D9.6 Educational material on IDMP for end users of prescribing and dispensing systems and their suppliers

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Grant Agreement No. 875299 Project acronym: UNICOM Project full title: Up-scaling the global univocal identification of medicines in the context of Digital Single Market strategy Call identifier: H2020-SC1-DTH-2019 Deliverable D9.6: Educational material on IDMP for end users of prescribing and dispensing systems and their suppliers Version: 1.0 Status: Final Dissemination Level1: PU Due date of deliverable: 29.05.2024 Actual submission date: 10.06.2024 Work Package: WP9: Medicinal Product Dictionaries and Clinical System Software Lead partner for this deliverable: IHD Partner(s) contributing: Deliverable type2: R Main author(s): Dipak Kalra IHD Robert Vander Stichele IHD Other author(s): Luc Nicolas EHTEL Christian Hay INFORMA Robert Stegwee CEN/TC 251 Julie James IHD 1 Dissemination level: PU: Public; CO: Confidential, only for members of the consortium (including the Commission Services); EU-RES: Classified Information: RESTREINT UE (Commission Decision 2005/444/EC); EU-CON: Classified Information: CONFIDENTIEL UE (Commission Decision 2005/444/EC); EU-SEC Classified Information: SECRET UE (Commission Decision 2005/444/EC) 2 Type of the deliverable: R: Document, report; DEM: Demonstrator, pilot, prototype; DEC: Websites, patent fillings, videos, etc.; OTHER; ETHICS: Ethics requirement; ORDP: Open Research Data Pilot Ref. Ares(2024)4161124 - 10/06/2024 UNICOM – D9.6 Page 2 of 42 1 Revision history Version Date Changes made Author(s) 0.1 12.10.2023 First complete content Dipak Kalra (IHD) 0.2 22.10.2023 Incorporating edits from Robert Vander Stichele Dipak Kalra (IHD) 0.3 1.11.2023 Incorporating edits from Julie James Dipak Kalra (IHD) 0.4 26.11.2023 Incorporating edits from Luc Nicolas and Robert Stegwee Dipak Kalra (IHD) 0.5 02.06.2024 Final version to Coordination 1.0 10.06.2024 Submission Statement of originality This deliverable contains original unpublished work except where clearly indicated otherwise. Acknowledgement of previously published material and of the work of others has been made through appropriate citation, quotation or both. UNICOM – D9.6 Page 3 of 42 2 Deliverable abstract This deliverable presents a short course for health and care professionals, primarily doctors and pharmacists, to enable them to acquire a basic understanding of the improved capability they should experience through their electronic health record, prescribing and pharmacy systems once the 5 ISO/CEN standards for Identification of Medicinal Products (IDMP) have been adopted across Europe and implemented in those systems. The course is organised for three personas of professionals: ● Health and care professionals who may encounter the need to care for patients from another country (introductory modules) ● Health and care professionals involved in clinical research or teaching (additional details about the information of flows of medicinal product information across the health and care ecosystem) ● Health and care professionals who analyse health data (deeper dive topics on the representation of medicinal product information) The reasons why IDMP knowledge is needed is introduced in Chapter 1. The benefits of IDMP enabled systems that professionals should in the future experience are explained in Chapter 2. The course is introduced in Chapter 3 along with its learning objectives. The modules are summarised in Chapter 4. Most of this written information is included within the online resources, which link to the actual educational videos. Keywords: IDMP, education, course This document contains material, which is the copyright of the members of the UNICOM consortium listed above, and may not be reproduced or copied without their permission. The commercial use of any information contained in this document may require a license from the owner of that information. This document reflects only the views of the authors, and the European Commission is not liable for any use that may be made of its contents. The information in this document is provided “as is”, without warranty of any kind, and accept no liability for loss or damage suffered by any person using this information. © 2019-2024. The participants of the UNICOM project. UNICOM – D9.6 Page 4 of 42 TABLE OF CONTENTS 1 Revision history ................................................................................................................................. 2 2 Deliverable abstract .......................................................................................................................... 3 3 List of abbreviations and definitions .................................................................................................. 5 4 Executive summary ........................................................................................................................... 6 5 The case for IDMP education ........................................................................................................... 7 6 Understanding the benefits of IDMP ................................................................................................. 8 6.1 The journey to IDMP adoption ................................................................................................ 8 6.2 The benefit scenarios from IDMP enabled systems ............................................................... 8 6.3 Implications for the developers of prescribing and dispensing systems .............................. 10 7 The online UNICOM course on IDMP for prescribers and dispensers ........................................... 11 7.1 Overview ............................................................................................................................... 11 7.2 The structure of the course ................................................................................................... 11 7.3 Learning objectives by module ............................................................................................. 12 8 Synopsis of the course .................................................................................................................... 14 8.1 Patient stories illustrating the value of having IDMP enabled apps ..................................... 14 8.2 An introduction to UNICOM and IDMP ................................................................................. 16 8.3 Overview of the IDMP international standards ..................................................................... 19 8.4 Medication information flows explained ................................................................................ 