Impact of the EMA/FDA alerts on the use of effective contraceptive method in women of childbearing age undergoing valproic acid treatment in a long-stay psychiatric center.

OBJECTIVE: We aimed to evaluate the impact of the European Medicines Agency (EMA) and Food Drug and Administration (FDA) alerts on the use of effective contraceptive method in women of childbearing age undergoing valproic acid treatment in a long-stay psychiatric center. MATERIAL AND METHODS: An interrupted time-series analysis of women of childbearing age admitted in a long-stay psychiatric center (2013-2019), according to the EMA/FDA restrictions dates (October 2014 and February 2018). RESULTS: Of the 82 cases included, 50 (61.0%) had an 'off-label' prescription. The percentage of cases with a contraceptive method before October 2014 (31.6%) increased to 61.5% after October 2014, p = 0.004. Women with an 'off-label' prescription after 2018 were more likely to use a contraceptive method than those before 2014, and there were not statistically significant differences in women with an 'under indication' prescription. CONCLUSIONS: The recent regulatory restrictions on the use of a contraceptive method had a positive effect, mainly in women with an 'off-label' prescription. No effect was seen in women with epilepsy, probably because the intervention had started long before.

Uso de los antipsicóticos en adultos mayores / Use of antipsychotics in older adults

Los síntomas psicóticos son frecuentes en las personas de edad avanzada. Al considerar el uso de antipsicóticos para el manejo de estos síntomas en dicha población, debe distinguirse entre el envejecimiento de personas con trastornos mentales preexistentes y las personas con síntomas psicóticos de nueva aparición. Estos últimos aumentan con la edad; mientras que los síntomas de enfermedades de aparición en edades más tempranas suelen atenuarse con la edad. Aunque los antipsicóticos se emplean en personas de edad avanzada, no existen pruebas de su eficacia; por el contrario, se sabe que pueden ser la causa de múltiples problemas, como una mayor sensibilidad a efectos adversos y un mayor riesgo de interacciones farmacológicas. Ante esta situación, considerando los datos de eficacia y seguridad, se impone el empleo de medidas no farmacológicas de tipo psicosocial en el tratamiento de los problemas psicóticos y conductuales de los ancianos. En caso de eficacia insuficiente de estas, puede estar justificado un uso prudente de fármacos antipsicóticos, limitado en dosis y duración, y controlando la relación beneficio/efectos adversos generados. La vigilancia cuidadosa de los efectos adversos, incluyendo los subjetivos, debe constituir una parte integral del plan terapéutico. La reevaluación periódica de la necesidad de su empleo debe hacerse siempre, con pautas de retirada lenta

Psychotic symptoms are frequent in the elderly. When using antipsychotics for the management of psychotic syndromes in this population, a distinction must be made between the aging of people with pre-existing mental disorders and those people with newly-onset psychotic symptoms. The latter increase with age, while the symptoms of early-onset diseases usually attenuate with age. Although antipsychotics are used in people of advanced age, there is no evidence of their efficacy. On the contrary, they can cause multiple problems, such as greater sensitivity to adverse effects and risk of drug interactions. Given the efficacy and safety data, the use of non-pharmacological interventions of a psychosocial type in the treatment of psychotic and behavioural problems in the elderly is mandatory. If they are not effective, the use of antipsychotic drugs can be justified, limited in dose and duration, and controlling the benefit/adverse effects ratio. Careful monitoring of adverse effects, including the subjective ones, should be an integral part of the therapeutic plan. The periodic re-evaluation of the need for their employment must always be made, and the withdrawal must be slow

Posible relación de loratadina con el desenlace fatal en un paciente de riesgo / Possible link of loratadine with a fatal outcome in an at-risk patient

Un varón de 62 años, polimedicado de forma crónica por enfermedad mental grave y persistente, EPOC, diabetes e hipotiroidismo, estabilizado desde hace bastantes meses, inició un tratamiento con loratadina por rinitis. Al día siguiente es encontrado desvanecido sin conocimiento y trasladado de urgencia al hospital general para cuidados intensivos, donde fallece un día después. El análisis del caso revela un posible «efecto mariposa» con desenlace fatal, desencadenado por un fármaco de bajo riesgo, dada la situación «al límite» de la terapia previa (AU)

