| Akan Oton at Catalent Pharma Solutions analyses the impact of track-and-trace technology on the reduction of pharmaceutical counterfeiting
Counterfeit drugs are an adverse symptom of the complexity of the pharmaceutical distribution network. Products change hands as many as 10 times, making penetration of counterfeit medications into the supply chain possible. This invariably has an impact on the safety of patients as well as on the bottom line of legitimate pharmaceutical manufacturers.
When companies manufacturing drugs conclude that they can effectively address the patient safety challenges posed by counterfeiters, as well as address the financial losses that counterfeiting creates, they will increasingly adopt track-andtrace solutions across the globe. However, regulators and legislators are not providing manufacturers with the luxury of time to arrive at that conclusion independently. Increasingly, local jurisdictions are taking action.
California’s ePedigree law, mandating item-level serialisation by January 2009, and the recently-passed United States Federal legislation (slated to take effect within 30 months from September 2007) will require the implementation of track-andtrace technology. These technologies provide a solution to the problems of counterfeiting, shrinkage and parallel trade. Mandating item-level serialisation with track-and-trace capabilities can significantly minimise the supply of substandard pharmaceuticals, which are expected to comprise $75 billion of the global market by 2010. TARGETING FAKE PRODUCTS
Consumers reliant on prescription medications have suffered health consequences by consuming fake drugs. Counterfeits look like the authentic product, but contain inadequate active ingredients or contaminants that are potentially dangerous to the consumer’s health, or they may be placebos and equally unsafe for patients with serious illnesses. California’s legislation is gaining public support as advocacy groups, legislators and pharmaceutical companies are acknowledging the severity of the issue. Documenting drug manufacturing and distribution through the supply chain has immediate consumer benefits as authenticity, confidence and the prime driver – consumer safety – are improved |
