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Can you tell the difference between a real Lipitor capsule and a fake one? Probably not.
They look alike. They smell alike. They taste alike. Even the packaging and labeling are identical.
In fact, the only difference between them is that one will lower your cholesterol, while the other will kill you.
As online pharmacies multiply, counterfeit drugs are becoming an increasingly big problem. According to the World Health Organization, more than 10 percent of the global medicines market is currently counterfeit.
Congress has finally decided to confront the problem with the Online Pharmacy Consumer Protection Act, sponsored by Sens. Dianne Feinstein (D-Calif.) and Jeff Sessions (R-Ala). The Act would require a valid prescription before online pharmacies could dispense drugs to patients. It would also subject noncompliant online drug sellers to criminal penalties and property seizures.
By confronting the safety issues associated with online drug access, the bill is a big step in the right direction. But it needs to go much further. It should require online pharmacies to be certified so customers can recognize which pharmacies are legitimate.
Unregulated online pharmacies are a prescription for disaster.
Tragic stories of people who’ve died after purchasing controlled substances through online pharmacies have become all too common. For example, Ryan Haight, a straight-A, talented high school scholar and athlete died because of an overdose of Vicodin, a powerful painkiller that he’d purchased without a prescription through an unregulated Internet pharmacy.
Unfortunately, these online drug peddlers feast upon an ever increasing demand: the National Survey of Drug Use and Health found that 6 million Americans aged 12 or older had used prescription psychotherapeutic drugs nonmedically in the previous month, and 3.1 million had abused OxyContin in their short lives. Distressingly, the bulk of new abusers are in the 12 to 17 year old age group.
Further, selling drugs of abuse creates harm, unregulated online pharmacies also maim and injure patients by passing off fakes.
Patients who access drugs through the Internet, who often represent some of the most vulnerable patient populations including the elderly and minorities, don’t know they are not getting the real thing because many diseases are “silent.”
Drugs treating high blood pressure, elevated cholesterol, cancer, and other illnesses don’t provide immediate or obvious clinical changes after being taken.
Further, if a patient is very sick or elderly, physicians often blame a downhill clinical course or death on the disease. So selling counterfeit or tainted drugs is the perfect crime. Online peddlers of fakes take advantage of these vulnerabilities.
Because of the lose-lose situation — patients getting the drugs of abuse they want; and patients not getting the drugs of treatment they need — online pharmacies must be effectively regulated.
However, mandating prescriptions alone is not enough. Unscrupulous online businesses will sell whatever to whomever, as long as they are paid. Just as they’ve embraced counterfeit drugs, they’ll also sell fake prescriptions.
The Feinstein-Sessions bill could help solve this problem by mandating that online pharmacies be accredited or certified before they are allowed to sell.
For example, VIPPS (Verified Internet Pharmacy Practice Sites) accreditation by the National Boards of Pharmacy or a similar program should be mandated.
The VIPPS program ensures Internet pharmacies are appropriately licensed, are legitimate online operators, and are verifying patient prescriptions. This process will ensure the pharmacies are selling only to those who need the drugs and are selling patients the real thing.
Medicines provide great social benefit. Strong, targeted regulatory means must be used to ensure that criminal drug dealers cannot use the Internet to exploit our children and our sick for their own nefarious ends.
Liang, M.D., Ph.D., J.D. is executive director of the Institute of Health Law Studies, California Western School of Law, as well as vice-president of the Partnership for Safe Medicines. |