Publications by authors named "Alicia Herrero"

28 Publications

  • Page 1 of 1

Inhaled bronchodilators use and clinical course of adult inpatients with Covid-19 pneumonia in Spain: A retrospective cohort study.

Pulm Pharmacol Ther 2021 Jun 12;69:102007. Epub 2021 Jun 12.

Pneumology Department, La Paz University Hospital, IdiPAZ, Madrid, Spain.

Background: In the current coronavirus health crisis, inhaled bronchodilators(IB) have been suggested as a possible treatment for patients hospitalized. Patients with evidence of Covid-19 pneumonia worldwide have been prescribed these medications as part of therapy for the disease, an indication for which this medications could be ineffective taken on account the pathophysiology and mechanisms of disease progression.

Objective: The main objective was to evaluate whether there is an association between IB use and length of stay. Primary end points were the number of days that a patient stayed in the hospital and death as a final event in a time to event analysis. Pneumonia severity, oxygen requirement, involved drugs, comorbidity, historical or current respiratory diagnoses and other drugs prescribed to treat coronavirus pneumonia were also evaluated.

Methods: A descriptive, observational, cross-sectional study was performed in this tertiary hospital in Madrid (Spain). Data were obtained regarding patients hospitalized with Covid-19, excluding those who were intubated. The primary and secondary outcomes such as duration of hospitalization and death were compared in patients who received IB with those in patients who did not.

Results: 327 patients were evaluated, mean age was 64.4 ± 15.8 years. Median length of hospitalization stay was 10 days. Of them 292 (89.3%) overcame the disease, the remaining 35 died. Patients who had received IB did not have less mortality rate (odds ratio 0.839; 95% CI: 0.401 to 1.752) and less hospitalization period when compared with patients who did not received IB (odds ratio 1.280; 95% CI: 0.813 to 2.027). There was no significant association between IB use and recovery or death. Hypertension and diabetes were the most common comorbidities. The prevalence of chronic respiratory disease in our cohort was low (21.1%). Anticholinergics were the IB more frequently prescribed for Covid-19 pneumonia. Better response in patients treated with inhaled corticosteroids was not observed.

Conclusion: Off-label indication of inhaled-bronchodilators for Covid-19 patients are common in admitted patients. Taken on account our results, the use of IB for coronavirus pneumonia apparently is not associated with a significantly patient's improvement. Our study confirms the hypothesis that inhaled bronchodilators do not improve clinical outcomes or reduce the risk of Covid-19 mortality. This could be due to the fact that the virus mainly affects the lung parenchyma and the pulmonary vasculature and probably not the airway. More researches are necessary in order to fill the gap in evidence for this new indication.
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http://dx.doi.org/10.1016/j.pupt.2021.102007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8196225PMC
June 2021

Characterization of myocardial injury in a cohort of patients with SARS-CoV-2 infection.

Med Clin (Barc) 2021 Mar 24. Epub 2021 Mar 24.

Cardiology Department, Hospital Universitario La Paz, Madrid, Spain.

Background: Myocardial injury has been identified as a common complication in patients with COVID-19. However, recent research has serious limitations, such as non-guideline definition of myocardial injury, heterogenicity of troponin sampling or very short-term follow-up. Using data from a large European cohort, we aimed to overcome these pitfalls and adequately characterize myocardial damage in COVID-19.

Methods: Consecutive patients with confirmed SARS-CoV-2 infection and available high-sensitive troponin I (hs-TnI), from March 1st to April 20th, 2020 who completed at least 1-month follow-up or died, were studied.

Results: A total of 918 patients (mean age 63.2±15.5 years, 60.1% male) with a median follow-up of 57 (49-63) days were included. Of these, 190 (20.7%) fulfilled strict criteria for myocardial injury (21.1% chronic, 76.8% acute non-ischemic, 2.1% acute ischemic). Time from onset of symptoms to maximum hs-TnI was 11 (7-18) days. Thrombotic and bleeding events, arrhythmias, heart failure, need for mechanical ventilation and death were significantly more prevalent in patients with higher hs-TnI concentrations, even without fulfilling criteria for myocardial injury. hs-TnI was identified as an independent predictor of mortality [HR 2.52 (1.57-4.04) per 5-logarithmic units increment] after adjusting for multiple relevant covariates.

Conclusion: Elevated hs-TnI is highly prevalent among patients with SARS-CoV-2 infection. Even mild elevations well below the 99th URL were significantly associated with higher rates of cardiac and non-cardiac complications, and higher mortality. Future research should address the role of serial hs-TnI assessment to improve COVID-19 prognostic stratification and clinical outcomes.
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http://dx.doi.org/10.1016/j.medcli.2021.02.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988449PMC
March 2021

Prediction of thromboembolic events and mortality by the CHADS2 and the CHA2DS2-VASc in COVID-19.

Europace 2021 06;23(6):937-947

Department of Cardiology, Hospital Universitario La Paz, CiberCV, IdiPaz, Madrid, Spain.

