Biologic Management for IBD

PRACTICAL IMPLICATIONS'

With increased specialty medication prescribing, associated costs, and the interest of health systems to establish specialty pharmacies for improved patient care, it is vital to define the pharmacist’s role within the patient’s health care team.

Pharmacists play a significant role in the medication-use process, from addressing gaps to optimizing adherence to assisting with acquisition and education of medication therapies.

The inclusion of a pharmacist on patients’ health care teams reduces a physician’s time spent on medication issues and permits more time for other aspects of patient care.

Through multiple venues, the pharmacist assists with coordination of care and enhances the overall care provided to a patient.

INTRODUCTION

Inflammatory bowel disease (IBD) is a general term used to describe inflammation and/or ulceration in the gastrointestinal (GI) tract. It may further be classified as Crohn’s disease (CD), ulcerative colitis (UC), or less commonly as indeterminate colitis, which is accountable for about 15% of IBD cases.^1-3 These chronic conditions have multiple similarities and differences, but if left untreated or managed inappropriately, various complications (eg, development of strictures, fistula, abscesses, perforation, toxic megacolon, infections and malignancies) may occur.⁴ Each year, IBD accounts for over 700,000 physician visits, 100,000 hospitalizations, 119,000 cases of disability, and more than $1.7 billion in costs to the health care system.⁵ Additionally, morbidity and mortality rates are higher for patients with IBD compared with the unaffected population.⁶ The general goals of treatment are to induce and maintain remission, minimize complications and disease manifestations, and improve overall quality of life.

The inflammatory CD consensus guideline, updated in 2013 by the American Gastroenterology Association, recommends the use of biologic medications to induce and maintain remission.⁷ Biologic response modifiers (BRMs) are substances derived from naturally produced antibodies known to modify the body’s response to infection and certain diseases. Tumor necrosis factor (TNF) inhibitors are a type of BRM used to treat a variety of inflammatory diseases, including IBD (Table 1).⁸ Although BRMs are proven to be effective, there are limitations associated with this therapy, such as adverse effects, the complexity of use, and insurance restrictions (eg, utilization management criteria); however, these limitations may be addressed with appropriate management. Regarding adverse effects, these medications induce immunosuppression, potentially leading to an increased risk of infections, certain malignancies, reactivation of tuberculosis (TB), and worsening heart failure or demyelinating disease.^8-10

Due to these risks, a baseline risk assessment and ongoing monitoring are recommended to ensure the safety of therapy. To optimize medication adherence and proper administration, detailed education is important and should be provided to patients by any health care providers in the clinic using educational materials developed by manufacturing companies. Given the cost of these medications, access may also be a barrier due to the benefit verification process—which confirms if the pre- scribed therapy is medically appropriate and necessary; however, with proper validation through prior authorizations, the process of acquisition may become easier.¹¹ Thus, while BRMs are recommended by guidelines, multiple steps must be taken to guarantee medication access, proper use, and safety.

Given the recent guideline changes in the management of CD, it is predicted that the use of biologics for the management of IBD will increase. Clinical management is necessary to ensure the safety and adherence of the medication, to minimize adverse events, and to evaluate the effectiveness of the therapy. IBD is associated with serious sequelae, and biologic therapy is complicated, so to address this, an integrated clinical practice model consisting of a pharmacist collaborating with gastroenterologists, fellows, medical residents, and nurse practitioners, was established at the University of Illinois Hospital and Health Sciences System (UI Health). The purpose of this article is to describe the roles of the pharmacist in the gastroenterology integrated clinical practice model with a focus on medication adherence and the management of self-injectable biologic medications used to treat IBD.

IBD PHARMACIST: ROLES AND RESPONSIBILITIES'

The role of the pharmacist in IBD management was originally developed to improve the continuity of care, with an emphasis on addressing gaps in the medication use process; thus, the pharmacist is involved with all aspects of patient care—from specialty pharmacy operations to clinical services. The pharmacist spends 2 half-days in clinic, and the remainder of the time is spent in the Specialty Pharmacy Service (SPS) call center, which was established in 2012 and is staffed by pharmacists, pharmacy technicians, and student pharmacists. By being involved in both clinical and operational aspects of patient care, the pharmacist is able to make meaningful contributions and thereby ensure the provision of optimal care. The ultimate goal of this model for the pharmacist is to improve medication access and provide patient care within the health system by being part of the patient care team.

As a member of the GI team, the pharmacist’s role is multifaceted and includes managing self-injectable BRM medications, solving medication-related insurance coverage issues, and providing education on the proper use and administration of BRMs (Figure).

