Guía de seguimiento farmacoterapéutico sobre dolor

Coordinador de esta edición Emilio García JiménezEsta guía tiene como objetivo facilitar la fase de estudio necesaria para realizar Seguimiento Farmacoterapéutico de un paciente. La fase de estudio trata de profundizar en los problemas de salud y en los medicamentos que toma el paciente, o sea, un análisis lo más completo posible del Estado de Situación del paciente a una fecha determinada. De dicho Estado de Situación se obtendrán las sospechas de Problemas Relacionados con Medicamentos (PRM) que el paciente puede estar sufriendo, y a partir de éstos se realizarán sucesivas intervenciones para intentar resolver los PRM

Adecuación de la prescripción de soporte nutricional a las guías de práctica clínica en pacientes con anorexia nerviosa

Background: nutritional support (NS) is a core element in the treatment of underweight patients with anorexia nervosa (AN). Objective: to analyze the adherence of NS prescriptions to clinical practice guidelines (CPGs) for AN patients and to compare the effectiveness, safety, and cost of NS according to adherence. Methods: this retrospective observational study included AN patients admitted to an Eating Disorders Unit between January 2006 and December 2009 and followed until December 2014. NS prescriptions were compared with guidelines published by the American Psychiatric Association (APA), the National Institute for Clinical Excellence (NICE), and the Spanish Ministry of Health and Consumption (SMHC). Adherence was defined as percentage of hospitalizations that followed all recommendations. Results: adherence to APA and NICE/SMHC was observed in 10.2% and 73.4%, respectively, of the total of 177 hospitalizations. Body weight and body mass index were higher at admission in the NICE/SMHC adherence versus non-adherence group (p < 0.001). Weight gain rate during hospitalization was higher (p = 0.009) in “APA adherence” (135.5 g/day) versus “non-adherence” (92.1 g/day) group. Hospital stay was significantly shorter (p = 0.025) in “NICE/SMHC adherence” (39.5 days) versus “non-adherence” group (50.0 days). NICE/SMHC adherence was associated with lower costs (p = 0.006). Conclusions: NS prescriptions for anorexic patients more frequently followed NICE/SMHC than APA recommendations. Over the short-term, APA adherence was associated with improved weight gain. Patients adhering to NICE/SMHC recommendations had shorter hospital stay and reduced costs, likely due to their more favorable nutritional status at admission

Medication Review with Follow-Up for End-Stage Renal Disease: Drug-Related Problems and Negative Outcomes Associated with Medication—A Systematic Review

Financial support received as a Doctoral Grant [reference number OAICE-143-2020] from the Office of International Affairs and External Cooperation, University of Costa Rica.Background: This article reviews the available scientific literature on drug-related problems and negative outcomes associated with medications identified by medication review with follow-up for end-stage renal disease and discussed with the physicians. Methods: A systematic review was conducted of the scientific literature retrieved from the following databases: MEDLINE (via PubMed), Web of Science, SCOPUS, Cochrane Library: The Cochrane Central Register and Control Trials (CENTRAL) and Literatura Latinoamericana y del Caribe (LILACS), Medicina en Español (MEDES), and the SciELO bibliographic database (a collection of scientific journals). The following terms were used as descriptors and searched in free text: “end-stage renal disease”, “medication review”, “drug-related problems”, and “negative outcomes associated with medication”. The following limits were applied: “humans” and “adults (more than 18 years)”. Results: A total of 59 references were recovered and, after applying inclusion/exclusion criteria, 16 articles were selected. Of these selected articles, 15 provided information on drug-related problems and only 1 on negative outcomes associated with medications. Conclusions: It can be concluded that drug-related problems and negative outcomes associated with medications affect patients with end-stage renal disease, mainly those receiving renal replacement therapy. More evidence is needed, especially on negative outcomes associated with medication.Office of International Affairs and External Cooperation, University of Costa Rica OAICE-143-202

