Chronic obstructive pulmonary disease (COPD) in Spain and the different aspects of its social impact: a multidisciplinary opinion document.

Chronic obstructive pulmonary disease (COPD) is one of the most prevalent diseases in the World, and one of the most important causes of mortality and morbidity. In adults 40 years and older, it affects more than 10% of the population and has enormous personal, family and social burden. Tobacco smoking is its main cause, but not the only one, and there is probably a genetic predisposition that increases the risk in some patients. The paradigm of this disease is changing in Spain, with an increase of women that has occurred in recent years. Many of the physio pathological mechanisms of this condition are well known, but the psychological alterations to which it leads, the impact of COPD on relatives and caregivers, the limitation of daily life observed in these patients, and the economic and societal burden that they represent for the health system, are not so well-known. A major problem is the high under-diagnosis, mainly due to difficulties for obtaining, in a systematic way, spirometries in hospitals and health-care centers. For this reason, the Fundación de Ciencias de la Salud and the Spanish National Network Center for Research in Respiratory Diseases (CIBERES) have brought together experts in COPD, patients and their organizations, clinical psychologists, experts in health economics, nurses and journalists to obtain their opinion about COPD in Spain. They also discussed the scientific bibliometrics on COPD that is being carried out from the CIBERES and speculated on the future of this condition. The format of the meeting consisted in the discussion of a series of questions that were addressed by different speakers and discussed until a consensus conclusion was reached.

Hurdles of environmental risk assessment procedures for advanced therapy medicinal products: comparison between the European Union and the United States.

An environmental risk assessment (ERA) consists of an analysis of the risks to human health and the environment that a medicinal product may cause due to its release during clinical development or after entering the market. Regulators in European Union (EU) and the United States (US) require that advanced therapy medicinal products (ATMPs) that are also genetically modified organisms (GMOs) undergo an ERA in order to be approved for marketing authorization. This work aims to review the regulatory issues that need to be taken into consideration for carrying out an ERA, comparing the EU and the US. The European regulatory framework for environmental procedures and the dissimilarities in its implementation across the Member States and its implications at a logistical level are analyzed in detail. In addition, this review provides a brief insight into the non-clinical and clinical assessments that should be carried out during the development of the product in order to conduct a successful ERA, and thus facilitate its marketing authorization and post-marketing monitoring. Finally, the need for a European harmonization regarding environmental procedures for ATMPs is discussed.

Therapeutic enquiries about biological agents as a tool to identify safety aspects and patterns of use.

BACKGROUND: Biotechnological agents (BA) are increasingly being used in clinical practice. We aimed to determine, whether enquiries about them to a therapeutic consultation service have also become more frequent, and to describe the information requested in these consultations. METHODS: We retrospectively reviewed 14 104 therapeutic consultations collected in a computerised database between 2000 and 2014. Enquiries about BA (monoclonal antibodies, fusion proteins or cytokine antagonists) were chosen. Information on the type of BA, underlying condition, type of enquiry and affiliation of the enquirer was retrieved and compared with data from consultations about other agents. RESULTS: During the study period, 365 enquiries about 30 different BA were received. Only 4% of them were received before 2004, while 48.8% were received after 2010. Rituximab, infliximab, adalimumab and etanercept were most frequently enquired about. Agent selection (n=184) and/or adverse effects (n=174) were the most frequent reasons for making an enquiry. Most enquiries about an agent selection were made about an off-label use (n=164), mainly for systemic autoimmune diseases (n=61). Over half of the enquiries about adverse effects were about their teratogenic potential (n=96). Enquiries about BA more often requested an opinion (87.7% vs 77.7%) were made by physicians (89.9% vs 76.9%), from a hospital (81.6% vs 44.5%) and regarded a specific patient (87.4% vs 74.5%). CONCLUSIONS: Therapeutic consultations about BA are increasing. Most of them are related to uncertainties of health professionals regarding any new medicine: their off-label use, actual adverse effects or the teratogenic potential of the involved agents.

Outcomes of off-label drug uses in hospitals: a multicentric prospective study.

