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The Anticholinergic Risk Scale and Anticholinergic Adverse Effects in Older Persons

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The Anticholinergic Risk Scale and Anticholinergic Adverse Effects in Older Persons ORIGINAL INVESTIGATION The Anticholinergic Risk Scale and Anticholinergic Adverse Effects in Older Persons James L. Rudolph, MD, SM; Marci J. Salow, PharmD; Michael C. Angelini, MA, PharmD; Regina E. McGlinchey, PhD Background: Adverse effects of anticholinergic medi- risk of anticholinergic adverse effects was assessed using cations may contribute to events such as falls, delirium, Poisson regression analysis. and cognitive impairment in older patients. To further assess this risk, we developed the Anticholinergic Risk Results: Higher ARS scores were associated with in- Scale (ARS), a ranked categorical list of commonly pre- creased risk of anticholinergic adverse effects in the GEM scribed medications with anticholinergic potential. The cohort (crude relative risk [RR], 1.5; 95% confidence in- objective of this study was to determine if the ARS score terval [CI], 1.3-1.8) and in the primary care cohort (crude could be used to predict the risk of anticholinergic ad- RR, 1.9; 95% CI, 1.5-2.4). After adjustment for age and verse effects in a geriatric evaluation and management the number of medications, higher ARS scores in- (GEM) cohort and in a primary care cohort. creased the risk of anticholinergic adverse effects in the GEM cohort (adjusted RR, 1.3; 95% CI, 1.1-1.6; c statis- tic, 0.74) and in the primary care cohort (adjusted RR, Methods: Medical records of 132 GEM patients were 1.9; 95% CI, 1.5-2.5; c statistic, 0.77). reviewed retrospectively for medications included on the ARS and their resultant possible anticholinergic adverse Conclusion: Higher ARS scores are associated with sta- effects. Prospectively, we enrolled 117 patients, 65 years tistically significantly increased risk of anticholinergic ad- or older, in primary care clinics; performed medication verse effects in older patients. reconciliation; and asked about anticholinergic adverse effects. The relationship between the ARS score and the Arch Intern Med. 2008;168(5):508-513 HE POPULATION OF THE ergic load.12-17 Most importantly, the re- United States is aging rap- duction of anticholinergic medications idly, and the number of per- may be a modifiable risk factor to avoid sons older than 65 years associated morbidity. will double to 70 million by In response to this, we developed the An- T2030.1 Providing medical care for the ag- ticholinergic Risk Scale (ARS), which is a ing patient presents challenges because tool for estimating the extent to which an these patients are at risk of comorbidities individual patient may be at risk of anti- and polypharmacy.2 Patients older than 65 cholinergic adverse effects that can lead to years are prescribed a mean of 6 medica- cognitive dysfunction and delirium. The tions.3 Age-related pharmacokinetic and ARS ranks medications for anticholiner- pharmacodynamic changes increase the gic potential on a 3-point scale (0, no or low 4,5 Author Affiliations: Geriatric risk of adverse effects and interactions. risk; 3, high anticholinergic potential). The Research, Education, and Although treatment guidelines such as ARS score for a patient is the sum of points Clinical Center, Veterans Affairs the Beers criteria can be used to identify for his or her number of medications. Boston Healthcare System medications that are considered inappro- The objective of this study was to vali- (Drs Rudolph, Salow, Angelini, priate in adults older than 65 years,6 12% date the ARS score against clinical symp- and McGlinchey), Division of to 21% of older patients in the United toms of anticholinergic toxic reactions in Aging, Department of Medicine, States use such agents.7,8 Medications with a retrospective geriatric evaluation and Brigham and Women’s Hospital anticholinergic properties have fre- management (GEM) cohort and also in a (Drs Rudolph and quently been cited in the literature as caus- prospective older primary care popula- McGlinchey), Massachusetts ing an increase in adverse events.9,10 Such tion. We hypothesized that (1) the ARS College of Pharmacy (Dr Angelini), and Departments conditions often lead to consequences such score would be positively associated with of Medicine (Dr Rudolph) and as falls, impulsive behavior, and loss of in- the risk of anticholinergic symptoms; (2) 11,12 Psychiatry (Dr McGlinchey), dependence. Higher rates of cognitive central adverse effects (falls, dizziness, and Harvard Medical School, dysfunction and delirium are found in pa- confusion) would be more prevalent Boston. tients experiencing a greater anticholin- among the GEM cohort than among the (REPRINTED) ARCH INTERN MED/ VOL 168 (NO. 5), MAR 10, 2008 WWW.ARCHINTERNMED.COM 508 Downloaded from www.archinternmed.com on April 23, 