Impact of the insertion of the clinical pharmacist in the Allogeneic Hematopoietic Stem Cells Transplantation team.

INTRODUCTION: Allogeneic Hematopoietic Stem Cells Transplantation (allo-HSCT) is capable of curing patients with neoplastic or non-neoplastic hematologic disorders or of prolonging their survival. This study assessed if the insertion of the clinical pharmacist in the allo-HSCT team modified the outcomes: transplantation-related mortality, grafting failure, incidence of Graft versus Host Disease, hospitalization time, time for grafting, number of readmissions, number of drug-related problems (DRPs), adherence and knowledge about pharmacotherapy. METHODS: Interventional study with historical control carried out in an allo-HSCT unit, in which the intervention group (IG) included 33 individuals who received pharmacotherapy follow-up. Control Group (CG) consisted of 28 individuals. RESULTS: A total of 250 DRPs were identified, 59 team's doubts were clarified, and 309 interventions were conducted in the IG. The DRPs mainly arose from safety (51.60%) and effectiveness (38.40%) problems. A mean of 9.36 (SD = 6.97) interventions per patient was obtained, mainly including dose reductions (19.09%), adjustments in administration time (18.12%), educational activities (15.21%) and drug removal (10.68%). Clinical significance of the interventions was considered high (75.7% extremely significant, very significant or significant), as well as their acceptability (89.7% accepted). Each patient attended a mean of 4.68 pharmaceutical consultations (SD = 1.91) after hospital discharge, presenting increase in knowledge (p = 0.0001) and in adherence (p = 0.0115). There was no evidence of differences between the groups in the other outcomes analyzed. CONCLUSIONS: The pharmacotherapy follow-up allowed detecting several DRPs and performing interventions of high clinical relevance and acceptability, in addition to improving adherence and individualizing the pharmacotherapy.

Can pharmacotherapeutic follow-up after allogeneic hematopoietic stem cell transplantation improve medication compliance?

BACKGROUND: Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) is currently one of the most effective therapies in onco-hematology. For the treatment of the disease and prevention of such complications, a complex pharmacotherapeutic regimen is employed. Non-compliance is prevalent among adolescents and young adults with chronic hematological diseases, being reported by up to 50% of the patients. OBJECTIVE: To evaluate the results of pharmacotherapeutic follow-up on medication compliance and on the knowledge about pharmacotherapy of patients who underwent allo-HSCT. METHODS: A single-arm, open-label and non-randomized intervention study developed in an allo-HSCT outpatient clinic. The participants attended pharmaceutical consultations and had their knowledge about pharmacotherapy and medication compliance measured by MedTake and Brief Medication Questionnaire (BMQ), respectively. RESULTS: A total of 27 patients attended pharmaceutical consultations (4.81 consultations/patient; SD = 1.80). There was an improvement in medication compliance and in knowledge between the first and last consultations (p < 0.05). In the final consultation, 70.37% of the patients showed compliance, with a knowledge rate of 98.35% (SD = 3.63). Non-compliant individuals presented a greater tendency to hospital readmissions. There was no relationship between medication compliance and sociodemographic variables, graft-versus-host disease, and knowledge about pharmacotherapy. CONCLUSIONS: Pharmacotherapeutic follow-up contributed to improving medication compliance. Knowledge about pharmacotherapy alone does not translate into behaviors, which corroborates the complexity of the biopsychosocial factors associated with medication compliance.

Contribution of Pharmaceutical Care to Person-centered Health Care and the Safety of Pharmacotherapy for Hospitalized Older Individuals in Brazil: An Investigative Single-arm Intervention Trial.

BACKGROUND: Adverse drug events (ADE) and medication errors (ME) provide large numbers of victims. Older people are more susceptible to these events, due to the continuing search for several chronic degenerative disease treatments. The Third Global Patient Safety Challenge announced the objective of reducing unnecessary polypharmacy, encouraging deprescription, and aiming to ensure the prescription of medications in an appropriate manner, based on the best evidence and taking into account the individual factors of people. OBJECTIVE: To evaluate whether Pharmaceutical Care (PC), when inserted in a geriatric ward and the context of person-centered health care, cooperates with the safety of pharmacotherapy in older individuals in Brazil. METHODS: This is an investigative, single-arm, preliminary study. INCLUSION CRITERIA: individuals aged ≥60 years and admitted to the geriatric ward between August 2019 to January 2020. The PC (with the practice of pharmacotherapeutic follow-up, medication reconciliation, and pharmacotherapy review) was made available to identify ADE and ME, as well as the associated factors and clinical outcomes, were analyzed. RESULTS: 60 participants were included. It was found that, on hospital admission, 93.3% of them were polymedicated and 86.7% had a history of using potentially inappropriate medications (PIM). ADE and ME were detected in 43 individuals (71.7%) and, in total, 115 incidents were identified, with drugs that act on the nervous system associated with them (31.9%). Acceptance of the PC's recommendations reached the rate of 85.2%. Polypharmacy (p=0.03) and the presence of multiple diseases (p=0.03) had an effect on the presentation of ADE and ME. The number of medications in use decreased in the comparison between admission and hospital discharge (p<0.0001). CONCLUSION: This investigative study indicated that ADE and ME are linked to the polypharmacy in use at the beginning of hospitalization. On the other hand, we showed that the PC (inserted in the multidisciplinary team) contributed to the deprescribing of medications at hospital discharge. Therefore, the PC can provide improvements in this scenario.