PURPOSE: The study aims to assess the clinical evidence, outcome and cost of off-label use of medicines in the hospital setting. METHODS: A multicentric prospective cohort study of patients treated with off-label medicines was carried out in five tertiary hospitals from May 2011 to May 2012. Information on clinical characteristics of patients, drugs, outcomes and costs was collected. Patients were followed up to 6 months, and information was assessed by reviewing clinical records and interviewing physicians. RESULTS: A total of 226 patients were included. The median (interquartile range (IQR)) age of patients was 46 (33-62) years; 59 % were women. Patients had received a median of three previous treatments, and a lack of response (or suboptimal) was the main reason for off-label use (72.1 %). A total of 232 off-label medicines were administered for 102 different indications. The most frequent medicines were rituximab (49; 21.1 %), botulinum toxin (25; 10.7 %) and omalizumab (14; 6.0 %). In 117 (51.8 %) cases, the level of clinical evidence for their use was low. A partial clinical response was observed in 82 patients (36.3 %), complete response in 71 (31.4 %) and stabilization in 11 (4.9 %). A total of 58 (26.5 %) patients had adverse effects, which in 11 (4.9 %) were severe. The median (IQR) cost per patient was 2,943.07 (541.9-5,872.54). CONCLUSIONS: There was a high variability of off-label medicines and indications. Although the clinical evidence of off-label medicines was often low, clinical response was observed in many patients with previous multiple treatment failure, but at the expense of some adverse effects and a high cost. Registers of patients would be helpful for clinical decisions, although clinical trials are needed.

Targeting striatal metabotropic glutamate receptor type 5 in Parkinson's disease: bridging molecular studies and clinical trials.

Metabotropic glutamate (mGlu) receptors are G protein-coupled receptors expressed primarily on neurons and glial cells modulating the effects of glutamatergic neurotransmission. The pharmacological manipulation of these receptors has been postulated to be valuable in the management of some neurological disorders. Accordingly, the targeting of mGlu5 receptors as a therapeutic approach for Parkinson's disease (PD) has been proposed, especially to manage the adverse symptoms associated to chronic treatment with classical PD drugs. Thus, the specific pharmacological blocking of mGlu5 receptors constitutes one of the most attractive non-dopaminergic-based strategies for PD management in general and for the L-DOPA-induced dyskinesia (LID) in particular. Overall, we provide here an update of the current state of the art of these mGlu5 receptor-based approaches that are under clinical study as agents devoted to alleviate PD symptoms.

Available evidence and outcome of off-label use of rituximab in clinical practice.

PURPOSE: To analyze the therapeutic indications for off-label use of rituximab, the available evidence for its use, the outcomes, and the cost. METHODS: This was a retrospective analysis of patients treated with rituximab for off-label indications from January 2007 to December 2009 in two tertiary hospitals. Information on patient characteristics, medical conditions, and therapeutic responses was collected from medical records. Available evidence for the efficacy of rituximab in each condition was reviewed, and the cost of treatment was calculated. RESULTS: A total of 101 cases of off-label rituximab use were analyzed. The median age of the patients involved was 53 [interquartile range (IQR) 37.5-68.0] years; 55.4 % were women. The indications for prescribing rituximab were primarily hematological diseases (46 %), systemic connective tissue disorders (27 %), and kidney diseases (20 %). Available evidence supporting rituximab treatment for these indications mainly came from individual cohort studies (53.5 % of cases) and case series (25.7 %). The short-term outcome (median 3 months, IQR 2-4 months) was a complete response in 38 % of cases and partial response in 32.6 %. The highest short-term responses were observed for systemic lupus erythematosus and membranous glomerulonephritis, and the lowest was for neuromyelitis optica, idiopathic thrombocytopenic purpura, and miscellaneous indications. Some response was maintained in long-term follow-up (median 23 months IQR 12-30 months) in 69.2 % of patients showing a short-term response. Median cost per patient was €5,187.5 (IQR €5,187.5-7,781.3). CONCLUSIONS: In our study, off-label rituximab was mainly used for the treatment of hematological, kidney, and systemic connective tissue disorders, and the response among our patient cohort was variable depending on the specific disease. The level of evidence supporting the use of rituximab for these indications was low and the cost was very high. We conclude that more clinical trials on the off-label use of rituximab are needed, although these may be difficult to conduct in some rare diseases. Data from observational studies may provide useful information to assist prescribing in clinical practice.

