Charles T. Makowski, Pharm.D., BCPS, pharmacy specialist, Henry Ford Health System, Detroit and Martin Ratusznik, B.S. Pharm, manager, Henry Ford Health System, Detroit

United States (U.S.) Healthcare System
In the United States (U.S.), improvements in population disease burden and access to quality health care lag behind that of other socioeconomically wealthy nations^1,2, despite the extent of its healthcare expenditures, including rapidly rising drug costs.^{3, 4} This climate has contributed to a shift toward value-based healthcare delivery, which strongly implicates a healthcare organization’s ability to implement healthcare information technology (HIT) and to mature its adoption of healthcare analytics. While regulatory and economic incentives have helped to rapidly drive widespread adoption of HIT⁵, it is unclear how effectively U.S. health systems are using healthcare data to transform healthcare delivery and affect patient outcomes.^{6, 7}

ASHP and MSHP have emphasized the strategic importance to health system pharmacy of automating the measurement and demonstration of pharmacy interventions, outcomes and value.^8–10 However, national ASHP surveys indicate low self-reported rates of implementation of automated pharmacy intervention measurement (less than 20% in 2011) and slow expansion (about 33% in 2017). To illustrate some of the successes and barriers with implementing analytics-related recommendations from ASHP and MSHP, this case study aims to describe a Michigan health system’s experience developing, implementing, and governing an inpatient pharmacy metrics dashboard for achieving strategic pharmacy goals.

Henry Ford Health System
Henry Ford Health System (HFHS) is a six-hospital, 2300-bed system located within Southeastern Michigan and outlying areas. The HFHS Clinical Pharmacy Service Line consists of 360 inpatient full-time equivalent positions covering acute care, ambulatory care and clinical shared services. Its analytics personnel includes one FTE-dedicated data scientist and one mixed drug information pharmacist/analyst position. Notable standardized HIT systems at HFHS include Epic electronic medical record with Microsoft SQL Server platform and Microsoft Power (Desktop and Report Server) for automated on-premises reporting and dashboards. Policies and practices governing medication use within HFHS are developed and approved through a system multidisciplinary Medication Management Committee and its six Formulary and Drug Specialty Subcommittees. HFHS Clinical Pharmacy Service Line relationship with HFHS Enterprise Analytics and Data Warehousing is at the project collaboration level.

Governance Structure
In October 2018, as part of its biennial strategic planning, the HFHS Clinical Pharmacy Service Line conducted a guided Strategic Planning Session amongst its pharmacy leadership, which utilized HFHS Mission/Vision/Values as a framework for developing five goals with underlying strategies and quality improvement (QI) plans for 2019–2020. See Table 1 for basic description of steps involved with creation of the inpatient pharmacy dashboards. Initially, only dashboard operational owners were provided dashboard access as a data acclimation period, followed by provision of broader access once dashboard owners were comfortable navigating the dashboards and interpreting their data.

Table 1. Steps involved with development and implementation of inpatient pharmacy dashboards.

HFHS Clinical Pharmacy Service Line Dashboards
The Strategic Planning Session ultimately yielded a 2019–2020 QI plan with several pharmacy service domains for dashboards, as shown in Table 2. All dashboard measures were attributed at the hospital and patient department levels (e.g., warfarin education based on discharge department/location), thus serving multiple valuable functions (e.g., identify outliers, prioritize QI activities, mutual validation of dashboards and stakeholders’ anecdotal experience). Various other factors appropriate to the respective dashboard were also available for user manipulation or observation (e.g., encounter type filters for areas targeting emergency department admissions, dispensing matrix showing of the dashboard measures at the medication level).

Table 2. Inpatient pharmacy dashboard descriptions, quality measures and results.

AKI: acute kidney injury. HFHS: Henry Ford Health System. INR: international normalized ratio.

Lessons Learned
Key themes that emerged in the year after implementing the inpatient pharmacy dashboards revolved around data-to-decision latency, accountability and HIT/data governance. Some dashboard owners required several meetings to validate, understand and apply dashboard content within the established QI structure. Participants with research/QI experience and the responsible data analyst’s presence is strongly recommended to support strategic data integration. Organizations with more mature adoption of data analytics tend to centralize analytics and data warehousing services and resources, which may challenge reliable pharmacy access to necessary resources.¹³ Pharmacy technical acumen is essential to navigating the negotiations that may become necessary to obtain access to appropriate and secure data tools/platforms within the organization’s HIT governance framework.

