Regulatory convergence and harmonization: barriers to effective use and adoption of common standards.

Objective To evaluate 1) the level of use and adoption of eight Technical Documents (TDs) published by the Pan American Network for Drug Regulatory Harmonization (PANDRH) member states and 2) identify the hurdles that can prevent countries from successfully adopting a common standard. Methods An in-depth analysis of the incorporation of PANDRH Technical Document No. 1 ("TDNo1") recommendations in member states' national requirements was carried out. Results The results illustrate the role of PANDRH in promoting convergence/harmonization among its members. Conclusions The study results show that the rate of use of TDs varied greatly by product/area and country. Timing, TD content, and product/area, and, more importantly, national capacities, are critical determinants of the level of TD guideline adoption. While PANDRH TDs have proven instrumental for the harmonization/convergence of member states' national requirements, as shown by the level of convergence across a majority of the national requirements issued for vaccine licensing, several countries had yet to incorporate common standards due, in large part, to weak national regulatory capacities. Therefore, harmonization/convergence initiatives should include the strengthening of national regulatory capacities as part of their core strategy, which will, in turn, allow for the incorporation and deployment of common standards in all participating countries.

[South-South cooperation to strengthen the medicines control laboratories of the Caribbean community (CARICOM)]. / Cooperación Sur-Sur para el fortalecimiento de los laboratorios de control de medicamentos de la Comunidad del Caribe (CARICOM).

Objective To describe the benefits obtained through South-South and triangular cooperation as a potential tool for strengthening medicine quality control in official medicines control laboratories (OMCLs) of the Region of the Americas. Methods Descriptive study of the project for strengthening drug quality control in OMCLs of the Caribbean community (CARICOM). Results Staff members of Argentina's National Administration for Drugs, Food, and Medical Technology (ANMAT) provided training to professionals from Guyana, Jamaica, Suriname, and Trinidad and Tobago. The project was funded by the Argentine Fund for South-South and Triangular Cooperation (FO.AR) and coordinated by the Pan American Health Organization (PAHO). Documents on good laboratory practice (GLP) developed by the World Health Organization (WHO) and the Pan American Network for Drug Regulatory Harmonization (PANDRH) were reviewed, and the area of physical and chemical controls was strengthened, primarily for drugs to treat tuberculosis, malaria, and HIV/AIDS, all of which are strategically important to those countries. Conclusion This type of collaboration makes it possible to share experiences, optimize resources, harmonize procedures and regulations, and strengthen human resource capacities. In addition, it is a valuable tool for reducing asymmetries in various areas among the different countries of our Region.

[Adverse drug reactions and prescription errors: morbi-mortality]. / Reacciones adversas medicamentosas y errores de prescripción: morbi-mortalidad.

Pharmacovigilance aims to detect, assess, understand and prevent any possible drug-related problem. The record of information related to adverse drug reactions (ADRs) after drug approval and risk management based on observational data are crucial for public health. The main goal was to assess the ADRs morbimortality and to describe prescription medical errors in a public hospital in the city of Buenos Aires. A prospective observational study was undertaken. ADR was defined as any clinical and/or biological noxious manifestation imputable to a drug, which occurs at the usually used dose in humans for disease prophylaxis, diagnosis or treatment. Global mortality was 7% (21/310). The observed mortality due to ADR accounted for 1% (3/310). One hundred and forty nine ADRs in 36% of patients were identified (111/310), and 11% (35/310) of the hospital admissions were due to ADRs. ADRs cause a great number of admissions and are responsible for preventable morbidity during hospitalization. Neither drug alone caused more than 6% of the ADRs. For this reason, in order to diminish ADRs, strategies should be addressed to multiple drug groups.

Risk factors associated with DRESS syndrome produced by aromatic and non-aromatic antipiletic drugs.

