BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings. / BIOBADATOP: Registro Español de Dermatitis Atópica. Descripción y primeros resultados.

BACKGROUND: In recent years, remarkable improvements in our understanding of atopic dermatitis (AD) have revolutionized treatment perspectives, but access to reliable data from clinical practice is essential. MATERIALS AND METHOD: The Spanish Atopic Dermatitis Registry, BIOBADATOP, is a prospective, multicenter database that collects information on patients of all ages with AD requiring systemic therapy with conventional or novel drugs. We analyzed the registry to describe patient characteristics, diagnoses, treatments, and adverse events (AEs). RESULTS: We studied data entries for 258 patients who had received 347 systemic treatments for AD. Treatment was discontinued in 29.4% of cases, mostly due to a lack of effectiveness (in 10.7% of cases). A total of 132 AEs were described during follow-up. Eighty-six AEs (65%) were linked to a systemic treatment, most commonly dupilumab (39AEs) and cyclosporine (38AEs). The most common AEs were conjunctivitis (11patients), headache (6), hypertrichosis (5), and nausea (4). There was 1severe AE (acute mastoiditis) associated with cyclosporine. CONCLUSIONS: Initial findings on AEs from the Spanish BIOBADATOP registry are limited by short follow-up times precluding comparisons or calculation of crude and adjusted incidence rates. At the time of our analysis, no severe AEs had been reported for novel systemic therapies. BIOBADATOP will help answer questions on the effectiveness and safety of conventional and novel systemic therapies in AD.

Usefulness of ICD-10 diagnosis triggers to identify adverse drug events in emergency care. / Utilidad de los diagnósticos alertantes CIE-10 para identificar acontecimientos adversos por los medicamentos en los servicios de urgencias.

OBJECTIVES: To assess the usefulness of a tool based on ICD-10 diagnostic codes to identify patients who consult an emergency department for adverse drug events (ADE). METHODS: Prospective observational study, in which patients discharged from an emergency department during May to August 2022 with a diagnosis coded with one of the 27 ICD-10 diagnoses considered as triggers were included. ADE confirmation was carried out by analyzing drugs prescribed prior to admission, and through a discussion among experts and a phone interview with patients after hospital discharge. RESULTS: 1,143 patients with trigger diagnoses were evaluated, of which 310 (27.1%) corresponded to patients whose emergency visit was attributed to an ADE. A 58.4% of ADE consultations were found with three diagnostic codes: K59.0-Constipation (n = 87; 28.1%), I16.9-Hypertensive Crisis (n = 72; 23.2%) and I95.1-Orthostatic hypotension (n = 22; 7.1%). The diagnoses with the highest degree of association with consultations attributed to ADE were E16.2-Hypoglycemia, unspecified (73.7%) and E11.65-Type 2 diabetes mellitus with hyperglycemia (71.4%), while diagnoses D62-Acute posthemorrhagic anemia and I74.3-Embolism and thrombosis of arteries of the lower limbs were not attributed to any case of ADE. CONCLUSIONS: The ICD-10 codes associated with trigger diagnoses are a useful tool to identify patients who consult the emergency services with ADE and could be used to apply secondary prevention programs to avoid new consultations to the health care system.

[Translated article] Usefulness of ICD-10 diagnostic triggers to identify adverse drug events in emergency care.

OBJECTIVES: To assess the usefulness of a tool based on ICD-10 diagnostic codes to identify patients who consult an emergency department for adverse drug events (ADE). METHODS: Prospective observational study, in which patients discharged from an emergency department during May to August 2022 with a diagnosis coded with one of the 27 ICD-10 diagnoses considered as triggers were included. ADE confirmation was carried out by analyzing drugs prescribed prior to admission, and through a discussion among experts and a phone interview with patients after hospital discharge. RESULTS: 1143 patients with trigger diagnoses were evaluated, of which 310 (27.1%) corresponded to patients whose emergency visit was attributed to an ADE. A 58.4% of ADE consultations were found with three diagnostic codes: K59.0-Constipation (n = 87; 28.1%), I16.9-Hypertensive Crisis (n = 72; 23.2%) and I95.1-Orthostatic hypotension (n = 22; 7.1%). The diagnoses with the highest degree of association with consultations attributed to ADE were E16.2-Hypoglycemia, unspecified (73.7%) and E11.65-Type 2 diabetes mellitus with hyperglycemia (71.4%), while diagnoses D62-Acute posthemorrhagic anemia and I74.3-Embolism and thrombosis of arteries of the lower limbs were not attributed to any case of ADE. CONCLUSIONS: The ICD-10 codes associated with trigger diagnoses are a useful tool to identify patients who consult the emergency services with ADE and could be used to apply secondary prevention programs to avoid new consultations to the health care system.

