Clinical and economic outcomes of medication therapy management services: the Minnesota experience.

OBJECTIVES: To (1) provide medication therapy management (MTM) services to patients, (2) measure the clinical effects associated with the provision of MTM services, (3) measure the percent of patients achieving Healthcare Effectiveness Data and Information Set (HEDIS) goals for hypertension and hyperlipidemia in the MTM services intervention group in relationship to a comparison group who did not receive MTM services, and (4) compare patients' total health expenditures for the year before and after receiving MTM services. DESIGN: Prospective study. SETTING: Six ambulatory clinics in Minnesota from August 1, 2001, to July 31, 2002. PATIENTS: 285 intervention group patients with at least 1 of 12 medical conditions using prestudy health claims; 126 comparison group patients with hypertension and 126 patients with hyperlipidemia were selected among 9 clinics without MTM services for HEDIS analysis. INTERVENTION: MTM services provided by pharmacists to BlueCross BlueShield health plan beneficiaries in collaboration with primary care providers. MAIN OUTCOME MEASURES: Drug therapy problems resolved; percentage of patients' goals of therapy achieved and meeting HEDIS measures for hypertension and hypercholesterolemia. Total health expenditures per person were measured for a 1-year period before and after enrolling patients in MTM services. RESULTS: 637 drug therapy problems were resolved among 285 intervention patients, and the percentage of patients' goals of therapy achieved increased from 76% to 90%. HEDIS measures improved in the intervention group compared with the comparison group for hypertension (71% versus 59%) and cholesterol management (52% versus 30%). Total health expenditures decreased from $11,965 to $8,197 per person (n = 186, P < 0.0001). The reduction in total annual health expenditures exceeded the cost of providing MTM services by more than 12 to 1. CONCLUSION: Patients receiving face-to-face MTM services provided by pharmacists in collaboration with prescribers experienced improved clinical outcomes and lower total health expenditures. Clinical outcomes of MTM services have chronic care improvement and value-based purchasing implications, and economic outcomes support inclusion of MTM services in health plan design.

Effects of collaborative drug therapy management on patients' perceptions of care and health-related quality of life.

BACKGROUND: It has been demonstrated that collaborative drug therapy management may result in enhanced medication adherence and improved clinical outcomes. It is not yet known whether CDTM is associated with patients' perceptions of care or self-reports of health-related quality of life. OBJECTIVES: Examine the impact of collaborative drug therapy management (CDTM) on patients' perceptions of care and health-related quality of life in 15 ambulatory clinics (6 intervention, 9 comparison) in the Fairview system of Minneapolis-St Paul, Minn. METHODS: The intervention was medication therapy management provided by pharmacists in collaboration with physicians (CDTM) for a 12-month period. Subjects were selected by age, gender, and presence of one of 12 medical conditions in the intervention (n=285) and comparison (n=285) group of patients. Comparison patients received usual care while intervention patients received at least 2 CDTM encounters. The CAHPS (formerly called the Consumer Assessment of Health Plans) 2.0 survey was administered to both the intervention and comparison groups poststudy to analyze patients' perceptions of care. The Short Form-12 (SF-12v2) was administered to intervention group patients pre-CDTM and 6 months post-CDTM to measure health-related quality of life in the intervention group. RESULTS: Differences in CAHPS scores were not statistically significant (P>.05), although there was a trend toward higher ratings of patients' personal doctor/nurse and doctors' communication in the CDTM intervention group relative to the comparison group. Physical role, social functioning, and physical component summary scales of the SF-12v2 improved significantly (P=.001, P=.014, and P=.024, respectively; P< or =.025 level). CONCLUSIONS: A trend toward improvements in patient perceptions of effectiveness of care using CAHPS suggests a need for further study. Health-related quality of life improvements in this study meet or exceed previous results incorporating pharmacists into primary care. Intensity and integration of CDTM services may be an explanation; however, prepost study design limits inferences.

Benzodiazepine use and physical disability in community-dwelling older adults.

