UNICOM 3rd NEWSLETTER

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Make medicines safely and accurately identified across Europe

June 2023 Issue 03

Find out who is active in the UNICOM consortium
WHO WE ARE ?

You are reading the third issue of the UNICOM newsletter. UNICOM has now entered its final year of activity and we will thus be focusing on disseminating its most important results and in ensuring their sustainability. Although created originally to support pharmacovigilance, a broad consensus exists today to state that the IDMP suite of standards should be the glue of an integrated ecosystem where interoperability is created at the source. We are however aware that some important decisions still need to be taken to guarantee a coordinated set of solutions that addresses all needs.. But there are now processes, facts and tools to support those decisions. Key players involved in the whole value chain have clearly understood the need to be mutually accountable for all use cases involving medicinal products and are continuing to collaborate on open questions. This often requires a deep revision not only of the systems but also of the roles central actors need to play.

Since 2022, all the national competent authorities (NCAs) involved in UNICOM have continued to make important progress towards IDMP implementation and share their experience and challenges with all the other European authorities with a very significant level of participation of both IT and business. The webinars provide a deep insight about the strategy followed by NCAs to become IDMP compliant, the lessons learnt to date, the remaining problems to solve and what they have started to do to support clinical practice.

During an event organised by the Swedish Presidency in May gathering all European NCAs, a vast majority of the participants declared that IDMP implementation was already in progress or included in their current strategies. Almost all agencies also declared they were willing to join new IDMP implementation support initiatives.

You may find here a number of examples extracted from national systems

Access the UNICOM NCAs Knowledge Transfer webinars

A major milestone was reached in October 2022 with the release of the electronic application form (eAF) tool for variation forms by the European Medicines Agency (EMA). This first release covers variations for CAPs (centrally authorised products). From August 2023 on, NAPs (nationally authorised products) will also be available in the eAF. Even if the compulsory use of the tool has been postponed to end of Q3 2024 and if forms for initial application and renewal are still pending for now, the signal has been received clear and loud by the Industry which is now speeding up its IDMP alignment. Rather than proceeding with multiple marginal costly adaptations, it is indeed much more rational for Industry to proceed with the refactoring of their databases as soon as possible. This might thus also ease the burden related to the conversion of legacy data within European agencies.

The FHIR framework is supporting the IDMP implementation, especially in the context of exchanging medicinal product data (e.g. eAFs). It is for UNICOM essential to contribute to the adaptations of underlying specifications and to avoid detrimental diverging implementations of FHIR and IDMP. UNICOM has taken several important initiatives to make this happen

Three webinars to help NCAs staff to get acquainted with the FHIR standard have been organised to date and more will follow in the second part of the year.

UNICOM has also developed a first version of a FHIR IDMP Implementation Guide: a combined set of specifications, including EMA guidance and MyHealth@EU specifications, which provides many advantages, including much faster reuse through inheritance: UNICOM is the first to use the visualisation of example data inside a FHIR IG. It is the result of intensive collaboration between all domains and competences available in the consortium creating the critical link between the regulatory and clinical domains. UNICOM will soon complement the guide with a CDA-FHIR mapping in UNICOM context, add all relevant terminology mappings and add new sections dedicated to the eHealth-regulatory bridge, data migration and will keep on reporting lessons learned. Learn more about this in this presentation.

See the DW products browser based on the IG		ACCESS the UNICOM FHIR Implementation guide

To clearly identify a medicinal product, three key attributes: substance, dose form and strength- need to be provided with a level of granularity adapted to each use case. To make sure that all use cases will be covered, the highest level of granularity should be created at the source, allowing then possible regrouping when needed. with the support of adapted user interfaces to improve global usability. We provide below a short overview of progresses made to date.

SUBSTANCES: : The UNICOM team has been providing intensive support to the Substance Validation Group members for the cleansing of substances, which led to the release of the EU-SRS substance database: they define characteristics of substances, such as molecular structures, amino acid sequences and relationships. It has been a joint and sustained effort between various national agencies and EMA to implement EU-SRS, to cleanse substance data, to build substance records in EU-SRS and to create substance management guides for use by the SVG. Substance data cleansing results have been provided to EMA for further processing in their Substances Management Services system (SPOR SMS), resulting in a significant improvement of SMS data quality. Also, key substance information from EU‑SRS is or will be made available in SMS. The data are published on a daily basis, on the EMA SPOR portal in CSV format.