Monitoring. One important aspect of BRM therapy is the need for base- line and ongoing laboratory monitoring. Due to the risks of serious infections and neoplastic disease, manufacturers of BRM therapy strongly recommend instituting baseline and ongoing surveillance of complete blood count and liver function, as well as performing assessment of symptoms relating to infections such as TB and hepatitis B. In February 2012, the UI Health Clinical Care Guidelines for BRMs were implemented institutionwide with the intent to reinforce safety monitoring recommendations and aid health care teams with clinical treatment decisions.¹² Given the unique position of the pharmacist in fulfilling clinical monitoring and medication-related activities, the pharmacist’s role evolved to ensure that appropriate monitoring of BRM therapy was completed prior to initiation and during the duration of treatment.

Medication access. In addition to the baseline clinical appropriateness review, the pharmacist oversees medication access via insurance coverage and medication dispensing. First, the patient’s pharmacy insurance information is obtained and provided to the SPS call center staff for insurance benefit verification for the selected therapy. In most circumstances, the BRM requires a prior authorization or may be subject to an insurance restriction such as prescription dispensing by a network specialty pharmacy outside UI Health. This may result in delayed access to medication due to the handoff from the health system to another outside entity. In the event that insurance coverage cannot be obtained for the selected BRM, the pharmacist identifies and discusses alternative options with the GI team; some of these options may include switching to another formulary agent or enrolling patients in medication assistance programs.

Patient education. Once insurance coverage of the medication is secured, the pharmacist educates the patient on self-administration, stability and storage requirements, and potential adverse effects. Additionally, the pharmacist highlights the significance of compliance with laboratory monitoring and reviews the importance of communicating with the GI team in the event of potential infection, worsening disease control, or issues obtaining or using the medication.

Refill management. If insurance coverage does not restrict medication access, patients are offered the choice to receive their medication from UI Health. This provides a number of benefits to the patient, including refill management with ongoing safety monitoring, direct communication with a provider, comprehensive medication coordination, and same-day home courier service using advanced cold-chain shipping methods. The SPS call center manages proactive refill coordination and also conducts monthly surveys to assess adherence, reinforce proper administration, and identify safety or tolerability issues (e Appendix, avail- able at www.ajmc.com). This survey provides valuable information for the pharmacist, and if needed, the pharma- cist can discuss interventions with the GI team. For example, if a patient complains of an injection site reaction, the pharmacist educates the patient about rotating the injection site and applying ice to numb the area pre- and post injection. However, if a patient complains about symptoms such as fever, the pharmacist conveys this information to the GI team for intervention determination. All communications are documented in the patient’s electronic medical record for improved continuity of care.

Medication reconciliation, vaccination screening, and shared medication appointments. Beyond medication therapy coordination from beginning to end, the pharmacist plays an active role in assisting with medication reconciliation and ensuring patients are current on necessary immunizations. Medication reconciliation is performed for all new patients during their initial clinic visit to create an accurate medication list, assess for duplications in therapy or drug interactions, and ensure issues with obtaining medications are resolved. Given that patients on immunosuppressive therapy are at an increased risk of infection, the pharmacist—when applicable—encourages patients to get vaccinated, and when necessary, clarifies misconceptions and addresses barriers to immunization.

Lastly, the pharmacist is actively involved with shared medical appointments (SMA) for IBD, which is a novel program to bring patients together to engage in conversation with multiple health care providers. SMA consists of a series of health care-related sessions, including topics on disease state overview, medical terminology, nutrition, exercise, mental health, and medications to treat IBD. The pharmacist provides education on IBD therapies including administration, steps of therapy, adverse effects, and general counseling tips. Patients engage in group discussions and are provided with the opportunity to ask any questions related to their medications. The purpose of the SMA is to encourage patients to under- stand and take accountability for their health, thereby potentially increasing adherence through this process.13

RESULTS

To assess the contribution of the pharmacist on medication adherence rates of self-injectable biologics in an integrated GI clinical practice model, a retrospective review of electronic medical charts from January 1, 2008, to December 31, 2013, was approved by the University of Illinois at Chicago institutional review board and then conducted. Patients 18 years or older with IBD who were prescribed adalimumab or certolizumab—the 2 most commonly utilized self- injectable biologics at UI Health—with a minimum of 4 consecutive refills at UI Health per calendar year, were included. Raw data pertaining to medication adherence were generated from the pharmacy dispensing system, and included refill number, refill process date, and day supply. Adherence was measured by calculating the medication possession ratio (MPR)¹⁴:

MPR = Total Rx Days of Supply/ (Last Prescription Date + Last Prescription Days Covered — First Prescription Date).

All data were analyzed using SAS version 9.2 (SAS Institute, Cary, North Carolina).

