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.

Hemorragias intracraneales de carácter evitable asociadas a anticoagulantes orales en pacientes con fibrilación auricular / Avoidable intracranial hemorrhages associated with oral anticoagulants in patients with atrial fibrillation

Introducción y objetivo. El aumento de la prescripción de anticoagulantes orales ha provocado un aumento de hemorragias intracraneales, la reacción adversa más grave asociada a este grupo farmacológico. El objetivo del estudio es evaluar el carácter evitable de hemorragias intracraneales asociada a anticoagulantes orales que causan ingreso hospitalario en pacientes con fibrilación auricular. Método. Supervisión de las historias clínicas de los pacientes que ingresaron en los Hospitales Universitarios Virgen del Rocío (01/01/03 al 31/03/07) con hemorragia intracraneal y fibrilación auricular; considerando hemorragia intracraneal asociada a anticoagulantes orales aquellas con una relación ≥ posible al aplicar el algoritmo de causalidad del Sistema Español de Farmacovigilancia. Para valorar el carácter evitable de la hemorragia intracraneal se ha estudiado la relación beneficio/riesgo del uso de anticoagulantes orales. Resultados. Al menos 20/57 (35,1%) hemorragias intracraneales asociadas a anticoagulantes orales pudieron ser potencialmente evitables, de las cuales en 7/20 (35%) el desenlace fue mortal, presentando secuelas 8/13 (61,5%) de los supervivientes. El fármaco sospechoso de interaccionar con anticoagulantes orales referenciado con mayor frecuencia fue el omeprazol, 11/57 (19%), a pesar de estar documentada esta interacción como altamente probable en la bibliografía y en los protocolos del Hospital. Conclusiones. La relación beneficio/riesgo del uso de anticoagulantes orales, el control estricto del Índice Normalizado Internacional, junto con las posibles interacciones medicamentosas deben ser evaluadas de forma individualizada y periódicamente para minimizar el riesgo de hemorragia intracraneal, que en un porcentaje elevado de casos es una reacción adversa potencialmente evitable y mortal (AU)

Introduction and objectives: The increase in oral anticoagulants prescription has caused an increase in intracranial hemorrhages, the most adverse reaction to this pharmacological group. The objective of this study is to evaluate the avoidability of the intracranial hemorrhages associated with oral anticoagulants that require hospitalization of patients with atrial fibrillation. Methods: Survey of the medical histories of the patients who were hospitalized in the University Hospital «Virgen del Rocío» (from 01/01/03 to 03/31/07) with intracranial hemorrhages and atrial fibrillation, considering as intracranial hemorrhages associated with oral anticoagulants those with a probable relationship applying the causality algorithm of the Spanish Pharmacological Surveillance System. In order to evaluate the avoidability of the intracranial hemorrhage the risk/benefit ratio of the use of oral anticoagulants has been studied. Results: At least 20 out of 57 (35.1%) intracranial hemorrhages associated with oral anticoagulants were potentially avoidable, in 7 cases out of those 20 (35 %) death was the outcome, and in 8 out of the remaining 13 (61.5%) the survivors suffered after–effects. Omeprazole was the drug more frequently involved in interactions with oral anticoagulants in 11 out of 57 cases (19%) although this interaction is categorized as highly probable in the bibliography and the protocols of the Hospital. Conclusions: The risk / benefit ratio of oral anticoagulants, the strict control of the International Normalized Ratio and the possible drug interactions, must be assessed individually and regularly to minimize the risk of intracranial hemorrhage that is often a potentially avoidable lethal adverse event (AU)

Análisis del proceso de selección de nuevos medicamentos en un hospital terciario. Años 2004–07 / Analysis of the selection process for new drugs in a tertiary hospital 2004–2007

