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1.
Injury ; 53(12): 3987-3992, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36244831

ABSTRACT

INTRODUCTION: Enhanced Recovery After Surgery (ERAS) protocols and educational programmes have been shown to accelerate orthopaedic surgery recovery with fewer complications, and improve patient-reported outcomes (PROs) for different types of surgery. The objective was to evaluate the impact of an ERAS programme including a patient school on health outcomes and PROs for Total Knee Replacement (TKR) surgery. MATERIAL AND METHODS: A multidisciplinary group created the programme and the patient school (preoperative consultations where the patients' surgical processes are explained and are also given instructions for an appropriate perioperative care management). An observational, prospective study was conducted on all patients operated for TKR from March 2021 to March 2022. Main health outcomes were: hospital stay length, surgical complications and surgery cancellations due to a wrong preoperative medication management. PROs evaluated were: patient satisfaction with pain management, the school, and quality of life before and after surgery (EQ-5D). RESULTS: One hundred thirty-three patients were included. Median hospital stay length was 3 days (IQR 3-5). Rate of surgical complications was 25.6%. No surgery was cancelled. Patient satisfaction rates with pain management and with the school were 8.10/10 and 9.89/10, respectively. Concerning quality of life, mean improvement in mobility and knee pain after the surgery was 0.66 (p < 0.05) and 0.84 (p < 0.05), respectively. CONCLUSIONS: The ERAS programme including a patient school was highly successful with a fast recovery, a short hospital stay length, no surgery cancellations, and improved PROs.


Subject(s)
Enhanced Recovery After Surgery , Humans , Length of Stay , Postoperative Complications/etiology , Prospective Studies , Quality of Life , Schools
2.
J Oncol Pharm Pract ; 25(5): 1099-1104, 2019 Jul.
Article in English | MEDLINE | ID: mdl-29792122

ABSTRACT

BACKGROUND: The objectives of this study were to determine if clinical trials in breast cancer, with an investigational drug, created direct drug cost savings for the healthcare system related to cost avoidance of the best standard of care treatments used in these studies. The aim was to quantify this potential drug cost avoidance. METHODS: We conducted a retrospective observational study of the drug cost avoidance during the study period (2014-2016). We included clinical trials with investigational drug, managed by pharmacy department and provided by the sponsor. The patients included had a therapeutic alternative defined as standard treatment that should have been received in case of not participating in the clinical trial. Direct cost savings, to national healthcare system, associated to clinical trials were calculated. RESULTS: Thirty-seven clinical trials with a total of 89 breast cancer patients were included in the study. A total of 62.2% were phase III and 75.7% belonged to the pharmaceutical industry. They provided a total cost avoidance of 957,246€ (1,130,028$), an average cost avoidance per patient of 10,756€ (12,697$). CONCLUSIONS: Our study suggests that those clinical trials in which investigational drug are provided or refunded by the sponsor provide substantial cost savings. Due to the shortage of published articles that calculate the cost avoided in medication, we cannot compare directly the results obtained in the different institutions.


Subject(s)
Breast Neoplasms, Male/drug therapy , Breast Neoplasms/drug therapy , Clinical Trials as Topic/economics , Drug Costs/statistics & numerical data , Breast Neoplasms/economics , Breast Neoplasms, Male/economics , Cost Savings , Drug Industry , Female , Humans , Male , Middle Aged , Pharmaceutical Services , Retrospective Studies
3.
J Clin Pharm Ther ; 43(6): 906-909, 2018 Dec.
Article in English | MEDLINE | ID: mdl-29956354

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: No studies have evaluated the use of sorafenib with the direct-acting antiviral ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV). CASE SUMMARY: Three hepatitis C virus genotype 1b-infected patients with well-preserved liver function were included in this prospective case series. The patients were taking sorafenib for advanced hepatocellular carcinoma and received OBV/PTV/r+DSV for 12 weeks. One patient discontinued sorafenib while concomitant treatment due to grade 2 fatigue and muscular pain. The other two patients reported only grade 1 adverse effects. Sustained virologic response at 24 weeks was achieved, and no tumour recurrences were found. WHAT IS NEW AND CONCLUSION: The concurrent use of OBV/PTV/r+DSV with sorafenib was considered safe and effective.


Subject(s)
Antineoplastic Agents/administration & dosage , Antiviral Agents/administration & dosage , Hepacivirus/genetics , Hepatitis C, Chronic/drug therapy , 2-Naphthylamine , Aged , Anilides/administration & dosage , Antineoplastic Agents/adverse effects , Antiviral Agents/adverse effects , Carbamates/administration & dosage , Carcinoma, Hepatocellular/drug therapy , Carcinoma, Hepatocellular/pathology , Cyclopropanes , Drug Therapy, Combination , Female , Genotype , Hepacivirus/isolation & purification , Hepatitis C, Chronic/virology , Humans , Lactams, Macrocyclic , Liver Neoplasms/drug therapy , Liver Neoplasms/pathology , Macrocyclic Compounds/administration & dosage , Male , Middle Aged , Proline/analogs & derivatives , Prospective Studies , Ritonavir/administration & dosage , Sorafenib/administration & dosage , Sorafenib/adverse effects , Sulfonamides/administration & dosage , Treatment Outcome , Uracil/administration & dosage , Uracil/analogs & derivatives , Valine
4.
J Healthc Qual Res ; 33(1): 33-47, 2018.
Article in Spanish | MEDLINE | ID: mdl-29456173

