Assessment and comparison of anticholinergic exposure in older adults at a Basic Health Unit in Porto Alegre / Avaliação e comparação da exposição anticolinérgica em idosos de uma Unidade Básica de Saúde de Porto Alegre

Objectives: To estimate the anticholinergic burden in geriatric patients using two scales and to assess the degree of agreement between them. Methods: Data from an observational study conducted in a primary health care service were used. Anticholinergic burden was assessed using the Belgian Scale Muscarinic Acetylcholinergic Receptor ANTagonist Exposure Scale and the Brazilian Scale of Medicines with Anticholinergic Activity. The cumulative anticholinergic burden score was classified using a categorical approach: Brazilian scale (0: none; 1 ­ 2: low; ≥ 3: high) and Belgian scale (0: none; 0.5 ­ 1.5: low; ≥ 2: high). The degree of agreement between the two instruments was obtained through Cohen's kappa coefficient. Results: A total of 374 older people were included, most of them female and aged between 60 and 69 years. At least one potentially inappropriate drug with anticholinergic activity was used by 60.70% of patients according to the Brazilian scale and 32.89% by the Belgian scale. On average, 20.85% were under high anticholinergic exposure. Overall, on both scales, the most commonly recurrent medications were those indicated for the treatment of psychiatric disorders. Agreement between the scales was moderate (Kappa = 0.43). Conclusions: A high percentage of older adults was exposed to drugs with an anticholinergic burden, posing risks to health and quality of life. Consensus is needed on how anticholinergic burden is calculated by these scores, as well as standardization of the list of included drugs.

Objetivos: Estimar a carga anticolinérgica em idosos com base em duas escalas e avaliar o grau de concordância entre estas. Metodologia: Foram utilizados dados de um estudo observacional realizado em um serviço de atenção primária. A carga anticolinérgica foi avaliada pela escala belga Muscarinic Acetylcholinergic Receptor ANTagonist Exposure Scale e da Escala Brasileira de Medicamentos com Atividade Anticolinérgica. A pontuação da carga anticolinérgica cumulativa foi classificada utilizando uma abordagem categórica: escala brasileira (0: nenhuma, 1 ­ 2: baixa, ≥ 3: alta) e escala belga (0: nenhuma, 0,5 ­ 1,5: baixa, ≥ 2: alta). O grau de concordância entre as duas ferramentas foi obtido por meio do coeficiente Capa de Cohen. Resultados: Foram incluídos 374 idosos, a maioria do sexo feminino e com idade entre 60 a 69 anos. O uso de pelo menos um medicamento potencialmente inapropriado com atividade anticolinérgica foi verificado em 60,70% dos idosos com a aplicação da escala brasileira e em 32,89% com a escala belga. Em média, 20.85% estavam sob alta exposição anticolinérgica. De modo geral, os medicamentos mais recorrentes, para ambas as escalas, foram os indicados para o tratamento de transtornos psiquiátricos. A concordância entre as escalas foi moderada (Capa = 0,43). Conclusão: Um percentual elevado de idosos estava exposto a medicamentos com carga anticolinérgica, representando riscos para a saúde e a qualidade de vida. É necessário um consenso sobre como calcular a carga anticolinérgica nos diferentes escores, bem como a padronização da lista de medicamentos incluídos.

Off-label use of drugs by age in Brazilian children: a population study. / Uso off-label de medicamentos segundo a idade em crianças brasileiras: um estudo populacional.

OBJECTIVE: To estimate the prevalence of off-label drug use by age in children 12 years old and younger in Brazil. METHOD: Population-based cross-sectional study (National Survey on Access, Use and Promotion of Rational Use of Medicines - PNAUM), including 7,528 children aged 12 years or younger. Face-to-face interviews were used to collect the data in the domiciles. The age-related off-label classification was carried out using the electronic medication compendium of National Agency of Sanitary Surveillance (ANVISA). Sociodemographic characteristics, presence of chronic disease, use of health services and characteristics of the informant were collected. Data were expressed by relative frequencies and 95% confidence intervals. Pearson's chi-square test was used to evaluate the statistical significance of the differences between the groups, with a significance level of 5%. Main outcome measure was the prevalence of off-label use. RESULTS: The prevalence of off-label use by age was 18.7% (95%CI 16.4 - 21.3). Children younger than 2 years old presented the highest prevalence of off-label use. The most frequently used off-label drugs by age were amoxicillin, nimesulide and the combination of phenylephrine and brompheniramine. CONCLUSION: The off-label use of drugs by age is common in the Brazilian pediatric population, especially among children under two years old.