There were a total of 215 charts reviewed and included in the study (Online Table 2). The MPR goal at UI Health was to exceed the industry standard, which is reported as higher than 80%.14,15 Findings show the MPR for UI Health over 5 years has consistently been 90% or greater, as detailed in Online Table 3. There was a slight decline in adherence rates in 2012 when the Clinical Care guidelines were implemented, where in order to comply with the new guidelines, temporary discontinuation of medication was warranted in some patients because of infection, pregnancy, expired labs, or hospitalization. While the MPRs reported may not be a true adherence metric because of these lapses in therapy, they highlight the pharmacist’s role in maximizing medication adherence while adhering to clinical monitoring guidelines.

PHYSICIAN’S PERSPECTIVE

From a physician’s perspective, in addition to ensuring the efficacy and safe- ty of biologic therapy and improving overall adherence rates, the integration of a pharmacist in the IBD practice model permits the gastroenterologist to practice at the height of his or her license. Based on a survey, 22% of physicians spend less than 30 hours per week in direct patient care, secondary to paperwork and administrative demands.^16-18 The process associated with securing medication access and monitoring biologic therapy for patients with IBD can be onerous, limiting physicians’ time spent with patients. By delegating medication-related duties to the pharmacist, the gastroenterologist is then able to spend more time on other aspects of IBD care, such as bone density, colon cancer screening/surveillance, and eye and skin disease manifestation.

Additionally, the pharmacist can serve as an extra resource for patient information. By obtaining a thorough medication reconciliation and his- tory, appropriate titrations or changes in therapy may be made in order to achieve the treatment goals of preventing relapse and improving quality of life for the patient. Furthermore, having the pharmacist participate in SMA sessions permits patients to obtain an in-depth perspective on medication options and the importance of disease management. Additionally, the potential gaps in patient care may be lessened by the SPS call center staff (including a pharmacist and technicians), who check in with patients on a monthly basis, and sometimes bring to light situations or conditions that may not be mentioned otherwise in a timely manner. With the pharmacist working side-by-side with the physician and other health care providers, a meaningful collaborative relationship is formed, which permits the provision of optimal patient care. Although the inclusion of pharmacists in multi-disciplinary teams enhances patient outcomes, this outpatient model is unique and innovative in that it encourages the pharmacist to become actively involved and accountable for the patient care he or she provides.^19,20

LIMITATIONS

The integrated system at UI Health allows for coordinated patient care and permits all providers to work closely with the patient. With this model, pharmacists can help to improve adherence rates, which ideally lead to reduced complications and hospitalization rates. Data collection of meaningful clinical outcomes, such as quality of life measures (eg, reduction of flare-ups), is warranted to further justify the pharmacist’s role.

Insurance companies utilize many strategies to attempt to control cost and reduce the waste of specialty medications (eg, through limiting medication distribution to in-network specialty pharmacies). A major benefit of a health system—based specialty pharmacy is the ability to employ clinical management at the highest level through regular communication with the patient and the subsequent ease of access to the prescriber. Within this collaboration, costs can be controlled by ensuring continued indication and adherence to the therapy. Additionally, drug waste can be prevented with temporary dis- continuation of medications when the patient is hospitalized or in contraindicated situations, such as an active infection. However, data regarding cost control have not been collected by the UI Health SPS. Additional research on initiatives taken by the pharmacist in providing clinical services and the resulting cost savings are warranted.

CONCLUSIONS

With the prescribing of specialty medication on the rise, as well as the associated rapid cost escalation and the interest of health systems in establishing a specialty pharmacy business for improved patient care and management, it is important to define and establish the role of a pharmacist within the health care team. Most specialty medications require initial and follow-up monitoring to ensure efficacious and safe use, as well as extensive education to empower patients to take accountability for their own health. In the integrated clinical practice model, including a pharmacist with both the provider team and the SPS call center promotes medication access and management of specialty medications. Through increased provider team involvement and participation with ongoing medication management, the pharmacist becomes more engaged with the responsibility of improving patient outcomes. Having a pharmacist involved in the clinical management of these medications enhances the overall patient care team model in a health system, but further research is needed to measure the value of the pharmacist in improving clinical outcomes and reducing costs.

This article was originally published in Am J Pharm Benefits (2015;7[5]:215-220). It appears here with permission from the publisher.

