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Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

The Food and Drug Administration is seeking public comment on a proposed framework for regulating software applications developed by drugmakers for use in conjunction with their prescription drug products...The new approach would treat most prescription drug apps, including dose calculators, symptom trackers and medication reminders, as promotional labeling...drugmakers would need only to submit to the agency copies of the content of what the apps display to consumers, following existing reporting requirements for promotional materials...In other cases, such as when a drugmaker wants to show that software has an effect on a clinical outcome and wants to include information about the software in the FDA-required drug labeling, prior FDA approval would be required...

Tens of thousands of people in Africa die each year because of fake and counterfeit medication...The drugs are mainly made in China but also in India, Paraguay, Pakistan and the United Kingdom...Almost half the fake and low-quality medicines reported to the World Health Organization between 2013 and 2017 were found to be in sub-Saharan Africa...“Counterfeiters prey on poorer countries more than their richer counterparts, with up to 30 times greater penetration of fakes in the supply chain...The counterfeit drug market is worth around $200 billion worldwide annually...making it the most lucrative trade of illegally copied goods...

The Department of Health and Human Services has recommended a ban on the chemicals in kratom that would make the popular herbal supplement as illegal as heroin or LSD…HHS asserted in a letter to the Drug Enforcement Administration that two chemicals in kratom should be classified as Schedule I substances... FDA...has said that kratom is “an opioid” and has been “associated” with dozens of deaths...Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids...Some states have already banned kratom, but it’s currently legal at the federal level. It’s sold in different forms, including dry powder and capsules. According to the American Kratom Association, millions of Americans use the substance.

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network..

Laura Joszt,  welcome to the Pharmacy Times News Network, Pharmacy Week in Review, , this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The British take enormous pride in their National Health Service…Get sick in Britain and you can see a doctor, get a scan or even have surgery for free...Unfortunately the system also depends on tax money that can’t keep pace with an ageing population who need greater care than ever. Its deficit is estimated to be closing in on £1 billion ($1.3 billion)...Many believe technology can make the NHS more efficient, and so it has partnered with private companies...to serve NHS patients at a lower cost, by connecting them with doctors on a video call or even an automated symptom checker...Some worry that such deals spell the slow-and-steady privatization of the NHS and a move (God forbid) towards a system that looks more like that of the United States. But Hancock (Matt Hancock - health secretary) believes these partnerships are necessary if the NHS is going to survive.

...UK Government and the European Commission published a draft Brexit withdrawal agreement. Like with every industry, the document has implications for the pharmaceutical industry, including clarification about the lack of disruption to supplies during the transition period and sharing of marketing authorisation information between the UK and EU member states...A key area of debate during the negotiation process was the impact of Brexit on the pharmaceutical industry, particularly the disruption in supply of medicines...The draft agreement stipulates that the transition period will last from 29 March 2019 until 31 December 2020. During this time the UK will continue to abide by all EU rules and remain under the jurisdiction of the European Court of Justice...The aim of the transition is to provide time for the UK to negotiate its relationship with the EU, particularly in terms of trade deals...the UK will share the “marketing authorisation dossier of a medicinal product” authorised by its Medicines and Healthcare products Regulatory Agency with EU member states or the European Medicines Authority...

Nevada’s public hospital in Las Vegas has been ordered to pay nearly $820,000 in sanctions and attorney fees for failing to produce required emails, text messages and computer records in an ongoing federal employee wages lawsuit...University Medical Center has until Dec. 5 to pay the penalty in the civil case alleging that thousands of nurses and other employees routinely worked through 30-minute meal periods for no pay...The court found that UMC had repeatedly violated its discovery obligations and its duty to preserve...noting that some electronically stored information that was turned over included “indecipherable codes complete with Japanese and Korean characters.”