NCPA - National Center for Policy Analysis


May 31, 2005

Paperwork requirements to track every drug sale from manufacturer to pharmacy will do little to protect the integrity of the drug supply chain, says Robb Miller, president of Caladon Health Solutions.

Paper pedigrees can easily be forged and can be used by counterfeiters to "wash" the product so that it appears legitimate. If a well-known and trusted company appears on the pedigree, the assumption is that the pedigree is legitimate, even though that company may have never handled the given product, says Miller.


  • Since the largest wholesalers move literally billions of units of prescription drugs annually, and thousands daily, manual entry of pedigree and lot number information would greatly slow the effectiveness of their distribution systems, which are designed to put urgently needed drugs into the hands of dispensers quickly.
  • These major wholesalers would be forced to employ hundreds of additional employees at each distribution center to track these manually generated pedigrees.
  • These costs would undoubtedly be passed on to the consumer through higher drug prices and would surely slow the distribution cycle of these highly automated wholesalers, putting consumers at risk of not receiving urgently needed medication in a timely fashion.

Finally, says Miller, the Food and Drug Administration and state agencies lack the personnel and financial resources to enforce the pedigree rules, considering the billions of units moving through the system.

Until technology is available to track drugs all the way through the system, only cooperation between wholesalers and regulators will reduce the threat of counterfeit drugs, says Miller.

Source: Robb Miller, "Tracking papers won't help: Enforcing "pedigree" law would be inefficient and costly to consumers," USA Today, May 31, 2005.


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