PALLIATIVE AND HOSPICE CARE ASHP REPORT ASHP Guidelines on the Pharmacist’s Role in Palliative and Hospice Care

Am J Health-Syst Pharm. 2016; 73: alliative care arose from the mod- bers of the interdisciplinary team.4,5 1351-67 Pern hospice movement and has Previously, health professionals ob- evolved significantly over the past tained the necessary skills and knowl- Christopher M. Herndon, Pharm.D., 50 years.1 Numerous definitions ex- edge for participation in the interdis- BCPS, CPE, FASHP, School of Pharmacy, Southern Illinois University ist to describe palliative care, all of ciplinary delivery of palliative care via Edwardsville, Edwardsville, IL. which focus on aggressively address- encompassing specialty areas (e.g., Douglas Nee, Pharm.D., M.S., Hospice ing suffering. The World Health Or- internal medicine, geriatrics, oncol- and Palliative Care, OptiMed, San Diego, ganization and the U.S. Department ogy).6,7 Numerous efforts to enhance CA. of Health and Human Services both professional education on palliative Rabia S. Atayee, Pharm.D., BCPS, Pain and Palliative Care Service, stipulate the tenets of palliative care care largely drove its eventual recog- University of California, San Diego, to include a patient-centered and nition as a medical subspecialty in Skaggs School of Pharmacy and 8,9 Pharmaceutical Sciences, La Jolla, CA. family-centered approach to care, 2006. with the goal of maximizing quality Specialized training programs and David S. Craig, Pharm.D., Department of Pharmacy, H. Lee Moffitt Cancer of life while minimizing suffering.2 In board certification opportunities exist Center & Research Institute, Tampa, FL. its clinical practice guidelines, the Na- today for most members of the pallia- Julie Lehn, Pharm.D., Palliative tional Consensus Project for Quality tive care interdisciplinary team.10-14 As Medicine, Banner University Medical Center, Phoenix, AZ. Palliative Care of the National Qual- the model of palliative care has pro- ity Forum (NQF) describes palliative gressed, so too has each team mem- Pamela S. Moore, Pharm.D., BCPS, CPE, Pain and Palliative Care, Summa care as “patient and family-centered ber’s potential for contribution. De- Health System, Akron, OH. care that optimizes quality of life by spite representation within the first Suzanne Amato Nesbit, Pharm.D., anticipating, preventing, and treating hospice demonstration project in the BCPS, CPE, Department of Oncology, Center for Drug Safety and Effectiveness, suffering . . . throughout the continu- United States, participation of the Department of Pharmacy, Johns Hopkins um of illness . . . addressing the physi- pharmacist as an essential member Hospital, Baltimore, MD. cal, intellectual, emotional, social, of the interdisciplinary team has been James B. Ray, Pharm.D., CPE, James and spiritual needs and to facilitate traditionally overlooked.15-18 Evidence A. Otterbeck OnePoint Patient Care, Department of Pharmacy Practice, patient autonomy, access to informa- of the pharmacist’s contribution to University of Iowa College of Pharmacy, tion, and choice.”2 NQF further speci- the delivery of palliative care and sup- Iowa City, IA. fies the foundation of palliative care portive care services beyond the origi- Bridget Fowler Scullion, Pharm.D., to include professional and family nal role of medication dispensing and BCOP, Palliative Care, Dana-Farber Cancer Institute, Boston, MA. collaboration, the availability of ser- compounding has garnered growing Robert G. Wahler Jr., Pharm.D., CPE, vices regardless of pursuit of curative recognition across numerous practice School of Pharmacy and Pharmaceutical or life-extending care, and, most im- settings.15-17,19-27 Sciences, University at Buffalo, The State University of New York, Buffalo, NY. portantly, the provision of care coor- Perhaps no other practice set- dinated by an interdisciplinary team.2 ting presents as diverse a collection Julie Waldfogel, Pharm.D., CPE, Pain and Palliative Care, Department The continuum of care provided by of potential roles and responsibilities of Pharmacy, Johns Hopkins Hospital, palliative care pharmacists (Figure 1) for the affiliated palliative and hos- Baltimore, MD. incorporates the concepts that cura- pice care (PHC) pharmacist. Here, tive and palliative care should coexist the PHC pharmacist may support the and that hospice care is an extension PHC services in an administrative of palliative care that occurs when cu- role (policy and procedure, formulary Address correspondence to Bruce rative care is no longer part of the pa- management), in a consultative role Hawkins ([email protected]). tient’s plan of care.3 (order set development, treatment al- The practice of palliative care, gorithm development, best practices Copyright © 2016, American Society of while rooted in traditional hospice education), and in advanced clinical Health-System Pharmacists, Inc. All rights and hematology and oncology pro- practice (medication therapy man- reserved. 1079-2082/16/0901-1351. grams, has changed dramatically in its agement services, pain and symptom DOI 10.2146/ajhp160244 delivery, competency assessment, and management consultations, and in- methods for preparing future mem- terdisciplinary team participation).

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Figure 1. Continuum of curative, palliative, supportive, and hospice care in disease trajectory. Reprinted under terms of the Creative Commons Attribution License from Guo Q, Jacelon CS, Marquard JL. An evolutionary concept analysis of palliative care. J Palliat Care Med. 2012; 2:1-6.

Purpose with a serious or life-limiting illness, in- of pharmacists, and time dedicated In 2002, ASHP published the ASHP cluding those enrolled in a formal hos- to the palliative care or hospice team. Statement on the Pharmacist’s Role in pice program. Corresponding duties required of the Hospice and Palliative Care.28 These Two levels of PHC services are de- PHC pharmacist in other areas of the guidelines extend beyond the scope scribed: (1) essential services, which pharmacy service and the extent of of that statement and are intended include core processes, and (2) desir- time required for administrative du- to define the role of the pharmacist able services, which include higher ties and obligations should be con- engaged in the practice of PHC. Role levels of practice, teaching, and re- sidered. Services provided by the definition will include goals for pro- search. The level of service provided PHC pharmacist will vary among viding services that establish general by the PHC pharmacist will vary based practices and should be designed to principles and best practices in the on the level of practice experience of best meet the needs of the site and care of this patient population. This the pharmacist as well as the level of the patient. document is based on literature re- palliative care services provided in sources, consensus of pharmacist ex- each respective setting. Services pro- Delineation and description perts in the field of PHC, therapeutic vided by a pharmacist will therefore Before the development of these practice guidelines, and regulatory be unique and should be designed to guidelines, a task force was appointed standards.1,2,4,29 best meet the needs of the institution, by the Section Advisory Group, Pain The terms palliative, end-of-life, hospice, or other healthcare practice and Palliative Care, within the Sec- hospice, and supportive care are fre- setting. tion of Ambulatory Care Pharmacists quently, and incorrectly, used inter- In concert with the palliative care of ASHP. A comprehensive literature changeably. While these philosophies team or hospice chief executive officer review was performed using PubMed, of care share similarities, each rep- and medical director, the PHC phar- EMBASE, PsychInfo, Google Scholar, resents overlapping yet delineable macist uses his or her professional and International Pharmaceutical Ab- points along the healthcare continuum. judgment to individually weigh the stracts to search for all relevant articles For the purposes of these guidelines, the factors that determine the extent of published between January 1975 and term PHC will be used to describe the services provided. These factors in- December 2014. The literature search common services afforded to patients clude the population served, number was conducted using MeSH terms and

