New & Improved!

Creating a System-wide Formulary and P&T Committee
March 2012 - Vol. 9 No. 3 - Page #12

To effectively manage pharmaceutical care within a health system, inconsistency must be eradicated, which requires standardization of the formulary, pharmacy clinical programs, treatment pathways, and medication-related policies and procedures. Considering the number of facilities, the leadership structure, the level of engagement of the medical staff, and the political environment of the health system, standardization efforts can be a daunting task, yet at Riverside Health System we have found this to be both achievable and rewarding in a multitude of ways.

Rationale for Standardization
Located in Southeastern Virginia, Riverside Health System began the journey toward overall standardization in 2001. At that time, the system consisted of three acute care hospitals, an inpatient rehabilitation hospital, and an inpatient behavioral health hospital, as well as long-term care facilities and physician office practices. The pharmacy leadership structure included a system director of pharmacy and system clinical manager. The initial focus of the standardization involved the acute care and rehabilitation hospitals as they shared a common pharmacy information system.

Riverside Regional Medical Center (RRMC) is a 510-bed, community-based teaching hospital located in Newport News, Virginia, and operates the only 24-hour hospital pharmacy in the Riverside Health System. Implementation of remote after-hours order entry for the health-system’s rural hospitals was seen as a safety imperative once profile-driven automated dispensing cabinets (ADCs) were implemented to provide the majority of inpatient medication needs. And because a key component to a successful remote order entry process is standardization of the formulary, processes, and pharmacy clinical programs, it became clear that standardization in these areas across the health system was called for.

Drivers of Standardization
Beginning in 2001, RRMC began to assume after-hours order entry for all health system inpatient facilities. At that time each hospital had its own pharmacy and therapeutics (P&T) committee, but pharmacy was one of the few disciplines operating with a system structure. The standardization process was led by the health system pharmacy clinical manager, who attended each P&T committee meeting. Standardized formulary preferences, clinical programs, and medication-related policies were developed at the system level and then presented at each individual committee for discussion and approval. This process was time-consuming for pharmacy system leadership, and did not always result in complete standardization as P&T committees often had varying opinions on formulary or medication-related policies and protocols. 

Two years later the health system implemented a new pharmacy information system that included a single formulary database for the health system, which became another driver for standardization. Although the pharmacy information system allowed for formulary items to be activated at the individual facility level, standardization provides the framework for consistency in medication order entry and pharmacy clinical programs.

RRMC implemented bar code medication administration (BCMA) in early 2005. Because the health system operates with a single formulary database, once a bar code is linked to a medication, it is available for all facilities to use. Through formulary standardization, the process to implement BCMA at each subsequent facility was streamlined, and ongoing maintenance is minimized. 
In 2005, Riverside Health System also transitioned to an organizational model that focuses on physician integration. This new physician leadership assisted with standardization of evidence-based clinical practice. Riverside simultaneously implemented clinical service lines, whose leadership included a service line administrator and service line physician chief, further supporting standardization across the health system continuum of care. Prior to that time, the effort to develop evidence-based, disease-specific order sets in key disciplines resulted in products that often were not adopted by the other facilities, and were not consistently updated based on newly emerging evidence. 



Computerized Prescriber Order Entry Impact 
The health system began the journey toward computerized prescriber order entry (CPOE) in 2008 with standardization of evidence-based, disease-specific order sets for the health system. Riverside partnered with a clinical decision support software vendor to facilitate the process, and assigned an internal project manager to ensure implementation timelines were met. In order to drive the standardization needed for a successful CPOE implementation, senior health system leadership supported the formation of a physician advisory committee (PAC) to oversee the order set development and approval process, as well as to make key decisions concerning CPOE implementation. 

PAC physician membership included all major specialties within the health system, as well as nursing and pharmacy leadership and representatives from radiology, laboratory, information systems, and quality. The PAC was granted authority from each facility’s medical executive committee to approve health-system order sets and to make CPOE implementation decisions. Because the vetting and approval of orders sets had historically been a function of individual facility P&T committees, in collaboration with a medical record/forms committee, it was imperative that system pharmacy leadership become an integral part of the PAC from the inception. System pharmacy leadership took on the role of liaison to the facility P&T committees.

Based on the CPOE implementation timeline and the need to develop and approve more than 200 order sets, the PAC initially met every two weeks. Web conferencing technology was used in order to conveniently accommodate all PAC members within the Riverside Health System. Before each meeting, voting members received all order sets for review and comment using an online collaboration tool. During the meeting, all comments were reviewed, recommendations for changes discussed, and order sets either approved or sent back for additional revisions. 

The Role of Pharmacy in Order Set Development
Pharmacy’s responsibilities in the development and approval of order sets encompassed the selection of formulary items to be included, embedding pharmacy’s clinical initiatives into the body of the order sets (eg, renal and IV-to-PO dosing), ensuring that medication order content and language met The Joint Commission (TJC) and Centers for Medicare and Medicaid Services (CMS) requirements, and confirming that order sets could be executed by facilities with both 24-hour and non–24-hour pharmacies. Considerations for non–24-hour pharmacies included decisions such as method to provide concentrated electrolytes and IV admixtures after hours. 