ABSTRACT

INTRODUCTION: The failure mode and effects analysis (FMEA) has been used as a tool in risk management and quality improvement. The objective of this study is to identify the weaknesses in processes in the clinical trials area, of a Pharmacy Department (PD) with great research activity, in order to improve the safety of the usual procedures. METHODS: A multidisciplinary team was created to analyse each of the critical points, identified as possible failure modes, in the development of clinical trial in the PD. For each failure mode, the possible cause and effect were identified, criticality was calculated using the risk priority number and the possible corrective actions were discussed. RESULTS: Six sub-processes were defined in the development of the clinical trials in PD. The FMEA identified 67 failure modes, being the dispensing and prescription/validation sub-processes the most likely to generate errors. All the improvement actions established in the AMFE were implemented in the Clinical Trials area. DISCUSSION: The FMEA is a useful tool in proactive risk management because it allows us to identify where we are making mistakes and analyze the causes that originate them, to prioritize and to adopt solutions to risk reduction. The FMEA improves process safety and quality in PD.


Subject(s)
Clinical Trials as Topic , Healthcare Failure Mode and Effect Analysis , Clinical Trials as Topic/standards , Data Accuracy , Humans , Interdisciplinary Communication , Medical Errors , Quality Improvement
5.
J Clin Pharm Ther ; 43(2): 273-275, 2018 Apr.
Article in English | MEDLINE | ID: mdl-28833364

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Limited data are available on eosinophilia as a drug adverse event. We describe a case of eosinophilia from lenalidomide therapy. CASE DESCRIPTION: A 50-year-old woman received lenalidomide, dexamethasone and cyclophosphamide as POEMS syndrome treatment. Eosinophil count rose during lenalidomide treatment and decreased in the periods off treatment. Naranjo nomogram suggested a probable association between the use of lenalidomide and eosinophilia. WHAT IS NEW AND CONCLUSION: Eosinophilia has rarely been described with lenalidomide. This case shows a clear temporal relationship between lenalidomide and eosinophilia.


Subject(s)
Eosinophilia/chemically induced , Thalidomide/analogs & derivatives , Angiogenesis Inhibitors/therapeutic use , Antineoplastic Agents, Hormonal/therapeutic use , Cyclophosphamide/therapeutic use , Dexamethasone/therapeutic use , Female , Humans , Lenalidomide , Middle Aged , POEMS Syndrome/drug therapy , Thalidomide/adverse effects , Thalidomide/therapeutic use
6.
Article in English | MEDLINE | ID: mdl-26872286

ABSTRACT

We assessed the impact of a pharmacotherapy follow-up programme on key safety points [adverse events (AE) and drug administration] in outpatients treated with oral antineoplastic agents (OAA). We performed a comparative, interventional, quasi-experimental study of outpatients treated with OAA in a Spanish hospital to compare pre-intervention group patients (not monitored by pharmacists during 2011) with intervention group patients (prospectively monitored by pharmacists during 2013). AE data were collected from medical records. Follow-up was 6 months, and 249 patients were included (pre-intervention, 115; intervention, 134). After the first month, AE were detected in 86.5% of patients in the pre-intervention group and 80.6% of patients in the intervention group, P = 0.096. During the remaining months, 79.0% patients had at least one AE in the pre-intervention group compared with 78.0% in the intervention group, P = 0.431. AE were more prevalent with sorafenib and sunitinib. In total, 173 drug interactions were recorded (pre-intervention, 80; intervention, 93; P = 0.045). Drug interactions were more frequent with erlotinib and gefitinib; food interactions were more common with sorafenib and pazopanib. Our follow-up of cancer outpatients revealed a reduction in severe AE and major drug interactions, thus helping health professionals to monitor the safety of OAA.


Subject(s)
Antineoplastic Agents/adverse effects , Neoplasms/drug therapy , Pharmacy Service, Hospital/methods , Administration, Oral , Aftercare , Aged , Ambulatory Care/methods , Analysis of Variance , Antineoplastic Agents/administration & dosage , Drug Interactions , Female , Humans , Male , Middle Aged , Patient Safety , Prospective Studies , Remote Consultation , Retrospective Studies , Socioeconomic Factors , Spain , Young Adult
7.
Rev. esp. pediatr. (Ed. impr.) ; 72(6): 381-386, nov.-dic. 2016. ilus
Article in Spanish | IBECS | ID: ibc-160655

ABSTRACT

La misión de nuestro Servicio de Farmacia es ‘Contribuir a mejorar la salud y la calidad de vida de la población del área sanitaria, mediante una prestación farmacéutica efectiva, segura y eñciente, en un marco de asistencia integral y continua’. Para llevarlo a cabo, la atención farmacoterapéutica se realiza de una manera descentralizada, con farmacéuticos consultores incorpo rados a los equipos clínicos. El nuevo hospital Materno-Infantil se inauguró en 2003 con prescripción electrónica, armarios automatizados de dispensación en toda la hospitalización, y actualmente dispone de dos farmacéuticos de plantilla ubicados físicamente en el edificio. El farmacéutico pediátrico es responsable de la prestación farmacéutica en su área, así como de la gestión clínica, logística , económica, de calidad, docencia e investigación. En este sentido, se han desarrollado líneas de trabajo para mejorar el circuito de utilización del medicamento, fundamentalmente en prescripción y administración. En el campo de la docencia, numerosos residentes, no solo de nuestro hospital, sino de otros Servicios de Farmacia tanto nacionales como internacionales, se forman en nuestra área de farmacia. Con respecto a la investigación, los farmacéuticos forman parte de la Red de Investigación en Salud Materno—Infantil y del Desarrollo (Red SAMID), liderando y colaborando en numerosos proyectos financiados en convocatorias selectivas nacionales (AU)


