The first published report of a dedicated pharmacist assigned to a transplant team appeared in the literature more than 25 years ago, in a 1976 case report on a renal transplant program published in the American Journal of Hospital Pharmacy.

Rita Alloway, PharmD, FCCP, BCPS, director of transplant clinical research at the University of Cincinnati, participating in a study visit with a post-renal transplant recipient enrolled in a clinical trial. As principal investigator, she is responsible for trial conduct and oversight along with many of the transplant team members.

For at least 20 years, specialty training in transplant pharmacy has been available—one of the earliest programs, at the University of Tennessee, was launched in the early 1990s by transplant pharmacist Rita Alloway, PharmD, FCCP, BCPS, now a research professor and the director of transplant clinical research at the University of Cincinnati. Currently, there are about 25 such programs.

But it has only been during the last five to 10 years that transplant pharmacy has truly begun to take off as a specialty. That’s largely the result of two major policy changes: In 2004, the United Network for Organ Sharing (UNOS) bylaws recognized pharmacists as an essential part of the patient care team, and in 2007, the Centers for Medicare & Medicaid Services (CMS) issued the mandate that, to qualify for reimbursement, every transplant program must include a designated, qualified expert in transplant pharmacology. (CMS does not specifically stipulate that this person must be a pharmacist, but in practice that’s how the role has been filled.)

Since then, the American Society of Transplantation (AST) has added a pharmacy group to its Communities of Practice; the group now has more than 160 members. The American College of Clinical Pharmacy (ACCP) now has a Practice and Research Network (PRN) devoted to immunology and transplantation, which grew from 170 to 332 members between 2004 and 2011. The American Society of Health-System Pharmacists (ASHP) holds an immunology/transplant networking session at each of its midyear clinical meetings. And as recently as last fall, the International Society for Heart & Lung Transplantation (ISHLT) added a Council on Pharmacy and Pharmacology.

Estimates put the number of dedicated transplant pharmacists currently practicing somewhere between 250 and 500, said Christin Rogers, PharmD, FCCP, BCPS, the clinical pharmacy coordinator for solid organ transplant at Beth Israel Deaconess Medical Center, in Boston. But even with all of this growth, the role of the transplant pharmacist is still evolving—and it isn’t always well defined.

“As far as CMS goes, none of the responsibilities of the transplant pharmacist are in black and white anywhere that you can read,” said Steven Gabardi, PharmD, FCCP, BCPS, an abdominal organ clinical transplant specialist at Brigham and Women’s Hospital and an assistant professor of medicine at Harvard Medical School, in Boston. “In our last CMS review, we got dinged as ‘deficient’ because I wasn’t seeing pretransplant patients as part of my day-to-day caseload, and they wanted more documentation of my presence in rounds. But other centers with the exact same practices have gotten a good review. It all depends on the review team.”

Meanwhile, Dr. Gabardi told Pharmacy Practice News, CMS showed little to no interest in the transplant pharmacist’s role in ambulatory care. “That’s the piece that takes up the biggest part of my day. I spend 30 hours a week in our post-transplant ambulatory care setting, following up with patients. But CMS has no stipulations on this; they just define our role as pretransplant and immediately post-transplant.”

Last year, a group of transplant pharmacists from the AST Transplant Pharmacists Community of Practice and the ACCP’s Immunology/Transplantation PRN, led by Nicole Weimert Pilch, PharmD, a clinical specialist in solid organ transplantation at the Medical University of South Carolina (MUSC), Charleston, published a paper in the American Journal of Transplantation, seeking to define the role of the transplant pharmacist.

The transplant pharmacist, as they described, is a true Renaissance clinician, who must “know how to care for the whole transplant patient, not just the new allograft. Oftentimes, this involves optimizing pharmacotherapy from the intensive care unit to the ambulatory care clinic for adult and pediatric patients. Knowledge of drug delivery, pharmacoeconomics, drug information, drug literature evaluation, statistics, immunology, pharmacokinetics, pharmacology, pharmacogenomics, pathophysiology, pharmacotherapy, pharmacovigilance, regulatory standards and safety are a necessity. Transplant pharmacists have substantial knowledge regarding novel and traditional immunosuppression, but they must mesh this with other pharmacotherapy knowledge in areas such as infectious diseases, cardiology, hepatology, nephrology, pulmonology, endocrinology, hematology, pediatrics and critical care to optimize outcomes in patients with multiple comorbidities.”

In other words, the transplant pharmacist is the ultimate multispecialty specialist, who must have practical expertise in virtually every condition that a transplant patient may present with or acquire along the way.

