Skills and practices of pharmacy staff for dispensing of drugs with fiscalized substances in drugstores and pharmacies.

OBJETIVE: To evaluate the skills and practices of pharmacy staff during the dispensing of tramadol (drug with fiscalized substance) in drugstores and pharmacies in Medellin, Colombia. METHODS: A cross-sectional study was performed. The simulated patient technique was used. The main outcomes included the information provided on the dispensed drug (tramadol), the use of tools to provide information, and the information provided on drug precautions and use recommendations. RESULTS: We visited 305 drugstores and pharmacies. The average dispensing time was 2.3 min (SD 1.1 min). In nine drugstores and pharmacies (3.0%), tramadol was not dispensed because it was not in stock. In 17 drugstores and pharmacies (5.7%), the simulated patients were actively informed by the dispensing pharmacy staff; of these, 16 provided oral information and one provided oral and written information. Eight patients (2.7%) received information regarding tramadol use. However, 99% of patients were not informed about tramadol side effects such as dependence, sedation, or hypnosis, and none of the simulated female patients were informed on the precautions related to tramadol use during pregnancy or lactation. CONCLUSIONS: Communication skills and appropriate practices of pharmacy staff are critical to patient self-care. However, this study shows their difficulty in counseling about precautions and use recommendations of drugs with fiscalized substances. These outcomes could inform future studies focusing on the rational use of these drugs in drugstores and pharmacies. It is necessary to improve the pharmacy staff competencies through continuing education programs, to facilitate access to information and training.

Design and development of a mobile app of drug information for people with visual impairment.

BACKGROUND: People with visual impairment presents difficulties to access the labels information of medicines. In this sense, technological tools can contribute to improve access to this information and the appropriate use of medicines in this population. However, currently, in Colombia, there are no tools to facilitate this process. OBJECTIVE: To design and development of a mobile app of drug information for people with visual impairment, which allows them to access information for the appropriate use of medicines. METHODS: A user-centered design process is carried out in four phases was used: a) Identification the needs and barriers for appropriate use of medicines; b) Lifting of requirements, c) Interface design and prototyping, and development of the mobile app, and d) Usability test. RESULTS: The study involved 48 people with visual disability, of which 69% required assistance for the use of medicines. The main barriers identified were access to information and dosing. A total of ten user requirements were identified, based on these and international accessibility standards FarmaceuticApp was designed and developed, incorporating the problems that were identified in the usability test. CONCLUSION: A mobile app of drug information for people with visual impairment using a user-centered design process was designed and developed, highlighting the importance of involving the users and other stakeholders in the design and development m-health technologies. FarmaceuticApp could contribute to the appropriate use of medicines and improve therapeutic adherence, as well as autonomy and independence in people with visual impairment.

[The clinical relevance of drug interactions in patients with human immunodeficiency virus infection: update 2015-2017]. / Relevancia clínica de las interacciones medicamentosas en pacientes infectados con el virus de la inmunodeficiencia humana: actualización 2015-2017.

BACKGROUND: The pharmacokinetics of anti-retrovirals (ARVs) can be modified by other concomitant medicinal products. It is timely to update the interactions between new ARVs and drugs of chronic use to maintain therapeutic success. AIM: To update information about drug interactions in patients with HIV/AIDS on antiretroviral therapy. METHODS: Comprehensive literature review in MEDLINE/PubMed database from January of 2015 to June of 2017, using the Mesh terms: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions. Publications with drug interactions in humans, in English or Spanish, and with full text were retrieved. Additionally, citation lists from identified articles were reviewed. The study inclusion was assessed by three independent researchers and by consensus among them when was necessary. Clinical relevance of drug interaction was grouped into levels according to seriously and probability of occurrence. RESULTS: 466 articles were identified; full text was accessed in 444. Of these, 164 provided interactions, which allowed the identification of a total of 534 pairs of drug interactions. The interactions that presented a higher risk of generating safety and effectiveness problems were 308 (57.7%) of level 2 and 35 (6.6%) of level 1. CONCLUSIONS: We identify 534 new pairs of drug interactions, of which 308 (64.2%) are the most clinically relevant.

