A new comment letter from the Senior Care Pharmacy Coalition (SCPC) to the Food and Drug Administration (FDA) requests modifications to proposed repackaging and distribution guidance as applied to long-term care (LTC) pharmacies. The SCPC understands and supports the FDA’s overarching objectives driving the draft guidance. However, by failing to acknowledge the characteristics and needs of patients in LTC facilities — and the unique role of and legal obligations already imposed on LTC pharmacies under federal and state law — the draft guidance would inadvertently undermine patient safety in nursing homes and other LTC facilities, and threaten regulatory compliance with Medicare and Medicaid rules.
The SCPC represents companies that own and operate independent long-term care (LTC) pharmacies in more than 40 states, serving over 350,000 patients in skilled nursing facilities (SNFs) and assisted living facilities (ALFs) every day.
In February, 2015 the FDA issued a “Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities,” which would have what the SCPC believes to be unintended but significant consequences for traditional LTC pharmacy practices. The letter, from SCPC President and CEO, Alan G. Rosenbloom, details the problems created by the draft guidance, and makes a specific request:
“Current LTC pharmacy practices have evolved to support the safe, effective, and efficient delivery of pharmaceutical care to residents in LTC facilities. Unfortunately, FDA’s Draft Guidance does not reasonably accommodate – and in some instances directly conflicts with – the policy goals, certain legal requirements, and current practices applicable to LTC sites of care. There are multiple examples in which the Department of Health and Human Services in other contexts (such as the Part D regulations) has recognized that LTC pharmacy is different, and should be treated differently, from traditional retail pharmacy. Yet, the Draft Guidance does not make any such distinction. This should be corrected in an updated FDA guidance document…
“We respectfully request that FDA revise the Draft Guidance to exclude from its scope all dispensing-related activities of LTC pharmacies – even if those activities involve the prepackaging or repackaging and staging of drug products in anticipation of dispensing to individual patients. The practices at issue are actively regulated under state and federal pharmacy law, Medicare and Medicaid law, and health network participation requirements and guidance. In addition, the drug products remain under the pharmacy’s control and responsibility until they are dispensed to individual patients pursuant to a prescription or chart order. As such, they properly remain within the traditional regulation of practice of pharmacy by state and federal regulators applying well-established professional pharmacy standards.”
Upon sending the letter, Rosenbloom said: “Unfortunately, the FDA Guidelines issued several months ago were developed without valuable input and perspective from the LTC community, and we intend to be active, constructive participants in shaping both the discussion and the eventual regulatory outcome.”
If finalized, Rosenbloom warned, the Draft Guidance would prohibit many essential patient safety care and regulatory compliance practices. Specifically, it could:
- Limit the ability of LTC pharmacies to prepackage pharmaceutical products, including drugs that remain in the pharmacy, without receipt of a patient-specific prescription/chart order. Under the Draft Guidance, LTC pharmacies could prepare medications in advance of a prescription/order, prepackage products for use in emergency kits or carts, or stock automated dispensing machines only if the pharmacy (i) met an uncertain “14-preceding-day” patient-specific quantity limitation, or (ii) undertook FDA-regulated “manufacturer” obligations applicable to commercial drug re-packagers. This 14-day requirement is not well-defined and unworkable for LTC pharmacies, given that the average patient in these facilities takes 10-12 prescription medications each day. As a result, LTC pharmacy practices would be significantly impacted in ways that could undermine patient safety;
- Prevent any dispatch of prepackaged/repackaged pharmaceuticals, packaged and sent from the pharmacy, in advance of receiving patient-specific prescriptions or chart orders (this specifically impacts emergency kits and remote dispensing practices); and,
- Impede pharmacy practice in a manner that would impact nursing home compliance with safety requirements specified as part of the Medicare and Medicaid Conditions of Participation, Conditions for Coverage and Requirements for nursing homes.
Concludes the letter: “A significant set of principles is at stake, and the SCPC respectfully suggests that routine LTC pharmacy practices have been, and remain, well-regulated and utterly unobjectionable under traditional pharmacy dispensing rubrics. We request that FDA expressly address LTC pharmacies within the Draft Guidance, and clarify that LTC pharmacies operating in compliance with state pharmacy laws are permitted to prepackage and repackage medications in anticipation of dispensing, so that regulation does not unintentionally hinder acceptable and desirable patient-supportive practices… In important respects, current practices reduce the number and complexity of human interventions and thereby help to reduce the incidence of medication errors and significantly improve patient safety.”