Patient-centered pharmacovigilance: A review

Purpose: To determine through a literature review, the current status of patients’ involvement in adverse drug reactions (ADRs) reporting.Methods: Eighteen (18) studies which were published within the period from 2010 to 2016 were reviewed. The studies were extracted from seven databases, viz, Google Scholars, Medline, Academic Search Complete “EBSCO”, Health and Medical Complete ProQuest, Science Direct- Elsevier, SCOPUS and Wiley Online Library.Results: The review revealed that although the reports by patients were of good quality, the patients’ awareness of, and attitude towards, ADR reporting were generally poor.Conclusion: The results of this review suggest the need for patients’ enlightenment on ADRs reporting. Information on how to improve ADRs reporting is provided.Keywords: Adverse drug reaction, Patients’ reporting; Systematic review, Patient-centeredpharmacovigilanc

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

Índex de Qualitat de la Prescripció Farmacèutica (IQF). Versió 2013

Índice de Calidad de la Prescripción Farmacéutica; IQSPrescription Quality Index; PQIÍndex de Qualitat de la Prescripció Farmacèutica; IQSL’Índex de Qualitat de Prescripció Farmacèutica (IQF) és una eina de la qual es dota al Catsalut per mesurar la dimensió científic-tècnica de la qualitat de la prescripció farmacèutica. L’objectiu final de l’IQF és fomentar l’ús dels fàrmacs més cost-efectius i reduir la variabilitat entre els professionals d’atenció primària i especialitzada de Catalunya. L’IQF és una eina de gestió que permet avaluar de manera quantitativa i qualitativa la prescripció farmacològica efectuada pels metges d’una organització. D’aquesta manera, permet identificar les millors pràctiques i establir el gold standard o patró d’or de la prescripció, així com realitzar comparacions (benchmarking). Proporciona informació per a la presa de decisions, permet fixar els objectius de millora i és una eina d’implantació de polítiques sanitàries mitjançant la seva introducció en els contractes de gestió.El Índice de Calidad de Prescripción Farmacéutica (IQF) es una herramienta de la que se dota al CatSalut para medir la dimensión científico-técnica de la calidad de la prescripción farmacéutica. El objetivo final del IQF es fomentar el uso de los fármacos mas coste-efectivos y reducir la variabilidad entre los profesionales de atención primaria y especializada de Cataluña. El IQF es una herramienta de gestión que permite evaluar de manera cuantitativa y cualitativa la prescripción farmacológica efectuada por los médicos de una organización. De esta forma, permite identificar las mejores prácticas y establecer el gold standard o patrón de oro de la prescripción, así como realizar comparacones (benchmarking). Proporciona información para la toma de decisiones, permite fijar los objetivos de mejora y es una herramienta de implantación de políticas sanitarias mediante su introducción en los contratos de gestión

Índex de Qualitat de la Prescripció Farmacèutica (IQF). Versió 2014

Índice de Calidad de la Prescripción Farmacéutica; IQSPrescription Quality Index; PQIÍndex de Qualitat de la Prescripció Farmacèutica; IQSL’Índex de Qualitat de Prescripció Farmacèutica (IQF) és una eina de la qual es dota al Catsalut per mesurar la dimensió científic-tècnica de la qualitat de la prescripció farmacèutica. L’objectiu final de l’IQF és fomentar l’ús dels fàrmacs més cost-efectius i reduir la variabilitat entre els professionals d’atenció primària i especialitzada de Catalunya. L’IQF és una eina de gestió que permet avaluar de manera quantitativa i qualitativa la prescripció farmacològica efectuada pels metges d’una organització. D’aquesta manera, permet identificar les millors pràctiques i establir el gold standard o patró d’or de la prescripció, així com realitzar comparacions (benchmarking). Proporciona informació per a la presa de decisions, permet fixar els objectius de millora i és una eina d’implantació de polítiques sanitàries mitjançant la seva introducció en els contractes de gestió.El Índice de Calidad de Prescripción Farmacéutica (IQF) es una herramienta de la que se dota al CatSalut para medir la dimensión científico-técnica de la calidad de la prescripción farmacéutica. El objetivo final del IQF es fomentar el uso de los fármacos mas coste-efectivos y reducir la variabilidad entre los profesionales de atención primaria y especializada de Cataluña. El IQF es una herramienta de gestión que permite evaluar de manera cuantitativa y cualitativa la prescripción farmacológica efectuada por los médicos de una organización. De esta forma, permite identificar las mejores prácticas y establecer el gold standard o patrón de oro de la prescripción, así como realizar comparacones (benchmarking). Proporciona información para la toma de decisiones, permite fijar los objetivos de mejora y es una herramienta de implantación de políticas sanitarias mediante su introducción en los contratos de gestión

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