RESUMEN
To rechallenge with clozapine for a patient who previously has experienced neutropenia or leucopenia or during clozapine treatment is a difficult clinical decision. Herein, we analyzed the results of such a rechallenge in 19 patients. We analyzed all the reports, from the database of the pharmacovigilance department of the Argentine National Administration of Drugs, Foods, and Medical Devices, of patients who were rechallenged with clozapine after a leucopenia or a neutropenia. Nineteen cases of rechallenge after leucopenia or neutropenia were reported between 1996 and 2014. One third of the patients re-exposed to clozapine developed a new hematologic adverse reaction. The second blood dyscrasia was less severe in 83% of the cases and had a shorter median latency as compared with the first (8 weeks vs 182 weeks, P = 0.0045). There were no significant differences for demographic and clinical characteristics of patients who developed a second dyscrasia as compared with those who did not. The present study shows that almost 70% of the patients rechallenged with clozapine after a leucopenia or a neutropenia did not develop a new hematological adverse effect, whereas the remaining 30% had a faster but less serious neutropenia.
Asunto(s)
Antipsicóticos/efectos adversos , Clozapina/efectos adversos , Leucopenia/inducido químicamente , Paraproteinemias/inducido químicamente , Adulto , Antipsicóticos/administración & dosificación , Clozapina/administración & dosificación , Femenino , Humanos , Leucopenia/sangre , Masculino , Persona de Mediana Edad , Neutropenia/sangre , Neutropenia/inducido químicamente , Paraproteinemias/sangre , Farmacovigilancia , Adulto JovenRESUMEN
Drug promotion and advertisement by pharmaceutical industry influence medical prescription and, in some cases, the information provided is incomplete or biased. The objective was to analyze the advertisements delivered by medical representatives and determine if the information was appropriate for rational prescribing. It is a prospective study (March to November 2018) by collecting print advertisements randomly received in neurology centers. It was evaluated if they met the ethical criteria established by the WHO, using as a reference leaflets from Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Food and Drugs Administration (FDA) and pharmacology books. A committee of pharmacology physicians analyzed if the content of the pamphlets was misleading according to the WHO. Sixty advertisements were analyzed, being anti-epileptics and antidepressants the most advertised drugs. The 33.3% (n = 20) of them included leaflets in accordance to ANMAT. One case presented an "off-label" indication. Drug action was presented in 31.7% (n = 19) of the pamphlets, adverse reactions in 40% (n = 24), posology in 45% (n = 27), contraindications in 38.3% (n = 23) and the necessary precautions in 36.7% (n = 22) of them. The information provided was false in 80% (n = 48) and 53.3% (n = 32) contained misleading images; and 69.2% (n = 18) of the graphics were false. The information provided by medical advertisements analyzed in this study would be insufficient to know and prescribe a new drug. Lack of information in posology, contraindication, drug action and adverse reactions do not contribute to rational use of medications.
La publicidad y promoción de medicamentos por parte de la industria farmacéutica ejerce influencia sobre la prescripción médica y, en algunos casos, la información provista es incompleta o sesgada. El objetivo fue analizar las publicidades entregadas por representantes médicos y determinar si la información era apropiada para la prescripción racional. Es un estudio prospectivo (marzo a noviembre 2018) mediante la recolección de publicidades impresas recibidas aleatoriamente en centros de neurología. Se evaluó si cumplían los criterios éticos establecidos por la OMS, utilizando como referencia prospectos de la Administración Nacional de Medicamentos, Alimentos y Tecnología médica (ANMAT), la Food and Drugs Administration (FDA) y libros de farmacología. Un comité de médicos farmacólogos analizó si el contenido de los folletos era engañoso según la OMS. Se analizaron 60 publicidades, siendo antiepilépticos y antidepresivos los más publicitados. El 33.3% (n = 20) incluían prospectos acordes según ANMAT. Un caso presentaba indicación off-label. Los folletos exponían el mecanismo de acción en el 31.7% (n = 19), las reacciones adversas medicamentosas 40% (n = 24), la posología en el 45% (n = 27), las contraindicaciones 38.3% (n = 23) y en 36.7% (n = 22) las precauciones necesarias. La información brindada era falaz en el 80% (n = 48) y el 53.3% (n = 32) tenían imágenes capciosas. El 69.2% (n = 18) de los gráficos eran capciosos. En el presente trabajo, la información brindada por la publicidad médica sería insuficiente para conocer y prescribir nuevos fármacos. La falta de información en la posología, contraindicaciones, mecanismos de acción y reacciones adversas no contribuyen al uso racional de medicamentos.
