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

The 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.

Withdrawal of hospital outpatient treatments in severe diseases due to unacceptable toxicity: A retrospective study from the register of patients and treatments.

AIM: To retrospectively analyse hospital outpatient treatment (HOT) withdrawal due to unacceptable toxicity at our hospital. Information regarding unacceptable toxicity leading to treatment withdrawal was recorded. METHODS: HOT interruptions because of unacceptable toxicity were identified from the Register of Patients and Treatments (RPT) (January 2014 to December 2017). Information regarding the demographic and clinical characteristics of patients, adverse drug reactions (ADRs) and drug treatments was retrieved from electronic health records. Causality and previous knowledge of ADRs were assessed according to the Spanish Pharmacovigilance System algorithm. Information regarding HOT risk management plans (RMPs) and their classification as inverted black triangle medicines was obtained from the European Medicines Agency (EMA). RESULTS: HOTs were withdrawn due to unacceptable toxicity in 136 (1.5%) registries corresponding to 135 (1.7%) patients. Fifty-one different HOTs (38.6% of those registered) were involved in 240 ADR/HOT pairs: 24 (47%) were additional monitoring medicines and 37 (72.5%) were EMA RMPs. The most frequent medicines involved in ADRs were lenalidomide (30, 12.5%) (mainly neutropenia, thrombocytopenia and bicytopenia), bevacizumab (19, 7.9%) (mainly venous and pulmonary thromboembolism) and sunitinib (13, 5.4%) (mainly thromboembolic events, diarrhoea and worsening of chronic renal failure). Cytopenia (40, 17.3%), diarrhoea (15, 6.5%), asthenia (9, 3.9%) and neuropathy (6, 2.6%) were the most frequent ADRs. All ADRs were severe, 10 (6 patients) had been poorly described or were unknown and only 9 (5 patients) had been reported by spontaneous notification. CONCLUSIONS: Valuable information regarding severe and unknown ADRs was obtained from the RPT. Such registers are useful tools to complement spontaneous ADR notifications.

Effectiveness and safety of drugs used for stroke prevention in a cohort of non-valvular atrial fibrillation patients from a primary care electronic database.

PURPOSE: The aim of this study was to assess effectiveness and safety of antithrombotics for stroke prevention in non-valvular atrial fibrillation in real-use conditions. METHODS: We used a population-based retrospective cohort study. Information emerges from SIDIAP, a database containing anonymized information from electronic health records from 274 primary healthcare centres of the Catalan Health Institute, Catalonia (Spain), with a reference population of 5 835 000 people. Population includes all adults with a new diagnosis of non-valvular atrial fibrillation registered in SIDIAP from 2007 to 2012. The main outcome of antithrombotics' effectiveness was stroke. The main outcomes of safety were cerebral and gastrointestinal haemorrhages. We also estimated all-cause mortality. We used multivariable Cox proportional hazard models to examine association between antithrombotic treatment and main outcomes. RESULTS: We included 22 205 subjects with non-valvular atrial fibrillation; 40.8% initiated on vitamin K antagonists (VKA), 33.4% on antiplatelets and 25.8% untreated. We found stroke-risk reduction with VKA, hazard ratio (HR) 0.72 (95% confidence interval (CI), 0.58-0.91), also seen in patients with CHADS2 ≥ 2, HR 0.65 (95%CI, 0.49-0.86), and CHA2 DS2 -VASc ≥ 2, HR 0.66 (95%CI, 0.52-0.84). We observed a higher risk of digestive bleeding with antiplatelets, HR 1.32 (95%CI, 1.01-1.73). Both VKA and antiplatelets were associated with reduction of all-cause mortality risk; HR 0.55 (95%CI, 0.49-0.62) and HR 0.89 (95%CI, 0.80-0.97), respectively. CONCLUSIONS: This study found a stroke-risk reduction associated with VKA and an increased risk of gastrointestinal bleeding associated with platelet-aggregation inhibitors in comparison with untreated patients. Both antithrombotic groups showed a reduction in all-cause mortality. Copyright © 2016 John Wiley & Sons, Ltd.

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.

PURPOSE: 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. PARTICIPANTS: 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. FINDINGS TO DATE: 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. FUTURE PLANS: 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.

Dabigatran - a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs.

BACKGROUND: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are 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 have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use. OBJECTIVE: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups. METHODOLOGY: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. RESULTS: There has been a plethora of activities among authorities to manage the prescribing of 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. CONCLUSION: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

Analysis of benzodiazepine withdrawal program managed by primary care nurses in Spain.

