Sweeten the pill: compliance as a first step in a data health check White Paper

White Paper / Pharmaceutical

Future-proofing with data

The recent introduction of Identification of Medicinal Products (IDMP) legislation within the European Union has highlighted the need to improve data management processes within the pharmaceutical sector. Although the industry routinely processes huge amounts of data, such as that generated in clinical trials, the legislation puts a new onus on companies to work with that data more efficiently so that, for example, products can be more easily tracked and reported on as they make their way through the supply chain. For this white paper, we argue that businesses should see IDMP as an opportunity to undertake a ‘data health check’ as a first step in creating a central repository of reliable, consistent and readily accessible information. This is key, we also argue, because the healthcare sector is on the cusp of entering an era when new techniques driven by data – notably personalised treatment plans monitored by devices connected to the Internet of Things (IoT) – will become progressively more important. A data health check is a way to begin preparing for this future. For more information, please contact Stibo Systems: [email protected] www.stibosystems.com

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White Paper / Pharmaceutical Introduction The regulation surrounding medicines is changing. To take just one example, in July 2016, legislation around the Identification of Medicinal Products (IDMP) came into force within the European Union (EU) [1]. Implementing global standards developed by the International Organization for Standardization (ISO) covering data elements, formats and terminologies, the legislation aims, to quote the European Medicines Agency (EMA), to “simplify the exchange of information between” [2] different stakeholders, including regulators, pharmaceutical companies and clinical trials sponsors. While this implementation of ISO IDMP standards is a European initiative, there’s a global element here too. Regulatory organisations around the world, such as the US Food and Drug Administration, are also working on alignment schemes to use IDMP standards [3]. Faced with these compliance challenges, there’s a temptation for those working within the pharmaceutical industry to see what’s happening simply as a burden, a business expense. Without wishing to downplay the difficulties, companies need to recognise there are good reasons to welcome recent regulatory change. That’s because the overall effect of new legislation will be to make the exchange of data easier. In turn, this will lead to long-term cost savings for the industry rooted in being more agile, in adding value to existing business processes, and in making it easier to trade internationally.

A first step in preparing for the future is for pharmaceutical businesses to undertake a ‘data health check’

But how should companies make the most of these new opportunities? A first step in preparing for the future is for businesses to gain tighter control of data, to undertake what we’ve dubbed a ‘data health check’. This needs to be done internally rather than by an outside contractor because it’s within companies that expertise about business-critical data resides. However, this data is typically dispersed so that companies hold huge amounts of information – on products, prices, customers, clinical information and much more – within different silos. Often this data is formatted differently for and by different systems, it’s overseen by stakeholders with different priorities, and data held in one part of the company may even contradict information held elsewhere. In contrast, what companies really need is data that’s consistent, trustworthy and readily accessible across the business. It needs to be clear who has responsibility for maintaining the data and ensuring its quality.

Data governance To undertake such a data health check, companies need to focus in on the discipline of data governance, which we can define as having people, processes and information technology working together to ensure the seamless management of data and enhance its value to the business. Successful implementation of a data governance strategy means companies can in turn be confident they hold reliable and consistent data that can be exchanged between departments, and with different parties in and around the supply chain, such as healthcare providers and regulators. In practical terms, for example, the information feeding into the Enterprise Resource Planning (ERP) system will be aligned with that being used in other enterprise software modules, and vice versa. This may involve utilising a master data management (MDM) solution [for more on MDM and the pharmaceutical industry, see page 11] to ease the process, but as we’ve already suggested, it’s also about refining business processes, and about building a team responsible for the accuracy, accessibility, consistency and completeness of a company’s data. This team needs to be responsible for both change management, defining and controlling data standards, and compliance. It’s also important to emphasise that data governance needs to be seen as an ongoing project rather than something that can be dealt with once a year [see ‘Six processes to ensure data governance success’, page 4, for more].

