Publications by authors named "Margarita Ruano"

8 Publications

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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

[Drug-induced QT interval prolongation: do we know the risks?].

Med Clin (Barc) 2015 Mar 18;144(6):269-74. Epub 2014 Mar 18.

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

Sudden cardiac death is an important cause of mortality in developed countries, most of them being consequence of acute ventricular arrhythmias. These arrhythmias, in some cases, owe to QT interval prolongation. A major risk factor for this condition is the use of drugs that prolong the QT interval. In fact, in recent years, one of the most common reasons for drug withdrawal or usage restrictions has been drug induced QT interval prolongation that involves both cardiovascular and non-cardiovascular drugs. Taking into account the severity that the occurrence of such an event may have, it is important for clinicians to know the risks of these drugs in certain patients. In this review we analyze the drugs that prolong the QT interval, the risk factors that can enhance QT prolongation and the drug interactions that can increase these risks.
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http://dx.doi.org/10.1016/j.medcli.2014.01.027DOI Listing
March 2015

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

[Colchicine: what's up, doc?].

Med Clin (Barc) 2012 Sep 28;139(7):295-9. Epub 2012 Mar 28.

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

Over de past years use off-label of colchicine has notably increased, mainly as a result of the latest studies published about its efficacy in the prevention of recurrence after acute or recurrent pericarditis and pericarditis after cardiac surgery. Nevertheless, colchicine use has been associated with serious drug interactions and toxicity with high morbimortality. Taking into account the recent results about the efficacy of colchicine in pericarditis management, we envisage an increase in the use of this drug by clinicians. In this review we analyse the risks and current recommendations for a safety use of this ancient drug.
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http://dx.doi.org/10.1016/j.medcli.2012.01.027DOI Listing
September 2012

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
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