Defining the Roles of Inflammatory Bowel Disease Clinical Pharmacists in the United States: A Systematic Review and National RAND/UCLA Consensus

Abstract

Background

Given the complexity of inflammatory bowel disease (IBD) care, utilization of multidisciplinary teams is recommended to optimize outcomes. There is a growing recognition that clinical pharmacists should be an integral part of this care model. We sought to define the roles of IBD clinical pharmacists in the United States.

Methods

A national multidisciplinary expert panel of 12 gastroenterologists and clinical pharmacists practicing in IBD clinics was assembled. We used the RAND/University of California, Los Angeles appropriateness method, with a total of 281 statements generated based on a systematic literature review and expert opinion. Each statement was anonymously rated as appropriate, uncertain, or inappropriate in 2 rounds of voting.

Results

The number of publications evaluating the clinical pharmacists’ roles in IBD is limited, primarily focusing on thiopurine initiation and monitoring, medication adherence, and switching to biosimilars. Medication education; medication initiation and monitoring; therapeutic drug monitoring; biosimilar management; health maintenance review; and transitions of care were deemed by the panel to be appropriate roles for IBD clinical pharmacists. In considering real-world settings, IBD clinical pharmacists should practice clinically under a predefined scope and primarily focus on complex treatments (eg, immunomodulators, biologics, and small molecules). Clinical pharmacists should also be included in practice settings with IBD specialized physicians. Additionally, clinical pharmacists caring for patients with IBD should be residency trained and board certified.

Conclusions

This consensus defines IBD clinical pharmacists’ roles and provides a framework for embedded clinical pharmacists in IBD care.

Introduction

The incidence and prevalence of the inflammatory bowel diseases (IBD), encompassing Crohn’s disease (CD) and ulcerative colitis (UC), is increasing worldwide.¹ In the United States, the prevalence of IBD has markedly increased by 123% over 9 years.² IBD is considered a complex condition, given the various genetic, environmental, and inflammatory mechanisms involved and the heterogeneity of the disease with regard to presentation and phenotype.³ Thus, available treatment options are deemed advanced and require high-level management and coordination to ensure optimal treatment efficacy and safety. These treatments are also costly, accounting for nearly half of all IBD-related expenditures.^4,5

To help optimize patient outcomes and control costs, the use of multidisciplinary care teams in IBD management has been proposed as a potential strategy.⁶ In this care delivery model, the gastroenterologist manages patients with IBD in conjunction with other healthcare professionals with unique expertise, including dietitians, social workers, psychologists/psychiatrists, nurses, and nurse practitioners.^6-8 One existing study highlights the impact of including other allied healthcare professionals in an IBD multidisciplinary team, noting that a care model integrated with psychologists and nurses with IBD expertise resulted in reduced emergency department utilization and healthcare costs.⁹ There is now a growing recognition that clinical pharmacists, given their extensive education in pharmacology and ability to navigate insurance- and pharmacy-related processes in practice, should also be central members of IBD multidisciplinary teams given the role and impact of medication management on disease status and quality of life.

Presently, there are no commonly accepted definitions or standardization of clinical pharmacists’ roles within an IBD team. This, however, is essential to (1) understanding how clinical pharmacists contribute to the care of patients with IBD, (2) promoting the inclusion of clinical pharmacists as part of the IBD multidisciplinary team, and (3) providing clarity on the necessary training for this role. To address this gap, we performed a systematic literature review and assembled a national U.S. multidisciplinary panel of IBD clinical pharmacists and gastroenterologists to participate in a 2-round RAND/University of California Los Angeles (UCLA) appropriateness process with the aim to standardize the role of clinical pharmacists in IBD care.

Methods

Systematic Review of Literature

Search methods for the systematic review are discussed in Supplementary Methods. Briefly, we conducted a formal literature search following standard methodology and incorporated studies that focused on clinical pharmacists’ involvement in adult IBD care. Pharmacists’ interventions and outcomes, when available, were collected and summarized, with key themes then identified and used to inform the RAND/UCLA survey statements.