Docencia sobre las fuentes comerciales de información de medicamentos y opinión de los estudiantes de medicina / Teaching on the commercial drug information and medical students opinion

Objetivo. Conocer la opinión de los estudiantes sobre un seminario que enseña la interacción de los médicos con las fuentes comerciales de información de los medicamentos. Sujetos y métodos. Se realizó una encuesta a los estudiantes de tercero de medicina sobre un seminario que trataba de las fuentes comerciales de información de medicamentos. El seminario incluyó una videograbación de un representante comercial de una empresa farmacéutica que presentaba un nuevo medicamento a un médico, y ejemplos de información sobre medicamentos incluida en el catálogo comercial Vademécum Internacional y en los anuncios publicitarios. Se preguntó a los estudiantes el grado de interés y de satisfacción con el seminario y qué nivel de utilidad creían que podían tener las actividades desarrolladas en el seminario en su futuro profesional. En la valoración de la opinión se utilizó una escala de Likert(de 0 a 10 puntos). Resultados. De 107 estudiantes que asistieron a los seminarios, 101 (94%) participaron en la encuesta. La edad media de los estudiantes fue de 21 años(desviación estándar –DE–: 2,2 años) y 75 fueron mujeres(74%). La puntuación media del grado de interés fue de7,4 (DE: 1,5), del grado de satisfacción de 7,5 (DE: 1,6) y del grado de potencial utilidad de 7,6 (1,6). Conclusión. Los estudiantes de medicina están interesados en las actividades docentes sobre las fuentes de información comercial, y consideran que pueden ser potencialmente útiles para su futuro profesional. Es necesario formar y preparar a los estudiantes de medicina para la interacción con las fuentes comerciales de medicamentos (AU)

Aim. To know the opinion of the students about the teaching activities carried out in a seminar about the interaction of physicians with the drug information sources from pharmaceutical companies. Subjects and methods. A survey was carried out to know the opinions from third year medical students after a seminar about drug information sources. The seminar included a video showing an encounter between a physician and a pharmaceutical company representative and further critical discussion of this interaction as well as other sources from pharmaceutical companies (drug commercial catalogue and advertisements). The information was gathered by means of a questionnaire that included variables related to the students ‘opinions about the interest, the satisfaction and utility on knowledge and skills acquired in seminar by means of a ten points Likert scale. Results. A total of 107 students attended the seminars and 101 (94%) participated in the survey. The mean age of students was 21 (standard desviation –SD–: 2.2) years and 75 were women (74%). The mean score of interest in the seminar was 7.4 (SD: 1.5), the mean score of satisfaction was7.5 (SD: 1.6) and the mean score of utility was 7.6 (SD: 1.6).Conclusion. Medical students are interested in this teaching activity on commercial drug information, they are satisfied with the activity, and they consider it to be useful. It is necessary to educate the students of medicine for the interaction with the marketing activities from pharmaceutical companies (AU)

Analgesic use and pain in the hospital settings.

AIM: The aim of this study was to assess the analgesic treatment and the prevalence of pain in patients treated with analgesics in hospitals. METHODS: Adult patients treated with analgesics were selected from a sample of 1,675 patients in a cross-sectional study carried out in 15 Catalonian hospitals (Spain). Patient characteristics, type of analgesics, treatment schedules, patients' pain intensity and clinical ward and hospital characteristics were assessed. Adherence to analgesic use guidelines was established according to the principles and recommendations of internationally recognised guidelines for pain management. Pain was determined by asking patients about pain intensity by means of a visual analogue scale (VAS). RESULTS: Analgesics were prescribed for 1,173 patients (70%; 95% CI: 67.4-72.6), in whom 57% (95% CI: 54.2-59.8) had pain and in whom 30.5% (95% CI: 27.9-33.1) pain intensity was greater than 30 mm. Adherence to analgesic treatment guidelines was judged appropriate in only 26.9% (95% CI: 24.4-29.4%) of all patients. The administered analgesic dose was in the recommended dose range in 42% (95% CI: 54-58) of all analgesics and in 28% (95% CI: 24-32) of opioid analgesics. A minority of patients was treated with a rescue schedule or patient-controlled analgesia (2%; 95% CI: 1.4-2.6). Pain prevalence was higher in those with analgesic treatment that did not adhere to guidelines (63.6%; 95% CI: 60.4-66.8) than in those considered as having appropriate adherence to guidelines (39.3%; 95% CI: 33.8-44.6) (p < 0.001). Adherence to analgesic treatment guidelines was higher in the large hospitals (21%; 95% CI: 18-24) than in medium and small hospitals (13%; 95% CI: 9-16) (p < 0.001). CONCLUSIONS: Although analgesic use is high in the hospital settings, adherence to the principles and recommendations of pain guidelines is low, and pain is usually common in patients treated with analgesics. These results once again emphasise the need to improve analgesic use and pain management in hospitals.