In conclusion, strategic pharmacy operations benefit from incorporating informatics/analytics into its strategic planning, but requires careful planning and stakeholder engagement to be successful. Pharmacy engagement in corporate HIT governance and technical know-how are essential to establishing and sustaining reliable infrastructure for effective automatable QI activities.

References:
1. GBD 2016 Healthcare Access and Quality Collaborators. Measuring performance on the Healthcare Access and Quality Index for 195 countries and territories and selected subnational locations: a systematic analysis from the Global Burden of Disease Study 2016. Lancet. 2018 Jun 2;391(10136):2236-2271.
2. Murray CJ, Atkinson C, Bhalla K, et al. The state of US health, 1990-2010: burden of diseases, injuries and risk factors. JAMA. 2013 Aug. 14;310(6):591-608).
3. American Health Care: Rethinking the Challenges, Opportunities and Possibilities. Committee for a Responsible Federal Budget. American Health Care: Health Spending and the Federal Budget. 2018 May 16. Available from: http://www.crfb.org/papers/american-health-care-health-spending-and-federal-budget. Accessed 2019 Nov. 15.
4. Hartman M, Martin AB, Espinosa N, et al. National Health Care Spending In 2016: Spending And Enrollment Growth Slow After Initial Coverage Expansions. Health Aff (Millwood). 2018 Jan;37(1):150-160.
5. Office of the National Coordinator for Health Information Technology. 2015 Edition Market Readiness for Hospitals and Clinicians, Health IT Quick-Stat #55. Available from: https://dashboard.healthit.gov/quickstats/pages/2015-edition-market-readiness-hospitals-clinicians.php. March 2019. Accessed 2019 Nov. 17.
6. American Hospital Association, Data & Insights. AHA Annual Survey Database. Available from: https://www.ahadata.com/hospitals/. Accessed 2019 Nov. 20.
7. Office of the National Coordinator for Health Information Technology. Available from: https://dashboard.healthit.gov/evaluations/library.php. Accessed 2019 Nov. 18.
8. Vermeulen LC, Eddington ND, Gourdine MA, et al. ASHP Foundation Pharmacy Forecast 2019: Strategic Planning Advice for Pharmacy Departments in Hospitals and Health Systems. Am J Health Syst Pharm. 2019 Jan. 16;76(2):71-100.
9. The consensus of the Pharmacy Practice Model Summit. Am J Health Syst Pharm. 2011 Jun 15;68(12):1148-52.
10. Bickel RJ, Collins CD, Lucarotti RL, et al. Moving the Pharmacy Practice Model Initiative forward within a state affiliate. Am J Health Syst Pharm. 2014 Oct. 1;71(19):1679-85.
11. American Society of Health-System Pharmacists. ASHP Practice Advancement Initiative. Available from: http://www.ashpmedia.org/pai/docs/PAI-Progress-Measures.pdf. Accessed 2019 Nov. 16.
12. Andrawis M, Ellison LTCC, Riddle S, et al. Recommended quality measures for health-system pharmacy: 2019 update from the Pharmacy Accountability Measures Work Group. Am J Health Syst Pharm. 2019 Jun 3;76(12):874-887.
13. Healthcare Information and Management Systems Society. HIMSS Analytics. Analytics Adoption Model for Analytics Maturity (AMAM). Available from: https://www.himssanalytics.org/amam. Accessed 2019 Nov. 12

MPA's 50/50 raffle tickets are now available for purchase! The drawing will be held Sunday, Feb. 23, 2020, in the MPA House of Delegates Session during MPA's Annual Convention & Exposition.

Two winners!
Grand Prize is 40%
Second Prize is 10%
Need not be present to win.

Contact Bridget Long at (517) 377-0220 to purchase tickets or for more details.

By Jessica Bessner, president, Michigan Pharmacists Association

It is with mixed emotions that I announce the future retirement of Larry Wagenknecht, pharmacist, FMPA, FAPhA and Chief Executive Officer (CEO) of the Michigan Pharmacists Association (MPA). After a distinguished 36 year career with MPA, Wagenknecht will retire effective Jan. 17, 2021.

Wagenknecht has been with the organization since 1983. During this time he has served in numerous roles including Associate Director of Public Affairs, Assistant Director, Executive Director and since 1994, CEO.

