Inappropriate prescribing in hospitalised Australian elderly as determined by the STOPP criteria

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1 Int J Clin Pharm (2012) 34: DOI /s RESEARCH ARTICLE Inappropriate prescribing in hospitalised Australian elderly as determined by the STOPP criteria Mohd Shahezwan Abd Wahab Karin Nyfort-Hansen Stefan R. Kowalski Received: 22 March 2012 / Accepted: 20 July 2012 / Published online: 3 August 2012 Ó Springer Science+Business Media B.V Abstract Background The elderly population is increasing worldwide. Due to age-related physiological changes that affect the pharmacokinetics and pharmacodynamics of drugs, the elderly are predisposed to adverse drug reactions. Prescribing of potentially inappropriate medications (PIMs) has been found to be prevalent among the elderly and PIM use has been associated with hospitalisations and mortality. Objectives This study aims to identify the prevalence and nature of pre-admission inappropriate prescribing by using the STOPP (screening tool of older people s prescriptions) criteria amongst a sample of hospitalised elderly inpatients in South Australia. Setting Medical, surgical and rehabilitation wards of a public teaching hospital in Adelaide, South Australia. Main outcome measure Pre-admission prevalence of PIM. Method Medication management plans of 100 patients of C65 years old were prospectively studied to determine the prevalence of pre-admission PIM use. Sixtyfive criteria of STOPP were applied to identify PIMs. Results The total number of pre-admission medications screened during the study period was 949; the median number of medicines per patient was nine (range 2 28). Overall the STOPP criteria identified 138 PIMs in 60 % of patients. The most frequently encountered PIM was opiates prescribed in patients with recurrent falls (12.3 %), followed by M. S. A. Wahab (&) Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Malaysia mohdsh2790@puncakalam.uitm.edu.my K. Nyfort-Hansen Repatriation General Hospital, Adelaide, SA, Australia S. R. Kowalski School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia benzodiazepines in fallers (10.1 %) and proton pump inhibitors when prescribed for peptic ulcer disease for longterm at maximum doses (9.4 %). The number of medications were found to have a positive correlation with pre-admission PIM use (r s = 0.49, P \ 0.01). Conclusions Pre-admission PIM use is highly prevalent among the studied population. Strategies to reduce PIM use should be undertaken by physicians and pharmacists. The use of the STOPP criteria in clinical practice to reduce prescriptions of inappropriate medications requires further investigation. Keywords Australia Elderly Potentially inappropriate prescribing (PIP) Potentially inappropriate medicines (PIM) Screening tool of older person s prescriptions (STOPP) Impact of findings on practice Pre-admission prescribing of potentially inappropriate medication is prevalent among elderly hospitalised patients. Re-evaluation of drug treatment upon admission is necessary to avoid continuation of potentially inappropriate medications. Clinical pharmacists and physicians could successfully use potentially inappropriate medication screening tools such as the STOPP criteria to evaluate medication use among the elderly. Introduction Population ageing is an increasing worldwide phenomenon [1] that is affecting the healthcare systems of many countries. According to projections by the Australian Bureau of

2 856 Int J Clin Pharm (2012) 34: Statistics 16.4 % of the Australian population will be aged over 65 years of age in 2015, compared to 13.6 % in 2010 [2]. The United Nations has estimated that the proportion of people worldwide aged over 65 will increase to 18.6 % in 2025 [1]. Compared to younger adults, the elderly have a fourfold higher chance of developing an adverse drug reaction (ADR) [3]. This increased risk is due to a combination of factors such as; multiple medical co-morbidities, polypharmacy, and age-related physiological changes that affect drug pharmacokinetics and pharmacodynamic responses [4]. Prescription of potentially inappropriate medications (PIMs) to elderly patients is common. Some drugs can be classified as PIMs because the risks of treatment potentially outweigh the benefits [5], while others may result from the inappropriate prescribing of drugs for longer periods than clinically indicated, the use of drugs that are likely to interact with other drugs and