[Multicenter study of pain assessment in hospitals]. / Estudio multicéntrico de la evaluación del dolor en el medio hospitalario.

OBJECTIVE: To evaluate the recording of pain intensity in hospital charts. METHODS: A cross-sectional study was carried out in 15 hospitals in a sample of admitted patients with pain. Clinical data, including pain intensity, were gathered from the hospital records. Multiple analysis of variance was used to identify factors related to the intensity of pain recorded in the patients' charts. RESULTS: A total of 1038 patients with a mean (SD) age of 56.1 (18.9) years were included. Pain intensity was noted in the charts of 47.9% (95% confidence interval [CI], 44.9%-50.9%) of the patients. Pain intensity had been noted for 68.9% (95% CI, 61.4%-76.4%) of the patients with cancer, 43% (95% CI, 38.2%-47.8%) of postoperative patients, 38.2% (95% CI, 35%-41.4%) of trauma patients, and 26.6% (95% CI, 16.9%-36.3%) of postpartum women. There was great interhospital variability. Factors associated with the recording of pain intensity in medical charts were hospital characteristics (large hospitals, teaching hospitals, hospitals and internal medicine and surgical specialities) and type of patient (cancer and trauma cases and patients reporting pain to the staff). CONCLUSION: There is inadequate written recording of intensity of pain in hospitals, even though there is considerable interhospital variation. Pain intensity assessment and recording is an indicator of quality of health care and should become a routine practice in hospital health care.

Estudio multicéntrico de la evaluación del dolor en el medio hospitalario / Multicenter study of pain assessment in hospitals

OBJETIVO: Evaluar el registro de la intensidad del dolor en los hospitales. MÉTODOS: Estudio transversal en 15 hospitales. Se seleccionó una muestra de los pacientes hospitalizados con dolor. Se recogió información clínica de los pacientes y del registro de la intensidad del dolor en las historias clínicas. Se realizó un análisis multivariante para identificar los factores relacionados con el registro de la intensidad del dolor en las historias clínicas. RESULTADOS: Fueron incluidos 1.038 pacientes con una edad media (DE) de 56,1 (18,9) años. Se registró la intensidad del dolor en las historias clínicas de un 47,9% (IC 95%: 44,9-50,9%) de los pacientes. Se anotó la intensidad del dolor en un 68,9% (IC 95%: 61,4-76,4%) de los pacientes neoplásicos, en un 43% (IC 95%: 38,2- 47,8%) de los postoperados, en un 38,2% (IC 95%: 35- 41,4%) de los traumáticos y en un 26,6% (IC 95%: 16,9- 36,3%) de las mujeres postparto. Se observó una amplia variabilidad entre los diferentes hospitales. Los factores relacionados con un mayor registro de la intensidad del dolor en las historias clínicas fueron las características hospitalarias (grandes hospitales, hospitales docentes y servicios de medicina y cirugía) y de los pacientes (neoplásicos, traumáticos y los que comunicaron el dolor al personal sanitario). CONCLUSIÓN: El registro de la intensidad del dolor de los pacientes en los hospitales es insuficiente aunque existe una amplia variabilidad entre los hospitales. El registro de la intensidad del dolor es un indicador de calidad asistencial y debería ser una actividad rutinaria en el proceso asistencial hospitalario

OBJECTIVE: To evaluate the recording of pain intensity in hospital charts. METHODS: A cross-sectional study was carried out in 15 hospitals in a sample of admitted patients with pain. Clinical data, including pain intensity, were gathered from the hospital records. Multiple analysis of variance was used to identify factors related to the intensity of pain recorded in the patients’ charts. RESULTS: A total of 1038 patients with a mean (SD) age of 56.1 (18.9) years were included. Pain intensity was noted in the charts of 47.9% (95% confidence interval [CI], 44.9%-50.9%) of the patients. Pain intensity had been noted for 68.9% (95% CI, 61.4%-76.4%) of the patients with cancer, 43% (95% CI, 38.2%-47.8%) of postoperative patients, 38.2% (95% CI, 35%-41.4%) of trauma patients, and 26.6% (95% CI, 16.9%-36.3%) of postpartum women. There was great interhospital variability. Factors associated with the recording of pain intensity in medical charts were hospital characteristics (large hospitals, teaching hospitals, hospitals and internal medicine and surgical specialities) and type of patient (cancer and trauma cases and patients reporting pain to the staff). CONCLUSION: There is inadequate written recording of intensity of pain in hospitals, even though there is considerable interhospital variation. Pain intensity assessment and recording is an indicator of quality of health care and should become a routine practice in hospital health care

Analgesics for pain after traumatic or orthopaedic surgery: what is the evidence--a systematic review.

