Many thanks to Anna Fraenkel and the team at IQPC for organising this year’s Packaging and Labelling Summit in Basel, it was a great event that was well attended.
I have pulled out a few my highlights of the event below.
Book launch and chairing the event
My colleague and co-author Andrew Love chaired the first day of the event and we took the opportunity to officially launch our new book, Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities, which is now available on Amazon.
Many thanks to those people who took the time to flick through the book during the event and give us some great immediate feedback.
Falsified medicines directive and serialisation
Clearly, given the recently published Falsified Medicines Directive in Europe, a focus of attention at the Summit was on serialisation. It took me back to my time managing serialisation at GSK to listen to the speakers from a number of Pharma companies and suppliers share their experience of implementing serialisation pilots and the first live implementations.
Of the many messages, a few came through from all the speakers:
- Serialisation is happening now, so if you haven’t started tackling it, then you need to.
- It takes years and lot of effort to build serialisation capabilities in any organisation.
- Whilst some people are trialling aggregation on packaging lines, the implications of this significantly more complex serialisation model are forcing companies to tread very carefully, often adopting local solutions for specific market requirements such as Turkey.
When asked about the likely timing of the publishing of the detail requirements for the legislation, which then drives the implementation timing three years later, the panel discussing the topic were unanimous in believing that these requirements would be published in late 2013 or early 2014. This would set a likely implementation date in most European countries of 2017.
Single dose pack marking
Dr Roberto Frontini, from the European Association of Hospital Pharmacists, gave a very interesting talk on research that demonstrates that individual dose, machine readable pack marking significantly increases patient safety.
I would emphasise that this has nothing to do with serialisation, as the requirement here is to mark the individual dose (e.g. a blister pocket or vial) with a machine readable code (e.g. 2D datamatrix) containing the product code (e.g. Global Trade Identification Number). With this, scanners and computer systems can be used in the process of dispensing and administering drugs to patients to ensure that they are receiving the right medicine.
If the information in this dose marking is limited to product codes, then the coding can be built into static packaging labelling and artwork, significantly simplifying it’s adoption by manufacturers.
Packaging’s role in patient compliance
Tassilo Korab from the European Healthcare Compliance and Packaging Council (EHCPC) gave a talk and hosted a round table discussion on the topic of packaging’s role in ensuring patient compliance. In the context of the discussion, compliance was taken to mean: right medicine; right dose; right application; right time and for the duration of the prescription. Soren Skovlund, form Novo Nordisk, also spoke on the topic.
Whilst research shows that the reasons poor compliance are many and complex, packaging and the information provided on it, and linked to it electronically, are clearly key elements to improving compliance. One of the key thrusts of the EHCPC’s argument, is that we need a better balance between the often opposing requirements of [providing information and motivation to patients to improve compliance] and the need to avoid [Pharma companies advertising too and unduly influencing drug choices.]
The EHCPC and it’s members believe that there will need to be a readjustment of the current regulatory focus in many countries on using packaging to ensure all the risks of a medicines are spelt out to patients, as this is not a very encouraging message where compliance is concerned.