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White Paper / Pharmaceutical Six processes to ensure data governance success

Data governance is about organisational change. To make data readily available, to ensure compliance and to manage risk (the value of data can change quickly), companies should consider the following six steps: uuBuild a clear vision and scope for your data governance initiative, so you can ensure that your organisation is able to fulfil it uuDefine standards and assign business rationale as to why each exists, define benefits that can be achieved and what level of quality should be reached to realise the benefit (not always 100%), and create metrics that show whether benefits are being realised uuDesign a data governance organisation that is suitable for managing the defined standards. This includes roles and responsibilities for processes used to manage activities (such as change management for standards) and changes to any external process that affects the organisation’s ability to govern (such as the IT project management process) uuEngage a Data Owner to own standards uuBuild a Data Quality Roadmap that documents current quality level, measures it against the requirements and proposes actions to bridge the gap and/or maintain good quality uuPopulate remaining data governance roles to operate ongoing compliance measures and manage activities identified in the Data Quality Roadmap In short, this is a strategically important undertaking that ultimately requires working towards creating and maintaining a consolidated and centralised repository of master data used by the whole business. This is necessary work not just because it helps the business today, but because of what lies ahead. Going forward, having tight control of data will only become more important because the IDMP legislation will inevitably be followed by further regulatory changes, some of which are already in the pipeline. Moreover, as new business models emerge and digital technologies transform the pharmaceutical industry, companies need to be agile and ready for an era where change isn’t just a one-off exercise but an ongoing process.

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White Paper / Pharmaceutical Towards transparency To get a taste of what lies ahead and chart where the industry is going, it’s worth focusing in more detail on the rollout of legislation that’s either occurring now or lies on the near horizon. As we’ve already noted, the EMA is currently overseeing the adoption of ISO IDMP standards within the EU. The legislation is set out in detail in Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) [4] and one of the overarching aims is to make it easier to exchange information between stakeholders. This was keyed off in part by problems with the EU Clinical Trial Directive 2001/20/EC [5], which was revised after its initial implementation led to a reduction in the number of clinical trials being conducted across Europe.

SPOR data defined

uuSubstance data: the ingredients of a medicine uuProduct data: the product’s marketing and medicinal information uuOrganisation data: the contact details for those responsible for different aspects of the medicine uuReferential data: covering a medicine’s controlled vocabularies‚ such as dosage, package codes and weight codes, explicitly defined for use in Europe Associated with this reduction, there was an increase in administrative expenses. It’s against this backdrop that the EMA sees the “underlying challenge of IDMP” as “fundamentally a master data challenge” that will involve the EMA establishing ISO IDMP-compliant business and data management services covering substance, product, organisation and referential (SPOR) data [see SPOR data defined, above].

Overall high level plan for SPOR Transition phase

Preparation phase

Maintenance phase

Product & substance submission

Product & substance pre-submission

Build technical services

R

Controlled vocabularies for IDMP Build technical services

O

P

S

Initial organisation dictionary

Finalisation of ISO documentation (standards review & technical specifications)

July 2016 Legal deadline

Terminology alignment Registration of new terms Expand and manage content

Terminology alignment Finalisation of EU implementation guides

Q3/Q4 2016

Preparation for electronic submission Terminology alignment (continuation)

Q1/Q2 2017 Publication of EU implementation guides

Implementation of initial electronic submission

Q1/Q2 2018 Kick off product & substance iteration 1

Expand and manage content (based on iterations)

Q3/Q4 2018 Enforcement of product & substance iteration 1

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp [6]

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White Paper / Pharmaceutical According to the EMA’s own roadmap [7] [8] [9] the preparation phase of this project is at an end and the transition phase has begun. There have been delays – ISO technical specifications around product and substance data won’t be published until 2017, for instance – yet the direction of travel is clear. In itself, this would be a major challenge for the industry, but it’s by no means the only new legislation. The problem of falsified medicines reaching patients is a constant concern for regulators and healthcare providers. It’s also a significant cost for the industry, estimated by the World Health Organisation at £36.9bn a year. It’s a problem that was addressed in the EU’s Falsified Medicine Directive [10] in 2011. This covers such areas as safety features on packaging, the introduction of an EU-wide logo to identify legal online pharmacies, tougher inspection rules and new record-keeping requirements. In practical terms, this means that, for example, by February 2019, each pack of medicine will have to have a unique serial number, coupled with a manufacturer product code, batch number and expiration date. This information will need to be encoded in GS1 2D Data Matrix form (essentially a next-generation barcode) and in human-readable form. This move towards standardisation and transparency within the supply chain puts a responsibility on companies to ensure high standards of data governance so that they can provide and maintain this information in a timely, cost-effective and reliable fashion.

