July 15, 2016 Julie Dohm, J.D., Ph.D. Senior Science Advisor Food and Drug Administration 10903 New Hampshire Avenue Building 51, Room 6117 Silver Spring, Maryland 20993 Re: Long-Term Care Pharmacy Dear Dr. Dohm: The Senior Care Pharmacy Coalition (“SCPC”), the American Health Care Association and the National Center for Assisted Living (“AHCA/NCAL”), and the American Society of Consultant Pharmacists (“ASCP”) appreciated the opportunity to participate in the pharmacy-focused listening session that you hosted on June 6, 2016. This letter provides a general comment about long-term care (“LTC”) pharmacy, and addresses three specific groups of questions related to LTC emergency kits (“e-kits”) that you and other representatives of the Food and Drug Administration (“FDA”) posed during the meeting. The SCPC, AHCA/NCAL, and ASCP (collectively, the “Associations”) believe it is extremely important that FDA is taking steps to understand the operational requirements, facility relationships, and practical considerations affecting LTC residents.1 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 repackagers or distributors. 1 Similar to information that the SCPC submitted in prior comments, a recent white paper found: “While the resident profile and length of stay vary for every facility, most long-term care residents have multiple comorbidities and are on numerous medications. The ‘typical’ skilled nursing facility (SNF) resident is female and over the age of 85.” On average, residents receive 12 prescription medications per month. McKesson, Becoming a Long-Term Care Pharmacy: Opportunities and Important Considerations (2015 [“Becoming an LTC Pharmacy”]) at 1, 3; available at http://becomeahealthmart.com/Websites/becomeapharmacy/images/Whitepaper-Becoming_a_LongTerm_Care_Pharmacy.pdf. Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 2 The Centers for Disease Control and Prevention (“CDC”) has projected that the number of people requiring long-term care will grow substantially between now and 2050:2 Most of this increase will be due to growth in the older adult population who need such services. Although people of all ages may need long-term care services, the risk of needing these services increases with age. Recent projections estimate that over two-thirds of individuals who reach age 65 will need long-term care services during their lifetime. Largely due to aging baby boomers, the population is expected to become much older, with the number of Americans over 65 projected to more than double, from 40.2 million in 2010 to 88.5 million in 2050. The estimated increase in the number of the “oldest old” – those aged 85 years and over – is even more striking. The oldest old are projected to almost triple, from 6.3 million in 2015 to 17.9 million in 2050, accounting for 4.5% of the total population. LTC pharmacies – sometimes called “closed-door” or “institutional” pharmacies – are a distinct subset within the pharmacy community. Skilled nursing facilities (“SNFs”), nursing facilities (“NFs”), 3 and many assisted living facilities (“ALFs”) contract with a single LTC pharmacy to prepare and dispense prescription drugs for individual patients, and to provide an array of consulting pharmacy and care planning services required by Medicare, Medicaid, state licensure laws, and professional standards. The Associations The SCPC is the national association for independent LTC pharmacies.4 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 SCPC advocates for public policies that protect patients, improve the quality of healthcare across a shifting care continuum, and strengthen the economic viability of independent LTC pharmacies and their ability to serve medically compromised seniors. 2 U.S. Centers for Disease Control and Prevention, Long-Term Care Providers and Services Users in the United States: Data From the National Study of Long-Term Care Providers, 2013–2014 (Feb. 2016) at 3, available at http://www.cdc.gov/nchs/data/series/sr_03/sr03_038.pdf. 3 Both the statute and the regulations use “skilled nursing facilities” to refer to facilities qualified to provide care and services to Medicare beneficiaries and use the term “nursing facilities” to refer to facilities qualified to provide care and services to Medicaid beneficiaries. For purposes of this letter, the terms “nursing home” or “nursing facility” refer to skilled nursing facilities and nursing facilities, as well as facilities regulated under state law as nursing homes. 4 Alongside a few major corporations, more than 1,100 independent LTC pharmacies serve the market in the U.S. Based on 2014-2015 data, the average independent LTC pharmacy is a single pharmacy serving 10 to 13 LTC facilities, with 80 to 100 residents per facility. Becoming an LTC Pharmacy at 3. Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 3 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. ASCP is the nation’s leading professional association representing America’s consultant pharmacists, whose mission is to provide comprehensive pharmaceutical care for the frail elderly. The Associations stand ready to provide further information to FDA with respect to LTC pharmacy topics. I. EXECUTIVE SUMMARY LTC pharmacies dispense patient-specific prescriptions to residents of contracted nursing facilities and many ALFs. FDA should expressly exempt these activities from the scope of its repackaging guidance. LTC pharmacy dispensing includes (although is not limited to) three common practices that are within the traditional practice of pharmacy and should clearly be exempt: II. Packaging drugs into special packaging (e.g., unit-dose packaging) required by LTC facilities for patient-specific prescriptions (whether such packaging occurs in anticipation of or after the receipt of the patient-specific prescriptions). Filling stock into a canister, blister card, or unit-dose container that will be placed in remote dispensing equipment at an LTC facility. Preparation and placement of emergency medications in e-kits required for LTC facilities. GENERAL STATUS: ALL LTC DRUGS SHOULD BE EXEMPT FROM FDA’S “REPACKAGING” GUIDANCE The Associations continue to request that FDA exempt all drugs dispensed through LTC pharmacies – including, but not limited to, those in e-kits – from the agency’s “repackaging” guidance. As discussed in our prior comments to the agency: LTC pharmacies are engaged in patient-specific dispensing, in accordance with state pharmacy laws. Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 4 This is true whether: o an LTC pharmacy places its drugs for dispensing in required “special packaging” in anticipation of or after receiving prescriptions for the product. (Put another way: all products leaving the pharmacy are identically packaged, labeled, documented, and shipped to an LTC resident, in full conformance with pharmacy and other law); o an LTC pharmacy fills stock into a canister, blister card, or unit-dose container that will be placed in remote dispensing equipment at an LTC facility. These automated dispensing systems are owned by the LTC pharmacy and both the systems and any medications in them remain under the care, custody, and control of the pharmacy. Moreover, the systems are monitored and controlled remotely by the pharmacist, and the pharmacist will not authorize dispensing of any medications from such systems without a patient-specific prescription or chart order; and o an LTC pharmacy prepares and places a small number of unit-dose quantities of emergency medications into an e-kit for possible urgent dispensing to an LTC resident following physician order. LTC pharmacy dispenses in such a manner for a very specific reason – to comply with the Centers for Medicare and Medicaid Services’ (“CMS”) requirements for Network Long Term Care Pharmacies (“NLTCP”), found in the CMS Part D Manual, Chapter 5, Section 50.5 (“Part D Manual”). 5 The Part D Manual expressly requires NLTCPs to dispense drugs in “special packaging.” Yet, most drugs cannot be purchased already prepackaged in such special packaging. Among other provisions, the Part D Manual requires: (1) Special Packaging – NLTCPs must have the capacity to provide specific drugs in unit of use packaging, bingo cards, cassettes, unit dose or other special packaging commonly required by LTC facilities. NLTCPs must have access to, or arrangements with, a vendor to furnish supplies and equipment including but not limited to labels, auxiliary labels, and packing machines for furnishing drugs in such special packaging required by the LTC setting. (2) Delivery Service – NLTCPs must provide for delivery of medications to the LTC facility up to 7 days each week (up to 3 times per day) and in-between regularly scheduled visits. Emergency delivery service must be available 24 5 See https://www.cms.gov/medicare/prescription-drugcoverage/prescriptiondrugcovcontra/downloads/memopdbmanualchapter5_093011.pdf. Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 5 hours a day, 7 days a week. Specific delivery arrangements will be determined through an agreement between the NLTCP and the LTC facility. NLTCPs must provide safe and secure exchange systems for delivery of medication to the LTC facility. In addition, NLTCPs must provide medication cassettes, or other standard delivery systems, that may be exchanged on a routine basis for automatic restocking. The NLTCP delivery of medication to carts is a part of routine “dispensing.” (3) Emergency Boxes – NLTCPs must provide “emergency” supply of medications as required by the facility in compliance with State requirements. (4) Emergency Log Books – NLTCPs must provide a system for logging and charging medication used from emergency/first dose stock. Further, the pharmacy must maintain a comprehensive record of a resident’s medication order and drug administration. Applicable guidance further explains that “to qualify as an LTC pharmacy for a Part D sponsor’s LTC pharmacy network, a pharmacy must currently have the capacity – either by itself or through subcontracts with other entities – to meet all these performance and service criteria, even if an LTC facility that pharmacy serves does not need a particular service subsumed under those performance and service criteria.” Thus, this special packaging is a mandate of federal law. As FDA already knows, it is the routine practice of LTC pharmacies to purchase many medications in bulk, and to place them into specialized packaging for dispensing to LTC residents.6 Unfortunately, the