PHARMACY

NACDS urges FDA to move carefully in risk management rules for opioids

BY Jim Frederick

ROCKVILLE, Md. Note to the Food and Drug Administration from the chain pharmacy industry: when it comes to beefing up oversight and regulation of some high-risk medications, slow and steady is the best approach.

As the FDA mulls new, broad-based requirements on the dispensing and monitoring of all medications in the opioid class of painkillers, the National Association of Chain Drug Stores is weighing in with a cautious, if qualified, endorsement. That support came today from Kevin N. Nicholson, NACDS VP and pharmacy adviser for government affairs and public policy, who addressed a joint meeting of the FDA’s Anesthetic and Life Support Drugs Advisory and Drug Safety and Risk Management Advisory committees.

The meeting was set up to study the agency’s proposal to require all painkillers in the opioid class of medicines to follow the FDA’s Risk Evaluation and Mitigation Strategies guidelines. The agency first unveiled new REMS requirements for the makers of some higher-risk specialty medications in 2007. Thus far, the biggest target for those new REMS requirements has been the opioid class of painkillers, given their narcotic properties and the risks they carry for abuse and addiction.

Nicholson told the joint panel that NACDS "supports the measured approach to REMS that the FDA appears to be embracing, as evidenced by the FDA’s proposal for the classwide opioid REMS." However, he added, "The FDA must carefully navigate between mitigating the risks of these medications while also not negatively impacting patient care."

"We are pleased that the proposed REMS for long acting and extended release opioids follows the advice of stakeholders that emphasizes caution and deliberation over speed," said the NACDS executive. "Take time to develop the REMS and allow for stakeholder input to prevent negative consequences."

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PHARMACY

Independent pharmacies tap into long-term care market with new center

BY Alaric DeArment

DENVER Healthcare services company Cardinal Health will work with the American Society of Consultant Pharmacies to help independent retail pharmacies tap into the long-term care market, Cardinal said Thursday.

According to statistics from 2008, the number of adults in the United States needing nursing home or assisted living care is expected to be 20 million by 2050. Officially launched at Cardinal’s Retail Business Conference in Denver this week, the Long Term Care Specialized Care Center will give independents access to long-term care field specialists, discounts on the ASCP’s policy and procedure manuals and continuing education courses and market analyses.

“Many independent pharmacists want to start serving the high-growth long-term care market, but doing so requires a specialized knowledge base and skill set,” Cardinal VP market management and product development Jay Williams said. “That’s why we’ve partnered with ASCP – the recognized expert in geriatric pharmacotherapy – to provide our customers with the education and building blocks they need to immediately start serving the medication needs of the long-term care facilities in their communities.”

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PHARMACY

GSK joins the National Pharmaceutical Council

BY Alaric DeArment

WASHINGTON British drug maker GlaxoSmithKline is the latest company to join health policy research organization the National Pharmaceutical Council, the NPC announced Thursday.

Established in 1953, the NPC sponsors and conducts scientific analyses of the use of drugs with support from drug companies. GlaxoSmithKline SVP private, public and institutional customers Jack Bailey will serve as the company’s representative on the NPC’s board of directors.

“As the nation moves forward with the implementation of healthcare reform, NPC’s research provides policy makers and implementers with keen insight on comparative effectiveness research and health-and-wellness issues,” Bailey said. “I welcome the opportunity to work with NPC and its staff as they move forward with these and other research areas impacting the pharmaceutical industry.”

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