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Reducing the anticholinergic and sedative load in older patients on polypharmacy by pharmacist-led medication review: a randomised controlled trial.

ABSTRACT: OBJECTIVE:To evaluate if a pharmacist-led medication review is effective at reducing the anticholinergic/sedative load, as measured by the Drug Burden Index (DBI). DESIGN:Randomised controlled single blind trial. SETTING:15 community pharmacies in the Northern Netherlands. PARTICIPANTS: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. INTERVENTION:A medication review by the community pharmacist in collaboration with the patient's general practitioner and patient. PRIMARY AND SECONDARY OUTCOMES MEASURES: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. 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 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. CONCLUSIONS: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. TRIAL REGISTRATION NUMBER:NCT02317666.

SUBMITTER: van der Meer HG

PROVIDER: S-EPMC6059312 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Reducing the anticholinergic and sedative load in older patients on polypharmacy by pharmacist-led medication review: a randomised controlled trial.

van der Meer Helene G HG Wouters Hans H Pont Lisa G LG Taxis Katja K

BMJ open 20180719 7

<h4>Objective</h4>To evaluate if a pharmacist-led medication review is effective at reducing the anticholinergic/sedative load, as measured by the Drug Burden Index (DBI).<h4>Design</h4>Randomised controlled single blind trial.<h4>Setting</h4>15 community pharmacies in the Northern Netherlands.<h4>Participants</h4>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.<h4>Intervention< ...[more]

PMID: 30030308

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Project description:BackgroundPatients taking medication with high anticholinergic and sedative properties are at increased risk of experiencing poor cognitive and physical outcomes. Therefore, precise quantification of the cumulative burden of their drug regimen is advisable. There is no agreement regarding which scale to use to simultaneously quantify the burden associated with medications.ObjectivesThe objective of this review was to assess the strengths and limitations of available tools to quantify medication-related anticholinergic burden and sedative load in older adults. We discuss specific limitations and agreements between currently available scales and models and propose a comprehensive table combining drugs categorized as high, moderate, low, or no anticholinergic or sedative activity as excerpted from the selected studies.MethodsA targeted search was carried out using the National Library of Medicine through PubMed using medical subject heading terms and text words around the following search terms: (anticholinergic OR sedative) AND (load OR burden OR scale) for studies published between 1 January 1945 and 5 June 2021. In addition, the following databases were searched using the same terms: MEDLINE-EBSCO, APA PsycInfo, CINAHL Plus, Cochrane Library, Scopus, OAIster, OVID-MEDLINE, Web of Science, and Google Scholar. Screening by titles was followed by an abstract and full-text review. After blind evaluation, agreement between reviewers was reached to establish drug characteristics and categories.ResultsAfter 3163 articles were identified, 13 were included: 11 assigned risk scores to anticholinergic drugs and two to sedative drugs. Considerable variability between anticholinergic scales was observed; scales included between 27 and 548 drugs. We generated a comprehensive table combining the anticholinergic and sedative activities of drugs evaluated and proposed a categorization of these drugs based on available scientific and clinical evidence. Our table combines information about 642 drugs and categorizes 44, 25, 99, and 474 drugs as high, moderate, low, or no anticholinergic and sedative activity, respectively.ConclusionsVariability and inconsistency exists among scales used to categorize drugs with anticholinergic or sedative burden. In this review, we provide a comprehensive table that proposes a new categorization of these drugs. A longitudinal study will be required to validate the new proposed anticholinergic and sedative burden catalog in an evidence-based manner.

Project description:BackgroundAnticholinergic/sedative medications are frequently used by older people, despite their negative impacts on cognitive and physical function. We explore the feasibility, acceptability and potential effectiveness of an innovative information technology (IT)-based intervention to prevent an increase in anticholinergic/sedative load in older people.MethodsThis was a prospective study in 51 Dutch community pharmacies. Pharmacists used an IT-based tool to identify patients aged ?65?years, with existing high anticholinergic/sedative loads (drug burden index ?2) and a newly initiated anticholinergic/sedative medication. We determined the following. Feasibility: number of eligible patients identified. Acceptability: pharmacists' satisfaction with the intervention, pharmacists' time investment and patients' willingness to reduce medication use. Potential effectiveness: number of recommendations, rate of agreement of general practitioners (GPs) with proposed recommendations and factors associated with agreement. To evaluate the latter, pharmacists conducted medication reviews and proposed recommendations to GPs for 5-10 patients selected by the IT-based tool.ResultsWe included 305 patients from 47 pharmacies. Feasibility: a mean of 17.0 (standard deviation, 8.8) patients were identified per pharmacy. Acceptability: 43 pharmacists (91.5%) were satisfied with the intervention. The median time investment per patient was 33?min (range 6.5-210). Of 35 patients, 30 (85.7%) were willing to reduce medication use. Potential effectiveness: pharmacists proposed 351 recommendations for 212 patients (69.5%). GPs agreed with recommendations for 108 patients (35.4%). Agreement to stop a medication was reached in 19.8% of recommendations for newly initiated medications (37 of 187) and for 15.2% of recommendations for existing medications (25 of 164). Agreement was more likely for recommendations on codeine [odds ratio (OR) 3.30; 95% confidence interval (CI) 1.14-9.57] or medications initiated by a specialist (OR 2.85; 95% CI 1.19-6.84) and less likely for pharmacies with lower level of collaboration with GPs (OR 0.15; 95% CI 0.02-0.97).ConclusionThis innovative IT-based intervention was feasible, acceptable and potentially effective. In one-third of patients an increase in anticholinergic/sedative load was prevented within reasonable time investment.

