Potentially Inappropriate Prescribing in Older People with Dementia in Care Homes

Transcription

1 ORIGINAL RESEARCH ARTICLE Drugs Aging 2012; 29 (2): X/12/ /$49.95/0 ª 2012 Adis Data Information BV. All rights reserved. Potentially Inappropriate Prescribing in Older People with Dementia in Care Homes A Retrospective Analysis Carole Parsons, 1 Sarah Johnston, 1 Elspeth Mathie, 2 Natasha Baron, 3 Ina Machen, 2 Sarah Amador 2 and Claire Goodman 2 1 School of Pharmacy, Queen s University Belfast, Belfast, UK 2 Centre for Research in Primary and Community Care, University of Hertfordshire, Hatfield, Hertfordshire, UK 3 General Practice & Primary Care Research Unit, Institute of Public Health, Cambridge, UK Abstract Background: Older people in general and care home residents in particular are at high risk of suboptimal or inappropriate prescribing. To date, research into potentially inappropriate prescribing (PIP) has not focused on care home residents and/or has not utilized the recently developed and validated Screening Tool of Older Persons potentially inappropriate Prescriptions (STOPP) criteria. Objective: The aim of this study was to estimate the prevalence of PIP in older people with dementia living in six residential care homes in England, using the STOPP criteria. Methods: A retrospective analysis was conducted using medication data collected for older people with dementia in six residential care homes in England who participated in the prospective, longitudinal EVIDEM End of Life (EoL) study. Of the 133 residents recruited to the study, medication administration records were available for and reviewed at two timepoints (approximately 16 weeks apart) for 119 residents and 110 residents, respectively. The prevalence of PIP at these timepoints was determined using 31 of the 65 STOPP criteria applicable when there is no access to residents medical records. Results: At the first timepoint, 68 potentially inappropriate medications (PIMs) were identified. Fifty-five residents (46.2%) were prescribed one or more PIM(s), eleven (9.2%) were prescribed two or more PIMs and two (1.7%) were prescribed three PIMs. Thirteen of the 31 STOPP criteria utilized in this study (41.9%) were used to identify PIP. Long-term (i.e. >1 month) neuroleptics (antipsychotics) were the most frequently prescribed PIMs (n = 25; 21.0%), followed by non-steroidal anti-inflammatory drugs (NSAIDs) for >3 months, proton pump inhibitors (PPIs) at maximum therapeutic

2 144 Parsons et al. dosage for >8 weeks, tricyclic antidepressants (TCAs) in patients with dementia and long-term (i.e. >1 month), long-acting benzodiazepines. At the second timepoint, 57 PIMs were identified; 45 residents (40.9%) were prescribed one or more PIM(s) and 10 (9.1%) were prescribed two or more PIMs, but only one resident (0.9%) was prescribed three PIMs. Of the 31 STOPP criteria utilized in this study, ten (32.3%) were used to identify PIP. Long-term (i.e. >1 month) antipsychotics were again the most frequently prescribed PIMs (n = 21; 19.1%), followed by PPIs at maximum therapeutic dosage for >8 weeks, NSAIDS for >3 months and TCAs in patients with dementia. A significant correlation was found at both timepoints between the number of medicines prescribed and occurrence of PIP. Conclusions: This study found that over two-fifths of older people with dementia residing in six residential care homes in England were prescribed at least one PIM at each timepoint. Long-term (i.e. >1 month) antipsychotics, NSAID use for >3 months and PPI use at maximum therapeutic dosage for >8 weeks were the most prevalent PIMs. Regular medication review that targets, but is not limited to, these medications is required to reduce PIP in the residential care home setting. The STOPP criteria represent a useful tool to facilitate such review in this patient population. Introduction The population of older people in the UK is increasing, in line with global demographic changes, with the fastest population increase in the number of people aged 85 years, the oldest old. [1] In 2010, 1.4 million people in the UK were aged 85 years, and by 2035, this is projected to increase to 3.6 million people, accounting for 5% of the total population. [1] Care homes are the main providers of long-term care for older people. These include homes that have on-site nursing care (nursing homes), those that provide personal care only (residential homes) and those that offer both residential and nursing care. [2] Residential homes, which provide the majority of long-term care for older people in England, do not have on-site nursing provision, and rely on primary healthcare professionals, namely general practitioners (GPs), nurses and community pharmacists, to meet