Sellers of Unapproved Drugs Proliferate Online, Posing a Serious Threat to Global Public Health, Reports NABP

The National Association of Boards of Pharmacy^® (NABP^®) today issued a report stressing the continuing global public health threat posed by unapproved drug products distributed via the Internet. As detailed in the Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: October 2013, most rogue online drug sellers reviewed by NABP in the last three months offer foreign drug products or medications not approved by the United States Food and Drug Administration (FDA), as do nearly half of all rogue sites NABP has reviewed since 2008. Global stakeholders – including regulators, public health organizations, and private entities – agree that drug products failing to meet national regulatory safeguards place patient health at risk. NABP and its member state boards of pharmacy continue to encourage and work with federal regulators and other public and private entities to educate the public about the dangers of unapproved drugs and other risks of buying medications from rogue Internet drug sellers.

Because many unapproved drugs fraudulently bear trademarked brand names, issues of intellectual property (IP) complicate international debates about how to stop their distribution. The report includes an overview of perspectives from US regulators and various international regulatory bodies and public entities. Both US and international stakeholders agree that medications not approved by national authorities, or circumventing approved distribution channels, pose dangers to patients. For example, the World Health Organization indicates that “spurious/falsely labelled/falsified/counterfeit” medical products can result in “treatment failure or even death.” The United Nations Office on Drugs and Crime, while distinguishing between drugs that violate IP rights and fraudulent drugs with dubious contents, notes that, for “the consumer, the results are the same.”

As indicated in the report released today, “Regardless of the terminology used to describe them, drug products that circumvent supply chain safeguards place patients at risk.” Two safeguards often bypassed by rogue online sellers are sourcing medications from drugmakers that use current Good Manufacturing Practices and sourcing medications from licensed wholesale distributors. Instead, drugs subject to poor quality controls, unregulated trade zones, and rogue wholesalers are frequently distributed by rogue sites, as highlighted in the report.

NABP has recently identified 109 additional rogue Web sites that are operating out of compliance with pharmacy laws and practice standards, bringing the total number of rogue Internet drug outlets identified to 10,288. Of the newly identified 109 rogue sites, 84 (77%) offer foreign or non-FDA-approved medications –  mostly fraudulent knockoffs of trademarked brand name drugs – placing consumers at risk of receiving unsafe and ineffective drugs. In addition, 98% of the 84 sites do not require a valid prescription, creating the potential for dangerous drug interactions and other health risks.

Additional findings on the more than 10,500 Internet drug outlets reviewed by NABP are also presented in the report released today. Nearly 97% of the sites reviewed operate out of compliance with US pharmacy laws and practice standards and those of many other developed countries, and are listed as Not Recommended on NABP’s consumer protection Web site, www.AWARErx.org. The 10,288 Internet drug outlets currently listed as Not Recommended are characterized as follows:

• 5,017 (49%) offer foreign or non-FDA-approved drugs
• 9,064 (88%) do not require a valid prescription
• 2,394 (23%) have a physical address located outside of the US, and most (62%) rogue sites post no address whatsoever
• 1,638 (16%) do not have secure sites, exposing customers to financial fraud and identity theft

To help US consumers find the safest sources for purchasing medicine online, NABP developed the VIPPS^® (Verified Internet Pharmacy Practice Sites^CM) accreditation program. Consumers are encouraged to look for the VIPPS Seal on an accredited site and check NABP’s list of accredited sites on its consumer protection Web site, www.AWARErx.org.

In addition, NABP is working to provide consumers worldwide with a trustworthy online space where they can find legitimate pharmacies through its .PHARMACY generic Top-Level Domain initiative. Only legitimate Web site operators that adhere to pharmacy laws in the jurisdictions in which they are based and to which they sell medicine will be able to register domain names in .PHARMACY.

For the full report with detailed findings on the characteristics of rogue Web sites, and an infographic, visit www.AWARErx.org/get-informed/safe-acquisition/not-recommended-sites.

NABP is the independent, international, and impartial Association that assists its state member boards and jurisdictions in developing, implementing, and enforcing uniform standards for the purpose of protecting the public health.