[Artículo traducido] Impacto de los corticoides sistémicos en el tiempo de hospitalización en pacientes con COVID-19

ObjectiveThe COVID-19 pandemic has posed a threat to hospital capacity due to the high number of admissions, which has led to the development of various strategies to release and create new hospital beds. Due to the importance of systemic corticosteroids in this disease, we assessed their efficacy in reducing the length of stay (LOS) in hospitals and compared the effect of 3 different corticosteroids on this outcome.MéthodWe conducted a real-world, controlled, retrospective cohort study that analysed data from a hospital database that included 3934 hospitalised patients diagnosed with COVID-19 in a tertiary hospital from April to May 2020. Hospitalised patients who received systemic corticosteroids (CG) were compared with a propensity score control group matched by age, sex and severity of disease who did not receive systemic corticosteroids (NCG). The decision to prescribe CG was at the discretion of the primary medical team.ResultsA total of 199 hospitalized patients in the CG were compared with 199 in the NCG. The LOS was shorter for the CG than for the NCG (median = 3 [interquartile range = 0–10] vs. 5 [2–8.5]; p = 0.005, respectively), showing a 43% greater probability of being hospitalised ≤ 4 days than > 4 days when corticosteroids were used. Moreover, this difference was only noticed in those treated with dexamethasone (76.3% hospitalised ≤ 4 days vs. 23.7% hospitalised > 4 days [p < 0.001]). Serum ferritin levels, white blood cells and platelet counts were higher in the CG. No differences in mortality or intensive care unit admission were observed.ConclusionsTreatment with systemic corticosteroids is associated with reduced LOS in hospitalised patients diagnosed with COVID-19. This association is significant in those treated with dexamethasone, but no for methylprednisolone and prednisone.     

[Artículo traducido] Prevalencia de reacciones adversas a medicamentos asociadas a visitas al servicio de urgencias y factores de riesgo de hospitalización

ObjectiveAdverse drug reactions increase morbidity and mortality, prolong hospital stay and increase healthcare costs. The primary objective of this study was to determine the prevalence of emergency department visits for adverse drug reactions and to describe their characteristics. The secondary objective was to determine the predictor variables of hospitalization for adverse drug reactions associated with emergency department visits.MethodsObservational and retrospective study of adverse drug reactions registered in an emergency department, carried out from November 15th to December 15th, 2021. The demographic and clinical characteristics of the patients, the drugs involved and the adverse drug reactions were described. Logistic regression was performed to identify factors related to hospitalization for adverse drug reactions.Results10,799 patients visited the ED and 216 (2%) patients with adverse drug reactions were included. The mean age was 70 ± 17.5 (18-98) years and 47.7% of the patients were male. A total of 54.6% of patients required hospitalization and 1.6% died from adverse drug reactions. The total number of drugs involved was 315 with 149 different drugs. The pharmacological group corresponding to the nervous system constituted the most representative group (n = 81). High-risk medications, such as antithrombotic agents (n = 53), were the subgroup of medications that caused the most emergency department visits and hospitalization. Acenocumarol (n = 20) was the main drug involved. Gastrointestinal (n = 62) disorders were the most common. Diarrhea (n = 16) was the most frequent adverse drug reaction, while gastrointestinal bleeding (n = 13) caused the highest number of hospitalizations. Charlson comorbidity index behaved as an independent risk factor for hospitalization (aOR 3.24; 95% CI: 1.47-7.13; p=0.003, in Charlson comorbidity index 4-6, and aOR 20.07; 95% CI: 6.87–58.64; p = 0.000, in Charlson comorbidity index ≥ 10).ConclusionsThe prevalence of emergency department visits for adverse drug reactions continues to be a non-negligible health problem. High-risk drugs such as antithrombotic agents were the main therapeutic subgroup involved. Charlson comorbidity index was an independent factor in hospitalization, while gastrointestinal bleeding was the adverse drug reaction with the highest number of hospital admissions.     