A 69-year-old man, who has been clinically chronic for severe and persistent mental illness, COPD, diabetes and hypothyroidism, stabilized for several months, began treatment with loratadine for rhinitis. The next day he is found unconscious and rushed to the general hospital for intensive care, where he dies a day later. The case analysis reveals a possible «butterfly effect», a fatal outcome caused by a low risk drug, given the «borderline» situation of prior therapy (AU)

[Antipsychotics for schizophrenia: the paradigm of psychiatric drugs]. / Antipsicóticos para la esquizofrenia: paradigma de los medicamentos psiquiá.

Antipsychotic drugs do not appear to reverse the causes of schizophrenia, and although they can relieve symptoms in the short to medium term, in the long term they may not be beneficial and could even be counterproductive. Their use should be limited to acute situations in which agitation and tension is disabling. The drugs have significant adverse effects, and given the refusal of a person to continue taking them, a harm reduction strategy to support and monitor the withdrawal may be preferable to coercion. There are alternatives to neuroleptics. Prescribers should be more vigilant and consider the assessments of users regarding the drugs' effects. Adherence to treatment guidelines is low, probably because the guidelines are based on clinical trials of deficient quality which consequently should be improved and extended over a greater period of time. The root of the problem is likely the tautology on the etiology and biological nature of what is known as schizophrenia, which in fact does not seem to be more than a commercial and ideological construct.

Uso de ácido valproico en unidades de psiquiatría de estancia prolongada / Use of valproic acid in long stay units of psychiatry

Objetivo: El ácido valproico es utilizado frecuentemente en psiquiatría para tratar la esquizofrenia y otras afecciones fuera de indicación de ficha técnica ("off-label"). A pesar de ello, su efectividad no ha sido suficientemente demostrada y su uso no está exento de efectos adversos. El presente estudio tiene como objetivo principal conocer la frecuencia de uso de ácido valproico tanto en las indicaciones recogidas en ficha técnica, como su utilización "off-label" en pacientes psiquiátricos. Método: Se diseñó un estudio transversal el 7 de julio de 2014 con una muestra de 167 pacientes residentes en un centro psiquiátrico. Se analizaron las siguientes variables: datos demográficos, tratamiento con ácido valproico y pauta posológica, tratamiento farmacológico asociado, monitorización de los parámetros de seguridad, interacciones y concentraciones de ácido valproico. Resultados: El ácido valproico se prescribió en 1 de cada 3 pacientes del centro. Se utilizó según las indicaciones aprobadas en ficha técnica en 8 (15%) de los 53 pacientes analizados: 5 (9%) de ellos con trastorno bipolar y 3 (6%) diagnosticados de epilepsia. Otros 5 pacientes (9%) se incluyeron en la indicación extendida de trastorno esquizoafectivo. El 76% (40) de los pacientes evaluados tenían prescrito ácido valproico fuera de indicación. La media de dosis de ácido valproico fue de 1,26 Dosis Diarias Definidas/paciente/día. Se encontró una media de 6 fármacos asociados al ácido valproico. El 18% de los pacientes presentó trombocitopenia. Conclusiones: El ácido valproico se utiliza frecuentemente en pacientes psiquiátricos fuera de indicación. Debería valorarse el beneficio-riesgo en esta población (AU)

Objective: Valproic acid is often used in psychiatry to treat schizophrenia and other conditions outside of indication ("off-label"). However, its effectiveness has not been sufficiently demonstrated and its use is not exempt of adverse effects. This study's main objective is to determine the frequency of use of valproic acid in approved indications and the "off-label" use in psychiatric patients. Methods: A cross-sectional study on July 7, 2014 with a sample of 167 patients residents in a psychiatric center was designed. Demographics, valproic acid treatment, posology and associated drug treatment, monitoring safety parameters, interactions and valproic acid concentrations. Results: Valproic acid is prescribed in 1 of 3 patients of the center. It was used in the approved indications in 8 (15%) of the 53 patients analyzed: 5 (9%) of them with bipolar disorder and 3 (6%) diagnosed with epilepsy. Other 5 patients (9%) were included in the extended schizoaffective disorder indication. 76% (40) of the evaluated patients were prescribed valproic acid off-label. The mean dose of valproic acid was 1.26 Defined Daily Dose / patient / day. An average of 6 drugs associated with valproic acid was found. 18% of patients had thrombocytopenia. Conclusions: Valproic acid is often used off-label in psychiatric patients. It should be assessed the benefit-risk in this population (AU)

[Use of valproic acid in long stay units of psychiatry]. / Uso de ácido valproico en unidades de psiquiatría de estancia prolongada.