UNICOM is now advocating a progressive wide open access to all public data. This is a major milestone for Europe but UNICOM advocates the use of a unique substance identifier at world level.

View the EU-SRS ecosystem

DOSE FORMS: UNICOM has documented that EDQM provides the highest level of granularity and has even contributed to an improvement of the standard UNICOM partners are using terms from EDQM, either directly or via EMA’s SPOR RMS systems. Discussions are also ongoing at transatlantic level to discuss the use of granular EDQM dose form versus combination of 4 basic characteristics.

STRENGTH: the strength of the substance can be expressed as either concentration strength or presentation strength. And then the value of strength needs to be determined considering both the reference strenght and the strength of moiety and modifier.

Can we integrate substance, dose form and strength to produce a unique Pharmaceutical Product Identifier or PhPID which could support all use cases and which would make any medicinal product recognisable anywhere in the world? There is indeed a risk that individual countries might not be able to apply business rules in n aligned and consistent way. WHO-UMC (Uppsala Monitoring Centre for Pharmacovigilance) is currently conducting a number of tests with voluntary agencies to provide the evidence needed to take the appropriate decision. The relationship between such an unique identifier and prescription by International Non-Proprietary Name (INN) and smart substitution has also been explored and a methodology has been developed to assure the link with the Anatomical Chemical Therapeutic Classification (ATC) and with other more clinically oriented classification

Watch this short interview of WHO-UMC to better understand the issue

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UNICOM has been in constant relationship with the European eHealth groups responsible for the policy, strategy and operational aspects of cross border services. UNICOM has proposed improvements based on IDMP specifications, dealing in particular with issues of complex medications and complex packaging. In June 2022, the use of the very SPOR SMS as a reference coding system for cross border services has also been approved but intermediary solutions have been identified to be able to test the specifications. The new assets are currently being tested and are expected to be integrated in routine operation from November 2023 on. Progress is of course very much dependent on the decision of Member States to support the eHDSI cross border services on one side and on the progress made by national medicinal products agencies to make their data IDMP compliant. The assets release of Wave 8 foreseen for June 2024 will further refine tne specifications.

Attributes

Software and extensions

eHDSI Piloting

Steps

UNICOM is documenting the benefits of IDMP for clinical practice, research, patient empowerment, personalised medicine and pharmacovigilance.

Norway, Belgium, Greece, Italy, Finland and the USA have collaborated with UNICOM to provide a limited (4 substances) but complete #IDMP/ #FHIR data set.
The process consists in collecting Data “AS IS”, and doing a central standardization to EDQM, limited to the minimal attribute list (variables relevant for pilots) and limited to 4 single and simple substances.
The project database is instrumental to the pilots of UNICOM (eHSDI cross-border services, substitution component, cross-national comparison, linking to international pharmacotherapeutic classifications, patient-facing apps, experiments in PhPID production).

Read below about the first results of this work and learn why we believe that IDMP can strongly reinforce Decision Support Systems in medication management in Europe and can change the way we look at phamacovigilance.

CLICK ON THE PICTURES TO ENLARGE

Our three next strategic Face-to-Face encounters

Participate in the UNICOM IHE Day in Rennes (France) on September 28 where we will be putting the UNICOM results to the test following the IHE methodology: No less than 5 scenarios are being developed, involving all stages in the value chain: submission of variations, updates to the Medicinal Product Dictionary, Updates to the National Contact Point for e-Health product database, cross-border ePrescribing and eDispensing and product lookup for patent facing apps

On October 19 & 20, within EMA premises in Amsterdam, the sixth transatlantic workshop will take place, in close relationship with the “Global IDMP Work Group” (GIDWG) involving US FDA, EMA and WHO-UMC

The next Unicom consortium meeting will take place in Ghent (Belgium) on November 28: We will focus on how best to use our results and support ALL European NCAs to take the IDMP and ensure the global sustainability of our assets. The meeting will be opened to no NCAs not active in the consortium.

IDMP in a capsule is now available in several languages

All CoE webinars and slides

UNICOM Ressources

We are disseminating all our results and are discussing open issues continusoulsy through the UNICOM Community of Expertise webinars and publish all our key resources on our website.

You are receiving this email because you signed up for our newsletter or attended one of our public events. The UNICOM Innovation Action has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 875299.

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