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1.
Stud Health Technol Inform ; 316: 1467-1471, 2024 Aug 22.
Artículo en Inglés | MEDLINE | ID: mdl-39176481

RESUMEN

Administrable dose form can be obtained after (no-)transformation from pharmaceutical dose form. Building on the creation of a small ontology of 428 pharmaceutical dose forms from EDQM to support alignment with other dose form ontologies (SNOMED-CT, RxNorm), the present study is focused on a simple ontology of 308 administrable dose forms, 27 Intended Sites and an intermediary level of 65 dose form groupers. The ontology was created after 432 pharmaceutical dose forms, 65 combined pharmaceutical dose forms and 73 combined terms were linked by EDQM to administrable dose forms during the UNICOM project. The article describes these resources, the resulting ontology, the differences between its top-level concepts and the source's. It presents the protocol for a validation study through expert review, as a preparation for use case studies.


Asunto(s)
Systematized Nomenclature of Medicine , Humanos , Preparaciones Farmacéuticas , Procesamiento de Lenguaje Natural , Vocabulario Controlado
2.
Int J Dermatol ; 60(3): 272-280, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-32767380

RESUMEN

Head louse infestations continue to be a concern of public health in most countries, including the most developed ones. The present recommendations are intended to inform and stress the role and impact of the different authorities, institutions, industry, and the public in the control of head lice in order to reduce the prevalence of this parasite. We encourage health authorities to pursue more effective methods to correctly identify such infestations, and evaluate existing and new pediculicides, medical devices, louse repellents, and louse- and nit-removal remedies. Pediculicides and medical devices must have verifiable claims in the instructions for use and should be tested periodically to document current levels of resistance by lice to the active ingredients and to the formulated products. Where the prevalence of lice is claimed to be epidemic, children should be periodically evaluated objectively to document the actual level of prevalence. Continuing education for health providers and the general population promises to correct misinformation regarding the biology, prevention, and management of lice. Parents should regularly inspect their children for head lice and treat as necessary. Health authorities are encouraged to eliminate policies and practices that rely upon school exclusion as a means to reduce incidence and prevalence, e.g., the 'no-nit' policy which lacks scientific justification, and are counterproductive to the health and welfare of children.


Asunto(s)
Infestaciones por Piojos , Pediculus , Dermatosis del Cuero Cabelludo , Animales , Niño , Humanos , Infestaciones por Piojos/diagnóstico , Infestaciones por Piojos/tratamiento farmacológico , Infestaciones por Piojos/epidemiología , Prevalencia , Salud Pública , Dermatosis del Cuero Cabelludo/diagnóstico , Dermatosis del Cuero Cabelludo/epidemiología , Dermatosis del Cuero Cabelludo/prevención & control , Instituciones Académicas
4.
Parasitol Res ; 114(5): 1779-92, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-25716822

RESUMEN

Head lice infestation is still a public health problem worldwide, with an intracountry and intercountry prevalence variation of 0.7 to 59%. There is a large variety of over-the-counter anti-louse products, but their efficacy is not always well assessed. Our objective was to test the pediculicidal and ovicidal efficacy of 21 over-the-counter head louse products, available in France during the period of 2008 to 2012. We tested children living in Tours City in central France and visiting preschools, primary schools, kindergarten, camps, and child care facilities, as well as children in their family houses, and were examined for the presence of lice. The products were collected from randomly selected pharmacies by covert investigators and then tested in the laboratory on an ex vivo sample of head lice and their eggs, collected from the hair of infested children. Living lice and unharmed eggs were collected from the scalps of 3-12 years old. The laboratory conditions for ex vivo testing mimicked the manufacturers' instructions for exposure time and application method. In 21 runs, 3919 living lice and 4321 undamaged living eggs were collected from the scalp of over 400 children. The 21 products were classified in three groups: 6 products in a group of potentially 100% pediculicidal activity and potentially 100% ovicidal activity, 8 products in a group of potentially 100% pediculicidal activity but insufficient ovicidal activity (including 2 products with claims of single application treatment), and 7 products in a group of insufficient pediculicidal activity and ovicidal activity. The pharmaceutical market for head lice products in France is swamped with poorly tested and ineffective products. Rigorous efficacy testing preregistration and periodic screening and testing of effectiveness in the post-registration period should be endorsed by the health authorities.


