ASHP Guidelines on Pharmacy Services in Solid Organ Transplantation

Abstract

Evidence of pharmacists’ contributions to the care of organ transplant recipients has existed since the 1970s. Since then, literature describing pharmacist’s impact on clinical and pharmacoeconomic outcomes has grown exponentially,1–14 with pharmacists establishing themselves as integral members of the transplantation community and expanding their presence in multiple areas, including pharmaceutical industry, research, academia, quality improvement, and clinical settings.15–20 Transplant pharmacists (sometimes referred to as clinical transplant pharmacists or solid organ transplantation pharmacists) have a strong presence in the areas of pharmacogenomics, innovative collaborative drug therapy management (CDTM), and prospective practice management. The United Network for Organ Sharing (UNOS) and the Centers for Medicare & Medicaid Services (CMS), respectively, require transplantation centers document the participation of a clinical transplant pharmacist or pharmacology expert on multidisciplinary transplantation teams in order to meet accreditation standards. These regulations make transplant pharmacy the only pharmacist specialty practice in the United States to have such a requirement.21–24 These mandates outline the responsibilities of the transplant pharmacist in preoperative and postoperative pharmaceutical management and education of transplant recipients. In response to the demand for pharmacists to meet these accreditation standards, some transplantation programs may meet the need by utilizing pharmacists without specific transplantation training or experience due to lack of fully trained personnel or funding resources. As of 2016, there were over 30,000 solid organ transplantations performed annually in the United States, and over 500,000 have been performed since the year 2000.25 Despite the volume of transplantations per year, there was a median of 1.4 transplant pharmacist full-time equivalents (FTE) per 100 transplantations performed, according to a national workforce survey conducted by the American Society of Transplantation across accredited U.S. transplantation programs.26 The median number of FTE did not increase beyond 1.4 FTE even in programs with >400 transplantations per year. These data indicate that transplant pharmacy services are provided by nonspecialists in many of these programs. Currently, there is no standard of practice for the provision of transplant pharmacy services, as the CMS Conditions of Participation allow for a broad interpretation for how to best meet the needs for each patient.27 This broad interpretation allows for a wide spectrum of transplant pharmacy services, with some centers providing a more inclusive model than others. This variability has led to recent CMS citations during program-specific surveys when the pharmacists involved in the care of transplant patients and donors were unable to provide sufficient evidence of qualifications, training, and expertise in transplantation. In 2011, the American Society of Transplantation (AST) Transplant Pharmacy Community of Practice, in collaboration with the American College of Clinical Pharmacy (ACCP) Immunology/Transplantation Practice and Research Network, developed a white paper that provided a blueprint for the training and qualifications of pharmacists working in transplant patient care and detailed the contributions of pharmacists serving the transplantation population.21 These guidelines augment the previously published work by promoting understanding of the evolving role of pharmacists’ contribution to the care of transplant recipients and living donors, helping define the role of the transplant pharmacist, suggesting goals for providing services to meet institution-specific needs, and describing best practices for transplant pharmacy services. These guidelines were developed based on primary literature, expert consensus on best practices, and CMS and Organ Procurement and Transplant Network (OPTN) bylaws, and are meant to aid transplant pharmacists, administrators, physicians, surgeons, allied health professionals (e.g., nurses, dietitians, financial coordinators, business managers), accreditors, surveyors, and others with a need to understand transplant pharmacy services. Although the nature of these services are unique to each solid organ and with each institution’s protocols and resources, these guidelines describe both transplant pharmacist services that meet the minimum required by regulations (as of publication) as well as optimal services. In conjunction with pharmacy, transplant surgery, and medicine administrators, each transplant pharmacist should use his or her professional judgment to individually weigh the factors that determine which services should be provided. These factors include the patient populations served, the number of pharmacists and time dedicated to services provided to the care of transplant patients, whether corresponding duties are required of transplant pharmacists in other areas of the hospital, and the extent of time dedicated to administrative, research, and quality endeavors. Finally, it should be noted that the many responsibilities described in these guidelines could not be provided by a single pharmacist. When used in these guidelines, the term transplant pharmacist should not be interpreted to imply that a single pharmacist could or should be expected to provide every service described. The pretransplantation phase includes all activities related to the assessment and evaluation of a donor or candidate’s readiness for transplantation and the execution of any plans to increase a donor or candidate’s success. This includes the initial assessment and any re-evaluation that may occur during the waiting list