In most cases, pharmacy drafted the medication sections of the order sets, using evidence-based best practice married with health system historical practice, before the order sets were submitted to the PAC for review and approval. Mini order sets that included medications commonly found in treatment pathways also were developed, including venous thromboembolism prophylaxis, prevention and treatment of nausea and vomiting, IV hydration, postoperative pain management, and bowel management protocols. This process not only streamlined order set development and approval, but also contributed to the increased efficiency of the CPOE build and testing process. Formulary standardization across the health system was key in the development and implementation of these order sets.

Transitioning to a System-wide P&T Committee
Based on the success of the health system PAC, and with the support of facility and health system leadership, the establishment of a system-wide P&T committee became a goal for 2009–2010. The primary goal of the system P&T committee was, and continues to be, to manage the formulary system for Riverside Health System (for additional responsibilities, see Table 1). The oversight of the system-wide P&T committee included system-wide informatics and order sets, as well as the integrity of after-hours order entry, all of which rely on standardization of formulary and pharmacy clinical services. An initial consideration was the membership structure, because we wanted to ensure representation from each facility. Riverside had recently opened a long-term, acute-care hospital, Hampton Roads Specialty Hospital, and purchased an additional acute-care facility, Riverside Shore Memorial Hospital. Ensuring global health system representation was a challenge because not all medical specialties were available at all facilities. Other considerations included whether a local P&T committee would still exist, and if so, which members would also be included as members of the system-wide P&T committee. Additionally, we had to determine which members would vote and which would not, as well as what would constitute a quorum for the purpose of voting on formulary or medication-related policies. 



To determine the membership, the system director of pharmacy and system clinical pharmacy manager sought input from the current chair of each P&T committee, as well as the administrator and physician administrator at each facility. All applicable literature relating to the development of system P&T committees also was reviewed. The decision was made to name the chair of the P&T committee at each facility a voting member in the system-wide P&T committee. As the largest facility representing the broadest physician population, the chair of the RRMC P&T committee was identified as the first chair of the system committee. All other medical disciplines were then identified, making sure that each facility had at least two physician representatives on the committee. All directors of pharmacy also were made members of the system committee, along with facility administrators and nursing leadership. For ancillary departments, a system representative was named, to give each facility at least one representative on the committee that was not a physician or pharmacist (see Table 2). Because we have a robust lifelong health division, a pharmacist and a physician with geriatric specialties were added so that the needs of the aging population would be taken into consideration in P&T decisions. 


Click here to view a larger version of this Table

In consideration of the attendees’ time, the regular meeting was scheduled for one hour bimonthly. It was determined that a local P&T should still exist to review facility-specific medication information, such as adverse drug events (ADEs) and medication-use evaluations, as well as to provide input into the facility-specific implementation of decisions made by the system P&T committee. The local P&T committee was scheduled to meet in the alternate months from the system committee. 

The system P&T committee’s bimonthly meetings were facilitated through Web-conferencing so that members from each hospital could dial-in from their respective facilities. An agenda was distributed two weeks before the meeting, and all related documents were available for review one week in advance. Owing to the sizeable number of items on the agenda, sending the material to the members prior to the meeting drove the ability to make decisions efficiently, without the risk of the item being tabled for two months until the next time the system P&T met. To ensure that all medication-related information was reviewed annually, system pharmacy leadership developed a standing agenda that assigned quarterly and annual reports to a specific monthly meeting each year. This balanced the agenda length of any given meeting and ensured that requirements of TJC and other regulatory bodies for medical staff review and approval of policies and other processes were completed (eg, annual review of high-risk drugs and look-alike/sound-alike medications). The process continues as described to the present day. 

Once the structure of the system-wide P&T committee was created, it was presented to the COO of Riverside Health System, who was the administrative sponsor of the project, as well as to the administrator and physician administrator at each facility. Approval was granted and the committee received authority by each medical executive committee to make medication-related decisions for their respective hospitals.

Putting the Plan into Action
The first meeting of the Riverside Health System P&T committee occurred in April 2010, with the goals of reviewing the committee charter, voting membership, voting quorum, and standing agenda items. In the first six months of the committee’s existence, several small revisions were made to the charter to improve the process further; for example, a quorum was redefined to give all facilities the opportunity to have their voices heard while ensuring that the process was not slowed down if one facility did not have physician representation. This change included designation of a back-up to the chair of each local P&T committee that could stand in if the chair was not available for the meeting. It also defined the quorum as three of the four acute care facilities with voting physician members in attendance at the committee. The directors of pharmacy also were tasked with the responsibility of making sure that they would have voting member participation from their facility for each meeting, since ensuring physician attendance can sometimes be challenging.

