Patients' contribution to drug safety in Catalonia: the interest of personal feelings on adverse drug reactions.

PURPOSE: There are few studies on the personal view retrieved by patients in the spontaneous reports' free-text section of suspected adverse drug reactions. METHODS: We analysed the suspected adverse drug reactions (ADRs) spontaneous reports sent to the Catalan Centre of Pharmacovigilance between 2013 and 2017. The information provided in the free-text section was classified as (1) temporal sequence, (2) description of symptoms, (3) description of psychological impact, (4) withdrawal effects, (5) alternative causes, and (6) rechallenge. The concordance level between the perceived severity by the reporter and the pharmacovigilance team was assessed by the Kappa index (ƙ). Usual descriptive statistics were used to describe variables. RESULTS: Nationally, 190 spontaneous reports described 383 ADRs, which 28.6% were unknown or poorly known in the literature, and 52.1% were serious. The most frequent ADRs were gastrointestinal (19.3%) and neurological (19.1%), and among the most common 213 suspected medicines, there were those used for nervous system conditions (18.8%). The agreement on the perception of ADRs' severity between citizens and centre's technicians was 'good' (K = 0.62 (0.51-0.72)). An analysis of the free-text section of reports showed that one-quarter of the reports provided useful additional data, like the psychobiosocial impact, which could explain the discrepancy between patients and health professionals in the classification of the severity of some ADRs. CONCLUSIONS: Patients' report free-text section provides relevant information, mainly about symptoms description, psychobiosocial impact and feelings. Therefore, it is a section to be enhanced and analysed. These findings should encourage the strengthening of citizens reporting.

Hemorragias en pacientes tratados con heparinas de bajo peso molecular / Hemorrhages among patients treated with low-molecular-weight heparins

Objetivo. Se han descrito diversos casos de pacientes con hemorragias graves por heparinas de bajo peso molecular (HBPM). El objetivo del estudio fue analizar los factores de riesgo hemorrágico de los pacientes diagnosticados de hemorragia por HBPM. Método. Estudio retrospectivo (1989-1999) de los pacientes diagnosticados de hemorragias por HBPM en un hospital universitario de tercer nivel. Se revisaron: a) las historias clínicas de los archivos hospitalarios y b) las notificaciones de reacciones adversas a medicamentos de un programa de monitorización intensiva de reacciones adversas hospitalarias. Se recogió información de las variables clínicas de los pacientes, del tratamiento, de la localización y de la gravedad de la hemorragia. Resultados. Se identificaron 36 pacientes diagnosticados de hemorragias por HBPM. La edad mediana de los pacientes fue de 76 años (mínimo 39 y máximo 94 años). En 11 (31 por ciento) pacientes la hemorragia se originó durante un tratamiento ambulatorio que motivó ingreso hospitalario. Todos los pacientes presentaban uno o más factores de riesgo hemorrágico: edad 65 años (34; 94 por ciento); comorbilidad de riesgo hemorrágico (28; 78 por ciento); uso de antiagregantes plaquetarios o antiinflamatorios no esteroideos (AINE) (17; 47 por ciento); duración del tratamiento > 7 días (17; 47 por ciento), y uso de dosis anticoagulantes (16; 44 por ciento). Las hemorragias más frecuentes fueron las gastrointestinales y las musculares (24; 67 por ciento). La mayoría de pacientes presentaron hemorragias mayores (26; 72 por ciento), y en 5 casos fueron mortales. En ningún paciente se ajustó la dosis mediante la monitorización de la actividad anti-Xa. Conclusiones. La mayoría de pacientes con hemorragias por HBPM tienen diversos factores de riesgo hemorrágico. Es necesaria una valoración cuidadosa de los factores de riesgo hemorrágico de los pacientes cuando se utilizan HBPM, y en especial en los tratamientos ambulatorios. Se deberían ajustar la dosis de las HBPM en los pacientes con factores de riesgo hemorrágico (AU)

[Hemorrhages among patients treated with low-molecular-weight heparins]. / Hemorragias en pacientes tratados con heparinas de bajo peso molecular.

OBJECTIVE: Several cases have been reported of patients with severe hemorrhages caused by low-molecular-weight heparins (LMWH). The objective of the present report was to analyse risk factors for hemorrhage among patients diagnosed of hemorrhage due to LMWH. METHODS: Retrospective study (1989-1999) of patients diagnosed of LMWH hemorrhages in a third-level teaching hospital. A review was made of: a) clinical records from hospital files; b) reports of adverse drug reactions from a program on intensive surveillance of hospital adverse reactions. Information was collected of clinical perameters of patients, treatment, site, and severity of hemorrhage. RESULTS: A total of 36 patients diagnosed of LMWH hemorrhages were identified. The median age of patients was 76 years (range: 39 to 94 years). In 11 (31%) patients, hemorrhage originated during an ambulatory treatment, which prompted hospital admission. All patients had one or more risk factors for hemorrhage: age > or = 65 years (34; 94%); co-morbidities with hemorrhagic risk (28; 78%); use of platelet anti-aggregants or NSAIDs (17; 47%); length of treatment > 7 days (17; 47%) and use of anticoagulant doses (16; 44%). Hemorrhages occurred most commonly in the gastrointestinal tract and muscles (24; 67%). Most patients had major hemorrhages (26; 72%); and in 5 cases hemorrhages were fatal. In no patient was the dose adjusted by anti-Xa activity monitoring. CONCLUSIONS: Most patients with LMWH hemorrhages have different risk factors for hemorrhage. A careful assessment of hemorrhagic risk factors on patients is needed when LMWH are used, particularly in the ambulatory setting. LMWH doses should be adjusted in patients with hemorrhagic risk factors.