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Mònica Andreu-March,1 Margarita Aguas Compaired,1,2 Montserrat Pons Busom,1,2 Eduardo L Mariño,1 Pilar Modamio1 1Clinical Pharmacy and Pharmaceutical Care Unit, Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain; 2Pharmacy Service, University Hospital Sagrat Cor, Barcelona, 08029, SpainCorrespondence: Pilar ModamioClinical Pharmacy and Pharmaceutical Care Unit, Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, Barcelona, 08028, SpainTel/Fax +34 934024544Email pmodamio@ub.eduPurpose: The main objective was to develop and validate a “Hospital Outpatients’ Information Needs Questionnaire” (HOINQ). Secondly, to identify patients’ preferred sources of information. Finally, to establish differences depending on the disease, as well as between sociodemographic and clinical variables.Patients and Methods: This is a transversal study based on a questionnaire. All adult hospital outpatients’ who collected their medication at the Pharmacy Service were consecutively recruited, regardless of their diagnosis time, treatment or disease. The Spanish version of the internationally validated European Organization for Research and Treatment Cancer Quality of Life Questionnaire (EORTC QLQ-25) aimed at oncology patients was used as the starting point. In order to be applicable on new target population, it was crucial to make several changes and ensure that it complies with the validity, viability and reliability criteria. The questionnaire prepared for validation was then obtained by a literature review (face validity), submitting the EORTC QLQ-25 to an expert committee (content validity), by piloting (viability) and Cronbach’s alpha statistical analysis (reliability). Once the questionnaire was completed, Cronbach’s alpha of the final study (reliability) and factor analysis (construct validity) were performed. Then, pertinent modifications were applied to obtain the HOINQ.Results: A total of 153 outpatients filled the questionnaire, which was widely accepted and required 5– 10 min to complete. Cronbach’s alpha coefficients met criteria > 0.7. Three factors were established by factor analysis: aspects about the disease, pharmacological and no-pharmacological treatment and satisfaction and perception of the information received. Participants felt satisfied (41– 52%) with the information amount, quality and usefulness, although 1 out of 3 stated wanting to know more about the different information areas. Younger patients (P-value < 0.05) and those who had been attending the Pharmacy Service for a longer time span (P-value < 0.01) reported receiving more information. On a 0 to 7 scale, medical specialists (mean = 6.28, SD = 1.38) followed by the rest of health care professionals (mean = 4.23– 4.63, SD = 2.25– 2.29) were selected as the preferred sources of information. HIV patients reported being more informed, while those with rheumatoid arthritis felt less informed (P-value < 0.05).Conclusion: The HOINQ was developed. It is a self-completed questionnaire, composed of three blocks: the 16-item information needs questionnaire, demographic and clinical variables, and patients’ preferred sources of information. It is an easy tool to use and replicate, both for patients and professionals.Keywords: information needs, outpatients, pharmacy service, questionnaire validation

El objetivo del presente trabajo fue describir y analizar la situación en España de los productos de venta ilícita, tanto medicamentos como complementos alimenticios, poniendo en conocimiento las principales acciones realizadas en los últimos meses y su contextualización a nivel mundial. Asimismo, servir de alerta sobre la magnitud del problema y la importancia del papel del farmacéutico comunitario. Se realizó una búsqueda de información tanto a nivel nacional como internacional y se realizó un análisis descriptivo de las Notas Informativas de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (medicamentos ilegales, uso humano, 2015). Los productos de venta ilícita representan un problema grave para la salud pública que no ha parado de aumentar. En España, en 2015 se publicaron 20 notas donde se prohibió y retiró un total de 35 productos. Dichos productos estaban comercializados como complemento alimenticio y presentaban un principio activo en cantidad suficiente para conferirle legalmente la condición de medicamento. El 86% se dirigía a la disfunción eréctil. Para minimizar este problema, es imprescindible la colaboración internacional, siendo la última y más importante operación PANGEA VIII, en junio del 2015, implicando a 115 países. En enero del 2016 entró en vigor la Convención Medicrime, tratado internacional sobre la falsificación de productos médicos y delitos similares. Por otro lado, también es necesario concienciar a la ciudadanía y dotarla de mecanismos para identificar el riesgo potencial. Los productos adquiridos fuera de los canales legales de distribución no aseguran el cumplimiento de las normas de correcta fabricación, distribución, ni posterior conservación y carecen de la información adecuada.

Background: The RALPH (Recognizing and Addressing Limited PHarmaceutical Literacy) interview guide makes it possible to identify patients with limited pharmaceutical knowledge and to assess their skills in the functional, communicative, and critical health literacy domains., Objective: (s): To perform a cross-cultural validation of the RALPH interview guide in Spanish population; to conduct a descriptive analysis based on patients' responses., Methods: A cross-sectional study of patients' pharmaceutical literacy skills was conducted in three stages: systematic translation, administration of the interview and analysis of psychometric properties. The target population included adult patients (≥18 years) who attend one of the participating community pharmacies in Barcelona (Spain). Content validity was evaluated by an expert committee. Viability was assessed in the pilot test, and reliability was assessed using internal consistency and intertemporal stability. Construct validity was assessed by factor analysis., Results: A total of 103 patients were interviewed at 20 pharmacies. Cronbach's alpha values based on standardized items ranged between 0.720 and 0.764. For the longitudinal component, the ICC test-retest reliability was 0.924. The factor analysis was verified by KMO (0.619) and Bartlett's test of sphericity (P-value <0.05). The definitive RALPH guide translated into Spanish maintains the same structure as the original. Some expressions were simplified, and the questions on the comprehension of warnings or specific instructions for use, contradictory information and shared decision-making were reformulated. Pharmaceutical literacy skills were seen to be most limited with regard to the critical domain. The responses of the Spanish patients were in agreement with the original results of the RALPH interview guide., Conclusions: The RALPH interview guide in Spanish complies with the requirements viability, validity, and reliability. This tool may be able to identify the low pharmaceutical literacy skills of patients coming to community pharmacies in Spain, and its use may also be extended to other Spanish-speaking countries., Competing Interests: Declaration of competing interest The authors report no conflicts of interest for this work., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)