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Journal of Evaluation in Clinical Practice ISSN 1365-2753
Prevalence of potentially inappropriate medicine use in older New Zealanders: a population-level study using the updated 2012 Beers criteria Sujita W. Narayan MPharmPrac, BPharm1 and Prasad S. Nishtala BPharm, MPharm, PG DipClinPharm, PhD2 1
PhD Candidate, 2Senior Lecturer, School of Pharmacy, University of Otago, Dunedin, New Zealand
Keywords aged, Beers criteria, high-risk medicines, older people, potentially inappropriate medicines Correspondence Dr Prasad S Nishtala School of Pharmacy University of Otago PO Box 56 Dunedin, 9054 New Zealand E-mail: [email protected] Accepted for publication: 24 February 2015 doi:10.1111/jep.12355
Abstract Rational, aims and objectives To examine the prevalence of potentially inappropriate medicines (PIMs) in older New Zealanders at a population level. Methods De-identified prescription data for all individuals ≥65 years were obtained from the Pharmaceutical Claims Data Mart for 2011. International Classification of Diseases10-AM (version 6) codes were used to extract diagnostic information from the National Minimum Datasets and PIMs were identified using the updated Beers 2012 criteria. Results 40.9% of older people were prescribed PIMs with approximately half dispensed ≥2 PIMs in 2011. Exposure was highest in individuals aged 65–74 years (68.9 ± 2.9). The most prevalent PIMs dispensed were diclofenac (6.0%), amitriptyline (4.9%), ibuprofen (4.6%), zopiclone (3.2%) and naproxen (3.0%). 66.3% of individuals were dispensed ≥1 and 80.8% were dispensed ≥2 medicines with a potential for drug-disease/syndrome interaction. Conclusions The updated Beers 2012 criteria identified that the use of PIMs at a population level is common in older New Zealanders.
Introduction Older people are prescribed multiple medicines, some of which are potentially inappropriate and pose an increased risk of morbidity, mortality and adverse drug events [1,2]. Potentially inappropriate medicines (PIMs) in older people are medicines whose potential risks outweigh their desired benefits [3]. In addition, medicines consumed at an inappropriate dose or for a longer duration than clinically indicated, medicines with risk of causing significant drug–drug or drug–disease interactions, or underuse of potentially beneficial medicines, and use of medicines that are not cost-effective have all been deemed as inappropriate medicines. Numerous explicit tools have been developed to assist clinicians to screen for PIMs. The first explicit criteria were developed by Beers et al. to identify potentially high-risk medicine use in older people [5]. Beers criteria was developed in 1991 and either updated and/or expanded in 1993, 1997, 2003, 2007 and recently in 2012 to update evidence and improve relevancy to clinical practice. The updated Beers 2012 Criteria is divided into three categories: potentially inappropriate medications and classes to avoid in older adults, potentially inappropriate medications and classes to avoid in older adults because of drug–disease or drug–
Journal of Evaluation in Clinical Practice (2015) © 2015 John Wiley & Sons, Ltd.
syndrome interactions where medications listed may exacerbate existing condition, and medications to be used with caution in older adults [4]. Beers criteria have been widely applied across different health systems, including older populations living in residential care and ambulatory care to identify high-risk prescribing, that is, medicines having a significant risk of harms and outweighs its potential benefit [4,6–8]. Observational studies have shown that medicines listed in the Beers criteria have been associated with adverse health outcomes such as increased mortality, delirium, gastrointestinal bleeding, falls, fractures and adverse drug events [9,10]. Furthermore, in community-dwelling older people and nursing home residents, exposures to inappropriate medicines identified by Beers criteria were associated with an increased risk of functional impairment and hospitalizations [3,11–13]. Conversely, other studies have failed to show any relationships with adverse outcomes with use of PIMs listed in the Beers criteria in hospitalized older adults [14,15]. Despite limitations to these criteria not addressing drug–drug interactions, overtreatment (dose and duration), limited applicability to other countries because of different prescribing patterns and drug availability, the Beers criteria remain one of the important tools in research to screen older people for high-risk prescribing. 1
Potentially inappropriate medicine use
S.W. Narayan and P.S. Nishtala
The New Zealand population is aging, and by 2061, people 65 years and older will comprise 22–30% of the total population [16]. In congruence, older people in New Zealand have a high level of exposure to prescribed medicines, potentially increasing the risk of experiencing adverse drug effects leading to poor health outcomes and increased health care utilization [12,17]. Some regional studies have examined aspects of medication use in older people; however, there is no population-level data describing the frequency or the type of PIMs use in older New Zealanders aged 65 years and above [18,19].
Objectives To pursue this research, we have three specific objectives: 1 To examine the prevalence of exposure to PIMs in older New Zealanders, at a population level, using the updated 2012 Beers criteria. 2 To examine the prevalence of exposure to PIMs that may potentially exacerbate existing disease or syndrome, using the updated 2012 Beers criteria. 3 To examine the prevalence of exposure to PIMs, which are specifically not recommended in older people with a specific preexisting diagnosis, using the updated Beers 2012 criteria.
Design and methods This study was approved by the Human Ethics Committee at the University of Otago, New Zealand, with ethical approval number 12/147.
Study design Cross-sectional analyses of prescription data for older individuals aged 65 years and above were captured in the Pharmaceutical
Characteristic Age (years) 65–74* 75–84 ≥ 85 Sex (female) Ethnicity European* Ma¯ori Asian Pacific MELAA Others/unknown Individuals exposed to PIMs ≥1 Median (range) Mean total number of dispensed medicines Chronic Disease Score (CDS)
Claims Data Mart (Pharms) dataset from 1 January 2011 to 31 December 2011.
Study population The Pharms extract contained prescription information for 559 625 individuals representing approximately 98% of the total population of older New Zealanders either living in the community or residential aged-care facilities. Of these, the diagnostic information for 180 978 individuals was either missing or unknown. The study population included all individuals within the study period who received at least one prescription medicine. Individuals with missing data in one or a combination of the following variables: (1) age; (2) sex; (3) medicine dose; (4) medicine strength, were excluded from the analyses. Ethnicity data recording and reporting are maintained by the Ministry of Health, New Zealand for all national health data collections. Data analysis was carried out on all ethnicities; however, the data on Europeans and Ma¯ori ethnicity only was reported as these are the largest two ethnicities in New Zealand.
Data source The following extracts were obtained from the Ministry of Health to undertake this study: 1 Pharmaceutical Claims Data Mart (Pharms) extract files for 2011 contained information on sex, date of birth, medicine, daily dose, frequency, quantity, prioritized ethnicity and District Health Board of domicile. 2 National Minimum Dataset (NMDS; 2007–2011) contained information on diagnosis code (ICD-10). The New Zealand Ministry of Health maintains national collections of prescription use (Pharms database), hospital discharges (NMDS) and mortality data. Individual records in these national collections include a unique 7-digit alphanumeric identifier, the
Value
PIMs exposure Odds ratio (95% confidence interval)
55.10% 32.10% 12.80% 54.91%
1 1.24 (1.23–1.26) 1.42 (1.39–1.44) 0.88 (0.87–0.89)
79.11% 4.70% 3.76% 2.64% 0.30% 9.49% 40.89% 0 (0–5) 5.64 ± 3.91 6.04 ± 4.97
1 0.85 (0.82–0.87) 0.49 (0.47–0.51) 0.63 (0.61–0.65) 0.65 (0.53–0.81) 0.72 (0.70–0.73) –
Table 1 Characteristics of the study population (n = 537 387)
– 1.06 (1.06–1.06)
*Reference category: PIMs, potentially inappropriate medicines. MELAA, Middle Eastern/Latin American/African.
2
© 2015 John Wiley & Sons, Ltd.
S.W. Narayan and P.S. Nishtala
Potentially inappropriate medicine use
Table 2 Potentially inappropriate medicines prescribed to the study population (n = 537 387) according to therapeutic class
Organ system or therapeutic category or drug Anticholinergics (excludes TCAs) Chlorpheniramine Promethazine Anti-Parkinson agents Benztropine Antithrombotics Dipyridamole (oral, short-acting) Anti-infective Nitrofurantoin Age (years) 65–74 75–84 ≥ 85 Cardiovascular Alpha1 blockers Doxazosin Prazosin Terazosin Alpha agonists, central Clonidine Methyldopa Antiarrhythmic drugs (class Ia, Ic, III) Amiodarone Flecainide Propafenone Sotalol Digoxin >0.125 mg day−1 Spironolactone > 25 mg day−1 Age (years) 65–74 75–84 ≥ 85 Central nervous system Tertiary TCAs Amitriptyline Clomipramine Doxepin >6 mg day−1 Imipramine Antipsychotics Chlorpromazine Haloperidol Trifluperazine Aripiprazole Clozapine Olanzapine Quetiapine Risperidone Barbiturates Phenobarbitone Benzodiazepines Short and intermediate acting Alprazolam Lorazepam Oxazepam Temazepam Triazolam Long acting Clonazepam Diazepam Non-benzodiazepine hypnotics Zopiclone Ergot mesylates
© 2015 John Wiley & Sons, Ltd.
