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1.
Br J Clin Pharmacol ; 89(12): 3758-3764, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37522371

RESUMEN

Deprescribing aims to address the problem of medication overuse in older adults. There has been an increasing number of systematic reviews of 'deprescribing'. We aimed to describe the categories of trials included in recent systematic reviews, and to make recommendations for future research. We categorized 122 trials included in eight recent deprescribing systematic reviews into: discontinuation, deprescribing implementation, medication optimisation (including medication initiation) and non-initiation trials. We identified heterogeneity and inconsistency in the categories of trials included in deprescribing systematic reviews. For example, 39 trials (32.0%) involved medication initiation in addition to the deprescribing component. It is now time for international researchers to develop and validate terminology used for trials involving discontinuation/deprescribing of medications, and to provide recommendations for evidence synthesis that will better inform future research, and translation into practice and policy.


Asunto(s)
Deprescripciones , Humanos , Anciano , Revisiones Sistemáticas como Asunto , Polifarmacia
2.
Age Ageing ; 52(1)2023 01 08.
Artículo en Inglés | MEDLINE | ID: mdl-36633299

RESUMEN

BACKGROUND: as a result of the high prevalence of polypharmacy in nursing homes (NHs), nursing home residents (NHRs) are exposed to numerous drug-drug interactions (DDIs) that can lead to adverse drug effects, and increased morbidity and mortality. OBJECTIVES: to evaluate (i) the prevalence of DDIs among NHRs and its evolution over time, and (ii) factors associated with a favourable evolution. DESIGN: posthoc analysis of the COME-ON study, a cluster-randomised controlled trial aiming at reducing potentially inappropriate prescriptions in NHs, through the implementation of a complex intervention. SETTING AND SUBJECTS: 901 NHRs from 54 Belgian NHs. METHODS: DDIs were identified using a validated list of 66 potentially clinically relevant DDIs in older adults. We defined a favourable evolution at 15 months as the resolution of at least one DDI present at baseline, without the introduction of any new DDI. Factors associated with a favourable evolution were analysed using multivariable logistic regression. RESULTS: at baseline, 475 NHRs (52.7%) were exposed to at least 1 DDI and 225 NHRs (25.0%) to more than one DDI. Most common DDI was 'Concomitant use of at least three central nervous system active drugs'. At 15 months, we observed a 6.3% absolute decrease in DDI prevalence in intervention group, and a 1.0% absolute increase in control group. The intervention, older age and private NH ownership were significantly associated with a favourable DDI evolution. CONCLUSION: a high prevalence of DDI in Belgian NHs was observed, but the COME-ON intervention was associated with a favourable evolution over time.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , Anciano , Interacciones Farmacológicas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Casas de Salud , Prescripción Inadecuada/prevención & control , Prescripción Inadecuada/efectos adversos , Prevalencia , Polifarmacia
3.
Age Ageing ; 52(1)2023 01 08.
Artículo en Inglés | MEDLINE | ID: mdl-36626323

RESUMEN

BACKGROUND: Diabetes overtreatment is a frequent and severe issue in multimorbid older patients with type 2 diabetes (T2D). OBJECTIVE: This study aimed at assessing the association between diabetes overtreatment and 1-year functional decline, hospitalisation and mortality in older inpatients with multimorbidity and polypharmacy. METHODS: Ancillary study of the European multicentre OPERAM project on multimorbid patients aged ≥70 years with T2D and glucose-lowering treatment (GLT). Diabetes overtreatment was defined according to the 2019 Endocrine Society guideline using HbA1c target range individualised according to the patient's overall health status and the use of GLT with a high risk of hypoglycaemia. Multivariable regressions were used to assess the association between diabetes overtreatment and the three outcomes. RESULTS: Among the 490 patients with T2D on GLT (median age: 78 years; 38% female), 168 (34.3%) had diabetes overtreatment. In patients with diabetes overtreatment as compared with those not overtreated, there was no difference in functional decline (29.3% vs 38.0%, P = 0.088) nor hospitalisation rates (107.3 vs 125.8/100 p-y, P = 0.115) but there was a higher mortality rate (32.8 vs 21.4/100 p-y, P = 0.033). In multivariable analyses, diabetes overtreatment was not associated with functional decline nor hospitalisation (hazard ratio, HR [95%CI]: 0.80 [0.63; 1.02]) but was associated with a higher mortality rate (HR [95%CI]: 1.64 [1.06; 2.52]). CONCLUSIONS: Diabetes overtreatment was associated with a higher mortality rate but not with hospitalisation or functional decline. Interventional studies should be undertaken to test the effect of de-intensifying GLT on clinical outcomes in overtreated patients.