21 8.5 The role of IDMP in clinical decision support........................................................................ 26 8.6 How IDMP could enable cross-border value to patients from ePIs ...................................... 28 8.7 Steps to make IDMP relevant for clinical care ...................................................................... 33 8.8 The representation of substance and strength ..................................................................... 35 8.9 Using IDMP in Adverse Event reporting ............................................................................... 39 9 Conclusion and next steps .............................................................................................................. 42 UNICOM – D9.6 Page 5 of 42 3 List of abbreviations and definitions Abbreviation Complete form API application programming interface HL7 Health Level Seven International ICSR individual case safety report IDMP identification of medicinal products IHE Integrating the Healthcare Enterprise MPD medicinal product dictionary NCA national competent authority PhPID pharmaceutical product identifier WHO World Health Organization UNICOM – D9.6 Page 6 of 42 4 Executive summary This deliverable presents a short course for health and care professionals, primarily doctors and pharmacists, to enable them to acquire a basic understanding of the improved capability they should experience through their electronic health record, prescribing and pharmacy systems, or other medication management systems, once IDMP has been adopted across Europe and implemented in those systems. The course is documented in this deliverable and is provided as an online course, which is already operational. The course is presented as nine videos, many of them close to 90 minutes long but a few shorter ones. These have been extracted as a subset from a much larger body of recorded presentations and webinars organised through the project by work package one, under the heading of its “Community of Expertise”. The online course is hosted by the i~HD Academy, which already hosts other health data related courses. It is intended to be used for continuing professional development or maybe incorporated within more substantial training programmes offered by third parties such as universities. Most health and care professionals do not need to know the details of IDMP, just as they do not need to know the details of the interoperability standards that enable the transfer of patient data between systems. The online course is therefore organised for three personas of professionals: introductory modules that should be relevant to any health and care professional who may encounter the need to care for patients from another country; additional details about the information of flows of medicinal product information across the health and care ecosystem for those involved in clinical research or teaching, and deeper dive topics on the representation of medicinal product information for those who analyse health data or are involved in pharmacovigilance. This deliverable has been written in a style that is intended to be understood by health and care professionals, as it is a source of text that has also been used for the introductory pages of the online course. The reasons why IDMP knowledge is needed is introduced in Chapter 5. The benefits of IDMP enabled systems that professionals should in the future experience are explained in Chapter 6. The course is introduced in Chapter 7 along with its learning objectives. Each of the nine modules is summarised in Chapter 8. Most of this written information is also included within the online resources, which link to the actual educational videos. It is recognised within the consortium that more comprehensive educational resources are needed regarding IDMP, its benefits and what is needed for its successful adoption and use, for a wide range of healthcare, regulatory and clinical research stakeholders. It is beyond the scope of this project to have developed these resources and educational programmes, and so the consortium is exploring avenues for future funding to develop this. The existing course for health and care professionals will be maintained on a long-term basis, post project, by partner i~HD. It is being provided for a modest cost recovery registration fee to enable its sustainability. UNICOM – D9.6 Page 7 of 42 5 The case for IDMP education Many health and care professionals (in particular, prescribers who are usually doctors and dispensers who are usually pharmacists) face challenges when supporting continuity of treatment or the safe provision of an additional medicinal product to patients who are taking medicines that have been given to them in another country. Such patients could be tourists, business travellers, refugees, people who choose to seek healthcare across borders or simply to obtain their medication in a different country to the one in which the medicines were prescribed. The challenges professionals face today are primarily because most medicinal products are licensed and marketed on a national basis. This means that product names and the details about them, including the packaging and packaged quantities, may vary between countries and it can be difficult to recognise an equivalent branded product in one country when they are interacting with a patient who shows them a product they have obtained from a different country, even within Europe. The situation can be complicated because products may not be marketed with exactly the same formulation and strength choices in each country, even by the same manufacturer. The best fit substitute for a patient’s existing (foreign) medicine might be a product produced by a different manufacturer. Finding this best fit alternative is error prone and therefore has patient safety risks. The ISO IDMP suite of standards formalise the comprehensive representation of medicinal 3 and pharmaceutical 4 products such that the details are consistently represented, and that each product can be issued with a globally unique identifier that is always applied equivalent products everywhere, and never reused as an identifier for different (non-equivalent) products. The combination of unique identifiers and comprehensive information that is primarily held in a computable form enables the information systems that process and present users with pharmaceutical and medicinal product details to be globally complete and accurate. The introduction of IDMP across the health and care ecosystem will not alter the diversity of products that exist across countries, but will enable any professional to reliably and accurately look up the details of a product their patient has obtained from a different country, and