Number of individuals prescribed PIMs (%) (n = 537 387)
275 (0.05%) 4809 (0.89%)
Comments
Recommendations as per BC Recommendations as per BC
395 (0.07%) 303 (0.06%) 15 167 (2.82%) 5445/15 167 (35.90%) 5659/15 167 (37.31%) 4063/15 167 (26.79%)
Recommendations as per BC Data were unavailable to identify the exact number of individuals dispensed PIMs based on CrCl; hence, individuals were stratified into age groups assuming individuals ≥ 85 years old would have a lower CrCl.
Recommendations as per BC 172 (0.03%) 223 (0.04%) 39 (0.01%) Recommendations as per BC 1230 (0.23%) 513 (0.10%) Recommendations as per BC 4930 (0.92%) 1902 (0.35%) 55 (0.01%) 5232 (0.97%) 3968 (0.74%) 13 593 (2.53%) 5115/13 593 (37.63%) 5348/13 593 (39.34%) 1330/13 593 (9.78%)
Data were unavailable to identify the exact number of individuals dispensed PIMs based on CrCl; hence, individuals were stratified into age groups assuming individuals ≥ 85 years old would have a lower CrCl.
Recommendations as per BC 26 367 (4.91%) 588 (0.11%) 4451 (0.83%) 1053 (0.20%) 430 (0.08%) 3257 (0.61%) 380 (0.07%) 120 (0.02%) 198 (0.04%) 1824 (0.34%) 7028 (1.31%) 5318 (0.99%)
Recommendations as per BC; data were unavailable to identify individuals prescribed antipsychotics for behavioural problems of dementia.
Recommendations as per BC 365 (0.07%) Recommendations as per BC 595 (0.11%) 6866 (1.28%) 1761 (0.33%) 6442 (1.20%) 7799 (1.45%) 5724 (1.07%) 5021 (0.93%) Recommendations as per BC 17 227 (3.21%) 144 (0.03%)
Recommendations as per BC
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Potentially inappropriate medicine use
S.W. Narayan and P.S. Nishtala
Table 2 Continued
Organ system or therapeutic category or drug Endocrine Androgens Testosterone Oestrogens with or without progestins Insulin, sliding scale Megestrol Gastrointestinal Metoclopramide Pain Non-COX-selective NSAIDs, oral Diclofenac Ibuprofen Ketoprofen Mefenamic Acid Naproxen Piroxicam Sulindac Indomethacin Skeletal muscle relaxants Orphenadrine
Number of individuals prescribed PIMs (%) (n = 537 387)
Comments
Recommendations as per BC 458 (0.09%) 3404 (0.63%)
Recommendations as per BC; data unavailable to identify specific conditions for prescription. Recommendations as per BC Recommendations as per BC
874 (0.16%) 141 (0.03%) 8320 (1.55%)
Recommendations as per BC; data unavailable to identify specific conditions for prescription. Recommendations as per BC
32 604 (6.01%) 24 620 (4.58%) 385 (0.07%) 11 (0.002%) 16 352 (3.04%) 5 (0.001%) 200 (0.04%) 27 (0.01%)
Recommendations as per BC Recommendations as per BC
3800 (0.71%)
TCAs, tricyclic antidepressants; BC, Updated Beers 2012 criteria; CrCl, creatinine clearance; NSAIDs, non-steroidal anti-inflammatory drugs.
National Health Index (NHI) identifier allowing linkage of the three databases. The pharmaceutical collections Pharms (Pharmaceutical Claims Data Mart), include records of all prescription claims made by community pharmacists funded by PHARMAC (Pharmaceutical management agency). Each prescription record includes the medicine name, date of medicine supplied, daily dose and total quantity supplied for each NHI. The patient diagnoses are coded according to the International Classification of Diseases and Related health problems 10th revision, Australian Modification (ICD-10-AM). Coding is undertaken by qualified clinical coders after a patient’s discharge, to identify principal diagnosis, additional diagnoses, complications, procedures and adverse events. Specific codes identify drugs, medicaments and biological substances causing adverse effects in therapeutic use.
PIMs exposure PIMs were identified using the updated Beers 2012 criteria, both independent of diagnosis and taking diagnosis or dose into consideration. Exposure to PIMs was considered if an individual was dispensed ≥1 medicine for any duration and at any given time, identified with the Beers criteria as inappropriate. Criteria related to identifying PIMs in lower urinary tract infections and peptic ulcer diseases were modified and adapted for this study. To detect medicines inappropriate for use in individuals with lower urinary tract symptoms and benign prostatic hyperplasia (BPH), only BPH was used as a diagnosis rather than both the symptoms. In addition, ICD-10 codes for peptic and gastrojejunal ulcers were included with history of gastric or duodenal ulcers. All medicines listed in the Beers criteria were not available in New Zealand or funded by PHARMAC. A list of these medicines is listed in Appendix 1. 4
Chronic Disease Score (CDS) The CDS is a risk-adjustment metric established in 1991, on patient demographics (age and gender) and account of dispensed medicines [20]. The CDS was used to compute scores for co-morbidities as diagnostic information was unavailable for approximately 33.7% of the study population.
Statistical analyses Means and standard deviations were reported for age, number of medicines and exposure to medicines in the Beers category in the study population. Proportions were reported for age groups, sex and ethnicities. Age was stratified into three age categories: 65–74 years, 75–84 years and ≥ 85 years. All statistical analyses were conducted using Stata® Corp Release 12 (StataCorp. 2011. Stata Statistical Software: Release 12. College Station, Texas: StataCorp LP. USA.). P < 0.05 was regarded as statistically significant.
Results The study used data extracted from Pharms for the year 2011 to identify the prevalence of exposure to PIMs in older New Zealanders. A total of 22 238 individuals were excluded from the analyses; hence, the study population, after eliminating missing data, consisted of 537 387 individuals aged 65 years and older, of which 54.9% were females. The mean age of these individuals was 74.7 years (±7.6) and the mean number of medicines dispensed was 5.6 (±3.9; Table 1). The prevalence of individuals exposed to PIMs in 2011 was 40.9% (219 677/537 387) with 78.5% of these individuals dispensed at least one PIM and 21.5% dispensed two or more PIMs.
© 2015 John Wiley & Sons, Ltd.
