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Background: Drug provocation tests (DPT) are considered the gold standard procedure to ascertain the diagnosis of beta-lactam (BL) allergy. Regarding route of administration, current recommendations prioritize oral challenges, considering them safer, and reserving the intravenous route for drugs for which this is the only formulation. Objective: To compare in terms of tolerance and safety two protocols of BL DPT, using an oral protocol (OR-DPT) and an intravenous protocol (IV-DPT). Methods: A descriptive, retrospective study was performed, including adult patients who underwent IV-DPT or OR-DPT for suspected immediate or delayed hypersensitivity to BL antibiotics, over a period of 4 years (between January 2018 and December 2021). Demographical data, index hypersensivity reactions' characteristics and tolerance to DPT were reviewed. Results: A total of 1036 patients underwent DPT, mean age of 56.8 (standard deviation, SD, 17.8) years, 655 were women (63.2%). Immediate drug hypersensitivity reactions (DHR) had occurred in 564 of patients (54.4%). OR-DPT were performed in 439 (42.4%) and IV-DPT in 597 (57.6%). The frequency of reactions during DPT, regardless of the route used, was low (3.6%): only 16 (3.6%) in OR-DPT and 21 (3.5%) in IV-DPT. From IV-DPT, 16 out 21 DHR during DPT were immediate compared with 4 out of 16 in OR-DPT. Adjusted relative risk of developing a hypersensitivity reaction during IV-DPT versus OR-DPT was 1.13 (95% confidence interval (CI)0.57-2.22). Conclusion: The results suggest that OR-DPT and IV-DPT are both safe procedures when adequately performed. However, IV-DPT protocols showed a higher rate of immediate DHR during DPT probably due to the selection of basal high-risk patients to undergo IV-DPT. In conclusion, IV-DPT may be considered as an option for challenges in drug-allergy studies, entailing a precise administration.
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Background: Data related to adverse drug reactions (ADRs), specifically immune-related adverse events (irAEs), in long-term treatment with immunotherapy in real-world practice is scarce, as is general information regarding the management of ADRs. Objectives: To characterize and describe the incidence of ADRs in patients who began immunotherapy treatment in clinical practice. Methods: In a prospective observational study cancer patients ≥18 years of age who were treated with a monotherapy regime of PD-1/PD-L1 inhibitors were evaluated. The study period was from November 2017 to June 2019 and patients were followed up until June 2021. Patients were contacted monthly by telephone and their electronic health records were reviewed. Each ADR was graded according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). Results: Out of 99 patients, 86 met the inclusion criteria. Most were male (67.4%), with a median age of 66 (interquartile range, IQR: 59-76). The most frequent cancer was non-small cellular lung cancer (46 cases, 53.5%), followed by melanoma (22, 25.6%). A total of 74 patients (86%) were treated with anti-PD-1 drugs and 12 (14%) were treated with anti-PD-L1 drugs. The median treatment durations were 4.9 (IQR: 1.9-17.0) and 5.9 months (IQR: 1.2-12.3), respectively. Sixty-three patients (73%) developed from a total of 156 (44% of the total number of ADR) irADRs, wherein the most frequent were skin disorders (50 cases, 32%, incidence = 30.5 irADRs/100 patients per year [p-y]), gastrointestinal disorders (29, 19%, 17.7 irADRs/100 p-y), musculoskeletal disorders (17, 11%, 10.4 irADRs/100 p-y), and endocrine disorders (14, 9%, 8.6 irADRs/100 p-y). A total of 22 irADRs (14%) had a latency period of ≥12 months. Twelve irADRs (7.7%) were categorized as grade 3-4, and while 2 (1.3%) were categorized as grade 5 (death). Sixty-one irADRs (39.1%) in 36 patients required pharmacological treatment and 47 irADRs (30.1%) in 22 patients required treatment with corticosteriods. Conclusion: The majority of patients treated with anti-PD1/PDL1-based immunotherapy experienced adverse reactions. Although most of these reactions were mild, 11.5% were categorized as grade 3 or above. A high percentage of the reactions were immune-related and occurred throughout the treatment, thereby indicating that early identification and close monitoring is essential.