Aims: Age, sex, and cardiovascular disease have been linked to thromboembolic complications and poorer outcomes in COVID-19. We hypothesize that CHADS2 and CHA2DS2-VASc scores may predict thromboembolic events and mortality in COVID-19.

Methods And Results: COVID-19 hospitalized patients with confirmed SARS-CoV-2 infection from 1 March to 20 April 2020 who completed at least 1-month follow-up or died were studied. CHADS2 and CHA2DS2-VASc scores were calculated. Given the worse prognosis of male patients in COVID-19, a modified CHA2DS2-VASc score (CHA2DS2-VASc-M) in which 1 point was given to male instead of female was also calculated. The associations of these scores with laboratory results, thromboembolic events, and death were analysed. A total of 3042 patients (mean age 62.3 ± 20.3 years, 54.9% male) were studied and 115 (3.8%) and 626 (20.6%) presented a definite thromboembolic event or died, respectively, during the study period [median follow 59 (50-66) days]. Higher score values were associated with more marked abnormalities of inflammatory and cardiac biomarkers. Mortality was significantly higher with increasing scores for CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-M (P < 0.001 for trend). The CHA2DS2-VASc-M showed the best predictive value for mortality [area under the receiver operating characteristic curve (AUC) 0.820, P < 0.001 for comparisons]. All scores had poor predictive value for thromboembolic events (AUC 0.497, 0.490, and 0.541, respectively).

Conclusion: The CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-M scores are significantly associated with all-cause mortality but not with thromboembolism in COVID-19 patients. They are simple scoring systems in everyday use that may facilitate initial 'quick' prognostic stratification in COVID-19.
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http://dx.doi.org/10.1093/europace/euab015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7928912PMC
June 2021

Characterization of NT-proBNP in a large cohort of COVID-19 patients.

Eur J Heart Fail 2021 03 1;23(3):456-464. Epub 2021 Feb 1.

Cardiology, Hospital Universitario La Paz, IdiPaz, CiberCV, Madrid, Spain.

Aims: Extensive research regarding the association of troponin and prognosis in coronavirus disease 2019 (COVID-19) has been performed. However, data regarding natriuretic peptides are scarce. N-terminal pro B-type natriuretic peptide (NT-proBNP) reflects haemodynamic stress and has proven useful for risk stratification in heart failure (HF) and other conditions such as pulmonary embolism and pneumonia. We aimed to adequately characterize NT-proBNP concentrations using a large cohort of patients with COVID-19, and to investigate its association with prognosis.

Methods And Results: Consecutive patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and available NT-proBNP determinations, from March 1st to April 20th, 2020 who completed at least 1-month follow-up or died, were studied. Of 3080 screened patients, a total of 396 (mean age 71.8 ± 14.6 years, 61.1% male) fulfilled all the selection criteria and were finally included, with a median follow-up of 53 (18-62) days. Of those, 192 (48.5%) presented NT-proBNP levels above the recommended cut-off for the identification of HF. However, only 47 fulfilled the clinical criteria for the diagnosis of HF. Patients with higher NT-proBNP during admission experienced more frequent bleeding, arrhythmias and HF decompensations. NT-proBNP was associated with mortality both in the whole study population and after excluding patients with HF. A multivariable Cox model confirmed that NT-proBNP was independently associated with mortality after adjusting for all relevant confounders (hazard ratio 1.28, 95% confidence interval 1.13-1.44, per logarithmic unit).

Conclusion: NT-proBNP is frequently elevated in COVID-19. It is strongly and independently associated with mortality after adjusting for relevant confounders, including chronic HF and acute HF. Therefore, its use may improve early prognostic stratification in this condition.
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http://dx.doi.org/10.1002/ejhf.2095DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8013330PMC
March 2021

Heart failure in COVID-19 patients: prevalence, incidence and prognostic implications.

Eur J Heart Fail 2020 12 7;22(12):2205-2215. Epub 2020 Oct 7.

Cardiology Department, Hospital Universitario La Paz, Madrid, Spain.

Aims: Data on the impact of COVID-19 in chronic heart failure (CHF) patients and its potential to trigger acute heart failure (AHF) are lacking. The aim of this work was to study characteristics, cardiovascular outcomes and mortality in patients with confirmed COVID-19 infection and a prior diagnosis of heart failure (HF). Further aims included the identification of predictors and prognostic implications for AHF decompensation during hospital admission and the determination of a potential correlation between the withdrawal of HF guideline-directed medical therapy (GDMT) and worse outcomes during hospitalization.

Methods And Results: Data for a total of 3080 consecutive patients with confirmed COVID-19 infection and follow-up of at least 30 days were analysed. Patients with a previous history of CHF (n = 152, 4.9%) were more prone to the development of AHF (11.2% vs. 2.1%; P < 0.001) and had higher levels of N-terminal pro brain natriuretic peptide. In addition, patients with previous CHF had higher mortality rates (48.7% vs. 19.0%; P < 0.001). In contrast, 77 patients (2.5%) were diagnosed with AHF, which in the vast majority of cases (77.9%) developed in patients without a history of HF. Arrhythmias during hospital admission and CHF were the main predictors of AHF. Patients developing AHF had significantly higher mortality (46.8% vs. 19.7%; P < 0.001). Finally, the withdrawal of beta-blockers, mineralocorticoid receptor antagonists and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers was associated with a significant increase in in-hospital mortality.