S.W. Narayan and P.S. Nishtala
Potentially inappropriate medicine use
Table 3 Potentially inappropriate medicines with drug–disease/syndrome interactions prescribed to individuals with an ICD-10 diagnosis (n = 356 409) Disease or syndrome
Number with disease or syndrome (%) (n = 356 409)
Cardiovascular Heart failure
29 911 (8.39%) 7501 (2.10%)
Syncope
Central nervous system Chronic seizures or epilepsy
52 142 (14.63%)
2056 (0.58%)
Delirium
9577 (2.69%)
Dementia and cognitive impairment
7440 (2.09%)
History of falls or fractures
Falls: 49 005 (13.75%)
Insomnia
Fracture: 13 291 (3.73%) 576 (0.16%)
Parkinson’s disease
3440 (0.97%)
Gastrointestinal Chronic constipation
History of gastric, peptic, gastrojejunal or duodenal ulcers Kidney and urinary tract Chronic kidney disease stages IV and V Urinary incontinence (all types)
30 355 (8.52%)
NSAIDS and COX-2 inhibitors Pioglitazone Non-dihydropyridine CCBs (for systolic heart failure) Diltiazem Verapamil Donepezil Doxazosin Prazosin Terazosin Chlorpromazine Olanzapine Chlorpromazine Clozapine Olanzapine Tramadol All TCAs and anticholinergics* Benzodiazepines Chlorpromazine Corticosteroids H2-receptor antagonists Zopiclone Anticholinergics Benzodiazepines H2-receptor antagonists Antipsychotics Anticonvulsants Antipsychotics Benzodiazepines Zopiclone TCAs SSRIs Theophylline Caffeine All antipsychotics except for quetiapine and clozapine Metoclopramide Prochlorperazine Promethazine
5065 (1.42%)
Oxybutynin Solifenacin Diltiazem Verapamil Chlorpheniramine Dexchlorpheniramine Promethazine Anticholinergics† Antipsychotics Tertiary TCAs Non-COX 2 selective NSAIDs
2340 (0.66%)
NSAIDs
5112 (1.43%)
Oestrogen oral and transdermal (excludes vaginal oestrogen) Doxazosin Prazosin Terazosin Inhaled anticholinergic agents Strong anticholinergic drugs, except antimuscarinics for urinary incontinence
3279‡
Benign prostate hyperplasia
Drug (PIMs)
(0.92%)
10 038 (2.82%)
Number of prescribed PIMs that are not recommended in disease or syndrome (%)
2072/29 911 (6.93%) 105/29 911 (0.35%)
Comments
Recommendations as per BC Recommendations as per BC
1165/7501 (15.53%) 74/7501 (0.99%) 763/52 142 (1.46%) 3802/52 142 (7.29%) 23/52 142 (0.04%) 1965/52 142 (3.77%) 57/52 142 (0.11%) 355/52 142 (0.68%) 2/2056 (0.10%) 1/2056 (0.05%) 31/2056 (1.52%) 54/2056 (2.63%) 2649/9577 (27.66%) 1538/9577 (16.06%) 15/9577 (0.16%) 2516/9577 (26.27%) 324/9577 (3.38%) 1233/9577 (12.87%) 1583/7440 (20.67%) 1140/7440 (15.32%) 166/7440 (2.23%) 2490/7440 (33.47%) Falls 4692/49 005 (9.57%) 4557/49 005 (9.30%) 4603/49 005 (9.39%) 5157/49 005 (10.52%) 5811/49 005 (11.86%) 8749/49 005 (17.85%) 1/576 (0.17%) 1/576 (0.17%) 206/3440 (5.99%)
Recommendations as per BC
Recommendations as per BC
Recommendations as per BC
Recommendations as per BC
Fracture 1227/13 291 (9.23%) 1092/13 291 (8.22%) 1166/13 291 (8.77%) 1350/13 291 (10.16%) 1547/13 291 (11.64%) 2312/13 291 (17.40%)
Recommendations as per BC
Recommendations as per BC Recommendations as per BC Recommendations as per BC
64/3440 (1.86%) 33/3440 (0.96%) 31/3440 (0.90%) 1484/30 355 (4.89%) 492/30 355 (1.62%) 3461/30 355 (11.40%) 357/30 355 (1.18%) 29/30 355 (0.10%) 18/30 355 (0.06%) 425/30 355 (1.40%) 9243/30 355 (30.45%) 1959/30 355 (6.45%) 3187/30 355 (10.50%) 450/5065 (8.88%)
101/2340 (4.32%) 21/3279 (0.64%) 102/3279 (3.11%) 1/3279 (0.03%) 4/3279 (0.12%) 1631/10 038 (16.25%)
Recommendations as per BC
Recommendations as per BC
Recommendations as per BC Recommendations as per BC (avoid in women)
Recommendations as per BC
BC, Updated Beers 2012 criteria; NSAIDs, non-steroidal anti-inflammatory drugs; COX, cyclooxygenase; CCBs, calcium channel blockers; HF, heart failure; AChEIs, acetylcholinesterase inhibitors; TCAs, tricyclic antidepressants; SSRIs, selective serotonin reuptake inhibitors. *Including chlorpromazine. † Drugs with strong anticholinergic properties including: antihistamines, antidepressants, antimuscarinics (for urinary incontinence), anti-Parkinson agents, antipsychotics, antispasmodics and skeletal muscle relaxants. ‡Female.
© 2015 John Wiley & Sons, Ltd.
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Potentially inappropriate medicine use
Drug Aspirin for primary prevention of cardiac events Dabigatran Age (years) 75–84 ≥ 85 Drugs that need monitoring of sodium levels Antipsychotics Carbamazepine Carboplatin Cisplatin SSRIs SNRIs TCAs Vincristine Vasodilators
Number of prescribed PIMs, which are to be used with caution (%)
S.W. Narayan and P.S. Nishtala
Comments
337/356 409 (0.09%)
% represents adults aged ≥ 80
5313/241 274 (2.20%)
% represents adults aged ≥ 75
Table 4 Potentially inappropriate medicines prescribed to individuals, which are advised to be used with caution in older people
4045/5313 (76.13%) 1268/5313 (23.87%) Recommendations as per BC 10851/537 387 (2.02%) 3825/537 387 (0.71%) 152/537 387 (0.03%) 27/537 387 (0.01%) 47 825/537 387 (8.90%) 3515/537 387 (0.65%) 44 729/537 387 (8.32%) 79/537 387 (0.01%) 22 017/537 387 (4.10%)
Recommendations as per BC
SSRIs, selective serotonin reuptake inhibitors; SNRIs, serotonin-norepinephrine reuptake inhibitors; TCAs, tricyclic antidepressants; BC, Beers 2012 criteria.
Exposure to PIMs was highest (51.6%) in individuals aged 65–74 years of age and greater in females (53.4%) in comparison with males (46.7%). More New Zealand Europeans were prescribed PIMs (82.5%) compared with the Ma¯ori population (4.5%). The diagnostic information was matched for 66.3% (356 409/537 387) of individuals present in the Pharms dataset. 44.8% (159 580/ 356 409) of individuals with an ICD-10 diagnosis were dispensed at least one PIM and 23.5% (37 569/159 580) were dispensed two or more PIMs. Further analysis on individuals with a documented ICD-10 diagnosis showed that 66.3% were dispensed at least one medicine and 80.8% were dispensed two or more medicines that may potentially exacerbate their disease or syndrome. The frequency of PIMs dispensed to individuals in the study population who received at least one PIM ranged from one to five indicating that approximately 0.01% (31/219 677) of these individuals were in fact dispensed five PIMs at some time in 2011. The most prevalent PIMs in the study population were diclofenac (6.0%) and amitriptyline (4.9%) followed by ibuprofen (4.6%), zopiclone (3.2%) and naproxen (3.0%; Table 2). Additional analysis was carried out to identify individuals who were prescribed PIMs that were specifically not recommended with certain diagnosis according to the updated Beers 2012 criteria. 33.5% of individuals with dementia and cognitive impairment were dispensed antipsychotics, 30.5% of those with chronic constipation received anticholinergics, 27.7% with delirium were dispensed tricyclic antidepressants and anticholinergics and 26.3% corticosteroids, and 20.7% of those with dementia and cognitive impairment received anticholinergic medicines (Table 3). Ten individuals with a diagnosis of hypertension were dispensed clonidine and 48 individuals with heart failure were dispensed a daily dose of spironolactone greater than 25 mg. Medicines dispensed, which are to be used in caution with specific disease, syndrome or age, were also identified. 11.8% of the study population were dispensed medicines requiring monitor6
ing for sodium levels, and 4.1% of individuals were dispensed vasodilators, which may potentially exacerbate syncope. (Table 4 & Fig. 1). Non-benzodiazepine hypnotics, alpha1 blockers and nonsteroidal anti-inflammatory drugs (NSAIDs) were prevalent in the study population. Zopiclone (7.0%) was the most frequently dispensed PIMs in individuals not recommended because of a specific disease or syndrome followed by doxazosin (6.9%), diclofenac (5.9%), amitriptyline (5.7%) and ibuprofen (4.8%). Additionally, use of medicines with anticholinergic properties and antipsychotics was common as 7.8% were dispensed with medicines with strong anticholinergic properties and 3.5% with antipsychotics. A high proportion (13.8%) of the study population were dispensed non-steroidal anti-inflammatory drugs (NSAIDs). 7.0% of individuals diagnosed with heart failure, 8.9% with a history of gastric, peptic, gastrojejunal or duodenal ulcers, and 4.3% of those diagnosed with chronic kidney disease stages IV and V were dispensed NSAIDs.
Discussion In this population-level study of older New Zealanders, the prevalence of PIMs in 2011 was 40.9%, and almost half of these individuals were dispensed two or more PIMs during the study period. Individuals in the 65–74 years age group had a higher exposure to PIMs (51.6%) compared with the older age groups. Similarly, more females (53.4%) and Europeans (82.5%) were prescribed PIMs compared with males and other ethnic groups. The most common PIMs dispensed to the study population were diclofenac and amitriptyline followed by ibuprofen, zopiclone and naproxen. Furthermore, 66.3% of individuals were dispensed medicines that could have potentially exacerbated their existing disease or syndrome. Of these, non-benzodiazepine hypnotics, alpha1 blockers and NSAIDs were the most common PIMs classes dispensed.