Relevancia clínica de las interacciones medicamentosas en pacientes infectados con el virus de la inmunodeficiencia humana: actualización 2015-2017 / The clinical relevance of drug interactions in patients with human immunodeficiency virus infection: update 2015-2017

Resumen Introducción: La farmacocinética de los anti-retrovirales (ARVs) puede ser modificada por otros medicamentos de uso concomitante. Es oportuno actualizar las interacciones entre nuevos ARVs y fármacos de uso crónico para mantener un éxito terapéutico. Objetivo: Actualizar información sobre interacciones medicamentosas en pacientes con infección por VIH/SIDA en terapia antiretroviral. Método: Revisión estructurada en MEDLINE/ PubMed utilizando los términos Mesh: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions, entre enero de 2015 y junio de 2017. Fueron seleccionadas publicaciones sobre interacciones medicamentosas en humanos, en inglés o español y con acceso a texto completo. Además, se incluyeron referencias de artículos considerados relevantes. La inclusión de los artículos fue evaluada por tres investigadores independientes y, en caso de requerirlo, por consenso entre ellos. La relevancia clínica se estableció, acorde con la gravedad y probabilidad de ocurrencia de la interacción. Resultados: Se identificaron 466 artículos, se accedió a texto completo a 444. De éstos, 164 aportaron interacciones, lo que permitió identificar un total de 534 parejas de interacciones medicamentosas. Las interacciones que presentaron un mayor riesgo de generar problemas de seguridad y efectividad fueron 308 (57,7%) de nivel 2 y 35 (6,6%) de nivel 1. Conclusiones: Se identifican 534 parejas nuevas de interacciones medicamentosas, de ellas 308 (64,2%) de mayor relevancia clínica.

Background: The pharmacokinetics of anti-retrovirals (ARVs) can be modified by other concomitant medicinal products. It is timely to update the interactions between new ARVs and drugs of chronic use to maintain therapeutic success. Aim: To update information about drug interactions in patients with HIV/AIDS on antiretroviral therapy. Methods: Comprehensive literature review in MEDLINE/PubMed database from January of 2015 to June of 2017, using the Mesh terms: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions. Publications with drug interactions in humans, in English or Spanish, and with full text were retrieved. Additionally, citation lists from identified articles were reviewed. The study inclusion was assessed by three independent researchers and by consensus among them when was necessary. Clinical relevance of drug interaction was grouped into levels according to seriously and probability of occurrence. Results: 466 articles were identified; full text was accessed in 444. Of these, 164 provided interactions, which allowed the identification of a total of 534 pairs of drug interactions. The interactions that presented a higher risk of generating safety and effectiveness problems were 308 (57.7%) of level 2 and 35 (6.6%) of level 1. Conclusions: We identify 534 new pairs of drug interactions, of which 308 (64.2%) are the most clinically relevant.

Aproximación para establecer y evaluar la relevancia clínica de las interacciones medicamentosas en el tratamiento de pacientes infectados con virus de hepatitis C, revisión estructurada (actualización 2015-2017) / Structured review of establishing and evaluating clinical relevance of drug interactions in hepatitis C virus treatment (Update 2015 - 2017)

Resumen Objetivo: establecer y evaluar la relevancia clínica de las interacciones medicamentosas en el tratamiento de pacientes con hepatitis C. Método: se realizó una búsqueda en PubMed/MedLine de artículos publicados en inglés y en español, desde el 1 de enero de 2015 hasta el 30 de marzo de 2017, utilizando los términos Mesh: Hepatitis C AND drug interactions OR herb-drug interactions OR food-drug interactions, de estudios realizados en humanos. La relevancia clínica de las interacciones medicamentosas se estableció y evaluó con base en la probabilidad de ocurrencia y la gravedad de la interacción. Resultados: se identificaron 184 artículos, de los cuales 92 se seleccionaron por el título y resumen para revisión completa, a 2 de ellos no fue posible acceder al texto completo. De estos, 57 aportaban interacciones, lo que permitió identificar 155 parejas de interacciones medicamentosas, de las cuales 154 (99,4 %) fueron farmacocinéticas y 1 (0,6 %) farmacodinámica. Por su parte, de las 155 parejas, 34 (21,9 %) se valoraron de nivel 1; 73 (47,1 %) de nivel 2; 48 (31,0 %) de nivel 3; y 0 (0,0 %) de nivel 4. Además, se identificaron 29 parejas agrupadas como interacciones con evidencia de ausencia de relevancia clínica. Conclusiones: más de 99 % de las interacciones medicamentosas de relevancia clínica son farmacocinéticas, asociadas con cambios en el metabolismo y el transporte de fármacos; el simeprevir y la terapia 3D (Paritaprevir/Ritonavir+ Ombitasvir+Dasabuvir) fueron los medicamentos con mayor número de interacciones.