period, as described in Appendix A. At a minimum, a transplant pharmacist should be present during the multidisciplinary patient selection committee meeting. Transplant pharmacists are expected to present an objective assessment of the candidate’s pharmacologic and nonpharmacologic risks pertaining to transplantation.28,29 Although each assessment should be tailored to the individual patient, an assessment of anticoagulation, drug interactions, medications related to mental health, medications for chronic pain, medication allergies, hormonal contraception and replacement therapy, current use of immunosuppressants or immunomodulators, issues with drug absorption, illicit substance use or abuse, and use of herbal supplements or nutraceuticals should be completed. Although not universal, an assessment of immunologic risk as it pertains to induction therapy selection and need for desensitizing therapies during the selection meeting provides an opportunity to discuss protocol versus off-protocol decisions and may expedite the perioperative immunosuppressant selection process. The impact of current pharmacologic therapies on pretransplantation testing (i.e., false-positive drug screens, timing of vaccinations in relation to antibody titers) and peri- and post-transplantation risks should be discussed at this time. In addition, an assessment of nonpharmacologic risks and socially related risks should be presented, in conjunction with members of the multidisciplinary team, including transplant social workers and financial coordinators.28,29 Transplant pharmacists are well-suited to identify gaps in health literacy, markers of medication nonadherence, and preexisting intolerances and adverse effects to pharmacotherapy that may affect post-transplantation immunosuppressant adherence. Along with financial coordinators, pharmacy technicians and community/specialty pharmacy partners, transplant pharmacists should be involved in conversations regarding pharmacy benefit and out-of-pocket medication costs and proactively understand the specific distribution requirements of each patient’s pharmacy benefit manager. Along with the initial assessment, a thorough mitigation plan, when warranted, should be presented, along with any risks identified. Risks may be identified in one of two ways. The first is a basic chart review, which includes assessing the demographics of the patient (age, race, height, weight, body surface area, body mass index, distance from transplantation program, type of insurance), basic vitals, a complete medication list (including nonprescription medications, dietary supplements, and herbal remedies) and immunologic history (cause of end-stage organ disease, calculated panel reactive antibody, unacceptable antigens, deceased versus live-donor transplant). This type of review is limited in the breadth of information available and in its dependence on the accuracy of information provided. A more comprehensive face-to-face assessment includes the elements of the basic chart review and may include a health literacy assessment, an interview to elucidate barriers to adherence, accuracy of the medication history, and provision of initial medication education. of transplant pharmacy services in the pretransplantation meet the requirements for individual centers based on developed in with CMS Conditions of Participation and in the care of a patient a transplant is to from the pretransplantation phase from the transplantation Transplant pharmacists work with professionals in all of care to a provision of transplantation medication and each of Transplant pharmacists are with providing comprehensive pharmacy services to transplant recipients during the performed as of this of services are in Appendix A. In the transplant pharmacist workforce was to data including perioperative pharmacy services the of the pharmacists performed medication and review, to both and medications, performed as of the multidisciplinary team, and provided medication education to the transplant As of comprehensive pharmacy services, the transplant pharmacist as the medication provides drug information to all members of the (including information regarding and in collaborative at the for the transplant medications used for induction and therapy as well as in the for on use per The role of the transplant pharmacist may on the and of medications, such as and and of (e.g., to patient and a presence the of optimal therapy, and in a the it is that transplant pharmacists be provided or factors to include the of the transplant pharmacist’s clinical duties information (e.g., order as well as the and with or The of living related and of and is factors to this and and the of transplantation. The transplant pharmacist is for providing comprehensive pharmacy services to the living donor as well as the transplant These services include and and education on the expertise of the transplant pharmacist is to medication to the risk to the or to its health and Transplant pharmacists are required members of the multidisciplinary transplant Transplant pharmacists provide services to the team, as described in Appendix A. collaboration with all members of the should be by the transplant pharmacist. In to participation in preoperative evaluation and as a of the patient selection the transplant pharmacist with their primary and as well as with in the perioperative to to as described collaboration with the transplantation social financial and others should be to medication to and on work during the When collaboration on with members of the provide patients with to As described by and to pharmacotherapy is with which is to decisions regarding medication by CMS in the United States on the and are for in transplantation and are in transplantation. to medications for and patient by The transplant