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Antecedentes: La información sobre la incidencia de insuficiencia renal aguda (IRA) intrahospitalaria relacionada con medicamentos y las características de los pacientes es escasa. Objetivo: Estimar la incidencia de IRA relacionada con medicamentos en pacientes hospitalizados y comparar sus características con las de los pacientes con IRA relacionada con otras causas. Métodos: Cohorte prospectiva de pacientes con IRA intrahospitalaria (julio de 2010-julio de 2011). Se recogió información sobre características y antecedentes de los pacientes, factores de riesgo y gravedad de la IRA según la clasificación RIFLE, y medicación durante la hospitalización. El análisis de la imputabilidad de los fármacos y la evaluación de la relación causal se realizó siguiendo los métodos y el algoritmo del Sistema Español de Farmacovigilancia. Resultados: Un total de 194 casos presentaron un episodio de IRA intrahospitalaria. La edad mediana de los pacientes fue de 72 años (RI 20); el 60% eran hombres. La incidencia de IRA intrahospitalaria fue de 9,6 por cada 1.000 ingresos. Un 77,8% de los casos presentaron riesgo o daño renal según la clasificación RIFLE. En 105 (54,1%) casos, la IRA se relacionó con medicamentos; principalmente diuréticos, medicamentos que actúan sobre el sistema renina-angiotensina, inmunosupresores, bloqueadores β-adrenérgicos, bloqueantes de los canales de calcio, medios de contraste y antiinflamatorios no esteroideos. La morbilidad cardiovascular fue mayor y la frecuencia de factores de riesgo de IRA y la mortalidad menores en los pacientes con IRA relacionada con medicamentos. Conclusiones: La mitad de los episodios de IRA intrahospitalaria se relacionaron con medicamentos. Los pacientes con IRA relacionada con medicamentos presentaron más antecedentes patológicos cardiovasculares, pero menos factores de riesgo de IRA y una menor mortalidad (AU)
Introduction: The information available on the incidence and the characteristics of patients with acute renal failure (ARF) related to drugs is scarce. Objectives: To estimate the incidence of drug-related ARF in hospitalised patients and to compare their characteristics with those of patients with ARF due to other causes. Material and methods: We selected a prospective cohort of patients with ARF during hospital admission (July 2010-July 2011). Information on patients demographics, medical antecedents, ARF risk factors, ARF severity according to the RIFLE classification and hospital drug administration was collected. We analysed the relationship of drugs with the ARF episodes using Spanish Pharmacovigilance System methods and algorithm. Results: A total of 194 cases had an episode of hospital-acquired ARF. The median age of patients was 72 years [IQR 20]; 60% were men. The ARF incidence during hospitalization was 9.6 per 1,000 admissions. According to the RIFLE classification, a risk of kidney damage or kidney injury was present in 77.8% of cases. In 105 (54.1%) cases, ARF was drug-related; the drugs most frequently involved were diuretics, agents acting on the renin-angiotensin system, immunosuppressants, β-blocking agents, calcium channel blockers, contrast media and non-steroid anti-inflammatory drugs. Patients with drug-related ARF had more multi-morbidity, fewer ARF risk factors and lower mortality. Conclusions: Half of ARF episodes during hospitalisation were drug related. Patients with drug-related ARF had higher cardiovascular morbidity than those with ARF related to other causes, but they had a lower frequency of ARF risk factors and mortality (AU)
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Humanos , Injúria Renal Aguda/induzido quimicamente , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Hospitalização/estatística & dados numéricos , Fatores de Risco , Estatísticas Hospitalares , Estudos ProspectivosRESUMO
INTRODUCTION: The information available on the incidence and the characteristics of patients with acute renal failure (ARF) related to drugs is scarce. OBJECTIVES: To estimate the incidence of drug-related ARF in hospitalised patients and to compare their characteristics with those of patients with ARF due to other causes. MATERIAL AND METHODS: We selected a prospective cohort of patients with ARF during hospital admission (July 2010-July 2011). Information on patients' demographics, medical antecedents, ARF risk factors, ARF severity according to the RIFLE classification and hospital drug administration was collected. We analysed the relationship of drugs with the ARF episodes using Spanish Pharmacovigilance System methods and algorithm. RESULTS: A total of 194 cases had an episode of hospital-acquired ARF. The median age of patients was 72 years [IQR 20]; 60% were men. The ARF incidence during hospitalization was 9.6 per 1,000 admissions. According to the RIFLE classification, a risk of kidney damage or kidney injury was present in 77.8% of cases. In 105 (54.1%) cases, ARF was drug-related; the drugs most frequently involved were diuretics, agents acting on the renin-angiotensin system, immunosuppressants, ß-blocking agents, calcium channel blockers, contrast media and non-steroid anti-inflammatory drugs. Patients with drug-related ARF had more multi-morbidity, fewer ARF risk factors and lower mortality. CONCLUSIONS: Half of ARF episodes during hospitalisation were drug related. Patients with drug-related ARF had higher cardiovascular morbidity than those with ARF related to other causes, but they had a lower frequency of ARF risk factors and mortality.