These ‘track-and-trace’ regulations will result in all parties within the sector having to deal with vast amounts of data. Again, businesses will need high standards of data governance. Here, it’s also worth noting that data provided by partners will need to be integrated with information generated internally, and companies need to be able to stand behind this information, to be sure it’s reliable. There are further factors to consider at both national and international levels. In Britain, for example, the implementation by the National Health Service (NHS) of its eprocurement Strategy [11] means that suppliers have to adopt GS1 and Pan-European Public Procurement Online (PEPPOL) standards [12] in order to work with NHS trusts. While the picture in Europe is more fragmented and eprocurement less developed within many countries than in the UK, the European Federation of Pharmaceutical Industries and Associations envisages GS1 standards similarly being employed throughout Europe [13]. This will inevitably speed up the pace of change within the procurement space as healthcare providers automate processes in order to keep costs down.

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White Paper / Pharmaceutical Consistent themes The sheer amount of legislation can seem dizzying, but take a step back and, time and again, the same themes emerge: uu A move towards ensuring the consistency of data and greater transparency within the supply chain uu An emphasis on patient safety so that, for instance, when a medicine needs to be recalled it can be identified

across territories and supply chains

uu The need to support digital transformation within the industry, a theme we address in greater detail later in this

white paper There’s also a global perspective to consider as regulators harmonise their approaches. In the US, for example, the 2010 Physician Payments Sunshine Act requires pharmaceutical companies to track their financial relationships with doctors and teaching hospitals, with the overall aim of uncovering any potential conflicts of interest. The Drug Supply Chain Security Act (DSCSA) [14], signed into law in 2013, in the words of the FDA, “outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States”. According to the EMA, the rollout of ISO IDMP standards is broadly consistent with what’s happening in the US, and practices “are aligned with one another” [15] – and at a macro level the Transatlantic Trade and Investment Partnership [16] promises greater harmonisation between the European Union and North America (should it ever be enacted). Nevertheless, there will always be differences between the approaches different regions adopt towards the pharmaceutical sector. Some of these will be subtle, others less so.

The opportunity for the pharmaceutical industry These subtleties, especially noticeable across Europe with its different models of healthcare, in themselves illustrate why the EMA’s characterisation of IDMP as “fundamentally a master data challenge” is apposite. A move towards harmonisation, however imperfect and slow, affords companies an opportunity to focus in on data as a business asset. Get better control of data and make sure it’s consistent, and it’s not just easier for the business to share and work with this data across different departments, but it becomes far easier to use this information across multiple jurisdictions and territories, and for different purposes.

Companies with good control of data are better able to tailor processes to make the most of new business opportunities and to communicate across the supply chain

Take procurement as an example. As we’ve already noted, while the current use of automated eprocurement is patchy, the EU wants to encourage electronic procurement between the public service and business, and in 2008 initiated the PEPPOL project [17] to facilitate this. Looking specifically at the healthcare sector, there’s also been a huge growth in the number of e-prescriptions, such as those offered in Sweden by Apoteket AB (the country’s publicly owned pharmacy company) or via the NHS’s Electronic Prescription Service (EPS) [18]. In both of these areas, those with good control of data are better able to tailor business processes to make the most of the opportunities and to communicate across the supply chain. This makes companies more efficient and leads to a reduction in costs. From the perspective of healthcare providers, it seems intuitive to suggest they are likely to favour suppliers that make these business processes as frictionless as possible. There’s also a strong element of future-proofing here. As we explore in more detail in the final section of this white paper, new digital technologies are starting to reshape the healthcare sector. This is about much more than streamlined workflows and smoother supply chain management. In the future, all aspects of healthcare will be data driven. This doesn’t just mean data about products, but data relating to patients too. Examples of data sets here include: uu The personalised data generated by devices we wear and which are connected to the Internet of Things (IoT) uu The data gathered for genome-wide association studies that look for links between certain genes and

conditions

uu More traditional studies of outcomes for different treatments

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White Paper / Pharmaceutical A background in data One of the advantages the pharmaceutical sector has here is that an appreciation of the value of data is hardwired into its own DNA. Specifically, clinical data management (CDM) is a key discipline within drug development and, through ensuring treatments are safe and effective, getting new drugs to market. Regulation is moving towards greater transparency. EU Clinical Trial Regulation legislation [19] coming into operation in 2018 is aimed at creating consistency across the EU and also aims to ensure “information is made publicly available on the authorisation, conduct, and results of each clinical trial carried out in the EU”. Specifications for an EU clinical trial portal and database [20] have been published. Within the legislation, there are safeguards around such areas as the protection of personal data and commercially important information but again, the idea of information being more easily shared is to the fore. This in itself flags up another reason for better data governance. With increasing amounts of data being exchanged, companies need to be able to manage this data efficiently, and to be able to separate out the data that’s most important and relevant to different aspects of the business.

