A multidisciplinary consensus statement on the optimal pharmacological treatment for metastatic hormone-sensitive prostate cancer.

Androgen deprivation therapy (ADT) is the mainstay treatment for metastatic hormone-sensitive prostate cancer (mHSPC). The addition of docetaxel or new hormone therapies (abiraterone, apalutamide, or enzalutamide) improves overall survival and is currently the standard of care. However, the decision on the specific regimen to accompany ADT should be discussed with the patient, considering factors such as possible associated toxicities, duration of treatment, comorbidities, patient preferences, as there is no sufficient evidence to recommend one regimen over the other in most cases. This paper summarizes the evidence on the management of mHSPC and provides consensus recommendations on the optimal treatment in combination with ADT in mHSPC patients, with special attention to the patient's clinical profile.

Análisis e implementación de un modelo asistencial basado en la integración de un farmacéutico de hospital en un Servicio de Hematología y Hemoterapia / Analysis and implementation of a healthcare model based on the integration of a hospital pharmacist in a Hematology and Hemotherapy Service

Objetivo: Analizar el impacto sanitario y económico, así como evaluar la actividad clínica y asistencial, que supone la integración de un farmacéutico de hospital en un Servicio de Hematología y Hemoterapia. Material y métodos: Se trata de un estudio observacional prospectivo, unicéntrico, realizado en un hospital de tercer nivel desde enero de 2014 hasta febrero de 2019, diseñado para definir las funciones y las actividades clínicas a realizar por un farmacéutico de hospital integrado en un Servicio de Hematología de un hospital de tercer nivel y medir los resultados que se obtienen mediante la adopción de este nuevo modelo asistencial integrado Hematología-Farmacia, basado en la multidisciplinariedad. Resultados: El farmacéutico se integró totalmente en la actividad clínica diaria del equipo multidisciplinar perteneciente al Servicio de Hematología y Hemoterapia, siendo un facilitador del trabajo diario de los profesionales del Servicio de Hematología y un mediador de las necesidades de ambos servicios implicados (Hematología y Farmacia). Esta integración permitió garantizar la seguridad en la administración de tratamientos hematológicos en 9.125 pacientes hematológicos, reducir los errores de medicación en un 95%, detectar y notificar 45 reacciones adversas a medicamentos, diseñar medidas de eficiencia y seguimiento de las mismas en patologías de elevado impacto económico como mieloma múltiple, leucemia linfática crónica, leucemia mieloide crónica y hemofilia, consiguiendo un ahorro de 1.500.000 euros, entre otros resultados. Conclusiones: La integración de un farmacéutico de hospital en un Servicio de Hematología constituye una medida de innovación y eficiencia, mejora la calidad asistencial, garantiza la seguridad, favorece la sostenibilidad del sistema sanitario y facilita la incorporación de innovación. (AU)

Objective: To analyze the health and economic impact and to evaluate the clinical and care activity of the integration of a hospital pharmacist in a Hematology and Hemotherapy Service. Material and methods: This is a prospective, single-centre, observational study conducted in a tertiary hospital from January 2014 to February 2019, designed to define the functions and clinical activities to be performed by a hospital pharmacist integrated into a Hematology and Hemotherapy Service of a tertiary hospital and to measure the results obtained by adopting this new integrated Hematology-Pharmacy care model, based on multidisciplinarity. Results: The pharmacist was fully integrated into the daily clinical activity of the multidisciplinary team belonging to the Hematology and Hemotherapy Service, being a facilitator of the daily work of the professionals of the Hematology Service and a mediator of the needs of both services involved (Hematology and Pharmacy). This integration made it possible to guarantee safety in the administration of hematological treatments in 9,125 hematological patients, to reduce medication errors by 95%, to detect and notify 45 adverse drug reactions, to design efficiency measures and follow-up of these in pathologies with a high economic impact such as multiple myeloma, chronic lymphatic leukemia, chronic myeloid leukemia and hemophilia, achieving savings of 1,500,000 euros, among other results. Conclusions: The integration of a hospital pharmacist in a Hematology and Hemotherapy Service constitutes a measure of innovation and efficiency, improves the quality of care, guarantees safety, favours the sustainability of the health system and facilitates the incorporation of innovation. (AU)

Randomized, double-blind, controlled trial, phase III, to evaluate the use of platelet-rich plasma versus hyaluronic acid in hip coxarthrosis. / Ensayo clínico fase III para evaluar la eficacia y seguridad del uso de plasma rico en plaquetas frente a ácido hialurónico en coxartrosis.

