Scope Of Hematology/ Oncology Pharmacy Practice
Scope of Hematology/Oncology Pharmacy Practice
HOPAHematology/Oncology Pharmacy Association8735 W. Higgins Road, Suite 300Chicago, IL 60631-2738www.hoparx.orgCopyright 2013 Hematology/Oncology Pharmacy Association
Notes and AcknowledgmentsThis document was written to define the scope of practice of hematology/oncology pharmacy within the United States,using U.S. laws and regulations governing pharmacy. However, regional or international laws and regulations could beapplied as appropriate to define the scope of practice outside the United States. The authors and HOPA Board membersthank peer reviewers Lily Leu, PharmD, Janet L. Espirito, PharmD BCOP, Virginia Spadoni, PharmD BCOP, and Amy HatfieldSeung, PharmD BCOP, for their thoughtful review and comments; the HOPA members for their comments and contributionsto the profession; and the HOPA staff for their editorial, project management, and publication contributions.3 HOPA SCOPE OF HEMATOLOGY/ONCOLOGY PHARMACY PRACTICE
Introduction and FoundationThe purpose of a healthcare scope of practice documentshould be to unify and establish a setting for demonstratingthe value of a profession in improving patient outcomes.Without a unified definition or scope of practice documentto support a profession, it is very difficult to demonstrateconsistent value and justify resources. Hematology/oncology pharmacy is a diverse specialty within health care,positively affecting patients across the cancer care continuum. The practice of hematology/oncology pharmacyvaries across different healthcare systems and practices,and a need to identify commonalities between divergentpractice settings, cultures, and patient populations remains.Although certification for oncology pharmacy exists (e.g.,board certified oncology pharmacist [BCOP]), it largelyreflects direct patient care activities. Many oncology pharmacists, however, perform activities or functions that falloutside of the board certification domains. The purpose ofthis scope of practice document is to describe the evolutionof hematology/oncology pharmacy and address the knowledge, skills, and functions of a hematology/oncology pharmacist (primarily related to direct patient care) to promotea better understanding of the profession. For the purposesof this document, hematology/oncology pharmacists will bereferred to as oncology pharmacists.History of Oncology PharmacySpecialty training in oncology pharmacy has been available since the 1980s through residency or fellowshiptraining programs. Residency programs offer an organized,directed postgraduate training in a defined area of pharmacy practice, whereas fellowships focus on preparing theparticipant to become an independent researcher.1 Residency training has evolved since its inception, includingestablishment and refining of accreditation standards, expansion of program offerings from sites other than collegesof pharmacy, and transition from multiple residency typesto a two-tier approach that requires a fundamental development program before specialization.2One way to unify a profession is to define criteria forcertification. Since 1998, the Board of Pharmacy Specialties (BPS) has defined criteria for board certificationin oncology pharmacy. Prior to the availability of boardcertification, some pharmacists functioned in a specializedcapacity within cancer care; however, no consistent training or established duties to dictate daily activities existed.In the 1990s, a small group of oncology specialty pharmacists representing the American Society of Health SystemPharmacists (ASHP) proposed certification based on thepremise that as a member of the cancer care team, oncology pharmacists possess specialized knowledge and training, ensuring optimal drug therapy, and bring a uniqueability and perspective to the patient care team (Board ofPharmacy Specialties, written communication, September 1992). Based on this proposal, the BPS acknowledgedoncology pharmacy as a specialty, and the first certification examination was offered in 1998. Continual effortsare used by BPS to ensure that certification examinationremains relevant and reflects current practice throughpeer-based recognition and exam content. A council ofexperts in each area of specialization works with BPSand psychometric consultants to develop the bank of testitems. The content of these items is developed by practitioners working in the field and is vetted for psychometricvalidity, ensuring a democratic examination with real-liferelevance. At least every 5 years, BPS conducts a roledelineation survey to identify any changes in practice thatmay require modification of the exam content. To date, thecontent domains for BCOP remain largely related to directpatient care, reflecting current practice patterns, but donot include all activities that oncology pharmacists mayperform (Appendix 1).3 As of February 2013, the numberof BCOPs worldwide is 1,289, includes people from 17countries, and continues to grow.4 Thirty-three percent ofpharmacists who have self-identified