Analysis of clinical outcomes in older individuals who received pharmaceutical care and posthospital discharge follow-up.

BACKGROUND: Previous evidence underscores the need to assess potential clinical outcomes resulting from pharmaceutical care interventions and to monitor patient's progress to evaluate their clinical evolution, which is crucial for bolstering the relevance of implementing pharmaceutical care in healthcare services. AIMS: To conduct an in-depth analysis of pharmaceutical care practices in a geriatric ward and monitor the clinical outcomes of older people served. METHODS: This interventionist study was conducted in the geriatrics ward of a Brazilian university hospital. The research intervention occurred between January and May 2022, with a follow-up conducted for up to 90 days after patients' hospital discharge. Older patients in the geriatrics ward received pharmaceutical care, including medication reconciliation, medication review, and pharmacotherapeutic follow-up, aimed at identifying and resolving drug-related problems (DRPs). The clinical relevance of DRPs and pharmaceutical recommendations was evaluated. Additionally, analyses were conducted on mortality and rehospitalization outcomes in older patients at 30, 60, and 90 days following initial hospital discharge. RESULTS: Of the patients evaluated, a significant 88.3% exhibited at least one DRP (with an average of 2.6 ± 1.9 DRPs per patient), with the majority classified as need/indication problems (38.9%). The acceptance rate of pharmaceutical recommendations was 80.9%, with the majority categorized as very significant relevance (60.4%). DRPs were predominantly of serious clinical relevance (50.9%). In patients whose clinical indicators could be monitored, 95.5% showed some clinical response (in vital signs, laboratory tests and/or clinical status evolution) potentially related to resolved DRPs. Association analysis revealed that a higher number of medications in use before hospitalization correlated with a greater identification of DRPs during hospitalization (p = 0.03). At hospital discharge, 23.6% of patients were no longer using polypharmacy. In total, 16 patients (26.7%) died during the study period. Among patients who did not die during hospitalization (n = 54), 20 patients (37%) experienced rehospitalizations within 90 days following discharge. CONCLUSION: This study facilitated the consolidation of pharmaceutical care implementation in a geriatric ward. We conducted identification, evaluation, and proposed evidence-based solutions, as well as monitored cases for outcome analysis. It is anticipated that this methodology will inspire future research and the implementation of pharmaceutical care-related services.

Selection dynamics of HCV genotype 3 resistance-associated substitutions under direct-acting antiviral therapy pressure.

The chronic hepatitis C (CHC) treatment is currently based on the use of direct-acting antivirals (DAAs), and patients infected with hepatitis C virus genotype 3 (GT3) have emerged as a more difficult-to-cure population. The NS5A inhibitor daclatasvir (DCV) and sofosbuvir (SOF), an NS5B viral polymerase inhibitor, are among the drugs that compose more effective and safer treatment regimens. The virus genetic variability is related to resistance-associated substitutions (RASs) that adversely impact DAAs effectiveness. The aims of this study were to analyze the association of NS5A and NS5B RASs and other clinical factors with DAAs regimens effectiveness in patients with GT3 CHC infection. This was a prospective cohort study performed in a Brazilian university hospital. Individuals older than 18 years with GT3 CHC treated with SOF + DCV ± ribavirin (RBV) or SOF + peginterferon (PEG) + RBV were included. Blood samples were collected at baseline and post-treatment. A total of 121 patients were included. Sustained virological response rates were 87.6% for the SOF + DCV ± RBV group and 80.0% for the SOF + PEG + RBV arm. Cirrhosis, prior treatment with interferon/PEG + RBV, and baseline NS5A RAS were associated with higher risk of treatment failure. The NS5A analysis suggested that A30K, Y93H, and RAS at site 62 were related to failure. Interestingly, a likely compensatory effect was shown between A30K and A62T. Emergence of Y93H was always associated with RAS at position 62. The RASs dynamics comprehension is an important tool to indicate more effective treatment for GT3 patients.

