Carmen Catizone: Americans Can Protect Themselves from Web Sites Selling Dangerous Counterfeit Drugs

Food and Drug Administration (FDA) recently warned consumers about a potentially dangerous counterfeit version of Adderall tablets being sold on the Internet – the tablets contained the painkillers tramadol and acetaminophen rather than the active ingredients of the authentic ADHD drug, Adderall. In addition, thousands of packages containing unapproved and counterfeit drug products sold to unsuspecting Americans on Internet sites continue to be seized by US Customs and Border Protection. The Web sites peddling these products place Americans’ health at risk, distributing products that can cause more harm than good.

The AWAR_XE consumer protection encourages consumers to make an informed choice when buying medications online by using resources provided by the National Association of Boards of Pharmacy^® (NABP^®). As part of its mission to protect the public’s health, NABP has reviewed, more than 9,800 Web sites selling prescription drugs. AWARxE alerts consumers that only 3%, or 328, of these sites appear to be in compliance with state and federal laws and NABP patient safety and pharmacy practice standards. The other 97% of these sites are considered rogue sites and are listed as Not Recommended on the AWARxE Web site, www.AWARErx.org.

Of the sites reviewed, those currently listed as Not Recommended are characterized as follows:

• 87% do not require a valid prescription
• 50% offer foreign or non-FDA-approved drugs
• 59% use an online questionnaire to evaluate patient      health and medication needs, which can be very dangerous
• 24% are located outside of the United States and      selling drugs illegally to patients in the US

Lives have been lost due to people buying medicines from sites that send dangerous drugs without medical oversight that may have been tampered with, expired, or even fake.

FDA regulations and federal and state laws help ensure a secure drug supply chain for products distributed within the US, such as those purchased by patients at the local community pharmacy. In fact, the US drug supply chain is one of the safest in the world. But what happens when consumers go outside of this safety net by purchasing drug products on the Internet that are shipped from locations around the world?

Many Web sites selling prescription drugs are unlicensed, operating illegally, or operating from foreign countries where medicines shipped to the United States are unregulated. Thus, there is no way of knowing whether the drug product received is contaminated, sub-potent, super-potent, expired, or counterfeit, or whether it has been stored and shipped under proper conditions to maintain its effectiveness. Counterfeit drug products often contain too little or too much of the active pharmaceutical ingredient, and often these products contain toxins such as glue, chalk, and rat poison.

And that Canadian online pharmacy with the cheaper prices? It may be calling itself a “Canadian pharmacy,” but it may actually obtain its medications from countries in Asia, South America, or Eastern Europe, where quality standards are more lax and counterfeit medications more widespread. While counterfeit medications can surface anywhere, they are significantly more common in developing foreign countries. That is the problem with buying medicine from foreign sources – you never know what you’re getting.

In addition, it is illegal for pharmacies in Canada to fill prescriptions unless ordered by Canadian-licensed prescribers. So, if an online Canadian pharmacy is in compliance with Canadian law, it would not fill a prescription written by a US doctor. Also, Web sites using online questionnaires to issue “prescriptions,” do not establish the valid patient-prescriber relationship recommended by both Canadian and US authorities and required by law for many prescriptions in the US. Further, US law does not permit Internet pharmacies in Canada to sell medications for importation to United States residents. So, AWARxE cannot recommend any Canadian site selling drugs to Americans because FDA regulations prohibit this activity. Prescription drugs imported from other countries are not FDA-approved and their safety and effectiveness cannot be ensured because they are outside the legal structure and regulatory resources provided by Congress.

Safest Way to Shop for Medicine Online

There are also legitimate, licensed Internet pharmacies that dispense drugs to patients in the US in compliance with federal and state regulations. However, it can be difficult for consumers to know which sites are legitimate Internet pharmacies when thousands of rogue drug outlets use state-of-the-art sites that may look like legitimate online pharmacies.

AWAR_XE wants consumers to know about the safest way to purchase prescription medications online. When ordering prescription medication online, consumers can look for the VIPPS^® (Verified Internet Practice Pharmacy Sites^CM) seal, and check the VIPPS list on www.AWARErx.org to make sure the site is listed there.  VIPPS-accredited sites are in agreement with all federal and state regulations and NABP safety standards. Some VIPPS-accredited sites may even offer discount prescription programs to help offset the cost of medications.

Association Takes Further Steps to Protect Public Health from Rogue Sites

To potentially provide consumers with another powerful tool for distinguishing legitimate Internet pharmacies from the thousands of rogue Internet drug outlets, NABP, with the support of a global coalition of stakeholders, has applied to the Internet Corporation for Assigned Names and Numbers (ICANN) to become the official registry that will operate the new .pharmacy generic Top-Level Domain (gTLD). Under the NABP proposed plan, the .pharmacy gTLD will be restricted to legitimate Web site operators throughout the globe that adhere to the pharmacy laws specific to the jurisdictions in which the pharmacy is domiciled and to which it sells prescription drugs.

Through the AWARxE program, NABP is raising awareness among consumers, regulators, legislators and other stakeholders about the dangers of rogue Internet drug outlets and counterfeit drugs, as well as the safest way to purchase medications online by using a VIPPS-accredited Internet pharmacy. NABP also works with boards of pharmacy, federal regulators, and other public and private stakeholders to educate the public about these issues. Through communication and cooperation, NABP strives to advance the efforts of regulators and other entities to curtail the online trade of illicit and counterfeit medications. NABP publishes its research in the quarterly Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators.

In addition to providing the most recent NABP statistics on rogue Internet drug outlets, the April 2012 issue of the report explains how the ongoing shortage of certain medications has created a lucrative niche market for counterfeiters and so-called gray market distributors. The April 2012 report is available for download from the AWARxE Web site at http://www.awarerx.org/Not_Recommended_Sites.php.

Carmen A. Catizone, MS, RPh, DPh

Executive Director, National Association of Boards of Pharmacy

AWARxE^® is a consumer protection program provided by the National Association of Boards of Pharmacy Foundation^®. The National Association of Boards of Pharmacy is an impartial professional organization that supports the state boards of pharmacy in creating uniform regulations to protect public health.