[Artículo traducido] Atención farmacéutica y asma: protocolo de una revisión de revisiones sistemáticas

IntroductionRecent systematic reviews and meta-analyses suggest that pharmacists' interventions in asthma patients have a positive impact on health-related outcomes. Nevertheless, the association is not well established and the role of clinical pharmacists is poorly represented, as well as severe asthma patients.The aim of this overview of systematic reviews is to identify published systematic reviews assessing the impact of pharmacists' interventions on health-related outcomes measured in asthma patients, as well as to describe key components of the interventions, the outcomes assessed and any associations between pharmacists' interventions and health-related outcomes.MethodsPubMed, Embase, Scopus and the Cochrane Library will be searched from inception to December 2022. Systematic reviews of all study designs, severity of asthma and level of care that measured health-related outcomes will be considered. Methodological quality will be assessed using A Measurement Tool to Assess Systematic Reviews 2. Two independent investigators will perform the study selection, quality assessment and data collection, any discrepancy will be solved by a third investigator. Both narrative findings and meta-analysis of primary study data included in the systematic reviews will be synthesized. If data are appropriate for quantitative synthesis, the measures of association will be expressed as the risk ratio and difference in means.DiscussionThe first results on the establishment of a multidisciplinary network for the management of asthmatic patients have shown the benefits of integrating different levels of care in disease control and morbidity reduction. Further studies showed benefits in hospital admissions, patients' basal oral corticosteroid dose, exacerbations and quality of life of asthma patients.A systematic review is the most appropriate design in order to summarize the literature and identify the evidence of the benefits of interventions performed by clinical pharmacists in asthma patients, especially those with severe uncontrolled asthma, and encourage future studies to stablish the role of clinical pharmacists in asthma units.Registration detailsSystematic review registration number: CRD42022372100.     

[Artículo traducido] Mejora de la calidad de las publicaciones y avance en los paradigmas de la investigación en Farmacia Práctica clínica y social: la Declaración de Granada

Pharmacy and pharmaceutical sciences embrace a series of different disciplines. Pharmacy practice has been defined as “the scientific discipline that studies the different aspects of the practice of pharmacy and its impact on health care systems, medicine use, and patient care”. Thus, pharmacy practice studies embrace both clinical pharmacy and social pharmacy elements. Like any other scientific discipline, clinical and social pharmacy practice disseminates research findings using scientific journals. Clinical pharmacy and social pharmacy journal editors have a role in promoting the discipline by enhancing the quality of the articles published. As has occurred in other health care areas (i.e., medicine and nursing), a group of clinical and social pharmacy practice journal editors gathered in Granada, Spain to discuss how journals could contribute to strengthening pharmacy practice as a discipline. The result of that meeting was compiled in these Granada Statements, which comprise 18 recommendations gathered into six topics: the appropriate use of terminology, impactful abstracts, the required peer reviews, journal scattering, more effective and wiser use of journal and article performance metrics, and authors’ selection of the most appropriate pharmacy practice journal to submit their work. © 2023 The Author(s) Published by Elsevier Inc, Springer Nature, Brazilian Society of Hospital Pharmacy and Health Services, Elsevier Inc, Royal Pharmaceutical Society, Biomedcentral, Sociedad Española de Farmacia Hospitalaria (S.E.F.H), Pharmaceutical Care España Foundation, European Association of Hospital Pharmacists, Faculty of Pharmacy     

[Artículo traducido] Estudio transversal de posibles incompatibilidades entre los medicamentos intravenosos en una unidad de cuidados intensivos neonatales de Indonesia

ObjectiveThe purpose of this study is to determine the most common incompatible and unknown compatibility drug combinations and determine the compatibility of each pair of drugs used in hospitals based on reference books and journals.MethodsThis is a prospective cross-sectional study. All babies who were admitted to the Neonatal Intensive Care Units from May First to July 31^st 2021 were sample of the study. Patients who did not receive at least two drugs coadministrated concurrently and who stayed less than 24 hours were excluded. Only drug-drug combinations were considered and the other non-drug administrations (electrolyte solutions, parenteral nutritions, and blood products) were excluded. Compatibility data were obtained from literature and online search engines (micromedex NeoFax Essentials 2020, UCL Hospitals Injectable Medicines Administration Guide: Pharmacy Department, 3rd Edition, Trissel Handbook on injectable drugs 15th edition, and published journals).ResultsThe most commonly prescribed drug combinations were ampicillin-gentamicin (31.72%), amikacin-ampicillin sulbactam (9.05%), amikacin-ampicillin sulbactam-aminophylline (3.08%). The most common drug incompatible combination was ampicillin-gentamicin (31.71%), for the most drug combinations whose compatibility unknown were amikacin-ampicillin sulbactam (9.05%).ConclusionsThe high prevalence of incompatible drugs and unknown compatibility was identified, so checking its compatibility can be carried out through a two-dimensional chart to minimize the incidence of incompatibilities.     