Secukinumab as Biological Treatment for Psoriatic Arthritis in Real Clinical Practice. / Secukinumab como tratamiento biológico en la artritis psoriásica en práctica clínica real.

INTRODUCTION: Clinical trials of secukinumab have demonstrated their efficacy and safety in psoriatic arthritis as biological first choice or after inadequate response to other biological treatments. OBJECTIVE: To analyze the efficacy and safety of secukinumab in peripheral psoriatic arthritis over 12 months in real clinical practice. MATERIAL AND METHODS: Patients with active peripheral psoriatic arthritis who started treatment with secukinumab according to the technical specifications were included. Efficacy and safety were evaluated from baseline to 12 months comparing naive and non-naive to biological therapy patients. RESULTS: A total of 76 patients were included (22 naive and 54 non-naive to biological) with an age of 51.9 years (10.3) and duration of the disease of 9.5 years (7.1). Of them, 31.6% with dactylitis, 51.3% with enthesitis and the baseline DAPSA was 19.0 (9.8). The retention rate was high, 90.9% in naive and 81.5% in non-naïve patients, and the percentage of patients with a DAPSA less than or equal to 14 was higher in the naive patients even after adjusting for age, sex and FAMEsc (P=.016). The safety data were similar to those described in the clinical trials. CONCLUSIONS: Secukinumab is effective and safe in 12-month treatment in peripheral active psoriatic arthritis in real clinical practice, after inadequate response to TNF or as first biological treatment.

Sofosbuvir-based regimens for HCV in stage 4-stage 5 chronic kidney disease. A systematic review with meta-analysis.

BACKGROUND: Hepatitis C is an important agent of liver damage in patients with chronic kidney disease and the advent of DAAs has dramatically changed the management of HCV positive patients, including those with advanced CKD. Sofosbuvir is the backbone of many anti-HCV regimens based on DAAs but it remains unclear whether it is appropriate for HCV-infected patients with stage 4-5 CKD. STUDY AIMS AND DESIGN: We performed a systematic review of the literature with a meta-analysis of clinical studies in order to evaluate the efficacy and safety of SOF-based DAA regimens in patients with stage 4-5 CKD. The primary outcome was sustained viral response (as a measure of efficacy); the secondary outcomes were the frequency of SAEs and drop-outs due to AEs (as measures of tolerability). The random-effects model of DerSimonian and Laird was adopted, with heterogeneity and stratified analyses. RESULTS: Thirty clinical studies (n=1537 unique patients) were retrieved. The pooled SVR12 and SAEs rate was 0.99 (95% confidence intervals, 0.97; 1.0, I2=99.8%) and 0.09 (95% CI, 0.05; 0.13, I2=84.3%), respectively. The pooled SVR12 rate in studies with high HCV RNA levels at baseline was lower, 0.87 (95% CI, 0.75; 1.0, I2=73.3%) (P<0.001). The pooled drop-out rate due to AEs was 0.02 (95% CI, -0.01; 0.04, I2=16.1%). Common serious adverse events were anemia (n=26, 38%) and reduced eGFR (n=14, 19%). SAEs were more common in studies adopting full-dose sofosbuvir (pooled rate of SAEs 0.15, 95% CI, 0.06; 0.25; I2=80.1%) and in those based on ribavirin (0.15, 95% CI, 0.07; 0.23, I2=95.8%). Six studies (n=69 patients) reported eGFR levels at baseline/post- antiviral therapy; no consistent changes were found. CONCLUSIONS: SOF-based regimens appear safe and effective in patients with stage 4-5 CKD. Serum creatinine should be carefully monitored during therapy with SOF in patients with CKD. Randomized controlled studies in order to expand our knowledge on this point are under way.

Objectives and methodology of BIOBADASER phase iii. / Objetivos y metodología de la fase iii de BIOBADASER.

OBJECTIVE: Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III). METHODOLOGY: Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER Phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase iii began on 17 December 2015. RESULTS: During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations. CONCLUSIONS: BIOBADASER Phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores.

Biosimilars: A new scenario in biologic therapies. / Fármacos biosimilares: un nuevo escenario en las terapias biológicas.