Conclusions: Patients with COVID-19 have a significant incidence of AHF, which is associated with very high mortality rates. Moreover, patients with a history of CHF are prone to developing acute decompensation after a COVID-19 diagnosis. The withdrawal of GDMT was associated with higher mortality.
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http://dx.doi.org/10.1002/ejhf.1990DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7461427PMC
December 2020

Bragg Peak Localization with Piezoelectric Sensors for Proton Therapy Treatment.

Sensors (Basel) 2020 May 25;20(10). Epub 2020 May 25.

Institut d'Investigació per a la Gestió Integrada de les Zones Costaneres (IGIC), Universitat Politècnica de València (UPV), Gandia, 46730 València, Spain.

A full chain simulation of the acoustic hadrontherapy monitoring for brain tumours is presented in this work. For the study, a proton beam of 100 MeV is considered. In the first stage, Geant4 is used to simulate the energy deposition and to study the behaviour of the Bragg peak. The energy deposition in the medium produces local heating that can be considered instantaneous with respect to the hydrodynamic time scale producing a sound pressure wave. The resulting thermoacoustic signal has been subsequently obtained by solving the thermoacoustic equation. The acoustic propagation has been simulated by FEM methods in the brain and the skull, where a set of piezoelectric sensors are placed. Last, the final received signals in the sensors have been processed in order to reconstruct the position of the thermal source and, thus, to determine the feasibility and accuracy of acoustic beam monitoring in hadrontherapy.
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http://dx.doi.org/10.3390/s20102987DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7287827PMC
May 2020

Off-label use of inhaled bronchodilators in hospitalised patients in Spain: a multicentre observational study.

Eur J Hosp Pharm 2020 Apr 24. Epub 2020 Apr 24.

Pneumology, La Paz University Hospital, Madrid, Spain.

Background: Off-label prescription of inhaled bronchodilators (IB) is frequent, despite the fact that they can be ineffective and increase avoidable healthcare costs.

Objective: To analyse the frequency of off-label prescription of IB in hospitalised patients. Indications and level of evidence, involved drugs, medical specialties prescribing off-label IB and patients' adherence to IBs were also evaluated.

Method: A descriptive, observational, cross-sectional study was performed in four tertiary hospitals in Spain. The main outcome measure was the number of patients prescribed off-label IBs. Prescriptions were checked against the European Medicines Agency-approved indications. The level of evidence supporting off-label prescription of IBs (according to MICROMEDEX 2.0) was also analysed. Patients were interviewed to test differences (off-label vs on-label) in adherence and knowledge about their inhaled therapy.

Results: 217 patients were prescribed IBs, 92 of whom were givend off-label IBs (54.7% men, mean age 73.9±12.9 years). The most common off-label prescriptions for IBs were: unspecified dyspnoea (not related to COPD or asthma) (27.2%), respiratory infections (23.9%) and heart failure (22.8%). 76.8% of patients did not have evidence supporting them. Beta-agonist+corticosteroids and anticholinergics were most commonly prescribed off-label. Internal Medicine was the main medical specialty involved. There were no differences between off-label and on-label users in terms of patients' knowledge about treatment and adherence.

Conclusion: Off-label indications for IBs are common in hospitalised patients and are generally indicated without scientific support. Dyspnoea not related to COPD or asthma, respiratory infections and heart failure were the main off-label indications, most frequently treated with anticholinergics and beta-agonists+corticosteroids, for which their efficacy and safety has not been proved. Our results show that prescribing needs to be improved to follow the evidence that exists. Moreover, further research focused on off-label indications is needed to clarify whether they are effective, safe and cost-effective.
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http://dx.doi.org/10.1136/ejhpharm-2019-002171DOI Listing
April 2020

The Pandemic Requires a Coordinated Global Economic Response.

Inter Econ 2020 1;55(2):66-67. Epub 2020 Apr 1.

Bruegel, Rue de la Charité 33, 1210 Brussels, Belgium.

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http://dx.doi.org/10.1007/s10272-020-0871-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7110260PMC
April 2020

Cost evolution of biological drugs in rheumatoid arthritis patients in a tertiary hospital: Influential factors on price.

Reumatol Clin (Engl Ed) 2021 Jun-Jul;17(6):335-342. Epub 2019 Dec 24.

Rheumatology Department, La Paz University Hospital, Madrid, Spain.

Objective: To assess the evolution of cost per patient/year and the cost per patient/year/drug in patients with rheumatoid arthritis (RA) receiving biological treatments. To analyze and quantify the factors influencing this evolution, such as the optimization of the biological drugs, the use of biosimilars, and official discounts and discounts obtained after negotiated procedures. In addition, to assess specific clinical parameters of disease activity in these patients.