“Obviously, a lot of our role is direct patient care,” said David Taber, PharmD, BCPS, who directs the solid organ transplant pharmacy residency at MUSC, which now has 3.3 full-time equivalent transplant pharmacy positions in addition to its residents. “Even when a patient first comes into the clinic to determine if they’re an acceptable candidate for transplant, we meet with the patient and do an assessment. On the inpatient side, we are very proactive about coordinating care, verifying all the medical reconciliations the team does on both admission and discharge, and making sure that all the medications dispensed during their stay are appropriate. Most of the medications they get after transplant, they fill at our pharmacy, and we work very closely with our inventory staff to get their medications procured and deal with any prior authorizations.”

David Taber, PharmD, BCPS, training a solid organ transplant pharmacy resident at the Medical University of South Carolina.

Sometimes, the transplant pharmacist must act as an advocate for patients within pharmacy itself, said Eric Tichy, PharmD, BCPS, a clinical pharmacy specialist in solid organ transplantation and director of the transplant pharmacy residency at Yale-New Haven Hospital, in Connecticut. “These patients are special. Their medications absolutely have to be there on time. We can’t afford to have patients miss doses because things aren’t there.”

In the outpatient phase, the transplant pharmacist is particularly involved during the acute period one to three months after discharge. “During this time period, they’re very high risk. There are a lot of medication changes still going on, and the patient is still learning them, so there’s a high risk for medication errors or adverse events,” according to Dr. Taber. “In our program, the transplant pharmacist will see the patient on every appointment during the acute post-discharge phase and review all their meds with them. Further out, we act more on a consultant level, just because of sheer manpower issues. We have a couple of thousand post-transplant patients, and we just can’t see every one every time.”

It’s not a 9-to-5 job, stressed Dr. Rogers. “You come in before most other people do and leave much later because the questions never stop.” She begins her day by reviewing all the previous night’s admissions, to ensure that the patients are all on the appropriate medications. She noted that although it is always essential, this function is particularly important in institutions such as hers that perform transplants in the HIV-positive population.

“The pharmacist not only plays a key role in figuring how to appropriately dose the tacrolimus in the perioperative period, but they also must be involved when there are changes in the HIV patients’ antiretroviral [ARV] regimen,” Dr. Rogers said. “For example, if an HIV patient developed resistance to a raltegravir [Isentress, Merck]-based ARV regimen and had to be changed to a protease inhibitor–based regimen, the patient’s weekly tacrolimus dose would have to be decreased by close to 99% to account for the drug interaction.”

Patient education is another key component of the transplant pharmacist’s role. Dr. Rogers meets with each patient two or three times to discuss all their medications and how they will incorporate them into their daily routine once they are discharged.

“A unique program that we have at Beth Israel, which I implemented a few years ago, is a self-medication program,” she said. The inpatient pharmacy prepares a kit for each patient with all their new transplant-related medications. “Every time the meds are due, they have to set up their medication cup themselves and use their medication card to figure out what’s changed. As soon as they’re awake and alert and able to read the medication card, they’re doing it.”

Good transplant pharmacists also get involved with clinical research, noted Dr. Tichy. “Transplant is a relatively small field and there’s not a lot of big clinical trials being done, so even small experiences are of relevance.” For example, he noted that when generic tacrolimus became available, there was controversy within the transplant community as to whether or not there were safety issues with generic versions of transplant medications. “So, I worked with three other transplant pharmacists in the Northeast, and we pooled our data to produce something of great relevance to other institutions: a finding that there isn’t really any additional safety risk with generics.”

Transplant pharmacists also are actively conducting research on the newer immunosuppressive agents, belatacept (Nulojix, Bristol-Myers Squibb) and everolimus (Zortress, Novartis), and the new antivirals telaprevir (Incivek, Vertex) and boceprevir (Victrelis, Schering-Plough). “For example,” he said, “transplant pharmacists are involved with the REMS [Risk Evaluation and Mitigation Strategies] program required for use of belatacept at our sites, as well as identifying potential patients who might benefit from this new therapy.” In addition, Dr. Tichy said, “The antivirals have known drug-drug interactions with the transplant immunosuppressants—tacrolimus, cyclosporine, sirolimus [Rapamune, Wyeth], and everolimus—however, there are no industry-sponsored studies looking at the use of these agents in transplant recipients.” He noted that several transplant pharmacists have been conducting studies in this area, several of which were presented at the American Transplant Congress in June.

What’s next for this rapidly growing specialty? Dr. Alloway would like to see further evolution of the transplant pharmacist’s role. “Several mid-level provider subgroups have formed physician collaborative practice agreements, allowing these providers to manage unique medical subspecialties under the auspices of limited-practice guidelines,” she observed. “It would be interesting to see pharmacists who specialize in transplantation develop collaborative agreements for immunosuppression management with physician collaborators. With the pharmacist model, incorporation of unique patient education and medication supply strategies that promote medication adherence would be novel. I believe this practice could significantly improve long-term survival by addressing the most simple questions of medication availability and adherence to the prescribed regimen.”

Dr. Gabardi reported that he has been on a Novartis scientific advisory board; Drs. Taber, Alloway, Tichy and Rogers reported no relevant financial conflicts of interest.