News you can use: health & drug safety updates

2009

  • May 26, 2009
    This draft guidance describes factors FDA considers when evaluating advertisements (ads) and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C 21 Act or the Act) and relevant regulations. The draft guidance discusses factors that are relevant to the disclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these factors. This guidance responds to stakeholder
  • May 19, 2009
    Dr. Carolyn Clancy, Director of the federal Agency for Health Care Research and Quality (AHRQ), describes the evolving concept of the medical home in this advice column. A medical home takes a team approach to primary care and puts the patient at the center of that team. The idea isn't new, but it’s getting tested in new and larger ways. Medical home teams often work in a primary care doctor’s office or clinic. Team members can include doctors, nurses, pharmacists, and physical therapists. They help coordinate their patients' care across a range of
  • May 15, 2009
    In a continuing effort to empower parents with the tools to stop medicine abuse among teens, the leading manufacturers of over-the-counter (OTC) cough medicines are adding a new educational icon on the packaging of products containing dextromethorphan. The icon will be on the majority of cough medicines containing dextromethorphan, including brand name and private label products, by the end of 2009. OTC cough medicines containing dextromethorphan can be very dangerous when intentionally abused in extreme amounts to get high. While educational efforts
  • May 14, 2009
    The Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Food and Drug Administration (FDA) recently launched an initiative to help ensure the safe use of methadone. Methadone is a prescription drug best known as a treatment for addiction and dependence on heroin and other narcotic pain medicines. It is also prescribed to treat moderate-to-severe chronic pain patients. The campaign responds to concerns about an escalating number of poisoning deaths linked to the improper use of this medication. The National
  • May 7, 2009
    An expert panel of the American Geriatrics Society warned that non-steroidal anti- inflammatory drugs (NSAIDs) or high-dose aspirin should not be used long-term for adults 75 or older with chronic pain. The panel stated that people who cannot get relief with alternatives like acetaminophen might be better of taking opiates. The guideline recommends that acetaminophen be considered as initial and ongoing pharmacotherapy of patients with mild to moderate musculoskeletal pain, but — in a significant departure from the 2002 guideline — recommends that
  • May 5, 2009
    The National Association of Boards of Pharmacy® (NABP®) released a position paper examining the lawlessness of Web sites selling prescription medicine over the Internet. “To see why this ‘wild west’ of an electronic marketplace is a problem, one need only follow the trail of dead and injured patients,” the paper asserts. The report calls to task the various parties whose activities allow this trend to continue and challenges lawmakers and regulators to rein in this dangerous underground marketplace. In the document, NABP revisits the call to action of its 2003 “Position Paper on
  • April 20, 2009
    The National Institute on Drug Abuse (NIDA) today announced availability of a NIDA-Modified Alcohol, Smoking, and Substance Involvement Screening Test or ASSIST). This Web-based interactive tool guides clinicians through a short series of screening questions and, based on the patient’s responses, generates a substance involvement score that suggests the level of intervention needed. The tool also provides links to resources for conducting a brief intervention and treatment referral, if warranted. (Note: NIDA recommends reading the ASSIST
  • April 8, 2009
    In 2006 the year the nation’s Part D prescription drug program began, Medicare’s share of outpatient prescription medications increased by $38 billion over 2005 according to the Agency for Healthcare Research and Quality. Prior Medicare drug coverage was limited to certain beneficiaries, such as people with who required dialysis or a transplant due to severe kidney disease. AHRQ’s analysis found that between 2005 and 2006:
  • Medicare spending for outpatient prescription drugs rose from $5.9 billion to $44.3 billion.
  • April 7, 2009
    The “Diabetes Ten City Challenge,” a program that brings together employers, pharmacists and people with diabetes to work together to reign in diabetes- related health care costs as well as improve patient health is showing promise, according to a report released today by the American Pharmacists Association (APhA) Foundation. Conducted by the APhA with support from GlaxoSmithKline, Inc., 30 employers in 10 U.S. cities established a voluntary health benefit for employees, dependents and retirees with diabetes.
  • April 6, 2009
    The number of American children and teens taking drugs to lower blood pressure and control diabetes has risen significantly since 2004, according to a new study. The study is one of several reports on childhood obesity in the April issue of Archives of Pediatrics & Adolescent Medicine. Researchers at CVS Caremark used the company’s drug database to track prescriptions filled on behalf of children and adolescents. Increases in all age groups [between] 6 to 18 years of age were noted. The youngest age group, the 6-to-10-year population, realized the
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