Implementación del Proceso Estandarizado de Evaluación Farmacoterapéutica en pacientes hospitalizados y ambulatorios / Implementation of the standardized process of Pharmacotherapeutic evaluation in inpatients and outpatients

Objetivos el seguimiento farmacoterapéutico (SFT) realizado por el farmacéutico clínico puede enmarcarse dentro de 3 actividades: la identificación, la resolución y la prevención de eventos adversos a medicamentos. Estas deben ajustarse a los requerimientos y los recursos de cada institución, generando la necesidad de desarrollar procedimientos que aumenten la eficiencia del SFT y garanticen la seguridad del paciente. Los farmacéuticos clínicos de la Red de Salud UC-CHRISTUS Chile desarrollamos un Proceso Estandarizado de Evaluación Farmacoterapéutica (PEEF). El objetivo principal del estudio fue evaluar el impacto de esta herramienta en términos del número de evaluaciones e intervenciones de los farmacéuticos clínicos y secundariamente determinar el ahorro de costos potenciales y directos asociados a las intervenciones en la Unidad de Cuidados Intensivos (UCI). Método estudio cuasi-experimental que evaluó la frecuencia y tipo de evaluaciones e intervenciones realizadas por los farmacéuticos clínicos en unidades de pacientes adultos de la Red UC-CHRISTUS, previo y posterior a la utilización del PEEF. La distribución de variables se evaluó mediante el test Shapiro–Wilk, la asociación entre el uso del PEEF y el número de evaluaciones e intervenciones fue realizada mediante el test Chi cuadrado. La evaluación de costos asociados a las intervenciones del farmacéutico clínico en UCI se realizó utilizando la metodología propuesta por Hammond et al.10. Resultados el total de pacientes evaluados pre- y pos-PEEF fue de 1.781 y 2.129, respectivamente. Las evaluaciones e intervenciones en el periodo pre-PEEF fueron 5.209 y 2.246, en el periodo pos-PEEF fueron 6.105 y 2.641, respectivamente. El aumento de las evaluaciones como de las intervenciones fue significativo solo en las unidades de mayor complejidad. La reducción potencial de costos estimados en el periodo pos-PEEF en UCI fue de 492.805 dólares americanos. ... (AU)

Objectives The Pharmacotherapeutic follow-up program (PFU) carried out by the clinical pharmacist can be categorized within 3 fundamental activities; identification, resolution and prevention of adverse drug events. These must be adjusted to the requirements and resources of each institution, developing procedures to increase PFU efficiency and to guarantee patient safety. The clinical pharmacists of UC-CHRISTUS Healthcare Network developed a Standardized Pharmacotherapeutic Evaluation Process (SPEP). The main goal of our study is to evaluate the impact of this tool through the pharmacist evaluation number and pharmacist interventions number. Secondarily to determine the potential and direct cost savings associated with the pharmacist interventions in an Intensive care unit (ICU). Methods A quasi-experimental study evaluated the frequency and type of pharmacist evaluation and pharmacist interventions performed by clinical pharmacists in adult patients units of UC-CHRISTUS Healthcare Network, before and after the implementation of SPEP. The distribution of variables was evaluated using the Shapiro–Wilk test and the association between the use of SPEP and the pharmacist evaluation and pharmacist interventions number was performed using the Chi-square test. The cost evaluation associated with pharmacist interventions in the ICU was carried out using methodology proposed by Hammond et al. Results A total number of 1,781 patients was evaluated before and 2,129 after the SPEP. The pharmacist evaluation and pharmacist interventions number in the before-SPEP period were 5,209 and 2,246. In the after-SPEP period were 6,105 and 2,641, respectively. The increase in both the pharmacist evaluation and pharmacist interventions number was significant only in critical care patients. The potential cost saving in after-SPEP period in the ICU was USD 492,805.... (AU)

Una visión actual del tratamiento farmacológico para la obesidad / A current vision of the pharmacological treatment for obesity

