Trends in Non-prescription Drug Recalls in Japan.

Recalls of non-prescription drugs can contribute to preventing harm to human health, however, they also interrupt the supply of medicines to the market. The aim of the present study was to investigate the trends in non-prescription drug recalls in Japan. Class I, II, and III recalls reported from April 2009 to March 2014 were obtained from the websites of the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. Each drug recall was classified according to year, dosage form, therapeutic category, and reasons for the recall. The trends over the 5 year period were assessed for each class. A total of 220 recalls were reported in the 5-year study period. The numbers of drug recalls were 21, 16, 80, 58, and 45 in 2009, 2010, 2011, 2012, and 2013, respectively. The drugs recalled consisted of 177 internal medications, 35 topical agents, and 8 others. Drug recalls were observed in 12 therapeutic categories of drug effects. The largest number of recalls was for Chinese herbal medicines and crude drugs. Of all the drug recalls in 2011, Chinese herbal medicines and crude drugs produced by one manufacturer accounted for 84%. Slightly more than half (54%) of drug recalls were due to a violation of the regulations. One manufacturer recalled many drugs because of non-compliance with the standard regulations for manufacturing drugs after 2011. In conclusion, non-prescription drug recalls can occur for any drug regardless of the dosage form and therapeutic category.

¿Son las bases de datos bibliográficas una buena fuente de la evidencia científica en la retiradade fármacos del mercado? / Are scientific literature databases a good source of scientific evidence for discontinuing a drug form the market?

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Réquiem por el tetracepam / Requiem for tetrazepam

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Product recall: a Croatian experience (2000-2010).

BACKGROUND: Timely and efficient recall of products known or suspected to be non-conforming is an important measure in the prevention of adverse events and in patients' safety. Product recall in the transfusion service is regulated by professional standards and legal acts, but publications presenting results related to the implementation of these procedures are quite rare. MATERIALS AND METHODS: Data from the Croatian Institute of Transfusion Medicine (CITM) on the procedures of product recall during an 11-year period (2000-2010) were retrospectively analyzed. Reasons for product recall, their frequency, level of severity and efficiency of the procedures are presented and discussed. RESULTS: During the study period, there were 245 procedures of product recall, for an average of 22 (18-29) procedures/year, all of low extent (1-25 products). Recall was required for 1/3,571 blood products issued, while the frequency of laboratory test report recalls was 1/5,447 patients. The leading reasons for product recall were suspected bacterial contamination of blood products (30.2%) and suspected or demonstrated non-conformity of laboratory test reports (28.6%). In total, 99 (40.4%) product recalls were categorized as class I, 30 (12.2%) as class II and 116 (47.3%) as class III. DISCUSSION: According to the available literature data, the product recall procedures were performed quite infrequently by the CITM and were of low extent. There was a remarkable decreasing trend in the rate of product recall due to non-conformities or errors made at the CITM, along with a constant or increasing rate of recalls because of biological variability of blood products.

Prescripción en Cascada y Desprescripción / No disponible

La prescripción en cascada se produce cuando un nuevo fármaco es prescrito para "tratar" una reacción adversa producida por otro fármaco, basándose en la creencia errónea de que una nueva condición médica se ha desarrollado. Los acontecimientos adversos asociados a la prescripción en cascada se producen cuando el segundo fármaco aumenta la severidad de la reacción adversa producida por el primer fármaco, o cuando el segundo fármaco expone al paciente a la aparición de nuevas reacciones adversas. La clave para prevenir la prescripción en cascada reside en la prevención y rápida detección de las reacciones adversas. Los profesionales de la salud deben ser capaces de reconocer cuándo un medicamento debe ser retirado y cómo hacerlo. La desprescripción debe considerarse cuando existe polimedicación, reacciones adversas a medicamentos, ineficacia del tratamiento, caídas o cuando los objetivos del tratamiento han cambiado. Un enfoque cauteloso de la desprescripción incluye dos principios: retirar los fármacos de uno en uno y disminuir las dosis gradualmente durante semanas o meses(AU)