[Central nervous system adverse events potentially associated with drugs used for COVID-19: scoping reviewEventos adversos en el sistema nervioso central potencialmente relacionados con los medicamentos para tratar la COVID-19: revisión exploratoria]. / Eventos adversos no sistema nervoso central potencialmente relacionados aos medicamentos utilizados na COVID-19: revisão de escopo.

Objective: To identify central nervous system (CNS) adverse events potentially associated with prophylaxis or drug treatment for COVID-19, and to describe the characteristic of the individuals affected. Methods: A scoping review was performed using a search strategy to retrieve articles from PubMed, EMBASE, SciELO, Scopus, CINAHL and BVS databases. Studies reporting on individuals receiving prophylactic or curative drugs for COVID-19 with at least one CNS adverse event were included. Articles reporting on CNS adverse events associated with medication for other health conditions were excluded. Results: The search retrieved 1 547 articles, eight of which met the inclusion criteria. Seven studies had an observational design. A total of 3 035 individuals were assessed, of whom 1 701 were health care professionals and 1 978 were women. Curative treatment with hydroxychloroquine, chloroquine, lopinavir/ritonavir, and azithromycin was the most frequent (n = 5). The most common adverse events were headache, dizziness, mood disturbances, and drowsiness. Suicide was the most frequent severe event. Six adverse events were unexpected for hydroxychloroquine, chloroquine, and doxycycline. Conclusion: Potential CNS adverse events were unspecific and in general potentially associated with the use of hydroxychloroquine (monotherapy or associated with antibiotics). The data confirm the unfavorable risk/benefit profile of these drugs for the prevention and management of signs and symptoms of SARS-CoV-2 infection.

Objetivo: Identificar los eventos adversos en el sistema nervioso central (SNC) potencialmente relacionados con el uso de medicamentos empleados para profilaxis o tratamiento de la COVID-19, y caracterizar a las personas afectadas. Métodos: Se realizó una revisión exploratoria a partir de una estrategia de búsqueda en las bases de datos PubMed, EMBASE, SciELO, Scopus, Cummulative Index to Nursing and Allied Health Literature (CINAHL) y la Biblioteca Virtual de Salud (BVS). Se incluyeron estudios de personas que emplearon medicamentos con fines profilácticos o curativos para la COVID-19 y presentaron al menos un evento adverso en el SNC. Se excluyeron los artículos en los cuales se notificaron eventos adversos en el SNC potencialmente relacionados con medicamentos para tratar otros problemas de salud. Resultados: Se recuperaron 1 547 artículos, de los cuales ocho cumplieron con los criterios de admisibilidad. Siete estudios tuvieron un diseño observacional. Se analizaron 3 035 personas, de las cuales 1 701 eran profesionales de salud y 1 978, mujeres. El tratamiento más utilizado fue el curativo (n = 5), con hidroxicloroquina, cloroquina, lopinavir/ritonavir y azitromicina. Los eventos adversos comúnmente citados fueron dolor de cabeza, mareos, trastornos del estado de ánimo y somnolencia. El suicidio fue el evento grave más frecuente. Seis eventos inesperados (mioclonías, temblor, trastorno de la marcha, disgeusia, hiperhidrosis y desasosiego) guardaron relación con el empleo de hidroxicloroquina, cloroquina y doxiciclina. Conclusión: Los eventos adversos del SNC fueron inespecíficos y, en general, posiblemente estuvieron relacionados con el uso de hidroxicloroquina (sola o combinada) para el tratamiento curativo de la COVID-19. Los datos corroboran la relación desfavorable de riesgo/beneficio de esos medicamentos en la prevención y el manejo de los signos y síntomas de la infección por el SARS-CoV-2.