Fundamentos: La obesidad es una patología muy prevalente a nivel mundial. La prevención, modificación deestilo de vida, tratamiento nutricional, psicológico y tratamiento farmacológico son estrategias para combatiresta enfermedad. El objetivo de esta revisión es analizar las evidencias existentes sobre la eficacia de losfármacos en la reducción del peso corporal y otros parámetros antropométricos y metabólicos relacionados.Métodos: Se ha realizado una búsqueda en PubMed y ScienceDirect de los artículos publicados en los últimos10 años seleccionando ensayos clínicos con fármacos en hombres y mujeres adultos obesos.Resultados: La naltrexona-bupropión es la asociación de fármacos contra la obesidad que obtiene mejoresresultados en la reducción de los parámetros antropométricos y metabólicos (perfil lipídico y presión arterial),seguida de la liraglutida 3,0 mg y el orlistato; la semaglutida es el hipoglucemiente que reduce más estosparámetros. La mejora de la calidad de vida no es relevante y los efectos adversos muy similares entre losfármacos. En fármacos nuevos o en estudio no se observan mejores resultados.Conclusiones: Los fármacos indicados para la obesidad en nuestro entorno son eficaces y seguros, lasemaglutida puede ser otra opción para el tratamiento. Hace falta más evidencia para incluir nuevos fármacosentre los comercializados contra la obesidad. (AU)

Background: Obesity is a very prevalent disease worldwide. Prevention, lifestyle modification, nutritional,psychological and pharmacological treatment are strategies to combat this disease. The objective of this reviewis to analyze the existing evidence on the efficacy of drugs in reducing body weight and other relatedanthropometric and metabolic parameters.Methods: A search was made in PubMed and ScienceDirect of the last 10 years, selecting clinical trials withdrugs in obese adult men and women.Results: Naltrexone-bupropion is the anti-obesity drug association that obtains the best results in reducinganthropometric and metabolic parameters (lipid profile and blood pressure), followed by liraglutide 3.0 mg andorlistato; semaglutide is the hypoglycemic agent that reduces these parameters the most. The improvement inquality of life is not relevant and the adverse effects are very similar between the drugs. Better results are notobserved in new or in-study drugs.Conclusions: The drugs indicated for obesity in our country are effective and safe, and semaglutide can alsobe a good option for obesity treatment. More evidence is needed to include new drugs among those marketedagainst obesity. (AU)

Diabetic Heart Failure with Preserved Left Ventricular Ejection Fraction: Review of Current Pharmacotherapy.

Diabetes is associated with several diabetic-related abnormalities which increase the risk of onset or worsening of heart failure. Recent studies showed that the majority of diabetic patients present with heart failure with preserved ejection fraction (HFpEF), and the prevalence of HFpEF in diabetics is alarming. Moreover, outcomes in HFpEF are poor and could be compared to those of heart failure with reduced ejection fraction (HFrEF), with 1-year mortality ranging between 10 and 30%. In contrast to HFrEF, there is very limited evidence for pharmacologic therapy in symptomatic patients with preserved ejection fraction, and therefore, the optimal selection of treatment for diabetic HFpEF remains challenging. This narrative review article summarizes the currently available data on the pharmacological treatment of HFpEF in patients with diabetes.

Questioning Established Theories and Treatment Methods Related to Iron and Other Metal Metabolic Changes, Affecting All Major Diseases and Billions of Patients.

The medical and scientific literature is dominated by highly cited historical theories and findings [...].

Editorial on the Special Issue "Botulinum Toxin for the Treatment of Neurological Disorders: Where We Are and Where We Need to Go".

Over the past 30 years, botulinum toxin (BoNT) has seen an ever-expanding use in disorders afflicting the nervous system [...].

Building better biobetters: From fundamentals to industrial application.

Biological drugs or biopharmaceuticals off patent open a large market for biosimilars and biobetters, follow-on biologics. Biobetters, in particular, are new drugs designed from existing ones with improved properties such as higher selectivity, stability, half-life and/or lower toxicity/immunogenicity. Glycosylation is one of the most used strategies to improve biological drugs, nonetheless bioconjugation is an additional alternative and refers to the covalent attachment of polymers to biological drugs. Extensive research on novel polymers is underway, nonetheless PEGylation is still the best alternative with the longest clinical track record. Innovative trends based on genetic engineering techniques such as fusion proteins and PASylation are also promising. In this review, all these alternatives wereexplored as well as current market trends, legislation and future perspectives.