Asunto(s)
Diabetes Mellitus Tipo 2 , Hipoglucemia , Humanos , Femenino , Anciano , Masculino , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Multimorbilidad , Polifarmacia
4.
Eur J Clin Pharmacol ; 78(10): 1633-1646, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-35896803

RESUMEN

PURPOSE: Successful deprescribing requires understanding the attitudes of older adults and caregivers towards this process. This study aimed to capture these attitudes in four French-speaking countries and to investigate associated factors. METHODS: A multicenter cross-sectional study was conducted by administrating the French version of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire in Belgium, Canada, France, and Switzerland. Community-dwelling or nursing home older adults ≥ 65 years taking ≥ 1 prescribed medications and caregivers of older adults with similar characteristics were included. Multivariate logistic regressions were carried out to examine factors associated with willingness to deprescribe. RESULTS: A total of 367 older adults (79.3 ± 8.7 years, 63% community-dwelling, 54% ≥ 5 medications) and 255 unrelated caregivers (64.4 ± 12.6 years) of care recipients (83.4 ± 7.9 years, 52% community-dwelling, 69% ≥ 5 medications) answered the questionnaire. Among them, 87.5% older adults and 75.6% caregivers would be willing to stop medications if the physician said it was possible. Reluctance to stop a medication taken for a long time was expressed by 46% of both older adults and caregivers. A low score for the factor "concerns about stopping" (older adults: aOR: 0.21; 95% CI: 0.07-0.59), and a high score for the factor "involvement" (older adults: aOR: 2.66; 95% CI: 1.01-7.07; caregivers: aOR: 11.28; 95% CI: 1.48-85.91) were associated with willingness to deprescribe. CONCLUSIONS: A significant proportion of older adults and caregivers of French-speaking countries are open to deprescribing. Despite this apparent willingness, deprescribing conversations in clinical practice remains marginal, emphasizing the importance of optimizing the integration of existing tools such as rPATD.


Asunto(s)
Deprescripciones , Anciano , Actitud , Cuidadores , Estudios Transversales , Humanos , Polifarmacia , Encuestas y Cuestionarios
5.
Age Ageing ; 51(1)2022 01 06.
Artículo en Inglés | MEDLINE | ID: mdl-34794171

RESUMEN

BACKGROUND: identifying drug-related hospital admissions (DRAs) in older people is difficult. A standardised chart review procedure has recently been developed. It includes an adjudication team (physician and pharmacist) screening using 26 triggers and then performing causality assessment to determine whether an adverse drug event (ADE) occurred (secondary to an adverse drug reaction, overuse, misuse or underuse) and whether the ADE contributed to hospital admission (DRA). OBJECTIVE: to assess the performance of those triggers in detecting DRA. DESIGN: retrospective study using data from the OPERAM (OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people) trial. SETTINGS: four European medical centres. SUBJECTS: multimorbid (≥ 3 chronic medical conditions) older (≥ 70 years) inpatients with polypharmacy (≥ 5 chronic medications) were enrolled in the OPERAM trial (N = 2,008) and followed for 12 months. We included patients with ≥1 adjudicated hospitalisation during the follow-up. METHODS: the positive predictive value (PPV; number of DRAs identified by trigger/number of triggers) was calculated for each trigger and for the tool as a whole. RESULTS: of 1,235 hospitalisations adjudicated for 832 patients, 716 (58%) had at least one trigger; an ADE was identified in 673 (54%) and 518 (42%) were adjudicated as DRAs. The overall PPV of the trigger tool for detecting DRAs was 0.66 [0.62-0.69]. CONCLUSIONS: this tool performs well for identifying DRAs in older people. Based on our results, a revised version of the tool was proposed but will require external validation before it can be incorporated into research and clinical practice.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Preparaciones Farmacéuticas , Anciano , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/diagnóstico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Hospitalización , Hospitales , Humanos , Polifarmacia , Estudios Retrospectivos
6.
BMC Geriatr ; 22(1): 88, 2022 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-35100982

