Analysis of the Relationship of Drug Utilization Index with Anti-infective Effect of AECOPD Patients / 中国药房

OBJECTIVE:To investigate the relationship of drug utilization index(DUI)of antibiotics with therapeutic efficacy of patients with acute exacorbation of chronic obstructive pulmonary disease(AECOPD). METHODS:By the method of drug utili-zation evaluation,inpatients with AECOPD in our hospital during 2013-2015 were selected as the research object. Diagnosis and treatment information prescribing information of patients were collected,and inpatients only receiving one kinds of antibiotics dur-ing hospitalization stay were selected to evaluate the relationship of therapeutic efficacy with rehospitalization indexes. RESULTS:A total of 2155 AECOPD patients were enrolled in the study. Among antibiotics with DDDs>500,antibiotics with DUI close to 1.0 was cefotiam hydrochloride for injection,and that with DUI far higher than 1.0 was Cefodizime sodium for injection,while that with DUI much less than 1.0 was Piperacillin sodium and sulbactam sodium for injection. There was statistical significance in therapeutic efficacy between Cefotian hydrochloride for injection and Piperacillin sodium and sulbaactam for injection (P0.05). There was no statistical significance in therapentic efficacy or rehospital-ization between cefotiam hydrochloride for injection and cefodizimes sodium for injection(P>0.05). CONCLUSIONS:DUI is as-sociated with therapeutic efficacy,but the rationality of antibiotics can not be simple judged according to the distance between DUI and 1.0. A variety of confounding and bias factors should be integrated to avoid misreading and misjudgment.

Evaluation of Antibiotics Use in Acute Exacerbation of Chronic Obstructive Pulmonary Diseases in Our Hospital during 2013-2015 / 中国药房

OBJECTIVE:To evaluate the effectiveness,safety and economics of antibiotics for inpatients with acute exacerba-tion of chronic obstructive pulmonary diseases (AECOPD),in order to promote rational use of antibiotics. METHODS:In retro-spective study,AECOPD inpatients were selected as research objects during 2013-2015 to evaluate the use of antibiotics. RE-SULTS:Three thousand one hundred and eighty-six AECOPD patients were enrolled in the study,and utilization ratio of antibiot-ics was above 90%. DDDs of Cefordizime sodium for injection ranked the first place in 3 years and was decreased in 2015,while those of β-lactam and carbapenems were increased. DDC of Meropenem for injection and Imipenem/cilastatin sodium for injection were the highest. Drug utilization index(DUI)of Cefodizime for injection was far more than 1.0,while DUI of Piperacillin sodi-um and sulbactam sodium for injection was much less than 1.0. Sort ratio(B/A)of Cefodizime sodium for injection ranged 1-2 in 3 years. B/A of Piperacillin sodium and sulbactam sodium for injection,Imipenem and cilastatin sodium for injection,Meropenem for injection were lower than 1.0. CONCLUSIONS:The indication of anti-infective treatment in AECOPD patients have been mas-tered strictly in our hospital;the utilization ratio of antibiotics is decreased year by year;the types of antibiotics are rational rela-tively,and the number of antibiotics which is rationally used is increased year by year. But the rationality of Cefodizime sodium for injection and Piperacillin sodium/sulbactam sodium for injection need to be improved.

Reacciones adversas no descritas en embarazadas de Cuba / Non-described adverse reactions in pregnant women in Cuba

Introducción: el perfil de seguridad de los medicamentos en las embarazadas es incompleto, porque estas se excluyen de los ensayos clínicos. El propósito de la Farmacovigilancia es detectar reacciones adversas nuevas a medicamentos. Objetivo: caracterizar las reacciones adversas no descritas en embarazadas en Cuba. Método: se realizó un estudio descriptivo y transversal. El universo fue las reacciones adversas medicamentosas en embarazadas registrada en la base de datos del sistema de Farmacovigilancia cubano, la muestra fue de 126 reacciones no descritas reportadas de 2003 a 2012. Las variables fueron datos demográficos, reacción adversa, gravedad, sistema de órganos, medicamento, grupo farmacológico, nivel de atención y notificador; se consideró reacción adversa medicamentosa no descrita, aquella que no aparece en el Formulario Nacional de Medicamentos. El análisis estadístico fue descriptivo. Resultados: las reacciones adversas no descritas predominaron en gestantes de 20 a 30 años (57 por ciento), con edad gestacional sin precisar (77 por ciento). El 2003 fue el año de mayor reporte (26,0 por ciento). Las reacciones indeseables más frecuentes fueron cefalea, taquicardia y náuseas (7,9 por ciento), las moderadas (52,3 por ciento), que afectaron el sistema nervioso central (21,4 por ciento), producidas por antimicrobianos (23 por ciento), Prenatal® (14,2 por ciento) y fármacos con categoría de riesgo B (33 por ciento) en el embarazo, reportadas más por médicos (67 por ciento) del nivel secundario de salud (56 por ciento). Conclusiones: las reacciones adversas medicamentosas no descritas en embarazadas representaron una pequeña proporción de las notificadas en la década estudiada, con características similares a las reacciones adversas descritas solo para gravedad, categoría de riesgo del fármaco en embarazo y profesional notificador(AU)