© 2015 John Wiley & Sons, Ltd.
S.W. Narayan and P.S. Nishtala
Potentially inappropriate medicine use
Figure 1 Potentially inappropriate medicines dispensed to individuals in the study population. TCAs, tricyclic antidepressants; SSRIs, selective serotonin reuptake inhibitors; SNRIs, serotonin-norepinephrine reuptake inhibitor.
The results of our study, in part, are consistent with another study conducted in Dunedin, New Zealand, which showed that 42.7% of community-dwelling people aged ≥75 years were exposed to one or more PIM identified using the updated Beers 2012 criteria. In this study population, doxazosin, diclofenac, zopiclone, amitriptyline and ibuprofen were the most common identified PIMs [19]. A systemic review carried out by Opondo et al. and other international studies have identified amitriptyline as a common PIM prescribed to the older population [21]. A significant use of medicines with anticholinergic properties and antipsychotics was of concern as prior research has shown that anticholinergic use among older people is associated with an increased risk of morbidity, mortality and cognitive decline. In addition, antipsychotic drugs have shown to be associated with neurological adverse effects, metabolic and cardiovascular adverse
© 2015 John Wiley & Sons, Ltd.
effects and all-cause mortality in this vulnerable population, in particular, patients with dementia are at an increased risk of falls and mortality [22,23]. Similarly, a large proportion of individuals were dispensed NSAIDs despite well-established research that NSAIDs carry significant dose-related risks of cardiovascular, renal and hematological adverse events in older people [24,25]. Studies have shown that the exposure to PIMs in older people varied depending on the version of the Beers criteria used, the population being studied, prescribing patterns based on cost and locally recommended guidelines and formularies [26,27]. A retrospective cross-sectional study by Niwata et al. showed that 21.1% of Japanese individuals aged ≥ 65 years, living in long-term care facilities, were treated with at least one PIM [28]. In a study conducted in Ireland, 32% of acutely ill individuals aged 65 years and older were regularly receiving at least one PIM prior to hos7
Potentially inappropriate medicine use
pital admission while another study conducted in the United States identified 40.7% of older individuals received at least one PIM. All the above studies had used the Beers 2003 criteria to identify PIMs [29,30]. This study has a number of limitations. As mentioned by authors of similar studies carried outside of the United States, not all medicines listed in the Beers criteria were available in New Zealand or funded by PHARMAC. A list of these medicines is listed in the Appendix. Additionally, the specifications of the minimum dataset obtained from the Ministry of Health had only the first 20 diagnosis recorded. Further limitations were the unavailability of laboratory data such as creatinine clearance (CrCl) values. To overcome this limitation, individuals were stratified into different age groups; an assumption was made that those above 85 years of age would have lower CrCl values and hence impaired renal function. Moreover, unsubsidized prescription medicines and over-the-counter medicines not captured by Pharms may have underestimated the prevalence of PIMs in this study population. A major strength of the study is that for the first time, a nationwide prescription database was used, which captured almost the entire population of older people in New Zealand. At the time of this study, the charge for fully subsidized medicines was NZ $3 for all older adults; hence, a large proportion of dispensing to this group would have also been captured. Because of the wide prescription coverage in this population, selection bias may have been eliminated. In addition, the availability of ICD-10 codes for individuals enabled the utilization of the specific categories for which PIMs are inappropriate according to the Beers 2012 criteria. It is evident from the findings of this study that a large proportion of older people in New Zealand are dispensed PIMs. The likelihood of using PIMs in older people include, but are not limited to, unavailability of suitable alternatives, multiple attending clinicians, lack of a comprehensive evaluation of the patient medicines and absence of prescriber education [31]. However, it is important to recognize that targeting high-risk prescribing in older people represents an opportunity to reduce the costs associated with the harm from use of inappropriate medicines and encourages clinicians to consider safer alternatives. Reducing high-risk prescribing will also help to reduce cost, given that more than a large percentage of health care consumption occurs in this age group. Previous research has shown that utilization of PIMs is associated with poor health outcomes. A significant proportion of inappropriate medicines use can be prevented at the prescribing or dispensing process.
Conclusion The updated Beers 2012 criteria identified that the use of inappropriate medicines at a population level is common in older New Zealanders. Overall, the results of PIMs exposure are similar to international studies. Using the criteria, we were able to uncover that a substantial number of older New Zealanders were prescribed NSAIDs, amitriptyline and zopiclone. On a population level, Beers criteria may be useful as a quality indicator to guide policy to reduce high-risk prescribing in older people.
Conflict of interest The authors declare no conflict of interest. 8
S.W. Narayan and P.S. Nishtala
Acknowledgements The authors would like to thank the Analytical Services, Ministry of Health of New Zealand for supplying the prescription data extracted from the Pharms database. S. W. N. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
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15. Laroche, M. L., Charmes, J. P., Nouaille, Y., Picard, N. & Merle, L. (2007) Is inappropriate medication use a major cause of adverse drug reactions in the elderly? British Journal of Clinical Pharmacology, 63 (2), 177–186. 16. Statistics New Zealand (2012) Demographic trends: 2011. Wellington: Statistics New Zealand. Published 31 January 2012 (online). ISSN 1177-8075. Available at: http://www.stats.govt.nz/browse_for_stats/ population/estimates_and_projections/demographic-trends-2011.aspx ( accessed 10 January 2013). 17. Lin, H. Y., Liao, C. C., Cheng, S. H., Wang, P. C. & Hsueh, Y. S. (2008) Association of potentially inappropriate medication use with adverse outcomes in ambulatory elderly patients with chronic diseases: experience in a Taiwanese medical setting. Drugs and Aging, 25 (1), 49– 59. 18. Tucker, M. & Hosford, I. (2008) Use of psychotropic medicines in residential care facilities for older people in Hawke’s Bay, New Zealand. The New Zealand Medical Journal, 121 (1274), 18–25. 19. Nishtala, P. S., Bagge, M. L., Campbell, A. J. & Tordoff, J. M. (2013) Potentially inappropriate medicines in a cohort of communitydwelling older people in New Zealand. Geriatrics & Gerontology International, 14 (1), 89–93. 20. Clark, D. O., Von Korff, M., Saunders, K., Baluch, W. M. & Simon, G. E. (1995) A chronic disease score with empirically derived weights. Medical Care, 33 (8), 783–795. 21. De Wilde, S., Carey, I. M., Harris, T., Richards, N., Victor, C. & Hilton, S.R. (2007) Trends in potentially inappropriate prescribing amongst older UK primary care patients. Pharmacoepidemiology and Drug Safety, 16 (6), 658–667. 22. Steinberg, M. & Lyketsos, C. G. (2012) Atypical antipsychotic use in patients with dementia: managing safety concerns. The American Journal of Psychiatry, 169 (9), 900–906.
23. Carriere, I., Fourrier-Reglat, A., Dartigues, J. F., Rouaud, O., Pasquier, F. & Ritchie, K. (2009) Drugs with anticholinergic properties, cognitive decline, and dementia in an elderly general population: the 3-city study. Archives of Internal Medicine, 169 (14), 1317–1324. 24. Barkin, R. L., Beckerman, M., Blum, S. L., Clark, F. M., Koh, E. K. & Wu, D. S. (2010) Should nonsteroidal anti-inflammatory drugs (NSAIDs) be prescribed to the older adult? Drugs and Aging, 27 (10), 775–789. 25. Barkin, R. L. & Buvanendran, A. (2004) Focus on the COX-1 and COX-2 agents: renal events of nonsteroidal and anti-inflammatory drugs-NSAIDs. American Journal of Therapeutics, 11 (2), 124–129. 26. O’Sullivan, D. P., O’Mahony, D., Parsons, C., Hughes, C., Murphy, K. & Patterson, S. (2013) A prevalence study of potentially inappropriate prescribing in Irish long-term care residents. Drugs and Aging, 30 (1), 39–49. 27. Egger, S. S., Bachmann, A., Hubmann, N., Schlienger, R. G. & Krahenbuhl, S. (2006) Prevalence of potentially inappropriate medication use in elderly patients: comparison between general medical and geriatric wards. Drugs and Aging, 23 (10), 823–837. 28. Niwata, S., Yamada, Y. & Ikegami, N. (2006) Prevalence of inappropriate medication using Beers criteria in Japanese long-term care facilities. BMC Geriatrics, 6, 1. 29. Gallagher, P. F., Barry, P. J., Ryan, C., Hartigan, I. & O’Mahony, D. (2008) Inappropriate prescribing in an acutely ill population of elderly patients as determined by Beers’ criteria. Age and Ageing, 37 (1), 96–101. 30. Fick, D. M., Mion, L. C., Beers, M. H. & L Waller, J. (2008) Health outcomes associated with potentially inappropriate medication use in older adults. Research in Nursing & Health, 31 (1), 42–51. 31. Rambhade, S., Chakarborty, A., Shrivastava, A., Patil, U. K. & Rambhade, A. (2012) A survey on polypharmacy and use of inappropriate medications. Toxicology International, 19 (1), 68–73.