Tratamiento de la neutropenia febril: filgrastim y pegfilgrastim

Objetivos: El uso terapéutico de los factores estimulantes de colonias de granulocitos resulta desconocido en comparación con el uso como profilaxis de los mismos. El objetivo de este estudio fue recopilar la información relativa al uso terapéutico encontrada en estudios llevados a cabo del año 2003 en adelante. Métodos: La búsqueda se realizó en siete bases de datos electrónicas en mayo de 2012. Resultaron elegibles los estudios publicados en inglés, francés y español desde el año 2003 en adelante. Se buscaron estudios que abordasen el uso terapéutico de filgrastim y pegfilgrastim en neutropenia febril secundaria a quimioterapia. La búsqueda se completó revisando las referencias de los artículos seleccionados. Resultados: Hubo cuatro estudios que reunieron los criterios de selección. Uno se llevó a cabo en un hospital del Líbano, otro en un hospital británico, otro fue un estudio multicéntrico en España y el último se realizó en Australia a través de una encuesta electrónica a especialistas en cáncer. En el estudio del Líbano, 59 de 137 ciclos de tratamiento con factores estimulantes de colonias de granulocitos se realizaron como uso terapéutico. En el estudio LEARN en España, el 29,7% de los pacientes que usaron factores estimulantes de colonias de granulocitos los utilizaron como tratamiento, al igual que el 17,3% de los pacientes que recibieron pegfilgrastim. El 9,7% de los tratamientos con filgrastim fueron terapéuticos en el hospital británico. Finalmente, en Australia, el 27% de los hematólogos utilizarían factores estimulantes de colonias de granulocitos en el primer caso de los que se les presentaron (bajo riesgo de complicaciones médicas). El 7% de los oncólogos los utilizaría en su caso de bajo riesgo de complicaciones médicas y el 9% los utilizaría en el segundo caso (riesgo mayor). La duración media de la terapia en los diferentes estudios varió de 4,8 a 6 días. El efecto adverso más frecuente fue el dolor de huesos. Conclusiones: Según los resultados de esta revision, los factores estimulantes de colonias de granulocitos de uso diario se utilizaron más que el pegfilgrastim para uso terapéutico, siendo el último poco utilizado e incluso considerado una excepción. Las terapias fueron cortas y seguras.Aim: The use of granulocyte colony-stimulating factors in the therapeutic setting of febrile neutropenia is still unknown with regard to the prophylaxis one. The aim of the present work was to collect the information about this therapeutic use found out in the studies performed since 2003. Methods: Seven electronic databases were searched in May 2012. Eligibility included works published in English, French and Spanish from 2003 on. Studies that involved the therapeutic use of filgrastim or pegfilgrastim in chemotherapy-induced febrile neutropenia were sought. Reviews, meta-analysis and works published as abstracts were excluded. The search was completed by checking the reference lists from the selected studies. Results: One of them was performed in a hospital in the Lebanon, another one in a British hospital, another was a multi-centre study in Spain and the last one was performed in Australia through an electronic survey made to cancer specialists. In the Lebanon study, 59 out of 137 granulocyte colony-stimulating factors treatment courses were performed in the therapeutic setting. In the LEARN study in Spain 29.7% patients treated with daily granulocyte colony-stimulating factors used them as treatment, so did 17.3% patients receiving pegfilgrastim. 9.7% treatments with filgrastim were therapeutic in the British hospital. Finally, in Australia 27% haematologist would use granulocyte colony-stimulating factors in case 1 (low risk of medical complications). 7% oncologists would use them in their low risk case of medical complications and 9% would use them in case 2 (higher risk). The mean duration of the therapy in the different studies ranged between 4.8 and 6 days. The most frequent adverse effect was bone pain. Conclusions: The results from the present review showed that daily granulocyte colony-stimulating factors were used more than pegfilgrastim in the treatment setting, being the latter used very little and even considered an exception. Therapies were short and safe

Number needed to treat and associated cost analysis of cenobamate versus third-generation anti-seizure medications for the treatment of focal-onset seizures in patients with drug-resistant epilepsy in Spain

Medicamentos anticonvulsivos; Cenobamato; EficienciaMedicaments anticonvulsius; Cenobamat; EficiènciaAnti-seizure medications; Cenobamate; EfficiencyIntroduction Epilepsy is a serious neurological disease, ranking high in the top causes of disability. The main goal of its treatment is to achieve seizure freedom without intolerable adverse effects. However, approximately 40% of patients suffer from Drug-Resistant Epilepsy (DRE) despite the availability of the latest options called third-generation Anti-Seizure Medications(ASMs). Cenobamate is the first ASM approved in Spain for the adjunctive treatment of Focal-Onset Seizures (FOS) in adult patients with DRE. The introduction of a new drug increases the number of therapeutic options available, making it important to compare it with existing alternatives in terms of clinical benefit and efficiency. Purpose This study aimed to compare the clinical benefit, in terms of the Number Needed to Treat (NNT), and the efficiency, in terms of Cost per NNT (CNT), associated with cenobamate versus third-generation ASMs used in Spain for the adjunctive treatment of FOS in patients with DRE. Methods The Number Needed to Treat data was calculated based on the ≥50% responder rate and seizure freedom endpoints (defined as the percentage of patients achieving 50% and 100% reduction in seizure frequency, respectively), obtained from pivotal clinical trials performed with cenobamate, brivaracetam, perampanel, lacosamide, and eslicarbazepine acetate. The NNT was established as the inverse of the treatment responder rate minus the placebo responder rate and was calculated based on the minimum, mid-range Daily Defined Dose (DDD), and maximum doses studied in the pivotal clinical trials of each ASM. CNT was calculated by multiplying the annual treatment cost by NNT values for each treatment option. Results In terms of NNT, cenobamate was the ASM associated with the lowest values at all doses for both ≥50% responder rate and seizure freedom compared with the alternatives. In terms of CNT, for ≥50% responder rate, cenobamate was the ASM associated with the lowest CNT values at DDD and lacosamide and eslicarbazepine acetate at the minimum and maximum dose, respectively. For seizure freedom, cenobamate was associated with the lowest CNT value at DDD and the maximum dose and lacosamide at the minimum dose. Conclusions Cenobamate could represent the most effective ASM in all doses studied compared to the third-generation ASMs and the most efficient option at DDD for both ≥50% responder rate and seizure freedom. This study could represent an important contribution towards informed decision-making regarding the selection of the most appropriate therapy for FOS in adult patients with DRE from a clinical and economical perspective in Spain.This study was sponsored by Angelini Pharma España, S.L.U