vast majority of drugs dispensed to nursing home residents by LTC pharmacies are not available for purchase from a manufacturer, supplier, or repackager, in the type of unit dose specialized packaging required by the CMS regulations and sub-regulatory guidance. While some limited number of products are available for purchase, the vast majority of products dispensed by LTC pharmacies are not available from manufacturers, suppliers or repackagers in appropriately compliant packaging.7 It is for this reason that LTC pharmacies today undertake their own efforts to package medications being dispensed to nursing home residents in the needed packaging – because the products are simply not available otherwise. If the draft Guidance is finalized as proposed, however, the only alternative available to LTC 6 For example, in 2013, CMS issued a regulation and guidance pursuant to Section 3310 of the Affordable Care Act of 2010 that requires certain drugs for Medicare Part D beneficiaries residing in skilled nursing facilities to be dispensed in quantities of 14 days or less. In response to this requirement many LTC pharmacies invested in dispensing technology (Talyst, AP Passport, Strip Packaging, etc.) that would reduce waste. CMS’ regulation effectively requires LTC pharmacy to utilize dispensing technology that requires “repackaging.” This is but another example of the regulatory conflict that the proposed Guidance will create if finalized without exempting LTC pharmacy from its scope. 7 SCPC members estimate that products available from manufacturers, suppliers, or repackagers in compliant packaging is 10% or less. Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 6 pharmacies would be to register themselves as repackagers. We suggest that having thousands of community-based LTC pharmacists taking on this significant regulatory burden cannot have been Congress’ intent under the DQSA, and we suggest that FDA is likely not interested in regulating the nearly 1,400 entities engaged in providing LTC pharmacy services. 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. While we appreciate that the cost of compliance is not FDA’s concern, there is no evidence that LTC pharmacy repackaging has ever created a health or safety issue for LTC residents. Thus, we respectfully suggest that in light of the CMS and State regulatory requirements, FDA should continue to exercise its enforcement discretion over LTC pharmacy repackaging, and exclude LTC pharmacy from the draft Guidance’s repackaging requirements. III. QUESTIONS FROM FDA LISTENING SESSION The foregoing discussion concerns a number of core dispensing activities that would be adversely impacted -- and that warrant exemption in any event -- from FDA’s repackaging guidance. FDA posed the following questions during the June 6 listening session. 1. Are LTC emergency kits (“e-kits”) distinguishable from physician office stock? If pharmacy distribution of prescription drug products for office stock use may be limited, why should e-kit medications that LTC pharmacies supply to nursing homes be treated differently? RESPONSE: As noted above, federal Medicare and Medicaid Requirements of Participation mandate that LTC nursing facilities in the U.S. make emergency (as well as routine) medications available to patients.8 In other words, there is a legal responsibility for patient care. The Associations are not aware of a similar, affirmative requirement applicable to physician office stock. 8 42 C.F.R. § 483.60 (LTC facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in § 483.74(h)). See also the Part D Manual quoted above. The crossreferenced 42 C.F.R. § 483.74 requires a Part D participating facility to be “administered in a manner than enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.” Subparagraph (h) expressly authorizes the use of outside resources: “If the facility does not employ a qualified professional person to furnish a specific service to be provided by the facility, the facility must have that service furnished to residents by a person or agency outside the facility…” (emphasis added). Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 7 Furthermore, e-kits involve LTC pharmacy “dispensing” to patients, whereas office stock involves drug “distribution” from one entity to another. The vast majority of LTC facilities do not employ staff physicians9 or maintain in-house pharmacies. Instead, these facilities rely upon contracted LTC pharmacies to dispense routine and emergency medications following prescription by a patient’s physician. E-kits are an officially recognized tool by which very small quantities of pharmaceutical products can be staged by a 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. E-kits have been required by CMS since at least 1987. They have been acknowledged and allowed by the federal Drug Enforcement Administration (“DEA”) for more than 35 years: 10 To facilitate the dispensing of controlled substances in emergencies, DEA has allowed pharmacies to place in LTCFs [long-term care facilities] “emergency kits” that are routinely stocked with commonly dispensed controlled substances (45 FR 24128, April 9, 1980). These kits are considered extensions of the pharmacy and are controlled under