RESUMEN

BACKGROUND: Benzodiazepine receptor agonist (BZRA) use is highly prevalent in hospitalised older people although these drugs are associated with numerous and serious adverse events. Deprescribing can reduce risks associated with chronic BZRA use. The aim of this study was to measure the prevalence of, and factors associated with, BZRA deprescribing in acute geriatric units. METHODS: During a one-year period, this multicentre retrospective study included patients aged ≥70 years, hospitalised in acute geriatric units, and using ≥1 BZRA on admission. BZRA deprescribing at discharge was defined as: ≥25% decrease in lorazepam-equivalent admission dose; discontinuation of all BZRAs; or cessation of a rescue prescription at discharge. BZRA cessation was defined as discontinuation of all BZRAs at discharge. We identified social, medical, geriatric and medication factors associated with BZRA deprescribing using logistic regression. RESULTS: In total, 561 patients were included (mean age: 85.3±5.9 years, 70% of women). BZRA deprescribing occurred in 240 (42.8%), including 85 with BZRA cessation (15.2%). Deprescribing occurred more frequently in patients with a BZRA-related adverse event on admission or during hospital stay (odds ratio (OR) 4.5; 95% confidence interval [2.6; 7.9]), with an antidepressant (1.6 [1.1; 2.4]) and a higher lorazepam-equivalent dosage on admission (OR 1.2 [1; 1.4]), and less frequently in patients with antipsychotic drug (OR 0.5 [0.3; 0.8]). BZRA cessation was more likely in patients with a BZRA-related adverse event (OR 2.2 [1.2; 4.3]) and a lower lorazepam-equivalent dosage on admission (OR 0.5 [0.3; 0.6]). CONCLUSIONS: During hospitalisation in the acute geriatric units of our hospital, BZRA deprescribing occurred in 42.8% of the patients. Identification of an BZRA-related adverse event by the treating physician appears to be a major factor: this reactive deprescribing accounted for 74% of cases in our study. Further prospective studies are needed to measure long-term persistence of in-hospital deprescribing and encourage proactive management.


Asunto(s)
Deprescripciones , Receptores de GABA-A , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Hospitales , Humanos , Estudios Retrospectivos
7.
BMC Geriatr ; 21(1): 571, 2021 10 18.
Artículo en Inglés | MEDLINE | ID: mdl-34663238

RESUMEN

BACKGROUND: Drug-drug interactions (DDIs) are highly prevalent in older patients but little is known about prevalence of DDIs over time. Our main objective was to assess changes in the prevalence and characteristics of drug-drug interactions (DDIs) during a one-year period after hospital admission in older people, and associated risk factors. METHODS: We conducted a sub-study of the European OPERAM trial (OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people), which assessed the effects of a structured medication review (experimental arm) compared to usual care (control arm) on reducing drug-related hospital readmissions. All OPERAM patients (≥70 years, with multimorbidity and polypharmacy, hospitalized in four centers in Bern, Brussels, Cork and Utrecht between December 2016 and October 2018, followed over 1 year) who were alive at hospital discharge and had full medication data during the index hospitalization (at baseline i.e., enrolment at admission, and at discharge) were included. DDIs were assessed using an international consensus list of potentially clinically significant DDIs in older people. The point-prevalence of DDIs was evaluated at baseline, discharge, and at 2, 6 and 12 months after hospitalization. Logistic regression models were performed to assess independent variables associated with changes in DDIs 2 months after baseline. RESULTS: Of the 1950 patients (median age 79 years) included, 1045 (54%) had at least one potentially clinically significant DDI at baseline; point-prevalence rates were 58, 57, 56 and 57% at discharge, and 2, 6 and 12 months, respectively. The prevalence increased significantly from baseline to discharge (P < .001 [significant only in the control group]), then remained stable over time (P for trend .31). The five most common DDIs -all pharmacodynamic in nature- accounted for 80% of all DDIs and involved drugs that affect potassium concentrations, centrally-acting drugs and antithrombotics. At 2 months, DDIs had increased in 459 (27%) patients and decreased in 331 (19%). The main factor predictive of a change in the prevalence of DDIs was hyperpolypharmacy (≥10 medications). CONCLUSIONS: DDIs were very common; their prevalence increased during hospitalization and tended to remain stable thereafter. Medication review may help control this increase and minimize the risk of adverse drug events.