Asunto(s)
Publicidad , Preparaciones Farmacéuticas , Industria Farmacéutica , Humanos , Estudios Prospectivos , Derivación y ConsultaRESUMEN
The putative Pueyo's vaccine was a commercial venture that obtained marketing authorization in 1946, a turbulent period of Argentine history. After a few months, health authorities withdrew financial support from the state to buy the vaccine and required patients to sign a written consent to receive that product. An independent investigation did not find any evidence of benefit in non-clinical and clinical evaluation of the putative vaccine.
Asunto(s)
Medios de Comunicación de Masas , Vacunas , Humanos , Mercadotecnía , Tuberculosis , Vacunas contra la Tuberculosis , IncertidumbreRESUMEN
This work describes the main functions and attributions of the National Administration of Medicines, Food and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) of Argentina in the control and supervision of pharmaceutical products. The four properties that a medicine must full-fill (efficacy, safety, quality and accessibility) are described, and the role of ANMAT with regard to each one is specified. Criteria employed in the classification of pharmaceutical products marketed in Argentina with the regulatory agency permission are specified, and a reference to pharmaceutical products not registered before the Agency is also included.
Asunto(s)
Industria Farmacéutica/legislación & jurisprudencia , Monitoreo de Drogas/normas , Control de Medicamentos y Narcóticos/legislación & jurisprudencia , Argentina , HumanosRESUMEN
Resumen La publicidad y promoción de medicamentos por parte de la industria farmacéutica ejerce influencia sobre la prescripción médica y, en algunos casos, la información provista es incompleta o sesgada. El objetivo fue analizar las publicidades entregadas por representantes médicos y determinar si la información era apropiada para la prescripción racional. Es un estudio prospectivo (marzo a noviembre 2018) mediante la recolección de publicidades impresas recibidas aleatoriamente en centros de neurología. Se evaluó si cumplían los criterios éticos establecidos por la OMS, utilizando como referencia prospectos de la Administración Nacional de Medicamentos, Alimentos y Tecnología médica (ANMAT), la Food and Drugs Administration (FDA) y libros de farmacología. Un comité de médicos farmacólogos analizó si el contenido de los folletos era engañoso según la OMS. Se analizaron 60 publicidades, siendo antiepilépticos y antidepresivos los más publicitados. El 33.3% (n = 20) incluían prospectos acordes según ANMAT. Un caso presentaba indicación off-label. Los folletos ex ponían el mecanismo de acción en el 31.7% (n = 19), las reacciones adversas medicamentosas 40% (n = 24), la posología en el 45% (n = 27), las contraindicaciones 38.3% (n = 23) y en 36.7% (n = 22) las precauciones necesarias. La información brindada era falaz en el 80% (n = 48) y el 53.3% (n = 32) tenían imágenes capcio sas. El 69.2% (n = 18) de los gráficos eran capciosos. En el presente trabajo, la información brindada por la publicidad médica sería insuficiente para conocer y prescribir nuevos fármacos. La falta de información en la posología, contraindicaciones, mecanismos de acción y reacciones adversas no contribuyen al uso racional de medicamentos.
Abstract Drug promotion and advertisement by pharmaceutical industry influence medical prescription and, in some cases, the information provided is incomplete or biased. The objective was to analyze the advertisements deliv ered by medical representatives and determine if the information was appropriate for rational prescribing. It is a prospective study (March to November 2018) by collecting print advertisements randomly received in neurology centers. It was evaluated if they met the ethical criteria established by the WHO, using as a reference leaflets from Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Food and Drugs Ad ministration (FDA) and pharmacology books. A committee of pharmacology physicians analyzed if the content of the pamphlets was misleading according to the WHO. Sixty advertisements were analyzed, being anti-epileptics and antidepressants the most advertised drugs. The 33.3% (n = 20) of them included leaflets in accordance to ANMAT. One case presented an "off-label" indication. Drug action was presented in 31.7% (n = 19) of the pam phlets, adverse reactions in 40% (n = 24), posology in 45% (n = 27), contraindications in 38.3% (n = 23) and the necessary precautions in 36.7% (n = 22) of them. The information provided was false in 80% (n = 48) and 53.3% (n = 32) contained misleading images; and 69.2% (n = 18) of the graphics were false. The information provided by medical advertisements analyzed in this study would be insufficient to know and prescribe a new drug. Lack of information in posology, contraindication, drug action and adverse reactions do not contribute to rational use of medications.