Wagenknecht has been a key leader in positive change at MPA. During his time with the Association, he has been at the forefront of the continuous evolution of the pharmacy industry and MPA. Changes include the creation and growth of the Michigan Health Professional Recovery Corporation, MPA Executive Fellowship program, Pharmacy Technician Certification Board (PTCB) and the Michigan Health Information Network (MiHIN).

An active member of the pharmacy community, Wagenknecht has held seats on the MiHIN Board, PTCB Board of Governors, Michigan Healthcare Stakeholders Opioid Stewardship Collaborative and numerous other boards and committees.

Upon the announcement of his retirement, Wagenknecht said “It has been a pleasure and an honor to work to improve patient health care and the pharmacy profession for the pharmacists, pharmacy technicians and student pharmacists in Michigan. I have had numerous opportunities to do things that I would have never dreamed of. The opportunities and success of MPA are due to the great staff, members of the MPA Executive Board and individual members that have provided leadership and insights to drive the change that has occurred. There still is much to do and we will be working over the next 13 months to continue to make improvements, and plan the course for the future of MPA!”

The MPA Executive Board is establishing a national search committee to fill the vacancy with Wagenknecht’s retirement. Information on the search will be forthcoming.

For questions regarding this announcement and future steps, please contact me via email.

By Makenzie Thelen, Pharm.D. Candidate 2020, University of Michigan, Ann Arbor

Oral semaglutide (Rybelsus) was approved Sept. 20, 2019, for the treatment of type 2 diabetes along with diet and exercise.^1,2 Semaglutide is the first oral GLP-1 agonist to be approved in the USA, the remaining options being injectable formulations.¹ GLP-1 is a hormone that is often deficient in patients with type 2 diabetes.¹ GLP-1 enhances insulin secretion from the pancreas in a glucose-dependent manner, suppresses liver glucose production, and slows gastric motility.¹ In addition to lowering blood glucose and A1C, GLP-1 agonists promote weight loss. The basis of oral semaglutide’s Food and Drug Administration (FDA) approval are the PIONEER clinical trials which included 9,543 adult participants over 10 trials.³

PIONEER 2 compared oral semaglutide 14 mg once daily to empagliflozin 25 mg once daily in adults with type 2 diabetes also taking metformin. At week 26, participants taking semaglutide had an A1C decrease of 1.3% compared to empagliflozin participants who had an A1C decrease of 0.9% (p<0.001). Both groups experienced weight loss, with the oral semaglutide 14 mg group having a mean change of -3.8kg and the empagliflozin 25 mg having -3.7 kg.² In PIONEER 3, oral semaglutide also demonstrated statistically superior A1C lowering effects when compared to sitagliptin 100 mg. Oral semaglutide 14 mg lowered A1C by 1.3% compared to sitagliptin 100 mg that lowered A1C by 0.8% (p<0.001) at week 26.²

Oral semaglutide 14 mg was also compared to liraglutide 1.8 mg, a subcutaneous GLP-1 agonist as part of PIONEER 4 in combination with metformin with or without an SLGT2 inhibitor. The two GLP-1 agents were found to be non-inferior to each other in their A1C reduction. The liraglutide 1.8 mg group had an A1C decrease of 1.1% while the oral semaglutide group had a decrease of 1.2% at week 26.^2,4 The oral semaglutide group experienced significantly more weight loss (4.4 kg) when compared to liraglutide (3.1 kg, p<0.001) and had a similar adverse event profile.⁴

Overall, the PIONEER trials have demonstrated that oral semaglutide is superior in lowering A1C compared to other once daily oral agents empagliflozin and sitagliptin. Oral semaglutide also had a similar efficacy and side effect profile when compared to the injectable GLP-1 agonist liraglutide. However, not all patients able to take oral medications may be good candidates for oral semaglutide.

Semaglutide as a once daily oral option may be attractive to patients who are hesitant to begin or continue injection therapy and may increase adherence. However, there are some special instructions that need to be followed with semaglutide therapy. Oral semaglutide must be taken 30 minutes with four ounces of water before the first food or beverage of the day. If the patient waits less than 30 minutes, efficacy will be reduced.² By waiting more than 30 minutes, absorption of oral semaglutide may be increased.² This differs significantly from injectable semaglutide, which may be given at any time of day without regards to meals.⁵ Patients with type 2 diabetes may have other comorbid conditions or therapies that would prohibit following the instructions of oral semaglutide.