AIMS OF THE STUDY: To compare efficacy and safety of a home-made platelet-rich plasma (PRP) solution versus hyaluronic acid in patients with hip osteoarthritis not responding to conservative treatment and to correlate cellular composition of PRP to clinical outcomes. MATERIAL AND METHODS: This is a phase III clinical trial, double-blinded, controlled and randomised into two treatment groups (PRP and hyaluronic acid). Patients received one hip ultrasound-guided injection. Follow up was 12 months. Pain was assessed using VAS score, HHS and WOMAC were used as functional scores, analgesia, adverse events, cellular components (PRP group) in peripheral blood and in PRP were recorded. Clinical response was assessed using OARSI criteria. RESULTS: Seventy-four patients were included. Both groups improved in VAS, WOMAC and HHS score and reduced the amount of analgesia (p<.05). Significant differences were seen at 1 year post-treatment in HHS score (PRP 70.9 [3.7-58], hyaluronic acid 60.2[43-74.2] p<.05). No adverse events were observed in none of the groups. Platelet concentration was different between responders and non-responders (at 1 month, non-responders 449[438-578] x103 platelets/µl versus responders 565 [481-666] x103 platelets/µl, p<.044). There was a correlation between leukocytes concentration and clinical scores (VAS at six months, r=0.748, p<.013, WOMAC at 6 months r=0.748, p <.013). Patients with early stage hip OA showed higher response rate to PRP compared with late stage (11.51 OR, 95%CI 2.34-50.65, p<.03). CONCLUSIONS: Platelet-rich plasma injection improved hip function, reduced pain and the use of analgesia. It is important to bear in mind the cellular composition in order to achieve a better clinical response.

Pharmacogenetic biomarkers of response in Crohn's disease.

Crohn's disease (CD) is a chronic condition, which affects the immune system. It can also affect any part of the digestive tract and be associated with external manifestations. The causes of the disease remain unknown, although it seems to be the result of a combination of factors, such as genetic predisposition, environment, lifestyle and the composition of the microbiota, among others. The treatment protocol begins with a change in eating and smoking habits, and is continued with different lines of treatment, including corticosteroids, immunomodulators and biologic therapy (infliximab and adalimumab), which have shown differences in response among patients, especially with biologic treatment. Several studies have considered the possibility that these differences in response are caused by the genetic variability of patients. Many genes have been investigated as potential predictors of response to biological drugs, such as ADAM17, ATG16L1, EMSY, CASP9, CCNY, CNTN5, FASLG, FCGR, NOD2, PTGER4, IL13, IL1B, IL27, IL11, IL17F, TNF and TNFR genes. In this review, we will gather the information on influence of gene polymorphisms investigated to date on response to biological drugs in CD patients.

Negative outcomes associated with medication in patients with chronic atrial fibrillation who present at the emergency department.

WHAT IS KNOWN AND OBJECTIVE: Medication is the main treatment option for patients with chronic atrial fibrillation. However, medication can have negative effects. We aimed to detect negative outcomes associated with medication that led to patients with chronic atrial fibrillation presenting themselves to hospital emergency departments. We assessed the severity of those outcomes and comment on whether they could have been avoided. METHODS: This descriptive, cross-sectional study included all patients with chronic atrial fibrillation who attended the emergency department of our tertiary hospital. We used the Dader method to identify and evaluate the negative outcomes associated with medication through interviews with patients and scrutiny of the clinical charts. RESULTS AND DISCUSSION: Of the 198 eligible patients who presented at the emergency department, 134 (67·7%) did so because of negative outcomes associated with medication (41% related to necessity, 32·1% to effectiveness and 26·9% to safety); 67·9% of those negative outcomes could have been avoided. In terms of severity, 6·7% were mild, 31·3% moderate, 51·5% severe and 10·4% fatal. The Anatomical Therapeutic Chemical Classification anatomical group most frequently associated with negative outcomes was the cardiovascular system, followed by blood/blood-forming organs. WHAT IS NEW AND CONCLUSION: A high percentage of patients with chronic atrial fibrillation presenting at hospital emergency departments had negative outcomes associated with medication. Some led to deaths. More than half of these were severe, and most could have been avoided.