Objetivo Describir la estructura de la Comisión de Farmacia y Terapéutica y el proceso de selección de nuevos medicamentos de un hospital terciario. Material y métodos Se revisan todas las actas de la Comisión de Farmacia y Terapéutica y las Guías para la Incorporación de Nuevos Fármacos recibidas en el periodo 2004–2007 en el Hospital Universitario Virgen del Rocío. Se realiza un estudio descriptivo que recoge variables relacionadas con el fármaco (grupo terapéutico, vía de registro, vía de administración y categoría legal), con el solicitante (servicio al que pertenece, categoría profesional y tipo de petición) y con el resultado de la evaluación (decisión final adoptada y tiempo de retraso entre la petición y la decisión).Resultados De los 72 medicamentos solicitados, se aprobaron 45 (62,5%), 6 como equivalentes terapéuticos, 36 (80%) con recomendaciones específicas y 3 (4,2%) sin ninguna restricción. De los fármacos no incluidos, en 12 (81,1%) fue por insuficiente evidencia de su eficacia comparada con el tratamiento actual. El grupo terapéutico solicitado con más frecuencia fue el de los antineoplásicos, destacando Oncología y Hematología entre los peticionarios. Destaca el alto porcentaje de solicitantes que aportaron ensayos clínicos (97,2%) y datos referentes al coste (84,7%).Conclusiones Existe un alto grado cumplimentación de la Guía para la Incorporación de Nuevos Fármacos en nuestro centro que garantiza una decisión final por parte de la Comisión de Farmacia y Terapéutica basada en la evidencia científica (AU)

Material and methods All annals of the P&TC and the New Drug Incorporation Guides (GINF) to incorporate new drugs received at Hospital Virgen del Rocío between 2004 and 2007 were reviewed. We carried out a descriptive study which collected variables having to do with the drug (drug type, type of register, route of administration and legal category), the petitioner (responsible division, professional category and request type) and the result of the evaluation (final decision, elapsed time between the request and the decision). Results Of the 72 requested drugs, 45 (62.5%) were approved: six as equivalent treatments, 36 (80%) with specific recommendations, and three (4.2%) with no restrictions. Twelve drugs (81.1%) were not included due to insufficient evidence of their effectiveness compared with the current treatment. The most frequently-requested drug type was the antineoplastics, most commonly requested by Oncology and Haematology divisions. We highlight the fact that many of the petitioners included clinical trials (97.2%) and data referring to costs (84.7%) (AU)

[Analysis of the selection process for new drugs in a tertiary hospital 2004-2007]. / Análisis del proceso de selección de nuevos medicamentos en un hospital terciario. Años 2004-07.

OBJECTIVE: The purpose of this study is to describe the structure of the CFyT, the Pharmacy and Therapeutics Committee, and a tertiary hospital's selection process for new drugs. MATERIAL AND METHODS: All annals of the P&TC and the New Drug Incorporation Guides (GINF) to incorporate new drugs received at Hospital Virgen del Rocío between 2004 and 2007 were reviewed. We carried out a descriptive study which collected variables having to do with the drug (drug type, type of register, route of administration and legal category), the petitioner (responsible division, professional category and request type) and the result of the evaluation (final decision, elapsed time between the request and the decision). RESULTS: Of the 72 requested drugs, 45 (62.5%) were approved: six as equivalent treatments, 36 (80%) with specific recommendations, and three (4.2%) with no restrictions. Twelve drugs (81.1%) were not included due to insufficient evidence of their effectiveness compared with the current treatment. The most frequently-requested drug type was the antineoplastics, most commonly requested by Oncology and Haematology divisions. We highlight the fact that many of the petitioners included clinical trials (97.2%) and data referring to costs (84.7%). CONCLUSIONS: There is a high level of compliance with the GINF guide in our centre, which guarantees that the P&TC's final decision is based on scientific evidence.

[The knowledge and attitude of consumers in relation to the use of NSAIDs. An intervention study]. / Conocimientos y actitud de los usuarios en relación al empleo de AINE. Estudio de intervención.