A prescribing cascade occurs when a new medicine is prescribed to ‘treat’ an adverse reaction to another drug in the mistaken belief that a new medical condition requiring treatment has developed. Adverse outcomes associated with prescribing cascades can result when the second drug increases the severity of the adverse reaction to the first drug or when the second drug places the patient at risk of additional adverse drug reactions. The key to preventing prescribing cascades lies in the avoidance and early detection of adverse drug reactions and an increased awareness and recognition of the potential for adverse reactions. Medicines have adverse effects and the use of multiple medicines, polypharmacy, can be associated with poorer outcomes. Health professionals need to recognise when medicines should be ceased and how to deprescribe. Deprescribing could be considered when there is polypharmacy, adverse drug reactions, ineffective treatment, falls or when treatment goals have changed. If patients are slowly weaned off their medicines, withdrawal and rebound syndromes are usually not serious. A cautious approach to deprescribing includes two principles - stop one drug at a time and wean doses slowly over weeks and months(AU)

Shortage of perioperative drugs: implications for anesthesia practice and patient safety.

Several medications used in clinical perioperative medicine are currently cited on the national shortage list. Medication shortages may be attributed to lack of raw materials, manufacturing issues, and discontinuation of production. Medication shortage has a substantial impact on patient care, and is responsible for creating an environment conducive to an increase in medication errors. Anesthesiologists should be taking an active role with the pharmacy and hospital management to alert caregivers and help to prevent adverse effects on patient care and safety.

El futuro de la insulina inhalada tras la retirada de Exubera®: ®El fin del principio» / Future of inhaled insulin after Exubera ® withdrawal: ®The end of the beginning»

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Tratamiento farmacológico del insomnio: ventajas e inconvenientes. Cómo sustituir la medicación hipnótica / Pharmacological treatment of insomnia: advantages and disadvantages. Replacing hypnotics

La prevalencia estimada indica que alrededor de un tercio de la población adulta manifiesta síntomas de insomnio, de los que en un 9-12% manifiestan consecuencias diurnas. De éstos, sólo el 10% son tratados de forma adecuada. El insomnio es la mayoría de las veces un síntoma. Descubrir la etiología será fundamental para aplicar un correcto tratamiento. Existe una alta comorbilidad entre el insomnio y otras patologías médicas. Además de las causas médicas, los factores sociales, del entorno, psicológicos, conductuales y cronobiológicos también pueden causar insomnio. Pero realmente, una de las causas más frecuentes de insomnio crónico es el llamado insomnio psicofisiológico. Consiste en la presencia de ansiedad diurna somatizada con la asociación de unos hábitos de sueño erróneos. El tratamiento del insomnio debe estar dirigido hacia la eliminación de la causa que produce el trastorno, y provocar una mejoría sintomática. El insomnio transitorio y de corta duración, puede ser tratado con fármacos hipnóticos. En el insomnio crónico siempre tendrá que tratarse la causa que lo produce y los fármacos hipnóticos se utilizarán como complemento. El insomnio crónico está asociado a un aumento del riesgo de depresión y un uso (o incluso abuso) crónico de hipnóticos (AU)

Estimates indicate that around one third of the adult population has insomnia symptoms, of which 9%-12% has diurnal consequences. Of these, only 10% receive adequate treatment. Insomnia is usually only a symptom. Discovering its etiology is fundamental in order to apply correct treatment .There is a high comorbidity between medical insomnia and other pathologies. In addition to medical causes, social, environmental, psychological, behavioral and chronobiological factors also can also cause insomnia. One of the frequent causes of chronic insomnia is psychophysical insomnia. It consists of the presence of externalized diurnal anxiety along with counterproductive sleep habits. The treatment of insomnia ust be directed towards the elimination of the causes that produce the problem, and to alleviate the symptoms. Transitory, shot term insomnia can be dealt with using hypnotics. In chronic insomnia, the root causes that produce it need to be treated and hypnotics us ed as a complement. Chronic insomnia is associated with an increased risk of depression and a chronic use (or even abuse) of hypnotics (AU)