Asunto(s)
Preparaciones Farmacéuticas , Polifarmacia , Anciano , Interacciones Farmacológicas , Hospitalización , Hospitales , Humanos , Prevalencia
8.
Malar J ; 19(1): 63, 2020 Feb 10.
Artículo en Inglés | MEDLINE | ID: mdl-32041619

RESUMEN

BACKGROUND: Efficient testing to identify poor quality artemisinin-based combination therapy (ACT) is important to optimize efforts to control and eliminate malaria. Healthcare professionals interact with both ACT and malaria patients they treat and hence could observe, first-hand, suspect poor quality artemisinin-based combinations linked to poor malaria treatment outcomes and the factors associated with inappropriate use or treatment failure. METHODS: A cross-sectional study of 685 HCP perspectives about the efficacy of ACT between June and July 2018 at selected health facilities in Uganda. Medicine samples were obtained from the seven regions of Uganda and tested for quality using the Germany Pharma Health Fund™ minilabs. RESULTS: The average age of the 685 respondents was 30 (SD = 7.4) years. There was an almost equal distribution between male and female respondents (51:49), respectively. Seventy percent (n = 480) were diploma holders and the nurses contributed to half (49%, n = 334) of the study population. Sixty-one percent of the HCPs reported having ever encountered ACT failures while treating uncomplicated malaria. Nineteen percent of HCPs thought that dihydroartemisinin/piperaquine gave the most satisfactory patient treatment outcomes, while 80% HCPs thought that artemether/lumefantrine gave the least satisfactory patient treatment outcomes, possibly due to dosing schedule and pill burden. Healthcare professionals from the Central region (OR = 3.0, CI 0.3-1.0; P = 0.0001), Eastern region (OR = 5.4, CI 2.9-9.8; P = 0.0001) and Northern region (OR = 5.3, CI 2.9-9.9; P = 0.0001) had a higher chance of encountering ACT failure in 4 weeks prior to the survey as compared to those from the western region. Healthcare professionals from private health facilities also had higher chances of encountering ACT failures in past 4 weeks as compared to those from public health facilities (OR = 2.7, CI 1.7-3.9; P = 0.0001). All 192 samples passed the quality screening tests. The random sample of 10% of all samples randomly obtained by the laboratory staff also passed the chemical content analysis and dissolution tests. CONCLUSION: ACT medicines are widely available over-the-counter to the public and it is very difficult to report and monitor a decrease in efficacy or treatment failure. The perspectives of HCPs on treatment failure or lack of efficacy may potentially guide optimization efforts of sampling methodologies for the quality survey of ACT medicines.


Asunto(s)
Antimaláricos/uso terapéutico , Artemisininas/uso terapéutico , Personal de Salud , Malaria/tratamiento farmacológico , Vigilancia de Productos Comercializados , Adulto , Antimaláricos/administración & dosificación , Combinación Arteméter y Lumefantrina/administración & dosificación , Artemisininas/administración & dosificación , Estudios Transversales , Resistencia a Medicamentos , Quimioterapia Combinada , Femenino , Personal de Salud/clasificación , Personal de Salud/estadística & datos numéricos , Humanos , Modelos Logísticos , Malaria/prevención & control , Masculino , Cooperación del Paciente , Plasmodium falciparum/efectos de los fármacos , Quinolinas/administración & dosificación , Sesquiterpenos/administración & dosificación , Encuestas y Cuestionarios , Comprimidos , Insuficiencia del Tratamiento , Uganda
9.
BMC Health Serv Res ; 20(1): 220, 2020 Mar 17.
Artículo en Inglés | MEDLINE | ID: mdl-32183810