Methods: Retrospective, observational study conducted in a Spanish tertiary hospital. Adult patients diagnosed with RA under treatment from 2009 to 2017 were included.

Results: 320, 270 and 389 patients were included in 2009, 2013 and 2017, respectively. The patient/year cost decreased from 10,789€ in 2009, 7491€ in 2013 to 7116€ in 2017. In 2017, due to the established competition, discounts of 14% and 29.5% were achieved on etanercept and its biosimilar; 11.5%, 17.8%, 17.9%, 17.3% on adalimumab, certolizumab, golimumab and tocilizumab IV respectively, and 24.6% and 43.1% on infliximab and its biosimilar. The percentage of patients optimized in 2017 was 35.2%. The annual saving in 2017 was 1,288,535€ (830,000€ due to dose optimization and/or administration regimens, 249,666€ corresponding to 7.5% of the official discount and 208,868€ after negotiated procedures).

Conclusion: The annual cost per patient in RA decreased considerably due to different factors, such as discounts on the purchase of drugs due to official discounts and negotiated procedures, together with the optimization of therapies, the latter being the factor that contributed most to this decrease.
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http://dx.doi.org/10.1016/j.reuma.2019.10.004DOI Listing
December 2019

Acoustic Localization of Bragg Peak Proton Beams for Hadrontherapy Monitoring.

Sensors (Basel) 2019 Apr 26;19(9). Epub 2019 Apr 26.

Institut de Matemàtica Multidisciplinar, Universitat Politècnica de València (UPV), 46022 València, Spain.

Hadrontherapy makes it possible to deliver high doses of energy to cancerous tumors by using the large energy deposition in the Bragg-peak. However, uncertainties in the patient positioning and/or in the anatomical parameters can cause distortions in the calculation of the dose distribution. In order to maximize the effectiveness of heavy particle treatments, an accurate monitoring system of the deposited dose depending on the energy, beam time, and spot size is necessary. The localized deposition of this energy leads to the generation of a thermoacoustic pulse that can be detected using acoustic technologies. This article presents different experimental and simulation studies of the acoustic localization of thermoacoustic pulses captured with a set of sensors around the sample. In addition, numerical simulations have been done where thermo-acoustic pulses are emitted for the specific case of a proton beam of 100 MeV.
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http://dx.doi.org/10.3390/s19091971DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6539756PMC
April 2019

Persistence of biological agents over an eight-year period in rheumatoid arthritis and spondyloarthritis patients.

Farm Hosp 2019 01 1;43(1):24-30. Epub 2019 Jan 1.

Servicio de Reumatología. Hospital Universitario la Paz, Madrid.

Objective: To calculate the persistence, over a period of eight years, the retention rate of first and second-line of treatment with biological agents in  patients with rheumatoid arthritis, spondyloarthritis and psoriatic arthritis and to compare retention rates of the various drugs for each pathology.

Method: Retrospective observational study that included patients affected by  rheumatoid arthritis, spondyloarthritis and psoriatic arthritis, who started  treatment with biological agents between January 2009 and December 2012 and followed until December 2016.

Results: 132, 87 and 33 patients were included in rheumatoid arthritis, spondyloarthritis and psoriatic arthritis, respectively. The median  retention duration of all biological agents for the first and second-line, was 30.9 months and 14.0 months, respectively for rheumatoid arthritis; 63.06  months and 25.6 months, respectively in spondyloarthritis. Psoriatic arthritis did  not reach the median (> 70 months in first-line) (first line p = 0.002). Individual drug survival in first line: the median retention duration of tocilizumab was 58.3 months, followed by etanercept (p = 0.79) in rheumatoid arthritis. For spondyloarthritis, golimumab and etanercept had greater retention than the other drugs (they did not reach the median): adalimumab was 63.0 months and for infliximab was 50.1 months. In psoriatic arthritis, golimumab,  infliximab and etanercept not reach the median and they had greater retention than adalimumab (59.4 months). Individual drug survival in second  line: tocilizumab was the most persistent drug (median 22.1 months) in  rheumatoid arthritis, and golimumab for spondyloarthritis and psoriatic arthritis.

Conclusions: Tocilizumab and etanercept in rheumatoid arthritis, and golimumab in spondyloarthritis and psoriatic arthritis also, were the most persistent drugs in first-line and second-line treatment.
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http://dx.doi.org/10.7399/fh.11080DOI Listing
January 2019

Cost evolution of biological agents for the treatment of spondyloarthritis in a tertiary hospital: influential factors in price.

Int J Clin Pharm 2018 Dec 8;40(6):1528-1538. Epub 2018 Sep 8.

Rheumatology Department, La Paz University Hospital, Paseo de la Castellana 261, 28046, Madrid, Spain.

