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Home , ATC code N05, Psycholeptic

research Quality use of medicines in

Michael Somers residential aged care Ella Rose Dasha Simmonds Claire Whitelaw Janine Calver Christopher Beer

Background Approximately 190 000 people in high risk of ADEs in frail older people. For example, Older people are more likely to be Australia were estimated to have anticholinergic drugs commonly produce adverse exposed to polypharmacy. People in 2006, with the prevalence effects in elderly people and are more likely to be with dementia, especially those living expected to increase to 465 000 by 2031.1 prescribed to people with dementia than those in residential aged care facilities The prevalence of dementia increases without.7 (RACFs), are at particularly high risk of with age, from 6.5% of Australians aged are commonly used harm. We sought to describe medications prescribed for a sample of 65 years and over to 22% of Australians to manage the behavioural and psychological 2 people with dementia living in RACFs. aged 85 years and over. Dementia is symptoms of dementia (BPSD), such as associated with a large burden of disease psychosis, depression, agitation, aggression Methods in Australia’s aging population, costing and disinhibition.1,8 There is concern that A total of 351 residents with dementia Australia $1.4 billion in 2003.2 Most of this are used too frequently as a aged over 65 years were recruited from 36 RACFs in Western Australia. burden was associated with residential first line treatment for BPSD, with the risks of 2 Data on all medications prescribed aged care facilities (RACFs). Dementia antipsychotic use outweighing the benefits at their were collected, including conventional is the medical problem most frequently likely level of use.8 For example, , an medications, herbal medications, managed by general practitioners prescribed frequently for the and minerals. attending RACFs.3 Ninety-six percent treatment of aggression, has been associated with 9 Results of people with dementia living in care increased risk of cerebrovascular adverse events. Polypharmacy was identified in accommodation in Australia have Recognised experts in clinical geriatric 91.2% (average 9.75 medications per moderate or severe dementia, compared care, clinical geriatric , person); one-third were prescribed an to only 7% of people with dementia living pharmacoepidemiology and psychopharmacology antipsychotic medication; and 50.4% in households.1 Therefore people requiring have established the ‘Beers Criteria’, a list of were found to be taking at least one residential care tend to be among the potentially inappropriate medications (PIMs).10,11 potentially inappropriate medication. frailest and sickest in the community, This list was created using a consensus method, The combination of antipsychotics and with substantial physical and behavioural based on an extensive literature review and was the most frequently needs and multiple comorbidities. questionnaire.10,11 The Beers Criteria identifies observed drug-drug interaction, being medications that should be avoided altogether, prescribed to 15.7% of participants. Polypharmacy, defined as the concurrent use of five as well as doses, frequencies and duration of Discussion or more medications, can result in an increased other medications that should be avoided in People with dementia living in RACFs are risk of drug-drug interactions (DDIs) and adverse the elderly.10,11 These medications have been commonly exposed to polypharmacy. drug events (ADEs).4 People with dementia are identified as being associated with higher medical Prescription of contraindicated at a higher risk of polypharmacy, with greater costs, increased rates of ADEs and poorer health medications, antipsychotics, medications increased risk as the disease progresses.5 A study outcomes.10,11 with high anticholinergic burden, and combinations of potentially inappropriate of Victorian RACFs found that one-third of drug A considerable number of people in RACFs mediations is also common. There related problems are caused by overprescribing, are exposed to dangerous DDIs, with one study may be substantial scope to improve including unnecessary drugs, duplication of therapy demonstrating that 60.2% of elderly inpatients were prescribing for older people with or inappropriate duration.6 Other causes of drug prescribed potential DDIs.7 The study participants dementia living in RACFs. related problems included dosing errors, suboptimal were most likely to be exposed to DDIs involving 6 Keywords: dementia; polypharmacy; drug monitoring, and underprescribing. Certain psychotropic medications, notably antipsychotics adverse effects classes of drugs are particularly associated with a with antidepressants, which can cause further