Biomodulina T: una nueva opción terapéutica contra la COVID-19 / Biomodulin T: a new therapeutic option against COVID-19

RESUMEN Para potenciar la inmunidad en personas con deterioro gradual del sistema inmune, causado por el envejecimiento o por padecer diferentes comorbilidades, el Grupo de las Industrias Biotecnológica y Farmacéutica de Cuba (BioCubaFarma) ha introducido el producto Biomodulina T. Este se ha utilizado, además, como parte del protocolo de prevención y para el tratamiento de pacientes positivos al SARS-CoV-2. La inmunidad dependiente del timo, incluida la inmunidad de células T y la producción de anticuerpos, disminuye con el tamaño del órgano en los adultos, lo que se conoce como "inmunosenescencia". La Biomodulina T es un extracto diafiltrado de timo de ternera; tiene una acción citorrestauradora e inmunomoduladora, que ha demostrado su eficacia en diferentes grupos de riesgo, dentro de los cuales los ancianos ocupan un lugar especial. En la actual situación epidemiológica nacional e internacional su inclusión en los protocolos de actuación es clave. El uso de este medicamento en un grupo vulnerable, como los ancianos, representa un horizonte esperanzador en tanto se avanza en la producción de vacunas nacionales que sean seguras y eficaces (AU).

ABSTRACT To boost immunity in people with gradual deterioration of the immune system, caused by aging or suffering from different comorbidities, the Group of the Biotechnology and Pharmaceutical Industries of Cuba (Biotechnology Farma) has introduced the product Biomodulin T. This has also been used as part of the prevention protocol and for the treatment of patients positive to SARS-CoV-2. Thymus-dependent immunity, including T-cell immunity and antibody production, decreases with organ size in adults, which is known as "immunosenescence." Biomodulin T is a diafiltered extract of veal thymus; it has a cytorestaurative and immunomodulatory action, which has demonstrated its effectiveness in different risk groups, within which elder people occupy a special place. In the current national and international epidemiological situation its inclusion in the protocols of action is significant. The use of this medication in a vulnerable group, such as elder people, represents a hopeful horizon as progress is made in the production of safe and effective national vaccines (AU).

Fat-Fit Patterns, Drug Consumption, and Polypharmacy in Older Adults: The EXERNET Multi-Center Study.

BACKGROUND: Physical fitness levels and the amount of accumulated adipose tissue (fatness) relate to current and future individuals' heath status. Nevertheless, the interrelationships of their combined patterns with polypharmacy and the types of medications consumed have not been sufficiently investigated. METHODS: This cross-sectional study was carried out in six Spanish regions between 2008 and 2009 with a sample of older community-dwelling adults (≥65 years old) without dementia or cancer. Fitness was measured with one-leg balance and senior fitness tests, as well as by measuring weight and fat mass with a bioelectrical impedance analyzer. Polypharmacy was defined as the use of five or more medications. An analysis of variance was performed for comparisons between the physical fitness and fatness patterns and the medication consumed. RESULTS: A total of 1709 elders were included in the study (72.1 ± 5.2 years). The two unfit patterns were those with the highest drug consumption. The High-Fat-Unfit pattern was the one that had the most significant consumption and had the highest percentage of polymedicated subjects. The Low-Fat-Fit pattern had a significantly lower percentage of people that did not consume any medications. The highest percentages of drug consumption in 7 of the 10 groups that were included were concentrated in the two unfit patterns. CONCLUSIONS: This study highlights the importance of fitness in older adults, as it is at least as important as the avoidance of accumulation of excess fat with respect to the consumption of a smaller number of medicines.

New Drugs Approved in 2020.

In 2020, the US Food and Drug Administration approved 53 novel drugs. Thirty-six of the 53 (68%) drugs were reviewed and approved through an expedited review pathway, and 31 of the 53 (58%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the US Food and Drug Administration in 2020.

The search for disease-modifying agents in decompensated cirrhosis: From drug repurposing to drug discovery.

Patients with decompensated cirrhosis are currently managed through targeted strategies aimed at preventing or treating specific complications. In contrast, a disease-modifying agent should, by definition, be aimed at globally addressing 'decompensated cirrhosis'. To be defined as a disease-modifying agent in decompensated cirrhosis, interventions need to demonstrate an unequivocal benefit on the course of disease in well-designed and adequately powered randomised clinical trials with hard endpoints (i.e. patient survival). These trials also need to define the target population, dosage and timing of administration, factors guiding treatment, temporary or permanent stopping rules, transferability to daily clinical practice, cost-effectiveness, and global treatment access. By eliminating the underlying cause of cirrhosis, aetiologic treatments can still influence the course of decompensated disease by halting or slowing down disease progression or even inducing reversion to the compensated state. In contrast, there remains an unmet clinical need for disease-modifying agents which can antagonise key pathophysiological mechanisms of decompensated cirrhosis, such as portal hypertension, gut translocation, circulatory dysfunction, systemic inflammation, and immunological dysfunction. However, in the last few years, the repurposing of "old drugs" that have already been prescribed for more limited indications in hepatology or for other diseases has provided a few candidates, including human albumin, statins, and poorly absorbable oral antibiotics, which are under further evaluation in large-scale randomised clinical trials. New disease-modifying agents are also expected to be identified in the next decade through the systematic repurposing of existing drugs and the development of novel molecules which are currently undergoing pre-clinical or early clinical testing.