The mission of our Pharmacy Service is to help to increase health and life quality in our population health area providing an effective, safe and efficient pharmaceutical care in an integral and continuos health assistance framework. In order to do that, pharmaceutical care has been decentralized by integrating consultant pharmacists in clinical teams. The new maternity and children's hospital opened up in 2003 with computerized order entry, automatic dispensing systems in all in-patients wards and two staff pharmacists located in the same building at present. Pediatric pharmacists are not only responsible for providing pharmaceutical care in their areas, but also they are in charge of the clinical, logistic, economic and quality management as well as teaching and researching tasks. Accordingly, several strategies have been implemented in order to improve medication use circuit, especially in prescription and administration stages. Regarding teaching tasks, a great number of residents, not only from our own hospital, but also from other national and international Pharmacy Departments, choose our rotation to develop training skills in our area. In terms of research activities, pharmacists are members of the Research Network on Maternal and Child Health and Development (Red SAMID) and have led and collaborated in several funded national competitive projects (AU)


Subject(s)
Humans , Male , Female , Child , Adult , Community Pharmacy Services/organization & administration , Pharmacy Service, Hospital/standards , Pharmaceutical Services/organization & administration , Pharmaceutical Services/standards , Maternal and Child Health , Maternal-Child Health Services , Maternal-Child Health Centers/organization & administration , Maternal-Child Health Centers/standards , Automation/methods , Research/trends
8.
Med. intensiva (Madr., Ed. impr.) ; 40(7): 411-421, oct. 2016. tab
Article in Spanish | IBECS | ID: ibc-156446

ABSTRACT

OBJETIVOS: Estimar el impacto de la implantación de bombas de infusión inteligentes en una unidad de cuidados intensivos pediátricos en cuanto al número y tipo de errores de administración interceptados DISEÑO: Estudio observacional, prospectivo, realizado de enero de 2010 a marzo de 2015 con las bombas volumétricas y de jeringa disponibles en el hospital. Ámbito: Unidad de Cuidados Intensivos Pediátricos de un hospital general de tercer nivel. PARTICIPANTES: Todas las infusiones programadas con bomba de infusión en los pacientes ingresados en la Unidad de Cuidados Intensivos Pediátricos. INTERVENCIONES: Elaboración de una biblioteca de fármacos con límites de seguridad a través de la cual se programarían todas las infusiones intravenosas prescritas. Variables principales: Se analizó la adherencia a la biblioteca de fármacos y el número y tipo de errores evitados según las alarmas generadas en el sistema. RESULTADOS: Se interceptaron 283 errores reales de programación durante los 62 meses que duró el estudio. En el 58% de los errores estuvo implicado un fármaco de alto riesgo, como agonistas y antagonistas adrenérgicos, sedantes, analgésicos, bloqueantes neuromusculares, opiáceos, potasio e insulina. Durante este período, la adherencia media de los usuarios al software de seguridad fue del 84%. CONCLUSIONES: La implantación de bombas de infusión inteligentes ha demostrado ser eficaz en la intercepción de errores de programación relacionados con fármacos de alto riesgo. Esta herramienta es susceptible de implantarse en otras unidades de pacientes críticos, tanto adultos como pediátricos. La colaboración multidisciplinar es clave para el éxito del proceso


OBJECTIVES: To estimate the impact of smart pump implementation in a pediatric intensive care unit in terms of number and type of administration errors intercepted. DESIGN: Observational, prospective study carried out from January 2010 to March 2015 with syringe and great volumen infusion pumps available in the hospital. SETTING: A tertiary level hospital pediatric intensive care unit. PARTICIPANTS: Infusions delivered with infusion pumps in all pediatric intensive care unit patients. INTERVENTIONS: Design of a drug library with safety limits for all intravenous drugs prescribed. MAIN VARIABLES: Users' compliance with drug library as well as number and type of errors prevented were analyzed. RESULTS: Two hundred and eighty-three errors were intercepted during 62 months of study. A high risk drug was involved in 58% of prevented errors, such as adrenergic agonists and antagonists, sedatives, analgesics, neuromuscular blockers, opioids, potassium and insulin. Users' average compliance with the safety software was 84%. CONCLUSIONS: Smart pumps implementation has proven effective in intercepting high risk drugs programming errors. These results might be exportable to other critical care units, involving pediatric or adult patients. Interdisciplinary colaboration is key to succeed in this process


Subject(s)
Humans , Infusion Pumps , Medication Therapy Management/organization & administration , Intensive Care Units, Pediatric/organization & administration , Patient Safety , Administration, Intravenous/methods , Tertiary Healthcare
9.
J Clin Pharm Ther ; 41(4): 444-446, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27159430

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Limited data are available on co-administration of acenocoumarol with direct-acting antiviral agents for chronic hepatitis C virus infection. CASE SUMMARY: We report a case of a patient who required a significant increase in acenocoumarol weekly dose probably due to an interaction with ombitasvir/paritaprevir/ritonavir and/or dasabuvir. A causality assessment of the drug-drug interaction leading to a reduced INR was conducted according to the Naranjo algorithm. A score of 6 suggested that the adverse drug reaction was probable. WHAT IS NEW AND CONCLUSION: Because of possible INR abnormalities during the concomitant use of acenocoumarol, ombitasvir/paritaprevir/ritonavir and dasabuvir, clinicians should closely monitor INR values.

