[Adequacy of the safety of metamizole and agranulocytosis]. / Adecuación de la seguridad del metamizol y agranulocitosis.

OBJECTIVE: To analyze whether the drug safety update issued by the Spanish Agency of Medicines and Healthcare Products (AEMPS), dated October 30, 2018, on agranulocytosis and metamizole contains accurate and necessary information to protect patients from the presentation of this adverse reaction (AR) and if the official documentation of medicines containing metamizole for doctors, pharmacists and the general population conforms to the guidelines of the AEMPS to reduce this risk. SETTING AND PARTICIPANTS: Drug safety update, bibliographic search, information at the European Medicines Agency on metamizole drugs marketed in Spain, technical datasheets, leaflets, Bot PLUS Health Information Database and Catalog of Pharmaceutical Specialties. Notification of 4cases of agranulocytosis due to metamizole after the drug safety update was issued. MAIN INTERVENTIONS AND MEASUREMENTS: Comparison of the key points of the drug safety update and official documents on metamizole with the bibliography. Description of the 4cases of agranulocytosis due to metamizole and application of the causality and severity algorithm. RESULTS: The drug safety update contains omissions and contradiction in respect to the bibliography and the actual use of metamizole in healthcare practice. The official documents show a lack of updating, unapproved indications and doses higher than those recommended. The drug safety update has not stopped the presentation of cases of agranulocytosis due to metamizole. CONCLUSIONS: The AEMPS drug safety update can be improved and it is necessary to update the official information documents on metamizole for health professionals and patients in order to decrease the risk of agranulocytosis.

Hemodynamic impact of isobaric levobupivacaine versus hyperbaric bupivacaine for subarachnoid anesthesia in patients aged 65 and older undergoing hip surgery.

BACKGROUND: The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. We conducted a descriptive, observational pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus hyperbaric bupivacaine for hip fracture surgery. DESCRIPTION: Hundred twenty ASA status I-IV patients aged 65 and older undergoing hip fracture surgery were enrolled. The primary objective of our study was to compare hemodynamic effects based on systolic blood pressure (SBP) and dyastolic blood pressure (DBP) values, heart rate (HR) and hemoglobin (Hb) and respiratory effects based on partial oxygen saturation (SpO2%) values. The secondary objective was to assess potential adverse events with the use of levobupivacaine versus bupivacaine. Assessments were performed preoperatively, at 30 minutes into surgery, at the end of anesthesia and at 48 hours and 6 months after surgery. Among intraoperative events, the incidence of hypotension was statistically significantly higher (p <0.05) in group BUPI (38.3%) compared to group LEVO (13.3%). There was a decrease (p <0.05) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 30 minutes intraoperatively (19% in group BUPI versus 17% in group LEVO). SpO2% increased at 30 minutes after anesthesia onset (1% in group BUPI versus 1.5% in group LEVO). Heart rate (HR) decreased at 30 minutes after anesthesia onset (5% in group BUPI versus 9% in group L). Hemoglobin (Hb) decreased from time of operating room (OR) admission to the end of anesthesia (9.3% in group BUPI versus 12.5% in group LEVO). The incidence of red blood cell (RBC) transfusion was 13.3% in group BUPI versus 31.7% in group LEVO, this difference was statistically significant. Among postoperative events, the incidence of congestive heart failure (CHF) was significantly higher in group BUPI (8,3%). At 6 months after anesthesia, no differences were found. CONCLUSIONS: Given the hemodynamic stability and lower incidence of intraoperative hypotension observed, levobupivacaine could be the agent of choice for subarachnoid anesthesia in elderly patients.

Gender influence in the quantity of drugs used in primary care.

OBJECTIVE: To analyze whether for an equal health problem there are gender differences in the drugs used in an adult population attended in the Health Care Centers of the Valencian Community (Spain). METHODS: A cross-sectional analytical study was carried out between February-August 1997. The independent variables were: socio-economic parameters, frequency of visits, and self-perceived or diagnosed health problems, and the dependent one the number of drugs consumed. RESULTS: Of the 812 patients considered, 801 consumed medication. Eighty percent of the health problems for which drugs were used involved 5 apparatuses and systems (mean: 3.3 health problems/patient). The 5 most consumed therapeutic groups accounted for 81% of the total (mean: 4.5 drugs/patient). Significant differences were recorded, with greater female consumption in the central nervous system and genitourinary tract therapeutic groups, and with greater male consumption in relation to the respiratory system and systemic anti-infectious therapy. Drug use increased with age, lowest educational level, lowest professional categories, and with the highest frequency of visits to the physician. Significant differences were also recorded in drug use by occupational status, marital status and family structure. The multivariate analysis showed the number of health problems and the frequency of visits accounted for 82.2% of the variability of the variable <>. The variability accounted for by gender was explained by the variable health problems, the main factor underlying drug consumption among women and men. CONCLUSION: The main finding is probably that women do not use larger numbers of drugs than men if health problems and frequency of visits are controlled.

