Abstract
Pharmacists play an important role in monitoring medications among all populations, with particular importance among older adults with chronic conditions using multiple medications. This project will use data collected through an ongoing clinical trial funded by the National Institute on Aging, which will test the impact of a pharmacist-based deprescribing protocol on meaningful clinical outcomes, including the risk of dementia and quality of life in older adults. Pharmacists performing the intervention record measures related to their attempts to deprescribe (reduce or stop) high-risk medications such as the type of titration schedules employed, duration of titration schedules, outcome of the deprescribing attempt, patterns of communication (between pharmacist and patient and/or physician), and physician satisfaction. This data will be used to identify deprescribing rates, revise the study protocol to optimize safety and efficiency as needed, and contribute to an existing gap in clinical recommendations when deprescribing high-risk medications in older adults.
Significance
Certain medications are considered high-risk in older adults due to their potential to cause more harm than benefit. Anticholinergics are a group of high-risk medications that block acetylcholine receptors within the nervous system and has been associated with a higher risk of dementia. However, no clinical trial has been conducted to determine if stopping these medications can reduce the risk of dementia.1 With support from the National Institute on Aging, the Regenstrief Institute, in conjunction with Purdue University and the IU School of Medicine, are conducting the first trial to determine if reducing or stopping use of specific high-risk medications results in a lower risk of dementia. In order to fully test this hypothesis, this study aims to reduce the burden of high-risk medications by at least 50% among current users. Initial findings suggest this is achievable; however, there is no published literature available for pharmacists and physicians to ensure the safe reduction or cessation of these high-risk medications. Therefore, it will be important to monitor the rate of deprescribing, and revise our methods as needed to sustain this rate in order to test the study’s hypothesis that reducing use of high-risk medications may reduce the risk of dementia.
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Additionally, the role of the pharmacist continues to expand within the clinical setting, distancing itself from traditional storage and distribution activities, and moving into consultative and direct patient care with prescribing authority available through collaborative practice agreements with physicians. One valuable role is in determining the risks and benefits of high-risk medications among older adults. Addressing the use of high-risk medication in older adults has the potential to prevent any adverse effects of the medication and may reduce unnecessary hospital admissions and healthcare costs.2 The issue of medication-induced diseases among older adults requires immediate attention as more and more people are affected.
While many pharmacists are well-positioned to improve the quality of medication use among older adults using multiple medications, there are currently no evidence-based recommendations to guide pharmacists in safe, effective practices of deprescribing to reduce unnecessary harms from medications. The outcomes reported at the end of this trial will provide a robust description of the clinical impact of deprescribing high-risk medications in older adults. However, through this work, we will have the opportunity to report the processes and clinical approaches to deprescribing high-risk medications and thus contribute to literature guiding the safety of deprescribing in older adults.
Project Objective
This project will utilize data collected by pharmacists from an ongoing randomized controlled trial testing the impact of a pharmacist-based deprescribing intervention being conducted among older adults receiving primary care within local healthcare systems. The original proposal anticipated a deprescribing success rate of 50%, defined as either a reduction in dose of high-risk medications by 50% among the entire population, or a complete cessation among 50% of the population. The project aims to quantify the rate of deprescribing achieved in the first 3 months of the study, describe adherence to the study protocol, and identify opportunities to improve efficiency, safety, and acceptability in order to safely achieve the expected deprescribing rate throughout the 5-year trial.
Methodology
In this project, I will extract data from an existing database collected by intervention pharmacists and physicians. The database was designed to capture relevant information relating to the intervention including titration schedules for reducing or stopping high-risk medications, the duration of the titration schedules, whether the attempt was successful, and the method and frequency of communication between the intervention pharmacists and physicians. I will evaluate these measures and create descriptive statistics (means/averages, ranges, common variables) using both Microsoft Excel and statistical software made available by Regenstrief Institute. I will report identified statistics to intervention pharmacists and offer feedback on study parameters. If needed, medical record data is available for me that could inform the clinical context around successful and unsuccessful findings. Because these measures are not included as outcomes in the funded trial, we can review and evaluate these measures without compromising the statistical analysis plan of the larger trial.