Background Spending on biological agents has risen dramatically due to the high cost of the drugs and the increased prevalence of spondyloarthritis. Objective To evaluate the annual cost per patient and cost for each biological drug for treating patients with spondyloarthritis from 2009 to 2016, and to calculate factors that affect treatment cost, such as optimizing therapies by monitoring drug serum levels, the use of biosimilar-TNF inhibitors, and official discounts or negotiated rebates in biologicals acquired by the pharmacy department. Method Retrospective, observational study in a Spanish tertiary hospital. Main outcome Annual cost per patient and per drug. Factors that influenced the costs and socio-demographic parameters and disease activity. Results A total of 129, 215, and 224 patients were treated in 2009, 2013, and 2016, respectively. The annual cost per patient decreased: EUR11,604 in 2009, EUR8513 in 2013, and EUR7464 in 2016. The introduction of new drugs drives economic competition, leading to total savings per drug, with discounts reaching 5.8, 12.4, 16.7, 17.7, 13.7, and 24.8% for original infliximab, etanercept, adalimumab, ertolizumab, golimumab, and secukinumab, respectively, while rebates for biosimilar infliximab reached 31.90% in 2016. The number of patients with optimized therapies reached 47.5% in 2016, which led to cost savings of EUR798,614, in addition to savings from official discounts and rebates of EUR252,706 and savings from optimized therapies of EUR545,908 in 2016. Conclusion The cost of biological treatments declined after official discounts, negotiated rebates, and optimized therapies, leading to a significant decrease in the annual cost per patient. The greatest contribution to economic savings in biological therapy according to our study was biological therapy optimization.
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http://dx.doi.org/10.1007/s11096-018-0703-zDOI Listing
December 2018

Switch to belatacept in kidney graft recipients.

Nefrologia 2017 Sep - Oct;37(5):550-552. Epub 2017 Feb 21.

Nephrology Department, University Hospital La Paz, Madrid, Spain.

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http://dx.doi.org/10.1016/j.nefro.2016.11.001DOI Listing
October 2018

Informed consent in clinical research; Do patients understand what they have signed?

Farm Hosp 2016 05 1;40(3):209-18. Epub 2016 May 1.

Hospital Pharmacy Unit. Hospital Universitario La Paz. IdiPaz, Madrid..

Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial.
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http://dx.doi.org/10.7399/fh.2016.40.3.10411DOI Listing
May 2016

New technologies as a strategy to decrease medication errors: how do they affect adults and children differently?

World J Pediatr 2016 Feb 18;12(1):28-34. Epub 2015 Dec 18.

Department of Pneumology, La Paz University Hospital, Madrid, Spain.

Background: Medication error can occur throughout the drug treatment process, with special relevance in children given the risk of adverse effects resulting from a medication error is more prevalent than in adults. The significance of medication error in children is also greater because small error that would be tolerated in adults can cause significant damage in children. Moreover, the likelihood of injury is higher than in adults.

Data Sources: Based on the data published, most medication errors take place in prescribing and administration stages in both populations. Taking in account that child's risk factors are different from those of adults, with some specific causes to pediatrics, we have reviewed available data about new technologies as a strategy to reduce pediatric medication errors.

Results: Even though there is a lack of standardized definitions and terminology that makes studies difficult to compare, we checked that new technologies have proven to be effectives in reducing medication errors, mainly computerized physician order entry (CPOE) and platforms to aid decision-making. However, we also observed that the use of these informatic tools can also generate new errors.

Conclusions: Implementation of CPOE programs for pediatrics, communication improvement between healthcare professionals taking care of admitted children and the knowledge of these programs should be the mayor priorities for the safety of hospitalized children.
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http://dx.doi.org/10.1007/s12519-015-0067-6DOI Listing
February 2016

Reasons for initiation of proton pump inhibitor therapy for hospitalised patients and its impact on outpatient prescription in primary care.

Rev Esp Enferm Dig 2015 Nov;107(11):652-8

Hospital Universitario La Paz. Madrid.

Background: Proton-pump-inhibitors are often prescribed unnecessarily in hospitals, which in turn induces their prescriptions after discharge.

Objective: To evaluate patients starting treatment with proton-pump-inhibitors during hospitalisation and proportion of inappropriate prescriptions. Patient risk factors and whether initiation in hospital induced their continuation in ambulatory care were also analyzed.

Methods: An observational, cross-sectional study in a tertiary hospital (1350 beds) was carried out on the first Tuesday in February 2015. Pharmacists screened admitted patients treated with proton-pump-inhibitors using an electronic prescription program (FarmaTools®-5.0). They also checked patients' home medications before admission by accessing a primary care program (Horus®). Authorized indications according to Spanish-Medicines-Agency and those recommended in Spanish-Clinical-Practice-Guidelines were considered appropriate. Hospital-medical-records were checked to know whether proton-pump-inhibitors were prescribed at discharge.