healthcare needs, including prescribing and supply of medications and medication review. [3] Prescribing is one of the most common medical interventions experienced by older people resident in care homes. [4,5] In addition to age-related changes in pharmacokinetics and pharmacodynamics, [6] older people in general and those in care homes in particular are at high risk of adverse drug events, drug-drug interactions [7-9] and suboptimal or inappropriate prescribing. [10,11] Medicines for older people are considered appropriate when they have a clear evidence-based indication, are well tolerated by the majority and are cost-effective. [12] In contrast, inappropriate prescribing encompasses a range of suboptimal prescribing practices but may be defined as the use of a particular medication for which the risks outweigh the potential benefits. [11,13] Potentially inappropriate medications (PIMs) have no clear evidence-based indication, carry a substantially higher risk of adverse effects compared with that associated with their use in younger people, or are not cost effective. [12] The appropriateness of prescribing in older people may be assessed by process (that is, what providers do) or using outcome measures that are implicit or explicit, [11,14] details of which have been summarized in table I. The limitations of Beers criteria detailed in table I have resulted in the development and

3 Prescribing in Residential Care Homes 145 Table I. Implicit and explicit measures of appropriateness of prescribing Implicit measures Judgement-based [11,15] Highly patient specific [16] Require access to large amounts of clinical data and highly trained clinician assessors [16] Explicit measures Criterion-based and developed from evidence-based guidelines, published reviews, expert opinion and consensus techniques [14,17] Require a limited degree of clinical judgement [11] Beers criteria traditionally regarded as gold standard for assessing potentially inappropriate prescribing in older patients [17] Beers criteria have a number of limitations in context of European prescribing [14,17,18] ; almost half of the drugs included in the criteria are unavailable or very seldom used in Europe, [18-20] some drugs listed are not contraindicated in older people in the British National Formulary (e.g. amitriptyline, diazepam, doxazosin, naproxen [12,18] ) and other contraindicated drugs are omitted [14,18,19] validation of a more comprehensive explicit process measure of potentially inappropriate prescribing (PIP) for use in European countries, the Screening Tool of Older Persons potentially inappropriate Prescriptions (STOPP). [21] Inappropriate prescribing in older people can lead to substantial morbidity, mortality and wastage of health resources. [11] To date, research into PIP has focused on community-dwelling or hospitalized older people [12,14,22-24] and/or has measured PIP using Beers criteria. [19,24-32] Few studies have used STOPP to determine the prevalence of PIP in long-term care to date, [33,34] and such studies have been conducted in the nursing home setting. However, the majority of older people resident in care homes, many of whom have dementia (52.2%), [35] live in care home facilities that have no on-site clinician or nursing provision and that rely wholly on primary healthcare services for medical care. The overall aim of this study was therefore to estimate the prevalence of PIP in older people with dementia living in residential care homes. Additional objectives included estimating the prevalence of PIP according to specific STOPP criteria and investigating the associations between PIP, number of medications prescribed, age and sex of the resident, and care home. Methods The eligible study population comprised all residents from six residential care homes in the southeast of England who were participating in the Evidence-based Interventions in Dementia End of Life (EVIDEM EoL) study and for whom medication administration records (MARs) were available at baseline and at two further timepoints (approximately 16 weeks apart) at which data were collected over the 12-month data collection period. The EVIDEM-EoL study had a prospective design, tracking the events and care experienced by older people with dementia over 2 years, and was undertaken between April 2008 and June It employed both quantitative and qualitative methods of data collection, including review of care notes at 4-monthly intervals, interviews with people with dementia, care home staff and healthcare professionals, and document review of guidance and protocols on the end-of-life care used by the care homes. [36] Ethical approval for the EVIDEM-EoL study was granted by the National Health Service (NHS) Southampton and South West Hampshire Research Ethics Committee in July 2008 (MREC Ref: 08/H0502/74). The Care Quality Commission (CQC, formerly Commission for Social Care Inspection) directory of care homes and care services was used to identify care homes within an hour s journey of the study centre that met the inclusion criteria of being registered to provide residential care for older people with dementia, having a minimum of 25 beds and being assessed as providing a good (2 star or above) standard of care. Ten care homes were purposively selected to reflect a range of ownership (private, charitable, faith-based, large commercial chain) and geographical location (urban, suburban and rural)

