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Current key priorities for the rare diseases patients community in the EU 当前欧盟罕见病患者社区的主要优先事项
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2009-0231
Flaminia Macchia-Bangsgaard, Y. Cam
{"title":"Current key priorities for the rare diseases patients community in the EU","authors":"Flaminia Macchia-Bangsgaard, Y. Cam","doi":"10.3233/PPL-2009-0231","DOIUrl":"https://doi.org/10.3233/PPL-2009-0231","url":null,"abstract":"Rare diseases patients face a lack of access to correct diagnosis, lack of information and public awareness, lack of scientific knowledge and expertise, lack of research, lack of therapeutic development, lack of appropriate healthcare, high cost for most of few existing drugs, inequalities in access to treatment and care, and lack of specialised social services. Because of their rarity these patients are a particularly vulnerable segment of the EU population which disserves a European wide strategy based on social justice and equity. Therefore, key priorities for rare diseases patients are issues that are generally taken for granted for patients suffering from more common diseases, such as getting an adequate diagnosis relatively quickly, being offered a range of treatments from which they can chose together with their knowledgeable doctor – the most appropriate one for their specific case, and hopefully being cured or being able to manage their disease towards an improvement of their condition. For most rare diseases patients, this is not the case. Recently, this situation linked to an overall lack of public awareness has started to change and improve, mainly thanks to the relentless work of patient groups and fruitful partnering amongst all interested parties.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132370215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Econometric approaches in evaluating costs and outcomes within pharmacoeconomic analyses 计量经济学方法在药物经济学分析中评估成本和结果
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2011-0345
G. Skrepnek, E. Olvey, A. Sahai
{"title":"Econometric approaches in evaluating costs and outcomes within pharmacoeconomic analyses","authors":"G. Skrepnek, E. Olvey, A. Sahai","doi":"10.3233/PPL-2011-0345","DOIUrl":"https://doi.org/10.3233/PPL-2011-0345","url":null,"abstract":"Cost and outcomes data within pharmacoeconomic analyses often possess distributional properties that require advanced statistical approaches to yield robust findings. An analyst’s failure to recognize and control for these characteristics may result in inappropriate evaluations of statistical associations or causal effects which may ultimately support incorrect policy decisionmaking. Given the importance of appropriate analysis and interpretation in pharmacoeconomics, the purpose of this paper is to address the more common statistical issues encountered in assessing healthcare costs or outcomes, emphasizing approaches that may be employed to analyze these data. More specifically, statistical methods used commonly with retrospective cohort analyses are presented including least squares (e.g., ordinary least squares, OLS), logarithmic transformations, log-plus-constant models, two-part models, maximum likelihood estimation (MLE), and generalized linear models (GLM) and extensions, among others.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"74 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133977154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 28
Specific requirements regarding module 4 模块4的具体要求
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-140414
María Dolores Robador González
{"title":"Specific requirements regarding module 4","authors":"María Dolores Robador González","doi":"10.3233/PPL-140414","DOIUrl":"https://doi.org/10.3233/PPL-140414","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"217 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133204386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Immunoglobulin use in management of inflammatory neuropathy 免疫球蛋白在炎性神经病变治疗中的应用
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2009-0240
C. Koski
{"title":"Immunoglobulin use in management of inflammatory neuropathy","authors":"C. Koski","doi":"10.3233/PPL-2009-0240","DOIUrl":"https://doi.org/10.3233/PPL-2009-0240","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"40 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125965731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Homeopathy: The lost of credibility of the Institutions 顺势疗法:机构信誉的丧失
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2011-0315
J. Valverde
{"title":"Homeopathy: The lost of credibility of the Institutions","authors":"J. Valverde","doi":"10.3233/PPL-2011-0315","DOIUrl":"https://doi.org/10.3233/PPL-2011-0315","url":null,"abstract":"The conclusions of The House of Commons Science and Technology Committee report examining the policy on homeopathy, it is a careful and thoughtful analysis. It is the best example of the responsibility of the Parliaments for protects the health right of the patients. His proposals will be valid for all the countries and will be global principle for regulation. It is unacceptable for the National Health Authorities to license placebo products conferring upon them some of the status of medicines. Even if medical claims on labels are prohibited, the official licensing itself lends direct credibility to a product. Licensing paves the way for retail in pharmacies and consequently the patient’s view of the credibility of homeopathy may be further enhanced. The Governments runs the risk of endorsing homeopathy as an efficacious system of medicine. It is time to break this chain. Homeopathy should not be funded and the Agencies of Medicaments should stop licensing homeopathic products. Not changes the actual situation will lose the credibility of the Health Institutions. It is one more political inconsistency.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"137 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123524844","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