PURPOSE: DRESS (drug reaction with eosinophilia and systemic symptoms) is an idiosyncratic entity associated with the use of drugs. Its pathophysiology is not known, but is associated with immunological or genetic factors. The incidence is 0.4 cases per 1,000,000 general population. The syndrome usually develops at the beginning of treatment and is characterized by the presence of rash, fever, eosinophilia and systemic manifestations. The aim of our study was to describe the clinical manifestation and treatment of patients with DRESS associated with antiepileptic drugs (AEDs). METHODS: This is a descriptive study with the aim of describing the clinical manifestation and treatment associated with DRESS produced by aromatic and non-aromatic AEDs. RESULTS: Eight patients treated with AEDs developed DRESS between January 2007 and May 2010 at our hospital. All had dermatological manifestations, eosinophilia and systemic (haematological and hepatic) manifestations that could be attributed to treatment with aromatic AEDs (carbamazepine, 2 patients; lamotrigine, 3 patients; phenytoin, 3 patients). Therapeutic management included removal of the drug from the therapeutic regime, symptomatic management, life support and use of corticosteroids. There was no mortality associated with the syndrome. Reversion of systemic manifestations was very slow: between 1 and 6 months. CONCLUSIONS: DRESS is a severe cutaneous reaction, with high morbidity and mortality, whose development seems to be associated with individual susceptibility, type of antiepileptic drug used (more common with aromatic drugs), titration rate and concomitant medications.

Would it be recommended treating multiple sclerosis relapses with high dose oral instead intravenous steroids during the COVID-19 pandemic? Yes.

The emergence of novel Coronavirus 2019 and the subsequent pandemic are presenting a challenge to neurologists managing patients with multiple sclerosis (MS). The clinical management has dramatically altered and it was necessary to change and/or adapt it to the new situation. Regarding relapses management, the use of intravenous corticosteroids and hospitalization during MS relapses increase the risk of viral exposure. OBJECTIVE: To review the efficacy and safety of high dose oral corticosteroids in acute relapses treatment compared to intravenous corticosteroids. METHODS: Descriptive review of the utility of high dose oral corticosteroids for MS relapses treatment was performed. We searched the literature available on PubMed and Scientific Electronic Library Online (Scielo). We focused on different trials comparing the use of high dose intravenous vs oral corticosteroids. RESULTS: Five studies were selected. One hundred and eighty two patients receiving treatment with high dose oral corticosteroids were included. The most frequent schedule was oral methylprednisolone 1000 mg (over three days). There were no significant differences between both routes of corticosteroids administration. CONCLUSION: Neurologists should be aware of the current evidence on the similar efficacy of both oral and intravenous corticosteroids for MS relapses. Using oral steroids during the pandemic would be a safe option for patients.

Periventricular nodular and subcortical neuronal heterotopia in adult epileptic patients.

Developmental malformations are brain abnormalities that occur during embryogenesis. Neuronal migration disorders, including heterotopic lesions, constitute one type of such abnormalities. The aim of the study was to compare the epileptic clinical patterns of patients with periventricular nodular heterotopia (PNH) (G1) with those affected by subcortical heterotopia (SCH) (G2) looking for differences between both groups which, eventually, might suggest the type of the underlying malformation. The variables studied in both groups were: type of the heterotopia depicted on MRI studies, sex, age, age at seizure onset, annual seizure frequency, localization of the ictal symptomatogenic zone, characteristics of the EEG, other associated anomalies on the magnetic resonance images (MRI) besides the heterotopia, and response to treatment. The only difference found between both groups was the type of heterotopia as shown by MRI studies. The other assessed variables did not significantly (p>0.05) differ between groups. No differences in the clinical features characterizing epilepsy could be found in patients with PNH or SCH, being the images the only tool able to differentiate them.

Visual defects associated with vigabatrin: a study of epileptic argentine patients.

OBJECTIVE: The aim of the present study was to assess visual alterations in a population of Argentine patients treated with the antiepileptic drug vigabatrin. METHODS: Twenty patients receiving vigabatrin and 15 patients receiving carbamazepine were examined with automated perimetry using a Humphrey 120-point full screening strategy. In addition, scotopic flash electroretinograms were performed. RESULTS: Of 20 patients treated with vigabatrin, two were unable to cooperate with testing. Of the remaining 18 patients, all but two showed at least one non-detected point inside the central 40 degrees of the visual field of each eye. Of the 15 carbamazepine-treated patients, three were unable to perform the study. None of the remaining 12 patients showed visual field defects. Both a- and b-wave amplitudes of the scotopic electroretinogram were significantly reduced in 12 patients receiving vigabatrin. CONCLUSIONS: Visual field defects among patients on vigabatrin therapy may occur with a higher frequency than previously recognized. The Humphrey 120-points full field screening test and electroretinography are useful tools to assess the visual dysfunction associated with vigabatrin.