1352 AM J HEALTH-SYST PHARM | VOLUME 73 | NUMBER 17 | SEPTEMBER 1, 2016 PALLIATIVE AND HOSPICE CARE ASHP REPORT keywords alone and in combination Essential clinical roles and understanding of the pathophysiol- with other terms, including pharma- activities ogy of common life-limiting illnesses cy, pharmacist, pharmaceutical care, Essential clinical roles and activi- and their corresponding symptoms. pharmacotherapy, medication therapy ties for the PHC pharmacist may vary Recent CMS guidance documents management, hospice, end of life, ter- widely, and services may be provided changed the expectations for hos- minal illness, palliative care, support- either directly or indirectly to the pa- pice medication responsibility from ive care, symptom management, and tient, depending on the practice set- those under the current Medicare Part pain management. ting. While not an exhaustive list of D program, and a growing role for Similar to other areas of specialty potential practice sites for the PHC the PHC pharmacist is anticipated, or subspecialty practice within the pharmacist, settings of PHC delivery particularly in the types of services profession of pharmacy, some level of include various hospice settings, hos- provided by a PHC pharmacist on palliative and supportive care knowl- pitals, outpatient clinics, outpatient hospice admission.19,26,32-34 Transitions- edge is essential for all pharmacists community pharmacies, home care of-care planning on admission is of providing patient care, regardless of or long-term care (LTC) facilities, and paramount importance to reduce the scope or setting. The European Asso- consulting and managed care settings. risk of analgesic or symptom control ciation for Palliative Care (EAPC) re- Essential clinical roles and activities of gaps. The PHC pharmacist should cently updated a two-part guidance the PHC pharmacist are presented in be intimately involved in the medi- document on essential competen- Table 1, and aspects of those roles and cation history and reconciliation of cies for healthcare and social workers activities that traverse the various PHC new hospice admissions, with special involved in the delivery of palliative practice settings are discussed below. attention being paid to nonprescrip- care.1,4 In that guidance document, Hospice programs. The PHC tion medications and dietary supple- EAPC delineates recommendations pharmacist providing care within hos- ments. Prompt identification of high- for those providing general palliative pice must be thoroughly familiar with risk or problem-prone drug therapies care (i.e., palliative care services pro- symptom management and reduc- should occur. Medication review to vided by primary care and nonpal- tion. Hospice services are provided assess appropriateness of continued liative care specialists) and those pro- in the following settings: standalone treatment given each drug’s potential viding specialist palliative care (i.e., hospice inpatient units and hospice benefit, burden, and ability to admin- health professionals whose main ac- residential units, LTC facilities, and ister, based on each patient’s progno- tivity focuses on delivery of palliative hospitals, in addition to the more tra- sis, should occur, paying particular care). These guidelines also incorpo- ditional home care paradigm. PHC attention to the identification of non- rate that dichotomy. pharmacists also must be cognizant essential and futile treatment regi- To address the heterogeneous na- of the many regulatory requirements mens. Equally important is the com- ture of the pharmacy profession, the associated with controlled substanc- munication of drug-related changes pharmacist’s roles and activities de- es, medication reimbursement re- to the patient and family. CMS’s Con- scribed herein will be categorized as quirements, and commonly managed ditions of Participation mandate that either essential or desirable. Essential symptoms. The Centers for Medicare the interdisciplinary group confer roles and activities describe the prac- and Medicaid Services (CMS), as part with an individual possessing edu- tice of palliative and supportive care of the Conditions of Participation, cation and training in drug manage- pharmacy, whereas desirable roles and stipulate that hospices are responsible ment to perform this ongoing review, activities denote delivery of palliative for the costs associated with all ser- though CMS stops short of dictating and supportive care services by phar- vices, including medications, related that these services be provided by a macist specialists at the highest level to the terminal diagnosis and related licensed pharmacist. of advanced practice, such as leading conditions for which the patient was Caregiver and family education palliative and supportive care teams, referred and that are contributing to should extend beyond the patient’s engaging in medication therapy man- the terminal prognosis.30,31 (The ter- death. Providing guidance on safe dis- agement, teaching, and contributing minal prognosis includes the terminal posal of medications to avoid diver- to new knowledge of the field. Essen- and related diagnoses that contribute sion and improper disposal is easily tial and desirable roles and activities, to the terminal prognosis, to include overlooked but could have a signifi- as outlined within these guidelines, the symptoms caused or exacerbated cant impact on the family’s health and should not be considered mutually by the terminal diagnosis, related di- public health. The PHC pharmacist, exclusive. Recommendations will fo- agnosis or treatment of terminal and regardless of practice setting, must be cus on the pharmacist’s roles and ac- related diagnosis.) Pharmacists are familiar with current federal and state tivities within clinical practice and often called upon to review all patient laws regarding drug disposal as well administration as well as practice and medications, both at admission and as local options for safe disposal (e.g., professional development. periodically, requiring a thorough drug take-back programs).

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Table 1. Essential Clinical and Administrative Roles, Practice Activities, and Examples of Tasks, Skills, and Knowledge of the PHC Pharmacista Role and Specialty Practice Activity Example(s) of Tasks, Skills, and Knowledge Direct patient care • Optimize the outcomes of symptom management • Conduct patient symptom assessment and drug therapy and palliative care patients through the expert management, including comorbid conditions provision of evidence-based, patient-centered • Review and provide recommendations on managing medication therapy as an integral part of an ineffective, futile, and nonessential medications interdisciplinary team • Review pharmacotherapy and facilitate discussion with • Serve as an authoritative resource on the optimal patients, caregivers, and families to reset therapeutic goals use of medications in symptom management and • Participate in hospice or palliative care planning meetings, palliative care inpatient patient care rounds, or consultations as appropriate • Anticipate transitions of care when recommending, based on setting initiating, modifying, or discontinuing • Document direct patient care activities appropriately pharmacotherapy for pain and symptoms • Establish collaborative pharmacist–patient and pharmacist– caregiver relationships • Provide concise, applicable, comprehensive, and timely responses to formal or informal requests for drug information • Recommend alternative routes of medication administration when traditional routes are not feasible or are impractical Medication order review and reconciliation • Manage and improve the medication-use process in • Assist with preparation and dispensing of medications for patient care settings symptom management and palliative care patients following existing standards of practice and the organization’s policies and procedures • Contribute to the work of the team that secures access for drugs used in a patient’s regimen, including facilitation of REMS programs • Assist in drug shortage management, including patient- focused and supply/management decisions • Employ medication adherence strategies • Perform opioid equianalgesic conversions • Conduct clinical medication regimen reviews to identify and resolve medication-related problems associated with symptom management Education and medication counseling • Demonstrate excellence in the provision of • Ensure safe and legal disposal of medication medication counseling to patients, caregivers, and families Administrative roles • Ensure safe use of medications in the treatment of • Pharmacy and therapeutics committee implementation and pain and symptoms participation • Medication supply chain management • Medication formulary and therapeutic substitution/interchange policy development and oversight • Development of medication-use policies and procedures • Support development of medication-use algorithms that follow evidence-based best practices • Perform continuous quality-improvement reviews toward medication-use compliance • Medication administration management (e.g., pumps, dosage forms, stock medication) • Safe and effective disposal of medications • Support medication contract negotiations with pharmacy vendors (e.g., PBMs, retail pharmacies, purchasing groups, wholesalers) aPHC = palliative, supportive, and hospice care, REMS = risk evaluation and mitigation strategy, PBM = pharmacy benefit manager.

