Drug Serialization and Tracking

Article November 25, 2014 Read time:

Projects: Drug Safety

Drugs can pass through many intermediaries in the supply chain before reaching a pharmacy, creating opportunities for criminals to insert illegitimate products. As a result, stolen and counterfeit medicines have made it onto pharmacy shelves and reached patients numerous times over the past decade.

In 2012, 48 people were charged in a scheme to purchase and repackage an estimated $500 million worth of prescription drugs that had already been dispensed in the New York City area. They sold the diverted product to licensed wholesalers that in turn sold the drugs back to pharmacies, exposing patients to potentially contaminated or expired medicines.¹

The Food and Drug Administration discovered counterfeit cancer medications in the United States several times in 2012 and 2013.² The fake products contained no active ingredient, and it is not known how many cancer patients received these products.

The Drug Supply Chain Security Act of 2013 establishes a national system in which unique serial numbers are placed on every prescription drug package that allows supply chain partners and regulators to trace drugs from the pharmacy back to the manufacturer.³ The law, which will be phased in over a 10-year period, creates new tools that can improve detection of suspect pharmaceutical products in the drug supply chain.

¹ Federal Bureau of Investigation, “Manhattan U.S. Attorney Announces Charges Against 48 Individuals in Massive Medicaid Fraud Scheme Involving the Diversion and Trafficking of Prescription Drugs,” news release (July 17, 2012), http://www.fbi.gov/newyork/press-releases.

²U.S. Food and Drug Administration, “Counterfeit Version of Avastin in U.S. Distribution,” accessed May 1, 2014, http://www.fda.gov/drugs/drugsafety/ucm291960.htm; U.S. Food and Drug Administration, “Altuzan (bevacizumab): Counterfeit Product—Contains No Active Ingredient,” http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298583.htm; U.S. Food and Drug Administration, “Another Counterfeit Cancer Medicine Found in U.S.—Illegal Practice Puts Patients at Risk,” http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm298047.htm; U.S. Food and Drug Administration, “Health Care Provider Alert: Another Counterfeit Cancer Medicine Found in United States: Purchasing Unapproved Drugs Is Risky Business,” http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/ucm338283.htm.

³ U.S. Food and Drug Administration, “Drug Supply Chain Security Act (DSCSA),” http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainsecurityact/default.htm.