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Aligning Formulary Restrictions Across a Health System and Improving Access to and Clarity of Medication Restrictions

Sarah Solano PharmD
Jordan Dow PharmD, MS
Terry Audley RPh, FASHP
Nitish Bangalore PharmD, BCPS

INTRODUCTION

The Centers for Medicare and Medicaid Services (CMS) requires that a formulary be established and maintained as a condition of participation.1 At the time of this initiative, the Froedtert and Medical College of Wisconsin (F&MCW) health system was composed of three hospitals. Froedtert Hospital was established in 1980;2 Community Memorial Hospital, established in 1964, joined the F&MCW health system in 2001;3 and St. Joseph’s Hospital, established in 1930,4 joined in 2008. Each hospital joined the health system with its own formulary, in compliance with CMS. As part of a strategic initiative to streamline and improve product inventory management, formulary medication alignment began in 2013. However, formulary medication restrictions were not aligned, leaving inconsistencies among the sites. As our health system is expected to grow, complete formulary alignment is all the more imperative.

Restricting medication use as a means to influencing the use of medications can lead to reduced costs, improved therapeutic outcomes, and increased adverse-event prevention.5 The process of aligning the formulary restrictions was initiated in 2014, with the alignment of 12 restricted medications. At the start of the current restrictions-alignment initiative, over 100 unaligned medication restrictions existed. In addition, there was confusion among prescribers and pharmacists about which medications were restricted, what the restrictions were, and where they could access information about the restrictions.

The primary objective was to align 100% of the formulary medication restrictions, and secondary objectives included improving ease of access to restriction information and improving the clarity surrounding medication restrictions for staff.

METHODS

A gap analysis was performed to identify differences between each site’s medication restrictions and site-specific interventions, and to determine whether any interventions were in place in the EMR. Every discrepancy was noted and analyzed, and a unique recommendation was made for each restricted medication. The recommendations included a system-wide formulary restriction, removal of the restriction, or removal of the medication from the formulary. If a formulary restriction was recommended, an accompanying intervention in the EMR was recommended as well. The gap analysis, proposed restrictions, and proposed interventions were reviewed by the PNT planning committee. This committee is comprised of pharmacy staff and includes at least one representative from each site. The committee discussed each medication, and reviewed current restrictions, the proposed modifications to the restriction status, and any accompanying interventions. The committee then either approved or made changes to the proposed restrictions and interventions. Once agreement was reached via group discussion, the aligned formulary medication restrictions were presented to the PNT committee for approval. Subsequently, the restriction information was added to each drug monograph in the online medication-information database and the interventions were built into the EMR. There was a total of five types of intervention: restriction removal; “outpatient use only” added to the medication name in the EMR; order-specific questions built into the EMR; alternative alerts added to the EMR; and information added to the order instructions seen by providers (when ordering a restricted medication) and by pharmacists (when verifying a restricted medication). A formalized workflow was developed to guide pharmacists when they are verifying restricted medication orders (Figure 1).

Education was then provided to pharmacists and encompassed the following: the background of the health system’s formulary alignment and restriction alignment; the institution’s definition of restricted medication; interventions made in the EMR; the formal workflow required when ordering a restricted medication; and where restricted medication resources could be found. After education was completed, a survey was sent to the inpatient pharmacists practicing at each site to determine the perception of the impact of all interventions (see Figure 2). Due to the scope of this project, education and project assessment were limited to pharmacists only.

RESULTS

The primary objective was achieved with the alignment of medication restrictions increasing from 11% to 100%. Of the 110 medication restrictions that were not aligned, 17 restrictions were removed, 37 medications were restricted to outpatient use only, and 56 restricted medications were further aligned across the health system (Table 1).

More than 120 pharmacists had the opportunity to participate in the survey. In total, there were 15 respondents, 5 of whom did not answer the post-implementation and education questions. Because of the limited number of responses, all of them were used to analyze the data. Table 2 summarizes the responses. After implementation and education, more pharmacists utilized the online medication-information database for information on restricted medications, and fewer pharmacists had dificulty finding the information. Lastly, respondents had the opportunity to provide written comments. One respondent stated that improvements have been seen in the last year and that having links to the EMR medication-information database has made the process more transparent. Another respondent stated that the workflow chart is helpful in daily activities.