There is no doubt that biologic therapies provide added value for health systems. However, due to their special nature, they also raise some questions that make highly rigorous and demanding quality control and monitoring of their use indispensable. This circumstance is reinforced with the appearance on the scene of biosimilars, which, given their lower cost, are having an increasing impact on the international market. The purpose of this article is to review the major issues posed by their manufacture, distribution and control systems, as well as the most important aspects related to their safety in clinical practice. In this report, we assess the pharmacovigilance of these products, with special attention to traceability, as a key tool to enable earlier detection of adverse events.

[Medication errors in a neonatal unit: One of the main adverse events]. / Los errores de tratamiento en una unidad neonatal, uno de los principales acontecimientos adversos.

INTRODUCTION: Neonatal units are one of the hospital areas most exposed to the committing of treatment errors. A medication error (ME) is defined as the avoidable incident secondary to drug misuse that causes or may cause harm to the patient. The aim of this paper is to present the incidence of ME (including feeding) reported in our neonatal unit and its characteristics and possible causal factors. A list of the strategies implemented for prevention is presented. MATERIAL AND METHODS: An analysis was performed on the ME declared in a neonatal unit. RESULTS: A total of 511 MEs have been reported over a period of seven years in the neonatal unit. The incidence in the critical care unit was 32.2 per 1000 hospital days or 20 per 100 patients, of which 0.22 per 1000 days had serious repercussions. The ME reported were, 39.5% prescribing errors, 68.1% administration errors, 0.6% were adverse drug reactions. Around two-thirds (65.4%) were produced by drugs, with 17% being intercepted. The large majority (89.4%) had no impact on the patient, but 0.6% caused permanent damage or death. Nurses reported 65.4% of MEs. The most commonly implicated causal factor was distraction (59%). Simple corrective action (alerts), and intermediate (protocols, clinical sessions and courses) and complex actions (causal analysis, monograph) were performed. CONCLUSIONS: It is essential to determine the current state of ME, in order to establish preventive measures and, together with teamwork and good practices, promote a climate of safety.

Prevalence and quality of informed consent for patients undergoing cosmetic procedures: a cross sectional study / Prevalencia y calidad del consentimiento informado de los pacientes sometidos a procedimientos estéticos: un estudio transversa / Prevalência e qualidade de consentimento informado para pacientes submetendo-se a procedimentos cosméticos: um estudo transversal

Abstract: Background: Failure of the physician to disclose potential risks and benefits associated with cosmetic procedures is one of the main causes of legal disputes over informed consent. The objective was to assess the prevalence and quality of the informed consent given by patients who undergone cosmetic procedures and its association with post-procedure adverse events. Methods: It was a cross-sectional, online, questionnaire-based study conducted during September and October 2020. Eligible adult male and female patients who were attending a governmental dermatology clinic at Al-Kharj city (Saudi Arabia) were invited to join the study. Results: A total of 246 patients were included in the study. Out of 246, 111 (45.1%) patients performed at least one cosmetic procedure before, and 89 (80.2%) of them signed an informed consent. 62 (69.7%) of them signed a consent before the procedure, 17 (19.1%) reported post-procedure adverse events, 16 (18.0%) reported dissatisfactions, and 27 (30.3%) reported either. None of the consent characteristics were significantly associated with higher prevalence of post-procedure adverse events or non-satisfactions. Conclusions: The prevalence and the quality of informed consent before cosmetic procedures are inadequate. Urgent corrections are required to protect the patient's rights and to legally protect the treating physician.

Resumen: Antecedentes: El hecho de que el médico no revele los posibles riesgos y beneficios asociados a los procedimientos estéticos es una de las principales causas de las disputas legales sobre el consentimiento informado. El objetivo fue evaluar la prevalencia y la calidad del consentimiento informado dado por los pacientes sometidos a procedimientos estéticos y su asociación con los eventos adversos posteriores al procedimiento. Métodos: Fue un estudio transversal, online, basado en un cuestionario, realizado durante septiembre y octubre de 2020. Se invitó a participar en el estudio a pacientes adultos de ambos sexos que acudían a una clínica dermatológica gubernamental en la ciudad de Al-Kharj (Arabia Saudí). Resultados: Un total de 246 pacientes fueron incluidos en el estudio. De los 246, 111 (45,1%) pacientes se habían sometido al menos a un procedimiento cosmético antes, y 89 (80,2%) de ellos firmaron un consentimiento informado. 62 (69,7%) de ellos firmaron un consentimiento antes del procedimiento, 17 (19,1%) informaron de acontecimientos adversos posteriores al procedimiento, 16 (18,0%) informaron de insatisfacciones y 27 (30,3%) informaron de cualquiera de los dos. Ninguna de las características del consentimiento se asoció significativamente con una mayor prevalencia de acontecimientos adversos posteriores al procedimiento o insatisfacciones. Conclusiones: La prevalencia y la calidad del consentimiento informado antes de los procedimientos cosméticos son inadecuadas. Se requieren correcciones urgentes para proteger los derechos del paciente y proteger legalmente al médico tratante.

