Análisis modal de fallos y efectos aplicado a la elaboración de citostáticos intravenosos / Failure mode effect analysis applied to preparation of intravenous cytostatics

Objetivo. Identificar los riesgos en la elaboración de citostáticos intravenosos de forma proactiva, priorizarlos y establecer medidas de mejora en la seguridad de los procedimientos utilizados. Material y métodos. Se utilizó la metodología «análisis modal de fallos y efectos». Un equipo multidisciplinar identificó los modos de fallo del proceso a través de tormenta de ideas. Se evaluó el impacto asociado a cada modo de fallo con el número de prioridad de riesgo (NPR), en el que intervienen 3 variables: ocurrencia, gravedad y detectabilidad. Se establecieron medidas de mejora para todos los modos de fallo identificados; se consideraron críticos aquellos con un NPR > 100. Se calculó también el NPR final (teórico) que se obtendría con las medidas propuestas y se rediseñó el proceso. Resultados. Se identificaron un total de 34 modos de fallo. El NPR inicial acumulado fue de 3022 (rango: 3-252), y tras las acciones recomendadas el NPR final fue de 1292 (rango: 3-189). Se obtuvieron puntuaciones de NPR > 100 en 13 modos de fallo; solo el subproceso de dispensación estuvo exento de puntos críticos (NPR > 100). Se consiguió una reducción del NPR final >50% en 9 modos de fallo. Conclusiones. Esta metodología de análisis de riesgo prospectiva nos permite priorizar los puntos débiles del sistema para optimizar el empleo de recursos y conseguir una mejora sustancial en la seguridad de la elaboración de citostáticos mediante la introducción del doble chequeo y el etiquetado de productos intermedios (AU)

Objective. To proactively identify risks in the preparation of intravenous cytostatic drugs, and to prioritise and establish measures to improve safety procedures. Material and methods. Failure Mode Effect Analysis methodology was used. A multidisciplinary team identified potential failure modes of the procedure through a brainstorming session. The impact associated with each failure mode was assessed with the Risk Priority Number (RPN), which involves three variables: occurrence, severity, and detectability. Improvement measures were established for all identified failure modes, with those with RPN > 100 considered critical. The final RPN (theoretical) that would result from the proposed measures was also calculated and the process was redesigned. Results. A total of 34 failure modes were identified. The initial accumulated RPN was 3022 (range: 3-252), and after recommended actions the final RPN was 1292 (range: 3-189). RPN scores > 100 were obtained in 13 failure modes; only the dispensing sub-process was free of critical points (RPN > 100). A final reduction of RPN > 50% was achieved in 9 failure modes. Conclusions. This prospective risk analysis methodology allows the weaknesses of the procedure to be prioritised, optimize use of resources, and a substantial improvement in the safety of the preparation of cytostatic drugs through the introduction of double checking and intermediate product labelling (AU)

[Failure mode effect analysis applied to preparation of intravenous cytostatics]. / Análisis modal de fallos y efectos aplicado a la elaboración de citostáticos intravenosos.

OBJECTIVE: To proactively identify risks in the preparation of intravenous cytostatic drugs, and to prioritise and establish measures to improve safety procedures. MATERIAL AND METHODS: Failure Mode Effect Analysis methodology was used. A multidisciplinary team identified potential failure modes of the procedure through a brainstorming session. The impact associated with each failure mode was assessed with the Risk Priority Number (RPN), which involves three variables: occurrence, severity, and detectability. Improvement measures were established for all identified failure modes, with those with RPN>100 considered critical. The final RPN (theoretical) that would result from the proposed measures was also calculated and the process was redesigned. RESULTS: A total of 34 failure modes were identified. The initial accumulated RPN was 3022 (range: 3-252), and after recommended actions the final RPN was 1292 (range: 3-189). RPN scores >100 were obtained in 13 failure modes; only the dispensing sub-process was free of critical points (RPN>100). A final reduction of RPN>50% was achieved in 9 failure modes. CONCLUSIONS: This prospective risk analysis methodology allows the weaknesses of the procedure to be prioritised, optimize use of resources, and a substantial improvement in the safety of the preparation of cytostatic drugs through the introduction of double checking and intermediate product labelling.