Week |
Activity |
Week 1 |
Observe intervention pharmacists, data entry process, learn data extraction methods |
Week 2 |
Calculate descriptive statistics and provide summary of deprescribing rates and titration schedules |
Week 3 |
Calculate descriptive statistics for agreement between pharmacists and physicians in setting titration schedules |
Week 4 |
Quantify and describe the communication methods used to communicate between pharmacists and physicians |
Week 5 |
Analyze statistics and create report of draft findings |
Week 6 |
Present draft report to study investigators and study pharmacists for feedback and revision |
Week 7 |
Revise draft report based on feedback and identify study parameters needing modification if needed |
Week 8 |
Finalize report, develop recommendations to improve efficiency, safety, and/or implementation into clinical practice |
Week 9 |
Prepare final report and presentation for BSI and prepare abstract submission for Midwest Medication Safety Symposium |
Feasibility
Upon acceptance into the program, I will complete necessary certifications for addition to the approved IRB protocol. This project will require a computer with Microsoft Office, and I will be provided data extracted from the study database to perform the study objectives. The planned descriptive statistics can be accomplished within basic Microsoft Office modules or statistical software. Most of this project will be completed on site at Regenstrief Institute. While partnering with Regenstrief Institute, I will have weekly meetings with co-mentors Dr. Noll Campbell, a Butler Pharmacy graduate, and Dr. Richard Holden to review progress. Additionally, I will have the opportunity to participate in meetings with the pharmacists and interventionists involved with the study.
BSI Absence
The partnership between Regenstrief Institute and Butler University College of Pharmacy and Health Sciences will allow me to work on location at Regenstrief Institute in downtown Indianapolis for the entirety of the project. I will still be attending all BSI luncheons and cultural events as scheduled in the BSI requirements. I will also be in contact regularly with my Butler Faculty Mentor, Dr. Kimberly Beck, to discuss my progress throughout the course of the BSI.
Personal Interest
My interest in this project is derived from my curiosity surrounding the burden of overprescribing in an aging population. In high school, I was fortunate to have several opportunities to visit local nursing homes where I was able to witness how overprescribing affected real individuals. The toll of numerous medications on certain individuals was quite evident yet there seemed to be little to no effort made to mitigate the load. The study that this project would be centered around is one such example of how pharmacists can help these individuals especially when they are prescribed high-risk medications. The data from this project could potentially be used to the recognize the need for deprescribing as well as strengthen the role of the pharmacist in managing specific medications for at-risk patients.
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As a pharmacy student, I have taken several courses that have introduced me to the concepts involved in this project. Last semester, I was enrolled in pathophysiology (RX 316). This course explained how various medications can increase the loss of functionality of bodily structures leading to the development of common age-related diseases. Treating a disease like Alzheimer’s intrigues me as it is one of the most pressing health epidemics in the United States and continues to impede on the lives of more and more people. I am moved by the fact that this project can aid future literature on deprescribing. Proper deprescribing is a critical component of managing chronic illnesses as it has to potential to lessen the burden on the patient and improve treatment outcomes.3 Another course that impacted this project was the non-traditional healthcare professional (RX 499-21) where I gained an interest in working with clinical trials. This project will give me the opportunity to shadow research assistants to learn more about research design and conducting clinical trial research. The BSI experience would provide numerous opportunities to explore this field.
Participation in the Butler Summer Institute would be a transformational learning experience for both my success as a student and my future aspirations within the pharmaceutical field. Today’s medical field is becoming more interconnected among various healthcare professions and this project would allow me to work closely with many professions thus providing me the opportunity to fine-tune my interprofessional communication skills. Through this partnership with Regenstrief, I hope to further develop my research skills including data analysis and report writing. These skills will complement my preparations for post-graduation programs such as a fellowship or residency as well as benefit my future career within pharmacy. I am still undecided on my career plans following graduation, but I am actively exploring the realm of drug design and oncology research. I firmly believe the BSI will leave a lasting impression on my student career and the research experience may ultimately help me determine the career path best suited for me.
Presentations
Following completion of this project, I will present my findings via an oral presentation during the last week of the BSI. Additionally, I plan to draft a proposal and present at the Midwest Medication Safety Symposium in Indianapolis later this year in September.
References
- Campbell NL, Boustani MA. Adverse cognitive effects of medications: turning attention to reversibility. JAMA Intern Med. 2015;175(3):408–409. doi:10.1001/jamainternmed.2014.7667
- Lee JK, Alshehri S, Kutbi HI, Martin JR. Optimizing pharmacotherapy in elderly patients: the role of pharmacists. Integr Pharm Res Pract. 2015;4:101–111. Published 2015 Aug 11. doi:10.2147/IPRP.S70404
- Whitman A, DeGregory K, Morris A, Mohile S, Ramsdale E. Pharmacist-led medication assessment and deprescribing intervention for older adults with cancer and polypharmacy: a pilot study. Support Care Cancer. 2018;26(12):4105–4113. doi:10.1007/s00520-018-4281-3
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