March 27, 2008

Regulating Online Pharmacies

Bryan A. Liang, MD, PhD, JD

According to some sources, there are at least 1,000 Web sites selling prescription drugs. Of course, not all of which are legitimate.  Considering the sheer number of hits an Internet search for "online pharmacy" returns, it's not surprising that the U.S. Senate has put the Online Pharmacy Consumer Protection Act of 2007 on its legislative calendar.  

One provision in the Act will prohibit an online pharmacy from selling a controlled substance over the Internet without a valid prescription. This is not an isolated concern. In fact, recently a Utah couple was in the news for their role in an international counterfeit drug operation in which they received and distributed shipments of hundreds of drugs, sometimes thousands of tablets, without a license or doctor's supervision.

As I've noted elsewhere, by confronting the safety issues associated with online drug access, requiring a prescription is 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.

Stories of people who've died after purchasing controlled substances through online pharmacies are tragic. 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 seller.

Unfortunately, online drug peddlers prey upon an 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. The bulk of new abusers are in the 12- to 17-year-old age group.

Further, beyond selling drugs of abuse to children, 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 patients 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.

Unregulated online sellers represent a lose-lose situation—patients getting the drugs of abuse they want; and patients not getting the drugs of treatment they need.

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.

Regulating these pharmacies should include verification that consumers have a valid prescription. But these sellers should also be licensed in the state where they sell drugs just like normal pharmacies, and be subject to rigorous oversight standards, such as the VIPPS program--the Verified Internet Pharmacy Practice Site accreditation program created by the National Association of Boards of Pharmacy.

The idea of ensuring that pharmacies verify prescriptions is a good one. But it is only a start. Oversight must include assurances that they are legitimate, have a license, and verify the need for the medications they dispense.

For more information about buying safely online, go to SafeMedicines.org.