Adecuación de la seguridad del metamizol y agranulocitosis / Adequacy of the safety of metamizole and agranulocytosis

Objetivo: Analizar si la nota informativa de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), de 30 de octubre del 2018, sobre agranulocitosis y metamizol contiene la información precisa y necesaria para proteger a los pacientes de la aparición de esta reacción adversa (RA) y si la documentación oficial de los medicamentos con metamizol para médicos, farmacéuticos y población general está adaptada a las directrices de la AEMPS para disminuir el riesgo. Emplazamiento y participantes: Nota informativa, búsqueda bibliográfica, información sobre los medicamentos con metamizol comercializados en España en la Agencia Europea del Medicamento, fichas técnicas, prospectos, base de datos de información sanitaria Bot PLUS y Catálogo de Especialidades Farmacéuticas. Notificación de 4casos de agranulocitosis por metamizol posteriores a la fecha de la nota informativa. Intervenciones y mediciones principales: Comparación de los puntos clave de la nota informativa y de los documentos oficiales sobre metamizol con la bibliografía. Descripción de 4casos de agranulocitosis por metamizol y aplicación del algoritmo de causalidad y gravedad. Resultados: La nota informativa presenta ausencias y dudas respecto a la bibliografía y al uso de metamizol en la práctica asistencial. Los documentos oficiales presentan faltas de actualización, indicaciones no aprobadas y dosis superiores a las recomendadas. La nota informativa no ha frenado la presentación de casos de agranulocitosis por metamizol. Conclusiones: La nota informativa de la AEMPS es mejorable y es necesario actualizar los documentos oficiales de información sobre el metamizol para profesionales sanitarios y pacientes para disminuir el riesgo de agranulocitosis.(AU)

Objective: To analyze whether the drug safety update issued by the Spanish Agency of Medicines and Healthcare Products (AEMPS), dated October 30, 2018, on agranulocytosis and metamizole contains accurate and necessary information to protect patients from the presentation of this adverse reaction (AR) and if the official documentation of medicines containing metamizole for doctors, pharmacists and the general population conforms to the guidelines of the AEMPS to reduce this risk. Setting and participants: Drug safety update, bibliographic search, information at the European Medicines Agency on metamizole drugs marketed in Spain, technical datasheets, leaflets, Bot PLUS Health Information Database and Catalog of Pharmaceutical Specialties. Notification of 4cases of agranulocytosis due to metamizole after the drug safety update was issued. Main interventions and measurements: Comparison of the key points of the drug safety update and official documents on metamizole with the bibliography. Description of the 4cases of agranulocytosis due to metamizole and application of the causality and severity algorithm. Results: The drug safety update contains omissions and contradiction in respect to the bibliography and the actual use of metamizole in healthcare practice. The official documents show a lack of updating, unapproved indications and doses higher than those recommended. The drug safety update has not stopped the presentation of cases of agranulocytosis due to metamizole. Conclusions: The AEMPS drug safety update can be improved and it is necessary to update the official information documents on metamizole for health professionals and patients in order to decrease the risk of agranulocytosis.(AU)

Effects of dopamine in isolated rat colon strips.

The aim of the present work is to investigate the effects of dopamine on isolated rat colon strips, and whether dopamine receptors are involved in these effects. Experiments on spontaneous motility and under potassium contraction were performed with dopamine and isoprenaline, both in the absence and presence of antagonists (distal colon strips, isotonic recording, Tyrode solution, 31 degrees C, 1 g of resting tension). At higher concentration (10(-4) mol/L), dopamine abolished spontaneous motility of the rat colon and this effect was not modified by antagonists. In isolated rat colon strips that were depolarized with potassium, dopamine produced concentration-dependent relaxation, without significant differences in reserpinized rats. Preincubation with sulpiride or Sch 23390, dopamine antagonists, did not modify the effects of dopamine. Propranolol shifted the concentration-response curve to the right, though in a noncompetitive manner. Prazosin and yohimbine (alpha-antagonists) did not modify the response to dopamine. Isoprenaline produced a concentration-dependent relaxant response to the KCl-induced contraction antagonized by propranolol, but not by prazosin, in a noncompetitive manner. In conclusion, dopamine exhibits a relaxant effect on the isolated rat colon, which is not mediated by specific dopamine receptors or alpha-adrenoceptors but it may be mediated by atypical beta-adrenoceptors.

Prescribers' indications for drugs in childhood: a survey of five European countries (Spain, France, Bulgaria, Slovakia and Russia).

