Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America

[ABSTRACT]. Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determined whether reliance was used in the authorization process. Subgroups of reference national regulatory authorities (NRAs) and non-reference NRAs were compared. Results. 56 authorizations of 10 different COVID-19 vaccines were identified in 18 countries, of which 25 (44.6%) used reliance and 12 (21.4%) did not. For the remaining 19 (33.0%) it was not possible to determine whether reliance was used. Reference agencies used reliance less often (40% of authorizations with a known pathway) compared to non-reference agencies (100%). The median review time was just 15 days and does not meaningfully differ between reliance and non-reliance authorizations. Conclusions. This study demonstrated that for these vaccines, despite reliance pathways being associated with numerous rapid authorizations, independent authorization review times were not considerably longer than reliance reviews; reliance pathways were not a prerequisite for rapid authorization. Nevertheless, reliance pathways provided rapid authorizations in response to the COVID-19 emergency.

[RESUMEN]. Objetivos. Determinar dónde y cuándo se usaron las decisiones de autoridades regulatorias de otras jurisdicciones y la naturaleza de estos mecanismos para autorizar vacunas contra la COVID-19 en América Latina. Métodos. Se realizó un estudio observacional para evaluar las características de todas las autorizaciones de vacunas contra la COVID-19 en América Latina. Para cada autorización se determinó si se emplearon las decisiones de autoridades regulatorias de otras jurisdicciones en el proceso de autorización. Se compararon subgrupos de autoridades regulatorias nacionales (ARN) consideradas de referencia con otras ARN no usadas como referencia. Resultados. Se determinó dónde se otorgaron 56 autorizaciones de 10 vacunas diferentes contra la COVID–19 en 18 países; de estas 56 autorizaciones, 25 (44,6%) hicieron uso de las decisiones de autoridades regulatorias de otras jurisdicciones y 12 (21,4%), no. Para las 19 restantes (33,0%) no fue posible determinar si se hizo uso de las decisiones de autoridades regulatorias de otras jurisdicciones. Los organismos de referencia utilizaron las decisiones de autoridades regulatorias de otras jurisdicciones con menos frecuencia (40% de las autorizaciones con un mecanismo conocido) en comparación con los organismos no usados como referencia (100%). El plazo medio de revisión fue de tan solo 15 días y no difiere significativamente entre las autorizaciones que emplearon decisiones de autoridades regulatorias de otras jurisdicciones y las que no las emplearon. Conclusiones. En este estudio se demostró que, a pesar de que los mecanismos de utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se asocian en muchos casos con autorizaciones rápidas, para estas vacunas los plazos de revisión independiente para la autorización no fueron considerablemente mayores que los de las revisiones que emplearon decisiones de autoridades regulatorias de otras jurisdicciones. También se demostró que para obtener una autorización rápida no se requería la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones. Sin embargo, estos mecanismos proporcionaron autorizaciones rápidas en respuesta a la emergencia por la COVID–19.

[RESUMO]. Objetivos. Mapear a tempestividade e a natureza do uso de decisões regulatórias de outras autoridades (reliance regulatório) para autorização de vacinas contra a COVID-19 na América Latina. Métodos. Em um estudo observacional, foram avaliadas as características de todas as autorizações de vacinas contra COVID-19 na América Latina. Para cada autorização, foi determinado se foram utilizadas decisões de outras autoridades regulatórias para embasar o processo de autorização. Foram comparados subgrupos de autoridades reguladoras nacionais (ARN) de referência (ARNr) e ARN não consideradas de referência. Resultados. Foram identificadas 56 autorizações de 10 vacinas diferentes contra a COVID-19 em 18 países, das quais 25 (44,6%) utilizaram decisões de outras ARN como base para o registro e 12 (21,4%) não. Para as 19 (33,0%) autorizações restantes, não foi possível determinar se decisões de outras ARN foram utilizadas. As ARNr utilizaram decisões de outras autoridades com menos frequência (40% das autorizações com via regulatória conhecida) em comparação com as ARN não consideradas de referência (100%). A mediana do tempo de tramitação foi de apenas 15 dias, sem diferença significativa entre processos nos quais foram utilizadas decisões de outras agências e processos que não as utilizaram. Conclusões. Este estudo demonstrou que, para estas vacinas, apesar de o uso do reliance regulatório estar associado a várias autorizações rápidas, os tempos de tramitação não foram consideravelmente maiores em autorizações independentes do que quando foram utilizadas decisões de outras ARN; o reliance regulatório não foi um pré-requisito para autorização rápida. No entanto, o uso de tais processos viabilizou autorizações rápidas em resposta à emergência de COVID-19.

Compliance with antibiotic prophylaxis guidelines in caesarean delivery: a retrospective, drug utilization study (indication-prescription type) at an Ecuadorian hospital.