Expanding Virchow Robin spaces in the midbrain causing hydrocephalus.

We describe a patient who showed cystic lesions in the midbrain and obstructive hydrocephalus. MR imaging features corresponded to abnormal dilatation of perivascular spaces. Similar clinical and MR imaging findings were described in previous reports of patients presenting with mesencephalo-thalamic expanding lacunae; the diagnosis of some of those cases was confirmed at postmortem examination This condition is extremely rare but should be part of a differential diagnosis when evaluating cystic abnormalities in this area of the brain.

[Declaration of Helsinki: its vicissitudes during the last five years]. / Declaración de Helsinki. Sus vicisitudes en los últimos cinco años.

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.

[Mechanism of action of antiepileptic drugs]. / Mecanismo de acción de las drogas antiepilépticas.

Antiepileptic drugs (DAEs) act through different mechanisms of action: increase in central inhibition, inhibition of excitatorios mechanisms and modification of the excitability through their action on the ionic channels. Epilepsy is characterized by an abnormal and hypersynchronic unloading of a neuronal population. The activity of numerous drugs is associated to increase in gabaergic activity. Another group of drugs decreases excitatory mechanisms, through the inhibition of ionic channels, or through a decrease in the activity of the excitatory neurotransmitters. There are some of antiepileptic drugs, especially within the group of drugs of recent appearance, for wich the mechanism of action remains unknown.

La ética de los diseños y métodos alternativos de ensayos clínicos. Una reflexión sobre el Foro Global de Bioética en Investigación del 2017

La reunión anual del Foro Global de Bioética en Investigación (GFBR, por sus siglas en inglés) se llevó a cabo en Bangkok, Tailandia, el 28 y 29 de noviembre 2017 y trató sobre la ética de los diseños y métodos alternativos de ensayos clínicos en países de bajos y medianos ingresos. En esta reunión se discutieron otras formas de generar evidencias tales como los ensayos aleatorizados por conglomerado (cluster randomized trials), que consisten en la asignación al azar de grupos en lugar de individuos independientes a una intervención, aquellos en los cuales una intervención se agrega a los conglomerados de manera escalonada (stepped wedge); los ensayos con plataformas adaptativas (adaptative platforms), que permiten modificaciones al ensayo o procedimientos estadísticos del ensayo después de su inicio, sin menoscabar su validez e integridad; y los modelos con infecciones controladas en seres humanos (controlled human infection models o CHIM)...

Regulatory convergence and harmonization: barriers to effective use and adoption of common standards / La convergencia y la armonización regulatorias: barreras en el uso y la adopción eficaces de normas comunes

Objective. To evaluate 1) the level of use and adoption of eight Technical Documents (TDs) published by the Pan American Network for Drug Regulatory Harmonization (PANDRH) member states and 2) identify the hurdles that can prevent countries from successfully adopting a common standard. Methods. An in-depth analysis of the incorporation of PANDRH Technical Document No. 1 (“TDNo1”) recommendations in member states’ national requirements was carried out. Results. The results illustrate the role of PANDRH in promoting convergence/harmonization among its members. Conclusions. The study results show that the rate of use of TDs varied greatly by product/area and country. Timing, TD content, and product/area, and, more importantly, national capacities, are critical determinants of the level of TD guideline adoption. While PANDRH TDs have proven instrumental for the harmonization/convergence of member states’ national requirements, as shown by the level of convergence across a majority of the national requirements issued for vaccine licensing, several countries had yet to incorporate common standards due, in large part, to weak national regulatory capacities. Therefore, harmonization/convergence initiatives should include the strengthening of national regulatory capacities as part of their core strategy, which will, in turn, allow for the incorporation and deployment of common standards in all participating countries.