In the two years since the establishment of the system P&T committee, system pharmacy leadership continues to evaluate its effectiveness and make process changes as required; for example, we added a system pharmacy conference call the week prior to the meeting of the system P&T committee. The goal of this call is to ensure that all directors of pharmacy and clinical managers are in agreement on the recommendations that will be made. This change was made so that pharmacy leadership could present a united voice to the committee to facilitate effective decision-making. 

Communication Challenges
One of the challenges that we faced was how to best communicate the decisions that the system P&T committee has made to all stakeholders. Owing to the complexity of the health system and the facility-specific medical staff committee structure, it was decided that the primary communication to the medical staff would be through the local P&T chair’s presentation to the facility’s medical executive committee. A system P&T newsletter is also distributed to all medical staff members and made available on the physician Web portal. In addition, for those facilities that have medical staff department meetings, pharmacy is a member and presents the major themes of the meeting as they impact that particular specialty. Pharmacy and nursing staff also are provided information via the newsletter and given focused education as it relates to specific initiatives, such as when new medications are added to the renal dosing program or the therapeutic interchange list. 

Advantages to a System-wide P&T Approach
One of the advantages to a system-wide approach to P&T has been the decreased time to implementation of medication-related initiatives. Under the prior model with six P&T committees, consensus building was difficult because not all system stakeholders were present at the same meeting. With the implementation of the system P&T committee, decisions are implemented promptly at the end of the month following each meeting, which allows time for the local P&T committee to discuss facility-specific implementation and for health-system pharmacy to educate staff on P&T decisions.

Another advantage to this approach is the synergy between the system PAC and system implementation of CPOE. When developing order sets for implementation into CPOE, there is standardization with formulary and medication processes, which facilitates build and implementation. When new safety information for medications becomes available, the process for modifying order sets within CPOE and providing appropriate warnings for clinicians is also streamlined owing to a standardized formulary and support from both the system P&T committee and the PAC. 

The process for managing the increasing number of drug shortages over the past two years has been streamlined through the oversight of the system-wide P&T committee. When evaluating therapeutic alternatives or restrictions, the system formulary approach, supported by a system CPOE approach, streamlines the work required to quickly implement formulary modifications necessary during drug shortages. The standardization of the formulary across the organization also allows for the sharing of products during shortages based on the shortage strategies implemented. 

With the pressure in health care to reduce expenditures, the system P&T committee has played a critically important role. Two years ago, Riverside engaged an outside consultant to evaluate supply chain spend opportunities. The system P&T committee became the value analysis team for the pharmacy supply chain. Compared with other areas of the health system, the value analysis process has been embedded in the P&T committee for many years through evaluation of formulary decisions based on efficacy, safety, and cost. The move to a system-wide approach to formulary management and the implementation of the system-wide P&T committee created a consolidated platform from which to review pharmacy supply chain initiatives through formulary preference, restricted use criteria, therapeutic interchange, generic product conversion, and pharmacy clinical programs. To date, the pharmacy supply chain initiative at Riverside Health System has been responsible for more than $10 million in cost savings annually, with $1 million of that savings attributable to the policies of the system P&T committee. The COO/CFO of Riverside Health System holds the system P&T committee as the gold standard for how other value analysis teams should function, and requested that the system director of pharmacy present the P&T committee structure to the value analysis team steering committee at one of the first monthly meetings.

The standardization in formulary and medication-related programs also facilitated the development of a more versatile staffing model. Medical and clinical staff now can cover more than one facility, either temporarily or permanently. The consistency that is driven by a system-wide approach to P&T greatly enhances this process, and provides for safer, more efficient care through consolidated formulary, order sets, clinical decision support rules, and pharmacy clinical programs. 

Expanding the Organization-wide Approach
Inspired by the successes of the system-wide P&T committee, other areas of the organization want to partner with us to facilitate transitions of care within the health system. The system director of pharmacy is now a member of the quality committee for lifelong health, and has provided input to jump-start the formulary standardization process in that division. Pharmacy is also an ad hoc member of the Riverside Medical Group quality committee that evaluates medication therapy in physician office practices, and is involved in initiatives such as anticoagulation therapy monitoring. As the process matures, the goal will be to move medication-related decisions for both the lifelong health and Riverside Medical Group into the system P&T committee structure so that an organizational approach is in place for formulary management that encompasses all aspects of the health system.

Conclusion
Creating an efficient, system-wide P&T committee and a standardized formulary at Riverside Health System has been an evolving process spanning a number of years, resulting in a uniform approach to the delivery of cost-effective, evidence-based pharmaceutical care through CPOE and pharmacy clinical programs. It also has provided the framework for the facilities within Riverside Health System to be recognized for the care they provide by outside organizations, including TJC and The Leapfrog Group. The journey will continue as Riverside Health System seeks to leverage the system approach to medication management across the entire continuum of care.

 


Cindy Williams, RPh, received her BS in pharmacy from Virginia Commonwealth University and has completed the executive management program for pharmacy leaders at the Wharton School and The Pharmacy Leadership Institute at Boston University. Since 2001, Cindy has served as system director of pharmacy for Riverside Health System in Newport News, Virginia. 

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