Asunto(s)
Antiparasitarios/farmacología , Insecticidas/uso terapéutico , Pediculus/efectos de los fármacos , Animales , Femenino , Francia , Humanos , Óvulo/efectos de los fármacos
5.
Hum Psychopharmacol ; 30(2): 85-93, 2015 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25639725

RESUMEN

OBJECTIVE: Chronic use of benzodiazepines and Z-drugs (BZD/Zs) has been linked to cognitive decline. In this one-year prospective cohort study, we explored the impact of chronic BZD/Z use on cognitive decline compared to nonusers. METHODS: In cognitively capable BZD/Z users and nonusers in 10 Belgian nursing homes, we investigated cognition with the MiniMentalStateExamination(MMSE) at baseline and one year. A decrease of ≥ 4 points on the MMSE (clinically relevant decrease) was used in multiple logistic regression. We collected baseline demographics, functional, psychometric and social characteristics potentially influencing cognition. RESULTS: In both the 131 BZD/Z users and 95 nonusers, the cognition decreased significantly over time, but without significant difference between the groups. Clinically relevant decrease was present in 34% BZD/Z users and 27% nonusers (NS). Controlled for age, gender, education and BZD/Z use, the significant risk factors for clinically relevant cognitive decline were depression, hearing and functional impairment. Frequent reading was associated with less MMSE decrease. Our findings could not demonstrate with statistical significance that BZD/Z use was associated with fast cognitive decline. The risk factors for fast decline were depression, hearing and functional impairment, and the absence of a reading attitude. In addition, BZD/Z use and depression were associated, indicating a complex relationship.


Asunto(s)
Benzodiazepinas/efectos adversos , Trastornos del Conocimiento/inducido químicamente , Hipnóticos y Sedantes/efectos adversos , Casas de Salud , Anciano , Anciano de 80 o más Años , Bélgica , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pruebas Neuropsicológicas , Escalas de Valoración Psiquiátrica , Psicometría , Factores de Riesgo , Trastornos del Sueño-Vigilia/tratamiento farmacológico , Estadísticas no Paramétricas
6.
Eur J Clin Pharmacol ; 70(10): 1251-60, 2014 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-25098683

RESUMEN

PURPOSE: Guidelines discourage chronic benzodiazepines and related Z drugs (BZD/Zs) for sleep problems. However, prevalence among nursing home residents remains high. Discontinuing these drugs is widely recommended but seems difficult to implement. The aim of our study was to evaluate the overall feasibility in the nursing home, in terms of willingness towards discontinuation and success rate at 8 months, together with the impact on withdrawal symptoms, change in sleep quality, quality of life and medication use. METHODS: In a convenience sample of five nursing homes (823 residents), we included cognitively competent residents with chronic BZD/Z use for insomnia. We investigated sleep quality [with Pittsburgh Sleep Quality Index (PSQI)], quality of life (EQ-5D) and withdrawal symptoms [Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)]. Success rate was analysed with survival analysis. RESULTS: Of the 135 eligible residents, both general physician (GP) and resident were willing to initiate discontinuation in 38 residents. Reasons for refusing to initiate discontinuation among GPs was the unmotivated patient and among residents the reluctance towards change. At 8 months, 66.0% were successful discontinuers, with the subjective PSQI component evolving favourably (p = 0.013) and a decreasing number of midnight awakenings (p = 0.041). In the relapse group (n = 13), the quality of life decreased (p = 0.012), with mainly an increase of problems with activities and pain/discomfort. In both groups, the withdrawal symptoms, functionality and medication use did not change. CONCLUSION: Discontinuation of chronic BZD/Z use is feasible in the nursing home setting without noticeable withdrawal symptoms, without a switch in medication use, without detrimental effect on quality of life and with a positive effect on the self-perceived sleep quality.


Asunto(s)
Benzodiazepinas/administración & dosificación , Hipnóticos y Sedantes/administración & dosificación , Casas de Salud , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Benzodiazepinas/uso terapéutico , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Hipnóticos y Sedantes/uso terapéutico , Masculino , Proyectos Piloto , Guías de Práctica Clínica como Asunto , Calidad de Vida , Síndrome de Abstinencia a Sustancias/epidemiología , Encuestas y Cuestionarios
7.
Drugs Aging ; 31(9): 677-82, 2014 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-25145751

