Otsuka Pharmaceutical won FDA approval for an upgraded version of Abilify, the antipsychotic drug first approved 15 years ago to treat schizophrenia, bipolar disorder, and depression. Otsuka collaborated with Proteus Digital Health, the company that designed the futuristic sensor technology. The new product, Abilify MyCite, can be swallowed just like any other pill or capsule. When that happens, the ingestible sensor inside it sends a message to a patch worn by the patient, which then transmits the information to a mobile app that the patient can monitor.
News you can use: health & drug safety updates
November 15, 2017
November 13, 2017
The FDA is hosting a two-day public workshop for interested stakeholders who are working on the challenges of improving pain management while addressing the opioid abuse epidemic. To be held on December 11 and 12, 2017, from 8:30 AM to 5 PM at the Sheraton Silver Spring Hotel in Silver Spring, MD. Registration must occur by 12/01/2017. Electronic or written comments on this workshop must be submitted by 02/18/2018.
November 6, 2017
Deaths by drug overdose in the United States increased by more than 17% in 2016, according to a report released Friday by CDC. Preliminary data from the 50 states show that from the fourth quarter of 2015, through the fourth quarter of 2016, the rate of fatal overdoses rose to nearly 20 people per 100,000 from 16.3 per 100,000. CDC had previously estimated that about 64,000 people died from drug overdoses in 2016. Drug overdoses have become the leading cause of death for Americans under 50. In recent years, according to Dr. Robert Anderson, chief of the C.D.C. mortality statistics branch, the deaths have been driven by overdoses of synthetic opioids, mostly fentanyl, rather than heroin.
November 1, 2017
NCPIE serves as co-editor for a monthly column in Pharmacy Today (American Pharmacists Association) The column is entitled “One-to-One” and is intended to help develop pharmacists’ medication communication and counseling skills to promote safe and appropriate medicine use.
October 31, 2017
USP, a long-time representative on the NCPIE board of directors, recently convened a roundtable to explore strategies to protect the public’s health, as well as assist first-responders and healthcare providers. The roundtable gathered additional input and feedback about these strategies. The four approaches being developed are:
- Recommendations for effectively and safely storing and disposing of opioid prescriptions in order to help prevent misuse, including how this information should be communicated;
- Clear prescription label information to ensure patients understand that a prescribed drug is an opioid and can be addictive;
- Easy-to-follow instructions for using naloxone, so that first responders and others (including family, friends, and others who may not be trained healthcare providers) can quickly understand when and how to administer this life-saving antidote; and
- New standards for healthcare providers to counsel patients about appropriate use of prescription opioids and how to avoid misuse.
In the coming months, USP will release a report based on these discussions which will inform the work of USP’s Healthcare Quality and Safety Expert Committee, whose members have been developing the concepts discussed at the roundtable. All proposed new or revised standards will be open to public comment for 90 days.
October 31, 2017
Healthline partners with the U.S. Pain Foundation and the National Council on Patient Information and Education (NCPIE) for new social media campaigns. To further its mission to be patients’ most trusted ally as they pursue health and well-being, Healthline is created two awareness campaigns this month: #MakeItVisible and #DontMix. Both campaigns are taking place across social media platforms until October 31, 2017.
October 30, 2017
More than 50% of people in 10 states who died from opioid overdoses in the last 6 months of 2016 tested positive for fentanyl, according to new research. Out of 5,152 opioid overdose deaths in those states, CDC researchers found that nearly 3,000 tested positive for fentanyl—and more than 700 tested positive for fentanyl analogs, including carfentanil. The researchers examined opioid overdose deaths in 10 states.
October 26, 2017
Fight the Fakes is a global campaign to raise awareness about the dangers of fake medicines. The campaign gives a voice to those who have been personally impacted and shares the stories of those working to put a stop to this threat to public health. It seeks to build a global movement of organizations and individuals who will shine light on the negative impact that fake medicines have on people around the globe and to reduce the negative consequences on individuals worldwide.
October 24, 2017
The FDA warns pet owners against using internet pharmacies that sell pet medicines without a prescription in a new Consumer Update. Many pet owners turn to the internet when buying pet medicines to save money and time, but as FDA’s Center for Veterinary Medicine (CVM) notes, pet owners should look closely at websites to ensure they are ordering from a reputable pharmacy and protecting their pets from counterfeit or unapproved medicines. Online pharmacies that do not require a prescription present a red flag, as do websites that offer “evaluations” by one of their veterinarians on staff after looking over a form filled out by the pet owner. FDA’s Consumer Update also offers tips for pet owners on how to recognize legitimate online pharmacies, including looking for those sites with a .pharmacy domain. Consumers can trust these sites as safe and legitimate because they have been evaluated against a set of safety standards under NABP’s .Pharmacy Verified Websites Program. In addition to identifying a site by seeing .pharmacy in the web address, a list of verified sites is also available at www.safe.pharmacy/buying-safely.
October 18, 2017
Thomas E. Menighan, Executive Director and CEO of the American Pharmacists Association, offered one specific remedy for increased drug prices to the Senate Senate’s Health, Education, Labor and Pensions (HELP) Committee. Menighan urged the Senate to pass S109, the Pharmacy and Medically Underserved Areas Enhancement Act, which would amend the Social Security Act to provide Medicare coverage for pharmacist services.
Menighan also took a firm position on pharmaceutical rebates; under questioning from Senator Alexander, who asked “Why do we need rebates at all? Wouldn’t it increase transparency if manufacturers created a list price? Wouldn’t it make it simpler for us to figure out where the money goes?” Menighan said that his organization opposes rebates “in all their forms.” Additionally, Menighan reiterated APhA’s position against legalizing the importation of non-FDA approved drugs, saying that pharmacists shouldn’t have to worry about diversion and counterfeits and that ultimately the practice would do more harm than good. APhA is a NCPIE member represented on the NCPIE Board of Directors.