NASHVILLE — A Nashville drug wholesaler, Cumberland Distribution, busted for buying diabetes, blood pressure and HIV medicines on the streets of Miami and New York and then reselling the pills to pharmacies nationwide sparks an important question: Just how safe are the drugs in your medicine cabinet?
The short answer, government and pharmaceutical experts say, is they're probably safe. But consumer advocates say there's no way to tell for sure.
The United States has one of the safest distribution systems in the world. "The FDA concern, however, is that the U.S. drug supply is vulnerable to criminal activities, such as diversion and theft of legitimate drugs to drug counterfeiting," said Food and Drug Administration spokesman Chris Kelly.
That has consumer advocates and some lawmakers concerned.
Late last year, Congress passed sweeping new regulations after a meningitis outbreak caused by tainted drugs manufactured in compounding pharmacies killed 64 patients nationwide. Hundreds more were sickened by the tainted drugs.
Included in that legislation is the Drug Supply Chain Security Act, which creates a new national electronic "track and trace" system that eventually will require unique product identifiers — such as bar codes — on all pharmaceutical drug packages. The system will enable manufacturers, wholesale drug distributors, repackagers and pharmacies to verify every step along the drug supply chain to ensure medications do not come from counterfeit sources.
The short answer is that there's not much consumers can do for now.
Dr. Michael Carome, director of Public Citizen's Health Research Group
However, the FDA said it will take 10 years to put that new system — which should electronically track all medications bought and sold in the U.S. — into place. But without that system, guarantees for the safety of medications are few.
"The short answer is that there's not much consumers can do for now," said Dr. Michael Carome, director of Public Citizen's Health Research Group, a consumer advocacy organization.
"Imagine these pharmacies that had the wool being pulled over their eyes," he said. "How can one reasonably expect a consumer to know that, a) the drugs in the bottle weren't stolen or counterfeit or, b) aren't tainted. There's no easy way to make the assessment."
In January, U.S. Sen. Lamar Alexander, R-Tenn., urged the FDA to pick up its pace, but thus far, the agency's timeline has remained unchanged. Federal officials say creating the new nationwide computer tracking system linking thousands of pharmacies, drug manufacturers and middlemen will be a complicated and difficult process.
Pharmacists say there's little cause for alarm
In the meantime, pharmacist groups point out that most chain drugstores, supermarket pharmacies and independent stores have longtime relationships with legitimate manufacturers and suppliers, and say consumers have little cause for alarm.
National chain stores such as Walgreens and Wal-Mart are authorized distributors for many of the nation's largest pharmaceutical companies, leaving no room for middlemen who could tamper with, substitute or divert the drugs.
And many independent pharmacies join buying cooperatives that purchase medicines directly from manufacturers or the nation's biggest and best-known wholesalers, said Ferrell Haile, a state senator from Gallatin, Tenn. He is also a pharmacist who sits on the board of American Pharmacy Cooperative Inc., a buying group of 1,300 small pharmacies across the country.
Scam raises questions
Haile said he finds it difficult to understand how the drugs sold by the company that ran the scam — Nashville-based Cumberland Distribution — could have made their way to legitimate, licensed pharmacies, which typically have long-term relationships with their suppliers.
"I've never heard of (Cumberland), so who are they selling to?" he said. "I've never gotten a call from them. I've never gotten a call from an independent pharmacist asking about this group. Who is buying from them?"
The scam involved Cumberland buying pills through networks of "diverters" in Miami and New York who purchased them from people on the street or in nursing homes, then repackaged and resold the drugs to pharmacies across the country. Federal authorities say the scam netted $60 million in sales over a three-year period before a raid shut down the operation in 2009. Federal authorities have not released the names of the pharmacies that bought the drugs.
Last week, husband and wife Charles and Brenda Edward entered guilty pleas in the scheme. A third person, Jerrod Nichols Smith, will stand trial on related charges in October.
"Consumers should always talk to their pharmacist," said Baeteena Black, executive director of the Tennessee Pharmacists Association. "Talk to them anytime you get a new prescription or anytime you receive a medication that looks different than the one you've had before. ... Look at those labels and ask questions. Being an informed consumer and asking questions is the best safeguard."