OBJECTIVES: To evaluate knowledge in the general population about the rational use of non-steroidal analgesic-antithermal-anti-inflammatory drugs (NSAIDs), and whether an informative intervention could improve their knowledge. DESIGN: An intervention study with a control group. The subjects were polled before and after intervention, which consisted in the passive distribution of informative leaflets on NSAIDs to the experimental group. The replies of the subjects of both groups were compared. SETTING: "Cerro del Aguila" (experimental group) and "Polígono Norte" (control) health districts in Sevilla. PARTICIPANTS: 348 inhabitants (174 from each district), selected for age and sex in line with the proportions on the Municipal Roll, with people under 15 excluded. MEASUREMENTS AND MAIN RESULTS: About 30% did not spontaneously remember any NSAID. Almost 90% did not spontaneously remember any medical reaction. Self-medication and/or consumption on the advice of non-qualified people were as common as medical prescription. CONCLUSIONS: Passive distribution of leaflets was useless as a way of improving users' knowledge of NSAIDs. The intervention needs to be actively carried out by the doctor, with consistency over time and back-up from other health educationalists.

[Gingival hyperplasia associated with amlodipine]. / Hiperplasia gingival asociada a amlodipino.

Drug-induced gingival hyperplasia is a well documented unwanted side effect within the literature. It has been associated with the use of three different types of pharmaceutical agents, including phenytoin, cyclosporine and calcium channel blocking agents. Amlodipine belongs to the dihydropyridine-derived calcium blocking agents that may cause the side effect of drug-induced gingival hyperplasia. In the present study the possible pathogenic mechanisms, clinical and histologic presentation and therapeutic indications of amlodipine-induced gingival hyperplasia are discussed.

[Adverse reaction to cefonicid analogous to serum sickness]. / Reacción adversa al cefonicid análoga a la enfermedad del suero.

We report a case of a male who was treated with cephonicid because of a surgical complication. Serum-sickness like symptoms were diagnosed two weeks later. Medical references are discussed.

[Adverse reactions to drugs reported by the primary care physicians of Andalusia. Analysis of underreporting]. / Reacciones adversas a medicamentos notificadas por los médicos de atención primaria de Andalucía. Análisis de la infranotificación.

OBJECTIVE: To discover the sort of adverse reactions to medication (ARM) notified by Primary Care doctors and identify the under-notification of those cases having special clinical-epidemiological interest. DESIGN: Retrospective study in which 2,597 ARM corresponding to 1,467 Yellow Cards (YC) were analysed. These were notified by Primary Care doctors to the Centro Andaluz de Farmacovigilancia (Andalusian Drug-watch centre) during the period from 1/6/90 to 31/12/92. To assess the seriousness of the ARM, their terminological classification and imputability, the criteria used in the WHO's international "Yellow Card" programme of spontaneous notification were followed. MEASUREMENTS AND MAIN RESULTS: 77.2% of all notifications were from Primary Care, of which 7.4% were of special interest due to their serious or novel character. However an undernotification of serious and well-known ARM was detected, such as digestive haemorrhages (1.07/10(6) inhibitants per year), anaphylactic shock (0.34/10(6) inhab/year), agranulocytosis (0.23/10(6) inhab/year) and aplastic anaemia (0.05/10(6) inhab/year), among others. CONCLUSIONS: Most of the main under-notified ARM are generated in the community but treated in hospital Casualty departments. Therefore it would be useful to develop specific Drug-watch programmes in the hospitals themselves.

[User knowledge and attitude in relation to drug use for pain, fever or inflammation]. / Conocimientos y actitud de los usuarios en relación al empleo de medicamentos para el dolor, la fiebre o la inflamación.

OBJECTIVE: To find how users identified non-steroidal analgesic/antipyretic/anti-inflammatory drugs (NSAID) and their adverse reactions, as well as where the prescriptions were obtained and where users inquired when in doubt. DESIGN: An observation study carried out by means of a structured questionnaire administered to 174 residents in our basic health area. SETTING: Cerro del Aguila Basic Health Area in Sevilla. PARTICIPANTS: The 174 residents, chosen at random, by quotas corresponding to the Census' demographic characteristics. People under 15 were excluded. MEASUREMENTS AND MAIN RESULTS: 32.2% had no spontaneous memory of having taken any NSAID: 86.8% did not remember any possible adverse reaction to medication. Only 49.3% of the NSAID declared were prescribed by a doctor. 17.8% took NSAID daily and 5.7% took more than one medicine containing NSAID every day. CONCLUSIONS: In our health area, health education, both to identify NSAID as a pharmacological group and any possible adverse reactions, needs to be strengthened.