[Artículo traducido] Consenso de la Sociedad Española de Farmacia Hospitalaria sobre el manejo fármacoterapéutico óptimo de la dermatitis atópica

AimThis study’s aims are: 1) To use the Delphi method to determine the level of consensus among HPs as regards the factors involved in the current approach to patients with AD; 2) To identify potential areas for improvement in hospital pharmacy in terms of dealing with patients with severe AD; and 3) To contribute to adequate pharmaceutical care for patients with AD by drawing up recommendations.MethodsA two-round Delphi survey with participation from HPs from all over Spain. Three theme-based blocks were set out: 1) AD; 2) Management of patients with severe AD in the Hospital Pharmacy setting; and 3) Unmet needs (pathology, patient, treatment and management).ResultsThe 42 HPs participating reached a consensus in recognizing the impact of severe AD on the patients suffering from it, the need to encourage adherence and the recommendations to use scales that take into account the patient's quality of life and indicators of the patient’s experience. It has also been demonstrated that it is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team. Finally, it is advisable to use drugs that have demonstrated long-term effectiveness and safety for patients with severe AD, given the disease´s chronic nature.ConclusionsThis Delphi consensus highlights the impact of severe AD on patients, the importance of a multidisciplinary and holistic approach, in which HP play a major role. It also highlights the importance of increased access to new drugs to improve health outcomes.     

Revisión de la legislación sobre la investigación clínica en el Sistema Nacional Salud y los servicios de farmacia hospitalaria

The call for public funding for the Spanish Health Care System clinical research with drugs for human use projects Subprogramme highlights the need for hospital pharmacy services to include the manufacture of investigational drugs which are the subject of a clinical trial, developed by either a researcher or a group of researchers, within its activities.This article discusses the legislation concerning the manufacture of investigational drugs and the requirements that the pharmacy services must meet in order to develop, distribute, or conceal an investigational drug in a clinical trial sponsored by a professional from the SHS.     

Antídotos: guía de utilización y stock mínimo en el servicio de urgencias

ObjectiveTo develop a guide for antidotes and other medications used to counteract poisoning, and define the stock in an emergency department, as a safety priority for the part-time pharmacist assigned to the unit.MethodA search of specialist databases and web portals of the Spanish Society of Toxicology and the British National Poisons Information Service, as well as toxicology databases, TOXICONET, information from other hospitals, tertiary sources, Micromedex and Medline.ResultsThe Guide contains 42 active ingredients and is accessible to the Pharmacy and Emergency departments in electronic format. A minimum emergency stock was agreed based on the daily treatment of a 100 kg patient. This information, including updated expiry dates, is available at the emergency department antidote stock facilities and in electronic format. On a monthly basis, the pharmacist reviews the need to replace any drugs, due to their expiry date or lack of use.DiscussionThe lack of evidence from high quality antidote studies, the variability due to the difficulties of updating sources and some geographical differences in their use means that decision-making can be difficult.It would be useful to have minimum quantity recommendations from societies of toxicology, regulatory agencies and organisations such as the Joint Commission on the Accreditation of Healthcare Organisations. It would also be useful to have a suprahospital risk assessment to optimise management and ensure the availability of antidotes which are expensive, have a limited shelf life, or of which demand is difficult to forecast.     

Análisis de minimización de costes de fludarabina (Beneflur®) oral vs. vía intravenosa en España

IntroductionVarious international studies have shown that fludarabine is effective, safe, and efficient for treating B-cell chronic lymphocytic leukemia (B-CLL). The purpose of the present study was to carry out a cost-minimization analysis for two alternative forms of fludarabine (oral and intravenous) used to treat B-CLL in Spain.MethodsThe presence of clinical evidence about the treatment equivalence of the two options being compared (oral fludarabine vs. intravenous fludarabine) led us to carry out a cost-minimization analysis. A pharmacoeconomic model was constructed to compile data from the literature and experts’ opinions in order to determine the use of health resources associated with the treatment; unit costs were obtained from Spanish databases. The analysis contemplated two perspectives: that of the national health service, which includes only direct health costs, and the social perspective, which also includes the indirect costs that result from loss of productivity.ResultsAlthough fludarabine in its oral form has a higher purchase price than generic intravenous fludarabine does, increased administration costs for the latter, which is used in hospitals, mean that oral fludarabine use produces total savings of €1,908 and €1,292 for single-drug therapy and combined therapy with cyclophosphamide, respectively. Including indirect costs increased the savings associated with the oral form of the drug.ConclusionsIn B-CLL patients, treatment with oral fludarabine has a lower cost than treatment with intravenous fludarabine, in both single-drug therapy and combined therapy. Various sensitivity analyses confirmed these results and showed that oral fludarabine should be the treatment of choice for B-CLL in Spain, unless contraindicated.     