OBJECTIVE: Valproic acid is often used in psychiatry to treat schizophrenia and other conditions outside of indication ("off-label"). However, its effectiveness has not been sufficiently demonstrated and its use is not exempt of adverse effects. This study's main objective is to determine the frequency of use of valproic acid in approved indications and the "off-label" use in psychiatric patients. METHODS: A cross-sectional study on July 7, 2014 with a sample of 167 patients residents in a psychiatric center was designed. Demographics, valproic acid treatment, posology and associated drug treatment, monitoring safety parameters, interactions and valproic acid concentrations. RESULTS: Valproic acid is prescribed in 1 of 3 patients of the center. It was used in the approved indications in 8 (15%) of the 53 patients analyzed: 5 (9%) of them with bipolar disorder and 3 (6%) diagnosed with epilepsy. Other 5 patients (9%) were included in the extended schizoaffective disorder indication. 76% (40) of the evaluated patients were prescribed valproic acid off-label. The mean dose of valproic acid was 1.26 Defined Daily Dose / patient / day. An average of 6 drugs associated with valproic acid was found. 18% of patients had thrombocytopenia. CONCLUSIONS: Valproic acid is often used off-label in psychiatric patients. It should be assessed the benefit-risk in this population.

Objetivo: El ácido valproico es utilizado frecuentemente en psiquiatría para tratar la esquizofrenia y otras afecciones fuera de indicación de ficha técnica ("off-label"). A pesar de ello, su efectividad no ha sido suficientemente demostrada y su uso no está exento de efectos adversos. El presente estudio tiene como objetivo principal conocer la frecuencia de uso de ácido valproico tanto en las indicaciones recogidas en ficha técnica, como su utilización "off-label" en pacientes psiquiátricos. Método: Se diseñó un estudio transversal el 7 de julio de 2014 con una muestra de 167 pacientes residentes en un centro psiquiátrico. Se analizaron las siguientes variables: datos demográficos, tratamiento con ácido valproico y pauta posológica, tratamiento farmacológico asociado, monitorización de los parámetros de seguridad, interacciones y concentraciones de ácido valproico. Resultados: El ácido valproico se prescribió en 1 de cada 3 pacientes del centro. Se utilizó según las indicaciones aprobadas en ficha técnica en 8 (15%) de los 53 pacientes analizados: 5 (9%) de ellos con trastorno bipolar y 3 (6%) diagnosticados de epilepsia. Otros 5 pacientes (9%) se incluyeron en la indicación extendida de trastorno esquizoafectivo. El 76% (40) de los pacientes evaluados tenían prescrito ácido valproico fuera de indicación. La media de dosis de ácido valproico fue de 1,26 Dosis Diarias Definidas/paciente/día. Se encontró una media de 6 fármacos asociados al ácido valproico. El 18% de los pacientes presentó trombocitopenia. Conclusiones: El ácido valproico se utiliza frecuentemente en pacientes psiquiátricos fuera de indicación. Debería valorarse el beneficio-riesgo en esta población.

