Some highlights from this week’s Pharmaceutical Traceability, Packaging & Labeling Forum in Boston

Some highlights from this week’s Pharmaceutical Traceability, Packaging & Labeling Forum in Boston

I ran a workshop on global serialisation legislative requirements which seemed to get great reviews from the audience. Don’t forget that we offer a legislative update service, so if you need to stay up to date with serialisation legislation feel free to email me about it.

Here are a couple of the interesting points that I took from the conference, one related to serialisation and the other related to labeling and artwork.

US DQSA Serialization implementation discussions: EPCIS and aggregation

At present, for lot level reporting in the USA, the established EDI ASN model is being used to report product sale information from Manufacturers to Wholesalers. Many of us are very concerned that this model is not sustainable in a serialised world for a number of reasons, including: EDI is a push-only model and provides no support for querying information; EDI tends to be used with a local or regional flavor, which is not saleable globally. GS1’s EPCIS standards were developed specifically to meet the needs of serialization communication in global supply chains and meets these and other concerns.  It was great to hear Scott Mooney from McKesson, speaking in support of the use of the EPCIS standard as the way forward in the USA.

Whilst the Drug Quality & Security Act only requires serialization “reporting” in 2023, there is a lot of discussion around the need for wholesalers to have serialization and potentially aggregation information prior to this date. The 2019 deadline requires them to only process serialized product, which provides one such motive to receive serialization information. Given that the big wholesalers effectively mandated the option of electronic reporting for lot traceability at the end of 2014, it is entirely possible that if they require reporting, then it will become the de facto requirement. Manufacturers need to manage this risk as it has potentially significant serialization program implications.

Driving better labeling and artwork using Human Factors style studies

Medication errors are a major cause of issue in the healthcare industry. A quick read of the 1999 report from the Institute of Medicine on “Breaking the Silence” demonstrates this.

Many of you will be are aware of the Medical Devices product development process and will know about the requirement to use Human Factors Studies to investigate and optimise product design with representative user groups. Recently, a number of Pharma companies have been using this technique to optimise their product labeling and artwork designs to reduce medication errors. Both Julie Retzinger from Vertex and Julie Gertart-Rothholz from Merck spoke about great work they had done to optimise carton and IV bag designs. The results are really simple and cost effective ways in which labeling designs can be changed to make a real difference to improve patient safety. Julie’s work is being published in December’s issue of the Journal of Safety Research.

Thanks to Lauren and the team at IQPC for organising another great event.

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