What to watch for when choosing a compounder

September 26, 2005

Significant deviations from good manufacturing processes in repackaging and relabeling active pharmaceutical ingredients are what the Food & Drug Administration cited in a letter sent to Pragmatic Materials Inc. in June. During site visits in February, the agency found that the company, which repackages ingredients for use by pharmacies for compounding drug products, had not performed the appropriate tests to support the expiration dates assigned to at least six ingredients. Violations such as these can ignite fear and concern in hospital pharmacists and administrators who are outsourcing their sterile or nonsterile products to compounders to save staff time, cut hospital costs, and comply with new regulations.

Significant deviations from good manufacturing processes in repackaging and relabeling active pharmaceutical ingredients are what the Food & Drug Administration cited in a letter sent to Pragmatic Materials Inc. in June. During site visits in February, the agency found that the company, which repackages ingredients for use by pharmacies for compounding drug products, had not performed the appropriate tests to support the expiration dates assigned to at least six ingredients. Violations such as these can ignite fear and concern in hospital pharmacists and administrators who are outsourcing their sterile or nonsterile products to compounders to save staff time, cut hospital costs, and comply with new regulations.

Just last year, the Joint Commission on Accreditation of Healthcare Organizations adopted the USP-National Formulary (USP-NF) Chapter 797, which describes proper handling of sterile preparations. This has prompted many hospitals to look to outsourcing in order to comply with the new requirements.

"You must go into this with your eyes wide open," said Eric S. Kastango, R.Ph., M.B.A., FASHP, of Clinical IQ, LLC, who spoke on this issue at the recent ASHP summer meeting in Boston. When decid-ing if outsourcing is necessary, Kastango believes that pharmacists should first ask themselves, "What do I do well?" and "How can I minimize risk?"

"Vendors need to understand your organization and your work flow," Kastango told the audience. Discuss practical issues with vendors, he said, such as when physicians do their rounding, when orders are written, and when product will be needed each day. Will they provide quality assurance? Will they work with the clinicians in your hospital? Ask the vendor about its commitment to quality and for a list of other institutions they work with, said Kastango. Visit the compounding facilities between 12 AM and 5 AM, when they actually mix the total parenteral nutrition (TPN) and other sterile products. "Don't show up at 9 AM for coffee, donuts, and nice conversation."

When selecting a vendor, also consider costs, reputation, scope of product offering, and flexibility. "Are they willing to work with you, or do they want you to change to fit into their business model?" Obviously, "some things are non-negotiable, such as software and cut-off times," he said.

Location is also a big concern. In his experience, Kastango said, he has found that the vendor should be within 60 miles of the hospital, especially for TPN compounding. Also, he told his audience, "ask about their back-up plan. How will they get products to you in a snowstorm or hurricane?

"If you don't articulate your goals clearly and explain exactly what you want, then outsourcing will become your worst nightmare," Kastango added. On the other hand, "if done correctly, it could be one of the best decisions you ever make, because it frees up some of your resources. It allows you to focus on what you do best."

But along with the benefits, there is risk associated with outsourcing, including the potential loss of control over product quality or the failure of a vendor to deliver critical services. "Ultimately, it is the hospital that is accountable for these products," explained Darryl S. Rich, Pharm.D., MBA, FASHP. Rich, a hospital and home care field representative for JCAHO, said, "The nature and scope of pharmacy services provided must be defined in writing as part of a contract or written agreement." This contract, he said, must specify that the outside pharmacy will adhere to JCAHO standards in the preparation of these medications.

"The hospital must evaluate the products and services provided in order to determine whether they are being provided according to the contract, JCAHO standards, and the level of safety and quality that the hospital expects," Kastango explained.