DISCUSSION

Our study is limited by the fact that it was an internal pharmacy department study that was evaluated by our department. A limitation of our findings is that the staff survey was administered one time, after implementation and education took place. Thus, pharmacists were asked to reflect on activities that had occurred a year earlier, prior to implementation, in order to answer the pre-implementation portion of the survey. This method introduced the risk for temporal bias. There may have been other changes during implementation that affected our results. Also, the time delay may have resulted in respondents not accurately remembering details about what the practice for restricted medications was like a year earlier. In retrospect, the survey questions should have been created near the beginning of the initiative and the survey should have been administered both pre-implementation and post-implementation. The potential drawback with this method is that response rates are notoriously low and administering more than one survey may have put us at risk for an even lower response rate, making a comparison between pre-implementation and post-implementation difficult.

CONCLUSION

This initiative demonstrates the feasibility of aligning medication restrictions across an expanding health system, having restriction information at the point of order entry and order verification, and incorporating medication-restriction information into an online database. Overall, the initiative has been considered a success by members of our health system. Staff pharmacists have provided positive feedback on the initiative and to date, we have not had any provider resistance.

Formulary maintenance is an ongoing process. Thus, currently aligned and updated medication restrictions will need to be modified as use, indications, and practices change. Likewise, as new medications are reviewed for formulary status, any restrictions associated with those medications should be discussed as part of the review process. Lastly, a metric to track and monitor restricted medication use outside of approved uses needs to be developed. Such a tool will allow for monitoring trends and practice changes, and will assist in identifying ways to improve the restricted medications processes.

Figures and Tables

Restricted Medication Order Pharmacist Workflow

Formulary Restrictions Staff Survey

Medication Restriction Alignment

Aligned Restriction Status Number of Restricted Medications
Restriction removed (e.g., Oxycodone CR) 17
Restricted to outpatient use only (e.g., Pegfilgrastim) 37
Restriction aligned across the health system (e.g., IV acetaminophen) 56
Total number of aligned medications at the end of project 110

Staff Survey Questions and Responses

Survey Question Pre-implementation Responsea Post-implementation Responsea
Response Question

Where did you most often find information regarding restricted medications?

 Electronic medical record 4 4

 Online medication information database 5 7

 Organization intranet site 0 1

 Department intranet site 5 1

On a scale of 1–4 (1 being very difficult, 4 being very easy), how easy is it to find information about restrictions?

 1 and 2 9 1

 3 and 4 6 8

On a scale of 1–4 (1 being not at all clear, 4 being very clear), how clear are medication restrictions at the point of prescribing or verifying?

 1 and 2 7 3

 3 and 4 7 7

How often do you encounter restricted medications?

 1–2 times per day 1 1

 1–2 times per week 5 3

 1–2 times per month 7 5

 < 1 time per month 2 1

Based on what you see in practice, when restricted medications are ordered, how often are they ordered outside of PNT-approved uses?

 0–25% 7 4

 26–50% 5 4

 51–75% 2 2

 76–100% 0 0

On a scale of 1–4 (1 being not at all confident, 4 being very confident), how confident are you in your ability to follow the restricted medication order policy?

 1 and 2 7 2

 3 and 4 7 7

aNumber of people who chose the response

Author bio: 
Dr. Solano is a Clinical Staff Pharmacist at Froedtert Health in Milwaukee, Wisconsin; Dr. Dow is Regional Director of the Mayo Clinic in Eau Claire, Wisconsin; Dr. Audley is a Pharmacy Clinical Manager at Froedtert Health in West Bend, Wisconsin; and Dr. Bangalore is a Pharmacy Manager at Froedtert Health in Menomonee Falls, Wisconsin.

References

  1. U.S. Government Publishing Office. 42 CFR 482 25 Condition of Participation Pharmaceutical Services. Available at: http://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-sec482-25/content-detail.html.. Published October 1. 2011 Accessed December 13, 2018
  2. Froedtert & the Medical College of Wisconsin. About Froedtert and the Medical College of Wisconsin regional health network June 30, 2018; Available at: https://www.froedtert.com/about. Accessed December 13, 2018
  3. Froedtert & the Medical College of Wisconsin. Community Memorial Hospital history  Available at: https://www.froedtert.com/community-memorial/history. Accessed December 13, 2018
  4. Froedtert & the Medical College of Wisconsin. History of St. Joseph’s Hospital  Available at: https://www.froedtert.com/st-josephs/history. Accessed December 13, 2018
  5. Tyler L, Cole S, Russell May J, et al. ASHP guidelines on the pharmacy and therapeutics committee and the formulary system. Am J Health Syst Pharm 2008;65;(13):1272–1283. Accessed December 19, 201810.2146/ajhp080086