Abstract Objective: This study-s objective is to establish and evaluate the clinical relevance of drug interactions during treatment of patients with hepatitis C. Method: A PubMed/MedLine search was conducted for articles published in English and Spanish from January 1, 2015 to March 30, 2017 using the terms Mesh: Hepatitis C AND drug interactions OR herb-drug interactions OR food-drug interactions, from studies conducted in humans. The clinical relevance of drug interactions was established and evaluated based on probability of occurrence and severity of interactions. Results: Of the 184 four articles identified, 92 were selected by title and abstract for full review. The full texts of two articles could not be accessed. Of the remaining articles, 57 describ ed relevant interactions. Of the 155 pairs of drugs that interact that were identified, 154 (99.4%) were pharmacokinetic, and one (0.6%) was pharmacodynamic. Thirty-four of the 155 pairs (21.9%) were assessed at level 1; 73 (47.1%) were assessed at level 2; 48 (31.0%) were assessed at level 3, none were assessed at level 4. In addition, 29 pairs of interacting drugs had no evidence of clinical relevance. Conclusions: More than 99% of clinically relevant drug interactions are pharmacokinetics and are associated with changes in metabolism and transport of drugs. Simeprevir and 3D (Paritaprevir/Ritonavir+ Ombitasvir+Dasabuvir) therapy had the greatest number of interactions.

Relevancia clínica de interacciones de antibióticos relacionadas con cambios en la absorción: revisión estructurada / Clinical relevance of drug interactions with antibiotics related to changes in the absorption: Structured review

Resumen Introducción: Durante el proceso de uso de los medicamentos es complejo establecer un esquema terapéutico eficaz y seguro, especialmente en los pacientes geriátricos, debido a la polimedicación. En este sentido, a medida que aumenta el número de medicamentos también aumenta la probabilidad de aparición de una interacción medicamentosa que podría tener consecuencias clínicas importantes. El objetivo de este estudio fue establecer y evaluar la relevancia clínica de las interacciones de antibióticos relacionadas con cambios en la absorción. Métodos: Búsqueda en PubMed/Medline y Embase de artículos en inglés y español, acceso a texto completo, sin fecha límite, en humanos. La relevancia clínica se estableció con base a la probabilidad y la gravedad. Se identificaron 85 artículos, 46 informaron interacciones de antibióticos relacionadas con cambios en la absorción. Los resultados se orientaron en los antibióticos comercializados en Colombia, acorde con la base de datos del Instituto Nacional de Vigilancia de Medicamentos y Alimentos. Resultados: Se identificaron 74 parejas de interacciones medicamentosas de medicamentos comercializados en Colombia, 63 fueron clínicamente relevantes y 11 con evidencia de ausencia de interacción. Conclusiones: La absorción de los antibióticos puede modificarse por factores como el uso simultaneo de medicamentos o alimentos; igualmente, los antibióticos pueden afectar la biodisponibilidad de algunos medicamentos, principalmente por modificaciones en la microbiota y generando interacciones clínicamente relevantes. El 67 % de las interacciones identificadas son de riesgo alto.