Resumo: Contexto: A falha do médico em comunicar os potenciais riscos e benefícios associados a procedimentos cosméticos é uma das principais causas de disputas legais sobre consentimento informado. O objetivo foi avaliar a prevalência e qualidade do consentimento informado dado a pacientes que sofreram procedimentos cosméticos e sua associação com eventos adversos pós-procedimento. Métodos: Estudo transversal, online, baseado em questionário, realizado durante setembro e outubro de 2020. Pacientes homens e mulheres, adultos elegíveis, de uma clínica dermatológica governamental da cidade de Al-Kharj (Arábia Saudita) foram convidados a participar do estudo. Resultados: Um total de 246 pacientes foram incluídos no estudo. Dos 246, 111 (45.1%) pacientes realizaram pelo menos um procedimento cosmético anterior e 89 (80.2%) deles assinaram um consentimento informado. 62 (69.7%) deles assinaram um consentimento antes do procedimento, 17 (19.1%) relataram eventos adversos pós-procedimento, 16 (18.0%) relataram insatisfações e 27 (30.3%) relataram ambos. Nenhuma das características do consentimento foram significativamente associadas com mais alta prevalência de eventos adversos pós-procedimento ou não satisfação. Conclusões: A prevalência e a qualidade do consentimento informado antes de procedimentos cosméticos são inadequados. Correções urgentes são requeridas para proteger os direitos dos pacientes e para legalmente proteger o médico responsável.

[Adverse events self-declaration system and influenza vaccination coverage of healthcare workers in a tertiary hospital]. / Sistema de autodeclaración de acontecimientos adversos y cobertura de vacunación antigripal en profesionales sanitarios en un hospital universitario de tercer nivel.

INTRODUCTION: During the influenza vaccination campaign 2011-2012 we established a self-declaration system of adverse events (AEs) in healthcare workers (HCW). The aim of this study is to describe the vaccinated population and analyse vaccination coverage and self-declared AEs after the voluntary flu vaccination in a university hospital in Barcelona. METHODS: Observational study. We used the HCW immunization record to calculate the vaccination coverage. We collected AEs using a voluntary, anonymous, self-administered survey during the 2011-2012 flu vaccination campaign. We performed a logistic regression model to determine the associated factors to declare AEs. RESULTS: The influenza vaccination coverage in HCW was 30.5% (n=1,507/4,944). We received completed surveys from 358 vaccinated HCW (23.8% of all vaccinated). We registered AEs in 186 respondents to the survey (52.0% of all respondents). Of these, 75.3% (n=140) reported local symptoms after the flu vaccination, 9.7% (n=18) reported systemic symptoms and 15.1% (n=28) both local and systemic symptoms. No serious AEs were self-reported. Female sex and aged under 35 were both factors associated with declaring AEs. CONCLUSIONS: Our self-reporting system did not register serious AEs in HCW, resulting in an opportunity to improve HCW trust in flu vaccination.

[Towards a safety culture in the neonatal unit: Six years experience]. / Caminando hacia una cultura de seguridad en la unidad neonatal: experiencia de 6 años.

INTRODUCTION: A safety culture is the collective effort of an institution to direct its resources toward the goal of safety. MATERIAL AND METHODS: An analysis is performed on the six years of experience of the Committee on the Safety of Neonatal Patient. A mailbox was created for the declaration of adverse events, and measures for their correction were devised, such as case studies, continuous education, prevention of nosocomial infections, as well as information on the work done and its assessment. RESULTS: A total of 1287 reports of adverse events were received during the six years, of which 600 (50.8%) occurred in the neonatal ICU, with 15 (1.2%) contributing to death, and 1282 (99.6%) considered preventable. Simple corrective measures (notification, security alerts, etc.) were applied in 559 (43.4%), intermediate measures (protocols, monthly newsletter, etc.) in 692 (53.8%), and more complex measures (causal analysis, scripts, continuous education seminars, prospective studies, etc.) in 66 (5.1%). As regards nosocomial infections, the prevention strategies implemented (hand washing, insertion and maintenance of catheters) directly affected their improvement. Two surveys were conducted to determine the level of satisfaction with the Committee on the Safety of Neonatal Patient. A rating 7.5/10 was obtained in the local survey, while using the Spanish version of the Hospital Survey on Patient Safety Culture the rate was 7.26/10. CONCLUSIONS: A path to a culture of safety has been successfully started and carried out. Reporting the adverse events is the key to obtaining information on their nature, etiology and evolution, and to undertake possible prevention strategies.

