Exploratory analysis of requests for authorization to dispense high-cost medication to COPD patients: the São Paulo "protocol".

OBJECTIVE: A resolution passed by the government of the Brazilian state of São Paulo established a protocol for requesting free COPD medications, including tiotropium bromide, creating regional authorization centers to evaluate and approve such requests, given the high cost of those medications. Our objective was to analyze the requests received by an authorization center that serves cities in the greater metropolitan area of (the city of) São Paulo between 2011 and 2016. METHODS: Data regarding the authorization, return, or rejection of the requests were compiled and analyzed in order to explain those outcomes. Subsequently, the clinical and functional data related to the patients were evaluated. RESULTS: A total of 7,762 requests for dispensing COPD medication were analyzed. Requests related to male patients predominated. Among the corresponding patients, the mean age was 66 years, 12% were smokers, 88% had frequent exacerbations, and 84% had severe/very severe dyspnea. The mean FEV1 was 37.2% of the predicted value. The total number of requests decreased by 24.5% from 2012 to 2013 and was lowest in 2015. Most (65%) of the requests were accepted. The main reasons for the rejection/return of a request were a post-bronchodilator FEV1/FVC ratio > 0.7, a post-bronchodilator FEV1 > 50% of the predicted value, and failure to provide information regarding previous use of a long-acting ß2 agonist. During the study period, the total number of requests returned/rejected decreased slightly, and there was improvement in the quality of the data included on the forms. CONCLUSIONS: Here, we have identified the characteristics of the requests for COPD medications and of the corresponding patients per region served by the authorization center analyzed, thus contributing to the improvement of local public health care measures.

COPD Assessment Test (CAT) is a Valid and Simple Tool to Measure the Impact of Bronchiectasis on Affected Patients.

The COPD assessment test (CAT) is a short questionnaire developed to help patients and clinicians to assess the impact of symptoms in routine clinical practice. We aimed to validate and to test the reproducibility of CAT in patients with bronchiectasis and correlate with the severity of dyspnea, aerobic and functional capacity, and physical activity in daily life. This is a cross-sectional study, patients with bronchiectasis underwent spirometry, cardiopulmonary exercise test (CPET), incremental shuttle walk test (ISWT), Saint George`s Respiratory Questionnaire (SGRQ), and received pedometer. CAT was applied twice (CAT-1 and CAT-2, 7 to 10 days apart). The severity of bronchiectasis was assessed by E-FACED and bronchiectasis severity index (BSI). A total of 100 patients were evaluated (48 ± 14 years, 59 women, FVC: 67 ± 22% pred, FEV1: 52 ± 25% pred). According to CAT, 14% patients presented low, 40% medium, 32% high, and 14% very high impact. The higher the CAT, the worse the severity of bronchiectasis, dyspnea, quality of life, performance on the CPET, and smaller the distance walked (DW) on the ISWT and number of steps (NS) per day. There was significant correlation between CAT and SGRQ, E-FACED, BSI, NS, ISWT, oxygen uptake, and workload at CPET. CAT-1 and CAT-2 presented similar values: 21 (13-26) and 19 (13-26), respectively. The CAT is a valid and reproducible instrument in patients with bronchiectasis presenting good correlation with clinical, functional, and quality of life measurements. This easy-to-use, easy-to-understand, quick, and useful tool may play an important role to assess the impact of bronchiectasis on both daily medical practice and clinical trial settings.

Validation of scores of use of inhalation devices: valoration of errors / Validação de escores de uso de dispositivos para inalação: valoração dos erros cometidos

AbstractObjective: To validate two scores quantifying the ability of patients to use metered dose inhalers (MDIs) or dry powder inhalers (DPIs); to identify the most common errors made during their use; and to identify the patients in need of an educational program for the use of these devices.Methods: This study was conducted in three phases: validation of the reliability of the inhaler technique scores; validation of the contents of the two scores using a convenience sample; and testing for criterion validation and discriminant validation of these instruments in patients who met the inclusion criteria.Results: The convenience sample comprised 16 patients. Interobserver disagreement was found in 19% and 25% of the DPI and MDI scores, respectively. After expert analysis on the subject, the scores were modified and were applied in 72 patients. The most relevant difficulty encountered during the use of both types of devices was the maintenance of total lung capacity after a deep inhalation. The degree of correlation of the scores by observer was 0.97 (p < 0.0001). There was good interobserver agreement in the classification of patients as able/not able to use a DPI (50%/50% and 52%/58%; p < 0.01) and an MDI (49%/51% and 54%/46%; p < 0.05).Conclusions: The validated scores allow the identification and correction of inhaler technique errors during consultations and, as a result, improvement in the management of inhalation devices.

