SCPC, ASCP, AHCA/NCAL Letter to FDA: Facts Caution Against Imposition of Inappropriate New Regulatory Burdens on Nation’s Long Term Care (LTC) Pharmacies, Patients

Washington, DC — The Senior Care Pharmacy Coalition (SCPC), the American Society of Consultant Pharmacists (ASCP), the American Health Care Association and the National Center for Assisted Living (AHCA/NCAL) have sent a new letter to the Food and Drug Administration (FDA) commenting on the Agency’s draft Repackaging Guidance, and educating the Agency about long term care (LTC) pharmacy operations. The joint letter specifically addresses the numerous existing regulatory requirements that ensure quality pharmaceutical care for U.S. seniors in long term care facilities, and explains why the imposition of inappropriate new “repackaging” requirements may conflict with existing regulation.

The letter also thanks the FDA for hosting a listening session last month to share ideas regarding the FDA’s February 2015 Draft Guidance entitled, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities,” and addresses three specific groups of questions related to LTC emergency kits (“e-kits”) FDA posed during the meeting.

“The SCPC, ASCP, and AHCA/NCAL believe it is extremely important that FDA is taking steps to understand the operational requirements, facility relationships, and practical considerations affecting LTC residents,” states the letter. “FDA must recognize the demands of other regulators that control LTC care for our nation’s vulnerable seniors, and avoid imposing inappropriate new burdens on complex and already well-controlled systems. FDA also must recognize that the practice patterns of LTC pharmacies are truly those of professional pharmacy, not commercial product manufacturers, wholesalers or repackagers.”

Alan Rosenbloom, SCPC President and CEO, explained that during the listening session, FDA posed questions related to LTC pharmacies that made it clear the FDA would be helped by greater awareness how skilled nursing facilities (SNFs) are structured and staffed; why and how they contract with specialized LTC pharmacies to manage complex prescription drug needs for individual residents; and why certain packaging formats are required for LTC dispensing to help ensure accurate medication and satisfy Medicare and other federal and state health care requirements.

“FDA is contemplating a Guidance document that would needlessly limit, or require outsourcing of, packaging activities that currently occur within LTC pharmacies — driving up cost and waste in the LTC system, and potentially risking care for patients,” Rosenbloom observed. “For example, before dispensing medication many LTC pharmacies currently pre-package drug products from bulk into individual blister cards. FDA’s proposed guidance would arbitrarily limit the quantity that pharmacies could package – even if the pharmacy had justification for the quantity based on its dispensing patterns and predictions.”

The letter also explains why current federal laws mandate that emergency kits (e-kits) be held on-site at LTC facilities; details why e-kits are different from physician “office stock;” points out that LTC pharmacies must manage e-kit medications because nursing facilities generally are not staffed with on- site pharmacists or physicians who would be authorized to procure and dispense the products directly; notes why e-kits necessarily involve the packaging of very small quantities into unit-dose packaging (they are intended only as emergency or starter doses); and comments that these very small quantities are not commercially available at reasonable cost.

The letter concludes: “The Associations have focused in large part in this letter on issues that FDA raised specifically with regard to e-kits. We reiterate, however, that elements of FDA’s draft Guidance on repackaging threaten other very important practices in the LTC pharmacy sector (e.g., ability to prepackage and stage drug products for patient-specific dispensing in accordance with federal and state pharmacy law, and the ability of LTC pharmacies to use remote dispensing technology to more efficiently and effectively dispense medications to patents). Our prior comment letters provide ample justification for FDA to modify its proposed repackaging guidance to avoid jeopardizing these practices, all of which are well within the traditional professional practice of pharmacy. We respectfully request that FDA expressly acknowledge the activities of LTC pharmacies as “dispensing” for LTC patients. This is legally appropriate, and should help resolve some of the implementation concerns that have arisen from the draft Guidances published to date.”

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The SCPC is the national association for independent LTC pharmacies. Our member pharmacies provide care and services to patients in LTC facilities in more than 40 states occupying approximately 400,000 beds across the country.

The American Society of Consultant Pharmacists (ASCP) is the only international professional society devoted to optimal medication management and improved health outcomes for all older persons. ASCP’s members manage and improve drug therapy and improve the quality of life of geriatric patients and other individuals residing in a variety of environments, including nursing facilities, sub-acute care and assisted living facilities, psychiatric hospitals, hospice programs, and home and community-based care.

AHCA/NCAL represents over 13,000 skilled nursing facilities, or 1.063 million beds, and more than 209,000 assisted living facility beds. With such a membership base, AHCA/NCAL represents the vast majority of SNFs and a rapidly growing number of ALFs.