|Year : 2021 | Volume
| Issue : 1 | Page : 1-8
|Pharm.D.s and M.D.s in the Transplant World – Friends, Foes, Competitors or All are in Evolution?
Mahmoud M Mohamed1, Tibor Fulop2, Karim Magdy Soliman3
1 Department of Medicine, Division of Nephrology, University of Tennessee, Memphis, TN, USA
2 Department of Medicine, Division of Nephrology, Medical University of South Carolina; Ralph H. Johnson VA Medical Center, Charleston, SC, USA
3 Department of Medicine, Division of Nephrology, Medical University of South Carolina, Charleston, SC, USA
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|Date of Web Publication||16-Jun-2021|
| Abstract|| |
Mutual trust, efforts, and commitment between patients and providers are essential for a successful, long-lasting renal transplant. From the renal transplant recipient’s side, non-adherence to the medication has gained recognition as a predominant cause of late antibody-mediated rejection. Since the early 1970s, pharmacists have been involved in the care of transplant recipients and the incorporation of transplant pharmacists has improved the outcomes in solid organ transplantation. Such involvement of clinical pharmacists extends beyond improving graft outcomes: various studies demonstrated benefits in the care of diabetes, hypertension, and hyperlipidemia, with commensurate reduction of cardiovascular risk. From a unique perspective, this overview aimed to discuss the emerging role of Pharm. D.s and clinical pharmacists in general as it relates to team care, education of patients and healthcare providers and the sometimes conflicting relationship between physicians and pharmacists. Additional clinically relevant studies from culturally diverse settings are needed to explore the responsibilities of clinical team members to ensure optimized teamwork efforts without overlapping and duplication of efforts.
|How to cite this article:|
Mohamed MM, Fulop T, Soliman KM. Pharm.D.s and M.D.s in the Transplant World – Friends, Foes, Competitors or All are in Evolution?. Saudi J Kidney Dis Transpl 2021;32:1-8
|How to cite this URL:|
Mohamed MM, Fulop T, Soliman KM. Pharm.D.s and M.D.s in the Transplant World – Friends, Foes, Competitors or All are in Evolution?. Saudi J Kidney Dis Transpl [serial online] 2021 [cited 2021 Jul 31];32:1-8. Available from: https://www.sjkdt.org/text.asp?2021/32/1/1/318510
| Introduction|| |
Teamwork and commitments are essential for a successful, long-lasting renal transplant (RT). Sub-optimal medication adherence has gained recognition as a predominant and potential cause of irreversible graft inflammation.,,,,,, Studies have shown that non-adherence to medications in these has 5–7 times higher odd values for graft loss compared to those who are adherent., The estimated rate of non-adherence to medication after RT is about 36 cases per 100 patients per year.
Since the early 1970s, pharmacists have been involved in the care of transplant recipients. Mitchell from the University of Rochester in 1971 were the first to introduce the concept of transplant pharmacists, who actively participated in the medical management of organ transplant recipients and provided direct patient medication counseling. Subsequently, various studies in multiple disciplines highlighted the pivotal medical and economic impacts of pharmacists participating in patient care teams.,,,, Clinical pharmacist intervention plays an essential role in improving pharmacotherapy compliance. The pharmacist reviews and optimizes medication therapy, encourages adherence, provides instructions on how to take the prescribed medication, assists with the enrolment into medication assistance programs and provides recommendations to the health-care team. Transplant medications are notoriously sensitive to drug levels and careful monitoring and drug adjustment will both decrease adverse outcomes and side effects and minimize non-compliance. A randomized control trial compared patients who received traditional care from the interdisciplinary group (control group) and traditional care in combination with clinical pharmacy services (the intervention group) (N = 12 for each group). The intervention group had a higher overall adherence rate and a longer period of adherence time until the 1st non-adherent month, defined as ≤80% adherence. There were fewer adverse drug reactions and lower costs with increased patient satisfaction and improved health outcomes for patients with clinical pharmacist participation.,
In the United States, the United Network of Organ Sharing (UNOS), a quasi-governmental organization’s by-laws were amended in 2004 to identify pharmacists as a necessary component of the transplant team and included a description of their specific roles and responsibilities. The U.S. Centers for Medicare and Medicaid Services (a major paper of health-care for the elderly and disabled, including those with terminal renal failure) outline the important role of the transplant pharmacist, which leads to increasing the number and demand for transplant pharmacists across the US. Martin and Zavala conducted a survey to assess the roles of transplant pharmacists across each aspect of transplant recipient care. Out of 41 responding centers, 36 had clinical pharmacists incorporated into their transplant teams. These pharmacists were involved in the management of kidney (86%), liver (71%), pancreas (50%), heart (25%), and lung (7%) transplants. Their emerging role makes it mandatory to outline the responsibilities of different team members to ensure a maintained teamwork effort without overlapping.
