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What you need to know now about California e-Pedigree

Where it stands today, what meds are exempt, and what companies have promised to make the date requirements on the pending law.

Pharmaceutical industry input will be welcomed at upcoming meetings concerning pending e-Pedigree law. “Come tell us how you are doing, where you are running into problems,” said Virginia Herold, executive officer of the California State Board of Pharmacy (www.pharmacy.ca.gov/about/e_pedigree_laws.shtml), which initiated e-Pedigree legislation to protect the public.

Herold called in to Mettler Toledo’s (www.mt.com) Pharma Exchange July 10-11 in Chicago with an update on California’s pending e-Pedigree law.
“Overly complex drug distribution makes investigation involving diversion and counterfeiting difficult,” Herold told the audience of 80-plus suppliers, end users, and consultants. “That’s what drove e-Pedigree law in the first place, protection of the public.”
 
Herold cited a recent case where the typical pharmaceutical supply chain model of manufacturer to wholesaler to pharmacy revealed a complex web of one wholesale broker overseeing 28 wholesalers (21 of which were non-licensed in California) and 17 pharmacies.
 
“Pedigree means a record, in electronic form, containing information regarding each transaction resulting in change of ownership of a given dangerous drug,” said Herold, “from sale by a manufacturer through acquisitions and sales by one or more wholesalers, manufacturers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug.”
 
Most important, the pedigree shall be created and maintained in an interoperable electronic system (hence e-Pedigree), ensuring compatibility throughout all stages of distribution. This means a manufacturer cannot simply adopt a serialization strategy without getting wholesalers and pharmacies on board with compatible technology. Drug manufacturers and repackagers are strongly encouraged to serialize drug products and initiate e-Pedigrees as soon as possible, with all participants in the supply chain ready to receive and pass these electronic pedigrees.
 
The need for e-Pedigree
“Why is e-Pedigree needed?” asked Herold. Drug diversion, drug thefts from supply chain, and low penalties for prosecution make the rewards worth the risk of being caught, recalls finding their way back into the supply chain, and market manipulations and “manufactured” drug shortages to drive up pricing, were some of the reasons cited.
Herold pointed to actual thefts, an Eli Lily warehouse where $75 to $80 million worth of drugs was stolen, a Teva truck stolen with $11.8 million worth of drugs inside, a GSK warehouse for $5 million. Clearly, this is big criminal activity.
 
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