Situación del dolor en los hospitales de Cataluña

En el ámbito hospitalario, diferentes estudios en todo el mundo han demostrado que el dolor es un problema relevante. La importancia de un tratamiento adecuado del dolor hospitalario ha sido reconocida de forma institucional por la Joint Commission on Accreditation of Healthcare Organizations de los Estados Unidos, que ha incluido el tratamiento del dolor hospitalario entre los estándares de buena práctica clínica

Use of venous thromboprophylaxis and adherence to guideline recommendations : a cross-sectional study

Background: Consensus Conferences and Guidelines for deep vein thrombosis prophylaxis have been published, which recommend the use of prophylactic heparins in patients with risk of venous thromboembolism (VTE). The aim of this study was the assessment of the prophylaxis of VTE and the adherence to accepted guideline recommendations throughout the hospital. Methods: A cross-sectional study was carried out in a teaching hospital after guidelines were implemented. Patients' risk factors of deep vein thrombosis, risk categories of patients, and prophylaxis used in different wards were recorded. Appropriate adherence to the guidelines was analysed. Results: Of 397 patients, prophylaxis was used in 231 patients (58%), and low-molecular-weight heparins (LMWH) were used in 224 of them (97%). Patients with prophylaxis had a higher mean number of risk factors (SD) than those without prophylaxis [3.1 (1.4) vs 1.9 (1.4); p < 0.05)]. Prophylaxis was used in 72% and 90% of moderate and high-risk patients respectively. Appropriate adherence to all guideline recommendations was observed in 42% of patients. Adherence to guidelines was high as regards the use of prophylaxis according to patients' risk factors (78%) and the use of appropriate types of prophylaxis (99%), but was low regarding appropriate heparin dosage (47%) and preoperative dosage (37%). Appropriate prophylaxis use was higher in critical care and surgical wards than in medical wards. Conclusion: Prophylaxis of VTE is generally used in risk patients, but appropriate adherence to guidelines is less frequent and variable among different wards. Continuing medical education, discussion and dissemination of guidelines, and regular clinical audit are necessary to improve prophylaxis of VTE in clinical practice

Regulatory framework for advanced therapy medicinal products in Europe and United States

Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. The European Union (EU) and the United States (US) are fostering their development. For both regions, ATMPs fall under the regulatory framework of biological products, which determines the legal basis for their development. Sub-classifications of advanced therapies are different between regions, while in EU, there are four major groups, i.e., gene therapy, somatic cell therapy, tissue-engineered therapies, and combined advanced therapies; in US, the sub-classification covers two major groups of products, i.e., gene therapy and cellular therapy. The inclusion criteria that define a gene therapy are equivalent in both regions, and the exclusion criteria are directly related to the indications of the product. In the EU, there is a clear differentiation between cell- and tissue-based products regarding their classification as advanced therapies or coverage by other legal frameworks, whereas in US, there is a broader classification about whether or not these products can be categorized as biologic products. Both in EU and in US, in order to classify a cell- or a tissue-based product as an advanced therapy, it must be ensured that the processing of the cells implies a manipulation that alters their biological characteristics, although the term of manipulation in US differentiates between structural and non-structural cells and tissues. The regulatory terminology used to define ATMPs and their sub-classification reveals some differences between EU and US

Actualización en el tratamiento farmacológico de la artrosis

En la Conferencia de la OARS (Osteoarthritis Research Society, 1996) los medicamentos utilizados en el tratamiento de la artrosis se clasificaron según su mecanismo de acción en fármacos de acción sintomática y/o acción modificadora del curso de la enfermedad. Los medicamentos de acción sintomática comprenden los que actúan de forma rápida, como los analgésicos, antiinflamatorios no esteroideos (AINE) y corticoides, y los que actúan de forma más lenta como la glucosamina (vía oral), el condroitinsulfato (vía oral) y el ácido hialurónico (vía intraarticular), que también se denominan fármacos modificadores de los síntomas (symptomatic slow acting drug for osteoarthritis o SYSADOA) o del curso de la enfermedad

An update on adenosine A2A receptors as drug target in Parkinson's disease

Adenosine receptors are G protein-coupled receptors (GPCRs) that mediate the physiological functions of adenosine. In the central nervous system adenosine A2A receptors (A2ARs) are highly enriched in striatopallidal neurons where they form functional oligomeric complexes with other GPCRs such us the dopamine D2 receptor (D2R). Furthermore, it is assumed that the formation of balanced A2AR/D2R receptor oligomers are essential for correct striatal function as the allosteric receptor-receptor interactions established within the oligomer are needed for properly sensing adenosine and dopamine. Interestingly, A2AR activation reduces the affinity of striatal D2R for dopamine and the blockade of A2AR with specific antagonists facilitates function of the D2R. Thus, it may be postulated that A2AR antagonists are pro-dopaminergic agents. Therefore, A2AR antagonists will potentially reduce the effects associated with dopamine depletion in Parkinson's disease (PD). Accordingly, this class of compounds have recently attracted considerable attention as potential therapeutic agents for PD pharmacotherapy as they have shown potential effectiveness in counteracting motor dysfunctions and also displayed neuroprotective and anti-inflammatory effects in animal models of PD. Overall, we provide here an update of the current state of the art of these A2AR-based approaches that are under clinical study as agents devoted to alleviate PD symptom

Implementing reflective multicriteria decision analysis (MCDA) to assess orphan drugs value in the Catalan Health Service (CatSalut)