Objetivo. Evaluar (1) la medida en que se usan y se han adoptado ocho documentos técnicos (DT) publicados por los estados miembros de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica (Red PARF) y (2) definir los obstáculos que pueden impedir que los países adopten una norma común. Métodos. Se realizó un análisis minucioso de la incorporación de las recomendaciones contenidas en el Documento Técnico No. 1 (“DTNo1”) de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica en los requisitos nacionales de los estados miembros. Resultados. Los resultados ilustran el papel que desempeña la Red Panamericana para la Armonización de la Reglamentación Farmacéutica en la promoción de la convergencia y armonización entre sus miembros. Conclusiones. Los resultados del estudio indican que el uso de los DT varía enormemente según el producto o el área y el país. El momento, el contenido del DT, el producto o área y, lo que es más importante, la capacidad nacional son factores determinantes del grado de adopción de las directrices contenidas en los DT. Si bien los DT de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica han sido decisivos en la armonización y convergencia de los requisitos nacionales de los estados miembros, como demuestra el grado de convergencia de la mayor parte de los requisitos nacionales emitidos para la concesión de licencias para vacunas, varios países no habían incorporado normas comunes todavía debido, en gran parte, a una capacidad de reglamentación nacional deficiente. Por lo tanto, las iniciativas en pro de la armonización y convergencia deben comprender el fortalecimiento de la capacidad de reglamentación nacional como parte de su estrategia central, lo cual permitirá, a su vez, que se incorporen y desplieguen normas comunes en todos los países participantes.

Regulatory convergence and harmonization: barriers to effective use and adoption of common standards / La convergencia y la armonización regulatorias: barreras en el uso y la adopción eficaces de normas comunes

ABSTRACT Objective To evaluate 1) the level of use and adoption of eight Technical Documents (TDs) published by the Pan American Network for Drug Regulatory Harmonization (PANDRH) member states and 2) identify the hurdles that can prevent countries from successfully adopting a common standard. Methods An in-depth analysis of the incorporation of PANDRH Technical Document No. 1 (“TDNo1”) recommendations in member states’ national requirements was carried out. Results The results illustrate the role of PANDRH in promoting convergence/harmonization among its members. Conclusions The study results show that the rate of use of TDs varied greatly by product/area and country. Timing, TD content, and product/area, and, more importantly, national capacities, are critical determinants of the level of TD guideline adoption. While PANDRH TDs have proven instrumental for the harmonization/convergence of member states’ national requirements, as shown by the level of convergence across a majority of the national requirements issued for vaccine licensing, several countries had yet to incorporate common standards due, in large part, to weak national regulatory capacities. Therefore, harmonization/convergence initiatives should include the strengthening of national regulatory capacities as part of their core strategy, which will, in turn, allow for the incorporation and deployment of common standards in all participating countries.

RESUMEN Objetivo Evaluar (1) la medida en que se usan y se han adoptado ocho documentos técnicos (DT) publicados por los estados miembros de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica (Red PARF) y (2) definir los obstáculos que pueden impedir que los países adopten una norma común. Métodos Se realizó un análisis minucioso de la incorporación de las recomendaciones contenidas en el Documento Técnico No. 1 (“DTNo1”) de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica en los requisitos nacionales de los estados miembros. Resultados Los resultados ilustran el papel que desempeña la Red Panamericana para la Armonización de la Reglamentación Farmacéutica en la promoción de la convergencia y armonización entre sus miembros. Conclusiones Los resultados del estudio indican que el uso de los DT varía enormemente según el producto o el área y el país. El momento, el contenido del DT, el producto o área y, lo que es más importante, la capacidad nacional son factores determinantes del grado de adopción de las directrices contenidas en los DT. Si bien los DT de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica han sido decisivos en la armonización y convergencia de los requisitos nacionales de los estados miembros, como demuestra el grado de convergencia de la mayor parte de los requisitos nacionales emitidos para la concesión de licencias para vacunas, varios países no habían incorporado normas comunes todavía debido, en gran parte, a una capacidad de reglamentación nacional deficiente. Por lo tanto, las iniciativas en pro de la armonización y convergencia deben comprender el fortalecimiento de la capacidad de reglamentación nacional como parte de su estrategia central, lo cual permitirá, a su vez, que se incorporen y desplieguen normas comunes en todos los países participantes.

