IDMP (IDENTIFICATION OF MEDICINAL PRODUCTS) How A Pilot Program Can Help Answer the Questions of Data Sources and Costs to Compliance

Transcription

1 IDMP (IDENTIFICATION OF MEDICINAL PRODUCTS) How A Pilot Program Can Help Answer the Questions of Data Sources and Costs to Compliance Authored by Tom Beatty Principal Consultant, Regulatory Optimization Paragon

2 Introduction To prepare for the coming IDMP requirements, a pilot program using a product sampling will tell you much about how you need to proceed with your full IDMP compliance plan for international requirements. IDMP: A Hot Topic with an Interesting History Simply put, IDMP continues the progression of tools for patient safety that began with the standards for Individual Case Safety Reporting (ICSRs) in 1995, 1 with the goal of having data about medicinal products clearly and unambiguously organized using the structure of 5 ISO Standards (Illustration): 1 ICH guideline E2B (R3) on electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide EMA/ CHMP/ICH/287/1995 2

3 IDMP: How We Got Here The path to IDMP is an interesting study in cross collaboration between industry, health authorities, and standards organizations. After the establishment of ICSRs, other standards began to be developed, like the Study Data Tabulation Model (STDM) 2, and the Standard for the Exchange of Non-Clinical Data (SEND) 3. Then the International Conference on Harmonisation (ICH) developed the ectd 4, which really moved regulatory reporting and submissions into an electronic format and has been adopted by the ICH regions. Then HL7 s Structured Product Labeling (SPL) 5 was introduced - especially in the US market - and it adjusted and added structure to data that were being submitted to the agencies, and has improved messaging to agencies, doctors, and pharmacists and will eventually feed into patient electronic health records. In the past, these various types of clinical and non-clinical information have tended to exist in various silos. In the EU, the EVMPD initiative - and its extended version xevmpd 6 - started to pull together these disconnected sources to have a coherent view of product data in the EU. IDMP is the next step - a much broader view that is being developed by the ISO organization - that includes many more elements than the EVMPD/xEVMPD requirements included. But the overarching goal of IDMP connects back to improving patient safety through improvement in the fluency and accuracy of ICSRs, and further finding new ways to connect data elements about a product in a meaningful way. Examples of these are: product change management, data integrity compliance, and rapid product data integration after mergers and acquisitions. IDMP: An International Standard Though the current EU 2018 first compliance date is the prime mover for the initial standards, IDMP will become truly global in the near future across all regions. The FDA Timeline on IDMP has not changed - there still is the expectation that the Federal notice will come out later in 2016, and once it is published, the Draft Guidance will be released shortly after. So IDMP filings to the FDA may be expected by late 2017 if the draft guidance is released later this year. Code will be applied to each of the IDMP elements, so if there is an adverse effect or an adverse reaction to a specific product in the market, health authorities can easily identify where that product is marketed on a global scale, and pull it from these markets if necessary - or add a warning to the product if needed. Health Canada, Japan s Ministry of Health, Labour and Welfare, and the World Health Organization (WHO) are observing the progress of IDMP in the EU and US to gain insight for their own near future IDMP plans and data usage....idmp filings to the FDA may be expected by late 2017 if the draft guidance is released later this year. 2 Developed by the Submissions Data Standards team of CDISC, it became the standard for submitting tabulated data for Clinical trials in Work on CDISC s Standard for Exchange of Nonclinical Data (SEND) began in 2002 with the FDA pilot plan announced in By December 2014 SEND data is required for all IND & BLA submissions. 4 (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG) developed the ectd which is the fully electronic version of the CTD which began being accepted in FDA is requiring that all NDAs, BLAs, ANDAs, and DMFs be submitted in ectd format in May, HL7s SPL has been required for submissions to CDER since The SPL Working group meets periodically to continue improving the SPL standard. 6 EudraVigilance Medicinal Product Directory (EVMPD) has been extant since 2005 and its extended version xevmpd - with expanded fields and documents had been required of European MAH s since

