ABSTRACT
Individuals with multiple sclerosis (MS) may experience a variety of visible and invisible symptoms and, as they age, comorbidities related and unrelated to their MS. This can result in a complex medication regimen that includes disease-modifying therapies, symptom management drugs, and prescriptions for other comorbid disorders.
We reviewed the existing literature to discover how to optimally integrate neurology clinical pharmacists into the MS care team and how clinical pharmacists can directly support both providers and patients through their expertise in pharmacology and medication management.
With approaches founded on a shared decision-making process alongside neurology providers, patients, and care partners, clinical pharmacists can help meet the complex challenges of MS care in a variety of ways. Especially within MS clinics, they are well positioned to enhance current neurology practices given their extensive training in comprehensive medication management and their ability to identify nuances in medication management to promote pharmacovigilance and patient-centered care.
Neurology clinical pharmacists bring multifaceted medication management and patient counseling and education skills to the MS care team and can support the shared decision-making process by serving as an accessible resource for patients and clinicians. By building trusted partnerships between neurology providers and clinical pharmacists, MS care teams can achieve effective and efficient patient care. Future research should compare clinical and patient-reported outcomes between patients receiving standard care and those receiving multidisciplinary, pharmacist-integrated care.
In recent years, pharmacotherapy choices for individuals with multiple sclerosis (MS) have expanded; as of February 2023, there are 8 injectable, 10 oral, and 5 intravenous infusion treatments approved by the United States Food and Drug Administration (FDA) for use as MS disease-modifying therapies (DMTs), with generic equivalents arriving as additional considerations.1 Multiple sclerosis DMTs are among the most expensive medications, with the median annual cost of FDA-approved MS DMTs exceeding $90,000.2 In addition, out-of-pocket expenses for medications can exceed $6000 a year for Medicare patients.2 Taken with average indirect costs in 2019 of $17,407 ($21,741 with caregivers),3 MS represents a substantial economic burden. Cost is a major concern among patients and providers and is likely an important factor in DMT preferences and care access. In addition, navigating a complex coverage and financial support environment can be challenging for both patients and providers.2,4 Individuals with MS may experience a variety of visible and invisible symptoms (eg, fatigue, bladder dysfunction, vision changes, cognitive changes) associated with MS lesions and age-related comorbidities, which can result in complex medication regimens that often include MS DMTs, symptom management, adjunctive therapies, and herbal/nutraceutical treatment for comorbid disorders.5-7
Clinical pharmacists are well-positioned to enhance patient care as part of neurology practices given their extensive training and knowledge in neurology pharmacotherapy and comprehensive medication management.8,9 They can also provide guidance to patients and providers on how to select cost-effective MS treatments and identify additional funding sources. Moreover, clinical pharmacists have provider status in many states and can manage patients as part of a collaborative team. Clinical pharmacists are, therefore, becoming increasingly important as part of the provider care team as individuals with MS navigate complex treatment decisions.10
In this review, we define the need to optimally integrate neurology clinical pharmacists into the MS care team and describe how clinical pharmacists can directly support both providers and patients through their expertise in pharmacology and medication management. We also provide models for integrating clinical pharmacists into MS care. By building trusted partnerships between neurology providers and clinical pharmacists, MS care teams can achieve more effective and efficient patient care.
METHODS
This review is based on literature searches of PubMed for articles that examined the supportive role of clinical/specialty pharmacists as part of the MS care team. Additional articles and websites were identified and reviewed based on the authors’ experience and knowledge.
