Análisis de publicidades sobre medicamentos neurológicos recibidos durante la consulta médica / Analysis of advertising on neurological drugs received during the medical consultation

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.

Uso de oseltamivir durante la pandemia de gripe a (H1N1): análisis de las reacciones adversas reportadas al sistema nacional de farmacovigilancia de ANMAT / Use of oseltamivir during influenza A (H1N1) pandemic: analysis of adverse reactions reported to the ANMAT national pharmacovigilance system

INTRODUCCIÓN: Oseltamivir es un medicamento antiviral usado para profilaxis y tratamiento de la gripe. Sus efectos adversos son conocidos a través de los ensayos clínicos y por la experiencia adquirida en la última epidemia de gripe aviar. Dentro de las reacciones más graves se han reportado casos de anafilaxia, eventos cutáneos y manifestaciones psiquiátricas como alucinaciones, delirium e ideación suicida. OBJETIVO: en julio de 2009, el departamento de Farmacovigilancia de ANMAT lanzó el Plan Nacional de Farmacovigilancia para Drogas Antivirales con el objetivo de recolectar mayor información de seguridad de estos medicamentos durante su uso masivo, con especial atención a las manifestaciones cutáneas, hepáticas y neuropsiquiátricas. MÉTODOS: se analizaron todas las notificaciones recibidas durante junio - noviembre de 2009. Los datos considerados fueron: sexo, edad, notificador, modalidad terapéutica, severidad, clasificación delefecto adverso principal e imputabilidad asignada. RESULTADOS: serecibieron 179 notificaciones, la mayoría asociadas a la modalidad tratamiento. Las reacciones adversas más reportadas involucraron al sistema gastrointestinal, siendo en su mayoría leves y autolimitadas. Con respecto a los casos psiquiátricos reportados, su severidad y variabilidad obliga a prestar especial atención a estas notificaciones. Se reportaron además casos de prolongación del Intervalo QTc, evento no descripto previamente en la literatura. CONCLUSIÓN: Dada la escasa experiencia en la Argentina y el estrecho perfil de seguridad de este fármaco, es indispensable continuar con una vigilancia activa del mismo.

INTRODUCTION: Oseltamivir is an antiviral drug used for profhylaxis and treatment of influenza. Adverse effects are known through clinical trials and in large part by the experience gained after its use in the last outbreak of avian influenza in Asia. Among the most serious reactions are reported cases of anaphylaxis, cutaneous events and psychiatric symptoms such as hallucinations, delirium and suicidal behaviour. OB JECTIVE: in line with various international regulatory authori ties, during July 2009, the ANMAT through Pharmacovigilance Department launched the National Pharmacovigilance Plan for antiviral drugs used for prophylaxis and treatment of the pandemic H1N1 influenza virus. The plan called for reporting any signs or symptoms, paying particular attention to the cutaneous, hepatic and neuropsychiatric symptoms. METHOD:we analyzed all reports received during June to November 2009. The data considered were: sex, age, notifier, therapeutic modality, severity, classification of main side effect and imputation assigned. RESULTS: 179 notifications were received, most associated with treatment modality. As can be seen world wide, in Argentina, the great majority of reported adverse reactions involve the gastrointestinal system, being mostly mild and self-limiting. Given the variability and severity of psychiatric cases reported it is very important to pay close attention to these reports. Reported cases include the QTc interval prolongation, an event not previously described in the literature. CONCLUSIONS: it is essential to continu e with proactive monitoring of this drug because of the limited current experience and the benefits/ risks ratio of the safety profile of this drug.

Transferring the financial risks of pharmaceutical benefits from a large health care provider in Argentina to a consortium of pharmaceutical companies

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...

Declaracion de Helsinki: sus vicisitudes en los ultimos cinco años / Declaration of Helsinki: its vicissitudes during the last five years

The Declaration of Helsinki is one of the major ethical guidelines for conducting clinical research. Along its existence it has been modified on diverse occasions, the latest one in October 2000. The objective of this article is to carry out a revision of the discussions that were taken up at this latest modification and the debates raised since its promulgation which still continue, fundamentally in relation to the use of placebo in pharmacological clinical investigation. This includes a revision of the most outstanding articles and of the opinions of the participants in the discussions that have been published in the last five years. The scientists' arguments in favor or against the use of placebo are pointed out. We consider that it is difficult to find simple answers to the questions raised by the use of placebo in clinical trials both in developed countries and in countries under development and that the Declaration of Helsinki continues to constitute a guide of ethical ideal which all those involved in clinical research should try to take into consideration