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Industry alerts patient groups to new schedule of hydrocodone combination products

BY Michael Johnsen

WASHINGTON — The Drug Enforcement Administration’s final rule moving hydrocodone combination products from Schedule III to the more-restrictive Schedule II officially went into effect on Monday. 
 
The rule change had represented an implementation challenge for retail pharmacy as the industry had only 45 days to become compliant with the final rule. Originally, NACDS had requested 180 days to allow pharmacies to become compliant with the rule. 
 
With 135 million in HCP products dispensed in 2012, according to IMS Health, that represents a significant volume of prescriptions that have to be handled differently both in terms of how the product is stored, as well as how refills are processed. 
 
“The main impact [on retail pharmacy] was getting ready. That was the biggest challenge,” Kevin Nicholson, VP public policy and regulatory affairs for the National Association of Chain Drug Stores told DSN. “We were concerned when there was only a 45-day implementation timeline. Everyone’s ready, [however],” he said. “We’re working hard to implement it and make sure patients have minimal disruption, despite the challenges patients will be facing with the new rule.”
 
In addition to updating pharmacy systems and supply chain protocols, patients may face challenges in refilling their hydrocodone prescriptions under DEA’s final rule. Prescriptions for these products that are issued on or after Oct. 6 must comply with requirements for Schedule II prescriptions and refills of these prescriptions will be prohibited. However, prescriptions issued before Oct. 6 that have authorized refills may be dispensed in accordance with DEA rules until April 8, 2015. Yet, state law, insurance limitations and some pharmacy quality and safety operations and processes may not allow for these prescriptions to be refilled. “That’s important as well because even though the DEA is saying the refills can still be used, the reality is in many or most cases, the refills will not be able to be used,” Nicholson said. 
 
 
Moving forward, NACDS has been working with patient groups and physician groups to alert them around what the HCP schedule change means for them. “The  biggest challenge [now] is continuing to educate the patients and the doctors so that they know that these medications are now in this more restrictive class — they can’t be called into the pharmacy; they can’t be refilled — and we’ve done a good job with that, too ,” Nicholson said. “We’ve been working with NCPA, the American Medical Association. We’ve been talking with the patient groups [like] the American Cancer Society, Cancer Action Network,” he said. “We want to make sure that no one is surprised by this new requirement.”
 
The National Association of Chain Drug Stores has also recently placed its support behind new legislation introduced on Sept. 18 — S. 2862, the Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 — which calls for a collaborative, coordinated approach to curbing prescription drug abuse and safeguarding patients. 
 
Introduced by Sens. Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I., the bill would establish a congressionally-mandated report from the Department of Health and Human Services, facilitated in consultation with the Drug Enforcement Administration and the White House Office of National Drug Control Policy, that would identify obstacles to legitimate patient access to controlled substances, issues of diversion of these products, and opportunities to better coordinate federal, state and stakeholder activities that can reduce prescription drug abuse without compromising access to medications for patients who legitimately need them.  
 
The Senate bill largely mirrors the House bill, H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act of 2014, which was introduced earlier this year by Reps. Marsha Blackburn, R-Tenn., and Tom Marino, R-Pa.  Also backed by NACDS, that bill passed the House in August. 
 
 
 
 
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FDA approves Gilead’s hepatitis C remedy Harvoni (ledipasvir and sofosbuvir)

BY Michael Johnsen

SILVER SPRING, Md. – The Food and Drug Administration on Friday approved Gilead's Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus genotype 1 infection.
 
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection, the agency stated. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
 
Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.
 
“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and healthcare professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”
 
Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.
 
 
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.
 
Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15% to 30% of these people will go on to develop cirrhosis.
 
Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor, if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
 
Harvoni and Sovaldi are marketed by Gilead based in Foster City, Calif. Olysio is marketed by Janssen Pharmaceutical based in Raritan, N.J.
 
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Cardinal Health helps launch $13 million molecular imaging facility

BY Michael Johnsen

COLUMBUS, Ohio – The Ohio State University, Cardinal Health and State of Ohio Third Frontier Commission on Wednesday announced the completion of a five-year long project to create a new, $13 million molecular imaging pharmaceuticals center that aims to shape the future of the medical diagnostic industry.
 
The state-of-the-art, 27,000-square-foot facility — called the Translational Research Center for Molecular Imaging Pharmaceuticals at the Wright Center of Innovation in Biomedical Imaging — will combine Ohio State's Wright Center of Innovation in Biomedical Imaging's research capabilities with Cardinal Health's developmental, manufacturing and commercialization expertise for molecular imaging agents.
 
The facility will research and produce specialized pharmaceuticals called "imaging agents," which are injected into the body and seek out particular cellular functions that are indicative of specific disease processes. These imaging agents are visible using sophisticated imaging equipment, and help aid in both the diagnosis and treatment of diseases including cancer, cardiovascular and neurological disorders.
 
"This research center is another example of how effective private-public partnerships can be at creating investment and opportunity right here in Ohio," said Ohio Lt. Governor Mary Taylor. "Strong leadership from Cardinal Health and The Ohio State University, in collaboration with the State of Ohio, will not only create good-paying jobs, but also provide opportunities to conduct cutting-edge research leading to new breakthroughs in medical imaging, diagnostics and pharmaceuticals."
 
The facility is located on Ohio State's west campus, in close proximity to its Wexner Medical Center, Veterinary Medical Center, West Campus Technology and Incubator facilities — with the ultimate goal of ensuring the new facility is fully integrated into key infrastructure at the university.
 
"The competitively awarded Ohio Third Frontier funding has been the key enabler to transform Ohio's technology and innovation environment and bring us all together to synergize our collective teams, resources and potential to shape the future of Ohio's economy, precision health care and scientific discoveries," said Michael Knopp,  principal investigator and director of the Wright Center.
 
 
The new center supports more than 80 employees, including Ohio State researchers and Cardinal Health radiopharmaceutical manufacturing and nuclear pharmacy operations personnel. In addition, an endowed faculty position as the Ohio Molecular Imaging Pharmaceutical Scholar — along with other researchers — have been added to the faculty and staff of Ohio State's Department of Radiology.
 
"We are very excited that this collaboration between Cardinal Health and Ohio State will advance medical imaging to more effectively alert patients to seek treatment for life-threatening diseases," said Ohio State president Michael Drake. "The university's research expertise paired with the development capacity of Cardinal Health will expedite the discovery and delivery of quality health care while promoting a critical industry in our region."
 
The new molecular imaging technology center will provide Ohio State researchers with unique manufacturing capabilities and expertise to aid in their research and creation of new molecular imaging agents in Positron Emission Tomography, also known as PET imaging. As new imaging pharmaceuticals move through the drug approval pipeline, Cardinal Health will also support their development, manufacturing and dispensing for clinical drug trials in Ohio and across its national network of radiopharmaceutical facilities.
 
"This public-private partnership positions central Ohio as a state-of-the-art location for the research, development, clinical investigational trials and full commercialization of new molecular imaging agents," said George Barrett, chairman and CEO of Cardinal Health. "By helping physicians diagnose disease at its earliest stages and evaluate the efficacy of treatment, these new imaging pharmaceuticals can save lives and help reduce the overall cost of health care."
 
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