Results: Three hundred seventy nine patients were analysed. Two hundred ninety four of them were prescribed proton-pump-inhibitors (77.6%). Treatment was initiated during admission for 143 patients (48.6%, 95% CI: 42.8-54.5). Of them, 91 (63.6%, 95% CI: 55.2-71.5) were inappropriate, mainly due to its inclusion unnecessarily in protocols associated with surgeries or diseases (56 cases of 91, 61.5%). Additional inappropriate indications were surgical stress ulcer prophylaxis for surgeries without bleeding risks (19.8%) and polypharmacy without drugs that increase the risk of bleeding (18.7%). Of 232 discharge reports assessed, in 153 (65.9%, 95% CI: 59.5-72), proton-pump-inhibitor continuation was recommended, of them, 51 (33.3%) were initiated at admission.

Conclusion: In hospitalized patients there is a high prevalence of prescription of proton-pump-inhibitors unnecessarily. The superfluous use is often associated with the prescription of treatment protocols. Those treatments started in the hospital generally did not contribute to over-use existing primary care, most of them were removed at discharge.
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http://dx.doi.org/10.17235/reed.2015.3882/2015DOI Listing
November 2015

Analysis of clinical trials and off-label drug use in hospitalized pediatric patients.

Arch Argent Pediatr 2014 Jun;112(3):249-53

Servicio de Farmacia, Hospital Universitario La Paz, Madrid, España.

Introduction. The lack of pediatric clinical trials (PCTs) leads to an off-label drug use (OLDU) in children. Our objective was to analyze the number and design of PCTs and OLDU in children in the past years. Population, material and methods. Observational and retrospective study on PCTs and OLDU in children, conducted from 2007 to 2012 in a 252-bed children's hospital. The number and design of PCTs and OLDU in children were analyzed by year and by characteristics. Results. Eighty-seven PCTs and 449 active ingredients corresponding to 1049 drugs prescribed to hospitalized children were evaluated.Of these, 117 (26%) were used off-label. The number of PCTs increased from 2008 to 2011. In 2011, 52.2% of PCTs were non-randomized and uncontrolled studies, and only 39.1% were randomized, controlled trials. Of all studied drugs, 77% corresponded to off-label use. OLDU in children remained steady throughout the study period. Conclusions. In our hospital, the number of pediatric research studies has increased in the past years, being non-randomized and uncontrolled studies the most frequent. OLDU in children has not changed.
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http://dx.doi.org/10.5546/aap.2014.249DOI Listing
June 2014

Symptomatic thromboembolic events in patients treated with intravenous-immunoglobulins: results from a retrospective cohort study.

Thromb Res 2014 Jun 1;133(6):1045-51. Epub 2014 Apr 1.

Department of Clinical Pharmacology, Hospital Universitario La Paz, IdiPAZ, School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain. Electronic address:

Aims: To estimate the incidence and predictors of symptomatic arterial and venous thromboembolic events (TEE) from intravenous immunoglobulin (IVIg) therapy according to its indications.

Methods: We performed a retrospective cohort study of patients seen at our institution and treated with IVIg over a 36-month period. Indications, comorbility and comedication associated with TEE were identified by a stepwise logistic regression analysis.

Results: Of 303 patients included with at least one infusion of IVIg over three years, TEE were identified in a total of 50 patients treated with IVIg, for an incidence of 16.9% (CI 95%: 13.0-21.6); 27 (54%) arterial (9.1%;CI 95%: 6.3-13.0%) and 23 (46%) venous TEE (7.8%; CI95%: 5.2-11.4%), overall mortality was 32%. Per indication there were more patients with autoimmune conditions, secondary immunodeficiency, dysimmune neuropathies, acute rejection of solid organ transplantation and sepsis. Patients with TEE were significantly older, were more likely to be men, they had more comorbid conditions; the doses of IVIg were high (589.4mg/kg/day vs 387.0mg/kg/day, p<0.001) and differences in comedication were found. The stepwise logistic regression analysis retained high doses of IVIg (OR 3.03; CI 95%: 1.49-5.67) and diuretics therapy (OR 1.69; CI 95%: 1.06-3.97) when combined with the usual comorbid confounders.

Conclusions: The incidence of TEE from IVIg therapy remains high at one in six patients treated. The most remediable factor is a high daily IVIg load. Decreasing the daily IVIg dose together with carefully weighing diuretics therapy and comorbid risk factors may be the keys to saving lives.
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http://dx.doi.org/10.1016/j.thromres.2014.03.046DOI Listing
June 2014

Potential medication errors associated with computer prescriber order entry.

Int J Clin Pharm 2013 Aug 11;35(4):577-83. Epub 2013 Apr 11.

Clinical Pharmacy Consultant, Pharmacy Department, La Paz University Hospital, Paseo de La Castellana 261, 28046, Madrid, Spain.

Introduction: To assess the frequency of medication errors (ME) induced or enhanced by computerized physician order entry (CPOE). Error type, drug classes involved, specialty, patient outcome and system failures were also evaluated.

Methods: Observational quantitative study in a large tertiary care medical center over March 2012 3 years after CPOE implementation. Pharmacists detected ME associated with CPOE (those that wouldn't have occurred if the clinician had prescribed manually) and unassociated in pharmacological treatments in inpatients of 13 specialties (421 beds). Main outcome measured were ME associated and unassociated with CPOE.

