Hospitals Address Compounding Concerns
The hospital couldn't afford "to install robotic pharmacy systems with the required state-of-the-art information and safety systems at each of our decentralized pharmacies. But by creating a centralized pharmacy, we could purchase and install those systems. In addition, we gained economy of scale and lower costs that create more value for the patient, and we can have better quality assurance and safety systems for the patient," he says.
Not all hospitals, however, have the capability of building their own central pharmacies to compound drugs for their patients.
But Brigham & Women's is doing the next best thing, says Churchill. Its team aggressively requests a lot of data and documentation, and then physically inspects the compounding pharmacy premises before signing the contract to purchase products, as well as in every year of the contract.
After the NECC outbreak, Brigham & Women's brought some operations in house. But it couldn't do that for everything it needed. It had to find another pharmacy to compound intrathecal pain pumps, for example, and it inspected three facilities, ultimately selecting one to replace NECC.
Brigham & Women's had hired or contracted with compounding pharmacy experts in quality management, microbiology, and pharmacy practice, and those conversant with the technicalities of U.S. Pharmacopeial Convention 797 safety and sterility standards. And it has also developed its own audit and inspection tool.
"We look for the facility's licenses, names of people who run the facility and their licenses, the pharmacists and their licenses," Churchill says. There are assessments of whether the facility has a separate negative pressure clean room, "so you don't get hazardous or toxic chemicals blowing around and contaminating another patient's drugs."
And there are inquiries about staff training and competency assessments as well as reviews of records, policy and procedure documents, and documents showing that the facility regularly tests for contamination in a variety of important preparation areas.
The process includes what Churchill calls a "system tracer."
"We ask them about a product we bought from them, the dates it was purchased, and we ask them to pull every record that was associated with that," including all testing and certification records, a list of all employees involved and their credentials, and continuing education requirements in the state they're licensed, Churchill says. "We want to see test results for fingertip touch testing and media growth testing. We want to see everything that employees have done to ensure that employees who worked on the product were competent to do so."
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