Pharmacogenetics role in the safety of acenocoumarol therapy.

Vitamin K antagonists (VKAs) remain as the most prescribed drug for treatment and prevention of thrombotic disorders in many countries, despite the recent approval of the new oral anticoagulants (NOACs). Although effectiveness and safety of VKAs are tightly associated to maintaining the patient within the international normalised ratio (INR) therapeutic range (TWR), they have been likened to NOACs when patients are in good INR control (≥66% of TWR). Therefore, assessing the safety of patients should be a priority in the selection of the anticoagulation therapy. The aim of this study was to evaluate the association between CYP2C9*2, CYP2C9*3, VKORC1, CYP4F2*3, ABCB1 C3435T, APOE, CYP2C19*2 and CYP2C19*17 gene polymorphisms and treatment safety in 128 patients diagnosed with atrial fibrillation or venous thromboembolism during the initial first seven months of acenocoumarol therapy. After the first month, VKORC1-T-allele and APOE-E3/E3 genotype were independently associated to higher time above therapeutic range (TAR) and lower time below the therapeutic range (TBR). After seven months, VKORC1 T-allele predicted higher TAR, and was also associated to increased INR>4, particularly the TT-genotype (odds ratio [OR]: 32; 95% confidence interval [CI95%]: 6-175; p=810⁻5). C-alleles for CYP2C9*3 (OR: 5.5; CI95%: 1.8-17; p=0.003) and ABCB1 (OR: 8.9;CI95%: 1.1-70; p=0.039) independently influenced on INR>6 . Patients VKORC1-TT/ABCB1-C remained 26.8% [19.7-38.9] TAR, with associated relative risk (RR) for INR>4 1.8 higher (CI95%: 1.2-2.5; p=0.015). Patients VKORC1-TT also presented the highest risk of bleeding events (RR: 3.5;CI95%: 1.4-8.4; p=0,010). In conclusion, VKORC1, CYP2C9*3, APOE and ABCB1 genotypes should be considered in prevention of overanticoagulation and bleeding events in the initiation of acenocoumarol therapy.

[Boceprevir and telaprevir safety in routine clinical practice]. / Seguridad de boceprevir y telaprevir en la práctica clínica habitual.

PURPOSE: To compare the safety profile of telaprevir (TLV) and boceprevir (BOC) with each other and with those described in clinical trials (CT). MATERIAL AND METHODS: Retrospective multicenter observational study. Variables collected: age, sex, type of patient (naive, nonresponder or recurrent), fibroscan, Hb nadir, neutrophil and platelet count, presence of rash, anorectal discomfort, number of patients treated with erythropoiesis stimulating factors (EPO) and colony stimulating factors granulocyte (G-CSF). RESULTS: BOC vs CT: anemia (56.5% vs. 49%.), Thrombocytopenia (56.5% vs 32%, p = 0.023). neutropenia (17.4% vs. 29.5%). Use of EPO (13% vs 43%;. p = 0.008), pruritus (13% vs. 21.1%), rash (16.1% vs. 8.7%), anorectal discomfort (4.3% vs. 0%, p = 0.0001), dysgeusia (47.8% vs. 37%). TLV vs. CT: anemia (51.2% vs. 32%, p = 0.014), neutropenia (2.3 vs 3.6%), thrombocytopenia (41.9% vs. 27.4%, p = 0.05), pruritus (39.5% vs 47), rash (16.3% vs 55%, P <0.001), anorectal discomfort (39.5% vs 26%), dysgeusia (14% vs. 9.5%). BOC vs TLV: anemia (56.5% vs 51.2%), neutropenia (17.4% vs 2.3%), thrombocytopenia (56.5% vs 41.9%), rash (8.7% vs 16.3%), pruritus (39.5% vs 13%) and anorectal discomfort (4.3% vs 39.5%, P = 0.006), dysgeusia (14% vs 47.8%, P = 0.007), EPO (13% vs. 25.6%). GCSF was used for a patient treated with TLV. CONCLUSIONS: 1. BOC and TLV have shown a worse safety profile for anemia, thrombocytopenia and anorectal discomfort than those described in CT. 2. As in CT, anemia, neutropenia and thrombocytopenia were more common with BOC. Patients treated with TLV experienced more pruritus, rash and anorectal discomfort.

