Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 30
Filtrar
1.
BMC Health Serv Res ; 15: 11, 2015 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-25609265

RESUMO

BACKGROUND: Pharmaceutical expenditure is currently rising by 16% per annum in China, greater in recent years. Initiatives to moderate growth include drug pricing regulations, essential medicine lists and encouraging generic prescribing. These are principally concentrated in hospitals, which currently account for over 80% of total pharmaceutical expenditure. However, no monitoring of prescribing and perverse incentives encouraging physicians and hospitals to profit from drug procurement encourages irrational prescribing. This includes greater utilisation of originators versus generics as well as injectables when cheaper oral equivalents are available. The objective of the paper is to assess changes in proton pump inhibitor (PPI) utilisation and expenditure in China as more generics become available including injectables. METHODS: Observational retrospective study of PPI utilisation and procured expenditure between 2004 and 2013 in the largest teaching hospital in Chongqing District as representative of China. RESULTS: Appreciable increase in PPI utilisation during the study period rising 10.4 fold, with utilisation of generics rising faster than originators. Oral generics reached 84% of total oral preparations in 2013 (defined daily dose basis), with generic injectables 93% of total injectables by 2013. Injectables accounted for 42% of total PPI utilisations in 2008 and 2009 before falling to below 30%. Procured prices for oral preparations reduced over time (-34%). Generic oral omeprazole in 2010 was 87% below 2004 originator prices, mirroring reductions seen in Western Europe. Injectable prices also decreased over time (-19%). However, injectables typically 4.3 to 6.8 fold more expensive than equivalent orals - highest for injectable lansoprazole at 13.4 to 18.0 fold. High utilisation of more expensive oral PPIs as well as injectables meant that PPI expenditure increased 10.1 fold during the study period. Lower use of injectables, and only oral generic omeprazole, would result in accumulated savings of CNY249.65 million, reducing total accumulated expenditure by 84%. CONCLUSIONS: Encouraging to see high utilisation of generic PPIs and low prices for oral generics. However, considerable opportunities to enhance prescribing efficiency through greater use of oral generic omeprazole.


Assuntos
Omeprazol/uso terapêutico , Padrões de Prática Médica/tendências , Inibidores da Bomba de Prótons/uso terapêutico , Administração Oral , China , Custos de Medicamentos , Uso de Medicamentos , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Previsões , Refluxo Gastroesofágico/tratamento farmacológico , Refluxo Gastroesofágico/economia , Gastos em Saúde , Humanos , Injeções Intravenosas , Padrões de Prática Médica/economia , Inibidores da Bomba de Prótons/economia , Estudos Retrospectivos
2.
BMC Med ; 12: 98, 2014 Jun 13.
Artigo em Inglês | MEDLINE | ID: mdl-24927744

RESUMO

BACKGROUND: Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders.The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone. METHODS: Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)). RESULTS: There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72% in Ireland. CONCLUSION: Consistent findings of no increased prescribing of risperidone post generics with limited specific demand-side measures suggests no 'spillover' effect from one class to another encouraging the preferential prescribing of generic atypical antipsychotic drugs. This is exacerbated by the complexity of the disease area and differences in the side-effects between treatments. There appeared to be no clinical issues with generic risperidone, and prices inversely reflected measures to enhance their utilisation.


Assuntos
Antipsicóticos/uso terapêutico , Medicamentos Genéricos/uso terapêutico , Recursos em Saúde/economia , Risperidona/uso terapêutico , Adulto , Antipsicóticos/economia , Prescrições de Medicamentos , Medicamentos Genéricos/economia , Europa (Continente) , Humanos , Hipertensão/tratamento farmacológico , Pessoa de Meia-Idade , Padrões de Prática Médica , Atenção Primária à Saúde , Análise de Regressão , Estudos Retrospectivos , Risperidona/economia , Esquizofrenia/tratamento farmacológico
3.
Gut ; 62(12): 1692-703, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23092766