BACKGROUND: Preoperative antibiotic prophylaxis is essential for preventing surgical site infection (SSI). The aim of this study was to evaluate compliance with international and local recommendations in caesarean deliveries carried out at the Obstetrics and Gynaecology Service of the Ambato General Hospital, as well as any related health and economic consequences. METHODS: A retrospective indication-prescription drug utilization study was conducted using data from caesarean deliveries occurred in 2018. A clinical pharmacist assessed guidelines compliance based on the following criteria: administration of antibiotic prophylaxis, antibiotic selection, dose, time of administration and duration. The relationship between the frequency of SSI and other variables, including guideline compliance, was analysed. The cost associated with the antibiotic used was compared with the theoretical cost considering total compliance with recommendations. Descriptive statistics, Odds Ratio and Pearson Chi Square were used for data analysis by IBM SPSS Statistics version 25. RESULTS: The study included 814 patients with an average age of 30.87 ± 5.50 years old. Among the caesarean sections, 68.67% were emergency interventions; 3.44% lasted longer than four hours and in 0.25% of the deliveries blood loss was greater than 1.5 L. Only 69.90% of patients received preoperative antibiotic prophylaxis; however, 100% received postoperative antibiotic treatment despite disagreement with guideline recommendations (duration: 6.75 ± 1.39 days). The use of antibiotic prophylaxis was more frequent in scheduled than in emergency caesarean sections (OR = 2.79, P = 0.000). Nevertheless, the timing of administration, antibiotic selection and dose were more closely adhered to guideline recommendations. The incidence of surgical site infection was 1.35%, but tended to increase in patients who had not received preoperative antibiotic prophylaxis (OR = 1.33, P = 0.649). Also, a significant relationship was found between SSI and patient age (χ2 = 8.08, P = 0.036). The mean expenditure on antibiotics per patient was 5.7 times greater than that the cost derived from compliance with international recommendations. CONCLUSIONS: Surgical antibiotic prophylaxis compliance was far below guideline recommendations, especially with respect to implementation and duration. This not only poses a risk to patients but leads to unnecessary expenditure on medicines. Therefore, this justifies the need for educational interventions and the implementation of institutional protocols involving pharmacists.

Surgical antibiotic prophylaxis: is the clinical practice based on evidence?

OBJECTIVE: To assess the surgical antibiotic prophylaxis. METHODS: This was a descriptive study performed at a public tertiary care university hospital gathering prescription, sociodemographic and hospitalization data of inpatients admitted in 2014 who used antimicrobial drugs. This data were obtained from the hospital electronic database. The antimicrobial data were classified according to the anatomical, therapeutic chemical/defined daily dose per 1,000 inpatients. An exploratory analysis was performed using principal component analysis. RESULTS: A total of 5,182 inpatients were prescribed surgical antibiotic prophylaxis. Of the total antimicrobial use, 11.7% were for surgical antibiotic prophylaxis. The orthopedic, thoracic and cardiovascular postoperative units, and postoperative intensive care unit comprised more than half of the total surgical antibiotic prophylaxis use (56.3%). The duration of antimicrobial use of these units were 2.2, 2.0, and 1.4 days, respectively. Third-generation cephalosporins and fluoroquinolones had the longest use among antimicrobial classes. CONCLUSION: Surgical antibiotic prophylaxis was inadequate in the orthopedic, postoperative intensive care, thoracic and cardiovascular postoperative, gynecology and obstetrics, and otolaryngology units. Therefore, the development and implementation of additional strategies to promote surgical antibiotic stewardship at hospitals are essential.

Surgical antibiotic prophylaxis: is the clinical practice based on evidence? / Antibioticoprofilaxia cirúrgica: sua prática clínica está baseada em evidências?

ABSTRACT Objective: To assess the surgical antibiotic prophylaxis. Methods: This was a descriptive study performed at a public tertiary care university hospital gathering prescription, sociodemographic and hospitalization data of inpatients admitted in 2014 who used antimicrobial drugs. This data were obtained from the hospital electronic database. The antimicrobial data were classified according to the anatomical, therapeutic chemical/defined daily dose per 1,000 inpatients. An exploratory analysis was performed using principal component analysis. Results: A total of 5,182 inpatients were prescribed surgical antibiotic prophylaxis. Of the total antimicrobial use, 11.7% were for surgical antibiotic prophylaxis. The orthopedic, thoracic and cardiovascular postoperative units, and postoperative intensive care unit comprised more than half of the total surgical antibiotic prophylaxis use (56.3%). The duration of antimicrobial use of these units were 2.2, 2.0, and 1.4 days, respectively. Third-generation cephalosporins and fluoroquinolones had the longest use among antimicrobial classes. Conclusion: Surgical antibiotic prophylaxis was inadequate in the orthopedic, postoperative intensive care, thoracic and cardiovascular postoperative, gynecology and obstetrics, and otolaryngology units. Therefore, the development and implementation of additional strategies to promote surgical antibiotic stewardship at hospitals are essential.