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

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

Eventos adversos no sistema nervoso central potencialmente relacionados aos medicamentos utilizados na COVID-19: revisão de escopo

[RESUMO]. Objetivo. Identificar eventos adversos no sistema nervoso central (SNC) potencialmente associados ao uso de medicamentos para profilaxia ou tratamento da COVID-19, bem como caracterizar os indivíduos acometidos. Métodos. Desenvolveu-se uma revisão de escopo a partir de estratégia de busca nas bases de dados PubMed, EMBASE, SciELO, Scopus, Cummulative Index to Nursing and Allied Health Literature (CINAHL) e Biblioteca Virtual em Saúde (BVS). Foram incluídos estudos com indivíduos que utilizaram medicamentos como medida profilática ou curativa para COVID-19 e que apresentaram ao menos um evento adverso no SNC. Foram excluídos os artigos que reportaram eventos adversos no SNC potencialmente associados a medicamentos para outras condições de saúde. Resultados. Recuperaram-se 1 547 artigos, dos quais oito atenderam aos critérios de elegibilidade. Em sete estudos, o desenho foi do tipo observacional. Foram analisados 3 035 indivíduos, dos quais 1 701 eram pro- fissionais da saúde e 1 978, mulheres. A terapia mais utilizada foi a curativa (n = 5), com hidroxicloroquina, cloroquina, lopinavir/ritonavir e azitromicina. Os eventos adversos comumente descritos foram dor de cabeça, tontura, distúrbios de humor e sonolência. Suicídio foi o evento grave mais frequente. Seis eventos foram ines- perados para hidroxicloroquina, cloroquina e doxiciclina (mioclonias, tremor, distúrbio de marcha, disgeusia, hiperidrose e inquietação). Conclusão. Os eventos adversos no SNC foram inespecíficos e, geralmente, potencialmente associados ao uso de hidroxicloroquina em monoterapia ou em associação para tratamento curativo da COVID-19. Os dados corroboram a relação desfavorável de risco/benefício desses medicamentos na prevenção e no manejo dos sinais e sintomas da infecção por SARS-CoV-2.

[ABSTRACT]. Objective. To identify central nervous system (CNS) adverse events potentially associated with prophylaxis or drug treatment for COVID-19, and to describe the characteristic of the individuals affected. Methods. A scoping review was performed using a search strategy to retrieve articles from PubMed, EMBASE, SciELO, Scopus, CINAHL and BVS databases. Studies reporting on individuals receiving prophylactic or cura- tive drugs for COVID-19 with at least one CNS adverse event were included. Articles reporting on CNS adverse events associated with medication for other health conditions were excluded. Results. The search retrieved 1 547 articles, eight of which met the inclusion criteria. Seven studies had an observational design. A total of 3 035 individuals were assessed, of whom 1 701 were health care professio- nals and 1 978 were women. Curative treatment with hydroxychloroquine, chloroquine, lopinavir/ritonavir, and azithromycin was the most frequent (n = 5). The most common adverse events were headache, dizziness, mood disturbances, and drowsiness. Suicide was the most frequent severe event. Six adverse events were unexpected for hydroxychloroquine, chloroquine, and doxycycline. Conclusion. Potential CNS adverse events were unspecific and in general potentially associated with the use of hydroxychloroquine (monotherapy or associated with antibiotics). The data confirm the unfavorable risk/benefit profile of these drugs for the prevention and management of signs and symptoms of SARS-CoV-2 infection.

[RESUMEN]. Objetivo. Identificar los eventos adversos en el sistema nervioso central (SNC) potencialmente relacionados con el uso de medicamentos empleados para profilaxis o tratamiento de la COVID-19, y caracterizar a las personas afectadas. Métodos. Se realizó una revisión exploratoria a partir de una estrategia de búsqueda en las bases de datos PubMed, EMBASE, SciELO, Scopus, Cummulative Index to Nursing and Allied Health Literature (CINAHL) y la Biblioteca Virtual de Salud (BVS). Se incluyeron estudios de personas que emplearon medicamentos con fines profilácticos o curativos para la COVID-19 y presentaron al menos un evento adverso en el SNC. Se excluyeron los artículos en los cuales se notificaron eventos adversos en el SNC potencialmente relacionados con medicamentos para tratar otros problemas de salud. Resultados. Se recuperaron 1 547 artículos, de los cuales ocho cumplieron con los criterios de admisibi- lidad. Siete estudios tuvieron un diseño observacional. Se analizaron 3 035 personas, de las cuales 1 701 eran profesionales de salud y 1 978, mujeres. El tratamiento más utilizado fue el curativo (n = 5), con hidro- xicloroquina, cloroquina, lopinavir/ritonavir y azitromicina. Los eventos adversos comúnmente citados fueron dolor de cabeza, mareos, trastornos del estado de ánimo y somnolencia. El suicidio fue el evento grave más frecuente. Seis eventos inesperados (mioclonías, temblor, trastorno de la marcha, disgeusia, hiperhidrosis y desasosiego) guardaron relación con el empleo de hidroxicloroquina, cloroquina y doxiciclina. Conclusión. Los eventos adversos del SNC fueron inespecíficos y, en general, posiblemente estuvieron rela- cionados con el uso de hidroxicloroquina (sola o combinada) para el tratamiento curativo de la COVID-19. Los datos corroboran la relación desfavorable de riesgo/beneficio de esos medicamentos en la prevención y el manejo de los signos y síntomas de la infección por el SARS-CoV-2.