ResumoObjetivo: Validar dois escores para medir a habilidade de pacientes em utilizar inaladores pressurizados (IPs) ou inaladores de pó (IPos), verificar os erros mais comuns na sua utilização e identificar os pacientes que necessitam de um programa educacional para o uso desses dispositivos.Métodos: Este estudo foi realizado em três etapas: validação da confiabilidade dos escores de uso dos dispositivos inalatórios; validação do conteúdo dos escores utilizando-se uma amostra de conveniência; e realização de testes para a validação de critério e a validação discriminante desses instrumentos em pacientes que preenchiam os critérios de inclusão do estudo.Resultados: A amostra de conveniência foi composta por 16 pacientes, e houve discordância interobservador em 19% e 25% para os escores de IPo e IP, respectivamente. Após a análise de expertos no assunto, os escores sofreram modificações e foram aplicados em 72 pacientes. A dificuldade mais relevante no uso de ambos os dispositivos foi a manutenção da capacidade pulmonar total após inspiração profunda. O grau de correlação dos escores por observador foi de 0,97 (p < 0,0001). Houve boa concordância interobservador na classificação dos pacientes como aptos/não aptos para uso de IPo (50%/50% e 52%/58%; p < 0,01) e de IP (49%/51% e 54%/46%; p < 0,05).Conclusões: Os escores validados permitem identificar e corrigir os erros da técnica inalatória ao longo das consultas e, em consequência, melhorar o manejo dos dispositivos para inalação.

A workshop on asthma management programs and centers in Brazil: reviewing and explaining concepts.

OBJECTIVE: To report the results of a workshop regarding asthma management programs and centers (AMPCs) in Brazil, so that they can be used as a tool for the improvement and advancement of current and future AMPCs. METHODS: The workshop consisted of five presentations and the corresponding group discussions. The working groups discussed the following themes: implementation of asthma management strategies; human resources needed for AMPCs; financial resources needed for AMPCs; and operational maintenance of AMPCs. RESULTS: The workshop involved 39 participants, from all regions of the country, representing associations of asthma patients (n = 3), universities (n = 7), and AMPCs (n = 29). We found a direct relationship between a lack of planning and the failure of AMPCs. Based on the experiences reported during the workshop, the common assumptions about AMPCs in Brazil were the importance of raising awareness of managers; greater community participation; interdependence between primary care and specialized care; awareness of regionalization; and use of medications available in the public health system. CONCLUSIONS: Brazil already has a core of experience in the area of asthma management programs. The implementation of strategies for the management of chronic respiratory disease and their incorporation into health care system protocols would seem to be a natural progression. However, there is minimal experience in this area. Joint efforts by individuals with expertise in AMPCs could promote the implementation of asthma management strategies, thus speeding the creation of treatment networks, which might have a multiplier effect, precluding the need for isolated centers to start from zero.

OBJETIVO: Relatar os resultados de uma oficina de trabalho sobre programas e centros de atenção a asmáticos (PCAAs) no Brasil para que possam servir como instrumento para melhoria e avanço dos PCAAs existentes e criação de novos. MÉTODOS: A oficina de trabalho constituiu-se de cinco apresentações e discussões em grupos. Os grupos de trabalho discutiram os seguintes temas: implementação de uma linha de cuidado em asma; recursos humanos necessários para os PCAA; recursos necessários para financiar os PCAA; e manutenção do funcionamento dos PCAAs. RESULTADOS: A oficina envolveu 39 participantes de todas as regiões do país, representando associações de asmáticos (n = 3), centros universitários (n = 7) e PCAAs (n = 29). Evidenciou-se uma relação direta entre a ausência de planejamento e o insucesso dos PCAAs. Com base nas experiências brasileiras elencadas durante a oficina, as premissas comuns foram a importância da sensibilização do gestor, maior participação da comunidade, interdependência entre a atenção primária e a especializada, observação da regionalização e utilização dos medicamentos disponíveis no sistema público de saúde. CONCLUSÕES: O Brasil já tem um núcleo de experiências na área programática da asma. A implementação de uma linha de cuidado em doenças respiratórias crônicas e sua inclusão nas redes de saúde parecem ser o caminho natural. Porém, a experiência nessa área ainda é pequena. Agregar pessoas com experiência nos PCAAs na elaboração da linha de cuidado em asma encurtaria tempo na criação de redes de atenção com possível efeito multiplicador, evitando que se partisse do zero em cada local isolado.