OBJECTIVE: To assess analgesic drugs in the treatment of postoperative pain after traumatic and orthopaedic surgery (TOS). DESIGN: A systematic review of randomised clinical trials (RCTs). DATA SOURCES: Electronic PubMed, EMBASE, The Cochrane Library, and hand searches. STUDY SELECTION: RCTs of analgesics administered by oral, intramuscular, intravenous, subcutaneous or rectal route, were compared to other analgesics or placebo, in patients under TOS. Study design, characteristics of the study population, analgesic drugs tested, pain intensity and pain relief scores, and adverse effects were assessed. RESULTS: Ninety-two RCTs (9,596 patients) met our inclusion criteria. Forty-two (46%) were placebo-controlled, and 50 (54%) were direct comparisons between non-opioid, opioid, and/or combinations of both. Patients' mean age (SD) was 49 years (18). In most trials, gastrointestinal ulcer, liver and renal diseases were exclusion criteria. Only 30 trials (33%) were double-blind and reported standardised outcomes of pain intensity and pain relief; 19 of these were single-dose, and follow up of analgesic effects lasted no more than 12 h in 23 (77%). Globally, only nine trials (10%) were double blind, described dropouts or withdrawals, performed analysis by intention to treat, and reported the effects magnitude. CONCLUSION: Evidence from RCTs on the treatment of postoperative pain after TOS is inadequate for clinical decision making. Assessment of analgesics in pain after TOS should be based on agreed clinically relevant outcomes, in representative patients, and for longer observation periods. In addition, it should include direct comparisons between candidate drugs or their combinations and between various drug administration schedules.

Utilisation of antihyperglycaemic drugs in ten European countries: different developments and different levels.

AIMS/HYPOTHESIS: The aim of this study was to compare developments in the utilisation of antihyperglycaemic drugs (AHGDs) in ten European countries. SUBJECTS AND METHODS: Data on the yearly utilisation of insulin and oral AHGDs were collected from public registers in Denmark, Finland, Norway, Sweden, Belgium, England, Germany, Italy, Portugal and Spain, and were expressed as defined daily doses per 1,000 inhabitants per day. RESULTS: Total AGHD utilisation increased everywhere, but at different rates and levels. Insulin utilisation doubled in England and Germany, but hardly changed in Belgium, Portugal or Italy. Sulfonylurea utilisation doubled in Spain, England and Denmark but was reduced in Germany and Sweden. Metformin utilisation increased greatly everywhere. There were two- to three-fold differences in AHGD utilisation even between neighbouring countries. In Finland, there were more users of both insulin (+120%) and oral AHGDs (+80%) than in Denmark, and the daily oral AHGD doses were higher. In Denmark and Sweden, AHGD utilisation was equal in subjects aged <45 years, but in those >or=45 years of age, both insulin and oral AHGD utilisation were twice as high in Sweden. CONCLUSIONS/INTERPRETATION: The ubiquitous increase in AHGD utilisation, particularly metformin, seems logical, considering the increasing prevalence of type 2 diabetes and the results of the UK Prospective Diabetes Study. However, the large differences even between neighbouring countries are more difficult to explain, and suggest different habits and attitudes in terms of screening and management of type 2 diabetes.

Prevalence of pain in adults admitted to Catalonian hospitals: a cross-sectional study.

