Cumplimiento de la normatividad en la publicidad televisiva de medicamentos de venta libre en Colombia. Estudio descriptivo retrospectivo 2018 / Compliance with regulations in the television advertising of over-the-counter drugs in Colombia. Retrospective descriptive study 2018

Resumen Introducción: la publicidad televisiva es una estrategia utilizada por la industria farmacéutica para ofrecer sus productos. En el caso de los medicamentos de venta libre, se tiene la responsabilidad de ajustarse a la normativa relacionada con estos productos, con el propósito de proteger al televidente de influencias negativas por posible publicidad imprecisa o engañosa. Objetivo: evaluar el cumplimiento normativo de la publicidad televisiva de medicamentos de venta libre en Colombia de agosto de 2018 en los canales nacionales Caracol y RCN. Metodología: se revisaron las grabaciones de anuncios publicitarios de medicamentos en los canales Caracol y RCN. Aleatoriamente, se seleccionaron los días 2, 4, 22 y 26 de agosto de 2018. La revisión de las grabaciones se realizó por dos evaluadores independientes. Los datos de los anuncios publicitarios se analizaron con estadística descriptiva. Resultados: se identificaron 624 anuncios publicitarios relacionados con medicamentos de venta libre: 601 pautas (96,3 %) y 23 comerciales (3,7 %). Entre los 624 anuncios emitidos, 226 (36,2 %) de 18 medicamentos no cumplieron con algunas condiciones establecidas en la normatividad. Discusión: este estudio, comparado con la publicación del 2014, mostró un incremento en la cantidad de anuncios que no cumplen con la norma, pasando de 8 % a 36,2 %. La principal situación de incumplimiento se debe al tamaño de la fuente, que puede limitar la lectura en poblaciones especiales. Conclusiones: los anuncios televisivos emitidos en los canales nacionales Caracol y RCN, en un 36,2 %, no cumplen con los requisitos definidos por la normatividad vigente.

Abstract Introduction: Advertising broadcast by mass media is a strategy used by the pharmaceutical sectors to offer their products. For of over-the-counter drugs, this sector is responsible for complying with the regulations related to these products, in order to protect the viewers from negative influences, for possible inaccurate or misleading advertising. Objective: To evaluate regulatory compliance in television advertising of over-the-counter drugs in Colombia in August 2018 on Caracol and RCN national channels. Methods: The recordings of the drug advertisements of two national television channels Caracol and RCN were reviewed. The days 2, 4, 22, 26 of august 2018 were randomly selected. Two independent evaluators reviewed the recordings. The data from the advertisements was analyzed with descriptive statistics. Results: A total of 624 commercials related to over-the-counter drugs were identified: 601 guidelines (96.3%) and 23 commercials (3.7%). Among the 624 advertisements broadcast by both national channels, 226 (36.2%) of 18 drugs did not meet some of the conditions established in the regulations. Discussion: Compared to the work done in 2014, shows that there was an increase in the number of advertisements that do not comply with the norm (from 8% to 36.2%). The main non-compliance situation presented by advertisements is related to the source size since small letters can limit the reading of special populations. Conclusion: 36.2% of the television advertisements broadcast on the national television channels Caracol and RCN do not meet the requirements defined by current regulations.

How to link patients with suspicious COVID-19 to health system from the community pharmacies? A route proposal.

Colombia confirmed its first case of the COVID-19 on March 6th, 2020. On March 16th, 2020, 54 cases have been confirmed (36 imported and 18 associated), therefore, Colombia is at highest alert, and it is now trying to avoid or minimize the last stage of "community transmission". We present a route proposal that shows how the community pharmacist may develop his responsibility to contribute to the early detection and appropriate referral of possible cases of the COVID-19. In the route have been considered three possible entrances depending on the needs of the users: anti-flu drugs, symptoms related to COVID-19 infection or the request for items for hygiene and prevention of transmission such as alcohol and face masks. Later, self-care education should be given, and the possible cases should be reported to the telephone lines designated by the mayor or the governor, continuing the healthcare process. Community pharmacies and pharmacy staff play a crucial role in minimizing the stage of "community transmission" of COVID-19, through properly detection and management of possible cases and customer education.

Epidemiology of drug-induced liver injury in a University Hospital from Colombia: Updated RUCAM being used for prospective causality assessment.

INTRODUCTION AND AIM: Epidemiological information regarding drug-induced liver injury in some Latin American countries remains limited. Therefore, disease prevention and health promotion strategies are imperative to reduce drug-induced liver injuries and its fatal outcomes. This study aimed to collect epidemiological data regarding drug-induced liver injury and identify associated factors in patients admitted to a university hospital in Colombia. METHODS AND PATIENTS: A prospective study was conducted for 1 year to assess the incidence of drug-induced liver injury in patients aged >18 years who showed elevated values in liver tests. Data were collected after obtaining informed consent from the patients. The updated Roussel Uclaf Causality Assessment Method was applied to assess the causality of drug-induced liver injury. RESULTS: The study included 286 patients with elevated values in liver tests, 18 of whom presented with drug-induced liver injury. The mean age of patients was 54.7±19.1 years. The associated pharmacological groups were anti-infectives and anticonvulsants (isoniazid, rifampicin, nitrofurantoin, phenytoin, and valproic acid), with a total of 15 drugs. The affected patients presented with cytopenia, jaundice, nausea, vomiting, or hepatomegaly. The most common type of liver injury was hepatocellular, and most patients recovered satisfactorily. The number of patients who had highly probable and probable causality grading was 1 and 9, respectively. CONCLUSION: The incidence of drug-induced liver injury in a university hospital in Colombia was 6%. Comorbidities and concomitant drugs are risk factors for drug-induced liver injury. TRIAL REGISTRATION: Registered in The Cuban Public Registry of Clinical Trials (identifier RPCEC00000242).

Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment naïve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011-2012.

BACKGROUND: Generic drug policies are often associated with concerns about the quality and effectiveness of these products. Phase IV clinical trials may be a suitable design to assess the effectiveness and safety of generic drugs. The objective of this study was to describe the effectiveness and the safety of the generic abacavir/lamivudine and efavirenz in treatment-naïve HIV-infected patients. METHODS: A monocentric, nonrandomized, open-label, phase IV study in treatment naïve HIV-infected patients 18 years or older with indication to receive abacavir/lamivudine and efavirenz were recruited from a program that provides comprehensive outpatient consultation and continuing care. The primary end-point was to achieve viral load <40 copies/mL at 12 months after baseline to assess effectiveness. Secondary end-point of the study were 1) to asses increasing in T-CD4 lymphocytes levels as accompaniment to asses effectiveness, and 2) to assess both gastrointestinal, skin, and central nervous system symptoms, and lipid profile, cardiovascular risk, renal, and hepatic function as safety profile. Data were determined at baseline, 3, 6, and 12 months. Close clinical monitoring and pharmaceutical care were used for data collection. Wilcoxon matched-pairs signed-rank test was used to compare proportions or medians. RESULTS: Sixty patients were invited to participate in the study; 42 were enrolled and 33 completed the follow-up. Of the nine patients excluded from the study, only one was withdrawn due to adverse events. At 12 months, 31 of 42 patients (73.8 % in intention-to-treat analysis) achieved a viral load of HIV1 RNA <40 copies/mL. There was a significant increase (172 cells/mm3) in the median for CD4 T lymphocyte count. The adverse events were mild and met the safety profile for this antiretroviral regimen, mainly of central nervous system symptoms, skin rash, lipid abnormalities, and an increase of 2 % in the median of the percentage of cardiovascular risk. CONCLUSIONS: The clinical outcomes of generic version of abacavir/lamivudine and efavirenz in HIV treatment naïve patients showed the expected safety and effectiveness profile of proprietary ARV drugs. TRIAL REGISTRATION: Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000202 . Registered 19 November 2015.

Interacción warfarina y acetaminofén Evaluación para establecer su relevancia clínica / Warfarin and acetaminophen interaction Assessment to establish its clinical relevance

Objetivo: realizar una revisión estructurada de la interacción warfarina y acetaminofén, buscando establecer su relevancia clínica y profundizar en el mecanismo de dicha interacción. Método: revisión estructurada en PubMed/Medline, de artículos en inglés y español, buscando los términos warfarin AND (acetaminophen OR paracetamol) en el título o resumen. La búsqueda se complementó con las referencias de artículos valorados como importantes. Los trabajos se agruparon en: relacionados con el aumento de sangrado por la interacción warfarina-acetaminofén, o relacionados con el mecanismo de la interacción. Resultados: se identificaron 45 artículos, de los cuales se incluyeron 15 en la revisión: 11 relacionados con el aumento del riesgo de sangrado por la interacción y cuatro con el mecanismo de la interacción. La gravedad del efecto (aumento de la probabilidad de sangrado) se consideró moderada; mientras que la probabilidad de aparición fue valorada como definida. Además, se identificó una relación entre la dosis de acetaminofén y el riesgo de sangrado. Por su parte, el N-acetil-para-benzoquinona-imina (metabolito del acetaminofén) inhibe enzimas del ciclo de la vitamina K y tiene un efecto sinérgico con el efecto anticoagulante de la warfarina. Conclusiones: la relevancia clínica de la interacción warfarina - acetaminofén es de riesgo alto, debido a que la gravedad del efecto (aumento del riesgo de sangrado) es moderada y su probabilidad de presentación es definida. Por tanto, estos dos medicamentos pueden ser utilizados conjuntamente, pero se debe realizar una estricta monitorización. El metabolito N-acetil-para-benzoquinona-imina es el responsable del aumento del efecto anticoagulante de la warfarina. (Acta Med Colomb 2013; 38: 22-27).

Objective: to make a structured review of the interaction between warfarin and acetaminophen, seeking to establish its clinical relevance and deepen in the mechanism of this interaction. Method: structured review of PubMed/Medline of articles in English and Spanish, looking warfarin and acetaminophen or paracetamol in the title or abstract. The search was complemented with references of articles rated as important. The papers were grouped in: related to increased bleeding due to warfarin-acetaminophen interaction, or related to the mechanism of the interaction. Results: we identified 45 articles, of which 15 were included in the review: 11 related to increased risk of bleeding due to the interaction and 4 with the mechanism of the interaction. The severity of the effect (increased likelihood of bleeding) was considered moderate, whereas the probability of appearance was rated as definite. In addition, we identified a relationship between the dose of acetaminophen and the risk of bleeding. In turn, the N-acetyl-para-benzoquinone-imine (metabolite of acetaminophen) inhibits enzymes of the vitamin K cycle and has a synergistic effect with the anticoagulant effect of warfarin. Conclusions: the clinical relevance of the interaction warfarin-acetaminophen is of high risk due to the fact that the severity of the effect (increased risk of bleeding) is moderate and the probability of its presentation is definite. Therefore, these two drugs can be used together, but a strict monitoring should be conducted. The metabolite N-acetyl-para-benzoquinone-imine is responsible for the increase in the anticoagulant effect of warfarin. (Acta Med Colomb 2013; 38: 22-27).