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Reducing the Anticholinergic and Sedative Load in Older Patients on Polypharmacy by Pharmacist-Led Medication Review: a Randomised Controlled Trial

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Reducing the Anticholinergic and Sedative Load in Older Patients on Polypharmacy by Pharmacist-Led Medication Review: a Randomised Controlled Trial Open access Research BMJ Open: first published as 10.1136/bmjopen-2017-019042 on 19 July 2018. Downloaded from Reducing the anticholinergic and sedative load in older patients on polypharmacy by pharmacist-led medication review: a randomised controlled trial Helene G van der Meer,1 Hans Wouters,1,2 Lisa G Pont,3 Katja Taxis1 To cite: van der Meer HG, ABSTRACT Strengths and limitations of this study Wouters H, Pont LG, et al. Objective To evaluate if a pharmacist-led medication Reducing the anticholinergic review is effective at reducing the anticholinergic/ and sedative load in older ► A successfully completed randomised controlled sedative load, as measured by the Drug Burden Index patients on polypharmacy by trial, which was the first to focus on changing anti- pharmacist-led medication (DBI). cholinergic and sedative load by medication review. review: a randomised Design Randomised controlled single blind trial. ► Appropriately powered to detect a clinically relevant controlled trial. BMJ Open Setting 15 community pharmacies in the Northern medium difference. 2018;8:e019042. doi:10.1136/ Netherlands. ► Showing the effect of ‘real world’ practiced medi- bmjopen-2017-019042 Participants 157 community-dwelling patients aged ≥65 cation review, rather than the theoretical approach ► Prepublication history and years who used ≥5 medicines for ≥3 months, including at described in guidelines. additional material for this least one psycholeptic/psychoanaleptic medication and ► Three-month follow-up might have been too short to paper are available online. To who had a DBI≥1. detect full effects of medication review, for example, view these files, please visit Intervention A medication review by the community due to stepwise reduction of medication, however the journal online (http:// dx. doi. pharmacist in collaboration with the patient’s general very few dosage changes were seen. org/ 10. 1136/ bmjopen- 2017- practitioner and patient. 019042). Primary and secondary outcomes measures The http://bmjopen.bmj.com/ Received 8 August 2017 primary outcome was the proportion of patients whose BACKGROUND Revised 29 March 2018 DBI decreased by at least 0.5. Secondary outcomes were Older people suffer from many medical Accepted 6 June 2018 the presence of anticholinergic/sedative side effects, falls, conditions and use more medication than cognitive function, activities of daily living, quality of life, any other age group. Multiple medication hospital admission and mortality. Data were collected at use in combination with age-related physi- baseline and 3 months follow-up. ological changes increase the risk of medi- Results Mean participant age was 75.7 (SD, 6.9) years in the intervention arm and 76.6 (SD, 6.7) years in the control cation related harm including adverse drug arm, the majority were female (respectively 69.3% and events, drug-drug-interactions and drug-dis- on September 26, 2021 by guest. Protected copyright. 1 72.0%). Logistic regression analysis showed no difference ease-interactions. Medications with anticho- 1Groningen Research in the proportion of patients with a≥0.5 decrease in linergic and/or sedative properties are of Institute of Pharmacy, Unit of DBI between intervention arm (17.3%) and control arm particular concern in older people, because PharmacoTherapy, Epidemiology (15.9%), (OR 1.04, CI 0.47 to 2.64, p=0.927). Intervention they worsen cognitive impairment and phys- and Economics, University patients scored higher on the Digit Symbol Substitution ical functioning, increase the risk of falls and of Groningen, Groningen, Test, measure of cognitive function (OR 2.02, CI 1.11 to negatively impact activities of daily living, Netherlands 2 3 2Department of General 3.67, p=0.021) and reported fewer sedative side effects hospitalisation and mortality. Despite Practice, University Medical (OR 0.61, CI 0.40 to 0.94, p=0.024) at follow-up. No the risks, these medications are commonly Centre Groningen, University significant difference was found for other secondary prescribed to older individuals.4 5 Different of Groningen, Groningen, The outcomes. measures have been developed to quantify Netherlands Conclusions Pharmacist-led medication review as 6 3 the anticholinergic load in patients. The Discipline of Pharmacy, currently performed in the Netherlands was not effective Graduate School of Health, Drug Burden Index (DBI) determines an in reducing the anticholinergic/sedative load, measured University of Technology Sydney, individual’s exposure to anticholinergic and Sydney, New South Wales, with the DBI, within the time frame of 3 months. Preventive