to be able to match that foreign product with the closest safe match in their own country. This could enable a professional to understand the medicines that a patient under their care is taking even if they were prescribed and dispensed in another country, to be able to provide an additional supply of a safe equivalent product available in their country (i.e. substitution), be able to prescribe or to recommend the purchase of an additional necessary medicinal product that will be compatible with a patient’s existing medication list, and be able to accurately identify a medicinal product when reporting an adverse event through formal reporting mechanisms. It is recognised that most health and care professionals do not need to know the details of IDMP, just as they do not need to know the details of the interoperability standards that enable the transfer of patient data between systems, although it is important that they understand the importance of an integrated ecosystem. The online course is therefore organised for three personas of professionals. Most will only need to take the first three modules which cover the basic understanding of cross border information about medicinal products, what IDMP is, and the most common scenarios in which they might need to utilise it, for example when making a product substitution. Another three modules will be additionally useful for health and care professionals who wish to have a more detailed understanding of how product information flows across the ecosystem, and the different information systems that need to be interoperable with respect to product information. These modules may be relevant to practitioners involved in research, who participate in clinical trials or who teach new professionals. The final three modules go into greater detail on the specification of medicinal product information, such as the dose form and strength, and will be relevant to practitioners who conduct real world data research that involves medicinal product information. 3 proprietary products for human use intended to be placed on the market and to industrially manufactured Medicinal Products, the marketing of which has been authorised by a Medicines Regulatory Agency (Source ISO IDMP) 4 medicinal products in the dose form approved for administration in line with the regulated product information (Source ISO IDMP) UNICOM – D9.6 Page 8 of 42 6 Understanding the benefits of IDMP 6.1 The journey to IDMP adoption The primary information resource referenced by electronic prescribing and dispensing systems is a medicinal product dictionary (MPD). MPDs contain facts about medicines: their composition, relationships between different medicinal product objects, products, packages, abstract objects that represent interoperable groups of products; knowledge about medicines - contraindications, drug-drug interactions, allergy etc. which may then be used in active decision support; and legal and financial information for the environments in which they operate. MPDs were historically developed on a national basis, and ensured that they contained all of the medicinal products that are licensed and available for prescribing or over-the-counter purchase within individual countries. MPDs are nowadays becoming cross-border resources and can contain information about medicinal products that are licensed and used in multiple countries. MPDs are usually developed and licensed by specialist companies, who employ experts in pharmaceutical and medicinal products and relevant structural and semantic representation experts. Most electronic health record and pharmacy information system developers license these products. Member States are currently implementing different strategies to ensure the use of quality validated data, either though the provision of a unique validated source - which often includes information related to scientific evidence, reimbursement and authorisations - or through the publication of official referentials. MPD developers increasingly need to manage a matching process between the medicines in each country. Through IDMP this can be more streamlined by mapping to international standard product identifiers. 6.2 The benefit scenarios from IDMP enabled systems The users of electronic health record, prescribing and dispensing systems and other medication management systems will not be exposed to the detail of IDMP as a standard and as a formalised representation of product information. They will hopefully experience international medicinal product capability as new features and functions within their systems, in the coming years. There are several scenarios in which these features may be manifest and enable their practice to be safer. A wide IDMP implementation would also allow HCPs living in countries with less mature digital infrastructure and without access to (affordable) MPDs to access to validated product knowledge available in other countries. Looking up the details of medicines from another country People who are on existing medicines may seek medical advice or experience new symptoms requiring medical intervention when in a country that is not the origin of the medicines they routinely take. They may seek that advice from a doctor or a pharmacist, perhaps in order to find out if any of their existing medicines may be causing their symptoms as a side-effect, or the practitioner may wish to disentangle newly reported symptoms from the possible influence of a patient’s medication list. At present, professionals may struggle to know what a foreign medicine is, if it is shown to them by the patient, especially if all of the packaging information is in another language. Their need-to-know about medicines the patient is taking may be more extreme in the case of an emergency, such as an accident, when the medicines might be amongst the patient’s effects but without the conscious capability of the patient to provide any explanations. In the future, if a cross-border online electronic patient summary is available, it may be possible for a professional to access the summary even if the patient is unconscious (provided they are carrying some identification) and to look up their medication list even if they are not carrying any medicines with them. However, even in that online situation, the medication list is likely to be presented in the form of national product names in the patient’s country of origin. UNICOM – D9.6 Page 9 of 42 Regrettably today the commonest solution is an Internet search, which is prone to error and the risk of misinformation. Even this is not possible if the character set used in the country of origin is not the same as the character set in use by the practitioner, because they cannot even type the product name into