Appendix Updated Beers 2012 criteria – list of medicines not available in New Zealand or funded through PHARMAC Therapeutic group
Medicines not available in New Zealand or not funded by PHARMAC
Anticholinergics (excluding tricyclic antidepressants) Anti-Parkinson’s agents Antispasmodics Cardiovascular Central nervous system
Brompheniramine, carbinoxamine, clemastine, dexbrompheniramine, dexchlorpheniramine, doxylamine, tripolidine
Endocrine Gastrointestinal Pain
© 2015 John Wiley & Sons, Ltd.
Trihexyphenidyl Belladonna alkaloids, clidinium-chlordiazepoxide, hyoscyamine Guanabenz, guanfacine, reserpine, dofetilide, dronedarone, ibutilide Chlordiazepoxide-amitriptyline, perphenazine-amitriptyline, molindone, promazine, triflupromazine, asenapine, iloperidone, paliperidone, mesoridazine, amobarbital, butabarbital, butalbital, mephobarbital, pentobarbital, secobarbital, estazolam, clorazepate, flurazepam, quazepam, zolpidem, zaleplon, isoxsuprine Methyltestosterone, desiccated thyroid Trimethobenzamide Meperidine, etodolac, meclofenamate, nabumetone, oxaprozin, tolmetin, ketorolac, carisoprodol, chlorzoxazone, cyclobenzaprine, metaxalone
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Journal of Evaluation in Clinical Practice ISSN 1365-2753
Prevalence of potentially inappropriate medicine use in older New Zealanders: a population-level study using the updated 2012 Beers criteria Sujita W. Narayan MPharmPrac, BPharm1 and Prasad S. Nishtala BPharm, MPharm, PG DipClinPharm, PhD2 1
PhD Candidate, 2Senior Lecturer, School of Pharmacy, University of Otago, Dunedin, New Zealand
Keywords aged, Beers criteria, high-risk medicines, older people, potentially inappropriate medicines Correspondence Dr Prasad S Nishtala School of Pharmacy University of Otago PO Box 56 Dunedin, 9054 New Zealand E-mail: [email protected] Accepted for publication: 24 February 2015 doi:10.1111/jep.12355
Abstract Rational, aims and objectives To examine the prevalence of potentially inappropriate medicines (PIMs) in older New Zealanders at a population level. Methods De-identified prescription data for all individuals ≥65 years were obtained from the Pharmaceutical Claims Data Mart for 2011. International Classification of Diseases10-AM (version 6) codes were used to extract diagnostic information from the National Minimum Datasets and PIMs were identified using the updated Beers 2012 criteria. Results 40.9% of older people were prescribed PIMs with approximately half dispensed ≥2 PIMs in 2011. Exposure was highest in individuals aged 65–74 years (68.9 ± 2.9). The most prevalent PIMs dispensed were diclofenac (6.0%), amitriptyline (4.9%), ibuprofen (4.6%), zopiclone (3.2%) and naproxen (3.0%). 66.3% of individuals were dispensed ≥1 and 80.8% were dispensed ≥2 medicines with a potential for drug-disease/syndrome interaction. Conclusions The updated Beers 2012 criteria identified that the use of PIMs at a population level is common in older New Zealanders.
Introduction Older people are prescribed multiple medicines, some of which are potentially inappropriate and pose an increased risk of morbidity, mortality and adverse drug events [1,2]. Potentially inappropriate medicines (PIMs) in older people are medicines whose potential risks outweigh their desired benefits [3]. In addition, medicines consumed at an inappropriate dose or for a longer duration than clinically indicated, medicines with risk of causing significant drug–drug or drug–disease interactions, or underuse of potentially beneficial medicines, and use of medicines that are not cost-effective have all been deemed as inappropriate medicines. Numerous explicit tools have been developed to assist clinicians to screen for PIMs. The first explicit criteria were developed by Beers et al. to identify potentially high-risk medicine use in older people [5]. Beers criteria was developed in 1991 and either updated and/or expanded in 1993, 1997, 2003, 2007 and recently in 2012 to update evidence and improve relevancy to clinical practice. The updated Beers 2012 Criteria is divided into three categories: potentially inappropriate medications and classes to avoid in older adults, potentially inappropriate medications and classes to avoid in older adults because of drug–disease or drug–
Journal of Evaluation in Clinical Practice (2015) © 2015 John Wiley & Sons, Ltd.
syndrome interactions where medications listed may exacerbate existing condition, and medications to be used with caution in older adults [4]. Beers criteria have been widely applied across different health systems, including older populations living in residential care and ambulatory care to identify high-risk prescribing, that is, medicines having a significant risk of harms and outweighs its potential benefit [4,6–8]. Observational studies have shown that medicines listed in the Beers criteria have been associated with adverse health outcomes such as increased mortality, delirium, gastrointestinal bleeding, falls, fractures and adverse drug events [9,10]. Furthermore, in community-dwelling older people and nursing home residents, exposures to inappropriate medicines identified by Beers criteria were associated with an increased risk of functional impairment and hospitalizations [3,11–13]. Conversely, other studies have failed to show any relationships with adverse outcomes with use of PIMs listed in the Beers criteria in hospitalized older adults [14,15]. Despite limitations to these criteria not addressing drug–drug interactions, overtreatment (dose and duration), limited applicability to other countries because of different prescribing patterns and drug availability, the Beers criteria remain one of the important tools in research to screen older people for high-risk prescribing. 1
Potentially inappropriate medicine use
S.W. Narayan and P.S. Nishtala
The New Zealand population is aging, and by 2061, people 65 years and older will comprise 22–30% of the total population [16]. In congruence, older people in New Zealand have a high level of exposure to prescribed medicines, potentially increasing the risk of experiencing adverse drug effects leading to poor health outcomes and increased health care utilization [12,17]. Some regional studies have examined aspects of medication use in older people; however, there is no population-level data describing the frequency or the type of PIMs use in older New Zealanders aged 65 years and above [18,19].
Objectives To pursue this research, we have three specific objectives: 1 To examine the prevalence of exposure to PIMs in older New Zealanders, at a population level, using the updated 2012 Beers criteria. 2 To examine the prevalence of exposure to PIMs that may potentially exacerbate existing disease or syndrome, using the updated 2012 Beers criteria. 3 To examine the prevalence of exposure to PIMs, which are specifically not recommended in older people with a specific preexisting diagnosis, using the updated Beers 2012 criteria.
Design and methods This study was approved by the Human Ethics Committee at the University of Otago, New Zealand, with ethical approval number 12/147.
Study design Cross-sectional analyses of prescription data for older individuals aged 65 years and above were captured in the Pharmaceutical
Characteristic Age (years) 65–74* 75–84 ≥ 85 Sex (female) Ethnicity European* Ma¯ori Asian Pacific MELAA Others/unknown Individuals exposed to PIMs ≥1 Median (range) Mean total number of dispensed medicines Chronic Disease Score (CDS)
Claims Data Mart (Pharms) dataset from 1 January 2011 to 31 December 2011.
Study population The Pharms extract contained prescription information for 559 625 individuals representing approximately 98% of the total population of older New Zealanders either living in the community or residential aged-care facilities. Of these, the diagnostic information for 180 978 individuals was either missing or unknown. The study population included all individuals within the study period who received at least one prescription medicine. Individuals with missing data in one or a combination of the following variables: (1) age; (2) sex; (3) medicine dose; (4) medicine strength, were excluded from the analyses. Ethnicity data recording and reporting are maintained by the Ministry of Health, New Zealand for all national health data collections. Data analysis was carried out on all ethnicities; however, the data on Europeans and Ma¯ori ethnicity only was reported as these are the largest two ethnicities in New Zealand.