Big data This issue is only going to become more pressing, especially as we’ve now entered the age of so-called ‘big data’, a term that refers to data sets so large that they require huge processing power to analyse. Within the healthcare sector, the situation is further complicated by there being so many different data sets – product data, reference data, patient data and so on. One way to illustrate the opportunities and challenges of big data is to think about where complex data sets meet and overlap, and what that might mean. In this context, an initiative such as the not-for-profit Project Data Sphere platform [21], launched in April 2014, is a glimpse of the future for the way it offers “one place where the research community can broadly share, integrate and analyse historical, patient-level data from academic and industry phase III cancer clinical trials”. The platform is open to those working for life science companies, hospitals and institutions, as well as independent researchers. The overarching idea is that new treatments will emerge from the sharing of rich – and big – data sets. This is genuinely exciting, but there are inherent challenges around how to handle such information. It’s one thing to have access to data, but quite another to extract useful insights from it, particularly if looking at data from different sources. Strong data governance helps here because it enables companies to establish policies, processes and rules to help define the purpose and use of different data sets.

Digital challenges

The Internet of Things

The use of digital technologies within the pharmaceutical sector is already yielding some revolutionary new approaches. In 2015, the FDA accepted an application to evaluate a new drug-sensor-app system from Proteus Digital Health that tracks when a patient has taken an active pill that also contains a tiny chip [22]. An app, connected to a sensor worn on the body, monitors when a pill has been taken. The initial application here relates to the anti-psychotic drug Abilify because those with schizophrenia often stop taking their drugs. However, this technology might also be applicable to those with dementia, who find it difficult to remember which medicines they’ve taken, or those who have to take a cocktail of drugs for a condition such as Parkinson’s disease. Situations where not taking any pills, or taking too many pills, can have serious side effects could be managed by this system.

3D printing

In March 2016, Aprecia Pharmaceuticals began selling Spritam, a drug to treat epilepsy. Nothing too unusual there, except the pills are manufactured using 3D printing technology [23], the first time a drug made in this way has been approved by the FDA. The manufacturing process isn’t just for the sake of novelty: the idea is that the pills dissolve much quicker than conventional pills, are easier to take and allow greater precision over how much of the drug is being administered [24].

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White Paper / Pharmaceutical Looking more widely at the way emerging technologies are set to transform the pharmaceutical sector, global management consulting firm McKinsey has identified key trends within healthcare and defined “four areas of digital opportunity” [25] for the pharmaceutical sector. Sketching out a business landscape where there’s a greater emphasis on outcome-based care, a rise in the number of ‘engaged’ patients who demand information and a bigger say in their own care, and new competitors entering the market. It sees these opportunities as being around: uu The increased use of advanced analytics uu Providing personalised care: supporting sensors and digital services that provide personalised, 24/7 treatment uu Greater engagement with both medical professionals and patients: digital technologies make the exchange

of information much more immediate, which in turn drives the demand for access to information and, at a practical level, for example, makes patients question why they need to visit a doctor’s surgery to renew a prescription uu Real-time responsiveness: expect a combination of cloud and mobile technologies, sensors embedded in IoT-enabled devices, next-generation business analytics, etc to facilitate a new wave of automation in business processes The linking theme is that all these activities both rely upon and generate huge amounts of data. Looking even further ahead, it may well be that new business models grow from these developments, another reason for companies to strive to take control of data in order to be able to make the most of these new opportunities as they arise.

In conclusion As we’ve outlined, the pharmaceutical industry is undergoing huge change, driven both by legislators and, longer term, by the adoption of digital technologies that will transform business and healthcare practices. Companies’ success in navigating this evolving business landscape will, in great part, rest on using the data it holds efficiently and, when it comes to developing new business models, imaginatively. More immediately, finding new business value from existing data supports the development of innovative and safer healthcare. To return to where we began, it’s for these kinds of reasons that we advocate using the recent rollout of IDMP legislation as an opportunity to undertake a data health check. Even leaving aside the need to do this as a way of future-proofing the business, the reality is that many companies within the pharmaceutical sector still hold information in silos, with different departments holding data, sometimes on the same products, in separate files and in a variety of formats.

