{"title":"Supply challenges: The collector's view","authors":"Gordon Naylor","doi":"10.3233/PPL-2009-0249","DOIUrl":"https://doi.org/10.3233/PPL-2009-0249","url":null,"abstract":"Human blood plasma sets the global plasma fractionation industry apart. Plasma has unique characteristics as a human-derived biological material that go well beyond the physical and economic properties of any other industrial raw material – although these properties are also critical. This chapter is intended to briefly provide an overview of the global supply of plasma as a source of life-saving therapies and the issues that the plasma collection industry faces today. The global supply of plasma that is used for fractionation into therapies is approximately 32 million liters today. Most plasma used is called “normal” – meant in a statistical sense in that the plasma is drawn from the general population. In addition, smaller (but critically) important volumes of “hyper-immune” plasma is produced which typically has elevated levels of a particular antibody. These hyper-immune plasmas can be produced either by donor screening and selection or by immunizing the donors to elicit a particular immuno-response. In addition, plasma is used directly for therapy in many countries and smaller volumes are used for various diagnostic purposes. The other major distinction is between “recovered” and “source” plasma. The former is produced as a by-product of whole blood collection. The cellular components are separated from the whole blood and (usually) used for transfusion or another therapy, leaving the “recovered” plasma. Source plasma is similarly separated from whole blood, but the separation is done almost simultaneously with blood donation and the cellular components are returned to the donor almost immediately. This process is called plasma-pheresis. In most countries, the process is automated (“auto-pheresis”) through filtration or centrifugation technologies. Putting the pieces together, almost all the plasma used for fractionation in the world is either NRP (Normal Recovered Plasma) or NSP (Normal Source Plasma) – and this nomenclature will be used for the rest of this chapter. For various historical, cultural and regulatory reasons, recovered plasma is most commonly collected by not-for-profit organizations such as agencies of government, the National Societies of the Red Cross and Red Crescent or community blood banks. The focus of these organisations is often primarily upon the cellular components of whole blood. It is also generally true that donors of whole blood consider themselves","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"1 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":"124221544","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}
{"title":"Pharmacoepidemiology and patient safety in the critically ill","authors":"A. Patanwala, J. Barletta, B. Erstad","doi":"10.3233/PPL-2011-0344","DOIUrl":"https://doi.org/10.3233/PPL-2011-0344","url":null,"abstract":"Critically ill patients are at the greatest risk of experiencing preventable and non-preventable adverse drug events (ADEs) compared to other patient populations. Information on ADEs concerning these patients is derived from a wide spectrum of sources such as surveillance studies involving large databases to landmark clinical investigations. Historically there has been a lack of consistency with regard to definitions of commonly used terms such as medication error, ADE, and preventability, which is a fundamental to appropriately conduct and interpret results of epidemiological investigations in this setting. However, attempts have been made to standardize this terminology by national organizations. The increased risk of ADEs in the critically ill patient population is due to a variety of reasons, which include the routine use of the intravenous route of drug administration, medications with a low therapeutic index and high complexity, ‘off-label’ use and an environment that may be conducive to errors. Reporting of ADEs is largely voluntary and is generally underreported and skewed towards the most serious events. Other methods for surveillance of ADEs in the critical care setting include medical record review and direct observation. Each of these methods has their own limitations and the data obtained can vary depending on the method used. A combination of data from all of these methods is likely to produce the most comprehensive information to improve patient safety.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"60 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":"121706827","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}
{"title":"Compassionate use of medicinal products","authors":"José M. Suñé-Arbussá","doi":"10.3233/PPL-2009-0221","DOIUrl":"https://doi.org/10.3233/PPL-2009-0221","url":null,"abstract":"Law 25/1990 on Medicinal Products (published in BOE n. 306, 22 December), provides in Article 37.5 “Exceptionally the Minister of Health and Consumption may grant authorization, subject to the conditions expressed in it, for the prescription and application of ‘products undergoing clinical research to patients not included in a clinical trial, when the doctor, under his exclusive responsibility and with the express consent of the patient, considers it indispensable to treat him with them and justifying the reasons for undertaking such treatment to the health authority”. Art. 8.11 that sets out the Definitions defines a Product undergoing clinical research as ‘one which is destined to be employed only by experts qualified by their scientific training and experience for research in persons or in animals on their safety and efficacy’. Art. 6.2 establishes “The legal treatment of medicinal devices will be subject to the application of this Law and its general control of substances or combinations of substances especially qualified as ‘products undergoing