Data source The following extracts were obtained from the Ministry of Health to undertake this study: 1 Pharmaceutical Claims Data Mart (Pharms) extract files for 2011 contained information on sex, date of birth, medicine, daily dose, frequency, quantity, prioritized ethnicity and District Health Board of domicile. 2 National Minimum Dataset (NMDS; 2007–2011) contained information on diagnosis code (ICD-10). The New Zealand Ministry of Health maintains national collections of prescription use (Pharms database), hospital discharges (NMDS) and mortality data. Individual records in these national collections include a unique 7-digit alphanumeric identifier, the
Value
PIMs exposure Odds ratio (95% confidence interval)
55.10% 32.10% 12.80% 54.91%
1 1.24 (1.23–1.26) 1.42 (1.39–1.44) 0.88 (0.87–0.89)
79.11% 4.70% 3.76% 2.64% 0.30% 9.49% 40.89% 0 (0–5) 5.64 ± 3.91 6.04 ± 4.97
1 0.85 (0.82–0.87) 0.49 (0.47–0.51) 0.63 (0.61–0.65) 0.65 (0.53–0.81) 0.72 (0.70–0.73) –
Table 1 Characteristics of the study population (n = 537 387)
– 1.06 (1.06–1.06)
*Reference category: PIMs, potentially inappropriate medicines. MELAA, Middle Eastern/Latin American/African.
2
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Potentially inappropriate medicine use
Table 2 Potentially inappropriate medicines prescribed to the study population (n = 537 387) according to therapeutic class
Organ system or therapeutic category or drug Anticholinergics (excludes TCAs) Chlorpheniramine Promethazine Anti-Parkinson agents Benztropine Antithrombotics Dipyridamole (oral, short-acting) Anti-infective Nitrofurantoin Age (years) 65–74 75–84 ≥ 85 Cardiovascular Alpha1 blockers Doxazosin Prazosin Terazosin Alpha agonists, central Clonidine Methyldopa Antiarrhythmic drugs (class Ia, Ic, III) Amiodarone Flecainide Propafenone Sotalol Digoxin >0.125 mg day−1 Spironolactone > 25 mg day−1 Age (years) 65–74 75–84 ≥ 85 Central nervous system Tertiary TCAs Amitriptyline Clomipramine Doxepin >6 mg day−1 Imipramine Antipsychotics Chlorpromazine Haloperidol Trifluperazine Aripiprazole Clozapine Olanzapine Quetiapine Risperidone Barbiturates Phenobarbitone Benzodiazepines Short and intermediate acting Alprazolam Lorazepam Oxazepam Temazepam Triazolam Long acting Clonazepam Diazepam Non-benzodiazepine hypnotics Zopiclone Ergot mesylates
© 2015 John Wiley & Sons, Ltd.
Number of individuals prescribed PIMs (%) (n = 537 387)
275 (0.05%) 4809 (0.89%)
Comments
Recommendations as per BC Recommendations as per BC
395 (0.07%) 303 (0.06%) 15 167 (2.82%) 5445/15 167 (35.90%) 5659/15 167 (37.31%) 4063/15 167 (26.79%)
Recommendations as per BC Data were unavailable to identify the exact number of individuals dispensed PIMs based on CrCl; hence, individuals were stratified into age groups assuming individuals ≥ 85 years old would have a lower CrCl.
Recommendations as per BC 172 (0.03%) 223 (0.04%) 39 (0.01%) Recommendations as per BC 1230 (0.23%) 513 (0.10%) Recommendations as per BC 4930 (0.92%) 1902 (0.35%) 55 (0.01%) 5232 (0.97%) 3968 (0.74%) 13 593 (2.53%) 5115/13 593 (37.63%) 5348/13 593 (39.34%) 1330/13 593 (9.78%)
Data were unavailable to identify the exact number of individuals dispensed PIMs based on CrCl; hence, individuals were stratified into age groups assuming individuals ≥ 85 years old would have a lower CrCl.
Recommendations as per BC 26 367 (4.91%) 588 (0.11%) 4451 (0.83%) 1053 (0.20%) 430 (0.08%) 3257 (0.61%) 380 (0.07%) 120 (0.02%) 198 (0.04%) 1824 (0.34%) 7028 (1.31%) 5318 (0.99%)
Recommendations as per BC; data were unavailable to identify individuals prescribed antipsychotics for behavioural problems of dementia.
Recommendations as per BC 365 (0.07%) Recommendations as per BC 595 (0.11%) 6866 (1.28%) 1761 (0.33%) 6442 (1.20%) 7799 (1.45%) 5724 (1.07%) 5021 (0.93%) Recommendations as per BC 17 227 (3.21%) 144 (0.03%)
Recommendations as per BC
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S.W. Narayan and P.S. Nishtala
Table 2 Continued
Organ system or therapeutic category or drug Endocrine Androgens Testosterone Oestrogens with or without progestins Insulin, sliding scale Megestrol Gastrointestinal Metoclopramide Pain Non-COX-selective NSAIDs, oral Diclofenac Ibuprofen Ketoprofen Mefenamic Acid Naproxen Piroxicam Sulindac Indomethacin Skeletal muscle relaxants Orphenadrine
Number of individuals prescribed PIMs (%) (n = 537 387)
Comments
Recommendations as per BC 458 (0.09%) 3404 (0.63%)
Recommendations as per BC; data unavailable to identify specific conditions for prescription. Recommendations as per BC Recommendations as per BC
874 (0.16%) 141 (0.03%) 8320 (1.55%)
Recommendations as per BC; data unavailable to identify specific conditions for prescription. Recommendations as per BC
32 604 (6.01%) 24 620 (4.58%) 385 (0.07%) 11 (0.002%) 16 352 (3.04%) 5 (0.001%) 200 (0.04%) 27 (0.01%)
Recommendations as per BC Recommendations as per BC
3800 (0.71%)
TCAs, tricyclic antidepressants; BC, Updated Beers 2012 criteria; CrCl, creatinine clearance; NSAIDs, non-steroidal anti-inflammatory drugs.
National Health Index (NHI) identifier allowing linkage of the three databases. The pharmaceutical collections Pharms (Pharmaceutical Claims Data Mart), include records of all prescription claims made by community pharmacists funded by PHARMAC (Pharmaceutical management agency). Each prescription record includes the medicine name, date of medicine supplied, daily dose and total quantity supplied for each NHI. The patient diagnoses are coded according to the International Classification of Diseases and Related health problems 10th revision, Australian Modification (ICD-10-AM). Coding is undertaken by qualified clinical coders after a patient’s discharge, to identify principal diagnosis, additional diagnoses, complications, procedures and adverse events. Specific codes identify drugs, medicaments and biological substances causing adverse effects in therapeutic use.
PIMs exposure PIMs were identified using the updated Beers 2012 criteria, both independent of diagnosis and taking diagnosis or dose into consideration. Exposure to PIMs was considered if an individual was dispensed ≥1 medicine for any duration and at any given time, identified with the Beers criteria as inappropriate. Criteria related to identifying PIMs in lower urinary tract infections and peptic ulcer diseases were modified and adapted for this study. To detect medicines inappropriate for use in individuals with lower urinary tract symptoms and benign prostatic hyperplasia (BPH), only BPH was used as a diagnosis rather than both the symptoms. In addition, ICD-10 codes for peptic and gastrojejunal ulcers were included with history of gastric or duodenal ulcers. All medicines listed in the Beers criteria were not available in New Zealand or funded by PHARMAC. A list of these medicines is listed in Appendix 1. 4
Chronic Disease Score (CDS) The CDS is a risk-adjustment metric established in 1991, on patient demographics (age and gender) and account of dispensed medicines [20]. The CDS was used to compute scores for co-morbidities as diagnostic information was unavailable for approximately 33.7% of the study population.
Statistical analyses Means and standard deviations were reported for age, number of medicines and exposure to medicines in the Beers category in the study population. Proportions were reported for age groups, sex and ethnicities. Age was stratified into three age categories: 65–74 years, 75–84 years and ≥ 85 years. All statistical analyses were conducted using Stata® Corp Release 12 (StataCorp. 2011. Stata Statistical Software: Release 12. College Station, Texas: StataCorp LP. USA.). P < 0.05 was regarded as statistically significant.