| The Evolution of Clinical Transplant Pharmacists|| |
[Table 1] summarizes the various studies on the evolution of the role of clinical pharmacists in organ transplant management, The success of the Asheville Project in early 2000 led to what became known as “medication therapy management.” Pharmaceutical care services shifted from a handful of pharmacists to the creation of the clinical pharmacist who is trained to provide cognitive care. The American College of Clinical Pharmacy defines clinical pharmacy as the “area of pharmacy concerned with the science and practice of rational medication use.” That includes community pharmacists with registered pharmacy (RPh) degrees and pharmacological degrees (Pharm.D.s). After 1990, the Bachelor of Science programs were converted to Pharm.D titles. The Pharm.D degree requires a minimum of six years to complete unlike the Bachelor of Science programs that required only four years for completion. The training of the pharmacist pursuing a career in organ transplantation shifted from “on-the-job training” to receiving advanced training through formal residency and/or fellowships. The American Society of Health-System Pharmacists now offers a pharmacy residency in solid organ transplantation. The current postgraduate training standard for transplant pharmacists should include the completion of a one-year general pharmacy practice residency followed by a one-year specialized transplant residency. A specialized fellowship training in basic and clinical research specifically for transplant pharmacists is also available.
|Table 1: Summary of studies emphasizing the evolution of Pharm.D.s and interaction with M.D.s|
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The transplant pharmacist has taken on many functions of clinicians in the day-to-day management of organ transplant recipients. To be effective team members, clinical transplant pharmacists must combine the principles of several subspecialties. Knowledge of drug delivery, pharmaco-economics, drug information, drug literature evaluation, statistics, immunology, pharmacokinetics, pharmacology, pharma-cogenomics, pathophysiology, pharmacotherapy, pharmacovigilance, regulatory standards and safety are all a necessity., Also, gaining knowledge in other areas such as transplant immunology, infectious diseases, cardiology, hepatology, nephrology, pulmonology, endocrinology, hematology, pediatrics, and critical care is pivotal to optimize outcomes in patients with multiple co-morbidities.,,,, The transplant pharmacist’s role has expanded significantly to include the continual assessment of drug therapy prescribing, appropriateness, effectiveness, and safety monitoring, including drug concentrations and pharmacokinetics, pharmacodynamics, drug (drug, food, over-the-counter and dietary supplements) interactions, drug administration, delivery and costs. Transplant pharmacists, in coordination with the rest of the patient’s care team, play an essential role in coordinating drug therapy, as they follow the patient throughout their continuum of care.
| The Impact of Clinical Pharmacists on the Improvement of Solid Organ Transplantation|| |
The increasing complexity of health-care and competing burden for the physicians’ time, including electronic medical record, teaching physicians’ expectations for graduate medical education have re-assigned the role of the teams’ pharmacists in the last two decades. The role of the transplant pharmacist has become pivotal during the pre-, peri- and post-transplant period. Clinical pharmacists improve patient adherence to medications with a unique approach. They have a tremendous role to educate patients about all aspects of their medications, assess the risks of nonadherence and answer questions raised by team members and patients alike. Handing out information sheets and providing support by phone or email were activities performed by pharmacists in many of the studies., Timely responses to emails and electronic chart secure inquiries became a measured factor of system quality and patients’ satisfaction benchmark. Musgrave et al have conducted a prospective cohort study analyzing the data from 64 abdominal solid-organ transplant patients and matched them to a total of 128 retrospective patients. They found that the involvement of clinical pharmacists in completing the discharge medication reconciliations prevented 119 errors from reaching the patient and are considered “near-misses”. Also, at the first clinic visit, they identified an additional 72 medication errors that occurred at the time of discharge and intervened to correct these errors. Other studies showed an increase in the achievement of target serum concentrations of oral immunosuppressant medications.,,
The enrollment of transplant pharmacists has improved the outcomes of solid organ transplantation. Chisholm et al studied the effects of medication therapy management on the clinical outcomes and health-related quality of life of 36 renal transplant recipients. They found a significant reduction in the number of graft reections a year after enrollment compared to a year before it. Additionally, a greater number of patients reached target serum cyclosporine levels and the health-related quality of life assessment score was significantly increased. Klein et al reported fewer rejection episodes after enrolment in pharmaceutical care. The pivotal role of clinical pharmacists extends beyond the graft outcome. Migliozzi et al conducted a study including 84 hypertensive patients after renal transplantation. Patients were enrolled in a program combining electronic home blood pressure monitoring and pharmacist-provided medication therapy management services in a renal transplantation clinic. The clinical pharmacist provided patients with required training on the proper procedure to use the electronic home blood pressure device, recommended frequency and timing of blood pressure monitoring, and methods to upload blood pressure readings to the online patient portal. The clinical pharmacist reviewed and discussed home blood pressure logs with the patients, prepared for the initial clinic appointment, and proposed modifications to drug therapy regimens to physicians. The authors reported early and clinically relevant reductions in mean systolic and diastolic blood pressure values in renal transplant recipients after enrollment. On the other hand, Pinelli et al addressed the feasibility of establishing a pharmacist-managed diabetes and cardiovascular risk-reduction clinic (PMDC) for the care transition of kidney transplant recipients with diabetes. The authors included 25 1st-year and 22 referred kidney transplant recipients to be managed by the PMDC. They analyzed the mean change in hemoglobin A1C from baseline to three and six months. The PMDC intervention led to a statistically significant reduction in A1C at three months, which was maintained during the six-month follow-up. As a secondary endpoint, they found that body mass index remained stable at baseline at both three and six months despite the concomitant use of steroids and insulin therapy. Other studies demonstrated the benefits of clinical pharmacists in the improvement of low-density lipoprotein cholesterol, total cholesterol, and triglycerides.
