The pharmaceutical legal framework is a very important infrastructure in achieving predefined goals in pharmaceutical sector: Accessibility, quality, and rational use of medicine. This study aims to review the current pharmaceutical sector-related legal provisions in Iran where the Food and Drug Organization (FDO) is in charge of regulating all issues related to the pharmaceutical sector. The main laws and regulations enacted by parliament and cabinet and even internal regulations enacted by the Ministry of Health or Iran FDO are reviewed. Different laws and regulations are categorized according to the main goals of Iran national drug policy.
Background: Pegylated (PEG) interferon beta 1a has been approved by the United States Food and Drug Administration (USFDA) as an alternative to interferon beta 1a for multiple sclerosis (MS). Due to its higher price, this study aimed to evaluate the cost-effectiveness of PEG-interferon beta 1-a compared with interferon beta 1a from an Iranian payer perspective. Methods: A Markov model was designed according to health states based on Expanded Disability Status Scale (EDSS) and one-month cycles over a 10-year time horizon. Direct medical and non-medical costs were included from a payer perspective. Results: The incremental cost-effectiveness ratio (ICER) was estimated around 11111 US dollars (USD) per quality-adjusted life-year (QALY) gained for the PEG-interferon versus interferon regimen [with currency rate of 29,000 Iranian Rial (IRR) to 1 USD in 2016]. Conclusion: Considering the cost-effectiveness threshold in Iran [three times of gross domestic product (GDP) per capita or 15,945 USD], PEG-interferon beta 1-a could be considered as a cost effective treatment for Iranian patients with MS.
Objectives: Descrever as principais neoplasias malignas com tratamentos complexos (cirurgia, quimioterapia e radioterapia combinados) em homens e mulheres, segundo ano de diagnóstico, em um hospital público. MethOds: Foram incluídos pacientes acima de 18 anos, com ou sem diagnóstico prévio, mas sem tratamento, atendidos na instituição durante o período de 2008-2012, obtidos a partir das informações do Registro Hospitalar de Câncer (RHC). Proporções e intervalos com 95% de confiança (IC95%) foram calculados por sexo e ano de diagnóstico estratificado para as seguintes neoplasias malignas: mama, próstata, cabeça e pescoço, gastrointestinal, cólon e reto, tireoide e pulmão. Results: O peso das neoplasias com tratamentos complexos é diferente entre homens e mulheres. Tumores de mama representam entre 20% a 26% do total de tumores em mulheres dependendo do ano de diagnóstico. Em 2010, os tumores de próstata representaram 39% (IC95% 37,5%-40,7%) do total de neoplasias malignas em homens. Tumores de cabeça e pescoço representam aproximadamente 11% (IC95% 10,1%-11,2%) do total de casos em homens, enquanto que para mulheres o valor é de 2,7% (2,4%-3,0%), observandose aumento dessa carga no ano de 2012. Tumores de cólon e reto representam 11% dos casos em mulheres para o período total, já para os homens essa proporção foi de 8,6%. O câncer de pulmão representou uma variação positiva de 34% entre 2011 e 2012 para as mulheres, por outro lado, em homens a variação foi negativa, diminuindo em 1,1% a proporção de casos para o mesmo período. Tumores de tiroide são mais frequentes em mulheres, representando entre 5,4% a 8,5% do total. cOnclusiOns: Informações fornecidas por Registros Hospitalares de Câncer são utilizadas para a gestão e administração dos recursos. Conhecer o perfil dos pacientes e as mudanças dos diagnósticos estabelecidos permite alocar recursos conforme a necessidade de tratamentos complexos.Objectives: Avaliar o impacto do encaminhamento precoce para cuidados paliativos na utilização de serviço de emergência por pacientes com câncer avançado, em um centro de referência para o tratamento oncológico em São Paulo, Brasil. MethOds: Estudo retrospectivo realizado no Instituto de Câncer do Estado de São Paulo (ICESP). Foram considerados elegíveis, pacientes maiores de 18 anos, com diagnóstico de câncer, que foram a óbito no período de 01/01/2010 a 31/12/2013 e que fizeram uso dos serviços de cuidados paliativos do ICESP. Dados sociodemográficos, clínicos e o número de visitas à emergência foram coletados a partir de registros médico-hospitalares. Os pacientes foram classificados em "cuidado paliativo precoce" (início de cuidados paliativos três meses ou mais antes do óbito) e "cuidado paliativo tardio" (início de cuidados paliativos menos de três meses antes do óbito). Results: Foram incluídos 2985 pacientes que preencheram os critérios de inclusão. A idade média no momento do primeiro atendimento em cuidados paliativos foi de 64,5 anos para o sexo masculino e de 64,3 anos para o sexo feminino. A maioria dos pacient...
To systematically review the clinical outcomes of olmesartan as monotherapy or in combination with other antihypertensive agents in the treatment of hypertension. MethOds: We searched the electronic databases PubMed and Cochrane Library from inception until December 2015, using predetermined key-words by a group of experts with relevant methodological and clinical expertise. Eligible studies were selected using predetermined inclusion and exclusion criteria, limiting articles to those published in the English language. The study selection process proceeded in two main stages. Background information of the study, participants' characteristics and study outcomes were collected using data extraction forms developed specifically to address the review issues in hand. A quality assessment of the studies was conducted by two reviewers, using the Detsky method. Results: The literature search identified a total of 50 full articles that met the inclusion criteria. In general results from clinical trials evaluating the efficacy of olmesartan as monotherapy and as combination therapy demonstrated that olmesartan provided better antihypertensive BP-lowering efficacy compared with other antihypertensive agents and compared with component monotherapies. Furthermore, treatment with olmesartan either as monotherapy or in combination with HCTZ or amlodipine compared with the component monotherapies or compared with other combination therapies was generally well tolerated, with similar nature and frequency of adverse events among them. cOnclusiOns: Evidence from the present systematic review confirms the antihypertensive efficacy and good safety profile of olmesartan both as monotherapy and as combination therapy.
Policymakers should advocate the multiple-fraction method instead of the single-fraction method in the treatment of patients with painful bone metastases.
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