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Expediting Formulary Standardization in a Multihospital Health System Using Layered Learners
Drug formularies are an integral part of successful medication management within hospitals and health systems. The American Society of Health-System Pharmacists (ASHP) guidelines1 specifically outline the need for a formulary management process, as well as a P&T committee to manage the formulary within an institution. In addition, the guidelines call for a standardized formulary “among components of integrated health systems when standardization leads to improved patient outcomes and safety.”1 Formulary standardization with a unified P&T committee across multiple hospitals has been described as a time-intensive and potentially contentious process,2–4 but a more streamlined formulary and medication management system can reap benefits related to patient safety, cost containment, and improved drug utilization.5,6
BJC HealthCare, a multihospital health system in St. Louis, Missouri, formed a centralized, system-level P&T committee in 2011. The committee’s initial efforts focused on clinical alignment of processes to promote appropriate utilization, with less emphasis on formulary standardization. After formation of the system P&T committee, the combined formulary for the BJC system consisted of any product purchased by any BJC hospital in the prior 12 months, which comprised 1,854 unique medications, independent of the drug form, dose, or route. By 2015, BJC HealthCare had begun work on implementing a new electronic medical record (EMR) system, and the need for a more streamlined formulary became readily apparent. As the system moved toward an integrated, single-platform EMR, the priorities of the system P&T committee shifted toward simplifying the formulary, including development and standardization of therapeutic interchanges across the system while maximizing clinical and financial benefit. The committee recognized a significant challenge in completing this work in the short period required for EMR implementation. Given that pharmacy students and residents were already embedded in facilities across the organization, the system P&T committee sought to leverage their skills to expedite formulary standardization.
The purpose of this paper is to describe how a multihospital health system approached standardization of formulary and therapeutic interchanges over a 15-month period by working through the subcommittees supporting the system P&T committee and by using a layered learner approach to complete the task in an expedited manner before implementation of the system-wide EMR.
BJC HealthCare is a nonprofit health care system consisting of 15 hospitals, including adult and pediatric academic medical centers that serve as the primary teaching hospitals for Washington University School of Medicine, as well as community hospitals in urban, suburban, and rural communities. Additional comprehensive services include home health, behavioral health, and an employed medical group. BJC hospitals serve as teaching sites for pharmacy students (introductory and advanced pharmacy practice experiences) from area colleges of pharmacy and pharmacy residents in postgraduate year (PGY) 1 and PGY 2.
BJC HealthCare developed a system-level P&T committee in 2011 in response to a need for resource conservation and clinical alignment in medication utilization across hospitals. The committee currently includes two physician co-chairs: one representing the academic hospitals and one representing community hospitals. Each hospital or care delivery site is represented on the system P&T committee, and each hospital receives one vote per decision. The pediatric formulary is separate from this process and is determined by the St. Louis Children’s Hospital P&T committee, which acts as a clinical panel of the system P&T committee. Clinical panels are multi disciplinary teams of clinical specialists whose purpose is to make formulary, quality, and safety recommendations for medications used in their specialty area. In addition to the pediatric P&T committee, there are clinical panels for oncology, coagulation, and infectious diseases. The system also has clinical expert councils that include physicians and other clinicians who drive decision-making in specialized service lines, such as surgery, interventional cardiology, and radiology. The system P&T committee and clinical expert councils have a collaborative relationship, but the system P&T committee retains formulary decision-making responsibilities. The pharmacy specialty team provides recommendations in areas not covered by a clinical panel or a clinical expert council. BJC’s overall P&T system structure is outlined in
Impetus for Change
Among the 15 hospitals in BJC HealthCare, there were four separate EMR systems for the inpatient settings and multiple systems within ambulatory locations. As the system planned a transition to a new single-platform EMR, the pharmacy specialty team was approached by the system-level EMR implementation team to assist with simplifying formulary products by reducing the number of similar items and standardizing therapeutic interchanges. Product classes with high variation, a more complex build in the new EMR system, or no current clinical panel were identified for review by the EMR implementation team. These included: 1) angiotensin-converting enzyme inhibitors; 2) angiotensin II receptor blockers; 3) beta blockers; 4) topical anesthetics; 5) topical steroids; and 6) minerals, vitamins, and electrolytes.