Uso off-label de medicamentos segundo a idade em crianças brasileiras: um estudo populacional / Off-label use of drugs by age in Brazilian children: a population study

RESUMO: Objetivo: Estimar a prevalência de uso off-label de medicamentos segundo a idade em crianças de 0 a 12 anos no Brasil. Métodos: Estudo transversal de base populacional (Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - PNAUM), incluindo 7.528 crianças de 0 a 12 anos de idade. Entrevistas individuais face a face foram utilizadas para coletar os dados nos domicílios. A classificação off-label segundo a idade foi realizada por meio de consulta ao compêndio eletrônico da Agência Nacional de Vigilância Sanitária (ANVISA). Características sociodemográficas, presença de doença crônica, uso de serviços de saúde e características do informante foram coletadas. Os dados foram expressos por frequências relativas e intervalos de confiança de 95% (IC95%). O teste do χ2 de Pearson foi usado para avaliar a significância estatística das diferenças entre os grupos, com um nível de significância de 5%. A principal medida de desfecho foi a prevalência de uso off-label segundo a idade. Resultados: A prevalência de uso off label por idade foi de 18,7% (IC95% 16,4 - 21,3). Crianças com menos de 2 anos apresentaram maior prevalência desse uso em relação às mais velhas. Os medicamentos com maior frequência de uso off-label segundo a idade foram amoxicilina, nimesulida e a combinação de fenilefrina com bronfeniramina. Conclusão: O uso off-label de medicamentos segundo a idade é comum na população pediátrica brasileira, especialmente nas crianças menores de 2 anos de idade.

Abstract: Objective: To estimate the prevalence of off-label drug use by age in children 12 years old and younger in Brazil. Method: Population-based cross-sectional study (National Survey on Access, Use and Promotion of Rational Use of Medicines - PNAUM), including 7,528 children aged 12 years or younger. Face-to-face interviews were used to collect the data in the domiciles. The age-related off-label classification was carried out using the electronic medication compendium of National Agency of Sanitary Surveillance (ANVISA). Sociodemographic characteristics, presence of chronic disease, use of health services and characteristics of the informant were collected. Data were expressed by relative frequencies and 95% confidence intervals. Pearson's chi-square test was used to evaluate the statistical significance of the differences between the groups, with a significance level of 5%. Main outcome measure was the prevalence of off-label use. Results: The prevalence of off-label use by age was 18.7% (95%CI 16.4 - 21.3). Children younger than 2 years old presented the highest prevalence of off-label use. The most frequently used off-label drugs by age were amoxicillin, nimesulide and the combination of phenylephrine and brompheniramine. Conclusion: The off-label use of drugs by age is common in the Brazilian pediatric population, especially among children under two years old.

Drug-Related Morbidity in Brazil: A Cost-of-Illness Model.

OBJECTIVES: To estimate the proportion of patients with drug-related morbidities (DRMs), DRM preventability, and the cost of illness of the DRMs in Brazil. METHODS: We used the decision-analytic model initially developed by Johnson and Bootman (Drug-related morbidity and mortality. A cost-of-illness model. J Manag Care Pharm 1996;2:39-47), which was adapted to the reality of the present study. A hypothetical cohort of patients in ambulatory care setting was simulated considering the perspective of the Brazilian public health system. Direct costs related to health care were obtained from the national databases, and the probability of occurrence of DRMs was established by a panel of clinical experts. Sensitivity analyses were conducted. RESULTS: An estimated 59% ± 14% of all patients assisted by the health system suffer some DRMs. Given these cases, 53% ± 18% were considered preventable. The average cost of managing a patient with any DRM was US $155. The cost of illness of the DRMs in Brazil would account for nearly US $18 billion (US $9-$27 billion) (best and worst case scenarium) annually. This amount is 5 times higher than what the Ministry of Health spends to guarantee free medicines in Brazil. Hospitalizations and long-term stays in hospital correspond to 75% of this cost. The sensitivity analysis showed that the model is sensitive to variations in these two outcomes. CONCLUSIONS: According to the model, a large proportion of patients experience DRM and the economic impact to solve these problems is substantial for the health system. Considering that more than half of these cases are preventable, it could be possible to achieve an enormous saving of resources through actions that improve the process of medication use.