Asunto(s)
Humanos , Preparaciones Farmacéuticas , Publicidad , Derivación y Consulta , Estudios Prospectivos , Industria FarmacéuticaRESUMEN
OBJECTIVE: The National Institute of Social Services for Retirees and Pensioners (NISSRP) is a nationwide health care financing agency and service provider in Argentina. Among its services, the NISSRP provides outpatient drug coverage to more than 3.3 million beneficiaries, mainly senior citizens and disabled persons. In 1997, to help cope with its rising costs, the NISSRP agreed to transfer the risk for the cost of outpatient medications and cancer-treatment drugs to a consortium of pharmaceutical companies in exchange for a fixed monthly payment. The objective of this study was to determine the impact that this new approach had on three things: (1) the level of expenditures for the medicines that were included in the agreement, (2) the pattern of nonrational prescribing for NISSRP beneficiaries, and (3) this pattern's relationship with macroeconomic variables and the pattern of prescribing for Argentina as a whole. METHODS: We compared outpatient-medicine consumption in 1999 with consumption before the agreement went into effect. RESULTS: The actual amount that NISSRP beneficiaries spent out-of-pocket climbed from US$ 336.13 million in 1996 to US$ 473.36 million in 1999, an increase of almost 41%. The nominal amount "spent" by the NISSRP in 1999 was US$ 601.11 million, versus a real amount of US$ 374.75 million in 1996, an "increase" of 60% (that increase for the NISSRP was only theoretical since the agreement specified the fixed monthly amount that the NISSRP would have to pay to the pharmaceutical consortium). In contrast with the increased real spending by NISSRP beneficiaries, Argentina's economy remained stable over the assessed period, with the consumer price index even falling by 0.8%. We found high levels of nonrational drug use in the NISSRP system in both 1996 and 1999, indicating a serious ongoing problem. CONCLUSIONS: An agreement with pharmaceutical companies, like the one we have described, might add an element of financial predictability for institutions such as the NISSRP. However, such an agreement can easily result in an increased economic burden for health care beneficiaries, and without any improvement in the services that they receive. This type of agreement requires extensive mechanisms for control, follow-up, and updating, and it also risks making nonrational drug prescribing the accepted rule. While perhaps feasible, the requirements for this kind of agreement are actually very difficult to put into place, requiring additional efforts from institutions such as the NISSRP.
Asunto(s)
Industria Farmacéutica/economía , Personal de Salud/economía , Medición de Riesgo/economía , Anciano , Argentina , Industria Farmacéutica/estadística & datos numéricos , Economía/estadística & datos numéricos , Honorarios Farmacéuticos/estadística & datos numéricos , Personal de Salud/estadística & datos numéricos , Humanos , Honorarios por Prescripción de Medicamentos/estadística & datos numéricos , Medición de Riesgo/estadística & datos numéricosRESUMEN
OBJECTIVE: The National Institute of Social Services for Retirees and Pensioners (NISSRP) is a nationwide health care financing agency and service provider in Argentina. Among its services, the NISSRP provides outpatient drug coverage to more than 3.3 million beneficiaries, mainly senior citizens and disabled persons. In 1997, to help cope with its rising costs, the NISSRP agreed to transfer the risk for the cost of outpatient medications and cancer-treatment drugs to a consortium of pharmaceutical companies in exchange for a fixed monthly payment. The objective of this study was to determine the impact that this new approach had on three things: (1) the level of expenditures for the medicines that were included in the agreement, (2) the pattern of nonrational prescribing for NISSRP beneficiaries, and (3) this pattern's relationship with macroeconomic variables and the pattern of prescribing for Argentina as a whole. METHODS: We compared outpatient-medicine consumption in 1999 with consumption before the agreement went into effect. RESULTS: The actual amount that NISSRP beneficiaries spent out-of-pocket climbed from US$ 336.13 million in 1996 to US$ 473.36 million in 1999, an increase of almost 41 percent. The nominal amount "spent" by the NISSRP in 1999 was US$ 601.11 million, versus a real amount of US$ 374.75 million in 1996, an "increase" of 60 percent (that increase for the NISSRP was only theoretical since the agreement specified the fixed monthly amount that the NISSRP would have to pay to the pharmaceutical consortium). In contrast with the increased real spending by NISSRP beneficiaries, Argentina's economy remained stable over the assessed period, with the consumer price index even falling by 0.8 percent. We found high levels of nonrational drug use in the NISSRP system in both 1996 and 1999, indicating a serious ongoing problem. CONCLUSIONS: An agreement with pharmaceutical companies, like the one we have described, might add an element of financial predictability for institutions such as the NISSRP. However, such an agreement can easily result in an increased economic burden for health care beneficiaries, and without any improvement in the services that they receive. This type of agreement requires extensive mechanisms for control, follow-up, and updating, and it also risks making nonrational drug prescribing the accepted rule. While perhaps feasible, the requirements for this kind of agreement are actually very difficult to put into...