Introduction: The safety profile of drugs in pregnant women is incomplete because they are excluded from the clinical assays. The purpose of pharmacosurveillance is to detect new adverse drug reactions. Objective: To characterize the non-described adverse reactions in pregnant women in Cuba. Method: A descriptive and cross-sectional study was conducted and the universe of study was adverse drug reactions in pregnant women reported to the database of the Cuban pharmacosurveillance system. The sample was made up of 126 non described reactions reported from 2003 to 2012. The variables were demographic data, adverse reaction, severity, system of organs, medication, pharmacological group, level of care and notification. Non described adverse reaction was considered as that one not included in the National Formulary of Drugs. The statistical analysis was descriptive. Results: Non described adverse reactions predominated in pregnant women aged 20 to 30 years (57 percent), with imprecise gestational age (77 percent). The most reported year (26 percent) was 2003. The most common undesirable reactions were headache, tachycardia and nauseas (7.9 percent), the mild reactions (52.3 percent) affected the central nervous system (21.4 percent) caused by antimicrobials (23 percent), Prenatal® (14.2 percent) and risk B drugs (33 percent) in pregnancy reported more by physicians (67 percent) of the secondary health care level (56 percent). Conclusions: Adverse drug reactions which are not described in pregnant women represented a small portion of the notified ones in the studied decade, with similar characteristics to those of described adverse reactions in terms of severity, category of drug risk in pregnancy and notifying professional(AU)

Epidemiological Characteristics of Adverse Reaction Induced by Chinese Activating Blood Herbal Injection / 中国中医药信息杂志

Objective To investigate the epidemiological characteristics of adverse reaction induced by Chinese activating blood herbal injection. Methods Domestic medicinal periodicals issued during 1972-2011 were searched, and 566 adverse drug reaction (ADR) cases were analyzed by database establishment and statistic method. Results Totally 566 ADR cases involving 16 different kinds of traditional Chinese medicine injection were collected, and 139 cases were related to Fufang Danshen Injection. The incidence of ADR was 51.77%(293 cases) in the male and 48.23%(273 cases) in the female. Average age of patients was (55.01±16.07) years old. The incidence of circulation system damage (206 cases, 23.22%) dominated in ADRs. The number of ADR which occurred within half an hour was 357 cases (64.79%) and the original disease most were cardiovascular and cerebrovascular diseases (384 cases, 67.84%). Conclusion ADR induced by Chinese activating blood herbal injection are commonly seen in middle-aged and elderly people, and often involved circulation system.

Eventos adversos observados años después del tratamiento con factor de transferencia / Adverse events occurred some years after the application of a transfer factor treatment

Introducción: el factor de transferencia es un inmunoestimulante que se emplea en varias enfermedades, su seguridad en las condiciones de la práctica médica no se ha establecido. Objetivos: identificar eventos adversos presentados años después de finalizado el tratamiento con factor de transferencia y determinar la relación entre su utilización y los eventos observados. Métodos: estudio observacional, retrospectivo, de fármacovigilancia activa. El universo estuvo constituido por 413 pacientes tratados con este fármaco entre los años 2001 y 2004 en 11 hospitales de La Habana. El periodo de observación abarcó los 6 a 8 años posteriores al tratamiento. Los pacientes fueron entrevistados acerca de la presencia de infecciones, cáncer y otros eventos, en su hogar. Si un evento era la muerte, se entrevistaba al familiar para registrar causa y fecha. Resultados: se entrevistaron 356 pacientes, 66 (18,53 por ciento) presentaron al menos un evento adverso, 21(31,8 por ciento) en mayores de 60 años. Se registraron 87 eventos adversos, 8 (9,2 por ciento) fueron infecciones como hepatitis B, hepatitis C, foliculosis, mononucleosis y verrugas vulgares, 1 (1,1 por ciento) cáncer y 78 (89,7 por ciento) otros eventos. Su relación con la administración del fármaco resultó condicional en 64 (73,6 por ciento) pacientes e improbable en 21 (24,1 por ciento), en esta última categoría se incluyeron las infecciones y la mayoría de los eventos mortales. Conclusiones: los eventos adversos que se registraron en los pacientes, años después de haber recibido tratamiento con factor de transferencia, no se consideran relacionados con su administración, aunque necesitan ser vigilados pues la información obtenida en este estudio debe ser contrastada con un mayor número de observaciones y estudios observacionales controlados