Pharmaceutical care for patients with persistent asthma: assessment of treatment compliance and use of inhaled medications.

OBJECTIVE: To evaluate treatment compliance and use of inhaled medications of patients with asthma receiving complementary pharmaceutical care. METHODS: A controlled prospective parallel study involving a study group and a control group. We selected 60 patients with persistent asthma and using metered-dose inhalers (MDIs), dry powder inhalers (DPIs) or both. The patients were evaluated three times over 60 days. Instructions were provided to the patients in the study group at all visits but only at the first visit to those in the control group. The patients using < 80% or > 120% of the total number of prescribed doses were classified as noncompliant. The inhalation technique was quantified by a scoring system. A satisfactory technique was defined as a score higher than 7 (maximum, 9) for MDIs and higher than 4 (maximum, 5) for DPIs. RESULTS: The final study sample comprised 28 study group patients and 27 control group patients, of whom 18 (64.3%) and 20 (74.7%), respectively, were considered treatment compliant. From the first to the third visits, there were increases, in the study and control groups, in the median MDI-use score (from 3 [range, 0-5] to 8 [range, 8-9]; p < 0.001; and from 5 [range, 2-6] to 7 [range, 6-8]), as well as in the median DPI-use score (from 3 [range, 2-4] to 5 [range, 4-5] and from 3 [range, 2-4] to 4 [range, 3-5]). CONCLUSIONS: The counseling provided by the pharmacist to the patient was important to assist in the implementation of the appropriate inhalation technique, especially for MDI use.

Atenção farmacêutica ao portador de asma persistente: avaliação da aderência ao tratamento e da técnica de utilização dos medicamentos inalatórios / Pharmaceutical care for patients with persistent asthma: assessment of treatment compliance and use of inhaled medications

OBJETIVO: Avaliar a aderência ao tratamento e a técnica de utilização de dispositivos inalatórios em pacientes com asma após atenção farmacêutica complementar. MÉTODOS: Estudo prospectivo controlado com dois grupos paralelos: grupo estudo e grupo controle. Foram selecionados 60 asmáticos persistentes, utilizando regularmente inaladores dosimetrados (IDs), inaladores de pó seco (IPS) ou ambos. Os pacientes foram avaliados em três visitas durante 60 dias. As instruções foram fornecidas em todas as visitas aos pacientes do grupo estudo e apenas na primeira visita do grupo controle. Os pacientes que utilizaram < 80 por cento ou > 120 por cento do total de doses prescritas foram classificados como não aderentes. A manobra inalatória foi quantificada por escores, e uma técnica satisfatória foi definida por uma pontuação superior a 7 (máximo, 9) para o uso de ID e superior a 4 (máximo, 5) para o uso de IPS. RESULTADOS: Concluíram o estudo 28 pacientes no grupo estudo e 27 no grupo controle, dos quais 18 (64,3 por cento) e 20 (74,7 por cento), respectivamente, foram classificados como aderentes. Houve um aumento nas medianas dos escores do uso de ID entre a primeira e a terceira visitas tanto no grupo estudo quanto no grupo controle (de 3 [variação, 0-5] para 8 [variação, 8-9]; p < 0,001; e de 5 [variação, 2-6] para 7 [variação, 6-8]), assim como nas medianas dos escores do uso de DPS (de 3 [variação, 2-4] para 5 [variação, 4-5]; e de 3 [variação, 2-4] para 5 [variação, 4-5]). CONCLUSÕES: A orientação fornecida pelo farmacêutico ao paciente foi importante para auxiliar na adequada realização da técnica inalatória, principalmente quanto ao uso de IDs.