Protocol for the implementation of pharmaceutical care in geriatrics: strategy for safety in health care.

OBJECTIVE: To describe the experience of the implementation of pharmaceutical care in a geriatric hospital unit and to propose an instructional protocol for the practice. METHODS: Experience report that became the practice manual of pharmaceutical care in geriatrics (MaP-CFarmaGeri) of a Brazilian hospital and was structured in three topics (1. Situational diagnosis; 2. Adequacy of the procedure and service provision; 3. Practice exercise). RESULTS: The situational diagnosis comprised the collection of data on the structure of the ward and the epidemiological profile. The pharmaceutical services provided included pharmacotherapeutic follow-up, medication reconciliation and pharmacotherapy review. The certification of the content of this procedure was attested by specialists from a multiprofessional team and the technique served more than 60 patients in practice, with good acceptance by the participants. FINAL CONSIDERATIONS: The MaP-CFarmaGeri proved to be a satisfactory strategy in the implementation of pharmaceutical care in geriatrics and can support this insertion in similar locations.

Eventos adversos no sistema nervoso central potencialmente relacionados aos medicamentos utilizados na COVID-19: revisão de escopo / Central nervous system adverse events potentially associated with drugs used for COVID-19: scoping review / Eventos adversos en el sistema nervioso central potencialmente relacionados con los medicamentos para tratar la COVID-19: revisión exploratoria

RESUMO Objetivo. Identificar eventos adversos no sistema nervoso central (SNC) potencialmente associados ao uso de medicamentos para profilaxia ou tratamento da COVID-19, bem como caracterizar os indivíduos acometidos. Métodos. Desenvolveu-se uma revisão de escopo a partir de estratégia de busca nas bases de dados PubMed, EMBASE, SciELO, Scopus, Cummulative Index to Nursing and Allied Health Literature (CINAHL) e Biblioteca Virtual em Saúde (BVS). Foram incluídos estudos com indivíduos que utilizaram medicamentos como medida profilática ou curativa para COVID-19 e que apresentaram ao menos um evento adverso no SNC. Foram excluídos os artigos que reportaram eventos adversos no SNC potencialmente associados a medicamentos para outras condições de saúde. Resultados. Recuperaram-se 1 547 artigos, dos quais oito atenderam aos critérios de elegibilidade. Em sete estudos, o desenho foi do tipo observacional. Foram analisados 3 035 indivíduos, dos quais 1 701 eram profissionais da saúde e 1 978, mulheres. A terapia mais utilizada foi a curativa (n = 5), com hidroxicloroquina, cloroquina, lopinavir/ritonavir e azitromicina. Os eventos adversos comumente descritos foram dor de cabeça, tontura, distúrbios de humor e sonolência. Suicídio foi o evento grave mais frequente. Seis eventos foram inesperados para hidroxicloroquina, cloroquina e doxiciclina (mioclonias, tremor, distúrbio de marcha, disgeusia, hiperidrose e inquietação). Conclusão. Os eventos adversos no SNC foram inespecíficos e, geralmente, potencialmente associados ao uso de hidroxicloroquina em monoterapia ou em associação para tratamento curativo da COVID-19. Os dados corroboram a relação desfavorável de risco/benefício desses medicamentos na prevenção e no manejo dos sinais e sintomas da infecção por SARS-CoV-2.

ABSTRACT Objective. To identify central nervous system (CNS) adverse events potentially associated with prophylaxis or drug treatment for COVID-19, and to describe the characteristic of the individuals affected. Methods. A scoping review was performed using a search strategy to retrieve articles from PubMed, EMBASE, SciELO, Scopus, CINAHL and BVS databases. Studies reporting on individuals receiving prophylactic or curative drugs for COVID-19 with at least one CNS adverse event were included. Articles reporting on CNS adverse events associated with medication for other health conditions were excluded. Results. The search retrieved 1 547 articles, eight of which met the inclusion criteria. Seven studies had an observational design. A total of 3 035 individuals were assessed, of whom 1 701 were health care professionals and 1 978 were women. Curative treatment with hydroxychloroquine, chloroquine, lopinavir/ritonavir, and azithromycin was the most frequent (n = 5). The most common adverse events were headache, dizziness, mood disturbances, and drowsiness. Suicide was the most frequent severe event. Six adverse events were unexpected for hydroxychloroquine, chloroquine, and doxycycline. Conclusion. Potential CNS adverse events were unspecific and in general potentially associated with the use of hydroxychloroquine (monotherapy or associated with antibiotics). The data confirm the unfavorable risk/benefit profile of these drugs for the prevention and management of signs and symptoms of SARS-CoV-2 infection.