Expert Consensus Process

Recruitment of panelists

A total of 6 clinical pharmacists and 6 gastroenterologists involved in IBD care were chosen to participate. Initially, an open call was sent to the IBD Pharmacy Practice Network, which is a group of pharmacists who are involved in IBD medication management and embedded in specialty pharmacies and/or outpatient clinics across the United States. The IBD Pharmacy Practice Network was founded by 3 IBD pharmacists in May 2021, given the lack of resources and recognition for IBD clinical pharmacists within existing pharmacy and IBD organizations in the United States, with the aim to unite IBD pharmacists with the goals to expand knowledge, gain recognition, and optimize medication outcomes in IBD. At the time of this study, the organization consisted of 38 members, and now has expanded to over 60 members.

Selection criteria of pharmacist participants included (1) membership in the IBD Pharmacy Practice Network and (2) spending at least 3 full days a week in an IBD clinic providing clinical management to these patients. The selected IBD pharmacists then invited an IBD gastroenterologist whom they closely work with within their institution. This approach was chosen to form a panel that is well acquainted with the role of IBD pharmacists. In addition, formation of teams with the IBD gastroenterologist is critical to establishing an IBD pharmacist’s position. Due to worldwide variations in pharmacists’ licensure, scope, and regulations, the panel setting was limited to the United States to help ensure that these variations would not be a limiting factor or barrier to garnering consensus about the IBD pharmacists’ roles.

RAND/UCLA Appropriateness Method

Statements were generated based on the systematic review as well as expert opinion of the RAND panel. The focus of statements was on defining the role of the IBD pharmacist in the United States. Initial statements were sent to the panel for comments (Round 0), prior to an introductory call. The RAND/UCLA appropriateness method was employed to identify and summarize the best available evidence and assess face validity and feasibility of statements relating to pharmacists’ role as identified from the systematic review.^10,11 A complete list of statements was circulated via an online survey and rated for appropriateness in 2 voting rounds. Moderated teleconferences occurred prior to first round voting to review statements and after the first voting round to discuss results. A detailed overview of the process and exact steps is provided in the Supplementary Methods.

Results

Systematic Literature Review

A total of 96 records were identified. After removing duplicates, 81 citations were screened based on title and abstract, of which 34 records underwent full-text review, when available. Fifteen studies met the inclusion criteria, with the overall quality of studies ranging from low to moderate, primarily due to study design or lack of a robust comparator group (Supplementary Figure 1, Supplementary Table 1). Details of the incorporated studies, including interventions and outcomes, are described and listed in the Supplementary Results. To briefly summarize, the following themes representative of the roles of IBD clinical pharmacists were identified and included in the initial list of statements: provision of medication management (eg, education, initiation, monitoring, and dose adjustment, primarily for thiopurines, biosimilar implementation and adoption, therapeutic drug monitoring), optimization of medication adherence, and delivery of targeted services, such as transitions of care and smoking cessation.

RAND/UCLA Process

Survey Development

With the findings gathered from the systematic literature review and in combination with expert opinion, statements generated were grouped into the following categories: referral indications, medication start, medication monitoring, health maintenance, biosimilars, clinical trials, training and credentials, and practice setting. The first survey consisted of 254 statements. After a moderated teleconference to review results of first-round voting, the survey was revised to consist of 281 statements and recirculated to the panel for second-round voting.

Appropriateness of Statements

During statement generation, the need to separately query the ideal state vs real-world state was recognized. Ideal state referred to a practice site having unlimited resources and access to a full-time dedicated IBD clinical pharmacist. Conversely, the real-world state acknowledged resource limitations in practice and need for prioritization of certain tasks and responsibilities. When applicable, panelists were asked to rate the appropriateness or priority of certain statements in ideal and/or real-world state.