Biological treatments for moderate-to-severe psoriasis: indirect comparison.

WHAT IS KNOWN AND OBJECTIVE: Psoriasis is a chronic skin disease for which there is an increasing range of treatment options. Biological agents (ustekinumab, adalimumab, infliximab and etanercept) are indicated for moderate-to-severe plaque-type psoriasis in adults who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA Unfortunately, with new drugs, the pivotal trials leading to their licensing are often placebo-controlled trials rather than comparative trials vs. established therapies. Therefore, inference on comparative effectiveness of the newer agents must be derived indirectly, through estimation of effects of the new agents vs. a common comparator. The objective of this study is to compare the relative efficacy of the biological agents through a systematic review of the indirect clinical trial evidence. METHODS: A systematic literature search was performed for clinical trials of biological agents in psoriasis. Pivotal, randomized, double-blind, controlled (placebo) trials using intention-to-treat analysis were selected for detailed analysis. Trials must include PASI 75 as a primary end point. The indirect comparison was performed using the method of Bucher adjusted with the ITC calculator (Indirect Treatment Comparisons of the Canadian Agency for Drugs and Technologies in Health), etanercept being the reference drug. We defined delta value for therapeutic equivalence as a difference in the efficacy of 25% among the different treatment options. RESULTS AND DISCUSSION: Fourteen studies (four for ustekinumab, three for adalimumab, three for infliximab and four for etanercept) were included. The indirect comparison results reveal that ustekinumab, adalimumab and infliximab were statistically superior to etanercept with an absolute risk difference for PASI 75 of 12% (95% CI = 5·9-18%), 11% (95% CI = 5·3-16·7%) and 24% (29·7-18·3%) respectively. However, in all situations, the 95% confidence interval does not achieve clinical relevance as no delta exceeds the previously set value (25%). WHAT IS NEW AND CONCLUSION: Ustekinumab, adalimumab, infliximab and etanercept can be regarded as clinical equivalents for the treatment of psoriasis. Choice between these agents therefore depends on their relative safety profiles, individual contra-indications and cost effectiveness.

Autorización de usos de medicamentos fuera de indicación en un hospital de tercer nivel / Off-label approval of drug use in a tertiary hospital

Fundamento y objetivo. Comisión de Farmacia y Terapéutica (CFT) evalúa peticiones de usos fuera de indicación con un modelo de informe abreviado. El objetivo fue realizar un análisis descriptivo de esta actividad y estudiar la tasa de autorizaciones. Material y métodos. Estudio descriptivo de los informes de la CFT del hospital entre septiembre de 2009 y abril de 2011. Se analizó tipo de fármaco por grupo terapéutico y por tipo de dispensación, indicación y servicio peticionario. Además, se estudió la decisión final adoptada como variable principal y porcentaje de solicitudes aprobadas según características del medicamento evaluado, indicación solicitada, alternativas usadas, evidencia y coste, como resultados secundarios. Resultados. De un total de 51 solicitudes analizadas, un 60,8% fueron medicamentos de uso hospitalario y un 54,9% citostáticos. Destacaron las indicaciones oncohematológicas (43,2%) y autoinmunes (35,3%). Los servicios con más peticiones fueron Hematología (11 peticiones aprobándose el 72,7%), Oncología y Pediatría (10 peticiones aprobándose el 50% para ambas). Se aprobaron el 60,8% de las peticiones. De las no autorizadas, 11 no agotaron las alternativas terapéuticas y 8 no presentaban evidencia suficiente para ser aceptadas. El 47,1% de los medicamentos solicitados tenían un coste/paciente entre 10.000-100.000 euros aprobándose el 58,3% (coste por tratamiento completo si tenía duración definida o coste por año en tratamientos crónicos). Conclusión. Hay una gran actividad de la CFT que crece con los años. La mayoría de las solicitudes son de fármacos de uso hospitalario, sobre todo de citostáticos por Oncohematología. Existe una alta tasa de autorización con una alta variabilidad según servicio y tipo de evidencia. La diferencia, entre aprobados y no aprobados respecto al coste sigue una lógica de coste-efectividad(AU)