[Improvement of the knowledge on allergic cross-reactions between two drug groups: beta-lactams and NSAIDS]. / Mejora del conocimiento sobre reacciones alérgicas cruzadas en dos grupos de medicamentos: ß-lactámicos y AINEs.

OBJECTIVES: To identify opportunities for improving the available knowledge of health care professionals (particularly, physicians, pharmacists, and nurses) on crossed allergic reactions (CAR) to penicillins and NSAIDs. METHOD: Quasi-experimental prospective pre-exposure study at a 412-beds hospital. An assessment of the knowledge on CAR to penicillins and NSAIDs was performed by means of anonymous questionnaires before (1st questionnaire) and after (2d questionnaire) the implementation of a series of improvement measures: protocol of "patient allergic to drugs", pocket card, poster with summarized information, and informative talks. The questionnaires served as the CRF and the statistical analysis was done with the SPSS v18.0 software. RESULTS: The mean number of errors in the first questionnaire on CARs of penicillin allergic patient and on CARs of NSAIDs allergic patients was 20.53 and 27.62, respectively. The mean number of errors in the second questionnaire on CARs of penicillin allergic patient and on CARs of NSAIDs allergic patients was 2.27 and 7.26, respectively. All the results were significant for a p level < 0.005. CONCLUSIONS: - There is insufficient knowledge on CARs to penicillins and NSAIDS, which justifies improvement measures. - After the implementation of improvement measures, there is an increased knowledge on CARs to penicillins and NSAIDs in the study groups.

Objetivos: Identificar oportunidades de mejora, sobre el conocimiento disponible del personal sanitario (en concreto a personal médico, farmacéutico y de enfermería), sobre reacciones alérgicas cruzadas (RAC) de penicilinas y AINEs. Método: Estudio prospectivo cuasiexperimental pre-exposición en un hospital de 412 camas. Se realizó una valoración del conocimiento sobre RAC de penicilinas y AINEs, a través de encuestas anónimas, antes (1a encuesta) y después (2a encuesta) de la implantación de una serie de medidas de mejora: protocolo "paciente alérgico a medicamentos", tarjeta de bolsillo, póster resumen de información y charlas divulgativas. Las propias encuestas sirvieron de hoja de recogida de datos y el análisis estadístico se llevó a cabo con el programa SPSS v18.0. Resultados: La media de errores en las 1as encuestas sobre "RAC en paciente alérgico a penicilinas" y sobre "RAC en paciente alérgico a AINEs", fue de 20,53 y 27,62, respectivamente. La media de errores en las 2as encuestas sobre "RAC en paciente alérgico a penicilinas" y sobre "RAC en paciente alérgico a AINEs", fue de 2,27 y 7,26, respectivamente. Todos los resultados se consideraron significativos para un nivel 945;< 0,05. Conclusiones: - No se dispone de un nivel adecuado de conocimiento sobre RAC de penicilinas y AINEs, lo que justifica la realización de un ciclo de mejora. - Tras la implantación de las medidas de mejora se aprecia un aumento en el nivel de conocimiento sobre RAC en penicilinas y AINEs, en los grupos de estudio.

Conciliación de los medicamentos en los servicios de urgencias / Medication reconciliation in emergency departments

Los errores de medicación (EM) son comunes en el ámbito hospitalario y conducen aun incremento de la morbilidad y mortalidad y de los costes económicos. Estos errores ocurren sobre todo durante la transición de pacientes entre los diferentes niveles asistenciales. La posibilidad de que se produzcan estos errores se ve aumentada en los servicios de urgencias (SU) por la naturaleza de éstos. Desde instituciones sanitarias a nivel mundial, se reconoce la conciliación de la medicación (CM) como la solución a esta problemática. Se define como el proceso que consiste en obtener un listado completo y exacto de la medicación previa del paciente y compararlo con la prescripción médica después de la transición asistencial. Si se encuentran discrepancias deben considerarse y, si es necesario, modificar la prescripción médica para finalmente comunicar al siguiente responsable en salud del paciente y al propio paciente, la nueva lista conciliada. Este documento de consenso ofrece una serie de recomendaciones generales para la conciliación de los medicamentos. Incluye para cada subgrupo una serie de recomendaciones específicas de tipo farmacológico, que permiten un abordaje personalizado del tratamiento del paciente que acude a urgencias en base a las características clínicas individuales. Existirán casos en los que se desestime las recomendaciones aquí descritas, ya que la relación riesgo/beneficio requerirá una valoración individualizada. Esta valoración individualizada para el paciente se llevará a cabo por el equipo multidisciplinar responsable de su asistencia sanitaria (AU)