their Internet search. A global medicinal product look up feature would allow the practitioner to discover information about each product the patient is taking wherever it was dispensed, and hopefully in the future be able to have this information presented to them in their own language. The risk of error could be reduced further if the professional is able to scan the two dimensional data matrix on the product packaging. This would be necessary if the source medicinal product packaging uses a different character set (e.g. Greek, Russian). The international patient summary that is available online, especially for cross-border scenarios, may in future use global identifiers (or identifiers that can be mapped across countries) for every product in the medication list and for every medicinal product mentioned in an allergy list. Safer prescribing and substitution Thanks to MPDs and to existing clinical decision support functions within electronic health record and dispensing systems, health and care professionals have access to alerts in situations where they might be about to prescribe or dispense a new product to a patient that is contraindicated or introduces pharmacokinetic or physiological complications alongside their existing medication list. Allergy alerts and contraindication alerts are usually also built into these systems, connecting with the clinical details within an electronic health record or, in future, an online international patient summary. These functions work well today provided that the existing medication list originates from the same country as the health professional, and the same country as the product they intend to introduce to the patient. Clearly, though, these systems will fail if a patient’s existing medication list originates from a different country (unless the prescribing or dispensing system is connected to a multi-country MPD, which specifies the country per product included). Even if they do not require new treatments, a number of travelling patients will require continuity of medicine supply. This could be because they have accidentally miscalculated the amount of medicine to bring from home to cover the duration of their stay, or if their stay is unexpectedly extended, or if they have lost their medication such as if their luggage has gone astray or been stolen. As mentioned above, medicinal products are authorised and packaged on a national basis and a precise equivalent might not be available in another country. The safe substitution of a best fit alternative requires firstly the accurate identification of the existing medicinal product and secondly a different form of decision support that could guide a professional to find the closest match alternatives. IDMP-enabled MPDs that have interconnection with global databases of medicinal products, and which are used by electronic prescribing and dispensing systems, will enable cross-border patients to experience the same safety of care as they do today within borders. Accurate safety reporting The reports of adverse events when taking a medicine are systematically collated, initially at regional or national levels and shared globally (although not always as easily combinable data), in order to discover safety signals as quickly as possible when an adverse event is being frequently reported. This global pooling of incidents accelerates the discovery of issues that may require a change to the product information, perhaps providing additional guidance to prescribers and patients, possibly amending the profile of patients for whom the product is suitable, possibly introducing the need for monitoring for a particular symptom or laboratory value, or exceptionally the withdrawal of the product. Reporting is undertaken using various (non-standard) adverse event reporting forms. These forms might be manually completed by a health and care professional to report an adverse event they have detected with a patient. (Patients can also report adverse events directly.) Unfortunately, how a medicinal product is documented within adverse reaction reporting form varies hugely in the way it is described and the level of detail given. It can be very difficult for the recipient of the form to accurately identify the medicinal product, by brand, formulation and strength, in order to match a report with other equivalent reports about the same product. A further complicated step is to match national product descriptions at an international level in order to globally pool the incoming reports. This is time-consuming and retain UNICOM – D9.6 Page 16 of 42 8.2 An introduction to UNICOM and IDMP Topic An introduction to UNICOM and IDMP Presenters Karl Stroetmann, empirica Filippo Magrini, DataWizard Robert Vander Stichele, i~HD Jack Shanahan, Irish Pharmacy Union George Dafoulas, Larisa and EHTEL Filippo Magrini, DataWizard Commentators: Dipak Kalra, i~HD; Sara Riggare, a patient researcher from Sweden; Stephanie Kohl, European Association of Hospital Pharmacists Video An introduction to UNICOM and IDMP.mp4 YouTube URL https://www.youtube.com/watch?v=X2G7qgsAy_o Duration 1 hour 32 minutes Target audience ● Health and care professionals, especially prescribers and dispensers ● EHR system and pharmacy system developers Learning objectives ● To understand the health system and safety drivers for accelerating the adoption of IDMP ● To recognise the benefits a patient might have if he or she could view and share information about their medications when visiting another country. ● To appreciate the value to health and care professionals in having internationally interoperable (IDMP enabled) clinical systems for prescribing, dispensing, decision support and as a look up. ● To recognise the human and economic cost of delay in IDMP adoption, but also the complexity involved in its adoption. Synopsis Why IDMP is important This webinar focuses on explaining why the global identification of medicines is so important. Karl begins by explaining that the strongest driver for having the comprehensively adopted global identification for all pharmaceutical and medicinal products is pharmacovigilance. It is presently time consuming and inefficient to identify accurately the medicinal product behind every reported adverse event, because of the imprecision in how the medicinal product is documented. This can be speeded up through a standard identifier. Adverse event reports could then be pooled at a global level rapidly, leading to timely safety warnings and hopefully in the future to fewer adverse events. One of the prescribing and dispensing risk situations is substitution, when an alternative product has to be given to a patient, for example when they have travelled to another country and need continuity