FDA Compounding Listening Session Beneficial to Reiterate the Unique Role, Value of Long Term Care (LTC) Pharmacies

DATE: June 9, 2016

SCPC Suggests Additional Listening Session Specifically for LTC Stakeholders Due to Level of Interest

 

Washington, DC – In thanking the Food and Drug Administration (FDA) for holding a recent listening session regarding provisions of the Drug Quality and Security Act (DQSA), Senior Care Pharmacy Coalition (SCPC) President and CEO, Alan G. Rosenbloom, said the gathering served as a productive forum to reiterate the need for FDA to ensure its implementation does not inadvertently create unanticipated burdens on dispensing practices in specialized settings like LTC facilities and pharmacies.

“The SCPC appreciates the opportunity to sustain our focus and sharing of ideas concerning the Draft Guidance the agency issued in February 2015 entitled ‘Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities,’” said Rosenbloom. “We remain deeply concerned that the Guidance as drafted would jeopardize patient health and safety in LTC facilities, threaten regulatory compliance with Medicare and Medicaid requirements for literally every LTC facility and associated pharmacy in America, and materially alter long-standing LTC pharmacy practices and procedures.”

Rosenbloom said the Draft Guidance would add substantial compliance cost but little positive impact on drug quality or security, and that other organizations and public commentators share these concerns. The SCPC President and CEO offered two recommendations during the listening session:

First, he said the materials previously submitted by SCPC to FDA not only identify significant concerns but also propose viable solutions the FDA could and should adopt in formulating its final guidance and enforcement policies;

Second, given the substantial level and volume of comments that FDA has received concerning these issues, he respectfully suggested that the agency add an additional Listening Session to this round of public input — specifically for LTC pharmacy stakeholders.

Rosenbloom used the session to again point out that LTC pharmacies differ distinctly from other types of pharmacies in that they typically are “closed door” or “institutional” pharmacies serving exclusively patients in LTC facilities such as skilled nursing facilities (SNFs) or nursing homes. Unlike many hospital-based institutional pharmacies, he said, LTC pharmacies are not located on the campuses of LTC facilities; rather, they are separately located and must deliver medications to LTC facilities.

“Federal Medicare and Medicaid laws, regulations and guidance affirmatively authorize this arrangement in support of efficient nursing home operation,” Rosenbloom continued. “These laws and guidance impose specific and extensive pharmacy services requirements on the LTC facilities and pharmacies participating in those programs. State pharmacy licensure laws and DEA regulations also set forth standards for the fulfillment of LTC patient prescriptions, and for managing certain ‘emergency’ medications that must be available for urgent dispensing to a resident following a physician’s order. Other types of pharmacies are not subject to these same requirements, which are designed specifically to address LTC operations and dispensing constraints.”

To access SCPC comments to FDA, click here: December 2015 and May 2015.