OBJECTIVES: To determine whether benzodiazepine use is associated with incident disability in mobility and activities of daily living (ADLs) in older individuals. DESIGN: A prospective cohort study. SETTING: Four sites of the Established Populations for Epidemiologic Studies of the Elderly. PARTICIPANTS: This study included 9,093 subjects (aged > or =65) who were not disabled in mobility or ADLs at baseline. MEASUREMENTS: Mobility disability was defined as inability to walk half a mile or climb one flight of stairs. ADL disability was defined as inability to perform one or more basic ADLs (bathing, eating, dressing, transferring from a bed to a chair, using the toilet, or walking across a small room). Trained interviewers assessed outcomes annually. RESULTS: At baseline, 5.5% of subjects reported benzodiazepine use. In multivariable models, benzodiazepine users were 1.23 times as likely as nonusers (95% confidence interval (CI) = 1.09-1.39) to develop mobility disability and 1.28 times as likely (95% CI = 1.09-1.52) to develop ADL disability. Risk for incident mobility was increased with short- (hazard ratio (HR) = 1.27, 95% CI = 1.08-1.50) and long-acting benzodiazepines (HR = 1.20, 95% CI = 1.03-1.39) and no use. Risk for ADL disability was greater with short- (HR = 1.58, 95% CI = 1.25-2.01) but not long-acting (HR = 1.11, 95% CI = 0.89-1.39) agents than for no use. CONCLUSION: Older adults taking benzodiazepines have a greater risk for incident mobility and ADL disability. Use of short-acting agents does not appear to confer any safety benefits over long-acting agents.

Use of nonprescription medications for perceived cardiovascular health.

BACKGROUND: Nonprescription products (over-the-counter drugs; vitamins/minerals; and nonvitamin, nonmineral supplements) are promoted or advertised for cardiovascular health. The extent of nonprescription products used specifically for perceived cardiovascular health (NONRX-CVH) is unknown. This study aimed to (1) determine prevalence and types of nonprescription medications used for NONRX-CVH, (2) compare the demographics of NONRX-CVH users to persons using nonprescription medications in general, and (3) determine the prevalence of use of NONRX-CVH among those taking a prescription medication for a cardiovascular reason. METHODS: A cross-sectional survey comprised the probability sample of 3128 adults in the Minneapolis-St. Paul area in the 2000-2002 Minnesota Heart Survey. Trained interviewers collected medication information from participants using a structured medication inventory approach. RESULTS: Analysis in 2005 shows that 10% of participants (n=315) self-reported taking one or more nonprescription medications in the past 2 weeks for a perceived cardiovascular health purpose. Among these individuals, prevalence of use of vitamin/mineral supplements, nonvitamin/nonmineral supplements, and over-the-counter products for a cardiovascular purpose was 37.5%, 21.3%, and 54.6%, respectively. Popular NONRX-CVHs were aspirin (52.1%), vitamin E (24.4%), garlic (9.8%), and omega-3/fish oils/fatty acids (3.8%). NONRX-CVH users were older than general nonprescription users (p<0.001). Of 613 people using a prescription drug for cardiovascular reasons, 135 (22%) reported using one or more NONRX-CVH medications. CONCLUSIONS: Use of NONRX-CVHs, especially aspirin, vitamin E, and herbals, is common, and older patients may use aspirin or dietary supplements for this purpose. Physicians having patients with cardiovascular disease should ask about nonprescription medication usage, as some NONRX-CVHs may be inappropriate.

Dementia and Alzheimer's disease in community-dwelling elders taking vitamin C and/or vitamin E.

BACKGROUND: Since increased oxidative stress may impair cognition and be a risk factor for dementia, there has been interest in determining whether use of antioxidants could protect against such events. OBJECTIVE: To determine whether supplement use of vitamins C and/or E in a community-based sample of older African American and white individuals delayed incident dementia or Alzheimer's disease (AD). METHODS: We selected a subgroup from the Duke Established Populations for Epidemiologic Studies of the Elderly, a longitudinal study of community-representative persons aged 65-105 years living in 5 adjacent counties in North Carolina, and followed them for dementia (1986-1987 through June 2000). Information gathered during in-home interviews included sociodemographic characteristics, health status, health service use, and vitamin use. Diagnosis of dementia and AD was based on evaluations using the clinical and neuropsychological batteries of the Consortium to Establish a Registry for Alzheimer's Disease, with final determination by consensus agreement of specialists using Diagnostic and Statistical Manual of Mental Disorders, third revision, and National Institute for Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders criteria. RESULTS: Of 616 persons initially dementia-free (mean age 73 y; 62% female; 62% African American), 141 developed dementia, of whom 93 developed AD. Increased age and mobility problems were risk factors for dementia (only age for AD), while an increased number of outpatient visits reduced the likelihood of developing dementia. Neither use of any vitamins C and/or E (used by 8% of subjects at baseline) nor high-dose use reduced the time to dementia or AD. CONCLUSIONS: In this community in the southeastern US where vitamin supplement use is low, use of vitamins C and/or E did not delay the incidence of dementia or AD.