10.
Med Intensiva ; 40(7): 411-21, 2016 Oct.
Article in English, Spanish | MEDLINE | ID: mdl-27026063

ABSTRACT

OBJECTIVES: To estimate the impact of smart pump implementation in a pediatric intensive care unit in terms of number and type of administration errors intercepted. DESIGN: Observational, prospective study carried out from January 2010 to March 2015 with syringe and great volumen infusion pumps available in the hospital. SETTING: A tertiary level hospital pediatric intensive care unit. PARTICIPANTS: Infusions delivered with infusion pumps in all pediatric intensive care unit patients. INTERVENTIONS: Design of a drug library with safety limits for all intravenous drugs prescribed. MAIN VARIABLES: Users' compliance with drug library as well as number and type of errors prevented were analyzed. RESULTS: Two hundred and eighty-three errors were intercepted during 62 months of study. A high risk drug was involved in 58% of prevented errors, such as adrenergic agonists and antagonists, sedatives, analgesics, neuromuscular blockers, opioids, potassium and insulin. Users' average compliance with the safety software was 84%. CONCLUSIONS: Smart pumps implementation has proven effective in intercepting high risk drugs programming errors. These results might be exportable to other critical care units, involving pediatric or adult patients. Interdisciplinary colaboration is key to succeed in this process.


Subject(s)
Infusion Pumps , Infusions, Intravenous , Intensive Care Units, Pediatric , Child , Child, Preschool , Female , Humans , Male , Medication Errors , Prospective Studies
11.
J Clin Pharm Ther ; 41(1): 59-63, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26778738

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Regular blood transfusions in the management of myelodysplastic syndrome (MDS) often lead to iron overload. The main objective of this study was to evaluate the impact of medication adherence on the effectiveness of deferasirox for the treatment of transfusional iron overload in patients with MDS. Secondary objectives were to describe treatment effectiveness and safety in daily clinical practice. METHODS: A longitudinal, retrospective, observational study was carried out in a university hospital. The inclusion criteria were age over 18 years, MDS diagnosis and treatment with deferasirox for transfusion-dependent iron overload during the period of study (from January 2011 to April 2015). Treatment effectiveness was estimated by serum ferritin (SF), and adherence was measured by medication possession ratio (MPR). Clinically relevant analytical alterations during the treatment and reasons for treatment discontinuation were also assessed. RESULTS: Thirty-five patients were included in the study. Median SF at baseline was 1636 µg/L, and it decreased to 1399 µg/L during follow-up. The median adherence rate was 92%, although only 54·8% of the patients maintained deferasirox adherence ≥90% during the whole duration of treatment. Adherence rate was inversely correlated to SF (r = -0·288, P = 0·004). The median (p25, p75) duration of treatment was 11 (3·0, 37·8) months. The most common reasons for treatment discontinuation were renal toxicity (35%) and patient's death (25%). WHAT IS NEW AND CONCLUSION: Deferasirox's effectiveness, measured by the decrease in SF, was significantly better in adherent patients. The most frequent reason for treatment discontinuation was renal toxicity. Developing strategies to improve deferasirox treatment adherence and monitoring renal function in those patients should be key points in pharmaceutical care.


Subject(s)
Benzoates/therapeutic use , Iron Chelating Agents/therapeutic use , Iron Overload/drug therapy , Myelodysplastic Syndromes/therapy , Triazoles/therapeutic use , Aged , Benzoates/administration & dosage , Benzoates/adverse effects , Blood Transfusion/methods , Deferasirox , Female , Ferritins/blood , Follow-Up Studies , Hospitals, University , Humans , Iron Chelating Agents/administration & dosage , Iron Chelating Agents/adverse effects , Iron Overload/etiology , Longitudinal Studies , Male , Medication Adherence , Middle Aged , Retrospective Studies , Transfusion Reaction , Treatment Outcome , Triazoles/administration & dosage , Triazoles/adverse effects
12.
Int J Clin Pract ; 70(2): 156-62, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26709847

ABSTRACT

AIM: The aim of the study was to evaluate the effectiveness of a multidisciplinary intervention to reduce the risk of bleeding associated with antithrombotic drugs in patients with acute coronary syndrome (ACS). METHODS: We designed a pre-post quasi-experimental intervention study using retrospective cohorts. The first cohort was analysed to detect correctable measures contributing to bleeding (PRE: January-July 2010). Second, a bundle of interventions was implemented and third, a second cohort of patients was evaluated to investigate the impact of our measures in bleeding reduction (POST: September 2011-February 2012). RESULTS: A total of 677 patients were included (377 in PRE and 300 in POST). The bundle of interventions was: Overdose avoidance measures: the percentage of patients overdosed was reduced by 66.3% (p < 0.001). Institutional protocol update to include the latest recommendations regarding bleeding prevention: In POST, the percentage of patients treated with fondaparinux increased (2.4% vs. 50.7%; p < 0.001). In PRE, 11 patients were treated with the combination of abciximab and bivalirudin; whereas in POST, only one patient received the combination (p = 0.016). Mandatory measurement of body weight: the percentage of patients with unknown body weight was reduced by 35% (p = 0.0001). In POST, the total bleeding rate was reduced by 29.2% (31.6% in PRE vs. 22.4%, p < 0.05, OR: 0.62; 95% CI: 0.44-0.88). It was necessary to implement the interventions in 11 patients to prevent one bleeding episode (95% CI: 7-39). CONCLUSION: The multidisciplinary programme has been effective in reducing bleeding episodes. The interventions were effective in reducing antithrombotic drugs overdosage, incorporating the use of fondaparinux to the NSTE-ACS therapeutic arsenal, limiting the use of bivalirudin with abciximab and obtaining body weight for most patients.