the pharmacy’s DEA registration. Again, the same requirement of a valid prescription delivered to the pharmacy prior to dispensing applies with respect to these kits; however, they provide an immediate supply of drugs in emergencies and eliminate the need to wait for a delivery from the pharmacy in such circumstances. E-kits also are also recognized under state laws. For example, Nebraska law specifies that: Drugs may be administered to residents of a long-term care facility by authorized personnel of the long-term care facility from the contents of emergency boxes located within such long-term care facility if such drugs meet all of the following requirements: (1) All emergency boxes shall be provided by and all emergency boxes containing such drugs shall be sealed by a supplying pharmacy with the seal on such emergency boxes to be of such a nature that it can be easily identified if it has been broken….11 Examples from other states are available.12 9 See further discussion of this issue in Section III.2, below. 10 DEA, Dispensing of Controlled Substances to Residents at Long Term Care Facilities, Notice; Solicitation of information, 75 Fed. Reg. 37463, 37465 (June 29, 2010). 11 12 Neb. Rev. Stat. § 71-2412 (emphasis added). See, e.g., Arkansas State Board of Pharmacy Regulation 05-00-0005 (all contents of the emergency kit will be provided by one pharmacy designated by the long term-care facility). Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 8 The Associations are not aware of a comparable regime or set of laws or regulations that require physicians to maintain office stocks of drug products. There is, furthermore, a legal distinction between e-kit drug products, which are ultimately controlled by the pharmacist and “dispensed” from an e-kit only following a patientspecific prescription or chart order by a practitioner, versus “distribution” of drug products from a manufacturer, wholesaler, or other supplier to a physician for non-patient-specific office stock and subsequent dispensing or administration. A pharmacy providing drug product for use in an e-kit is the “practice of pharmacy.”13 FDA has long recognized that the “practice of pharmacy” is exempt from certain FDA oversight and regulation. For example, 21 C.F.R. § 207.10 provides an exception to the registration requirement for “pharmacies that operate under applicable local laws regulating dispensing of prescription drugs and that do not manufacture or process drugs for sale other than in the regular course of the practice of the profession of pharmacy.…” Furthermore, FDA Compliance Manual 7356.002B on Field Alert Reporting Requirements for Drug Repackagers and Relabelers states that “[p]re-packagers operating within the practice of pharmacy and distributing (selling) drugs upon receipt of written prescriptions” are excluded from the repackaging/repackager requirements. Lastly, in FDA’s May 1999 Guidance document titled “Container Closure Systems for Packaging Human Drug and Biologics” when discussing repackagers, FDA expressly noted that the “discussion does not apply to the repackaging of drugs products for dispensing under the practice of pharmacy.” Even if FDA may not find this legal distinction fully clear, the Associations are aware that FDA has recognized in other institutional/health care facility settings that the practice of pharmacy may take place across physically separate, but closely allied, operations – and that certain preparatory activities may occur even before a prescription has been issued. 14 We respectfully request similar consideration in this institutional health care setting. (LTC pharmacies should not be treated as outpatient pharmacies.) The Associations believe it is evident that the preparation, dispatch, and ongoing management of e-kits falls within “dispensing” and the traditional practice of pharmacy. In any case, it is appropriate for FDA to interpret the practice of pharmacy to cover the staging of e-kit drugs by LTC pharmacies at LTC facilities as the type of physically separate, but directly allied, operations that coordinate directly to serve LTC residents’ urgent needs. The same cannot be said for the sale of drug product to a prescriber for office use. 13 The Associations intend in this letter to clarify how e-kits (which are managed primarily by the issuing pharmacy through the time of dispensing) are different than office stock. 14 Just this year, for example, FDA proposed criteria to recognize scenarios in which centralized institutional pharmacies may compound and dispatch products for nearby institutional locations, even in advance of any patientspecific prescription being issued. See Draft Guidance for Industry: Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act (April 2016). Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 9 2. Why does the LTC pharmacy need to manage e-kits? Can an LTC nursing facility purchase and hold commercially-supplied drug products for emergency use directly from a manufacturer or wholesaler? RESPONSE: As noted above, licensed pharmacists and licensed physicians are generally authorized by applicable training and state professional laws to dispense prescription drug products to patients.15 However, LTC nursing facilities generally do not employ full-time physicians or full time pharmacists. Federal Medicare and Medicaid requirements specify that physicians must see each nursing home resident only once every thirty days absent specific patient need. They also specify that LTC nursing facilities must have a consulting pharmacist, but he or she need not be, and is not, on-site on a full-time basis. Although federal law also requires that each LTC nursing facility employ a Medical Director, he or she is not at the facility on a full-time basis. Accordingly, LTC facilities have neither a physician nor pharmacist present at all times to handle day-to-day pharmaceutical management and dispensing. On-site LTC facility staff typically include registered nurses, licensed practical nurses, and certified nursing assistants, as well as physical, occupational, and speech therapists. These professionals perform most aspects of dayto-day patient care, but they typically are not independently authorized to prescribe or dispense medications to LTC patients.16 Absent staff pharmacists or physicians, an LTC facility is not an “authorized trading partner” that could lawfully order or obtain prescription drug products from a manufacturer, wholesaler, or repackager. 17 Therefore, even if an LTC nursing facility wanted to purchase prescription drug products from a manufacturer, wholesaler, or repackager, it is not permitted to do so. In comparison, a state-licensed LTC pharmacy is an “authorized trading partner” that can procure pharmaceuticals for dispensing under the Federal Food, Drug, and Cosmetic Act and state pharmacy law. Similarly, well-established controlled substance regulatory policies require that an authorized dispenser must retain control over e-kit controlled substances within LTC facilities. 15 See, e.g., 211 Pa. Code § 211.9 (Program Standards for Long-Term Care Nursing Facilities/Pharmacy Services): “Facility policies shall ensure that … [o]nly licensed pharmacists shall dispense medications for residents. Licensed physicians may dispense medications to the residents that are in their care.” 16 See generally 42 C.F.R. § 483.60, 483.75. As a reminder, LTC residents are generally older and frailer than the average beneficiary; in SNFs, NFs, and ALFs combined, each patient takes on average 10 to 12 medications per day. Drug dispensing and management for such patients requires extraordinarily attentive management to ensure the safe, accurate, and efficient administration of medications to residents, avoid medication mix-ups or administration delays, and prevent both diversion and waste of products stored and administered in LTC facilities. 17 See, e.g., 21 U.S.C. §§ 360eee(2)-(3) and 360eee-1. See also 21 U.S.C. § 353(b)(1) (authorizing the dispensing of prescription-restricted drugs only upon written or oral prescription of a practitioner licensed by law to administer such drug, and deeming the act of dispensing a drug contrary to the provisions of that paragraph to render a drug misbranded while held for sale). Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 10 For example, DEA has enabled the placement of e-kits containing controlled substances in nonDEA-registered LTC facilities, provided the facility follows procedures that delineate: a DEA-registered source; security safeguards for each e-kit; responsibility for proper control and accountability within the LTC facility (including a requirement that the LTC facility and the DEA-registered clinic, pharmacy, or co-practitioner maintain complete and accurate records of the controlled substances placed in the e-kit, the disposition of these controlled substances, and a requirement for periodic physical inventories); and specification of the emergency medical conditions under which the controlled substances may be administered to patients in the LTC facility (including requirements that medication be administered by authorized personnel only as expressly authorized by the individual practitioner).18 LTC facilities also are required by 42 C.F.R. § 483.75(i) to designate a physician as Medical Director, responsible for implementation of resident care policies and the coordination of medical care in the facility. This is not, however, an attending physician role: While medical directors also can serve as attending physicians for individual patients, the roles and function of a medical director are separate from those of an attending physician. The medical director’s role involves the coordination of facility-wide medical care, while the attending physician’s role involves primary responsibility for the medical care of individual residents.19 LTC facilities must ensure that the medical care of each resident is supervised by a physician who assumes the principal obligation and responsibility to manage the resident’s medical condition and who agrees to visit the resident as often as necessary to address resident medical care needs. The frequency of visits, however, is appropriate to the resident’s medical condition, stability, and recent and previous medical history, and must be no less than once every 30 days for the first 90 days after admission, and at least once every 60 days thereafter. The arrangement does not establish an on-site physician with authority to manage and dispense emergency medications for his own – let alone all – patients within an LTC facility. 