LTC Pharmacies To FDA: Don’t Treat Us As Compounding Repackagers

DATE: July 29, 2016

Three trade associations jointly wrote to FDA Senior Science Advisor Julie Dohm on July 15 seeking carve-outs for Long Term Care (LTC) pharmacies under the agency’s draft repackaging guidance released in February 2015. The associations argue the guidance conflicts with Medicare and Medicaid requirements and would unduly force LTC pharmacies to register as repackagers in order to stay in business.

FDA released a draft guidance, entitled “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities,” in February 2015 laying out scenarios where FDA would not take action under the Federal Food, Drug & Cosmetic Act (FD&C) against compounding pharmacies that repackage drugs, but didn’t carve out LTC pharmacies.

The Senior Care Pharmacy Coalition (SCPC), a trade association of independent LTC pharmacies, the American Society of Consultant Pharmacies (ASCP), an organization of consultant pharmacists and the American Health Care Association/National Center for Assisted Living (AHCA/NCAL), the trade association of skilled nursing facilities, wrote to Dohm that the February 2015 guidance would harm their practices.

“In sum, the FDA Guidance, if finalized as proposed regarding LTC pharmacy, would require all LTC pharmacies to either leave the LTC business or register as repackagers — something that the typical LTC pharmacy consisting of a single facility with under $5 million in revenue can ill afford to do,” the July 15 letter states.

Alan G. Rosenbloom, president and CEO of SCPC, told Inside Health Policy that LTC pharmacies are “collateral damage,” since the guidance was written primarily to deal with compounders. While Rosenbloom commended FDA’s attempts to understand the needs of LTC pharmacies, he maintained that the agency is struggling to come up with an appropriate solution to regulate this subset of pharmacies.

LTC pharmacies are distinct from retail pharmacies and provide prescription medicines to long-term care facilities, such as skilled nursing facilities (SNFs) and assisted living facilities (ALFs). LTC pharmacies are not housed within LTC facilities but industry groups argue LTCs operate within the traditional practice of pharmacy.

In their letter, the associations request that packaging drugs into special packaging for specific patients; filling stock that will be used for remote dispensing; and preparation and placement of emergency medicines in e-kits be exempt from the final guidance on repackaging.

However, Rosenbloom told Inside Health Policy that the cleanest solution would be to exempt LTC pharmacies from the purview of this guidance.

The July 15 letter specifically addresses questions about the preparation of e-kits raised by FDA in a June 2016 listening session.

“E-kits are an officially recognized tool by which very small quantities of pharmaceutical products can be staged by an LTC pharmacy — still under the pharmacy’s control — in advance of (but in anticipation of) being dispensed pursuant to patient-specific prescriptions or chart orders,” explains the letter.

Under Federal Medicare and Medicaid Requirements of Participation, LTC facilities must provide access to e-kits, according to the letter. “E-Kits have been required by CMS since at least 1987,” reads the letter.

FDA’s guidance requires drugs to be “repackaged and distributed” only “after (a) the receipt of a valid prescription for an identified, individual patient directly from the prescribing practitioner, patient, or patient’s agent; or (b) a written order in a patient’s chart in a health care setting.”

The associations argue that the guidance may conflict with existing CMS requirements. “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,” states the letter.

At press time, CMS did not respond to requests for comment.

While FDA has focused attention on the issue of e-kits, the associations argue that other business practices would also be challenged under the guidance.

“The Associations have focused in large part in this letter on issues that FDA raised specifically with regard to e-kits,” states the letter. “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).”

LTC pharmacies commonly prepackage individual doses of medications in blister packs — commonly known as bingo cards — that can be labeled for an individual patient once a script is received and then delivered to the care center. This is a key step in reducing errors and making sure medications are delivered expeditiously, according to Rosenbloom.

The July 15 guidance only permits repackaging without distributing in advance of a prescription or order “in a quantity that does not exceed the amount of drug product that the state-licensed pharmacy or the Federal facility repackaged pursuant to patient-specific prescriptions or written orders in a previous, consecutive 14-day period, and based on a history of receipt of prescriptions or written orders over a consecutive 14-day period for such repackaged drug products.”

 This would require pharmacists to keep count of the quantity they have prepackaged in a 14 day period — creating an “unworkable” situation, according to Rosenbloom.

Some LTC pharmacies utilize remote dispensing technologies, where medications can be housed on a care facility premises but drugs are only dispensed upon digital authorization by a pharmacist, instead of prepackaging in blister packs. However, the letter maintains that the guidance would also poses challenges for remote dispensing.

Multiple organizations — including a long term care pharmacy service providers Omnicare and PharMerica; and the National Community Pharmacists Association — submitted comments on the draft guidance, highlighting concerns over its impacts on LTC pharmacies.

FDA declined to address specifics of the letter but said the agency was reviewing the submission. “FDA is reviewing SCPC’s submission to the Agency,” said FDA in an emailed statement to Inside Health Policy. “We are considering input from SCPC and other stakeholders as we work on the draft guidance, ‘Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.’”

Click here to see the original article on the Inside Health Policy website.