Subject(s)
Acute Coronary Syndrome/drug therapy , Anticoagulants/therapeutic use , Fibrinolytic Agents/therapeutic use , Hemorrhage/prevention & control , Platelet Aggregation Inhibitors/therapeutic use , Acute Coronary Syndrome/complications , Aged , Aged, 80 and over , Female , Hemorrhage/etiology , Humans , Male , Middle Aged , Retrospective Studies
13.
Int J Clin Pract ; 69(1): 81-6, 2015 Jan.
Article in English | MEDLINE | ID: mdl-24852483

ABSTRACT

AIMS: The aim of the study was to evaluate the impact of the ENDORSE study results on thromboprophylaxis prescribing patterns in medical patients attending the Emergency Department (ED) by assessing prescribing appropriateness at admission. METHODS: A cross-sectional, observational, descriptive study was designed and included all adult medical patients admitted from an ED between 20 November 2012 and 26 November 2012 at a large tertiary hospital. Patients to whom anticoagulants were prescribed for therapeutic purposes, patients admitted to Intensive Care Unit or maternity wards were excluded. Prescribing appropriateness was assessed using the Padua Prediction Score (ACCP 2012 guideline) for thromboembolic risk assessment and the NICE model to determine risk of bleeding. The primary end-point was the adequacy of thromboprophylaxis prescribed at the ED according to the ACCP 2012 guideline. RESULTS: A total of 393 patients were examined and 207 patients were included in the study (53.1% were male) with a median age of 75.3 years. The most common diagnosis at admission was related to a respiratory disease (41.1%). In 34.8% of the patients (72 patients), the recommendation of prophylaxis according to ACCP 2012 guideline did not match with the prophylaxis prescribed at admission. Reasons for non-concordance were undertreatment (14.5%) and overtreatment (20.3%). CONCLUSIONS: The adequacy of thromboprophylaxis in high risk patients for VTE has improved compared with the ENDORSE study. However, the percentage of patients with discordant prescriptions remains high. Despite the existence of treatment omissions, this percentage has been overcome by patients overtreated.


Subject(s)
Anticoagulants/therapeutic use , Practice Patterns, Physicians'/statistics & numerical data , Aged , Aged, 80 and over , Cross-Sectional Studies , Drug Utilization/statistics & numerical data , Emergency Service, Hospital , Female , Hospitalization/trends , Humans , Male , Middle Aged , Thromboembolism/drug therapy , Thromboembolism/prevention & control , Venous Thrombosis/drug therapy , Venous Thrombosis/prevention & control
14.
J Clin Pharm Ther ; 39(4): 376-82, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24702274

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Primary immune thrombocytopenia (ITP) is characterized by accelerated platelet destruction, as well as suboptimal platelet production. Thrombopoietin (TPO) receptor agonists bind to and activate human TPO receptor, and have been shown to increase platelet counts. In this study, we assessed the effectiveness and safety of long-term administration of TPO agonist romiplostim in adult and paediatric patients. METHODS: This is a retrospective observational study that included every ITP patient (adults and children) who received romiplostim since its inclusion in our institutional formulary. Data on patients' demographics, romiplostim doses, platelet counts, use of rescue medication and concurrent therapies were collected. Outcomes for effectiveness evaluation were proportion of patients who achieved a platelet response (platelet count >50 × 10(9) per litre and double the platelet count at baseline on any scheduled visit, excluding counts obtained within 8 weeks after receipt of rescue medications), proportion of patients who achieved a durable response (platelet responses during 6 or more weeks of the last 8 weeks of treatment), proportion of patients needing rescue medication, proportion of patients able to stop or reduce concurrent treatment and mean number of weekly platelet responses. Safety was assessed on the basis of the incidence of adverse events documented on the patients' medical records. RESULTS AND DISCUSSION: This study enrolled ten adults and four paediatric patients. None of the paediatric patients and one adult patient had been splenectomized (contraindicated in the other adults). In the adult population, eight achieved a response at least once during treatment, and 1 achieved a durable response. Four patients needed rescue medication (mostly intravenous immunoglobulins). Three patients were able to stop concurrent ITP therapies, and the mean number of weekly platelet responses was 6. All four paediatric patients achieved a response at least once during treatment, and three achieved durable responses. Three patients needed rescue medication. The only patient who was receiving concurrent ITP medication was able to stop it, and the mean number of weekly platelet responses was 25. No serious adverse events were registered during treatment in either population. WHAT IS NEW AND CONCLUSION: The effectiveness of romiplostim was variable with few adult patients achieving a durable response. Our paediatric patients responded better with most achieving a durable response. The treatment was safe for both groups of patients. Studies should be conducted to identify patients more likely to benefit from this treatment.