Despite the apparent burden of recruiting high-earning team members, many studies showed a significant cost benefit after the enrollment of clinical pharmacists in patient care.,, A study was conducted to analyze the cost-benefit of a clinical pharmacist-managed medication assistance program in a renal transplant clinic. It reported a net cost avoidance of $124,793 for the year of the program with a benefit-to-cost ratio of 7.5:1. The benefit of the clinical transplant pharmacist’s involvement significantly outweighs the cost.
| Shortage of Clinical Transplant Pharmacists|| |
Given all the aforementioned additive values of clinical transplant pharmacists, the Centers for Medicare and Medicaid Services require their enrollment as part of the accreditation process. To meet the accreditation standards, some transplant centers may have hired pharmacists without specific organ transplantation training due to the lack of available fully trained personnel. Taber et al conducted a survey to assess the current workforce of transplant pharmacists across accredited US solid organ transplant programs. They reported responses to the survey from 176 individuals representing 113 centers. The vast majority of responders earned a doctorate-level degree (Pharm.D) and has been practicing for less than 10 years. The median number of full-time transplant pharmacists per 100 transplants was 1.4. Most of them reported that they care for more than one organ type (60%) and 28% rotate coverage between organ types and between inpatient and outpatient services. Only 64% reported that their time is dedicated entirely to transplant. More than half of the respondents felt they had inadequate staff to perform the required activities, especially in large-volume transplant programs. This highlighted the urgent need for more well-trained clinical transplant pharmacists.
| Pharm.D. and M.D. in the Transplant World|| |
Although the role of the clinical transplant pharmacist is expanding in current practice, few studies have investigated the relationship between the clinical transplant pharmacists and other members of the transplant teams. Physicians and pharmacists are often described as adversaries rather than members of the same team. Conflicts between physicians and pharmacists tend to happen because of their different focuses on patient care. Physicians are generally lukewarm towards pharmacists transitioning into territories and responsibilities held formerly by physicians. Crawford et al conducted an online survey on the practice of transplant specialist physicians on assessing medication adherence, prescription management and requesting clinic appointments and laboratory tests. They found that most physicians performed frequent screenings for kidney graft dysfunction that may indicate non-adherence to medication, maintained regular transplant clinic visits with patients and emphasized the importance of medication education. The role of the transplant pharmacist was limited to providing long-term medication follow-up support exclusively. Nevertheless, Lee et al studied the clinical transplant pharmacist’s role in medication therapy management in a kidney transplant ambulatory clinic. Transplant pharmacists performed 3581 reviews for 1271 kidney transplant recipients. The authors identified 663 drug-related problems and 180 discrepancies in approximately 24% of the reviews performed during the study period. Transplant pharmacists provided 753 recommendations that were accepted by physicians, and 33 that were accepted with modifications. The overall acceptance rate was 93%. Chisholm et al reported an overall acceptance rate of 96%. It is important for both physicians and pharmacists to foster collaboration between each other. Both should understand the role of each profession clearly. As shown, most of this experience is from North America and preciously little is reported about the rest of the world.
Miscommunication is another significant risk factor that may lead to many deleterious outcomes. In their national survey, Taber et al reported that pharmacists communicate significant issues to the team either verbally (42%), by charting (35%), or email (11%). This can lead to diverse or duplication of orders. More studies are needed to outline the responsibilities of different team members to ensure maintaining teamwork effort without overlapping. Nevertheless, this should not be an obstacle in the way of the progression of the clinical transplant pharmacist’s pivotal role, which of no doubt has become a cornerstone in the development of solid organ transplantation.
| Summary|| |
Similar to the evolution of multicellular organisms, complex health-care organizations are not simply about growing in number but attaining increasing complexity and specialization. With the competing pressures on physicians’ time, clinical specialty pharmacists are displaying an increased role in providing care to transplant recipients. Rules of engagements and outcome-focused team cooperation need to evolve with the increasing complexity of the healthcare system to maintain maximal efficacy. Moreover, additional studies are needed on the subject from culturally diverse settings and gaining experience reaching beyond the United States and North America.
Conflict of interest: None declared.
| Acknowledgment|| |
Dr. Fülöp is a current employee of the United States Veterans Health Administration. However, the views and opinions expressed herewith is the Author’s own and do not reflect the official views or opinion or endorsed by the United States Veteran Health Administrations.
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Karim Magdy Soliman
Department of Medicine, Division of Nephrology, Medical University of South Carolina, Charleston, SC 29425
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