OBJECTIVE: The Drug Burden Index (DBI) calculates a person\'s exposure to anticholinergic and sedative medications. We aimed to review randomized controlled trials (RCTs) of deprescribing interventions that reported the DBI as an outcome, their characteristics, effectiveness in reducing the DBI, and impact on other outcomes.
METHODS: Systematic review with meta-analysis.
METHODS: RCTs of deprescribing interventions where the DBI was measured as a primary or secondary outcome in humans within any setting were included.
METHODS: Electronic databases, citation indexes, and gray literature were searched from April 1, 2007, to September 1, 2023. Quality was assessed using the Cochrane risk-of-bias tool.
RESULTS: Of 1721 records identified, 9 met the inclusion criteria. Six interventions were delivered by pharmacists and 3 were delivered by pharmacists/nurses or pharmacists/geriatricians. All interventions required at least intermediate-level skills and involved multiple components and target groups. Studies were conducted in the community (n = 5), nursing homes (n = 2), and hospitals (n = 2). The mean or median age was ≥75 years and most participants were women in all studies. Most (n = 6) studies were underpowered. The follow-up period ranged from 3 to 12 months. Three studies reported a lower DBI in the intervention group compared with control: 1 pharmacist independent prescriber-delivered in nursing homes (adjusted rate ratio, 0.83; 95% CI, 0.74 to 0.92), 1 pharmacist/nurse practitioner-delivered in hospital (adjusted mean difference (MD), -0.28; 95% CI, -0.51 to -0.04), and 1 geriatrician/pharmacist-delivered in hospital (MD, -0.28; 95% CI, -0.52 to -0.04). Meta-analysis showed no difference in the change in DBI between control and intervention groups in the community including nursing homes (MD, -0.03; 95% CI, -0.08 to 0.01) or hospital setting (MD, -0.19; 95% CI, -0.45 to 0.06). Interventions had inconsistent effects on cognition and no effect on other reported outcomes.
CONCLUSIONS: RCTs of deprescribing interventions had no significant impact on reducing DBI or improving outcomes. Further suitably powered studies are required.

The Drug Burden Index (DBI) measures an individual\'s total exposure to anticholinergic and sedative medications. This systematic review aimed to investigate the association of the DBI with clinical and prescribing outcomes in observational pharmaco-epidemiological studies, and the effect of DBI exposure on functional outcomes in pre-clinical models.
A systematic search of nine electronic databases, citation indexes and gray literature was performed (April 1, 2007-December 31, 2022). Studies that reported primary data on the association of the DBI with clinical or prescribing outcomes conducted in any setting in humans aged ≥18 years or animals were included. Quality assessment was performed using the Joanna Briggs Institute critical appraisal tools and the Systematic Review Centre for Laboratory animal Experimentation risk of bias tool.
Of 2382 studies screened, 70 met the inclusion criteria (65 in humans, five in animals). In humans, outcomes reported included function (n = 56), cognition (n = 20), falls (n = 14), frailty (n = 7), mortality (n = 9), quality of life (n = 8), hospitalization (n = 7), length of stay (n = 5), readmission (n = 1), other clinical outcomes (n = 15) and prescribing outcomes (n = 2). A higher DBI was significantly associated with increased falls (11/14, 71%), poorer function (31/56, 55%), and cognition (11/20, 55%) related outcomes. Narrative synthesis was used due to significant heterogeneity in the study population, setting, study type, definition of DBI, and outcome measures. Results could not be pooled due to heterogeneity. In animals, outcomes reported included function (n = 18), frailty (n = 2), and mortality (n = 1). In pre-clinical studies, a higher DBI caused poorer function and frailty.
A higher DBI may be associated with an increased risk of falls and decreased function and cognition. Higher DBI was inconsistently associated with increased mortality, length of stay, frailty, hospitalization or reduced quality of life. Human observational findings with respect to functional outcomes are supported by preclinical interventional studies. The DBI may be used as a tool to identify older adults at higher risk of harm.

OBJECTIVE: 1) To understand and investigate the experiences of accredited clinical pharmacists (ACP) using computerised clinical decision support systems (CCDSS) during medication reviews for older people, including those living with dementia; 2) To design, develop, validate, and evaluate a CCDSS that incorporates pharmacological and other deprescribing tools to aid person-centred management of high-risk medications in older adults living with and without dementia.
METHODS: This study consisted of three phases and was designed on scenario-based methodology: a) the development phase, which included an exploratory survey and prototype building; b) the validation phase, which included qualitative data collection and usability testing with ACPs, general practitioners (GPs) and carers for people living with dementia; and c) the evaluation phase, using mixed-methods analyses.
RESULTS: The exploratory survey found that ACPs required a flexible, and reliable CCDSS to support them with clinical decisions regarding high-risk medication use in older adults. The Goal-directed Medication review Electronic Decision Support System (G-MEDSS)© was developed and validated using quantitative and qualitative feedback received from ACPs, GPs and carers for people with dementia. The mean (SD) System Usability Scale score was 69.0 (12.9), which indicated fair-good usability.
CONCLUSIONS: Involving end-users in the design process refined and improved the design of G-MEDSS, allowing for a person-centred and goal-directed delivery of pharmaceutical care. G-MEDSS allows healthcare practitioners conducting medication reviews for older adults living with and without dementia to tailor pharmaceutical care to meet their goals and preferences. Future studies may explore integration of G-MEDSS with prescribing or dispensing software.