Overall, 221 (79%) statements were considered appropriate, 25 (9%) inappropriate, and 35 (12%) uncertain. Select statements, including panelist ratings and categorization, are listed in Table 1. A list of all statements can be found in Supplementary Table 2. A summary of IBD clinical pharmacists’ roles in ideal vs real-world states is provided in Figure 1.

Findings

Referral Indications

The panel determined that in both the ideal and real-world states, IBD clinical pharmacists should see and manage patients for IBD medication education/initiation, monitoring, health maintenance review/coordination, biosimilar management, therapeutic drug monitoring, transitions of care, and polypharmacy. Conversely, the panelists were uncertain about IBD clinical pharmacists’ involvement in clinical trials, given that not all pharmacists may be interested in research or qualified to participate as an investigator/co-investigator, but when considering real-world state, they determined that it was inappropriate for IBD clinical pharmacists to be directly involved in clinical trials. Most panelists noted clinical trials are often led by full-time research teams, which would likely consist of an independent research pharmacist.

Medication Start

In the ideal state, the panel determined IBD clinical pharmacists should be able to provide medication education and monitor medication efficacy and safety for various medications used in IBD, including steroids, antibiotics, 5-aminosalicyclates, thiopurines, methotrexate, biologics, Janus kinase (JAK) inhibitors, sphingosine 1-phosphate receptor (S1PR) modulators, tacrolimus, and cyclosporine. Additionally, the panelists believed that it was appropriate for IBD clinical pharmacists to reconcile medication lists and allergies; review prior IBD treatment history, including reasons for therapy failure; and identify and manage potential drug interactions prior to treatment initiation. Moreover, IBD clinical pharmacists would be best equipped to provide education on medication administration, storage, and proper disposal instructions for patients initiated on self-injectable medications, including biologics and methotrexate. However, in the real-world state, it was determined that IBD clinical pharmacists should prioritize providing medication education and completion of baseline labs primarily for more advanced therapies vs steroids, antibiotics, or oral and rectal 5-aminosalicyclates due to resource limitations.

Given the extensive coordination efforts associated with the initiation of IBD therapies, particularly biologics and small molecules, the panel found it appropriate for IBD clinical pharmacists to oversee and participate in the following steps: (1) counsel patients on the treatment initiation process, (2) enter prescriptions for self-injectable/oral therapies or therapy/infusion plans under collaborative practice agreements, (3) provide prior authorization appeal services, either in the form of appeal letters or peer to peer, (4) discuss with patients the alternative treatment options decided by the gastroenterologist if the prior authorization is denied, (5) route prescriptions for self-injectable and oral therapies to the contracted specialty pharmacy under collaborative practice agreements, and (6) follow up with patients to ensure that infusions are scheduled or that self-injectable/oral therapies have been received. While it was deemed IBD clinical pharmacists should be capable of identifying preferred infusion site for patients receiving intravenous medications and enrolling patients into nurse ambassador, copay, or patient assistance programs, the panelists could not reach a consensus about the appropriateness or priority of these tasks in real-world settings, even if the pharmacists were provided with appropriate administrative support or resources. Regarding forwarding clinical records and documents to necessary parties (eg, home infusion companies, external hospital) and completing and submitting prior authorizations, the panel found these tasks to be inappropriate in the real-world state, given the purely administrative nature of these tasks, which do not require the knowledge and training of IBD clinical pharmacists. Confirmation of patients’ treatment initiation date was deemed to be appropriate for IBD clinical pharmacists if appropriate administrative support was provided.

In the real-world setting, the panel identified that it would be appropriate for the IBD clinical pharmacists to assess pre-determined treatment response, as outlined in the collaborative practice agreement, such as symptom assessment ± biomarker evaluation during induction specifically for biologics, JAK inhibitors, S1PR modulators, tacrolimus, and cyclosporine. The panel could not reach consensus about IBD pharmacists’ role with thiopurine treatment response assessment during induction, due to the delayed onset to treatment effect and likelihood that patients would have a follow-up with the gastroenterologist during that time. Additionally, low priority was placed on IBD clinical pharmacists assessing steroids, antibiotics, and methotrexate induction response, as these patients likely have closer follow-up with their gastroenterologists due to acute disease severity.