RESUMEN

OBJECTIVES: Chronic use of benzodiazepines and z-drugs (BZD/Zs), the most commonly used symptomatic treatment for sleep problems, is discouraged because of the unproven long-term effectiveness. In this study, we evaluated 1-year evolution of subjective sleep quality of chronic BZD/Z users compared with nonusers. METHODS: All cognitively competent residents from ten Belgian nursing homes were screened and compiled in a group of chronic BZD/Z users or nonusers, based on the medication chart. We collected demographic, functional and psychometric characteristics (depressive symptoms with the 8-item Geriatric Depression Scale), sleep parameters (with the Pittsburgh Sleep Quality Index-PSQI) and medication use. We analysed evolution of sleep quality with nonparametric statistics. Associations with worsening of sleep quality were analysed with linear regression. RESULTS: We collected data of 131 BZD/Z users and 95 nonusers. The mean age in both groups was 85 years and 77 % was female. Over a period of 1 year, the PSQI score evolved from 5.2 to 5.8 (p = 0.035) in the BZD/Z users, and from 4.3 to 4.7 (p = 0.078) in the nonusers. Though the mean deterioration in 1 year did not differ significantly between both groups, the BZD/Z users had a significantly worse sleep quality compared with nonusers at both time points. Depressive symptoms were significantly associated with worsening sleep quality (ß = -0.243, p < 0.001). CONCLUSION: Sleep quality in chronic BZD/Z users significantly decreased over 1 year and was significantly worse than in nonusers at the end of this period. This study suggests that using BZD/Zs chronically does not maintain or improve sleep quality. Depressive symptoms are an important factor in the deterioration of sleep quality.


Asunto(s)
Benzodiazepinas/administración & dosificación , Trastornos del Sueño-Vigilia/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Bélgica , Benzodiazepinas/efectos adversos , Estudios de Cohortes , Trastorno Depresivo Mayor/complicaciones , Esquema de Medicación , Femenino , Servicios de Salud para Ancianos , Humanos , Estudios Longitudinales , Masculino , Casas de Salud , Calidad de Vida , Trastornos del Sueño-Vigilia/complicaciones , Trastornos del Sueño-Vigilia/psicología , Encuestas y Cuestionarios
9.
Sleep Med ; 14(7): 614-21, 2013 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-23692988

RESUMEN

OBJECTIVES: We aim to describe subjective sleep quality among long-term users of benzodiazepines (BZDs) in Belgian nursing homes, to compare it to nonusers, and to investigate determinants of poor sleep quality. METHODS: All mentally competent residents from 10 nursing homes were screened and compiled in a group of long-term BZD users or in a group of nonusers based on the medication chart. We collected demographic, functional, and medication characteristics and global and specific sleep parameters using the Pittsburgh Sleep Quality Index (PSQI). Linear regression was used to investigate which parameters were associated with sleep quality. RESULTS: Of the 300 residents, 178 (59%) were long-term BZD users and 122 were nonusers. The 2 groups did not differ in demographic and functional characteristics (mean age, 85.5 y; range, 57-100; 75% women). The users reported significantly more difficulties with falling asleep, had more midnight awakenings, felt less rested in the morning, and had a poorer self-perceived sleep quality compared to nonusers. Sleep duration and time to fall asleep did not differ. The self-perceived sleep quality was mainly determined by difficulties during initiation of sleep. After controlling for demographic, medication, and functional characteristics, BZD use remained strongly associated with poor sleep (r=0.173; P=.003), and a study centre effect (differences among nursing homes) was observed (r=0.229; P<.001). CONCLUSION: Our findings do not support long-term effectiveness of BZDs; long-term users slept more poorly than nonusers and were even more outspoken in users of long-acting BZDs. In future longitudinal comparative studies of sleep quality, unexplained variability needs further assessment with medical, psychologic, and institutional parameters.


Asunto(s)
Benzodiazepinas/efectos adversos , Casas de Salud , Trastornos del Inicio y del Mantenimiento del Sueño/inducido químicamente , Sueño/efectos de los fármacos , Anciano , Anciano de 80 o más Años , Benzodiazepinas/administración & dosificación , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Análisis Multivariante , Factores de Riesgo , Índice de Severidad de la Enfermedad , Trastornos del Inicio y del Mantenimiento del Sueño/epidemiología
10.
J Am Med Dir Assoc ; 14(5): 379.e1-6, 2013 May.
Artículo en Inglés | MEDLINE | ID: mdl-23557831

