10 packaging safety considerations for pharma
The task of meeting the 'Safety Features' requirements of the EU Falsified Medicines Directive (EU-FMD) is daunting, and the details of the proposed legislation are not widely understood. Christoph Krähenbühl reviews the final draft Delegated Act (DA) and summarises the key actions for pharma companies.
The final draft of the EU-Falsified Medicines Directive 'Safety Features' Delegated Act (DA), posted in August on the EU Commission website, is very close to the definitive version due to be adopted soon.
This means that, by early 2019 (or even late 2018), every pharma manufacturer that supplies Europe – whether originators, generics manufacturers, virtual pharma companies, parallel traders, re-packagers or CMO's – must have adapted its packs, implemented tamper evidence capability, and established systems, processes and master data to be in full compliance with the EU-FMD. If they do not, they can no longer sell their products in the European market.
The deadline for implementation is approaching at speed, so what do pharma manufacturers need to take into account? Below is an outline of the 10 main considerations:
1. Timelines for EU states: The EU-FMD will impact every participant in the healthcare supply chain in 32 states in Europe from late 2018 or early 2019. This includes the 28 EU member states and three non-EU European Economic Area (EEA) members Norway, Iceland and Liechtenstein, as well as Switzerland. The exceptions are Belgium, Italy and Greece, which are deemed to have pre-existing features in place that will see their compliance timeline extended by a further six years.
2. Scope of products: All prescription-only medicines supplied to the public are in the scope of this legislation and the first items on the over-the-counter (OTC) blacklist have already been announced. The list of prescription medicines that are excluded contains radionuclides, medicinal gases, IV solutions in Anatomical Therapeutic Chemical (ATC) therapeutic subgroup B05B 'blood substitutes and perfusion solutions', contrast media and homeopathic medicinal products, among others. The proposed blacklist of OTC products that will be subject to the safety features requirements is even shorter and currently consists of two strengths of omeprazole capsules. The inclusion of this product gives a good indication of how the risk-based approach will be administered: this is not only a product that is OTC in some markets and prescription-only in others, but omeprazole was also subject to falsification alerts in April 2013.
3. Unique identifier and data carrier: Every manufacturer needs the capability to generate, print, capture, verify, store and manage the 4- or possibly 5-element unique identifier carried in a 2D Data Matrix printed on every pack. Getting the right code on the right pack sounds trivial but there are a number of practical challenges. It requires a sound understanding of product codes, in particular the GTIN/NTIN situation, a robust master data management system and process, high data quality and, above all, the understanding in the organisation that what is required is a step change from managing the product code carried on the sales pack as part of the artwork to ensure the correct code is printed alongside the other data elements.
4. Pack, artwork, tamper evidence: The key concept at the core of the EU-FMD from the outset is the systematic mandatory verification of all packs at the point of dispense. This verification includes both the unique identifier and the tamper-evidence device. Chapters 3 to 6 (Articles 10 to 30) describe what this means in practice for many of the alternative dispensing practices found in Europe's complex healthcare supply chain, e.g. for pharmacists and people operating in healthcare institutions.
5. Item level but also 'aggregation ready': While the European approach focuses on the pack/item level for the major use case envisioned (point-of-dispense verification), there are a number of situations where operating at a higher level of aggregation will make a lot of sense, and has been deemed acceptable by the lawmaker. It does, therefore, make sense that even if manufacturers limit their implementation to item level initially, their requirements should specify the aspiration to provide 'aggregation-ready' equipment at least.
6. Europe-wide 'repositories' infrastructure: Responsibility to upload the data to the repositories has now been assigned to the Marketing Authorisation Holders (MAH) supplying pharmaceutical products into the European market. This obliges every MAH to establish a secure and capable company repository to fulfil their data reporting, data management and record-keeping obligations.
7. Obligations on parallel distributors/repackagers: Article 40 sets out the obligation on all brand owners and repackagers, to ensure the decommissioning of the unique identifier of a medicinal product in every national or supranational repository for products that have been recalled, (temporarily) withdrawn or – and that is new in this version of the DA – have been stolen or will be provided as free samples (Article 41). This means that brand owners and parallel distributors will require the system capability to upload additional 'status changes' of the serial numbers and – as an additional obligation on repackagers – to capture and upload the serial numbers of the packs that have been 'consumed' when creating the new packs that will be parallel distributed.
8. Challenges for contract manufacturers: Contract manufacturers (CMOs) may not fall under the direct data upload obligation but it is difficult to see how they would be in a position to control the supply of the appropriate information to their customers without also establishing a CMO company repository. In fact, given the typical CMO's position of supplying multiple customers and possibly managing a complex mix of prescription and OTC products for a wide range of markets, the size of the challenge facing them may well dwarf the challenges faced by other pharma manufacturers.
9. Cost implications: In addition to establishing, maintaining and operating their in-house serialisation and tamper-evidence capability at line, and at corporate repository, level, pharma manufacturers are required to fund the establishment, and on-going operation, of the Europe-wide repositories system infrastructure. This will add to the cost on manufacturers, though the good news is that, through the various organisations representing their interests at the European level, much work has already been done to establish an effective but cost-effective approach in the form of the European Stakeholder Model.
10. Technology and support: What needs to be covered in terms of technology – at line and corporate level – is significant. However, establishing that serialisation technology stack is only part of the work that needs to be undertaken, and against the background of tight timelines, companies starting their implementation journey now cannot afford to risk getting things wrong at this late stage. The budget for every EU-FMD readiness programme therefore needs to make provision not just for the technology but for expert help and support.
About the author:
Christoph Krähenbühl is a respected serialisation expert and thought leader in coding and serialisation for the pharmaceutical industry. With partner Ian Haynes, he runs 3C Integrity, a specialist consulting firm which runs training programmes to prepare pharma companies of all sizes for implementation, as well as offering tailored consultancy to companies on serialisation.
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