INES: Interactive tool for construction and extrapolation of partitioned survival models.

BACKGROUND: INES (INteractive model for Extrapolation of Survival and cost) provides an open-access tool powered by R that implements three-state partitioned survival models (PSM). This article describes the properties of the tool, and the situations where INES may or may not be suitable. METHODS: INES is designed to be used by investigators or healthcare professionals who have a good grasp of the principles of economic evaluation and understand the strengths and weaknesses of partitioned survival models, but are not sufficiently familiar with a statistical package such as Excel or R to be able to construct and test a de-novo PSM themselves. INES is delivered to the user via a batch file. Once downloaded to the user's hard drive, it interacts with the user via a portable version of R with web interactivity built in Shiny. INES requires absolutely no knowledge of R and the user does not need to have R or any of its dependences installed. Hence the user will deal with a standalone Shiny app. Inputs (digitalized survival curves, unit costs, posology, hazard ratios, discount rate) can be uploaded from a template spreadsheet. RESULTS: The INES application provides a seamlessly integrated package for estimating a set of parametric hazard functions for progression free and overall survival, selecting an appropriate function from this menu, and applying this as an input to a PSM to calculate mean costs and quality-adjusted life years. Examples are given that may serve as a tutorial. CONCLUSION: INES offers a rapid, flexible, robust and transparent tool for parametric survival analysis and calculating a PSM that can be used in many different contexts.

Analysis of first-line treatment in older patients with metastasic colorectal cancer.

OBJECTIVE: The purpose of this study was to analyse the effectiveness and safety of first-line treatment of metastatic colorectal cancer (CRCm) in older patients treated in a tertiary hospital. MATERIAL AND METHODS: This was an observational and retrospective study, including patients aged 75 years or older, with CRCm, who received chemotherapy treatment in 2017. The main variables studied were type of treatment, Progression-Free Survival (PFS), Overall Survival (OS), dose reductions, and treatment delays due to adverse events. RESULTS: A total of 59 patients (71.2% men) with a median age of 76 years were enrolled in this study. About 70% presented colon cancer, with the left colon being the most frequent location. They were treated with 9 different schemes, in most cases using polychemotherapy and biological agents. The median PFS and OS was 12 and 30 months, respectively. A total of 23/59 of patients started treatment at doses lower than recommended in the clinical practice guidelines. In terms of safety, 34/59 of patients had at least one dose reduction, and 30/59 suffered one treatment delay. The most frequent adverse reactions were asthenia, peripheral neuropathy, diarrhoea, and palmoplantar erythrodysesthesia. CONCLUSION: Our patients presented baseline clinical characteristics similar to the general adult population, with no tumour characteristics associated with advanced age. The efficacy and toxicity were similar to those in the clinical trials, although our patients had more dose reductions. Considering the heterogeneity of patients and in the absence of clinical trials in the older population, real-life studies can be very useful.

Olaparib as first line in BRCA-mutated advanced ovarian carcinoma: Is it cost-effective in Spain?

OBJECTIVE: To estimate the cost-effectiveness of olaparib after being funded by the Spanish National Health Service (SNHS) as first-line monotherapy maintenance treatment in patients with advanced high-grade serous ovarian carcinoma (HGSOC) and BRCA mutations in Spain. METHODS: A semi-Markov model with one-month cycles was adapted to the Spanish healthcare setting, using the perspective of the SNHS, and a time horizon of 50 years. Two scenarios were compared: receiving olaparib vs. no maintenance treatment. The model comprised four health states and included the clinical results of the SOLO1 study, along with the direct healthcare costs associated with the use of first-line and subsequent treatment resources (2020 €). A discount rate of 3% was applied for future cost and quality-of-life outcomes. A probabilistic sensitivity analysis (PSA) was also carried out and a cost-effectiveness threshold of €25,000 per quality adjusted life year (QALY) was considered. RESULTS: The introduction of olaparib as a first-line maintenance treatment for advanced HGSOC patients with BRCA mutations implied a cost of €131,614.98 compared to €102,369.54 without olaparib (difference: €29,245.44), with an improvement of 2.00 QALYs (5.56 and 3.57, respectively). Therefore, olaparib is cost-effective for advanced HGSOC patients with BRCA mutations, with an incremental cost-effectiveness ratio of €14,653.2/QALY. The results from the PSA showed that 92.1% of the simulations fell below the €25,000/QALY threshold. The model showed that olaparib could improve the overall survival by 2 years, vs. no maintenance treatment. CONCLUSIONS: Olaparib as first-line maintenance treatment is cost-effective in advanced HGSOC patients with BRCA mutations in Spain.

