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Buyer beware: importing drugs comes with big risks

At first blush, importing medicines sounds great – a patient without insurance or facing a high deductible or co-pay may find the prices quite attractive, not to mention the possibility of being able to bypass a doctor’s office visit to get a prescription. But importation carries major risks.

The quality and authenticity of drugs plucked outside the tight regulatory system that FDA administers in the US are highly suspect. In fact, counterfeiting and trafficking of medicines is a multi-billion dollar dangerous business.

Here’s a closer look at the risks of importation:

  • The US is the gold standard when it comes to regulating the safety of our medicines. Regulatory oversight from FDA and federal and state government agencies plays a critical role in helping keep counterfeit medicines from infiltrating the US healthcare system.  The origins of drugs imported from abroad and outside regulated channels of commerce are uncertain. Investigations have revealed, for instance, drugs being advertised on the internet as “Canadian” even though they have never been in Canada, let alone subject to regulatory oversight by Canadian health authorities.

  • Foreign “pharmacies” and other sellers of prescription drugs for import into the US are largely beyond the regulatory reach of US authorities that regulate the practice of pharmacy (such as state boards of pharmacy). In fact, the National Association of Boards of Pharmacy found that 96% of 10,000 online drug sellers were not in compliance with US pharmacy laws and standards. Of those drug sellers not in compliance, 88% did not require a valid prescription and 91% appeared to have affiliations with fraudulent or illegal online pharmacies!

  • The likelihood of low-cost drugs advertised on the internet being counterfeit and potentially dangerous to health is high. As CNN reported, quoting an online seller from Pakistan, “We sell all over the world, to America, Europe, China, Iran and Iraq. All over. But we do not take these medications ourselves, nor do we recommend them to anyone we know, because they are not good quality medications.”

ZINNAT is a GSK Antibiotic. Chemical testing showed no presence of the API (Cefuroxime Axetil). Example case from Ecuador.

 

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These aren’t hypothetical risks. As a global company, we have first-hand knowledge of the counterfeit threat. In 2016, there were 57 instances of counterfeit GSK prescription products in 14 different countries; 21 different products, including 4 vaccines, were confirmed to be fake. Going back to 2013, there have been 68 different counterfeit prescription drug products in 18 separate countries. That’s 68 counterfeit products discovered in the last three years for just our company alone!  In the US in particular, the market where the world’s “gold standard” of drug oversight and regulation is in effect, opening this Pandora’s Box of risk to patients is simply not good policy.

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