of supply, but their original product is not UNICOM – D9.6 Page 17 of 42 available in that country. Safe substitution is therefore another complementary driver for a global identifier. Public health intelligence gathering and research are other important drivers for internationally used identifiers. Karl points out that the market for medicines is primarily national which has fuelled the use of national identification systems, which use national identifiers, document and classify medicines differently. Products can have different names in different countries, sometimes the same name being used for different products across countries which can be very dangerous. There is an urgent need for countries to adopt international standards for the specification of all of their products, so that these can be mapped to each other, common global identifiers issued. This will bring value to multiple health, regulatory and research stakeholders. UNICOM’s mission is to further develop the existing ISO IDMP standard where needed, assist with its implementation and adoption, and diffuse awareness of it and the benefits of using it. An example patient story Filippo then tells the patient story of Piero, who has an accident while on holiday abroad and needs to communicate his regular medications to an ambulance team and in a hospital emergency department. He also needs to have information about his emergency treatments so that he can communicate those back to his doctor at home. Filippo explains the challenges he would face today and how things would be different if he had access to all of his medicines that could display the product to professionals in different countries. GP perspective – clinical decision support Robert then introduces the role of clinical decision support systems that support safe prescribing, especially in cases of polypharmacy. Implementing a cross-border medicinal products capability into decision support is complicated and expensive, due to the challenge of aligning the large list of products that are licensed in each country. If each national database were mapped to IDMP, cross-border matching would be accurate and efficient. Pharmacist perspective Jack then walks through the advantages of IDMP to a pharmacist. Apart from product names, pharmacists have access to their ATC codes. These are somewhat useful but lack detailed specificity and not all medicines are included. He further points out that many pharmacy systems are not interoperable, so communication between them is impossible in cases where a patient attends an unfamiliar pharmacy - especially in another country. Jack illustrates these issues through a patient scenario, visiting Ireland but unable to trace their Belgian prescribed product. IDMP would allow the Irish pharmacist to look up with confidence the Belgian product, and to check for interactions against any other products being taken or purchased. GP perspective – cross-border care George explains the challenge faced by practitioners in Greece, who have many patients who spend only the winter in Greece. A lot of these are elderly, with many conditions and medications that are prescribed for the rest of the year in another EU country, and are entitled to have continuity of care and of medicines while in Greece. GPs and pharmacists are challenged to look up the details of these medicinal products, to discover their drug interactions and side effects and to make a substitution. ATC codes are not precise enough, and might not be discoverable for non-Greek medicines. Being able to scan the IDMP 2D data matrix of a product brought into the clinic or pharmacy by a patient would provide a safe and reliable way of identifying each medicine. Discussion with a patient and with the European Association of Hospital Pharmacists Dipak introduces Sara and Stephanie, to comment on the presentations. Stephanie is pleased to note that UNICOM is aligning with the EMA mission of promoting IDMP adoption, and that it focuses on patients travelling across borders. There is also an important alignment with the European Commission drive to support patients having access to their medical summary everywhere across Europe. Sara finds it very important to keep a personal track of her medicines and her consumption of them. ICT systems, medicinal product knowledge and understanding, and the behaviour of people, need to be worked on together. UNICOM – D9.6 Page 18 of 42 The story of Piero resonates with both Sara and Stephanie. Filippo reports that a recent consumer survey undertaken by the project had confirmed substantial interest by patients in having an app that could display their medication list and details in a way that would be understood when they are in a different European country. Although survey respondents felt that this app should be provided by their health system or health insurance, a surprising proportion would be willing to pay for it if it was not provided. Robert welcomes the possibility that patients would have an app like this, as a means of detecting medication list errors and entries that might be out of date, and to support meaningful dialogue about a patient’s medication use. George emphasises the importance of the app being certified and the information it presents coming from a qualified source. If the medication list has also come from a trusted source the app would be useful to patients and also to health professionals. The urgency for adoption Discussions turn to the recognised cost and workload of adopting IDMP across all health and care systems. Karl reports that the EMA estimates around 200,000 patient deaths per annum in Europe alone, due to adverse medication events. The European Commission estimates that the societal economic burden of this is close to €80 billion. Addressing this issue is therefore urgent societally and economically. Karl emphasises the complexity of the challenge and the importance of multi-stakeholder cooperation to accelerate IDMP adoption. He goes onto outline some of the areas of complexity and their interdependencies. UNICOM – D9.6 Page 19 of 42 8.3 Overview of the IDMP international standards Topic Overview of the IDMP international standards Presenters Robert Stegwee Chair of CEN TC/251 Video 3 IDMP in a capsule.mp4 YouTube URL https://www.youtube.com/watch?v=OfctZZoBRkk Duration 33 minutes Target audience ● Health and care professionals, especially prescribers and dispensers ● EHR system and pharmacy system developers Learning objectives ● To recognise why the cross-border identification of medicinal products is vital for patient safety ● To understand the areas of information specified in the IDMP suite of standards ● To understand the role of the pharmaceutical product identification (PhPID) to