RESUMO Objetivo: Avaliar a utilização de antibioticoprofilaxia cirúrgica. Métodos: Foi realizado um estudo descritivo em um hospital universitário de cuidado terciário por meio de coleta de dados de prescrição, sociodemográficos e de hospitalização sobre todos os pacientes internados em 2014 que utilizaram pelo menos um medicamento antimicrobiano. Esses dados foram coletados da base de dados eletrônica do hospital. O consumo de antimicrobianos foi analisado de acordo com a classificação anatômica terapêutica e química/dose diária definida por mil pacientes-dia. Realizou-se uma análise exploratória por meio da análise de componentes principais. Resultados: Um total de 5.182 pacientes internados receberam prescrição de antibioticoprofilaxia cirúrgica, que corresponde a 11,7% do total de antibióticos utilizados no hospital. As unidades de ortopedia, pós-operatória de cirurgia torácica e cardiovascular e terapia intensiva pós-operatória foram responsáveis pela utilização de mais da metade (56,3%) da antibioticoprofilaxia cirúrgica. A duração de uso desses antimicrobianos nessas unidades foi 2,2, 2,0 e 2,4 dias, respectivamente. Cefalosporinas de terceira geração e fluoroquinolonas foram as classes de antimicrobianos com tempo de utilização mais longo. Conclusão: A utilização de antibioticoprofilaxia cirúrgica foi inadequada nas unidades de ortopedia, pós-operatória de cirurgia torácica e cardiovascular, terapia intensiva pós-operatória, ginecologia e obstetrícia e otorrinolarigonlogia. Portanto, são importantes o desenvolvimento e a implantação de estratégias que promovam o uso racional de antibioticoprofilaxia cirúrgica nos hospitais.

One-day point prevalence of healthcare-associated infections and antimicrobial use in four countries in Latin America.

BACKGROUND AND AIMS: Experience in the region shows that in some countries there is very good surveillance of Healthcare-associated infections (HAIs) in health services, but there is no national data consistently in all countries. Therefore, we set to estimate the total burden of HAIs and antimicrobial use in acute care hospitals in Brazil, Venezuela, Mexico, and Colombia using the one-day point prevalence methodology. METHODS: The survey was conducted between June and July 2016. In each ward or unit, HAIs and antimicrobial use data were collected on a single day by a trained team of researchers. Also, for each patient, we collected data on risk factors for infections. RESULTS: One out of ten individuals surveyed had at least one healthcare-associated infection (HAI). Pneumonia and surgical site infections were the most relevant among the surveyed countries. Most of the surveyed participants, regardless of their HAI status, received antibiotics except the individuals managed in Brazil. Carbapenems and third-generation Cephalosporins were among the most frequently used antibiotics. CONCLUSION: Our results add to WHO's recent efforts to understand HAIs prevalence and antibiotic consumption in low and middle-income countries, of which we studied three that were not included in their last report.

Conocimiento de protocolos de terapia antibiótica por estudiantes de Odontología de universidades costarricenses / Knowledge of Antibiotic Therapy Protocols by the Students of Costa Rican Dental Schools

RESUMEN El conocimiento de protocolos antibióticos es escencial para garantizar su correcto uso en nuestros pacientes. Una mala selección de terapia antibiótica, puede estar asociada con el desarrollo de efectos adversos, inefectividad terapéutica o desarrollo de resistencia bacteriana entre otros. El objetivo de este estudio fue evaluar el nivel de conocimiento sobre el uso de los protocolos de antibioticoterapia, por parte de los estudiantes que se encontraban realizando la práctica clínica de su Universidad. El estudio se realizó en tres universidades costarricenses que imparten la carrera de Odontología. Se realizó un estudio descriptivo de tipo transversal, donde se aplicó un cuestionario a los estudiantes. Dicho instrumento constó de treinta preguntas cerradas, dividido en cinco segmentos, donde se evaluaron generalidades de los antibióticos, indicaciones y condiciones clínicas de su uso, protocolos especiales del uso de los antibióticos, datos demográficos y generalidades académicas de cada uno de los participantes. Se observó que los estudiantes de Odontología obtuvieron un 40% de respuestas correctas relacionadas al conocimiento de generalidades de los antibióticos, un 40% de respuestas acertadas en las preguntas sobre indicaciones clínicas y un 32.8% de las preguntas sobre protocolos especiales fue correcta. El conocimiento de los estudiantes de las universidades participantes es bajo, por lo que se recomienda reforzar los programas de estudio, la implementación de seminarios que refuercen esta área, así como la constante revisión de literatura que actualice los conocimientos adquiridos en la disciplina de la Farmacología, especialmente en el uso y manejo de antibióticos.

ABSTRACT The knowledge of antibiotic protocols is essential to guarantee its correct use in our patients. A poor selection of antibiotic therapy may be associated with the development of adverse effects, therapeutic ineffectiveness or development of bacterial resistance among others. The aim of this study was to assess the level of knowledge of antibiotic therapy protocols in students of the last year of Dentistry during their clinical practice in different costa rican universities. The study was performed at three of the costa rican universities that offer the career of Dentistry. A descriptive transversal study was performed by applying a questionnaire in different dental schools, to the students undergoing clinical practice. The questionnaire consisted in thirty closed questions and was divided in five segments, assessing the knowledge of general aspects of antibiotics, indications and clinical conditions for antibiotic therapy, and the special protocols in this field. Demographic data and certain academic of the students interviewed were also recorded. From the students who participated in the study, 40% answer correctly the segment concerning general knowledge of antibiotics, 40% to the segment of clinical indications for antibiotic protocols and only the 32,8% of the answers of special antibiotic protocols was correct. The general knowledge of antibiotic protocols of the students surveyed was low. It is recommended to reinforce the study programs and the implementation of seminars to strengthen this area, as well to reinforce the discipline of constant revision of literature in order to update their acquired knowledge in Pharmacology.

