Impact of a system to assist in clinical decision-making in primary healthcare in Catalonia : prescription Self Audit

Altres ajuts: Institut Universitari d'Investigació en Atenció Primària (IDIAP Jordi Gol). Scholarship to complete a PhD thesis in primary care.In 2008, in the context of a complete computerisation of medical records, the Institut Català de la Salut (ICS, Catalan Health Institute) implemented a system in its electronic clinical workstation (ECW) to assist decision-making at the prescription level. This system is known as Self Audit, and it supports physicians in reviewing the medication of their patients. Self Audit provides lists of patients presenting medication-related problems (MRPs) that have potential for improvement, and provides therapeutic recommendations that are easy to apply from the system itself. The aim of this study was to analyse the main results derived from the use of Self Audit in primary care (PC) in Catalonia, and the effect of an incentive-based safety indicator on the results obtained. A descriptive cross-sectional study was carried out to analyse variations in the MRPs detected by Self Audit during 2016, 2017, and 2018 in PC in Catalonia. The effect of a safety indicator on the results obtained was also studied. This safety indicator includes the most clinically relevant MRPs (i.e., therapeutic duplications, safety alerts from the Spanish Medicines Agency, and incidences of polymedication in patients over 65 years of age). Variation in the MRPs was measured using the differences between two evaluation points (initial and final). An MRP was considered resolved if the recommendation specified in the alert was followed. The prescriptions of 6411 PC doctors of the ICS who use the ECW and provide their services to 5.8 million Catalans through 288 PC teams were analysed. Analysis of the total safety-based MRPs detected by Self Audit gave overall resolutions from April to December of 9% (21,547) in 2016, 7% (15,924) in 2017, and 1% (2392) in 2018 out of the total number of MRPs recorded in April each year. Examination of the 3 types of MRPs with the highest clinical relevance that were linked to the safety indicator gave overall resolutions of 41% in 2016 (17,358), 20% in 2017 (7655), and 21% in 2018 (8135). The ICS Self Audit tool assists in reducing the number of safety-based MRPs in a systematic manner, and yields superior results for the MRPs linked to a safety indicator included in the incentives of PC physicians

Impact of a system to assist in clinical decision-making in primary healthcare in Catalonia: prescription Self Audit

Clinical safety; Decision support system; Primary careSeguridad clínica; Sistema de soporte a la decisión; Atención primariaSeguretat clínica; Sistema de suport a la decisió; Atenció primàriaBackground In 2008, in the context of a complete computerisation of medical records, the Institut Català de la Salut (ICS, Catalan Health Institute) implemented a system in its electronic clinical workstation (ECW) to assist decision-making at the prescription level. This system is known as Self Audit, and it supports physicians in reviewing the medication of their patients. Self Audit provides lists of patients presenting medication-related problems (MRPs) that have potential for improvement, and provides therapeutic recommendations that are easy to apply from the system itself. The aim of this study was to analyse the main results derived from the use of Self Audit in primary care (PC) in Catalonia, and the effect of an incentive-based safety indicator on the results obtained. Methods A descriptive cross-sectional study was carried out to analyse variations in the MRPs detected by Self Audit during 2016, 2017, and 2018 in PC in Catalonia. The effect of a safety indicator on the results obtained was also studied. This safety indicator includes the most clinically relevant MRPs (i.e., therapeutic duplications, safety alerts from the Spanish Medicines Agency, and incidences of polymedication in patients over 65 years of age). Variation in the MRPs was measured using the differences between two evaluation points (initial and final). An MRP was considered resolved if the recommendation specified in the alert was followed. The prescriptions of 6411 PC doctors of the ICS who use the ECW and provide their services to 5.8 million Catalans through 288 PC teams were analysed. Results Analysis of the total safety-based MRPs detected by Self Audit gave overall resolutions from April to December of 9% (21,547) in 2016, 7% (15,924) in 2017, and 1% (2392) in 2018 out of the total number of MRPs recorded in April each year. Examination of the 3 types of MRPs with the highest clinical relevance that were linked to the safety indicator gave overall resolutions of 41% in 2016 (17,358), 20% in 2017 (7655), and 21% in 2018 (8135). Conclusions The ICS Self Audit tool assists in reducing the number of safety-based MRPs in a systematic manner, and yields superior results for the MRPs linked to a safety indicator included in the incentives of PC physicians.The primary care component of this study was funded by the Institut Universitari d’Investigació en Atenció Primària (IDIAP Jordi Gol). Scholarship to complete a PhD thesis in primary care

Spontaneously Reported Adverse Drug Reactions and Their Description in Hospital Discharge Reports: A Retrospective Study