The timeline was the primary challenge in meeting the project goals. The EMR team requested that the standardization work be completed within 12 to 18 months in order to meet the EMR go-live deadline. Previous class reviews and standardization work had required four to 16 weeks for completion. Given the volume of work and limited time, the system P&T committee had three aims: reduce the overall time needed for standardization work, utilize all available resources, and complete the work correctly the first time to avoid appeals to decisions.
Layered Learning Practice Model
Given the short timeline, BJC’s system P&T committee employed a concept known as layered learning to assist with standardizing the formulary. Layered learning has been implemented in a number of practice settings as a team-based approach to care delivery that incorporates clinical pharmacists, pharmacy residents, and pharmacy students, allowing for expansion of pharmacy services while providing valuable clinical experiences to residents and students.7–13 The P&T committee recognized the formulary standardization tasks as an opportunity to engage students and residents in order to adhere to the EMR implementation timeline. In addition, the formulary standardization work aligned well with learning objectives for PGY-1 residents.14
Students who assisted in the efforts were located at a community facility for a general hospital rotation or at BJC HealthCare’s corporate offices for a medication safety and outcomes rotation. Students were given dedicated time during their rotation to complete the project. Pharmacy residents were located in both community and academic practice settings (three facilities). For PGY-1 residents at the academic hospital, the projects were part of the six-week management and drug information rotation; for community hospital residents, the projects were completed during either their longitudinal or focused management rotation. There was flexible time within each rotation to complete the project. For PGY-2 residents, projects were completed along with the clinical responsibilities of the rotation to simulate the typical workflow of a clinical specialist. PGY-2 residents primarily aided with new product reviews in their area of specialty training.
Employing the layered learner approach, the formulary standardization effort was allocated to students, residents, clinical pharmacy specialists, and pharmacy leadership according to the complexity of the drug class under review (
The therapeutic class review assignments were shared across BJC hospitals to decrease the burden on any single hospital, and assignments were coordinated by the co-chair of the pharmacy specialty team. Those preparing class reviews were provided with available existing data, which included the drug purchase history and copies of interchanges in use throughout the system. The individual reviewer was expected to prepare a review of the drug class, to develop recommendations for formulary agents and appropriate therapeutic interchanges when applicable, and to present the findings to stakeholders through-out the health system. Recommendations were given to the appropriate clinical panel or the pharmacy specialty team for initial review and discussion as a group. Additional feedback was requested and discussed among relevant stakeholders (physicians, nursing, and other ancillary support teams) over the ensuing weeks. Feedback was discussed again with the clinical panel and modifications were made to the initial recommendations. Lastly, the system P&T committee reviewed and voted on the final recommendations.
Descriptive statistics on the number of therapeutic class reviews that were performed, as well as the total number of unique agents that were reviewed, are reported. The total of unique agents does not include variations in form, dose, or route. Only the inpatient setting and hospital infusion clinics were affected by the formulary changes and are included in the analysis; retail pharmacies, home care, and medical group practices were not impacted.
Supply cost-savings were determined by calculating the difference between the patient volume-adjusted cost 12 months prior to the implementation of a formulary change and 12 months post-change. A patient volume-adjusted calculation was chosen to ensure that savings were due to the intervention and not due to volume fluctuations. Purchasing data from both time periods for the medications undergoing class review were divided by adjusted admissions in each period. Total admissions were adjusted using inpatient and outpatient pharmacy revenue to account for outpatient areas not included in the admission count, such as ambulatory surgery or the emergency department. The volume-adjusted differences in costs by medication class were multiplied by adjusted admissions to calculate total savings.
Over the 15-month study period (May 2015 to July 2016), 27 therapeutic class reviews were conducted. These reviews were performed in six departments by personnel ranging in skill level from pharmacy students to senior pharmacy management; 15 learners participated in the class reviews. The average time to conduct a class review to a P&T decision was 6.9 weeks (range, two to 16 weeks). Twenty-six of the 27 class reviews were accepted on initial presentation to the system P&T committee. A total of 346 unique agents were reviewed during the study period, with 153 items (44%) being retained on the formulary, and 193 agents (56%) classified as nonformulary. In addition to the formulary deletions, several additional dosage forms and sizes were removed to simplify the order entry and product selection process within the future EMR. As of October 2016, 1,571 unique items remained on the BJC formulary, a reduction of 283 items (15%) compared with the 2012 formulary. This includes new items added during this period. Overall, the alignment of formulary medications and interchanges in the 27 classes resulted in an estimated $1.185 million savings in supply costs over the ensuing 12 months after changes were implemented, not including additional savings associated with decreased waste.
The standardization of formulary and therapeutic interchanges can be expedited by using a layered learner model, in combination with a robust, shared responsibility in the review process. This model can be used in other settings to accelerate the formulary review process. Beyond standardization, this project achieved several other accomplishments. The system-level P&T committee now has a regular cadence for class reviews, a continuous project pipeline, and a better understanding of the approval pathway. The process has also generated a standard review template based on the Joint Commission’s standards for selecting medications15 and an implementation checklist, thus improving the overall efficiency of product reviews.
While the use of layered learners is not a novel concept, employing students and residents to aid in formulary standardization across a multihospital system has not been described previously. Prior examples of layered learners in the pharmacy setting have incorporated students and residents in direct patient care, such as patient education and medication reconciliation,9 though engaging learners in administrative tasks has also been reported.12 The use of layered learners did create some challenges, as multiple preceptors across system facilities had different views and desires for learning experiences. However, engaging students and residents in this task ultimately provided a new and valuable learning experience while completing necessary work for the organization. This type of innovation is increasingly encouraged as a means of expanding the duties of hospital pharmacies when time and resources are limited.16 As BJC continues to utilize this approach, the team has become more successful in obtaining the necessary information for layered learners and more clearly defining preceptor expectations. One of the greatest benefits for hospital-level preceptors is an increased appreciation for the challenges and opportunities at other facilities within BJC’s complex health system.
Challenges associated with system-wide formulary standardization were largely related to the different needs of the individual facilities, such as utilization of premixed medications versus admixture in the pharmacy, as well as differences in the patient populations and prescribing patterns across facilities. Facilities varied in regard to participation in clinical research, generating differences of opinion among prescribers on the importance of certain medications on the formulary. The leverage of the system P&T committee, led jointly by academic and community physicians, helped diminish some of these challenges, as did the formal process for appeals. In addition, the system P&T committee was well established for a number of years prior to this standardization process, which allowed the team to embrace this work more easily and establish a plan for completion.
The system P&T committee continues to be presented with ongoing challenges, including drug shortages, pricing escalations, and costly specialty medications. As BJC HealthCare seeks to evolve to a more consistent formulary, it has recognized that consistent and diligent reviews of therapeutic classes are a requirement to ensure that new contracting opportunities are maximized. In addition, many medications have now become branded generics, as many agents are now produced by a limited number of manufacturers.17,18 This presents unique opportunities for pharmacy leaders to work with prescribers to fully understand how these medications are utilized and to identify any potential alternatives that may lessen the financial impact to the health system. As hospitals continue to deal with a growing number of high-cost specialty and niche medications, it is increasingly important to ensure that robust processes are in place to review these novel therapies.19 There is often limited or no available evidence to support therapeutic standardization or interchanges in these drug classes. A strong understanding of third-party payments, including location of services rendered, will be a critical competency for pharmacy leaders now and in the foreseeable future.
There are some limitations to this analysis. The data are retrospective and were not initially collected for study purposes. In addition, the analysis was not designed to fully detect the impact of standardization on costs or patient outcomes. The cost analysis is limited by inability to account for savings due to contract changes. It is unknown how many patients may have utilized home medications due to the removal of their home agents from the formulary, nor did the team evaluate possible adverse drug events that may have occurred due to therapeutic interchanges during transitions of care. Finally, the outcomes of this project focused on standardization of the formulary and less on the experience of the layered learners. Next steps by the team may involve evaluating student experiences through a survey or other means to ensure the outcomes of the learning experience are upheld.