Evaluation of Influenza A H1N1 infection and antiviral utilization in a tertiary care hospital.

BACKGROUND: Influenza A H1N1 infections carry a significant mortality risk. This study describes inpatients with suspected and confirmed Influenza A H1N1 infection who were prescribed oseltamivir, the risk factors associated with infection, the association between infection and mortality, and the factors associated with in-hospital mortality in infected patients. METHODS: This study was a matched case-control study of hospitalized patients who underwent real-time polymerase chain reaction testing for Influenza A H1N1 and were treated with oseltamivir from 2009 to 2015 in a tertiary care hospital. Cases (patients with positive Influenza A H1N1 testing) were matched 1:1 to controls (patients with negative test results). RESULTS: A total of 1405 inpatients who underwent PCR testing and received treatment with oseltamivir were identified in our study and 157 patients confirmed Influenza A H1N1. Almost one third of patients with Influenza A H1N1 were diagnosed in the pandemic period. There was no difference in mortality between cases and controls. Immunocompromised status, requirement of vasoactive drugs, mechanical ventilation, acute hemodialysis, albumin administration, surgical procedures and thoracic procedures and length of stay were associated with increased risk of death in Influenza A H1N1 infected patients. CONCLUSIONS: We found no increased risk of mortality for patients with proven Influenza A H1N1 when compared to similar patients without confirmed Influenza.

I've got Toothache, I need Antibiotics: a UK Perspective on Rational Antibiotic Prescribing by Dentists.

Antibiotics do not cure toothache. This headline message of the United Kingdom's (UK) Dental Antimicrobial Stewardship (AMS) toolkit's posters and leaflets is aimed at patients; clinicians are expected to know this already. Evidence based clinical guidelines exist to set clear standards for good clinical practice yet there are barriers to compliance. The national AMS audit tool is designed for clinicians to review their management of acute dental conditions, including but not limited to the prescription of antibiotics. In this article we aim to help dental teams protect their patients and themselves from adverse events related to antibiotic prescription. It explores the emergent problem of Clostridium difficile, antibiotic resistance and severe sepsis, and considers some of the barriers, which clinicians have suggested, contribute to the unjustified prescription of antibiotics. Dentists must weigh the risks against the benefits before prescribing any antibiotic.

Inappropriately prescribed and over-the-counter antimicrobials in the Brazilian Amazon Basin: We need to promote more rational use even in remote places.

BACKGROUND: Being aware of consumption patterns of antimicrobials is the first step in designing and implementing strategies to change behaviors and, thus, to reduce the occurrence of antimicrobial resistance. The present survey was carried out to identify and describe the use of antimicrobials without prescription in riverside dwellers of the Brazilian Amazon Basin. METHODS: A cross-sectional study was carried out from a conglomerate stratified sample in the rural municipality of Coari, Amazonas State, Brazil, between April and July 2016. The survey was conducted in the riverside dwellers' homes, and information was collected on all antimicrobials taken with and without medical or dental prescription for a 30-day period, together with indications of their use before the interview. RESULTS: A total of 492 riverside dwellers were included in the present survey; 346 (70.3%) had taken at least one medication during the previous month, and 74 (21.3% of those taking a medicine) used an antimicrobial. Two-thirds of the patients treated with an antimicrobial (49; 66.2%) obtained it without a prescription. Additionally, one-third of the antimicrobials consumed by the study sample (25) were used for non-infectious or non-bacterial conditions. DISCUSSION: The present survey showed not only that inappropriate use of antimicrobials is present in remote places such as the Amazon Basin, but also that one-third of those antimicrobials were taken to treat non-infectious or non-bacterial conditions. In addition to an unnecessary risk of adverse effects to the exposed populations, the inappropriate use of antibiotics without prescription helps to increase antibiotic-resistant strains. In the present case, this was happening near one of Latin America's most important water supplies, which could contribute to the global impact of antimicrobial resistance.

I've got toothache, i need antibiotics: a uk perspective on rational antibiotic prescribing by dentists

Abstract Antibiotics do not cure toothache. This headline message of the United Kingdom's (UK) Dental Antimicrobial Stewardship (AMS) toolkit's posters and leaflets is aimed at patients; clinicians are expected to know this already. Evidence based clinical guidelines exist to set clear standards for good clinical practice yet there are barriers to compliance. The national AMS audit tool is designed for clinicians to review their management of acute dental conditions, including but not limited to the prescription of antibiotics. In this article we aim to help dental teams protect their patients and themselves from adverse events related to antibiotic prescription. It explores the emergent problem of Clostridium difficile, antibiotic resistance and severe sepsis, and considers some of the barriers, which clinicians have suggested, contribute to the unjustified prescription of antibiotics. Dentists must weigh the risks against the benefits before prescribing any antibiotic.