RESUMEN

OBJECTIVES: The aim of this study was to develop and test the effect of an instrument, Pharmanurse, to facilitate nurse-driven adverse drug reaction (ADR) screening as an input for interdisciplinary medication review in nursing homes. DESIGN: Intervention study with a pre-posttest design PARTICIPANTS: All residents of a convenience sample of 8 nursing homes of more than 80 beds were eligible if they resided at least 1 month in the nursing home and took 4 or more different medications. Residents receiving palliative care were excluded. INTERVENTION: The intervention consisted of interdisciplinary medication review, prepared by nurse observations of potential ADRs using personalized screening lists generated by the Pharmanurse software. Pharmanurse is specifically adapted to use by nurses and to use in nursing homes. MEASUREMENTS: Outcome parameters were the number of ADRs detected by nurses, ADRs confirmed by general practitioners, and medication changes. After the intervention, health care professionals involved completed a questionnaire to evaluate the value and the feasibility of the intervention. RESULTS: Nurses observed 1527 potential ADRs in 81% of the 418 residents (mean per resident 3.7). Physicians confirmed 821 ADRs in 60% of the residents (mean per resident 2.0). As a result, 214 medication changes were planned in 21% of the residents (mean per resident 0.5) because of ADRs. Health care professionals gave the Pharmanurse intervention a score of 7 of 10 for the potential to improve pharmacotherapy and 83% of the physicians were satisfied about nurses' screening for ADRs. CONCLUSIONS: The Pharmanurse intervention supports nurses in ADR screening and may have the potential to improve pharmacotherapy.


Asunto(s)
Quimioterapia Asistida por Computador , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Evaluación en Enfermería/métodos , Casas de Salud , Anciano , Anciano de 80 o más Años , Bélgica , Monitoreo de Drogas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Grupo de Atención al Paciente , Administración de la Seguridad , Programas Informáticos
11.
Eur J Clin Pharmacol ; 69(7): 1485-96, 2013 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-23529548

RESUMEN

BACKGROUND: Anticholinergic drugs are often involved in explicit criteria for inappropriate prescribing in older adults. Several scales were developed for screening of anticholinergic drugs and estimation of the anticholinergic burden. However, variation exists in scale development, in the selection of anticholinergic drugs, and the evaluation of their anticholinergic load. This study aims to systematically review existing anticholinergic risk scales, and to develop a uniform list of anticholinergic drugs differentiating for anticholinergic potency. METHODS: We performed a systematic search in MEDLINE. Studies were included if provided (1) a finite list of anticholinergic drugs; (2) a grading score of anticholinergic potency and, (3) a validation in a clinical or experimental setting. We listed anticholinergic drugs for which there was agreement in the different scales. In case of discrepancies between scores we used a reputed reference source (Martindale: The Complete Drug Reference®) to take a final decision about the anticholinergic activity of the drug. RESULTS: We included seven risk scales, and evaluated 225 different drugs. Hundred drugs were listed as having clinically relevant anticholinergic properties (47 high potency and 53 low potency), to be included in screening software for anticholinergic burden. CONCLUSION: Considerable variation exists among anticholinergic risk scales, in terms of selection of specific drugs, as well as of grading of anticholinergic potency. Our selection of 100 drugs with clinically relevant anticholinergic properties needs to be supplemented with validated information on dosing and route of administration for a full estimation of the anticholinergic burden in poly-medicated older adults.


Asunto(s)
Envejecimiento , Antagonistas Colinérgicos/efectos adversos , Farmacovigilancia , Antagonistas Colinérgicos/clasificación , Antagonistas Colinérgicos/uso terapéutico , Bases de Datos Farmacéuticas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , Preparaciones Farmacéuticas/clasificación , Polifarmacia , Riesgo
12.
Trop Med Int Health ; 18(4): 416-25, 2013 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-23379471