Introduction: the transfer factor is an immunostimulant that is used to treat several diseases but its safety in the medical practice has not been assured yet. Objectives: to identify the adverse events occurred some years after the end of a transfer factor treatment and to determine the association of the use and the observed events. Methods: observational active drug surveillance study. The universe of study was 413 patients who were treated with the transfer factor from 2001 to 2004 in eleven hospitals located in La Habana province. The observation period ranged 6 to 8 years after the treatment. The patients were interviewed at home on the occurrence of infections, cancer or any other events. If some death occurred, then a family member was interviewed to record the cause and the date of the decease. Results: three hundred fifty six patients were interviewed; 66(18.53 percent) stated at least one adverse event and 21(31.80 percent) events occurred in over 60 years-old patients. Eighty seven adverse effects were recorded; 8 (9.20 percent) comprised infections such as hepatitis B, hepatitis C, foliculosis, mononucleosis and warts, one (1.10 percent) event corresponded to cancer and 78 (89.70 percent) to other type of events. Their relationship with the administration of the drug was considered as conditional in 64 events (73.60 percent) and as unlikely in 21 (24.10 percent) events comprising infections and most of the fatal events. Conclusions: the adverse events observed in the patients, some years after the end of the treatment with the transfer factor, were not considered to be related to the administration of this drug; however, they must be under surveillance since the information obtained from this study should be compared with the information collected by a higher number of observations and of controlled observational studies

Eventos adversos observados después del tratamiento con factor de transferencia / Adverse events after treatment with the transfer factor

Introducción: el factor de transferencia es un inmunoestimulante que se emplea en una amplia gama de enfermedades. Su eficacia y seguridad han sido evaluadas en ensayos clínicos prerregistro, pero se conoce poco sobre su seguridad en condiciones de la práctica habitual, de ahí la necesidad de vigilar su uso y contribuir a establecer su relación beneficio/riesgo. Objetivos: identificar eventos adversos en pacientes tratados con factor de transferencia, determinar grado de asociación fármaco-evento observado y su gravedad. Métodos: estudio observacional, descriptivo, prospectivo y multicéntrico de farmacovigilancia activa. Se observó durante el año siguiente al término del tratamiento con factor de transferencia, a una serie de 282 pacientes tratados por su médico de asistencia entre abril de 2001 y abril de 2002, en 9 hospitales en La Habana. Se analizaron los eventos adversos presentados, su gravedad, si existía asociación con el fármaco, la cantidad de eventos por paciente, la dosis administrada y la edad del paciente. Resultados: el 13,8 por ciento de los pacientes observados tuvo al menos un evento adverso, de ellos 38,5 por ciento tenía entre 45-59 años. Los esquemas de tratamiento con dosis altas y prolongadas no provocaron más eventos que los ya encontrados. Se identificaron 80 eventos adversos, 55 por ciento leves y en 80 por ciento se consideró improbable su relación con el medicamento. Ninguno se clasificó definitivo o probable, mientras que eventos como fiebre, artralgia, disnea, mialgia, alergia y astenia, se consideraron reacciones adversas posibles y leves. Conclusiones: la mayoría de los eventos adversos presentados, durante el año siguiente de finalizado el tratamiento con factor de transferencia, fueron leves y no relacionados con su uso. Aun así, los productores del medicamento deberían advertir a profesionales y pacientes sobre las reacciones adversas posibles detectadas