2009 ©2008 American Medical Association. All rights reserved. primary care cohort, attributable to the fact that the GEM medical record was conducted among participants. This review cohort had more cognitive impairment and increased sen- of systems identified anticholinergic adverse effects, including sitivity to anticholinergic medications10; and (3) the GEM falls, dry mouth, dry eyes, dizziness, confusion, and constipa- and primary care cohorts would be equally susceptible tion. In the prospective cohort study, a modified review of sys- to peripheral adverse effects (dry mouth, dry eyes, and tems (20 questions) that included the same adverse effects was conducted among the primary care patients. We assigned 1 point constipation), and the ARS would identify increased risk for each adverse effect and used the summed number of anti- of peripheral adverse effects similarly in both cohorts. cholinergic adverse effect points in our analysis. To better cap- ture the nature of the adverse effects and to evaluate our second METHODS hypothesis, we categorized the anticholinergic adverse effects as central effects (falls, dizziness, and confusion) and as periph- eral effects (dry mouth, dry eyes, and constipation). SUBJECTS This study enrolled 2 cohorts of patients. The retrospective co- COVARIATES hort consisted of 132 participants, 65 years or older, seen con- secutively in GEM clinics at the Veterans Affairs Boston Health- From the electronic medical record, we collected information care System from July 1, 2004, to March 31, 2005. on patient age and serum creatinine level. Age was collected be- Multidisciplinary GEM clinics conducted patient and family in- cause of the increased anticholinergic medication use and sub- 10 terviews by a geriatrician (J.L.R.), nurse practitioner, social sequent anticholinergic adverse effects associated with age. Se- worker, and pharmacist (M.J.S. and M.C.A.). The pharmacist per- rum creatinine level was collected because decreased renal formed medication reconciliation based on the electronic medi- function can affect drug excretion. From the medication recon- cal record and the patient’s presentation of medications or a medi- ciliation, we counted the total number of medications that the cation list. The prospective cohort comprised 117 male subjects, patient was taking, excluding topical, ophthalmic, otologic, and 65 years or older, who were attending primary care clinics at the inhaled medications. The total number of medications pre- 19 Veterans Affairs Boston Healthcare System from September 1, scribed has been used as a surrogate for medical comorbidity. 2005, to June 30, 2006. We selected male subjects because of the predominance of men in our population and the high pro- STATISTICAL ANALYSIS portion of men in our retrospective cohort. Subjects in the pro- spective cohort provided written informed consent. The Veter- Data on medications and adverse effects were collected by geri- ans Affairs Boston Healthcare System institutional review board atric pharmacy residents who were blinded to the ARS group- and research and development review committees approved the ings and study aims. All statistical analyses were performed using protocols. commercially available software (STATA SE version 9.1; Stata- Corp LP, College Station, Texas). DEVELOPMENT OF THE ARS The GEM and primary care cohorts were compared using t test for continuous variables and ␹2 test for dichotomous and The 500 most prescribed medications within the Veterans Af- ordinal variables. Our primary exposure was the ARS score for fairs Boston Healthcare System were reviewed independently by a patient. Our primary outcome was the count of anticholin- 1 geriatrician (J.L.R.) and by 2 geropharmacists (M.J.S. and ergic adverse effects. Because our exposure and outcome vari- M.C.A.) to identify medications with known potential to cause ables were not normally distributed, we categorized the par- anticholinergic adverse effects. Topical, ophthalmic, otologic, and ticipants in both cohorts into the following 3 groups: (1) those inhaled medication preparations were excluded from review. All with an ARS score of 0 (no ARS medications), (2) those with medications generated by these reviews were (1) entered into an ARS score or 1 or 2, and (3) those with an ARS score of 3 or the National Institute of Mental Health psychoactive drug screen- higher. The anticholinergic adverse effect count was com- ␹2 ing program KiBank database18 to determine the dissociation con- pared with and within these ARS groups using test. Because our exposure and outcome variables did not con- stant (pKi) for the cholinergic receptor; (2) input into Microme- dex (Thomson Micromedex, Greenwood Village, Colorado), an form to a normal distribution, we selected Poisson regression evidence-based review of all Food and Drug Administration– for unadjusted and multivariate
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