with a hematology/oncology interest have indicated they are BCOPs.5 Thesedata suggest that a large proportion of oncology pharmacists are not certified. BPS, in a white paper outlining their5-year vision for pharmacy specialties, envisions a futuremodel where board certification will be the expectationfor pharmacists engaged in direct patient care by 2017.6The reasons for not obtaining board certification may bemultifactorial (e.g., not recognized or required by employer, not able to meet the requirements for examination, doesnot reflect current job responsibilities, expense). Althoughboard certification represents an advanced level of oncologypharmacy practice, many oncology pharmacists performsimilar functions as a BCOP. The Hematology/OncologyPharmacy Association (HOPA) encourages certification butdoes not wish to minimize the experience, knowledge, andskills of those who are not board certified. Therefore, thisdocument was developed to identify commonalities amongoncology pharmacists in an effort to unify practice.History of the Hematology/Oncology PharmacyAssociationHOPA, a professional society for hematology/oncologypharmacists and associates, was launched in 2004. The goalof HOPA is to have an oncology pharmacist as an integralmember of the care team for all individuals affected by cancer. HOPA supports pharmacy practitioners and promotesand advances oncology pharmacy through (1) educational efforts, (2) development and endorsement of practicestandards to support roles and responsibilities of oncologypharmacists, (3) research, and (4) advocacy efforts. The4 HEMATOLOGY/ONCOLOGY PHARMACY ASSOCIATION
association comprises not only hematology/oncology pharmacists (regardless of board certification) but also pharmacyinterns, residents, fellows, nurses, technicians, researchers, administrators specializing in hematology/oncologypractice, students and other trainees, and other healthcareprofessionals with an interest in hematology/oncology.HOPA membership is primarily based in the United States,but it does include members from the around the world. In2010, the HOPA Foundation was created to support researchefforts of oncology pharmacists to further optimize the careof individuals affected by cancer.Also in 2010, HOPA updated its strategic plan, whichincluded a priority focused on developing HOPA as thesource for practice standards to support roles and responsibilities of oncology pharmacists.7 One objective of thatgoal area was to increase the understanding of oncologypharmacists’ scope of practice across the cancer care continuum. Therefore, the HOPA Board identified and invited10 HOPA members with varying backgrounds, practicesites, and geographical locations to form a task force todevelop the scope of practice document, representing thewide spectrum of practices within oncology pharmacy(see Appendix 2). This document was vetted for veracity on several levels and may be used in many differentaspects (see Table 1).Table 1. Uses for the HOPA Scope ofOncology Pharmacy Practice DocumentDefine or create job descriptions and responsibilitiesDefine educational offeringsDefine institutional competencies, standards, andcertificationDefine quality improvement activitiesDevelop and evaluate pharmacy service deliverysystems and organizational structuresEducate other healthcare professionalsProvide roles, challenges, and future directions ofprofessionSupport certification activitiesSupport health policy advocacyDefinitions and GoalsOncology pharmacy practice is a specialty practice areawithin the domain of pharmacy practice. To understandthe specialty of oncology pharmacy, it is important to firstunderstand the roles of individuals involved in pharmacypractice.DefinitionsPharmacistPharmacists represent a broad range of expertise and levelsof practice, skill, and responsibilities. Following graduation from a school of pharmacy, a pharmacist is licensedafter meeting the requirements of the state or jurisdictionin which the pharmacist wishes to practice. Usually thisinvolves passing a national board exam that assesses theknowledge gained in pharmacy school and experientialtraining, a drug law exam, and at least 1,740 hours of practice experience (see Pharmacy Trainee below). Some statesalso require additional laboratory or practice exams.8Once licensed, pharmacists may practice in a varietyof settings and perform various tasks, including interpretation, evaluation, and implementation of medicationorders; dispensing of prescription drugs; administrationof drugs (e.g., immunizations); participation in drug anddevice selection, drug utilization review, or drug-relatedresearch; and provision of patient counseling and medication therapy management.8 In addition, pharmacists areresponsible for compounding and labeling of drugs anddevices, proper and safe storage of drugs and devices,and maintenance of required records. Pharmacists mayalso provide patient care services through collaborativepharmacy practice agreements, whereby pharmacists havejoined to work in conjunction with physicians under protocol to