RESUMEN Objetivo. Identificar los eventos adversos en el sistema nervioso central (SNC) potencialmente relacionados con el uso de medicamentos empleados para profilaxis o tratamiento de la COVID-19, y caracterizar a las personas afectadas. Métodos. Se realizó una revisión exploratoria a partir de una estrategia de búsqueda en las bases de datos PubMed, EMBASE, SciELO, Scopus, Cummulative Index to Nursing and Allied Health Literature (CINAHL) y la Biblioteca Virtual de Salud (BVS). Se incluyeron estudios de personas que emplearon medicamentos con fines profilácticos o curativos para la COVID-19 y presentaron al menos un evento adverso en el SNC. Se excluyeron los artículos en los cuales se notificaron eventos adversos en el SNC potencialmente relacionados con medicamentos para tratar otros problemas de salud. Resultados. Se recuperaron 1 547 artículos, de los cuales ocho cumplieron con los criterios de admisibilidad. Siete estudios tuvieron un diseño observacional. Se analizaron 3 035 personas, de las cuales 1 701 eran profesionales de salud y 1 978, mujeres. El tratamiento más utilizado fue el curativo (n = 5), con hidroxicloroquina, cloroquina, lopinavir/ritonavir y azitromicina. Los eventos adversos comúnmente citados fueron dolor de cabeza, mareos, trastornos del estado de ánimo y somnolencia. El suicidio fue el evento grave más frecuente. Seis eventos inesperados (mioclonías, temblor, trastorno de la marcha, disgeusia, hiperhidrosis y desasosiego) guardaron relación con el empleo de hidroxicloroquina, cloroquina y doxiciclina. Conclusión. Los eventos adversos del SNC fueron inespecíficos y, en general, posiblemente estuvieron relacionados con el uso de hidroxicloroquina (sola o combinada) para el tratamiento curativo de la COVID-19. Los datos corroboran la relación desfavorable de riesgo/beneficio de esos medicamentos en la prevención y el manejo de los signos y síntomas de la infección por el SARS-CoV-2.

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

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

Protocol for the implementation of pharmaceutical care in geriatrics: strategy for safety in health care / Protocolo para la implementación de la atención farmacéutica en geriatría: estrategia de seguridad en la atención sanitaria / Protocolo da implantação do cuidado farmacêutico na geriatria: estratégia para segurança na assistência à saúde

ABSTRACT Objective: To describe the experience of the implementation of pharmaceutical care in a geriatric hospital unit and to propose an instructional protocol for the practice. Methods: Experience report that became the practice manual of pharmaceutical care in geriatrics (MaP-CFarmaGeri) of a Brazilian hospital and was structured in three topics (1. Situational diagnosis; 2. Adequacy of the procedure and service provision; 3. Practice exercise). Results: The situational diagnosis comprised the collection of data on the structure of the ward and the epidemiological profile. The pharmaceutical services provided included pharmacotherapeutic follow-up, medication reconciliation and pharmacotherapy review. The certification of the content of this procedure was attested by specialists from a multiprofessional team and the technique served more than 60 patients in practice, with good acceptance by the participants. Final considerations: The MaP-CFarmaGeri proved to be a satisfactory strategy in the implementation of pharmaceutical care in geriatrics and can support this insertion in similar locations.

RESUMEN Objetivo: Describir la experiencia de implementar la atención farmacéutica en una unidad hospitalaria geriátrica y proponer un protocolo instructivo para la práctica. Métodos: Informe de experiencia que se convirtió en el manual de la práctica de la atención farmacéutica en geriatría (MaP-CFarmaGeri) de un hospital brasileño y se estructuró en tres temas (1. Diagnóstico situacional; 2. Adecuación del procedimiento y prestación del servicio; 3. Ejercicio de práctica). Resultados: El diagnóstico situacional comprendió el relevamiento de datos sobre la estructura de la sala y el perfil epidemiológico. Los servicios farmacéuticos ofrecidos incluyeron seguimiento farmacoterapéutico, conciliación de medicamentos y revisión de farmacoterapia. La certificación del contenido de este procedimiento fue certificada por especialistas de un equipo multidisciplinario y la técnica trató a más de 60 pacientes en la práctica, con buena aceptación por parte de los participantes. Consideraciones finales: El MaP-CFarmaGeri demostró ser una estrategia satisfactoria en la implementación de la atención farmacéutica en geriatría y puede apoyar esta inserción en lugares similares.