Abstract Introduction: During the process of drug use, it is demanding to establish an effective and safe therapeutic scheme, especially in elderly patients, because they are polymedicated. In this sense, while the number of medications increases also increases the likelihood of the appearance of an interaction drug, which could have significant clinical consequences. The objective of this study was toestablish and evaluate the clinical relevance of drug interactions whit antibiotics related to changes in the absorption. Methods: A search in PubMed / MedLine and Embase was made for articles in English and Spanish, full-text access, without a cut-off date, in humans. The clinical relevance was established based on the probability of occurrence and the severity of the interaction. The results were oriented in the antibiotics commercialized in Colombia, according to the database of Invima. Results: 74 pairs of drug interactions of drugs marketed in Colombia were identified, 63 were clinically relevant and 11 with evidence of absence of interaction. Conclusion: The absorption of antibiotics can be modified by factors such as the simultaneous use of drugs or food; equally, antibiotics can affect the bioavailability of some drugs, mainly by modifications in the microbiota and generating clinically relevant interactions. 67% of the identified interactions are high risk.

Percepción de los estudiantes de los programas de Química Farmacéutica, Tecnología en Regencia de Farmacia y Medicina de la Universidad de Antioquia frente al uso terapéutico de los cannabinoides / Perception of the students of the programs of Pharmaceutical Chemistry, Technology in Regency of Pharmacy and Medicine of the University of Antioquia about the therapeutic use of cannabinoids

Resumen Introducción: La planta Cannabis sativa (marihuana) contiene un número aproximado de 60 cannabinoides, de los cuales, el delta-9-tetrahidrocannabinol es el componente más estudiado para ser utilizado con fines medicinales. El conocimiento adecuado por parte de los ciudadanos de esta estrategia terapéutica es un proceso clave para garantizar la aceptación y la buena adherencia al tratamiento. Objetivo: Establecer la percepción que tienen los estudiantes de pregrado de Química Farmacéutica, Tecnología en Regencia de Farmacia y Medicina de la Universidad de Antioquia, en cuanto al uso de los productos de extractos de cannabis como tratamiento medicinal. Método: Estudio observacional de corte transversal, a partir de encuestas a estudiantes a través de un formulario en línea. Resultados: Se aplicaron 374 encuestas, 232 (62%) estudiantes de pregrado de Química Farmacéutica y Tecnología en Regencia de Farmacia y 142 (38%) de Medicina. De los estudiantes, 222 (59,4%) eran del sexo femenino, con una edad promedio de 22,5 años, y 348 (94%) viven en estrato socioeconómico bajo y medio. El 60,2% de los estudiantes dicen tener un conocimiento inadecuado sobre la utilización de la marihuana medicinal, la utilización de cannabinoides medicinales, la reglamentación y la seguridad. Relacionado con la opinión sobre la utilización medicinal, 356 (95,2%) de los encuestados estuvieron de acuerdo. Conclusiones: La mayoría de los estudiantes manifestaron un conocimiento inadecuado sobre la utilización de los cannabinoides terapéuticos. Además, gran parte de los estudiantes están de acuerdo con la utilización de la marihuana medicinal.

Abstract Introduction: Cannabis sativa (marijuana) contains approximately 60 cannabinoids, of which, delta-9-tetrahydrocannabinol is the most studied component to be used for medicinal purposes. Adequate knowledge by citizens of this therapeutic strategy is a key process to guarantee the acceptance and the good adherence to the treatment. Objective: To establish the perception of undergraduate students of Pharmaceutical Chemistry, Technology in Regency of pharmacy and medicine of the University of Antioquia, as regards to the use of cannabis extracts products as medicinal treatment. Method: Observational cross-sectional study, based on surveys to students through an online form. Results: 374 surveys were obtained, 232 (62%) from students of Pharmaceutical Chemistry and Technology in Regency of Pharmacy, and 142 (38%) from Medicine. 222 (59.4%) of the students that were female, with a mean age of 22.5 years, and 348 (94%) live in low and middle socioeconomic strata. 60.2% of students claim to have inadequate knowledge regarding the use of medical marijuana, the use of medicinal cannabinoids, regulation and safety. Related to the opinion of the medicinal use, 356 (95.2%) respondents agreed. Conclusions: Most of the students expressed inadequate knowledge about the use of therapeutic cannabinoids. In addition, the vast majority of students agree with the use of medical marijuana.