RESUMEN

OBJECTIVE: To assesses the safety and rationale of antibacterial fixed-dose combinations in the private sector in Latin America and determine the extent of their use. METHODS: Analysis of FDCs was based on retail sales data for eight Latin American countries (Argentina, Brazil, Chile, Colombia, Mexico, Peru, Uruguay and Venezuela) between 1999 and 2009. FDCs were classified according to the pre-defined criteria. Use was expressed as daily defined doses per 1000 inhabitants per day (DDD/TID). RESULTS: A total of 175 antibacterial FDCs contained a mean of 1.3 antibacterial substances and 3.2 other active substances. Thirty-seven (21%) FDCs were classified as unsafe, 124 (70%) as lacking sufficient evidence for efficacy and only 14 (9%) of all FDCs were considered rational, for example amoxicillin and clavulanic acid. Consumption of unsafe FDCs decreased by 0.011 DDD/TID (95% CI: -0.012 to -0.009) annually, from 0.173 DDD/TID in 1999 to 0.070 DDD/TID in 2009 (overall decrease, 59.7%). Consumption of FDCs lacking sufficient evidence decreased by 30.3% (-0.018 DDD/TID [95% CI: -0.028 to -0.008] annually), while use of rational FDCs increased by 17.1% (from 1.283 DDD/TID to 1.497 DDD/TID annually). CONCLUSION: The majority of antibacterial FDCs in the private sector lack therapeutic benefit. Despite the decrease in the consumption of unsafe antibacterials and those lacking sufficient evidence, their use remains high and their marketing does not fit into strategies of prudent use of antibiotics to contain antibacterial resistance.


Asunto(s)
Antibacterianos/administración & dosificación , Utilización de Medicamentos/estadística & datos numéricos , Instituciones Privadas de Salud/normas , Antibacterianos/efectos adversos , Relación Dosis-Respuesta a Droga , Combinación de Medicamentos , Resistencia a Medicamentos , Quimioterapia Combinada , Utilización de Medicamentos/normas , Instituciones Privadas de Salud/estadística & datos numéricos , Humanos , América Latina , Factores de Tiempo
13.
Drugs Aging ; 29(9): 759-69, 2012 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23018612

RESUMEN

BACKGROUND: Since antidepressants are prescribed for multiple indications, the use of an antidepressant cannot be equated with a diagnosis of depression. OBJECTIVE: The objective of this study was to examine the quality of antidepressant prescribing in Belgian nursing homes, with a critical evaluation of indications and dosages, to see whether depression was appropriately treated in terms of drug choice, the indications for which antidepressants were being prescribed and whether there was underdosing. METHODS: This analysis was based on data obtained in the Prescribing in Homes for the Elderly in Belgium (PHEBE) study, a cross-sectional, descriptive study of a representative, stratified, random sample of 1,730 residents from 76 Belgian nursing homes. The PHEBE study investigated overall drug utilization in Belgian nursing homes in 2006. Clinical and medication data for the present study were obtained from this study. A 28-item checklist of clinical conditions was designed ad hoc for the PHEBE study and sent to the residents' general practitioners (GPs) to collect clinical information. We copied the residents' medication charts, classified the drugs using the Anatomical Therapeutic Chemical (ATC) classification system codes and transferred the drug names and dosages into a database. Information on indications was retrospectively obtained from the GPs, so that we could link the indication to each medication. Minimum effective doses (MEDs) of antidepressants to treat major depression were obtained from the literature to assess underdosing. RESULTS: The overall use of antidepressants in nursing homes was 39.5 % (95 % CI 37.2, 41.8). The physicians classified 34.2 % (95 % CI 32.0, 36.4) of the residents as having depression, and 80.9 % of these patients were treated with an antidepressant. Indications among the single antidepressant users (n = 551) were depression (66.2 %), insomnia (13.4 %), anxiety (6.2 %) and neuropathic pain (1.6 %). In the indication of depression, 74.8 % used a selective serotonin reuptake inhibitor (SSRI), predominantly citalopram, sertraline and escitalopram. Venlafaxine was used by 10.7 % of the residents. Dosages for these antidepressants were equal to or higher than the MED. But when trazodone, amitriptyline or mirtazapine were used to treat depression, respectively, 92.3, 55.5 and 44.5 % of prescribed dosages were below the MED. In the indication of insomnia, most of the time, trazodone (90.5 %) or mirtazapine (5.4 %) were used, and in lower dosages than those required for depression treatment (

Asunto(s)
Antidepresivos/uso terapéutico , Bases de Datos Factuales , Prescripciones de Medicamentos/estadística & datos numéricos , Casas de Salud/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Bélgica , Estudios Transversales , Demencia/complicaciones , Depresión/complicaciones , Depresión/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad
14.
Ageing Res Rev ; 11(1): 78-86, 2012 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-21856452