Dacomitinib in first-line treatment of advanced EGFR-mutated non-small-cell lung cancer: a cost-effectiveness analysis.

Aim: To assess the cost-effectiveness of first-line treatment with dacomitinib compared with gefitinib in patients newly diagnosed with advanced NSCLC EGFR-positive in the context of Spain. Materials & methods: A partitioned survival model was developed including costs, utilities and disutilities to estimate quality-adjusted life-year (QALY) and incremental cost-effectiveness ratio when treating with dacomitinib versus gefitinib. Results: Dacomitinib presented higher QALYs (0.51) compared with gefitinib (0.45). Dacomitinib costs were €33,061 in comparison with €26,692 for gefitinib arm. An incremental cost-effectiveness ratio of €111,048 was obtained for dacomitinib. Conclusion: Dacomitinib was more effective in terms of QALYs gained than gefitinib. However, to obtain a cost-effectiveness alternative, a discount greater than 25% in dacomitinib acquisition cost is required.

Cost-effectiveness analysis of infliximab, adalimumab, golimumab, vedolizumab and tofacitinib for moderate to severe ulcerative colitis in Spain.

OBJECTIVE: Despite the biological drugs, the treatment of moderate to severe ulcerative colitis is still a challenge, particularly in resource-limited settings. The aim of this study was to assess the efficiency of biological drugs and tofacitinib for moderate to severe ulcerative colitis in the Spanish context. METHODS: A Markov model was built to simulate the progression of moderate to severe ulcerative colitis in a cohort of patients. The model used a time horizon of 10 years. The perspective chosen was the National Health Service, with a discount rate of 3%, and a threshold of €30,000/quality adjusted life-year (QALY). It carried out a one-way sensitivity analysis and probabilistic sensitivity analysis. RESULTS: The comparison of infliximab with adalimumab and golimumab estimated an incremental cost-effectiveness ratio (ICER) of €43,928.07/QALY and €31,340.69/QALY, with a difference of - 0.43 and - 0.82 QALY, respectively. Vedolizumab vs infliximab achieved an ICER of €122,890.19/QALY with a gain of 0.46 QALY. The comparison of infliximab with tofacitinib yielded an estimated ICER of €270,503.19/QALY, with a slight gain in QALY (0.16). The one-way sensitivity analysis showed a robust study. CONCLUSION: For a threshold of €30,000/QALY, adalimumab was the most cost-effective treatment versus infliximab for moderate to severe ulcerative colitis in Spain.

Network meta-analysis of first-line treatments in transplant-ineligible multiple myeloma patients.

OBJECTIVES: Multiple myeloma (MM) is a complex disease. Lack of direct comparisons among treatments and incorporation of new alternatives make it necessary to perform studies that allow for clinical decision-making. A network meta-analysis (NMA) was developed to evaluate the comparative efficacy among different therapeutic alternatives in newly diagnosed transplant-ineligible MM patients. METHODS: MEDLINE® and EMBASE® were systematically searched up for these drugs: lenalidomide, thalidomide, bortezomib, and daratumumab. Comparative phase II-III randomized clinical trials (RCTs) were included. Progression-free survival (PFS) was selected as efficacy outcome. The NMA was developed using Bayesian methods. Fixed- and random-effects models were assessed using deviance information criteria. RESULTS: The systematic search yielded 593 results. Ten RCTs were included. No differences were observed between fixed- and random-effects models. The combination of daratumumab, bortezomib, melphalan, and prednisone showed the best HR in PFS (reference treatment). Along with this scheme, the best PFS results were obtained by combination of daratumumab, lenalidomide, and dexamethasone (HR 1.2, 95% CrI 0.64-2.4) and bortezomib with lenalidomide and dexamethasone (HR 1.6, 95% CrI 0.81-3.0). CONCLUSIONS: Schemes with the best PFS results were daratumumab treatments and combination of bortezomib, lenalidomide, and dexamethasone, although the latter scheme has been analyzed in heterogeneous populations.

