What so great about this you ask? Well, all European countries (and Canada too!) drug companies make and package the drugs they sell. That's not the law in the USA. A wholsaler sells a powder to another packager, then that company re-packages it, etc. often more than 6 times...leaving a lot of room for discrepancy and crime. Once you lose chain of custody, you lose everything...
•Some drugs take a circuitous route from factory to pharmacy shelf as they are bought and sold by wholesalers, changing hands four, five, six times or more. Sometimes, the pharmacies can't find out exactly who had the drugs.
Fake drugs show up in U.S. pharmacies A Threat to Our National Drug SupplyFROM 2003!
Fake drugs show up in U.S. pharmacies
By Julie Appleby, USA TODAY
As more high-priced prescription medications hit the market, they are proving irresistible to counterfeiters, who have successfully slipped fake, mislabeled and mishandled drugs into U.S. pharmacies. Some examples:
•Investigators have seized vials of anemia treatments Procrit and Epogen containing 20 times less active ingredient than labeled.
•AIDS patients who rely on Serostim to prevent muscle wasting have fallen ill after injecting a fake.
•Pharmacists have alerted the Food and Drug Administration to white pills labeled "aspirin" in bottles of schizophrenia treatment Zyprexa.
•Ten different types of counterfeit drugs moved through Florida in the past two years, investigators say, including Procrit, Epogen, Serostim, Zyprexa, antifungal Diflucan and AIDS drugs Combivir and Retrovir.
Many of the fakes are so good that pharmacists have trouble telling them from the real thing. Investigators and pharmacists say the problem of counterfeit, mislabeled or mishandled drugs could spread beyond the relatively few medications affected now unless state and federal regulators tighten requirements for the nation's drug wholesalers. (Chart: Counterfeit drugs in circulation)
"I've been in this business for 40 years," says pharmacist Lowell Anderson of Bel-Aire Pharmacy in White Bear Lake, Minn. "I have less confidence in the integrity of the supply line today than ever before. It scares me."
What some investigators are calling the biggest jump in fake-drug cases in more than a decade is fueled by three things: increasingly sophisticated forged labels, an abundance of small wholesalers buying and reselling medications, and a growing number of expensive new treatments that can net forgers large profits.
While still only a tiny fraction of the $192 billion worth of drugs sold in the USA annually, the amount of counterfeit or adulterated drugs could grow as additional costly, genetically engineered medications hit the market in coming years, investigators fear.
"There is a huge amount of profit to be made for those able to counterfeit these products," says Gregg Jones, an investigator at Florida's Department of Health.
The lowest dosage of a vial of the anemia treatment Epogen, for example, costs about $25. Recently, investigators found low-dose vials had been relabeled by a sophisticated forger. The vials then appeared to contain the highest dosage available, which sells for $495, netting a profit of up to $470 a vial for those who faked the labels.
What concerns health professionals is not just that some unscrupulous dealers are making money off the system, but that "Grandma could be going through kidney dialysis with counterfeit drugs," says Rick Allen, deputy director of the Georgia Drugs and Narcotics Agency.
Investigators say the cases show there are growing holes in the U.S. drug safety net:
•In most states, it's too easy to get a wholesaler's license to distribute drugs to pharmacies and hospitals. Hundreds — and in some states, thousands — of wholesalers are licensed. An abundance of distributors means more opportunities for problem drugs to enter the system, regulators say.
In Florida, where nearly 1,400 wholesalers are licensed to distribute prescription medications, a grand jury report in February urged lawmakers to toughen licensing requirements. Stricter penalties are needed, the report said, for adulterating drugs, including first-degree felony charges in cases in which patients die. The report did not mince words about the quality of some wholesalers.
"Uneducated, inexperienced ... rank amateurs, many with criminal records, make up a sizable portion of Florida's drug wholesalers," the grand jury said. "No one has to go to (wholesalers') warehouses to buy their tainted product, for eventually they show up in our hospitals, clinics and pharmacy shelves."