Medication Monitoring

When incorporating resource limitations, panelists determined that it is appropriate for IBD clinical pharmacists to routinely assess treatment response and safety, including completion of routine labs as outlined in a collaborative practice agreement, for patients specifically on thiopurines, methotrexate, biologics, JAK inhibitors, S1PR modulators, tacrolimus, and cyclosporine. While the panel thought IBD clinical pharmacists should assess treatment safety of steroid therapy and assist with steroid tapers as clinically appropriate, they felt that it was inappropriate for the pharmacist to assess treatment response, due to long-term use of steroids being considered inappropriate.

The panel believed that IBD clinical pharmacists should routinely reconcile patients’ medication list and allergies, identify and manage potential drug interactions with IBD therapies, help address adverse drug events from IBD therapies, identify medication non-adherence and implement strategies to optimize treatment adherence, and interpret labs and adjust medication regimens independently as appropriate. Additionally, the panel thought that it was appropriate for the IBD clinical pharmacists to follow-up with stable patients every 3 to 12 months for medication management and monitoring.

Regarding therapeutic drug monitoring for thiopurines, biologics, tacrolimus, and cyclosporine, the panel believed that it is appropriate for IBD clinical pharmacists to coordinate obtaining levels, interpret these results, and adjust medication dose based on the results in collaboration with the gastroenterologist under a collaborative practice agreement.

Health Maintenance

It was considered appropriate by the panel that IBD clinical pharmacists should review, identify, and provide education on the following health maintenance needs: (1) immunizations, (2) smoking cessation, (3) skin cancer screening, (4) cervical cancer screening, (5) osteoporosis screening, and (6) complementary and alternative medicine use. Additionally, the panelists identified that it was appropriate for IBD clinical pharmacists to provide education about nutrient deficiencies and anemia but were uncertain if it was appropriate for pharmacists to evaluate for these conditions in patients with IBD. Panelists were uncertain if the IBD clinical pharmacists should assess and provide education on colorectal cancer screening and anxiety/depression screening. Regarding coordination efforts relating to health maintenance needs, the panel felt that it was appropriate for the IBD clinical pharmacists to help coordinate immunizations and smoking cessation only.

Additional responsibilities deemed appropriate by the panel included counseling on prevention of nonsteroidal anti-inflammatory drug use and being involved in transitions of care and phone/message triages.

Biosimilars

Given the evolving treatment landscape of IBD with biosimilars, the panelists identified IBD clinical pharmacists’ roles in the processes related to biosimilar implementation, adoption, and use in clinical practice. Defined tasks included advocating for biosimilar use; overseeing the formulary process to have biosimilars added; providing biosimilar education to gastroenterologists, staff, and patients; converting patients to biosimilars with the approval of patients’ gastroenterologists; overseeing the insurance process for biosimilar conversion; monitoring outcomes posttransition; and addressing the nocebo effect as it occurs.

Clinical Trials

The role of IBD clinical pharmacists in clinical trials was debated among the panelists given the resource limitations and time needed to be involved in processes related to clinical studies, such as screening and enrollment. With these considerations, the panel deemed that it is appropriate for the IBD clinical pharmacists to assist with patient recruitment, provide transitions of care service when transitioning from placebo or discontinued treatment, and participate in the presentation and publication of study results and finding. Conversely, participating in the clinical care of patients involved in clinical investigational drug trials and completing adverse drug reaction reports were deemed inappropriate roles. The panelists were uncertain if IBD clinical pharmacists should participate in interdisciplinary team meetings relating to clinical investigational drug trials.