provide optimal medication therapy and desiredpatient outcomes.9-15 This allows pharmacists to ordermedications under a physician’s supervision. Pharmacistsare also continually optimizing patient safety and qualityof services through effective use of emerging technologies(e.g., robotics, bar-code technology), competency-basedtraining, and continual participation in accredited educational activities to gain additional knowledge and skills.16Pharmacists may further specialize in an area of pharmacy practice beyond that which is required for licensure.17 For a pharmacist to gain the knowledge, skills, andcompetencies needed to perform a specialty pharmacyjob, several paths may be taken. A pharmacist may receiveon-the-job training, complete a postgraduate residency (1or 2 years), complete a postgraduate fellowship, or obtainadvanced specialty board certification. Current specialtiesrecognized by BPS include ambulatory care pharmacy,critical care pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, pediatric pharmacy,pharmacotherapy, and psychiatric therapy.185 HOPA SCOPE OF HEMATOLOGY/ONCOLOGY PHARMACY PRACTICE
Pharmacy TraineeAn internship in the United States, consisting of at least1,740 hours of experience gained during and/or afterpharmacy school completion and before licensure, isrequired by all state boards of pharmacy.8 During aninternship, the pharmacist intern practices directly undera licensed pharmacist. Additional on-the-job training mayoccur at the site where the intern practices.Pharmacy residents are also considered “trainees,” andstandards exist for these training programs as well. ASHPhas established an accreditation program for residencies inthe United States. Accreditation is currently optional buthighly recommended. Accreditation establishes standardsby which all programs are measured and held accountable.It also allows for a unified understanding of what activities graduates from accredited programs are competent toperform.Residency training is designed to formalize and condense on-the-job training experiences. Currently, thepostgraduate year-1 (PGY-1) pharmacy residency trainingenhances general competencies in managing medicationtherapy outcomes for a broad range of disease states,managing pharmacy operations, and fostering leadershipskills.19 Postgraduate year-2 (PGY-2) residency trainingis designed to build upon the competencies developedin the PGY-1 residency; increase the trainee’s depth ofknowledge, skills, and medication management abilities ina focused area of practice (e.g., oncology, nutrition support, ambulatory care); and, when available, prepare thepharmacist for board certification.20 Pharmacy fellowshipsare highly individualized postgraduate training programsdesigned to develop competency and expertise in the scientific research process and practice skills relevant to conducting research related to a particular knowledge area.21Oncology PharmacistsThe specialty of oncology pharmacy incorporates all of theknowledge, skills, and expertise of pharmacy practice, witha focus and skill set that are specific to the area of oncology.Like pharmacists in general, oncology pharmacists represent a broad range of expertise and levels of practice, skills,and responsibilities. The standard path to gain the knowledge, skills, and expertise required in oncology pharmacy isthrough specialty residency training (described in the nextparagraph). The only available formal method to assess anoncology pharmacist’s knowledge, as it relates to the fourcontent domains, is through the BCOP examination (Appendix 1).3 A BCOP, per BPS, recommends, designs, implements, monitors, and modifies pharmacotherapeutic plansto optimize outcomes in patients with malignant diseases.22This represents a high level of expertise and is primarily focused on direct patient care activities, while incorporatingother important aspects of practice (e.g., medication safety,formulary management, and guideline and policy develop-ment/implementation).22 Although “competence” includesknowledge, skills, and abilities to perform tasks, not allof these aspects are tested by the BPS process. The BCOPdesignation signifies that the person has met a rigorousstandard above and beyond the usual training. Currently,certification is largely optional and not required in manysettings.To become an oncology pharmacist, two general pathsmay be taken (see Figure 1).22 One path represents a formalized progression through a PGY-1 residency program,then a PGY-2 oncology specialty residency, then 1 year ofexperience with more than 50% time spent in oncologypharmacy activities, followed by successful completion ofthe BCOP examination. Once these steps are completed, thepharmacist is then recognized as a BCOP. The other general path to practice in oncology pharmacy may consist of acombination of traditional, nontraditional, formal, informal, validated, and invalidated steps. This path may leadto board certification if all of the eligibility criteria are metto sit for the exam (see below), or it may not lead to boardcertification