Thursday, August 15, 2013

Premier healthcare alliance Reinforces Leadership Role in Reducing Drug Shortages, Creating Safer and Healthier Marketplace

— The Premier healthcare alliance announced new agreements with a broader scope of generic drug manufacturers to provide drugs on the drug shortage list, including bringing new manufacturers into the generic injectable market. This is part of the alliance’s ongoing commitment to solve drug shortages for American patients.

The first of these agreements is with Heritage Pharmaceuticals Inc., a subsidiary of Emcure Pharma Ltd., to offer alliance members safer and more reliable access to drugs on the Food and Drug Administration (FDA) shortage list, including:
  • Cidofovir, used to treat viruses in AIDS patients. Heritage received the 2013 Healthcare Distribution Management Association best new generic product introduction of the year award for its launch of Cidofovir.
  • Ondansetron, which prevents nausea and vomiting caused by surgery or cancer therapy.
Heritage also has a deep pipeline of products pending at the FDA and is working closely with the FDA to receive expedited review for approval of additional shorted drugs. Under their contracts, Premier will be able to rapidly make the products available to members at specially negotiated pricing and terms.

In addition to Heritage, Premier has signed contracts with a number of emerging suppliers that are investing in the development and production of shorted generic injectables.

“The Premier alliance is determined to lead the effort to solve our nation’s drug shortage problem to benefit care providers and the patients they serve,” said Michael J. Alkire, Premier’s chief operating officer. “We’re aggressively exploring all opportunities to bring high-quality suppliers with the capacity to produce shorted drugs to the market. Through our scale, experience and expertise, we’re able to assist smaller suppliers and those new to the generic injectable market by adding their products to our contracts and making the FDA aware of these alternate sources.”

“Our priority is to provide the best possible care to our patients, and ensuring a reliable supply of essential medication is a critical aspect in that mission,” said Don Mabe, R.Ph, MBA, MHA, chair of the National Pharmacy Committee, a panel of pharmacists overseeing the strategic direction of Premier’s pharmacy program, and a health system pharmacy executive. “By working to create a healthier marketplace through private sector solutions, we can increase market access and safely enhance stability and supply.”

While some progress has been made, the short supply of drugs continues to afflict hospitals and healthcare providers. According to the University of Utah Drug Information Services, providers still face 300 ongoing drug shortages, basically the same number they faced a year ago. Many of these medicines are essential to patient care, and include those used in chemotherapy, sedation to conduct surgeries and emergency treatments for heart attack patients.

Shortages are also extremely costly to hospitals and to the healthcare system as a whole. It’s estimated that shortages could cost U.S. hospitals at least $415 million annually through the purchase of more expensive generic or therapeutic substitutes and enhanced labor costs.

The Premier alliance is a national leader in finding private sector solutions to drug shortages. This includes working with and supporting the Accelerated Recovery Initiative program that the Generic Pharmaceutical Association (GPhA) created with the cooperation of the FDA.

“Premier continually works with our members and manufacturers to help prevent and mitigate the impact of drug shortages on patients nationwide,” said Premier’s President of Supply Chain Services Durral R. Gilbert. “Our focus is on continually balancing safety with access and cost, while using market forces to encourage competition and high quality.”

Premier has dedicated itself to ending our nation’s drug shortages through:
  • Policy efforts:
    • Premier was one of the first organizations to highlight the drug shortage crisis to our nation while recommending legislative solutions.
    • The alliance continues to work with the FDA, GhPA and legislators, encouraging federal actions to increase access to drug products and improve drug safety.
  • Safe distribution:
    • Working with selected pharmaceutical distributors to manage drugs on the shortage list through allocation programs that prevents uneven distribution across care providers.
    • Establishing a voluntary and transparent contracting process;
    • Rewarding manufacturers for redundant supply chain suppliers, high quality performance and commitment to manufacture drugs in short supply.
    • Limiting the risk of shortages due to manufacturer quality issues through contracts with 130 generic manufacturers approved by Premier’s National Pharmacy Committee, and
    • Moving significant market share among manufacturers in the bid process by offering dual or multi-awarded contracts to suppliers for products that are currently on the FDA drug shortage list. 
  • Failure-to-supply program
    • Premier also offers an automated failure-to-supply program, helping hospitals easily capture millions of dollars in compensation when drug shortages occur and the provider has to purchase an alternate drug at a higher cost.

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