OBJECTIVE: To evaluate treatment compliance and use of inhaled medications of patients with asthma receiving complementary pharmaceutical care. METHODS: A controlled prospective parallel study involving a study group and a control group. We selected 60 patients with persistent asthma and using metered-dose inhalers (MDIs), dry powder inhalers (DPIs) or both. The patients were evaluated three times over 60 days. Instructions were provided to the patients in the study group at all visits but only at the first visit to those in the control group. The patients using < 80 percent or > 120 percent of the total number of prescribed doses were classified as noncompliant. The inhalation technique was quantified by a scoring system. A satisfactory technique was defined as a score higher than 7 (maximum, 9) for MDIs and higher than 4 (maximum, 5) for DPIs. RESULTS: The final study sample comprised 28 study group patients and 27 control group patients, of whom 18 (64.3 percent) and 20 (74.7 percent), respectively, were considered treatment compliant. From the first to the third visits, there were increases, in the study and control groups, in the median MDI-use score (from 3 [range, 0-5] to 8 [range, 8-9]; p < 0.001; and from 5 [range, 2-6] to 7 [range, 6-8]), as well as in the median DPI-use score (from 3 [range, 2-4] to 5 [range, 4-5] and from 3 [range, 2-4] to 4 [range, 3-5]). CONCLUSIONS: The counseling provided by the pharmacist to the patient was important to assist in the implementation of the appropriate inhalation technique, especially for MDI use.

Assessment of the ventricular function of patients with advanced chronic obstructive pulmonary disease by using magnetic resonance imaging.

OBJECTIVE: To assess the mechanisms that may be involved in the evolution of right and left ventricular dysfunction in patients with chronic obstructive pulmonary disease (COPD). METHODS: Magnetic resonance imaging was used in 11 control patients (group C) and 27 patients with COPD, who were divided into 2 groups, COPDc and COPDs, according to the presence or absence of right ventricular dysfunction, respectively. Doppler echocardiography was used for assessing the degree of pulmonary hypertension. RESULTS: The right ventricular diameter was similar in the 3 groups, COPDs, COPDc and C (29+/-8 mm; 31+/-7 mm; and 30+/-6 mm; respectively, P=NS). Right ventricular hypertrophy was observed only in the COPD groups (8+/-2 mm and 9+/-3 mm vs 5+/-1 mm; P<0.01). The percentage of systolic right ventricular lateral wall thickening (%RVLWT) in the 3 groups were as follows: 86+/-82% vs 41+/-35% vs 86+/-89%; P=NS). Different left ventricular ejection fractions were observed in the groups as follows: 69+/-9% vs 55+/-16% vs 76+/-6%; P < 0.01. A positive and significant linear correlation was observed between the left ventricular (LV) diastolic diameter and the LV systolic volume (r = 0.72; P < 0.01). No correlation was observed between the pulmonary volumes, arterial blood gas analysis, and ventricular function. CONCLUSION: No correlation was observed between the severity of pulmonary function and the degree of ventricular function impairment. Whether a preserved %RVLWT means the possibility of reversibility of right ventricular function remains to be elucidated. However, the presence of the phenomenon of ventricular interdependence was confirmed.

Análise da função ventricular de pacientes com doença pulmonar obstrutiva crônica avançada pela ressonância magnética / Assessment of the ventricular function of patients with advanced chronic obstructive pulmonary disease by using magnetic resonance imaging

OBJETIVO: Avaliar os possíveis mecanismos envolvidos na evolução da disfunção ventricular direita e esquerda em pacientes com doença pulmonar obstrutiva crônica (DPOC). MÉTODOS: A ressonância magnética foi aplicada em 27 pacientes com DPOC divididos em grupos, DPOCc e DPOCs, de acordo com a presença ou ausência de disfunção ventricular direita, respectivamente, e 11 controles (grupo C). O exame Doppler ecocardiográfico foi empregado para análise do grau de hipertensão pulmonar. RESULTADOS: O diâmetro do ventrículo direito foi similar nos 3 grupos, DPOCs, DPOCc e C, 29±8 mm vs 31±7 mm vs 30±6 mm; p NS, respectivamente. Foram observados hipertrofia ventricular direita somente nos grupos DPOC (8±2 mm e 9±3 mm vs 5±1 mm; p<0,01), percentual de espessamento sistólico da parede lateral do ventrículo direito similar ( por centoRVLWT) (86±82 por cento vs 41±35 por cento vs 86±89 por cento; p NS) e diferentes frações de ejeção ventricular esquerda entre os 3 grupos (69±9 por cento vs 55±16 por cento vs 76±6 por cento; p<0,01); correlação linear positiva e significante entre o diâmetro diastólico do ventrículo esquerdo (VE) e o débito sistólico do VE (r=0,72, p < 0,01). Não houve correlação entre os volumes pulmonares e a gasometria arterial com a função ventricular. CONCLUSAO: Não houve correlação entre a gravidade da função pulmonar e o grau de comprometimento da função ventricular. Fica a ser elucidado se um preservado por centoRVLWT significa a possibilidade de reversibilidade da função ventricular direita. No entanto, confirmamos a presença do fenômeno da interdependência ventricular.