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FOR IMMEDIATE RELEASE
Contact: Carolyn Hickey
Phone: 703-243-9262

Arlington, VA (February 9, 2004) — Drug shortages, product integrity, and primary and secondary distribution channels all present unique challenges in ensuring the safety of products for patient care. The Health Industry Group Purchasing Association’s new guidelines offer suggestions, which health care providers should consider as they contemplate accessing the dynamic pharmaceutical distribution chain.

The guidelines, titled, Integrity of the Pharmaceutical Supply Chain: Product Sourcing for Patient Safety, was adopted unanimously by HIGPA’s Board of Directors and were released today at the Association’s 2004 National Pharmacy Forum in Marina del Rey, California by HIGPA’s Pharmacy Working Group.

“Drug shortages are among the reasons hospital pharmacists are increasingly facing choices in sourcing products on a daily basis to meet patient care needs. They, in turn, consult with their respective group purchasing organization (GPO) pharmacy executive on how best to address this situation,” said Allen Dunehew, Chair of HIGPA’s Pharmacy Working Group and Amerinet’s Vice President of Pharmacy.

When a health care provider is in urgent need of a product that is unavailable in the routine distribution channel an alternative source must be accessed. The following are guidelines HIGPA’s Pharmacy Working Group suggests should be followed whenever possible prior to the urgent need to obtain product:

• Establish the integrity of the source prior to the need.
• Require that the alternative source provide the following as a minimum:
  • Provide a pedigree back to the previous source.
  • Certify that it is not a diverted product.
  • Certify that actions by the alternative source will not alter any original manufacturer warranties or guarantees.
  • Certify that the product has been stored and handled consistent with product labeling requirements.
• Consider development of a list of key pharmaceutical products that will not be purchased from sources other than the manufacturer, or authorized distribution channel.

The HIGPA Pharmacy Working Group also reviewed the issues surrounding drug importation by health care providers and patients and outlined the minimum safeguards that are critical to have in place prior to importation. They include:

• Electronic pedigree that can provide secure tracking of product at the individual package level throughout the supply chain regardless of its source.
• Development by the FDA of acceptable and efficient regulations on reimportation and importation to ensure product integrity of the imported product.
• Development of technology that tracks storage conditions and validates conformance to USP standards for products that require storage within a narrow temperature range throughout the supply chain.
• Assurance that entities in other countries, which export products to the U.S. market, are regulated appropriately, using the same standards as are required of U.S. supply chain participants.

Pursing importation as a cost savings strategy without implementation of the above safeguards places an undue risk on patient care and is counter to current initiatives to improve patient care and safety, the guidelines state. Going forward, the position of the Food and Drug Administration (FDA) on importation/reimportation should serve as a key indicator for the acceptability of this method of procuring products.

“GPOs unique role in the marketplace provides them an ideal opportunity to help their hospital members deal with drug shortages,” said HIGPA’s President and CEO Robert Betz, Ph.D. “I commend our Pharmacy Working Group for addressing these issues and providing guidelines to providers when they seek to outsource products outside the traditional distribution channel.”

HIGPA formed the Pharmacy Working Group in 2002 to address some of the issues facing GPOs and their health care provider members. A primary focus of the Pharmacy Working Group is to support the efforts by GPO provider members to improve the quality and safety of patient care. To this end, the Pharmacy Working Group produced these guidelines.

To obtain copies of the guidelines visit HIGPA's web site—www.higpa.org—or contact Carolyn Hickey, HIGPA Director of Communications, at (703) 243-9262.

HIGPA is a chartered trade association of over 175 health care purchasing and supply chain organizations. HIGPA's Industry Members include purchasing groups, associations, and health care provider alliances. HIGPA's Trading Partner members include many of the world's leading health care product manufacturers, distributors, wholesalers and related suppliers. According to a recent study conducted by a former principal analyst at the Congressional Budget Office, hospitals save patients over $30 billion each year by purchasing products through group contracts.

To learn more about HIGPA or the group purchasing industry, visit www.higpa.org or call 703-243-9262.

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