Check drug wholesalers' backgrounds

Hospitals and pharmacies must check their drug wholesalers’ backgrounds to protect themselves from counterfeit drugs.

The issue of counterfeit drugs is important to pharmacists because counterfeit drug cases have steadily risen since the 1990s. The Food and Drug Administration investigated 22 counterfeit cases in 2002, up from four in 1998, according to its Web site, www.fda.gov.

Part of the problem is that counterfeiting technology has improved, allowing more people to take part in the lucrative drug trade, says Susan Winckler, RPh, Esq., vice president of policy and communications and staff counsel for the American Pharmacists Association in Washington, DC.

“They might not only make an elegant product but an elegant label as well,” Winckler says.

The secondary market—when drugs are in a wholesaler’s possession—is often where the counterfeit problem originates, Winckler says. Drugs frequently move around from one wholesaler to another before reaching the hospital or pharmacy, usually to move a product to a certain area more quickly, she says.

That presents the opportunity for counterfeit drugs to enter the market. Government officials in Florida noticed problems with counterfeit products moving into the state in 2000, says Gregg Jones, pharmaceutical program manager at the Bureau of Statewide Pharmaceutical Services, division of the Florida Department of Health in Tallahassee, FL.

The state began noticing labels with adhesives—a red flag for counterfeit drugs—and fake pedigree papers, which help verify the drug’s authenticity.

The label adhesives and missing package inserts typically show the drugs have already been used, while the fake pedigrees are usually associated with counterfeit drugs in the wholesale market, Jones says.

The state passed a new law in May that requires each drug to have a pedigree paper that passes from the manufacturer through the wholesaler to the hospital or pharmacy. Florida has required pedigree papers since 1992, but the requirements were difficult to enforce because the federal government did not have strict regulations, Jones says.

Hospitals and pharmacies will now be able to see the source of the medication and its travels through the wholesale process, Jones says. They can decide whether or not to purchase a drug based on where it has been.

Not many states currently require a pedigree paper to accompany a drug through the wholesale process, Jones says. Florida will phase in the pedigree requirement until 2006, when it will take full effect.

The new law also makes it more difficult for doctors and pharmacies to wholesale drugs without a license, Jones says.

In the past, some physicians would receive drugs such as Lupron or Zoladex at a reduced price and sell it back to wholesalers for a profit, he says.

Florida’s new prescription drug protection law has a maximum penalty of life in prison if a counterfeit drug caused serious injury or death. Drug counterfeiting carried a five-year maximum prison sentence in the past.

TIP: Physically examine the drug. If it looks different than normal, notify the manufacturer.

Also, remind patients to speak up if they notice anything unusual during their treatments. Hospitals and the FDA noticed some counterfeit injections when patients said they burned or stung, Winckler says.

Wholesale oversight is not as extensive as it should be, Winckler says. Although wholesalers must maintain their facilities and adhere to certain standards, laws vary from state to state and not enough regulators exist to verify a distributor’s integrity.

Some manufacturers allow hospitals and pharmacies to purchase direct and cut out the wholesale process, but it would usually cost the organization more, Winckler says.

With wholesalers, manufacturers only have to deal with five or six distribution outlets instead of 70,000 or more if they sold direct to hospitals or pharmacies, she says.

Hospitals and pharmacies need to be able to rely on their distributors’ integrity. Industry leaders have discussed using electronic tracking technology to help verify a drug’s authenticity, but uniform standards would need to be in place nationwide, Jones says.

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