RESUMEN

BACKGROUND: Several approaches to medication optimisation by identifying drug-related problems in older people have been described. Although some interventions have shown reductions in drug-related problems (DRPs), evidence supporting the effectiveness of medication reviews on clinical and economic outcomes is lacking. Application of the STOPP/START (version 2) explicit screening tool for inappropriate prescribing has decreased inappropriate prescribing and significantly reduced adverse drug reactions (ADRs) and associated healthcare costs in older patients with multi-morbidity and polypharmacy. Therefore, application of STOPP/START criteria during a medication review is likely to be beneficial. Incorporation of explicit screening tools into clinical decision support systems (CDSS) has gained traction as a means to improve both quality and efficiency in the rather time-consuming medication review process. Although CDSS can generate more potential inappropriate medication recommendations, some of these have been shown to be less clinically relevant, resulting in alert fatigue. Moreover, explicit tools such as STOPP/START do not cover all relevant DRPs on an individual patient level. The OPERAM study aims to assess the impact of a structured drug review on the quality of pharmacotherapy in older people with multi-morbidity and polypharmacy. The aim of this paper is to describe the structured, multi-component intervention of the OPERAM trial and compare it with the approach in the comparator arm. METHOD: This paper describes a multi-component intervention, integrating interventions that have demonstrated effectiveness in defining DRPs. The intervention involves a structured history-taking of medication (SHiM), a medication review according to the systemic tool to reduce inappropriate prescribing (STRIP) method, assisted by a clinical decision support system (STRIP Assistant, STRIPA) with integrated STOPP/START criteria (version 2), followed by shared decision-making with both patient and attending physician. The developed method integrates patient input, patient data, involvement from other healthcare professionals and CDSS-assistance into one structured intervention. DISCUSSION: The clinical and economical effectiveness of this experimental intervention will be evaluated in a cohort of hospitalised, older patients with multi-morbidity and polypharmacy in the multicentre, randomized controlled OPERAM trial (OPtimising thERapy to prevent Avoidable hospital admissions in the Multi-morbid elderly), which will be completed in the last quarter of 2019. TRIAL REGISTRATION: Universal Trial Number: U1111-1181-9400 Clinicaltrials.gov: NCT02986425, Registered 08 December 2016. FOPH (Swiss national portal): SNCTP000002183. Netherlands Trial Register: NTR6012 (07-10-2016).


Asunto(s)
Sistemas de Apoyo a Decisiones Clínicas , Hospitalización , Prescripción Inadecuada/prevención & control , Conciliación de Medicamentos/métodos , Lista de Medicamentos Potencialmente Inapropiados , Anciano , Enfermedad Crónica/tratamiento farmacológico , Estudios de Cohortes , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Humanos , Multimorbilidad , Polifarmacia , Proyectos de Investigación
11.
BMC Med ; 16(1): 21, 2018 02 13.
Artículo en Inglés | MEDLINE | ID: mdl-29433501

RESUMEN

BACKGROUND: Comparisons of clinical trial findings in systematic reviews can be hindered by the heterogeneity of the outcomes reported. Moreover, the outcomes that matter most to patients might be underreported. A core outcome set can address these issues, as it defines a minimum set of outcomes that should be reported in all clinical trials in a particular area of research. The objective in this study was to develop a core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy. METHODS: Firstly, eligible outcomes were identified through a systematic review of trials of medication review in older patients (≥65 years) and interviews with 15 older patients. Secondly, an international three-round Delphi survey in four countries involving patients, healthcare professionals, and experts was conducted to validate outcomes to be included in the core outcome set. Consensus meetings were conducted to validate the results. RESULTS: Of the 164 participants invited to take part in the Delphi survey, 150 completed Round 1, including 55 patients or family caregivers, 55 healthcare professionals, and 40 experts. A total of 129 participants completed all three rounds. Sixty-four eligible outcomes were extracted from 47 articles, 32 clinical trial protocols, and patient interviews. Thirty outcomes were removed and one added after Round 1, 18 outcomes were removed after Round 2, and seven after Round 3. Results were discussed during consensus meetings. Consensus was reached on seven outcomes, which constitute the core outcome set: drug-related hospital admissions; drug overuse; drug underuse; potentially inappropriate medications; clinically significant drug-drug interactions; health-related quality of life; pain relief. CONCLUSIONS: We developed a core outcome set of seven outcomes which should be used in future trials of medication review in multi-morbid older patients with polypharmacy.


Asunto(s)
Polifarmacia , Calidad de Vida/psicología , Anciano , Comorbilidad , Técnica Delphi , Humanos , Cumplimiento de la Medicación , Encuestas y Cuestionarios
12.
J Antimicrob Chemother ; 73(6): 1630-1638, 2018 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-29579214