RESUMO Objetivo: Descrever a experiência da implantação do cuidado farmacêutico em uma unidade hospitalar de geriatria e propor um protocolo instrutivo da prática. Métodos: Relato de experiência que se converteu no manual da prática do cuidado farmacêutico na geriatria (MaP-CFarmaGeri) de um hospital brasileiro e foi estruturado em três tópicos (1. Diagnóstico situacional; 2. Adequação do procedimento e oferta do serviço; 3. Exercício da prática). Resultados: O diagnóstico situacional compreendeu o levantamento dos dados sobre a estrutura da enfermaria e o perfil epidemiológico. Os serviços farmacêuticos ofertados incluíram o acompanhamento farmacoterapêutico, com a conciliação de medicamentos e a revisão da farmacoterapia. A certificação do conteúdo desse procedimento foi atestada por especialistas de uma equipe multiprofissional e a técnica atendeu mais de 60 pacientes na prática, com boa aceitação dos participantes. Considerações finais: O MaP-CFarmaGeri mostrou ser uma estratégia satisfatória na implantação do cuidado farmacêutico na geriatria e pode amparar essa inserção em locais semelhantes.

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

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

Cost-benefit analysis of pharmacist interventions over 36 months in a university hospital.

OBJECTIVE: To perform a cost-benefits analysis of a clinical pharmacy (CP) service implemented in a Neurology ward of a tertiary teaching hospital. METHODS: This is a cost-benefit analysis of a single arm, prospective cohort study performed at the adult Neurology Unit over 36 months, which has evaluated the results of a CP service from a hospital and Public Health System (PHS) perspective. The interventions were classified into 14 categories and the costs identified as direct medical costs. The results were analyzed by the total and marginal cost, the benefit-cost ratio (BCR) and the net benefit (NB). RESULTS: The total 334 patients were followed-up and the highest occurrence in 506 interventions was drug introduction (29.0%). The marginal cost for the hospital and avoided cost for PHS was US$182±32 and US$25,536±4,923 per year; and US$0.55 and US$76.4 per patient/year. The BCR and NB were 0.0, -US$26,105 (95%CI -31,850 - -10,610), -US$27,112 (95%CI -33,160-11,720) for the hospital and; 3.0 (95%CI 1.97-4.94), US$51,048 (95%CI 27,645-75,716) and, 4.6 (95%CI 2.24-10.05), US$91,496 (95%CI 34,700-168,050; p < 0.001) for the PHS, both considering adhered and total interventions, respectively. CONCLUSIONS: The CP service was not directly cost-benefit at the hospital perspective, but it presented savings for forecast cost related to the occurrence of preventable morbidities, measuring a good cost-benefit for the PHS.

Use of statins for the secondary prevention of stroke: are we respecting the scientific evidences?

BACKGROUND: Stroke accounts for approximately as 5.0% of disability-adjusted years of life and 10.0% of all deaths worldwide. Secondary stroke prevention in surviving individuals, which includes the use of statins, reduces atherothrombotic stroke recurrence, complications and mortality. The present study aimed to characterize the Brazilian population with stroke history and estimate the prevalence of statin use as secondary prevention. METHODS: This is a population-based cross-sectional study conducted in Brazilian urban areas. A total of 41.433 individuals were interviewed, representing 171 million of Brazilians, based on post-stratification weights. We included only participants aged 20 years or older who answered "yes" to the following question: "Did any doctor ever tell you that you had a stroke?" The main outcome was the prevalence of statin use among individuals who answered affirmatively. To identify the factors associated with stroke occurrence, the participants were categorized according to clinical and sociodemographic characteristics. RESULTS: Only 24.2% (95% CI 19.9 - 29.1) of those who reported history of stroke regardless of other conditions also reported statin use. However, the results indicated that 52.9% (95% CI 43.6 - 62.0) of individuals who reported a previous diagnosis of dyslipidemia stated the use of statins. Regarding patients who reported stroke and did not report dyslipidemia history, only 9.1% (95% CI 5.9 - 13.8) referred to use statins. CONCLUSION: This study showed a low prevalence of statin use by individuals with a history of stroke in Brazil. Actions involving the organization of services and training of professionals may positively impact the rates of stroke recurrence.

Cost-effectiveness analysis is a mandatory strategy for health systems: evidence from a study involving therapies for hepatitis C.

Cost-effectiveness analysis is essential in health decision making. Several countries use it as synthesis of evidence to incorporate health technologies. The protease inhibitors (PI) boceprevir (BOC) and telaprevir (TVR) are indicated for chronic hepatitis C treatment and were incorporated in guidelines worldwide. Pre-marketing clinical trials showed higher sustained virological response rates in relation to previous therapies, but the incorporation of PIs generated a significant financial impact. The aim of this study was to discuss the relevance of cost-effectiveness analysis through a study that involved the inclusion of PIs in a clinical protocol. The analysis was part of a real-life study that included patients infected with hepatitis C virus genotype 1 treated in a tertiary university hospital in Brazil. Triple therapies (TT) with ribavirin (RBV), peginterferon α-2a (Peg-INF α-2a) and BOC or TVR were compared to dual therapy with RBV and Peg-INF α-2a. Sensitivity analysis of the cost-effectiveness ratio indicated an 88.2% chance of TTs presenting a higher cost per cure. The incremental cost-effectiveness ratios (ICER) exceeded the Brazilian gross domestic product (GDP) per capita by three times in all proposed scenarios. The sensitivity of ICER showed an 88.4% chance of TT not being cost-effective. The impact of PI incorporation was negative and the conduct about this could have been different if a previous cost-effectiveness analysis had been conducted.