Use of high-risk medications is common and associated with adverse effects in older adults, including those living with dementia. A Computerised Clinical Decision Support System (CCDSS) called G-MEDSS© (Goal-directed Medication Review Electronic Decision Support System) contains tools that identify medications with anticholinergic and sedative effects and align older adult\'s health and medication goals of care with medication management strategies.
To describe the utility of a CCDSS called G-MEDSS in Home Medicines Review (HMR) by an accredited clinical pharmacist (ACP) using a mixed-methods process evaluation method.
A mixed-methods process evaluation was conducted as part of a nation-wide cluster-randomised clinical trial evaluating the effectiveness of implementing G-MEDSS in HMR. Data were collected from ACPs and HMR recipients (the patient) using a feedback survey (ACPs and HMR recipients) and one-on-one telephone interviews (HMR recipients). Quantitative and qualitative data were combined at the start of analysis. Content analysis of the qualitative data was conducted, and emerging categories were linked to quantitative data.
Feedback surveys were completed by eight ACPs and 26 HMR recipients; 11 HMR recipients completed one-on-one telephone interviews. Overall, ACPs and HMR recipients who received the intervention reported a positive attitude towards the utility of G-MEDSS in HMR. ACPs reported that G-MEDSS enhanced their ability to make evidence-based recommendations about anticholinergic and sedative medications, and to better align HMR recommendations with HMR recipients\' goals of care. However, ACPs described that it was difficult to obtain goals of care from HMR recipients. HMR recipients gave mixed reports about the ACPs consultations: some HMR recipients reported that they were engaged in discussions about their views on medications, whilst other participants reported that discussions about their concerns towards medications and goals was limited.
This study suggests that a CCDSS, such as G-MEDSS, demonstrates good utility to assist ACPs to identify and assess anticholinergic and sedative medications. Given the mixed feedback from the ACPs on the different components of the G-MEDSS, further refinement of these tools and their use in combination in practice may be needed.

Older people living in the community have a high prevalence of polypharmacy and are vulnerable to adverse drug events. Home Medicines Review (HMR) is a collaborative medication review service involving general practitioners (GPs), accredited clinical pharmacists (ACPs) and patients, which aims to prevent medication-related problems. This study aims to evaluate the implementation of a Computerised Clinical Decision Support System (CCDSS) called G-MEDSS© (Goal-directed Medication Review Electronic Decision Support System) in HMRs to deprescribe anticholinergic and sedative medications, and to assess the effect of deprescribing on clinical outcomes.
This study consists of 2 stages: Stage I - a two-arm parallel-group cluster-randomised clinical trial, and Stage II - process evaluation of the CCDSS intervention in HMR. Community-dwelling older adults living with and without dementia who are referred for HMR by their GP and recruited by ACPs will be included in this study. G-MEDSS is a CCDSS designed to provide clinical decision support for healthcare practitioners when completing a medication review, to tailor care to meet the patients\' goals and preferences. The G-MEDSS contains three tools: The Goals of Care Management Tool, The Drug Burden Index (DBI) Calculator©, and The revised Patients\' Attitudes Towards Deprescribing (rPATD) questionnaire. The G-MEDSS produces patient-specific deprescribing reports, to be included as part of the ACPs communication with the patient\'s GP, and patient-specific reports for the patient (or carer). ACPs randomised to the intervention arm of the study will use G-MEDSS to create deprescribing reports for the referring GP and for their patient (or carer) when submitting the HMR report. ACPs in the comparison arm will provide the usual care HMR service (without the G-MEDSS).
The primary outcome is reduction in DBI exposure 3 months after HMR ± G-MEDSS intervention between comparison and intervention groups. The secondary outcomes include changes in clinical outcomes (physical and cognitive function, falls, institutionalisation, GP visits, medication adherence and mortality) 3-months after HMR.
This study is expected to add to the evidence that the combination of CCDSS supporting medication review can improve prescribing and clinical outcomes in older adults.
The trial was registered on the Australian New Zealand Clinical Trials Registry ACTRN12617000895381 on 19th June 2017.