Results The study used data extracted from Pharms for the year 2011 to identify the prevalence of exposure to PIMs in older New Zealanders. A total of 22 238 individuals were excluded from the analyses; hence, the study population, after eliminating missing data, consisted of 537 387 individuals aged 65 years and older, of which 54.9% were females. The mean age of these individuals was 74.7 years (±7.6) and the mean number of medicines dispensed was 5.6 (±3.9; Table 1). The prevalence of individuals exposed to PIMs in 2011 was 40.9% (219 677/537 387) with 78.5% of these individuals dispensed at least one PIM and 21.5% dispensed two or more PIMs.
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Table 3 Potentially inappropriate medicines with drug–disease/syndrome interactions prescribed to individuals with an ICD-10 diagnosis (n = 356 409) Disease or syndrome
Number with disease or syndrome (%) (n = 356 409)
Cardiovascular Heart failure
29 911 (8.39%) 7501 (2.10%)
Syncope
Central nervous system Chronic seizures or epilepsy
52 142 (14.63%)
2056 (0.58%)
Delirium
9577 (2.69%)
Dementia and cognitive impairment
7440 (2.09%)
History of falls or fractures
Falls: 49 005 (13.75%)
Insomnia
Fracture: 13 291 (3.73%) 576 (0.16%)
Parkinson’s disease
3440 (0.97%)
Gastrointestinal Chronic constipation
History of gastric, peptic, gastrojejunal or duodenal ulcers Kidney and urinary tract Chronic kidney disease stages IV and V Urinary incontinence (all types)
30 355 (8.52%)
NSAIDS and COX-2 inhibitors Pioglitazone Non-dihydropyridine CCBs (for systolic heart failure) Diltiazem Verapamil Donepezil Doxazosin Prazosin Terazosin Chlorpromazine Olanzapine Chlorpromazine Clozapine Olanzapine Tramadol All TCAs and anticholinergics* Benzodiazepines Chlorpromazine Corticosteroids H2-receptor antagonists Zopiclone Anticholinergics Benzodiazepines H2-receptor antagonists Antipsychotics Anticonvulsants Antipsychotics Benzodiazepines Zopiclone TCAs SSRIs Theophylline Caffeine All antipsychotics except for quetiapine and clozapine Metoclopramide Prochlorperazine Promethazine
5065 (1.42%)
Oxybutynin Solifenacin Diltiazem Verapamil Chlorpheniramine Dexchlorpheniramine Promethazine Anticholinergics† Antipsychotics Tertiary TCAs Non-COX 2 selective NSAIDs
2340 (0.66%)
NSAIDs
5112 (1.43%)
Oestrogen oral and transdermal (excludes vaginal oestrogen) Doxazosin Prazosin Terazosin Inhaled anticholinergic agents Strong anticholinergic drugs, except antimuscarinics for urinary incontinence
3279‡
Benign prostate hyperplasia
Drug (PIMs)
(0.92%)
10 038 (2.82%)
Number of prescribed PIMs that are not recommended in disease or syndrome (%)
2072/29 911 (6.93%) 105/29 911 (0.35%)
Comments
Recommendations as per BC Recommendations as per BC
1165/7501 (15.53%) 74/7501 (0.99%) 763/52 142 (1.46%) 3802/52 142 (7.29%) 23/52 142 (0.04%) 1965/52 142 (3.77%) 57/52 142 (0.11%) 355/52 142 (0.68%) 2/2056 (0.10%) 1/2056 (0.05%) 31/2056 (1.52%) 54/2056 (2.63%) 2649/9577 (27.66%) 1538/9577 (16.06%) 15/9577 (0.16%) 2516/9577 (26.27%) 324/9577 (3.38%) 1233/9577 (12.87%) 1583/7440 (20.67%) 1140/7440 (15.32%) 166/7440 (2.23%) 2490/7440 (33.47%) Falls 4692/49 005 (9.57%) 4557/49 005 (9.30%) 4603/49 005 (9.39%) 5157/49 005 (10.52%) 5811/49 005 (11.86%) 8749/49 005 (17.85%) 1/576 (0.17%) 1/576 (0.17%) 206/3440 (5.99%)
Recommendations as per BC
Recommendations as per BC
Recommendations as per BC
Recommendations as per BC
Fracture 1227/13 291 (9.23%) 1092/13 291 (8.22%) 1166/13 291 (8.77%) 1350/13 291 (10.16%) 1547/13 291 (11.64%) 2312/13 291 (17.40%)
Recommendations as per BC
Recommendations as per BC Recommendations as per BC Recommendations as per BC
64/3440 (1.86%) 33/3440 (0.96%) 31/3440 (0.90%) 1484/30 355 (4.89%) 492/30 355 (1.62%) 3461/30 355 (11.40%) 357/30 355 (1.18%) 29/30 355 (0.10%) 18/30 355 (0.06%) 425/30 355 (1.40%) 9243/30 355 (30.45%) 1959/30 355 (6.45%) 3187/30 355 (10.50%) 450/5065 (8.88%)
101/2340 (4.32%) 21/3279 (0.64%) 102/3279 (3.11%) 1/3279 (0.03%) 4/3279 (0.12%) 1631/10 038 (16.25%)
Recommendations as per BC
Recommendations as per BC
Recommendations as per BC Recommendations as per BC (avoid in women)
Recommendations as per BC
BC, Updated Beers 2012 criteria; NSAIDs, non-steroidal anti-inflammatory drugs; COX, cyclooxygenase; CCBs, calcium channel blockers; HF, heart failure; AChEIs, acetylcholinesterase inhibitors; TCAs, tricyclic antidepressants; SSRIs, selective serotonin reuptake inhibitors. *Including chlorpromazine. † Drugs with strong anticholinergic properties including: antihistamines, antidepressants, antimuscarinics (for urinary incontinence), anti-Parkinson agents, antipsychotics, antispasmodics and skeletal muscle relaxants. ‡Female.
© 2015 John Wiley & Sons, Ltd.
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Potentially inappropriate medicine use
Drug Aspirin for primary prevention of cardiac events Dabigatran Age (years) 75–84 ≥ 85 Drugs that need monitoring of sodium levels Antipsychotics Carbamazepine Carboplatin Cisplatin SSRIs SNRIs TCAs Vincristine Vasodilators
Number of prescribed PIMs, which are to be used with caution (%)
S.W. Narayan and P.S. Nishtala
Comments
337/356 409 (0.09%)
% represents adults aged ≥ 80
5313/241 274 (2.20%)
% represents adults aged ≥ 75
Table 4 Potentially inappropriate medicines prescribed to individuals, which are advised to be used with caution in older people
4045/5313 (76.13%) 1268/5313 (23.87%) Recommendations as per BC 10851/537 387 (2.02%) 3825/537 387 (0.71%) 152/537 387 (0.03%) 27/537 387 (0.01%) 47 825/537 387 (8.90%) 3515/537 387 (0.65%) 44 729/537 387 (8.32%) 79/537 387 (0.01%) 22 017/537 387 (4.10%)
Recommendations as per BC
SSRIs, selective serotonin reuptake inhibitors; SNRIs, serotonin-norepinephrine reuptake inhibitors; TCAs, tricyclic antidepressants; BC, Beers 2012 criteria.