Potential drug-disease interactions in frail, hospitalized elderly veterans.

BACKGROUND: Drugs can improve quality of life for many older people, but they may cause adverse health outcomes (eg, drug-disease interactions) if used inappropriately. OBJECTIVE: To determine the prevalence of potential drug-disease interactions as defined by explicit criteria and examine associations between sociodemographic and health status variables and potential drug-disease interactions. METHODS: The study design was cross-sectional. We evaluated 397 frail elderly inpatients from the Geriatric Evaluation and Management trial conducted at 11 Veterans Affairs Medical Centers. Drug-disease interactions were defined using explicit criteria from consensus expert panels of geriatricians from the US and Canada. RESULTS: Overall, 159 (40.1%) patients had one or more potential drug-disease interaction. The most common potential interactions were calcium-channel blockers and heart failure (12.3%) and beta-blockers and diabetes (6.8%). Multivariable logistic regression analyses revealed that age > or =75 years (adjusted OR 2.43; 95% CI 1.52 to 3.88), being married (adjusted OR 1.77; 95% CI 1.11 to 2.82), comorbidity index defined by Charlson method (adjusted OR 1.19; 95% CI 1.05 to 1.34), and use of multiple prescription drugs (5-8: adjusted OR 4.17; 95% CI 1.96 to 8.88, > or =9: adjusted OR 9.22; 95% CI 4.26 to 19.95), were significantly (p < 0.05) associated with having one or more potential drug-disease interaction. CONCLUSIONS: Potential drug-disease interactions are common in hospitalized elderly patients and are related to specific sociodemographic and health status factors. Further research is needed to examine the relationship between health outcomes and drug-disease interactions.

Impact of inappropriate drug use on health services utilization among representative older community-dwelling residents.

BACKGROUND: There is limited objective information regarding the impact of drugs identified as inappropriate by drug utilization review (DUR) or the Beers drugs-to-avoid criteria on health service use. OBJECTIVE: The goal of this study was to examine the predictive validity of DUR and the Beers criteria employed to define inappropriate drug use in representative community residents, aged >or=68 years, as determined by the relationship of these criteria to health service use in older community residents. METHODS: Data came from participants in the Duke University Established Populations for Epidemiologic Studies of the Elderly seen in 1989/1990 and for whom information was also available 3 years later. Two sets of inappropriate drug use criteria were examined: (1) DUR regarding dosage, duration, duplication, and drug-drug and drug-disease interactions; and (2) the Beers criteria, applied to drug use reported in an in-home interview. Outpatient visits and nursing-home entry were determined by personal report; hospitalization information came from Medicare Part A files from the Centers for Medicare and Medicaid Services. RESULTS: A total of 3165 participants were available at the fourth interview in 1989/1990. The majority were aged >74 years (51.1%), white (64.8%), women (64.7%), had fair or poor health (77.0%), consistently saw the same physician (86.9%), and possessed supplemental health insurance (62.8%). Use of inappropriate drugs meeting DUR criteria, especially for drug-drug or drug-disease interaction problems, was associated with increased outpatient visits (P<0.05) but not with time to hospitalization or time to nursing home entry. The use of inappropriate drugs according to the Beers criteria was associated with reduced time to hospitalization (adjusted hazard ratio, 1.20; 95% CI, 1.04-1.39) but not to outpatient visits or nursing home entry. CONCLUSIONS: Our data suggest that in representative community residents aged >or=68 years, current criteria for inappropriate drug use should be used with caution in evaluating quality of care because they have minimal impact on use of health services. We found increases only in the use of outpatient services (with DUR) and more rapid use of hospitalization (with the Beers criteria).

Histamine2 receptor antagonist use and decline in cognitive function among community dwelling elderly.

