News you can use: health & drug safety updates


  • April 1, 2016
    FDA released on Thursday draft guidance on biosimilar labels. According to the guidance, biosimilar labeling—as with generics—should include a description of the clinical data that supported safety and efficacy of the reference product. FDA notes, however, that in situations where a biosimilar is not approved for the same indications as its reference product—unlike with generics—"it may be necessary to include information in the biosimilar product labeling relating to an indication(s) for which the biosimilar product applicant is not seeking licensure, in order to
  • April 1, 2016

    Medication errors come in all shapes and sizes, from overdoses to misunderstanding doses to drug name mix-ups to patients receiving the wrong medication or using the wrong dosage units. In fact, since 2000, FDA has received more than 95,000 voluntary reports of medication errors. Even though there are systems in place to prevent medication errors, it often comes down to the pharmacist to keep patients safe and make sure they are getting the right medications at the right dose.

  • March 30, 2016
    SAMHSA is pleased to announce the release of a new pocket guide for health professionals, Medication-Assisted Treatment of Opioid Use Disorder. This pocket guide offers: 1) A checklist for prescribing medication. 2) FDA-approved medications for use in the treatment of opioid use disorder. 3) Screening and assessment tools, including an 11-item scale, the Clinical Opiate Withdrawal Scale; and Best practices and patient care.
  • March 29, 2016
    Almost all physicians who write prescriptions for opioid painkillers exceed the federally recommended three-day dosage limit, according to a survey by the National Safety Council. The survey found 99 percent of doctors exceed the three-day limit. Almost one-quarter of doctors prescribe opioids for a month. While almost 85 percent of doctors screen for signs of prior opioid painkiller abuse, only one-third asks about a family history of addiction, the survey found. When signs of abuse are uncovered, only 5 percent offer direct help
  • March 22, 2016
    The Food and Drug Administration (FDA) is warning about several safety issues with the entire class of opioid pain medicines. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks.
  • Opioids can interact with antidepressants and migraine medicines to cause a serious central nervous system
  • March 22, 2016
    More than 15% of older Americans took potentially life-threatening combinations of prescription medications, over- the-counter drugs and dietary supplements in 2011, according to a study published in JAMA Internal Medicine. The 2011 numbers represented a twofold increase from 2005, when 8.4% of seniors did so. Patients should always tell their doctor and pharmacist about all of the drugs and supplements they are taking, or plan to take, including over-the-counter medications, said lead researcher Dr. Dima Qato.
  • March 22, 2016
    Earlier this month, the American Pharmacists Association (APhA) House of Delegates voted to adopt new policy on the labeling and measurement of oral liquid medications. The new policy would support moving away from outdated dosing cups and teaspoons in favor of oral syringes and cups that measure only in the metric system (milliliter -mL) as the standard for prescribing and measuring all oral liquid medications. Numerous and sometimes fatal events have occurred as a result of confusion from not having unified measuring standards. Multiple national
  • March 21, 2016
    The guide, launched online by the National Institute on Drug Abuse, (NIDA), offers research-based principles that affect a child’s self-control and overall mental health, starting during pregnancy through the eighth year of life. It recognizes that while substance use generally begins during the teen years, it has known biological, psychological, social, and environmental roots that begin even before birth. Principles of Substance Abuse Prevention for Early Childhood addresses the major influences on
  • March 16, 2016
    As part of the urgent response to the epidemic of overdose deaths, CDC issued new recommendations for prescribing opioid medications for chronic pain, excluding cancer, palliative, and end-of-life care. The CDC Guideline for Prescribing Opioids for Chronic Pain, United States, 2016 will help primary care providers ensure the safest and most effective treatment for their patients.
  • March 14, 2016
    Script Your Future (SYF) wallet cards and medication adherence infographics are now available in English, Spanish, Chinese, Vietnamese, Hmong, and Russian. The materials are free for download, printing, distribution, and web site linking. The National Consumers League (NCL) leads the Script Your Future campaign, with partners from every sector of the health care system, including health care professionals, patient communities, family caregivers, pharmacies, health insurance plans, pharmaceutical companies and associations, as well as government agencies
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