Medication errors, which are common in hospitals, lead to higher morbidity, mortality, and expenditure. Errors are most common when patients are transferred from one level of care to another, and the likelihood of mistakes is higher in emergency departments because of the intrinsic nature of emergency care. The internationally recognized remedy for this situation is medication reconciliation, defined as the process of obtaining a complete, accurate list of the patient's prior medications and comparing it to the list of medicines prescribed after admission to a new level of care. Discrepancies should be considered and prescriptions changed if necessary. Both the person who will be responsible for the next phase of care and the patient should be informed of the new list of medications. This consensus statement offers a set of general recommendations for medication reconciliation. Specific recommendations for each subgroup of medications are also included to allow emergency department prescribing to be tailored to individual patient characteristics. The recommendations in this statement should be overridden in some cases if the risk-benefit ratio suggests that further individualization is required. Individualized assessment of medications should be carried out by a multidisciplinary team responsible for the patient’s care (AU)

Effectiveness of oxaliplatin desensitization protocols

INTRODUCTION: Hypersensitivity reaction (HSR) to antineoplastic drugs can force doctors to stop treatment and seek other alternatives. These alternatives may be less effective, not as well tolerated and/or more expensive. Another option is to use desensitization protocols that induce a temporary state of tolerance by gradually administering small quantities of the antineoplastic drug until the therapeutic dosage is reached. The aim of this study is to assess the effectiveness of oxaliplatin desensitization protocols. MATERIALS AND METHODS: A retrospective observational study was carried out between January 2006 and May 2011. The inclusion criteria were patients undergoing chemotherapy treatment with oxaliplatin who had developed an HSR to the drug and who were candidates for continuing the treatment using a desensitization protocol. The patients' clinical records were reviewed and variables were gathered relating to the patient, the treatment, the HSR, and the desensitization protocol administered. The data were analysed using version 18.0 of the statistics program SPSS. RESULTS: A total of 53 desensitization protocols were administered to 21 patients. In 89 % of these cases, no new reactions occurred while the drug was being administered. New reactions of mild severity only occurred in 11 % of cases, and none of these reactions were severe enough for treatment to be stopped. All patients were able to complete the desensitization protocol. CONCLUSION: This study confirms that oxaliplatin desensitization protocols are safe and effective and allow patients to continue with the treatment that initially caused an HSR (AU)

Mejoras en las consultas de pacientes externos tras la implantación de un robot automático de dispensación / Improvement of the outpatient clinics after the implementation of an automated robot for delivery

Objetivos: Describir mejoras en logística, gestión y satisfacción de los pacientes tras la implantación de un robot de dispensación (RAD) en las consultas externas de Farmacia. Material y métodos: Diseño pre-post intervención: implantación de un RAD. El estudio se llevó a cabo en un hospital de tercer nivel. Debido a un cambio de ubicación de las consultas externas, se planificó un nuevo circuito de medicamentos. Se implementaron modificaciones en los programas de farmacia para la integración con el RAD. Se midió el stock inmovilizado, diferencia ente las existencias reales-virtuales para medicamentos antirretrovirales; medidos en porcentaje respecto al total y el índice de rotación de stock. Se compararon encuestas de satisfacción de 2007-2011 tras la realización de distintos cambios en las consultas. Resultados: El circuito de medicamentos así como los cambios informáticos realizados resultaron eficaces para el mantenimiento de existencias de medicamentos. El stock inmovilizado descendió en el periodo de estudio 2.209.935,77€. El índice de rotación descendió de 1,87 a 0,79. El robot ha reducido la espera a menos de 10 minutos en un 90% respecto a las encuestas anteriores. Discusión: La incorporación del RAD a las consultas ha significado mejoras en la logística, en la gestión y en la satisfacción de los pacientes (AU)