Reacció adversa al fàrmac; Informe d'alta hospitalària; FarmacovigilànciaReacción adversa al medicamento; Informe de alta hospitalaria; FarmacovigilanciaAdverse drug reaction; Hospital discharge report; PharmacovigilanceThe inclusion of spontaneously reported adverse drug reactions (ADRs) in hospital discharge reports was examined, in addition to the factors associated with their inclusion, the resulting therapeutic decisions, and any recommendations made upon patient discharge regarding the suspected offending drugs. ADRs that were spontaneously reported during 2017 and 2018 to the pharmacovigilance program were retrospectively analyzed. Information regarding patient characteristics, drug treatments, and ADRs was collected from the ADR notifications and from patient electronic medical records. The dependent variable was the mentioning of ADRs in the discharge reports, while characteristics of the ADRs, pharmacovigilance causality algorithms, and some of the suspected drugs themselves were the independent variables during bivariant analysis. A total of 286 reports of suspected ADRs from 271 patients (50.2% female; 77% adults) were included. Information regarding the ADRs was present in the discharge reports for 238 reports (83.2%); the ADR seriousness and the lack of potential alternative causes were the only associated factors. Withdrawal or withdrawal and substitution by an alternative drug were the most common therapeutic decisions, although often no recommendation was made. Overall, there is still room for improvement in terms of including information related to ADRs in hospital discharge reports.This research received no external funding

Effectiveness, safety and costs of thromboembolic prevention in patients with non-valvular atrial fibrillation : phase I ESC-FA protocol study and baseline characteristics of a cohort from a primary care electronic database

Atrial fibrillation is the most common arrhythmia. Its management aims to reduce symptoms and to prevent complications through rate and rhythm control, management of concomitant cardiac diseases and prevention of related complications, mainly stroke. The main objective of Effectiveness, Safety and Costs in Atrial Fibrillation (ESC-FA) study is to analyse the drugs used for the management of the disease in real-use conditions, particularly the antithrombotic agents for stroke prevention. The aim of this work is to present the study protocol of phase I of the ESC-FA study and the baseline characteristics of newly diagnosed patients with atrial fibrillation in Catalonia, Spain. The data source is System for the Improvement of Research in Primary Care (SIDIAP) database. The population included are all patients with non-valvular atrial fibrillation diagnosis registered in the electronic health records during 2007-2012. A total of 22 585 patients with non-valvular atrial fibrillation were included in the baseline description. Their mean age was 72.8 years and 51.6% were men. The most commonly prescribed antithrombotics were vitamin K antagonists (40.1% of patients) and platelet aggregation inhibitors (32.9%); 25.3% had not been prescribed antithrombotic treatment. Age, gender, comorbidities and co-medication at baseline were similar to those reported for previous studies. The next phase in the ESC-FA study will involve assessing the effectiveness and safety of antithrombotic treatments, analysing stroke events and bleeding episodes' rates in our patients (rest of phase I), describing the current management of the disease and its costs in our setting, and assessing how the introduction of new oral anticoagulants changes the stroke prevention in non-valvular atrial fibrillation

Safer prescription of drugs : impact of the PREFASEG system to aid clinical decision-making in primary care in Catalonia

In 2008, the Institut Català de la Salut (ICS, Catalan Health Institute) implemented a prescription decision support system in its electronic clinical workstation (ECW), which automatically generates online alerts for general practitioners when a possible medication-related problem (MRP) is detected. This tool is known as PREFASEG, and at the time of beginning a new treatment, it automatically assesses the suitability of the treatment for the individual patient. This analysis is based on ongoing treatments, demographic characteristics, existing pathologies, and patient biochemical variables. As a result of the assessment, therapeutic recommendations are provided. The objective of this study is to present the PREFASEG tool, analyse the main alerts that it generates, and determine the degree of alert acceptance. A cross-sectional descriptive study was carried out to analyse the generation of MRP-related alerts detected by PREFASEG during 2016, 2017, and 2018 in primary care (PC) in Catalonia. The number of MRP alerts generated, the drugs involved, and the acceptance/rejection of the alerts were analysed. An alert was considered "accepted" when the medication that generated the alert was not prescribed, thereby following the recommendation given by the tool. The MRP alerts studied were therapeutic duplications, safety alerts issued by the Spanish Medicines Agency, and drugs not recommended for use in geriatrics. The prescriptions issued by 6411 ICS PC physicians who use the ECW and provide their services to 5.8 million Catalans through 288 PC teams were analysed. During the 3 years examined, 67.2 million new prescriptions were analysed, for which PREFASEG generated 4,379,866 alerts (1 for every 15 new treatments). A total of 1,222,159 alerts (28%) were accepted. Pharmacological interactions and therapeutic duplications were the most detected alerts, representing 40 and 30% of the total alerts, respectively. The main pharmacological groups involved in the safety alerts were nonsteroidal anti-inflammatory drugs and renin-angiotensin system inhibitors. During the period analysed, 28% of the prescriptions wherein a toxicity-related PREFASEG alert was generated led to treatment modification, thereby helping to prevent the generation of potential safety MRPs. However, the tool should be further improved to increase alert acceptance and thereby improve patient safety. The online version contains supplementary material available at 10.1186/s12911-021-01710-

Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs

Background : There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction. Objective : To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities. Methodology : (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies. Results : Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice. Conclusion : Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding