Hepatotoxicity by Drugs

Hepatotoxicity is the injury or liver damage caused by exposure to drugs; it is an adverse drug reaction that may be uncommon but serious. The hepatic injury can be classified into hepatocellular, cholestatic and mixed, caused by increase in alanine aminotransferase and alkaline phosphatase than upper limit of normal. The risk factors include idiosyncrasy, age, gender, alcohol consumption, concomitant use of other drugs, previous or underlying liver disease, genetic and environmental factors. Liver toxicity manifestations are generally accompanied by nonspecific symptoms such as abdominal pain, jaundice, fever, nausea, vomiting, diarrhea, pruritus and rash. Identification of hepatotoxicity is a complex process to perform; therefore, clinical scales have been developed, such as the Roussel Uclaf Causality Assessment Method (CIOMS/RUCAM) and the Clinical Diagnostic Scale (M & V CDS). Additionally, there is no specific treatment for hepatotoxicity, which is based on suspending the suspected drug and treating symptoms. The most commonly associated pharmacological groups are antibiotics, nonsteroidal anti-inflammatory analgesics (NSAIDs), antidepressants and anticonvulsants. Drug-induced liver injury has been an adverse event, hard to identify, prevent and treat; thereby, the pharmacist intervention can contribute to the diminution of the deleterious effects in patient health

Legalización del consumo de cannabis recreativo en adultos y problemas de salud mentales

Mental health problems are included in the non-communicable diseases and together to other problems associated with well-being, they are attributed up to 21 % of global deaths. Therefore, it is necessary to analyze and establish the risk/benefit ratio of policy related to mental health, for example, in the case of the legalization of recreational cannabis use in adults. Cannabis is the most widely used “illicit” drug in Western countries, essentially because it increases sociability and euphoria. In the last decade, several countries have endorsed policies aimed at legalizing the commercialization of recreational cannabis in adults. In this sense, there is controversy about the effect of this type of policy on the percentage of people who consume this substance and on their health. However, it could be expected that this type of initiative will improve the percentage of people who consume this substance. Increased marijuana use may lead to a higher prevalence of mental health problems, including psychosis and schizophrenia. The existence of an association between cannabis use and psychosis (including schizophrenia) is accepted. In this framework, recognizing the benefits of policies to legalize the use of recreational cannabis in adults, advancing from a drug prohibition approach to one focused on harm reduction, it is convenient to evaluate and define the effect of this type of policies. Also, this kind of policies should be linked to informative and educational programs to clarify the risks of consumption, including, dependence and mental health problems.Los problemas de salud mental hacen parte de las enfermedades no trasmisibles y se les atribuye, con otras enfermedades asociados al bienestar, hasta un 21 % de las muertes mundiales. Por ello, es necesario analizar y establecer la relación riesgo/beneficio de políticas relacionadas con la salud mental, caso de la legalización del consumo de cannabis recreativo en adultos. El cannabis es la droga “ilícita” de mayor consumo en los países occidentales, en esencia por incrementar la sociabilidad y la euforia. En la última década, varios países han promulgado normas orientadas a legalizar la comercialización de cannabis recreativo en adultos. En este sentido, existe controversia del efecto de este tipo de iniciativas, en el porcentaje de personas que consumen esta sustancia y en la salud de los mismos. Sin embargo, se podría esperar que este tipo de iniciativas favorezca un aumento en el porcentaje de personas que consumen esta sustancia. El aumento del consumo de marihuana puede favorecer una mayor prevalencia de problemas de salud mental, incluyendo psicosis y esquizofrenia. Se acepta la existencia de una asociación entre consumo de cannabis y psicosis (incluyendo esquizofrenia). En este marco, reconociendo los beneficios de las políticas de legalización del consumo de cannabis recreativo en adultos, orientadas a superar el enfoque prohibicionista y a buscar la reducción del daño, es conveniente evaluar y definir el efecto de las mismas. Además, estas iniciativas se deben acompañar de programas informativos y educativos, orientados a sintetizar los riesgos del consumo, incluyendo, la dependencia y problemas de salud mentales

Legalization of recreational cannabis use in adults and mental health problems

Los problemas de salud mental hacen parte de las enfermedades no trasmisibles y se les atribuye, con otras enfermedades asociados al bienestar, hasta un 21 % de las muertes mundiales. Por ello, es necesario analizar y establecer la relación riesgo/beneficio de políticas relacionadas con la salud mental, caso de la legalización del consumo de cannabis recreativo en adultos. El cannabis es la droga “ilícita” de mayor consumo en los países occidentales, en esencia por incrementar la sociabilidad y la euforia. En la última década, varios países han promulgado normas orientadas a legalizar la comercialización de cannabis recreativo en adultos. En este sentido, existe controversia del efecto de este tipo de iniciativas, en el porcentaje de personas que consumen esta sustancia y en la salud de los mismos. Sin embargo, se podría esperar que este tipo de iniciativas favorezca un aumento en el porcentaje de personas que consumen esta sustancia. El aumento del consumo de marihuana puede favorecer una mayor prevalencia de problemas de salud mental, incluyendo psicosis y esquizofrenia. Se acepta la existencia de una asociación entre consumo de cannabis y psicosis (incluyendo esquizofrenia). En este marco, reconociendo los beneficios de las políticas de legalización del consumo de cannabis recreativo en adultos, orientadas a superar el enfoque prohibicionista y a buscar la reducción del daño, es conveniente evaluar y definir el efecto de las mismas. Además, estas iniciativas se deben acompañar de programas informativos y educativos, orientados a sintetizar los riesgos del consumo, incluyendo, la dependencia y problemas de salud mentales.Mental health problems are included in the non-communicable diseases and together to other problems associated with well-being, they are attributed up to 21 % of global deaths. Therefore, it is necessary to analyze and establish the risk/benefit ratio of policy related to mental health, for example, in the case of the legalization of recreational cannabis use in adults. Cannabis is the most widely used “illicit” drug in Western countries, essentially because it increases sociability and euphoria. In the last decade, several countries have endorsed policies aimed at legalizing the commercialization of recreational cannabis in adults. In this sense, there is controversy about the effect of this type of policy on the percentage of people who consume this substance and on their health. However, it could be expected that this type of initiative will improve the percentage of people who consume this substance. Increased marijuana use may lead to a higher prevalence of mental health problems, including psychosis and schizophrenia. The existence of an association between cannabis use and psychosis (including schizophrenia) is accepted. In this framework, recognizing the benefits of policies to legalize the use of recreational cannabis in adults, advancing from a drug prohibition approach to one focused on harm reduction, it is convenient to evaluate and define the effect of this type of policies. Also, this kind of policies should be linked to informative and educational programs to clarify the risks of consumption, including, dependence and mental health problems

Effectiveness of a continuing education program of drugs with fiscalized substance to improve pharmacy staff competencies: A multicenter, cluster-randomized controlled trial

Background: Drugs with fiscalized substances without a correct prescription may lead to undesirable side effects. Pharmacy staff needs to improve their competencies (knowledge, skills, and attitudes) to contribute to providing ambulatory pharmacy services and minimizing medication errors. Continuing education programs (CEP) could favor access to relevant and quality information on health promotion, disease prevention, and the rational use of drugs. Objective: To evaluate the effectiveness of a continuing education program to improve pharmacy staff competencies to enhance the use of drugs with fiscalized substances. Methods: A multicenter, prospective, parallel-group, cluster-randomized, controlled clinical trial was conducted in drugstores and pharmacies in Colombia (ambulatory retail establishments). The intervention group (IG) received a CEP: a web-based social networking site, a virtual course, a dispensing information system, and face-to-face training. The control group (CG) received general written material on the correct use of drugs. We measured pharmacy staff’s skills, attitudes, and knowledge self-reported scores, and the simulated patient technique was used to assess the participant skills and attitudes in real practice. We used a questionnaire designed for this study, which was evaluated by a group of experts and piloted and showed a Cronbach’s alpha of 0.96. Results: Three hundred five drugstores and pharmacies were enrolled in two groups: IG (n = 153) and CG (n = 152). Out of the 750 potential participants, 88% (n=659) agreed to participate. The pharmacy staff’s skills, attitudes, and knowledge self-reported scores post-intervention were higher than baseline in both groups; however, the IG had statistically significantly higher scores than the CG. Post-intervention, the self-efficacy skills and attitudes in the IG improved by 88% (22 of 25) and in six of the seven assessed knowledge components (p<0.001). However, the dispensing criteria evaluated with simulated patient methodology showed no statistically significant differences between groups in the pharmacy staff’s skills and attitudes in real practice. Conclusions: Providing a continuing education program using different educational strategies improved the pharmacy staff’s competencies (assessed knowledge and self-reported skills and attitudes) to enhance the use of drugs with fiscalized substances. However, there were no improvements in skills and attitudes in real practice. These findings could show that pharmacy staff needs additional and continuous training/sustainability.Committee for Development Research and the sustainability of the University of AntioquiaprogramRandox Laboratorie

Clinical Relevance of Drug Interactions in People Living with Human Immunodeficiency Virus on Antiretroviral Therapy—Update 2022: Systematic Review

Background: The clinical outcomes of antiretroviral drugs may be modified through drug interactions; thus, it is important to update the drug interactions in people living with HIV (PLHIV). Aim: To update clinically relevant drug interactions in PLHIV on antiretroviral therapy with novel drug interactions published from 2017 to 2022. Methods: A systematic review in Medline/PubMed database from July 2017 to December 2022 using the Mesh terms antiretroviral 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 access were retrieved. The clinical relevance of drug interactions was grouped into five levels according to the gravity and probability of occurrence. Results: A total of 366 articles were identified, with 219 (including 87 citation lists) were included, which allowed for the identification of 471 drug interaction pairs; among them, 291 were systematically reported for the first time. In total 42 (14.4%) and 137 (47.1%) were level one and two, respectively, and 233 (80.1%) pairs were explained with the pharmacokinetic mechanism. Among these 291 pairs, protease inhibitors (PIs) and ritonavir/cobicistat-boosted PIs, as well as integrase strand transfer inhibitors (InSTIs), with 70 (24.1%) and 65 (22.3%) drug interaction pairs of levels one and two, respectively, were more frequent. Conclusions: In PLHIV on antiretroviral therapy, we identify 291 drug interaction pairs systematically reported for the first time, with 179 (61.5%) being assessed as clinically relevant (levels one and two). The pharmacokinetic mechanism was the most frequently identified. PIs, ritonavir/cobicistat-boosted PIs, and InSTIs were the antiretroviral groups with the highest number of clinically relevant drug interaction pairs (levels one and two).Committee for Development Research (CODI)Sustainability program (2018–2019), Universidad de Antioqui

Prevalence of self-treatment with complementary products and therapies for weight loss: A randomized, cross-sectional Study in Overweight and Obese Patients in Colombia

AbstractBackground:The use of complementary and alternative medicine for weight loss is becoming increasingly common worldwide. In overweight or obese patients, this practice could be harmful. Available data concerning the use of complementary therapies and products (CTPs) for weight loss in these patients in Colombia are limited.Objectives:The aims of this study were to determine the prevalence of self-treatment with CTPs in overweight or obese patients in Colombia and to explore the relationship between CTP use and demographic, anthropometric, and biochemical parameters.Methods:This randomized, cross-sectional study was conducted at a registered dieticians' office located at the Center for Nutritional Care, School of Nutrition and Dietetics, University of Antioquia, Medellín, Colombia, and at an outpatient clinic attended by a registered dietician located at the Pablo Tobón Uribe Hospital, Medellín, Colombia. The study enrolled a random sample of overweight (body mass index [BMI], 25–30 kg/m2) or obese (BMI, >30 kg/m2) male and female patients aged 20 to 50 years received nutritional treatment in Colombia in 2002. Data concerning the use of weight-loss CTPs were gathered, and their possible association with demographic, anthropometric, and biochemical data was explored.Results:This randomized study comprised 94 patients (70 women, 24 men; mean [SD] age, 36.5 [9.7] years; mean [SD] BMI, 28.4 [4.2] kg/m2). Forty-nine (52.1%) patients reported self-treatment with weight-loss CTPs; 40 (42.6%) patients used complementary products, and 21 (22.3%) used complementary therapies. Among the products, inadequately identified herbal medicines (ie, absence of available information concerning the composition of the products or information could not be obtained from the patient [many of the products used were not authorized for distribution in Colombia]), folkloric or home remedies, and commercial diets were most commonly used (40.0%, 40.0%, and 27.5%, respectively). The use of CTPs was more prevalent in women compared with men (P < 0.001; odds ratio [OR] = 6.43). In women, CTP use was significantly higher in patients with a higher educational level (P = 0.008; OR = 3.82) and in those who were single (P = 0.038; OR = 2.97). The use of CTPs was also more frequent in patients with a negative view of their current nutritional therapy (P = 0.002; OR = 6.8).Conclusions:In the small group of overweight and obese patients in this study, 52.1% used CTPs. In obese women, those with a higher educational level and/or who were single were more likely to use CTPs. Patients were also more likely to use CTPs if they had a negative view of their current nutritional therapy

Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, clusterrandomized controlled trial

We thank the University of Antioquia, Laproff Laboratories, and all the people who participated in the study and were essential for its successful completion.Background: Health disorders, due to the use of drugs with fiscalized substances, including controlled substances, have become a common problem in Colombia. Multiple reasons can help explain this problem, including selfmedication, since access to these drugs may be easier. Also, there is a lack of knowledge that these drugs are safer than illicit drugs. The use of these drugs without a valid medical prescription and follow-up can have negative consequences such as drug abuse, addiction, and overdose, and eventually, have negative health consequences. Pharmacy staff is essential to both assure the correct drug use and minimize prescription errors to help outpatients have better management of their pharmacotherapy. For this reason, it is necessary to increase key competencies like knowledge, skills, and attitudes in the pharmacy staff of ambulatory (outpatients) pharmacies. Methods: This study is a prospective, cluster-randomized, parallel-group, multicenter trial of drugstores and drugstores/pharmacies (ambulatory pharmacies). The study is designed to determine the effectiveness of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in drugstores and drugstores/pharmacies. Pharmacy staff will be randomly selected and assigned to one of the study groups (intervention or control). The intervention group will receive a continuing education program for over 12 months. The control group will receive only general information about the correct use of complex dosage forms. The primary objective is to evaluate the effectiveness of a continuing education program to improve pharmacy staff competencies (knowledge, skills, and attitudes) to improve the ambulatory (outpatient) pharmacy services: dispensation, health education, and pharmacovigilance of drugs with fiscalized substances. The secondary outcomes include (a) processes associated with the management of drugs with fiscalized substances in drugstores and drugstores/pharmacies, including regulation compliance; (b) degree of implementation of ambulatory (outpatient) pharmacy services targeting these drugs in drugstores and drugstores/pharmacies; (c) patient satisfaction with such services; and (d) pharmacy staff satisfaction with the continuing education program. Discussion: This clinical trial will establish whether providing a continuing education program for the adequate utilization of drugs with fiscalized substances improves pharmacy staff competencies regarding these drugs. Trial registration: ClinicalTrials.gov NCT03388567. Registered on 28 November 2017. First drugstore or drugstore/ pharmacy randomized on December 1, 2018. Protocol version: 0017102017MC Keywords: Dispensation, Health education, Pharmacovigilance, Drugstores, Pharmacies, Pharmacy staff, Fiscalized substances, Controlled drugsCommittee for Development Research (CDR)University of AntioquiaLaproff Laboratorie

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 notiicación 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 deinidos 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 deinieron los ítems a incluir en la propuesta de formato. Resultados: Se identiicaron 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 deinió el contenido del formato de reporte de RAM por pacientes. Conclusión: Se diseña y presenta una propuesta de formato de reporte de RAM por pacientes ambulatorios en Colombia, con la información identiicada 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&nbsp;accessed. We defined the contents of the ADR report format by patients. Conclusion: We design and develop a proposal of ADR reporting format by outpatient in Colombia, which has the information identified as key. The&nbsp;format requires a process of validation and evaluation of its functionality in contributing to achieving the objectives of pharmacovigilance

INCIDENCIA DE RESULTADOS CLÍNICOS NEGATIVOS ASOCIADOS A LA UTILIZACIÓN DE MEDICAMENTOS TRAZADORES/SEÑALADORES EN PACIENTES HOSPITALIZADOS, MEDELLÍN-COLOMBIA

RESUMENObjetivo: Determinar la incidencia de resultados clínicos negativos–RNM en pacientes hospitalizados con prescripción de medicamentos trazadores/señaladores durante su estancia hospitalaria.Método: Diseño: Estudio de cohorte abierta. Ámbito: Institución de Salud de alta complejidad - Medellín. Periodo: noviembre de 2013 – noviembre de 2015. Muestra: Grupos (expuestos y no expuestos) se clasificaron como pacientes con uno o más medicamentos trazadores y sin ellos, en una relación 1 (expuestos): 2 (no expuestos); ambos grupos se parearon por variables socio-demográficas y clínicas; edad con una diferencia no mayor a +/- 5 años, sexo, diagnóstico principal y comorbilidades principalmente. Variables: número de medicamentos trazadores; mediante seguimiento farmacoterapéutico  - SFT se  identificaron problemas de necesidad, efectividad y seguridad asociada a los medicamentos. Resultados: Se incluyó 324 pacientes, 108 (33,3%) expuestos y 216 (66,7%) no expuestos. La edad media fue 52 años (DE 25,7), 198 (61%) hombres. El 31,2% (101) de los pacientes presentó algún tipo de RNM. En los expuestos, la incidencia de RNM fue 43,5% (47 pacientes) y en los no expuestos la frecuencia de RNM fue 25% (54 pacientes). Se observó mayor incidencia de RNM en pacientes con 2 a 3 medicamentos (49,1%) (RD: 0,666 IC95%: 0,503-0,883). El riesgo asociado a la exposición al factor de riesgo (RR) fue 1,74 (IC 95%; 1,27 – 2,38) (P= 0,01). Conclusiones: La utilización de medicamentos trazadores/señaladores está asociada a la presentación de RNM. Por tanto, esta estrategia se podría utilizar para la identificación,  priorización y selección de pacientes en los programas de farmacoseguridad. ABSTRACT Objective: To determine the incidence of negative clinical results – MNR in hospitalized patients with prescription tracer/marker drugs during their hospital stay. Method: Design: open cohort study. Scope: high complexity Health Institution - Medellin. Period: November 2013 - November 2015. Sample: groups (exposed and unexposed) were classified as patients with one or more tracer drugs and without them, in a ratio 1 (exposed): 2 (not exposed); both groups were matched by socio-demographic and clinical variables; age with a difference no greater than +/- 5 years, sex, main diagnosis and comorbidities mainly. Variables: number of tracer drugs; Pharmacotherapeutic follow-up - SFT identified problems of need, effectiveness and safety associated with drugs. Results: We included 324 patients, 108 exposed (33.3%) and 216 unexposed (66.7%). The average age was 52 years (SD: 25.7), 198 (61%) patients were male. 31.2% (101) of patients had some type of medication Negative Results. In those exposed, the incidence of MNR was 43.5% (47 patients) and in the no exposed the frequency of MNR was 25% (54 patients). A higher incidence of MNR was observed in patients with 2 to 3 medications (49.1%) (RD: 0.666 IC95%: 0.503-0.883). The risk associated with the risk factor (RR) was 1.74 (CI 95% 1.27 - 2.38) (P = 0.01). Conclusions: The use of tracer/marker drugs is associated with the presentation of MNR. Therefore, this strategy could be used to identify and prioritize the selection of patients who must enter the pharmacy safety programs