February 12, 2013
Facilities have role in health care system;
nationwide effort to better regulate compounding pharmacy under
way
A story in last Thursday’s Washington
Post, “Compounding pharmacies have been linked to death, illnesses and
safety failures for years,”investigated the track records at three
large-scale compounding facilities, two of which compound and repackage sterile
medications for hospitals.
Like many stories in the months since the October 2012 meningitis outbreak,
this one emphasizes a lack of oversight of compounding pharmacies. The story
gives less attention, however, to such facilities’ role in the health care
system; practical reasons these facilities don’t adhere to the same regulations
as drug manufacturers; and feasible solutions to undeniable problems.“Sterile compounding pharmacies meet a very practical need of smaller hospitals by aggregating demand and meeting all patient safety requirements,” said Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA, APhA Executive Vice President and CEO. “There is little disagreement in the pharmacy profession that greater clarity and regulatory oversight are important to protect public health as the primary objective.”
“It’s not a question of if we need [outside compounding facilities]. It’s a question of how we apply the oversight,” said Cynthia Reilly, BSPharm, Director of the Medication Safety and Quality Division of the American Society of Health-System Pharmacists (ASHP).
That’s “the million-dollar question,” Reilly said. “Should these facilities comply with USP [United States Pharmacopeia] <797> or something more like current Good Manufacturing Practices? I don’t think we have all the answers for that yet, but there is a sense that more oversight will be needed on a federal level.”
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