The data debate: management, retention and authentication of product data in the context of the EU falsified medicines directive

Transcription

1 White Paper The data debate: management, retention and authentication of product data in the context of the EU falsified medicines directive Introduction In the third of a series of features designed to help pharmaceutical manufacturers prepare for the impending implementation of the EU Falsified Medicines Directive (FMD), Craig Stobie, head - global Life Sciences team at Domino Printing Sciences, examines the thinking behind how the vast amounts of data acquired under the auspices of the FMD will be collected, stored and interrogated and why. In previous features relating to the Falsified Medicines Directive and how it affects pharmaceutical manufacturing and packing, we looked firstly at the Hidden Challenges of Serialisation from a hardware and Overall Equipment Effectiveness (OEE) perspective and subsequently Beyond Serialisation at the potential benefits of data aggregation creating hierarchical relationships at each stage of the packaging process to the supply chain. Effectively we have considered how best to achieve item-level serialisation and how going beyond the brief [aggregation is not a specified requirement of the FMD] to create linkages between bundles, cartons, cases and pallets can offer significant return on investment. While for most producers the past couple of years will rightly have been about building the correct hardware eco-system and setting the correct operating landscape to achieve a consistently high standard of robust marking, thoughts must now turn to the framework within which the data generated will be managed. In this paper, we will take a look at the role of those bodies supervising the generation of data and those responsible for its management and how manufacturers can prepare the ground for positive data management.

2 The data debate: management, retention and authentication of product data in the context of the EU falsified medicines directive GS1 the supply chain supremo As the global standards body for product identification, GS1 s mission is to make companies more efficient by establishing a common language when it comes to identifying, locating, transporting and trading goods. The organisation is both independent and not-for-profit. GS1 s healthcare teams have been carefully structuring their response to the impending FMD legislation. With its focus on the whole of the supply chain, GS1 has a rare, holistic perspective on the product journey from its source, the manufacturer through a complex distribution chain to its final destination, the patient. In common with Domino and many other industry voices, GS1 acknowledges the move from batch to item-level serialisation as a sea change for the pharmaceutical industry. The EU FMD is a very complicated set of regulations, but what is more problematic is that some manufacturers are reluctant to start investing in equipment until the finite detail is confirmed in late Although there may be little change from what has been mooted thus far, the caution stems from the fact that significant capital investment is at stake and that investment must be fit for purpose. With an average life cycle of 18-months to for investment approvals, thousands of manufacturers will be scrambling to be FMD compliant before the end of While the timeline for enactment of the Directive has slipped marginally since 2011, it is an inevitability and therefore imperative that pharmaceutical suppliers are legislation compliant, in order to continue to produce and sell their products. To help the entire community meet this deadline, GS1 continues to scrutinise the requirements of the FMD, particularly in terms of data standards and structures, to ensure that mandates emanating from Brussels are clear and unambiguous. Through its Healthcare Users Group, GS1 is establishing and qualifying a network of suppliers that can provide the level of advice needed for the implementation of the standards. In the UK, GS1 is looking at FMD on two levels. The first is dealing with the Department of Health and the NHS and addressing the education of 300,000 employees who will become responsible for scanning medicine packs. The aim is to have a full plan for training and accreditation in place by April however it is an ongoing process due to the staff turnover within the NHS, which is around 15% annually. The second level which is the area that concerns Domino and its partners most is dealing with the suppliers to the NHS. That means educating suppliers who service and maintain NHS facilities as well as pharmaceutical and medical equipment providers.