4 Why this Matters to your Business Don t underestimate IDMP - approximately 500 elements per product! IDMP is a challenging mandate and assembling the required data is not a simple exercise. You will need to accurately assemble approximately 500 data elements for each product across the product s complete lifecycle, from investigation through post-marketing. This means you will be talking and meeting with business and technical resources across functional areas and asking for their help in finding where specific data actually reside. Often you will have to have follow-on conversations with other function leaders or system owners until you find where the data reside -- or perhaps find that they do not exist. There will be impact to your business across many functions - and you will need to get an accurate estimate of what it will cost to comply with IDMP in time for the approaching compliance deadlines. But there will be benefits as well. For each product, you will know more about its composition manufacturing, excipients, package sets, and labeling than before IDMP. There will be a new level of trust in product data - down to a granular level - and it can be reused in submissions, filings, and other regulated documents with greater confidence. To get started, Paragon suggests doing a pilot project of a sampling of individual product presentations from your portfolio to get a sense of where these data may reside in your organization, in what state it exists, and how consumable it is to pull together for IDMP. Assembling IDMP elements for a sample of your products will provide a useful measure of how dispersed across your organization s landscape the IDMP data elements are. This will help you find a gauge of what level of effort - in terms of time, resources, and cost - that will be needed to reach full IDMP compliance for all products in the future. An IDMP Pilot Plan: The Essentials Assemble the right team - As stated above, IDMP will significantly impact many parts of your business. You will likely find required data from a wide variety of functional areas and systems in your organization. After gaining C-suite level support / ownership for your IDMP Pilot Program, the next key thing to do is assemble experienced global leaders from various functions where IDMP data might reside. These include, but are not limited to: (a) Regulatory (b) Labeling (c) Chemistry, Manufacturing, and Control (CMC) (d) Clinical Affairs (e) Pharmacovigilance / Safety (f) Supply Chain (g) Discovery / Developmental Chemistry These team members will be essential to the success of the project, so they should have executive authority in their respective areas. They should be able to arrange necessary system access for the project team, and offer guidance on where structured and unstructured data may reside. Most importantly, they should be able to remove obstacles to finding the essential data elements. You will need to accurately assemble approximately 500 data elements for each product across the product s complete lifecycle, from investigation through post-marketing. 4

5 Have a Plan for Finding IDMP Data During an IDMP pilot project, you will likely find data in a variety of business functions, systems, data repositories, and even file cabinets. Data will likely be in structured and unstructured forms and be prepared there will be gaps! Below is a chart showing many of the places where Paragon teams have found IDMP elements: IDMP - Finding the Data Starting places to find required fields ISO Medicinal Product Pharmaceutical Product Substance Dose Forms Units of Measure Category Medicinal Product: MPID Marketing Authorization Packaged Medicinal Product Ingredient, Substance Strength Pharmaceutical Product & Device Clinical Particulars Organization Manufacturer / Establishment Investigational Medical Product Pharmaceutical Product: PhPID Adjuvants and Devices Substance and Specified Substance Manufacturing Data, role in product Phamaceutical Dose Forms Presentation, Administration, Packaging Units of Measure Metrology, unit description & mapping Potential Sources Structured Data Sources RIM & Regulatory systems (e.g., InSight) CTMS and etmf systems ERP systems Labeling systems edocument management systems SPL submissions Master data Semi/Unstructured Data Sources xevmpd / SmPC (EU) USPI (US) esubmission PDF archives Paper archives Exrternal Data Sources EU Reference Data List Ginas (future) 5

6 Start with a Holistic Analysis of Your Data Landscape Before your project teams begin populating data, we suggest taking a macro view of the total universe of data elements that presently exist in your landscape which may be mapped to IDMP fields with varying degrees of ease. This holistic / big picture analysis will help you: Use your internal expertise - A key component of the meta-analysis will have the pilot project team talking to many different system owners and supporters to get a sense of where specific elements reside. Define where structured data likely reside - Back-end access to data dumps from structured systems can give a good sense of which fields may be mapped to required IDMP elements, and how close those structured elements are to the final form. Map potential sources of semi and unstructured data - There will be a substantial number of semistructured and unstructured elements that may be in various stages of consumability: from PDF or MS Word format in a document management system (with varying degrees of metadata), all the way to paper documents in archives. Conformance - A key part of this holistic analysis is evaluating your present structured and unstructured elements to see how closely they align with the Controlled Vocabularies of IDMP which are still evolving. This analysis will inform your level of effort and resources needed to reach full IDMP Compliance. Identify authoritative sources of elements - There will be IDMP elements duplicated across your system landscape. You will need to have an order of precedence as to which source of a duplicative element is considered authoritative. (e.g., structured data is exhausted before unstructured). Understanding business processes around Data flows and consumption across systems is vital to the success of this segment of the program. The key concept here is: how do we go from system to system and know you are talking about the same element? This hard look at processes can form foundational improvement in the governance of key data across your organization. A key part of this holistic analysis is evaluation your present structured and unstructured elements to see how closely they align... 6