match medicines between national medicinal product dictionaries ● To recognise the importance of global identification to collate adverse event information across countries, for pharmacovigilance Synopsis Why is IDMP needed, and what does it comprise? This tutorial explains why the suite of standards for the Identification of Medicinal Products (IDMP) is needed, and what aspects of medicine information are formalised through it. Robert, an international standards expert, starts by presenting a patient story that illustrates why it is important to have very accurate and precise cross-border recognition of medicinal products. The story illustrates the negative impact an incorrect medicinal product substitution can have, if the medicinal product the patient is taking in their original country cannot be accurately identified and locally matched in the country they are visiting. He explains the IDMP suite of CEN/ISO standards, that comprise: ● Substance (EN ISO 11238) ● Dose form (EN ISO 11239) ● Strength (EN ISO 11240) ● Medicinal product (EN ISO 11616) ● Medicinal product package (EN ISO 11615) UNICOM – D9.6 Page 20 of 42 The goal of IDMP is to provide clinicians with complete and understandable medicinal product information to support their prescribing of medications, regardless of the brand-name, to enable the safest possible substitution by a pharmacist of a medicine within a country (if a brand is not available) or across borders (if brand is not marketed in another country), to enable the accurate reporting of adverse drug events for specific medicines and to reduce the risk of falsified medicines. Pharmaceutical product identification and Medicinal Product Dictionaries Robert explains the process whereby companies that develop and/or manufacture products (market authorisation holders) obtain approval and product identifiers at each national level and the process for developing global product identifiers (the PhPID) and the 2D DataMatrix barcode (the Global Trade Item Number - GTIN). Robert goes on to explain what a medicinal product dictionary (MPD) is, and the kinds of information an MPD might contain, potentially including regulated product information, accompanying scientific documentation, preferred medication substitution, dose recommendations and those calculations which might be age or gender specific, and insurance and pricing information. He emphasises that MPDs are usually nationally specific, because they are aligned with local regulations and guidelines including pricing and reimbursement data. An MPD provides a rich computable resource that can be utilised by prescribing and dispensing systems, and more broadly within electronic health record systems. Using the PhPID to match medicinal products across countries The PhPID is the global identifier that can be used to recognise the same medicinal product across different national MPDs. This is the process whereby the person in the patient story should have received the correct substitution for her medicine when she was abroad. The tutorial presents a second richer narrated patient story illustrating the value of medicines identification for an over-the-counter purchase, through an app that enables the patient to verify that the proposed purchase will not adversely interact with her regular medications. The importance of the accurate identification of medicinal products for pharmacovigilance Robert continues the tutorial by explaining how linking precisely identified medicines to electronic health record information can enable documented and reported adverse event to be accurately associated with the correct medicinal product. It is important to be able to combine adverse event reporting from multiple countries and always match incoming reports to the correct globally identified pharmaceutical product. He explains the role of the WHO Uppsala Monitoring Centre in developing PhPIDs, receiving and collating adverse events within the global pharmacovigilance network. UNICOM – D9.6 Page 21 of 42 8.4 Medication information flows explained Topic Medication information flows explained Presenters Ian Green – SNOMED International José Costa Teixeira –IHE Europe Robert Stegwee –CEN/TC 251 Health Informatics Source Medication information flows explained.mp4 YouTube URL https://www.youtube.com/watch?v=bUd-96DmrNg Duration 1hour 20 minutes Target audience ● Health and care professionals interested in medicinal product information ● EHR system and pharmacy system developers Learning objectives ● To understand the information flows relating to medicinal products that take place within the health and care ecosystem ● To recognise the importance of interoperability standards for reliable information exchange, and the information properties to be represented ● To understand the role in particular of interoperability standards in representing medicinal products ● To recognise the value of routinely documenting the clinical indication for a medication prescription Synopsis The landscape of use of medication data is quite broad and diverse. When looking at standards for the exchange of medication data, including the terminology mappings needed to cross the borders between the different domains, it is important to identify the original sources of the data being exchanged. These sources are the key first step in making sure that the necessary data is captured and coded with the requisite quality and level of detail. The medicinal product information flows relating to patient care In this three person educational webinar, Ian starts by introducing the complete medicines life cycle, the communication of medicinal product information, and emphasises that for this presentation he focuses on the final stages of the medicines life cycle, prescribing, dispensing and administration including patient adherence. UNICOM – D9.6 Page 22 of 42 He presents the clinical data landscape with which clinicians and pharmacist engage, within healthcare provider systems, between systems and across borders. He emphasises the many categories of clinical data that would normally be held in electronic health records, sometimes also in laboratory and pharmacy systems, that are interpreted alongside medication information, for example by clinical decisions support systems. He explains the different terminology systems frequently used for the different categories of clinical information, and the information model standards that are used for higher level sets of health information. Pharmacovigilance may require a two-way connection to electronic health records, initially for reporting adverse events to pharmacovigilance systems, and potentially in the other direction if there is a need to obtain additional background health information