Resumo Antibióticos não curam dor de dente. Tal mensagem, encontrada no título dos panfletos e cartazes da caixa de ferramentas Gerenciamento Antimicrobiano Odontológico (AMS) do Reino Unido, é direcionada aos pacientes; os clínicos já deveriam saber disso. Diretrizes clínicas baseadas em evidência existem para estabelecer padrões claros à boa prática clínica, ainda que existam barreiras para sua observância. A ferramenta AMS para monitoramento nacional é voltada para clínicos revisarem sua conduta frente às condições dentais agudas, inclusive mas não limitada à prescrição de antibióticos. Neste artigo, visa-se colaborar com equipes odontológicas a fim de protegerem a si e a seus pacientes contra situações adversas relacionadas ao uso de antibióticos. Explora-se o problema emergente do Clostridium difficile, resistência bacteriana a antimicrobianos e sepsis severa, além de considerar algumas das barreiras que clínicos têm sugerido como geradoras de prescrições inapropriadas de antibióticos. Os dentistas devem pesar riscos e benefícios antes de prescrever qualquer antibiótico.

Respiratory medication used in COPD patients from seven Latin American countries: the LASSYC study.

Background: Limited information is available regarding medication use in COPD patients from Latin America. This study evaluated the type of medication used and the adherence to different inhaled treatments in stable COPD patients from the Latin American region. Methods: This was an observational, cross-sectional, multinational, and multicenter study in COPD patients attended by specialist doctors from seven Latin American countries. Adherence to inhaled therapy was assessed using the Test of Adherence to Inhalers (TAI) questionnaire. The type of medication was assessed as: short-acting ß-agonist (SABA) or short-acting muscarinic antagonist (SAMA) only, long-acting muscarinic antagonist (LAMA), long-acting ß-agonist (LABA), LABA/LAMA, inhaled corticosteroid (ICS), ICS/LABA, ICS/LAMA/LABA, or other. Results: In total, 795 patients were included (59.6% male), with a mean age of 69.5±8.7 years and post-bronchodilator FEV1 of 50.0%±18.6%. The ICS/LAMA/LABA (32.9%) and ICS/LABA (27.7%) combinations were the most common medications used, followed by LABA/LAMA (11.3%), SABA or SAMA (7.9%), LABA (6.4%), LAMA (5.8%), and ICS (4.3%). The types of medication most commonly used in each Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2013 category were ICS/LABA (A: 32.7%; B: 19.8%; C: 25.7%; D: 28.2%) and ICS/LAMA/LABA (A: 17.3%; B: 30.2%; C: 33%; D: 41.1%). The use of long-acting bronchodilators showed the highest adherence (good or high adherence >50%) according to the TAI questionnaire. Conclusion: COPD management in specialist practice in Latin America does not follow the current guideline recommendations and there is an overuse of ICSs in patients with COPD from this region. Treatment regimens including the use of long-acting bronchodilators are associated with the highest adherence.

Statin use in Brazil: findings and implications.

INTRODUCTION AND OBJECTIVES: Statins have become an integral part of treatment to reduce cardiac events in patients with cardiovascular disease. However, their use within the public healthcare system in Brazil is unknown. Consequently, we sought to determine and characterize statin use in primary healthcare delivered by the public health system (SUS) in Brazil and evaluate associated patient factors to improve future use. METHODS: Cross-sectional study with a national representative sample from five Brazilian regions, derived from the National Survey on Access, Use and Promotion of Rational Use of Medicines using a multi-stage complex sampling plan. Patients over 18 years old were interviewed from July 2014 to May 2015. The prevalences of statin use and self-reported statin adherence were determined amongst medicine users. The associations between statin use and sociodemographic/health condition variables were assessed using logistic regression. RESULTS: A total of 8803 patients were interviewed, of whom 6511 were medicine users. The prevalence of statin use was 9.4% with simvastatin (90.3%), atorvastatin (4.7%) and rosuvastatin (1.9%) being the most used statins. Poor adherence was described by 6.5% of patients. Statin use was significantly associated with age ≥65 years old, higher educational level, residence in the South, metabolic and heart diseases, alcohol consumption and polypharmacy. CONCLUSIONS: This is the first population based study in Brazil to assess statin use in SUS primary healthcare patients. Addressing inequalities in access and use of medicines including statins is an important step in achieving the full benefit of statins in Brazil, with the findings guiding future research and policies.