Fiabilidad y validez externa de un cuestionario de conocimiento sobre riesgo y enfermedad cardiovascular en pacientes que acuden a farmacias comunitarias de España / Reliability and external validity of a questionnaire to assess the knowledge about risk and cardiovascular disease and in patients attending Spanish community pharmacies

OBJETIVOS: Determinar la fiabilidad test-retest de un cuestionario, con validación preliminar, para valorar el conocimiento sobre riesgo cardiovascular (RCV) y enfermedad cardiovascular, en pacientes atendidos en farmacias comunitarias de España.complementar la validez externa, estableciendo la relación entre una actividad educativa y el aumento del conocimiento sobre RCV y enfermedad cardiovascular. DISEÑO: Subanálisis del estudio clínico controlado EMDADER-CV, en el que se aplicó un cuestionario de conocimiento sobre RCV en 4 momentos. Emplazamiento. Farmacia comunitaria española. PARTICIPANTES: Trescientos veintitrés pacientes del grupo control, de los 640 que finalizaron el estudio. MEDICIONES PRINCIPALES: Coeficiente de correlación intraclase para evaluar la fiabilidad en 3 comparaciones (postactividad educativa con semana 16, postactividad educativa con semana 32, y semana 16 con semana 32); y prueba no paramétrica de Friedman para establecer la relación entre una actividad educativa oral y escrita con el aumento del conocimiento. RESULTADOS: Para los 323 pacientes, en las 3 comparaciones, los valores del coeficiente de correlación intraclase fueron 0,624; 0,608 y 0,801 (fiabilidad aceptable-buena a excelente). Por su parte, la prueba de Friedman mostró relación entre la actividad educativa y el aumento del conocimiento, estadísticamente significativa (p < 0,0001). CONCLUSIONES: Acorde con el coeficiente de correlación intraclase, el cuestionario orientado a valorar el conocimiento sobre el RCV y enfermedad cardiovascular tiene una fiabilidad entre aceptable y excelente, lo cual, sumado a la validación previa, indica que dicho instrumento cumple los criterios de validez y fiabilidad. Además, el cuestionario evidencia capacidad de relacionar un aumento en el conocimiento con una intervención educativa, característica que complementa su validez extern¡a

OBJECTIVES: To determine the test-retest reliability of a questionnaire, with a validation preliminary, to assess knowledge of cardiovascular risk (CVR) and cardiovascular disease in patients attending community pharmacies in Spain. To complement the external validity, establishing the relationship between an educational activity and the increase in knowledge about CVR and cardiovascular disease. DESIGN: Sub-analysis of a controlled clinical study, EMDADER-CV, in which a questionnaire about knowledge concerning CVR was applied at 4 different times. LOCATION: Spanish Community Pharmacies. Participants. There were 323 patients in the control group, from the 640 who completed the study. Main measurements. Intraclass correlation coefficient to assess the reliability in 3 comparisons (post-educational activity with week 16, post-educational activity with week 32, and week 16 with week 32); and the non-parametric Friedman test to establish the relationship between an oral and written educational activity with increasing knowledge. RESULTS: For the 323 patients in the 3 comparisons, the intraclass correlation coefficient values were 0.624; 0.608 and 0.801, respectively (fair-good to excellent reliability). So, the Friedman test showed a statistically significant relationship between educational activity and increased knowledge (p < 0,0001). CONCLUSIONS: According to the intraclass correlation coefficient, the questionnaire aimed at assessing the knowledge on CVR and cardiovascular disease has a reliability between acceptable and excellent, which added to the previous validation, shows that the instrument meets the criteria of validity and reliability. Furthermore, the questionnaire showed the ability to relate an increase in knowledge with an educational intervention, feature that complements its external validity

Relevancia clínica de las interacciones medicamentosas en pacientes infectados con el virus de la inmunodeficiencia humana: actualización 2009-2014 / The clinical relevance of drug interactions in patients with human immunodeficiency virus infection: update 2009-2014

Objective: To update information about drug interactions in patients with HIV/AIDS. Methods: Comprehensive literature review in MEDLINE/PubMed database from May of 2009 to December of 2014, using the Mesh terms: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions. Publications with drug interactions in humans, in English or Spanish, and with full text were retrieved. Additionally, citation lists from identified articles were reviewed. The study inclusion was assessed by three independent researchers and by consensus among them when was necessary. Clinical relevance of drug interaction was grouped into four levels according to seriously and probability of occurrence. Results: Global, 546 different references were retrieved and 243 were selected. In addition 11 further manuscripts were identified in the references of the included articles. Overall, 935 pairs of drug interactions were identified, 95.7% pharmacokinetic (823 by enzyme induction or inhibition and 67 by changes in bioavailability). Of the 935 pairs of drug interactions, 402(43%) were classified as levels 1 or 2. Conclusions: The most clinically relevant antiretroviral drug interactions are due to pharmacokinetic mechanism, mainly induction or enzyme inhibition, according to previous reviews, the protease inhibitors remain as the antiretrovirals with the highest number of clinical relevant interactions.

Objetivo: Actualizar información sobre interacciones medicamentosas en pacientes con VIH/SIDA. Métodos: Revisión estructurada en MEDLINE/PubMed utilizando los términos Mesh: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions, entre mayo de 2009 y diciembre de 2014. Publicaciones sobre interacciones medicamentosas, en humanos, en inglés o español y con acceso a texto completo fueron seleccionadas. Además, se incluyeron referencias de artículos considerados relevantes. La inclusión de los artículos fue evaluada por tres investigadores independientes y, en caso de requerirlo, por consenso entre ellos. La relevancia clínica se estableció en cuatro niveles, acorde con la gravedad y probabilidad de ocurrencia de la interacción. Resultados: Se identificaron 546 artículos, de los cuales se seleccionaron 273; además, se incluyeron 11 referencias relevantes. Se identificaron 935 parejas de interacciones medicamentosas, 95,7% farmacocinéticas. De este grupo, 823 mediadas por inducción o inhibición enzimática y 67 por cambios en la biodisponibilidad. De las 935 parejas de interacciones, 402 (43%) fueron relevantes clínicamente (niveles 1 o 2). Conclusiones: Las interacciones medicamentosas con anti-retrovirales de mayor relevancia clínica se deben a mecanismos farmacocinéticos, principalmente inducción o inhibición enzimática. Acorde con revisiones previas, los inhibidores de proteasa continúan siendo los anti-retrovirales con mayor número de interacciones relevantes.

Propuesta de formato de reporte de sospecha de reacciones adversas a medicamentos por pacientes ambulatorios en Colombia / Suggestion of a form for outpatient reporting of suspected adverse drug reactions in Colombia

Introducción: La obtención de información precisa y oportuna relacionada con las reacciones adversas medicamentosas resulta clave; utiliza estrategia como notificación voluntaria o por un profesional sanitario, ante la autoridad competente. Objetivo: Diseñar una propuesta de formato de reporte de reacciones adversas medicamentosas (RAM) por pacientes ambulatorios en Colombia, basado en recomendaciones de otros países y en requerimientos mínimos definidos para este tipo de formatos. Metodología: Revisión estructurada en PUBMED/MEDLINE de artículos publicados en inglés o español, utilizando los términos Pharmacovigilance AND Patients; y Pharmacovigilance reporting AND patient report. Se incluyeron artículos con información sobre reporte de RAM por pacientes. Con el soporte de la información de la revisión, al igual que con los requerimientos establecidos en las Guías del International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2A y E2B (R3), se construyó una lista de chequeo, la cual fue confrontada con la revisión de los formatos para el reporte por pacientes de 50 países pertenecientes al Uppsala Monitoring Center. Finalmente, se definieron los ítems a incluir en la propuesta de formato. Resultados: Se identificaron 104 artículos, de los cuales 5 cumplieron con los criterios de inclusión. Se elaboró una lista de chequeo con 34 ítems, la cual fue confrontada con 33 formatos, de los 50 países a los que se pudo acceder y, con ello, se definió el contenido del formato de reporte de RAM por pacientes. Conclusiones: Se diseña y presenta una propuesta de formato de reporte de RAM por pacientes ambulatorios en Colombia, con la información identificada como clave. El formato requiere de un proceso de validación y valoración de su funcionalidad en la contribución al logro de los objetivos de la farmacovigilancia.

Introduction: Obtaining accurate and timely information related to adverse drug reactions is key; uses strategy as voluntary reporting by health professionals or to the competent authority. Objective: To design a proposal of format for reporting adverse drug reactions (ADRs) by outpatients in Colombia based on recommendations from other countries and definite minimum requirements for this type of format. Methodology: We completed a structured review in PubMed/MEDLINE database of articles published in English or Spanish, using the terms Pharmacovigilance AND Patients, and Pharmacovigilance reporting and patient report. Articles with information about patients reporting ADR where included. With the support of the information from the review, as with the requirements established in the guidelines from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2A and E2B (R3). We developed a checklist, and then we contrasted the items with the information registered in the format for reporting by patients from 50 countries belonging to the Uppsala Monitoring Center with. Finally, we defined the items to be included in the proposed format. Results: From structured review, we identified 104 articles, of which five met the inclusion criteria. We developed a checklist with 34 items, and then we confronted the 34 items with information registered in 33 of the 50 formats of the countries that we may accessed. We defined the contents of the ADR report format by patients. Conclusions: We design and develop a proposal of ADR reporting format by outpatient in Colombia, which has the information identified as key. The format requires a process of validation and evaluation of its functionality in contributing to achieving the objectives of pharmacovigilance.

Aproximación para establecer y evaluar la relevancia clínica de las interacciones medicamentosas en el tratamiento de pacientes infectados con virus de hepatitis C genotipo 1: Revisión estructurada / A Structured Review of Approaches for Establishing and Evaluating Clinical Relevance of Drug Interactions in Patients with Hepatitis C Virus Genotype 1

Objetivo: establecer y evaluarla relevancia clínica de interacciones medicamentosas en el tratamiento de pacientes con hepatitis C genotipo 1. Método: se realizó una búsqueda en PubMed/MedLine de artículos publicados en inglés y en español, desde el diciembre de 2004 a diciembre de 2014, utilizando los términos Mesh: Hepatitis C AND drug interactions OR herb-drug interactions OR food-drug interactions, de estudios realizados en humanos. Además, la búsqueda se complementó con la revisión, en el mismo período, sobre interacciones de antiretrovirales y hepatitis C en humanos, utilizando los términos Mesh: (Anti-retroviral agents AND Hepatitis C AND drug interactions OR herb-drug interactions OR food-drug interactions). La relevancia clínica de las interacciones medicamentosas se definió y evaluó con base a la probabilidad de ocurrencia y la gravedad de la interacción. Resultados: se identificaron 228 artículos, de los que se pudo acceder al texto completo en 212. De estos, 62 aportaban interacciones, lo que permitió identificar 128 parejas de IM, de las cuales 120 (93,7%) fueron farmacocinéticas y 8 (6,3%) farmacodinámicas. Por su parte, de estas 128 parejas, 2 (1,6%) fueron valoradas de nivel 1: 110 (53,7%) de nivel 2; 16 (7,8%) de nivel 3; y 0 (0%) de nivel 4. Además, se identificaron 78 parejas agrupadas como interacciones con evidencia de ausencia de relevancia clínica. Conclusiones: más del 90% de las interacciones medicamentosas de relevancia clínica son farmacocinéticas asociadas a cambios del metabolismo hepático, el telaprevir fue el medicamento con mayor número de interacciones.

