Use ASHP tool to evaluate compounding pharmacies
Senate ponders new laws for 'gray area'
A compounding-pharmacy assessment tool developed by the American Society of Health-System Pharmacists (ASHP) can provide critical guidance for hospitals in the wake of the national meningitis outbreak.
"The patients who relied on these medications deserved much better," said Kasey Thompson, PharmD, ASHP vice president of policy, planning and communications. "We have developed an assessment tool based on our guidelines that helps pharmacists in hospitals and health systems comprehensively evaluate sterile compounding service providers and use comparative data for their vendor selection process. Our guidelines and assessment tool are available free as a public service to the health care community and others."
The online tool includes a number of key questions to help health care facilities evaluate a prospective compounding pharmacy with due diligence. (See http://ow.ly/fpNqq)
Thompson testified at a Nov 15, 2012 hearing of the U.S. Senate Health, Education, Labor and Pensions Committee. The panel is considering possible new regulations and other actions in the wake of a national meningitis outbreak linked to contaminated steroid products distributed by the New England Compounding Center (NECC) in Framingham, MA.
"Unfortunately, the NECC appeared to have been operating in a manner that falls far short of standards for compounding sterile preparations," Thompson told the committee. "Further, the scale and scope of NECC's operation more nearly resembles pharmaceutical manufacturing rather than pharmacy compounding."
In general, the majority of compounded medications hospitals use are prepared in-house by pharmacy departments, he explained.
"However, hospitals also enlist the help of qualified compounding pharmacies for some compounded preparations for several reasons," Thompson said. "For example, they may not have the necessary equipment or facilities to prepare some high-risk preparations, or they may face medication shortages for commercial products that can only be replicated by a compounding pharmacy."
ASHP tools and guidelines can help health care facilities make informed choices, but oversight of compound pharmacies is still critical, he noted.
"We cannot rely solely on the due diligence of purchasers to take the place of proper licensing, inspections and oversight of entities producing compounded medications, especially for those entities that are manufacturing in large quantities and shipping across the country," he said. "Pharmacists and other health care providers should not be expected to perform the jobs of regulators by visiting and inspecting pharmacies or manufacturers that they do business with."
The distinction between traditional pharmacy compounding and manufacturing appears to be "a regulatory gray area" between state boards of pharmacy and the Food and Drug Administration, he added.
"We recognize the regulatory challenges of defining the activities in this gray area, but we firmly believe that specific definitions are essential so that mass production of the scope and scale done by NECC falls within the regulatory jurisdiction of FDA, rather than state boards of pharmacy," Thompson testified.
Compounding pharmacies range from small pharmacy operations that compound medications for individual patients directly under their care to large-scale operations that prepare compounded medications in the volumes required to serve the needs of health systems and physician offices, he said.
"A number of variables make distinguishing between compounding and manufacturing difficult," Thompson said. "Therefore, both functions might be better viewed as a continuum of activities stratified by the potential for risk of patient harm — each requiring defined procedures, equipment, training, and quality controls."
Oversight of traditional compounding is clearly within the purview of states, while the FDA at the other end of the continuum oversees pharmaceutical manufacturing, he explained.
"As legislative proposals are considered, it will be important to reaffirm the role of state boards of pharmacy to license and regulate traditional compounding while recognizing that large-scale compounding of sterile products may require oversight by the FDA in cooperation with state boards of pharmacy," Thompson said. There may be a need for a special category of FDS oversight that falls between compounding and manufacturing but does not require formal drug approval, he said.
"For example, if a compounding pharmacy sells to other organizations and not directly to patients, then they may need to be regulated by the FDA," he said. "[This] would allow hospitals, clinics, and physician offices to purchase sufficient quantities of compounded product as is necessary to meet patient needs, while doing so under the assurance that they are making those purchases from appropriately regulated sources."
Existing laws were not enforced
Testifying on the same panel at the hearing, David Miller, vice president and CEO of the International Academy of Compounding Pharmacists (IACP), argued that enforcing existing laws could have prevented the outbreak.
"Not only does Massachusetts have state sterility requirements and United States Pharmacopeia Standard compliance requirements, but it retains the right to pull a pharmacy's license if [it] is practicing outside the scope of its licensing requirements," Miller testified. "By all current indications, the operations of NECC were clearly outside of the scope of the state's licensure requirements and their license should have been pulled long ago."
The state and the FDA should have worked together to force the pharmacy to register as a manufacturer and comply with Current Good Manufacturing Practice Guidelines, he told the committee.
"Unfortunately, NECC showed a blatant disregard for existing rules and regulations," Miller said.
Millions of Americans have unique health needs that off-the-shelf prescription medicines cannot meet. For them, customized medicines — prescribed or ordered by licensed prescribers and mixed safely by trained, licensed compounding pharmacists — are the only way to better health, Miller emphasized.
"As a result, federal requirements designed for large-scale manufacture of uniformly dosed drugs do not apply to compounding pharmacies," he said. "Massachusetts's Board obviously failed to execute its responsibilities both to its citizens as well as patients in other states in which NECC was licensed by not conducting regular inspections."
A compounding-pharmacy assessment tool developed by the American Society of Health-System Pharmacists (ASHP) can provide critical guidance for hospitals in the wake of the national meningitis outbreak.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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