ARIC Manuscript Proposal #2493. PC Reviewed: 2/10/15 Status: A Priority: 2 SC Reviewed: Status: Priority:

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1 ARIC Manuscript Proposal #2493 PC Reviewed: 2/10/15 Status: A Priority: 2 SC Reviewed: Status: Priority: 1. a. Full Title: Potentially inappropriate medication use in older people: Prevalence and outcomes. b. Abbreviated Title (Length 26 characters): Potentially inappropriate medications in elderly. 2. Writing Group: Khalid Alburikan, Jo Ellen Rodgers, Samuel T. Savitz, Sally Stearns, and others welcome. I, the first author, confirm that all the coauthors have given their approval for this manuscript proposal. KAA First author Name: Address: Khalid Alburikan, PharmD, BCPS Division of Pharmacotherapy and Experimental Therapeutics Eshelman School of Pharmacy University of North Carolina at Chapel Hill CB#7569, Kerr 3201 Chapel Hill, NC Phone: (919) Fax: (919) kalburikan@unc.edu ARIC author to be contacted if there are questions about the manuscript and the first author does not respond or cannot be located (this must be an ARIC investigator). Name: Jo E. Rodgers, PharmD, FCCP, BCPS Address: Division of Pharmacotherapy and Experimental Therapeutics Eshelman School of Pharmacy University of North Carolina at Chapel Hill CB#7569, Kerr 3201 Chapel Hill, NC Phone: (919) Fax: (919) jerodgers@unc.edu 3. Timeline: Analyses to start following receipt of ARIC part D medications claim and visit 5 data. It is anticipated that results of this study will be submitted as an abstract for presentation at the 2015 Healthy Aging Summit, with manuscript submission following shortly thereafter. 4. Rationale: Potentially inappropriate medication (PIM) use is highly prevalent among older people, affecting up to 40% of patients in nursing homes. (D. M. Fick et al., 2003) The elderly are particularly vulnerable to PIMs because of numerous comorbidities, polypharmacy and age-related changes in the pharmacokinetics and pharmacodynamics of the drugs. (Beers et al., 1991)Studies have demonstrated that the exposure to PIMs is associated with an increase in morbidity, adverse drug reactions (ADRs), hospitalizations, mortality and healthcare costs; however, those studies were done outside the U.S or in small base community patients. (Fillenbaum et al., 2004; Fu et al., 2007) The first explicit tool identifying PIM was the Beers criteria, published in 1991,(Beers et al., 1991) which is most often used for the clinical identification of PIMs and in research studies.

2 The Beers criteria were initially designed for nursing home residents, but were updated in 1997, 2003 and 2012 to be applied to all elderly patients. In the 2012 version, the updated drugs to avoid list consisted of drugs that had been withdrawn from the market and drugs that could potentially interact with others and cause problems in adults, including the elderly. (D. M. Fick et al., 2003; Donna M. Fick & Semla, 2012) Study Objectives: The study will address the following objectives: 1. Report the incidence of PIM from Examine the association of the use of PIM with the risk of death and hospitalization. 3. Examine the association of the use of PIM with functional and cognitive status measured at Visit 5. Design and analysis (study design, inclusion/exclusion, outcome and other variables of interest with specific reference to the time of their collection, summary of data analysis, and any anticipated methodologic limitations or challenges if present). Study population: All ARIC cohort study participants who were on Medicare Part D from 2006 onward will be eligible for inclusion for objectives 1-3. Objective 3 can only be analyzed for cohort members who participated in Visit 5. The exposure of interest is the use of PIM, as observed from the Part D claims from PIM will be defined according to the 2012 American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults, as noted in Appendix-1. The American Geriatrics Society (AGS) and the work of an interdisciplinary panel of 11 experts in geriatric care and pharmacotherapy who applied a modified Delphi method to the systematic review and grading to reach consensus on the updated 2012 AGS Beers Criteria. Fifty-three medications or medication classes encompass the final updated Criteria, which are divided into three categories: potentially inappropriate medications and classes to avoid in older adults, potentially inappropriate medications and classes to avoid in older adults with certain diseases and syndromes that the drugs listed can exacerbate, and finally medications to be used with caution in older adults. This update has much strength, including the use of an evidence-based approach using the Institute of Medicine standards and the development of a partnership to regularly update the Criteria. Outcomes: For the first objective, to best describe the prescribing practices for PIM, we will identify patients receiving any single PIM, as well as patients receiving from 2 to 4 PIM (in any combination). For the second and third objectives we will identify the outcomes associated with the use of PIM through Will use surveillance data and visit 5 data to identify the outcomes of interest. Analytical methods: We will use descriptive analyses to report the overall rate of PIM, the most commonly used PIM, combinations of PIMs and the length of time that cohort members experience any PIM. We will use logistic regression analyses to examine association of outcomes, with PIM. The methods for Objective 2 will be finalized once we know the incidence and prevalence of PIM;