Background and objective. The Pharmacy and Therapeutics Committee (PTC) evaluates the requests for off-label uses with an abbreviated report format. The aim of this study is to perform a descriptive analysis of this activity and to study the rate of approvals. Material and Methods. A descriptive study was performed on the PTC reports in a tertiary hospital between September 2009 and April 2011. The type of drug by treatment group and by type of dispensing, indication and requesting department was analysed. The final decision adopted was studied as the primary outcome, and the percentage of requests approved according to the characteristics of the drug evaluated, indication requested, alternatives used, evidence and cost, as secondary outcomes. Results. A total of 51 applications were analysed, of which 60.8% were drugs for hospital use and 54.9% cytostatic. The most requested indications were the onco-haematological (43.2%) and autoimmune (35.3%). Haematology was the department that made most requests (11 requests with 72.7% approved), Oncology and Paediatrics (both with 10 requests, with 50% approved). Almost two-thirds (60.8%) of the requests were approved. Of those that were not approved, 11 had not used up the therapeutic alternatives, and 8 had no evidence. Just under half (47.1%) of the drugs requested had a cost/patient between 10,000-100,000 euros,of which 58.3% were approved (cost per course of treatment if it had a defined period, or cost of treatment per year for chronic treatment). Conclusion. There is an increase in the activity of the PTC that is growing over the years. Most applications focus on drugs for hospital use and cytostatic drugs by Onco-haematology. There is a high rate of approval by the PTC, and high variability in the percentage of approval depending on the department and the evidence of use. The difference between approved and unapproved requests followed a logic of cost-effectiveness(AU)

[Off-label approval of drug use in a tertiary hospital]. / Autorización de usos de medicamentos fuera de indicación en un hospital de tercer nivel.

BACKGROUND AND OBJECTIVE: The Pharmacy and Therapeutics Committee (PTC) evaluates the requests for off-label uses with an abbreviated report format. The aim of this study is to perform a descriptive analysis of this activity and to study the rate of approvals. MATERIAL AND METHODS: A descriptive study was performed on the PTC reports in a tertiary hospital between September 2009 and April 2011. The type of drug by treatment group and by type of dispensing, indication and requesting department was analysed. The final decision adopted was studied as the primary outcome, and the percentage of requests approved according to the characteristics of the drug evaluated, indication requested, alternatives used, evidence and cost, as secondary outcomes. RESULTS: A total of 51 applications were analysed, of which 60.8% were drugs for hospital use and 54.9% cytostatic. The most requested indications were the onco-haematological (43.2%) and autoimmune (35.3%). Haematology was the department that made most requests (11 requests with 72.7% approved), Oncology and Paediatrics (both with 10 requests, with 50% approved). Almost two-thirds (60.8%) of the requests were approved. Of those that were not approved, 11 had not used up the therapeutic alternatives, and 8 had no evidence. Just under half (47.1%) of the drugs requested had a cost/patient between 10,000-100,000 euros,of which 58.3% were approved (cost per course of treatment if it had a defined period, or cost of treatment per year for chronic treatment). CONCLUSION: There is an increase in the activity of the PTC that is growing over the years. Most applications focus on drugs for hospital use and cytostatic drugs by Onco-haematology. There is a high rate of approval by the PTC, and high variability in the percentage of approval depending on the department and the evidence of use. The difference between approved and unapproved requests followed a logic of cost-effectiveness.

Consensus method to update the GINF formulary request form

Objective: To update the Guideline for the Introduction of New Drugs in the Formulary (GINF form) using the RAND/UCLA appropriateness method, which combines the best available evidence and an expert panel’s judgement. Study Design/Methods: Two procedures were employed to detect where improvements could be made to the former versions of the request form and to transform them into concrete scenarios, found from a telephone survey with GINF form users, and a structured review of the scientific literature. The list of scenarios was later assessed by an expert panel. In a series of successive rounds, the rest of the research team critically assessed the expert panel’s result, applying a score. Results: A total of 52 improvement proposals were registered; 31 of them dealt with the form structure and the remaining 21 referred to the form process. Six formulary request forms were selected from the literature review. The final version included 24 assessed scenarios mainly addressing clinical trials’ validity, qualitative assessment and local implications of the requested drug. Conclusions: A new version of the GINF form has been developed. Much improvement has been made based on the guide users’ opinion, available evidence and similar experiences that have been carried out internationally. The whole process has been subject to the experts’ opinion following a contrasted, consensus methodology: RAND/UCLA appropriateness method (AU)