Results: We found 714 ME with 85.857 drug prescriptions (a 0.8 % error rate, 95 % CI 0.6-0.7). Percentage of error associated with CPOE was 77.7 %. The main types of error related to CPOE were wrong medication selection (20.9 %) and improper data placement (20.3 %). Failures with medications prescribed in primary care, unavailable in the hospital pharmacy, were involved in 21.6 % of all ME. Errors involving surgical specialties were double those involving medical specialties (1.2 vs. 0.6 %). Most ME associated with CPOE were potential errors (90 %). During the study system failures occurred four times.

Conclusions: The use of CPOE minimises the occurrence of medication errors, however, they still occur. Most errors are associated with the CPOE technology. We therefore face a new challenge in the prevention of ME that require a change in strategy for patient safety. Continued training of prescribers, standardization of the electronic prescription programs and integration between computer applications in hospitals and with primary care should be a priority.
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http://dx.doi.org/10.1007/s11096-013-9771-2DOI Listing
August 2013

Improving linezolid use decreases the incidence of resistance among Gram-positive microorganisms.

Int J Antimicrob Agents 2013 Feb 28;41(2):174-8. Epub 2012 Dec 28.

Department of Clinical Pharmacology, Hospital La Paz Health Research Institute (IdiPAZ), School of Medicine, Universidad Autónoma de Madrid, Arzobispo Morcillo s/n, 28029 Madrid, Spain.

Surveillance studies have shown the emergence of infections with linezolid-resistant bacteria. The relationship between appropriate linezolid use and the spread of linezolid resistance among Gram-positive microorganisms in a single tertiary referral centre was evaluated. In an initial observational study, a prospective prescription-indication study was conducted on intensive care areas and haematology, neurosurgery, vascular surgery and nephrology wards during 2009. An intervention through follow-up feedback on audit results from May-June 2010 was then conducted. From July-December 2010, a second drug-use study of linezolid was conducted, with the same objectives and methodology. To assess the antimicrobial pressure of linezolid, an ecological study was conducted from 2006-2010 in the same hospital wards. Indications for linezolid in the initial study were considered suitable in 38.5% of cases, whilst in the second study the rate was 51.2% (33% increase). Linezolid consumption fell by 57% in the second half of 2010. A significant correlation was found between its inadequate use (DDD/1000 patient-days) and the incidence of linezolid-resistant strains/1000 patient-days (r=0.93; P=6.9e-024); 85% of the variability in the incidence of linezolid resistance was predicted by its inadequate use. Its partial correlations were significant for Enterococcus faecium (r=0.407; P=0.049), Staphylococcus epidermidis (r=0.874; P=2.3e-008) and Staphylococcus haemolyticus (r=0.406; P=0.049) but not Staphylococcus aureus (r=0.051; P=0.704). A relationship was found between appropriate linezolid use and the incidence of linezolid-resistant strains of E. faecium, S. epidermidis and S. haemolyticus.
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http://dx.doi.org/10.1016/j.ijantimicag.2012.10.017DOI Listing
February 2013

Strategies for improving documentation and reducing medication errors related to drug allergy.

Int J Clin Pharm 2011 Dec 29;33(6):879-80. Epub 2011 Oct 29.

New technologies like computerized physician order entry systems, that includes a support alert for drug allergies, can be an effective tool to prevent medical errors related to drug hypersensitivity most of them caused by lack of documentation and information.
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http://dx.doi.org/10.1007/s11096-011-9578-yDOI Listing
December 2011

The assisted electronic prescription in patients hospitalised in a chest diseases ward.

Arch Bronconeumol 2011 Mar 4;47(3):138-42. Epub 2011 Mar 4.

Servicio de Farmacia, Hospital Universitario La Paz, Madrid, España.

Patient medical care requires a level of individualised care, so technological support is becoming increasingly necessary, if not essential. Even so, the effort required to apply new technologies in the health system is not always sufficient, taking into account that they could be key factors for the safety of the patient. Treatments are often prescribed manually, which could lead to errors due to ambiguity of the prescriptions, illegibility, calculation errors or transcription errors. The increasing sophistication of computer systems and programs used in the hospital care setting can be fundamental in reducing risks for the patient, detecting and correcting errors, contributing to making decisions using help support and reducing costs in the long-term. Polymedicated patients with the usual multiple diseases in medical specialty departments, such as Chest Diseases, can particularly benefit from the application of these new technologies.
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http://dx.doi.org/10.1016/j.arbres.2010.11.004DOI Listing
March 2011

[Computerized physician order entry as a new technology for patients' safety].

Med Clin (Barc) 2011 Apr;136(9):398-402

Servicio de Farmacia, Hospital Universitario La Paz, Madrid, España.

Concern about patient safety is a priority in the quality policy of health systems. In the pharmacotherapeutic process, from prescription to administration of drugs, failures that cause unwanted effects in patients may occur. This is especially common in patients with multiple pathologies and polypharmacy, common in medical specialities services. To analyze and identify the causes that trigger medical errors is essential to prevent their occurrence. In this context, computerized physician order entry appear as an attractive tool for ensuring patients safety.
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http://dx.doi.org/10.1016/j.medcli.2010.02.012DOI Listing
April 2011

Effect of two kinds of Er:YAG laser systems on root surface in comparison to ultrasonic scaling: an in vitro study.

