FDA investigating fingolimod after report of rare brain infection
August 29th 2013In a Drug Safety Communication, FDA has reported that a patient in Europe being treated for multiple sclerosis and who had no history of using natalizumab (Tysabri) developed progressive multifocal leukoencephalopathy (PML) while taking fingolimod (Gilenya).
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Canadian Medical Association calls expanded pharmacist functions beneficial
August 27th 2013Pharmacists in Canada were recently given broader responsibilities including, in certain provinces, prescribing privileges, vaccination abilities, and the ability to order and interpret laboratory tests. This newly expanded role for Canadian pharmacists can benefit both patients and physicians, according to an article in the Canadian Medical Association Journal.
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Real-world performance becomes key in drug selection
August 20th 2013Drug evaluation and selection models are changing. Safety and efficacy have become the starting point for consideration by many payers. What they really want to see is evidence of superior performance in real world patient populations.
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Broader-spectrum antibiotics over-prescribed in ambulatory settings
August 19th 2013The majority of antibiotics prescribed for adults in ambulatory care settings are broad-spectrum agents, most commonly fluoroquinolones and macrolides. These are frequently prescribed for conditions where no antibiotic therapy is needed at all, such as for bronchitis and colds, which are caused by viruses, according to a study published online July 25, 2013, in the Journal of Antimicrobial Chemotherapy.
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Accountable care organizations (ACOs) are groups of doctors, hospitals, and other healthcare providers, who come together voluntarily to give coordinated high quality care to the patients they serve. Coordinated care helps ensure that patients, especially the chronically ill, get the right care at the right time, with the goal of avoiding unnecessary duplication of services and preventing medical errors. When an ACO succeeds in both delivering high-quality care and spending healthcare dollars more wisely, it will share in the savings it achieves for the Medicare program.1 The overall goal of the ACO is to reduce costs by focusing on preventative care and disease management.
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It is estimated that 30 million people will gain access to medical care beginning in 2014, with implementation of the Patient Protection and Affordable Care Act (ACA). Administratively, the federal government and most states have not worked out the details of how patients will gain access to the healthcare system, let alone receive care. Primary care providers (PCPs) are ill-prepared to accept this enormous influx of new patients, which will place an even greater strain on the already strapped primary care workforce. Estimates are that an additional 17,000 PCPs are currently needed, and another 40,000 PCPs may be needed by 2025 to care for the nation’s aging population. How best to handle this large influx of patients into the healthcare system is at issue.
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Health economic analysis shows canagliflozin monotherapy may reduce costs of type 2 diabetes
August 12th 2013Results from a health economic and outcomes research (HECOR) simulation analysis show that canagliflozin (Invokana, Janssen), along with lifestyle management, may reduce long-term complications and associated costs for adult patients with type 2 diabetes compared to a treatment sequence without canagliflozin.
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In July of 2012, a provision in the newly ratified Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA), paved the way for the FDA to further assist drug manufacturers in expediting the development and introduction of new drugs demonstrating early signs of advancement in the treatment of key conditions. Known as the “breakthrough therapy” designation, this new tool is seen by many as yet another positive sign that the FDA is committed to ensuring that innovative drug products are brought to market even more quickly for the millions of patients with serious medical conditions, desperately in need of new therapeutic options.
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