BACKGROUND: Benzodiazepine (BZD), the long-term treatment of which is harmful for cognitive function, is widely prescribed by General Practitioners in Spain. Based on studies performed in other countries we designed a nurse-led BZD withdrawal program adapted to Spanish Primary Care working conditions. RESULTS: A pseudo-experimental (before-after) study took place in two Primary Care Centres in Barcelona. From a sample of 1150 patients, 79 were identified. They were over 44 years old and had been daily users of BZD for a period exceeding six months. Out of the target group 51 patients agreed to participate. BZD dosage was reduced every 2-4 weeks by 25% of the initial dose with the optional support of Hydroxyzine or Valerian. The rating measurements were: reduction of BZD prescription, demographic variables, the Short-Form Health Survey (SF-12) to measure quality of life, the Medical Outcomes Study (MOS) Sleep Scale, and the Goldberg Depression and Anxiety Scale.By the end of the six-month intervention, 80.4% of the patients had discontinued BZD and 64% maintained abstinence at one year. An improvement in all parameters of the Goldberg scale (p <0.05) and in the mental component of SF-12 at 3.3 points (p = 0.024), as well as in most components of the MOS scale, was observed in the group that had discontinued BZD. No significant differences in these scales before and after the intervention were observed in the group that had not discontinued. CONCLUSIONS: At one year approximately 2/3 of the patients had ceased taking BZD. They showed an overall improvement in depression and anxiety scales, and in the mental component of the quality of life scale. There was no apparent reduction in the sleep quality indicators in most of the analysed components. Nurses in a Primary Care setting can successfully implement a BZD withdrawal program.

Lipid-lowering drugs in ischaemic heart disease: a quasi-experimental uncontrolled before-and-after study of the effectiveness of clinical practice guidelines.

BACKGROUND: Cardiovascular diseases(CVD), specifically ischaemic heart disease(IHD), are the main causes of death in industrialized countries. Statins are not usually prescribed in the most appropriate way. To ensure the correct prescription of these drugs, it is necessary to develop, disseminate and implement clinical practice guidelines(CPGs), and subsequently evaluate them. The main objective of this study is to evaluate the effectiveness of the implementation of consensual Lipid-lowering drugs (LLD) prescription guidelines in hospital and primary care settings, to improve the control of Low-Density Lipoprotein Cholesterol (LDL-C) levels in patients with IHD in the Terres de l'Ebre region covered by the Catalonian Health Institute. Secondary objectives are to assess the improvement of the prescription profile of these LLDs, to assess cardiovascular morbimortality and the professional profile and participant centre characteristics that govern the control of LDL-C. DESIGN: Quasi-experimental uncontrolled before and after study. The intervention consists of the delivery of training strategies for guideline implementation (classroom clinical sessions and on-line courses) aimed at primary care and hospital physicians. The improvement in the control of LDL-C levels in the 3,402 patients with IHD in our territory is then assessed. SCOPE: Primary care physicians from 11 basic health areas(BHAs) and two hospital services (internal medicine and cardiology). SAMPLE: 3,402 patients registered with IHD in the database of the Catalan Institute of Health(E-cap) before December 2008 and patients newly diagnosed during 2009-2010. VARIABLES: Percentage of patients achieving good control of LDL-C, measured in milligrams per decilitre. The aim of the intervention is to achieve levels of LDL-C < 100 mg/dl in patients with IHD. Secondary variables measure type and time of diagnosis of IHD, type and dose of prescribed cholesterol-lowering drugs, level of physician participation in training activities and their professional profile. DISCUSSION: The development of prescription guidelines previously agreed by various medical specialists involved in treating IHD patients have usually improved drug prescription. The guideline presented in this study aims to improve the control of LDL-C by training physicians through presential and on-line courses on the dissemination of this guideline, and by providing feedback on their personal results a year after this training intervention.

Estándares de calidad de la prescripción farmacológica en hospitales y en atención primaria / Quality indicators of drug prescription in hospitals and in primary care

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Investigación en atención primaria como fuente de conocimiento / Primary health care research as source

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[Antimicrobial susceptibility of uropathogens and outcome following antibiotic treatment for urinary tract infections in primary health care]. / Sensibilidad antimicrobiana de los uropatógenos y resultados del tratamiento antibiótico de las infecciones urinarias en atención primaria.