RESUMO

OBJECTIVE: To compare the incidence of six gastrointestinal cancers (colorectal, oesophageal, gastric, liver, gallbladder and pancreatic) among the six main 'non-White' ethnic groups in England (Indian, Pakistani, Bangladeshi, Black African, Black Caribbean and Chinese) to each other and to Whites. METHODS: We analysed all 378 511 gastrointestinal cancer registrations from 2001-2007 in England. Ethnicity was obtained by linkage to the Hospital Episodes Statistics database and we used mid-year population estimates from 2001-2007. Incidence rate ratios adjusted for age, sex and income were calculated, comparing the six ethnic groups (and combined 'South Asian' and 'Black' groups) to Whites and to each other. RESULTS: There were significant differences in the incidence of all six cancers between the ethnic groups (all p<0.001). In general, the 'non-White' groups had a lower incidence of colorectal, oesophageal and pancreatic cancer compared to Whites and a higher incidence of liver and gallbladder cancer. Gastric cancer incidence was lower in South Asians but higher in Blacks and Chinese. There was strong evidence of differences in risk between Indians, Pakistanis and Bangladeshis for cancer of the oesophagus, stomach, liver and gallbladder (all p<0.001) and between Black Africans and Black Caribbeans for liver and gallbladder cancer (both p<0.001). CONCLUSIONS: The risk of gastrointestinal cancers varies greatly by individual ethnic group, including within those groups that have traditionally been grouped together (South Asians and Blacks). Many of these differences are not readily explained by known risk factors and suggest that important, potentially modifiable causes of these cancers are still to be discovered.


Assuntos
Neoplasias Gastrointestinais/epidemiologia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Povo Asiático/estatística & dados numéricos , População Negra/estatística & dados numéricos , Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/etnologia , Inglaterra/epidemiologia , Neoplasias Esofágicas/epidemiologia , Neoplasias Esofágicas/etnologia , Etnicidade , Feminino , Neoplasias da Vesícula Biliar/epidemiologia , Neoplasias da Vesícula Biliar/etnologia , Neoplasias Gastrointestinais/etnologia , Humanos , Incidência , Neoplasias Hepáticas/epidemiologia , Neoplasias Hepáticas/etnologia , Masculino , Pessoa de Meia-Idade , Neoplasias Pancreáticas/epidemiologia , Neoplasias Pancreáticas/etnologia , Fatores de Risco , Fatores Sexuais , População Branca/estatística & dados numéricos
4.
BMC Med ; 11: 179, 2013 Aug 13.
Artigo em Inglês | MEDLINE | ID: mdl-23941275

RESUMO

Considerable variety in how patients respond to treatments, driven by differences in their geno- and/ or phenotypes, calls for a more tailored approach. This is already happening, and will accelerate with developments in personalized medicine. However, its promise has not always translated into improvements in patient care due to the complexities involved. There are also concerns that advice for tests has been reversed, current tests can be costly, there is fragmentation of funding of care, and companies may seek high prices for new targeted drugs. There is a need to integrate current knowledge from a payer's perspective to provide future guidance. Multiple findings including general considerations; influence of pharmacogenomics on response and toxicity of drug therapies; value of biomarker tests; limitations and costs of tests; and potentially high acquisition costs of new targeted therapies help to give guidance on potential ways forward for all stakeholder groups. Overall, personalized medicine has the potential to revolutionize care. However, current challenges and concerns need to be addressed to enhance its uptake and funding to benefit patients.


Assuntos
Atenção à Saúde/métodos , Assistência ao Paciente/métodos , Medicina de Precisão/métodos , Atenção à Saúde/tendências , Estudos de Viabilidade , Previsões , Humanos , Assistência ao Paciente/tendências , Farmacogenética/métodos , Farmacogenética/tendências , Medicina de Precisão/tendências
5.
Acad Psychiatry ; 37(3): 182-6, 2013 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-23632929

RESUMO

OBJECTIVE: The proportion of U.K. medical students applying for psychiatry training continues to decline, whereas, in Somaliland, there are no public-sector psychiatrists. This pilot study assessed the usefulness and feasibility of online, instant messenger, peer-to-peer exchange for psychiatry education between cultures. METHOD: Twenty medical students from King's College, London, and Hargeisa University (Somaliland) met online in pairs every 2 weeks to discuss prearranged psychiatric topics, clinical cases, and treatment options, completing online evaluations throughout. RESULTS: Average ratings of the enjoyment, academic helpfulness, and interest of sessions were 4.31, 3.56, and 4.54 (of a maximum of 5), respectively; 83% would recommend the partnership to a friend. CONCLUSION: This partnership enabled students on both sides to exploit psychiatry-learning resources at the other's disposal, outside the standard medical education context, illustrating the benefits to medical students in dramatically different locations of partnership through telemedicine. This pilot study presents an innovative, cost-effective, under-used approach to international medical education.


