By DUANE MARSTELLER -- The Tennessean
CLEVELAND, Tenn. -- When inspectors described what they found inside a Massachusetts compounding pharmacy linked to a national fungal meningitis outbreak, Cindy Smith made her pharmacy staff read the report.
They read about mold and bacteria in two "clean rooms" that were supposed to be sterile. They read about labeling errors that made it difficult to tell sterile and non-sterile ingredients apart. They read details about "yellow residue" and "green residue" and other unknown foreign substances on various pieces of equipment.
The U.S. Food and Drug Administration report made for a difficult read, but one that Smith felt was necessary.
"I wanted them to understand how really easy it is to get lazy, to get careless, and what the consequences are of that," said Smith, the pharmacist-in-charge of Medical Center Compounding Pharmacy, based in this city of 41,000 about 25 miles northeast of Chattanooga.
Compounding pharmacies prepare custom medications according to a doctor's specifications to meet an individual patient's need. These medications often are not commercially available or are not in the form, concentration or dosage needed by the patient. Pharmacists make the medications from scratch, using raw chemicals, powders and specialized equipment.
Smith says the conditions found at New England Compounding Center in Framingham, Mass., are not representative of her pharmacy or the broader industry.
Her pharmacy occupies a corner of a building that also houses an institutional pharmacy and a medical-supply store. The compounding pharmacy is off-limits to customers, but they can watch certified pharmacy technicians -- clad in plastic hair caps, surgical masks and shoe covers, scrubs, lab coats and blue latex gloves -- working behind several large plate-glass windows.
Inside, the pharmacy is divided into sterile and nonsterile sections, with the sterile area subdivided into an anteroom and a clean room. All medications that are injected, given intravenously or used in the eye must be prepared in the sterile area, Smith said. Pills, liquids, ointments and creams typically are produced in the non-sterile section.
The production process is detailed in a three-ring binder that is nearly 3 inches thick.
Technicians receive prescriptions via a computer inside the pharmacy. They then print out labels, call up the formula for the medication and collect all of the necessary ingredients, which are in containers with bar codes affixed to them.
The technicians scan each bar code with a handheld infrared scanner to confirm they have the right ingredients. They can't begin to compound the medication until all ingredients check out, Smith said.
The U.S. Pharmacopeia, which outlines pharmaceutical standards, "requires double, triple, quadruple checking," she said. "We still do that, but this (computerized verification process) is an added safety feature."
Technicians then weigh each ingredient on digital scales and begin compounding the medication. They work on one prescription at a time, from start to finish, to further reduce the chance for error.
The finished product goes to Smith, who checks a computer system that tracks every step to confirm the medicine was made properly before releasing it for sale to the patient.
The pharmacy also has other features designed to maintain sterility.
For example, the floor, cabinets, countertops, walls and ceiling are all white, making it easier to tell that they're clean, Smith said. Technicians frequently clean countertops and equipment, and mop the floor two or three times daily, regularly rotating among disinfecting cleaners.
"You mix it up because bacteria can get resistant to anything over time, so you have to constantly stay ahead of that," Smith said.
The pharmacy's air conditioner is set at 64 degrees, well below the 72-degree maximum that is allowed, to retard potential mold or mildew growth.
The sterile area
Even more precautions are taken for the sterile area.
Before they can enter the anteroom, technicians must step on a "tacky mat" that removes dirt and dust from the bottom of their shoe covers. A negative pressure system also pushes air out of the room when someone enters it from the nonsterile area.
Once inside the anteroom, technicians must wash their hands for a full minute, and put on gloves, gowns, hair caps and masks. They also use a convection oven to sterilize ingredients and equipment.
They use a small, pass-through chamber made of stainless steel to transfer items between the anteroom and clean room. The chamber, as well as the doorway between the anteroom and clean room, also has a negative-pressure system that forces air out and prevents contaminants from entering.
While most of those precautions are mandated by regulators, some go beyond that, Smith said. For example, the coat worn by technicians in the clean room is destroyed after a single day's use.
Some of the pharmacy's protocols also exceed those set by the Pharmacy Compounding Accreditation Board, a voluntary accrediting organization.
Smith's pharmacy is among only three in Tennessee and just 166 nationwide that are accredited by the board. That's a fraction of the estimated 7,500 U.S. pharmacies that specialize in advanced-level compounding.
One reason for the low accreditation rate is that it takes time, money and effort to obtain that certification, said Joe Cabaleiro, the board's executive director. "It's not easy, and it's meant to be that way," he said.
Despite the added effort and expense, Smith said her pharmacy's owner believed obtaining accreditation was important.
"What we do here is so instrumental to keeping people safe," Smith said. "As we have seen, you can literally hold a patient's life in your hands. That's a huge responsibility."