Introduction: the transfer factor is an immunologic stimulant used in a wide range of diseases. Its safety and efficiency have been evaluated in pre-registration clinical trials, but little is known about its safety margin under regular practical conditions, hence the need of closely watching its use and setting the benefit-risk relation. Objectives: to identify adverse events in patients treated with the transfer factor and to determine the level of association of the drug and the observed adverse event and severity. Methods: prospective, multicentered, descriptive and observational study of active drug surveillance. Two hundred and eighty two patients, who were attended by their physicians from April 2001 to April 2002 in 9 hospitals of Havana, were observed for one year after the end of a treatment with the transfer factor. The occurrence of adverse events as well as their severity, association with the drug, the number of events per patient, the supplied dosage and the age of the patient was all analyzed. Results: in this group of patients, 13,8 percent had at least one adverse effect; 38,5 percent were aged 45 to 59 years. The treatment schemes with high and prolonged dosage did not cause any further event. Eighty adverse effects were identified, 55 percent mild and 80 percent were considered as unlikely related with the drug. None of them was definitive or probable whereas fever, arthralgia, dysnea, myalgia, allergy and asthenia were considered as possible mild adverse reactions. Conclusions: most of adverse events during the year after the end of treatment with the transfer factor were mild and unrelated to the use of the drug. However, the drug manufacturers should advise professionals and patients on the possible occurrence of adverse reactions

Farmacovigilancia de interacciones medicamentosas en pacientes afiliados al sistema de salud de Colombia / Drug surveillance of medication interactions in patients affiliated to the health system in Colombia

Objetivos: determinar las posibles interacciones medicamentosas que generen problemas relacionados con medicamentos de seguridad, necesidad o efectividad, mediante la búsqueda activa en bases de datos de pacientes afiliados al Sistema General de Seguridad Social en Salud.Métodos: a partir de las bases de datos de dispensación de medicamentos deAudifarma S.A, a unos 3,7 millones de usuarios del país, se hizo una revisiónsistemática de estadísticas de una serie de medicamentos identificados porpresentar interacciones.Resultados: del total de pacientes que tomaban omeprazol se encontró que 12,3 porciento recibían concomitantemente hidróxido de magnesio mas aluminio; 1,7 porciento recibían ranitidina; 1,0 porciento sucralfato, además 0,3 porciento tomaban simultáneamente omeprazol+ sucralfato + hidróxido de magnesio y aluminio y 0,4 porciento omeprazol + ranitidina + hidróxido de magnesio y aluminio, que no potencian el efecto antiulceroso o pueden antagonizar sus acciones. También se halló que el 0,2 porciento de pacientes que tomaban verapamilo recibían al mismo tiempo digoxina o metil digoxina con riesgo de aumentar la toxicidad y antagonizar el efecto inotrópico. Todos los casos fueron notificados a los responsables de su atención sanitaria.Discusión: interacciones medicamentosas representan un riesgo potencial, el cual debe ser tenido en cuenta por los médicos prescriptores. La fármacovigilancia permite optimizar recursos y prevenir eventos adversos que puedan potencialmente causar morbilidad o letalidad. Se recomienda considerar la búsqueda en bases dedatos para reforzar los programas de vigilancia de uso de medicamentos en el país.

Objectives: to determine the possible medication interactions that generateproblems related to safety medications, needs or effectiveness, throughout theactive search in data bases of patients affiliated to the General Health System of Social Security. Methods: based on the data base from Audifarma S.A. in regards to the distribution of medications to 3.7 million of users in the country, a systematic review of thestatistics of a series of drugs identified for presenting interactions. Results: out of the total of patients that were taking omeprazol, it was found that 12.3% at the same time received magnesium hydroxide plus aluminum; 1.7%received ranitidine; 1.0% sucralfate, and also 0.3% were at the same time taking omeprazol + sucralfate+magnesium hydroxide and aluminum and 0.4% omeprazol + ranitidine+magnesium hydroxide and aluminum, which do not maximize the anti ulcerous effect or may antagonize its actions. It was also found that 0.2% of the patients was taking verapamil and at the same time received digoxin or methyl digoxin with the risk of increasing the toxicity and antagonizing its inotropic effect. All these cases were notified to those responsible for their sanitary attention. Discussion: medication interactions represent a potential risk, which has to be considered by the prescribing doctors. Drug surveillance allows the optimization of resources and the prevention of adverse events which may potentially cause mortality or be lethal. It is recommended that data bases be searched in order to reinforce the surveillance programs in relation to the use of medicines in the country.