Assuntos
Educação de Graduação em Medicina/métodos , Grupo Associado , Psiquiatria/educação , Estudantes de Medicina , Telemedicina/métodos , Adulto , Djibuti , Feminino , Humanos , Masculino , Projetos Piloto , Reino Unido
6.
Qual Prim Care ; 21(1): 7-15, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23735629

RESUMO

BACKGROUND: There are on-going initiatives in Scotland to improve the quality and efficiency of prescribing in primary care. Activities to enhance prescribing of angiotensin-converting enzyme inhibitors (ACEIs) versus angiotensin receptor blockers (ARBs) include prescribing guidance, guidelines, benchmarking, prescribing targets and financial incentives. These measures stabilised reimbursed expenditure for renin-angiotensin inhibitor drugs between 2001 and 2007 despite a 159% increase in volumes. Generic losartan was included in the Drug Tariff from July 2010. As there is no appreciable difference between ARBs, and the prices of generic losartan are falling, health boards should be actively encouraging its prescribing. AIM: To primarily assess changes in utilisation patterns of losartan versus other ARBs after July 2010. Second, to assess the utilisation of generic versus originator losartan. METHOD: We used an interrupted time series analysis of ARB utilisation, measured in defined daily doses (DDDs) before and after July 2010. Utilisation data were obtained from the NHS National Services Scotland Corporate Warehouse. RESULTS: There was no significant change in the utilisation pattern of losartan or other ARBs combined before or after the introduction of generic losartan. Losartan accounted for 32% of total ARBs 12 months after listing. Between 98 and 99% of losartan was prescribed generically. In March 2012, the price of losartan was 88% below prepatent prices with potential savings of ?8m per year. CONCLUSION: Specific measures are needed to change prescribing habits especially with complex messages. The cost of deriving savings must be weighed against other quality initiatives and other ARBs losing or shortly losing their patents.


Assuntos
Anti-Hipertensivos/uso terapêutico , Medicamentos Genéricos/uso terapêutico , Hipertensão/tratamento farmacológico , Losartan/uso terapêutico , Padrões de Prática Médica/estatística & dados numéricos , Atenção Primária à Saúde , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/economia , Revisão de Uso de Medicamentos , Humanos , Losartan/administração & dosagem , Losartan/economia , Escócia
8.
Dermatol Online J ; 18(4): 16, 2012 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-22559031

RESUMO

We describe the use of MedicineAfrica.com, an innovative social networking portal, to deliver real-time, intercontinental, case-based dermatology teaching to geographically scattered trainee physicians in Somaliland by tutors based in the United Kingdom.


Assuntos
Atitude do Pessoal de Saúde , Dermatologia/educação , Educação de Pós-Graduação em Medicina/métodos , Internet , Rede Social , Humanos , Somália
13.
PLoS One ; 11(5): e0154347, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27135830