Antipsicóticos para la esquizofrenia: paradigma de los medicamentos psiquiátricos / Antipsychotics for schizophrenia: the paradigm of psychiatric drugs

Los antipsicóticos no parecen revertir las causas de la esquizofrenia y, aunque son fármacos que pueden aliviar los síntomas a corto y mediano plazo, a largo plazo pueden no ser beneficiosos e incluso ser contraproducentes. Su empleo debería limitarse a situaciones agudas con agitación y tensión incapacitante. Presentan considerables efectos adversos y, ante la negativa de una persona a seguir tomándolos, adoptar una estrategia de reducción de daños apoyando y supervisando la retirada puede ser preferible a la coerción. Existen alternativas a los neurolépticos. Los prescriptores deberían estar más atentos y considerar las valoraciones que los usuarios hacen de sus efectos. El apego a las guías de tratamiento es escaso, seguramente por basarse en ensayos clinicos de calidad deficente, que deben mejorar y prolongarse en el tiempo. La raíz del problema probablemente se encuentra en la tautología sobre la etiología y naturaleza biológica de lo que llaman esquizofrenia, que realmente no parece ser más que un constructo ideológico-comercial.(AU)

Antipsychotic drugs do not appear to reverse the causes of schizophrenia, and although they can relieve symptoms in the short to medium term, in the long term they may not be beneficial and could even be counterproductive. Their use should be limited to acute situations in which agitation and tension is disabling. The drugs have significant adverse effects, and given the refusal of a person to continue taking them, a harm reduction strategy to support and monitor the withdrawal may be preferable to coercion. There are alternatives to neuroleptics. Prescribers should be more vigilant and consider the assessments of users regarding the drugs effects. Adherence to treatment guidelines is low, probably because the guidelines are based on clinical trials of deficient quality which consequently should be improved and extended over a greater period of time. The root of the problem is likely the tautology on the etiology and biological nature of what is known as schizophrenia, which in fact does not seem to be more than a commercial and ideological construct.(AU)

Antipsicóticos para la esquizofrenia: paradigma de los medicamentos psiquiátricos / Antipsychotics for schizophrenia: the paradigm of psychiatric drugs

Los antipsicóticos no parecen revertir las causas de la esquizofrenia y, aunque son fármacos que pueden aliviar los síntomas a corto y mediano plazo, a largo plazo pueden no ser beneficiosos e incluso ser contraproducentes. Su empleo debería limitarse a situaciones agudas con agitación y tensión incapacitante. Presentan considerables efectos adversos y, ante la negativa de una persona a seguir tomándolos, adoptar una estrategia de reducción de daños apoyando y supervisando la retirada puede ser preferible a la coerción. Existen alternativas a los neurolépticos. Los prescriptores deberían estar más atentos y considerar las valoraciones que los usuarios hacen de sus efectos. El apego a las guías de tratamiento es escaso, seguramente por basarse en ensayos clinicos de calidad deficente, que deben mejorar y prolongarse en el tiempo. La raíz del problema probablemente se encuentra en la tautología sobre la etiología y naturaleza biológica de lo que llaman esquizofrenia, que realmente no parece ser más que un constructo ideológico-comercial.

Antipsychotic drugs do not appear to reverse the causes of schizophrenia, and although they can relieve symptoms in the short to medium term, in the long term they may not be beneficial and could even be counterproductive. Their use should be limited to acute situations in which agitation and tension is disabling. The drugs have significant adverse effects, and given the refusal of a person to continue taking them, a harm reduction strategy to support and monitor the withdrawal may be preferable to coercion. There are alternatives to neuroleptics. Prescribers should be more vigilant and consider the assessments of users regarding the drugs' effects. Adherence to treatment guidelines is low, probably because the guidelines are based on clinical trials of deficient quality which consequently should be improved and extended over a greater period of time. The root of the problem is likely the tautology on the etiology and biological nature of what is known as schizophrenia, which in fact does not seem to be more than a commercial and ideological construct.

Seguimiento de las recomendaciones sobre psicofarmacología y su repercusión conductual en la discapacidad intelectual / Expert psychopharmacologic recommendations follow-up and its behavioral impact on intellectual disability patients