Baseline resistance associated substitutions in HCV genotype 1 infected cohort treated with Simeprevir, Daclatasvir and Sofosbuvir in Brazil.

BACKGROUND: The World Health Organization estimates that 1% of the world population (71 million) is infected with hepatitis C virus (HCV). In 2015, three direct-acting antivirals (DAAs), simeprevir (SMV), sofosbuvir (SOF) and daclatasvir (DCV) were included in the Brazilian protocol for the treatment of chronic hepatitis C. Despite the fact that the use of these drugs is associated with higher treatment response rates and with lower incidence of side effects, studies have shown the association between the presence of viral resistance mutations and the failure of pharmacological treatment. AIM: This way, this study aimed to evaluate the safety and effectiveness of treatment for HCV genotypes 1a and 1b infected patients with these DAAs, also analyzing the occurrence and prevalence of baseline resistance associated substitutions (RAS), observing the impact of these mutations into the treatment success. METHODS: Clinical data were collected from all the 262 HCV infected patients included for comparative analysis, while serum samples collected from 144 of these individuals, before treatment, were submitted to molecular biology approaches for mutation analysis into NS3, NS5A and NS5B regions. RESULTS: Regarding the treatment regimens, 49.6% of the patients received SOF+DCV±ribavirin and 50.4% used SOF+SMV±ribavirin. The sustained virological response at 12 weeks post-treatment (SVR12) rate was 92.7% (93.9% for SOF plus DCV and 91.7% for SOF plus SMV). No clinical or laboratorial factor was statistically associated with SVR. The most common adverse reactions were haematological events, nausea/vomiting, headache and asthenia. Out of 144 blood samples, 70 (48.6%) had detected RAS, 34.8% treated with SOF+DCV±ribavirin and 61.3% SOF+SMV±ribavirin. The resistance mutations against SMV were detected into NS3: substitutions G122S (28%), I170V (22.7%), Y56F (17.3%) and V132I (14.7%). The mutations against DCV R30Q (9.1%), P58H (6.1%) and Q62E (6.1%) were observed into NS5A, and for SOF the mutations A421V (10.6%), L159F (6.4%) and C316N (6.4%) were present inside NS5B viral protein. Four patients did not reach SVR, three of them presented viruses carrying RAS (1 treated with SOF+DCV and 2 with SOF+SMV). Some of these mutations, like R30Q (present in relapsing samples) and L159F, are well known by their influence on antiviral resistance, while others, like C316N, have a compensatory effect on viral fitness, maintaining these baseline RAS. CONCLUSION: The use of treatment regimens composed of SOF and DCV or SOF and SMV showed a high SVR rate, despite of a high rate of RAS, and a good tolerability profile in patients with HCV genotype 1. However, the high occurrence of baseline RAS observed in this casuistic is still a concern and studies like this show the necessity to understand how they are maintained in the population and to direct more efficiently the use of DAAs.

Cost-benefit analysis of pharmacist interventions over 36 months in a university hospital

ABSTRACT OBJECTIVE: To perform a cost-benefits analysis of a clinical pharmacy (CP) service implemented in a Neurology ward of a tertiary teaching hospital. METHODS: This is a cost-benefit analysis of a single arm, prospective cohort study performed at the adult Neurology Unit over 36 months, which has evaluated the results of a CP service from a hospital and Public Health System (PHS) perspective. The interventions were classified into 14 categories and the costs identified as direct medical costs. The results were analyzed by the total and marginal cost, the benefit-cost ratio (BCR) and the net benefit (NB). RESULTS: The total 334 patients were followed-up and the highest occurrence in 506 interventions was drug introduction (29.0%). The marginal cost for the hospital and avoided cost for PHS was US$182±32 and US$25,536±4,923 per year; and US$0.55 and US$76.4 per patient/year. The BCR and NB were 0.0, -US$26,105 (95%CI −31,850 − -10,610), -US$27,112 (95%CI −33,160-11,720) for the hospital and; 3.0 (95%CI 1.97-4.94), US$51,048 (95%CI 27,645-75,716) and, 4.6 (95%CI 2.24-10.05), US$91,496 (95%CI 34,700-168,050; p < 0.001) for the PHS, both considering adhered and total interventions, respectively. CONCLUSIONS: The CP service was not directly cost-benefit at the hospital perspective, but it presented savings for forecast cost related to the occurrence of preventable morbidities, measuring a good cost-benefit for the PHS.

