ABSTRACT
Background: INR is used to monitor the treatment with vitamin K antagonists. A strategy to reduce waiting times for sampling is to measure INR in a capillary sample using a portable point of care (POC) type coagulometer. Aim: To evaluate the correlation of CoaguChek Pro II™, Xprecia™ and microINR™ with venous INR measured at the clinical laboratory and their ease of use. Materials and Methods: Patients provided capillary and venous blood samples for parallel tests comparing Xprecia™ Stride with CoaguChek Pro II™ and with venous INR, microINR™ with CoaguChek Pro IITM and with venous INR. The devices' ease of use was assessed surveying the sampling staff. Results: The three tested devices had good correlation coefficients with venous INR: CoaguChek Pro IITM 0.953 and 0.962; Xprecia™ of 0.912 and microINR™ of 0.932. The correlation coefficient of Xprecia™ with CoaguChek Pro IITM was 0.937 and microINR™ with CoaguChek Pro IITM was 0.976. Conclusions: CoaguChek Pro IITM, Xprecia™ and microINR™ results had a good correlation coefficient with INR measured at the laboratory. Our results indicate that, in the hands of trained users, POC-type coagulometers are reliable and acceptable for routine use in anticoagulant treatment control.
Subject(s)
Humans , Male , Female , Middle Aged , Aged , Point-of-Care Systems/standards , International Normalized Ratio/instrumentation , Reference Standards , Capillaries , Thromboplastin/therapeutic use , Chile , Reproducibility of Results , Drug Monitoring/instrumentation , Drug Monitoring/standards , International Normalized Ratio/standards , Anticoagulants/therapeutic useABSTRACT
Esta revisão de escopo objetiva descrever e caracterizar o sistema de farmacovigilância do Brasil (SINAF) e averiguar o atendimento aos requisitos mínimos propostos pela Organização Mundial da Saúde para um desempenho funcional de sistemas nacionais dessa natureza. A estratégia de pesquisa bibliográfica utilizou recomendações do STARLITE e termos de busca nas bases de dados MEDLINE/PubMed, Google, Imprensa Nacional da República do Brasil e website da Agência Nacional de Vigilância Sanitária (Anvisa), compreendendo o período entre 1999, ano de criação da Anvisa, e março de 2016. Foram incluídas 47 (4,4%) publicações, de um total de 1.068 identificadas, prevalecendo, nesta ordem: 14 normas jurídicas (29,8%), 13 (27,6%) documentos técnicos e 10 (21,3%) artigos científicos. Os estudos e documentos técnicos analisados compreenderam a criação, em âmbito federal, da primeira unidade técnica de farmacovigilância do sistema de notificação de eventos adversos, o Centro Nacional de Monitorização e a Câmara Técnica de Medicamentos. A taxa de notificação de eventos adversos a medicamentos no Brasil correspondeu, em 2013, a 36 notificações/1 milhão de habitantes, bastante inferior à meta proposta na literatura internacional, que sugere 300 notificações/1 milhão de habitantes. Este estudo identificou aspectos estruturais e funcionais que podem comprometer o desempenho do SINAF, como a falta de legislação que institua oficialmente o próprio sistema e suas finalidades.
Esta revisión de alcance tiene como objetivo describir y caracterizar el sistema de farmacovigilancia de Brasil (SINAF) y constatar su adscripción a los requisitos mínimos propuestos por la Organización Mundial de la Salud, respecto al desempeño funcional de los sistemas nacionales de esta naturaleza. La estrategia de investigación bibliográfica utilizó recomendaciones del STARLITE y términos de búsqueda en las bases de datos MEDLINE/PubMed, Google, Imprenta Nacional de la República de Brasil y de la página web de la Agencia Nacional de Vigilancia Sanitaria (Anvisa), comprendiendo el período entre 1999, año de creación de la Anvisa, y marzo de 2016. Se incluyeron 47 (4,4%) publicaciones, de un total de 1.068 identificadas, predominando por este orden: 14 normas jurídicas (29,8%), 13 (27,6%) documentos técnicos y 10 (21,3%) artículos científicos. Los estudios y documentos técnicos analizados incluyeron la creación, en el ámbito federal, de la primera unidad técnica de farmacovigilancia del sistema de notificación de eventos adversos, el Centro Nacional de Monitoreo y la Cámara Técnica de Medicamentos. La tasa de notificación de eventos adversos en medicamentos dentro de Brasil correspondió, en 2013, a 36 notificaciones/1 millón de habitantes, bastante inferior a la meta propuesta en la literatura internacional, que sugiere 300 notificaciones/1 millón de habitantes. Este estudio identificó aspectos estructurales y funcionales que pueden comprometer el desempeño del SINAF, como la falta de legislación que instituya oficialmente al propio sistema y sus finalidades.