7 Pick a Sample of Product Presentations Across a Broad Range of your Products Rather than try to populate elements of all your products or all presentations of a product family, focus on single specific presentations of a sample of your products. These sample presentations should represent a broad view of the types of products your company offers. A small sample of product presentations keeps the effort manageable and the pilot project budget reasonable. Pilot product mix is important - If your portfolio is broad, we suggest choosing an older established product, a newer product, a combination (pharma/device) product if you have one, an acquired product, and an investigational product. Each of these types of products tends to have descriptive data in various states of quality - which will become important as you assemble the required elements for your IDMP effort. Consider the Iterations Compliance with Iteration 1 of IDMP means you essentially have to gather 79 data elements about each product. Full IDMP Compliance will require Iterations Substance elements and approximately 500 data elements for population. Rather than narrowing the scope of your pilot effort to Iteration 1 or 1 & 2 only, we suggest conducting your pilot program so that you attempt to populate as many of the Iteration Substance data elements. This way you avoid the risk of a quick fix approach to IDMP compliance and have a clearer picture of the level of effort to reach full compliance. Looking at all iterations will give you the information needed to make strategic rather than iterative and reactive choices about eventual full IDMP Compliance....sample presentations should represent a broad view of the types of products your company offers. 7

8 Capture the Data Properly A good data collection tool is essential - but does not need to be overly complex. At Paragon, we have built a data collection tool that has all present IDMP required elements broken out by their specific ISO, Iteration, and other key descriptors. Below is an example of one of our tools (populated with fictional data for illustration): As our team members search through systems and repositories for IDMP elements, they are captured in our tool with exact descriptions of where the elements were found. One of the key benefits of an IDMP pilot program is getting a good sense of where - and in what state - elements exist: structured, semi-structured, unstructured, and unavailable (gap). Pay Attention to Metrics As you proceed through your pilot program, you should first look to exhaust structured data sources for elements, and then proceed to semi-structured, and finally, unstructured and paper sources. You will probably find many gaps, and certain fields will be not applicable to your products. Also, there will be elements in which controlled vocabularies and element descriptions are not yet available. Keeping track of metrics for the number of elements for each type above is important. For example, pulling a data element directly from a structured source takes far less time that finding an element in PDF format in a document repository or in a paper document. So, it is important to know how many element of each type for accurate estimation of what it will take to reach full IDMP compliance. Remember - These metrics will form the basis for your calculation of level of effort needed to reach compliance - when multiplied out over the total number of SKU s for which you will be required to provide IDMP Data. 8

9 The Important Thing is to Get Moving Now Because of delays in the formulation of IDMP standards, many companies have taken a wait and see attitude around IDMP compliance. Now that the standards have become firmer, with specific elements per iteration, and ISO implementation guides being released, it is important to get your IDMP compliance efforts in gear. An IDMP pilot program is a really sensible way to get your organization IDMP Aware, and provide a logical, metrics driven approach to begin assembly of pilot product IDMP elements, and to quantify - as accurately as possible - what it will cost to reach full IDMP Compliance. About Paragon Solutions Paragon is a consulting firm that helps health and life sciences companies become high-performing, compliant, and digitally connected. Paragon powers business transformation and delivers better business outcomes by providing valuable consulting services as a trusted partner to our clients. We do this by building long-term client relationships based on our domain expertise, creative ideas, pragmatic consulting services, and quality delivery of solutions. For more information, visit us online at or call Follow Us twitter.com/consultparagon linkedin.com/company/paragon 9 Copyright 2017 Paragon Solutions is a registered trademark of Paragon Solutions, Inc.