RESULTS
Neurology Clinical Pharmacists Offer Diverse Expertise and Qualifications
There are a variety of paths that clinical pharmacists may take to arrive at a career working in neurology and with individuals with MS (TABLE 1). After earning a doctor of pharmacy (PharmD) degree, individuals must pass the North American Pharmacist Licensure Examination to practice as pharmacists, and most need to complete at least 1 year of clinical residency or fellowship to become clinical pharmacists.8,11,21 The American Society of Health-System Pharmacists (ASHP) and the American College of Clinical Pharmacy (ACCP) provide directories for identifying accredited pharmacy residency training programs.13,14 Furthermore, relicensure for clinical pharmacists entails the fulfillment of continuing pharmacy education requirements, which vary by state and are overseen by the Accreditation Council for Pharmacy Education.22 Clinical pharmacists also take the Multistate Pharmacy Jurisprudence Examination as an assessment of their ability to apply laws/regulations specific to their state of practice.12
During the first year of residency and general training, or postgraduate year (PGY) 1, pharmacists gain experience in multiple inpatient and outpatient clinical areas and administration/policy and participate in research.21 Many PGY-1 residency programs have rotations in neurology, which may include both inpatient and outpatient experiences. Additional specialized training in areas such as psychiatry, oncology, transplant, or neurology can be obtained during a PGY-2 program in either inpatient or outpatient clinical settings. A PGY-2 resident in neurology can obtain additional training in subspecialties such as epilepsy, stroke, neurocritical care, or neurosurgery. Pharmacy residency programs are akin to their medical counterparts in that they provide valuable training under supervision of an experienced colleague; however, they differ from medical residency programs with respect to their shorter duration (1-2 years vs 3-7 years) and the experience gained in multiple clinical areas in the first year rather than entering into a specialty from the start.21,23
There are only 2 PGY-2 pharmacy residency program specific to neurology in the United States: within the US Department of Veterans Affairs Greater Los Angeles Healthcare System in California and at Grady Memorial Hospital in Georgia. These 1-year specialty programs provide residents with clinical experience in neuroscience areas ranging from general neurologic disorders to neurocritical care. The only neurology-focused pharmacy fellowship program in the United States is the Neurology Clinical Research Fellowship at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado. This program is intended to be a 2-year fellowship for any pharmacist regardless of whether they completed a PGY-1 or a general training year. In the Skaggs program, a fellow experiences interdisciplinary clinical research, clinical practice in neurology-focused ambulatory clinics (eg, MS, epilepsy, movement disorders), inpatient consults, and academia.
Aside from these neurology-focused residency and fellowship programs, clinical pharmacists typically develop MS-specific expertise through independent learning and training received from neurology providers while working with individuals with MS. Work experience may be derived from inpatient neurology services, outpatient clinics, neurocritical care units, MS clinics, as well as specialty pharmacies. In addition to these programs, clinical pharmacists can gain research and teaching experience throughout their careers. Moreover, in the past, the ASHP and the ACCP have funded “mini-fellowships” intended for practicing clinical pharmacists learning a new skill set to enhance their current practice; efforts are ongoing in some schools of pharmacy to formalize this process and gain funding from professional societies and/or through competitive grants funded by pharmaceutical companies. Many clinical pharmacists serve as preceptors for pharmacy students during clinical rotations; their experience and guidance can raise awareness about MS during pharmacy training, which can promote interest in pursuing MS clinical pharmacy roles. Each clinical pharmacist will bring a unique perspective and skill set to the MS care team based on their individual education, training, certification(s), work experience, and passion.
Clinical pharmacists may be recognized for their knowledge in practice and/or research by becoming fellows of the ACCP or the ASHP, joining the American Academy of Neurology as an Advanced Practice Provider, and/or obtaining board certifications relevant to MS care. Candidates for Fellowship in the ACCP must have practiced clinical pharmacy for at least 10 years on nomination and must submit an application for review. Clinical pharmacists may also pursue board certifications for certain specialties that may inform MS care, including ambulatory care, psychiatry, and general pharmacotherapy.15,24 The corresponding certifications are Board Certified Ambulatory Care Pharmacist (BCACP), Board Certified Psychiatric Pharmacist (BCPP), and Board Certified Pharmacotherapy Specialist (BCPS), which encompass many disease states relevant to MS and MS symptom management. To be eligible for the BCACP and BCPP examinations, applicants must have 1 of the following 3 things: (1) 4 years of relevant practice experience, (2) completion of a PGY-1 residency plus 1 (BCACP) or 2 (BCPP) additional years of relevant practice experience, or (3) completion of a specialty PGY-2 residency in the corresponding specialty.15 For the BCPS certification, applicants must have 3 years of relevant practice experience or have completed a PGY-1 residency.15 Similar to the BCPS, the National Association of Specialty Pharmacy developed the Certified Specialty Pharmacist certification for clinical pharmacists demonstrating competency in specialty pharmacy services and who meet the experience requirement of 3000 hours of specialty pharmacy practice in the previous 4 years.16
Several professional networks for clinical pharmacists practicing in the psychiatry and neurology specialties may serve as resources for board certification and MS education. For example, the ACCP has a Practice and Research Network (PRN) specific to the central nervous system, allowing networking between pharmacists specializing in neurology and psychiatry.18 This PRN is a forum where professionals can develop leadership and presentation skills along with collaboration and networking with peers. The American Association of Psychiatric Pharmacists (AAPP; formerly named the College of Psychiatric and Neurologic Pharmacists) is another professional organization with psychiatric and neurologic pharmacists and other health care members who practice in the United States.19 The AAPP provides a review course for the BCPP examination and is a great resource for MS education. Clinical pharmacists are eligible to take a certification examination in MS from the Consortium of Multiple Sclerosis Centers (CMSC) and earn the title of Multiple Sclerosis Certified Specialist.20 The Consortium has a subgroup of pharmacy providers, PharMS, and is a tremendous resource to obtain education specific to MS and network with other pharmacists in the field.20 The National Multiple Sclerosis Society is beginning to incorporate clinical pharmacists into their working groups, which focus on education and advocacy for individuals with MS and clinicians.