This scoping review aims to describe and characterize the Brazilian pharmacovigilance system Brazil (SINAF) and verify to what extent it meets the minimum requirements proposed by the World Health Organization for the functional performance of this type of national system. The literature search strategy used STARLITE recommendations and search terms in MEDLINE/PubMed, Google, the Brazilian National Press, and the website of the Brazilian Health Regulatory Agency (Anvisa), from 1999, when Anvisa was created, to March 2016. The review included 47 publications (4.4%), out of a total of 1,068 identified, in the following order: 14 legal provisions (29.8%), 13 (27.6%) technical documents, and 10 (21.3%) scientific articles. The studies and technical documents covered the creation of the first pharmacovigilance technical unit at the federal level, the reporting system for adverse events, the National Monitoring Center, and the Technical Chambers on Medications. The reporting rate for adverse drug events in Brazil in 2013 was 36 reports per million inhabitants, considerably lower than the target proposed in the international literature, which suggests 300 reports per million inhabitants. This study identified structural and functional aspects that can compromise the performance of SINAF, such as lack of legislation officially establishing the system itself and its objectives.
Subject(s)
Humans , Drug Monitoring/standards , Adverse Drug Reaction Reporting Systems/legislation & jurisprudence , Pharmacovigilance , World Health Organization , Brazil , Government Regulation , Government AgenciesABSTRACT
Adesão inadequada à corticoterapia inalatória é comum e contribui para um controle clínico insatisfatório, aumento da morbidade, mortalidade e dos custos do setor. Este artigo de revisão foi conduzido utilizando-se bancos de dados Medline, HighWire, Literatura Latino-Americana e do Caribe em Ciências da Saúde e pesquisa direta, entre 1992 e 2008. Os métodos para avaliar a adesão, citados em ordem crescente de sua objetividade, são: relato do paciente ou seus familiares, julgamento clínico, pesagem da medicação, dispensação de medicação, dosadores eletrônicos e análise bioquímica (pouco utilizada). As taxas de adesão variaram de 30 a 70 por cento. A adesão determinada pelo relato do paciente/familiares e julgamento clínico é reconhecidamente exagerada quando comparada à obtida através do dosador eletrônico. O clínico deve sempre lembrar que as taxas reais de adesão são menores do que as relatadas pelo paciente e isso deve ser considerado, se não houver bom controle da doença. A pesagem do spray quantifica a medicação e infere adesão, porém pode ocorrer esvaziamento deliberado e compartilhamento da medicação. A farmácia fornece datas de dispensação e recarga da medicação. Esta estratégia é válida e deveria ser utilizada em nosso meio. O uso de dosador eletrônico é o método mais acurado para avaliar adesão, ele fornece a data e horário de cada disparo na utilização da medicação, porém é oneroso. Os resultados obtidos com dosadores demonstraram que a adesão foi menor que a esperada. Melhorar o conhecimento do médico sobre a adesão do seu paciente e utilizar métodos acurados para acessá-la é um caminho a seguir.
Nonadherence to inhaled corticosteroid therapy is common and has a negative effect on clinical control, as well as increasing morbidity rates, mortality rates and health care costs. This review was conducted using direct searches, together with the following sources: Medline; HighWire; and the Latin American and Caribbean Health Sciences Literature database. Searches included articles published between 1992 and 2008. The following methods of assessing adherence, listed in ascending order by degree of objectivity, were identified: patient or family reports; clinical judgment; weighing/dispensing of medication, electronic medication monitoring; and (rarely) biochemical analysis. Adherence rates ranged from 30 to 70 percent. It is recognized that the degree of adherence determined by patient/family reports or by clinical judgment is exaggerated in comparison with that obtained using electronic medication monitors. Physicians should bear in mind that true adherence rates are lower than those reported by patients, and this should be considered in cases of poor clinical control. Weighing the spray quantifies the medication and infers adherence. However, there can be deliberate emptying of inhalers and medication sharing. Pharmacies provide the dates on which the medication was dispensed and refilled. This strategy is valid and should be used in Brazil. The use of electronic medication monitors, which provide the date and time of each triggering of the medication device, although costly, is the most accurate method of assessing adherence. The results obtained with such monitors demonstrate that adherence was lower than expected. Physicians should improve their knowledge on patient adherence and use accurate methods of assessing such adherence.
Subject(s)
Adolescent , Child , Humans , Adrenal Cortex Hormones/therapeutic use , Aerosols/therapeutic use , Asthma/drug therapy , Bronchodilator Agents/therapeutic use , Drug Monitoring/methods , Patient Compliance , Administration, Inhalation , Drug Monitoring/standards , Nebulizers and Vaporizers , Patient Education as Topic , Self AdministrationABSTRACT
With rational use of antiretroviral therapy (ART), human immunodeficiency virus (HIV) infection has been transformed into a chronic manageable illness like diabetes and hypertension. These guidelines provide information on state of art, evidence based approach for use of ART in Indian context. When to initiate ART? Antiretroviral therapy is indicated for all symptomatic HIV infected persons regardless of CD4 counts and plasma viral load (PVL) levels. In asymptomatic patients, ART should be offered when the CD4 counts < 200/mm3 and should be considered in patients with CD4 counts between 200-250/mm3. Therapy is not recommended for patients with CD4 count more than 350/ mm3. Involvement of patient in all treatment decisions and assessing readiness is critical before initiating ART. What to start with? A non-nucleoside reverse transcriptase inhibitor (NNRTI) based regimen is recommended for antiretroviral naïve patients. The choice between nevirapine and efavirenz is based on differences in adverse events profiles; cost and availability of convenient fixed dose combinations and need for concomitant use of rifampicin. A backbone of 2-nucleoside reverse transcriptase inhibitors (NRTIs) is combined with the NNRTI. Various combinations and ART strategies not to be used in clinical practice has been enlisted. How to follow up? Recommendations have been made for baseline evaluation and monitoring of patients on ART. These include guidelines on laboratory and clinical evaluation. A plasma viral load at 6 months after initiation of first-line ART is strongly recommended. Yearly estimation of lipid profile has been recommended. How to identify and manage ART failure? The guidelines recognize the issue of identifying ART failure late if only CD4 counts are used for monitoring. In the absence of resistance testing various second-line regimens have been enlisted. A boosted protease inhibitor based regimen is recommended in this situation to be combined with 2-NRTIs. Special situations Recommendations have been made for use of ART in HIV-TB, HIV-HBV, and HIV-HCV co-infected patients. In patients with active TB and a CD4 count < 200/mm3, initiation of ART is recommended as soon as the anti-TB treatment is tolerated. Efavirenz is the only ARV drug, which can be safely used with rifampicin. In pregnancy use of single dose nevirapine for reducing risk of mother to child transmission of HIV is not recommended, because of the risk of development of resistance. For post-exposure prophylaxis taking ART treatment history of the source patient is crucial in designing an effective regimen.
Subject(s)
Acquired Immunodeficiency Syndrome/diagnosis , Anti-HIV Agents/adverse effects , Antiretroviral Therapy, Highly Active/standards , CD4 Lymphocyte Count , Drug Interactions , Drug Monitoring/standards , HIV Infections/diagnosis , Humans , India , Patient ComplianceABSTRACT
Intervenções farmacológicas com hipolipemiantes devem ser monitoradas periodicamente para avaliar eficácia e parâmetros de segurança. As estatinas são drogas normalmente bem toleradas e os seus principais efeitos colaterais incluem aumento das enzimas hepáticas (AST e ALT) e muscular (CK). O tratamento deve ser interrompido ou diminuído no caso de um aumento significativo das AST ou ALT (> 3x LSN), ou CK (> 10x LSN). Outros agentes hipolipemiantes também podem produzir hepatotoxicidade ou miosite, fibratos e ácido nicotínico, especialmente em associação com as estatinas ou na presença de anormalidades metabólicas (tireoidite, hepatopatia e nefropatia). Acido nicotínico pode também aumentar os níveis plasmáticos de glicose e ácido úrico. Testes laboratoriais podem ser utilizados no seguimento da terapia hipolipemiante e devem ser repetidos a cada três meses durante o primeiro ano e então em intervalos de seis meses. Intervalos menores são recomendados para casos especiais.
