course in Houston, said he oversees and checks each prescription before it is released to patients.
“We’ve been blessed as a pharmacy to have had very few errors over the years,” he said. “I can’t say we’ve never made a mistake in our pharmacy or lab, but there have been no adverse offenses occur since I’ve been here.”
Preuitt said pharmacists must continue their education to remain proficient at compounding practices, as well as maintain the lab.
Preuitt employs two compounding technicians who trained in Houston and on the job to provide medications to patients.
Ball said compounding pharmacies must regularly send samples to labs and are subject to random visits from the FDA and state pharmacy boards.
IACP has developed a tool called the Compounding Pharmacy Assessment Questionnaire to discuss compounding with hospitals and physicians and raise awareness of policies and procedures.
“Consumers should feel assured that local compounding pharmacies are safe and reliable,” Ball said. “Compounding pharmacies fill a life-and-death mission, and patients should be assured that they’re practicing at the highest standards.”
Beek encourages patients to ask about a pharmacy’s accreditation and standards of quality before filling a prescription.
“If physicians are sending patients to a compounding pharmacy, the patient should stay on top of what the pharmacy is doing in terms of quality, whether it’s up on the latest accreditation and testing,” he said.
Copyright 2012 The Decatur Daily. All rights reserved. AP contributed to this report.
|High School Sports||@DecaturPreps|