RESUMEN

Objectives: To develop a population model describing temocillin pharmacokinetics (PK) in patients undergoing haemodialysis and investigate how pharmacokinetic/pharmacodynamic (PD) targets can be met with different dosage regimens. Patients and methods: Sixteen patients received the currently licenced dosing of 1, 2 or 3 g of temocillin (total of 61 doses) corresponding to an inter-dialytic period of 20, 44 or 68 h, respectively, and a dialysis period of 4 h. A non-linear mixed-effects model was developed jointly for total and unbound temocillin serum concentrations. The performance of clinically feasible dosing regimens was evaluated using a 5000-subject Monte Carlo (MC) simulation for determining the highest MIC for which the PK/PD target of 40%ƒT>MIC would be reached in 90% of patients [probability of target attainment (PTA)]. This PK study was registered at ClinicalTrials.gov (NCT02285075). Results: Temocillin unbound and total serum concentrations (429 samples) were used to fit an open two-compartment model with non-linear albumin binding and first-order elimination. In addition to total body clearance, dialysis clearance was modelled using the Michaels function. The currently licenced dosing achieved a 90% PTA for an MIC up to 8 mg/L. A new temocillin dosage regimen was designed that would achieve a 90% PTA for an MIC of 16 mg/L (MIC90 of target organisms) adjusted to patient weight and inter-dialytic period. Conclusions: Currently licensed dosage regimen is suboptimal for MICs >8 mg/L (frequently found in clinical isolates). Model-based simulations allowed suggestion of a new dosage regimen with improved probability of microbiological success, applicability in routine clinical practice and more appropriate for empirical therapy.


Asunto(s)
Antibacterianos/administración & dosificación , Antibacterianos/farmacocinética , Cálculo de Dosificación de Drogas , Penicilinas/administración & dosificación , Penicilinas/farmacocinética , Diálisis Renal/estadística & datos numéricos , Adulto , Anciano , Anciano de 80 o más Años , Peso Corporal , Femenino , Infecciones por Bacterias Gramnegativas/tratamiento farmacológico , Humanos , Masculino , Pruebas de Sensibilidad Microbiana , Persona de Mediana Edad , Método de Montecarlo , Dinámicas no Lineales , Adulto Joven
13.
Br J Clin Pharmacol ; 84(7): 1544-1556, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29522647

RESUMEN

AIMS: To determine the preventability of serious adverse drug reactions (ADRs) related to the use of direct oral anticoagulants (DOACs), and to explore contributing factors to preventable ADRs. Results were compared with vitamin K antagonists (VKAs). METHODS: We conducted a prospective observational study in the emergency departments of two teaching hospitals from July 2015 to January 2016. Patients admitted with a thrombotic or bleeding event while under DOAC or VKA were included. Four independent reviewers assessed causality, seriousness and preventability of ADRs using pilot-tested scales. For cases of serious and potentially preventable ADRs, we performed semi-structured interviews with general practitioners to identify contributing factors to ADRs. The primary outcome was the proportion of serious ADRs that were potentially preventable. RESULTS: The analysis included 46 DOAC and 43 VKA patients (median age 79 years). Gastrointestinal (n = 34) and intracranial (n = 16) bleedings were the most frequent ADRs. Results were that 53% of DOAC- and 61% of VKA-related serious ADRs were deemed potentially preventable. Prescribing issues and inadequate monitoring were frequent for DOAC and VKA respectively. We identified many causes of preventable ADRs that applied to all oral anticoagulants, such as pharmacodynamic drug interactions and lack of communication. CONCLUSIONS: More than half of serious ADRs were potentially preventable for both DOACs and VKAs. Interventions focusing on prescribing, patient education and continuity of care should help improve the use of DOACs in practice.


Asunto(s)
Anticoagulantes/efectos adversos , Hemorragia Gastrointestinal/prevención & control , Hemorragias Intracraneales/prevención & control , Tromboembolia/prevención & control , Administración Oral , Anciano , Anciano de 80 o más Años , Anticoagulantes/administración & dosificación , Fibrilación Atrial/prevención & control , Continuidad de la Atención al Paciente , Servicio de Urgencia en Hospital/estadística & datos numéricos , Femenino , Hemorragia Gastrointestinal/inducido químicamente , Hemorragia Gastrointestinal/epidemiología , Hospitalización/estadística & datos numéricos , Humanos , Hemorragias Intracraneales/inducido químicamente , Hemorragias Intracraneales/epidemiología , Masculino , Educación del Paciente como Asunto , Estudios Prospectivos , Accidente Cerebrovascular/prevención & control , Tromboembolia/inducido químicamente , Tromboembolia/epidemiología , Vitamina K/antagonistas & inhibidores
14.
Br J Clin Pharmacol ; 84(11): 2600-2614, 2018 11.
Artículo en Inglés | MEDLINE | ID: mdl-30007041