PURPOSE: Previous studies have reported mixed results regarding the use of histamine(2) receptor antagonist use and cognitive function. This study evaluated the relationship between the use of histamine(2) receptor antagonists and cognitive decline among community dwelling elderly. METHODS: This cohort study included 2082 subjects from the Duke Established Populations for Epidemiologic Studies of the Elderly who were not cognitively impaired at baseline (1989/90). Histamine(2) receptor antagonist use was determined during in-home interviews. Cognitive function was assessed at 3 and 7 years after baseline by two measures: (1) incident cognitive impairment defined by the short portable mental status questionnaire (SPMSQ); and (2) cognitive decline (increase in two or more SPMSQ errors). Analyzes used multivariable discrete-time hazard models with weighted data adjusted for sampling design and controlled for demographic, health behavior characteristics and health status. RESULTS: At baseline, nearly 5% of participants used a histamine(2) receptor antagonist. During follow-up, incident cognitive impairment occurred in 24.0%, whereas 34.5% increased by two or more errors on the SPMSQ. In multivariable models, current histamine(2) receptor antagonist users compared to never users had a higher risk for cognitive impairment (Adj. RR 1.51; 95%CI 0.93-2.47) and for decline in performance (increase of two or more errors) on the SPMSQ (Adj. RR 1.24; 95%CI 0.74-2.08). A nonsignificant increased risk of cognitive impairment and decline with either higher dose or short-term use was found whereas a nonsignificant protective effect on cognitive decline with current long-term use was seen. CONCLUSIONS: These results suggest no beneficial effects, and perhaps a detrimental effect, of histamine(2) receptor antagonist use on cognitive function in community dwelling elderly.

Inappropriate medication use among frail elderly inpatients.

BACKGROUND: Inappropriate prescribing in frail elderly inpatients has not received as much investigation as in frail elderly nursing home patients. OBJECTIVE: To determine the prevalence and predictors of inappropriate prescribing for hospitalized frail elderly patients. METHODS: The study was conducted at 11 Veterans Affairs Medical Centers and involved a sample of 397 frail elderly inpatients. Inappropriate prescribing was measured by physician-pharmacist pair's consensus ratings for 10 criteria on the Medication Appropriateness Index (MAI). The MAI ratings generated a weighted score of 0-18 per medication (higher score = more inappropriate) and were summed across medications to achieve a patient score. RESULTS: Overall, 365 (91.9%) patients had > or =1 medications with > or =1 MAI criteria rated as inappropriate. The most common problems involved expensive drugs (70.0%), impractical directions (55.2%), and incorrect dosages (50.9%). The most common drug classes with appropriateness problems were gastric (50.6%), cardiovascular (47.6%), and central nervous system (23.9%). The mean +/- SD MAI score per person was 8.9 +/- 7.6. Stepwise ordinal logistic regression analyses revealed that both the number of prescription (adjusted OR 1.28; 95% CI 1.21 to 1.36) and nonprescription drugs (adjusted OR 1.17; 95% CI 1.06 to 1.29) were related to higher MAI scores. Analyses excluding the number of drugs revealed that the Charlson index (adjusted OR 1.62; 95% CI 1.12 to 2.35) and fair/poor self-rated health (adjusted OR 1.15; 95% CI 1.05 to 1.26) were related to higher MAI scores. CONCLUSIONS: Inappropriate drug prescribing is common for frail elderly veteran inpatients and is related to polypharmacy and specific health status characteristics.

Antidiabetic drug therapy of African-American and white community-dwelling elderly over a 10-year period.

OBJECTIVES: To determine the prevalence and predictors of antidiabetic medication use over a 10-year period in a general population of African-American and white community-dwelling elderly. DESIGN: Survey. SETTING: Five adjacent counties (one urban and four rural) in the Piedmont area of North Carolina. PARTICIPANTS: Those aged 65 and older present at the baseline (n=4,136), second (n=3,234), third (n=2,508), and fourth (n=1,633) in-person waves of the Duke Established Populations for Epidemiologic Studies of the Elderly. MEASUREMENTS: The use of six discrete categories of antidiabetic medications (insulin, first-generation oral sulfonylureas, second-generation oral sulfonylureas, metformin, oral combination therapy, and insulin combination therapy) was determined. Multivariate analyses, using weighted data adjusted for sampling design, were conducted to assess the association between antidiabetic medication use and race and other sociodemographic, health-status, and access-to-healthcare factors at baseline and 10 years later. RESULTS: Antidiabetic medications were taken by 21.4% of the population at baseline; this increased to 28.1% at the 10-year follow-up (P<.001). Insulin was the most commonly used drug at baseline (7.9%). The use of second-generation sulfonylureas increased, and use of first-generation sulfonylureas decreased over the 10-year time period. Combination antidiabetic therapy and metformin use was infrequent throughout the study. Multivariate analyses revealed that, at baseline, African Americans were nearly twice as likely (adjusted odds ratio (AOR)=1.93, 95% confidence interval (CI)=1.46-2.54) to receive any antidiabetic medication as their white counterparts. Other significant (P<.05) factors were hypertension (AOR=1.38, 95% CI=1.03-1.84), stroke (AOR=1.98, 95% CI=1.43-2.73), one or more mobility difficulties (AOR=1.29, 95% CI=1.01-1.66), continuity of care (AOR=1.74, 95% CI=1.20-2.54), and multiple doctor visits (1-4 visits, AOR=1.69, 95% CI=1.08-2.65; >/=5 visits, AOR=3.15, 95% CI=1.95-5.07). Being underweight (AOR=0.45, 95% CI=0.30-0.67) and being cognitively impaired (AOR=0.60, 95% CI=0.41-0.87) were factors significantly (P<.05) associated with a decreased risk of antidiabetic medication use. At the 10-year follow-up, similar trends were seen associating these sociodemographic, health-status, and access-to-healthcare factors with antidiabetic medication use. CONCLUSION: Antidiabetic medication use is common and increases over time for community-dwelling elderly. Race is significantly associated with antidiabetic medication use, even after controlling for other sociodemographic, health-status, and access-to-healthcare variables.

