Drug Topics - November 26, 2007 - (Page 13)

www.drugtopics.com NOVEMBER 26, 2007 DRUG TOPICS 13 NEWS Roundup tion with the benefit continues to be high (83%), with 52% of respondents saying they are “very” satisfied. In addition, 93% of respondents report being satisfied with getting the medicines they need and 79% are satisfied with their overall prescription drug costs through Part D. The survey was conducted among 1,001 seniors over 65 who said they have some kind of drug coverage. The margin of error was 3.1%. Almost a third of the sample (313 respondents) consisted of people who were self-identified as having Medicare Part D or Medicare Advantage. They were described in the survey as having Medicare Rx. “Most people on the Medicare Rx program say it is working for them, and these are people who are taking six or more prescriptions,” said Tirey. “They are heavy users of the program.” The survey also pointed to some areas where awareness about the benefit could be improved. While more than 71% of those enrolled in Part D are aware of additional help available to them, 27% of those surveyed were unaware of programs through Medicare and Social Security that can assist low-income seniors in paying for Part D prescriptions. To view the survey results, go to www.medicaretoday.org. Herb Kuhn, deputy director of CMS, who was also on hand, said, “Our research shows that, on average, beneficiaries are saving $1,200 a year.” Noting that open enrollment in the program begins on Nov. 15, he said CMS is offering a new Web-based plan finder, available at www.Medicare.gov. A new Medicare handbook is being mailed out to seniors. “On Nov. 15, we will have information available for people to compare plans,” Kuhn said. “For example, customer service ratings and a lot of information will be posted for the first time.” FDA said these 15 members were chosen from among 240 nominations received. The committee, whose formation was recommended by an Institute of Medicine 2006 report, will meet for the first time in the first quarter of 2008. Hospitals must disclose secondary diagnoses CMS has launched a new Web page to provide information on a new rule that requires hospitals to submit “present on admission” (POA) information for all Medicare patients with acute care diagnoses. Next year, hospitals will be required to submit POA information on Medicare claims upon discharge, but CMS has been accepting POA information on claims as of Oct. 1. The Web page provides information on the new rule, reporting requirements, coding, and affected hospitals. The Web page can be found at: http://www.cms.hhs.gov/ HospitalAcqCond/. FDA, NIH, CHPA to hold adolescent OTC drug use workshop In the Federal Register of Nov. 5, the FDA announced that it, along with National Institutes of Health (NIH), and the Consumer Healthcare Products Association (CHPA), will hold a public workshop on Dec. 6 entitled “Adolescent Over-the-Counter Drug Product Use.” The purpose of the workshop is to gain an understanding of current use of OTCs by adolescents, including adolescent decision-making skills (compared with adult skills) and other factors influencing adolescent OTC use. Information gathered at the workshop and submitted comments will be used to identify when it would be most appropriate for consumer studies on OTCs to enroll adolescents and to define the type of consumer research and study designs needed to support the OTC product approval in the adolescent population. Those who wish to make an oral presentation during the open public session should register by Nov. 21. Submit written or electronic comments by Jan. 31, 2008. For more information e-mail Faith.Dugan@fda.hhs.gov. FDA forms Risk Communication Advisory Committee The FDA has set up a 15-member Risk Communication Advisory Committee to advise the agency on how best to communicate to the public the risks and benefits of FDAregulated products. Among these 15 members, encompassing physicians, consumer advocates, and others, is a pharmacy professor— Betsy Lynn Sleath, Ph.D., associate professor of pharmaceutical Betsy Lynn outcomes and policy at the UniSleath, Ph.D. versity of North Carolina. The Dietary supplement adverse event reporting rules effective Dec. 22 The Natural Products Association recently hosted a Web seminar to explain the new government rules requiring reporting of adverse events caused by dietary supplements. The regulation goes into effect Dec. 22. Richard Kingston, Pharm.D., president of regulatory and scientific affairs at SafetyCall International, who was on hand to explain the new law, said, “One thing that came out of the legislation has to do with the definition of an adverse event. It is any health-related http://www.drugtopics.com http://www.cms.hhs.gov/HospitalAcqCond http://www.fda.gov/OHRMS/DOCKETS/98fr/cd0795.pdf http://www.medicaretoday.org http://www.Medicare.gov http://www.drugtopics.com/drugtopics/Over+The+Counter/New-law-requires-OTC-adverse-event-reporting/ArticleStandard/Article/detail/401646?searchString=adverse%20event%20reporting%20of%20dietary%20supplements%20article%20by%20sandra%20levy

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Drug Topics - November 26, 2007 Contents Cough & Cold Recommendations May Impact Other Products More Novelty OTCs Elbow Onto Store Shelves Medication Reconciliation Policies Incomplete at Many Hospitals Hospitals Regress in Reconciling Drugs in 2006 Latest News Roundup

Drug Topics - November 26, 2007

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