Project description:In 2010 the 'Polymedication Check' (PMC), a pharmacist-led medication review, was newly introduced to be delivered independently from the prescriber and reimbursed by the Swiss health insurances. This study aimed at evaluating the impact of this new cognitive service focusing on medicines use and patients' adherence in everyday life.This randomised controlled trial was conducted in 54 Swiss community pharmacies. Eligible patients used ?4 prescribed medicines over >3 months. The intervention group received a PMC at study start (T-0) and after 28 weeks (T-28) while the control group received only a PMC at T-28. Primary outcome measure was change in patients' objective adherence, calculated as Medication Possession Ratio (MPR) and Daily Polypharmacy Possession Ratio (DPPR), using refill data from the pharmacies and patient information of dosing. Subjective adherence was assessed as secondary outcome by self-report questionnaires (at T-0 and T-28) and telephone interviews (at T-2 and T-16), where participants estimated their overall adherence on a scale from 0-100%.A total of 450 patients were randomly allocated to intervention (N = 218, 48.4%) and control group (N = 232, 51.6%). Dropout rate was fairly low and comparable for both groups (N Int = 37 (17.0%), NCont = 41 (17.7%), p = 0.845). Main addressed drug-related problem (DRP) during PMC at T-0 was insufficient adherence to at least one medicine (N = 69, 26.7%). At T-28, 1020 chronic therapies fulfilled inclusion criteria for MPR calculation, representing 293 of 372 patients (78.8%). Mean MPR and adherence to polypharmacy (DPPR) for both groups were equally high (MPRInt = 88.3, SD = 19.03; MPRCont = 87.5, SD = 20.75 (p = 0.811) and DPPRInt = 88.0, SD = 13.31; DPPRCont = 87.5, SD = 20.75 (p = 0.906), respectively). Mean absolute change of subjective adherence between T-0 and T-2 was +1.03% in the intervention and -0.41% in the control group (p = 0.058). The number of patients reporting a change of their adherence of more than ±5 points on a scale 0-100% between T-0 and T-2 was significantly higher in the intervention group (NImprovement = 30; NWorsening = 14) than in the control group (NImprovement = 20; NWorsening = 24; p = 0.028).Through the PMC pharmacist were able to identify a significant number of DRPs. Participants showed high baseline objective adherence of 87.5%, providing little potential for improvement. Hence, no significant increase of objective adherence was observed. However, regarding changes in subjective adherence of more than ±5% the PMC showed a positive effect.Clinical trial registry database, NCT01739816; first entry on November 27, 2012.

Project description:Background/objectiveAs pharmacists work to ensure reimbursement for chronic disease management services on the national level, evidence of their impact on important health metrics, such as medication adherence, is needed. However, summative evidence is lacking on the effectiveness of pharmacists to improve medication adherence in older adults. The objective was to assess the effectiveness of pharmacist-led interventions on medication adherence in older adults (65+ years).Design/setting/participantsUsing a systematic review and meta-analytic approach, a comprehensive search of publications in PubMed, Scopus, CINAHL, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Google Scholar was conducted through April 2, 2020 for randomized clinical trials of pharmacist-led interventions to improve medication adherence in older adults. A standardized mean difference effect size (Cohen's d) was calculated for medication adherence in each study. Study effect sizes were pooled using a random-effects model, with effect sizes weighted by inverse of its total variance.MeasurementsMedication adherence using any method of measurement.ResultsAmong 40 unique randomized trials of pharmacist-led interventions with data from 8822 unique patients (mean age, range: 65-85 years), the mean effect size was 0.57 (k = 40; 95% Confidence Interval [CI]: 0.38-0.76). When two outlier studies were excluded from the analysis, the mean effect size reduced to 0.41 (k = 38; 95% CI: 0.27-0.54). A sensitivity analysis of medication adherence outcome by time point resulted in a mean effect size of 0.64 at 3 months (k = 12; 95% CI: 0.32-0.97), 0.30 at 6 months (k = 13; 95% CI: 0.11-0.48), 0.22 at 12 months (k = 12; 95% CI: 0.08-0.37), and 0.36 for outcome time points beyond 12 months (k = 5; 95% CI: 0.02-0.70).ConclusionThis meta-analysis found a significant improvement in medication adherence among older adults receiving pharmacist-led interventions. Implementation of pharmacist-led interventions supported by Medicare reimbursement could ensure older adults' access to effective medication adherence support.