Objetivos. El Instituto Nacional de Servicios Sociales para Personas Jubiladas y Pensionadas (INSSPJP) es una agencia nacional que financia y provee servicios de salud en Argentina. Entre los servicios que provee figura la cobertura del costo de medicamentos adquiridos por la vía ambulatoria a más de 3,3 millones de beneficiarios, principalmente personas de edad avanzada o discapacitadas. En 1997, con el fin de ayudar a sufragar el aumento de los costos, el INSSPJP acordó transferir el riesgo de los costos de los medicamentos para pacientes ambulatorios y para el tratamiento del cáncer a un consorcio de compañías farmacéuticas a cambio de una cuota mensual fija. El objetivo del presente estudio es determinar qué impacto ha tenido esta medida en tres aspectos: 1) el nivel del gasto en los medicamentos abarcados por el acuerdo; 2) la tendencia a prescribir medicamentos de forma no racional para beneficiarios del INSSPJP y 3) la relación que muestra esta tendencia con las variables macroeconómicas y los patrones de prescripción en toda la Argentina. Métodos. Comparamos el consumo de medicamentos por pacientes ambulatorios en 1999 con el consumo antes de la entrada en vigor del acuerdo. Resultados. La cantidad que los beneficiarios del INSSPJP gastaron de su bolsillo aumentó de $US 336,13 millones en 1996 a $US 473,36 millones en 1999, aumento que equivale a casi 41%. La cantidad nominal "gastada" por el INSSPJP en 1999 fue de $US 601,11 millones, frente a la cantidad real gastada en 1996, que fue de $US 374,75 millones. Esto representa un "aumento" de 60% (el aumento para el INSSPJP es solo teórico, ya que en el acuerdo se especificaba la cantidad mensual fija que esta entidad tendría que pagarle al consorcio de compañías farmacéuticas). A diferencia del aumento del gasto real que afectó a los beneficiarios del INSSPJP, la economía argentina permaneció estable durante el período estudiado, cuando el índice de precios al consumidor hasta se redujo en 0,8%. Hallamos un uso frecuente de medicamentos de forma irracional en el sistema del INSSPJP tanto en 1996 como en 1999, dato que apunta a la presencia de un problema importante. Conclusiones. Un acuerdo con compañías farmacéuticas como el aquí descrito podría aportar un elemento de pronosticabilidad para instituciones tales como el INSSPJP. No obstante, un acuerdo de este tipo bien podría aumentar la carga económica de los beneficiarios de las prestaciones de salud, sin que mejoren en modo alguno los servicios que reciben. Los acuerdos de este tipo exigen que haya complejos mecanismos de control, seguimiento y actualización, y al mismo tiempo acarrean el peligro de que la prescripción irracional de medicamentos se convierta en práctica habitual. Aunque su factibilidad no es de dudar, los mecanismos que exigen estos acuerdos son muy difíciles de implantar y su puesta en marcha plantea la necesidad de medidas adicionales por parte de instituciones como el INSSPJP