diseases, or prescription of a medication with no clear indication. Consistent with other international reports, PIM prescribing rates of between 40 and 50 % have been reported for elderly Australian inpatients [6 8]. Prescription of PIMs has been identified as an important preventable cause of morbidity and mortality among the elderly [9 11]. The prevention or reduction of PIMs in the elderly is therefore of critical importance. Several screening tools have been developed to assist identification of PIMs. The Beers criteria developed in 1991 [10] and updated in 1997 [12], 2002 [13] and 2012 [14] are the most widely used and studied tool for the identification of PIMs [10, 15, 16]. Despite their common application, the Beers criteria have been criticised for their limitations especially when used in healthcare settings outside of the United States (US) [16]. These include listings of drugs that are not available in non- US countries. Only 63 % of drugs listed in the Beers criteria are available in Australia [7]. Beers criteria are also unable to detect prescribing omissions, underuse of medications, drug drug interactions, inappropriate dosing of renally cleared drugs and duplication of drug classes [16, 17]. The Screening Tool of Older Persons Prescriptions (STOPP) and Screening Tool to Alert Doctors to the Right Treatment (START) criteria were developed by a group of Irish researchers in 2006 using the Delphi consensus method. The STOPP criteria detect PIMs while the START criteria identify potentially prescribing omissions (PPO) in the elderly [17]. The STOPP criteria comprise 33 instances of potentially inappropriate prescribing (PIP) not included in the 2003 Beers criteria [17]. Objectives The applicability of the STOPP criteria in Australian healthcare settings is unknown and studies examining PIM use in elderly hospitalised patients in Australia are limited. The objective of the present study is to identify the prevalence and nature of pre-admission PIM prescribing by using the STOPP criteria in elderly inpatients admitted to an Australian hospital. Methods A prospective cross sectional study was performed on a group of elderly inpatients at the Repatriation General Hospital (RGH), Daw Park, Adelaide, a 300-bed acute care public teaching hospital specialising in the care of the elderly and veterans. The hospital provides a range of general medical and surgical services to people living in Adelaide. Population To permit collection of data within time constraints of the study, only the first 100 patients C65 years of age admitted to a medical, surgical or rehabilitation ward of the hospital were included in the study. Patients admitted into the intensive care unit (ICU), coronary care unit (CCU) or psycho geriatric (PG) unit were excluded due to limited access into these units. Elderly patients who received treatment at the emergency department (ED) without admission were also excluded. Data collection Data collection took place over 2 weeks in March Patients information, including medical histories, current diagnoses, pre-admission medications, and biochemical data were recorded from a combination of electronic and paper-based records. The hospital s electronic database of investigation results (Oacis) was used to obtain all laboratory results. Data on medication use was extracted from the medication management plan (MedMap), a form used by clinical pharmacists to document patients medication use prior to and during admission. Assessment of inappropriate medicine The frequency of PIMs in the studied sample was evaluated using the STOPP criteria. Sixty-five clinically significant criteria for PIP in the elderly have been proposed as PIMs by the STOPP criteria [18]. All criteria in the STOPP were applied in this study. As this study was not intended to evaluate PPO issues, the START criteria were not applied. Data collection was conducted by the primary researcher, supported by one hospital based and one independent academic clinical pharmacist. This study was

