JAMDA 17 (2016) 276.e9e276.e14

JAMDA journal homepage: www.jamda.com

Original Study

Burden of Potentially Harmful Medications and the Association With Quality of Life and Mortality Among Institutionalized Older People Anna-Liisa Juola MD a, b, *, Sarita Pylkkanen MSc (Pharm) c, Hannu Kautiainen PhD b, J. Simon Bell PhD d, Mikko P. Bjorkman MD, PhD b, Harriet Finne-Soveri MD, PhD e, Helena Soini RN, PhD f, Kaisu H. Pitkälä MD, PhD b a

City of Porvoo, Health Services, Porvoo, Finland Department of General Practice, and Helsinki University Hospital, Unit of Primary Health Care, University of Helsinki, Finland Faculty of Pharmacy, Division of Social Pharmacy, University of Helsinki, Carea Central Hospital Pharmacy, Kotka, Finland d Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Australia; School of Pharmacy and Medical Sciences, Sansom Institute, University of South Australia, Adelaide, Australia; and Kuopio Research Centre of Geriatric Care, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland e National Institute for Health and Welfare, Helsinki, Finland f City of Helsinki, Department of Social Services and Health Care, Developmental and Operational Support, Helsinki, Finland b c

a b s t r a c t Keywords: Inappropriate prescribing nursing home assisted living facilities quality of life psychological well-being

Objectives: This study investigated the overlap among 3 different definitions of potentially harmful medication (PHM) use and the corresponding associations with resident quality of life and mortality. Design: Cross-sectional study with 3-year follow-up for mortality. Setting: Assisted living facilities and nursing homes in Helsinki and Kouvola, Finland. Participants: A total of 326 residents. Measurements: PHM use was defined as (1) use of medications with anticholinergic properties, (2) use of Beers Criteria medications, and (3) concomitant use 3 or more psychotropic medications. Health-related quality of life (HRQoL) was assessed using the 15D and psychological well-being (PWB) scale. Residents self-rated their own health using a 4-point scale. Mortality data were obtained from central registers. Results: There were 38.0%, 28.2%, and 12.6% of residents who used PHMs according to 1 (G1), 2 (G2), and 3 definitions (G3), respectively. Overall, 21.2% of residents did not use PHMs according to any of the 3 definitions (G0). There were no significant differences in comorbidity, cognition, or functioning among groups. In adjusted analyses, there was a stepwise association between use of multiple PHMs and poorer self-rated health, poorer PWB, and poorer HRQoL. There was no association in adjusted analyses between PHM use and 3-year mortality (47.8%e63.8%). Conclusion: PHM use is highly prevalent in institutional settings, regardless of the definition of inappropriateness. Residents who used multiple categories of PHMs were at greatest risk of poor HRQoL, poor PWB, and poor self-rated health. However, there was no apparent association with increased mortality. Given the importance of quality of life as an outcome to older people, further efforts are needed to minimize PHM use in this setting. Ó 2016 AMDA e The Society for Post-Acute and Long-Term Care Medicine.

The authors declare no conflicts of interest. This study was funded by the Päivikki and Sakari Sohlberg Foundation, the Uulo Arhio Foundation, Helsinki University Hospital, Societas Gerontologica Fennica, the Medical Society of Kouvola, the Helsinki City Social Services Department, and the Kouvola City Services for the Elderly. These organizations have had no impact on the research process, results, or final manuscript. * Address correspondence to Anna-Liisa Juola, MD, City of Porvoo, Health Services, PO Box 23, 006101 Porvoo, Finland. E-mail address: anna-liisa.juola@fimnet.fi (A.-L. Juola). http://dx.doi.org/10.1016/j.jamda.2015.12.011 1525-8610/Ó 2016 AMDA e The Society for Post-Acute and Long-Term Care Medicine.