BACKGROUND AND OBJECTIVE: An increase in the resistance to antimicrobial agents among bacteria causing urinary tract infections (UTI) has been reported. The aim of this study was to relate uropathogen susceptibility to prescribed antibiotics for UTI to the clinical outcome after therapy in primary health care patients. METHODS: A prospective longitudinal study, including 118 women diagnosed with UTI was carried out in primary health care centers. The results of urine culture, antimicrobial susceptibility testing and the prescribed antibiotic treatment were recorded. The patients' clinical outcome and the results of follow-up urine cultures after therapy were also recorded. RESULTS: The uropathogens isolated were susceptible to the prescribed antibiotic in 86% of patients. Clinical improvement at two weeks was observed in 91% of patients with bacteria sensitive to the prescribed antibiotics and 7% of patients with resistant bacteria (P = 0.06). At 4-6 weeks, there were no clinical symptoms in 88% of patients with sensitive bacteria and 71% of patients with resistant bacteria (p = 0.23). In follow-up urine cultures, bacteria had been eradicated in 74% of patients with sensitive bacteria and 50% with resistant bacteria (p = 0.34). CONCLUSIONS: The majority of women diagnosed with UTI in primary health care had uropathogens sensitive to the prescribed antibiotic and treatment was effective at short term in this study. The results of antimicrobial susceptibility testing were not always related to the clinical outcome; bacterial resistance may overestimate the risk of therapeutic failure in UTI.

Sensibilidad antimicrobiana de los uropatógenos y resultados del tratamiento antibiótico de las infecciones urinarias en atención primaria / Antimicrobial susceptibility of uropathogens and outcome following antibiotic treatment for urinary tract infections in primary health care

Antecedentes y objetivo. Se ha descrito un aumento de las resistencias a los antimicrobianos en las bacterias productoras de infecciones del tracto urinario (ITU). El objetivo del estudio fue relacionar la sensibilidad de los microorganismos al tratamiento antibiótico prescrito con la evolución clínica de las pacientes con ITU diagnosticadas en atención primaria. Métodos. Estudio longitudinal y prospectivo en centros de atención primaria, que incluyó a 118 mujeres diagnosticadas de ITU. Se analizaron los resultados de los urocultivos, los antibiogramas y el tratamiento antibiótico prescrito. Se realizó un seguimiento de la evolución clínica de las pacientes y de los resultados de los urocultivos de control. Resultados. Las bacterias del urocultivo fueron sensibles al antibiótico prescrito en el 86% de las pacientes tratadas. El 91% de las pacientes con bacterias sensibles al antibiótico prescrito y el 71% de las pacientes con un microorganismo resistente refirieron una mejoría clínica a las 2 semanas (p = 0,06). No presentaron síntomas clínicos a las 4-6 semanas el 88% de las pacientes con bacterias sensibles y el 71% de las pacientes con bacterias resistentes (p = 0,23). En los urocultivos de control se erradicaron las bacterias en el 74% de las pacientes con bacterias sensibles y en el 50% de las pacientes con bacterias resistentes (p = 0,34). Conclusiones. En este estudio, la mayoría de las mujeres diagnosticadas de ITU en atención primaria tuvieron uropatógenos sensibles a los antibióticos prescritos y el tratamiento a corto plazo fue efectivo. Los resultados del antibiograma no siempre se correlacionan con el resultado clínico y las resistencias antimicrobianas pueden sobreestimar el riesgo de fracaso terapéutico en las ITU (AU)

Background and objective. An increase in the resistance to antimicrobial agents among bacteria causing urinary tract infections (UTI) has been reported. The aim of this study was to relate uropathogen susceptibility to prescribed antibiotics for UTI to the clinical outcome after therapy in primary health care patients. Methods. A prospective longitudinal study, including 118 women diagnosed with UTI was carried out in primary health care centers. The results of urine culture, antimicrobial susceptibility testing and the prescribed antibiotic treatment were recorded. The patients' clinical outcome and the results of follow-up urine cultures after therapy were also recorded. Results. The uropathogens isolated were susceptible to the prescribed antibiotic in 86% of patients. Clinical improvement at two weeks was observed in 91% of patients with bacteria sensitive to the prescribed antibiotics and 7% of patients with resistant bacteria (P = 0.06). At 4-6 weeks, there were no clinical symptoms in 88% of patients with sensitive bacteria and 71% of patients with resistant bacteria (p = 0.23). In follow-up urine cultures, bacteria had been eradicated in 74% of patients with sensitive bacteria and 50% with resistant bacteria (p = 0.34). Conclusions. The majority of women diagnosed with UTI in primary health care had uropathogens sensitive to the prescribed antibiotic and treatment was effective at short term in this study. The results of antimicrobial susceptibility testing were not always related to the clinical outcome; bacterial resistance may overestimate the risk of therapeutic failure in UTI (AU)

Prevención primaria del infarto de miocardio con ácido acetilsalicílico / Primary prevention of acute myocardial infarction with aspirin

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