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Inpatient palliative and sup- tered.37-39 Given the inability to closely hospice inpatient facility. These phar- portive care teams. The develop- observe outpatient PHC patients, tai- macists collaborate with the hospice ment of institutional palliative care lored monitoring plans are required, care team in a number of activities, teams is becoming more common while balancing the risks and benefits including medication therapy re- in U.S. hospitals and health systems. of a selected drug therapy is critical views, clinical consults, and medica- Pharmacists may be engaged in nu- (e.g., symptoms, adverse drug effects, tion regulatory compliance oversight merous capacities, ranging from de- drugs with a narrow therapeutic range, and guidance. centralized, full-time, or part-time opioids). Unique challenges may be team members dedicated to the PHC encountered in this setting, requir- Desirable clinical roles and team to reactive participation and ing assistance from the PHC pharma- activities consultation when requested. Phar- cist regarding the safe use of and risk Desirable clinical roles and ac- macists who lead PHC teams require mitigation for opioids (e.g., previous tivities of a PHC pharmacist represent even greater expertise.16,33 PHC phar- patient or family history of substance those typically reserved for the phar- macists should be involved in symp- use disorder or drug diversion). macist engaged in dedicated pallia- tom management strategies as well as Consulting, distributive, and tive or supportive care services. These facilitating timely medication admin- compounding services. Many pa- activities will, in most cases, embody istration, monitoring and reporting tients residing in LTC facilities may the highest levels of service provided adverse drug reactions, providing ed- either be candidates for PHC or cur- by the pharmacist allowed by the in- ucation to patients and their families, rently under the care of a hospice or- stitution’s scope of practice policies and monitoring for drug–drug and ganization. Pharmacists serving in and state’s pharmacy practice act. drug–disease interactions. Regardless a consulting capacity to these LTC Most notably, the PHC pharmacist of scope of practice for the PHC phar- facilities may significantly improve will often participate in the direct care macist, the necessary knowledge and symptom management. In addition, of patients with respect to symptom skills remain unchanged. advocating for patients who may be assessment, laboratory monitoring, Outpatient palliative and sup- noncommunicative is essential. Es- medication management, and pre- portive care teams. A growing sec- sential roles of the PHC pharmacist scribing in states that grant prescrip- tor of palliative and supportive care serving in this capacity include en- tive authority to pharmacists through strives to deliver PHC to patients re- suring routine use of medications as collaborative practice agreements quiring pain and symptom manage- needed for pain or other symptom (CPAs). A PHC pharmacist should ac- ment in an outpatient setting. These management, conducting appropri- tively seek and engage in collaborative services may be housed within oncol- ate monitoring for required mainte- practice whenever allowed by the state ogy and other similar group practices nance medications, and having a thor- and institution. Practicing at the top as well as larger primary care services ough understanding of the interplay of one’s professional license in this under the patient-centered medical between regulatory compliance and regard will facilitate provision of care home model.22,35,36 In addition, many the needs of the patient (e.g., antipsy- to patients who otherwise may not hospices and health systems are es- chotic use for terminal agitation in an have the opportunity for specialized tablishing palliative care programs LTC facility). services. Pharmacists will be actively to address symptom relief in patients Pharmacists working in distribu- involved with patient and family who have yet to initiate their hospice tive or compounding services sup- medication-use education to support benefit or are not yet hospice ap- porting PHC also have an important their understanding of prescribed propriate. The PHC pharmacist in role in the provision of care. The art therapies and compliance with the this setting must be thoroughly fa- and science of preparing specially plan of care. Desirable clinical roles miliar with the medications used to compounded medication formula- and activities of the PHC pharmacist alleviate suffering, with state and tions support the provision of per- are described in Table 2, and aspects federal controlled substances laws, sonalized care to the terminally ill. of those roles and activities that tra- and with the nuances between stan- The dispensing pharmacist will utilize verse the various PHC practice set- dard community-dwelling patients, his or her education and knowledge tings are discussed below. patients residing in LTC facilities, pa- to ensure that the patient and family Hospice programs. The care model tients residing in assisted-living fa- members understand the role of pre- in many home care hospice pro- cilities, and patients receiving hospice scribed medications and necessary grams, in which the patient’s pri- care. In the outpatient setting, the precautions with their use. mary physician remains in that role, PHC pharmacist’s assistance is often Many state regulations require has evolved to utilize the PHC phar- sought when medication formularies hospices to retain a consultant or em- macist as the hospice team member and cost are of concern or drug ad- ployed pharmacist for oversight of all who develops specific medication ministration difficulties are encoun- medication-use processes within a recommendations through a consul-

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Table 2. Desirable Clinical and Administrative Roles, Practice Activities, and Examples of Tasks, Skills, and Knowledge of the PHC Pharmacista Desirable Role and Specialty Practice Activity Examples of Specific Tasks, Skills, and Knowledge Direct patient care • Conduct advanced pain and symptom assessment, • Complete thorough history and symptom analysis including comorbid conditions • Perform limited physical examination • Establish and maintain a collaborative practice • Prescribe, order, or recommend medication therapy in the agreement with managing medical practitioner management of symptoms and pain using evidence-based • Initiate, modify, and discontinue medication therapy medicine when available • Monitor medication therapy using patient and caregiver • Order or recommend and interpret labs or tests history and order, recommend, or interpret laboratory • Utilize or recommend validated, patient-specific, uni- or and test results multidimensional assessment tools and screens (e.g., Patient • Develop an accountable role within the PHC Health Questionnaire, McGill Pain Questionnaire, Edmonton interdisciplinary team Symptom Assessment Scale, Beck Depression Inventory) • Thoroughly understand scope of practice and roles of • Coordinate seamless transitions of care from hospital to nonpharmacist members of the PHC team home, home to hospital, hospital to LTC facility, LTC facility to • Participate in or lead family meetings hospital, or any setting to hospice • Establish goals of care and educate patient and family • Develop institutional, evidence-based, or guideline-driven on medication therapy decisions (e.g., discontinuation policies, order sets, and protocols of futile or nonessential medications) • Create competencies that support the daily practice and • Participate in or lead decisions on hospice or growth of the PHC role outpatient palliative care appropriateness and referral • Develop a collaborative practice agreement that promotes • Guide transitions of care patient-centered care and supports practicing at the top of • Assist in health-system policy as it relates to PHC pharmacy license • Educate patients, caregivers, and families regarding medications Education • Develop health profession students’ understanding of • Develop didactic and experiential PHC learning experiences PHC (e.g., lectures, rotations, residency, shadowing) • Develop practicing health professionals’ understanding • Serve as a preceptor for pharmacy students and other health of PHC students • Serve as a preceptor for PGY1 PHC rotation • Serve as a preceptor for PGY2 PHC specialty residency Scholarship • Contribute to the body of knowledge of PHC via • Conduct and disseminate research via publication, poster writing, speaking, or research presentation, and lecturing • Participate in development of clinical guidelines, guidance documents, or treatment algorithms Administrative roles • Practice development and management • Policy and procedure/guideline development (e.g., ketamine, • Interdisciplinary leadership propofol, or lidocaine infusions; palliative sedation) • Proposal of new or expanded PHC pharmacy services • Establish reimbursement structure for pharmacist services • Ensure coverage and scheduling of PHC pharmacist services • Development of postgraduate training opportunities (e.g., PGY2 pain and palliative care residencies) • Maintain a leadership role on organizational committees (e.g., chair or vice-chair the pharmacy and therapeutics committee) • Develop interprofessional continuing-education programs aPHC = palliative, supportive, and hospice care, PGY1 = postgraduate year 1, PGY2 = postgraduate year 2, LTC = long-term care.

tative process. These PHC pharma- Inpatient palliative and sup- policy–directed automatic consulta- cists are practicing as specialists in portive care teams. The PHC phar- tion (e.g., upon ordering of high-risk palliative care and often are familiar macist should provide direct patient medications in nonadvanced care with palliative medication provi- care services of varying scopes within units). Typically, direct patient care sion and can make patient-specific the inpatient setting. These services services provided to inpatients by the and cost-effective recommendations may result from specialty team con- PHC pharmacist will be directed by that are widely accepted by primary sultation, from individual consul- the pharmacy and therapeutics com- physicians.34,40 tation, or as part of health-system mittee and medical staff executive

1356 AM J HEALTH-SYST PHARM | VOLUME 73 | NUMBER 17 | SEPTEMBER 1, 2016 PALLIATIVE AND HOSPICE CARE ASHP REPORT committee. The individual institu- While the direct patient care ser- care during patient handoffs between tion or health system must direct the vices of PHC pharmacists practicing healthcare providers and a historical credentialing and privileging of PHC in the hospice environment are not account of the effectiveness of previ- pharmacists in the absence of board frequently described, their impact on ous medication regimens. PHC phar- certification availability. Other equally patient care is noteworthy. CMS regu- macists may also be engaged in assist- important functions of the inpatient lations concerning the provision of ing in the enrollment and discharge of PHC pharmacist include medication hospice services may preclude a PHC PHC patients from hospice care. stewardship utilizing the principles of pharmacist from acting as the sole Educating and training student pharmaceutical care practice, adverse- provider for a patient or directing an pharmacists and other clinicians. effect anticipation and monitoring, interdisciplinary team. PHC pharmacists should be actively pain and symptom management, pa- Supporting transitions of care. engaged in the education and training tient and family education, discharge An important desirable clinical role of students, pharmacists, and patient and transition planning, and follow-up for PHC pharmacists is the active sup- care clinicians of various disciplines. coordination of care between multiple port of patients transitioning from ag- They possess knowledge about the providers after transitions to new set- gressive treatment to comfort-focused rational and practical use of medica- tings. Pharmacists may even be called care. The PHC pharmacist is in an tions that is often not taught in didac- on to lead a PHC team, which would ideal position to assist in evaluat- tic learning environments or in clini- require even greater expertise.16,33 ing the changing risk:benefit ratio of cal or experiential training outside Outpatient palliative and sup- medications as the patient transitions that specific to palliative care provid- portive care. Lack of access to pallia- through the continuum of care. Pa- ers. In addition to the clinical and ad- tive care providers in ambulatory clin- tients experiencing a steady decline ministrative expertise required by the ic settings creates an opportunity for a often declare for themselves when a inpatient PHC pharmacist, teaching PHC pharmacist to provide symptom treatment is no longer beneficial or staff peers, the PHC team, and health management to a variety of patient tolerable, either orally or through the profession students should be consid- populations. The resulting improve- inability to continue the regimen (e.g., ered part of these essential activities. ment in quality of life and potential due to lost availability of intravenous Scholarship. Ongoing evalua- reduction in the number of acute access or ability to administer oral tion of current practices and the dis- visits to the physician office or emer- medications). Equally important is semination of novel treatments or gency department for symptom- the ability to recognize when a given processes are critical for the contin- related complaints would represent treatment has failed to demonstrate ued improvement in patient care and the primary quality indicator for such continued benefit and should be dis- sustainability of the PHC pharmacist. a pharmacist. The PHC pharmacist continued (e.g., reevaluation of lipid- Scholarship should be pursued when should simultaneously be aware of the lowering therapy, dementia-related possible and in any form to share best relative financial impact of medica- medications, certain chemotherapy practices, research methodology, and tion therapies. Consideration of cost agents).41 For patients with chronic outcomes. Clinical research in pal- and insurance coverage at the time illnesses who experience intermittent liative care and hospice is lacking, and of medication selection is paramount severe exacerbations, there may be the PHC pharmacist should contrib- in the outpatient setting. In addition, multiple inflection points and changes ute to the overall body of knowledge avoidance of high-cost medications between life-prolonging and symptom- when possible. when other equally effective and tol- focused approaches. The PHC phar- erated therapies are available reduces macist should assist the patient, fam- Essential administrative roles the likelihood of interruption to opti- ily, caregiver, and other healthcare and activities mal symptom control should the pa- providers in navigating the changes The pharmacist’s essential admin- tient transition to hospice care. When in medication regimens that are nec- istrative roles and activities in PHC possible, having the PHC pharmacist essary to provide a patient-centered, should incorporate basic practice ac- work within a clinic focused on pallia- cost-effective, and (when available) tivities that promote positive treatment tive care enhances the interdisciplin- evidence-based approach. Evaluation outcomes, adverse-event avoidance, ary approach to patient care. Although for discontinuation of medications and medication cost containment. it is arguably an essential role of phar- should occur, at a minimum, dur- A primary component of the PHC macists in any practice setting, PHC ing transitions of care.42,43 The PHC pharmacist’s role is continuous re- pharmacists should possess the basic pharmacist is often one of the few view of medications. Continuous re- understanding and skills necessary to consistent members of the interdisci- view of patient medication records identify the risk for and current sub- plinary team and therefore has an es- and ongoing contact with the primary stance abuse among patients, caregiv- sential role in this process. His or her physician, as well as with the patient ers, and family members. involvement allows for continuity of or caregiver, are essential to minimiz-

AM J HEALTH-SYST PHARM | VOLUME 73 | NUMBER 17 | SEPTEMBER 1, 2016 1357 ASHP REPORT PALLIATIVE AND HOSPICE CARE ing medication-related problems and medication use, pharmacists are well medications identified as necessary expenses while improving outcomes positioned to support the develop- to continue and not covered under the and efficacy. ment and updating of medication-use hospice plan of care, a source of pay- Pharmacists engaged in the devel- policies and procedures to achieve ment must be determined (e.g., pa- opment and oversight of a medication compliance. tient pay, supplemental health insur- formulary will support palliative and As a representative of a hospice or- ance, Medicare Part D).46 During this end-of-life care programs to achieve ganization, the PHC pharmacist is in evaluation, the pharmacist can identi- evidence-based and cost-effective an excellent position to support con- fy alternative, cost-effective therapies medication use, minimize delays in tract negotiations with pharmacy pro- appropriate for the patient’s medical therapy due to drug shortages, and viders (e.g., local retail pharmacies, conditions. This admission medica- contain medication expenses. Hos- pharmacy benefit managers, purchas- tion review process alone can result in pices and palliative care programs ing groups, national pharmacy pro- significant cost savings for a hospice.40 will often seek to develop standards vider groups). The PHC pharmacist Hospital and institutional prac- to ensure consistency in the care of should also work with local pharmacy tice. Pharmacists working in large patients. Part of this effort is the de- providers to ensure that appropriate healthcare organizations, hospitals, velopment of policies and procedures medications are consistently available and other institutions have additional to guarantee that activities associated to the hospice and communicate reg- opportunities to shape institutional with medication use are consistent ularly with them regarding prescrip- medication-use policies and proce- across all levels of care. tion adjudication concerns, coverage, dures regarding drug-related proto- Hospice. Proactive review of pa- and other required quality and regula- cols, formulary development, and al- tient medication regimens over time tory issues. gorithms by providing evidence-based can significantly reduce medication If a hospice is of sufficient size recommendations that can improve burden and costs. Ongoing rapport to support a dedicated pharmacy the safety and efficacy of analgesics and dialogue must be sustained with and therapeutics committee, the PHC as well as other commonly used pal- the hospice or palliative care physi- pharmacist must be an active mem- liative care agents. Other important cian and nurse, as well as with the ber and would ideally serve in a lead- roles for PHC pharmacists include (1) patient or caregiver. This dialogue is ership capacity. The pharmacist’s participating in institutional commit- essential to establish and maintain a role would involve input into all tees and medication safety–reporting picture of the patient’s functional sta- aspects of medication-use manage- systems that address medication errors, tus, providing the opportunity for the ment, ranging from decisions on ap- adverse drug reactions, and the safety of PHC pharmacist to identify and rec- proved medications prescribed under analgesics and symptom-management ommend changes in nonessential or the hospice plan of care, continuous agents, (2) acting as a resource and overly burdensome medication thera- quality-improvement activities, pol- actively participating in the pharmacy py or the addition of medications for icy development for medication use, and therapeutics committee or similar symptom management. An extensive therapeutic substitution parameters, committees, (3) serving as an institu- and more comprehensive example tiered medication selection, and pro- tional resource to healthcare profes- of the medication review process oc- tocol or algorithm development. sionals, patients, and patients’ fami- curs at hospice interdisciplinary team An essential activity for PHC lies on the optimal use of medications meetings. pharmacists is evaluating all patient in symptom management and pal- The PHC pharmacist’s contributions medications on patient admission to liative care, (4) providing continuous to the development of medication-use a hospice program for payment un- evaluation and review of all existing policies and procedures will serve to der the hospice plan of care. The PHC drug-related protocols and algorithms strengthen compliance with federal pharmacist is equipped to address the to ensure that they reflect current best and state regulations and with best suitability of medications, given the practices, and (5) assisting in the de- practices. All hospices are regulated hospice diagnosis and related con- velopment of urgency plans that ad- by state and federal agencies, which ditions contributing to the terminal dress inappropriate use of emergency include standards associated with prognosis. Upon the physician’s cer- department services or hospital ad- medication use. In addition, 75% of tification of a terminal prognosis, the mission. In addition, it is essential that hospices report accreditation with PHC pharmacist, in discussion either the PHC pharmacist assist the institu- agencies such as the Joint Commis- with the admitting nurse or during the tion or health system in compliance sion, Community Health Accredi- team nurse’s initial visit, will provide with accreditation, legal, regulatory, tation Program, and Accreditation payment approval of medications to and safety requirements related to the Commission for Health Care.44,45 be covered under the hospice plan of use of analgesics and other symptom- With a working knowledge of regula- care as well as identify and discon- management agents. The activities tory and accreditation standards on tinue nonessential medications. For discussed above provide considerable