Polypharmacy is highly prevalent among older people living in institutional settings.1,2 Age-related changes in pharmacokinetics and pharmacodynamics mean that older people are susceptible to adverse drug events (ADEs).3 Older people have a high prevalence of multimorbidity and geriatric syndromes. These present a challenge to clinicians seeking to optimize medical care.4 Numerous definitions of potentially harmful medications (PHMs) have been applied in institutional settings.5 The most common method to define PHMs is Beers Criteria.6e8 Use of 3 or more psychotropic medications,9 and

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anticholinergic medications have also been defined as potentially inappropriate.8,10 Estimates of the prevalence of PHMs in institutional settings using the 2003 Beers Criteria vary between 21% and 48%.11,12 PHM use defined using Beers Criteria has been associated with ADEs, increased health care costs, and functional decline.6,11 However, evidence for an association with mortality is limited. Anticholinergic medications have side effects including falls, dry mouth, dry eyes, constipation, cognitive decline, confusion, and hallucinations.13,14 Anticholinergic medications have been associated with hospitalizations,15,16 although evidence for an association with mortality is mixed.16e18 The Swedish National Board of Health and Welfare uses the quality indicator “3 or more psychotropic medications.”19 The reported prevalence of psychotropic medications in institutional settings ranges from 57% to 85%.20e22 Psychotropic medications are associated with a range of ADEs including falls and fractures.23 Antipsychotic use in persons with dementia has been associated with an increased risk of stroke and death.24 There has been minimal research into the association between medication use and quality of life (QoL) in institutional settings. An Australian study reported that polypharmacy and Drug Burden Index (DBI), a measure of sedative and anticholinergic medication use, were associated with self-reported resident QoL.25 However, the same study reported that use of Beers Criteria medications was not associated with resident QoL. Previous studies have investigated the overlap and predictive validity of different definitions of PHM use in community based samples of older people.26,27 However, to our knowledge, no studies have explored the overlap between different definitions of PHMs and the associations with resident QoL and mortality in institutional settings. The objective of this study was to investigate the overlap among 3 different definitions of PHM use and the corresponding associations with resident QoL and mortality. We hypothesized that residents who used PHMs according to multiple definitions would have a lower QoL and be at possible increased risk of mortality. Methods Design, Setting, and Participants This study used baseline data from a randomized controlled trial in Helsinki assisted living facilities.28 These data were pooled with data collected using the same methods in nursing homes in Kouvola in 2011. Helsinki is the largest city and Kouvola is a middle-sized city in Finland. Assisted living facilities are similar to traditional nursing homes but provide 24-hour nursing care and a “homelike” environment. Primary care physicians are responsible for the provision of medical care in each setting. The resident inclusion criteria were age 65 years or older, permanent residence in an assisted living facility or nursing home, being a native Finnish speaker, use of at least 1 medication, and an estimated life expectancy of at least 6 months. There were 426 residents in the assisted living facilities and nursing homes. Of these 426 residents, 326 (76.5%) consented to participate (227 residents in Helsinki and 99 residents in Kouvola). Experienced and trained study nurses performed the study assessments. Information on medication and diagnoses was retrieved from each resident’s medical records. Medication Assessment Each resident’s medication use was assessed as the point prevalence on the day of assessment and included medications charted for both regular and as-needed (PRN) use. All medications were coded using the Anatomical Therapeutic Chemical (ATC) classification system recommended by the World Health Organization (WHO).29 PHM