sedative medication taking into account the strategies, signalling a rising load and taking action before Australia dose.7 8 A high DBI has been associated with chronic use of anticholinergic/sedative medication is impairments in both physical and cognitive Correspondence to established may be more successful. functions among older individuals.9 10 Hence, Helene G van der Meer; Trial registration number NCT02317666. h. g. van. der. meer@ rug. nl decreasing exposure to anticholinergic and van der Meer HG, et al. BMJ Open 2018;8:e019042. doi:10.1136/bmjopen-2017-019042 1 Open access BMJ Open: first published as 10.1136/bmjopen-2017-019042 on 19 July 2018. Downloaded from sedative medication, as measured by the DBI, may have were aged ≥65 years, living independently, using ≥5 medi- important health benefits in older people. cations for ≥3 months, including at least one psycholeptic Two small Australian studies suggest that medication or psychoanaleptic medication (Anatomic Therapeutic review could be a promising strategy in reducing the DBI Classification (ATC) code N05 or N06)26 and with a in community dwelling older people.11 12 Medication DBI≥1 were identified by the pharmacist and invited to review is ‘a structured critical examination of a person’s participate in the study. Exclusion criteria were limited medicines with the objective of reaching an agreement life expectancy (<3 months), non-Dutch language with the person about treatment, optimising the impact of speaker or advanced dementia. Patients who had received medicines, minimising the number of medication-related a medication review within the past 9 months before the problems and reducing waste’.13 While meta-analyses of study period and patients who needed a medication studies in different settings show a lack of effectiveness review urgently were also excluded. Exclusion criteria on outcomes such as mortality or hospital (re-)admis- were identified by the pharmacist with whom the patient sions,14–16 these studies included different types of medi- was registered. The study protocol has been published cation review. Well-structured medication review with elsewhere.27 good cooperation between pharmacist and general prac- titioner (GP) and involvement of the patient was most Randomisation, allocation and blinding likely to be successful.17 18 Furthermore fee-for-pharma- Eligible patients were approached by the pharmacist and cist-led medication review seemed to have positive health asked to provide written informed consent. In each phar- benefits on the patient.19 The most effective method macy, patients willing to participate were then matched in for medication review remains unknown. Focusing on pairs by gender, age, DBI and number of medications. One specific subgroups such as older people with multiple patient of each pair was randomly assigned to the inter- comorbidities and polypharmacy20 or patients suffering vention condition. All participants gave written consent from pain21 may be one strategy to optimise medication prior to the intervention allocation. The randomisation review associated benefits. To date, there is no consensus process was conducted by the principal investigator, who on the effectiveness of medication review as a strategy to was not involved in recruitment or data collection. The reduce anticholinergic and sedative load as measured by researchers who enrolled the patients and collected the the DBI. Therefore, the primary aim of this study was to data were kept blind to the allocation. Pharmacists and evaluate if a medication review is an effective strategy to patients could not be kept blind, but were explicitly asked reduce anticholinergic and sedative load as measured by not to reveal study allocation for individual patients to the the DBI. Secondarily, we evaluated the effect of a medi- researchers who collected the data. Therefore, this was a cation review on patient outcomes including cognitive single blind study. function, risk of falls, activities of daily living and quality http://bmjopen.bmj.com/ of life. Intervention The intervention was a medication review conducted by the community pharmacist in close collaboration with METHODS the patients’ GP and, if needed, other medical specialists. Study design, setting and participants In the Netherlands, medication review consisted of five We conducted a randomised controlled, single blind trial steps.25 Step one was a face-to-face consultation between in 15 community pharmacies from December 2014 until the pharmacist and patient to discuss medication use. October 2015 in the Northern Netherlands. Pharmacies Second, the pharmacist undertook a pharmacothera- on September 26, 2021 by guest. Protected copyright. were recruited via the regional association of pharma- peutic medication review, identified potential pharma- cists and participation was voluntary. One pharmacist per cotherapeutic problems taking into account the patient’s pharmacy
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