1358 AM J HEALTH-SYST PHARM | VOLUME 73 | NUMBER 17 | SEPTEMBER 1, 2016 PALLIATIVE AND HOSPICE CARE ASHP REPORT opportunities for pharmacists to be or pain emergencies). The PHC phar- nicating the care plan to other provid- involved in establishing and support- macist should play a key or leading ers, staff, families, and caregivers in- ing medication-use practice patterns role in the interdisciplinary develop- volved in the patient’s care. Because of that positively affect patient out- ment of algorithms to standardize the his or her knowledge of disease proc- comes and the financial well-being of approach to common palliative care esses and treatment regimens, the institutions. symptoms such as agitation, anxiety, interdisciplinary PHC team pharma- anorexia, cachexia, constipation, de- cist is well positioned to provide such Desirable administrative roles lirium, dyspnea, fatigue, nausea, pain, communication. and activities secretions, and sleep disturbances. Desirable administrative roles and Education. Maintenance and im- Practice development, activities include quality improve- provement of different aspects of pal- advocacy, and advancement ment, oversight and improvement of liative care education are important The clinical and administrative education, practice development and to the continued sustainability of the roles of the PHC pharmacist in any advancement, and advocacy. pharmacist’s role in PHC practice. setting rely on sound practice devel- Quality improvement. As the The development and oversight of opment, advocacy, and engagement pharmacist with a distinct skill set postgraduate year 2 (PGY2) specialty to promote practice advancement. serving on an interdisciplinary PHC pharmacy residency programs that Recommendations regarding practice team, there is a unique opportunity incorporate education and training development, advocacy, and advance- to identify processes or protocols in PHC are essential to the growth of ment are outlined in Appendix A and that need development or revision the specialty. Another key educational presented below. to improve the quality of care deliv- component is ensuring that core PHC Practice development. When ered. One avenue for achieving this competency is incorporated into post- developing the proposed role of a goal is a leadership role on the phar- graduate year 1 (PGY1) pharmacy resi- PHC pharmacist within an institu- macy and therapeutics committee or dencies and other specialty residen- tion, health system, or hospice, the similar committees. Participation in cies. Integration into the curricula at identification of the key stakeholders, such committees is also an essential colleges of pharmacy can provide stu- examination of the infrastructure or administrative role, but by practicing dent pharmacists with the basic skills currently offered services, and per- at a higher level the PHC pharmacist and knowledge about the medication formance of a needs assessment are may provide services such as care set management approach for a pallia- required. This process will provide development to guide the use of com- tive care patient, and these learning the groundwork for the focus and po- plex, high-cost, or high-risk therapies experiences should be taught by those tential utility of the PHC pharmacist. (e.g., lidocaine or ketamine). Revisions practicing at the highest levels to en- A commonly encountered barrier to to existing practices might include courage continued forward movement the establishment of new services, updating institution medication ad- of the profession. Interprofessional regardless of setting, is the overcom- ministration guidelines to allow for education of nursing students, medi- mitment of the PHC pharmacist or the use of medications or dosages that cal students and residents, and pal- underestimation of the time require- are typically restricted to an intensive liative care physician fellows through ment for the services proposed. The treatment unit or similar setting (e.g., didactic and experiential teaching is Center for the Advancement of Pallia- development of protocols for pal- another important role for the PHC tive Care provides excellent resources liative sedation or refractory terminal pharmacist. Modeling the role of the guiding the first steps, whether estab- delirium). PHC pharmacist for learners in other lishing an entirely new PHC service or Quality-improvement processes disciplines not only teaches them core simply adding personnel to the team. related to drug delivery or medica- skills in medication management of For example, if the institution’s main tion use are also an important area of the palliative care patient but also priorities are preventing long inpa- practice. Medication-use evaluation promotes the expertise of pharmacists tient stays, curtailing futile high-cost or drug utilization review may iden- in the minds of future palliative care resource utilization, and facilitating tify the need for significant practice clinicians. Nurse practitioners, nurses, discharges, then the focus of the pro- changes (e.g., development of safe and physician assistants can also ben- posed position should be on the inpa- practices for the use of methadone for efit from a pharmacist’s expert knowl- tient setting. On the other hand, if the pain control, approval of opioid guide- edge through inservice or continuing- institution’s priorities focus on pre- lines). Quality-improvement processes education programs hosted by the venting frequent emergency depart- usually align with the development of health system or area professional ment visits or hospital admissions for clinical practice guidelines or algo- organizations. pain and symptom issues that can be rithm development for the expert palli- A significant amount of a palliative managed though outpatient services, ative care team (e.g., palliative sedation care team’s time is devoted to commu- then the proposal should seek to pro-

AM J HEALTH-SYST PHARM | VOLUME 73 | NUMBER 17 | SEPTEMBER 1, 2016 1359 ASHP REPORT PALLIATIVE AND HOSPICE CARE vide services within the outpatient there is a paucity of specialized train- federal prison system. Typically, the setting. ing programs that prepare pharma- credentialing officer within these or- Consideration should be given to cists interested in PHC practice. This ganizations can assist obtaining regis- the funding of such a position, which creates a very real chasm when con- tration. A sample CPA for a PHC phar- should be established at the begin- sidering specific PHC privileges in to- macist is provided in Appendix C. ning of such discussions. Engagement day’s climate for pharmacists seeking Attention should be given to cre- of nonclinical departments (e.g., fi- to enter this area of practice without ating an infrastructure to sustain nance) is critical. There are numerous an already developed and successful pharmacy’s involvement on the in- practice models for clinical pharmacy service or practice. terdisciplinary PHC team. Integrating PHC services, including drug informa- Other considerations include the pharmacists into a health system’s tion, drug utilization review, clinical PHC team design, referral-only versus palliative care staffing matrix may interdisciplinary team involvement, automatically triggered evaluation, be a first step to accomplishing this. and medication therapy manage- scope of practice for the PHC pharma- Proactively budgeting for additional ment through collaborative protocols. cist, and documentation processes. pharmacy positions as the number The needs assessment also applies to A key element to the documentation of consultations performed per year evaluating what the PHC pharmacist process will be the reimbursement increases would also support sustain- will need for continued professional or billing model that is established. ability of PHC pharmacists’ presence. development. Reimbursement regulations are ever- To justify such positions, the PHC After identification of the funding changing and specific for various pharmacist must be familiar with re- source for the PHC pharmacist and practice settings, as described earlier. imbursement models and opportuni- the anticipated level of support for the Those seeking to establish or expand ties to further support these positions. PHC service, a formal job description PHC pharmacist services should seek Competencies and certifica- or policy of roles and responsibili- out resources and guidance on best tion. There are no recognized board ties will need to be drafted and vet- practices for sustainability, including certification opportunities for phar- ted by all potential stakeholders. A both revenue generation and cost- macists with a unique expertise in the model job description on roles and avoidance tracking. area of palliative and supportive care responsibilities of the PHC pharma- Before the development of a prac- in the United States. Without the op- cist appears in Appendix B. Typical ac- tice model for the PHC pharmacist, portunity for board certification to tivities may include daily review of pa- the department or team should evalu- verify PHC pharmacists’ expertise, it tient medications for which the PHC ate the state-specific laws and relevant is difficult to advocate for their impor- team has been consulted, regular pharmacy practice act rules by which tance to health-system administra- consultation team and house staff the pharmacist must abide. Depend- tors, payers, and other professionals. educational programming, and rep- ing on the practice site, the scope Lack of certification also complicates resentation on quality-improvement of practice may differ significantly. the credentialing and privileging committees or task forces. The hetero- Advanced scope of practice phar- process of such clinicians. The Board geneity of PHC programs in today’s macists may often undertake greatly of Pharmacy Specialties (BPS) previ- institutions precludes a complete de- expanded roles in patient care under ously conducted a role delineation scription for every model or setting. In CPAs approved by a pharmacy and study to investigate the feasibility of some institutions, the PHC pharma- therapeutics committee or executive recognizing pain and palliative care cist plays an indispensable role in the medical staff. At the time of writing, as a specialty within the profession of development of new policies and pro- pharmacists practicing under appro- pharmacy. Although BPS did not elect cedures concerning such difficult top- priately drafted CPAs may hold Drug to pursue pain and palliative care as a ics as palliative sedation and terminal Enforcement Administration (DEA) recognized specialty when combined, wean from mechanical ventilation. practitioner registration in California, perhaps differentiating between the Health systems or hospices must Massachusetts, Montana, New Mexico, two distinct yet often overlapping develop standardized policies to ad- North Carolina, North Dakota, and clinical skill sets will provide sufficient dress the clinical credentialing and Washington. DEA is currently review- demarcation in future consideration. privileging of the PHC pharmacist. ing Idaho’s Pharmacy Practice Act and BPS is also investigating opportunities There are several common barriers to Controlled Substances Act for possible for added qualifications in numerous this undertaking. First, no profession- inclusion. Pharmacists licensed in one areas, including palliative care. recognized board certification cur- of these states may additionally obtain There are opportunities for phar- rently exists for the PHC pharmacist fee-exempt DEA registration if em- macists to further enhance their train- to demonstrate knowledge or skills ployed and practicing within the U.S. ing in palliative and supportive care. above the minimum competency Armed Forces, Department of Veter- The ASHP Research and Education state licensure examinations. Second, ans Affairs, Indian Health Service, or Foundation Pain and Palliative Care