Concurrent with the establishment of a system P&T committee, the use of multiple layers of pharmacy personnel can provide effective and timely formulary standardization within a large health system. The use of layered learners is an important tool, as it allows students and residents to serve as pharmacist-extenders. While this work was performed within a multihospital system, any institution with students or residents that maintains a formulary may find value in this process. Other institutions should explore opportunities to expand learning experiences to include formulary standardization.
BJC HealthCare’s P&T Structure
The Layered Learner Approach to Class Reviews
Process for Class Reviews
- Tyler LS, Cole SW, May JR, et al. ASHP guidelines on the pharmacy and therapeutics committee and the formulary system. Am J Health Syst Pharm 2008;65;(13):1272–1283.
- Wakefield DS, Ward MM, Loes JL, et al. Creating a shared formulary in 7 critical access hospitals. J Rural Health 2010;26;(3):283–293.
- Reddan JG, Sheehan AH, Eskew J, Elmes G. Integration of a medication management infrastructure in a large, multihospital system. Am J Health Syst Pharm 2004;61;(23):2557–2561.
- Glassman PA, Good CB, Kelley ME, et al. Physician perceptions of a national formulary. Am J Manag Care 2001;7;(3):241–251.
- ASHP Expert Panel on Medication Cost Management. ASHP guidelines on medication cost management strategies for hospitals and health systems. Am J Health Syst Pharm 2008;65;(14):1368–1384.
- Karas A, Kuehl B. Leveraging hospital formularies for improved prescribing. Healthc Manage Forum 2014;27;(1 suppl):S17–S27.
- Pinelli NR, Eckel SF, Vu MB, et al. The layered learning practice model: lessons learned from implementation. Am J Health Syst Pharm 2016;73;(24):2077–2082.
- Delgado O, Kernan WP, Knoer SJ. Advancing the pharmacy practice model in a community teaching hospital by expanding student rotations. Am J Health Syst Pharm 2014;71;(21):1871–1876.
- Bates JS, Buie LW, Amerine LB, et al. Expanding care through a layered learning practice model. Am J Health Syst Pharm 2016;73;(22):1869–1875.
- Bates JS, Buie LW, Lyons K, et al. A study of layered learning in oncology. Am J Pharm Educ 2016;80;(4):68
- Loy BM, Yang S, Moss JM, et al. Application of the layered learning practice model in an academic medical center. Hosp Pharm 2017;52;(4):266–272.
- Sin JH, Li H, Jandovitz N, et al. Dynamic interplay of pharmacy learners during a solid organ transplantation learning experience. J Pharm Pract 2017; 897190017715392
- Soric MM, Glowczewski JE, Lerman RM. Economic and patient satisfaction outcomes of a layered learning model in a small community hospital. Am J Health Syst Pharm 2016;73;(7):456–462.
- American Society of Health-System Pharmacists. Required competency areas, goals, and objectives for postgraduate year one (PGY1) pharmacy residencies 2015; Available at: www.ashp.org/-/media/assets/professional-development/residencies/docs/required-competency-areas-goals-objectives. Accessed April 18, 2017
- The Joint Commission. Revision to MM.02.01.01—Hospital Accreditation Program December 22, 2011; Available at: www.jointcommission.org/assets/1/18/Revision_to_MM.02.01.01_HAP_20111222.pdf. Accessed September 1, 2017
- Gubbins PO, Micek ST, Badowski M, et al. Innovation in clinical pharmacy practice and opportunities for academic–practice partnership. Pharmacotherapy 2014;34;(5):e45–e54.
- Alpern JD, Stauffer WM, Kesselheim AS. High-cost generic drugs—implications for patients and policymakers. N Engl J Med 2014;371;(20):1859–1862.
- Vega AD, Meola PP,
et al. Commentary on current trends in rising drug costs and reimbursement below cost. Manag Care 2016;25;(4):41–49. Barcelo RJ Jr
- Lee J. Hospitals take steps to control drug costs Modern Healthcare. November 29, 2014; Available at: www.modernhealthcare.com/article/20141129/MAGAZINE/311299983. Accessed May 18, 2017