Dive Brief:

• FDA formally warned patients and their caregivers Monday not to use pre-owned test strips to check health conditions, making it clear that used test strips could give inaccurate results or lead to infection.
• Sellers are marketing test strips from previous owners, or versions that are not authorized for sale in the United States, either directly or through online marketplaces such as Amazon, eBay and Craigslist, FDA said.
• The strips are part of at-home tests used for a range of diseases and conditions, including blood glucose monitoring, warfarin therapy, pregnancy and cholesterol testing.

Dive Insight:

An underground economy is thriving for test strips, particularly those for blood sugar monitoring by diabetes patients, due to the expense of the items. Test strips sold via online marketplaces often come from people with health insurance who have accumulated extra supplies, according to a report by NPR. The resale of unused test strips for blood glucose is legal.

In another twist, some sellers are thought to be obtaining low-priced diabetes test strips intended for mail-order customers and supplying them to pharmacies for sale at a higher price. Swiss drugmaker Roche has filed several U.S. lawsuits over what it claims are fraudulent schemes involving diabetes test strips, Reuters reported.

FDA, in its safety communication to the public, outlined a number of issues with previously owned test strips that could compromise safety. For starters, inaccurate results from at-home tests may cause a patient to use too much or too little medication, potentially leading to serious injury or even death. Furthermore, used test strips may have been tampered with, or the vials may contain small amounts of blood from the previous owner, which could put patients at increased risk of infection.

Pre-owned test strips may not have been stored properly, particularly if they were removed from their original packaging. Recommended temperature and humidity conditions may have been compromised, or expiration dates changed or covered up. These factors could produce inaccurate test results, FDA said.

The agency also cautions test strips not authorized for sale in the U.S. could be faulty or poor quality because they have not been reviewed by the agency for safety and effectiveness.

FDA said If a seller does not verify a patient's prescription, such as for test strips used with warfarin meters, it is a red flag that a product may be pre-owned or not authorized for sale in the United States.