Evaluación económica de intervenciones en enfermedades oncológicas en España: revisión sistemática y análisis comparativo

ObjectiveTo review standard methods used to evaluate the efficiency of oncology interventions, comparing their main characteristics with those of the studies aimed for other conditions.MethodsWe performed a systematic review and comparative analysis calculating odds ratios (OR). We searched the biomedical literature to assess economic evaluation studies on malignant neoplasms in Spain published between 1983 and 2008. Their characteristics were reviewed and summarised, including the following variables: journal and year of publication, intervention, type and design of study, perspective, type of costs, financing source, and decision-making recommendations.ResultsSixty-three studies were included. Main characteristics of the reports were: cost-effectiveness analysis and therapeutic interventions (60.3%; n = 38). Seventeen studies (27.0%) used an observational design. Economic evaluations of malignant neoplasms showed the following associations (compared to those studies addressing other causes [n = 411]): cost minimisation analysis (OR: 1.73; 95% confidence interval [CI]: 0.91-3.27), diagnostic interventions (OR: 2.18; 95% CI: 1.07-4.43), decision analysis design (OR: 0.46; 95% CI: 0.24-0.87), societal perspective (OR: 0.20; 95% CI: 0.05-0.86) and for-profit source of financing (OR: 0.52; 95% CI: 0.30-0.93).ConclusionsEconomic evaluations of interventions for malignant neoplasms are not common despite the gradual increase produced during recent years in Spain. Reports presented heterogeneity in the quality of the information regarding the methods and the data sources used. Further efficiency evaluations of oncology interventions are needed and methodological quality should be warranted.     

Análisis probabilístico de minimización de costes de darbepoetin alfa frente a epoetina alfa en el tratamiento de la anemia secundaria a insuficiencia renal crónica. Valoración en la práctica clínica española

IntroductionThe direct transfer of the results of pharmaco-economic studies between countries may not be suitable if the proper adaptations are not made to take into account differences in treatment patterns, resource use and costs from country to country.ObjectiveTo estimate the cost in Spain of treating anaemia secondary to chronic renal failure with darbepoetin alpha or epoetin alpha from a review and analysis of available current information. In addition, the role of the route of administration as a main driver of the cost will be analysed.MethodPopulation: patients with chronic kidney failure induced anaemia. Data: Medline and Embase search of studies directly comparing erythropoiesis stimulating agents. Analysis: Cost minimization analysis from the perspective of a hospital pharmacy department. The main outcome chosen was the difference between the average cost per patient undergoing a 30-day treatment with epoetin alpha versus darbepoetin alpha.Resultsa) haemodialysis: changing from epoetin alpha to darbepoetin alpha is associated with a cost reduction of 8.67 %; CI 95 %, ?1.34 to 17.92 (€ 17.48; CI 95 %, ?2.70 to 36.13); probabilistic analysis showed that the use of darbepoetin alpha could be associated with a cost-saving probability of 94.9 %. The IV administration yielded a decrease in costs of about 16.00 %; CI 95 %, ?2.38 to 36.77 (€ 41.78, CI 95 %: ?6.21 to 96.04). b) Pre-dialysis: darbepoetin alpha is associated with a cost reduction of about 11-32 %.ConclusionsThe use of darbepoetin alpha for the treatment of chronic renal failure induced anaemia (haemodialysis and pre-dialysis) shows higher cost efficiency than epoetin alpha in Spain; these differences increase with IV administration.     

Análisis de la Guía de excelencia para la realización de ensayos clínicos en farmacia hospitalaria

The document «Guide to Excellence in the Conduct of Clinical Trials in Hospital Pharmacy» was drawn up by hospital pharmacists and representatives of the pharmaceutical industry. Its objective is to unite criteria, introduce improvements in communication, harmonize and digitalize processes in all phases of development of a clinical trial in hospital pharmacy services.This special article includes the reflections of the Working Group of the Spanish Society of Hospital Pharmacy about this document. The analysis is based on its participation in the drawing of the guide of excellence, and includes its most relevant aspects, including those which, despite being discussed during the process of preparing the document, were finally not included, for reasons of synthesis or for further analysis and agreement.While recognizing the undoubted value of a so far unprecedented first document of consensus, the Clinical Trials Working Group also highlights the future challenges that both hospital pharmacists and pharmaceutical companies have ahead in order to improve the quality of the management of clinical trials.The Clinical Trials Working Group believes that the existence of communication routes both with the pharmaceutical industry and other agents involved in the conducting of clinical trials, as well as the improved visibility of the hospital pharmacist as an expert in the management of investigational medicines, will help achieve a better management of clinical trials in our environment and the assignment of the necessary human and material resources to reach excellence.