Pharmacy Services in Solid Organ Transplantation

476 Medication Therapy and Patient Care: Specific Practice Areas–Guidelines ASHP Guidelines on Pharmacy Services in Solid Organ Transplantation Evidence of pharmacists’ contributions to the care of organ the American College of Clinical Pharmacy Immunology/ transplant recipients has existed since the 1970s. Since then, Transplantation Practice and Research Network, developed literature describing pharmacist’s impact on clinical and a white paper that provided a blueprint for the training and pharmacoeconomic outcomes has grown exponentially,1-14 qualifications of pharmacists working in transplant patient with pharmacists establishing themselves as integral members care and detailed the contributions of pharmacists serving of the transplantation community and expanding their the transplantation population.21 These guidelines augment presence in multiple areas, including pharmaceutical industry, the previously published work by promoting understanding research, academia, quality improvement, and clinical of the evolving role of pharmacists’ contribution to the care settings.15-20 Transplant pharmacists (sometimes referred to as of transplant recipients and living donors, helping define clinical transplant pharmacists or solid organ transplantation the role of the transplant pharmacist, suggesting goals for pharmacists) have a strong presence in the areas of pharmaco- providing services to meet institution-specific needs, and genomics, innovative collaborative drug therapy management describing best practices for transplant pharmacy services. (CDTM), and prospective practice management. These guidelines were developed based on primary litera- The United Network for Organ Sharing (UNOS) and ture, expert consensus on best practices, and CMS and Organ the Centers for Medicare & Medicaid Services (CMS), re- Procurement and Transplant Network (OPTN) bylaws, and spectively, require transplantation centers document the are meant to aid transplant pharmacists, administrators, phy- participation of a clinical transplant pharmacist or pharma- sicians, surgeons, allied health professionals (e.g., nurses, cology expert on multidisciplinary transplantation teams dietitians, financial coordinators, business managers), ac- in order to meet accreditation standards. These regulations creditors, surveyors, and others with a need to understand make transplant pharmacy the only pharmacist specialty transplant pharmacy services. practice in the United States to have such a requirement.21-24 Although the nature of these services are unique to These mandates outline the responsibilities of the transplant each solid organ and with each institution’s protocols and pharmacist in preoperative and postoperative pharmaceuti- resources, these guidelines describe both transplant pharma- cal management and education of transplant recipients. In cist services that meet the minimum required by regulations response to the demand for pharmacists to meet these ac- (as of publication) as well as optimal services. In conjunc- creditation standards, some transplantation programs may tion with pharmacy, transplant surgery, and medicine admin- meet the need by utilizing pharmacists without specific istrators, each transplant pharmacist should use his or her transplantation training or experience due to lack of fully professional judgment to individually weigh the factors that trained personnel or funding resources. determine which services should be provided. These fac- As of 2016, there were over 30,000 solid organ trans- tors include the patient populations served, the number of plantations performed annually in the United States, and pharmacists and time dedicated to services provided to the over 500,000 have been performed since the year 2000.25 care of transplant patients, whether corresponding duties Despite the volume of transplantations per year, there was are required of transplant pharmacists in other areas of the a median of 1.4 transplant pharmacist full-time equivalents hospital, and the extent of time dedicated to administrative, (FTE) per 100 transplantations performed, according to a na- research, and quality endeavors. Finally, it should be noted tional workforce survey conducted by the American Society that the many responsibilities described in these guidelines of Transplantation across accredited U.S. transplantation could not be provided by a single pharmacist. When used programs.26 The median number of FTE did not increase in these guidelines, the term transplant pharmacist should beyond 1.4 FTE even in programs with >400 transplanta- not be interpreted to imply that a single pharmacist could or tions per year. These data indicate that transplant pharmacy should be expected to provide every service described. services are provided by nonspecialists in many of these programs. Currently, there is no standard of practice for Pharmacy Services in the the provision of transplant pharmacy services, as the CMS Pretransplantation Phase Conditions of Participation allow for a broad interpretation for how to best meet the needs for each patient.27 This broad The pretransplantation phase includes all activities related interpretation allows for a wide spectrum of transplant phar- to the assessment and evaluation of a donor or candidate’s macy services, with some centers providing a more inclusive readiness for transplantation and the execution of any plans model than others. This variability has led to recent CMS to increase a donor or candidate’s success. This includes citations during program-specific surveys when the pharma- the initial assessment and any re-evaluation that may occur cists involved in the care of transplant patients and donors during the waiting list period, as described in Appendix A. were unable to provide sufficient evidence of qualifications, training, and expertise in transplantation. Pharmacologic Evaluation. At a minimum, a transplant pharmacist should be present during the multidisciplinary Purpose patient selection committee meeting. Transplant pharmacists are expected to present an objective assessment of the In 2011, the American Society of Transplantation, Transplant candidate’s pharmacologic and nonpharmacologic risks Pharmacy Community of Practice, in collaboration with pertaining to transplantation.28,29 Although each assessment Medication Therapy and Patient Care: Specific Practice Areas–Guidelines 477 should be tailored to the individual patient, an assessment pretransplantation phase through inpatient discharge from of anticoagulation, drug interactions, medications related the transplantation encounter. Transplant pharmacists to mental health, medications for chronic pain, medication work with healthcare professionals in all settings of care allergies, hormonal contraception and replacement therapy, to ensure a seamless medication-use process, provision current use of immunosuppressants or immunomodulators, of transplantation medication education, and discharge issues with drug absorption, illicit substance use or abuse, planning through each transition of care.21,22 and use of herbal supplements or nutraceuticals should be completed. Although not universal, an assessment of im- Direct Patient Care of the Transplant Recipient. Transplant munologic risk as it pertains to induction therapy selection pharmacists are charged with providing comprehensive and need for desensitizing therapies during the selection pharmacy services to transplant recipients during the peri- meeting provides an opportunity to discuss protocol versus transplantation hospitalization.1,2,27,29 Activities routinely off-protocol decisions and may expedite the perioperative performed as part of this suite of services are outlined in immunosuppressant selection process. The impact of cur- Appendix A. In 2015, the transplant pharmacist workforce rent pharmacologic therapies on pretransplantation testing was surveyed to enumerate several data points, including (i.e., false-positive drug screens, timing of vaccinations in perioperative pharmacy services performed.26 Notably, the relation to antibody titers) and peri- and post-transplantation vast majority of the surveyed pharmacists routinely per- risks should be discussed at this time. formed medication and laboratory review, recommended changes to both transplantation-related and unrelated medi- Nonpharmacologic Evaluation. In addition, an assessment cations, performed bedside rounding as part of the multidis- of nonpharmacologic risks and socially related risks ciplinary team, and provided medication education to the should be presented, in conjunction with members of the transplant recipient. As part of comprehensive pharmacy multidisciplinary team, including transplant social workers services, the transplant pharmacist serves as the medication and financial coordinators.28,29 Transplant pharmacists are expert, provides drug information to all members of the team well-suited to identify gaps in health literacy, markers of (including information regarding drug-drug interactions), medication nonadherence, and preexisting intolerances and and participates in collaborative decision-making, especially adverse effects to pharmacotherapy that may affect post- at the bedside, for the transplant recipient. transplantation immunosuppressant adherence. Along with Certain medications used for induction and mainte- financial coordinators, pharmacy technicians and community/ nance therapy as well as in the treatment for rejection warrant specialty pharmacy partners, transplant pharmacists should restrictions

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