clinical research’ authorised for their use in clinical trials or research on animals”. The Direction General of Pharmacy and Health Products on communication 12 February 1992 wrote “In exceptional cases and in accordance with Art. 38.5 of the above-mentioned Law (on Medicinal Products) authorisation may be granted for the importing of products undergoing clinical research for patients not included in a clinical trial, when the doctor, under his exclusive responsibility and with the express consent of the patient considers it indispensable and justifies its compassionate use”. This was the first time that the phrase ‘compassionate use’ was used in an official document although always limited to products undergoing clinical research. Only three years after the Law on Medicinal Products appeared, the Royal Decree 561/1993, 16 April, establishing the requisites for undertaking clinical trials with medicinal products (published in BOE 13May), in Art. 23.1 introduced the definition of compassionate use in the following terms: “Compassionate use is understood as the employment in patients isolated and outside a clinical trial, of products undergoing clinical research, or the employment of pharmaceutical specialities for diseases or","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"485 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":"116536037","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}
{"title":"Legal regulation on orphan drugs ten years after the Communitarian regulations were passed","authors":"Rafael Barranco Vela","doi":"10.3233/PPL-2010-0297","DOIUrl":"https://doi.org/10.3233/PPL-2010-0297","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":" 6","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"120937323","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}
{"title":"Patient engagement in health technology assessment (HTA)","authors":"Jacqueline Bowman-Busato","doi":"10.3233/PPL-2011-0324","DOIUrl":"https://doi.org/10.3233/PPL-2011-0324","url":null,"abstract":"Epposi is an independent, not-for-profit, partnership-led and multi-stakeholder think tank based in Brussels, Belgium, committed to supporting the realisation of the EU-2020 strategic vision through the health and wellbeing of its citizens. Our Goal is to work at the “cutting edge” of European health policy-making providing members and the wider public with high-quality independent research, capacity-building, knowledge exchange and dissemination with the aim of bridging the gap between innovation and improved public health outcomes. Membership is equally weighted between academic sciences, industry and patient organisations.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"2 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":"130010037","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}
{"title":"Monopoly in the pharmaceutical sector","authors":"Onorevole Giacomo Leopardi","doi":"10.3233/PPL-2010-0303","DOIUrl":"https://doi.org/10.3233/PPL-2010-0303","url":null,"abstract":"Almost every EU country has a form of regulation for the pharmaceutical sector, the level of which varies by country, motivated by the unique nature of medicine as a consumers good, different from any other good. In the majority of EU countries this circumstance allows the monopoly of the profession to extend to the dispensing of all medicine subject to prescription and, in many countries, also to the non-prescription ones. (See Table 1). In no case, however, is it possible to sell prescription medicine outside pharmacies through alternative distribution channels. Today, the selling of non-prescription medication is reserved to pharmacies in roughly 60% of EU countries (Belgium, Bulgaria, Cyprus, Estonia, Finland, France, Germany, Greece, Latvia, Lithuania, Luxemburg, Malta, Romania, Slovakia, Spain and Sweden). In all the other countries, the selling of non-prescription medicine is allowed outside the pharmacy in authorized selling points, with or without the presence of a pharmacist.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"32 2 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":"125708740","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}
{"title":"Paediatric intensive care","authors":"Marek Migdal","doi":"10.3233/PPL-2010-0294","DOIUrl":"https://doi.org/10.3233/PPL-2010-0294","url":null,"abstract":"From setting up the ventilator to managing low cardiac output, Paediatric Intensive Care gives practical and realistic advice for children's doctors and nurses in intensive care. Information is organized by system or specialty, and presented in easily accessible \"5 minute chunks,\" making it easy to get the answers you need, but is also extensively cross-referenced so that different aspects of a particular clinical problem are also covered. The handbook contains answers to specific problems and provides guidance on how to manage specific issues, and will become an indispensable guide for all those who provide care for sick children.","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":"134190857","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}
{"title":"Efforts to develop orphan drugs: The FDA experience","authors":"Linda C. Ulrich","doi":"10.3233/PPL-2010-0266","DOIUrl":"https://doi.org/10.3233/PPL-2010-0266","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"1120 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":"134434784","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}
{"title":"Advanced Therapy: Rules and experiences of the Phase I Italian Competent Authority","authors":"A. Meneguz","doi":"10.3233/PPL-2010-0261","DOIUrl":"https://doi.org/10.3233/PPL-2010-0261","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"29 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":"130940317","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}
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
