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An association for buying groups issues guidelines for hospitals on how to cope with drug shortages
In an effort to combat the potentially tragic effect of the inadvertent use of counterfeit or substandard drugs, the Health Industry Group Purchasing Association (HIGPA) has written guidelines to help health-system pharmacists purchase safe medications from secondary distribution channels during drug shortages.
"When vital medications are in short supply, which happens often and for many reasons, it can create a life-threatening situation," said Fred Asbell, HIPGA's director of strategic initiatives. "We wanted to offer some guidance on how to protect drug integrity to minimize the potential of purchasing drugs that are altered, adulterated, or even counterfeit."
HIGPA, in Arlington, Va., is a trade association of about 175 healthcare group purchasing organizations, manufacturers, distributors, professional associations, and provider alliances. Its Pharmacy Working Group produced the guidelines, titled "Integrity of the Pharmaceutical Supply Chain: Product Sourcing for Patient Safety," which strongly urge pharmacists to gather as much information as possible about a distributor before they need to turn to secondary sources.
"Pharmacists are ultimately responsible for the safety of a system's drug supply, so it's critical that they know who they are purchasing a drug from," said Asbell. "And they need to have that information in hand before their need arises, before they're forced to rely on the fax-of-the-day." He was referring to the frequent notices pharmacists receive from secondary and gray market distributorsas well as primary distribution channelspromoting drug deals, some offering reduced prices, sometimes through the bundling of a variety of drugs. "The problem is that if hospitals need a product badly and they're presented with a source, they may move with too little information to make a safe decision," he said.
Pharmacists in the field say fax-of-the-day offers can be unremitting and enticing. "Too-good prices on a fax-of-the-day can contribute to a too-quick decision," said Ed Maurino, R.Ph., director of pharmacy at Banner Lassen Medical Center in Susanville, Calif. He added that while he always tries to use tried-and-true sources, "at a small rural hospital like mine, we don't always have the time to do as much checking as we'd like."
Faxes-of-the-day are, in fact, "a potential land mine for health-system pharmacists," said Doug Scheckelhoff, R.Ph., director of pharmacy practice sections of ASHP. "Responding to a fax without carefully checking out the source puts patient safety at risk. HIGPA has done a good job of identifying the issues that help avoid the greatest risk."
The HIGPA guidelines proposed that the following process be followed before the need for replacements from alternative sources becomes urgent:
Pharmacists should determine the integrity of potential sources before their need and establish a list of approved secondary suppliers. They can do this through well-established sources and communication with local peers. The guidelines added that "evaluation of secondary suppliers in advance may be difficult due to the sporadic nature of availability. The secondary supplier who fulfilled the last need may not have the current product, which then necessitates the consideration of another alternative supplier in the secondary channel."
Despite time limitations, the guidelines said R.Ph.s should require that the alternative sources provideat a minimuma pedigree back to the previous source. "Their unwillingness to do this should be a cause for caution," said Asbell. Sources should also provide certification that the drug is not a diverted product, that actions by the alternative source will not alter any original manufacturer warranties or guarantees, that the product has been stored and handled consistent with product labeling requirements.
The purchaser "should make every effort possible to validate that the product was stored properly throughout the distribution process for any product that requires special handling and storage such as a narrow temperature range," said the guidelines.
Pharmacists should consider developing a list of key pharmaceuticals that will not be purchased from sources other than the manufacturer or authorized distribution channel.
Emerging technology such as radio frequency identification has the potential to create cradle-to-grave pedigrees, certified by all parties in the supply chain that handled a specific product, but "today's technology and systems do not support this, even in the primary distribution channel. In the meantime, we urge pharmacists to make every effort to thoroughly explore the integrity of alternative sources before they need to use those sources," advised Asbell. To refer to the guidelines, go to www.higpa.org/pdf/02-09-04HIGPARxProductSourcing.pdf.
Judy Chi. Be prepared before drug shortages occur, advises HIGPA.
Sep. 13, 2004;148:33.