Reprinted from Australian Family Physician Vol. 39, No. 6, june 2010 413 research Quality use of medicines in residential aged care cognitive deterioration.7 The scope of potential DDIs, and antipsychotic and PIM use in Australia 11 736 165 has only been studied to a limited extent. Potential participants Did not meet criteria Australia’s National Medicines Policy highlights quality use of medicines as a central objective and the Australian Commission on 79 Safety and Quality in Health Care has been 571 Refused participation established to, in part, promote quality use of medicines.12 Despite this, the problem of ADEs persists.12 Prescribing to elderly people 141 is complicated by several factors including 492 Did not participate for changing pharmacokinetics with age, increased other reasons (eg. deceased, likelihood of multiple comorbidities, the need relocated, consent not obtained from next of kin) for polypharmacy to address these conditions, 351 and poor communication between health Eligible and willing to professionals.12–15 This results in an increased participate Figure 1. Participant recruitment likelihood of practitioners failing to adjust medication doses in the elderly, and to monitor and review their medications.12 Consequently, the participants were prescribed at the time of Research Ethics Committee of the University of medications can be used at incorrect doses, data collection, either as a regular or pro re nata Western Australia. for longer durations than clinically indicated, (PRN or ‘as required’) medication. Data on all when they are ineffective, and when an equally medications was collected, including conventional Results effective but safer alternative is available.12 medications as well as herbal medications, Of the 351 participants in the study, the mean This study aimed to describe the patterns of vitamins and minerals. age was 85.24 (SD: 7.87); 75.4% were female. prescribing for a sample of older people with The drug data was cleaned by removing The mean MMSE score was 12.50 (SD: 7.61). dementia living in RACFs, including: items that were not medications (eg. hearing Polypharmacy was identified in 320 • number of medications prescribed aid), removing duplicate drugs, correcting participants (91.2%). The number of medications • extent of use spelling errors, converting all drugs to generic taken by each participant ranged from 1 to 21 • use of potentially inappropriate medications names, and coding all drugs using the World (mean: 9.75, SD: 3.88). • drug-drug interactions Health Organization Anatomical, Therapeutic, One-hundred and seventeen (33.3%) of • anticholinergic burden. and Chemical (ATC) Classification System.16 the study participants were prescribed an The number of drugs was counted, with antipsychotic, with nine of these 117 being Methods polypharmacy defined as five or more drugs. The prescribed two antipsychotic medications A total of 351 people were included in the study number of psycholeptic (ATC code N05, including (Table 2). Risperidone, prescribed to 55 study (Figure 1). Inclusion criteria were: resident of a antipsychotics [N05A], [N05B] and participants, was the most commonly used Western Australian RACF; recorded diagnosis of / [N05C]) and antidepressants antipsychotic. Other commonly prescribed dementia; age over 65 years; Mini-Mental State (N06A) were also counted. The modified Beers antipsychotics were (prescribed to 22 Examination (MMSE) score of <24. Residents were Criteria were used to define PIMs (Table 1).10 participants), (17 participants), and excluded if the facility staff identified them as A list of potential DDIs was compiled using (15 participants). being acutely medically unstable or suffering from previously published data.7,17 The anticholinergic Fifty-five (15.7%) study participants were delirium, or in the terminal stages of dementia or a drug scale was used to determine anticholinergic prescribed a combination of antipsychotics and comorbid illness. burden.18,19 Using the scale, each medicine antidepressants. Consent for trial participation was sought was rated on a scale from 0–3 according to Potentially inappropriate medications were from the participant if able to give consent. their anticholinergic activity, with a rating of prescribed to 177 participants (50.4%). Of these Agreement for trial participation was also sought 0 indicating no anticholinergic potential and 3 participants, 115 (32.8%) were taking one from residents’ surrogates (next of kin or other indicating marked anticholinergic potential,18 and potentially inappropriate medication, 55 (15.7%) identified proxy) and the GP. the scores summed. were taking two, while seven participants Data collected from residents comprised Data were analysed with descriptive statistics (2.0%) were taking three. The short acting part of the baseline data in a larger ongoing in the Statistical Package for the Social Sciences , (92 residents) and randomised trial of educational interventions. 16.0 (SPSS).20 (52 residents), were the most frequently The medication survey recorded medications that The research was approved by the Human prescribed PIMs.

414 Reprinted from Australian Family Physician Vol. 39, No. 6, june 2010 Quality use of medicines in residential aged care research

Table 1. Potentially inappropriate medications*10 Hyoscyomine Orphenadrine Amiodarone Desiccated thyroid Indomethacin Oxaprozin Dexchlorpheniramine Isoxsurpine Oxazepam Amphetamines Ketorolac Oxybutynin (except ) Dicyclomine Pentazocine Belladonna alkaloids Digoxin Meperidine amitriptyline Bisacodyl Piroxicam Dipyridamole Cascara segrada Disopyramide Propantheline Chlorazepate Doxazosin Propoxyphene Methyldopa Chlordiazepoxide amitriptyline Ergot mesyloids Methyldopa- Chlorpheniramine Ethacrynic acid hydrochlorothiazide Temazepam Chlorpropamide Ferrous sulfate Methyltestosterone Chlorzoxazone oil Ticlopidine Cimetidine Naproxen Clidinium-chlordiazepoxide Guanadrel Neoloid Trimethobenzamide Guanethidine Nifedipine Tripelennamine Cyclandelate Nitrofurantoin Cyclobenzaprine Oestrogens only * Not all of these drugs are available in Australia. Some medications are only potentially inappropriate in higher doses, certain forms or for certain conditions