RESUMEN

BACKGROUND: Within the treatment of dementia, management of behavioural and psychological symptoms (BPSD) is a complex component. PURPOSE: We wanted to offer a pragmatic synthesis of existing specific practice recommendations for managing BPSD, based on agreement among systematically appraised dementia guidelines. DATA SOURCES: We conducted a systematic search in MEDLINE and guideline organisation databases, supplemented by a hand search of web sites. STUDY SELECTION: Fifteen retrieved guidelines were eligible for quality appraisal by the Appraisal of Guidelines Research and Evaluation instrument (AGREE), performed by 2 independent reviewers. DATA EXTRACTION: From the 5 included guidelines, 18 specific practice recommendations for BPSD were extracted and compared for their level of evidence and strength. DATA SYNTHESIS: No agreement was found among dementia guidelines for the majority of specific practice recommendations with regard to non-pharmacological interventions, although these were recommended as first-line treatment. Pharmacological specific practice recommendations were proposed as second-line treatment, with agreement for the use of a selection of antipsychotics based on strong supporting evidence, but with guidance for timely discontinuation. LIMITATIONS: The appraisal of the level of agreement between guidelines for each specific practice recommendation was complicated by variation in grading systems, and was performed with criteria developed a posteriori. CONCLUSION: Despite the limited number of recommendations for which agreement was found, guidelines did agree on careful antipsychotic use for BPSD. Adverse events might outweigh the supporting evidence of efficacy, weakening the recommendation. More pivotal trials on the effectiveness of non-pharmacological interventions, as well as guidelines specifically focusing on BPSD, are needed.


Asunto(s)
Síntomas Conductuales/terapia , Demencia/psicología , Demencia/terapia , Adhesión a Directriz/tendencias , Trastornos Neurocognitivos/terapia , Guías de Práctica Clínica como Asunto/normas , Anciano , Anciano de 80 o más Años , Síntomas Conductuales/etiología , Protocolos Clínicos/normas , Demencia/complicaciones , Psiquiatría Geriátrica/métodos , Psiquiatría Geriátrica/normas , Psiquiatría Geriátrica/tendencias , Humanos , Trastornos Neurocognitivos/etiología , Evaluación de Resultado en la Atención de Salud/métodos , Evaluación de Resultado en la Atención de Salud/normas , Evaluación de Resultado en la Atención de Salud/tendencias
15.
Drug Saf ; 32(4): 283-91, 2009.
Artículo en Inglés | MEDLINE | ID: mdl-19388720

RESUMEN

Benefit-risk assessment should be ongoing during the life cycle of a pharmaceutical agent. New products are subjected to rigorous registration laws and rules, which attempt to assure the availability and validity of evidence. For older products, bias in benefit-risk assessment is more likely, as a number of safeguards were not in place at the time these products were registered. This issue of bias in benefit-risk assessment of older products is illustrated here with an example: buflomedil in intermittent claudication. Data on efficacy were retrieved from a Cochrane systematic review. Data on safety were obtained by comparing the number of reports of serious adverse events and fatalities published in the literature with those reported in postmarketing surveillance databases. In the case of efficacy, the slim basis of evidence for the benefit of buflomedil is undermined by documented publication bias. In the case of safety, bias in reporting to international safety databases is illustrated by the discrepancy between the number of drug-related deaths published in the literature (20), the potentially drug-related deaths in the WHO database (20) and deaths attributed to buflomedil in the database of the international marketing authorization holder (11). In older products, efficacy cannot be evaluated without a thorough search for publication bias. For safety, case reporting of drug-related serious events and deaths in the literature remains a necessary instrument for risk appraisal of older medicines, despite the existence of postmarketing safety databases. The enforcement of efficient communication between healthcare workers, drug companies, national centres of pharmacovigilance, national poison centers and the WHO is necessary to ensure the validity of postmarketing surveillance reporting systems. Drugs considered obsolete because of unfavourable benefit-risk assessment should not be allowed to stay on the market.


Asunto(s)
Claudicación Intermitente/tratamiento farmacológico , Pirrolidinas/uso terapéutico , Vasodilatadores/uso terapéutico , Sistemas de Registro de Reacción Adversa a Medicamentos , Bases de Datos Factuales , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , Vigilancia de Productos Comercializados , Sesgo de Publicación , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de Riesgo
16.
BMC Palliat Care ; 8: 20, 2009 Dec 30.
Artículo en Inglés | MEDLINE | ID: mdl-20042090