Subject(s)
Purpura, Thrombocytopenic, Idiopathic/drug therapy , Receptors, Fc/therapeutic use , Recombinant Fusion Proteins/therapeutic use , Thrombopoietin/therapeutic use , Adolescent , Age Factors , Aged , Aged, 80 and over , Child , Female , Hospitals, University , Humans , Male , Middle Aged , Platelet Count , Purpura, Thrombocytopenic, Idiopathic/physiopathology , Recombinant Fusion Proteins/adverse effects , Retrospective Studies , Spain , Thrombopoietin/adverse effects , Treatment Outcome
15.
Rev. calid. asist ; 29(1): 22-28, ene.-feb. 2014. tab, graf
Article in Spanish | IBECS | ID: ibc-119121

ABSTRACT

Introducción: Objetivo: conocer el porcentaje de prescripciones potencialmente inapropiadas según los criterios STOPP/START en los tratamientos ambulatorios de los pacientes mayores de 65 años que ingresan en una unidad de medicina interna, e identificar los errores de prescripción más frecuentes. Material y métodos: Estudio observacional prospectivo realizado entre octubre y diciembre de 2012. Variables registradas: edad, sexo, índice de comorbilidad de Charlson, motivo de ingreso y tratamiento farmacológico ambulatorio. Resultados: Se recogieron los datos de 131 pacientes (edad media 80,2 años; 58,8% varones, mediana del índice de comorbilidad de Charlson 2; media de medicamentos por paciente: 8,6). Principales motivos de ingreso: descompensación de insuficiencia cardiaca, infección respiratoria, exacerbación de EPOC, infección del tracto urinario, neumonía y síndrome constitucional. Se detectaron 121 prescripciones potencialmente inapropiadas en 73 pacientes (55,7%). Los criterios STOPP más frecuentes fueron las duplicidades terapéuticas. Los criterios START más frecuentes fueron la omisión de estatinas y antiagregantes plaquetarios en la prevención primaria del riesgo cardiovascular en pacientes con diabetes mellitus y al menos un factor de riesgo cardiovascular. Conclusiones: El porcentaje de pacientes con prescripciones inapropiadas encontrado es similar al obtenido en estudios semejantes. Más de la mitad de los pacientes ancianos presentaron al menos una prescripción inapropiada. Esto hace necesario una búsqueda conjunta de errores por exceso y por defecto en la prescripción de fármacos, con el fin de realizar una evaluación más completa de la práctica de prescripción e intentar conseguir la optimización de la terapéutica de los pacientes mayores, especialmente los más frágiles (AU)


Introduction: The aim of this study was to establish the percentage of potentially inappropriate prescriptions, according to STOPP/START criteria, in the ambulatory treatments of patients over65 years admitted to an internal medicine unit, and to identify the most common prescription errors. Material and methods: A prospective, observational study was performed between October and December 2012. The variable recorded were, age, gender, Charlson comorbidity index, reason for hospitalisation and pharmacological ambulatory treatment. Results: Data from 131 patients were collected (Mean age: 80.2 years; 58.8% male, mean Charlson comorbidity index: 2; mean number of medications per patient: 8.6). Main reasons for hospitalisation: decompensated heart failure, respiratory infection, exacerbated COPD, urinary tract infection, pneumonia, and unintended weight loss. There were 121 potentially inappropriate prescriptions detected in 73 patients (55.7%). The most common STOPP criteria were therapeutic duplicities. The most common START criteria were the omission of statins and antiplatelets in primary prevention for cardiovascular risk in patients with diabetes mellitus and at least one cardiovascular risk factor. Conclusions: The percentage of patients with inappropriate prescriptions was similar to those obtained in similar studies. Over 50% of elderly patients had at least one inappropriate prescription. This warrants a joint search for errors by excess and by default in the prescription of medications, with the aim of performing a more complete evaluation of prescription practice and to achieve optimization of therapy in elderly patients, especially the most fragile (AU)


Subject(s)
Humans , Male , Female , Aged , Aged, 80 and over , Medication Errors/statistics & numerical data , Drug Prescriptions/statistics & numerical data , Hospitalization/statistics & numerical data , Aged/statistics & numerical data , Ambulatory Care/statistics & numerical data , Prospective Studies , Chronic Disease/drug therapy
16.
Rev Calid Asist ; 29(1): 22-8, 2014.
Article in Spanish | MEDLINE | ID: mdl-24161896

ABSTRACT

INTRODUCTION: The aim of this study was to establish the percentage of potentially inappropriate prescriptions, according to STOPP/START criteria, in the ambulatory treatments of patients over 65 years admitted to an internal medicine unit, and to identify the most common prescription errors. MATERIAL AND METHODS: A prospective, observational study was performed between October and December 2012. The variable recorded were,age, gender, Charlson comorbidity index, reason for hospitalisation and pharmacological ambulatory treatment. RESULTS: Data from 131 patients were collected (Mean age: 80.2 years; 58.8% male, mean Charlson comorbidity index: 2; mean number of medications per patient: 8.6). Main reasons for hospitalisation: decompensated heart failure, respiratory infection, exacerbated COPD, urinary tract infection, pneumonia, and unintended weight loss. There were 121 potentially inappropriate prescriptions detected in 73 patients (55.7%). The most common STOPP criteria were therapeutic duplicities. The most common START criteria were the omission of statins and antiplatelets in primary prevention for cardiovascular risk in patients with diabetes mellitus and at least one cardiovascular risk factor. CONCLUSIONS: The percentage of patients with inappropriate prescriptions was similar to those obtained in similar studies. Over 50% of elderly patients had at least one inappropriate prescription. This warrants a joint search for errors by excess and by default in the prescription of medications, with the aim of performing a more complete evaluation of prescription practice and to achieve optimization of therapy in elderly patients, especially the most fragile.