[Validation of a method for notifying and monitoring medication errors in pediatrics]. / Validación en pediatría de un método para notificación y seguimiento de errores de medicación.

OBJECTIVE: To analyze the impact of a multidisciplinary and decentralized safety committee in the pediatric management unit, and the joint implementation of a computing network application for reporting medication errors, monitoring the follow-up of the errors, and an analysis of the improvements introduced. MATERIAL AND METHODS: An observational, descriptive, cross-sectional, pre-post intervention study was performed. An analysis was made of medication errors reported to the central safety committee in the twelve months prior to introduction, and those reported to the decentralized safety committee in the management unit in the nine months after implementation, using the computer application, and the strategies generated by the analysis of reported errors. MEASURED VARIABLES: Number of reported errors/10,000 days of stay, number of reported errors with harm per 10,000 days of stay, types of error, categories based on severity, stage of the process, and groups involved in the notification of medication errors. RESULTS: Reported medication errors increased 4.6 -fold, from 7.6 notifications of medication errors per 10,000 days of stay in the pre-intervention period to 36 in the post-intervention, rate ratio 0.21 (95% CI; 0.11-0.39) (P<.001). The medication errors with harm or requiring monitoring reported per 10,000 days of stay, was virtually unchanged from one period to the other ratio rate 0,77 (95% IC; 0,31-1,91) (P>.05). The notification of potential errors or errors without harm per 10,000 days of stay increased 17.4-fold (rate ratio 0.005., 95% CI; 0.001-0.026, P<.001). CONCLUSIONS: The increase in medication errors notified in the post-intervention period is a reflection of an increase in the motivation of health professionals to report errors through this new method.

Incapacidad de los pacientes por acontecimientos adversos en la Unidad de Cuidados Intensivos Polivalentes / Inability of patients due to adverse events in the Polyvalent Intensive Care Unit

INTRODUCCIÓN: la seguridad del paciente se basa en la necesidad de contrarrestar los efectos nocivos que tienen los eventos adversos sobre los pacientes. OBJETIVO: determinar el impacto de los acontecimientos adversos, en término de incapacidad, que aparecieron en los pacientes en que se reportó dicho incidente adverso. MÉTODOS: se realizó un estudio descriptivo prospectivo en la Unidad de Cuidados Intensivos Polivalentes del Hospital Provincial de Cienfuegos durante los meses de febrero-abril 2010. Para determinar la gravedad según categoría y su relación con invalidantes del paciente, se revisó el formulario internacional de la Sociedad Española de Medicina Intensiva y Unidades Coronarios. El universo lo constituyeron los 110 pacientes ingresados en el servicio durante el periodo de estudio. RESULTADOS: los de mayor prevalencia fueron los de categoría B y C para un total de 28,18 % y 25,45 %, representando los 31 y 28 incidentes comunicados; los de mayor gravedad fueron los incidentes asociados a la vía aérea, el 25,45 %; a pesar de dichos eventos adversos los pacientes no sufrieron invalidantes en términos de incapacidad física. CONCLUSIONES: se identificó la gravedad de los acontecimientos adversos y se determinó que no hubo invalidantes fatales en los pacientes que participaron en el estudio.

INTRODUCTION: patient safety is based on the need to counter the harmful effects that adverse events on patients. OBJECTIVE: To determine the impact of adverse events, in terms of disability, which appeared in patients in whom this adverse event was reported. METHODS: A prospective study was conducted at the Polyvalent Intensive Care Unit of the Provincial Hospital of Cienfuegos during the months of February to April 2010. To determine the severity according to category and disabling the patient regarding the international form of revised Spanish Society of Intensive Care and Coronary Units. The universe was composed of 110 patients admitted to the service during the study period. RESULTS: The most prevalent were those of category B and C for a total of 28.18% and 25.45%, representing 31 and 28 reported incidents; The most serious incidents were associated with airway, 25.45%; despite these adverse events suffered no crippling patients in terms of disability. CONCLUSIONS: The severity of adverse events were identified and it was determined that there were no fatal disabling in patients enrolled in the study.