Commendable as they are, FDA’s efforts to promote patient safety through mandated bar coding and encouraged RFID tagging are not enough. And, even if every ministry of health around the world were to do the same, it still wouldn’t be enough.
Why? Because country-specific regulations may satisfy the needs of those countries, but they often clash—or simply just don’t click—when products move across borders throughout the global supply chain. When it comes to automatic identification, codes developed for one tracking system won’t necessarily be recognized by another.
How can a manufacturer of products supplied to the global marketplace keep up with all the regulations and still be able to track and trace its own products with ease? By working with other manufacturers to harmonize auto-ID standards. In this month’s roundtable discussion (p. 48) with pharmaceutical and medical device packagers, these professionals describe their voluntary work toward harmonization in the GS1 global Healthcare User Group (HUG).
“Multinational companies are struggling to keep up with individual market needs that keep being put out there in the form of regulations that are divergent from one another,” says Rich Hollander, senior director of packaging services for Pfizer. “The HUG was formed to develop global standards in the healthcare industry when it comes to automatic identification.”
The HUG’s efforts could very well obviate the need for auto-ID regulations. “We are seeing more and more interest from people who do not want mandates, such as regulatory bodies and governments,” says Peter Tomicki, global packaging project manager for Baxter and a HUG participant. “They would like to see one harmonized approach and then basically say, ‘Go follow that.’ We have seen participation from countries around the world. We are gaining traction in the industry.”
And the HUG may even challenge some regulations. In its bar code rule, for instance, FDA requires that the National Drug Code be encoded in a linear bar code. “The HUG feels that a linear symbology may be too limiting,” says Hollander. “We would like to allow the use of a two-dimensional bar code for reasons that were not articulated very effectively back in the rule-making process. The HUG is in the process of writing a letter to FDA to formally request that it reconsider the two-dimensional code.”
Our best hope against threats to patient safety lies with the product manufacturer. The HUG’s efforts are significant, precisely because stakeholders, not regulators, are doing the work. “If the healthcare industry can come up with global standards that make sense and meet the needs of stakeholders, we will have a powerful approach,” says Tomicki.
Daphne Allen