RESUMO

BACKGROUND: There is substantial variation in nervous system and intracranial tumour incidence worldwide. UK incidence data have limited utility because they group these diverse tumours together and do not provide data for individual ethnic groups within Blacks and South Asians. Our objective was to determine the incidence of individual tumour types for seven individual ethnic groups. METHODS: We used data from the National Cancer Intelligence Network on tumour site, age, sex and deprivation to identify 42,207 tumour cases. Self-reported ethnicity was obtained from the Hospital Episode Statistics database. We used mid-year population estimates from the Office for National Statistics. We analysed tumours by site using Poisson regression to estimate incidence rate ratios comparing non-White ethnicities to Whites after adjustment for sex, age and deprivation. RESULTS: Our study showed differences in tumour incidence by ethnicity for gliomas, meningiomas, pituitary tumours and cranial and paraspinal nerve tumours. Relative to Whites; South Asians, Blacks and Chinese have a lower incidence of gliomas (p<0.01), with respective incidence rate ratios of 0.68 (confidence interval: 0.60-0.77), 0.62 (0.52-0.73) and 0.58 (0.41-0.83). Blacks have a higher incidence of meningioma (p<0.01) with an incidence rate ratio of 1.29 (1.05-1.59) and there is heterogeneity in meningioma incidence between individual South Asian ethnicities. Blacks have a higher incidence of pituitary tumours relative to Whites (p<0.01) with an incidence rate ratio of 2.95 (2.37-3.67). There is heterogeneity in pituitary tumour incidence between individual South Asian ethnicities. CONCLUSIONS: We present incidence data of individual tumour types for seven ethnic groups. Current understanding of the aetiology of these tumours cannot explain our results. These findings suggest avenues for further work.


Assuntos
Neoplasias Encefálicas/epidemiologia , Sistema Nervoso/patologia , Distribuição por Idade , Povo Asiático/estatística & dados numéricos , População Negra/estatística & dados numéricos , Inglaterra , Estudos Epidemiológicos , Etnicidade/estatística & dados numéricos , Feminino , Humanos , Incidência , Masculino , População Branca/estatística & dados numéricos
14.
Expert Rev Pharmacoecon Outcomes Res ; 15(1): 157-69, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25348709

RESUMO

INTRODUCTION: Pharmaceutical expenditure is rising by 16% per annum in China and is now 46% of total expenditure. Initiatives to moderate growth include drug pricing regulations and encouraging international non-proprietary name prescribing. However, there is no monitoring of physician prescribing quality and perverse incentives. OBJECTIVES: Assess changes in angiotensin receptor blocker (ARB) utilization and expenditure as more generics become available; compare findings to Europe. METHODOLOGY: Observational retrospective study of ARB utilization and expenditure between 2006 and 2012 in the largest hospital in Chongqing district. RESULTS: Variable and low use of generics versus originators with a maximum of 31% among single ARBs. Similar for fixed dose combinations. Prices typically reduced over time, greatest for generic telmisartan (-54%), mirroring price reductions in some European countries. However, no preferential increase in prescribing of lower cost generics. Accumulated savings of 33 million CNY for this large provider if they adopted European practices. CONCLUSION: Considerable opportunities to improve prescribing efficiency in China.


Assuntos
Antagonistas de Receptores de Angiotensina/uso terapêutico , Medicamentos Genéricos/uso terapêutico , Padrões de Prática Médica/normas , Antagonistas de Receptores de Angiotensina/administração & dosagem , Antagonistas de Receptores de Angiotensina/economia , Benzimidazóis/economia , Benzimidazóis/uso terapêutico , Benzoatos/economia , Benzoatos/uso terapêutico , China , Custos de Medicamentos , Medicamentos Genéricos/economia , Humanos , Motivação , Padrões de Prática Médica/tendências , Estudos Retrospectivos , Telmisartan , Fatores de Tempo
15.
Expert Rev Clin Pharmacol ; 8(1): 77-94, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25487078

RESUMO

Medicines have made an appreciable contribution to improving health. However, even high-income countries are struggling to fund new premium-priced medicines. This will grow necessitating the development of new models to optimize their use. The objective is to review case histories among health authorities to improve the utilization and expenditure on new medicines. Subsequently, use these to develop exemplar models and outline their implications. A number of issues and challenges were identified from the case histories. These included the low number of new medicines seen as innovative alongside increasing requested prices for their reimbursement, especially for oncology, orphan diseases, diabetes and HCV. Proposed models center on the three pillars of pre-, peri- and post-launch including critical drug evaluation, as well as multi-criteria models for valuing medicines for orphan diseases alongside potentially capping pharmaceutical expenditure. In conclusion, the proposed models involving all key stakeholder groups are critical for the sustainability of healthcare systems or enhancing universal access. The models should help stimulate debate as well as restore trust between key stakeholder groups.