Future research should focus on determining Table 2. Psycholeptic and use the efficacy of other treatments for BPSD. Medication Number of study Percentage of study Psychological interventions and alternative participants participants medications may ameliorate BPSD without Antipsychotics 117 33.3% additional morbidity and mortality risk. The RACFs Anxiolytics 74 21.1% are resource limited environments however, and Antidepressants 169 48.1% frequent use of antipsychotic medications may Hypnotics and sedatives 97 27.6% reflect barriers to the use of nonpharmacologic interventions for BPSD. Given that BPSD may Mean anticholinergic burden score among that elderly people in Australian RACFs are be transient, pharmacotherapy of BPSD often the participants was 1.93 (SD: 1.68). Only 64 prescribed an average of seven medications, but does not need to be long term. Our data does not participants (18.2%) had no anticholinergic that people with dementia are at an increased include the length of time that antipsychotics had burden. Over 50% of the participants had risk of polypharmacy.6 The findings of this study been prescribed. an anticholinergic burden score of 1 (31.1%) are consistent with these findings. Drug-drug interactions are common among or 2 (21.1%). Twenty-five (7.1%) of the One-third of the study participants (n=117, elderly people with dementia, and previous participants were prescribed at least one 33.3%) were taking at least one antipsychotic studies have shown that the most frequently medication classed with marked anticholinergic medication. This finding is consistent with involved drugs are the psychotropic drug class.7 potential (anticholinergic burden score of 3). censuses of antipsychotic use among people These findings are reflected in this study, in which Amitriptyline and promethazine were the most with dementia in RACFs in the United States 55 people (15.7%) were prescribed a combination frequently prescribed medications with marked in 2004 (33.1%), and England in 1997 of antipsychotics and antidepressants. anticholinergic potential. (30.7%).21,22 Atypical antipsychotics are the The most commonly prescribed PIMs in most common pharmacological treatment for the present study were benzodiazepines, Discussion BPSD.8 It has been reported that antipsychotic notably temazepam, oxazepam, lorazepam and The present study has described prescribing for a medications have limited efficacy in the diazepam. Despite the dangers associated with population of Australian residents of RACFs with treatment of BPSD however, and may contribute use in the elderly, they are dementia. Previous literature has demonstrated to morbidity and mortality.8 frequently prescribed.6,11

Reprinted from Australian Family Physician Vol. 39, No. 6, june 2010 415 research Quality use of medicines in residential aged care