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Injúria Renal Aguda/induzido quimicamente , Pacientes Internados , Injúria Renal Aguda/sangue , Injúria Renal Aguda/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Anti-Inflamatórios não Esteroides/efeitos adversos , Antineoplásicos/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Meios de Contraste/efeitos adversos , Creatinina/sangue , Diuréticos/efeitos adversos , Feminino , Hospitalização , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Espanha/epidemiologiaAssuntos
Medicamentos Biossimilares , Medicamentos Biossimilares/economia , Medicamentos Biossimilares/farmacologia , Medicamentos Biossimilares/uso terapêutico , Custos de Medicamentos , Uso de Medicamentos/tendências , União Europeia , Humanos , Marketing de Serviços de Saúde , Programas Nacionais de Saúde , Aceitação pelo Paciente de Cuidados de Saúde , Honorários por Prescrição de Medicamentos , Espanha , Equivalência TerapêuticaRESUMO
OBJECTIVE: Adverse drug reactions (ADRs) are an important healthcare problem. The objective of this study was to review published articles analyzing the cost of ADRs in any healthcare setting. METHOD: We conducted a search of articles published on the cost of ADRs in the bibliographic databases from 1970 to 2010. We identified 28 studies and selected 16 that included cases of ADR fitting the World Health Organization's definition of these events. The information on the characteristics of the study design, the types of costs analyzed and the reported results were reviewed. RESULTS: The design features and populations included in the studies were heterogeneous. Only two studies explicitly defined the perspective adopted. Only five studies compared cases of ADR with matched controls without ADRs. All studies analyzed direct healthcare costs, but none analyzed indirect or intangible costs. Fourteen publications analyzed the costs of length of hospital stay. The average (SD) percentage of ADRs was 3.04% (0.2) [median 2.4%, range 0.7% to 26.1%]. The median length of hospital stay in patients with ADRs was 8.8 days (range: 0.15 to 19.2 days). Accounting systems and monetary costs varied widely. CONCLUSION: Studies on the costs of ADRs are highly heterogeneous and have evaluated direct healthcare costs in hospitals. Their results indicate that ADRs generate substantial costs. More studies using appropriate methodology are needed on the costs of ADRs.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Custos e Análise de Custo , Humanos , Inquéritos e QuestionáriosRESUMO
UNLABELLED: Intravenous immunoglobulin (IVIG) use in non-approved indications, the increase in consumption and its high cost recommend rationalisation in its utilisation. AIMS: To assess the use of IVIG in Spanish hospitals. METHODS: An observational, prospective and multicentre drug utilisation study was conducted in 13 tertiary Spanish hospitals. Data were collected for 3 months in patients receiving any IVIG. Patient demographics, indication for IVIG use, dosage regimen and cost of treatment were collected. RESULTS: Five hundred and fifty-four patients (mean age of 52 years) were included in the study. A total of 1,287 prescriptions were administered, and the average number of prescriptions per patient was 2.3. The mean daily dose was 24 g (range 0.6-90 g). Overall, IVIG was prescribed for authorised indications in 335 patients (60%) with 953 prescriptions (74%), for non-authorised indications with scientific evidentiary support in 86 patients (16%) with 137 prescriptions (11%), and non-authorised and non-accepted indications in 133 patients (24%) with 197 prescriptions (15%). The most frequent authorised indications were primary and secondary immunodeficiencies, and the most frequent non-authorised and non-accepted indications were multiple sclerosis and bullous dermatosis. The mean cost of IVIG per patient for authorised indications was 2,636.2