at all. Because these steps are not standardized,there is no way to easily ascertain the knowledge of anindividual taking this path unless he or she becomes boardcertified. Whether to become board certified is an individual decision that is often driven by both professional andpersonal reasons.Common practice settings for oncology pharmacistsinclude, but are not limited to, a cancer center, academic medical center, outpatient oncology center or infusioncenter, medical oncology community practice, communityretail pharmacy, managed care organization, home healthcare company, specialty or mail-order pharmacy, palliativecare or hospice setting, professional/regulatory/advocacyorganization, and the pharmaceutical industry.Knowledge, Skills, and Functions of anOncology PharmacistThe role of the oncology pharmacist is strikingly broad andincreasingly complex. Attempting to define the oncologypharmacist is a challenge because roles vary at the international, national, local, institutional, and even individuallevel. The scope of the position and the functions thatdefine it may be as varied as the individuals who practiceit. The only available formalized standards of practice arethe PGY-2 residency standards for oncology pharmacy andthe BCOP examination content domains. Table 2 provides ageneral summary of select core functions that contribute tothe role of the oncology pharmacist; however, many oncology pharmacists perform additional functions.3,23PGY-2 residencies in oncology are available, many ofwhich are accredited by ASHP. ASHP-accredited programs are designed to meet the needs of the specialty. Each6 HEMATOLOGY/ONCOLOGY PHARMACY ASSOCIATION
Figure 1. Pathways to Specialization in Oncology Pharmacy22 Green circles depict formal steps toward certification and practicing as an Oncology Pharmacist. Light green circles depict other (informal) steps toward certification and practicing as an Oncology Pharmacist. Orange circles depict requirements to sit for the BCOP exam (as defined by BPS); these are individually reviewed upon application for examination.PGY-1 Residency(After 2007, PGY-1required for PGY-2)1 yearPGY-2 ion as aBoard CertifiedOncologyPharmacist(BCOP)***Pharmacy school graduate andlicensed registered pharmacist(new or practicing) Pass licensure exam internship hours /- lab/ practice exam4 years practice**NoPostgraduateTrainingMay be working towardcertificationOther Postgraduate Training PGY-1 Residency PGY-2 Non-OncologyResidency Fellowship (researchfocused) Any combination ofaboveOncology PharmacistAbbreviations: PGY-1, postgraduate year 1 residency; PGY-2, postgraduate year 2 residency; BCOP, board-certified oncology pharmacist; BPS, Board of Pharmacy Specialties.* Effective January 1, 2013, only residencies accredited by the American Society of Health-System Pharmacists (ASHP) or residency programs that are under active consideration foraccreditation by ASHP are creditable for this purpose.** At least this amount of years as a practicing pharmacist with at least 50% of time spent in oncology pharmacy activities (as defined by the BPS oncology-pharmacy content outline).*** Certification currently not required but preferred for an oncology pharmacist position.ASHP-accredited oncology residency program is designedto prepare the graduate to (1) serve as an authoritativeresource on the optimal use of medications used to treat individuals with cancer; (2) optimize the outcomes of the careof individuals with cancer by providing evidence-based,patient-centered medication therapy as an integral partof an interdisciplinary team; (3) manage and improve themedication-use process in oncology patient care areas;(4) demonstrate excellence in the provision of trainingor educational activities for healthcare professionals andhealthcare professionals in training; (5) promote healthimprovement, wellness, and cancer prevention; (6) sustainthe ongoing development of expertise and professionalismin the practice of oncology pharmacy; (7) conduct oncologypharmacy practice research; and (8) function effectively inoncology settings participating in clinical investigations.23Recognizing the value of on-the-job training, the qualifications for BCOP include emphasis on oncology pharmacy experience, including either 4 years of practice with atleast 50% of time spent in oncology pharmacy activitiesor a graduate of a PGY-2 oncology residency plus 1 additional year of practice with at least 50% of time spent inoncology pharmacy activities (see Figure 1).22 The definition of oncology pharmacy activities includes the fourcontent domains of the BPS Oncology Pharmacy Exam: (1)clinical skills and therapeutic management (60%); (
oncology pharmacists in an effort to unify practice. History of the Hematology/Oncology Pharmacy Association HOPA, a professional society for hematology/oncology pharmacists and associates, was launched in 2004. The goal of HOPA is to have an oncology pharmacist as an integral member of the care team for all individuals affected by can-cer.
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