The risk of developing anticholinergic psychotropic medications may reflect barriers Psychogeriatr 2004;16:295–315. 10. Fick DM, Cooper JW, Wade WE, Waller JL, Maclean adverse effects is related to the anticholinergic to the implementation of nonpharmacologic JR, Beers MH. Updating the Beers criteria for poten- burden.18,19 Higher anticholinergic burdens are approaches to caring for people with dementia tially inappropriate medication use in older adults. Arch Intern Med 2003;163:2716–24. associated with a greater number of adverse and behaviours of concern. 11. Roughead EE, Anderson B, Gilbert AL. Potentially effects and are of particular concern in people inappropriate prescribing among Australian vet- erans and war widows/widowers. Intern Med J with dementia.18,19 In this study, 81.8% of study Authors Michael Somers BSc, is a graduate medical 2007;37:402–5. participants had an anticholinergic burden score student, University of Western Australia, Perth, 12. Basger BJ, Chen TF, Moles RJ. Inappropriate medication use and prescribing indicators in elderly of 1 or more with an average anticholinergic Western Australia. [email protected]. Australians: development of a prescribing indicators burden score of 1.93 (SD: 1.68). Kolinowski au tool. Drugs Aging 2008;25:777–93. et al23 found similar results, with an average Ella Rose BA, is a graduate medical student, 13. Roughead EE, Lexchin J. Adverse drug events: count- ing is not enough, action is needed. Med J Aust anticholinergic burden score of 2.55 (SD: 1.9). University of Western Australia, Perth, Western 2006;184:315–6. These data suggest that a substantial proportion Australia 14. national Prescribing Service. Indicators of quality Dasha Simmonds BSc, MOT, is a graduate medical prescribing in Australian general practice: a manual of participants are exposed to potential adverse for users. Available at www.outbackdivision.org.au/ anticholinergic effects. student, University of Western Australia, Perth, client_images/53626.pdf [Accessed 29 August 2009]. Western Australia 15. Gallagher P, Barry P, Ryan C, Hartigan I, O’Mahony D. Claire Whitelaw BSc (HumBiol), BSc(Nsg), is a Inappropriate prescribing in an acutely ill population Limitations of this study of elderly patients as determined by Beers’ criteria. graduate medical student, University of Western Age Ageing 2008;37:96–101. Relatively few studies have investigated the Australia, Perth, Western Australia 16. World Health Organization. The Anatomical use of medications and patterns of prescribing Therapeutic Chemical Classification System with Janine Calver PhD, is Research Associate in people with dementia. Using medication Defined Daily Doses (ATC/DDD) 2009. Available at Professor, School of Population Health, University www.who.int/classifications/atcddd/ [Accessed 4 charts allowed for reliable and systematic data of Western Australia, Perth, Western Australia June 2009]. collection. Limitations of the present study include Christopher Beer MBBS, FRACP, is Associate 17. lafata JE, Schultz L, Simpkins J, et al. Potential drug- drug interactions in the outpatient setting. Med Care potential volunteer bias, lack of detail regarding Professor, Western Australian Centre for Health & 2006;44:534–41. indication for medication use, duration of use, Ageing, Western Australian Institute for Medical 18. Carnahan RM, Lund BC, Perry PJ, Pollock BG, Culp KR. The anticholinergic drug scale as a measure of and dose. The data are descriptive and do not Research and the Centre for Medical Research, University of Western Australia, and a geriatrician drug-related anticholinergic burden: associations allow conclusions to be drawn regarding the with serum anticholinergic activity. J Clin Pharmacol and clinical pharmacologist, Royal Perth Hospital, 2006;46:1481–6. appropriateness of prescribing. Western Australia. 19. Rudolph JL, Salow MJ, Angelini MC, McGlinchey This study included older people with RE. The anticholinergic risk scale and anticholinergic dementia living in RACFs and cannot be Conflict of interest: none declared. adverse effects in older persons. Arch Intern Med 2008;168:508–13. generalised to the wider population of people 20. Statistical Products and Services Solutions (SPSS) for References Windows. 16.0 edn. Chicago: SPSS, Inc., 2007. with dementia, such as those living in the 1. Australian Institute of Health and Welfare. Dementia 21. Kamble P, Chen H, Sherer J, Aparasu RR. in Australia: National data analysis and develop- community, without further detailed investigation. Antipsychotic drug use among elderly nursing ment. Canberra: AIHW; 2006. Report No.: Cat. no. This study also does not describe facility home residents in the United States. Am J Geriatr AGE 53. Pharmacother 2008;6:187–97. characteristics. Future studies could investigate 2. Australian Institute of Health and Welfare. Older 22. lindesay J, Matthews R, Jagger C. Factors associ- differences in medication use between high Australia at a glance. Canberra: AIHW; 2007. Report ated with antipsychotic drug use in residential care: No.: Cat. no. AGE 52. changes between 1990 and 1997. Int J Geriatr and low care facilities. Future studies should 3. O’Halloran J, Britt H, Valenti L. General practitioner Psychiatry 2003;18:511–9. also describe duration of medication use, consultations at residential aged-care facilities. Med 23. Kolanowski A, Fick DM, Campbell J, Litaker M, J Aust 2007;187:88–91. and outline who is initiating the medications: Boustani M. A preliminary study of anticholinergic 4. leCouteur DG, Hilmer SN, Glasgow N, Naganathan burden and relationship to a quality of life indicator, GPs, geriatricians or other specialists. Finally, V, Cumming RG. Prescribing in older people. Aust engagement in activities, in nursing home residents Fam Physician 2004;33:777–81. with dementia. J Am Med Dir Assoc 2009;10:252–7. assessment of prescribing quality in the present 5. Elmstahl S, Stenberg I, Annerstedt L, Ingvad B. study was limited. Future studies should address Behavioral disturbances and pharmacological treat- ment of patients with dementia in family care giving: underutilisation of medications to provide a more a 2–year follow-up. Int Psychogeriatr 1998;10:239– complete assessment of prescribing quality. 52. 6. Elliot RA. Problems with medication use in the elderly: an Australian perspective. Journal of Conclusion Pharmacy Practice and Research 2006;36:58–66. This study suggests that people with dementia 7. Giron MST, Wang H-X, Bernsten C, Thorslund M, Winblad B, Fastbom J. The appropriateness of drug living in RACFs continue to be exposed to use in an older nondemented and demented popula- substantial polypharmacy and medications tion. J Am Geriatr Soc 2001;49:277–83. 8. Banerjee S. The use of antipsychotic medication with uncertain risk-benefit ratio. These data for people with dementia: time for action. London: suggest that there may be substantial scope Department of Health; 2009. 9. Black W, Almeida OP. A systematic review of the to improve prescribing for older people with association between the behavioral and psychologi- dementia living in RACFs. Substantial use of cal symptoms of dementia and burden of care. Int

416 Reprinted from Australian Family Physician Vol. 39, No. 6, june 2010