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FDA issues sweeping new requirements for long-acting opioids

BY Alaric DeArment

SILVER SPRING, Md. — Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

The agency announced new labeling changes and regulatory requirements for makers of extended-release and long-acting opioids, citing the risk the drugs carry of overdose, abuse and withdrawal. In response, a group also cautioned consumers to be careful when using non-steroidal anti-inflammatory drugs.

Among the changes, the language on the drugs’ safety labels will state that they should be used to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment when alternatives are unavailable, but they should not be used on an as-needed basis. In addition, they should be reserved for patients for whom alternatives such as non-opioid drugs are ineffective or unsafe. The drugs were previously indicated for moderate to severe pain in patients requiring continuous, around-the-clock treatment for an extended period of time.

Drugs affected by the decision include Purdue Pharma’s OxyContin (oxycodone) and Endo’s Opana ER (oxymorphone), as well as other branded and generic drugs in the class.

"The FDA is invoking its authority to require safety labeling changes and post-market studies to combat the crisis of misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities," FDA commissioner Margaret Hamburg said. "Today’s action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended-release opioids while seeking to preserve appropriate access for those patients who rely on these medications to manage their pain."

For clinical trials, drug companies will be required to assess known risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death. Another labeling change will warn that chronic use of the drugs during pregnancy can result in infants having neonatal opioid withdrawal syndrome, a potentially life-threatening condition.

Following the FDA’s announcement, the Eugene, Ore.-based Alliance for Rational Use of NSAIDs said that because many health professionals and patients would likely look to prescription and OTC NSAIDs as alternatives for pain management, consumers should use any NSAID at the lowest effective dose for the shortest period of time required to achieve a desired therapeutic outcome.

"Proper use of NSAIDs can save at least 100,000 hospital admissions per year," alliance chairman Byron Cryer said. "The alliance’s mission to support safe and effective use of NSAIDs is critical, particularly as the FDA limits the use of extended-release [and] long-acting opioids."


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CVS Caremark showcases outreach program to help customers understand health insurance options

BY Antoinette Alexander

WOONSOCKET, R.I. — CVS Caremark on Friday showcased the details of a companywide information and outreach program to help customers navigate their insurance options under the new healthcare law during a store visit in Orlando with U.S. Health and Human Services Secretary Kathleen Sebelius.

(Photo: CVS Caremark’s Larry Merlo discusses the pharmacy retailer’s outreach program with U.S. Health and Human Services Secretary Kathleen Sebelius)

The program includes retail events and brochure displays at more than 7,500 CVS/pharmacy stores and 650 MinuteClinic locations. Information is also available online at cvs.com/insurance.

"Providing information about new health insurance coverage opportunities is in keeping with our purpose of helping people on their path to better health," stated Larry Merlo, president and CEO of CVS Caremark, who led the tour with Sebelius. "Over the coming months, our pharmacists and stores will be serving a key role in providing a point of activation for customers to learn more."

A recent CVS Caremark survey found that pharmacies will be a primary resource to meet the needs of uninsured Americans, with 68% of those surveyed expecting retail pharmacies to offer health insurance information in store and/or online. Among those asking for help, Hispanics and the youngest group surveyed (aged 18 to 35) were significantly more likely to say they need help understanding the exchanges.

"Families look to their local pharmacy as a place they can go to for honest, straightforward advice they can trust," stated HHS Secretary Kathleen Sebelius. "Americans trust their pharmacists for tell-it-like-it-is advice about their health, and pharmacies, like CVS, have a special role in these efforts. We thank CVS Caremark and CVS stores nationwide for their commitment to providing Americans with the information they need about the Health Insurance Marketplace."

CVS/pharmacy will also be hosting approximately 5,000 in-store events with health insurance experts, including representatives of state exchanges and local health plans. In addition, in September, representatives from Get Covered America will be available at CVS/pharmacy Project Health free health screening events.


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UrgentRx announces new sales director hire

BY Jason Owen

DENVER — On Friday, UrgentRx, developer of fast-acting, over-the-counter flavored powder medications, announced Rick Hayward will be joining the company as the sales director for the food, drug and mass channels.

Hayward joins UrgentRx from Reckitt Benckiser, one of the world’s largest CPG manufacturers that acquired Schiff Nutrition in December 2012. While at Reckitt Benckiser, Hayward served as national account manager for CVS/pharmacy. Prior to the acquisition, he was a core team player at Schiff Nutrition for over 11 years where he held key positions such as national sales director for the natural/specialty channels and director of business development for the drug channel.

Prior to Schiff Nutrition, Hayward acted as the VP – brand development manager/region manager at Marketing Specialist Inc., a national food broker. While there, he spearheaded major initiatives for Heinz USA and the Minute Maid Co. across major food retailers within the Mid-Atlantic, New York, and Northeast markets.

“Mr. Hayward has spent his career growing some of the most well-known national and global brands,” stated Jordan Eisenberg, president and founder of UrgentRx. “His expertise managing and growing new brands within major food and drug chains will further propel UrgentRx’s rapid expansion across the country. We are thrilled to have him join our team.”

UrgentRx sells six flavored powder medications in credit card size packs for on-the-go use: Critical Care Aspirin to Go, Headache Relief to Go, Heartburn Relief to Go, Upset Stomach Relief to Go, Ache & Pain Relief to Go and Allergy Attack Relief to Go. Currently distributed in 10,500 stores, the company’s goal is to reach 20,000+ stores by the end of 2013.


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