O uso seguro de medicamentos no Brasil / The safe use of drugs in Brazil

A utilização apropriada de medicamentos essenciais é um dos componentes de melhor relação custo-efetividade da atenção sanitária moderna. A segurança do paciente, entendida como a redução do risco de dano desnecessário associado ao cuidado, tem sido considerada atributo prioritário da qualidade dos sistemas de saúde em todo o mundo. Segundo a Organização Mundial de Saúde (OMS), um em cada 10 pacientes sofre algum dano enquanto recebe cuidados de saúde e aproximadamente 43 milhões de problemas relacionados à segurança do paciente ocorrem todos os anos. Os Eventos Adversos (EA) são a terceira causa de mortes nos Estados Unidos da América, resultando em mais de 251 mil óbitos por ano. No Brasil, estima-se que os EA sejam a quinta causa de mortes no país, superados apenas pelas doenças dos aparelhos circulatório e respiratório, neoplasias e causas externas. Grande parte da pesquisa realizada sobre a segurança no uso de medicamentos concentrou-se no ambiente de cuidados secundários, devido à alta complexidade dos procedimentos e ao potencial de infecções adquiridas no hospital. No entanto, muitos incidentes de segurança dos pacientes hospitalizados têm suas raízes nos cuidados primários em saúde

Revisión con agujas y uso de bevacizumab en bulas de filtración encapsuladas / Needle revision and the use of bevacizumab in encapsulated filtration blebs

Objetivo: determinar la efectividad a mediano plazo de la revisión con aguja asociada a bevacizumab (avastin) en ampollas de filtración encapsuladas postrabeculectomía. Métodos: se realizó un estudio observacional descriptivo-prospectivo, de serie de casos (14 ojos, 14 pacientes), con antecedentes de quiste de Tenon a corto plazo postrabeculectomía (2 meses - 1 año). Se realizó revisión con aguja asociada a inyección subconjuntival de avastin (1 mg) hasta completar 3 dosis en días alternos. Se evaluaron la presión intraocular y el uso de colirios hipotensores preoperatorio y posoperatorio a la semana, 1 mes, 3 meses y 1 año. Se definió el éxito total (si en el posoperatorio la PIO era menor o igual a 21 mmHg sin necesidad de colirios hipotensores); parcial (si la PIO era menor o igual a 21 mmHg con el uso de hasta dos fármacos); y sin éxito (si la PIO era menor o igual a 21 mmHg con 3 colirios hipotensores o mayor que 21 mmHg). Se registraron las complicaciones quirúrgicas. Resultados: la edad media fue de 59,3 ± 8,4 (43-75). Predominó el sexo femenino (57 por ciento) y no existieron diferencias en cuanto al color de piel (7/7). El grado de reducción de la PIO fue regular a la semana y al mes, y malo a los 3 meses y al año, lo que requirió una nueva cirugía en 11 casos (78,6 por ciento). Las complicaciones más frecuentes fueron: hemorragia subconjuntival (71,4 por ciento de casos) y Seidel positivo (21,4 por ciento). Conclusiones: la revisión con aguja asociada al uso de avastin subconjuntival como tratamiento de la ampolla encapsulada no logra una reducción significativa de la presión intraocular(AU)

Objective: determine the medium-term effectiveness of needle revision with bevacizumab (avastin) in encapsulated filtration blebs after trabeculectomy. Methods: an observational descriptive prospective case-series study was conducted of 14 eyes of 14 patients with a history of Tenon cyst shortly (2 months - 1 year) after trabeculectomy. Needle revision was performed by avastin subconjunctival injection (1 mg) until completing 3 doses on alternate days. Evaluation of intraocular pressure and the use of hypotensive collyriums before and after surgery was conducted at 1 week, 1 month, 3 months and 1 year. Definitions were made of total success (IOP minor or equal 21 mmHg in the postoperative period without hypotensive collyriums), partial success (IOP minor or equal 21 mmHg with up to two drugs), and no success (IOP minor or equal 21 mmHg with 3 hypotensive collyriums or greater than 21 mmHg). Surgical complications were recorded. Results: mean age was 59.3 ± 8.4 (43-75) years. Female sex prevailed (57 percent) and no differences were found based on skin color (7/7). The degree of IOP reduction was fair at one week and one month, and bad at 3 months and one year, 11 cases (78.6 percent) requiring new surgery. The most common complications were subconjunctival hemorrhage (71.4 percent of the cases) and positive Seidel (21.4 percent). Conclusions: needle revision with subconjunctival avastin to treat encapsulated blebs does not achieve a significant reduction in intraocular pressure(AU)

Clinical pharmacology profile of care in Hepatology clinic.

Since 2010, the Clinical Gastroenterology and Hepatology Division of the Central Institute of Hospital das Clínicas of the University of São Paulo Medical School (HC-FMUSP, in the Portuguese acronym) has been developing specialized electives assistance activities in the Outpatient Specialty Clinic, Secondary Level, in São Paulo NGA-63 Várzea do Carmo. The objective of this study was to analyze the pharmacotherapeutic profile of patients. This is a cross-sectional and retrospective study in which patients were seen at the Hepatology sector and the results were submitted to descriptive statistics. During the study period, 492 patients were treated at the clinic, with a mean age of 58.9 years and frequency of 61.2% female and 74.8% living in São Paulo. This population was served by various other medical specialties (cardiology and endocrine among others) and the major liver diagnoses were: chronic hepatitis B and C and fatty liver. Comorbidities were also identified, such as diabetes, hypertension and dyslipidemia. Most patients took their medication in the Basic Health Units. We found that 30% of patients use of more than five medications and the most prescribed were omeprazole 208 (42.3%), metformin 132 (26.8%) and losartan 80 (16.3%). Because it is an adult/elderly population, with several comorbidities and polymedication, it is important to be aware of the rational use of medication. The multidisciplinary team is important in applying correct conducts for the safe use of medicines, to reduce the burden on health spending and improving the quality of life of patients.