Objective: Our objective was to establish and evaluate the clinical relevance of drug interactions in the treatment of patients with hepatitis C genotype 1. Method: We searched for articles published in English and Spanish from December 2004 to December 2014 in PubMed/MedLine. We used the following Medical Subject Headings (MESH): Hepatitis C and drug interactions OR herb-drug interactions OR food-drug interactions studies performed in humans. We conducted an additional complementary search for articles published in the same period about interactions of anti-retroviral and hepatitis C in humans using the following MESH: (Anti-retroviral agents AND Hepatitis C and drug interactions OR herb-drug interactions OR food -drug interactions). The clinical relevance of drug interactions was defined and evaluated based on the probability of occurrence and severity of interaction. Results: We identified 228 articles. Of these, it was possible to read the full text of 212. Of these, 62 contributed interactions which allowed us to identify 128 pairs of drug interactions, of which 120 (93.7%) were pharmacokinetic and 8 (6.3%) pharmacodynamic. Of these 128 pairs, two (1.6%) were rated Level 1: 110 (53.7%) were Level 2, 16 (7.8%) were Level 3, and 0 (0%) were Level 4. In addition, 78 pairs were identified that were grouped as interactions with evidence of absence of clinical significance. Conclusions: More than 90% of clinically relevant drug interactions are pharmacokinetic interactions associated with hepatic metabolism. Telaprevir has the greatest number of interactions.

[Reliability and external validity of a questionnaire to assess the knowledge about risk and cardiovascular disease and in patients attending Spanish community pharmacies]. / Fiabilidad y validez externa de un cuestionario de conocimiento sobre riesgo y enfermedad cardiovascular en pacientes que acuden a farmacias comunitarias de España.

OBJECTIVES: To determine the test-retest reliability of a questionnaire, with a validation preliminary, to assess knowledge of cardiovascular risk (CVR) and cardiovascular disease in patients attending community pharmacies in Spain. To complement the external validity, establishing the relationship between an educational activity and the increase in knowledge about CVR and cardiovascular disease. DESIGN: Sub-analysis of a controlled clinical study, EMDADER-CV, in which a questionnaire about knowledge concerning CVR was applied at 4 different times. LOCATION: Spanish Community Pharmacies. PARTICIPANTS: There were 323 patients in the control group, from the 640 who completed the study. MAIN MEASUREMENTS: Intraclass correlation coefficient to assess the reliability in 3 comparisons (post-educational activity with week 16, post-educational activity with week 32, and week 16 with week 32); and the non-parametric Friedman test to establish the relationship between an oral and written educational activity with increasing knowledge. RESULTS: For the 323 patients in the 3 comparisons, the intraclass correlation coefficient values were 0.624; 0.608 and 0.801, respectively (fair-good to excellent reliability). So, the Friedman test showed a statistically significant relationship between educational activity and increased knowledge (p < .0001). CONCLUSIONS: According to the intraclass correlation coefficient, the questionnaire aimed at assessing the knowledge on CVR and cardiovascular disease has a reliability between acceptable and excellent, which added to the previous validation, shows that the instrument meets the criteria of validity and reliability. Furthermore, the questionnaire showed the ability to relate an increase in knowledge with an educational intervention, feature that complements its external validity.

[The clinical relevance of drug interactions in patients with human immunodeficiency virus infection: update 2009-2014]. / Relevancia clínica de las interacciones medicamentosas en pacientes infectados con el virus de la inmunodeficiencia humana: actualización 2009-2014.

OBJECTIVE: To update information about drug interactions in patients with HIV/AIDS. METHODS: Comprehensive literature review in MEDLINE/PubMed database from May of 2009 to December of 2014, using the Mesh terms: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions. Publications with drug interactions in humans, in English or Spanish, and with full text were retrieved. Additionally, citation lists from identified articles were reviewed. The study inclusion was assessed by three independent researchers and by consensus among them when was necessary. Clinical relevance of drug interaction was grouped into four levels according to seriously and probability of occurrence. RESULTS: Global, 546 different references were retrieved and 243 were selected. In addition 11 further manuscripts were identified in the references of the included articles. Overall, 935 pairs of drug interactions were identified, 95.7% pharmacokinetic (823 by enzyme induction or inhibition and 67 by changes in bioavailability). Of the 935 pairs of drug interactions, 402(43%) were classified as levels 1 or 2. CONCLUSIONS: The most clinically relevant antiretroviral drug interactions are due to pharmacokinetic mechanism, mainly induction or enzyme inhibition, according to previous reviews, the protease inhibitors remain as the antiretrovirals with the highest number of clinical relevant interactions.