The Official Medicare Set Aside Blog And Information Resource

FDA Grants OTC Status to Voltaren® 1% Gel

FDA, Medicare Set-Aside Blog, Medicare Set-Asides, Rx/Pharmacy on February 21, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Last Friday, while many of us may have been focused on Valentine’s Day activities, the Food and Drug Administration (FDA) was busy granting over-the-counter status to three products which were previously available only by prescription. One of those products was Voltaren (diclofenac) 1% gel, which is manufactured by GSK. When the product makes its OTC […] Continue

Gabapentin Abuse on the Rise

FDA, Medicare Set-Aside Blog, MSAs, Rx/Pharmacy on April 25, 2019
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

All of the focus on the opioid crisis may have overshadowed a growing trend of abuse and misuse for another drug that’s well known to those of us in the workers’ compensation industry . . . gabapentin. Ironically, the growing trend of gabapentin abuse is related to the opioid crisis. In an effort to adhere […] Continue

Sublocade – A New Once-Monthly Injection for the Treatment of Opioid Use Disorder

CMS, FDA, Medicare, Medicare Set-Aside Blog, Medicare Set-Asides, MSP News, Opioids on February 5, 2018
Posted by Katherine Bales, RN, JD

The opioid crisis continues to be one of the most talked about issues facing the health care community, and the nation as a whole, having been declared a national public health emergency. In response, pharmaceutical companies have been actively working on ways to treat the crisis with the development of alternative treatment methods. The FDA […] Continue

FDA Requests Endo Pharmaceuticals Withdraw Opana ER From the Market

FDA, Medicare Set-Aside Blog, Opioid, Opioids on June 9, 2017
Posted by Erin O'Neill, PA-C, JD

On June 8, 2017, the Food and Drug Administration (FDA) requested that Endo Pharmaceuticals withdraw Opana ER from the market, citing concerns of ongoing misuse and abuse of the drug. As you will recall from our prior blog post, in March 2017, an FDA advisory committee found that the risks associated with use of Opana ER […] Continue

FDA Advisory Committee Finds Opana ER Risks Outweigh Benefits

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on March 21, 2017
Posted by Erin O'Neill, PA-C, JD

On March 14, 2017, a Food and Drug Administration (FDA) advisory committee found that the risks associated with use of Opana ER (oxymorphone hydrochloride) outweighed the potential benefits. Opana ER is an opioid pain medication, which was first introduced in 2006 and then reintroduced in a new abuse deterrent formulation in 2012. The new formulation was designed […] Continue