use was defined as (1) use of medications with anticholinergic properties, (2) use of Beers Criteria medications, and (3) concomitant use of 3 or more psychotropic medications. Our list of medications with anticholinergic properties was derived by combining several published lists, and has been published previously.7,14,28 We used the 2003 version of Beers Criteria independent of diagnoses because the 2012 update had not been published when we commenced our study.7 We used the Swedish National Board of Health and Welfare quality indicator “3 or more psychotropic medications,” with psychotropic medications deemed to include included antipsychotics (ATC-N05A), antidepressants (ATC-N06A), anxiolytics (ATC-N05B), and hypnotics (ATC-N05C). When calculating the total number of PHMs taken by each resident, each medication was only counted once, even if it was included in multiple definitions. Residents were grouped as those who did not use PHMs according to any of the 3 definitions (G0), and residents who used PHMs according to 1 (G1), 2 (G2), or 3 definitions (G3). Main Outcomes The main outcomes were health-related QoL (HRQoL) assessed using the 15D and the psychological well-being (PWB) scale.30 The 15D is a generic measure of HRQoL, with scores ranging from 0 (poorest) to 1 (excellent).31 The 15D includes domains related to mobility, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. An advantage of the 15D is that it can be completed by interviewing a resident’s proxy. We selected the 15D because it is well validated and has been shown to have good sensitivity to changes in QoL following health service interventions. The PWB scale includes 6 items related to life satisfaction (yes/no), feeling useful (yes/no), having plans for the future (yes/no), having zest for life (yes/no), feeling depressed (seldom or never/sometimes/often or always), and loneliness (seldom or never/sometimes/often or always).32 The PWB score was calculated by summing the scores from each item and dividing by the number of items completed by the participant. A score of 1 represents the best and 0 the poorest well-being. The PWB scale has good reliability, criterion validity with the WHO Quality of Life-BREF (WHOQOL-BREF), and prognostic validity.30,32 The other main outcome was mortality. Data on mortality over the 3-year followup were obtained from central registers. Other Measures and Definitions Demographic information that was collected included each resident’s age, gender, and education level. Residents rated their own health using a 4-point scale (healthy, quite healthy, quite unhealthy, and unhealthy). For the purpose of the analyses, these results were categorized as healthy (healthy, quite healthy) or unhealthy (quite unhealthy, unhealthy). Nutritional status was evaluated by using the Mini Nutritional Assessment (MNA).33 Dependence in physical functioning was assessed using the personal care items of the Clinical Dementia Rating (CDR) scale.34 CDR personal care class 2 (“needs at least assistance in dressing, personal hygiene, and caring for personal belongings”) was defined as dependence in activities of daily living (ADLs). Resident’s mobility was assessed using the mobility item within the MNA (bed or chair bound/able to get out of bed or chair but does not go out/goes out). For the purpose of the analyses, residents were considered immobile if they were deemed bed or chair bound. Residents’ diagnoses were retrieved from medical records and the Charlson Comorbidity Index was calculated.35 Dementia stage was evaluated using the CDR scale, with 0 representing no dementia, 0.5 possible dementia, 1 mild dementia, 2 moderate dementia, and 3 severe dementia.34 Cognitive status was assessed using the Mini Mental State Examination (MMSE).36

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Statistical Analyses Results for continuous variables were presented using means with SDs. Categorical variables were described as percentages (%). The clinical and demographic characteristics of residents in G0, G1, G2, and G3 were compared. Statistical significance for hypotheses of linearity was evaluated by analysis of variance (ANOVA), Cochran-Armitage test, or logistic models. In the case of violation of the assumptions (non-normality), a bootstrap-type test was used. The relationship between group allocation and each of the main outcomes was analyzed with multivariate forward stepwise continuation-ratio logistic regression for ordered response data. The normality of the variables was tested by using the Shapiro-Wilk W-test. All analyses were performed using STATA software (version 14.0) (StataCorp LP, College Station, TX). Ethical Considerations The Ethics Committee of Helsinki University Central Hospital approved the study protocol. Participating residents and their closest proxy received information about the study and its content and purpose, and each participant gave written informed consent to participate. If a resident’s Mini Mental State Examination (MMSE) was less than 20, his or her closest proxy provided informed consent before any study procedures commenced. Results Among the 326 participants in the study, 41 residents (12.6%) used PHMs included in all 3 definitions, 92 residents (28.2%) used PHMs included in 2 definitions, and 124 (38.0%) used PHMs included in 1 definition (Figure 1). There were 69 (21.2%) residents who did not use PHMs according to any of the definitions. Residents who used PHMs from all 3 definitions were younger than those who used no PHMs (Table 1). Otherwise, there were no differences in demographic characteristics, comorbidity, mobility, physical functioning, nutrition, MMSE, or CDR between groups in unadjusted or adjusted analyses. Self-rated health was significantly different between groups, with the proportion of residents feeling healthy (86.2%) being highest among residents in G0. The respective figures for G1, G2, and G3 were 70.8%, 65.3%, and 66.7%, respectively (P ¼ .020, adjusted for age and gender). There was a stepwise association between PHM use and PWB and HRQoL. PWB was highest in G0 (0.74). The respective figures in G1, G2, and G3 were 0.68, 0.67, and 0.61, respectively (P ¼ .0041, adjusted for age and gender). The same pattern of association existed for

Fig. 1. Overlap and burden in the use of potentially harmful drugs according to 3 different criteria (Beers criteria,7 drugs with anticholinergic properties [DAPs],28 or >2 psychotropics19) among residents in institutional settings in Finland.