Training and Credentials

Based on currently available programs, the panel considered 1 year of postgraduate training (general, ambulatory care, or specialty pharmacy-focused) and board certification in ambulatory care pharmacy to be appropriate training and credentials for IBD clinical pharmacists.

Other training and credential considerations were queried. The panelists found an IBD preceptorship program with existing IBD pharmacists similar to the Crohn’s and Colitis Foundation Advanced Practice Provider Preceptor Program or a certificate issued postcompletion training, shadowing, or curriculum to be appropriate. The panel deemed a 12 month postgraduate fellowship in an IBD center to be inappropriate and was uncertain about the appropriateness of board certification in gastroenterology as well as a 3- or 6-month shadowing/training experience with an IBD center.

Practice Setting

The inclusion of a dedicated IBD pharmacist in any practice setting employing an IBD specialty physician, including academic IBD center, GI private practice, or hospital-based GI practice was deemed appropriate by the panel. Uncertainty regarding inclusion of an IBD pharmacist in a practice setting without an IBD specialist was noted. Last, the panel endorsed support for IBD pharmacists to practice under a collaborative scope of practice.

Discussion

Clinical pharmacists are licensed healthcare professionals who work directly with physicians, other allied healthcare professionals, and patients to optimize medication management and patient outcomes.¹² These individuals earn a doctor of pharmacy (PharmD) degree after completing 4 years of graduate education and often complete accredited postgraduate residency training in direct patient care settings to gain clinical experiences. Specialized board certification is also available to further highlight a clinical pharmacist’s knowledge and clinical experiences.¹³ Once in clinical practice, clinical pharmacists stay up to date with therapeutics by completing continuing education to maintain licensure and board certification.¹⁴ Given these credentials, collaborating physicians can grant patient care privileges, permitting clinical pharmacists to manage medications, including medication education and efficacy/safety monitoring. The value of embedded clinical pharmacists has been well recognized in many clinical practice areas, such as internal medicine and oncology.^15,16

There is growing interest to embed clinical pharmacists into IBD teams given the expansion of complex and costly treatments.^4,17 Presently, there is limited literature describing and evaluating clinical pharmacists’ roles in IBD, including initiating and monitoring thiopurines, improving medication adherence, and spearheading the biosimilar transition process. However, given (1) the clinical pharmacists’ ability to practice under a collaborative scope of agreement and participate in direct patient care, (2) current utilization of novel biologic and small molecule treatments, which consists of distinct pre-treatment and monitoring considerations, and (3) the inclusion of clinical pharmacists into IBD multidisciplinary teams, we sought to comprehensively define the roles of clinical pharmacists caring for patients with IBD within the United States.

Using a rigorous methodology, we identified that IBD clinical pharmacists are well positioned to take on the following roles: (1) medication management, including education, initiation, and efficacy/safety monitoring of immunomodulators and advanced therapies (primarily biologics, JAK inhibitors, and S1PR modulators), (2) biosimilar implementation, adoption, and transition, and (3) discussion and evaluation of health maintenance needs, specifically coordinating immunizations and providing smoking cessation resources. The panel particularly highlighted the high likelihood of resource limitations (eg, full-time equivalence and amount of embedded clinical pharmacists) in many IBD practices, emphasizing that, as a result, IBD pharmacists should be primarily utilized in a clinical capacity and focus on medication monitoring, including therapeutic drug monitoring as applicable, and optimization of complex and costly treatments, particularly biologics, JAK inhibitors, and S1PR modulators.¹⁸ Administrative tasks, particularly prior authorizations and patient enrollment into pharmaceutical-sponsored programs, were considered roles that are appropriate for other members of the IBD team, given that these activities do not necessarily require clinical expertise. Conversely, administrative tasks associated with biosimilar implementation and switching (eg, identifying the preferred product, ensuring that the correct product is ordered and submitted for authorization, enrolling into the correct copay assistance program) and the level of coordination required between the pharmacy, infusion center, clinic, and patients were considered appropriate for IBD clinical pharmacists. Inclusion of clinical pharmacists in this role has been previously demonstrated to result in high biosimilar uptake and significant institutional cost savings.¹⁹ These roles permit IBD trained clinical pharmacists to practice at the top of their license by applying their knowledge and skills to manage advanced therapies and optimize medication efficacy and safety.