3 Int J Clin Pharm (2012) 34: approved by the Flinders Medical Centre Clinical Research Ethics Committee. Due to de-identification of patients data and non-direct involvement in the study, informed consent was not required. Statistical analysis All data were collated using Microsoft Excel and subsequently transferred to SPSS Version 15.0 (SPSS Inc., Chicago, IL, USA) for statistical analysis. To determine the statistical relationship between the numbers of medications prescribed, age, and the occurrence of PIMs, one-tailed bivariate correlations (using Spearman s q correlation coefficient) for nonparametric data were calculated. Results Demographics The baseline characteristics of the study population are described in Table elderly inpatients (51 males and 49 females, age mean: ± 7.3 years, range: ) were included in the study. The majority of subjects (49 %) were aged between 76 and 85, 32 % were older than 85 years old and only 19 % were in the age group. Nine hundred and forty-nine pre-admission medications from 100 MedMaps were screened in the study. The lowest number of pre-admission medications received by an elderly inpatient was 2 and the highest was 28 (mean 9.49 ± 4.96). Prior to admission, 61 % of the elderly inpatients in this study took less than 10 medications a day. 36 % of the elderly inpatients were prescribed medications and 3 % of the elderly inpatients took more than 20 medications. Potentially inappropriate prescribing The STOPP criteria identified a total of 138 pre-admission PIMs distributed among 60 elderly inpatients. Prior to admission, 49 subjects were treated with 1 3 PIMs and 11 were prescribed more than 3 PIMs (Table 2). The highest documented number of pre-admission PIMs for the elderly inpatients in this study was 6 and the lowest was 1 (mean: 1.38 ± 1.53). Patients in the year age group were the highest recorders of pre-admission PIMs (48.3 %). A positive correlation was found between the number of medications prescribed and the occurrence of PIMs (r s = 0.495, P \ 0.01). The correlation between age and PIM use was not significant (r s =-0.142, P = 0.079). Twenty-seven (41.5 %) of the 65 criteria of STOPP were used to identify PIMs. The most frequently encountered pre-admission PIMs by the STOPP criteria are Table 1 Patient demographics Demographics Total (n = 100) Male 51 Female 49 Age, mean (years ± SD) ± 7.3 Age range (years) Age group [85 32 Total number of drugs prescribed 949 Number of prescriptions per patients \ [20 3 Mean number of drugs prescribed ± SD 9.49 ± 4.96 Range of drug prescriptions per patient 2 28 Table 2 Number of elderly inpatients with potentially inappropriate prescriptions (PIPs) identified by STOPP Number of potentially inappropriate prescriptions STOPP total (%) (n = 100) [3 11 Total 60 (60) Range of PIMs 1 6 Total potentially 138 inappropriate prescriptions Mean number of PIMs ± SD 1.38 ± 1.53 Gender Male (n = 51) 27 (52.9) Female (n = 49) 33 (67.3) Age group [85 14 detailed in Table 3. Among the 65 STOPP criteria, 38 were not encountered. The top three PIMs found in this study are highlighted in Table 4. The highest prevalence of PIMs identified were long-term opiates prescribed to elderly inpatients with history of recurrent falls (12.32 %). The second highest was benzodiazepines prescribed to elderly inpatients with a fall risk (10.14 %), and third highest was PPIs prescribed for peptic ulcer disease at full therapeutic dose for more than 8 weeks (9.42 %). Prescribing of duplicate drug classes accounted for a total of 9 PIMs (6.5 %). All drug groups in STOPP were involved in this study. The highest prevalence of PIMs was in relation to

4 858 Int J Clin Pharm (2012) 34: drugs that adversely affected fallers with 38 occurrences (Table 3). Discussion More than half (60 %) of our study population received at least one PIM prior to hospital admission. We found a positive correlation between the number of medications prescribed and the occurrence of PIMs (r s = 0.495, P \ 0.01), similar to the findings from previous studies [19 23]. Our study showed no correlation between age and PIMs. In our study, PIMs were identified by using the validated STOPP criteria [17, 24]. The STOPP criteria contain a list of PIMs that should be avoided in the elderly based on the consensus opinion of a panel of experts and current clinical evidence [18]. The STOPP criteria were chosen due to several limitations of the Beers criteria when applied in Australia. Firstly, the Beers criteria contain many medications that have never been available in Australia such as trimethobenzamide, carisoprodol, and guanadrel [25]. It also lists some medications that have been withdrawn from the country such as chlorpropamide, phenylbutazone, and reserpine [25]. In addition, drugs such as disopyramide, cimetidine, and ticlopidine listed in the criteria are rarely, if ever now used in Australia. Recently the Beers criteria have been updated by an expert