3 for example, we may need to use a longitudinal approach that looks at the likelihood of hospitalization or death in one time period as a function of PIM in a prior time period. Objective 3 will use a cross-sectional approach where we model the likelihood of poor functional or cognitive status as a function of any PIM in the year prior to the fifth clinic visit. We will adjust all analyses for demographic factors (age, gender, and race) as well as the measures of comorbidities (hypertension, diabetes, arrhythmias and coronary artery disease). 7. a. Will the data be used for non-cvd analysis in this manuscript? x Yes No b. If Yes, is the author aware that the file ICTDER03 must be used to exclude persons with a value RES_OTH = CVD Research for non-dna analysis, and for DNA analysis RES_DNA = CVD Research would be used? x Yes No (This file ICTDER03 has been distributed to ARIC PIs, and contains the responses to consent updates related to stored sample use for research.) 8. a. Will the DNA data be used in this manuscript? Yes x No b. If yes, is the author aware that either DNA data distributed by the Coordinating Center must be used, or the file ICTDER03 must be used to exclude those with value RES_DNA = No use/storage DNA? Yes No 9. The lead author of this manuscript proposal has reviewed the list of existing ARIC Study manuscript proposals and has found no overlap between this proposal and previously approved manuscript proposals either published or still in active status. ARIC Investigators have access to the publications lists under the Study Members Area of the web site at: x Yes No 10. What are the most related manuscript proposals in ARIC (authors are encouraged to contact lead authors of these proposals for comments on the new proposal or collaboration)? 11. a. Is this manuscript proposal associated with any ARIC ancillary studies or use any ancillary study data? Yes x No b. If yes, is the proposal A. primarily the result of an ancillary study (list number* ) B. primarily based on ARIC data with ancillary data playing a minor role (usually control variables; list number(s)* ) *ancillary studies are listed by number at 12a. Manuscript preparation is expected to be completed in one to three years. If a manuscript is not submitted for ARIC review at the end of the 3-years from the date of the approval, the manuscript proposal will expire. b. The NIH instituted a Public Access Policy in April, 2008 which ensures that the public has access to the published results of NIH funded research. It is your responsibility to upload manuscripts to PUBMED Central whenever the journal does not and be in compliance with this policy. Four files about the public access policy from are posted in under Publications, Policies & Forms. shows you which journals automatically upload articles to Pubmed central.

4 References: Beers, M. H., Ouslander, J. G., Rollingher, I., Reuben, D. B., Brooks, J., & Beck, J. C. (1991). Explicit criteria for determining inappropriate medication use in nursing home residents. UCLA Division of Geriatric Medicine. Arch Intern Med, 151(9), Fick, D. M., Cooper, J. W., Wade, W. E., Waller, J. L., Maclean, J. R., & Beers, M. H. (2003). Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med, 163(22), doi: /archinte Fick, D. M., & Semla, T. P. (2012) American Geriatrics Society Beers Criteria: New Year, New Criteria, New Perspective. Journal of the American Geriatrics Society, 60(4), doi: /j x Fillenbaum, G. G., Hanlon, J. T., Landerman, L. R., Artz, M. B., O'Connor, H., Dowd, B.,... Schmader, K. E. (2004). Impact of inappropriate drug use on health services utilization among representative older community-dwelling residents. Am J Geriatr Pharmacother, 2(2), Fu, A. Z., Jiang, J. Z., Reeves, J. H., Fincham, J. E., Liu, G. G., & Perri, M., 3rd. (2007). Potentially inappropriate medication use and healthcare expenditures in the US communitydwelling elderly. Med Care, 45(5), doi: /01.mlr

5 Appendix-1