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FDA Approves SAMSCA(TM) (tolvaptan), The First And Only Oral Vasopressin Antagonist To Treat Patients With Clinically Significant Hypervolemic
Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) announced that the U.S. Food and Drug Administration (FDA) has approved SAMSCA(TM) (tolvaptan) as the only oral selective vasopressin antagonist for the treatment of patients with clinically significant hypervolemic and euvolemic hyponatremia (serum sodium less than 125 mEq/L, or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) including patients with heart failure, cirrhosis, and the syndrome of inappropriate anti-diuretic hormone (SIADH). Patients requiring urgent treatment to raise serum sodium to prevent or to treat serious neurological deficits should not be treated with SAMSCA. Additionally, it has not been established that raising serum sodium with SAMSCA provides a symptomatic benefit to patients. SAMSCA, an oral vasopressin V2-receptor antagonist, will be commercialized in the United States by Otsuka America Pharmaceutical, Inc. (OAPI).

Media Looks At Surgeon General Nominee's Potential Influence On HIV/AIDS, Other Health Issues
The AP/Lexington Herald-Leader on Tuesday examined the nomination of Alabama physician Regina Benjamin for U.S. Surgeon General by President Obama, the history of the position and how former Surgeon Generals have addressed health issues such as HIV/AIDS (Stobbe, 7/14). According to Advocate.com, "During her speech accepting the nomination, Benjamin acknowledged her familiarity with HIV complications and issues, as her brother died at the age of 44 of an HIV-related illness. Having such a personal experience, especially a loss, due to HIV/AIDS could have a strong impact on her policy and public health campaigns, [Phil Curtis, director of government affairs at AIDS Project Los Angeles], told Advocate.com on Tuesday." The article states, "Curtis said that Benjamin has the ability to reach out to communities that have been largely underserved by efforts to reduce the rate of infection," and she "will also be able to contribute to Congress"s current debate on health care policy, including strategies for early HIV prevention, and accessibility to prescription drugs" (Garcia, 7/14).
News of the day
Godel Technologies Europe Helps NHS Save Lives With Online Training Technology, UK
Manchester based software engineering company, Godel Technologies Europe Ltd, is to implement a virtual learning portal for the NHS.
Public Health

CQC Seeks Feedback On Guidance For Registration Of All Health And Adult Social Care Services, UK

The Care Quality Commission (CQC) today (Monday) launched a consultation on guidance outlining what health and adult social care services will need to do to meet new legally enforceable registration standards. From April 2010, the regulator will begin to put in place the first ever registration system covering all health and adult social care services in England, whether they are public or independent. The CQC today released guidance on what services must do to meet the 29 registration requirements set by the government. It said the new system would fundamentally change the way services are regulated and how regulation will be used to drive improvement in services. The registration requirements set essential common quality standards across the care sector and will replace the current standards in place for health and adult social care services. The CQC worked with a range of stakeholders to develop the guidance, including people who use services, people providing services, professional bodies and other regulators. The guidance focuses on what constitutes a positive outcome for a person receiving care and what services should be doing to achieve that outcome. It will be used to decide whether a service should be registered, whether it should maintain registration and whether further action from CQC is needed. The CQC is asking for feedback on whether the guidance appropriately reflects the registration requirements and if it reflects what should rightly be expected of a safe, quality health or adult social care service. Cynthia Bower, chief executive of the CQC, said the introduction of registration for all providers of health and social care was a "fundamental change" to the way quality of care would be safeguarded. "This is a big change to the way health and adult social care services are regulated and how we drive improvement in services. People have a right to expect a certain standard of care, regardless of whether they are receiving health or adult social services and regardless of whether it is in the public or independent sector. "Registration will make sure that health and adult social care providers across the country are meeting essential common quality standards. It will make the system fairer, more transparent, and make it easier for people to compare providers. "The registration standards and our guidance on what providers need to do to meet them are legally enforceable. "Our focus will be on driving improvements, but we do have a range of new enforcement powers at our disposal if providers aren"t doing all they should be to deliver safe, quality services." Ms Bower added that the views of people who use services would be central to the consultation process. She said: "We"ve spent a lot of time talking with people who use services and they tell us they want us to focus less on policy and processes and more on people. We think that"s the right way forward so the starting point for all the guidance is what constitutes a positive outcome for people using services." Both the registration requirements and the underpinning guidance will be legally enforceable. The CQC has tough new powers to deal with providers that do not meet the new standards and the guidance, including imposing conditions on registration, fines and in extreme cases, cancellation of registration. Services have to register to be legally allowed to operate. Currently, the NHS is regulated differently to independent health and adult social care services. Independent health and adult social care services currently must register with the regulator and comply with the National Minimum Standards in order to maintain registration. NHS providers are currently registered against a single registration requirement relating to healthcare-associated infections, but must also meet the Standards for Better Health. Registration will be phased-in from 2010 and the National Minimum Standards and the Standards for Better Health will be in force until services are required to register. The Department of Health has recently completed a consultation on registration requirements and will take final legislation through Parliament. It is expected that NHS providers will be the first to register under the new system. They will be required to declare their compliance with the registration requirements and guidance in January 2010, with registration by 1 April. All providers of adult social care services and independent providers of healthcare services will be registered under the new system by 1 October 2010. From 2011, registration will, subject to legislation, begin to be introduced for general practices, all dental practices, and private and voluntary ambulances. This will be the first time that many of these primary care services will come under the direct scope of independent regulation. Consultation on the Guidance for Registration closes on 24 August. For all the consultation documents, visit the CQC website at http://www.cqc.org.uk or call the customer service centre on 03000 61 61 61. About the CQC The Care Quality Commission (CQC) is the (new) independent regulator of all health and adult social care in England. We inspect all health and adult social care services in England, whether they"re provided by the NHS, local authorities, private companies or voluntary organisations. And, we protect the interests of people detained under the Mental Health Act. We make sure that essential common standards of quality are met everywhere care is provided, from hospitals to private care homes, and we work towards their improvement. We promote the rights and interests of people who use services and we have a wide range of enforcement powers to take action on their behalf if services are unacceptably poor. Our work brings together independent regulation of health, mental health and adult social care (for the first time). Before 1 April 2009, this work was carried out by the Healthcare Commission, the Mental Health Act Commission and the Commission for Social Care Inspection. Our aim is to make sure better care is provided for everyone, whether that"s in hospital, in care homes, in people"s own homes, or anywhere else that care is provided. Care Quality Commission


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