3 A big problem for small suppliers The changes mandated by the EU FMD legislation present some very significant logistical challenges for manufacturers, a diverse group which includes research based pharmaceutical providers, contract packagers or generics manufacturers. The research based pharmaceutical companies are largely perceived to be in a better position, as they are often larger and usually have the specialists and the budgets to cope with the demands of the FMD. For smaller and medium sized companies who operate on smaller budgets, the ability to develop the broad solution needed can be a challenge. On the positive side however they are more agile, potentially making it easier to embrace change. Either way it will be a challenge for companies of all sizes, albeit for different reasons. Manufacturers may know a little about data but for most companies, printing serialised barcodes onto packs on moving production lines in a dynamic environment will be a new challenge. Many manufacturers have no experience of putting structured data into a global data pool, for instance, which is a central requirement of the FMD. The requirements are also more stringent because of the nature of the regulated environment in which the pharmaceutical industry operates. GS1 UK is conducting trials with some of the major NHS Trusts (the regional bodies charged with running the NHS) to see how many current suppliers are working with GS1 standards. The top 15 to 20 per cent, accounting for around half of products supplied to the NHS, are compliant but the bulk of the suppliers in the market up to 70,000 according to the Department of Health have yet to be accredited to put information into a data pool. The Electronic Product Code Information System (EPCIS) will be run by the Department of Health with input from GS1 and every code issued and used will go through its verification process. It is a way of structuring data globally and, although more complex in the pharmaceutical industry, is already proven in the food and beverage markets, enabling a supermarket in Hong Kong to access the same data as a store in Hartlepool, UK. The system works well in the food and beverage markets but will need to be far more complex and multi-layered to reflect the array of mandatory information on a typical pharmaceutical pack.

4 The data debate: management, retention and authentication of product data in the context of the EU falsified medicines directive Code alert According to most current requirements, manufacturers need only apply a simple alphanumeric expiry date and a lot number to each item. Generally speaking, they have never had to apply a barcode on a production line in a dynamic environment. Under the auspices of the FMD, each item will have four vital pieces of information the GTIN, expiry date, lot or batch number and a unique identifier, and where the market requires it a fifth line of text for a national identification number. Each prescription piece, single ampoule or vial, and every pharmaceutical pack must be uniquely identifiable, using both human- and machine-readable information. This involves a complicated process of taking data from the manufacturer s own internal software architecture, applying individual codes to each pack, reading them, verifying them, rejecting them if necessary and then putting the information back in the data pool for publication and reuse. The machine-readable element of each pack mark will be encoded using the ECC200 2D Data Matrix (DM) standard, which can incorporate up to 144 x 144 cells and is therefore eminently capable of handling the necessary volumes of information. The DM has the ability to encode 50 characters in a symbol that is readable at 2mm 2 or 3mm 2 and can still be read with a 20% contrast ratio a huge benefit when data must be acquired in a single pass or tracked along a supply chain. With an error rate of less than 1 in 10 million characters scanned, the ECC200 2D Data Matrix is the newest version of the code and can still be read even after sustaining 30% damage along the logistics process. This gives it a huge advantage when reading and authentication is such an important part of the FMD process. With the exception of China, the majority of countries are proposing to use the ECC200 2D Data Matrix as the machinereadable code of choice, albeit with some differences. In Europe, a transitional period will support countries such as France, which had already embarked on a national serialisation scheme CIP13 before the EU Directive was first publicised in A degree of flexibility within the FMD coding standards will also be required to accommodate countries that will incorporate a national reimbursement number within the code, such as Germany. Even though most countries use a DM for their anticounterfeit measures, the encoded data requirements vary from country to country. The verification process uses specialist vision systems to ensure the code conforms to the relevant standards - currently ISO The reader camera uses the information for movement tracking or inventory stock checks or patient and medicine verification in the case of the FMD.