Benzodiazepine use and physical performance in community-dwelling older women.

OBJECTIVES: To determine whether benzodiazepine use in older women increased the risk of decline in physical function. DESIGN: A four-year prospective cohort study. SETTING: The communities of Iowa and Washington counties, Iowa. PARTICIPANTS: Eight hundred eighty-five women aged 70 and older who had completed physical performance tests in 1988 and 1992. MEASUREMENTS: Benzodiazepine use was determined during in-home interviews and classified by dose, duration, indication for use, and half-life. Physical performance tests included an assessment of standing balance, walking speed (8-foot distance), and repeated chair raises. RESULTS: Ninety (10.2%) reported benzodiazepine use at baseline. After adjustment for baseline physical performance score and potential confounders, benzodiazepine use was associated with a greater decline in physical performance over 4 years than nonuse (beta=-1.16; standard error (SE)=0.25; P<.001). The use of higher-than-recommended dose was related to decline (beta=-2.26; SE=0.47; P<.001), and use of lower doses was not (beta=-0.53; SE=0.46; P=.246). Long-term use (>or=3 years) was related to decline (beta=-1.65; SE=0.34; P<.001), whereas recent and past use were not. Similar results were obtained when restricting the sample to those without disability at baseline. CONCLUSION: This study provides evidence that older women who used benzodiazepines were at risk for decline in physical performance. Subgroup analyses indicated that risk was greater with use of higher-than-recommended doses or for long duration (>or=3 years). These findings highlight the importance of using benzodiazepines at the lowest effective dose for a limited duration in older women.

Adverse drug reaction risk factors in older outpatients.

BACKGROUND: Adverse drug reactions (ADRs) are common in older (age >or=65 years) outpatients (prevalence, 5%-35%), but there is no consensus on factors that put these patients at high risk for ADRs. Identifying a uniform set of risk factors would be helpful to develop risk models for ADRs for older outpatients and to implement targeted interventions for those patients at high risk for ADRs. OBJECTIVE: The aim of this study was to identify potential risk factors for ADRs in older outpatients through a survey of geriatric experts and to determine their prevalence. METHODS: A comprehensive literature search was conducted to find published articles on ADRs in older patients. Forty-four potential risk factors were identified through the literature search and 6 additional factors were suggested by the expert panel. Through a modified 2-round survey, based on the Delphi consensus method, of an expert panel of 5 physicians and 5 pharmacists, the probability that each of these 50 potential factors could contribute independently to placing an older outpatient at high risk for an ADR was rated on a 5-point Likert scale. After the survey responses were received, means and 95% Cls were calculated. Consensus was defined as a lower 95% confidence limit >or=4.0. Potential risk factors that reached consensus were then applied to a sample of older outpatients to determine their prevalence. RESULTS: After 2 rounds, the expert panel reached consensus on 21 factors, including 12 medication-related factors and 9 patient characteristics. The most prevalent medication-related risk factors were opioid analgesics; warfarin; non-acetylsalicylic acid, non-cyclooxygenase-2 nonsteroidal anti-inflammatory drugs; anticholinergics; and benzodiazepines. The most prevalent patient characteristics included polypharmacy, multiple chronic medical problems, prior ADR, and dementia. CONCLUSIONS: An expert panel was able to reach a consensus on potential risk factors that increase the risk for ADRs in older outpatients. Many risk factors were common in a sample of older outpatients. Future research is needed to determine the predictive validity of these risk factors for ADRs in older outpatients.

Impact of generosity level of outpatient prescription drug coverage on prescription drug events and expenditure among older persons.

