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.
Safe Alternatives for Reducing Healthcare Spending
Bryan A. Liang, MD, PhD, JD
Healthcare spending and prices are on the rise—again. The Centers for Medicare and Medicaid Services estimates that overall healthcare spending in America will reach $4.3 trillion annually by 2017. Given that healthcare costs are increasing at nearly three times the rate of inflation, it's no wonder Americans are seeking ways to keep their healthcare costs low.
Some are turning to the Internet, where thousands of Web sites promise big savings on prescription drugs. But Internet-based sales of pharmaceuticals are a major source of counterfeit medicines in industrial countries according to the World Health Organization. In fact, again according to WHO, Internet "pharmacies" ship fakes in more than 50 percent of cases.
Patients don't have to turn to questionable online sellers to get the medications they need. The Partnership for Prescription Assistance (PPA) is a safe alternative for patients who cannot afford to fill their prescriptions and get medicine they need.
The PPA is a clearinghouse of information that is a single point of access to more than 475 public and private patient assistance programs. The program offers language assistance and can provide information in over 100 different languages. Patients only need to answer a few short eligibility questions, which they can do online or by phone (1-888-477-2669) to find out if they quality for assistance programs.
It's always a good idea to save money - but patient safety should never be sacrificed. Being left untreated, injured, or killed is not a good tradeoff for purchasing from risky Internet sellers.
Heparin Havoc Continues
It looks as though the problems from China-sourced heparin are far from over. An unknown substance, similar in chemical makeup to heparin, has been found in batches of the blood thinner produced by U.S.-based Baxter International and Germany-based Rotexmedica.
In some cases, this mystery component comprised as much as 20 percent of the contaminated heparin. Unfortunately, we don't whether this was introduced into the product, whether it was a natural reaction resulting in a byproduct, or if there is some other explanation for the dozens of adverse reactions and at least 19 deaths associated with the product. In any event, it's worrying for patients and providers who rely on this common drug.
Beyond US and German recalls, three Japanese firms have also announced earlier this week a precautionary heparin recall linked to Scientific Protein Laboratories, which processed the raw materials from China used to make active ingredient in Baxter's heparin.
At this time, we don't know source of the heparin problem. But we do know that in the past, there have been dangerous substitutions made when supply shortages for the raw product have occurred. Unscrupulous suppliers don't hesitate to use foreign, possibly toxic, materials into a drug's raw materials if it will save them money. And as I said back in November, it's easier than ever for counterfeiters to use materials of questionable quality to penetrate the U.S. market since pharmaceutical supply chains are becoming increasingly global-and vulnerable.
If contaminates can penetrate and cause injury in heparin's legitimate supply chain, just imagine the possibility of them being used in contraband drugs from rogue online sellers.
If you order medicines online, make sure the Web site is part of the Verified Internet Pharmacy Practice Sites (VIPPS) program. The VIPPS identifies online pharmacy sites that are appropriately licensed, are legitimately operating via the Internet, and that have successfully completed a rigorous criteria review and inspection.
It is important to use all the tools and information at our disposal to protect ourselves. Remember, counterfeit drugs are unsafe at any cost.
Meeting of the Minds
It's an interesting phenomenon. We have general agreement that fake medicines put people in harms way - but an increasing number of these drugs are entering the world's markets. In fact, the World Health Organization estimates that up to 10 percent of all medicines are counterfeits, rising to 25 percent in some countries.
Collaborative efforts took place early last week when international business leaders met with the United States Trade Representative, World Customs Organization and World Intellectual Property Organization, urging them to swiftly complete the Anti-Counterfeiting Trade Agreement (ACTA). This global agreement would be the first of its kind for battling counterfeit drugs.
And as the New York Sun article points out, ACTA takes special aim at “combating what has become the most lucrative type of piracy around the world: fake prescription drugs.” This follows a recent report that intellectual property crimes almost doubled in 2007 compared to 2005, according to Department of Commerce officials.
The Sun’s article highlights how the widespread the problem of counterfeit drugs really is. For example, as of last December, authorities have discovered counterfeit versions of Pfizer drugs in at least 75 countries. And even more disturbing, seven of those counterfeits drug have turned up in legitimate supply chains in at least 25 countries.
This information shows that we need stronger enforcement measures and international cooperation if we are to ever combat the serious dangers these "products" pose to consumer safety. As global leaders work on enacting the ACTA, we need to remember that we are last barrier to harm -- so remember to protect yourself and your family.
As a first step, consumers can sign up for the SAFEMEDS EMAIL ALERT SYSTEM, which broadcasts FDA Counterfeit Alert Network notices as soon as they come out.