OBJECTIVE: To survey the prevalence of pain in patients admitted to different hospitals of Catalonia and to describe which factors are related to pain. METHODS: A cross-sectional study was performed in 1675 patients from fifteen hospitals in Catalonia (Spain). Clinical and demographic data, as well as the existence of pain intensity evaluations and analgesic therapy, were obtained from medical charts. Characteristics of pain were given by patients after being interviewed by trained interviewers. The main-outcome measure was the existence of pain (at the interview, in the previous 24h, at the admission and at any time after admission) that was assessed by a visual analogue scale (VAS). The relationship of prevalence of pain to patients' characteristics was carried out by means of a multiple-logistic-regression model with pain presence as the dependent variable of interest. RESULTS: A great variability in the prevalence and intensity of pain among different hospitals was observed. At the time of the interview, 48.5% (95% CI: 46.1-50.9%) of the patients had pain and the median VAS was 40mm (range: 10-100mm), and the prevalence of pain during the previous 24h was similar (47.6%; 95% CI: 45.2-50%). At admission, 26.7% (95% CI: 24.6-28.8%) of patients were in pain, whereas 62% (95% CI: 59.7-64.3%) reported having pain at some time during their stay. Pain intensity annotations were absent in 51.3% (95% CI: 47.9-54.7%) of the medical records of the patients with pain. The factors associated with pain were younger age, female gender, presence of surgery, orthopaedic surgery wards, large hospital and prescribed analgesics. CONCLUSION: A high prevalence of clinically relevant pain in in-patients was found as well as a great variability according to type of patients, clinical wards and hospitals. This study gives clear evidence of the lack of adequate management of pain in the majority of the hospitals and calls for the implementation of organisational and educational measurements that may settle this epidemic problem.

Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital.

AIM: To describe the opinions of hospital physicians concerning problems regarding the spontaneous reporting of adverse drug reactions (ADRs) and ways to solve them. METHODS: A qualitative study was carried out. Fifteen focus groups were conducted among physicians working in a tertiary teaching hospital. A total of 208 physicians from different medical specialities participated. The focus group discussions were recorded by three different observers and the transcripts of each session were analysed for issues and themes emerging from the text. RESULTS: Four types of obstacles to spontaneous reporting were considered particularly important: (i) problems with the ADR(S) diagnosis; (ii) problems with the usual workload and lack of time; (iii) problems related to the organization and activities of the pharmacovigilance system; (iv) and problems related to potential conflicts. The potential solutions suggested for improving spontaneous reporting were to define the kind of ADR(S) which should be reported, to facilitate an easy contact and quick access to the hospital pharmacovigilance system, to facilitate information and support for reporting and feedback of pharmacovigilance activities. CONCLUSIONS: The perception of the different obstacles by the hospital physicians is an important factor in determining the causes of the underreporting of ADRs and addressing these obstacles could lead to an improvement in spontaneous reporting. A closer relationship between the doctors and the pharmacovigilance centre is suggested as a means of solving these problems. More information is needed to improve the spontaneous reporting of ADR(S) in specialized healthcare.

Consumo y gasto de fármacos antipsicóticos / Consumption and cost of antipsychotic drugs

Introducción. En los últimos años se han comercializado nuevos fármacos antipsicóticos atípicos. El objetivo del estudio es analizar la evolución del patrón de consumo y del gasto farmacéutico de los fármacos antipsicóticos durante los últimos años y el impacto que han tenido los nuevos fármacos antipsicóticos atípicos. Métodos. A partir de la base de datos ECOM del Ministerio de Sanidad y Consumo español se han seleccionado los datos de ventas de los fármacos antipsicóticos en Cataluña durante el período 1990-2001. Los fármacos se han clasificado en típicos o clásicos y atípicos. Los datos de consumo se han expresado en dosis diarias definidas (DDD) por 1.000 habitantes y por día de tratamiento (DHD) y los de gasto en euros constantes. Resultados. El consumo de antipsicóticos aumentó de 3,31 DHD en 1990 a 6,04 DHD en 2001. El consumo de los típicos disminuyó (del 100 % del consumo en 1990 a un 46 % en 2001) y aumentó el de los atípicos (del 1% del consumo en el año 1993 a un 54 % en el año 2001). Se constató un cambio en el patrón de uso de los diferentes fármacos. En el año 1990 los fármacos más consumidos fueron el flupentixol (0,86 DHD) y el haloperidol (0,67 DHD), y en el año 2001 la olanzapina (1,69 DHD) y la risperidona (1,30 DHD). Los fármacos con un mayor incremento del consumo fueron la olanzapina, que multiplicó por cinco su consumo de 1997 a 2001, y la risperidona, que multiplicó por 20 su consumo de 1994 a 2001. Durante el período de estudio el gasto aumentó unas 13 veces, sobre todo a causa del incremento del gasto de los antipsicóticos atípicos (de menos del 1% del gasto total en 1993 a un 92 % del gasto total en 2001). El coste de la DDD de los antipsicóticos se incrementó (6,48e en 1990 y 20,31e en 2001); sin embargo, el de los antipsicóticos típicos disminuyó (6,48e en 1990 y 4,62e en 2001) y el de los atípicos aumentó (2,06e en 1993 y 15,69e en 2001). Conclusión. La comercialización de los nuevos antipsicóticos atípicos ha tenido un extraordinario impacto sobre el consumo y el gasto de los medicamentos antipsicóticos. Se debería evaluar la relación coste/efectividad de los nuevos antipsicóticos atípicos en la práctica clínica para determinar los recursos económicos destinados al gasto de los diferentes fármacos antipsicóticos