Subject(s)
Ambulatory Care/statistics & numerical data , Drug Prescriptions/statistics & numerical data , Drug Therapy, Computer-Assisted , Frail Elderly , Inappropriate Prescribing/statistics & numerical data , Aged , Aged, 80 and over , Diagnosis-Related Groups , Drug Prescriptions/standards , Drug Utilization/statistics & numerical data , Female , Guideline Adherence , Hospitals, General/statistics & numerical data , Hospitals, University/statistics & numerical data , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Inappropriate Prescribing/prevention & control , Male , Medication Errors/prevention & control , Platelet Aggregation Inhibitors/therapeutic use , Polypharmacy , Practice Guidelines as Topic , Spain
17.
Farm Hosp ; 37(2): 151-5, 2013.
Article in Spanish | MEDLINE | ID: mdl-23789759

ABSTRACT

INTRODUCTION: Time of permanence is a useful measure of success in last generation antiretroviral (LGA) therapy: raltegravir, darunavir, etravirine and maraviroc. The aim of our study was to analyze the permanence of antiretroviral therapy (ART) containing at least one LGA, and to compare it with other ART used in experienced patients. METHODS: Observational case-control study. It included adult outpatients whose ART was switched between 01/05/2008 and 01/09/2009. Cases (patients with at least one LGA) were matched (1:1) with pretreated patients who switched to an ART without any LGA (controls). The primary endpoint was the permanence of ART. The follow-up was conducted from the modification of ART to a year after the closure of the inclusion period. Results were adjusted for confounding variables: CD4 and viral load (VL) at baseline, MDR HIV infection and time from the first ART. RESULTS: 112 patients were included in each group. The permanence of ART was 16.7 months (cases) vs 16.8 months (controls), although statistically significant differences were not found after adjusting for confounding variables. Toxicity was the main reason of discontinuation (53.3% in cases vs 45.2% in controls, p = 0.70). The mean decrease in the logarithm of the VL was 0.89 in cases and 0.58 in controls (p = 0.223). The increase of CD4/microL was 77 and 73 respectively (p = 0.480). CONCLUSION: The permanence of ART in patients whose treatment contains a LGA is similar to those without any LGA.


Introducción: La permanencia es una medida útil del éxito de los tratamientos antirretrovirales de última generación (AUG): raltegravir, darunavir, etravirina y maraviroc. El objetivo de nuestro estudio fue analizar la permanencia de los tratamientos antirretrovirales (TAR) que contenían al menos un AUG, y compararla con otros TAR utilizados en pacientes experimentados. Métodos: Estudio observacional, de casos y controles, de pacientes adultos externos cuyo TAR fue modificado entre 01/05/2008 y 01/09/2009. Los casos (pacientes con al menos un AUG) fueron emparejados (relación 1:1) con pacientes pretratados que cambiaron a un TAR sin AUG (controles). La variable principal fue la permanencia del TAR. El seguimiento se realizó desde la modificación del TAR hasta un año después del cierre del período de inclusión. Los resultados se ajustaron por las variables de confusión: CD4 y carga viral (CV) basales, infección VIH multirresistente y tiempo desde el primer TAR. Resultados: Se incluyeron 112 pacientes en cada grupo. El tiempo de permanencia del TAR fue 16,7 meses (casos) vs 16,8 meses (controles), sin encontrarse diferencias estadísticamente significativas ajustando por las variables de confusión. La toxicidad fue el principal motivo de discontinuación (53,3% en casos vs 45,2% en controles, p = 0,70). La media en la disminución del logaritmo de la CV fue 0,89 en los casos y 0,58 en los controles (p = 0,223). El incremento de CD4/microL fue 77 y 73 respectivamente (p = 0,480). Conclusión: La permanencia del TAR en los pacientes cuyo tratamiento contiene algún AUG es similar a la de los pacientes que no lo contienen.


Subject(s)
Anti-Retroviral Agents/therapeutic use , HIV Infections/drug therapy , Adult , Case-Control Studies , Female , Humans , Male , Middle Aged , Time Factors
18.
Farm. hosp ; 37(2): 151-155, mar.-abr. 2013. ilus, tab
Article in Spanish | IBECS | ID: ibc-115666

ABSTRACT

Introducción: La permanencia es una medida útil del éxito de los tratamientos antirretrovirales de última generación (AUG): raltegravir, darunavir, etravirina y maraviroc. El objetivo de nuestro estudio fue analizar la permanencia de los tratamientos antirretrovirales (TAR) que contenían al menos un AUG, y compararla con otros TAR utilizados en pacientes experimentados. Métodos: Estudio observacional, de casos y controles, de pacientes adultos externos cuyo TAR fue modificado entre 01/05/2008 y 01/09/2009. Los casos (pacientes con al menos un AUG) fueron emparejados (relación 1:1) con pacientes pretratados que cambiaron a un TAR sin AUG (controles). La variable principal fue la permanencia del TAR. El seguimiento se realizó desde la modificación del TAR hasta un año después del cierre del período de inclusión. Los resultados se ajustaron por las variables de confusión: CD4 y carga viral (CV) basales, infección VIH multirresistente y tiempo desde el primer TAR. Resultados: Se incluyeron 112 pacientes en cada grupo. El tiempo de permanencia del TAR fue 16,7 meses (casos) vs 16,8 meses (controles), sin encontrarse diferencias estadísticamente significativas ajustando por las variables de confusión. La toxicidad fue el principal motivo de discontinuación (53,3% en casos vs 45,2% en controles, p =0,70). La media en la disminución del logaritmo de la CV fue 0,89 en los casos y 0,58 en los controles (p =0,223). El incremento de CD4/microL fue 77 y 73 respectivamente (p =0,480). Conclusión: La permanencia del TAR en los pacientes cuyo tratamiento contiene algún AUG es similar a la de los pacientes que no lo contienen (AU)


