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Media Coverage
''Report: State Prescription Monitoring Programs Falling Short''
"Forty-nine states, including Maine, now operate a prescription monitoring program - or are putting one in place - to track the powerful pain medication dispensed by pharmacies. These databases have already helped in the fight to curtail diversion and abuse of prescribed opioids. But the way they operate - and how the data they collect gets used - varies widely from state to state. A new report out today argues that these electronic monitoring programs are still being under-utilized in the fight against prescription drug abuse, and should be used in a similar way in all states.
The research arrives at a timely moment for policy makers in Maine. For months, a task force, appointed by Attorney General William Schneider, has been looking at the different tools the state is using to battle the pain pill epidemic here.
Prescription drug overdoses kill more Maine residents every year than car accidents. And the number of oxycodone prescriptions dispensed in Maine has gone up by as much as 50 percent over the past six years. It's the same story in more and more states across the country.
"We had nearly half a million emergency room visits in 2009, a cost to insurers estimated at more than $70 billion from prescription drug abuse, and a huge upsurge in recent years in numbers of prescriptions--increased more than 300 percent since 1999," says Allan Coukell, who runs the Pew Health Group's medical program."
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The Pew Health Group and Medtronic, Inc. file a joint letter to the U.S. Department of Health and Human Services urging implementation of the Physician Payments Sunshine Provision, which will require that manufacturers of drugs, devices,biologics or medical supplies report to the agency payments made to physicians and teaching hospitals.
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Nearly nine in 10 Americans recognize that antibiotics are effective treatments for fighting bacterial infections like strep throat, but more than a third mistakenly believe the drugs are also appropriate treatments for viral infections such as the common cold. Test your antibiotics IQ and take the quiz.
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"Representatives from the FDA and industry expressed serious concerns about the potential impact of sequestration Monday, saying it's not a good time to shortchange the agency when it's under so much pressure to help bring innovative new drugs to market."
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Passed by Congress on June 26 and signed by President Obama on July 9, the FDA Safety and Innovation Act will increase inspections of foreign manufacturers that supply 80 percent of the ingredients in our pharmaceuticals, putting American companies on the same footing as their foreign competitors. In addition, it requires drug makers to hold their suppliers to high standards.
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"While thousands of Americans have benefited from hip replacements over the years, problems with metal-on-metal implants can lead to troubles requiring surgery to replace defective devices, experts say. Writing earlier this month in the New England Journal of Medicine, Pew's Joshua Rising and colleagues said that "there is now compelling evidence that these implants fail at a higher rate than hip prostheses made of other materials."
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The U.S. Senate today joined the House in passing Food and Drug Administration Safety and Innovation Act (S. 3187), a bill to support the U.S. Food and Drug Administration’s drug and device reviews. The bill now goes to President Obama to be signed and implemented.
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"A Food and Drug Administration bill designed to increase inspections of foreign drug factories, while also speeding approvals of new drugs at home, is headed to the president’s desk after an overwhelming approval in the U.S. Senate."
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Pew Prescription Project Director Daniel Carlat opines in the Philadelphia Inquirer: "Monetary relationships among doctors and drug and device companies are not inherently bad; in fact, they are crucial for advancing medical research and patient care. Yet they can also skew prescribing practices and research results. That's why transparency and education are such an elegant solution: They allow these often important relationships to exist, but only on the condition that other professionals and patients are fully informed about them."
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The de novo process as it exists now is not achieving its purpose of streamlining the path to move new devices onto the marketplace and has instead added unnecessary and time-consuming requirements.
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In 2008, the Food and Drug Administration (FDA) launched the Sentinel Initiative, a national electronic system designed to “track the safety of drugs, biologics, and medical devices once they reach the market.” By proactively monitoring data from electronic health records and other sources rather than relying on spontaneous reporting from manufacturers and health care providers, the Sentinel system can more quickly identify safety issues.
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WASHINGTON—The U.S. House of Representatives Wednesday passed the Food and Drug Administration Safety and Innovation Act, a bill to support the FDA’s drug and device reviews. “We commend the House for passing the bipartisan Food and Drug Administration Safety and Innovation Act," said Allan Coukell, director of medical programs at the Pew Health Group.
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Allan Coukell, deputy director of the Medical Safety Project of the Pew Health Group, talked about drug safety on C-SPAN.
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Allan Coukell, Deputy Director, Medical Programs
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"Most of the antibiotics sold in the United States — 70 percent — go to the animals we eat, especially pigs and chickens. To speed up growth and to prevent the spread of disease in crowded conditions, growers put small amounts of antibiotics into animals’ daily feed."
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