Neurology Clinical Pharmacists as a Valuable Resource for MS Care Teams and Individuals With MS
Clinical pharmacists can help meet the complex challenges of MS care in a variety of ways, alongside neurology providers, patients, and care partners with approaches based on shared decision-making (FIGURE 1).
Since the advent of monoclonal antibodies and biologicals and their increasing prevalence in drug development, MS care has expanded to include multiple higher-efficacy pharmacotherapy options; however, the utilization of some of the newer pharmacologic therapies approved by the FDA can be limited by the uncertainty of drug interactions and their adverse event profiles.6 Clinical pharmacists are essential resources to manage the expanding treatment landscape and can provide a pharmacologic perspective on patient-specific treatment strategies with alternative modalities for medication management in which pharmacovigilance is critical.25 In fact, pharmacists’ expertise has been used to develop risk-stratified treatment algorithms to improve the quality, affordability, and equity of MS care.26
Clinical pharmacists are equipped to consult with providers on DMT decision-making or other drug selection; to develop and perform protocols for premedication, drug monitoring, and dose adjustments; and to identify and avert DMT adverse events.27,28 In addition, pharmacists can review health records and alert the provider if a patient needs additional assessment or MS specialist care or if they may benefit from a particular targeted therapy or from DMT discontinuation.28 Moreover, because some patients do not have a primary care provider and may rely on their MS physician for the entirety of their care, clinical pharmacists can partner with neurology providers to devise a comprehensive and individualized medication regimen based on the patient’s individual needs, taking into consideration their MS diagnoses/symptoms, MS and non-MS comorbidities, previous approaches to treatment, current medication regimen, and other factors.25
As the interdisciplinary team’s medication experts, clinical pharmacists can recognize and prevent drug interactions, identify adverse events that relate to drug exposure, and avoid adverse events from complex medication regimens and/or polypharmacy. Elderly patients and patients with more advanced disease are at increased risk for drug interactions between MS therapies and symptomatic treatments for common comorbidities, such as medications used to treat psychiatric (anxiety, depression) or cardiovascular (hypertension, hyperlipidemia) comorbidities, epilepsy, migraine, fatigue, spasticity, urinary dysfunction, or insomnia.5,29,30 Pharmacists can guide patients and providers on drug interactions: identifying possible serious interactions, selecting alternatives, and counseling patients about interactions that do not require a change in therapy. A pharmacist can also have an overview of all of a patient’s prescriptions, which may be prescribed by different providers, to identify potential drug interactions and any unnecessary medications; as such, pharmacists provide an important link between patients and providers.31
The clinical pharmacist is well-positioned to provide patients and providers with specific guidance on appropriate DMTs, contraindications, treatment modifications, and monitoring. As patients age, complications may also arise from their altered pharmacokinetic profiles. Pharmacists can monitor and adjust treatments as a patient’s renal function declines with age. To mitigate toxicity from DMTs that have cardiovascular adverse effects, clinical pharmacists can support the management of vascular risk factors such as smoking, diabetes, hypertension, and hyperlipidemia. Most clinical pharmacists are specifically trained in smoking cessation and can be an important resource for patients looking to quit. Because MS is a disease than can affect women of childbearing age, careful consideration is required regarding disease management and the types of DMT that can be used during pregnancy and breastfeeding.32 Finally, clinical pharmacists can aid with additional considerations regarding new onset, exacerbation, or worsening of previous symptoms associated with disease progression by assisting with more stringent monitoring requirements.