Introduction: Time of permanence is a useful measure of success in last generation antiretroviral (LGA) therapy: raltegravir, darunavir, etravirine and maraviroc. The aim of our study was to analyze the permanence of antiretroviral therapy (ART) containing at least one LGA, and to compare it with other ART used in experienced patients. Methods: Observational case-control study. It included adult outpatients whose ART was switched between 01/05/2008 and 01/09/2009. Cases (patients with at least one LGA) were matched (1:1) with pretreated patients who switched to an ART without any LGA (controls). The primary endpoint was the permanence of ART. The follow-up was conducted from the modification of ART to a year after the closure of the inclusion period. Results were adjusted for confounding variables: CD4 and viral load (VL) at baseline, MDR HIV infection and time from the first ART. Results: 112 patients were included in each group. The permanence of ART was 16.7 months (cases) vs 16.8 months (controls), although statistically significant differences were not found after adjusting for confounding variables. Toxicity was the main reason of discontinuation (53.3% in cases vs 45.2% in controls, p = 0.70). The mean decrease in the logarithm of the VL was 0.89 in cases and 0.58 in controls (p = 0.223). The increase of CD4/microL was 77 and 73 respectively (p = 0.480). Conclusion: The permanence of ART in patients whose treatment contains a LGA is similar to those without any LGA (AU)


Subject(s)
Humans , Anti-Retroviral Agents/therapeutic use , Medication Adherence/statistics & numerical data , HIV Infections/drug therapy , Antiretroviral Therapy, Highly Active
19.
Farm. hosp ; 36(1): 43-49, ene.-feb. 2012. ilus, tab
Article in Spanish | IBECS | ID: ibc-107809

ABSTRACT

Resumen El farmacéutico, por su formación general en el ámbito de la Farmacia Hospitalaria, tiene la capacidad para analizar e implantar mejoras en los circuitos de prescripción, dispensación y administración de medicamentos, lo cual repercute en la mejora de la seguridad global en la utilización de medicamentos. El objetivo principal del farmacéutico pediátrico es mejorar la calidad asistencial del paciente mediante una atención individualizada a través de la validación de las prescripciones médicas y del seguimiento farmacoterapéutico, que permita una farmacoterapia efectiva, segura y eficiente. Esta revisión nace del fruto de una experiencia multidisciplinar entre el Servicio de Farmacia y la Unidad de Cuidados Intensivos Pediátricos, cuyos objetivos fueron analizar el papel del farmacéutico residente en la UCIP para establecer líneas de mejora en sus actividades que potencien el uso racional del medicamento y diseñar un programa docente para el farmacéutico pediátrico que pueda servir como modelo inicial para otros centros (AU)


The general training received by pharmacists in Hospital Pharmacy enables them to analyse and implement improvements in the prescription, dispensing and administration of medications. This may lead to an increase in the overall safety of the use of drugs. The main goal of the paediatric pharmacist is to improve patient care by greater attention to the individual via validation of medical prescriptions and pharmaceutical follow-up, leading to safe, effective and efficient pharmacotherapy. This is a multidisciplinary review by the Pharmacy Department and Paediatric Intensive Care Unit. The objectives were to analyse the role of a resident pharmacist in PICU to identify improvements to promote rational drug use, and to design a teaching program for paediatric pharmacists that may serve as a reference for other centres (AU)


Subject(s)
Pediatrics/education , Child Health Services , Pharmacy Service, Hospital/trends , Internship and Residency
20.
J Clin Pharm Ther ; 37(4): 459-63, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22211951

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: The validation of a method for recording pharmaceutical interventions measures the instrument's ability to provide consistent values when the same analysis is performed several times. Our aim was to validate the inter-rater reliability of the method used to record pharmaceutical interventions in our hospital. METHODS: We recorded interventions in a database, entering variables related to the patient, treatment and impact of the recommendation. We also recorded the type, cause and clinical significance of the negative outcome associated with use of the medicinal product (NOM). Twenty interventions performed during a 3-year study period (2007-2009) were randomly tested for consistency to analyse the kappa (κ) coefficient statistic of the recommendations as coded by nine senior and junior clinical pharmacists. RESULTS AND DISCUSSION: There were 87·8% global consistency for NOM cause, 66·1% for intervention impact and 95·0% for NOM type. Agreement was substantial for 'intervention reasons', with a κ value of 0·74 (95%CI 0·61-0·87), fair for 'intervention impact', with a κ value of 0·24 (95%CI 0·15-0·32) and excellent for 'NOM type', with a κ value of 0·87 (95%CI 0·71-1·00), respectively. Our results are globally good, especially with regard to the analysis of intervention reasons and NOM type, which matches other authors' findings. Furthermore, our validation method is suitable for recording and considering the impact of pharmaceutical interventions. WHAT IS NEW AND CONCLUSION: We describe a systematic method for clinical pharmacists to record their activities and assess their value. This methodology should help in the development of clinical pharmacy in Spain and should be translatable to other settings.


Subject(s)
Databases, Factual/standards , Documentation/methods , Pharmacists/organization & administration , Pharmacy Service, Hospital/organization & administration , Humans , Observer Variation , Reproducibility of Results
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