panel using a comprehensive, systematic review and grading of the evidence on drug-related problems and adverse drug events in the elderly [14]. Beers 2012 include 53 medications or medication classes which have either limited effectiveness in the elderly, are associated with serious problems such as falls or increase the risk of cognitive impairment. A new category of PIM which includes drugs that should be used cautiously in the elderly has been added. However as with the previous versions, the updated criteria still do not address issues such as under-prescribing, inappropriate dosing of renally cleared drugs, drug drug interactions, medication duplication and PPOs [14, 16, 17]. The utility and applicability of Beers 2012 criteria in Australia and other non-american settings is unknown. The most frequent PIM in our study concerned the use of opiates for long term use in elderly with recurrent falls (12.32 %). The STOPP criteria indicate long-term use of opiates in patient with recurrent falls as inappropriate due to risk of drowsiness, postural hypotension, and balance impairment that could increase risk of subsequent falls [25]. Despite being considered as inappropriate by the STOPP criteria [18], a decision to restrict opiates in the elderly may be impractical especially in those with chronic pain. However, care should be taken when giving opiates to elderly with a significant falls risk. The selection of pain medications should be closely evaluated and based on evidence-based guidelines such as the pain relief ladder by the World Health Organisations (WHO). Elderly patients who have high fall risk should be identified and appropriately educated regarding their increased risk. Prescription of benzodiazepines among elderly patients with falls risk was the second most prevalent PIM in this study, accounting for % of all PIMs identified. Benzodiazepines are considered inappropriate in the elderly due to their association with daytime sedation and the risk of falls and reduced sensorium [10, 26, 27]. Other screening tool such as the Beers criteria and MacLeod s criteria also regard prescription of benzodiazepines as inappropriate in the elderly [9, 10, 12, 13]. Despite extensive research that implicates benzodiazepine use with detrimental effects in elderly patients especially those with falls risk, the prescription of benzodiazepines in the elderly is still common and highly prevalent [6, 8, 27 33]. Prohibition of benzodiazepines in the elderly is unnecessary but its use should be limited whenever possible [34 36] or be substituted with non-drug therapies [9]. Benzodiazepines with shorter half-lives and those without active metabolites are the preferred options [34]. The third most prevalent PIM in our study was prescription of PPIs for peptic ulcer disease at full therapeutic dosage for more than 8 weeks (9.42 % of all PIMs). In general, after 8 weeks of therapy, it is recommended to stop the PPI, or alternatively, if symptoms persist, reducing the dose to a maintenance dose (e.g. omeprazole 20 mg daily) [25]. It is inappropriate to continue with the higher dose without at least considering a dose reduction. Previous studies that used STOPP have similarly found that the prescription of PPI is prevalent [15]. In Australia, from 2009 to 2010, esomeprazole and pantoprazole were two of the most commonly prescribed medications (6,256,960 and 3,815,186 prescriptions respectively) [37]. Government spending for esomeprazole during this period was A$ 203,325,839, making it the fifth highest cost drug on the Pharmaceutical Benefits Scheme [37]. However, prescription of a PPI is not considered as inappropriate by other screening tools such as the Beers criteria [10, 12, 13] and its long-term use has been argued as harmless in terms of ADRs [15]. However, published studies have reported that longterm prescription of PPI has been associated with many adverse effects such as deficiencies of vitamin B 12, calcium and iron, increased risk of osteoporosis, and increased risk of infections such as Clostridium difficile bowel infections and pneumonia, and increased risk of a few types of cancer [38]. A 2006 study has associated PPI use with increased risk of hip fracture [39]. In addition, prescription of PPIs has a major implication on healthcare costs. In 2006, expenditures of PPIs was estimated to be around $24 billion worldwide [38]. In Ireland, 10 % (approximately 64 million) of total national drug expenditure was for PPIs [15].