Cost-effectiveness analysis of second-line pharmacological treatment of acromegaly in Spain.

Objective: To estimate the cost-effectiveness of second-line pharmacological treatments in patients with acromegaly resistant to first-generation somatostatin analogues (FG SSA) from the Spanish National Health System (NHS) perspective.Methods: A Markov model was developed to analyze the cost-effectiveness of pegvisomant and pasireotide in FG SSA-resistant acromegaly, simulating a cohort of patients from the treatment beginning to death. Treatment with pegvisomant or pasireotide was compared to FG SSA retreatment. Efficacy data were obtained from clinical trials and utilities from the literature. Direct health costs were obtained from Spanish sources (€2018).Results: The Incremental Cost Effectiveness Ratio (ICER) of pegvisomant vs. FG SSA was €85,869/Quality-adjusted life years (QALY). The ICER of pasireotide vs. FG SSA was €551,405/QALY. The ICER was mainly driven by the incremental efficacy (4.41 QALY for pegvisomant vs. FG SSA and 0.71 QALY for pasireotide vs. FG SSA), with a slightly lower increase in costs with pegvisomant (€378,597 vs. FG SSA) than with pasireotide (€393,151 vs. FG SSA).Conclusion: The ICER of pasireotide compared to FG SSA was six times higher than the ICER of pegvisomant vs. FG SSA. Pegvisomant is a more cost-effective alternative for the treatment of acromegaly in FG SSA-resistant patients in the Spanish NHS.

Osimertinib in first-line treatment of advanced EGFR-mutated non-small-cell lung cancer: a cost-effectiveness analysis.

Aim: Osimertinib improves progression-free survival in first-line EGFR mutation-positive non-small-cell lung cancer. Materials & methods: A Markov cohort model including costs, utilities and disutilities, was conducted to estimate quality-adjusted life-year (QALY) and incremental cost-effectiveness ratio when treating with osimertinib versus standard first-line tyrosine kinase inhibitors (TKIs). Results: Osimertinib presented higher QALYs (0.61) compared with standard EGFR-TKIs (0.42). Osimertinib costs were €83,258.99, in comparison with €29,209.45 for the standard EGFR-TKIs. An incremental cost-effectiveness ratio of €273,895.36/QALY was obtained for osimertinib. Conclusion: Osimertinib was more effective in terms of QALYs gained than comparators (erlotinib-gefitinib). However, to obtain a cost-effectiveness alternative, a discount greater than 60% in osimertinib acquisition cost is required.

Cost-effectiveness of lenalidomide maintenance in patients with multiple myeloma who have undergone autologous transplant of hematopoietic progenitor cells.

The objective of this article is to analyze the ratio of cost-effectiveness and budgetary impact of lenalidomide treatment in patients with multiple myeloma who have undergone autologous transplant in Spain. The analyses were based on clinical trials CALGB 100104 and IFM 2005-02, from the perspective of the National Health System. The alternatives compared were the treatment with lenalidomide against maintenance without treatment (MwT). Efficiency measures used were years of life gained (YGs) and quality-adjusted life years (QALYs). According to the CALGB 100104 trial data, the average health costs of patients who were treated with lenalidomide for 120 months was €836,534.31 and without treatment was €528,963.63. The effectiveness of the lenalidomide group was 7.59YGs (5.72 QALY) against 6.58 of MwT (4.61 QALY). The incremental cost-utility ratio (ICUR) was €277,456.72/QALY and the incremental cost-effectiveness ratio was €303,191.05/YGs. From the analysis, the IFM2005-02 trial obtained 5.13 QALY in the lenalidomide group against the 4.98 QALY in the MwT group, with an ICUR of €1,502,780.55/QALY. In terms of budgetary impact, a range between 799 and 1452 patients susceptible to receive treatment with lenalidomide was assumed in Spain. In conclusion, the results show a high ICUR and budgetary impact, which adds uncertainty about the maximum prudent duration of the treatment.