Objectives: To discover the improvements in logistics, management and satisfaction of the patients after the implantation of a robot of dispensation (RAD) in the external consultations of Pharmacy. Material and Methods: Pre-post design: implantation of RAD. The study was conducted on a third level hospital. A new circuit of drugs was designed due to a change of location of the external consultations. Modifications on the pharmacy pro grams were implemented for the integration with RAD. The immobilized stock was measured, difference among the real-virtual existences for anti-retroviral drugs; measured as a percentage of the total and the index of rotation of the stock. Satisfaction surveys of 2007-2011 were compared after the realization of the different changes in the consultations. Results: The circuit of drugs as well as the computer changes made were efficient for the maintenance of the stock of drugs. The immobilized stock decreased 2.209.935,77€ during the pe riod of the study. The index of rotation decreased from 1.87 to 0.79. The robot has reduced the waiting to less than 10 minutes in 90% with regard to the previous surveys. Discussion: The incorporation of RAD in the consultations has meant improvements in the logistic, in the management and in (AU)

[Pilot study of intravenous fluid therapy management in adult patients at a tertiary care hospital]. / Estudio piloto sobre el manejo de la fluidoterapia intravenosa en pacientes adultos de un hospital de tercer nivel.

UNLABELLED: The purpose of intravenous fluid therapy (IFT) is to maintain or restore internal equilibrium by administering fluids and/or different electrolyte components. Its correct use and the prevention of complications arising from their misuse depend on the knowledge of the medical team on this subject. We analyzed this issue in different clinical areas of a tertiary hospital. MATERIAL AND METHODS: We performed a descriptive cross-sectional pilot study via a questionnaire given to physicians specializing in internal medicine (IM) and digestive system surgery (SDS) who perform clinical practice in hospital units with unit dose drug dispensing system. We designed an anonymous questionnaire with 25 questions relative to knowledge of theory and practices, as well as the opinion of physicians regarding IFT. We evaluated the association between nominal qualitative variables with the Chi-square or Fisher's exact test. The behavior of the quantitative variables was assessed using the t-student test. The analysis of the data was generated using SAS/STAT, Version 9. RESULTS: 28 questionnaires were collected from 13 surgeons and 15 digestive interns. Over 40% of specialists considered further education in IFT a necessity , especially regarding its prescription (SDS: 61.54%, IM: 71.43%). No statistically significant differences were found between the specialties in terms of perceived frequency of complications associated with IFT or in the frequency indication with the exception of hypovolemic shock, which is considered to be more prevalent in gastrointestinal surgery (p = 0.046). 90% of professionals prefer an individualized prescription. Statistically significant differences in terms of scores in the area of knowledge, with IM physicians achieving the highest scores (p = 0.014). There were also differences in attitude but they are not significant (p = 0.162). Knowledge of intravenous fluid increases with years of clinical experience (Spearman correlation coefficient = 0.386, p = 0.047). CONCLUSIONS: The professionals who prescribe IFT perceive the need to design IFT training programs, together with the production of guides and consensus protocols.

Efecto del seguimiento farmacoterapéutico en pacientes con hiperparatiroidismo secundario tratados con cinacalcet / Effect of pharmaceutical follow-up in patients with secondary hyperparathyroidism treated with cinacalcet

Objetivos: Evaluar el efecto de la intervención farmacéutica en la identificación de los problemas relacionados con medicamentos y en la mejora de los resultados clínicos deseados; evaluar la efectividad del cinacalcet para alcanzar los objetivos clínicos recomendados por la Guía Clínica KDOQI. Método Estudio cuasi experimental pre-post intervención. Pacientes con hiperparatiroidismo secundario a enfermedad renal crónica, con edad ≥ 18 años y en tratamiento con cinacalcet han sido seleccionados en la farmacia externa hospitalaria entre 2007-2009. El Método Dáder de Seguimiento Farmacoterapéutico y los cuestionarios de SMAQ y Moriski, para evaluar la adherencia, han sido usados en la primera entrevista. Tras el análisis de cada caso, el farmacéutico diseñaba la intervención adecuada. Los parámetros clínicos han sido consultados en la base de datos del laboratorio del hospital. Resultados Se incluyeron 34 pacientes, detectándose al inicio 29 problemas relacionados con medicamentos, entre ellos, la no adherencia ha sido el más común (15). Tras la intervención, restaron 9 problemas relacionados con medicamentos, lo que significa que 68,9% de ellos han sido resueltos (p < 0,001), alcanzando una adherencia del 80%. Los valores séricos de parathormona, calcio y CaxP disminuyeron significativamente tras 3 meses de tratamiento (p < 0,001, < 0,001 y 0,045, respectivamente), alcanzando las recomendaciones de la Guía Clínica KDOQI. Conclusión Esta intervención farmacéutica, simple y de fácil aplicabilidad, es efectiva en prevenir y resolver los problemas relacionados con medicamentos en estos pacientes, además de mejorar la adherencia al tratamiento y confirmar que cinacalcet es efectivo para lograr los resultados terapéuticos recomendados por la guía clínica KDOQI (AU)