Cooperación Sur-Sur para el fortalecimiento de los laboratorios de control de medicamentos de la Comunidad del Caribe (CARICOM) / South-South cooperation to strengthen the medicines control laboratories of the Caribbean community (CARICOM)

Objetivo. Describir los beneficios obtenidos a través de la cooperación Sur-Sur y Triangular, como una potencial herramienta para el fortalecimiento en el control de la calidad de los medicamentos en los Laboratorios Oficiales de Control de Medicamentos (LOCM) de la Región de las Américas. Métodos. Estudio descriptivo del proyecto para el fortalecimiento en el control de la calidad de los medicamentos en los LOCM de la Comunidad del Caribe (CARICOM). Resultados. La capacitación fue desarrollada por profesionales de la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) de Argentina, a profesionales de Guyana, Jamaica, Surinam y Trinidad y Tobago. El proyecto contó con financiamiento del Fondo Argentino de Cooperación Sur-Sur y Triangular (FO.AR) y coordinación de la Organización Panamericana de la Salud (OPS). Se revisaron los documentos de Buenas Prácticas de Laboratorio (BPL) de la Organización Mundial de la Salud (OMS) y de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica (Red-PARF) y se fortaleció el área de controles físicos químicos, principalmente en relación a medicamentos para el tratamiento de la tuberculosis, la malaria y el VIH/sida, todos de importancia estratégica para esos países. Conclusión. Este tipo de colaboraciones permiten transferir experiencia, optimizar los recursos, armonizar procedimientos y regulaciones y reforzar capacidades en término de recursos humanos, y constituyen una herramienta valiosa en la reducción de las asimetrías que pudieron establecerse en diferentes áreas entre diferentes países de nuestra región.

Objective. To describe the benefits obtained through South-South and triangular cooperation as a potential tool for strengthening medicine quality control in official medicines control laboratories (OMCLs) of the Region of the Americas. Methods. Descriptive study of the project for strengthening drug quality control in OMCLs of the Caribbean community (CARICOM). Results. Staff members of Argentina’s National Administration for Drugs, Food, and Medical Technology (ANMAT) provided training to professionals from Guyana, Jamaica, Suriname, and Trinidad and Tobago. The project was funded by the Argentine Fund for South-South and Triangular Cooperation (FO.AR) and coordinated by the Pan American Health Organization (PAHO). Documents on good laboratory practice (GLP) developed by the World Health Organization (WHO) and the Pan American Network for Drug Regulatory Harmonization (PANDRH) were reviewed, and the area of physical and chemical controls was strengthened, primarily for drugs to treat tuberculosis, malaria, and HIV/AIDS, all of which are strategically important to those countries. Conclusion. This type of collaboration makes it possible to share experiences, optimize resources, harmonize procedures and regulations, and strengthen human resource capacities. In addition, it is a valuable tool for reducing asymmetries in various areas among the different countries of our Region.

Reacciones adversas medicamentosas y errores de prescripción: morbi-mortalidad / Adverse drug reactions and prescription errors: morbi-mortality

La farmacovigilancia tiene por objeto la detección, evaluación, comprensión y prevención de cualquier problema relacionado a las drogas. La recolección de información relacionada a reacciones adversas medicamentosas (RAM) posterior a la aprobación y el manejo del riesgo basados en los datos observacionales son críticos para la salud pública.El objetivo primario fue evaluar la morbimortalidad de las reacciones adversas medicamentosas y describir los errores médicos de prescripción en un hospital público de la Ciudad de Buenos Aires. Se llevó a cabo un estudio prospectivo observacional. Se definió RAM como cualquier manifestación nociva, clínica y/o biológica imputable a un medicamento, que ocurra a las dosis habitualmente utilizadas en humanos para la profilaxis, diagnóstico o tratamiento de una enfermedad. La mortalidad global fue del 7% (21/310) y la atribuible a RAM observada fue del 1% (3/310). Se identificaron 149 RAMs en el 36% de los pacientes (111/310) y las RAM constituyeron el 11% (35/310) de los motivos de internación. Las RAM causan un número significativo de internaciones y son responsables de morbilidad evitable durante la internación. Ningún fármaco aislado causó más del 6% de las RAM, por lo que las estrategias para disminuirlas deben estar dirigidas a múltiples grupos farmacológicos.(AU)