The globalization of medicines as a challenge for governments 药物全球化是政府面临的挑战
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-160429
J. Valverde
{"title":"The globalization of medicines as a challenge for governments","authors":"J. Valverde","doi":"10.3233/PPL-160429","DOIUrl":"https://doi.org/10.3233/PPL-160429","url":null,"abstract":"Health is a global concern. The need for a globalized response is evident in the pharmaceutical industry. Although pharmaceutical products are developed and marketed internationally, they are currently regulated only at national level. The pharmaceutical agencies regulate medical products in a globalized environment. However, national regulations can create significant barriers to pharmaceutical availability. We must formulate our laws with a global focus. The globalization of regulation weakens national sovereignty but empowers transnational epistemic networks. For this reasons the pharmaceutical agencies are involved in several bilateral and multilateral cooperation activities with international partners. International cooperation is a key area of work for the agencies. This process will benefit of advancement in global governance and progress toward supranationalism. The internationalization of the pharmaceutical industry, highly globalized, involves changes in policies, lifestyle and culture, and has altered drug research, production, and regulation.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125235052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
The role of the pharmacist in the determination of pharmacotheraphy costs: Ischemic cardiopathy patients with smoking habits 药师在决定药物治疗费用中的作用:缺血性心脏病患者有吸烟习惯
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2010-0305
Nadia Vanina Ripari, E. Vega, María Eugenia Elorza, N. Moscoso, Daniel Palma Santiago, N. Budassi
{"title":"The role of the pharmacist in the determination of pharmacotheraphy costs: Ischemic cardiopathy patients with smoking habits","authors":"Nadia Vanina Ripari, E. Vega, María Eugenia Elorza, N. Moscoso, Daniel Palma Santiago, N. Budassi","doi":"10.3233/PPL-2010-0305","DOIUrl":"https://doi.org/10.3233/PPL-2010-0305","url":null,"abstract":"In the last decades the pharmacist has played a main role in the policies of costs containment in the health sector. The present study has been designed to assess this role in the costs containment of the pharmacological treatments of patients at a Coronary Care Unit (CCU) of a public hospital in Argentina, through an analitic and retrospective study. It has been observed that the pharmacist could determine in all the service a saving of $ 3,393.03 buying the prescriptive drugs at minimum prices during the analized period. However, it has been proved that there are costs which the pharmacist cannot modify, as in the case of certain risk factors that may increase the pharmacological costs in the treatment of a pathology. This cost variation has been proved in ischemic cardiopathy patients with smoking habits.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125395989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Telethon experience and its efforts towards the registration of new advanced therapies Telethon的经验及其对新先进疗法注册的努力
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2010-0285
C. Paganin
{"title":"Telethon experience and its efforts towards the registration of new advanced therapies","authors":"C. Paganin","doi":"10.3233/PPL-2010-0285","DOIUrl":"https://doi.org/10.3233/PPL-2010-0285","url":null,"abstract":"Telethon, since its establishment in 1990, raised a total of 382 million euros to finance external (research project, fellowships, research services and core facilities) and internal programs (TIGEM Institute, HSR-TIGET Institute, DTI Institute). Overall, Telethon research projects have addressed more than 400 genetic disorders and complex diseases (Fig. 1). A new Telethon Strategic Plan has been drafted for 2006–2010, and states the willingness to become an internationally recognised charity that progresses excellent laboratory research into clinical results to be made available to patients, by increasing the flexibility of funding and promoting relationships. One of Telethon major commitments is to transfer the results in preclinical research into clinical practice, by promoting translational research. This strategy includes the support of the clinical development for the most promising pre-clinical projects (Telethon Technology Transfer Office, Farmindustria Initiative) and the undertaking of regulatory activities (Fig. 2).","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"9 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130078112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The administrative information of the registration of a medicinal product dossier 药品档案注册管理信息
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-140399
Maria D. Cabezas
{"title":"The administrative information of the registration of a medicinal product dossier","authors":"Maria D. Cabezas","doi":"10.3233/PPL-140399","DOIUrl":"https://doi.org/10.3233/PPL-140399","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128830212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Gene therapy of haemoglobinopathy: An Italy-USA project 血红蛋白病的基因治疗:意大利-美国项目
Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2010-0290
A. Maggio, S. Acuto, P. Moi, R. Galanello, P. Comoli, F. Locatelli, Valentina Motta, A. Pecoraro, R. Marzo, Leda Ferro, M. Sadelain
{"title":"Gene therapy of haemoglobinopathy: An Italy-USA project","authors":"A. Maggio, S. Acuto, P. Moi, R. Galanello, P. Comoli, F. Locatelli, Valentina Motta, A. Pecoraro, R. Marzo, Leda Ferro, M. Sadelain","doi":"10.3233/PPL-2010-0290","DOIUrl":"https://doi.org/10.3233/PPL-2010-0290","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128937806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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