Finding new business value from existing data supports the development of innovative and safer healthcare

In contrast, strong data governance management, supported by a Master Data Management solution, enables companies to consolidate and centralise data. This data can then be easily shared across the business, and with suppliers, customers and regulatory bodies. This means, for example, that a company can efficiently share information on a medicine’s ingredients, effects and potential side effects with healthcare providers. More than this, it gives businesses a trusted resource of information that can be used both to drive business efficiencies today and to make the company more agile for the future.

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References: [1] [2] & [15] www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645. jsp&mid=WC0b01ac058078fbe2 [2] See [1] [3] www.fda.gov/BiologicsBloodVaccines/InternationalActivities/ucm356603.htm [4] http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:159:0005:0025:EN:PDF [5] http://ec.europa.eu/health/human-use/clinical-trials/directive/index_en.htm [6] http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp [7] www.ema.europa.eu/docs/en_GB/document_library/Other/2015/11/WC500196390.pdf [8] www.ema.europa.eu/docs/en_GB/document_library/Other/2015/04/WC500186290.pdf [9] www.ema.europa.eu/docs/en_GB/document_library/Other/2015/04/WC500186289.pdf [10] http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf [11] www.gs1uk.org/~/media/documents/marketing-documents/nhs_eprocurement_strategy.pdf?la=en [12] www.gs1.org/standards [13] www.efpia.eu/uploads/Modules/Documents/efpia-gs1-shared-vision-090312_2.pdf [14] www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ [15] See [1] [16] http://ec.europa.eu/trade/policy/in-focus/ttip/index_en.htm [17] www.peppol.eu/about_peppol/about-openpeppol-1 [18] www.nhs.uk/NHSEngland/AboutNHSservices/pharmacists/Documents/eps-patient-information-sheet.pdf [19] www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000629. jsp&mid=WC0b01ac05808768df [20] www.ema.europa.eu/docs/en_GB/document_library/Other/2014/12/WC500179339.pdf [21] www.projectdatasphere.org/projectdatasphere/html/about [22] www.wired.com/2015/09/pharma-wants-put-sensors-blockbuster-drug/ [23] www.computerworld.com/article/3048823/3d-printing/this-is-the-first-3d-printed-drug-to-win-fda-approval. html [24] https://www.aprecia.com/zipdose-platform/zipdose-technology.php [25] www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/the-road-to-digitalsuccess-in-pharma

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Master Data Management (MDM) and the pharmaceutical industry

MDM is based on the principle of making a company’s master data – in this case, the data associated with its core products – available and accessible to all of the systems and people that need it, within the company itself and beyond. An MDM solution will synchronise information on every product. It takes information from various disparate resources, at every stage of the supply chain, and creates a consolidated and centralised repository where product information can be prepared – not only for IDMP but also for sharing throughout the supply chain. In relation to the pharmaceutical industry, MDM is primarily employed to manage medicinal product information, but could additionally be used to support the sharing and governance of other critical business information, such as clinical trials information, big data, counterfeiting, financial reference data, or data on an organisation’s customers and employees. One important benefit of deploying an MDM solution is its ability to collect information from an organisation’s existing systems, making it consistent, accurate and available across the entire business. For example, rather than having to change existing applications, an MDM solution can leverage existing information sources and build compliant product views from them, in support of IDMP standards. Product managers can enrich this information, within the MDM solution, to suit a variety of business purposes including analytics, compliance, marketing and customer support. Indeed, an MDM solution could be used to collect as much information as possible from across the entire supply chain to provide a complete end-to-end view of a product’s lifecycle, which would enhance traceability and recall mechanisms. With integration with GS1 data pools as an integral part of an MDM solution, supporting the bi-directional exchange of information, adoption of these standards within the solution is easy, auditable and increases supply chain efficiencies. Ultimately, an MDM solution will enable the effective creation and management of a pharmaceutical company’s most important asset – its data.

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About Stibo Systems Stibo Systems is the global leader in Multidomain Master Data Management (MDM) solutions. Industry leaders rely on Stibo Systems to provide crosschannel consistency by linking product, customer, supplier data and other organisational data. This enables businesses to make more effective decisions, improve sales and build value. During the last 30 years, Stibo Systems has helped leading companies to develop a trusted source of strategic information. A privately held subsidiary of the Stibo A/S group, which was originally founded in 1794, Stibo Systems’ corporate headquarters is located in Aarhus, Denmark. For more information visit www.stibosystems.com or email [email protected]

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