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HRQoL, with the figures for G0 to G3 being 0.64, 0.60, 0.60, and 0.59, respectively (P ¼ .0031, adjusted for age and gender) (Table 1). There was a stepwise increase in the mean number of regular drugs from G0 to G3 (Table 2). The same patterns of association existed for PRN medications, anticholinergic medications, Beers Criteria medications, and psychotropic medications. The lowest number of PHMs was in G0 (0.8), whereas the respective figures in G1, G2, and G3 were 2.0, 3.6, and 4.3 (P < .001, adjusted for age and gender). The use of nonsteroidal anti-inflammatory drugs (NSAIDs) did not differ between the groups. In the forward stepwise ordered (continuation-ratio) logistic regression for burden of PHDs (by 4 classes from G0 to G3) entering all variables from Table 1 and number of regular drugs into the model, only younger age (odds ratio [OR] 0.94, 95% confidence interval [CI] 0.90e0.99, P ¼ .014), lower HRQoL according to 15D (0.57 per SD, 95% CI 0.39e0.85, P ¼ .006), and higher MMSE (1.06, 1.01e1.11, P ¼ .028) was associated with higher burden of PHDs. There was no difference in 3-year mortality between the groups. The proportion of residents who died at 3 years was 63.8% in G0, 62.1% in G1, 47.8% in G2, and 51.2% in G3 (P ¼ .10, adjusted for age and gender). Discussion The main finding of our study was the high burden of PHM use in assisted living facilities and nursing homes, with 12.6% of residents taking PHMs according to all 3 definitions, 28.2% according to 2 definitions, and 38.0% according to 1 definition. Only 21.2% of participants did not use PHMs according to any definition. Residents who used PHMs included in multiple definitions were at greatest risk of poor HRQoL, poor PWB, and poor self-rated health. However, there was no evidence for stepwise association between a higher burden of PHM use and increased mortality. Our finding that residents who used PHMs included in multiple definitions were at risk of poor QoL is clinically important. It has been suggested in previous studies that the PHM use could be associated with poorer health and lower QoL.37,38 Our finding substantiates those of Bosboom et al25 who reported an association between polypharmacy and DBI with poor QoL. Interestingly; however, Bosboom et al25 reported no association between Beers Criteria medications and poorer QoL. There are several possible explanations. First, it may reflect differences in prescribing practices between Finland and Australia. Second, anticholinergic and psychotropic medications were included in multiple PHM definitions in our study. These medications may result in the greater impairments in QoL than other Beers Criteria medications. This hypothesis is consistent with the finding of Bosboom et al25 that DBI rather than Beers Criteria medications were associated with poorer QoL because DBI is a measure of exposure of anticholinergic and sedative medications, many of which are psychotropic medications.39 Our study had a number of strengths and limitations. Strengths of our study included that the study nurses were experienced and well trained in resident assessment, and that medication data were extracted directly from each resident’s medication chart. This ensured that we obtained accurate data on medications that were actually administered to residents. Although the 15D and PWB scales are not dementia-specific scales they are well validated and widely used in the institutional setting. The 15D is validated for both resident self-report and completion by a proxy, however, research using other QoL scales has shown that there may be differences in resident self-reported and staff informant reported QoL.40 PHMs were defined using widely and well established criteria. Several anticholinergic medication lists have been published,14,41e43 but differences in medication availability mean that most are not directly applicable to Finland without modification. Therefore, we combined several published lists. QoL was better in the groups of residents who used fewer

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Table 1 Characteristics of Participants Divided in Groups Using No Harmful Drugs (G0), Using a Harmful Drug According to 1 Criterion (G1), Using Harmful Drugs According to 2 Criteria (G2), and Using Harmful Drugs According to 3 Criteria (G3) Group

Not Using Any Harmful Drug G0, n ¼ 69

One of 3 Criteria Fulfilled G1, n ¼ 124

Two of 3 Criteria Fulfilled G2, n ¼ 92

Three of 3 Criteria Fulfilled G3, n ¼ 41

P*

Py

Age, mean (SD) Females, % Education

Burden of Potentially Harmful Medications and the Association With Quality of Life and Mortality Among Institutionalized Older People.

This study investigated the overlap among 3 different definitions of potentially harmful medication (PHM) use and the corresponding associations with ...
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