Compounding pharmacies long have been able to fill the gap between mass-produced drugs and highly personal medical needs.
These pharmacies can customize a drug product into a liquid or a gas for patients who can't swallow pills. They can whip up a cough syrup without specific allergens. They can flavor a tablet with mint or tropical fruit to be more palatable. And they can compound drugs that are on back order -- such as Tamiflu for children.
"Maybe [the patient] can't take something that's commercially made because it's one-size-fits all. Or it's something that's not commercially made and they've got to have it," explains pharmacist Phil Smith at Access Pharmacy, which has been compounding drugs in the Hixson store for more than 50 years.
But over the last few months, state and federal officials have said the gap that compounding pharmacies have filled is a "regulatory black hole," leading to abuse by certain pharmacies.
"It has been a crazy few months for compounding," said Smith. "We have been letting our customers know that our chemicals are tested, our manufacturers are FDA tested and approved. Things like that let people know what our quality standards are."
A deadly meningitis outbreak, which killed 14 Tennesseeans, prompted heightened scrutiny from both state and federal regulators. Just last month, there were two more recalls of sterile compounded and repackaged drug products, first from a New Jersey compounding pharmacy after fungal contamination was found at a hospital. Days later, a compounding pharmacy in Martinez, Ga., recalled syringes of the drug Avastin after it received reports of eye infections among patients.
"There is a legitimate role for traditional pharmacy compounding," wrote FDA Commissioner Margaret A. Hamburg in a recent statement. "However, a new breed of specialty pharmacy compounding has evolved that has outgrown the law and can pose a threat to the health of the public."
The growing demands for drugs paired with the growing scrutiny thrust compounding pharmacies and the boards that oversee them into a quandary: How do you meet growing pharmaceutical needs amidst drug shortages, while adding enough safeguards to prevent another tragic outbreak?
Both sides of the predicament are being addressed at the state level in Tennessee. While the state pharmacy board is calling for increased regulations and more inspections, there is also a bill in the state House that seeks to alleviate the drug shortage by allowing compounding pharmacies to create drugs that do not have to be patient-specific.
Tennessee Pharmacy Association Executive Director Baeteena Black insists that the two initiatives are not contradictory, but work in tandem.
If Tennessee compounding pharmacies are able to widen the conditions under which they can dispense drugs, she says, local health care providers do not have to turn to out-of-state compounding pharmacies -- which could operate under sketchier safety policies.
"The list of drugs on the drug shortage has been growing and growing," she said. "In order for [compounding pharmacies] to meet those needs, we needed to make some amendments to that law."
Drug shortages have reached record highs in recent years, affecting everything from insulin pens to life-saving chemotherapy drugs.
But some consumer advocates say the bill goes directly against the kind of regulatory action the state should be pursuing.
"The proposed law would create a loophole in the current requirement that compounded drugs be dispensed based on individualized patient need, thereby freeing doctors and hospitals in Tennessee to purchase standardized, mass-produced drugs that are neither FDA-approved nor made under appropriate manufacturing standards," said Sarah Sorscher, attorney with the Public Citizen Heath Research Group.
COMPOUNDING VS. MANUFACTURING
Before drugs became mass-manufactured, compounding was routine among pharmacists, Smith said.
"Compounding is making a prescription that a doctor has written for that patient, and that's it," he says. "Manufacturing is making it in large quantities for commercial sale. Compounding pharmacies are not allowed to do that. ... We have to have a prescription for everything we make. We don't keep anything on the shelf."
But in the face of a national drug shortage, more and more doctors and patients depend on the pharmacies to create drugs they cannot get from pharmaceutical companies.
The recent meningitis outbreak shed light on the growing problem that some pharmacies -- like the New England Compounding Center -- essentially were operating as manufacturers, without having to comply with federal manufacturing regulations. Compounding pharmacies are regulated by state boards.
The Food and Drug Administration is pushing for increased oversight of companies that blur the line between compounding and manufacturing.
"The magnitude and complexity of these operations have outpaced the current patchwork of state laws that differ in prescription requirements and quality control rules," Hamburg said.
In Tennessee, the high number of meningitis victims spurred in-depth discussions and the formation of a state task force to analyze any changes that needed to be made in local compounding pharmacies, said Black.
One recommendation was to beef up state pharmacy inspections. While the number of pharmacies in the state has grown over the last several years, the number of inspectors has not. There are five inspectors to oversee more than 2,300 licensed pharmacies in the state. The state's Department of Health has since requested funding for more pharmacy inspectors.
Current law allows pharmacies to compound and dispense drugs only for patient-specific prescriptions. The proposed law would allow pharmacies to compound drugs that are not patient-specific, provided that the drug has been specifically ordered by a licensed health care prescriber and is not commercially available.
If passed, the law would let emergency departments order doses of a critical drug before a patient is admitted, saving what could be crucial time, Black says. The TPA began pushing for those amendments before the meningitis outbreak.
The bill is now in committee and has been sponsored by two pharmacists, Rep. David Shepherd, D-Dickson, and Sen. Ferrell Haile, R-Gallitin. But Black said the bill is not intended to benefit pharmacists.
"We were not asked to change this law by compounding pharmacies, but by hospitals and other medical providers who prefer to get drugs from somewhere in our state," she said.
But Public Citizen said the bill does not have enough safeguards to prevent abuse.
"The proposed law is ambiguous about when such mass purchases could occur," said Sorscher.
Black argues that the bill does have protective conditions, like requiring a quarterly report of the quantities of sterile drugs that are being compounded. The bill also tightens regulations on out-of-state pharmacies shipping drugs into the state.
"What we're putting in the law is the tip of the iceberg compared with what the board is doing in being specific in terms of regulations and trying to hire additional investigators," she said.
Contact staff writer Kate Harrison at firstname.lastname@example.org or 423-757-6673.