Network meta-analysis of tofacitinib versus biologic treatments in moderate-to-severe rheumatoid arthritis patients.

WHAT IS KNOWN AND OBJECTIVE: Rheumatoid arthritis (RA) is an autoimmune disease characterized primarily by inflammation and pain in the joints. Tofacitinib is an oral drug recently approved for RA treatment; it inhibits Janus protein kinases (JAK) that reduces RA symptoms when conventional DMARDs do not trigger a response. This study aimed to compare the efficacy of biological DMARDs in monotherapy or combined with methotrexate in RA patients and compare the treatments. METHODS: We reviewed the literature for articles published up to June 2017, evaluating the efficacy and safety of the biological DMARDs indicated for RA in patients with inadequate responses to conventional DMARDs and naïve to biological DMARDs, in similar populations, considering ACR50 as the efficacy variable. The odds ratio (OR) and 95% confidence interval (CI) were calculated for each drug combination, and these parameters were transformed into differences in responses to assess the effectiveness of the alternative medicines. Equivalence therapeutic alternatives (ETA) were ensured to assess the possibility of considering these medications with equivalent efficacy. A network meta-analysis (NMA) was performed using Bayesian approaches and the fixed-effects model. RESULTS AND DISCUSSION: Twenty-seven randomized clinical trials (RCTs) that met the pre-established criteria were identified. The 95% CI of biological DMARDs was higher than that of placebo without methotrexate, except for certolizumab, golimumab-m, anakinra-m and adalimumab monotherapy. These DMARDs performed significantly better than the placebo, except for etanercept, certolizumab, tofacitinib and golimumab. Certolizumab-m was better than anakinra-m and adalimumab, and tocilizumab alone or combined with methotrexate was superior to adalimumab. Etanercept-m yielded a higher difference in responses compared with the other biological DMARDs, which presented more homogeneous responses, except for adalimumab and anakinra-m, which yielded worse results. None of the biological DMARDs displayed ETA to etanercept-m; however, they displayed ETA with certolizumab-m, except for adalimumab and anakinra-m. WHAT IS NEW AND CONCLUSION: All biological DMARDs used in combination with methotrexate, except for etanercept, anakinra, certolizumab and tocilizumab without methotrexate, were displayed ETA on using ACR50 at week 24 in patients naïve to biological DMARDs. Etanercept displayed a greater difference in responses, although the high uncertainty of the comparative results prevented the confirmation of the increased efficacy of this drug.

Coste-efectividad e impacto presupuestario del tratamiento con evolocumab frente a estatinas y ezetimiba para la hipercolesterolemia en España / Cost-effectiveness and budget impact of treatment with evolocumab versus statins and ezetimibe for hypercholesterolemia in Spain

Introducción y objetivos: Analizar la razón de coste-efectividad y el impacto presupuestario del tratamiento con evolocumab (inhibidor de la PCSK9) para pacientes en prevención secundaria en el Sistema Nacional de Salud español. Métodos: Se realizaron, desde la perspectiva del sistema sanitario público, análisis de impacto presupuestario, modelos de árbol de decisión y Markov, basándose en el único ensayo clínico con datos de morbimortalidad (FOURIER). Las alternativas comparadas fueron evolocumab frente a estatinas y un 5% ezetimiba conjuntamente. La medida de eficacia utilizada fue el número de eventos cardiovasculares evitados. Se realizaron análisis de sensibilidad univariable y probabilístico. Resultados: El coste sanitario promedio de los pacientes tratados a 26 meses con evolocumab fue de 11.134,78 euros y de 393,83 euros con el estándar (estatinas + ezetimiba). El coste-efectividad incremental superó los 600.000 euros por evento cardiovascular evitado en las 2 variables (primera: muerte cardiovascular, infarto de miocardio, accidente cerebrovascular, hospitalización por angina inestable o revascularización coronaria; segunda: incluye los 3 primeros eventos). A 10 años, el modelo de Markov mostró un coste promedio de 471.417,37 frente a 13.948,45 euros con evolocumab y estándar respectivamente. El tratamiento con evolocumab en hipercolesterolemia familiar supondría anualmente entre 3 y 6,1 millones de euros, lo que supone una diferencia de 2,5-5,1 millones de euros con el tratamiento estándar (2017). Para el año 2021, en hipercolesterolemia no familiar (prevención secundaria), la diferencia osciló entre 204,3 y 1.364,7 millones de euros. Conclusiones: El evolocumab se asocia con menor frecuencia de eventos cardiovasculares, pero resulta ineficiente para los pacientes susceptibles de recibirlo en el Sistema Nacional de Salud