OBJECTIVES: This study examined the impact of drug coverage generosity on older persons' prescription events (fills) and expenditures. METHODS: A cross-sectional study was conducted of 6237 older persons from the 1995 Medicare Current Beneficiary Survey. Dependent variables were per capita prescription events and expenditures. Independent variables were insurance type and drug coverage generosity. Control variables included sociodemographic and health status factors. RESULTS: Regardless of insurance type, per capita prescription events increased as drug coverage generosity improved and then decreased at the most generous level. Per capita prescription expenditures increased as generosity improved; with generous prescription coverage, prescription expenditures were approximately 3 times those with Medicare only. CONCLUSIONS: Even when factors that affect drug use and insurance selection are controlled, prescription coverage generosity influences prescription use.

Use of inappropriate prescription drugs by older people.

OBJECTIVES: To determine the prevalence and predictors of inappropriate drug prescribing defined by expert national consensus panel drug utilization review criteria for community-dwelling older people. DESIGN: Survey. SETTING: Five adjacent urban and rural counties in the Piedmont area of North Carolina. PARTICIPANTS: A stratified random sample of participants from the fourth (n = 3,234) and seventh (n = 2,508) waves of the Duke Established Populations for Epidemiological Studies of the Elderly. MEASUREMENTS: The prescribing appropriateness for digoxin, calcium channel blockers, angiotensin-converting enzyme inhibitors, histamine(2) receptor antagonists, nonsteroidal antiinflammatory drugs (NSAIDs), benzodiazepines, antipsychotics, and antidepressants as determined by explicit criteria (through Health Care Financing Administration expert consensus panel drug utilization review criteria for dosage, duplication, drug-drug interactions and duration, and U.S. and Canadian expert consensus panel criteria for drug-disease interactions). Multivariable analyses, using weighted data adjusted for sampling design, were conducted to assess the association between inappropriate prescribing and demographic, health-status, and access-to-healthcare factors cross-sectionally and longitudinally. RESULTS: We found that 21.0 of the fourth wave and 19.2 of the seventh wave participants who used one or more agents from the eight drug classes had one or more elements identified as inappropriate. The therapeutic classes with the most problems were benzodiazepines and NSAIDs. The most common problems were with drug-disease interactions and duration of use. Longitudinal multivariable analyses found that participants who were white (adjusted odds ratio (AOR) = 1.67, 95 confidence interval (CI) = 1.28-2.17), were married (AOR = 1.40, 95% CI = 1.01-1.93), had arthritis (AOR = 1.74, 95% CI = 1.27-2.38), had one or more physical function disabilities (AOR = 1.42, 95% CI = 1.02-1.96), and had inappropriate drugs prescribed at wave 4 (AOR = 6.87, 95% CI = 5.11-9.22) were more likely to have inappropriate prescribing at wave 7. CONCLUSION: These results indicate that inappropriate prescribing is common among community-dwelling older people and persists over time. Longitudinal studies in older people are needed to examine the impact of inappropriate drug prescribing on health-related outcomes.

Impact of inappropriate drug use on mortality and functional status in representative community dwelling elders.

BACKGROUND: The predictive validity of Drug Utilization Review (DUR) and drugs-to-avoid criteria in elders is unknown. OBJECTIVES: To evaluate the relationship between use of inappropriate drugs as determined by these explicit criteria and mortality and decline in functional status in community dwelling elders. RESEARCH DESIGN: Cohort study. SUBJECTS: The fourth wave (3234 participants) of the Duke Established Populations for Epidemiologic Studies of the Elderly. MEASURES: Two sets of inappropriate drug-use criteria: (1) DUR with respect to dosage, duplication, drug-drug interactions, duration, and drug-disease interactions; and (2) Beers-modified criteria regarding drugs-to-avoid were applied to drug use reported in an in-home interview. Death was identified from the National Death Index; change in four functional status measures (basic self-care, intermediate self-care, complex self-management, physical function) was determined during the following 3 years. RESULTS: Use of inappropriate drugs identified by either set of criteria was not significantly associated with mortality. The drugs-to-avoid criteria identified no significant associations between use of these drugs and decline in functional status. With DUR criteria, however, the association between use of inappropriate drugs and basic self-care was significant and pronounced among those with drug-drug or drug-disease interaction problems (Adj. OR 2.04; 95% CI 1.32-3.16). CONCLUSIONS: Identifying the impact of inappropriate drug use may depend on the criteria applied. Further studies are needed that measure additional outcomes and use alternate measures of inappropriate drug use.