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Traineeship provides a three-level histories and are taking medications cists’ involvement in the daily man- program consisting of Web-based nar- (mainly controlled substances with agement and oversight of medication- rated lectures followed by onsite train- narrow therapeutic ranges) that re- use processes across all palliative and ing with an established PHC pharma- quire close clinical monitoring and supportive care venues, positively af- cist. There are various other training attention to regulatory compliance fecting patient outcomes while main- programs to further pharmacists’ issues, which should justify a phar- taining fiscal responsibility. understanding of palliative and sup- macist as an integral part of providing portive care outside of formalized comprehensive care to the patient. Acknowledgments residency or fellowship training. Advocacy efforts of the PHC phar- ASHP gratefully acknowledges the follow- Recommended journals, books, and macist should be multitiered and in- ing organizations and individuals for re- websites for professional develop- volve discipline-specific professional viewing these guidelines (review does not imply endorsement): American College ment of the PHC pharmacist are list- development, practice development, of Clinical Pharmacy Pain and Palliative ed in Appendix D. and quality-improvement initiatives. Care Practice Resource Network; American Development of didactic and Reaching out to state, regional, and Pharmacists Association; New Hampshire experiential education. The Strate- national professional organizations Society of Hospital Pharmacists; Melhim gic Planning Summit for the Advance- and legislators to discuss the impor- Bou Alwan, M.D.; Cynthia Brucato, Pharm.D., BCACP; Mitchell Buckley, Pharm.D., FASHP, ment of Pain and Palliative Care Phar- tance of pharmacist involvement in FCCP, SCCM, BCPS; Trinh T. Bui, Pharm.D.; macy, convened in 2009, produced a the PHC team must be universally Nina M. Cimino, Pharm.D., CPE; Steven comprehensive consensus document practiced to continue the growth of J. Crosby, M.A., FASCP; Emily Davies, on strategies to integrate standard- the field. Scholarly pursuits demon- Pharm.D., CPE; Sandra DiScala, Pharm.D., ized palliative care education in the strating the effects that PHC pharma- BCPS; Steven Dzierba, Pharm.D., M.S., BCPS, FASHP; Abimbola Farinde, Ph.D., doctor of pharmacy core curriculum, cists have on patient care are equally Pharm.D; Lauren Gashlin, Pharm.D., Jessica elective courses, PGY1 programs, and important. Erin Geiger-Hayes, Pharm.D., BCPS; Michael PGY2 palliative care specialty residen- A. Gillette, Pharm.D., BCPS (AQ–Cardiol- cies.29 There are currently 12 ASHP- Conclusion ogy), BCACP; Kerry Goldrosen, Pharm.D.; accredited or accreditation-eligible PHC pharmacists bring a diversity Timothy J. Ives, Pharm.D., M.P.H., FCCP, FASHP, CPP; Donna Jolly, Pharm.D., PGY2 palliative care or pain manage- of essential services to palliative and BCPS; Katherine Juba, Pharm.D., BCPS; ment programs and many others with supportive care teams. Central to the Syeda Saba A. Kareem, Pharm.D., BCOP; exposure or emphasis in pain or pal- role of the PHC pharmacist is symp- Allison R. King, Pharm.D.; Justin Kullgren, liative care.47 It is important that there tom management through participa- Pharm.D., CPE; Eric C. Kutscher, Pharm.D., are formal and standardized educa- tion in direct patient care, providing BCPP, FASHP; Maritza Lew, Pharm.D., PMP; Matthew Malone, D.O.; Fred tion programs available in the area of pharmacotherapy regimens that sup- Meister, Pharm.D.; James Ponto, M.S., PHC for pharmacists’ involvement in port optimal patient outcomes. Medi- BCNP; Jennifer Pruskowski, Pharm.D., the field to continue to grow. In ad- cation therapy management and the BCPS, CGP; Curt W. Quap, M.S. Pharm., dition, there is a training opportunity application of transitional continuity FASHP; James R. Rinehart, M.S., FASHP; for pharmacists in the one-year Inter- of care are key services pharmacists Eve M. Segal, Pharm.D.; Victoria Snyder; Dennis A. Tribble, Pharm.D., FASHP; professional Palliative Care Fellowship provide to patients in this care setting. Rebecca Wagner, Pharm.D.; Jody Jacobson Program offered by the Department of Collaborative practice opportuni- Wedret, FASHP, FCSHP; Ricke J. Weickum, Veterans Affairs. ties have strengthened the working Pharm.D., BCOP; Traci White, Pharm.D., Advocacy. The importance of the relationship with palliative and sup- PhC; and Amanda R. McFee Winans, role of a PHC pharmacist needs to be portive care medical practitioners, Pharm.D., BCPS. The contributions of Justine Coffey, J.D., L.L.M., to this docu- established at the national level, with furthering PHC pharmacist practice ment are gratefully acknowledged. individual pharmacists contributing development. In addition, PHC phar- grassroots advocacy. The Joint Com- macists may participate in advocacy, Disclosures mission palliative care certification research, and scholarly activities in The authors have declared no potential requirements currently do not include palliative and supportive care, fur- conflicts of interest. a palliative care pharmacist as a core thering the growth of this area of prac- member of the interdisciplinary pro- tice. The PHC pharmacist should pro- Additional information gram team as they do for physicians, vide education to student pharmacists Approved by the ASHP Board of Directors registered nurses, social workers, and and PGY1 and PGY2 residents, as well on March 15, 2016. Developed through the ASHP Section of Ambulatory Care chaplains. The current Joint Commis- as members of the interdisciplinary Pharmacists. sion requirements state that a clinical team, peers, patients, and caregivers. pharmacist should be “utilized” based Activities outlined in these guidelines References on patient needs. Most palliative care showcase a considerable breadth and 1. Gamondi C, Larkin P, Payne S. Core patients have complicated medical depth of opportunities for pharma- competencies in palliative care: an

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EAPC white paper on palliative care of a survey conducted in Australia recommendations from the strategic education—part 1. Eur J Palliat Care. and Canada. J Palliat Care. 2002; planning summit for pain and 2013; 20:86-91. 18:287-92. palliative care pharmacy practice. 2. National Consensus Project for 17. Hanif N. Role of the palliative care J Pain Symptom Manage. 2012; Quality Palliative Care. Clinical unit pharmacist. J Palliat Care. 1991; 43:925-44. practice guidelines for quality 7:35-6. 30. Centers for Medicare and Medicaid palliative care, 3rd ed. www. 18. O’Connor M, Pugh J, Jiwa M et al. The Services. Medicare and Medicaid nationalconsensusproject.org/ palliative care interdisciplinary team: programs: hospice conditions of guidelines_download2.aspx where is the community pharmacist? participation. Final rule. Fed Regist. (accessed 2016 Feb 19). J Palliat Med. 2011; 14:7-11. 2008; 73:32087-220. 3. Guo Q, Jacelon CS, Marquard JL. An 19. Atayee RS, Best BM, Daniels CE. 31. Centers for Medicare and Medicaid evolutionary concept analysis of Development of an ambulatory Services. Medicare program; FY 2015 palliative care. J Palliat Care Med. palliative care pharmacist practice. hospice wage index and payment rate 2012; 2:1-6. J Palliat Med. 2008; 11:1077-82. update; hospice quality reporting 4. Gamondi C, Larkin P, Payne S. Core 20. Chen J, Lu XY, Wang WJ et al. Impact requirements and process and competencies in palliative care: an of a clinical pharmacist-led guidance appeals for Part D payment for drugs EAPC white paper on palliative care team on cancer pain therapy in for beneficiaries enrolled in hospice. education—part 2. Eur J Palliat Care. China: a prospective multicenter Final rule. Fed Regist. 2014; 79:50451- 2013; 20:140-5. cohort study. J Pain Symptom 510. 5. Oya H, Matoba M, Murakami S et al. Manage. 2014; 48:500-9. 32. Craig DS. Introduction: pharmacist Mandatory palliative care education 21. 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J Pharm Pract. 2014; 27:46-52. on clinical outcomes in the palliative palliative care service on unnecessary 23. Gagnon L, Fairchild A, Pituskin E care setting. Am J Hosp Palliat Care. medication prescribing. Am J Geriatr et al. Optimizing pain relief in a 2011; 28:316-20. Pharmacother. 2009; 7:20-5. specialized outpatient palliative 35. Shah S, Dowell J, Greene S. Evaluation 8. Battley JE, Connell LC, O’Reilly S. radiotherapy clinic: contributions of of clinical pharmacy services in a Early specialty palliative care. N Engl a clinical pharmacist. J Oncol Pharm hematology/oncology outpatient J Med. 2014; 370:1075. Pract. 2012; 18:76-83. setting. Ann Pharmacother. 2006; 9. Berman HD. Palliative care is a 24. Gammaitoni AR, Gallagher RM, Welz 40:1527-33. specialty. Can Fam Physician. 2008; M et al. Palliative pharmaceutical 36. Valgus JM, Faso A, Gregory KM et al. 54:1526. care: a randomized, prospective study Integration of a clinical pharmacist 10. Ingleton C, Gardiner C, Seymour JE et of telephone-based prescription and into the hematology-oncology clinics al. Exploring education and training medication counseling services for at an academic medical center. Am J needs among the palliative care treating chronic pain. Pain Med. 2000; Health-Syst Pharm. 2011; 68:613-9. workforce. BMJ Support Palliat Care. 1:317-31. 37. Martin CM. Exploring new 2013; 3:207-12. 25. Hussainy SY, Box M, Scholes S. opportunities in hospice pharmacy. 11. Tice MA. Nurse specialists in home Piloting the role of a pharmacist Consult Pharm. 2009; 24:114-9. health nursing: the certified hospice in a community palliative care 38. Snapp J, Kelley D, Gutgsell TL. and palliative care nurse. Home multidisciplinary team: an Australian Creating a hospice pharmacy and Healthc Nurse. 2006; 24:145-7. experience. BMC Palliat Care. 2011; therapeutics committee. Am J Hosp 12. Von Gunten CF, Sloan PA, Portenoy 10:16. Palliat Care. 2002; 19:129-34. RK et al. 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Appendix A—Summary of recommendations • Pharmacists providing PHC services should practice to the for practice development, advocacy, and full capacity of institutional policies and state pharmacy advancement of the palliative and hospice care practice acts up to and including collaborative practice (PHC) pharmacist agreements and Drug Enforcement Administration practi- • Before the development or expansion of PHC pharmacy tioner registration services, a needs assessment, funding allocation, and • PHC pharmacists should take an active role in dissemi- staffing must be thoroughly evaluated nating best practices, scholarly pursuits, and other advo- • Job descriptions or scope of practice policies, as well as cacy efforts to further promote the profession within PHC institution credentialing, should be developed for all • PHC pharmacists must embrace the education of phar- pharmacists providing PHC services macy students and residents at all levels of PHC services