Objetivo: Diseñar una nueva versión de la Guía para la Introducción de Nuevos Fármacos (GINF), ˜utilizando para ello la metodología RAND/UCLA sobre el uso adecuado, que combina la mejor evidencia disponible con el juicio de un panel de expertos. Diseño del estudio/métodos: ˜ Se emplearon 2 procedimientos para detectar oportunidades de mejora de las versiones anteriores de la guía, que fueron transformadas en escenarios concretos: una encuesta telefónica a usuarios de la GINF, y una revisión estructurada de la literatura científica. Esta lista de escenarios fue evaluada por un panel de expertos mediante rondas sucesivas. El resto del equipo de investigación evaluó críticamente el resultado del panel de expertos. Resultados: Se registraron 52 propuestas de mejora, 31 de ellas se refieren a la estructura de la guía y las 21 restantes se refieren al procedimiento de utilización de la guía. En cuanto a la búsqueda bibliográfica, 6 de las guías de inclusión de nuevos medicamentos fueron seleccionadas. La versión final incluyó 24 de los escenarios propuestos orientados principalmente a la validez del ensayo clínico, la evaluación cualitativa y las consecuencias locales del fármaco solicitado. Conclusiones: La nueva versión de la guía GINF llevada a cabo incluye muchas mejoras extraídas tanto de la opinión de los usuarios de guía como de la mejor evidencia disponible y las experiencias similares que se han llevado a cabo a nivel internacional. Todo el proceso ha sido sometido a la opinión de los expertos tal como indica la metodología de consenso RAND/UCLA (AU)

Consensus method to update the GINF formulary request form.

OBJECTIVE: To update the Guideline for the Introduction of New Drugs in the Formulary (GINF form) using the RAND/UCLA appropriateness method, which combines the best available evidence and an expert panel's judgement. STUDY DESIGN/METHODS: Two procedures were employed to detect where improvements could be made to the former versions of the request form and to transform them into concrete scenarios, found from a telephone survey with GINF form users, and a structured review of the scientific literature. The list of scenarios was later assessed by an expert panel. In a series of successive rounds, the rest of the research team critically assessed the expert panel's result, applying a score. RESULTS: A total of 52 improvement proposals were registered; 31 of them dealt with the form structure and the remaining 21 referred to the form process. Six formulary request forms were selected from the literature review. The final version included 24 assessed scenarios mainly addressing clinical trials' validity, qualitative assessment and local implications of the requested drug. CONCLUSIONS: A new version of the GINF form has been developed. Much improvement has been made based on the guide users' opinion, available evidence and similar experiences that have been carried out internationally. The whole process has been subject to the experts' opinion following a contrasted, consensus methodology: RAND/UCLA appropriateness method.

[Implementation of the guidelines for the introduction of new drugs (GINF) in Andalusian hospitals]. / Implantación de la guía para la incorporación de nuevos fármacos (GINF) en los hospitales andaluces.

OBJECTIVE: To measure the level of implementation of the GINF (guidelines for the introduction of new drugs) in Andalusian hospitals, describe the characteristics of this implementation and analyse if any of the hospital s dependent variables could influence these characteristics. METHOD: A telephone survey was carried out in the hospitals included in the Department of Health list. The survey consisted of 11 closed questions on different variables in the hospital and the GINF use profile, and an open question about the improvements carried out and proposals for improvement. The results were analysed according to the type of hospital (category, training, geographical location) in order to detect possible differences. RESULTS: A target population of 31 hospitals was identified. The survey was carried out in 29 of these; the level of implementation was 96.5% in the responding hospitals. 23 hospitals used the GINF for 100% of drugs, 6 had carried out local modifications and 80% made proposals for improvement. Significant differences were found in the implementation of the GINF according to resident/intern pharmacist training (p = 0.049), the geographical location (p = 0.004) and the hospital category (p < 0.001). CONCLUSIONS: The GINF have been implemented in almost all public Andalusian hospitals as the guidelines for requesting new drugs. Very few local modifications have been carried out to the guidelines, although numerous proposals for improvement have been made. Differences in use have been identified (No. of drugs, different versions) according to the hospital characteristics (location, training and complexity classification). They are considered a useful tool and influence the drug selection process, in particular in training hospitals with a higher classification.