High-risk pregnancy: characterization of medication use profile and association with clinical and sociodemographic factors / Gestação de alto risco: caracterização do perfil de utilização de medicamentos e associação com fatores clínicos e sociodemográficos

Abstract Objectives: describe the profile of medication use and adherence, and the association with clinical and sociodemographic characteristics of high-risk pregnant women attended at a university hospital. Methods: cross-sectional study with data collected through a questionnaire applied on 386 pregnant women. Results: most participants were seen only by the gynecologist (75.1%), started prenatal in the first gestational trimester (86.8%), did not plan the pregnancy (61.9%), and performed an average of 8.2 (SD=4.4) prenatal consultations. The most frequent diagnoses were arterial hypertension (20.5%) and diabetes mellitus (19.7%). Prevalence of medication use was 99.7%, with an average of 5.1 (SD=2.1) medication per woman and 12.7% self-medication. Antianemics (88.9%) and analgesics (63.2%) were the most prevalent classes and 17.9% of the women reported the use of medication with significant gestational risk. Only 36.5% were considered adherent, 32.9% declared they were unaware of the indication of the medication in use and 42% did not receive guidance on the use of the medication during pregnancy. There is no evidence of association between the number of the medication used and clinical and sociodemographic aspects. Conclusions: there is a need to develop strategies to improve the care of this population, with emphasis on strengthening multi-professional care.

Resumo Objetivos: descrever o perfil de utilização de medicamentos e de adesão, e a associação com as características clínicas e sociodemográficas de gestantes de alto risco atendidas em um hospital universitário. Métodos: trata-se de um estudo transversal com dados coletados mediante um questionário estruturado aplicado à 386 gestantes. Resultados: a maior parte das participantes era acompanhada apenas pelo ginecologista (75,1%), iniciou o pré-natal no primeiro trimestre gestacional (86,8%), não planejou a gravidez (61,9%) e realizou em média 8,2 (DP=4,4) consultas de pré-natal. Os diagnósticos mais frequentes foram hipertensão arterial (20,5%) e diabetes mellitus (19,7%). A prevalência de uso de medicamentos foi 99,7%, com média de 5,1 (DP=2,1) medicamentos por mulher e 12,7% de automedicação. Os antianêmicos (88,9%) e analgésicos (63,2%) foram as classes farmacológicas mais prevalentes e 17,9% das gestantes referiram uso de fármacos com risco gestacional relevante. Apenas 36,5% das gestantes foram consideradas aderentes ao tratamento, 32,9% declararam desconhecer a indicação dos medicamentos em uso e 42% não receberam orientações sobre o uso de medicamentos durante a gestação. Não há evidências de associação entre o número de medicamentos utilizados e os aspectos clínicos e sociodemográficos. Conclusão: é necessário desenvolver estratégias para melhorar o atendimento desta população e o uso racional de medicamentos, com ênfase no fortalecimento do cuidado multiprofssional.

Selection dynamics of HCV genotype 3 resistance-associated substitutions under direct-acting antiviral therapy pressure

ABSTRACT The chronic hepatitis C (CHC) treatment is currently based on the use of direct-acting antivirals (DAAs), and patients infected with hepatitis C virus genotype 3 (GT3) have emerged as a more difficult-to-cure population. The NS5A inhibitor daclatasvir (DCV) and sofosbuvir (SOF), an NS5B viral polymerase inhibitor, are among the drugs that compose more effective and safer treatment regimens. The virus genetic variability is related to resistance-associated substitutions (RASs) that adversely impact DAAs effectiveness. The aims of this study were to analyze the association of NS5A and NS5B RASs and other clinical factors with DAAs regimens effectiveness in patients with GT3 CHC infection. This was a prospective cohort study performed in a Brazilian university hospital. Individuals older than 18 years with GT3 CHC treated with SOF + DCV ± ribavirin (RBV) or SOF + peginterferon (PEG) + RBV were included. Blood samples were collected at baseline and post-treatment. A total of 121 patients were included. Sustained virological response rates were 87.6% for the SOF + DCV ± RBV group and 80.0% for the SOF + PEG + RBV arm. Cirrhosis, prior treatment with interferon/PEG + RBV, and baseline NS5A RAS were associated with higher risk of treatment failure. The NS5A analysis suggested that A30K, Y93H, and RAS at site 62 were related to failure. Interestingly, a likely compensatory effect was shown between A30K and A62T. Emergence of Y93H was always associated with RAS at position 62. The RASs dynamics comprehension is an important tool to indicate more effective treatment for GT3 patients.

Antibiotic use in Brazilian hospitals in the 21st century: a systematic review.