about patients that have experienced an adverse event. Clinical trials are also increasingly making use of electronic health record information, either anonymized or through consent. The standards used for clinical trial regulatory submission are not the same as the ones conventionally used in electronic health records, and so there is a need for translating information UNICOM – D9.6 Page 23 of 42 between systems, and also the recognition that clinical trial systems often end up duplicating information that is in electronic health records. The medicinal product information flows needed for cross-border continuity of care José introduces the information flows that occur cross borders, in the case of a patient having a prescription dispensed in a different country to its creation, or if a patient needs healthcare and a new prescription in a country they are visiting. He explains the different information properties that need to be communicated, and that this information is often held in a standardised form within countries, but can be problematic to exchange between countries. The natural languages often being different between countries adds to the complexity of the challenge. This includes the many different identifiers for products used international level, which are not internationally recognisable. Different countries use different drug coding schemes, and classification systems. The details describing the particulars of each drug may also be organised quite differently within drug databases and information exchange message models, which he illustrates. The international standards used to communicate medicines information across-borders José then explains the different international standards that enable the consistent representation and communication of medicinal product information and the different characteristics of products, including how they work together to enable a complete standardised representation, and communication. He also emphasises the challenges with mapping data from a mixture of different sources into a standardised format, with examples, and why it is important to assess formally any negative impact on the quality of the data and any introduction of risk through incorrect mapping. he explains the importance of data governance and method data, and how this is tackled by the different standards organisations involved in representing and communicating medicines information. UNICOM – D9.6 Page 24 of 42 There is an ideal scenario of having a single trusted source of internationally recognised medicines and identifiers, or at least having this at a European level there was discussion during the webinar, in this recording, about whether the European Mets association should position itself as that trusted source and be able to provide. The importance of accurate medicines identification for patient safety Robert emphasises the importance of patient safety, which is at its most critical at the point of prescribing. Prescribing decisions may rely upon medicines information that originates from another clinician, even another country. This is also quite a distance in workflow terms from the regulatory decision-making that authorised the product. He points out that the need for safe medicines information flows is not limited to the single point of prescription, but to collaborating ICT systems supporting a community of health and care professionals who need to collaborate in optimising the medication list of each patient. The importance of specifying the indication for each prescribed medicine A medication list should indicate why each medicine has been prescribed, which is important to know when anybody undertakes medicines reconciliation, but unfortunately indication information is often missing from electronic health records and prescribing systems. Indication, and also concerns like allergies and experienced side effects, have therefore been made optional elements within standardised representations such as IHE profiles. If indication is captured, there are benefits to this information in addition to accurate patient medication reconciliation. One example is being able to look at the effectiveness of medicines use, across patients, such as the utilisation of antibiotics for different clinical indications and the effectiveness of antibiotic therapy in those situations. UNICOM – D9.6 Page 25 of 42 Another benefit is to be able to track off label uses of medicines. Robert illustrates the importance of accurate documentation in electronic health records including clinical indication, through a case study example of detecting off label use. The accurate, structured and coded, representation of medicines information, such as dose form, in electronic health records is vital for monitoring the safety and effectiveness of drugs, post marketing surveillance, and for the reuse of that data in future clinical research. Mappings between different information standards The closing discussion amongst speakers included considering the challenges of maintaining mappings between standards bodies and updating information systems such as electronic health record systems with those updated mapping. Mappings have to be well governed, accompanied by rigourous version control and release management strategies. UNICOM – D9.6 Page 32 of 42 or more identifies of medicinal products that are used within a country and potentially used internationally, and contain additional information about each product such as its available dose forms and strengths. She mentions the role of MPD in supporting prescribing, clinical decision support (drugdrug interaction checking, checking against allergies and medical conditions), reimbursement within a country, medicines substitution including cross-border and within supply chains. Reimbursement features are almost always national, because they will depend upon which drugs are approved for reimbursement within each health system, the prices of those medicines and what level of reimbursement is approved. For this reason MPDS store national identifiers. Global identifiers are not yet prevalent enough to be included, but this is the future direction. An MPD can support the use case of Helen by offering the PhPIDs for a variety of possible antibiotics for Helen, that the pharmacist can cross-reference to available products. Many other characteristics of the product can also be presented to Helen or her pharmacist. Several points were raised in the subsequent discussion. The experts explored how close we are to having a global substance identifier. A global IDMP working group comprising EMA, FDA and WHO is well advanced. For clinicians searching for a drug, or to find out if a patient is taking a particular category of medicines, it