RESUMEN

BACKGROUND: The prevalence and implementation of institutional end-of-life policies has been comprehensively studied in Flanders, Belgium, a country where euthanasia was legalised in 2002. Developing end-of-life policies in hospitals is a first step towards improving the quality of medical decision-making at the end-of-life. Implementation of policies through quality assessments, communication and the training and education of health care providers is equally important in improving actual end-of-life practice. The aim of the present study is to report on the existence and nature of end-of-life policy implementation activities in Flemish acute hospitals. METHODS: A cross-sectional mail survey was sent to all acute hospitals (67 main campuses) in Flanders (Belgium). The questionnaire asked about hospital characteristics, the prevalence of policies on five types of end-of-life decisions: euthanasia, palliative sedation, alleviation of symptoms with possible life-shortening effect, do-not-resuscitate decision, and withdrawing or withholding of treatment, the internal and external communication of these policies, training and education on aspects of end-of-life care, and quality assessments of end-of-life care on patient and family level. RESULTS: The response rate was 55%. Results show that in 2007 written policies on most types of end-of-life decisions were widespread in acute hospitals (euthanasia: 97%, do-not-resuscitate decisions: 98%, palliative sedation: 79%). While standard communication of these policies to health care providers was between 71% and 91%, it was much lower to patients and/or family (between 17% and 50%). More than 60% of institutions trained and educated their caregivers in different aspects on end-of-life care. Assessment of the quality of these different aspects at patient and family level occurred in 25% to 61% of these hospitals. CONCLUSIONS: Most Flemish acute hospitals have developed a policy on end-of-life practices. However, communication, training and the education of health care providers about these policies is not always provided, and quality assessment tools are used in less than half of the hospitals.

18.
Qual Saf Health Care ; 16(6): 440-5, 2007 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-18055888

RESUMEN

BACKGROUND AND OBJECTIVE: Indicators to measure the quality of healthcare are increasingly used by healthcare professionals and policy makers. In the context of increasing antimicrobial resistance, this study aimed to develop valid drug-specific quality indicators for outpatient antibiotic use in Europe, derived from European Surveillance of Antimicrobial Consumption (ESAC) data. METHODS: 27 experts (15 countries), in a European Science Foundation workshop, built on the expertise within the European Drug Utilisation Research Group, the General Practice Respiratory Infections Network, the ESCMID Study Group on Primary Care Topics, the Belgian Antibiotic Policy Coordination Committee, the World Health Organization, ESAC, and other experts. A set of proposed indicators was developed using 1997-2003 ESAC data. Participants scored the relevance of each indicator to reducing antimicrobial resistance, patient health benefit, cost effectiveness and public health policy makers (scale: 1 (completely disagree) to 9 (completely agree)). The scores were processed according to the UCLA-RAND appropriateness method. Indicators were judged relevant if the median score was not in the 1-6 interval and if there was consensus (number of scores within the 1-3 interval was fewer than one third of the panel). From the relevant indicators providing overlapping information, the one with the highest scores was selected for the final set of quality indicators-values were updated with 2004 ESAC data. RESULTS: 22 participants (12 countries) completed scoring of a set of 22 proposed indicators. Nine were rated as relevant antibiotic prescribing indicators on all four dimensions; five were rated as relevant if only relevance to reducing antimicrobial resistance and public health policy makers was taken into account. A final set of 12 indicators was selected. CONCLUSION: 12 of the proposed ESAC-based quality indicators for outpatient antibiotic use in Europe have face validity and are potentially applicable. These indicators could be used to better describe antibiotic use in ambulatory care and assess the quality of national antibiotic prescribing patterns in Europe.


Asunto(s)
Atención Ambulatoria/normas , Antibacterianos/uso terapéutico , Utilización de Medicamentos/normas , Guías como Asunto , Pautas de la Práctica en Medicina/normas , Indicadores de Calidad de la Atención de Salud , Antibacterianos/economía , Antibacterianos/farmacología , Benchmarking , Análisis Costo-Beneficio , Grupos Diagnósticos Relacionados , Farmacorresistencia Bacteriana , Utilización de Medicamentos/economía , Utilización de Medicamentos/estadística & datos numéricos , Europa (Continente) , Humanos , Formulación de Políticas , Vigilancia de la Población , Pautas de la Práctica en Medicina/economía , Pautas de la Práctica en Medicina/estadística & datos numéricos , Salud Pública
19.
J Clin Nurs ; 16(10): 1955-65, 2007 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-17880484