Defining a set of standardised outcome measures for newly diagnosed patients with multiple myeloma using the Delphi consensus method: the IMPORTA project

Objective: To define a standard set of outcomes and the most appropriate instruments to measure them for managing newly diagnosed patients with multiple myeloma (MM). Methods: A literature review and five discussion groups facilitated the design of two-round Delphi questionnaire. Delphi panellists (haematologists, hospital pharmacists and patients) were identified by the scientific committee, the Spanish Program of Haematology Treatments Foundation, the Spanish Society of Hospital Pharmacies and the Spanish Community of Patients with MM. Panellist's perception about outcomes' suitability and feasibility of use was assessed on a seven-point Likert scale. Consensus was reached when at least 75% of the respondents reached agreement or disagreement. A scientific committee led the project. Results: Fifty-one and 45 panellists participated in the first and second Delphi rounds, respectively. Consensus was reached to use overall survival, progression-free survival, minimal residual disease and treatment response to assess survival and disease control. Panellists agreed to measure health-related quality of life, pain, performance status, fatigue, psychosocial status, symptoms, self-perception on body image, sexuality and preferences/satisfaction. However, panellist did not reach consensus about the feasibility of assessing in routine practice psychosocial status, symptoms, self-perception on body image and sexuality. Consensus was reached to collect patient-reported outcomes through the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core questionnaire 30 (C30), three items from EORTC-QLQ-Multiple Myeloma (MY20) and EORTC-QLQ-Breast Cancer (BR23), pain Visual Analogue Scale, Morisky-Green and ad hoc questions about patients' preferences/satisfaction. Conclusions: A consensual standard set of outcomes for managing newly diagnosed patients with MM has been defined. The feasibility of its implementation in routine practice will be assessed in a future pilot study

Drug assessment by a Pharmacy and Therapeutics committee: from drug selection criteria to use in clinical practice

Background: In Spain, hospital medicines are assessed and selected by local Pharmacy and Therapeutics committees (PTCs). Of all the drugs assessed, cancer drugs are particularly important because of their budgetary impact and the sometimes arguable added value with respect to existing alternatives. This study analyzed the PTC drug selection process and the main objective was to evaluate the degree of compliance of prescriptions for oncology drugs with their criteria for use. Methods: This was a retrospective observational study (May 2007 to April 2010) of PTC-assessed drugs. The variables measured to describe the committee's activity were number of drugs assessed per year and number of drugs included in any of these settings: without restrictions, with criteria for use, and not included in formulary. These drugs were also analyzed by therapeutic group. To assess the degree of compliance of prescriptions, a score was calculated to determine whether prescriptions for bevacizumab, cetuximab, trastuzumab, and bortezomib were issued in accordance with PTC drug use criteria. Results: The PTC received requests for inclusion of 40 drugs, of which 32 were included in the hospital formulary (80.0%). Criteria for use were established for 28 (87.5%) of the drugs included. In total, 293 patients were treated with the four cancer drugs in eight different therapeutic indications. The average prescription compliance scores were as follows: bevacizumab, 83% for metastatic colorectal cancer, 100% for metastatic breast cancer, and 82.3% for non-small-cell lung cancer; cetuximab, 62.0% for colorectal cancer and 50% for head and neck cancer; trastuzumab, 95.1% for early breast cancer and 82.4% for metastatic breast cancer; and bortezomib, 63.7% for multiple myeloma. Conclusion: The degree of compliance with criteria for use of cancer drugs was reasonably high. PTC functions need to be changed so that they can carry out more innovative tasks, such as monitoring conditions for drug use