Clinical pharmacists can reduce concerns about inaccurately documented medication regimens in electronic health records that are not shared between health care facilities and rectify inaccurate records. Medication reconciliation can reduce related errors and health care costs by avoiding unnecessary medical encounters due to drug interactions. In addition, clinical pharmacists can review for nonpreferred DMT use and medication duplication and can anticipate potential drug–disease state and drug-drug interactions with herbal therapies, over-the-counter medications, cannabis, complementary and alternative therapies, and other traditional medications. In a recent survey of neurology providers working with clinical pharmacists, all strongly agreed that pharmacist involvement decreased time to therapy initiation and provider time spent on medication management.33 Faster initiation of treatment changes can prevent serious complications such as MS relapse or rebound disease and could reduce the risk of hospitalization or emergency department visits due to relapse in an untreated patient.34
In a retrospective medical record review of 64 patients seen for MS management with a documented clinical pharmacist intervention over approximately 1 year, 58.2% of interventions were made through direct patient care encounters.33 More than half of the pharmacist interventions were direct logistics support, such as supporting medication access by completing prior authorizations for insured patients or patient assistance program applications for uninsured/underinsured patients, recommending DMT modification based on type of coverage, contacting the patient to ensure the necessary medication access materials were completed, or liaising with the patient’s specialty pharmacy.33 Clinical pharmacists can also facilitate medication access by assisting patients with securing foundation financial support or free drug/copay assistance.35 Further logistics support with patient care involves clinical pharmacists assisting with medication access issues, appeals, peer to peer reviews, and arranging outpatient infusion services and home therapy. In some MS clinics, the logistical work with medication access is done by pharmacy technicians, which allows clinical pharmacists to focus on clinical concerns.
Some states have legislation and/or policies that allow collaborative practice agreements (CPAs) between physicians and clinical pharmacists in specialty clinics; for example, pharmacists can provide primary care services as a follow-up to physician care, such as providing chronic disease management.36 The CPAs can expand to medication and safety laboratory prescribing by pharmacists based on state-specific approval. Having the ability to prescribe medications within a pharmacist’s scope of practice allows for management of medications prescribed for MS symptoms, timely adjustments of doses (titration and dose reductions), treatment changes when necessary, and medication monitoring. With the ability to prescribe provided by these CPAs, clinical pharmacists can reduce provider time, health system and financial pressures, and burnout,37 and improve efficiency and quality of care.
As broader clinic support, clinical pharmacists can ensure standardization of patient education across the care team. Direct patient care services provided may include monitoring and updating drug monographs and patient education materials, as well as assisting with counseling/support of MS itself, medication adherence, and injectable therapies. In multiple studies, the addition of clinical pharmacists via integration of specialty pharmacy into neurology practice has been shown to increase medication adherence rates in individuals with MS.38,39
Adaptable to the needs of the individual clinic, neurology clinical pharmacists can impact the multidisciplinary team in many ways, even contributing to MS care outside of the clinic. They can be primary investigators or co-investigators on research and quality assurance and improvement projects. They can work with hospital pharmacy and therapeutics committees to advise on DMT use and recommend additions of new DMTs to formularies. They can participate in training neurology and pharmacy students, residents, and fellows. By playing roles in MS research and education, clinical pharmacists demonstrate the utility of team-based MS care and promote the widespread integration of clinical pharmacists in neurology clinics. The National Multiple Sclerosis Society currently includes pharmacists as part of the MS health care team needed to achieve optimal MS therapy management (FIGURE S1, available online at IJMSC.org).40
The contributions of clinical pharmacists as medication experts on multidisciplinary care teams have also been recognized in the management of other complex diseases, particularly cancer.41-44 In the 1990s, the ASHP acknowledged the important role that clinical pharmacists play on the cancer care team and, in 2013, the Hematology/Oncology Pharmacy Association issued a scope-of-practice statement supporting oncology pharmacists as integral members of the patient care team.41 Similar to the benefits seen with MS care teams, clinical pharmacists in oncology have improved medication safety, provided clinical care, and reduced medical costs.41,43,45
Models for Integrating Clinical Pharmacists Into MS Care
Two hurdles remain to integrating clinical pharmacists into team-based MS care: (1) the paucity of funding models and formal advanced training for pharmacists in outpatient neurology (ie, residencies, fellowships, mini-fellowships) and (2) the knowledge gap with neurology providers not understanding the role of clinical pharmacists and, thus, not knowing how to use them. Trust issues between providers and health plan pharmacists with respect to DMT use and costs have also been reported.28 Despite these hurdles, some robust funding models are available, as well as pending legislation intended to allow for improved reimbursement for clinical pharmacy visits.
A successful specialty pharmacy model has been described as 2 clinical pharmacists and 2 certified pharmacy technicians embedded within an academic health system to aid with individual patient care and broader tasks in the clinic.35 An additional benefit of this integration is increased internal prescription capture and, thus, revenue for the health system. Moreover, patient care is kept within the health system, where all levels of service are familiar with each other and share records, simplifying communication and leading to more accurate records, faster responses, and better patient care. Neurology clinical pharmacists may be hired directly by an MS center, a neurology clinic, or an academic medical center/school of pharmacy. In these collaborative models, clinical pharmacists may also provide access to funding for research projects and residency/fellowship training. The addition of the clinical pharmacist to the MS care team can ultimately help improve patient care and provider satisfaction.33,46
Another integration model is the multicomponent, health system–level intervention the MS Treatment Optimization Program (MSTOP), developed to reduce escalating DMT expenditures and improve patient outcomes.28 This program’s aim is to improve trust between providers and pharmacists by focusing on quality of treatment, with pharmacists providing pharmacy-related guidance.