Project description:BackgroundTargeted deprescribing of anticholinergic and sedative medications in older people may improve their health outcomes. This trial will determine if pharmacist-led reviews lead to general practitioners deprescribing anticholinergic and sedative medications in older people living in the community.Methods and analysisThe standard protocol items: Recommendations for Interventional Trials (SPIRIT) checklist was used to develop and report the protocol. The trial will involve older adults stratified by frailty (low, medium, and high). This will be a pragmatic two-arm randomized controlled trial to test general practitioner uptake of pharmacist recommendations to deprescribe anticholinergic and sedative medications that are causing adverse side effects in patients.Study populationCommunity-dwelling frail adults, 65 years or older, living in the Canterbury region of New Zealand, seeking publicly funded home support services or admission to aged residential care and taking at least one anticholinergic or sedative medication regularly.InterventionNew Zealand registered pharmacists using peer-reviewed deprescribing guidelines will visit participants at home in the community, review their medications, and recommend anticholinergic and sedative medications that could be deprescribed to the participant's general practitioner. The total use of anticholinergic and sedative medications will be quantified using the Drug Burden Index (DBI).OutcomesThe primary outcome will be the change in total DBI between baseline and 6-month follow-up. Secondary outcomes will include entry into aged residential care, prolonged hospitalization, and death.Data collection pointsData will be collected at the time of interRAI assessments (T0), at the time of the baseline review (T1), at 6 months following the baseline review (T2), and at the end of the study period, or end of study participation for participants admitted into aged residential care, or who died (T3).Ethics and disseminationEthical approval has been obtained from the Human, Disability and Ethics Committee: ethical number (17CEN265).Trial registrationClinicalTrials.gov ACTRN12618000729224 . Registered on May 2, 2018, with the Australian New Zealand Clinical Trials Registry.

Project description:BackgroundMedication review with follow-up (MRF) is a service where community pharmacists undertake a medication review with monthly follow-up to provide continuing care. The ConSIGUE Program assessed the impact and implementation of MRF for aged polypharmacy patients in Spanish Community Pharmacies. The present paper reports on the clinical impact evaluation phase of ConSIGUE.ObjectiveThe main objective of the study was to measure the effect of MRF on the primary outcome of the number of uncontrolled health problems. Secondary objectives were to analyze the drug-related problems (DRPs) identified as potential causes of ineffective or unsafe medications and the pharmacists' interventions implemented during MRF provision.MethodsAn open-label multi-centered cluster randomized study with comparison group (CG) was carried out in community pharmacies from 4 provinces in Spain during 6 months. The main inclusion criteria were patients over 64 years old, using 5 or more medicines. The intervention group (IG) received the MRF service (advanced medication review-type 3 MR) whereas patients in the CG received usual care.Results178 pharmacies recruited 1403 patients (IG= 688 patients; CG= 715 patients). During the 6 months of the study 72 patients were lost to follow up. The adjusted multi-level random effects models showed a significant reduction in the number of uncontrolled health problems over the periods in the IG (-0.72, 95% CI: -0.80, -0.65) and no change in the CG (-0.03, 95% CI: -0.10, 0.04). Main DRPs identified as potential causes of failures of uncontrolled health problems' treatment were undertreated condition (559 DRPs; 35.81%), lack of treatment adherence (261 DRP; 16.67%) and risk of adverse effects (207 DRPs; 13.53%). Interventions performed by pharmacist to solve DRP mainly included the addition (246 interventions; 14.67%) and change (330 interventions; 19.68%) of a medicine and educational interventions on medicine adherence (231 interventions; 13.78%) and non-pharmacological interventions (369 interventions; 22.01%).ConclusionsThis study provides evidence of the impact of community pharmacist on clinical outcomes for aged patients. It suggests that the provision of an MRF in collaboration with general medical practitioners and patients contributes to the improvement of aged polypharmacy patients' health status and reduces their problems related with the use of medicines.

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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.

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