Assuntos
Atenção à Saúde/métodos , Descoberta de Drogas/métodos , Revisão de Uso de Medicamentos/métodos , Preparações Farmacêuticas/administração & dosagem , Ensaios Clínicos Fase III como Assunto , Indústria Farmacêutica/métodos , Humanos
16.
J Comp Eff Res ; 3(4): 371-86, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25275234

RESUMO

BACKGROUND: Pharmaceutical expenditure has grown by 16% per annum in China, enhanced by incentives for physicians and hospitals. Hospital pharmacies dispense 80% of medicines in China, accounting for 46% of total hospital expenditure. Principal measures to moderate drug expenditure growth include pricing initiatives as limited demand-side measures. OBJECTIVE: Assess current utilization and expenditure including traditional Chinese medicines (TCMs) between 2006 and 2012. METHODS: Uncontrolled retrospective study of medicines to treat cardiovascular and cerebrovascular diseases in one of the largest hospitals in southwest China. RESULTS: Utilization increased 3.3-fold for cerebrovascular medicines, greatest for TCMs, with expenditure increasing 4.85-fold. Low prices for generics were seen, similar to Europe. However, there was variable utilization of generics at 29-31% of total product volumes in recent years. There continued to be irrationality in prescribing with high use of TCMs, and the utilization of different medicines dropping significantly once they achieved low prices. CONCLUSION: Prices still have an appreciable impact on utilization in China. Potential measures similar to those implemented among western European countries could improve prescribing rationality and conserve resources.


Assuntos
Doenças Cardiovasculares/tratamento farmacológico , Transtornos Cerebrovasculares/tratamento farmacológico , Uso de Medicamentos , Reforma dos Serviços de Saúde , China , Uso de Medicamentos/tendências , Medicamentos Genéricos/uso terapêutico , Custos Hospitalares/tendências , Humanos , Estudos Retrospectivos
17.
Front Pharmacol ; 5: 106, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24987370

RESUMO

INTRODUCTION: The appreciable growth in pharmaceutical expenditure has resulted in multiple initiatives across Europe to lower generic prices and enhance their utilization. However, considerable variation in their use and prices. OBJECTIVE: Assess the influence of multiple supply and demand-side initiatives across Europe for established medicines to enhance prescribing efficiency before a decision to prescribe a particular medicine. Subsequently utilize the findings to suggest potential future initiatives that countries could consider. METHOD: An analysis of different methodologies involving cross national and single country retrospective observational studies on reimbursed use and expenditure of PPIs, statins, and renin-angiotensin inhibitor drugs among European countries. RESULTS: Nature and intensity of the various initiatives appreciably influenced prescribing behavior and expenditure, e.g., multiple measures resulted in reimbursed expenditure for PPIs in Scotland in 2010 56% below 2001 levels despite a 3-fold increase in utilization and in the Netherlands, PPI expenditure fell by 58% in 2010 vs. 2000 despite a 3-fold increase in utilization. A similar picture was seen with prescribing restrictions, i.e., (i) more aggressive follow-up of prescribing restrictions for patented statins and ARBs resulted in a greater reduction in the utilization of patented statins in Austria vs. Norway and lower utilization of patented ARBs vs. generic ACEIs in Croatia than Austria. However, limited impact of restrictions on esomeprazole in Norway with the first prescription or recommendation in hospital where restrictions do not apply. Similar findings when generic losartan became available in Western Europe. CONCLUSIONS: Multiple demand-side measures are needed to influence prescribing patterns. When combined with supply-side measures, activities can realize appreciable savings. Health authorities cannot rely on a "spill over" effect between classes to affect changes in prescribing.