5 As an Open Source code, DM codes can also be read by mobile phones by downloading code specific mobile applications. This extends the usability of DM codes by providing an outlet for consumer verification of goods and medicines. If necessary, users can read and interpret DM codes to establish their provenance and determine if they are legitimate goods before sale. It provides the verification checks at the user level to establish an item s credentials well before final usage. GS1 will make available a whole raft of training and support material to help manufactures implement the ECC200 standard. The recommendation in the UK is for a GS1-approved Global Trade Identification Number (GTIN) while Germany and other countries will use both a GTIN and a national trade identification number (NTIN). It may take many years to switch over to a standardised system due to the lifespan of many existing products. This all adds to the complexity of the system as every country mandates different legislations. To some extent, there is no way around this problem, but the Falsified Medicines Directive will address this lack of standardisation. From 2018, every country must have the ability to accept and record GS1 data subjects they will have to accept information from the data pool, be able to verify it and track its journey from the first to last step. The European Medicines Verification System A core tenet of the FMD is a supranational database that will ensure safe access to medicines for patients by providing realtime verification of products with a single scan. To achieve this aim, a number of industry stakeholders, including EFPIA, came together under the European Stakeholder Model umbrella to establish the European Medicines Verification System (EMVS). To be run by the stakeholders on a not-for-profit basis, the EMVS is an interoperable, pan-european database which enables medicines to be verified instantaneously at the point of dispensing. As a central repository, the EU Hub also reduces complexity by creating a single interface for manufacturers across all Member States. Product data will be uploaded directly to this European Hub from the pharmaceutical manufacturer, contract packer or parallel distributor, such that it will contain a unique record for each item entering the supply chain. That record remains available for interrogation through to the point at which the product is dispensed, when the pharmacist or other dispenser scans the product. This action updates and effectively closes the record, such that the product is no longer live and available within the supply chain. So far, so good. However, routes to market are notoriously long and complex in the pharmaceutical sector, such that national databases are also essential to enable the random/risk-based verification which is deemed an essential safeguard of the EMVS. Risk assessment has been a key principle underpinning the design of the system, with Stakeholders pooling their respective expertise to identify and contain points of vulnerability within the system. Key to this is the ability to authenticate product via a code scan at any point in the supply chain. The Hub went live last year, when it was also announced that Germany s SecurPharm database would join forces with the European Stakeholder Model, enabling proof-of-principle of interoperability between national and European repositories to be demonstrated.

6 Until very recently, a major focus of this paper would have been the storage and management of the vast volumes of data generated by serialisation. Even ahead of the 2011 publication of the Directive, pilot serialisation projects were under way and without exception, data handling emerged as a significant issue. However, the past few years have seen cloud-based business models emerge and swiftly mature, such that cost-effective and highly secure data storage is widely available. Indeed, the fact that the EMVS itself is built on a cloud platform is the strongest possible signal that the technology s credentials are beyond question. Strategies around what data to keep locally and for how long will vary from one manufacturer to the next, however one of the major obstacles in this regard how and where to store local data has been removed. Our ten cent tour of the EMVS brings us back to one of the key challenges of serialisation, which is that each item now consists of two indivisible parts a physical asset and its data counterpart. Removing any item from the supply chain for reasons other than dispensing it creates significant challenges in managing the data asset, particularly where the serialisation scheme is randomised. The entire verification system depends on the ability to produce and read good quality item-level codes which is why the right first time principle is so critical. Good Serialisation Practice Irrespective of whether codes are produced by laser, ink jet or thermal transfer overprinting and whether they are aggregated through the supply chain using serialisationcapable print and apply labelling or outer case coding, there are a number of basic principles that can be applied to achieve the requisite standard of coding and a smooth passage through the supply chain. Collectively, Domino defines these as Good Serialisation Practice and believes that if Standard Operating Procedures are established and maintained under each heading, a clear and successful serialisation strategy will become self-evident. 1. Understand the data structure you need an expert who understands the standards and how to apply them 2. Place somebody in an ownership position to drive the process through the production environment 3. Understand your customers processes for managing data 4. Choose your partners early serialisation is too complicated for a one-fit solution. A partnered approach will cover all the bases 5. Make sure your company has integrated departments so you all understand what serialisation means. It means executive buy-in to ensure IT, marketing, manufacturing and logistics teams work collaboratively on the development of the system 6. Select your technology solution whether printing, validation, IT systems and design, you need to be clear on your preferred solution at the outset 7. Pay heed to Overall Equipment Effectiveness (OEE). All these extra processes are bound to slow things down, so make sure manufacturing does not suffer 8. Start early! Make sure the plans are in place now, even if the legislation has not been ratified. By the time they are, there will be intense pressure to meet the compliance deadline in