Implantación de la guía para la incorporación de nuevos fármacos (GINF) en los hospitales andaluces / No disponible

Objetivo: Medir el grado de implantación de la guía GINF enlos hospitales andaluces, describir las características de dichaimplantación y analizar si algunas variables dependientes del hospitalpudieran influir en las mismas.Método: Se realizó una encuesta telefónica a los hospitalesincluidos en catálogo de la Consejería de Salud. La encuesta constabade 11 cuestiones cerradas sobre diferentes variables del hospitaly del perfil de utilización de la GINF, y una cuestión abiertaque recogía mejoras realizadas y propuestas de mejora. Se analizaronlos resultados en función del tipo de hospital (categoría, docencia,localización geográfica) para detectar posibles diferencias.Resultados: Se identificó una población diana de 31 hospitales.La encuesta pudo realizarse en 29; el grado de implantaciónfue del 96,5% en los hospitales respondedores. Veintitrés hospitalesutilizaban la GINF para el 100% de los fármacos, seis habíanrealizado modificaciones locales pero el 80% realizó propuestasde mejora. Se encontraron diferencias significativas en la implantaciónde la GINF en función de la docencia FIR (p = 0,049), lalocalización geográfica (p = 0,004) y la categoría de los hospitales(p < 0,001).Conclusiones: La guía GINF ha sido implantada en la prácticatotalidad de los hospitales públicos andaluces para la solicitudde nuevos fármacos. La guía apenas ha sido modificada localmente,aunque se recogen numerosas propuestas de mejora. Se identificandiferencias en su utilización (número de fármacos, diferentesversiones) en función de las características del hospital (localización,docencia y complejidad). Es considerada una herramientaútil e influyente en el proceso de selección de medicamentos,sobre todo en los hospitales docentes de mayor complejidad

Objective: To measure the level of implementation of theGINF (guidelines for the introduction of new drugs) in Andalusianhospitals, describe the characteristics of this implementation andanalyse if any of the hospital’s dependent variables could influencethese characteristics.Method: A telephone survey was carried out in the hospitalsincluded in the Department of Health list. The survey consisted of11 closed questions on different variables in the hospital and theGINF use profile, and an open question about the improvementscarried out and proposals for improvement. The results wereanalysed according to the type of hospital (category, training, geographicallocation) in order to detect possible differences.Results: A target population of 31 hospitals was identified.The survey was carried out in 29 of these; the level of implementationwas 96.5% in the responding hospitals. 23 hospitals usedthe GINF for 100% of drugs, 6 had carried out local modificationsand 80% made proposals for improvement. Significant differenceswere found in the implementation of the GINF according toresident/intern pharmacist training (p = 0.049), the geographicallocation (p = 0.004) and the hospital category (p < 0.001).Conclusions: The GINF have been implemented in almost allpublic Andalusian hospitals as the guidelines for requesting newdrugs. Very few local modifications have been carried out to theguidelines, although numerous proposals for improvement havebeen made. Differences in use have been identified (No. of drugs,different versions) according to the hospital characteristics (location,training and complexity classification). They are considered auseful tool and influence the drug selection process, in particularin training hospitals with a higher classification

Similitud en la cumplimentación de las guías para la incorporación de nuevos fármacos (GINF) / No disponible

No disponible

Seguimiento farmacoterapéutico en pacientes hospitalizados en tratamiento con fentanilo transdérmico / Pharmacotherapeutic follow-up in patients in treatmente with transdermal fentanyl background and objectives