Introduction and objectives: To analyze the cost-effectiveness ratio and budget impact of treatment with evolocumab (PCSK9 inhibitor) for patients in secondary prevention in the Spanish National Health System. Methods: A budget impact analysis, decision tree and Markov models were designed under the public health system perspective, based on the only study with morbidity and mortality data (FOURIER). The alternatives compared were evolocumab vs statins, and dual therapy with ezetimibe in 5% of the population. The measure of effectiveness used was the number of cardiovascular events avoided. Univariate and probabilistic sensitivity analyses were performed. Results: The average annual cost of patients receiving evolocumab was 11 134.78€ and 393.83€ for standard treatment (statins plus ezetimibe). The incremental cost-effectiveness ratio was > 600 000 € per avoided cardiovascular event for both assessed outcomes (first: cardiovascular death, myocardial infarction, stroke, and hospitalization due to unstable angina or coronary revascularization; second: includes the first 3 events). To perform the 10-year Markov model, the average cost of standard treatment was 13 948.45€ vs 471 417.37€ with evolocumab. Treatment with evolocumab for patients with familial hypercholesterolemia would cost between 3 and 6.1 million euros, assuming a difference of 2.5 and 5.1 million euros with the standard treatment (2017). This difference would be between 204.3 and 1364.7 million euros (2021) for those with nonfamiliar hypercholesterolemia (secondary prevention). Conclusions: Treatment with evolocumab is associated with a lower frequency of cardiovascular events, but is inefficient for patients suitable to receive this drug in the Spanish National Health System

Coste-efectividad del evolocumab. Respuesta / Cost-effectiveness of evolocumab. Response

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Systematic review and network meta-analysis of treatment for moderate-to-severe ulcerative colitis.

Background Biological drugs for moderate-to-severe ulcerative colitis have changed the therapeutic perspective, while small-molecule inhibitors and new promising drugs suggest new options. Aim Assess comparative efficacy and safety of biological and new small oral drugs: commercialized and under-investigation ones for patients naïve to biological drugs. Methods A systematic review was conducted to identify the randomized clinical trials phase 2 or 3, in adults with moderate-to-severe ulcerative colitis treated with biological drugs (infliximab, adalimumab, golimumab, vedolizumab and etrolizumab) or new oral small molecules (tofacitinib and ozanimod) as first line. A Bayesian network metaanalysis was performed to inform comparative efficacy and safety of different treatments. Efficacy outcomes were clinical remission, clinical response and mucosal healing for induction therapy and clinical remission, mucosal healing and sustained clinical remission for maintenance therapy. Safety was assessed with serious adverse events and rates of infections. Results 14 references were included for network meta-analysis. For induction therapy, infliximab was the best drug for induction of clinical response and remission, while ozanimod showed to be the best for induction of mucosal healing. Tofacitinib had the highest rate of maintaining clinical remission. All treatments were similar for serious adverse events, and vedolizumab and tofacitinib had the highest rates of infections. Conclusion This network meta-analysis suggests infliximab may be the best therapeutic option for moderate-to-severe ulcerative colitis. Vedolizumab seems to have better outcomes in maintenance than in induction therapy and it appears superior to golimumab and adalimumab. Tofacitinib, ozanimod and etrolizumab show encouraging results.