Pharmacovigilance aims to detect, assess, understand and prevent any possible drug-related problem. The record of information related to adverse drug reactions (ADRs) after drug approval and risk management based on observational data are crucial for public health. The main goal was to assess the ADRs morbimortality and to describe prescription medical errors in a public hospital in the city of Buenos Aires. A prospective observational study was undertaken. ADR was defined as any clinical and/or biological noxious manifestation imputable to a drug, which occurs at the usually used dose in humans for disease prophylaxis, diagnosis or treatment. Global mortality was 7% (21/310). The observed mortality due to ADR accounted for 1% (3/310). One hundred and forty nine ADRs in 36% of patients were identified (111/310), and 11% (35/310) of the hospital admissions were due to ADRs. ADRs cause a great number of admissions and are responsible for preventable morbidity during hospitalization. Neither drug alone caused more than 6% of the ADRs. For this reason, in order to diminish ADRs, strategies should be addressed to multiple drug groups.(AU)

Reacciones adversas medicamentosas y errores de prescripción: morbi-mortalidad / Adverse drug reactions and prescription errors: morbi-mortality

La farmacovigilancia tiene por objeto la detección, evaluación, comprensión y prevención de cualquier problema relacionado a las drogas. La recolección de información relacionada a reacciones adversas medicamentosas (RAM) posterior a la aprobación y el manejo del riesgo basados en los datos observacionales son críticos para la salud pública.El objetivo primario fue evaluar la morbimortalidad de las reacciones adversas medicamentosas y describir los errores médicos de prescripción en un hospital público de la Ciudad de Buenos Aires. Se llevó a cabo un estudio prospectivo observacional. Se definió RAM como cualquier manifestación nociva, clínica y/o biológica imputable a un medicamento, que ocurra a las dosis habitualmente utilizadas en humanos para la profilaxis, diagnóstico o tratamiento de una enfermedad. La mortalidad global fue del 7% (21/310) y la atribuible a RAM observada fue del 1% (3/310). Se identificaron 149 RAMs en el 36% de los pacientes (111/310) y las RAM constituyeron el 11% (35/310) de los motivos de internación. Las RAM causan un número significativo de internaciones y son responsables de morbilidad evitable durante la internación. Ningún fármaco aislado causó más del 6% de las RAM, por lo que las estrategias para disminuirlas deben estar dirigidas a múltiples grupos farmacológicos.

Pharmacovigilance aims to detect, assess, understand and prevent any possible drug-related problem. The record of information related to adverse drug reactions (ADRs) after drug approval and risk management based on observational data are crucial for public health. The main goal was to assess the ADRs morbimortality and to describe prescription medical errors in a public hospital in the city of Buenos Aires. A prospective observational study was undertaken. ADR was defined as any clinical and/or biological noxious manifestation imputable to a drug, which occurs at the usually used dose in humans for disease prophylaxis, diagnosis or treatment. Global mortality was 7% (21/310). The observed mortality due to ADR accounted for 1% (3/310). One hundred and forty nine ADRs in 36% of patients were identified (111/310), and 11% (35/310) of the hospital admissions were due to ADRs. ADRs cause a great number of admissions and are responsible for preventable morbidity during hospitalization. Neither drug alone caused more than 6% of the ADRs. For this reason, in order to diminish ADRs, strategies should be addressed to multiple drug groups.

Mesial temporal lobe epilepsy and hippocampal sclerosis: cognitive function assessment in Hispanic patients.

PURPOSE: The goal of this study was to assess the cognitive function status in patients with mesial temporal lobe epilepsy and hippocampal sclerosis (TLE+HS) to determine their cognitive function profile and to correlate material-specific memory deficits with HS laterality diagnosed by MRI. METHODS: Seventy-one patients were assessed with a neuropsychological protocol that includes IQ, attention, handedness, verbal memory, visual memory, language, and the executive function. chi(2) and correlation tests were used. RESULTS: Memory impairment was found in 46 patients (66%): patients without any memory deficit (n=25), patients with verbal memory deficit (n=21), patients with visual memory deficit (n=17), patients with deficit for both types of memory (n=8). Correlation between MRI lesion and memory was 66%. Language was impaired in 33 patients (46%). Eighteen patients (25%) had a deficit of the executive function. CONCLUSIONS: Patients with TLE+HS presented with a deficit in material-specific episodic memory correlating in large proportion with HS lateralization. We also found language and executive function impairments.