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Sophie Daniel is head of consulting and General Services at ProductLife Group.
All indications are that the July 2016 deadline for transition from Europe's eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) to the new Identification of Medicinal Products (IDMP) is not achievable. Sophie Daniels reports.
All indications are that the July 2016 deadline for transition fromXEVMPD to the new global ISO standard, IDMP, is not achievable. Sophie Daniels reports.
Sometimes even the best-laid plans need adjustment to fit new circumstances or to ensure they deliver the right results, and such is now looking to be the case with the road map for implementation of the Identification of Medicinal Products (IDMP).
Although no new official deadline has been formally announced yet, the original, July 2016 target for migration to the new set of global International Organization for Standardization (ISO) standards for the IDMP-which will be the successor to the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)-is now considered unrealistic. The postponement has been caused by a number of practical hurdles, including delayed availability of ISO implementation guides, which are still being revised and updated to reflect ongoing changes to the standards themselves. It is likely to be January 2016 at the earliest before agreed ISO guidelines start to become available and as late as August 2016 before the final version of the ISO guideline on substances is complete. European guidance for the first stage of implementation for medicinal products is expected to be available in the first quarter of 2016, and for substances, in the second quarter of 2016.
Meeting of minds
The evolving situation was aired and discussed at a Webinar hosted by ProductLife Group (PLG) in late June 2015 as part of a series of thought leadership events held by PLG to cover regulatory issues in life sciences. The Webinar session followed a recent meeting of the European Union’s ISO IDMP task force. The task force provides recommendations for the European Medicines Agency (EMA) and national competent authorities (NCAs)-that is, those making decisions on implementation of the new standards.
The Webinar was well attended, and it pinpointed the level of concern about the topic by bringing together three expert commentators on regulatory and data standards requirements: Romuald Braun, vice president of strategy for life sciences at regulatory content management specialist INFOTEHNA Group; Andrew Marr, managing director at Marr Consultancy; and PLG’s own chief scientific officer, Erick Gaussens. All agreed that the likelihood of both a revised timetable for implementation and a more gradual, phased approach to IDMP implementation would be roundly beneficial.
Although the IDMP’s original purpose was to aid in identification of substances and medicines for pharmacovigilance purposes, the set of standards has evolved into something much broader and deeper than XEVMPD. If proven to be reliable, IDMP data could also be used for broader health-care purposes-for example, to support the provision of medical histories of patients treated abroad.
It is imperative then, that the standards be taken seriously by all involved parties and that organisations deliver high-quality data that is equal to the task of supporting higher standards of customer and patient care and safety.
Time to regroup
Meeting a less-pressured time scale will give organisations more time to adapt the requirements for their own strategic benefit, and the phased approach now favoured will be more manageable and realistic to achieve, the speakers noted. The speakers warned, however, against seeing the delay as an opportunity to put IDMP preparation efforts on hold and noting that there remains much that life sciences organisations can do to get a head start and thereby avoid storing up stress for later.
Marr, who is coordinating vendor and expert input to the European Union ISO IDMP task force-input that was not present when EVMPD standards were being developed-said the EMA and NCAs are confident that the European Commission will accept the new proposals once they are agreed to by the Heads of Medicines Agencies. “Only one real plan is being developed, which is to push forward with phased but dependent implementations for products, substances, organisations, and referentials [vocabularies],” Marr said.
Changes to guidelines
Five IDMP standards were set forth in 2012, three of which must now be updated based on issues identified during drafting of the associated implementation guides.
So far, four preliminary technical specifications/implementation guides have been produced for the four areas of products, substances, organisations, and vocabularies but none as yet for units of measurement. There is also a technical report on core principles of the maintenance of identifiers and terms.
There is still a lot more to come from the ISO in the next few months. The substances guide is probably the furthest advanced, though even it is still being refined. Even by, say, November, the substances guide is likely to be only in a position in which a second, updated version will be recommended for publication, and that could take until May 2016.
Guidelines for medicinal products and pharmaceutical products will also have to be updated following enhancements to the associated standards. Realistically, it is likely to be July or August 2016 at the earliest before final versions of the required implementation guides for Europe become available. Trying to rush them through could be detrimental to their quality.
Meanwhile, it could be 2017 before the technical intricacies around vocabularies have been finalised. Health Level Seven International’s structured product labelling models and messaging requirements for exchanging data are being tackled separately from the category-specific ISO implementation guides.
At the task force meeting on June 12, feedback was gathered from a series of subgroups that had been asked to come up with alternative proposals and timelines for implementation of the IDMP. The subgroup that was established to look at products proposed four iterations, with the first due to start 12 months after European Union guidance gets issued and with a 9-month transition period before compliance becomes a mandatory requirement.
Iteration one would cover XEVMPD along with provision for the medicinal product identifier, the pharmaceutical product identifier, and the package identifier-plus various other factors in support of product-life-cycle management. Guidance for this phase would be issued in the first quarter of 2016, with implementation in the first quarter of 2017 and enforcement in the fourth quarter of 2017.
Iteration two would prioritise provision of information for investigational medicinal products rather than more information for authorised products. This could catch out a number of companies, because it will not have been their focus before now; it could also result in more data issues because of relative immaturity in the management of information in this area. Guidance for this phase would be due in the fourth quarter of 2016, with implementation starting in the fourth quarter of 2017 and enforcement six months later.
Iterations three and four, to be defined during 2016, would include the remaining European Union requirements under Clinical Particulars, followed by information about packaged medicinal products and manufacturers.
A fifth iteration, to include veterinary products, has yet to be defined.
The next step is for the European Commission to respond to the new proposals, which will go before the Heads of Medicines Agencies on 7 July.
Right first time
At the Webinar, Marr commented that a more-phased approach with revised timelines would create a number of new opportunities-for example, opportunities for more-effective change management, better adoption of the new operating model, the chance to achieve a sustained higher quality of data, and time to calculate and plan for the necessary resources.
Instead of one huge, overwhelming programme of work, organisations would be able to start thinking in terms of four or five distinct projects with more-realistic timelines and more- easily-defined scopes, thereby creating the basis for real projects and informed planning, especially for companies that have not yet started their IDMP journeys. For those with projects already under way, the revised implementation plan offers an opportunity to review whether they’re doing things in the right order.
Braun advised that organisations should start now to ensure they are “on target without any of the hassle,” adding that companies will have to design and test business process with real users, real data, and real IDMP solutions. “By September 2015, you could have a first pilot under way with one product and could have begun expanding that and developing the integration by February 2016, so that by April, you have something that has been thoroughly tested and is even ready to use,” he said.
Having additional time to get the basics right means organisations also can explore scope for additional internal efficiency wins for their businesses by way of increased automation and streamlining of information management processes. With such wins, they can move beyond compliance and risk reduction as the primary benefits and on to delivery of real cost savings, clearer information visibility, and accelerated business processes.
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