A key element to help clinical pharmacists become a vital component of MS care teams outside of large academic centers is federal provider recognition in order to prescribe and bill for services. Federal legislation to grant federal provider status to pharmacists has been proposed.47 States are also taking action; Colorado enacted House Bill 21-1275 enabling Medicaid reimbursement for services by pharmacists, thus supporting the sustainability of pharmacists in collaborative practice models.36 Such changes would allow clinical pharmacists to provide clinical services to a broader population, including individuals from underserved communities for whom access to care and specialty medication can prove challenging. These legal changes could have a significant effect on the ability of smaller neurology practices to afford the services of a clinical pharmacist. Because it has been documented that pharmacists can lower the overall cost of health care and improve long-term chronic disease outcomes,36 the cost of hiring a pharmacist could be offset by the savings brought about by their involvement. This is particularly important when bearing in mind the considerable DMT expenditures previously mentioned and is reflected in the aims of programs such as MSTOP.28
CONCLUSIONS
Neurology clinical pharmacists bring multifaceted medication management and patient counseling and education skills to the MS care team and support the shared decision-making process as an accessible resource for patients and clinicians. They can liaise between multiple members of the MS and greater care teams (eg, specialty pharmacies, infusion centers, primary care providers) and patients. The role of a clinical pharmacist can continually adapt as MS care evolves toward patient-centric comprehensive management. Chronic disease management may be optimized through innovative integrated clinical pharmacy services (eg, DMT monitoring clinic, MS and pregnancy, immunization), highlighting how their role goes beyond DMT selection and initiation. To gain widespread awareness of the potential benefits of integrating clinical pharmacists within MS care teams, future research should compare outcomes (eg, medication adherence rates, disease activity, patient-reported quality of life, time to appropriate DMT initiation, and health care resource utilization) between patients receiving standard of care and those receiving multidisciplinary, clinical pharmacist–integrated care. Such research could offer valuable insight into the effective integration of clinical pharmacists within MS care teams. The future of neurology may include clinical pharmacist service through the creation of legislation and multiple revenue streams funding these positions to provide patient-centric comprehensive MS care.
Neurology clinical pharmacists provide valuable support to the busy multiple sclerosis clinic: their expertise enables them to manage complex treatment regimens and provide guidance on alternative and new therapies, and pharmacist involvement can also lower the overall cost of health care and improve outcomes.
Neurology clinical pharmacists can enhance patient-centered care by facilitating prompt treatment initiation and switching, preventing drug-drug interactions and disease complications, and providing patients with education, counseling, and support for treatment access and adherence.
ACKNOWLEDGMENTS:
We thank Lisa Aquillano, PharmD, BCPS, MSCS, of the Emory Clinic for her input during the early stage of manuscript development. Dr Bainbridge thanks Michelle Adkins, PharmD, for her review of and recommendations on this manuscript.
REFERENCES
FINANCIAL DISCLOSURES: Dr Bainbridge has received grant funding from GW Pharmaceuticals and honorarium for serving on an advisory board from Novartis. Dr Fuller has received consulting fees from Biogen, Novartis, Bristol Myers Squibb, Bayer, and EMD Serono. Dr Hellerslia has served on advisory boards for Boehringer Ingelheim and Novartis and has received grant funding from Genentech, Inc. Dr Kidd has served on advisory boards for EMD Serono and Novartis. Dr Merrill has served on advisory boards for Novartis and Bristol Myers Squibb. Dr Volger is an employee of Novartis Pharmaceuticals Corporation. Dr Montgomery has received honorarium for a nonpromotional education presentation and advisory board membership from Novartis. Dr Barnhart declares no conflicts of interest.
FUNDING/SUPPORT: Medical writing support, including assisting authors with the development of the manuscript drafts and incorporation of comments, was provided by Juliel Espinosa, PhD, and Meredith Whitaker, PhD, of Alphabet Health and was funded by Novartis Pharmaceuticals Corporation. This manuscript was developed in accordance with Good Publication Practice guidelines. The authors had full control of the content and made the final decision on all aspects of this publication.
Author notes
JB and JHM contributed equally to this work.
Note: Supplementary material for this article is available online at IJMSC.org.