Drug Shortages Opening the Door to Counterfeits in the US Warns Report

Drug shortages are driving desperate pharmacy managers to purchase from parallel importation sources that suspiciously have drugs that the manufacturers don’t – are they selling fake medication, stolen, or mishandled, or is it real?

360 drug shortages are predicted for 2011, reports Premier healthcare alliance, in a whitepaper dated August 2011, with the majority of drugs in short supply being those for sedation, emergency care and chemotherapy. While patients and doctors try to postpone care if possible, pharmacists and hospital administrators are scrambling to find sources of medication.

Filling the gap are “gray market” suppliers, who “offer to sell shortage products, typically at exorbitant prices,” though they are unauthorized to do so. Gray market suppliers, also known as parallel suppliers, have offered medications that were back-ordered or unavailable according to the manufacturer, at mark-ups averaging 650% of the standard price for the medication, but exceeding 4,500% for some medicines needed to treat the critically ill.

Marketing the medicines with language such as “We only have 20 of this drug left and quantities are going fast,” in emails and fliers, however these vendors provide products that “the manufacturer and reputable drug distributors can’t supply.” Researchers are concerned that these medications may be counterfeit, stolen, tampered, or mishandled.

Stolen drugs have been returned to the supply chain through gray market sources. The FDA discovered stolen insulin, improperly stored, returned the supply chain through a parallel source, with disastrous consequences. The insulin had lost potency and lives were at stake. The FDA also discovered counterfeit Lipitor that was repackaged through the parallel market and then sold into the legitimate supply chain.

Pharmacy researchers recommend that all medicines purchased have a verifiable pedigree, including the dates, names, and addresses of all parties involved in the transaction, as well as the specifics about the drug, including lot numbers, manufacturer origin. Purchasers must confirm the pedigree by contacting the manufacturer and the manufacturer’s distributor of record.

By S. Imber