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.

Lamotrigine therapeutic drug monitoring in a tertiary epilepsy centre / Monitorização terapêutica da lamotrigina em um centro terciário de epilepsia

Objective: to review the experience with lamotrigine therapeutic drug monitoring in a tertiary epilepsy centre aiming to characterize the plasma concentrations profile. Methods: inclusion of adults and children to whom lamotrigine concentrations were requested from October 2008 to April 2010. A chromatographic method was validated to determine lamotrigine concentrations. Reference range adopted (plasma): 2.5-15.0 mg/L. Results: 115 patients were included (86 adults, 29 children). Mean±standard deviation lamotrigine dosages for adults and children were statistically different (5.1±2.0 versus 7.4±3.4 mg/kg/day respectively, p<0.0001), so as lamotrigine concentrations (5.13±4.0 versus 9.0±5.6 mg/L respectively, p=0.0006). Approximately 68% of all quantifications were within the reference range. From the 29 quantifications below 2.5 mg/L, 27 corresponded to lamotrigine+enzyme inducers therapies. There was no correlation between lamotrigine concentrations and dosages neither for pediatric nor for adult groups. Patients on monotherapy had lamotrigine concentrations significantly higher than those on lamotrigine+inducers therapies (p<0.001), and patients on lamotrigine+valproic acid therapy had lamotrigine concentrations higher than those on lamotrigine+inducers (p<0.001). There was no significant difference among mean dosages according to different comedications. Conclusion: our observations about the influence of polytherapies on lamotrigine pharmacokinetics confirm the relevance of quantifying this antiepileptic drug plasma concentrations in the process of treatment optimization...

Objetivo: revisar a experiência de um centro terciário de epilepsia com a monitorização terapêutica da lamotrigina objetivando caracterizar o perfil de concentrações plasmáticas encontradas. Métodos: inclusão de todos adultos e crianças para os quais solicitou-se quantificação plasmáticas de lamotrigina de Outubro/2008 a Abril/2010. Um método cromatográfico foi validado para determinar as concentrações de lamotrigina. Intervalo de referência adotado (plasma): 2.5-15.0 mg/L. Resultados: 115 pacientes foram incluídos (86 adultos, 29 crianças). Média±desvio-padrão das doses de lamotrigina para adultos e crianças foram significativamente diferentes (5.1±2.0 versus 7.4±3.4 mg/kg/dia respectivamente, p<0.0001), assim como as concentrações (5.13±4.0 versus 9.0±5.6 mg/L, p=0.0006). Aproximadamente 68% das quantificações estavam dentro do intervalo de referência. Das 29 quantificações abaixo de 2.5 mg/L, 27 correspondiam a associações lamotrigina+indutores enzimáticos. Não houve correlação entre concentrações e doses de lamotrigina. Pacientes em monoterapia tiveram concentrações de lamotrigina significativamente maiores do que pacientes utilizando lamotrigina+indutores enzimáticos (p<0.001); pacientes em uso de lamotrigina+ácido valproico apresentaram concentrações maiores comparativamente àqueles em uso de lamotrigina+indutores (p<0.001). Não houve diferença significativa entre doses médias de acordo com diferentes comedicações. Conclusão: a influência de politerapias sobre a farmacocinética da lamotrigina confirma a relevância dese quantificar as concentrações plasmáticas deste antiepilético no processo de otimização terapêutica...

Interchangeability among therapeutic equivalents of lamotrigine: evaluation of quality of life

Epilepsy is the most common serious neurological disorder worldwide. Approximately 70% of patients with epilepsy have their seizures controlled by clinical and pharmacological treatment. This research evaluated the possible influence of interchangeability among therapeutic equivalents of LTG on the clinical condition and quality of life of refractory epileptic patients. The study was divided into three periods of 42 days, and an equivalent therapeutic LTG randomly dispensed for each period (two similars - formulations A and B, and the reference product - formulation C). The mean dose of LTG was 5.5 mg/kg/day. The presence of side effects tends to have a greater deleterious effect on quality of life of refractory epileptics compared to variations in number of seizures or changes in plasma concentrations. The results showed that independently of the drug prescribed, interchangeability among therapeutic equivalents can negatively impact epilepsy control.

Epilepsia é o distúrbio neurológico grave mais comum no mundo todo. Aproximadamente 70% dos pacientes com epilepsia têm suas crises controladas com tratamento clínico e farmacológico. Esta pesquisa avaliou a possível interferência da intercambialidade entre equivalentes terapêuticos da lamotrigina na condição clínica e na qualidade de vida dos pacientes com epilepsia refratária. O estudo foi dividido em três períodos de 42 dias e em cada período foi dispensado um equivalente terapêutico, aleatoriamente (dois similares - formulação A e B e o medicamento de referência - formulação C). A dose média de lamotrigina foi de 5,5 mg/kg/dia. A ocorrência de efeitos colaterais tende a ser mais decisiva para a redução da qualidade de vida em epilepsia refratária em relação às variações no número de crises ou alterações nas concentrações plasmáticas. Os resultados demonstram que, independentemente do medicamento prescrito, a intercambialidade entre equivalentes terapêuticos pode interferir no sucesso do controle da epilepsia.