Due to IBD and the immunosuppressive treatments used, patients are at increased risk for infections and other complications, such as anemia and osteoporosis. Patients who are smokers may be at increased risk of disease worsening or recurrence, warranting higher medication utilization.²⁰ While most of these complications can be prevented or minimized through proactive review and implementation of various interventions, health maintenance in many IBD practices is often suboptimal, placing patients at increased risk of negative sequalae and hospitalizations.^21-23 The panel identified that IBD clinical pharmacists are well equipped to assist with immunization coordination and smoking cessation. Prior studies have demonstrated that pharmacist involvement as an immunizer, advocator, or both has positively influenced immunization uptake.²⁴ Similarly, pharmacists have been shown to have a positive effect on smoking cessation rates.^25,26 The panel also thought that it was appropriate for IBD clinical pharmacists to provide education on other health maintenance needs, excluding colorectal cancer and anxiety/depression screening, likely given the complexities and higher level of care associated with these conditions.

IBD clinical pharmacists may practice in various settings, including private practice or hospital-based practice, as long as an IBD specialty physician is present. This is necessary to implement a collaborative practice agreement, which outlines the clinical pharmacist’s role (either independently or in conjunction with) under the gastroenterologist’s supervision. However, compared with other specialties that often require 1 or 2 years of specialized postgraduate training and board certification in order for clinical pharmacists to provide direct patient care, there is no defined training and credentials that clinical pharmacists are required to have to practice in IBD. Unfortunately, most pharmacy-based curriculums incorporate a very minimal and superficial focus on gastroenterology therapeutics, and there are no gastroenterology-specific postgraduate training programs or board certifications available.²⁷ Based on currently available resources, the panel deemed 1-year postgraduate residency and board certification in ambulatory care practice to be appropriate for clinical pharmacists practicing in IBD.

To further support the development and expansion of IBD clinical pharmacists, future directions include creation of specialized training programs and formalized evaluations of clinical pharmacists’ roles and impact in clinical practice and patient care. Implementation of training opportunities that consist of clinical shadowing experiences at an IBD center, multidisciplinary group discussions, and mentorship (similar to the Crohn’s and Colitis Foundation Advanced Practice Provider preceptorship program) would be valuable for clinical pharmacists to further develop their skillset and gain confidence in caring for the IBD population. Additionally, formal evaluations of clinical pharmacists’ impact on IBD practice and patient care, including medication utilization; quality-of-care metrics; patient outcomes including steroid use, emergency department utilization, and hospitalizations; and continuing education programs tailored for clinical pharmacists would be meaningful and are needed to support the inclusion and growth of clinical pharmacists in this practice area.

Our study is the first to define the roles of IBD clinical pharmacists by a national panel of IBD specialized gastroenterologists and clinical pharmacists across the United States. We employed rigorous methods to minimize bias for both the ideal and current practice landscape. Our results can be applied in clinical practice for practice sites looking to incorporate IBD clinical pharmacists or identify priority areas for their existing staff. Information from ideal state can be used to justify the need for IBD clinical pharmacists, while findings from the real-world state can be used to set up IBD clinical pharmacist services.