5 Int J Clin Pharm (2012) 34: Table 3 Potentially inappropriate medications (PIMs) identified by STOPP Criteria Total A. Cardiovascular drugs Digoxin at a long-term dose [125 lg/day with impaired renal function 1 Loop diuretic for dependent ankle oedema only i.e. no clinical signs of heart failure 2 Loop diuretic as first-line monotherapy for hypertension 0 Thiazide diuretic with a history of gout 0 Non-cardioselective b-blocker with chronic obstructive pulmonary disease (COPD) 0 b-blocker in combination with verapamil 0 Use of diltiazem or verapamil with NYHA class III or IV heart failure 0 Calcium channel blockers with chronic constipation 10 Use of aspirin and warfarin in combination without histamine H 2 -receptor antagonist (except cimetidine because of interaction with 0 warfarin) or proton pump inhibitor Dipyridamole as monotherapy for cardiovascular secondary prevention 1 Aspirin with a past history of peptic ulcer disease without histamine H 2 -receptor antagonist or proton pump inhibitor 0 Aspirin at dose [150 mg/day 0 Aspirin with no history of coronary, cerebral or peripheral vascular symptoms or occlusive event 0 Aspirin to treat dizziness not clearly attributable to cerebrovascular disease 0 Warfarin for first, uncomplicated deep venous thrombosis for longer than 6 months duration 0 Warfarin for first uncomplicated pulmonary embolus for longer than 12 months duration 0 Aspirin, clopidogrel, dipyridamole or warfarin with concurrent bleeding disorder 3 B. Central nervous system and psychotropic drugs Tricyclic antidepressants (TCAs) with dementia 0 TCAs with glaucoma 0 TCAs with cardiac conductive abnormalities 0 TCAs with constipation 5 TCAs with an opiate or calcium channel blocker 8 TCA s with prostatism or prior history of urinary retention 0 Long-term (i.e. [1 month), long-acting Benzodiazepines, e.g. chlordiazepoxide, flurazepam, nitrazepam, chlorazepate, 4 and Benzodiazepines with long-acting metabolites, e.g. diazepam Long-term (i.e. [1 month) neuroleptics as long-term hypnotics 0 Long-term neuroleptics ([1 month) in those with parkinsonism 0 Phenothiazines in patients with epilepsy 0 Anticholinergics to treat extrapyramidal side effects of neuroleptic medications 0 Selective serotonin re-uptake inhibitors (SSRIs) with a history of clinically significant hyponatremia 1 Prolonged use ([1 week) of first-generation antihistamines, i.e. diphenhydramine, chlorpheniramine, cyclizine, promethazine C. Gastrointestinal system Diphenoxylate, loperamide or codeine phosphate for treatment of diarrhea of unknown cause 1 Diphenoxylate, loperamide or codeine phosphate for treatment of severe infective gastroenteritis 0 Prochlorperazine (stemetil) or metoclopramide with parkinsonism 0 PPI for peptic ulcer disease at full therapeutic dosage for [8 weeks 13 Anticholinergic antispasmodic drugs with chronic constipation 0 D. Respiratory system Theophylline as monotherapy for COPD 0 Systemic corticosteroids instead of inhaled Corticosteroids for maintenance therapy in moderate to severe COPD 2 Nebulized Ipratropium with glaucoma 0 E. Musculoskeletal Non-steroidal anti-inflammatory drug (NSAID) with history of peptic ulcer disease or gastro-intestinal bleeding, unless 0 with concurrent histamine H 2 -receptor antagonist, PPI or misoprostol NSAID with moderate-to-severe hypertension 5 NSAID with heart failure 0

6 860 Int J Clin Pharm (2012) 34: Table 3 continued Criteria Total Long-term use of NSAID ([3 months) for symptom relief of mild osteoarthritis 2 Warfarin and NSAID together 0 NSAID with chronic renal failure 3 Long-term corticosteroids 1 Long-term NSAID or colchicine for chronic treatment of gout where there is no contraindication to allopurinol 1 F. Urogenital system Bladder antimuscarinic drugs with dementia 0 Antimuscarinic drugs with chronic glaucoma 4 Antimuscarinic drugs with chronic constipation 10 Antimuscarinic drugs with chronic prostatism 0 a-blockers in males with frequent incontinence, i.e. one or more episodes of incontinence daily 2 a-blockers with long-term urinary catheter in situ, i.e. more than 2 months 1 G. Endocrine system Glibenclamide or chlorpropamide with type 2 diabetes mellitus 1 b-blockers in those with diabetes mellitus and frequent hypoglycaemic episodes i.e. 1 episode per month 3 Estrogens with a history of breast cancer or venous thromboembolism 0 Estrogens without progestogen in patients with intact uterus 0 H. Drugs that adversely affect fallers Benzodiazepines 14 Neuroleptic