Blue Sphere Health

Pharmacy Broadband: EU Serialization’s Biggest Challenge?

The debate on serialization and the implementation of the Falsified Medicines Directive in Europe has tended to focus on the upstream tasks. Implementation of the pack coding, data sharing and tamper-evidence requirements will be a considerable burden on individual manufacturers and repackagers. Designing and building the central infrastructure needed to link systems together into national, regional and EU-wide architecture will also be difficult. Less attention has focused on the other end of the supply chain, at the pharmacy. Previous studies, most notably the pilot carried out by EFPIA in Sweden have been in tightly controlled environments. All of the EFPIA pharmacies were in metropolitan Stockholm, owned by the same entity, with existing broadband internet connections and pharmacists familiar with online working and Sweden’s ubiquitous e-prescription system. This is not to belittle the achievement of the multi-stakeholder team or negate the outputs of the pilot project, but to point out that the environment was about as optimal for success as possible. Now fast-forward two years and EFPIA is conducting its procurement process for a full-scale roll-out of this system across Europe. The full Request-For-Proposal has not, at the time of writing, been released. However, the initial scope diagram below (click diagram for larger image) shows that the project will provide an interface to pharmacy systems but does not deal with the implementation task itself. To make a traceability system secure, it is important to have rapid and universal take-up. This may be delayed by factors outside central control and one of the key issues might be broadband access. This is quite variable, as shown below for general public access. (Data from Eurostat via Google, refresh page if graph not visible.) The broadband penetration for general practitioner surgeries and pharmacies (see below) is a bit higher, as you would expect, but is still nowhere near 100% in many countries. The GP data is given as a proxy for the less complete pharmacy data set which does not cover some countries. Pharmacy data below (click diagram for larger image) are from the Pharmaceutical Group of the European Union (PGEU, personal communication) and GP data are from the EU e-Health Strategies Study published in 2011 (data points collated by Blue Sphere from individual country reports). Some of the individual data points are probably inaccurate, and the correlation between GP and pharmacy broadband usage is not consistent, but the overall theme is pretty clear. There are many countries in Europe where the medical profession is not fully online. The first serialization issue that needs to be addressed may be connecting pharmacies to the outside world in real time. EU broadband access may be variable, but trade barriers aren’t. Pharmaceuticals can be bought anywhere in the EU and sold anywhere else provided the seller makes the necessary pack and leaflet alterations to accommodate local requirements at the destination. The traceability systems which have been discussed to date rely on databases, whether national or EU-wide, to check dispensed serial numbers against uploaded data from manufacturers. For this checking process to be worthwhile, it needs to be at or before the point of dispensing the drug to the patient. Relying on offline verification at point-of-sale with periodic database reconciliation is not a feasible option. In the case of a suspicious event coming to light during the subsequent check, tracking down people hours or days after they received their medication may not be possible and is not safe as they may already have ingested a potentially dangerous counterfeit. Inbound inventory management (checking codes when stock is received rather than when it is dispensed) may reduce the risk but is still not a perfect answer. All the broadband implementation trends are in the right direction, and the issue will start to resolve over time, but to get moving quickly those late-adopters will need help. Those commissioning the prospective EU systems – whether it is EFPIA, EDQM, or the EU itself – will need to address this very local and time-consuming issue of getting pharmacists online as well as dealing with the big-picture IT procurement process. The vendors who are being asked to provide, implement and run the EU system(s) will want some clarity on the extent of their business opportunity and the potential risks and barriers to implementation. Pharmacists may demand financial and practical assistance as part of their agreement to participate. This cost should not fall on manufacturers, who are already paying their own manufacturing change costs plus underwriting the central architecture, but my instinct is that the EU will have to find significant budget from somewhere to make the Falsified Medicines Directive a reality in all its 27 member states. Leave a comment below or contact me at mark(dot)davison(at)bluespherehealth(dot)com

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Pharmaceutical Anti-Counterfeiting

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