Objectives: To assess the effect of pharmaceutical intervention in the identification of drug related problems, to improve desired clinical outcomes, and to evaluate the effectiveness of cinacalcet in achieving clinical outcomes recommended by the KDOQI Clinical Guidelines. Method: Quasi-experimental pre-post intervention study. Patients with Secondary Hyperparathyroidism due to Chronic Kidney Disease, aged ≥18 years and under treatment with cinacalcet were recruited at the hospital outpatient pharmacy between 2007 and 2009. Dáder follow-up method and SMAQ and Moriski questionnaires were used to verify adherence at the first interview. Then, the pharmacist analyzed each case and designed an adequate intervention. Clinical parameters were consulted in the hospital laboratory data base. Results: Thirty four patients were included, 29 drug-related problems were found before pharmacist intervention, and among these, non-adherence was the most common (15). After the intervention, 9 drug-related problems remained, which means that 68.9% of them were resolved (P<0.001), reaching an adherence of 80%. Parathyroid hormone, calcium and calcium phosphorus product serum levels decreased significantly after 3 months of treatment (P<0.001,<0.001 and 0.045, respectively), achieving the KDOQI Clinical Guideline recommendations. Conclusion: These results suggest that this simple and easy-to-apply intervention was effective in preventing and resolving drug-related problems in these patients. Moreover, it improved patient adherence and confirmed that cinacalcet treatmentis effective for achieving the clinical outcomes recommended by KDOQI clinical guidelines (AU)

Seguimiento de indicadores de calidad de la prescripción tras infarto agudo de miocardio / Monitoring of quality indicators of prescriptions after acute myocardial infarction

Objetivos. La enfermedad cardiovascular constituye la principal causa de muerte en todo el mundo. Diferentes fármacos han mostrado su eficacia en el manejo de los pacientes con síndrome coronario agudo, incorporándose a las recomendaciones establecidas por diferentes sociedades científicas. El objetivo de este estudio es valorar el seguimiento de los estándares de calidad establecidos en Andalucía para el manejo de pacientes con infarto agudo de miocardio con elevación del segmento ST y analizar la fuente de variabilidad que aporta el facultativo prescriptor. Método. Estudio observacional, descriptivo, de indicación-prescripción, que analizó todas las prescripciones incluidas en los informes de alta hospitalaria de pacientes atendidos en un hospital de tercer nivel tras sufrir infarto agudo de miocardio con elevación del segmento ST, entre agosto de 2005 y julio de 2007. Resultados. El total de pacientes incluidos fue 287. La prescripción de antiagregantes se realizó en 99,3% de los pacientes, ácido acetilsalicílico en 95,8%. El porcentaje que recibió betabloqueantes fue 89,5%, inhibidores de la enzima de conversión de la angiotensina (IECA) 74,2%, indicándose ARA-II en 2,85%. El uso de estatinas fue de 84,6%. La indicación de nitroglicerina sublingual condicional fue 60,3%. El uso de IECA y nitroglicerina sublingual mostró diferencias estadísticamente significativas según el facultativo prescriptor. Conclusiones. La adecuación de las prescripciones a las recomendaciones establecidas en Andalucía es alta. La prescripción de nitroglicerina sublingual condicional es el indicador que más se desvía de los estándares de calidad marcados. Su uso, junto con la indicación de IECA, son las recomendaciones que presentan mayor desviación en función del facultativo prescriptor(AU)