Cost-effectiveness and Budget Impact of Treatment with Evolocumab Versus Statins and Ezetimibe for Hypercholesterolemia in Spain.

INTRODUCTION AND OBJECTIVES: To analyze the cost-effectiveness ratio and budget impact of treatment with evolocumab (PCSK9 inhibitor) for patients in secondary prevention in the Spanish National Health System. METHODS: A budget impact analysis, decision tree and Markov models were designed under the public health system perspective, based on the only study with morbidity and mortality data (FOURIER). The alternatives compared were evolocumab vs statins, and dual therapy with ezetimibe in 5% of the population. The measure of effectiveness used was the number of cardiovascular events avoided. Univariate and probabilistic sensitivity analyses were performed. RESULTS: The average annual cost of patients receiving evolocumab was 11 134.78€ and 393.83€ for standard treatment (statins plus ezetimibe). The incremental cost-effectiveness ratio was > 600 000 € per avoided cardiovascular event for both assessed outcomes (first: cardiovascular death, myocardial infarction, stroke, and hospitalization due to unstable angina or coronary revascularization; second: includes the first 3 events). To perform the 10-year Markov model, the average cost of standard treatment was 13 948.45€ vs 471 417.37€ with evolocumab. Treatment with evolocumab for patients with familial hypercholesterolemia would cost between 3 and 6.1 million euros, assuming a difference of 2.5 and 5.1 million euros with the standard treatment (2017). This difference would be between 204.3 and 1364.7 million euros (2021) for those with nonfamiliar hypercholesterolemia (secondary prevention). CONCLUSIONS: Treatment with evolocumab is associated with a lower frequency of cardiovascular events, but is inefficient for patients suitable to receive this drug in the Spanish National Health System.

Cost-effectiveness analysis of infliximab, adalimumab, golimumab and vedolizumab for moderate to severe ulcerative colitis in Spain.

OBJECTIVES: Assess the efficiency of biologic treatment for moderate to severe ulcerative colitis (UC) which are indicated and financed for this pathology by Spain. METHODS: A Markov model was constructed to simulate the progression in a cohort of patients with moderate to severe UC. The perspective chosen was National Health Service with an over 10 years of time horizon, with a discount rate of 3%, and established threshold of €30,000/quality-adjusted life-year (QALY). RESULTS: The comparison between infliximab versus adalimumab achieved an incremental cost-effectiveness ratio (ICER) of €45,582/QALY, with a 0.900 QALYs difference of efficacy and an incremental cost of €41,036. Golimumab versus adalimumab reached an ICER of €2,175,992/QALY, with a difference of 0.001 QALY in efficacy and a raising cost to €2,611. The comparison between vedolizumab with adalimumab achieved an ICER of €90,532/QALY, 0.930 QALYs of difference and an increasing cost of €84,218. The probabilistic sensitivity analysis shows that adalimumab would be cost-effective in the 65.2% of the simulations, infliximab in the 18.4%, golimumab in the 16.4% and vedulizumab for the 0%. CONCLUSIONS: Among all these drugs studied, adalimumab is the most cost-effective drug for the treatment of moderate to severe UC for a threshold of €30,000/QALY in Spain.

Cost-effectiveness analysis of therapeutic options for chronic hepatitis C genotype 3 infected patients.

BACKGROUND: This study provides a cost-effectiveness analysis of therapeutic strategies for chronic hepatitis C genotype 3 infected patients in Spain. METHODS: A Markov model was designed to simulate the progression in a cohort of patients aged 50 years over a lifetime horizon. RESULTS: Sofosbuvir (SOF) plus peginterferon and ribavirin for 12 weeks was a cost-effective option when compared to standard of care (SoC) in the treatment of both 'moderate fibrosis' and 'cirrhotic' patients. Incremental cost-effectiveness ratios were €35,276/QALY and €18,374/QALY respectively. ICERs for SOF plus daclatasvir (DCV) regimens versus SoC were over the threshold limit considered, at €56,178/QALY and €77,378/QALY for 'moderate fibrosis' and 'cirrhotic' patients respectively. CONCLUSION: Addition of SOF to IFN-based regimens for genotype 3 was cost-effective for both 'moderate fibrosis' and 'cirrhotic' patients. IFN-free options including SOF and DCV association required price reductions lower than the list prices to be considered cost-effective.