4 146 Parsons et al. and invited to participate in the study. Following initial discussions with the care home managers, six care homes agreed to take part, and the research team followed up with separate meetings with staff, residents and relatives to discuss the scope and intention of the study, and to gauge interest and willingness to participate. All six care homes were registered to provide dementia care, and ranged in size from 46 to 67 beds. In four of the homes, GPs visited on a weekly basis; in one home, GPs visited on a monthly basis (and on request); and in one home, GPs visited only on request. Between two and four general practice surgeries provided services to each care home. Care home residents who were aged 65 years and who had a documented diagnosis of dementia or who were determined by senior care home staff as having cognitive impairment indicative of dementia were included in the study. All participants in the study were therefore considered to have dementia regardless of whether they were prescribed medications for dementia. Residents with dementia whom the care home manager thought it inappropriate to approach (for example, people in the terminal stage of the disease) or who lacked the capacity to consent and for whom a proxy could not be identified within the timeframe for recruitment were excluded from the study as detailed previously. [36] MAR sheets for each resident were examined retrospectively in January 2011 to determine PIP. Medications prescribed, including both regularly prescribed medications and medications prescribed on a when required (pro re nata) basis, were coded using the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system. [37] Dressings, medical devices such as catheters and associated equipment, nutritional supplements and gluten free products, complementary medicines, preparations for ear wax removal, needles, lancets, test strips and GlucoGel Ò were excluded from the analysis. Explicit Measurement of Potentially Inappropriate Prescribing (PIP) PIP was defined according to 31 of the 65 STOPP criteria (table II). A consensus panel of five experts working in geriatric pharmacotherapy, clinical pharmacology, pharmacoepidemiology and academic general practice considered these selected criteria to be applicable to data collected in a retrospective population study undertaken in Ireland using a pharmacy claims database (where diagnosis information was unavailable). [14] Where possible, the identification of prescription drugs was used as a proxy for diagnosis when applying the 31 STOPP criteria, for example, Parkinson s disease (ATC code N04), epilepsy (ATC code N03), chronic obstructive pulmonary disease (COPD) [ATC codes R03BA, R03BB, R03CC02, R03CC03, R03DA04], glaucoma (ATC code S01E), type 2 diabetes mellitus (ATC code A10B) and gout (ATC code M04). This approach was previously utilized when access to residents medical records was not possible. [14] Certain STOPP criteria specified a particular duration of treatment beyond which prescribing was potentially inappropriate, for example, longterm use (>1 month) of long-acting benzodiazepines or neuroleptics (antipsychotics), long-term use (>3 months) of non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief, and proton pump inhibitors (PPIs) for peptic ulcer disease at a maximum therapeutic dose for >8 weeks (table II). For these criteria, potential inappropriateness of medications was assessed by identifying continuing prescription of the medication at the data collection timepoints. Although medication data were collected at baseline, it was not possible to assess continuing prescription of medication at this timepoint; therefore appropriateness of prescribing was not assessed. However, the longitudinal design of the EVIDEM-EoL study enabled assessment of continuing prescription of medication and therefore applicability of certain STOPP criteria at timepoints 1 and 2. Statistical Analysis Data were analysed using PASW Statistics 18.0 (SPSS Inc., Chicago, IL, USA). Overall prevalence of PIP and prevalence of PIP according to each individual STOPP criterion were calculated as a percentage of all participating