INTRODUCTION: This systematic review aimed to assess antibiotic use in Brazilian hospitals in the 21st century, as well as to understand the different drug utilization metrics adopted to assess the consumption of these drugs. METHODS: We systematically reviewed five databases (MEDLINE [Medical Literature Analysis and Retrieval System Online], CENTRAL [The Cochrane Central Register of Controlled Trials], EMBASE® [Excerpta Medica Database], Scopus [Elsevier's abstract and citation database], and LILACS [Literatura Latino-Americana e do Caribe em Ciências da Saúde]) for observational or experimental studies that assessed antibiotic utilization in Brazilian hospitals. The main outcomes were the drug utilization metrics and the consumption of antibiotics. RESULTS: We included 23 studies, of which 43.5% were carried out in adult and pediatric care units, 39.1% in adult units, and 17.4% in pediatric units. Regarding the complexity of healthcare, 26.1% of the studies were performed in intensive care units. Two drug utilization metrics were used in these studies: the defined daily dose (DDD) and the percentage of antibiotic prescriptions. The most commonly used antibiotic classes were third-generation cephalosporins, carbapenems, fluoroquinolones, and combinations of penicillins when the DDD was the adopted drug utilization metric. CONCLUSIONS: Although few studies have been conducted, existing data indicate a high use of broad-spectrum antibiotics. We found that the lack of standardized antibiotic utilization metrics impaired the mapping of drug consumption at the national level.

INSAF-HAS: a tool to select patients with hypertension for pharmaceutical care.

OBJECTIVE: To develop and validate the content of a tool aimed to select patients with hypertension for pharmaceutical care, based on identification of individuals in greater need of attention. METHODS: The tool was developed and assessed for face and content validity, which was carried out in three stages. Phase I consisted of comprehensive literature review, which prompted the development of the first version of the tool. Phase II consisted of validation by an expert panel. Phase III consisted of a pilot study with hypertensive patients and preparation of the final version of the instrument. RESULTS: Literature review yielded 30 studies, out of which 13 factors associated with hypertension and cardiovascular disease control and complications were selected. Once the initial version of the tool named INSAF-HAS was obtained, four expert meetings were held, each leading to instrument improvement until a final consensus was reached. In the pilot study, INSAF-HAS was applied to 30 patients with a diagnosis of hypertension for applicability pretest; adjustments were made and the final version of INSAF-HAS obtained. CONCLUSION: The INSAF-HAS tool developed in this study has face and content validity, and may contribute to the selection of patients with hypertension in greater need of pharmaceutical care services.

INSAF-HAS: a tool to select patients with hypertension for pharmaceutical care / INSAF-HAS: ferramenta para seleção de pacientes com hipertensão arterial sistêmica e inserção em serviços de cuidado farmacêutico

ABSTRACT Objective To develop and validate the content of a tool aimed to select patients with hypertension for pharmaceutical care, based on identification of individuals in greater need of attention. Methods The tool was developed and assessed for face and content validity, which was carried out in three stages. Phase I consisted of comprehensive literature review, which prompted the development of the first version of the tool. Phase II consisted of validation by an expert panel. Phase III consisted of a pilot study with hypertensive patients and preparation of the final version of the instrument. Results Literature review yielded 30 studies, out of which 13 factors associated with hypertension and cardiovascular disease control and complications were selected. Once the initial version of the tool named INSAF-HAS was obtained, four expert meetings were held, each leading to instrument improvement until a final consensus was reached. In the pilot study, INSAF-HAS was applied to 30 patients with a diagnosis of hypertension for applicability pretest; adjustments were made and the final version of INSAF-HAS obtained. Conclusion The INSAF-HAS tool developed in this study has face and content validity, and may contribute to the selection of patients with hypertension in greater need of pharmaceutical care services.

RESUMO Objetivo Desenvolver e realizar a validação de conteúdo de uma ferramenta para seleção de pacientes com hipertensão arterial sistêmica a serem atendidos em serviços de cuidado farmacêutico, com base na identificação daqueles com maior necessidade dessa assistência. Métodos O instrumento foi desenvolvido e avaliado por validação de face e conteúdo, subdividida em três fases. A fase I abordou ampla revisão bibliográfica, que originou a versão inicial da ferramenta. Na fase II, realizou-se a validação com a análise de um painel de experts . A fase III foi composta por estudo piloto realizado com pacientes com hipertensão, tendo sido definida a versão final do instrumento. Resultados A partir da revisão bibliográfica, 30 estudos foram consultados, e foram selecionados 13 fatores associados ao controle e à ocorrência de complicações, relacionados à hipertensão arterial sistêmica e a doenças cardiovasculares. Por conseguinte, mediante a versão inicial da ferramenta intitulada INSAF-HAS, realizaram-se quatro reuniões com especialistas, para obtenção de consenso final. A cada encontro, o instrumento foi aprimorado. No estudo piloto, 30 pacientes com diagnóstico de hipertensão arterial sistêmica foram abordados para o pré-teste de avaliação da aplicabilidade e, após as adequações, obteve-se a versão final do INSAF-HAS. Conclusão A ferramenta elaborada INSAF-HAS apresenta validade de face e conteúdo. Ela deve contribuir para a seleção de pacientes portadores de hipertensão arterial sistêmica e com maior necessidade de participação em serviços de cuidado farmacêutico.