Prescribing indicators in primary health care in Belo Horizonte, Brazil: associated factors.

Background The prescription is one of the factors that influences rational use of medicines. The evaluation of prescribing indicators should contribute to organization of primary health care services. Objective The aim of this study was to evaluate prescribing indicators and associated factors in primary health care in the northeast health district, Belo Horizonte, Brazil. Setting Twenty primary health care units in the Northeast Health District, Belo Horizonte, Brazil. Method The study was cross sectional. Indicators proposed by World Health Organization were used to evaluate rational use of medicines. Main outcome measure Indicators evaluated were average number of medicines per prescription, proportion of medicines with antibiotic, injectable, medicines prescribed by generic name and medicines present in the essential medicines list. Results Three hundred and ninety-nine patients were interviewed. The average number of medicines per prescription was 3.5 (SD 2.2). The proportion of medicines with antibiotic, injectable, medicines prescribed by generic name and medicines present in the essential medicines list was 17.8, 9.8, 94.9, 91.4%, respectively. Patient age ≥60 years was positively associated with number of medicines per prescription (P = 0.00). Conclusion In the northeast health district of Belo Horizonte, the proportion of prescriptions of antibiotics and injections, the adoption of prescribing by generic name and the prescribing of essential medicines were satisfactory in this study considering reference values for these indicators and international scientific literature. However, the mean number of prescribed medicines requires a more in-depth evaluation.

Clinical pharmacology profile of care in Hepatology clinic / Perfil clínico farmacológico dos atendimentos no ambulatório de Hepatologia

Summary Since 2010, the Clinical Gastroenterology and Hepatology Division of the Central Institute of Hospital das Clínicas of the University of São Paulo Medical School (HC-FMUSP, in the Portuguese acronym) has been developing specialized electives assistance activities in the Outpatient Specialty Clinic, Secondary Level, in São Paulo NGA-63 Várzea do Carmo. The objective of this study was to analyze the pharmacotherapeutic profile of patients. This is a cross-sectional and retrospective study in which patients were seen at the Hepatology sector and the results were submitted to descriptive statistics. During the study period, 492 patients were treated at the clinic, with a mean age of 58.9 years and frequency of 61.2% female and 74.8% living in São Paulo. This population was served by various other medical specialties (cardiology and endocrine among others) and the major liver diagnoses were: chronic hepatitis B and C and fatty liver. Comorbidities were also identified, such as diabetes, hypertension and dyslipidemia. Most patients took their medication in the Basic Health Units. We found that 30% of patients use of more than five medications and the most prescribed were omeprazole 208 (42.3%), metformin 132 (26.8%) and losartan 80 (16.3%). Because it is an adult/elderly population, with several comorbidities and polymedication, it is important to be aware of the rational use of medication. The multidisciplinary team is important in applying correct conducts for the safe use of medicines, to reduce the burden on health spending and improving the quality of life of patients.

Resumo Desde 2010, a Divisão de Gastroenterologia e Hepatologia Clínica do Instituto Central do HC-FMUSP tem desenvolvido atividades assistenciais eletivas especializadas em Hepatologia no Ambulatório de Especialidades Nível Secundário de São Paulo no Estado de São Paulo NGA-63 Várzea do Carmo. O objetivo do estudo é analisar o perfil farmacoterapêutico dos pacientes. Trata-se de um estudo transversal e retrospectivo, no qual pacientes foram atendidos pelo setor de Hepatologia e os dados encontrados foram submetidos à estatística descritiva. Os resultados demonstraram que 492 pacientes foram atendidos nesse ambulatório durante o período do estudo com a média de idade de 58,9 anos, frequência de 61,2% do sexo feminino e 74,8% residindo na capital paulista. Essa população foi atendida por outras diferentes especialidades médicas (cardiologia e endócrino, entre outras), e os principais diagnósticos hepáticos foram hepatite crônica B e C e esteatose hepática. Também foram identificadas comorbidades como diabetes, hipertensão arterial e dislipidemia. Boa parte da população tende a retirar a sua medicação nas Unidades Básicas de Saúde. Foi verificado que 30% dos pacientes fazem uso de mais de cinco medicamentos, sendo os mais prescritos o omeprazol (208; 42,3%), metformina (132; 26,8%) e losartana (80; 16,3%). Por se tratar de uma população adulta/idosa, com diversas comorbidades e com polimedicação, é importante estar atento ao uso racional do medicamento. O atendimento da equipe multiprofissional é importante para aplicar tomadas de condutas corretas para a segurança no uso de medicamentos e diminuir a oneração em gastos em saúde, melhorando a qualidade de vida do paciente.

Medication adherence in patients with juvenile idiopathic arthritis.