Appendix B—Model job description or roles and py management, palliative sedation, and transi- responsibilities document for a palliative and tions of care. hospice care (PHC) pharmacist position 5. Respond to drug information requests from providers, Position purpose: nurses, and administrators pertaining to palliative and supportive care medications. The PHC pharmacist is responsible for (a) representation of 6. Review all medication profiles of all patients receiving pharmacy services on the palliative care/hospice care team hospice or palliative and supportive care services for and (b) representation of the palliative care/hospice team undertreated symptoms, untreated symptoms, or un- within pharmacy services in the provision of high-quality necessary medication therapy. PHC services to the patients of ______health 7. Oversee medication-use evaluations to optimize safe system/palliative care team/hospice and effective medication use for patients receiving pal- liative and supportive care services. Duties and responsibilities: 8. Evaluate medical literature for evidence-based 1. Serve as a resource to the medical, nursing, and phar- treatments. macy staff regarding the safe and effective manage- 9. Develop or implement treatment guidelines, protocols, ment of medications used in the treatment of pain and order sets, formulary management or interchanges, other symptoms. relatedness, and algorithms or critical pathways. 2. Conduct rounds on all patients with current con- 10. Provide submission, tracking, and follow-up for Medi- sultations for palliative and supportive care (where care Part D prior authorization for medications used by applicable). patients enrolled in the hospice benefit not related to 3. Attend all interdisciplinary PHC team meetings (where the terminal prognosis. applicable). 11. Manage department of pharmacy financials to include 4. Provide clinical consultations or recommendations expense, revenue, and budget as they pertain to pallia- to palliative care team, hospice staff, house staff, tive and supportive care services. and consulting providers on symptom manage- 12. Develop and manage health-system opioid risk mitiga- ment, pain control, cost-effective medication thera- tion and monitoring strategies.

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13. Participate in committees and task forces including 19. Review all submitted research protocols involving but not limited to pain, palliative and supportive care, patients receiving PHC services. sedation, transitions of care, and pertinent pharmacy 20. Support adherence and development of policies and and therapeutics committee or subcommittees. procedures that adhere to state and federal regula- 14. Provide on-call pharmacy PHC services when tions including Drug Enforcement Administration, appropriate. ______Board of Pharmacy, Community Health 15. Serve as department of pharmacy services representa- Accreditation Program, and Medicare Conditions of tive or palliative and supportive care services represen- Participation, where applicable. tative for site surveys or accreditation visits. 21. Serve as preceptor for ______introductory 16. Compile and manage relevant data to support perfor- pharmacy practice experience pharmacy students, mance measures as pertains to palliative and support- ______advanced pharmacy practice experience ive care. pharmacy students, ______postgraduate year 17. Oversee quality and performance improvement one pharmacy residents, and ______postgradu- activities pertaining to palliative and supportive care ate year two pharmacy residents. services. 22. Maintain necessary professional licensure or specialty 18. Provide educational programming on palliative and certification, where appropriate, to maintain the high- supportive care services to hospice staff, providers, est level of care to patients of the ______house staff, or department of pharmacy services staff health system or hospice. every ______months/weeks.

Appendix C—Sample collaborative practice The supervising physician maintains final responsibility agreement for a pharmacist seeking an for the PHARMACIST’s performance and maintains final re- advanced patient care practice in palliative sponsibility for the patient. Services rendered and procedures care in an outpatient setting performed by the PHARMACIST are pursuant to the written guidelines that are specific to the practice setting. I. Scope of practice The supervising physician directs and reviews the records This collaborative practice agreement (CPA) serves as a and practice of the PHARMACIST in a timely manner to as- delegation/authorization of specific roles, functions, and sure appropriate and safe patient care. authority by the supervising physician (PHYSICIAN) to the palliative and hospice care pharmacist (PHARMACIST) WE THE UNDERSIGNED AGREE TO THE TERMS AND consistent with the PHARMACIST’s education, training, and CONDITIONS OF THESE WRITTEN GUIDELINES. experience and within the scope of practice of the supervis- ing physician. ______Under these guidelines, the PHARMACIST will work Supervising Physician Date with the PHYSICIAN in an active practice to deliver pallia- tive and hospice care (PHC) services provided to patients of ______. PHARMACIST Date The PHARMACIST is authorized to render those services and perform those procedures outlined herein with prescrip- II. Functions tive authority for pharmacologic categories identified in The PHARMACIST is authorized to perform services and CPA attachment A and may utilize prescriptive authority as procedures relative to the pain and symptom management delegated in CPA attachment B. within the scope of this palliative and supportive care prac- The PHARMACIST must inform patients of his or her sta- tice as part of a multidisciplinary group to include physi- tus and provide the name of the supervising physician. The cians, nurse practitioners, physician assistants, and direct PHARMACIST may provide service only for those patients of care registered nurses. The active management of patients by the supervising or alternative physician. the PHARMACIST will be provided based on an established These written guidelines shall be reviewed and updated patient medical diagnosis and plan of care and performed annually by the PHYSICIAN and PHARMACIST. under the direction and supervision of the supervising physi- A copy of these guidelines along with the PHARMACIST’s cian and include the following. Drug Enforcement Administration (DEA) number (if appli- cable) shall remain on file at all sites where the PHARMACIST renders service.