BACKGROUND: Indication-based, in comparison to diagnoses-based, drug utilization studies in children are scarce in the literature. AIM: To determine the adequacy of the prescriber's indications for specific drug treatments compared to the current literature in five different European countries; and to show the possibilities of performing indication-based drug utilization studies. DESIGN: a descriptive, cross-sectional, international study. PATIENTS AND METHODS: Randomly selected sample of 12,264 paediatric outpatients seen in consultation rooms attended by paediatricians or general practitioners. Data on patient demographics, diagnoses, and pharmacological treatment, with therapeutic indications for each drug, were collected in pre-designed forms. Diagnoses and indications were coded using the ICD-9 and drugs according to the ATC classifications. RESULTS: Indications were registered for every drug prescribed in all locations. Antibiotic indications considered incorrect (common cold, upper respiratory tract infections, viral infections, general symptoms or "not specified") accounted from 24.1% of the total antibiotics prescribed in Tenerife to 67.4% in Slovakia. Incorrect indication of first-choice antibiotics prescribed in acute otitis media and tonsillitis ranged from 28.9% of total antibiotics use in Russia to 75.4% in Tenerife. Correct antibiotic indications ranged from 23.4% of total antibiotics used in Slovakia to 65.7% in Tenerife. Aspirin use in febrile viral conditions was detected mainly in Toulouse and Russia. CONCLUSION: The main areas for improvement detected were high use of mucolytics, prescription of aspirin in potential or established viral infections, overuse of antibiotics and identification of specific patterns of incorrect antibiotic prescription and clinical entities associated with each location.

Gender influence in the quantity of drugs used in primary care

Objective: To analyze whether for an equal health problem there are gender differences in the drugs used in an adult population attended in the Health Care Centers of the Valencian Community (Spain). Methods: A cross-sectional analytical study was carried out between February-August 1997. The independent variables were: socio-economic parameters, frequency of visits, and self-perceived or diagnosed health problems, and the dependent one the number of drugs consumed. Results: Of the 812 patients considered, 801 consumed medication. Eighty percent of the health problems for which drugs were used involved 5 apparatuses and systems (mean: 3.3 health problems/patient). The 5 most consumed therapeutic groups accounted for 81% of the total (mean: 4.5 drugs/patient). Significant differences were recorded, with greater female consumption in the central nervous system and genitourinary tract therapeutic groups, and with greater male consumption in relation to the respiratory system and systemic anti-infectious therapy. Drug use increased with age, lowest educational level, lowest professional categories, and with the highest frequency of visits to the physician. Significant differences were also recorded in drug use by occupational status, marital status and family structure. The multivariate analysis showed the number of health problems and the frequency of visits accounted for 82.2% of the variability of the variable «number of drugs consumed». The variability accounted for by gender was explained by the variable health problems, the main factor underlying drug consumption among women and men. Conclusion: The main finding is probably that women do not use larger numbers of drugs than men if health problems and frequency of visits are controlled (AU)

Objetivo: Analizar si para el mismo problema de salud hay diferencias de género en los medicamentos utilizados en una población adulta atendida en centros de salud de la Comunidad Valenciana. Métodos: Estudio observacional transversal analítico realizado entre febrero y agosto de 1997. Variables independientes: parámetros socioeconómicos, frecuentación de los servicios de salud y problemas de salud autopercibidos o diagnosticados. Variable independiente: número de medicamentos consumidos. Resultados: De los 812 pacientes, 801 tomaban medicamentos. El 80% de los problemas de salud por los que se medicaban pertenece a 5 aparatos y sistemas (media: 3,3 problemas de salud por paciente). Los 5 grupos terapéuticos más consumidos suponen el 81% del total (media: 4,5 medicamentos por paciente). Se evidenció un mayor consumo significativo por la mujer de medicamentos de los grupos terapéuticos del sistema nervioso central e infecciones genitourinarias, y mayor consumo por los varones de medicamentos de los grupos terapéuticos del sistema respiratorio y terapia antiinfecciosa sistémica. El uso de los medicamentos incrementó con la edad, el menor nivel educativo, menor categoría profesional y con la mayor frecuencia de visitas. También se encontraron diferencias significativas en el uso de medicamentos según la situación laboral, estado marital y la estructura familiar. El análisis multivariante mostró que el número de problemas de salud y la frecuencia de visitas explicaban el 82,2% de la variabilidad de la variable «número de medicamentos consumidos». La variabilidad representada por el género se explicó por la variable de problemas de salud, el principal factor subyacente del consumo de medicamentos entre mujeres y hombres. Conclusiones: El hallazgo principal es, probablemente, que las mujeres no utilizan mayor número de medicamentos que los hombres al ajustar por problemas de salud y la frecuencia de las visitas (AU)