confidence in the quality their internal records already show. A more likely problem would be a wholesaler assigning a legitimate label to a falsified drug. Also, the verification service only confirms a product’s identity at the end of the distribution chain, at purchase. These systems cannot track the chain of custody or monitor if the product has been stored and transported properly.

image

Sproxil standard labels with visible serial number and scratch-off covering the secret code number.
SOURCE: Ashifi Gogo.

A reliable system for tracking and tracing drugs through the distribution chain would greatly reduce the likelihood of falsified and substandard medicines reaching patients. Recent technological advances, such as the use of radio frequency identification and the expansion of mobile phones in developing countries, hold promise for supply chain security. The committee believes that manufacturers and governments should use these technologies to integrate all records of a drug’s chain of custody.

Recommendation 5-2: Congress should authorize and fund the U.S. Food and Drug Administration (FDA) to establish a mandatory track-and-trace system. In the interim, the FDA should convene a working group of stakeholders, including the International Federation of Pharmaceutical Manufacturers and Associations and the Generic Pharmaceutical Association, to promote voluntary track-and-trace for all supply chain actors in accordance with existing guidance.

A mandatory track-and-trace system for drugs is the best way to monitor the chain of custody and protect patients from unsafe drugs. A full track-and-trace system would allow all parties in the drug distribution chain to see a complete record of the product’s path from the manufacturer to the patient (Rappeport and Jack, 2012). Track-and-trace systems place unique demands on drug manufacturers, retailers, and wholesalers. Some may see the imposition of a drug pedigree system as a matter of pharmacy practice, and therefore under the jurisdiction of state boards of pharmacy, the state health department, or another state authority. To avoid confusion on this question, Congress should clearly authorize the FDA to require manufacturers to trace back finished dosage forms to their constituent ingredients. This authority should accompany an increase in funding to allow the agency, which has received many unfunded mandates in recent years, the staffing and technical upgrades necessary to monitor compliance (McCain, 2011; Palmer, 2010).

A track-and-trace system would allow pharmacists to identify suspicious drugs before dispensing them and would facilitate more efficient product recalls (Buynak, 2011; DeCardenas, 2007). Some versions of track-and-trace exist in the system already. Companies tag drug pallets or other bulk packages with radio frequency tags, for example, but use barcodes or other identifiers on smaller units (Lefebvre et al., 2011). Full track-and-trace will require changes to drug primary pack labels and changes to the packaging and repackaging practices at wholesale. These changes have delayed acceptance of full track-and-trace (Yukhananov, 2012).



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