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III. Patient care activities history of present illness, review of systems, physical exami- nation (when warranted), assessment of patient response The PHYSICIAN delegates authority to the PHARMACIST for to treatment plan, and treatment plan going forward. This the following patient care activities: documentation shall be in the form of a general SOAP note 1. PHARMACIST will conduct complete medical history and entered into the permanent patient chart or electronic medi- medication reconciliation, with emphasis on pharmaco- cal record. The referring or supervising PHYSICIAN shall therapy history, symptom assessment, and identification review and provide signature documentation on each patient of drug-related problems. seen by the pharmacist. a. Symptom assessment may include limited physical The referring or supervising PHYSICIAN may override assessment as well as the order and interpretation of any treatment decisions or orders made by the PHARMACIST laboratory and diagnostic tests related to drug therapy with communication made back to the PHARMACIST via management in accordance with current evidence- notation in the patient chart. based recommendations. b. Administering drugs and biologicals. V. Quality assurance and oversight c. Order of routine laboratory tests to ensure safe use Peer and PHYSICIAN oversight review will occur in accor- of prescribed medications and avoidance of misuse, dance with applicable state Pharmacy Practice Act rules, and abuse, or diversion. set forth in the Business and Professional Code for the State d. Order of 12-lead electrocardiogram in instances of of______. ongoing monitoring of pharmacotherapy, where warranted. VI. Severability e. Refer to specialists, when appropriate, based on cur- Either party may cancel this agreement via written notifica- rent evidence-based medicine or standard of care. tion. This collaborative practice agreement is subject to the f. Prescriptive authority to include initiation, modifica- ongoing licensure, credentialing, and privileging of both the tion, or discontinuation of the classes and categories PHARMACIST and PHYSICIAN. of drugs in attachment A for pain or symptoms based on current labeling, accepted medical practice, the Pharmacist qualifications: disease process and the patient’s condition, and, • Active registration to practice in the state of where available, evidence-based treatment guidelines ______and recommendations. • DEA license registration g. A pharmacist practicing collaboratively under the • Successfully completed clinical residency training (see Pharmacy Practice Act: State Pharmacy Law, Number curriculum vitae [CV]) xxxx.xx, xxxx.x, and the DEA Controlled Substance • Demonstrated clinical experience in direct patient care Act is authorized to order controlled substances to delivery (see CV work history) provide patient care. • Ongoing continuing education or activities related to the field of practice 2. The pharmacist will a. Thoroughly assess the patient’s response to the pre- VII. Effective date scribed treatment plan with regular assessments and This collaborative practice agreement is entered into on the evaluations conducted to include ______day of ______, 20___. i. Severity, duration, and frequency of symptoms ii. Therapeutic response For PHARMACIST: iii. Adverse drug effects iv. Renal and liver function ______b. Patients prescribed scheduled opioids for chronic ______pain will have an opioid agreement on file. Signature Printed Name Date c. All prescriptions will be limited to a quantity and for a length of time as are reasonably necessary. d. Pharmacist provides education on medications to For PHYSICIAN: patient or caregiver and family. ______IV. Communication and documentation ______Signature Printed The PHARMACIST shall, within ___ hours of seeing the Name Date patient, complete a chart or progress note with a detailed

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CPA attachment A CPA attachment B This list of medication classes and categories is not DELEGATION OF PRESCRIPTIVE AUTHORITY exhaustive yet provides examples of medications managed The PHARMACIST may prescribe medications in associa- by the PHC pharmacist for patients seen at the XYZ palliative tion with the scope of services described in the written and supportive care clinic: guidelines.

1. Antidepressants, including selective serotonin reuptake 1. The PHARMACIST is authorized to write and sign inhibitors, serotonin–norepinephrine reuptake inhibi- orders for medications in controlled substance tors, tri- and tetracyclic antidepressants, and atypical Schedules II, III, IV, and V and orders for general pre- antidepressants in the treatment of anorexia, anxiety, scription medications in association with the scope depression, insomnia, and pain of services described herein. 2. Antipsychotics, including first-, second-, and third- generation antipsychotics in the treatment of agitation, Appendix D—Recommended journals, books, anxiety, and delirium or other mood disorders and websites for professional development of 3. Corticosteroids (oral and topical) in the treatment of the palliative and hospice care pharmacist pain, skin lesions, swelling, ulcers, and wounds where Professional journals appropriate American Journal of Hospice and Palliative Care 4. Anticonvulsants, including first-, second-, and third- Annals of Palliative Medicine generation anticonvulsants in the treatment of anxiety, BMC Palliative Care depression, pain, and seizures British Medical Journal Supportive and Palliative Care 5. Nonsteroidal antiinflammatory drugs in the treatment Current Opinion in Supportive and Palliative Care of inflammation and pain International Journal of Palliative Nursing 6. Serotonin antagonists and phenothiazine derivatives in Journal of Community and Supportive Oncology the treatment of nausea Journal of Geriatrics and Palliative Care 7. Stimulants in the treatment of depression, fatigue, Journal of Hospice and Palliative Nursing opioid-associated sedation, and somnolence Journal of Pain and Palliative Care Pharmacotherapy 8. Benzodiazepines in the treatment of anxiety, dyspnea, Journal of Pain and Symptom Management and pain (abuse potential by patient will be assessed Journal of Palliative Care and documented) Journal of Palliative Care and Medicine 9. Skeletal muscle relaxants in the treatment of pain Journal of Palliative Medicine (abuse potential by patient will be assessed and Journal of Supportive Oncology documented) Palliative Care 10. Opioid agonists and antagonists in the treatment of Palliative Medicine cough, diarrhea, dyspnea, pruritus, pain, and respi- Palliative Medicine and Care ratory depression (abuse potential by patient will be Palliative and Supportive Care assessed and documented) Supportive Care in Cancer 11. Laxatives and stool softeners in the treatment of consti- pation and straining Books 12. Anticholinergic medications in the treatment of pain Appleton M. Good end: end-of-life concerns and conver- and terminal secretions sations about hospice and palliative care. Tuscon, AZ: 13. Other adjuvant analgesics, medications, or therapies Wheatmark; 2015. not listed above in the treatment of pain, symptoms, Bourke S, Peel ET, eds. Integrated palliative care of respiratory and medication-related adverse effects, including disease. New York: Springer; 2013. compounded preparations Bruera E, Higginson I, von Gunten CF et al., eds. Textbook of palliative medicine and supportive care. 2nd ed. Boca Raton, FL: CRC; 2014. Emanuel LL, Librach SL, eds. Palliative care: core skills and clinical competencies. 2nd ed. New York: Saunders Elsevier; 2011.

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Goldhirsch S, Chai E, Meier D, Morris J, eds. Geriatric pallia- Websites and other resources tive care. New York: Oxford Univ. Press; 2014. American Academy of Hospice and Palliative Medicine Goldstein NE, Morrison RS, eds. Evidence-based practice of www.aahpm.org palliative medicine. New York: Saunders Elsevier; 2012. American Society of Health-System Pharmacists. Pain Hanks G, Cherny NI, Christakis NA, eds. Oxford textbook of Management and Palliative Care PGY2 Outcomes, Goals, palliative medicine. 5th ed. New York: Oxford Univ. Press; and Objectives. www.ashp.org/menu/Accreditation/ 2015. ResidencyAccreditation McPherson ML, ed. demystifying opioid conversion calcula- tions: a guide for effective dosing. Bethesda, MD: Ameri- Center to Advance Palliative Care can Society of Health-System Pharmacists; 2009. www.capc.org Pantilat SZ, Anderson W, Gonzales M, Widera E, eds. Hospital City of Hope Pain and Palliative Care Resource Center based palliative medicine: a practical, evidence-based prc.coh.org approach. Hoboken, NJ; 2015. Growthhouse.org Protus BM, Kimbrel JM, Grauer PA, eds. Palliative care consul- www.growthhouse.org tant. Montgomery, AL: HospiScript; 2015. Quill TE, Bower KA, Holloway RG, eds. Primer of palliative Harvard Medical School Center for Palliative Care care. 6th ed. Glenview, IL: American Academy of Hospice www.hms.harvard.edu/pallcare and Palliative Medicine; 2014. International Association for Hospice and Palliative Care Sackheim KA. Pain management and palliative care: a com- www.hospicecare.com prehensive guide. New York: Springer; 2015. National Hospice and Palliative Care Organization Smith TJ. Geriatric palliative care: clinics in geriatric medi- www.nhpco.org cine. New York: Elsevier; 2015. Strickland JM, ed. Palliative pharmacy care. Bethesda, MD: National Palliative Care Research Center American Society of Health-System Pharmacists; 2009. www.npcrc.org Yennurajalingam S, Bruera E, eds. Oxford American hand- Society of Palliative Care Pharmacists book of hospice and palliative medicine. New York: Oxford www.palliativepharmacist.org Univ. Press; 2011. Curricular design resource Consensus recommendations from the Strategic Planning Summit for Pain and Pallliative Care Pharmacy Practice. J Pain Symptom Manage. 2012; 43:925-44.

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