RESUMEN

AIMS: We aimed to develop a standardized chart review method to identify drug-related hospital admissions (DRA) in older people caused by non-preventable adverse drug reactions and preventable medication errors including overuse, underuse and misuse of medications: the DRA adjudication guide. METHODS: The DRA adjudication guide was developed based on design and test iterations with international and multidisciplinary input in four subsequent steps: literature review; evaluation of content validity using a Delphi consensus technique; a pilot test; and a reliability study. RESULTS: The DRA adjudication guide provides definitions, examples and step-by-step instructions to measure DRA. A three-step standardized chart review method was elaborated including: (i) data abstraction; (ii) explicit screening with a newly developed trigger tool for DRA in older people; and (iii) consensus adjudication for causality by a pharmacist and a physician using the World Health Organization-Uppsala Monitoring Centre and Hallas criteria. A 15-member international Delphi panel reached consensus agreement on 26 triggers for DRA in older people. The DRA adjudication guide showed good feasibility of use and achieved moderate inter-rater reliability for the evaluation of 16 cases by four European adjudication pairs (71% agreement, κ = 0.41). Disagreements arose mainly for cases with potential underuse. CONCLUSIONS: The DRA adjudication guide is the first standardized chart review method to identify DRA in older persons. Content validity, feasibility of use and inter-rater reliability were found to be satisfactory. The method can be used as an outcome measure for interventions targeted at improving quality and safety of medication use in older people.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Hospitalización/estadística & datos numéricos , Errores de Medicación/estadística & datos numéricos , Anciano , Técnica Delphi , Estudios de Factibilidad , Femenino , Humanos , Masculino , Variaciones Dependientes del Observador , Proyectos Piloto , Reproducibilidad de los Resultados
15.
Thromb J ; 16: 28, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30455596

RESUMEN

BACKGROUND: Serious bleeding events have been frequently described in patients taking direct oral anticoagulants (DOAC). In secondary analyses of phase 3 trials, DOAC plasma concentrations were shown to correlate with bleeding outcomes. This study aimed to describe rivaroxaban plasma levels in patients admitted to the emergency department (ED) for bleeding events. For each patient, risk factors for experiencing bleeding events were also investigated. METHODS: This analysis was part of an observational study conducted in the ED of two teaching hospitals. Plasma samples from 10 rivaroxaban-treated patients admitted for bleeding events were collected. Rivaroxaban plasma concentrations were determined by calibrated chromogenic anti-Xa assay. The measured rivaroxaban levels were then extrapolated at trough using a published population pharmacokinetic (PopPK) model, and compared to on-therapy ranges observed in large clinical trials. For each patient, clinical, medication and ABCB1 genotype data were collected. RESULTS: Rivaroxaban measurements varied from 5 to 358 ng/ml, with a post-intake delay ranging from 9 to 38 h. At trough, estimated plasma concentrations were between 12 and 251 ng/ml (median value 94 ng/ml). Four patients had higher-than-expected rivaroxaban levels. Inadequate dose regimen, excessive alcohol consumption and lack of treatment reassessment were observed in several patients. Half of patients were taking ≥1 drug with potential pharmacokinetics interactions (e.g. amiodarone, diltiazem), while half of patients were taking ≥1 drug increasing the risk of bleeding. All 3 patients with available genotyping data and higher-than-expected rivaroxaban levels were heterozygous or homozygous mutated for the ABCB1 1236C > T, 2677G > T, 3435 C > T and rs4148738 single nucleotide polymorphisms (SNP). CONCLUSIONS: Rivaroxaban patients admitted to the ED for bleeding events showed highly variable plasma concentrations. This analysis underlines the usefulness of rapid DOAC measurement and the value of PopPK models to estimate concentrations at trough in a context where the post-intake delay is unmanageable. Close patient follow-up, including renal function assessment and drug interactions review, is essential for bleeding risk minimization.