pharmacist with transplant coordinators, social coordinators, and to for and to such medications multiple to include and pharmaceutical and others and should be by members of the transplant in with a transplant pharmacist. transplant pharmacists provide information to the of both in drug information and the A practice in transplantation is the of and specialty pharmacy transplant pharmacists are integral in the of the initial of medications of medications is for education (including the use of of medication and of the accuracy of and (i.e., versus This in of barriers to medications, such as the need for or need for patient programs. As the medication the transplant pharmacist is the on the multidisciplinary to provide or education to the and As described to the post-transplantation is related to organ education medication adherence, education the transplant pharmacist provides medication education to the and and the of understanding or such as include which may include or for or patients, medication training, and on CMS the for evidence of comprehensive pharmacy services provided to individual transplant recipients and transplant pharmacist in multidisciplinary In the perioperative period, the transplant pharmacist is required to their multidisciplinary care at minimum how the transplant pharmacist is involved in the transplant phase and phase of care for each transplant Transplant pharmacists should be to provide evidence of collaboration on sufficient and understanding of patient and education to and the medication of and expected is that there is evidence of the transplant pharmacist’s in the transplant and phase of transplantation is the of transplant pharmacists are in the management of transplant recipients. transplant recipients should have to a transplant pharmacist for the of their and the transplant pharmacist be of the multidisciplinary providing care to transplant patients, as described in Appendix A. and and are integral of the transplant pharmacist. As transplant pharmacists from a model to a role that prospective and participation on and in the is of patient care participation in selection and of medication and mitigation of adverse and of education regarding and of practices by the and teams at the time of is an expected of pharmacotherapy provided by a transplant pharmacist. The is to be present during and and a of the multidisciplinary on the number of patients and their these activities may be tailored to on the patients or on medications that a risk of patient when are used in are with of adverse or the activities may be based on a developed with or without clinical of the transplant pharmacist’s activities during the and with the multidisciplinary be to of care from the to as well as from each to the In to the management of transplantation the selection and of postoperative and in is a standard role for transplant and guidelines, centers each have their specific the of are with or require and medication in the are a when or medications, in for which are the of These medications have with and of and be both when are and when are and when are services provided by the transplant pharmacist that the of transplantation are drug therapy to other and providing patients with the need to understand their medication to medication expertise is an integral of patient adherence, and and such education the transplant to provide care to each patient therapy be in a number of and these according to the practice at a A of is during multidisciplinary patient care and patient care in the order and use of collaborative practice protocols as members of the transplantation medication to patients and their may include use of and medication medication during and The provision of medication education is an in transplantation. this education is provided by transplantation coordinators, dedicated or pharmacy in to transplant the primary education is provided by other than a transplant pharmacist, the transplant pharmacist should as the of the of the of medication adherence. Although this is provision of education in the post-transplantation phase is for the patient’s as well as assessment of the patient’s needs over time. pharmaceutical education the of care is a service each should The transplant pharmacist has the and to each in with At a minimum, the transplant pharmacist should provide education during the or from the transplantation include provision of education on adverse and goals of therapy of transplantation and A or should be to from and education on areas of should be provided on an in the post-transplantation should be provided beyond the post-transplantation time period, at transplantation at a minimum, more to adherence. activities that transplant pharmacists should be involved with or in a role include of transplantation medications, education on use of such as medication of medication use of medication of health and aid from the transplantation for medication medication or as well as the health Transplant pharmacists an integral role in the and of post-transplantation These protocols should not only the postoperative include care the of the collaborative practice and the transplant pharmacist is involved in of post-transplantation care to in with each The need to from protocols due to factors is a The transplant pharmacist is to identify adverse drug effects identified both and patient of protocol from a or from a or programs identify areas of need for protocol and When adverse drug effects are the transplant pharmacist is involved in and face-to-face patient regarding and of Evidence of therapy management and patient education in all should be the The of care from the transplantation to the post-transplantation is a for the transplant patient to The transplant pharmacist a role in patient and meeting The optimal