Therapeutic itinerary: trajectory for resolution of adverse events of patients using warfarin in Southern Brazil

Warfarin is the most used anticoagulant in primary health care. Due to the narrow therapeutic index, its users are more susceptible to adverse events. The objective of this study was to describe the itinerary of the public health sector patients for resolution of adverse events related to warfarin. It is a prospective open cohort, held for a period of 18 months with warfarin users of the Brazilian public health system. Data were collected by monthly interviews and from patient records. Results: Sixty nine patients were interviewed, 64 of them completed monitoring and five died. Bleeding and venous thromboembolism were more frequent in patients starting treatment. It was observed that when adverse events have occurred, in most cases the patient held self-care at home (57%). During the follow-up, five patients were hospitalized for bleeding. Approximately half of the patients did not present their INR exams to the doctor. Conclusions: This study demonstrates weaknesses in caring for these patients and the need to accompany them, aiming to standardize and guide the itinerary of the anticoagulated patient to solve their problems and improve safety in drug treatment, with less cost to the public health system.

Economic Impact of Emergency Visits due to Drug-Related Morbidity on a Brazilian Hospital.

OBJECTIVES: To estimate the cost of managing drug-related morbidity (DRM) that leads to visits to the emergency department of a Brazilian hospital. METHODS: This is a cost-of-illness study based on a retrospective cross-sectional analysis of patients' medical records. A questionnaire and analysis of medical records were used to identify patients who were being admitted to the emergency department because of DRM. The direct medical costs of patient management were estimated using a microcosting analysis, and a sensitivity analysis was conducted using the emergency department visit rates due to DRM reported in the literature. RESULTS: Of the total patients interviewed, 14.6% sought emergency care because of DRM and 58.9% were considered preventable. Mean treatment costs were US $900 ± $1,569 (range US $18-$10,847). An extrapolation based on all emergency visits in the last year resulted in annual total treatment costs of US $7.5 million (US $1.1-$1.4 million). It was observed that 39.3% of the total cost of DRM was attributed to adverse drug reactions, 36.9% to nonadherence to treatment, and 16.9% to incorrect dosages. CONCLUSIONS: Adverse drug reactions and nonadherence to treatment are important causes of morbidity and cost to the health service. Much of this resource is spent to treat preventable cases of DRM, which represents a great waste of resources.

Rational use of medicines: prescribing indicators at different levels of health care

This multicenter study aimed to investigate prescribing patterns of drugs at different levels of health care delivery in university-affiliated outpatient clinics located in eight cities in the South and Midwest of Brazil. All prescriptions collected were analyzed for various items, including WHO prescribing indicators. A total of 2,411 prescriptions were analyzed, and 469 drugs were identified. The number of drugs prescribed per encounter, the frequency of polypharmacy, and the percentage of encounters with at least one injection or antibiotic prescribed were higher in centers providing primary health care services, compared to those where this type of care is not provided. Most drugs (86.1%) were prescribed by generic name. In centers with primary health care services, drug availability was higher, drugs included in the National and Municipal Lists of Essential Medicines were more frequently prescribed, and patients were given more instructions. However, warnings and non-pharmacological measures were less frequently recommended. This study reveals trends in drug prescribing at different levels of health care delivery in university-affiliated outpatient clinics and indicates possible areas for improvement in prescribing practices.

