The Food and Drug Administration said in August it intends to withdraw its existing 2014 analgesic guidance for developing new pain drugs. The FDA plans to issue new guidance in 2019. The decision reflects the shift in the nation’s opioid crisis from being”largely dominated” by prescription drug addiction, to one that “increasingly implications the use of illicit drugs, including highly potent fentanyls,” said FDA Commissioner Scott Gottlieb, MD. The article reports that the FDA’s new guidance will explore developing nonopioid alternatives and extended-release anesthetics and “charging drug makers with assessing the benefits and risks when new opioid pain drugs are put into development.”
Federal officials unveiled its recommendations for first responders regarding protection from exposure to synthetic opioids, such as fentanyl. The agencies, including the U.S. Dept. of Justice, the Federal Bureau of Investigation and the White House’s Office of National Drug Control Policy, issued steps for law enforcement to take to protect themselves from exposure as well as what to do if exposure occurs.
The WV House of Delegates voted for Delegate Roger Hanshaw, a two-term Republican from Clay County, to be the new Speaker. He is the 58th Speaker of the WV House. Hanshaw is an attorney with Bowles Rice law firm in Charleston.
According to CDC reports, opioids were involved in 42,249 U.S. overdose deaths in 2016.
Physicians and health care professionals are writing fewer opioid prescriptions and using state prescription drug monitoring programs more than ever, indicates a report issued by the American Medical Association in May 2018. Specifically, the number of opioid prescriptions decreased by more than 55 million (a 22.2% decrease nationally, between 2013 and 2017. The report also found that more than 1.5 million physicians and other professionals are registered in state-based PBMPs to date, and more than 300.4 million PDMP queries were made by professionals in 2017.
The National Association of Boards of Pharmacy (NABP) amended the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) to provide the state boards of pharmacy with model language that may be used for developing state laws or board rules for purposes of protecting the public health. Amendments to the Model Act were incorporated as a result of the NABP Executive Committee-approved recommendations suggested by the Task Force on Best Practices for Veterinary Compounding, the Task Force on Long-Term Care Pharmacy Rules, and the 2017-2018 Committee on Law Enforcement/Legislation.
Snap, Inc., a technology and camera company, has updated its advertising policy related to online pharmacies. In the United States and Canada, an online pharmacy must be verified by NABP in order to advertise on Snap’s mobile app, Snapchat. Over 180 million people use Snapchat every day. Snapchat joins Google, Bing, Yahoo and Twitter in requiring that pharmacy-related advertisers obtain NABP verification.
Kentucky has hit a national PBM with a $1.5 million fine, finding that Caremark PCS Health, an affiliate of drugstore chain giant CVS, committed hundreds of violations in processing claims of individual pharmacies. The state Dept. of Insurance also put on probation for one year the company that dominates Kentucky’s Medicaid prescription drug business, processing most of the pharmacy claims for the $11 billion-a-year government health plan for low-income and disable people.
WVPA joins effort encouraging Congress to restore over-the-counter (OTC) medications to full tax-preferred status, eliminating the need to first obtain a prescription. The newly proposed law is contained in H. R. 6199.
Cardinal Health Executive Chairman George Barrett expressed regret that his drug company didn’t do more to stop the high-volume shipments of highly addictive prescription painkillers — hydrocodone and oxycodone — to Family Discount Pharmacy in Logan County and Hurley Drug in Mingo County. “With the benefit of hindsight, I wish we had moved faster and asked a different set of questions. I am deeply sorry we did not,” Barrett told a congressional committee during a hearing on Capitol Hill.