Health system pharmacists should consider cost balanced with convenience when debating adding oral semaglutide to their institution’s formulary. Oral semaglutide costs $772 for 30 tablets, putting it in the same price category as GLP-1 agonist injectables. However, ease of storage may mitigate some amount of operating costs and loss of drug due to refrigeration malfunctions.

Overall, oral semaglutide is the first oral GLP-1 agonist within a historical class of only injectable agents. It has a similar side effect and efficacy profile as other GLP-1 agonist injectables while having a similar cost. Its administration instructions may complicate medication regimens and lead to ineffective use or drug discontinuation. For patients with type 2 diabetes who are hesitant to begin injection therapy, oral semaglutide provides an effective treatment option in a drug class previously closed to them. In the future, look for more oral options in the GLP-1 agonist class and further studies evaluating the long-term effects of oral GLP-1 agonists.

References:
1. Food and Drug Administration. FDA approves first oral GLP-1 treatment for type 2 diabetes. (Sept. 20 2019). www.fda.gov/news-events/press-announcements/fda-approves-first-oral-glp-1-treatment-type-2-diabetes (accessed Nov. 14 2019).
2. Rybelsus (semaglutide tablets) prescribing information. Novo Nordisk Inc. 2019 September.
3. Center Watch. Rybelsus (oral semaglutide). www.centerwatch.com/drug-information/fda-approved-drugs/drug/100431/rybelsus-oral-semaglutide- (accessed Nov. 14 2019).
4. Pratley R, Amod A, Hoff, ST, et al. Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. Lancet 2019 Jul;394(10192):39-50.
5. Ozempic (semaglutide injection) prescribing information. Novo Nordisk Inc. 2019 April.

Marla M. Ekola, Pharm.D., BCPS, MBA, director of pharmacy, McLaren Greater Lansing, Lansing

Over the past several years, pharmacy technicians have experienced increased responsibility and an elevation in duties in the workplace. Technicians have always been the heart and soul of the health-system pharmacy. They keep operations running, preserve pharmacist’s sanity and strive to keep nurses happy. More and more pharmacy technicians are now nationally certified and all Michigan pharmacy technicians are licensed. The last time the Michigan Pharmacy Board rules were written, pharmacy technicians were referenced as pharmacy supportive personnel. Today’s pharmacy technicians provide many valuable services to our organizations. The Board of Pharmacy is in the process of rewriting rules to include expanded pharmacy technician roles. Formalization of these rules solidifies the pharmacy technician roles for pharmacy practice in Michigan. One of the prominent rule changes is expected to include product verification (previously known as tech-check-tech). The use of technology such as bar code scanning will allow technicians to perform product verification. The implication of this verification process will be significant for many of our health systems. Technicians already utilize bar code scanning in product verification. The implementation of these rules provides a venue for technicians to utilize this type of technology to pick and fill from automatic dispensing systems without a pharmacist verification. The efficiencies gained through these new rules and processes allow pharmacists more time for clinical tasks.

Michigan Department of Licensing and Regulatory Affairs (LARA) estimates the rules will take one year to complete.  The Request for Rule Making (RFR) was released on June 24, 2019.  On July 31, 2019 the Michigan Office of Administrative Hearings and Rules (MOAHR) concluded there was sufficient policy and legal bases for approving the RFR.  LARA has held pharmacy workgroup meetings to discuss the technician draft language (May 6, 2019, June 12, 2019 and Nov. 15, 2019). These are public meetings and have been well attended by various pharmacy representation. These workgroups help to develop applicable rules. Once the rules are finalized there will be a Regulatory Impact Statement (RIS) released 28 days before the public hearing. Once the public hearing happens, there is only one final, post-hearing workgroup where you can only discuss items that were brought up at the hearing.  Once approved by the Director of LARA, the rules move to the Joint Committee of Administrative Rules (lawmakers of this committee are from both the House and Senate). No changes to the rules proposed by LARA are allowed during this part of the process. The proposal is either “approved or not approved” and the rules are either accepted in their entirety or sent back to LARA for revision. All approved items become part of the rules which determines our pharmacy practice. The current general rules have been in place for many years without revision despite multiple efforts to update them. There has been careful scrutiny and deliberate thought to ensure that these rules provide a structure and framework that will last for many years without the need for significant revision.  It is an exciting time in Michigan as we continue to shape the future of pharmacy and expanding the roles of pharmacy technicians.

Special thanks to Paige Fults, Michigan Health & Hospital Association (MHA) and the MPA legislative team for collaboration on this topic.