Patent highlights August-September 2020.

A snapshot of noteworthy recent developments in the patent literature of relevance to pharmaceutical and medical research and development.

Drug related problems in clinical practice: a cross-sectional study on their prevalence, risk factors and associated pharmaceutical interventions.

Drug-related problems (DRP) cause preventable negative health outcomes, especially during hospital admissions. The aim of our study was to examine the prevalence and characteristics of DRP in regular clinical pharmacy, as well as to determine those factors associated with a higher risk of DRP in the hospital setting. We analyzed data from a standardized registry database of regular pharmacy practice (2015- 2016). DRP were classified according to the Pharmaceutical Care Network Europe v6.2 classification. Cross-sectional data were obtained from 1602 adults admitted to medical wards. Crude and adjusted binary logistic regressions were performed to identify associations between potential risk factors and DRP. Overall DRP prevalence was high across medical specialties (45,1%), in a population characterized by advanced age, polypharmacy and multimorbidity. Problems leading to DRP were mainly classified into two domains (effectiveness and adverse reactions), being drug and dose selection the most frequent causes. Interventions were accepted and DRP were totally or partially solved in 74.1% and 4.81% of cases, respectively. In the adjusted model polypharmacy, allergies, BMI > 25 kg/m2 and clearance < 30 mL/min were associated with a higher risk of DRP. The participation of clinical pharmacists into multidisciplinary teams promotes the detection and solution of DRP. Polypharmacy, obesity, renal impairment and allergy are associated with a higher risk of DRP during admission.

Trends in the pharmacological treatment of benign prostatic hyperplasia in the UK from 1998 to 2016: a population-based cohort study.

PURPOSE: To describe trends in the pharmacological treatment of BPH in the United Kingdom (UK) from 1998 to 2016. METHODS: We created a cohort of men with a diagnosis of BPH between 1998 and 2016 using the Clinical Practice Research Datalink. Using Poisson regression, we estimated annual prescription rates of 5αRIs, α-blockers, and combination therapy (5αRIs + α-blockers). Adherence was defined by a proportion of days covered > 80%. RESULTS: Our cohort included 192,640 men with BPH who generated 1,176,264 person-years (PYs) of follow-up. The mean age was 68.0 (standard deviation: 10.7) years. The prescription rate of all BPH medications during the study period was 347.6 per 100 PYs (95% CI 347.2-347.9). α-Blockers had the highest prescription rate (222.9 per 100 PYs, 95% CI 222.7-223.2); prescription rates of 5αRIs and combination therapy were 69.1 per 100 PYs (95% CI 69.0-69.3) and 55.5 per 100 PYs (95% CI 55.4-55.7), respectively. The prescription rate for combination therapy was 19 times greater in 2013-2016 than in 1998-2000 (rate ratio: 19.2, 95% CI 18.6-19.7), while the prescription rates for 5αRIs and α-blockers each doubled during this period (rate ratio: 1.86, 95% CI 1.84-1.88 and rate ratio: 2.02, 95% CI 2.01-2.04, respectively). The proportion of patients who were adherent at 1 year to 5αRIs (32.3%), α-blockers (44.0%), and combination therapy (45.6%) was low. CONCLUSION: The prescription rate of BPH medications increased substantially between 1998 and 2016 in the UK, with the greatest relative increase observed with combination therapy. Adherence to BPH medications was low in this population-based study.

Non-antibiotic medication use in an Indonesian community cohort 0-18 months of age.