Catalan healthcare; Decision-making; Multi-criteria decision analysis; Orphan drugsSanitat catalana; Presa de decisions; Anàlisi de decisions multicriteri; Medicaments orfesSanidad catalana; Toma de decisiones; Análisis de decisiones multicriteria; Medicamentos huérfanosBACKGROUND: Orphan medicines show some characteristics that hinder the evaluation of their clinical added value. The often low level of evidence available for orphan drugs, together with a high budget impact and an incremental cost-effectiveness ratio many times higher than drugs used for non-orphan diseases, represent challenges in their appraisal and effective access to clinical use. In order to explore how to handle these hurdles, the Catalan Health Service (CatSalut) began an initiative on a multidimensional assessment of drugs value during the appraisal process. Reflective multicriteria decision analysis (MCDA) using analytical methods was chosen, since it may help to standardise and contextualize all the relevant data related with the drug that could contribute to a decision. The aim of the study was to determine whether the implementation of reflective MCDA methodology could support the decision-making process about orphan medicines in the context of CatSalut. METHODS: The assessment and decision-making process for orphan drugs in the Programa d'Harmonització Farmacoterapeutica (PHF) of CatSalut was prioritized to test the implementation of the reflective MCDA both a qualitative and quantitatively. A staged approach was used with the following main steps: selection and structuration of quantitative criteria (Core Model) and qualitative criteria (Contextual Tool), framework scoring and assessment of three orphan drug case studies. This proof-of-concept would grant a continued refinement of the methodology and, if and when validated, its potential integration to other therapeutic areas of the PHF. RESULTS: The final framework was composed by 10 quantitative criteria (Core Model) and 4 qualitative criteria (Contextual Tool) according to the PHF goals being the most important criteria "disease severity", "unmet need", "comparative effectiveness" and "comparative safety /tolerability". The matrix developed for the case studies served as a guide for the selection of the essential information that the decision-makers were expected to include in a framework. The reflective discussion was considered the most relevant phase of the approach to support inputs for health decision-making processes reflecting both drug value and place in therapy. CONCLUSIONS: The study showed that reflective MCDA methodology could be implemented to complement the decision-making process in CatSalut, as an aid to determine the clinical added value for orphan medicines. MCDA provided transparency and a structured discussion during the committee meetings, thus increasing transparency and predictability of the relevant items supporting the agreements adopted on orphan drugs access

Actualización en la prevención de las úlceras gastroduodenales inducidas por antiinflamatorios no esteroideos y sus complicaciones

Los antiinflamatorios no esteroideos (AINE) son ampliamente prescritos para el tratamiento de cuadros clínicos de dolor y procesos inflamatorios. No obstante, producen efectos adversos gastrointestinales que pueden ser graves y ser causa de ingreso hospitalario, sobre todo en los pacientes de edad avanzada. Estos efectos adversos son un problema de extraordinaria relevancia clínica, por su magnitud y gravedad, y, por tanto, es muy importante su prevención. La prevención de las úlceras gastrointestinales inducidas por AINE y sus complicaciones se basa en: a) el uso, siempre que sea posible, de los analgésicos sin efecto antiinflamatorio, y b) si es necesario el uso de un AINE, en la selección de los que tienen menor riesgo, en el empleo de dosis bajas, y en el uso de tratamientos profilácticos asociados en los pacientes de mayor riesgo (edad avanzada, antecedentes de úlcera péptica y complicaciones gastrointestinales y tratamiento concomitante con fármacos anticoagulantes y corticoides, entre otros)

e-Learning en Farmacologia. Resultats de l'aplicació d'una nova metodologia

L'objectiu d'aquest estudi és desenvolupar estratègies per realitzar una docència funcional a Farmacologia. S'ha implementat una nova activitat d'e-Learning basada en unitats temàtiques (UT) mitjançant les quals els estudiants assoleixen coneixements teòrics i desenvolupen habilitats, com el treball en grup i l'autoaprenentatge que s'incrementa si les UT es proporcionen abans de la classe presencial. La valoració d'aquesta metodologia e-Learning per part dels estudiants és molt positiva

Utilització de l'e-Learning en Farmacologia. Metodologia emprada per implementar-lo.

El nostre objectiu docent és aconseguir una docència funcional. L'alumne ha de poder utilitzar els coneixements adquirits en la seva professió. Enlloc de retenir informació que romangui inert o s'oblidi, ha de realitzar activitats que li permetin aplicar els coneixements de farmacologia per resoldre situacions reals. Hem elaborat un vídeo que mostra la metodologia d'e-Learning i la seva valoració, per que pugui ésser d'utilitat a altres professors

Hospital doctors' views and concerns about pharmacovigilance

Purpose: The aim of the study was to evaluate the opinions and concerns of hospital doctors about adverse drug reactions (ADRs) and pharmacovigilance. Methods: A qualitative study was undertaken using focus groups in sessions on pharmacovigilance activities conducted in thirteen clinical services of a tertiary university hospital. A total of 296 physicians participated in these sessions by giving their opinions or expressing their doubts about ADR and pharmacovigilance activities which were recorded by different observers and subsequently analysed. Results: Doctors remarked on: a) the importance, concern, frequency and specific types of ADRs that were observed in clinical practice; b) problems of clinical decision making related to the suspected ADRs; c) methods for improving detection and reporting ADRs; d) monitoring of specific ADRs or ADRs caused by specific drugs; e) and measures to prevent and minimize the risk of ADRs. Physicians expressed doubts related to: a) the basic concepts of ADRs; b) the methods of ADR identification and evaluation; c) the objectives and procedures of pharmacovigilance programmes; d) and the impact of pharmacovigilance activities. Conclusions: Hospital doctors believe that ADRs are a matter for concern in their daily clinical practice, and monitoring ADRs as well as measures for preventing the risk of ADRs are needed. Nevertheless, doctors have doubts about what an ADR is, the accuracy of diagnostic methods, the development of pharmacovigilance activities and their impact on clinical practice. Pharmacovigilance should be better explained through a continuous feedback and close relationship with hospital doctors