Analysis of clinical pharmacist interventions in the neurology unit of a Brazilian tertiary teaching hospital.

It is estimated that around five to 10.0% of hospital admissions occur due to clinical conditions resulting from pharmacotherapy. Clinical pharmacist's activity can enhance drug therapy's effectiveness and safety through pharmacotherapy interventions (PIs), thus minimizing drug-related problems (DRPs) and optimizing the allocation of financial resources associated with health care. This study aimed to estimate the DRPs prevalence, evaluate PI which were performed by clinical pharmacists in the Neurology Unit of a Brazilian tertiary teaching hospital and to identify factors associated with the occurrence of PI-related DRP. A single-arm trial included adults admitted in the referred Unit from 2012 July to 2015 June. Patients were evaluated during their hospitalization period and PIs were performed based on trigger DRPs that were detected in medication reconciliation (admission or discharge) or during inpatient follow-up. Student's t-test, Chi-square test, Pearson and Multiple logistic regression models to analise the association among age, number of drugs, hospitalization period, and number of diagnoses with occurrence of DRPs. Analyses level of significance was 5%. In total 409 inpatients were followed up [51.1% male, mean age of 49.1 (SD 16.5)]. Patients received, on average, 11.9 (SD 5.8) drugs, ranging from two to 38 drugs per patient, and 54.3% of the sample presented at least one DRP whose most frequent description was "untreated condition". From all 516 performed PIs that resulted from DRPs, 82.8% were accepted and the majority referred to "drug introduction" (27.5%). Multiple logistic regression showed that age, length of hospital stay, number of drugs used, diagnosis of epilepsy, multiple sclerosis and myasthenia gravis would be clinical variables associated with DRP (p < 0,05). Monitoring the use of drugs allowed the clinical pharmacist to detect DRPs and to suggest interventions that promote rational pharmacotherapy.

Comparative efficacy of antiepileptic drugs for patients with generalized epileptic seizures: systematic review and network meta-analyses.

Background Valproate is a widely prescribed antiepileptic drug for generalized epilepsies, due to the extensive knowledge on its efficacy since it is on the market for many decades. However, a large number of new antiepileptic medicines was introduced into clinical practice and may be better options for treatment, considering that these medicines differ in terms of efficacy spectrum. Despite extensive research, questions regarding which medicine would constitute the first option for the monotherapy treatment of generalized epilepsy remain. Aim of the Review To compare the relative efficacy of all available antiepileptic drugs in the monotherapy treatment of generalized epileptic seizures; and also to compare all antiepoileptig drugs with valproate, which is the current first-line treatment for generalized epilepsy. Methods A systematic review for randomized controlled clinical trials was performed. Network meta-analyses used Bayesian random effects model. Sensitivity analyses determined the results´ robustness. The relative probability of two efficacy outcomes ("Seizure free" and "Therapeutic inefficacy") to happen for each medcicine was calculated using the Surface Under the Cumulative Ranking Curve. Results Seven papers (1809 patients) studied the efficacy of valproate, lamotrigine, phenytoin, carbamazepine, topiramate, levetiracetam, and phenobarbital in the treatment of generalized tonicclonic, tonic, and clonic seizures. Phenytoin demonstrated to be inferior to valproate in leaving the patient free of these seizures types [OR: 0.50 (95% CrI 0.27, 0.87)]. Lamotrigine (61%) showed the highest probability of presenting the outcome "Seizure free", followed by levetiracetam (47%), topiramate (44%), and valproate (38%) in the treatment of generalized tonic-clonic, tonic, and clonic seizures. Meanwhile, valproate exhibited greater chance of presenting the outcome "Therapeutic inefficacy" (62%). Regarding absence seizures itself, there was no difference in the efficacy of lamotrigine and ethosuximide when compared to valproate. However, the ranking indicates that ethosuximide (52%) and valproate (47%) are both more likely than lamotrigine to keep the patient free of seizures. Conclusions Lamotrigine, levetiracetam, and topiramate are as effective as valproate for treating generalized tonic-clonic, tonic, and clonic seizures. Meanwhile, valproate and ethosuximide are the best options for the treatment of absence seizures promoting better control of seizures, which is the primary goal of pharmacotherapy.