5 Prescribing in Residential Care Homes 147 Table II. STOPP criteria applied to medication administration record sheets for older patients with dementia residing in six residential care home facilities with no on-site nursing provision STOPP criterion description Cardiovascular system Digoxin >125 mg/day (increased risk of toxicity) Thiazide diuretic with gout (exacerbate gout) b-adrenoceptor antagonist (b-blocker) with COPD (risk of increased bronchospasm) b-blocker with verapamil (risk of symptomatic heart block) Aspirin (acetylsalicylic acid) and warfarin without histamine H 2 receptor antagonist (except cimetidine) or PPI (high risk of gastrointestinal bleeding) Dipyridamole as monotherapy for cardiovascular secondary prevention (no evidence of efficacy) Aspirin >150 mg/day (increased bleeding risk) Central nervous system and psychotropic drugs TCA with dementia (worsening cognitive impairment) TCA and glaucoma (exacerbate glaucoma) TCA and opioid or calcium channel antagonists (risk of severe constipation) Long-term (i.e. >1 month), long-acting benzodiazepines (risk of prolonged sedation, confusion, impaired balance, falls) Long-term (i.e. >1 month) neuroleptics (antipsychotics) [risk of confusion, hypotension, extrapyramidal side effects, falls] Long-term (i.e. >1 month) antipsychotics with parkinsonism (worsen extrapyramidal symptoms) Anticholinergics to treat extrapyramidal side effects of antipsychotic medications (risk of anticholinergic toxicity) Phenothiazines with epilepsy (may lower seizure threshold) Prolonged use (i.e. >1 week) of first-generation antihistamines (risk of sedation and anticholinergic side effects) Gastrointestinal system Prochlorperazine or metoclopramide with parkinsonism (risk of exacerbating parkinsonism) PPI for peptic ulcer disease at maximum therapeutic dosage a for >8 weeks (dose reduction or earlier discontinuation indicated) Respiratory system Theophylline with COPD (risk of adverse effects due to narrow therapeutic index) Nebulized ipratropium with glaucoma (exacerbate glaucoma) Musculoskeletal system Long-term use of NSAID (i.e. >3 months) for pain relief (simple analgesics preferable) Warfarin and NSAID (risk of gastrointestinal bleeding) Urogenital system Antimuscarinic drugs with dementia (risk of increased confusion, agitation) Antimuscarinic drugs with chronic glaucoma (>3 months) [risk of acute exacerbation of glaucoma] Endocrine system Glibenclamide or chlorpropamide with type 2 diabetes mellitus (risk of prolonged hypoglycaemia) Duplicate drug class prescription (optimization of monotherapy within a single drug class) Any duplicate drug class prescription, for example: Two concurrent opioids Two concurrent NSAIDs Two concurrent SSRIs Two concurrent antidepressants Two concurrent loop diuretics Two concurrent ACE inhibitors a PPI at maximum therapeutic dose = 40 mg/day omeprazole, pantoprazole or esomeprazole, 30 mg/day lansoprazole or 20 mg/day rabeprazole. COPD = chronic obstructive pulmonary disease; NSAID = non-steroidal anti-inflammatory drug; PPI = proton pump inhibitor; SSRI = selective serotonin reuptake inhibitor; STOPP = Screening tool of Older Persons potentially inappropriate Prescriptions; TCA = tricyclic antidepressant.

6 148 Parsons et al. residents. The association between PIP and number of medications prescribed was assessed using Spearman s r correlation coefficient. Other associations were assessed using chi-squared (w 2 ) tests for categorical variables and Mann-Whitney U or Kruskal-Wallis tests for continuous variables. Significance was set a priori at p Results Study Sample Demographics A total of 214 residents across the six care homes were eligible for participation in the EVI- DEM-EoL study. Of these, 133 residents were recruited (62.2%). Details of the recruitment of residential care homes and residents have been previously published. [36] MARs were reviewed at two timepoints for 119 residents and 110 residents, respectively, for whom the required information could be obtained. The characteristics of residents at timepoint 1 are presented in table III. The mean SD age was years and approximately 80% of participants were female. The median number of medications prescribed at both timepoints was 8 (range 1 17 at timepoint 1 and 1 18 at timepoint 2). Although the study population declined to 110 participants (due to drop-outs and deaths), the characteristics of the residents reviewed at timepoint 2 were similar to those at timepoint 1 (table III). The most frequently prescribed drug class at timepoints 1 and Table III. Resident characteristics at timepoints 