A worldwide call for the requirement to identify medicinal products throughout their life cycle has led to the development of a set of five new ISO norms. They were timetabled for a July 2016 implementation in the EU, but application of the standards, and the design and development of a workable technical framework is proving to be complicated, leading to unavoidable delays.
Identification of medicinal products (IDMP) will aid the activities of regulatory bodies worldwide by improving the robustness of pharmacovigilance and regulatory activities across regions. It will replace the EU’s xEVMPD (extended eudravigilance medicinal product dictionary) and the US FDA’s SPL (structured product labelling) systems.
The benefits are primarily aimed at patients to ensure that any adverse events are picked up, but IDPM will also provide regulators and marketing authorisation holders with unambiguous specifications on what information must be submitted.
An effective implementation
Compiling all the data for the new standards is no easy task; requirements will be significantly more comprehensive than is currently the case under the xEVMPD, with potentially hundreds of additional fields. It will also need to be fully compatible with the Healthcare Level Seven (HL7) messaging standards that are currently being developed by the European Medicines Agency (EMA) in parallel to define a format for the electronic exchange of data – potentially meaning investment in new supporting IT systems for marketing authorisation holders (MAHs).
For effective implementation, a cross-functional, corporate-wide effort will be required, aligning standards, master data management, data governance and identification. This will mean information needs to be consolidated across the entire life cycle of a product from many sources. It will be necessary to establish technical services to support the submission of the requisite data.
IDPM will require integration from numerous systems across organisations, and the need to convert data into a new format. It will also necessitate the use of controlled vocabularies and organisation dictionaries to enable consistent documentation, coding and exchange of information between regulators, manufacturers, suppliers and distributors.
The idea is that these new standards will support the application and processes where it might be necessary to reliably identify and trace the use of medicinal products. It requires a broad approach: capturing, transforming, aligning, governing and reporting data of medicinal products, investigational medicinal products, pharmaceutical products, clinical particulars, substance information, packaging, manufacturing, marketing authorisation and clinical trial authorisations. IDPM will undoubtedly have regional requirements and will have to evolve to meet more regulatory use cases throughout its life cycle.
One of the biggest tasks of implementing IDMP is a master data challenge. EMA considers there to be four domains of master data in the pharmaceutical regulatory process: substance, product, organisation and referential (SPOR) data, and will establish business services in each area. This will include data management services for:
substance data: describing the ingredients of a medicine
product data: describing the marketing and medicinal information relating to a product
organisation data: providing the contact details of organisations and individuals responsible for various aspects of a medicine
referential data: providing controlled vocabularies (dosage, pharmaceutical forms, country codes, package codes, weight codes and so on) for a medicine, which are explicitly defined for use in Europe.
The EMA intends to implement IDMP in phases, the first in the third quarter of 2016, when referential and organisations management services will be released. A transition phase will begin once it has been confirmed that these services have gone live, and will consist of two subphases.
First, there will be a product and substance data presubmission phase during which ISO documents and EU implementation guides are expected to be finalised and published. The relevant bodies will need to align their systems with the released terminologies and register any new terms to expand the controlled vocabularies required for the submission of substance and product data.
This will be followed by a product and substance data submission phase, in which EMA will convert existing medicinal product and substance entities into the HL7 format and assist industry in the submission of IDMP products via the new format. Pharmaceutical companies will be required to confirm this conversion performed by EMA, and to enrich the data with additional information.
Once everything is in place, stakeholders will be required to replace XEVPRM with HL7. At the same time, EMA will implement the substance data and product data management service, expected in early 2018. The xEVMPD format will then be decommissioned and the new format will become mandatory. During the following maintenance phase, EMA will continue to expand and manage the controlled vocabularies for referential, organisation and substance data within the respective data services.
A stitch in time
Businesses are being encouraged to act early in order to prepare for IDMP. Not only will there be a significant impact on budget and resources during implementation, it could also take a lot longer to put in place than previously thought. Although some of the information required for the new standards will have been created during the course of xEVMPD, the data requirements will be much more complex than with its predecessor, with the industry anticipating that it will require three to five times more effort than its predecessor. There will be new identifiers, categories and ways in which to express relationships between elements in data models.