Drug-resistant epilepsy and topiramate: Plasma concentration and frequency of epileptic seizures.

Topiramate (TPM) is a second-generation antiepileptic drug (AED), acting on drug-resistant epilepsy. The aim of the study was to evaluate the influence of the dose, use of other AEDs on TPM plasma concentration (Cp ), and frequency of epileptic seizures. A cross-sectional analytical study was developed with patients aged 18-60 years, for diagnosis of drug-resistant epilepsy, using TPM in monotherapy or associated with other AEDs. The following variables were analyzed: age, frequency of epileptic seizures, pharmacotherapeutic regimen with its respective doses, adherence to medication treatment, and adverse events score. Thirty-seven patients were included, 83.8% of the patients presented Cp below the therapeutic range. Multiple linear regression estimated that the increase of 1.0 mg/kg/d promoted an increase of 0.68 µg/mL in TPMCp , while the use of inducers predicted a reduction of 2.97 µg/mL (P < .001). Multiple Poisson regression predicts that an increase of 1.0 µg/mL in TPMCp decreased the patient's chance of presenting seizures, and patients using AED inducers were about ten times more likely to present seizures than those who do not use (P < .001). In addition, for patients using AED inducers with Cp below the therapeutic range, the mean number of seizures per month was greater than those with Cp within the therapeutic range. The prescribed dose and the use of AED inducers influence Cp of TPM, likewise the low Cp of first-line AEDs and of the adjuvant in the treatment, TPM, as well as low TPM dose seem to affect the control of epileptic seizures.

Efficacy and Tolerability of Antiepileptic Drugs in Patients with Focal Epilepsy: Systematic Review and Network Meta-analyses.

Several newer antiepileptic drugs (AEDs) have been introduced into clinical practice, offering choices for individualizing the treatment of epilepsy since AEDs have different efficacy and tolerability profiles. In particular, questions exist regarding which AEDs are the best options for the monotherapy of focal epilepsy. Is carbamazepine (CBZ), which is considered the standard treatment for focal epilepsy, still the best option for monotherapy of focal epilepsy, despite the emergence of new AEDs? In this systematic review, we compared the relative tolerability of all available AEDs for monotherapy of all types of epilepsy as well as their efficacy in the monotherapy of focal epilepsy. In addition, we compared CBZ with other AEDs for the monotherapy of focal epilepsy. We performed a search of the MEDLINE/PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials (CENTRAL) databases for randomized controlled clinical trials. To compare the relative efficacy and tolerability of the AEDs, we performed network meta-analyses using a Bayesian random-effects model. Sensitivity analyses were conducted to determine the robustness of the results. A total of 65 studies were included in this review, composing 16,025 patients. Clobazam, levetiracetam, lamotrigine, oxcarbazepine, sulthiame, topiramate, and valproate had the best efficacy profiles and demonstrated no evidence of superiority or inferiority compared with CBZ. However, CBZ showed the greatest risk of patient discontinuation due to intolerable adverse reactions, whereas lamotrigine had the best safety profile and an 81% probability of being the best for the tolerability outcome of patient withdrawals from the study due to intolerable adverse reactions, followed by sulthiame (60%) and clobazam (51%). The newer AEDs-levetiracetam, lamotrigine, oxcarbazepine, sulthiame, and topiramate-should be considered for monotherapy of focal epilepsy because they were demonstrated to be as effective as the older ones (CBZ, clobazam, and valproate) for the treatment of focal epilepsy and were more tolerable. Lamotrigine was the AED with the best tolerability profile, suggesting that it may be the best option for the treatment of focal epilepsy in children and adults.

Análise da assistência à saúde aos pacientes com hepatites virais B e C no estado do Amapá / Analysis of health care to patients with viral hepatitis B and C in the State of Amapá, Brazil