1 and 2 Characteristic Timepoint 1 (n = 119) Timepoint 2 (n = 110) Male [n (%)] 24 (20.2) 21 (19.1) Female [n (%)] 95 (79.8) 89 (80.9) Age (y; mean SD) Age range (y) Total number of medications prescribed Number of medications prescribed per patient Mean SD Median Range was non-opioid analgesics (77.3% and 74.5% of residents, respectively), followed by dermatological preparations (68.1% and 70.0%, respectively) and drugs for the cardiovascular system (63.0% and 61.8%, respectively). Although nonopioid analgesics were widely prescribed, opioid analgesics were prescribed for 14.8% and 13.6% of residents at timepoints 1 and 2, respectively. Furthermore, topical products for joint and muscular pain were prescribed for 7.8% and 10.0% of residents at timepoints 1 and 2, respectively, and anti-inflammatory and anti-rheumatic medications were prescribed for 5.2% and 3.6% of residents at these timepoints. Overall Prevalence of PIP At timepoint 1, a total of 68 PIMs were identified. Fifty-five residents (46.2%) were prescribed one or more PIM(s), 11 (9.2%) were prescribed two or more PIMs and two (1.7%) were prescribed three PIMs (table IV). Thirteen of the 31 STOPP criteria utilized in this study (41.9%) were used to identify PIP. At timepoint 2, a total of 57 PIMs were identified; 45 residents (40.9%) were prescribed one or more PIM(s) and 10 (9.1%) were prescribed two or more PIMs, but only one resident (0.9%) was prescribed three PIMs (table IV). Of the 31 STOPP criteria utilized in this study, ten (32.3%) were used to identify PIP. Prevalence of PIP According to Individual STOPP Criteria Table V presents the prevalence of PIMs associated with each individual STOPP criterion both overall and for each care home at timepoint 1. Long-term (i.e. >1 month) antipsychotics were the most frequently prescribed PIMs (n = 25; 21.0%), while the second most frequently prescribed PIMs were NSAIDS for >3 months. This was followed by PPIs at maximum therapeutic dosage for >8 weeks, tricyclic antidepressants (TCAs) in patients with dementia and long-term (i.e. >1 month), long-acting benzodiazepines. Timepoint 2 (table VI) showed similar results with long-term (i.e. >1 month) antipsychotics still being the most frequently prescribed PIMs (n = 21;

7 Prescribing in Residential Care Homes 149 Table IV. Number of patients with PIMs identified by STOPP criteria in each CH and overall at timepoints 1 and 2 Variable Number (%) of residents CH 1 CH 2 CH 3 CH 4 CH 5 CH 6 Total Timepoint 1 Residents Number of PIMs 1 or more 12 (60.0) 11 (52.4) 5 (33.3) 7 (33.3) 13 (46.4) 7 (50.0) 55 (46.2) 2 or more 2 (10.0) 2 (19.1) 0 (0) 3 (14.3) 1 (3.6) 1 (7.1) 11 (9.2) 3 0 (0) 2 (9.5) 0 (0) 0 (0) 0 (0) 0 (0) 2 (1.7) Timepoint 2 Residents Number of PIMs 1 or more 12 (63.2) 9 (45.0) 4 (28.6) 7 (33.3) 10 (40.0) 3 (27.3) 45 (40.9) 2 or more 3 (15.8) 3 (20.0) 1 (7.1) 2 (9.5) 1 (4.0) 0 (0) 10 (9.1) 3 0 (0) 1 (5.0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (0.9) CH = care home; PIM = potentially inappropriate medication; STOPP = Screening tool of Older Persons potentially inappropriate Prescriptions. 19.1%). However, the second most frequently prescribed PIMs were PPIs at maximum therapeutic dosage for >8 weeks, followed by NSAIDS for >3 months and TCAs in patients with dementia. Factors Associated with PIP A significant correlation was found at both timepoints between the number of medicines prescribed and the occurrence of PIP (correlation coefficient [r s ] = 0.335, p < 0.01) using Spearman s r correlation test; the likelihood of PIP increased with the number of drugs prescribed. However, there were no significant associations between age or sex and PIP, and no statistically significant differences were observed in the prevalence of PIP in the different care homes. Discussion This study appears to be the first to use the STOPP criteria to examine the appropriateness of prescribing in older people living in residential care homes (i.e. those homes that have no on-site nursing provision and that are reliant on primary care for medical care). Several studies investigating PIP in older people that used the STOPP criteria have been carried out in Europe in a variety of other settings, and have focused on community-dwelling or hospitalized older people. [14,22-24,38] In the primary care setting, Ryan et al. [24] reported a PIP prevalence rate of 21.4% in an Irish population, while further studies conducted in Ireland and Spain both reported that 36% of patients were taking at least one PIM. [14,34] In the hospital setting, studies have found that between 35% and 77% of all patients were taking at least one PIM, [22,23,34,38] whilst in the nursing home setting, the prevalence of PIMs has been reported