Wednesday, March 12, 2014

Federal Watchdogs to Turn Up the Heat on Pharmacy Compounding This Year

Pharmacy compounding — the mixing of two or more ingredients to tailor a drug to a specific patient’s needs — is shaping up to be a hot spot this year, as Medicare and FDA watchdogs turn up the heat on compounding by hospitals, compounding by manufacturers and the way in which they intersect. The increased scrutiny on compounding is raising the compliance and quality improvement stakes for a service that may fall through the regulatory cracks. The March 10 issue of Atlantic Information Services, Inc.’s (AIS) Report on Medicare Compliance offers a full overview of the issue and its ramifications.

When performed at hospitals, pharmacies and other health care facilities, compounding is governed by Chapter 797 of US Pharmacopeia (USP), which is enforced by state pharmacy boards, says Phillip Williams, Pharm.D., administrative director of pharmacy services for Edward-Elmhurst Healthcare in Naperville, Ill. Compounding sterile products by a manufacturer in large batches is regulated by the states and, depending on the circumstances, the FDA. In January, the agency urged hospitals to buy drugs only from compounders that voluntarily register with the agency and abide by “good manufacturing practices.”

Compounding also is a new target on the 2014 Work Plan for HHS’s Office of Inspector General, with the OIG eyeing practices inside hospitals and oversight by Medicare accreditors.

As the risks of drug compounding come into sharper focus, hospitals are caught between a rock and a hard place. Either hospitals try to shift the risks of compounding drugs by outsourcing more of them at the price of oversight, or bring compounding back in-house without providing adequate quality assurance, Margaret Hambleton, vice president and chief compliance officer at Dignity Health in California, says. “It again highlights the need for compliance to be aware of the hospital’s quality assurance and performance improvement plan, which is a requirement of its Medicare conditions of participation,” she says.

“It’s an area that has not had sufficient concern in hospitals and has not risen to the level of other organizational risks,” Hambleton continues. “If you haven’t done a gap analysis using experts, I recommend it.”

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