Although the timescale for implementation has not been officially confirmed, it is an opportunity to start making small steps towards preparing for it. By looking at the data as it is, companies can gain an insight into their data maturity capabilities, as well as process and organisational accountabilities, and highlight areas needing action. This should enable a faster response and enable companies to meet the timescales yet to be imposed.
There is the risk that many operating models will be insufficient or inadequate to enable IDMP requirements to be met, so it could also be a chance to integrate existing master data stores, or implement a whole new IT system altogether. IDMP needs to be integrated into the fabric of the company itself and must drive the construction of data models.
IDMP compliance will be achieved by:
- redefining all existing products, processes and procedures, but this could be seen as an extreme response in terms of costs and effort
- an integral approach, in which a regulatory information management (RIMS) solution contains all the data required to create and manage IDMP submissions; most pharmaceutical companies have established systems for regulatory affairs, supply chain, packaging, and the management of product, IDMP data would have to be entered multiple times, which exacerbates the risk of introducing data errors and inconsistencies
- creating data warehouses to systematically extract and transform information about medicinal products whenever an IDMP-compliant view of medicinal products is required – this could avoid having to retrofit existing information into a new data model while still enabling IDMP-compliant reports that regulators might require at any point.
IDMP implementation should be seen as an opportunity to improve – it’s unlikely to be the last standard enhancement, so it is a chance look at the master data management (MDM) and align with other functions within the company.
Organisations must discover how and where key data elements relating to IDMP exist in order to cleanse and transform them for consistency, before harmonising those elements and definitions across the enterprise. Thus, the name of each substance becomes consistent, as do units of measurement, names of vendors and suppliers, and much more. It presents the chance to reduce data duplications and inconsistencies by improving visibility and maintenance capabilities across the entire business. With this approach, underlying data schemes and relationship models could be effectively redefined as necessary to map to the IDMP standards. It will also allow for the discovery of missing data elements and to determine a best course of action to account for that data element in any reporting that may later be required.
By improving cross-functional information flows and cross-system reporting, there is the potential to better enable IT activities to support and complement the business functions. It’s an opportunity to increase operational effectiveness by improving business efficiencies associated with product master data, and reduce cost associated with managing, maintaining, integrating and reconciling data across the company’s functions and sites.
Implementing IDMP has the opportunity at least to allow companies to use these standards internally to overcome issues in their own systems. Companies could use the standards internally to help their systems talk to each other – quite apart from the external requirements. By implementing IDMP with a master data-driven methodology, companies can gain a single, trusted view of their product data giving them the opportunity to make better strategic and operational decisions, and to respond to change – whether imposed from without or elected from within – with greater agility, more speed and a better understanding of the ramifications.
The benefits for organisation are numerous. Regulatory bodies will be able to determine the currency and geography of marketing authorisations easily, while manufacturing can compare production across site and gain insight into quality, production costs, and overall equipment effectiveness. Supply chain managers will gain global inventory visibility and an improved ability to plan. Procurement will benefit from a consistent and complete view of spend across entire enterprises, improving the ability to negotiate and take advantage of volume-based discounts, and finance will acquire an accurate insight into inventory and stores, which can result in lower requirements for working capital and improved cash flow. On top of that, customer/patient services will receive complete information on products, thereby increasing patient/prescriber confidence, and R&D gains better and faster visibility into molecule performance in the market.
Right place, right time
It must be remembered that IDMP implementation isn’t just an IT-only initiative: it needs the right governance in place. It will be necessary to ensure all key stakeholders are involved in the planning process, and might be an opportunity to secure funding, sponsors and resources. It will require the collaboration of business units; the product master data needs to satisfy the IDMP standards but will be present in a wide set of functions and systems both within the organisation and their partners and suppliers. This means working together to modify systems, definitions and data sourcing capabilities. Some will be simple, others more extensive.
However a company decides to prepare for and implement the new standards, taking a modern approach to implementing IDMP will enable a company to identify data gaps within the business, and offer a more streamlined approach to collecting and maintaining their product data. Implementation may take longer than was previously thought, but it offers the opportunity for a company to transition from a document-centric to an information-centric organisation.