in various studies to range between 50% and 79%. [33,34,39] In this study, 46.2% and 40.9% of older people with dementia residing in six residential care homes in England were prescribed at least one PIM at timepoints 1 and 2, respectively. Despite the much smaller sample size, the prevalence of PIP in this population is somewhat similar to the PIP prevalence of 36% in the community-dwelling Irish population aged 70 years determined by a retrospective national population study of a pharmacy claims database using the same subset of the STOPP criteria applicable in the absence of detailed diagnosis information. [14] The most prevalent PIMs at timepoint 1 were long-term (i.e. >1 month) antipsychotics, followed by NSAIDs for >3 months and PPIs at maximum therapeutic dosage for >8 weeks, while at timepoint 2 the most prevalent PIMs were long-term antipsychotics, followed by PPIs at maximum therapeutic dosage for >8 weeks and

8 150 Parsons et al. then NSAIDs for >3 months. This is broadly consistent with the most prevalently prescribed PIMs in previous studies, [14,23,24] although in these studies potentially inappropriate long-term benzodiazepine use was more prevalent than long-term antipsychotic use. In this study, approximately one-fifth of residents were receiving potentially inappropriate long-term antipsychotics at both timepoints. Adverse effects associated with the inappropriate use of these agents have been documented as a significant problem, particularly in frail older people. [40-43] Although there is a dearth of literature regarding the use of psychotropic drugs (comprising antipsychotics, hypnotics and anxiolytics) in the residential care home setting, the over-use of these agents has been identified as a particular concern in the literature on prescribing and use of medicines in nursing homes. [42,44-50] Furthermore, a report published in 2009 by the Department of Health estimated that the use of antipsychotic drugs in patients with dementia results in an additional 1800 deaths and 820 serious adverse events such as stroke per year in the UK. [51] In the context of this body of literature, our findings highlight the need for tools such as STOPP that can support and facilitate medication review, for education and training in prescribing for healthcare professionals caring Table V. Prevalence by individual STOPP criterion of potentially inappropriate prescribing at timepoint 1 STOPP criterion description Number (%) of residents CH 1 (n = 20) CH 2 (n = 21) CH 3 (n = 15) CH 4 (n = 21) CH 5 (n = 28) CH 6 (n = 14) Total (n = 119) Cardiovascular system A12 Aspirin (acetylsalicylic acid) >150 mg/day (increased 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (7.1) 1 (0.8) bleeding risk) Central nervous system and psychotropic drugs B1 TCA with dementia (worsening cognitive impairment) 0 (0) 3 (14.3) 1 (6.7) 1 (4.8) 0 (0) 0 (0) 5 (4.2) B5 TCA and opioid or calcium channel antagonists (risk of 0 (0) 2 (9.5) 0 (0) 0 (0) 0 (0) 0 (0) 2 (1.7) severe constipation) B7 Long-term (i.e. >1 month), long-acting benzodiazepines 1 (5.0) 1 (4.8) 0 (0) 0 (0) 2 (7.1) 1 (7.1) 5 (4.2) (risk of prolonged sedation, confusion, impaired balance, falls) B8 Long-term (i.e. >1 month) neuroleptics (antipsychotics) [risk 4 (20.0) 8 (38.1) 2 (13.3) 5 (23.8) 4 (14.3) 2 (14.3) 25 (21.0) of confusion, hypotension, extrapyramidal side effects, falls] B11 Anticholinergics to treat extrapyramidal side effects of 0 (0) 0 (0) 0 (0) 0 (0) 1 (3.6) 0 (0) 1 (0.8) antipsychotic medications (risk of anticholinergic toxicity) B13 Prolonged use (i.e. >1 week) of first-generation 1 (5.0) 0 (0) 0 (0) 1 (4.8) 1 (3.6) 0 (0) 3 (2.5) antihistamines (risk of sedation and anticholinergic side effects) Gastrointestinal system C4 PPI for peptic ulcer disease at maximum therapeutic dosage for >8 weeks (dose reduction or earlier discontinuation indicated) 3 (15.0) 1 (4.8) 1 (6.7) 2 (9.5) 2 (7.1) 1 (7.1) 10 (8.4) Musculoskeletal system E4 Long-term use of NSAID (i.e. >3 months) for pain relief 5 (25.0) 0 (0) 1 (6.7) 0 (0) 4 (14.3) 1 (7.1) 11 (9.2) (simple analgesics preferable) Urogenital system F1 Antimuscarinic drugs with dementia (risk of increased 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (7.1) 1 (0.8) confusion, agitation) Duplicate drug class prescription J Two concurrent opioids 0 (0) 1 (4.8) 0 (0) 1 (4.8) 0 (0) 0 (0) 2 (1.7) J Two concurrent NSAIDS 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (7.1) 1 (0.8) J Two concurrent antidepressants 0 (0) 1 (4.8) 0 (0) 0 (0) 0 (0) 0 (0) 1 (0.8) CH = care home; NSAID = non-steroidal anti-inflammatory drug; PPI = proton pump inhibitor; STOPP = Screening tool of Older Persons potentially inappropriate Prescriptions; TCA = tricyclic antidepressant.