UNASSIGNED: The Ghent Older People\'s Prescriptions community Pharmacy Screening (GheOP3 S)-tool was recently developed as an explicit screening tool to detect drug-related problems (DRPs) and to help in performing medication reviews. In this study, we aimed (a) to describe the characteristics of the detected DRPs and the subsequent pharmacists\' recommendations with their acceptance and implementation rate resulting from a pharmacist-led medication review using the GheOP3 S-tool and (b) to assess the potential impact of the intervention.
METHODS: Prospective observational study in community-dwelling older patients (70 years or older, using five or more medications). Community pharmacists performed medication reviews resulting in the documentation of “GheOP3 S-related DRPs” and “other DRPs” with corresponding pharmacists\' recommendations. Acceptance was recorded during face-to-face pharmacist-general practitioner (GP) meetings. Implementation was assessed after a 3-month follow-up by consulting the electronic pharmacy record, the patient, and/or GP. The potential impact on the number of medications, the number of “GheOP3 S-related DRPs”, the anticholinergic and sedative burden quantified by the Drug Burden Index (DBI), and medication costs was assessed by a pre-post comparison of the patients\' medication lists.
RESULTS: Twenty-one pharmacists detected 470 DRPs with a median (IQR) of 6 (4-8) per patient in 75 patients (about half “GheOP3 S-related DRPs” and half “other DRPs”). Most prevalent recommendations were stopping (22.9%) and substituting (18.9%) medication. Overall acceptance was 66.9%. At follow-up, 42.9% of all recommendations were implemented. The number of GheOP3 S-criteria (P < .001) and the DBI scores (P = .033) significantly differed from baseline. This was not the case for the number of chronic medications and medication costs.
CONCLUSIONS: This study demonstrates a relatively high acceptance of pharmacists\' recommendations, although implementation could be improved. Pharmacist-led medication reviews with multidisciplinary meetings using the GheOP3 S-tool can have a potential impact on the number of DRPs and the anticholinergic and sedative burden of patients.

To evaluate if a pharmacist-led medication review is effective at reducing the anticholinergic/sedative load, as measured by the Drug Burden Index (DBI).
Randomised controlled single blind trial.
15 community pharmacies in the Northern Netherlands.
157 community-dwelling patients aged ≥65 years who used ≥5 medicines for ≥3 months, including at least one psycholeptic/psychoanaleptic medication and who had a DBI≥1.
A medication review by the community pharmacist in collaboration with the patient\'s general practitioner and patient.
The primary outcome was the proportion of patients whose DBI decreased by at least 0.5. Secondary outcomes were the presence of anticholinergic/sedative side effects, falls, cognitive function, activities of daily living, quality of life, hospital admission and mortality. Data were collected at baseline and 3 months follow-up.
Mean participant age was 75.7 (SD, 6.9) years in the intervention arm and 76.6 (SD, 6.7) years in the control arm, the majority were female (respectively 69.3% and 72.0%). Logistic regression analysis showed no difference in the proportion of patients with a≥0.5 decrease in DBI between intervention arm (17.3%) and control arm (15.9%), (OR 1.04, CI 0.47 to 2.64, p=0.927). Intervention patients scored higher on the Digit Symbol Substitution Test, measure of cognitive function (OR 2.02, CI 1.11 to 3.67, p=0.021) and reported fewer sedative side effects (OR 0.61, CI 0.40 to 0.94, p=0.024) at follow-up. No significant difference was found for other secondary outcomes.
Pharmacist-led medication review as currently performed in the Netherlands was not effective in reducing the anticholinergic/sedative load, measured with the DBI, within the time frame of 3 months. Preventive strategies, signalling a rising load and taking action before chronic use of anticholinergic/sedative medication is established may be more successful.
NCT02317666.

BACKGROUND: Older people often use medications with anticholinergic or sedative side effects which increase the risk of falling and worsen cognitive impairment. The Drug Burden Index (DBI) is a measure of the burden of anticholinergic and sedative medications. Medication reviews are typically done by a pharmacist in collaboration with a general practitioner to optimise the medication use and reduce these adverse drug events. We will evaluate whether a Multidisciplinary Multistep Medication Review (3MR) is an effective intervention to reduce a patient\'s DBI.
METHODS: A randomised controlled trial including 160 patients from 15 community pharmacies will be conducted. Per pharmacy, 1 pharmacist will perform a structured 3MR in close collaboration with the general practitioner, including the objective to reduce the DBI.
METHODS: Primary outcome--the difference in proportion of patients having a decrease in DBI ≥ 0.5 in the intervention and control groups at follow-up. Secondary outcomes--anticholinergic and sedative side effects, falls, cognitive function, activities of daily living, quality of life, hospital admission, and mortality.
BACKGROUND: The burden of patients will be kept at a minimum. The 3MR can be considered as usual care by the pharmacist and general practitioner. Medical specialists will be consulted, if necessary. The intervention is specifically aimed at older community-dwelling patients in an attempt to optimise prescribing, in particular, to reduce medication with anticholinergic and sedative properties. Study results will be published in peer-reviewed journals and will be distributed through information channels targeting professionals.
BACKGROUND: NCT02317666; Pre-results.