O Amapá é uma região hiperendêmica para hepatites virais B (HB) e C (HC), As Políticas Públicas de Saúde garantem o direito dos pacientes ao acesso universal e gratuito à assistência médica e ao tratamento das HB e HC, Neste sentido, o estudo avaliou a assistência à saúde oferecida aos pacientes com HB e HC, atendidos pelo SUS, no Amapá, Os dados foram coletados junto aos prontuários médicos e comparados com os Protocolos Clínicos e Diretrizes Terapêuticas para HB e HC e com a rede assistencial do SUS, Foram identificados e incluídos no estudo 123 pacientes atendidos no Centro de Referência em Doenças Tropicais, dos quais 43 e 85 pacientes apresentaram diagnóstico de HB e HC, respectivamente (cinco coinfectados com HB e HC), O acompanhamento clínico ambulatorial dos pacientes foi inferior a seis meses (período necessário para diagnóstico conclusivo de infecção crônica) para 53,7% dos pacientes devido ao abandono do tratamento, O exame de aminotransferases não foi solicitado à 37,4% dos pacientes e a biópsia hepática foi realizada por 84% dos pacientes com algum grau de severidade da doença, Dezessete pacientes receberam interferon-alfa peguilado como farmacoterapia inicial, mas a escolha inicial do esquema terapêutico mais potente não é recomendada pois não deixa opções para terapia de resgate em casos de resposta negativa à terapia inicial, A assistência à saúde dos pacientes com HB e HC no estado do Amapá apresenta deficiências, tais como o abandono do tratamento, inclusão e exclusão inadequada de pacientes nos protocolos de tratamento, além da dificuldade de acesso aos exames de diagnóstico e ao monitoramento da doença nos pacientes infectados...

Amapá, a Brazilian state, is a hyper endemic area for hepatitis B (HB) and C (HC). The Public Health Policies ensure the right of patients to free access to health care and treatment of HB and HC. Therefore, in this study it was evaluated the health care offered to patients with HB and HC attended by the Brazilian Unified Health System (SUS) in Amapá. The data were collected from the medical records and compared to the Therapeutic Guidelines and Clinical Protocols for HB and HC and to the healthcare network of the SUS. One hundred and twenty three patients treated at the Reference Center for Tropical Diseases were identified and included in the study, of which 43 and 85 patients were diagnosed with HB and HC, respectively (five co-infected with HB and HC). Clinical follow-up of patients was less than six months (period required for conclusive diagnosis of chronic infection) to 53.7% of patients due to treatment dropout. Examination of aminotransferases was not prompted to 37.4% of patients and liver biopsy was performed for 84% of patients with any degree of severity. Seventeen patients received pegylated alfainterferon as initial pharmacotherapy, however, the initial choice of the most potent regimen is not always indicated because it does not let options for a rescue therapy in case of a negative response to therapy. The healthcare provided to these patients in the Amapá state has deficiencies noted by the abandonment of treatment, diagnostic testing and unrealized monitoring and patients inadequately included or excluded from pharmacotherapy...

Evaluation of unlicensed and off-label antiepileptic drugs prescribed to children: Brazilian Regulatory Agency versus FDA.

BACKGROUND: Epileptic seizures are neurological disorders common in children; 4 to 10% of under 16-year olds have suffered at least one seizure. Antiepileptic drugs represent the basis of treatment for the majority of patients, but many of the drugs prescribed to pediatrics are used unlicensed and off-label. OBJECTIVE: To analyze the prevalence of use of unlicensed and off-label antiepileptic drugs, by the pediatric population, according to the Food and Drug Administration and the Brazilian National Health Surveillance Agency. Setting General Hospital of the Faculty of Medicine at Ribeirão Preto, Brazil. METHODS: A cross-sectional, retrospective and observational study was carried out. The daily prescriptions of children up to 12 years of age were collected for the analysis of antiepileptic drug use. Data of the registration number, sex, age, reason hospitalized, unit where hospitalized, drug prescribed, dosage, route and administration frequency were collected. MAIN OUTCOME MEASURE: Antiepileptic drugs prescribed for children were classified as unlicensed and off-label according to the term of the product's license registered in the Food and Drug Administration and the Brazilian National Health Surveillance Agency. RESULTS: Of the 6,637 pediatric patients identified during the study period, 583 (9.0%) received at least one antiepileptic drug. The most used antiepileptic drugs were phenobarbital, phenytoin, carbamazepine, valproic acid and clonazepam. As expected, the number of pharmaceutical dosage form classified as unlicensed or off-label was high in both agencies, but distinct between the two. The number of patients (n = 287) using unlicensed drugs was similar in the two agencies, but the use of off-label drugs was higher according to the analysis carried out by the North American agency (40.5%). CONCLUSIONS: Old-generation antiepileptic drugs are widely prescribed to children. The results found for the use of off-label drugs demonstrate the absence of uniformity in action between the agencies and a lack of integration between the studies carried out. Although legislation on the licensing of drugs aims to protect the patients from drugs that have not been scientifically evaluated, the scarcity of data about the safety of the therapeutic resources obliges the doctors to prescribe unlicensed and off-label antiepileptic drugs to the pediatric population.