Florida lawmakers on May 2 approved the changes recommended by the grand jury. The bill will go to the governor soon.
•Some drugs take a circuitous route from factory to pharmacy shelf as they are bought and sold by wholesalers, changing hands four, five, six times or more. Sometimes, the pharmacies can't find out exactly who had the drugs.
A few states are taking action against counterfeit and mislabeled drugs, but investigators are stretched thin in even the most aggressive states.
In Florida, for example, there are about 10 inspectors who monitor the state's 1,399 licensed wholesalers.
Nevada last year changed its licensing rules to make it tougher to become a drug wholesaler, resulting in an 80% drop in the number of secondary wholesalers. A proposal is pending before the Nevada legislature that would limit the number of times that prescription drugs could be sold and resold. The bill would also require wholesalers who purchase drugs from Nevada dealers to also have a state license.
Florida lawmakers on May 2 set tougher rules requiring wholesalers to have paperwork to document every transaction involving prescription drugs, starting with the manufacturer.
Such "pedigree paper" laws are resisted by the wholesale industry, who say the additional paperwork won't make the system safer because documents can be falsified, just as drugs can be counterfeited.
Requiring such paperwork for wholesalers would "be so inefficient that the legitimate distributors will just take a walk from the market," says Ron Streck, head of the Healthcare Distribution Management Association, a wholesalers group.
Streck says new technologies — such as invisible inks, holograms and computer tracking methods — are better than requiring more paperwork. A tracking system, such as that used now by some overnight mail delivery services, could be in place by 2006 to follow all prescriptions from manufacturer to pharmacy to patient.
"Once that happens, it will be very difficult to counterfeit any of those products," says Streck.By Julie Appleby
"There is a portion of the drug supply — no one knows how big — where drugs have traveled all over," says Louis Ling, general counsel for the Nevada State Board of Pharmacy. "No good can come to a drug that travels through seven or eight wholesalers and literally crosses the entire country."
Yet efforts to oversee the practice by requiring documentation every time drugs are bought or sold — all the way back to when they leave the factory — have been fought by the wholesale industry, which says such rules are burdensome. The FDA has never fully implemented a 1988 law aimed at tracing drugs to their source.
•Drugmakers are not required to report cases of counterfeit products to the FDA or consumers, which sometimes slows investigations. But last month, the drug industry's trade group said its members will voluntarily begin reporting suspected cases to the FDA within five days of discovery.
Drugmakers and wholesalers say they are doing everything they can to protect U.S. consumers. The U.S. drug supply, they say, remains the safest in the world. The solution they favor lies not in increased paperwork, but in better ways to mark drug packages so they can't be faked. They also support efforts to make it more difficult to get a wholesaler's license.
"We take it very seriously," says Ron Streck, president of the Healthcare Distribution Management Association, a trade group representing 78 wholesalers.
The FDA has opened 73 investigations into counterfeit or tampered-with drugs since 1998, with an uptick in the past two years. Thirty-two people have been arrested, the FDA says, and 25 convicted of conspiracy to introduce counterfeit drugs into commerce.
Inspectors in South Florida alone seized $20 million worth of adulterated pharmaceuticals in the past year, the grand jury says."We have in this country an overwhelming confidence in the safety of the drug supply, which has not been jeopardized until recently," investigator Jones says. "It's a nationwide problem."
Leaky distribution system
Most patients think prescriptions they pick up at the drugstore have traveled directly from the manufacturer. At least half of the time, that is likely the case.
An estimated 46% of prescription drugs go straight from manufacturers to hospitals and large pharmacy chains, while 54% go to wholesalers, according to the Florida grand jury report.
Of those drugs that go to wholesalers, 90% go to the three largest wholesalers in the country, Cardinal, McKesson and AmerisourceBergen, which together distribute more than $100 billion worth of drugs each year. They supply many of the nation's hospitals, drugstore chains and mail-order pharmacies.
The rest of the prescription drug market is more complex: drugs go from manufacturers to smaller wholesalers, considered the secondary market, which then sell to pharmacies, clinics, physicians and each other. The secondary market is where investigators say most of the problems occur.