Introduction. In recent years, new atypical antipsychotic drugs have been marketed. This study aims to analyze the evolution of the consumption pattern and pharmaceutical cost of the antipsychotic drugs during the last years and the impact that the new atypical antipsychotic drugs have had. Methods. Based on the ECOM database of the Ministry of Health and Consumer Affairs of Spain, the sales data of the antipsychotic drugs in Catalonia during the 1990-2001 period have been chosen. The drugs have been classified into typical or classical and atypical. Consumption data have been expressed in daily defined dose (DDD) per 1,000 inhabitants and per day of treatment (DID), and cost data in constant euros. Results. Antipsychotic consumption increased from 3.31 DID in 1990 to 6.04 DID in 2001. Typical drugs consumption decreased (from 100 % consumption in 1990 to 46 % in 2001) and that of the atypical ones increased (from 1% consumption in the year 1993 to 54% in the year 2001). A change in the use pattern of different drugs is verified. In the year 1990, the most consumed drugs were flupenthixol (0.86 DID) and haloperidol (0.67 DID), and in the year 2001 olanzapine (1.69 DID) and risperidone (1.30 DID). The drugs with a greater increase in consumption were olanzapine, which multiplied its consumption five fold from 1997 to 2001 and risperidone, which multiplied it by 20 from 1994 to 2001. During the study period, the cost increased 13 times, above all due to increase in cost of atypical antipsychotics (from less than 1 % of the total cost in 1993 to 92 % of the total cost in 2001). The DDD cost of antipsychotics increased (6.48e in 1990 and 20.31e in 2001). However, that of the typical antipsychotics decreased (6.48e in 1990 and 4.62e in 2001) and that of the atypical ones increased (2.06e in 1993 and 15.69e in 2001). Conclusion. The marketing of the new atypical antipsychotic drugs has had an extraordinary impact on antipsychotic drug consumption and cost. The cost/effectiveness ratio of the new atypical antipsychotic drugs in the clinical practice should be evaluated to determine the economic resources aimed at costs of the different antipsychotic drugs

[Consumption and cost of antipsychotic drugs]. / Consumo y gasto de fármacos antipsicóticos.

INTRODUCTION: In recent years, new atypical antipsychotic drugs have been marketed. This study aims to analyze the evolution of the consumption pattern and pharmaceutical cost of the antipsychotic drugs during the last years and the impact that the new atypical antipsychotic drugs have had. METHODS: Based on the ECOM database of the Ministry of Health and Consumer Affairs of Spain, the sales data of the antipsychotic drugs in Catalonia during the 1990-2001 period have been chosen. The drugs have been classified into typical or classical and atypical. Consumption data have been expressed in daily defined dose (DDD) per 1,000 inhabitants and per day of treatment (DID), and cost data in constant euros. RESULTS: Antipsychotic consumption increased from 3.31 DID in 1990 to 6.04 DID in 2001. Typical drugs consumption decreased (from 100 % consumption in 1990 to 46 % in 2001) and that of the atypical ones increased (from 1% consumption in the year 1993 to 54% in the year 2001). A change in the use pattern of different drugs is verified. In the year 1990, the most consumed drugs were flupenthixol (0.86 DID) and haloperidol (0.67 DID), and in the year 2001 olanzapine (1.69 DID) and risperidone (1.30 DID). The drugs with a greater increase in consumption were olanzapine, which multiplied its consumption five fold from 1997 to 2001 and risperidone, which multiplied it by 20 from 1994 to 2001. During the study period, the cost increased 13 times, above all due to increase in cost of atypical antipsychotics (from less than 1 % of the total cost in 1993 to 92 % of the total cost in 2001). The DDD cost of antipsychotics increased (6.48 euros in 1990 and 20.31 euros in 2001). However, that of the typical antipsychotics decreased (6.48 euros in 1990 and 4.62 euros in 2001) and that of the atypical ones increased (2.06 euros in 1993 and 15.69 euros in 2001). CONCLUSION: The marketing of the new atypical antipsychotic drugs has had an extraordinary impact on antipsychotic drug consumption and cost. The cost/effectiveness ratio of the new atypical antipsychotic drugs in the clinical practice should be evaluated to determine the economic resources aimed at costs of the different antipsychotic drugs.