16.
Br J Clin Pharmacol ; 83(5): 942-952, 2017 05.
Artículo en Inglés | MEDLINE | ID: mdl-27891666

RESUMEN

AIM: Medication review has been advocated as one of the measures to tackle the challenge of polypharmacy in older patients, yet there is no consensus on how best to evaluate its efficacy. This study aimed to assess outcome reporting in trials of medication review in older patients. METHODS: Randomized controlled trials (RCTs), prospective studies and RCT protocols involving medication review performed in patients aged 65 years or older in any setting of care were identified from: (1) a recent systematic review; (2) RCT registries of ongoing studies; (3) the Cochrane library. The type, definition, and frequency of all outcomes reported were extracted independently by two researchers. RESULTS: Forty-seven RCTs or prospective published studies and 32 RCT protocols were identified. A total of 327 distinct outcomes were identified in the 47 published studies. Only one fifth (21%) of the studies evaluated the impact of medication reviews on adverse events such as drug reactions or drug-related hospital admissions. Most of the outcomes were related to medication use (n = 114, 35%) and healthcare use (n = 74, 23%). Very few outcomes were patient-related (n = 24, 7%). A total of 248 distinct outcomes were identified in the 32 RCT protocols. Overall, the number of outcomes and the number and type of health domains covered by the outcomes varied largely. CONCLUSION: Outcome reporting from RCTs concerning medication review in older patients is heterogeneous. This review highlights the need for a standardized core outcome set for medication review in older patients, to improve outcome reporting and evidence synthesis.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Administración del Tratamiento Farmacológico , Evaluación de Resultado en la Atención de Salud/métodos , Anciano , Humanos , Polifarmacia , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación
18.
Age Ageing ; 45(5): 589-92, 2016 09.
Artículo en Inglés | MEDLINE | ID: mdl-27496930

RESUMEN

Explicit criteria, such as the STOPP/START criteria, are increasingly used both in clinical practice and in research to identify potentially inappropriate prescribing in older people. In an article on the STOPP/START criteria version 2, O'Mahony et al have pointed out the advantages of developing computerised criteria. Both clinical decision support systems to support healthcare professionals and software applications to automatically detect inappropriate prescribing in research studies can be developed. In the process of developing such tools, difficulties may occur. In the context of a research study, we have developed an algorithm to automatically apply STOPP/START criteria version 2 to our research database. We comment in this paper on different kinds of difficulties encountered and make suggestions that could be taken into account when developing the next version of the criteria.


Asunto(s)
Servicios de Salud para Ancianos , Prescripción Inadecuada , Anciano , Algoritmos , Bases de Datos Factuales , Sistemas de Apoyo a Decisiones Clínicas , Prescripciones de Medicamentos , Servicios de Salud para Ancianos/estadística & datos numéricos , Humanos , Prescripción Inadecuada/estadística & datos numéricos , Lista de Medicamentos Potencialmente Inapropiados/estadística & datos numéricos , Programas Informáticos , Diseño de Software
20.
BMC Geriatr ; 15: 156, 2015 Dec 02.
Artículo en Inglés | MEDLINE | ID: mdl-26630873

RESUMEN

BACKGROUND: Little is known about the prevalence and clinical importance of potentially inappropriate prescribing instances (PIPs) in the very old (>80 years). The main objective was to describe the prevalence of PIPs according to START (Screening Tool to Alert doctors to Right Treatment; omissions) and,STOPP (Screening Tool of Older Person's Prescriptions; over/misuse) and the Beers list (over/misuse). Secondary objectives were to identify determinants if PIPs and to assess the clinical importance to modify the treatment in case of PIPs. METHODS: Cross-sectional analysis of baseline data of the BELFRAIL cohort, which included 567 Belgian patients aged 80 and older in primary care. Two independent researchers applied the screening tools to the study population to detect PIPs. Next, a multidisciplinary panel of experts rated the clinical importance of the PIPs on a subsample of 50 patients. RESULTS: In this very old population (median age 84 years, 63 % female), the screening detected START-PIPs in 59 % of patients, STOPP-PIPs in 41 % and Beers-PIPs in 32 %. Assessment of the clinical importance revealed that the most frequent PIPs were of moderate or major importance. In 28 % of the subsample, the relevance of the PIP was challenged by the global medical, functional and social background of the patient hence the validity of some criteria was questioned. CONCLUSION: Potentially inappropriate prescribing is highly prevalent in the very old. A good understanding of the patients' medical, functional and social context is crucial to assess the actual appropriateness of drug treatment.


Asunto(s)
Prescripción Inadecuada , Pautas de la Práctica en Medicina , Atención Primaria de Salud , Anciano de 80 o más Años , Bélgica , Estudios de Cohortes , Estudios Transversales , Femenino , Humanos , Prescripción Inadecuada/prevención & control , Prescripción Inadecuada/estadística & datos numéricos , Masculino , Sistemas de Entrada de Órdenes Médicas/estadística & datos numéricos , Lista de Medicamentos Potencialmente Inapropiados/estadística & datos numéricos , Pautas de la Práctica en Medicina/normas , Pautas de la Práctica en Medicina/estadística & datos numéricos , Prevalencia , Atención Primaria de Salud/métodos , Atención Primaria de Salud/normas
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