Smaller wholesalers also sell to the three major wholesalers, which buy a fraction of their drugs from the secondary market, where medications may be more readily available or cheaper than buying directly from the manufacturer.
Many secondary wholesalers are legitimate, operating clean warehouses with the proper temperature controls and computer systems to keep track of inventory.
"There are some good ones out there," investigator Allen says. "They serve doctors and other places that the big boys won't sell to."
Still, some secondary wholesalers — and no one knows exactly how many — obtain medications illicitly, buying drugs at a discount from pharmacies or on the black market from Medicaid patients, say Allen and other investigators. Some wholesalers purchase drugs that have been stolen, illegally imported or adulterated, the Florida grand jury reported.
And their sheer number opens the door to unscrupulous dealers, investigators say. Some smaller wholesalers operate out of homes, strip malls, even storage sheds. Some mishandle delicate drugs.
In Nevada, a secondary wholesaler called Dalfens was charged with failing to keep records on $34 million of drugs it bought and sold from 1998 to 2000. The firm also left a box of medication that needed refrigeration out on its doorstep under the hot sun for hours, until an employee of a nearby pizza parlor noticed the package and put it in the parlor's refrigerator. The firm was fined $1 million. The case is on appeal.The Nevada State Board of Pharmacy said the firm's refusal to produce inventory records prevented regulators from tracing the drugs to their sources.
Drug-pricing strategies
Investigators say the pharmaceutical companies' pricing strategies also help fuel the temptation to "divert" drugs from legitimate channels.
One way that happens is through so-called closed-door pharmacies, which don't sell to the public. Instead, the firms claim they sell exclusively to nursing homes or certain other institutions that qualify for price discounts from drug manufacturers. But they illegally sell the drugs they've bought at a discount to wholesalers, who profit by re-selling those medications to other wholesalers.
Pharmacist John Gelinas, owner of Chimes Pharmacy in Berkeley, Calif., says those varying prices charged by drugmakers are partly to blame for the problem of mislabeled or mishandled drugs.
"They sell at 10 cents on the dollar to some people and at full price to us — that encourages diversion," says Gelinas, who also says he carefully inspects all shipments that arrive at his pharmacy.
Wholesalers look the other way when they buy from closed-door pharmacies — and are often not required to show documentation of where they purchased the drugs.
In congressional testimony last summer, William Hubbard, the FDA's associate commissioner of policy and planning, said, "It is easy to see how this system ... facilitates the entry of counterfeit and otherwise unsafe drugs into the marketplace."
The three major wholesalers distance themselves from the secondary wholesale market, saying they buy only 2% to 3% there.
Still, with each of the firms distributing billions of dollars worth of drugs each year, even a small percentage is a lot of individual drugs. One wholesaler was recently found to have 339 cartons of counterfeit anemia treatment Procrit in its warehouses, according to the FDA, which would not name the company because an investigation is ongoing.
Michael Kilpatric, a spokesman for Amerisource, says his company goes beyond federal requirements in checking the authenticity of the about 2% of product it buys from the secondary market.
The company deals with a limited number of secondary wholesalers, he says, and sends its own investigators on visits annually to make sure the wholesalers are legitimate. Amerisource will purchase only some products, such as Epogen and other high-cost biotech drugs, directly from the manufacturers. McKesson and Cardinal say they have similar rules.
"We're very careful about who we buy from," says Greg Yonko at McKesson. "We're acutely aware of what's going on in the market. We heard about counterfeit Procrit long before it got into the news."
Pharmacist Anderson says the industry should create standards to help determine "these are legitimate suppliers and these are not."
He and other pharmacists say that, in the meantime, they do all they can to check packaging to make sure drugs are legitimate. Anderson says he hasn't had any fake or adulterated drugs go through his pharmacy, but he wants to see more action from federal and state regulators: "The government ought to kick someone in the butt and say 'solve this.' "
Edited by nootropikamil, 11 June 2006 - 06:57 AM.
