News you can use: health & drug safety updates


  • December 30, 2014
    An FDA draft rule would require pharmaceutical manufacturers to distribute prescribing data for healthcare professionals electronically. “FDA is taking this action to ensure that the most current prescribing information for prescription drugs will be available and readily accessible to healthcare professionals at the time of clinical decision making and dispensing,” the agency stated. The electronic distribution requirements of this proposed rule would not apply to patient labeling (including patient package inserts and Medication Guides), or to prescribing information
  • December 24, 2014
    The U.S. Senate Special Committee on Aging unveiled a new bipartisan report earlier this week that focuses on ways to increase the use of generic drugs within the Medicare Part D program. The committee is calling on the Government Accountability Office to examine what is behind recent price increases for certain generic drugs like heart medication digoxin, which has been on the market for years. The issue of generic drug price spikes has recently attracted attention from the Justice Department and the Senate Committee on Health, Education, Labor & Pensions Subcommittee on Primary
  • December 18, 2014
    The AWARXE® Prescription Drug Safety Program supports the proper disposal of medications as a vital component in preventing accidental or intentional misuse of prescription drugs. To help visitors to more easily find disposal locations in their area, AWARXE has launched a location-based search tool. Typing an address, city, state, or zip code into the website’s new search tool will provide patients with a list and map of the closest medication disposal sites. Law
  • December 17, 2014
    Nonsteroidal anti-inflammatory drugs (NSAIDs) are a group of drugs that are used to relieve pain, reduce fevers and provide anti-inflammatory effects for swelling and redness. They are commonly used to treat headaches, muscle soreness, back pain, cramps, joint pain or aches from a cold. They are sold over the counter and may be prescribed at higher doses. The most common NSAIDs are aspirin, ibuprofen (such as Advil and Motrin) and naproxen sodium (such as Aleve). If you take NSAIDs, here are some questions you may want to discuss with your health care professional.
  • December 16, 2014
    QM Quality Matters Blog - U.S. Pharmacopeial Convention
  • December 11, 2014
    The Consumer Healthcare Products Association (CHPA) Board of Directors recently approved changes to CHPA’s voluntary guidelines addressing dosing of liquid pediatric over-the-counter (OTC) medicines. Key changes to the voluntary guidelines include: • Deleting “spoon” labeling (i.e., teaspoon, tablespoon) on dosing directions and dosing devices, • Specifying use of “mL” only in dosing directions and on devices, and • Deleting the provision in dosing directions of a definition of any volumetric unit of measure (i.e., mL = milliliter).
  • December 10, 2014
    The FDA relies upon mandated, industry-sponsored clinical trials to make decisions about medical products. In years past, questions about adequate and equal inclusion of women and people in racial minority groups have been raised. Many stakeholder groups want FDA to require drug companies to include certain percentages of demographic subgroups in clinical trials and analyze subgroup data by sex, race and age before a drug is approved. While the FDA has many regulations and policies in place regarding clinical trials, these studies are the responsibility of the manufacturer that is
  • December 10, 2014
    Nearly 7 million insured Americans filled at least one prescription for an opioid between 2009 and 2013, according to a new Express Scripts report. Data also showed that, while fewer patients are taking opioids these days, those that do so are using the drugs for longer periods. “Not only are more people using these medications chronically, they are using them at higher doses than we would necessarily expect,” stated Dr. Glen Stettin, Express Scripts senior vice president. “And they are using them in combinations for which there isn't a lot of clinical justification.” (source: NY Times).
  • December 8, 2014
    In a published study, researchers observed that people who received automated reminders were more likely to refill their blood pressure and cholesterol medications. The study included more than 21,000 Kaiser Permanente members in Oregon, Washington, Georgia, and Hawaii who had diabetes or heart disease and who were on medications for management of their disease from 2010-2011. The researchers examined the PROMPT reminder program and used three arms: usual care, an automated telephone intervention, and a personalized health report and educational mailings. The interactive
  • December 8, 2014
    There are over six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Women with pre-existing medical conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs to treat those conditions during pregnancy and breastfeeding. Women may also need to take medications for new or acute conditions that may occur during pregnancy or breastfeeding. The new labeling format and requirements reorganizes information and is structured to help inform health