9 Prescribing in Residential Care Homes 151 Table VI. Prevalence by individual STOPP criterion of potentially inappropriate prescribing at timepoint 2 STOPP criterion description Number (%) of residents CH 1 (n = 19) CH 2 (n = 20) CH 3 (n = 14) CH 4 (n = 21) CH 5 (n = 25) CH 6 (n = 11) Total (n = 110) Central nervous system and psychotropic drugs B1 TCA with dementia (worsening cognitive impairment) 0 (0) 3 (15.0) 1 (7.1) 1 (4.8) 1 (4.0) 0 (0) 6 (5.5) B5 TCA and opioid or calcium channel antagonists (risk of 0 (0) 2 (10.0) 0 (0) 0 (0) 0 (0) 0 (0) 2 (1.8) severe constipation) B7 Long-term (i.e. >1 month), long-acting benzodiazepines 0 (0) 0 (0) 0 (0) 0 (0) 2 (8.0) 0 (0) 2 (1.8) (risk of prolonged sedation, confusion, impaired balance, falls) B8 Long-term (i.e. >1 month) neuroleptics (antipsychotics) [risk 5 (26.3) 6 (30.0) 1 (7.1) 5 (23.8) 3 (12.0) 1 (9.1) 21 (19.1) of confusion, hypotension, extrapyramidal side effects, falls] B13 Prolonged use (i.e. >1 week) of first-generation 1 (5.3) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (0.9) antihistamines (risk of sedation and anticholinergic side effects) Gastrointestinal system C4 PPI for peptic ulcer disease at maximum therapeutic dosage for >8 weeks (dose reduction or earlier discontinuation indicated) 3 (15.8) 1 (5.0) 1 (7.1) 2 (9.5) 2 (8.0) 1 (9.1) 10 (9.1) Musculoskeletal system E4 Long-term use of NSAID (i.e. >3 months) for pain relief 4 (21.1) 0 (0) 1 (7.1) 0 (0) 3 (12.0) 0 (0) 8 (7.3) (simple analgesics preferable) Urogenital system F1 Antimuscarinic drugs with dementia (risk of increased 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (9.1) 1 (0.9) confusion, agitation) Duplicate drug class prescription J Two concurrent opioids 2 (10.5) 1 (5.0) 0 (0) 1 (4.8) 0 (0) 0 (0) 4 (3.6) J Two concurrent antidepressants 0 (0) 1 (5.0) 1 (7.1) 0 (0) 0 (0) 0 (0) 2 (1.8) CH = care home; NSAID = non-steroidal anti-inflammatory drug; PPI = proton pump inhibitor; STOPP = Screening tool of Older Persons potentially inappropriate Prescriptions; TCA = tricyclic antidepressant. for older adults and for support for care home staff when discussing symptoms and reviewing treatment with prescribers (GPs). PPIs prescribed at maximum therapeutic dosage for >8 weeks were identified as common PIMs, consistent with other studies using the STOPP criteria. [14,24] Long-term use of PPIs in older people has been associated with accelerated osteoporosis and an increased risk of hip fracture, [52] and with Clostridium difficile infections both in hospitalized patients [53] and acquired in the community. [54] NSAIDs were also identified as common PIMs, as reported by other studies using the STOPP criteria. [14,24] In this study, the number of medications prescribed was found to be associated with occurrence of PIP; an increase in the number of medications prescribed increased the likelihood of PIP. This has also been documented in previously published studies. [14,24,55-59] While our study suggested that there was no significant association between age and occurrence of PIP, some studies have shown that age is inversely associated with PIP, [55,60] while others have discovered a positive correlation between age and PIP. [24] Furthermore, our study did not find a significant association between sex and occurrence of PIP. A number of studies have reported a higher rate of inappropriate drug use in older women than in older men, [61-73] although the clinical relevance of this association remains uncertain. Inappropriate prescribing of medications in the residential home setting is not limited to a specific class of medications, such as antipsychotics. Regular medication reviews by prescribers, or as part of a pharmacist-led intervention, are required to reduce PIP in residential care homes, and in these reviews the prescribers should not focus only on antipsychotic prescribing but also target the most commonly inappropriately prescribed drug classes,