Cost-effectiveness analysis is a mandatory strategy for health systems: evidence from a study involving therapies for hepatitis C / Análise de custo-efetividade é uma estratégia essencial para os sistemas de saúde: as evidências de um estudo sobre terapias para hepatite C / El análisis de coste-efectividad es una estrategia esencial para los sistemas de salud: evidencias de un estudio sobre terapias para hepatitis C

Abstract: Cost-effectiveness analysis is essential in health decision making. Several countries use it as synthesis of evidence to incorporate health technologies. The protease inhibitors (PI) boceprevir (BOC) and telaprevir (TVR) are indicated for chronic hepatitis C treatment and were incorporated in guidelines worldwide. Pre-marketing clinical trials showed higher sustained virological response rates in relation to previous therapies, but the incorporation of PIs generated a significant financial impact. The aim of this study was to discuss the relevance of cost-effectiveness analysis through a study that involved the inclusion of PIs in a clinical protocol. The analysis was part of a real-life study that included patients infected with hepatitis C virus genotype 1 treated in a tertiary university hospital in Brazil. Triple therapies (TT) with ribavirin (RBV), peginterferon α-2a (Peg-INF α-2a) and BOC or TVR were compared to dual therapy with RBV and Peg-INF α-2a. Sensitivity analysis of the cost-effectiveness ratio indicated an 88.2% chance of TTs presenting a higher cost per cure. The incremental cost-effectiveness ratios (ICER) exceeded the Brazilian gross domestic product (GDP) per capita by three times in all proposed scenarios. The sensitivity of ICER showed an 88.4% chance of TT not being cost-effective. The impact of PI incorporation was negative and the conduct about this could have been different if a previous cost-effectiveness analysis had been conducted.

Resumo: A análise de custo-efetividade tem sido essencial para a tomada de decisões em saúde. Diversos países utilizam esse tipo de análise como síntese das evidências para incorporar as tecnologias em saúde. Os inibidores de protease (IPs) boceprevir (BOC) e telaprevir (TVR) são indicados para o tratamento da hepatite C crônica e foram incorporados nas diretrizes internacionais. Os ensaios clínicos pré-marketing demonstraram taxas mais altas de resposta virológica sustentada em relação às terapias anteriores, mas a incorporação dos IPs gerou um impacto financeiro significativo. O estudo teve como objetivo discutir a relevância da análise de custo-efetividade, através de um estudo que envolveu a inclusão de IPs em um protocolo clínico. A análise fez parte de um estudo de vida real que incluiu pacientes com infecção pelo vírus da hepatite C, genótipo 1, tratados em um hospital universitário terciário no Brasil. As terapias triplas (TTs) com ribavirina (RBV), peg-interferon α-2a (Peg-INF α-2a) e BOC ou TVR foram comparadas às terapias duplas com RBV e Peg-INF α-2a. A análise de sensibilidade da custo-efetividade indicou odds de 88,2% de TTs apresentarem custo mais elevado por paciente curado. Em todos os cenários propostos, as razões de custo-efetividade incremental (ICERs) superaram em três vezes o produto interno bruto (PIB) per capita brasileiro. A sensibilidade da ICER mostrou probabilidade de 88,4% das TTs não serem custo-efetivas. O impacto da incorporação dos IPs foi negativo, e a conduta teria sido diferente se tivesse sido realizada uma análise prévia de custo-efetividade.

Resumen: El análisis de coste-efectividad ha sido esencial para la toma de decisiones en salud. Diversos países utilizan este tipo de análisis como síntesis de evidencias para incorporar tecnologías en salud. Los inhibidores de proteasa (IPs) boceprevir (BOC) y telaprevir (TVR) se indican para el tratamiento de la hepatitis C crónica y fueron incorporados en directrices internacionales. Los ensayos clínicos pre-marketing demostraron tasas más altas de respuesta virológica sostenida, respecto a las terapias anteriores, pero la incorporación de los IPs generó un impacto financiero significativo. El objetivo del estudio fue discutir la relevancia del análisis de coste-efectividad, a través de un estudio que implicó la inclusión de IPs en un protocolo clínico. El análisis formó parte de un estudio de vida real que incluyó a pacientes con infección por el virus de la hepatitis C, genotipo 1, tratados en un hospital universitario terciario en Brasil. Las terapias triples (TTs) con ribavirina (RBV), peg-interferon α-2a (Peg-INF α-2a) y BOC o TVR se compararon con las terapias dobles con RBV y Peg-INF α-2a. El análisis de sensibilidad del coste-efectividad indicó odds de 88,2% de que las TTs presentaran un coste más elevado por paciente curado. En todos los escenarios propuestos, las razones de coste-efectividad incremental (ICERs) superaron tres veces el producto interno bruto (PIB) per cápita brasileño. La sensibilidad de la ICER mostró una probabilidad de que un 88,4% de las TTs no eran costo-efectivas. El impacto de la incorporación de los IPs fue negativo, y el resultado habría sido diferente si se hubiese realizado un análisis previo de coste-efectividad.

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.