18.
Expert Rev Pharmacoecon Outcomes Res ; 13(4): 469-82, 2013 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-23977975

RESUMO

Scotland has introduced a number of initiatives to enhance the prescribing of low-cost generic drugs versus originators and patent products in a class where these are seen as similar. The objective of this review is to appraise the influence of the various measures on subsequent utilization patterns and expenditure in high-volume classes to provide guidance. This review is principally a narrative review of published studies. The authors' found supply-side measures resulted in generic prices as low as 3% of pre-patent loss prices. Multiple demand-side measures resulted in high international non-proprietary name prescribing, and a considerable increase in prescribing efficiency for the proton pump inhibitors, statins, renin-angiotensin inhibitor drugs and selective serotonin reuptake inhibitors. There were no specific activities encouraging the prescription of losartan versus other angiotensin receptor blockers or risperidone versus other atypical antipsychotic drugs following generics and no change in their utilization patterns post generics. The authors can conclude multiple measures are needed to change physician prescribing habits. Authorities cannot rely on any 'spillover' effects to affect future prescribing, even in closely related classes.


Assuntos
Atitude do Pessoal de Saúde , Medicamentos Genéricos/uso terapêutico , Reforma dos Serviços de Saúde , Conhecimentos, Atitudes e Prática em Saúde , Política de Saúde , Formulação de Políticas , Padrões de Prática Médica , Redução de Custos , Análise Custo-Benefício , Custos de Medicamentos , Prescrições de Medicamentos , Medicamentos Genéricos/classificação , Medicamentos Genéricos/economia , Fidelidade a Diretrizes , Reforma dos Serviços de Saúde/economia , Gastos em Saúde , Política de Saúde/economia , Humanos , Planos de Incentivos Médicos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/economia , Escócia
19.
Front Pharmacol ; 4: 39, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23717279

RESUMO

BACKGROUND: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use. OBJECTIVE: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups. METHODOLOGY: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. RESULTS: There has been a plethora of activities among authorities to manage the prescribing of dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions, and monitoring of prescribing post-launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. CONCLUSION: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

20.
Heart ; 97(7): 544-50, 2011 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-20962342

RESUMO

OBJECTIVE: Exposure to air pollution is associated with increases in cardiovascular morbidity and mortality. This study was undertaken to determine the effect of diesel exhaust inhalation on heart rhythm and heart rate variability in healthy volunteers and patients with coronary heart disease. DESIGN AND SETTING: Double-blind randomised crossover studies in a university teaching hospital. PATIENTS: 32 healthy non-smoking volunteers and 20 patients with prior myocardial infarction. INTERVENTIONS: All 52 subjects were exposed for 1 h to dilute diesel exhaust (particle concentration 300 µg/m³) or filtered air. MAIN OUTCOME MEASURES: Heart rhythm and heart rate variability were monitored during and for 24 h after the exposure using continuous ambulatory electrocardiography and assessed using standard time and frequency domain analysis. RESULTS: No significant arrhythmias occurred during or following exposures. Patients with coronary heart disease had reduced autonomic function in comparison to healthy volunteers, with reduced standard deviations of the NN interval (SDNN, p < 0.001) and triangular index (p < 0.001). Diesel exhaust did not affect heart rate variability compared with filtered air (p > 0.05 for all) in healthy volunteers (SDNN 101 ± 6 vs 91 ± 6, triangular index 20 ± 1 vs 21 ± 1) or patients with coronary heart disease (SDNN 47 ± 5 vs 38 ± 4, triangular index 8 ± 1 vs 7 ± 1). CONCLUSIONS: Brief exposure to dilute diesel exhaust does not alter heart rhythm or heart rate variability in healthy volunteers or well-treated patients with stable coronary heart disease. Autonomic dysfunction does not appear to be a dominant mechanism that can explain the observed excess in cardiovascular events following exposure to combustion-derived air pollution.


Assuntos
Frequência Cardíaca/efeitos dos fármacos , Emissões de Veículos/toxicidade , Adulto , Idoso , Arritmias Cardíacas/etiologia , Doença das Coronárias/fisiopatologia , Estudos Cross-Over , Método Duplo-Cego , Eletrocardiografia Ambulatorial/métodos , Humanos , Exposição por Inalação/efeitos adversos , Masculino , Pessoa de Meia-Idade , Material Particulado/farmacologia , Material Particulado/toxicidade , Adulto Jovem
SELEÇÃO DE REFERÊNCIAS
Detalhe da pesquisa