Este estudo multicêntrico teve como objetivo investigar o padrão de prescrição de medicamentos para pacientes ambulatoriais atendidos em serviços de saúde vinculados a universidades com diferentes níveis de atenção, em oito cidades do sul e centro-oeste do Brasil. As prescrições coletadas foram submetidas à análise de diversos itens, incluindo os indicadores de prescrição propostos pela OMS. No total, 2.411 prescrições foram analisadas e 469 medicamentos foram identificados. O número de medicamentos prescritos por consulta, a frequência de polifarmácia e a porcentagem de consultas com pelo menos um medicamento injetável ou um antimicrobiano prescrito foram maiores em centros de saúde que ofereciam cuidados de atenção básica, em comparação com aqueles que não dispunham desse tipo de atendimento. A maioria dos medicamentos foi prescrita pelo nome genérico (86,1%). Em unidades com cuidados de atenção básica, a acessibilidade foi maior, a prescrição de medicamentos presentes nas Listas Nacional e Municipais de Medicamentos Essenciais foi mais frequente e instruções foram fornecidas aos pacientes mais comumente. Entretanto, advertências e medidas não farmacológicas foram indicadas com menor frequência. Este estudo revela tendências de prescrição de medicamentos em serviços de saúde ligados a universidades, com diferentes níveis de atenção, e indica possíveis áreas de melhoria na prática da prescrição.

Estoque domiciliar de medicamentos na comunidade ibiaense acompanhada pelo programa saúde da família, em Ibiá-MG, Brasil / Drug storage at home in the community assisted by the family health programme in Ibiá, MG, Brazil

O objetivo do estudo foi examinar o estoque de medicamentos na comunidade Ibiaense acompanhada pelo Programa Saúde da Família (PSF). Buscou-se descrever as características dos usuários, as condições de armazenamento, as classes terapêuticas, as formas farmacêuticas e a procedência dos medicamentos do estoque caseiro. Foram visitados 285 domicílios, no período de julho a setembro de 2004. Verificou-se que a média de medicamentos por domicílio foi de 8,4, e que 93,5 por cento das famílias entrevistadas apresentaram pelo menos um medicamento em estoque. Os medicamentos estocados em maior número foram: analgésicos (11,15 por cento), seguidos dos diuréticos (6,42 por cento), antibacterianos para uso sistêmico (5,82 por cento), anti-inflamatórios (5,08 por cento) e antiácidos (4,10 por cento). Embora seja considerável o número de medicamentos estocados nos domicílios, foi pequeno o número de medicamentos sem prescrição médica procedentes do Sistema Público de Saúde, sendo este um reflexo favorável dos serviços de Assistência Farmacêutica do Município. Apesar disso, foi verificado um elevado percentual (41,6 por cento) de medicamentos adquiridos em farmácias sem a devida prescrição médica (automedicação). Foi encontrado um percentual de 18,5 por cento de medicamentos vencidos. Verificou-se, também, que parte do estoque domiciliar resulta de prescrições com quantidades superiores às necessárias para o tratamento (20 por cento), do não cumprimento do tratamento prescrito (17 por cento) e da aquisição por conta própria (9 por cento). O estudo sugere a necessidade de orientação dos usuários em relação à utilização e ao armazenamento dos medicamentos, à sistematização dos registros de dados e oferece subsídios para adoção de decisões vinculadas ao processo de planejamento e execução das ações na Assistência Farmacêutica.

The objective of this study was to examine the stock of drugs in the community that is assisted by Programa Saúde da Família (PSF - Family Health Programme) in the city of Ibiá, state of Minas Gerais. The purpose was to describe users' characteristics, storage conditions, therapeutic classes and pharmaceutical forms, the origin of the drugs, as well as the cost of the drugs provided by the Public Health System. A total number of 285 households were visited from July to September 2004. It was verified that the average number of drugs per household was 8.4 and that 93.5% of the surveyed families had at least one sort of drug in stock. The most stored drugs were: analgesics (11.15%), diuretics (6.42%), antibacterials for systemic use (5.82%), anti-inflamatory drugs (5.08%) and antacids (4.10%). Although there is a considerable number of drugs stored in the households, the number of drugs without prescription coming from the Public Health System was small. This is a good consequence of the Pharmaceutical Assistance services in the municipality. On the other hand, it was prescription (self-medication). In addition, 18.5% of the drugs were no longer valid for use. Part of the drug storage at home results from prescriptions in amounts that are higher than what is necessary for treatment (20.0%), from non-completion of the prescribed treatment (17.0%) and from acquisition of drugs for self-medication (9.0%).The study suggests the need to educate users in relation to drugs utilization and storage, and the need to systematize data records in order to manage the resources more efficiently, which will lead to adequate decisions related to the Pharmaceutical Assistance policy.