Evaluación del grado de formación del personal que elabora las nutriciones parenterales en los Servicios de Farmacia / Training degree assessment of staff producing parenteral nutrition in Pharmacy Services

Objetivo: Evaluar el grado de formación del personal que elabora nutrición parenteral en los Servicios de Farmacia. Material y métodos: Se diseñó una encuesta on-line con 17 preguntas en la que se incluyeron los puntos más importantes en la elaboración de nutriciones parenterales. Para el diseño de la encuesta y el análisis posterior se utilizó la aplicación informática Survey monkey®. Resultados: Se obtuvieron un total de 135 respuestas. En el 95% de los Servicios de Farmacia existían normas escritas de elaboración. El 67% contestó que el fosfato se debía añadir cuando se empiezan a añadir los electrolitos y el 34% que no se realizaba la validación de la técnica aséptica de elaboración. En cuanto a la formación, el 19% no la había recibido, considerando necesario recibirla el 99%. Conclusiones: El personal encuestado presenta un grado de formación aceptable, pero son necesarios los cursos de formación que se deben fomentar desde los Servicios de Farmacia (AU)

Objective: To assess the level of expertise of Pharmacy personnel in the manufacturing of total parenteral nutrition. Material and methods: An on-line survey including 17 questions concerning key aspects of TPN manufacturing was designed. Survey monkey software was used to create the survey and to analize its results. Results: 135 answers were received. 95% of the participant Pharmacy services had written standard manufacturing procedures. 67% answered that phosphate salts should be the first electrolite to be additioned into the total parenteral nutrition and 34% affirmed that validation of the aseptic manufacturing technique was not performed. As far as personnel training was concerned, 19% of respondents had not received any specific training, although 99% considered it would be necessary to receive it. Conclusions: The polled personell has an acceptable level of expertise but adequate training courses are still necessary and should be promoted from Pharmacy services (AU)

[Training degree assessment of staff producing parenteral nutrition in Pharmacy Services]. / Evaluación del grado de formación del personal que elabora las nutriciones parenterales en los Servicios de Farmacia.

OBJECTIVE: To assess the level of expertise of Pharmacy personnel in the manufacturing of total parenteral nutrition. MATERIAL AND METHODS: An on-line survey including 17 questions concerning key aspects of TPN manufacturing was designed. Survey monkey software was used to create the survey and to analize its results. RESULTS: 135 answers were received. 95% of the participant Pharmacy services had written standard manufacturing procedures. 67% answered that phosphate salts should be the first electrolite to be additioned into the total parenteral nutrition and 34% affirmed that validation of the aseptic manufacturing technique was not performed. As far as personnel training was concerned, 19% of respondents had not received any specific training, although 99% considered it would be necessary to receive it. CONCLUSIONS: The polled personell has an acceptable level of expertise but adequate training courses are still necessary and should be promoted from Pharmacy services.

Objetivo: Evaluar el grado de formación del personal que elabora nutrición parenteral en los Servicios de Farmacia. Material y métodos: Se diseñó una encuesta on-line con 17 preguntas en la que se incluyeron los puntos más importantes en la elaboración de nutriciones parenterales. Para el diseño de la encuesta y el análisis posterior se utilizó la aplicación informática Survey monkey®. Resultados: Se obtuvieron un total de 135 respuestas. En el 95% de los Servicios de Farmacia existían normas escritas de elaboración. El 67% contestó que el fosfato se debía añadir cuando se empiezan a añadir los electrolitos y el 34% que no se realizaba la validación de la técnica aséptica de elaboración. En cuanto a la formación, el 19% no la había recibido, considerando necesario recibirla el 99%. Conclusiones: El personal encuestado presenta un grado de formación aceptable, pero son necesarios los cursos de formación que se deben fomentar desde los Servicios de Farmacia.