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Custos de Medicamentos , Uso de Medicamentos/estatística & dados numéricos , Hospitais Gerais/estatística & dados numéricos , Imunoglobulinas Intravenosas/economia , Imunoglobulinas Intravenosas/uso terapêutico , Fatores Imunológicos/economia , Fatores Imunológicos/uso terapêutico , Uso Off-Label/estatística & dados numéricos , Adulto , Idoso , Uso de Medicamentos/normas , Empatia , Feminino , Humanos , Imunoglobulinas Intravenosas/administração & dosagem , Imunoglobulinas Intravenosas/efeitos adversos , Fatores Imunológicos/administração & dosagem , Fatores Imunológicos/efeitos adversos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , EspanhaAssuntos
Aspirina/efeitos adversos , Fibrinolíticos/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Estômago/efeitos dos fármacos , 2-Piridinilmetilsulfinilbenzimidazóis , Fatores Etários , Idoso , Anti-Inflamatórios não Esteroides/efeitos adversos , Antiulcerosos/administração & dosagem , Antiulcerosos/uso terapêutico , Aspirina/administração & dosagem , Estudos de Coortes , Ensaios Clínicos Controlados como Assunto , Fibrinolíticos/administração & dosagem , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/prevenção & controle , Infecções por Helicobacter/complicações , Helicobacter pylori , Humanos , Lansoprazol , Metanálise como Assunto , Razão de Chances , Omeprazol/administração & dosagem , Omeprazol/análogos & derivados , Omeprazol/uso terapêutico , Úlcera Péptica Hemorrágica/induzido quimicamente , Úlcera Péptica Hemorrágica/prevenção & controle , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Bomba de Prótons , Risco , Fatores de Risco , Úlcera Gástrica/complicações , Úlcera Gástrica/prevenção & controle , Comprimidos com Revestimento Entérico , Fatores de TempoRESUMO
No disponible
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Humanos , Aspirina/administração & dosagem , Mucosa Gástrica , Aspirina/efeitos adversos , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/prevenção & controle , Estudos de Casos e Controles , Infecções por Helicobacter/complicações , Omeprazol/uso terapêutico , Bombas de Próton/antagonistas & inibidoresRESUMO
Introducción y objetivos. Se han elaborado unas recomendaciones de tratamiento de la insuficiencia cardíaca a partir de la revisión sistemática de la evidencia disponible sobre los distintos tratamientos farmacológicos. Material y métodos. La revisión se ha centrado en el tratamiento de la insuficiencia cardíaca crónica y sistólica. Se identificaron todos los estudios publicados en inglés sobre los tratamientos farmacológicos de la insuficiencia cardíaca. Para cada tratamiento se clasificaron las evidencias en función de: a) variables de eficacia (reducción de la mortalidad y de los ingresos hospitalarios, mejoría de la clase funcional, fracción de eyección y de la tolerancia al ejercicio), y b) nivel de calidad de la evidencia según una escala de evaluación. También se revisaron las evidencias sobre las comparaciones y las combinaciones de los tratamientos, y sobre su toxicidad y costes. Resultados. Las pautas de tratamiento han sido definidas en función de la clase funcional de la NYHA y se han clasificado en las categorías A, B o C según el nivel de calidad de la evidencia disponible. Las evidencias de mortalidad se han considerado las más importantes. Se han tenido en cuenta los fármacos de primera elección, las alternativas y otros posibles tratamientos. Conclusiones. Se dispone de suficiente información para elaborar recomendaciones terapéuticas en todas las fases de la insuficiencia cardíaca basadas en evidencias sobre variables, como la reducción de la mortalidad o de los ingresos hospitalarios. Esto pone de manifiesto el interés y la prioridad de utilizarlas en el proceso de evaluación y mejora de resultados en este proceso patológico (AU)