Compounding issues are always on the docket at pharmacy meetings, but the subject almost never draws the attention of mainstream media—at least in the absence of tragedy.
That’s precisely what caught the eye of USA Today, which recently rehashed a relatively recent episode involving contaminated heart-surgery solution from an outsourcing firm implicated in nearly a dozen illnesses and three deaths at a Virginia hospital.
The article prompted a response by the American Society of Health System Pharmacists (ASHP), and representatives of the group met recently with members of Congress to call for more active regulation of compounding by the Food and Drug Administration (FDA). Whether the latest revival of attention is sufficient to stir legislative action at the federal level remains to be seen.
Central to the matter, too, is the effect stricter industry standards are having on small hospitals, many of which cannot afford to meet the physical and financial burdens of complying with the rules. As these hospitals look to outside firms to prepare their sterile solutions, they may be putting themselves at risk, since not all outsourcing companies take adequate steps to ensure the safety of their products.
Deaths Prompt Lawsuits
In early August, USA Today reported on the trouble with bacteria-tainted cardioplegia surgery solution blamed for at least 11 illnesses and four deaths among patients at Mary Washington Hospital in Virginia from December 2004 to September 2005. The cases sparked lawsuits against the compounder, Central Admixture Pharmacy Services (CAPS), a Lanham, Md.–based division of B. Braun Medical, Inc., as well as the Fredericksburg facility.
CAPS is not a stranger to FDA action. A search of the agency’s Web site revealed several incidents in which the compounder’s products have been recalled because of safety issues. In 1998, for example, the company had to take back eight cases of heparin syringes that had been mismarked as saline flush syringes. Also that year, CAPS recalled nearly 137,000 syringes after some were found to be contaminated with Enterobacter cloacae, a leading cause of hospital-acquired infections. B. Braun declined to comment on its subsidiary.
In a letter to USA Today on August 9, ASHP CEO Henri R. Manasse Jr, PhD, ScD, called patient injury associated with compounding “entirely preventable.” He chose to target his comments not just on outsourcing firms but also hospitals themselves.
“It is imperative that pharmacists and pharmacy technicians be adequately trained and have sufficient facilities and equipment that meet technical and professional standards,” Dr. Manasse wrote. “When hospitals and other care settings outsource some aspects of pharmacy services such as sterile compounding, those organizations and their pharmacy departments must share the accountability for patient outcomes stemming from all medication-related activities performed by contractors on- or off-site.”
However, Dr. Manasse added, regulators also bear responsibility for ensuring the safety of compounded products. “The fact that Central Admixture Pharmacy Services is a Food and Drug Administration–registered facility suggests that a re-examination of the regulatory framework (including rigor and frequency of inspections) of commercial large-scale operations that compound sterile products for hospitals is in order,” he stated.
The extent of compounding is not fully known. Congressional testimony from the Government Accountability Office (GAO, formerly the Government Accounting Office) in 2003 cited a 2001 FDA estimate that 6% of all prescriptions were compounded. The GAO, however, stressed that there was “considerable uncertainty” about that figure.
Although the FDA regulates compounders—which also fall under rules set by state boards of pharmacy—ASHP fears that oversight is insufficient. “We do believe the regulatory framework through the FDA needs to be examined,” said Kasey Thompson, PharmD, the group’s Director of Patient Safety. “Apparently, it’s not the same as that covering a pharmaceutical manufacturer and may not have the same regulatory strength in terms of good compounding practices.”
Dr. Thompson and his ASHP colleagues recently went to Capitol Hill to brief senators about the issues surrounding compounding.
The pharmacy association is particularly concerned for its members from smaller hospitals that cannot shoulder the cost of complying with standards for sterile preparation—and as a result must outsource sterile product preparation.
“Implicit in this case is that a group like CAPS that’s registered with FDA and has national operations has advertised to meet professional standards, such as USP <797>, and can fill that void,” Dr. Thompson said, referring to the U.S. Pharmacopoeia’s 2004 rules governing sterile preparation of pharmaceuticals. “Outsourced compounding does fill a void, but you have to have faith in the outsourcer and the processes they use.”
Bill Zeruld, a spokesman for the U.S. Pharmacopoeia, said his group does not enforce the <797> standard, nor does it track how many hospitals or compounders comply with its requirements. Although the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) looks for <797> compliance in its inspections, the group said it does not collect data on the number of facilities nationwide that meet the standard.
Charlene Hill, a JCAHO spokeswoman, called <797> “a valuable set of guidelines that describe a best practice for establishing safe processes in compounding sterile medications.” However, Ms. Hill added, when surveying, “we’re not [assessing compliance with] those guidelines,” which are more specific than JCAHO’s own standards.
Pharmacy directors at hospitals that rely on outsourcing for their sterile products must know, Dr. Thompson said, that the onus of verifying the safety of those products rests ultimately on their shoulders. “The hospital has to definitively say that the outsourcer has safe processes in place and has documentation to prove its compounding operations are in compliance with state and federal laws, and nationally recognized standards of practice,” he said.
Pharmacy directors at hospitals that rely on outsourcing for their sterile products must know, Dr. Thompson said, that the onus of verifying the safety of those products rests ultimately on their shoulders. “The hospital has to definitively say that the outsourcer has safe processes in place and has documentation to prove its compounding operations are in compliance with state and federal laws, and nationally recognized standards of practice,” he said.
And as for hospitals that do their own compounding, ASHP offers “very comprehensive” training programs, documentation and even Internet-based information, Dr. Thompson added.
Piecemeal State Action
Some states have been trying to address the safety of compounded and outsourced pharmaceutical products, with mixed success. Missouri was the first state to implement random batch testing of compounded drugs, including both sterile and non-sterile products, according to the 2003 GAO testimony.
Louis Ling, JD, General Counsel for the Nevada Board of Pharmacy in Reno, said his agency has been working to create compounding rules for roughly the last four years. “The problem has been that throughout this period, JCAHO and USP have been shifting their standards, which makes it tough when you’re trying to shoot at a moving target,” Mr. Ling said.
Although Nevada’s regulations are not yet finalized, Mr. Ling said they will follow the dictates of USP <797>. Facilities will need to maintain their physical plants to the standards covering the highest risk levels for the products they will be working with, he said, and some form of testing regimen will exist. How rigorous those tests will be, and their frequency—whether random or routine—is unclear for the moment, Mr. Ling said. “That’s a point that we’re all discussing right now.”
What has been determined, he added, is that, in the case of outsourcing firms, the burden of testing will fall on the compounders, not the hospitals that purchase their products. “Somewhere along the way the compounding pharmacies are going to have to be verifying their methods for both potency, which addresses dilution issues, and sterility,” he said.
Like ASHP, the Nevada board is sensitive to the pressures facing the state’s smaller hospitals, many of which, particularly those in rural areas, have fewer than 100 beds. “Fortunately,” Mr. Ling said, “it appears that these regulations are not going to completely keep the rural hospitals from addressing the needs of their patients.”
The logic of outsourcing sterile product preparation is certainly understandable, given the economic and staffing pressures faced by many small hospitals. But as the CAPS episode illustrates, facilities that choose to outsource should have a way to control the quality of the products for which they contract.
“The most important thing is adherence to current standards and best practices, and having adequate facilities where sterility can be assured,” Dr. Thompson said. “Just as important,” he added, “is that staff are adequately trained and qualified,” and faithful to sound infection control practices and aseptic techniques.
“At the end of the day,” he said, “if somebody doesn’t wash his hands, you can have all the equipment in the world and you’re not going to have sterile products.”
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