Exposure to PIMs was highest (51.6%) in individuals aged 65–74 years of age and greater in females (53.4%) in comparison with males (46.7%). More New Zealand Europeans were prescribed PIMs (82.5%) compared with the Ma¯ori population (4.5%). The diagnostic information was matched for 66.3% (356 409/537 387) of individuals present in the Pharms dataset. 44.8% (159 580/ 356 409) of individuals with an ICD-10 diagnosis were dispensed at least one PIM and 23.5% (37 569/159 580) were dispensed two or more PIMs. Further analysis on individuals with a documented ICD-10 diagnosis showed that 66.3% were dispensed at least one medicine and 80.8% were dispensed two or more medicines that may potentially exacerbate their disease or syndrome. The frequency of PIMs dispensed to individuals in the study population who received at least one PIM ranged from one to five indicating that approximately 0.01% (31/219 677) of these individuals were in fact dispensed five PIMs at some time in 2011. The most prevalent PIMs in the study population were diclofenac (6.0%) and amitriptyline (4.9%) followed by ibuprofen (4.6%), zopiclone (3.2%) and naproxen (3.0%; Table 2). Additional analysis was carried out to identify individuals who were prescribed PIMs that were specifically not recommended with certain diagnosis according to the updated Beers 2012 criteria. 33.5% of individuals with dementia and cognitive impairment were dispensed antipsychotics, 30.5% of those with chronic constipation received anticholinergics, 27.7% with delirium were dispensed tricyclic antidepressants and anticholinergics and 26.3% corticosteroids, and 20.7% of those with dementia and cognitive impairment received anticholinergic medicines (Table 3). Ten individuals with a diagnosis of hypertension were dispensed clonidine and 48 individuals with heart failure were dispensed a daily dose of spironolactone greater than 25 mg. Medicines dispensed, which are to be used in caution with specific disease, syndrome or age, were also identified. 11.8% of the study population were dispensed medicines requiring monitor6
ing for sodium levels, and 4.1% of individuals were dispensed vasodilators, which may potentially exacerbate syncope. (Table 4 & Fig. 1). Non-benzodiazepine hypnotics, alpha1 blockers and nonsteroidal anti-inflammatory drugs (NSAIDs) were prevalent in the study population. Zopiclone (7.0%) was the most frequently dispensed PIMs in individuals not recommended because of a specific disease or syndrome followed by doxazosin (6.9%), diclofenac (5.9%), amitriptyline (5.7%) and ibuprofen (4.8%). Additionally, use of medicines with anticholinergic properties and antipsychotics was common as 7.8% were dispensed with medicines with strong anticholinergic properties and 3.5% with antipsychotics. A high proportion (13.8%) of the study population were dispensed non-steroidal anti-inflammatory drugs (NSAIDs). 7.0% of individuals diagnosed with heart failure, 8.9% with a history of gastric, peptic, gastrojejunal or duodenal ulcers, and 4.3% of those diagnosed with chronic kidney disease stages IV and V were dispensed NSAIDs.
Discussion In this population-level study of older New Zealanders, the prevalence of PIMs in 2011 was 40.9%, and almost half of these individuals were dispensed two or more PIMs during the study period. Individuals in the 65–74 years age group had a higher exposure to PIMs (51.6%) compared with the older age groups. Similarly, more females (53.4%) and Europeans (82.5%) were prescribed PIMs compared with males and other ethnic groups. The most common PIMs dispensed to the study population were diclofenac and amitriptyline followed by ibuprofen, zopiclone and naproxen. Furthermore, 66.3% of individuals were dispensed medicines that could have potentially exacerbated their existing disease or syndrome. Of these, non-benzodiazepine hypnotics, alpha1 blockers and NSAIDs were the most common PIMs classes dispensed.
© 2015 John Wiley & Sons, Ltd.
S.W. Narayan and P.S. Nishtala
Potentially inappropriate medicine use
Figure 1 Potentially inappropriate medicines dispensed to individuals in the study population. TCAs, tricyclic antidepressants; SSRIs, selective serotonin reuptake inhibitors; SNRIs, serotonin-norepinephrine reuptake inhibitor.
The results of our study, in part, are consistent with another study conducted in Dunedin, New Zealand, which showed that 42.7% of community-dwelling people aged ≥75 years were exposed to one or more PIM identified using the updated Beers 2012 criteria. In this study population, doxazosin, diclofenac, zopiclone, amitriptyline and ibuprofen were the most common identified PIMs [19]. A systemic review carried out by Opondo et al. and other international studies have identified amitriptyline as a common PIM prescribed to the older population [21]. A significant use of medicines with anticholinergic properties and antipsychotics was of concern as prior research has shown that anticholinergic use among older people is associated with an increased risk of morbidity, mortality and cognitive decline. In addition, antipsychotic drugs have shown to be associated with neurological adverse effects, metabolic and cardiovascular adverse
© 2015 John Wiley & Sons, Ltd.
effects and all-cause mortality in this vulnerable population, in particular, patients with dementia are at an increased risk of falls and mortality [22,23]. Similarly, a large proportion of individuals were dispensed NSAIDs despite well-established research that NSAIDs carry significant dose-related risks of cardiovascular, renal and hematological adverse events in older people [24,25]. Studies have shown that the exposure to PIMs in older people varied depending on the version of the Beers criteria used, the population being studied, prescribing patterns based on cost and locally recommended guidelines and formularies [26,27]. A retrospective cross-sectional study by Niwata et al. showed that 21.1% of Japanese individuals aged ≥ 65 years, living in long-term care facilities, were treated with at least one PIM [28]. In a study conducted in Ireland, 32% of acutely ill individuals aged 65 years and older were regularly receiving at least one PIM prior to hos7
Potentially inappropriate medicine use
pital admission while another study conducted in the United States identified 40.7% of older individuals received at least one PIM. All the above studies had used the Beers 2003 criteria to identify PIMs [29,30]. This study has a number of limitations. As mentioned by authors of similar studies carried outside of the United States, not all medicines listed in the Beers criteria were available in New Zealand or funded by PHARMAC. A list of these medicines is listed in the Appendix. Additionally, the specifications of the minimum dataset obtained from the Ministry of Health had only the first 20 diagnosis recorded. Further limitations were the unavailability of laboratory data such as creatinine clearance (CrCl) values. To overcome this limitation, individuals were stratified into different age groups; an assumption was made that those above 85 years of age would have lower CrCl values and hence impaired renal function. Moreover, unsubsidized prescription medicines and over-the-counter medicines not captured by Pharms may have underestimated the prevalence of PIMs in this study population. A major strength of the study is that for the first time, a nationwide prescription database was used, which captured almost the entire population of older people in New Zealand. At the time of this study, the charge for fully subsidized medicines was NZ $3 for all older adults; hence, a large proportion of dispensing to this group would have also been captured. Because of the wide prescription coverage in this population, selection bias may have been eliminated. In addition, the availability of ICD-10 codes for individuals enabled the utilization of the specific categories for which PIMs are inappropriate according to the Beers 2012 criteria. It is evident from the findings of this study that a large proportion of older people in New Zealand are dispensed PIMs. The likelihood of using PIMs in older people include, but are not limited to, unavailability of suitable alternatives, multiple attending clinicians, lack of a comprehensive evaluation of the patient medicines and absence of prescriber education [31]. However, it is important to recognize that targeting high-risk prescribing in older people represents an opportunity to reduce the costs associated with the harm from use of inappropriate medicines and encourages clinicians to consider safer alternatives. Reducing high-risk prescribing will also help to reduce cost, given that more than a large percentage of health care consumption occurs in this age group. Previous research has shown that utilization of PIMs is associated with poor health outcomes. A significant proportion of inappropriate medicines use can be prevented at the prescribing or dispensing process.
Conclusion The updated Beers 2012 criteria identified that the use of inappropriate medicines at a population level is common in older New Zealanders. Overall, the results of PIMs exposure are similar to international studies. Using the criteria, we were able to uncover that a substantial number of older New Zealanders were prescribed NSAIDs, amitriptyline and zopiclone. On a population level, Beers criteria may be useful as a quality indicator to guide policy to reduce high-risk prescribing in older people.
Conflict of interest The authors declare no conflict of interest. 8
S.W. Narayan and P.S. Nishtala
Acknowledgements The authors would like to thank the Analytical Services, Ministry of Health of New Zealand for supplying the prescription data extracted from the Pharms database. S. W. N. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
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Appendix Updated Beers 2012 criteria – list of medicines not available in New Zealand or funded through PHARMAC Therapeutic group
Medicines not available in New Zealand or not funded by PHARMAC
Anticholinergics (excluding tricyclic antidepressants) Anti-Parkinson’s agents Antispasmodics Cardiovascular Central nervous system
Brompheniramine, carbinoxamine, clemastine, dexbrompheniramine, dexchlorpheniramine, doxylamine, tripolidine
Endocrine Gastrointestinal Pain
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Trihexyphenidyl Belladonna alkaloids, clidinium-chlordiazepoxide, hyoscyamine Guanabenz, guanfacine, reserpine, dofetilide, dronedarone, ibutilide Chlordiazepoxide-amitriptyline, perphenazine-amitriptyline, molindone, promazine, triflupromazine, asenapine, iloperidone, paliperidone, mesoridazine, amobarbital, butabarbital, butalbital, mephobarbital, pentobarbital, secobarbital, estazolam, clorazepate, flurazepam, quazepam, zolpidem, zaleplon, isoxsuprine Methyltestosterone, desiccated thyroid Trimethobenzamide Meperidine, etodolac, meclofenamate, nabumetone, oxaprozin, tolmetin, ketorolac, carisoprodol, chlorzoxazone, cyclobenzaprine, metaxalone
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