Adverse drug reactions to anticoagulants in Spain: analysis of the Spanish National Hospital Discharge Data (2010-2013).

OBJECTIVE: To describe and analyse hospitalisations for adverse drug reactions (ADRs) involving anticoagulants. We also analysed the progress of the reactions over time, the factors related with ADRs. DESIGN: A retrospective, descriptive, epidemiological study. SETTING: This study used the Spanish National Hospital Discharge Database (Conjunto Mínimo Básico de Datos, CMBD), over a 4-year period. PARTICIPANTS: We selected CMBD data corresponding to hospital discharges with a diagnosis of ADRs to anticoagulants (International Classification of Diseases-Ninth Revision, Clinical Modification (ICD-9-CM) code E934.2) in any diagnostic field during the study period. MAIN OUTCOME MEASURES: We calculated the annual incidence of ADRs to anticoagulants according to sex and age groups. The median lengths of hospital stay and in-hospital mortality (IHM) were also estimated for each year studied. Bivariate analyses of the changes in variables according to year were based on Poisson regression. IHM was analysed using logistic regression models. The estimates were expressed as ORs and their 95% CI. RESULTS: During the study period, 50 042 patients were hospitalised because of ADRs to anticoagulants (6.38% of all ADR-related admissions). The number of cases increased from 10 415 in 2010 to 13 891 in 2013. Cumulative incidence of ADRs to anticoagulants was significantly higher for men than women and in all age groups. An adjusted multivariate analysis revealed that IHM did not change significantly over time. We observed a statistically significant association between IHM and age, with the highest risk for the ≥85 age group (OR 2.67; 95% CI 2.44 to 2.93). CONCLUSIONS: The incidence of ADRs to anticoagulants in Spain increased from 2010 to 2013, and was significantly higher for men than women and in all age groups. Older patients were particularly susceptible to being hospitalised with an adverse reaction to an anticoagulant.

[The role of models in economic evaluation of healthcare]. / Papel de los modelos en las evaluaciones económicas en el campo sanitario.

INTRODUCTION: The information on which decision-making in healthcare is based --especially information on new drugs or technologies-- comes mainly from phase III clinical trials, which are carried out according to clinical efficacy criteria. Placebos are frequently used as comparators. Therefore, no clinical or economic evidence is usually available to assess the new product or technology in real-life practice (effectiveness). Efficiency is seldom evaluated either. METHODS: The clinical evidence generated by clinical trials usually evaluates intermediate, not final clinical variables. This makes decision-making difficult, both for clinicians or health-care managers in areas as varied as financing drugs or technology, inclusion of these in a therapeutic formulary or in clinical pathways. CONCLUSION: To obtain clinical and economic information, modelling techniques have been developed in the field of health economics. This study reviews the justification of the use of models, their characteristics, methodological requirements and steps followed for their construction and resolution, while Markov models are explained.

[Management of vaccinations and prophylaxis of international travellers from community pharmacy (VINTAF study)]. / Seguimiento desde la farmacia comunitaria de la vacunación y la quimioprofilaxis de los viajeros internacionales. Estudio VINTAF.

OBJECTIVES: To improve and evaluate the travel advice by community pharmacists. DESIGN: Cross-sectional and prospective study. SETTING: Community pharmacies from Asturias, Barcelona, Madrid and Valencia. PARTICIPANTS: 483 travellers to high health risk countries who visit the community pharmacies and were agreed with the aims of the study. METHOD: Community pharmacists gave information regarding immunization and prophylaxis about travel-related disease according to the destination, type and duration of travel and other features of the tourist (age, taking medicines, diseases, etc.). MAIN MEASUREMENTS: Destination, adherence to the prophylaxis and vaccinations recommended, adverse effects and diseases the tourists have in the travel and one month after they are back. RESULTS: Only 6.3% of the travellers were effective vaccinated and took prophylaxis (all vaccines and prophylaxis according to the destination). 36.2% of the travellers experienced an illness while abroad. The commonest disease were travellers' diarrhoea (15.7%). The pharmacists were the only source of information about sunscreens, repellents, and other sanitary goods. CONCLUSIONS: The community pharmacists can give accurate information regarding immunization and prophylaxis about international travels. It is necessary to improve the communication between family physician, the tropical travel clinic and community pharmacists in order to improving compliance. It is necessary keep the bureaucratic barriers away to get this kind of drugs. The international tourists still travel without the necessary vaccines and prophylaxis to the high health risk areas.

Seguimiento desde la farmacia comunitaria de la vacunación y la quimioprofilaxis de los viajeros internacionales. Estudio VINTAF / Management of vaccinations and prophylaxis of international travellers from community pharmacy (VINTAF study)

Objetivos. Mejorar la captación de viajeros a zonas de riesgo sanitario por los farmacéuticos comunitarios y evaluar dicha actuación sanitaria. Diseño. Estudio observacional prospectivo. Emplazamiento. Farmacias comunitarias de Asturias, Barcelona, Madrid y Valencia. Participantes. Un total de 483 viajeros a zonas de riesgo que iban a las farmacias participantes y que dieron su consentimiento verbal para participar en el estudio. Intervenciones. Asesoramiento por parte de los farmacéuticos comunitarios a los viajeros sobre las vacunas, la quimioprofilaxis y el botiquín de viaje necesarios según el destino, la duración y las características de los viajeros (medicación concomitante, embarazo, comorbilidades, edad, etc.).Mediciones principales. Destino y duración del viaje, cumplimiento de vacunas y/o quimioprofilaxis recomendadas, reacciones adversas a ellas. Problemas de salud durante el viaje y al mes del regreso. Resultados. El 6,3 por ciento de los viajeros estaba protegido correctamente (todas las vacunas y quimioprofilaxis que necesitaban). El 36,2 por ciento de los viajeros tuvieron algún problema de salud durante el viaje, siendo la diarrea el más frecuente (15,7 por ciento). El botiquín de viaje fue recomendado sobre todo por el farmacéutico comunitario (89-95 por ciento).Conclusiones. Los farmacéuticos convenientemente formados están capacitados para asesorar a los viajeros sobre las vacunas, la quimioprofilaxis y el botiquín de viaje necesarios. Hay que mejorar la coordinación con los departamentos de medicina exterior y los médicos de familia correspondientes. Conviene disminuir las trabas burocráticas (visado de inspección) para la obtención de estos medicamentos. Los viajeros internacionales aún no van correctamente vacunados a las zonas de riesgo sanitario (AU)