18 DEA, Statement of Policy: Controlled Substances in Emergency Kits for Long Term Care Facilities (45 Fed. Reg. 24128; April 9, 1980). 19 CMS Manual System, Pub. 100-07 State Operations, Provider Certification, “Medical Director Guidance” (Nov. 28, 2005) at 2 (emphasis added). Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 11 3. Why do e-kits have to involve repackaging? Have LTC facilities/pharmacies approached 503B outsourcing facilities and/or FDA-registered commercial repackagers to provide e-kit products? FDA is aware of some compounding scenarios where 503B-compounded product was thought not to be available, but in fact was available somewhere. Can FDA help with communication/publicity about availability? RESPONSE: As documented in our prior written comments, repackagers may sometimes have unitdose medications available, but these are not commonly sold in volumes small enough to be available to individual LTC pharmacies for use in e-kits. In addition, based on anecdotal information that the SCPC previously provided to the agency, repackagers are reducing their business of unit-dose repackaging in ways that might previously have been useful to LTC pharmacies. As noted above, moreover, manufacturers, suppliers, and repackagers do not provide unit dose medications in the special packaging that LTC pharmacies are required by law to employ.20 LTC pharmacies also are typically only placing a few doses of commercially available product (not compounded items) into an e-kit, and that small number of doses is replenished only if and when a specific dose has been consumed during a patient emergency. Thus, the volume requirements are very small, and an independent LTC pharmacy may require only a few unit doses of a particular product during the course of a year. In current dispensing scenarios, for example, a pharmacy might buy two stock bottles of 100 tablets, prepare 5 unit-dose quantities for the e-kit, and retain the remaining 195 tablets available for routine prescription dispensing. It would not be viable for a pharmacy to order, a minimum quantity from a repackager (probably 500-1000 tablets of a unit-dosed medication) solely for e-kit use. (These products typically are not appropriate for non-e-kit dispensing. “Routine” dispensing for LTC patients typically must be prepared in a different type of special packaging, such as a patient-specific 30-day supply blister card.) The other alternatives relative to repackaging for e-kits are: 20 Wait for an emergency to arise and then have the pharmacy dispense the prescribed, emergency dose for a patient. This is not only inconsistent with applicable law and CMS Conditions of Participation, it also would place patients at increased risk, due to delay in the provision of emergency medication. In addition, it could well increase re-hospitalization, because the resident might have to be transferred to a hospital because he or she would receive emergency medications more quickly. In these cases, the patient still would be at increased risk. The Medicare program would have Due to the special packaging requirements imposed on LTC pharmacies regarding all medications dispensed to patients in LTC facilities, the lack of manufacturers, suppliers, or repackagers that provide unit dose medications that comply with these special packaging requirements also justifies LTC pharmacies “pre-packaging” or staging commonly dispensed medications on-site. Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 12 to expend funds unnecessarily to pay for the readmission. In addition, hospitals are liable to the Medicare program if their readmission rates are too high. Similar penalties will be imposed on LTC nursing facilities in 2018. Place an entire commercial package (e.g., bottle of 100 tablets) in an e-kit. As noted above, however, e-kit laws typically allow only limited doses of particular drugs to be held in e-kits (i.e., this approach likely would run afoul of state law). Even if this were permissible under current state law, this approach also increases diversion risk and waste of the extra product that would likely go unused before expiration. Based on the foregoing, the Associations do not believe that FDA can do anything to promote, communicate, or publicize FDA-registered commercial repackagers to produce very limited quantities of unit-dosed medications that comply with LTC pharmacy special packaging requirements for use in an e-kit. IV. CONCLUSION 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. We thank you for your consideration of these comments, and welcome any further questions that you may have. Please feel free to contact me at 717.503.0516 or arosenbloom@seniorcarepharmacies.org if you have any questions. Sincerely, Alan G. Rosenbloom President and CEO Senior Care Pharmacy Coalition Letter to Julie Dohm, J.D., Ph.D. July 15, 2016 Page 13 cc: Docket No. FDA–2014–D–1524 Holly Harmon, RN, MBA, LNHA Senior Director of Clinical Services American Health Care Association Peter Rankin Director of Policy & Advocacy American Society of Consultant Pharmacists
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