References

• Abraham C, Cho JH. Inflammatory bowel disease. N Engl J Med. 2009;361(21):2066-2078.
• Guindi M, Riddell RH. Indeterminate colitis. J Clin Pathol. 2004;57(12):1233-1244.
• Sobczak M, Fabisiak A, Murawska N, et al. Current overview of extrinsic and intrinsic factors in etiology and progression of inflammatory bowel diseases. Pharmacol Rep. 2014;66(5):766-775.
• Scherer JR. Inflammatory bowel disease: complications and extraintestinal manifestations. Drugs Today (Barc). 2009;45(3):227-241.
• Inflammatory bowel disease. CDC website. cdc.gov/ibd/index.htm. Published January 2014. Accessed August 1, 2014.
• Selinger CP, Leong RW. Mortality from inflammatory bowel diseases. Inflamm Bowel Dis. 2012;18(8):1566-1572.
• Terdiman JP, Gruss CB, Heidelbaugh JJ, Sultan S, Falck-Ytter YT. American Gastroenterological Association Institute guideline on use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn’s disease. Gastroenterology. 2013;145(6):1459-1463.
• Nielsen OH, Ainsworth MA. Tumor necrosis factor inhibitors for inflammatory bowel disease. N Engl J Med. 2013;369(8):754-762.
• Targownik LE, Bernstein CN. Infectious and malignant complications of TNF inhibitor therapy in IBD. Am J Gastroenterol. 2013;108(12):1835-1842.
• Mozaffari S, Nikfar S, Abdolghaffari AH, Abdollahi M. New biologic therapeutics for ulcerative colitis and Crohn’s disease. Expert Opin Biol Ther. 2014;14(5):583-600.
• Tu HT, Samuel DR. Limited options to manage specialty drug spending. Res Brief. 2012;(22):1-13.
• Hanson RL, Gannon MJ, Khamo N, Sodhi M, Orr AM, Stubbings J. Improvement in safety monitoring of biologic response modifiers after the implementation of clinical care guidelines by a specialty pharmacy service in an academic health system. J Manag Care Pharm. 2013;19(1):49-67.
• Taveira TH, Dooley AG, Cohen LB, Khatana SA, Wu WC. Pharmacist-led group medical appointments for the management of type 2 diabetes with comorbid depression in older adults. Ann Pharmacother. 2011;45(11):1346-1355.
• Zhao B, Wong EC, Palaniappan L; Palo Alto Medical Foundation Research Institute. Estimating patient adherence to medication with electronic health records data and pharmacy claims combined. SAS Institute website. http://support.sas.com/resources/papers/proceedings13/167-2013.pdf. Published 2013. Accessed August 1, 2014.
• Hess LM, Raebel MA, Conner DA, Malone DC. Measurement of adherence in pharmacy administrative databases: a proposal for standard definitions and preferred measures. Ann Pharmacother. 2006;40(7-8):1280-1288.
• Christino MA, Matson AP, Fischer SA, Reinert SE, Digiovanni CW, Fadale PD. Paperwork versus patient care: a nationwide survey of residents’ perceptions of clinical documentation requirement and patient care. J Grad Med Educ. 2013;5(4):600-604.
• Alromaihi D, Godfrey A, Dimoski T, Gunnels P, Scher E, Baker-Genaw K. Internal medicine residents’ time study: paperwork versus patient care. J Grad Med Educ. 2011;3(4):550-553.
• Crane M. Physician frustration grows, income falls — but a ray of hope. Medscape website. medscape.com/viewarticle/761870. Published April 24, 2014. Accessed August 1, 2014.
• Sen S, Bowen JF, Ganetsky VS, et al. Pharmacists implementing transitions of care in inpatient, ambulatory and community practice settings. Pharm Pract (Granada). 2014;12(2):439.
• Gastelurrutia P, Benrimoj SI, Espejo J, Tuneu L, Manques MA, Bayes-Genis A. Negative clinical outcomes associated with drug-related problems in heart failure (HF) outpatients: impact of a pharmacist in multidisciplinary HF clinic. J Card Fail. 2011;17(3):217-223.

Author Affiliations: Department of Pharmacy Practice (SB, NK, SA, RH, JS) and Department of Gastroenterology and Hepatology (NK, VK), University of Illinois at Chicago, Chicago, IL.

Funding Source: None.

Author Disclosures: Dr Hanson is an employee of the University of Illinois at Chicago, which derives pharmacy revenue generated from dispensing therapies; she is also a consultant for United Therapeutics. She has received honoraria for continuing education and lecture fees from United Therapeutics for speaking at the invitation of a commercial sponsor. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject mat- ter of this article.

Authorship Information: Concept and design (SB, NK, RH, JS, SA); acquisition of data (NK, JS, SA); analysis and interpretation of data (SB, NK, JS, SA); drafting of the manuscript (SB, NK, RH, VK, JS, SA); critical revision of the manuscript for important intellectual content (SB, NK, RH, VK, JS, SA); statistical analysis (SA); provision of study materials or patients (SB, VK); administra- tive, technical, or logistic support (NK); and supervision (SB, JS).