To enhance the practical applicability of our RAND analysis, we would like to briefly highlight strategies to assist with the justification for and integration of IBD clinical pharmacists into practice. Currently identified barriers in IBD care include (1) access and/or resource limitations among certain gastroenterology practices, including those in community or rural settings; (2) time-consuming and arduous process to prescribing advanced therapies, involving extensive patient education and successful completion of the prior authorization process, followed by treatment initiation and ongoing monitoring; and (3) high burnout among IBD specialists as a result of spending more time per appointment in the electronic health record, conducting extensive clinical review, and working outside regular hours.^28-31 Embedding clinical pharmacists to serve as extenders to gastroenterologists and advanced practice providers and oversee medication-related tasks could reduce these barriers. Clinical pharmacists are able to (1) spend time with patients to discuss advanced therapy options and considerations, (2) efficiently navigate the medication access and affordability process, and (3) frequently check in with patients to assist with medication monitoring, including coordination of laboratory orders and therapeutic drug monitoring as applicable. Given the clinical pharmacists’ ability to monitor patients on treatment longitudinally, gastroenterologists can optimize their availability to see both new and high-acuity patients in a timelier manner, while peripherally overseeing the management of their established patients. Clinical pharmacists can also assist with transitions of care, particularly when IBD treatment is initiated in the inpatient side and coordination of care and education are needed to ensure successful and timely transition to the outpatient setting.

Clinical pharmacists are also leveraging the electronic health record to reconcile medications lists and document all patient-related encounters in real time. Given the frequency of check-ins and documentation by the clinical pharmacist, the time and effort needed for chart review and additional documentation may be reduced for gastroenterologists. Last, clinical pharmacists may be able to extend their reach and serve as a resource for community and rural-based gastroenterology practices by participating in in programs designed to bring multidisciplinary tertiary care to gastroenterology practices and provide patients with access to evidenced-based educational resources, such as GI OnDemand (https://giondemand.com/). Thus, embedding clinical pharmacists in IBD teams to oversee and manage medication-related tasks permits for several benefits, including (1) improved patient access and (2) reduced administrative and clinical care burdens.

In addition to enhancing patient access and alleviating practice-related burdens, IBD clinical pharmacists may provide financial support for their practice. Depending on the practice setup, state pharmacy laws, level of supervision in place, and payor’s policy on whether the pharmacist is recognized as a provider, clinical pharmacists may generate revenue by billing for their patient care services.^32,33 If providing services directly in conjunction with a gastroenterologist (eg, pharamcist sees patient before or after gastroenterologist’s visit on the same day or provides transitions of care services by performing medication reconciliation or calling patients within 2 days of discharge), billing could occur at a higher level or through additional codes. Another way for clinical pharmacists to help generate revenue, if applicable, is to direct self-injectable and oral prescriptions to their practice’s specialty pharmacy and coordinate for patients to receive treatment at the practice’s infusion center. This process can also result in cost savings. If prior authorization approval permits for in-house specialty pharmacy and/or infusion center utilization, the revenue generated can also help offset some of the costs associated with the prior authorization process, such as time spent and personnel required. Additionally, utilization of in-house services has been shown to significantly improve patient care by resulting in higher treatment adherence and persistence, better clinical outcomes, and higher patient and provider satisfaction with services, which are all outcomes associated with reduced cost.³⁴

Clinical pharmacists may also support cost savings for their practice and healthcare. By conducting clinical and adherence assessments to optimize patients’ current therapies, pharmacists can help reduce flares, hospitalizations, and unnecessary transition to or use of other advanced therapies. Pharmacists are also well positioned to help with biosimilar conversions and could generate potential cost savings by switching patients on the reference product to the practice’s preferred biosimilar product. Last, patients with access to IBD clinical pharmacists may report greater satisfaction and engagement, given the additional services (eg, reduction in financial toxicity and medication education and monitoring) and touchpoints offered. This is meaningful, as high patient satisfaction and engagement have been shown to correlate with improved treatment adherence and patient outcomes.³⁵ Although studies evaluating the outcomes associated with implementation of clinical pharmacists into IBD practice are needed, the potential benefits outlined previously could be used to help justify and create an IBD clinical pharmacist position in practice.