drugs 4 First-generation antihistamines 0 Vasodilator drugs with persistent postural hypotension, i.e. recurrent [20 mmhg drop in systolic blood pressure 3 Long-term opiates in those with recurrent falls 17 I. Analgesic drugs Use of long-term powerful opiates, e.g. morphine or fentanyl as first-line therapy for mild-to-moderate pain 0 Regular opiates for more than 2 weeks in those with chronic constipation without concurrent use of laxatives 4 Long-term opiates in those with dementia unless indicated for palliative care or management of moderate/severe chronic pain syndrome 3 J. Duplicate drug classes Any duplicate drug class prescription, e.g. 2 concurrent opiates, NSAIDs, SSRIs, loop diuretics, ACE inhibitors 9 Total potentially inappropriate prescriptions 138 NYHA New York Heart Association, PPI proton pump inhibitor, COPD chronic obstructive pulmonary disease, NSAIDs non-steroidal antiinflammatory drugs, SSRIs selective serotonin reuptake inhibitors, ACE angiotensin converting enzyme Table 4 Top three potentially inappropriate medications identified by STOPP No. Inappropriate prescribing Occurrences 1 Long-term opiates in those with recurrent falls 17 2 Benzodiazepines in fallers 14 3 PPI for peptic ulcer disease at full therapeutic dosage for [8 weeks 13 An earlier study at the same hospital using Beers criteria, reported a lower pre-admission rate of PIMs, with 42 % of patients with at least one PIM [8]. In contrast to the present study Widagdo et al. showed no significant association between PIM occurrence and number of medications. Benzodiazepines, however were again a very common reason for recording a PIM [8]. The present study has several limitations. The study only reviewed a small sample size from one hospital. The results may not be consistent across differing elderly patient samples in different settings. Furthermore, physicians who have initiated PIMs in our subjects did not have the opportunity to explain their reasons for prescribing agents that the STOPP criteria list as inappropriate. Drugs identified as PIMs by the STOPP criteria could be clinically appropriate for certain patients. Another limitation is that the prevalence of ADRs possibly associated with PIM use was not evaluated. Nevertheless, the findings of this study demonstrated more than half of the study population received at least one PIM identified by the STOPP criteria prior to admission. Previous studies have shown a significant association between PIM use and hospitalisation [40, 41] and mortality

7 Int J Clin Pharm (2012) 34: [40]. Re-evaluation of drug treatment and stopping of PIMs during hospitalisation of patients should always be considered by physicians and pharmacists [26]. It is also important to consider other safer alternatives to prescribed PIMs when deciding on treatment options for elderly patients. If replacement of these drugs with appropriate substitutes is impossible, a prescription for short-term use rather than long-term use is recommended. When treating the elderly, physicians should prescribe drugs cautiously and closely monitor response. The STOPP criteria could be useful as an educational and evaluation tool for prescribers and pharmacists to help prevent inappropriate prescribing in elderly patients. To determine if application of the STOPP criteria has significant beneficial outcomes in terms of reducing ADRs, morbidity, mortality, and total health cost, large prospective multicentre randomised controlled trials should be performed. In Australia, the applicability and utility of the STOPP criteria should be studied further. Conclusion Prior to hospital admission, the prevalence of PIM use among hospitalised Australian elderly is high, with 60 % of patients in this study receiving at least one PIM based on the STOPP criteria. As the number of medications was found to be associated with increased risk of receiving PIMs, thoroughly reviewing the requirement for all medication is an important strategy for minimising PIM use. Funding None. Conflicts of interest References No conflicts of interest to declare. 1. Department of Economic and Social Affairs, Population Division. World population ageing, New York: United Nations; /. Accessed 6 June Australian Bureau of Statistics. Population by age and sex, Australian States and territories, June Belconnen, ACT: Australian Bureau of Statistics; Ausstats/abs@.nsf/mf/ Accessed 5 June Beijer HJ, de Blaey CJ. 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