model is for transplant pharmacists to have in medication from the to the transplantation to information and patient are medication during the which may due to and related to and patient Transplant pharmacists as a for medication medication and patient with optimal and medication patients are at risk for and chronic of protocols for the management of and chronic or is an integral role of the transplant or in each organ the transplant pharmacist be with the specific to each organ of these of These are and should only be used when and of the transplant pharmacist should the medication the transplant patient are to patient from disease, the of transplantation. such as and are the of these many of the medications for transplantation these As transplantation centers and transplant patients the need for transplantation to and collaborative practice many of these be by a transplant pharmacist along with The transplant pharmacist has the to medications and best practices to Transplant pharmacists in the care of patient populations as described in Appendix A. In a transplant pharmacist may have impact on the care provided to patients, the risks and unique issues with this transplant recipients present pharmacology such as an evolving in and of and many of these transplant pharmacists for patients need to be in of and patients may require not and transplant pharmacists as a for and for Along with pharmacology transplant recipients have and barriers unique to this Transplant pharmacists have a role in the and care of transplant recipients. A transplant pharmacist’s responsibilities include and assessment of and participation in of nonadherence, of education with and patients medication to and participation in to or this may be to for Transplant pharmacists with to including that chronic effects of transplantation is not and it is that transplant pharmacists have a role in and These should be by both transplantation and in are to medications that are due to limited data regarding during or care of patients or are transplant pharmacists should work with transplant to a for to a for including a that for the in of that occur as a and provide education to patients regarding their including such as medication transplant pharmacists in the care of of is the provision of risk evaluation and mitigation and elements to use education for As of transplantation medication transplant pharmacists provide education regarding timing of and to transplant pharmacists work with transplant and teams for management during and The breadth and of the transplant is and as the and medication management the transplant pharmacist. such as and patients, as well as patients with multiple require of transplant and the to the of best practices to the The transplant pharmacist is to provide patients with the optimal care in these to the requirements unique to transplantation transplant pharmacists many as described in Appendix A. As integral members of the multidisciplinary transplantation team, transplant pharmacists have the that allows to and transplantation and to quality and a of care for all transplant recipients and Transplantation is the of all pharmacy is that transplant pharmacists with the requirements in all of transplantation based on their which be in with As members of the multidisciplinary have in all of transplantation and transplant pharmacists are to have a role in of collaborative practice and Transplant pharmacists have been in of protocols to and and to transplantation as a for is an that transplant pharmacists quality related to pharmaceutical including not limited to the evaluation of adverse drug and in with and and transplant pharmacists from the have transplantation quality and the are to this unique their experience clinical research, of adverse and care during the and post-transplantation and transplantation protocol and review is to quality of review of and transplant pharmacists use and data to and and transplant of and immunosuppressant have been In addition, transplant pharmacists are in a unique to aid in of guidelines and protocols to and and the and issues that transplantation as a of post-transplantation are required as of for transplant pharmacists for transplant recipients. The transplantation pharmacy community is to pharmacist and in this specialty to the of clinical expertise is transplant pharmacists from to Transplant pharmacists are expected to and quality related to clinical as described in Appendix A. of include transplant pharmacist professional on a and national as well as including research, of and and of pharmacy for the and professional of transplant include the of Clinical and on the Immunology/Transplantation Practice and Research Network, the Transplant Pharmacy Community of Practice, and the Society for and Transplantation on Pharmacy and These are transplantation that during on and and provide In to the of these transplant pharmacists have for not only the the including such as Transplant pharmacists have been to on the of as well as and committee are to the work of the and provide in areas of and The of Pharmacy solid organ transplantation pharmacy as a specialty in is that practice a pharmacy specialty has been by the should in the specialty an be to the needs of current as an increase in the number of education and training in transplantation for pharmacists as well as pharmacy and Transplant pharmacists have in the education of other that in the transplant pharmacy of pharmacy have on with many pharmacy first to the or pharmacy practice or on is an to transplant pharmacy as a specialty for training of pharmacists provides a of and are in this specialty and to quality care of the transplant are year training programs as well as two in transplantation. 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