RESUMEN

AIMS AND OBJECTIVES: The aim of this paper was to illustrate the socially inclusive nature of the Bug Busting 'whole-school approach' to head louse eradication. BACKGROUND: In the UK, Belgium and Denmark, persistent head lice in families of all socio-economic status (SES) is a problem. Since 1995 in the UK and 1998 elsewhere, an educational programme intended to teach families how to detect and treat head lice by using the Bug Busting wet combing method has been organized in some areas. Local schools lead this community strategy for prevention, known as a 'whole-school approach' (UK). DESIGN AND METHODS: We describe five studies applying the Bug Busting approach, four set in districts where some disadvantaged families live (UK and Belgium) and a fifth set in Denmark. Feasibility and consumer satisfaction are examined. One UK study analyses data on area prescribing for head lice and the impact in a deprived locality of raising the profile of Bug Busting. RESULTS: We find parental education in Bug Busting enables families of all SES to participate in a 'whole-school approach' to head lice. Best results are obtained when each family has a Bug Buster Kit. This provides all the combs necessary with full instructions on their use with ordinary shampoo and conditioner to detect lice, eradicate an infestation mechanically, or to check the success of any treatment. In the UK, the promotion of the Bug Busting approach is reducing primary care expenditure on treatment for head lice and professional time spent with worried parents. As a result, healthcare providers can give time to the few families who require one-to-one guidance. RELEVANCE TO CLINICAL PRACTICE: Incorporation of the Bug Busting approach to head lice into clinical practice in school communities contributes to sustainable control whilst overcoming health inequalities in participating families.


Asunto(s)
Educación en Salud/organización & administración , Disparidades en el Estado de Salud , Infestaciones por Piojos/prevención & control , Pediculus , Dermatosis del Cuero Cabelludo/prevención & control , Servicios de Salud Escolar/organización & administración , Adolescente , Animales , Actitud Frente a la Salud , Bélgica , Niño , Preescolar , Dinamarca , Estudios de Factibilidad , Disparidades en Atención de Salud , Humanos , Control de Insectos/organización & administración , Infestaciones por Piojos/diagnóstico , Investigación en Evaluación de Enfermería , Padres/educación , Padres/psicología , Atención Primaria de Salud/estadística & datos numéricos , Evaluación de Programas y Proyectos de Salud , Dermatosis del Cuero Cabelludo/diagnóstico , Factores Socioeconómicos , Encuestas y Cuestionarios , Reino Unido
20.
Pharmacoepidemiol Drug Saf ; 16(1): 115-23, 2007 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-16700079

RESUMEN

PURPOSE: The ESAC project (European Study on Antibiotic Consumption) aims to collect antibiotic-use data through a European network of national surveillance systems. This paper reports on the retrospective data collection in ambulatory care for the period 1997-2002. METHODS: Valid data of antibiotic consumption of 24 European countries for 2002 and of 18 countries for the entire 6-year period was classified according to the Anatomical Therapeutic Chemical Classification (ATC) and expressed in defined daily dose (DDD) per 1000 inhabitants per day (DID). Overall and subgroup comparison of antibiotic consumption over time as well as between geographical clusters was performed. RESULTS: Total use of antibiotics in Europe remained at a median level of 20 DID in the period 1997-2002 with a wide variation between countries ranging from 9.8 DID in The Netherlands to 32.2 DID in France. A substantial increase in subclass consumption of co-amoxiclav and fluoroquinolones was noted while the use of narrow-spectrum penicillins, erythromycin, quinolones and sulfonamides decreased. Total consumption as well as seasonal fluctuations showed remarkable geographical clustering with low consumption and low variation between summer and winter in the North, high consumption patterns in the South and a mixed model in the East. CONCLUSIONS: Within the ESAC project, valid time series of antibiotic-use data are publicly available now, enabling to improve the study of determinants of use, the evaluation of governmental antibiotic consumption policies and the investigation of the associated emergence of antibiotic resistance.


Asunto(s)
Atención Ambulatoria/métodos , Atención Ambulatoria/estadística & datos numéricos , Antibacterianos/uso terapéutico , Revisión de la Utilización de Medicamentos/estadística & datos numéricos , Estaciones del Año , Atención Ambulatoria/tendencias , Cefalosporinas/uso terapéutico , Utilización de Medicamentos/estadística & datos numéricos , Revisión de la Utilización de Medicamentos/métodos , Revisión de la Utilización de Medicamentos/organización & administración , Europa (Continente) , Humanos , Penicilinas/uso terapéutico , Farmacoepidemiología/métodos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Quinolonas/uso terapéutico , Estudios Retrospectivos , Estreptograminas/uso terapéutico , Factores de Tiempo
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