Photomed Laser Surg 2010 Aug;28(4):497-504

Section of Graduate Periodontology, Faculty of Odontology, Universidad Complutense, Madrid, Spain.

Objective: To evaluate the capacity of Er:YAG laser application to eliminate calculus from periodontally affected root surfaces compared with ultrasonic scaling (US), as well as the possible root damage incurred from both types of instrumentation.

Background Data: The benefits of the use of the Er:YAG laser as a coadjuvant to conventional periodontal therapy have not yet been determined.

Materials And Methods: Forty human molars extracted due to advanced periodontal disease were used. A piezoelectric ultrasonic scaling (US) (Piezon Master EMS) at 28,500 Hz was performed in the right area of the root. Two kinds of Er:YAG lasers, KaVo Key II Laser at 120-140 mJ and KaVo Key III Plus Laser equipped with a fluorescence-controlled feedback system applied at 160 mJ with and without fluorescence feedback control, were used in the left area. The amount of residual calculus and the number and diameter of exposed dentinal tubules were calculated by scanning electron microscopy (SEM).

Results: No differences were identified as to the amount of residual calculus between the four different laser treatments and US. The number of exposed dentinal tubules was higher as the output energies were increased for the laser treatments without feedback control, with a moderate increase in the mean diameter of the exposed dentinal tubules. Hardly any dentinal tubule exposure was observed as a result of treatment with feedback control.

Conclusions: The capacity of the Er:YAG laser to remove calculus is comparable to US. Laser prototypes with feedback control allow a selective removal of calculus without any modification of the root surface.
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http://dx.doi.org/10.1089/pho.2009.2527DOI Listing
August 2010

Dental implants in a patient with Paget disease under bisphosphonate treatment: a case report.

Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2009 Mar;107(3):387-92

Department of Health Sciences III, Faculty of Health Sciences, Rey Juan Carlos University, Madrid, Spain.

Paget disease (PD) is an idiopathic disorder characterized by progressive enlargement and deformity of bones, resulting in structural weakness that may be unfavorable for the placement of osseointegrated dental implants. Currently, bisphosphonates are administered for the treatment of PD. However, the use of bisphosphonates has been associated with the onset of osteonecrosis of the jaws. This report deals with a case of a 64-year-old caucasian woman diagnosed with polyostotic PD 17 years earlier who had been treated with bisphosphonates for 7 years. The patient was referred for implant treatment, and after initial placement of 6 fixtures, the postoperative course was uneventful and no complications were registered during a follow-up period of 4 years. Within the limitations of this case, we report that dental implants can be successfully placed and loaded in patients suffering from PD without discontinuing the treatment with bisphosphonates, as long as the patient is not complaining from any additional unfavorable conditions. To the best of our knowledge, this is a unique case describing the successful placement of dental implants in a patient with PD treated with bisphosphonates. Nevertheless, more studies would be needed to optimize the clinical guidelines for the treatment of these patients.
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http://dx.doi.org/10.1016/j.tripleo.2008.11.024DOI Listing
March 2009

Characterization of TonB interactions with the FepA cork domain and FecA N-terminal signaling domain.

Biometals 2006 Apr;19(2):127-42

Structural Biology Research Group, Department of Biological Sciences, University of Calgary, Calgary, Alberta, T2N 1N4, Canada.

The mechanism of TonB dependent siderophore uptake through outer membrane transporters in Gram-negative bacteria is poorly understood. In an effort to expand our knowledge of the interaction between TonB and the outer membrane transporters, we have cloned and expressed the FepA cork domain (11-154) from Salmonella typhimurium and characterized its interaction with the periplasmic C-terminal domain of TonB (103-239) by isotope assisted FTIR and NMR spectroscopy. For comparison we also performed similar experiments using the FecA N-terminal domain (1-96) from Escherichia coli which includes the conserved TonB box. The FepA cork domain was completely unfolded in solution, as observed for the E. coli cork domain previously [Usher et al. (2001) Proc Natl Acad Sci USA 98, 10676-10681]. The FepA cork domain was found to bind to TonB, eliciting essentially the same chemical shift changes in TonB C-terminal domain as was observed in the presence of TonB box peptides. The FecA construct did not cause this same structural change in TonB. The binding of the FepA cork domain to TonB-CTD was found to decrease the amount of ordered secondary structure in TonB-CTD. It is likely that the FecA N-terminal domain interferes with TonB-CTD binding to the TonB box. Binding of the FepA cork domain induces a loss of secondary structure in TonB, possibly exposing TonB surface area for additional intermolecular interactions such as potential homodimerization or additional interactions with the barrel of the outer membrane transporter.
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http://dx.doi.org/10.1007/s10534-005-5420-0DOI Listing
April 2006
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