En la población con discapacidad intelectual (DI) hay una elevada morbilidad psiquiátricaconductual. Se estima que por este motivo entre 1/3 y 3/4 de estas personas reciben antipsicóticos. Existe un consenso de expertos para guiar la toma de decisiones farmacoterapéuticas en estos casos. Su aplicación conseguiría una mayor eficacia del tratamiento, reduciendo los problemas conductuales, mejorando las habilidades adaptativas. El “Inventory for client and agency planning” (ICAP) es un instrumento para valoración y evaluación de servicios para personas con DI, que incluye escalas para puntuación de problemas conductuales y de conductas adaptativas. Para determinar la asociación entre el seguimiento de las recomendaciones farmacoterapeuticas de los expertos y las puntuaciones de los problemas conductuales y las habilidades adaptativas en un grupo de sujetos con DI, se realizó un estudio observación transversal. El tratamiento farmacológico recibido por cada sujeto de un colectivo de sujetos diagnosticados de DI (CIE-10) se clasificó como conforme o no con las recomendaciones de la guía en lo referente a los criterios de indicación, dosis, duración y polifarmacia. Se compararon las puntuaciones de conducta adaptativa y de problemas de conducta del ICAP en función de la conformidad del tratamiento con los criterios. El cumplimiento del criterio de dosis se asoció con mejor conducta adaptativa (p<0,05), el cumplimiento de los criterios de duración y polifarmacia se asociahubo asociación entre cumplimiento del criterio de indicación con la puntuación de problemas de conducta, ni de las habilidades adaptativas (AU)

Subjects with Intellectual Disability (ID) are frequently affected by behavioral and psychiatric co-mobility. As a consequence between 1/3 and ¾ are under antipsychotic treatment. It is available an expert consensus guideline with the purpose of guiding pharmacological treatment decisions. The achievement of expert recommendations may optimize drug therapy efficacy and reduce behavioral problems as well as enhance adaptive abilities. The “Inventory for client and agency planning” (ICAP) is a psychometric tool designed to assess health care to ID patients, and includes items that grade behavioral and adaptive problems. We designed a transversal study in order to determine the association between the follow-up of expert recommendations and the scores achieved on behavioral and adaptive problems items. Drug therapy been prescribed to patients diagnosed of ID (CIE-10) was analyzed and classified into a dichotomous “Do” or “Do not” achieve guideline recommendations in regard of several pharmaceutical aspects such as drug therapy indication, dosage, treatment duration and poly-pharmacy. Scores from ICAP tool as compared to guideline compliance. Follow-up of dose criteria was associated to a better adaptive behavior (p<0,05) and follow-up of poly-pharmacy criteria and duration treatment criteria was associated better behavioral outcomes (p<0,05). We found no association between follow-up of indication criteria and behavioral or adaptive problems (AU)

The EPIFARM study: an observational study in 574 community pharmacies in Spain characterizing patient profiles of men asking for erectile dysfunction medication.

INTRODUCTION: Community pharmacists may be an important first point of contact for erectile dysfunction (ED) patients, but to date there are no reports of the characteristics of men approaching pharmacists for ED advice or treatment. AIM: To characterize the profiles of men with and without phosphodiesterase-5 inhibitors (PDE5i) prescription asking for ED treatment at the pharmacy. METHODS: A multicenter, observational, cross-sectional study was conducted in Spanish community pharmacies September-November 2008. Of men asking for ED advice or treatment, each investigator recruited one with and one without PDE5i prescription. Study pharmacists completed a questionnaire of patient demographic, clinical, and behavioural data including the Sexual Health Inventory for Men. MAIN OUTCOME MEASURES: Demographic characteristics and responses to questionnaires. RESULTS: Five hundred and seventy-four pharmacists recruited 1,147 patients; 1,113 were included for analysis. There were no statistical differences between the groups regarding weight, hypertension, diabetes mellitus, hypercholesterolemia, dyslipidemia, depression, or stress. There were no statistical differences in severity of ED (P=0.7892) or proportion of men without ED in each group (P=0.5755). ED symptoms had been present for a mean of 26 months in both groups before first consultation with a healthcare professional. The visit to the pharmacy was the first discussion about ED for 60.2% of the nonprescription group, and 50% of those who had previously discussed ED had done so with a pharmacist in the first instance. In the nonprescription group, 85.1% of men asked for a PDE5i. CONCLUSIONS: Many men approached a community pharmacist for ED treatment and those with and without a PDE5i prescription had an equivalent ED severity and comorbidity profile. Community pharmacists should be trained in current concepts underlying the diagnosis and management of ED to enable them to educate men and encourage them to seek further medical care, increasing the chance of early detection of undiagnosed comorbidities such as cardiovascular disease.