There are several imitations to our study. First, pharmacists who work predominantly in a specialty pharmacy were excluded. While pharmacists in this setting also care for patients with IBD, they are likely to have different roles and more administrative tasks.³⁶ Thus, the responsibilities of this specific cohort were not captured in our study and may be examined in a separate program. Additionally, the lack of patient representation in this study is a limitation. Collecting patient perspectives relating to the roles and impact of IBD clinical pharmacists in patient care could have further informed the drafted RAND/UCLA survey statements. This is another area for future studies. Similarly, our panel lacked representation from IBD-focused community hospital systems and private practices, which may have further influenced pharmacists’ roles. However, following our open call for participation, we did not identify any IBD clinical pharmacists practicing in these areas, highlighting a potential practice gap and opportunity. Last, gastroenterologists were specifically targeted for this panel, because as outlined in collaborative practice agreements, IBD clinical pharmacists work closely with them and under their supervision. However, as part of the multidisciplinary team, IBD clinical pharmacists may interact with other members, including nurses, colorectal team, and dietitians, and their perceptions were not captured herein, which could further influence pharmacists’ roles (eg, peri/postoperative medication assessment and coordination, identification of appropriate referrals). Similarly, future studies should explore the role of clinical pharmacists in IBD inpatient care, peri-operative care, and transitions of care.

Conclusion

In the present article, we define the roles of IBD clinical pharmacists in the United States. IBD clinical pharmacists are a valuable addition to the multidisciplinary team in providing services related to medication management and coordination as well as to health maintenance. Future studies are warranted to demonstrate the impact of clinical pharmacists alongside the gastroenterologist and multidisciplinary team on IBD patient outcomes.

Supplementary Data

Supplementary data is available at Inflammatory Bowel Diseases online.

Author Contribution

Conception and design: S.B., F.R. Data collection: all authors. Data analysis and interpretation: S.B., R.L., F.R. Manuscript drafting: S.B., F.R. Manuscript editing for important intellectual content: all authors. All authors have reviewed, contributed to, and approved the final version of this manuscript.

Conflicts of Interest

S.B. has served on the advisory board for Bristol Myers Squibb, Prometheus Labs, and Boehringer Ingelheim; and on the speakers bureau for Prometheus Labs. R.B. has served on the speakers bureau for AbbVie; received research funding from AbbVie; and served as a consultant to Pfizer and Fresenius Kabi. D.H.B. has served as a consultant for Janssen; and received research support from Medtronic and Takeda. B.L.C. has served as a consultant for AbbVie, Lilly, Pfizer, and TARGET RWE; served on the speakers bureau for AbbVie; and received an educational grant from Pfizer. R.C.U. has served as an advisory board member or consultant for AbbVie, Bristol Myers Squibb, Janssen, Pfizer, and Takeda; and received research support from AbbVie, Boehringer Ingelheim, Eli Lily, and Pfizer. B.P.V. has received consulting fees from AbbVie and Prometheus; and funding from Roche, Celgene, Takeda, Diasorin, Pfizer, and the Crohn’s and Colitis Foundation. M.R. has served as a consultant for AbbVie, Janssen, UCB, Takeda, Pfizer, Miraca Labs, Amgen, Celgene, Seres, Allergan, Genentech, Gilead, Salix, Prometheus, Lilly, TARGET Pharma Solutions, ALFASIGMA, S.p.A, BMS, and Trellis. F.R. has served as a consultant for Agomab, Allergan, AbbVie, Boehringer Ingelheim, Celgene, Cowen, Genentech, Gilead, Gossamer, Guidepoint, Helmsley, Index Pharma, Janssen, Koutif, Metacrine, Morphic, Origo, Pfizer, Pliant, Prometheus Biosciences, Receptos, RedX, Roche, Samsung, Takeda, Techlab, Thetis, and UCB; and received funding from the Crohn’s and Colitis Foundation of America, the Helmsley Charitable Trust, Kenneth Rainin Foundation, and the National Institutes of Health. All other authors have nothing to disclose. R.C.U. was supported by an National Institutes of Health K23 Career Development Award (5K23DK111995).

References