Objetivo: El dolor es una de las causas de consulta más frecuente en los centros de atención primaria. Aproximadamente la mitad de la población sufre crisis de dolor alguna vez al año, y un tercio de la misma sufre dolor crónico. Los objetivos del estudio son describir la incidencia y tipos de problemas relacionados con los medicamentos (PRM) de la terapia antiálgica con fentanilo transdérmico en pacientes hospitalizados, las intervenciones farmacéuticas realizadas, su aceptación por parte de los clínicos y su resolución. También comparar la incidencia de PRM, de intervenciones farmacéuticas, su aceptación y resolución según las variables: servicio clínico y diagnóstico, oncológico o no. Material y método: Evaluación y detección de PRM en pacientes que inician tratamiento con fentanilo transdérmico (FT) en un hospital de tercer nivel. El seguimiento de los pacientes fue de 7 días o superior hasta resolución de los PRM. Para la valoración del dolor se utilizó la Escala Visual Analógica (EVA). Resultados: Se estudiaron 30 pacientes, 129 pacientes-día. Se detectaron un total de 51 PRM. La incidencia de PRM ha sido mayor en pacientes con dolor de origen no oncológico (p<0,05). Los tipos de PRM de mayor a menor incidencia fueron PRM 1: 53% (no usa los medicamentos que necesita), PRM 3: 15,6% (usa un medicamento mal seleccionado), PRM 4: 15,6% (usa una dosis, pauta y/o duración inferior a la que necesita), PRM 6: 7,8% (usa un medicamento que le provoca una reacción adversa), PRM 2: 5,8% (el paciente usa medicamentos que no necesita) y PRM 5: 2% (el paciente usa una dosis, pauta y/o duración superior a la que necesita). La causa más común fue que no estaba prescrita la terapia analgésica de rescate. Se realizaron 45 intervenciones para resolver los PRM. La aceptación global de las recomendaciones fue del 84,45%. De un total de 35 intervenciones aceptadas, 34 (97,14%) consiguieron resolver el PRM. Conclusiones: La prevalencia de PRM es alta en la terapia analgésica y para conseguir evitarlos es necesario un seguimiento farmacoterapéutico del mismo. Para poder detectar otros PRM sería necesario realizar otros estudios con un seguimiento y población mayor (AU)

Pain is the most frequent reason of consultation in pi mary care centres. Approximately, half of the populatio suffers from pain crisis at some time in the year, and or third of those suffers from chronic pain. The aims of th study are to describe the incidence and types of drug th rapy problems (DTP), understood as negative clinical ou comes from antinociceptive therapy with transdermal fetanyl in hospitalized patients, the pharmacist interventions, their acceptance by the clinicians and their resolution. As well as to compare the incidence of DTP, of pharmacist interventions, their acceptance and resolution according to the following variables: clinical service and oncologic diagnostic or not. Material and method: Evaluation and detection of DTP in patients who initiate treatment with transdermal fentanyl (TF) in a third level hospital. The follow-up to the patients was during 7 days or longer up to resolution of the DTP. For the assessment of the pain perception the Visual Analogic Scale (VAS) was used. Results: 30 patients (129 patients/day) were studied. A total of 51 DTP were detected. The DTP incidence in patients with non-oncologic pain has been major (p<0.05). The DTP types from major to minor incidence were DTP 1: 53% (the patient suffers from a health problem as a consequence of not receiving the medication that he needs), DTP 3: 15.6% (the patient suffers from a health problem as a consequence of a non-quantitative ineffectiveness of the medication), DTP 4: 15.6% (the patient suffers from a health problem as a consequence of a quantitative ineffectiveness of the medication), DTP 6: 7.8% (the patient suffers from a health problem as a consequence of a quantitative safety problem of a medicine), DTP 2: 5.8% (the patient suffers from a health problem as a consequence of receiving a medicine that he does not need) and DTP 5: 2% (the patient suffers from a health problem as a consequence of a non-quantitative safety problem of a medicine). The most common reason was that the rescue analgesic therapy was not prescribed. 45 interventions were realized. The global acceptance of the recommendations was of 84.45%. From 35 accepted interventions, 34 (97.14%) achieved to solve the PRM. Conclusions: They are prevalent DTP in analgesic therapy and to avoid them a pharmacotherapy follow-up is necessary. There would be necessary the achievement of studies including a higher number of patients and with a longer follow-up period; then there might detect other DTP that were not possible in this case (AU)

Eficacia de ácido tricloroacético en fístula broncopleural / Effectiveness of trichloroacetic acid in the bronchopleural fistula

No disponible