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged, 80 and over , Coronary Artery Disease/prevention & control , Practice Guidelines as Topic , Liver/drug effects , Hyperlipidemias/drug therapy , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Alanine Transaminase/blood , Aspartate Aminotransferases/blood , Practice Patterns, Physicians'/standards , Creatine Kinase/blood , Liver/enzymology , Hyperlipidemias/prevention & control , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Biomarkers/blood , Drug Monitoring/methods , Drug Monitoring/standards , Time FactorsABSTRACT
It i an accepted fact that, in many countries, pharmacies are the predominat source of medical advice over-the-counter drugs, and supplies of "prescription-only" drugs for sale without a prescription. To assess the activities conducted by pharmacists or pharmacy counter assistants in response to a common health problem, a cross-sectional study was done at 114 pharmacies in Porto Alegre, Brazil. A fictitious case-history of cough was used by trained personnel entering the pharmacy and the subsequent activities by the pharmacist or pharmacy counter assistant were analyzed. Some kind of medication was provided in 101 (88.5 percent)of the pharmacies. Pharmacists gave medication in 80 percent of pharmacies, and pharmacy assistants in 95.5 percent (p<0.03). The class of medication most frequently dispensed was the expectorants (97 times, 92.4 percent), however, systemic antibiotics were provided in 11 pharmacies (10.5 percent). Of note, the pharmacists provided antibiotics more frequently than did pharmacy assistants (p=0.016). We conclude that pharmacy advice and symptomatic medical care (expectorants) are very common and that pharmacy assistants are more likely than pharmacists to provide medication. Of concern, when pharmacists were the drug dispensers of antibiotics which should be provided by prescription only, drugs were provided without proper diagnosis, and often incorrect dosages. This reflects a pontentially dangerous practice in need of careful evaluation, education and supervision.
Subject(s)
Anti-Bacterial Agents , Antitussive Agents/therapeutic use , Cough/drug therapy , Expectorants/therapeutic use , Nonprescription Drugs/administration & dosage , Nonprescription Drugs/adverse effects , Drug Prescriptions , Self Administration , Drug Monitoring/standards , Pharmacies/standardsABSTRACT
Las reacciones adversas a medicamentos (R.A.M.) se clasifican en de tipo A, relacionadas con la toxicidad del medicamento, y de tipo B, debido a un incremento de la susceptibilidad del paciente. El objetivo del presente trabajo consiste en detectar y evaluar las R.A.M. tipo B, y determinar sus factores de riesgo asociados. Se efectuó un estudio retrospectivo, utilizando estrategias
Subject(s)
Humans , Drug Monitoring , Product Surveillance, Postmarketing , Drug Approval/methods , Drug Monitoring/standards , Drug Evaluation/standards , Medicamentous Disease , Product Surveillance, Postmarketing/standards , Risk Factors , Rebound Effect , Adverse Drug Reaction Reporting Systems/standards , Adverse Drug Reaction Reporting Systems/organization & administrationABSTRACT
El litio es un fármaco de elección para el tratamiento de la manía y para el mantenimiento a largo plazo en la prevención de las crisis maníacas o depresivas del trastorno bipolar. Un conocimiento profundo del litio es necesario para alcanzar una utilización más segura y efectiva. Es un fármaco que debe ser utilizado con mucha precaución debido a su estrecha ventana terapéutica y la letalidad de la toxicidad relacionada con el mismo. Los pacientes deben ser evaluados clínica y paraclínicamente antes de iniciar la terapia con litio. Las interacciones farmacológicas deben ser tenidas presentes y se recomienda que la litemia, función tiroidea y función renal deben ser evaluadas mediante el laboratorio en asocio con un seguimiento clínico estricto. Las muestras de sangre para efectuar el monitoreo deben ser tomadas luego de cuatro días de estar tomando una dosis constante, doce horas después de la dosis de la noche y justo antes de tomar la de la mañana.
Subject(s)
Humans , Lithium/administration & dosage , Lithium/isolation & purification , Lithium/therapeutic use , Drug Monitoring , Drug Monitoring/standards , Drug Monitoring/trends , Drug Monitoring/statistics & numerical dataABSTRACT
La formulación racional requiere un conocimiento adecuado de la patología del paciente y de las propiedades farmacocinéticas y farmacodinámicas del medicamento seleccionado. El clínico debe elegir un esquema de dosis que alcance una concentración óptima en el órgano enfermo, la cual no debe ser demasiado baja ni demasiado alta; en el primer caso, no se logrará el objetivo terapéutico, mientras que en el segundo, los efectos adversos o tóxicos serán molestos o intolerables para el paciente. La finalidad del monitoreo terapéutico de drogas es darle al clínico la información que le permita individualizar el tratamiento para cada uno de sus pacientes. Este módulo evalúa la utilidad del monitoreo terapéutico de drogas para ciertos medicamentos en el manejo individual de los pacientes.