Medical speciality and pattern of medicines prescription.

OBJECTIVE: To describe the prescribing patterns and their quality in relation to the prescriber's medical specialty in a defined population. METHODS: The study was done on a random sample of all primary care medical prescriptions made through the social security system during 1 year in Andorra, a small European country. Number and type of prescribed medicines, prescribers' medical speciality and patients' age and gender were recorded. Medical specialties considered were General Practice, Paediatrics, Cardiology, Pneumology, Gynaecology, Ophthalmology and Other. A set of various quality indicators [World Health Organisation (WHO)/International Network for Rational Use of Drugs (INRUD) indicators and others] was used. RESULTS: The number of medicines prescribed per encounter varied depending on the prescriber's medical specialty and patient's age. Cardiologists and pneumologists tended to prescribe more medicines than other medical specialties. Patients older than 65 years received more prescriptions than younger adults, mostly at the expense of cardiovascular drugs. The contribution of the various groups and subgroups of medicines and the scores of various prescribing indicators showed wide variability across the medical specialties. CONCLUSION: Prescribing patterns and indicators of prescription quality show wide variability depending on the prescriber's medical specialty. This has important implications for priority setting in information, continuous education and research.

Oral antispastic drugs in nonprogressive neurologic diseases: a systematic review.

OBJECTIVE: To assess the efficacy of oral drugs in the treatment of spasticity in patients with nonprogressive neurologic disease (NPND). METHODS: Systematic review of double-blind randomized controlled trials of antispastic oral drugs in the treatment of spasticity in NPND. DATA SOURCES: Electronic MEDLINE, PubMed, Cochrane Library, and hand searches. RESULTS: Twelve studies (469 patients) were included (6 on stroke, 3 on spinal cord diseases, and 3 on cerebral palsy). Tizanidine was assessed in four trials (276 patients, 142 exposed), dantrolene in four (103, 93), baclofen in three (70, 55), diazepam in two (127, 76), and gabapentin in one (28, all exposed). Most trials were of small size, of short duration, and their methodologic quality was inadequate. Ten trials were controlled with placebo and only two were direct comparisons between drugs. Efficacy outcome variables were heterogeneous. Only four reports described the magnitude of the antispastic effect. The incidence of adverse drug effects (drowsiness, sedation, and muscle weakness) was high. CONCLUSION: Evidence on the efficacy of oral antispastic drugs in NPND is weak and does not include evaluation of patients' quality of life. If any, efficacy is marginal. Adverse drug reactions were common. Better methodologic instruments are needed for the evaluation of antispastic treatment.

[Use of levofloxacin in the hospital]. / Utilización hospitalaria de levofloxacino.

Levofloxacin is a new, recently commercialized fluoroquinolone. We aimed to assess the use of levofloxacin after its inclusion in the hospital drug guide. In a prospective observational study, patients treated with levofloxacin in a university hospital were selected from July 2000 to June 2001. Using a structured questionnaire, data were recorded on patients' demographic characteristics and comorbidities, indications for levofloxacin use and previous use of other antibiotics. In addition, the adherence to the instructions for use as recommended by the antibiotic subcommittee of the hospital, and the use of other alternative antibiotics were analyzed. Ninety-seven patients were treated [mean age 67 years; range 17-93; 64 men], of whom 83 (85.6%) had comorbidity and 51 (52.6%) a possible allergy to the betalactam antibiotics. The treatment began after the use of other antibiotics in 47 (48.5%) patients. The main clinical indications were pneumonia (54; 55.7%) and acute exacerbation of chronic bronchitis (25; 25.8%). The use of other antibiotics was possible in 56 (57.7%) patients, and levofloxacin was only used according to the recommended indications in 41 (42.3%). Levofloxacin is mainly used in the treatment of patients with respiratory infections, those who are allergic to the betalactam antibiotics and those previously treated with other antibiotics; however, in many cases, the use of other antibiotics may still be possible. As part of the antibiotic policy, it is necessary to define the indications of use for new antibiotics introduced in the hospital and surveillance studies need to be developed.