Determination of the economically justifiable price of cenobamate in the treatment of focal-onset seizures in adult patients with drug-resistant epilepsy in Spain

Anti-seizure medications; Cenobamate; Economically justifiable priceMedicamentos anticonvulsivos; Cenobamato; Precio económicamente justificableMedicaments anticonvulsius; Cenobamat; Preu econòmicament justificableObjective To determine the economically justifiable price (EJP) of cenobamate to become a cost-effective alternative compared with third-generation anti-seizure medications in the treatment of focal-onset seizures (FOS) in adult patients with drug-resistant epilepsy (DRE) in Spain. Methods Cost-effectiveness analysis compared cenobamate with brivaracetam, perampanel, eslicarbazepine acetate, and lacosamide. Markov model simulation of treatment pathway over a 60-year time horizon is presented. We determined the effectiveness and quality-adjusted life-years (QALYs) of health status and disutilities associated with treatment-related adverse events. Acquisition costs and use of medical resources were obtained from published literature and expert opinion. Base-case of cenobamate’s EJP calculated applying a willingness-to-pay (WTP) threshold of €21,000/QALY. Analyses were performed at different thresholds, including dominant price scenario. Result robustness was assessed through sensitivity analyses. Results Base-case shows that cenobamate’s daily EJP of €7.30 is cost-effective for a threshold of €21,000/QALY. At a daily price of €5.45, cenobamate becomes dominant over all treatment alternatives producing cost-savings for the national health system (NHS). Sensitivity analyses supported the robustness of base-case findings. Conclusions Treatment with cenobamate produces incremental clinical benefit over third-generation ASMs, and at the base-case, EJP could represent a cost-effective option for the adjunctive treatment of FOS in adult patients with DRE in Spain

A multi-stakeholder multicriteria decision analysis for the reimbursement of orphan drugs (FinMHU-MCDA study)

Medicaments orfes; Reemborsament; EspanyaMedicamentos huérfanos; Reembolso; EspañaOrphan drugs; Reimbursement; SpainBackground Patient access to orphan medicinal products (OMPs) is limited and varies between countries, reimbursement decisions on OMPs are complex, and there is a need for more transparent processes to know which criteria should be considered to inform these decisions. This study aimed to determine the most relevant criteria for the reimbursement of OMPs in Spain, from a multi-stakeholder perspective, and using multicriteria decision analysis (MCDA). Methods An MCDA was developed in 3 phases and included 28 stakeholders closely related to the field of rare diseases (6 physicians, 5 hospital pharmacists, 7 health economists, 4 patient representatives and 6 members from national and regional health authorities). Initially [phase A], a bibliographic review was conducted to identify the potential reimbursement criteria. Then, a reduced advisory board (8 members) proposed, selected, and defined the final list of criteria that could be relevant for reimbursement. A discrete choice experiment (DCE) [phase B] was developed to determine the relevance and relative importance weight of such criteria according to the stakeholders’ preferences by choosing between pairs of hypothetical financing scenarios. A multinomial logit model was fitted to analyze the DCE responses. Finally [phase C], the advisory board review the results using a deliberative process. Results Thirteen criteria were selected, related to 4 dimensions: patient population, disease, treatment, and economic evaluation. Nine criteria were deemed relevant for decision-making and associated with a higher relative importance: Health-related quality of life (HRQL) (23.53%), treatment efficacy (14.64%), availability of treatment alternatives (13.51%), disease severity (12.62%), avoided costs (11.21%), age of target population (7.75%), safety (seriousness of adverse events) (4.72%), quality of evidence (3.82%) and size of target population (3.12%). The remaining criteria had a < 3% relative importance: economic burden of disease (2.50%), cost of treatment (1.73%), cost-effectiveness (0.83%) and safety (frequency of adverse events) (0.03%). Conclusion The reimbursement of OMPs in Spain should be determined by its effect on patient’s HRQL, the extent of its therapeutic benefit from efficacy and the availability of other therapeutic options. Furthermore, the severity of the rare disease should also influence the decision along with the potential of the treatment to avoid associated costs.This project was carried out with an unrestricted grant from AELMHU (Asociación Española de Laboratorios de Medicamentos Huérfanos y Ultrahuérfanos). AELMHU was not involved in the design of the study and collection, analysis, and interpretation of data and writing the manuscript

XRD analysis of InGaN uniform layers grown on Si (111) without any buffer layers and on Sapphire

The International Workshop on Nitride Semiconductors (IWN) is a biennial academic conference in the field of group III nitride research. The IWN and the International Conference on Nitride Semiconductors (ICNS) are held in alternating years and cover similar subject areas