Objectives. Cardiovascular disease is the primary cause of death in the world. Various drugs have shown their efficiency in the management of patients with acute coronary syndrome, along with the recommendations established by different Scientific Societies. The objective of this survey is to assess the monitoring of the quality standards established in Andalusia for the management of patients with myocardial infarction with evaluation of the ST segment and to analyse the source of variability of the prescription provided by the physician. Method. An observational descriptive survey, of indication-prescription, which analysed all the prescriptions included in the hospital discharge reports in patients treated in a tertiary hospital after having suffered acute myocardial infarction with ST segment elevation, between August 2005 and July 2007. Results. A total of 287 patients were included. Antiplatelets were prescribed in 99.3% of the patients, and acetylsalicylic acid in 95.8%. The percentage of beta-blockers received was 89.5%, angiotensin converting enzyme inhibitors (ACEI) in 74.2%, with ARA-II indicated in 2.85%. The use of statins was 84.6%. The indication of conditional sublingual nitroglycerin was 60.3%. The use of ACEI and sublingual nitroglycerin showed statistically significant differences according to the prescribing physician. Conclusions. The fitness of the prescriptions to the recommendations established in Andalusia is high. The prescription of conditional sublingual nitroglycerin is the indicator which varies most in the quality standards established. Its use in conjunction with the indication of ACEI, are the recommendations which show a higher deviation depending on the prescribing physician(AU)

Validation of a method for recording pharmaceutical interventions.

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.

[Effect of pharmaceutical follow-up in patients with secondary hyperparathyroidism treated with cinacalcet]. / Efecto del seguimiento farmacoterapéutico en pacientes con hiperparatiroidismo secundario tratados con cinacalcet.

OBJECTIVES: To assess the effect of pharmaceutical intervention in the identification of drug-related problems, to improve desired clinical outcomes, and to evaluate the effectiveness of cinacalcet in achieving clinical outcomes recommended by the KDOQI Clinical Guidelines. METHOD: Quasi-experimental pre-post intervention study. Patients with Secondary Hyperparathyroidism due to Chronic Kidney Disease, aged ≥18 years and under treatment with cinacalcet were recruited at the hospital outpatient pharmacy between 2007 and 2009. Dáder follow-up method and SMAQ and Moriski questionnaires were used to verify adherence at the first interview. Then, the pharmacist analyzed each case and designed an adequate intervention. Clinical parameters were consulted in the hospital laboratory data base. RESULTS: Thirty four patients were included, 29 drug-related problems were found before pharmacist intervention, and among these, non-adherence was the most common (15). After the intervention, 9 drug-related problems remained, which means that 68.9% of them were resolved (P<0.001), reaching an adherence of 80%. Parathyroid hormone, calcium and calcium-phosphorus product serum levels decreased significantly after 3 months of treatment (P<0.001, <0.001 and 0.045, respectively), achieving the KDOQI Clinical Guideline recommendations. CONCLUSION: These results suggest that this simple and easy-to-apply intervention was effective in preventing and resolving drug-related problems in these patients. Moreover, it improved patient adherence and confirmed that cinacalcet treatment is effective for achieving the clinical outcomes recommended by KDOQI clinical guidelines.

Study of compliance with prescription information sheet of trastuzumab prescriptions in a tertiary level hospital.

INTRODUCTION: This study compares trastuzumab's actual conditions of use in clinical practice with those officially described on its summary of product characteristics. We also measure the cost associated with its use. METHODS: Observational study of the prescription/indication of trastuzumab in a tertiary hospital from January 2006 to 31 December 2007. We analysed whether trastuzumab use in clinical practice complied with its summary of product characteristics, concerning the following: HER2 over expression, indication (breast cancer), treatment plan, line of treatment, dosage, frequency and number of cycles. To measure cost, we calculated the total number of milligrams used and then multiplied it by the laboratory's sale price per milligram plus VAT. RESULTS: All patients (n=77) used trastuzumab for breast cancer. Sixty-two point two percent of patients presented with HER2+++ over expression. Twenty-nine treatment plans were used, that were not authorised on the summary of product characteristics. The total trastuzumab cost during the study period was €1537 622.73. CONCLUSIONS: Although trastuzumab is always used for breast cancer, it is used in conditions other than those described on its summary of product characteristics, both for HER2 over expression and treatment plans.