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FDA withdraws proposed rule that would have exposed generic-drug makers to liability
Wall Street Journal (12/13/18) Burton, Thomas
FDA on Thursday withdrew a proposal that would have opened up generic companies to possible product-liability lawsuits over drug safety. The agency had proposed a new federal rule in 2013 that would have allowed people to hold generic-drug companies legally liable for the side effects of medicines…
Dec 13, 2018 Publication Pharmacy Today Daily Edition
Effect of oral alfacalcidol on clinical outcomes in patients without secondary hyperparathyroidism receiving maintenance hemodialysis
Journal of the American Medical Association (12/11/18) Vol. 320, No. 22, P. 2325 Shoji, Tetsuo; Inaba, Masaaki; Fukagawa, Masafumi; et al.
The J-DAVID clinical trial was conducted to determine if treatment with active vitamin D sterols would reduce the risk of all-cause mortality in people with chronic kidney disease (CKD). This patient population has elevated cardiovascular risk, possibly as a byproduct of impaired vitamin D…
Dec 13, 2018 Publication Pharmacy Today Daily Edition
FDA announces more valsartan recalls, issues warning letter to API manufacturer
Loren Bonner, senior editor  
The valsartan recalls continued this month when FDA alerted patients and health professionals that Teva Pharmaceuticals issued a voluntary recall of valsartan-containing products manufactured using active pharmaceutical ingredient (API) from Mylan Pharmaceuticals. Mylan voluntarily recalled…
Dec 14, 2018 Article
Allied Against Opioid Abuse releases toolkit for pharmacists
Loren Bonner, senior editor
Pharmacists across the country are turning to resources from the Allied Against Opioid Abuse (AAOA) to help their patients understand the risks and responsibilities of prescription opioids.  AAOA launched in February 2018 as a national coalition and campaign to raise awareness for health…
Dec 11, 2018 Article
Show You Know
SHOW YOU KNOW is a fun and interactive multiple choice quiz. Each module is written by experts to be timely, quick, and comprehensive. Answers, explanations, and case studies are included to keep you as informed as possible. Make sure you complete the quiz to obtain more information on each subject…
Feb 15, 2018 Basic page
Government report on health reform says pharmacists should be paid for services
Loren Bonner, senior editor  
A new report from the Department of Health and Human Services (HHS) and other government officials laid out recommendations for reforming the U.S. health care system that includes allowing pharmacists and other health care providers to practice at the top of their professional license and be paid…
Dec 13, 2018 Article
FDA efforts to improve drug quality through oversight of data integrity and good manufacturing practice
FDA News Release (12/12/18) Gottlieb, Scott
FDA Commissioner Scott Gottlieb says overseeing the quality and safety of pharmaceutical manufacturing is key to efforts to ensure the safety of the nation's drug supply. Having clear guidelines for companies on how to prevent product quality issues is an important step to protecting patient safety…
Dec 12, 2018 Publication Pharmacy Today Daily Edition
Pennsylvania auditor general calls for greater oversight of PBMs
Pittsburgh Post-Gazette (12/12/18) Twedt, Steve
Pennsylvania Auditor General Eugene DePasquale on Tuesday called on legislators to demand more transparency and accountability from PBMs. In an 18-page report, DePasquale said Pennsylvania paid PBMs $2.86 billion in 2017 for Medicaid beneficiaries’ prescriptions. By comparison, the report…
Dec 12, 2018 Publication Pharmacy Today Daily Edition
Soaring insulin prices cause Minnesota lawmakers to draft remedies
Minneapolis Star Tribune (12/12/18) Howatt, Glenn
A group of Minnesota legislators is considering regulations to rein in the soaring cost of insulin. With more than 460,000 diabetics in Minnesota, legislators say they are hearing many complaints from frustrated and worried constituents. Rationing insulin can lead to illness, even death. A vial of…
Dec 12, 2018 Publication Pharmacy Today Daily Edition
FDA warns API manufacturer involved in valsartan recall
FDA News Release (12/11/18)
FDA has released a warning letter issued to Zhejiang Huahai Pharmaceutical (ZHP), the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart…
Dec 12, 2018 Publication Pharmacy Today Daily Edition