OBJECTIVE: The aim of this study was to investigate pharmacological treatment adherence of patients with juvenile idiopathic arthritis, attended in an outpatient pharmacy at a tertiary hospital in northeastern Brazil. METHODS: The analysis of adherence was performed along with caregivers, through a structured questionnaire based on Morisky, Green and Levine, which enabled the categorization of adherence in "highest", "moderate" or "low" grades, and through evaluating medication dispensing registers, which classified the act of getting medications at the pharmacy as "regular" or "irregular". Drug Related Problems (DRP) were identified through the narrative of caregivers and classified according to the Second Granada Consensus. Then, a pharmaceutical orientation chart with information about the therapeutic regimen was applied, in order to function as a guide for issues that influenced adherence. RESULTS: A total of 43 patients was included, with a mean age of 11.12 years, and 65.1% (n=28) were female. Applying the questionnaire, it was found "highest" adherence in 46.5% (n=20) patients, "moderate" adherence in 48.8% (n=21), and "low" adherence in 4.7% (n=2). Through an analysis of the medication dispensing registers, a lower level of adherence was observed: only 25.6% (n=11) of the participants received "regularly" the medications. Twenty-six DRP was identified, and 84.6% (n=22) were classified as real. There were no significant associations between socio-demographic variables and adherence, although some caregivers have reported difficulty in accessing the medicines and in understanding the treatment. CONCLUSION: Our findings showed problems in the adherence process related to inattention, forgetfulness and irregularity in getting medicines, reinforcing the need for the development of strategies to facilitate a better understanding of treatment and to ensure adherence.

Medication adherence in patients with juvenile idiopathic arthritis / Adesão ao tratamento farmacológico em pacientes com artrite idiopática juvenil por meio de questionários

ABSTRACT Objective: The aim of this study was to investigate pharmacological treatment adherence of patients with juvenile idiopathic arthritis, attended in an outpatient pharmacy at a tertiary hospital in northeastern Brazil. Methods: The analysis of adherence was performed along with caregivers, through a structured questionnaire based on Morisky, Green and Levine, which enabled the categorization of adherence in “highest”, “moderate” or “low” grades, and through evaluating medication dispensing registers, which classified the act of getting medications at the pharmacy as “regular” or “irregular”. Drug Related Problems (DRP) were identified through the narrative of caregivers and classified according to the Second Granada Consensus. Then, a pharmaceutical orientation chart with information about the therapeutic regimen was applied, in order to function as a guide for issues that influenced adherence. Results: A total of 43 patients was included, with a mean age of 11.12 years, and 65.1% (n = 28) were female. Applying the questionnaire, it was found “highest” adherence in 46.5% (n = 20) patients, “moderate” adherence in 48.8% (n = 21), and “low” adherence in 4.7% (n = 2). Through an analysis of the medication dispensing registers, a lower level of adherence was observed: only 25.6% (n = 11) of the participants received “regularly” the medications. Twenty-six DRP was identified, and 84.6% (n = 22) were classified as real. There were no significant associations between socio-demographic variables and adherence, although some caregivers have reported difficulty in accessing the medicines and in understanding the treatment. Conclusion: Our findings showed problems in the adherence process related to inattention, forgetfulness and irregularity in getting medicines, reinforcing the need for the development of strategies to facilitate a better understanding of treatment and to ensure adherence.

RESUMO Objetivo: Investigar a adesão ao tratamento farmacológico de pacientes com artrite idiopática juvenil, atendidos na farmácia ambulatorial de hospital terciário do Nordeste do Brasil. Métodos: A análise da adesão foi feita junto aos cuidadores, por meio de questionário estruturado com base no teste de Morisky, Green e Levine, que viabilizou a categorização da adesão em “máxima”, “moderada” ou “baixa”, e da avaliação dos registros de dispensação dos medicamentos, que classificou a retirada de medicamentos na farmácia como “regular” ou “irregular”. Os problemas relacionados com medicamentos (PRM) foram identificados por meio da narrativa dos cuidadores e classificados conforme o Segundo Consenso de Granada. Em seguida, aplicou-se uma tabela de orientação farmacêutica, que contém informações sobre o esquema terapêutico, de forma a esclarecer questões que influenciavam a adesão. Resultados: Participaram 43 pacientes, com média de 11,12 anos, 65,1%, (n = 28) do sexo feminino. Por meio do questionário, verificou-se adesão “máxima” em 46,5% (n = 20) dos pacientes, “moderada” em 48,8% (n = 21) e “baixa” em 4,7% (n = 2). Pelo registro de dispensação, observou-se um nível de adesão menor: apenas 25,6% (n = 11) dos participantes receberam os medicamentos “regularmente”. Identificaram-se 26 PRM, 84,6% (n = 22) classificados como “reais”. Não foram observadas associações significativas entre as variáveis sociodemográficas e a adesão, embora alguns cuidadores tenham relatado dificuldade de acesso ao medicamento e de compreensão do tratamento. Conclusão: Nossos achados demonstraram falhas no processo de adesão, relacionadas ao descuido, esquecimento e à irregularidade para receber os medicamentos, o que reforça a necessidade de estratégias para facilitar a compreensão do tratamento e garantir a adesão