10 152 Parsons et al. including long-term antipsychotics, NSAIDs and PPIs. The STOPP criteria represent a useful tool to facilitate this review of prescribing. Furthermore, new strategies to optimize prescribing for older people with dementia who live in residential homes that seek to address risk factors for drug-related morbidities should be a focus of future research efforts. [74] It is important to consider the limitations of this study. There were difficulties in obtaining all the necessary information from care home notes on occasion. The lack of access to residents medical records and hence the lack of detailed diagnosis information meant that all 65 STOPP criteria could not be applied, which may in itself contribute to inappropriate prescribing. However, the information available enabled us to apply 31 of the criteria, and these criteria have previously been identified as being applicable in the absence of detailed diagnostic information. [14] The low proportion of male participants in this study requires further, and larger, studies to be conducted to confirm and examine the association between sex and occurrence of PIP. Furthermore, these results must be interpreted in the knowledge that the STOPP criteria for PIP are not intended to replace the clinical judgement of the prescriber. Rather, they are designed to enhance clinical evaluation of medication use in older patients. [18] Finally, as this study was performed in older people with dementia living in residential care homes, our results are not generalizable to older people who do not have dementia or who reside in other settings. When considering the potential sources of bias, these are similar to those previously discussed in relation to the EVIDEM-EoL study, [36] including selection bias in how the participating care homes were identified and recruited (on the basis of a favourable assessment from the regulator and evidence of reasonable working relationships with healthcare providers). A further, less explicit, recruitment bias also emerged as the result of the differing responses from the care homes to the EVIDEM-EoL study. Notwithstanding these limitations, however, this study has provided data on the prevalence of PIP in a population of older people with dementia in the UK residential home setting, and to the authors knowledge, this is the first study to consider PIP in this patient population. Conclusions This study found that 46.2% and 40.9% of older people with dementia, residing in six residential care homes in England, were prescribed at least one PIM at two timepoints. Long-term (i.e. >1 month) antipsychotics, NSAID use for >3 months and PPI use at maximum therapeutic dosage for >8 weeks were the most prevalent PIMs in the study population. Prescribing decisions must be made in the context of regular medication review and access to detailed clinical information, considering clinical and functional status of patients. The STOPP criteria represent a useful tool to facilitate such review in which the most commonly inappropriately prescribed drug classes are targeted, thereby preventing an over-emphasis on antipsychotic prescribing and consequent concealment of prescribing of other significant PIMs. Acknowledgements Funding sources: Carole Parsons and Sarah Johnston had no financial support from any organization for the submitted work. Elspeth Mathie, Natasha Baron, Ina Machen, Sarah Amador and Claire Goodman had financial support from the National Institute for Health Research (NIHR) Programme Grants for Applied Research Funding scheme for the submitted work. The authors work was independent of the funders; the NIHR did not contribute to the study design; the collection, analysis or interpretation of data; the writing of the report; or the decision to submit the article for publication Conflicts of interest: None of the authors have any conflicts of interest that are directly relevant to the content of this article. Author contributions: Carole Parsons drafted the manuscript and participated in the analysis and interpretation of the data. Sarah Johnston participated in the analysis and interpretation of the data. Natasha Baron, Elspeth Mathie, and Ina Machen supported the data collection and analysis of the findings and commented on drafts of the manuscript. Sarah Amador supported data analysis and final checks on data. Claire Goodman is the lead investigator; she designed the study and contributed sections of the manuscript and commented on all drafts. Carole Parsons and Claire Goodman are guarantors for the study. The paper is an accurate representation of the study results. Other contributions: Elizabeth Stevenson assisted with the data collection and analysis of the findings. She has received

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