Combatting Diversion: One More Compelling Driver for Serialization

Stakeholders should take action before electronic pedigree infrastructure emerges.

By Steve Wood
President and CEO, Covectra

Over the last few years, prescription drug diversion and abuse has grown at alarming rates, resulting in an increase in the number of deaths and hospitalizations. Opioid addiction and abuse has become one the nation’s most serious healthcare crises. More than 23,000 people die each year from prescription drug abuse—more than are killed in traffic incidents.

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Vendors Highlight Serialization Solutions

Vendors showcased serialization solutions at Interphex 2013, as an air of urgency to put compliance measures in place this year has developed for pharmaceutical companies.
“It’s real, it’s here, it’s happening,” said Mike Salinas, director of manufacturing technology, M&W US, Inc., noting that non-compliance will jeopardize existing markets, as countries develop their various coding requirements, and California deadlines for a supply chain e-pedigree beckon in the US.

Daiichi Sankyo to Use Acsis Serialization Management Suite

Acsis Inc. reports that Daiichi Sankyo Inc. has selected the Acsis Serialization Management Suite for use at the company's packaging plant in Bethlehem, PA. Acsis will manage implementation and support as Daiichi Sankyo begins using the solution initially as a pilot toward full compliance with electronic pedigree mandates and other regulations. Acsis's serialization management solution will be coupled with vision and printing equipment from Cognex and Domino.

Systech International Adds to Its Board of Directors

Pharma serialization solutions provider Systech International is adding two professionals to its Board of Directors, John Bailye and Michael Fawkes. “We are delighted to welcome new members to our Board, John Bailye and Michael Fawkes, who bring a vast amount of industry experience and business acumen upon which Systech will draw as we continue to grow,” said Robert DeJean, President and CEO, Systech International, in a press release.

Optel Vision offers 3D Animated Track and Trace Video

The new video demonstrates a complete bottle line serialization process from IT server to warehouse, covering the various steps and details involved in serialization and track & trace.

California BoP Modifies First Proposed E-Pedigree Regs in Response to Public Comment

During its public board meeting on December 13, the California State Board of Pharmacy discussed written and oral comments provided in response to the first proposed regulations needed to implement the state’s electronic drug pedigree provisions.

AndersonBrecon Cited For Serialization Technology

AndersonBrecon announced it has become the first company to secure two awards in the same year at this year’s European Outsourcing Awards Madrid, Spain.

Serialization Addressed At Omega Design-Hosted IoPP Meeting

Omega Design Corporation,  a global provider of packaging machinery and serialization solutions, and bottle unscrambling technology , hosted the Fall meeting of the Institute of Packaging Professionals’ (IoPP) Drug and Pharmaceutical Packaging Committee from September 23-25, 2012 at its Exton, PA facility.

California Staggering Its E-Pedigree Regulations

As the California State Board of Pharmacy (CA BoP) begins initiating the adoption of regulations to implement the state’s electronic drug pedigree law, recent cases of fraud and diversion are coming to light, perhaps offering renewed justification for the law.

In July, dozens of people were charged in New York City for diverting and trafficking prescription drugs for treating HIV that were paid for by Medicaid, in some cases twice. Diverters reportedly purchased prescribed drugs from Medicaid beneficiaries, removed patient labeling from bottles, and added counterfeit labels as needed to redistribute the drugs back in the supply chain. According to a press release issued by the U.S.

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California Needs Stakeholder Input in Order to Permit Inference

With several drug manufacturers already employing 2-D bar coding as they prepare to meet California’s electronic pedigree rule, inference will be key to achieving both supply-chain efficiency and regulatory compliance.

Inference refers to inferring “the contents of a case, pallet, or other aggregate of individual units, packages, or containers of dangerous drugs, from a unique identifier associated with the case, pallet, or other aggregate, without opening each case, pallet, or other aggregate or otherwise individually validating each unit,” according to the California State Board of Pharmacy (CA BoP).

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