BACKGROUND: Rational medication use for treatment is mandatory, particularly in children as they are vulnerable to possible hazards of drugs. Understanding the medication use pattern is of importance to identify the problems of drug therapy and to improve the appropriate use of medication among this population. METHODS: A post-hoc study of the RV3-BB Phase IIb trial to children aged 0-18 months which was conducted in Indonesia during January 2013 to July 2016. Any concomitant medication use and health events among 1621 trial participants during the 18 months of follow-up were documented. Information on medication use included the frequency, formulation, indication, duration of usage, number of regimens, medication types, and therapeutic classes. RESULTS: The majority of participants (N = 1333/1621; 82.2%) used at least one non-antibiotic medication for treatment during the 18-month observation period. A total of 7586 medication uses were recorded, mostly in oral formulation (90.5%). Of all illnesses recorded, 24.7% were treated with a single drug regimen of non-antibiotic medication. The most common therapeutic classes used were analgesics/antipyretics (30.1%), antihistamines for systemic use (17.4%), cough and cold preparations (13.5%), vitamins (8.6%), and antidiarrheals (6.6%). The main medication types used were paracetamol (29.9%), chlorpheniramine (16.8%), guaifenesin (8.9%), zinc (4.6%), and ambroxol (4.1%). Respiratory system disorder was the most common reason for medication use (51.9%), followed by gastrointestinal disorders (19.2%), pyrexia (16.9%), and skin disorders (7.0%). CONCLUSION: A large number of children were exposed to at least one medication during their early life, including those where evidence of efficacy and safety in a pediatric population is lacking. This supports the need for further research on pediatric drug therapy to improve the appropriate use of medication in this population.

Proteasome, a Promising Therapeutic Target for Multiple Diseases Beyond Cancer.

Proteasome is vital for intracellular protein homeostasis as it eliminates misfolded and damaged protein. Inhibition of proteasome has been validated as a powerful strategy for anti-cancer therapy, and several drugs have been approved for treatment of multiple myeloma. Recent studies indicate that proteasome has potent therapeutic effects on a variety of diseases besides cancer, including parasite infectious diseases, bacterial/fungal infections diseases, neurodegenerative diseases and autoimmune diseases. In this review, recent developments of proteasome inhibitors for various diseases and related structure activity relationships are going to be summarized.

Emerging pharmacological therapies for ARDS: COVID-19 and beyond.

ARDS, first described in 1967, is the commonest form of acute severe hypoxemic respiratory failure. Despite considerable advances in our knowledge regarding the pathophysiology of ARDS, insights into the biologic mechanisms of lung injury and repair, and advances in supportive care, particularly ventilatory management, there remains no effective pharmacological therapy for this syndrome. Hospital mortality at 40% remains unacceptably high underlining the need to continue to develop and test therapies for this devastating clinical condition. The purpose of the review is to critically appraise the current status of promising emerging pharmacological therapies for patients with ARDS and potential impact of these and other emerging therapies for COVID-19-induced ARDS. We focus on drugs that: (1) modulate the immune response, both via pleiotropic mechanisms and via specific pathway blockade effects, (2) modify epithelial and channel function, (3) target endothelial and vascular dysfunction, (4) have anticoagulant effects, and (5) enhance ARDS resolution. We also critically assess drugs that demonstrate potential in emerging reports from clinical studies in patients with COVID-19-induced ARDS. Several therapies show promise in earlier and later phase clinical testing, while a growing pipeline of therapies is in preclinical testing. The history of unsuccessful clinical trials of promising therapies underlines the challenges to successful translation. Given this, attention has been focused on the potential to identify biologically homogenous subtypes within ARDS, to enable us to target more specific therapies 'precision medicines.' It is hoped that the substantial number of studies globally investigating potential therapies for COVID-19 will lead to the rapid identification of effective therapies to reduce the mortality and morbidity of this devastating form of ARDS.

How personalized are benefit and harm results of randomized trials? A systematic review.

OBJECTIVES: This study aimed to review the degree of personalization of benefit and harm in the reporting of recent high-profile randomized controlled trials (RCTs) involving pharmacological interventions. STUDY DESIGN AND SETTING: This study is a systematic review of RCTs published between 2012 and 2017 with at least one intervention evaluating drug therapy and meeting the "high-profile" threshold in a premier academic literature abstraction service. Our primary outcome was the proportion of trials reporting subgroup analyses of a combined benefit-harm outcome. Secondary outcomes included the proportion of trials reporting subgroup analyses or clinical prediction guide for benefits or harms. We assessed the quality of the subgroup analyses using a modified version of previously published credibility criteria. RESULTS: Of 296 eligible RCTs, nine studies (3%) reported a combined benefit-harm endpoint. We found subgroup analyses of a combined benefit-harm endpoint in three studies (1%), a benefit endpoint in 167 studies (56.4%), and a harm endpoint in 18 studies (6.1%). The overall quality of the subgroup analyses was poor. Only one study reported a clinical prediction guide for an outcome. CONCLUSION: Despite great interest in the personalization of therapies, it is rarely reported in high-profile trials. Lack of rigorous and widely accepted methods may be the major barrier.