is first necessary to have this linkage between databases of medicinal products, as provided by MPDs. EPIs are published today in PDF form. The enrichment of this with computable semantics is in development and will progressively offer opportunities to use the product information, as apps, and HER medication information. The PhPID can be specified at four different levels. Each of these has utility when constructing mappings. A rich MPD will use, and map, Level 4 information. However, the greater the level of detail, the greater the level of expertise needed to design the information flows and to define the mappings. UNICOM – D9.6 Page 33 of 42 8.7 Steps to make IDMP relevant for clinical care Topic Steps to make IDMP relevant for clinical care Presenters Robert Vander Stichele, professor of clinical pharmacology, expert at i~HD and retired general practitioner Source 7 Steps to make IDMP relevant for clinical care.mp4 YouTube URL https://www.youtube.com/watch?v=QzcAJXmezqg Duration 17 minutes 25 seconds Target audience ● Health and care professionals, especially prescribers and dispensers ● EHR system and pharmacy system developers Learning objectives ● To appreciate why accurate medicines identification is essential for clinical practice, especially for cross-border patients ● To recognise the complexity of representing the active substance, dose form, strength of a medicinal product ● To understand the importance of the PhPID as the global identifier of a pharmaceutical product Synopsis The importance of IDMP Robert begins by explaining the relevance of IDMP, and the global identification of medicines, to clinicians. He highlights in particular the importance of work that had been undertaken in the UNICOM project to support the robust generation of PhPID using the identification of the substance, the dose form and the strength of each pharmaceutical product. This reliability and consistency of PhPIDs is critical to achieve accurate global medicine identification. The complexity of specifying the active substance Starting by explaining the project context, Robert introduces the work done in UNICOM to develop a list of examples that illustrate many of the challenges of representing precisely the details of pharmaceutical products. He presents a walk-through of the complexity and potential for inconsistency using the example of amlodipine. Even the accurate identification of the substance can be challenging. There is an even greater risk of inconsistency between product databases in the case of compound products that contain more than one active substance. The complexity of specifying the dose form He explains the complexity of representing the dose form of a product in a standardised format. The PhPID global identification system requires that the dose form refers to the administrable dose form, in other words the form of the product ready to be administered to the patient. This will not necessarily be the same as the pharmaceutical dose form, which is the form in which it is packaged and transported. An example of the difference would be a powder to be mixed with a solvent in a syringe for administration to the patient. The powder and solvent quantities in their containers make up the pharmaceutical dose form but the liquid in the syringe is the administrable dose form. The international standardisation of this is in progress, because the existing predominant standard, EDQM, is not comprehensive with regard to its coverage of administrable forms, and there are also some variants in the standard across the world. The pathway forward will be for a more complete and internationally endorsed version of EDQM. The complexity of specifying the strength The representation of strength is also complex, and interdependent upon the representation of dose form. The strength may at times expressed as a reference value relative to a standardised unit such as strength in milligrams per 100 ML of a liquid, or may be expressed as the strength per volume that would UNICOM – D9.6 Page 34 of 42 normally be administered to a patient (the presentation strength). It is important to know whether any specification is expressed as the reference strength or the presentation strength. Looking ahead Robert closes by explaining how the PhPID, which utilises these three product features, can be used to interconnect a diversity of medicinal product and pharmaceutical product databases, map between coding schemes, and enable accurate cross-border identification and substitution of medicinal products. UNICOM – D9.6 Page 35 of 42 8.8 The representation of substance and strength Topic The representation of substance and strength Presenters Presenters: Isabel Chicharo (EMA) Petra Kristic (Merck KGaA) Jeff Martin (SMPA) Source 8 The representation of substance and strength.mp4 YouTube URL https://www.youtube.com/watch?v=WOket4UV1C8 Duration 1 hour 25 minutes Target audience ● Health and care professionals, especially pharmacists ● EHR system and pharmacy system developers Learning objectives ● To understand the complex nature of pharmaceutical product and medicinal product information ● To appreciate the work being undertaken to harmonise and clean historic product databases in order to provide a comprehensive IDMP compliant resource for future use ● To understand how the strength of a pharmaceutical product, medicinal product and administrable product may differ and why ● To learn about the possibility of errors and inconsistencies in these product descriptions that may impact on the safety of product substitution, especially across borders Synopsis The work in progress to harmonise and clean product databases at a European level Isabel provides a detailed explanation of the different databases of pharmaceutical and medical products used by medinas regulators, and the work currently in progress to migrate to a more comprehensive database and the data cleaning processes that need to undertaken. (Note: this part of the webinar may be more relevant to developers of medicinal product dictionaries and pharmacy systems than to EHR system developers and clinicians.) UNICOM – D9.6 Page 36 of 42 The complexity of representing strength Petra explains the elements of a pharmaceutical product description that are used to construct the PhPID. These encompass the active substance, the reference strength (strength per standardised unit) and the actual strength of the manufactured units of consumption, the administrable dose form of the medicinal product and potentially the device if the product is administered using a device. Strength can therefore be expressed in a standardised format, or in a way that reflects the way it is presented for consumption (see slide). She explains how the terms manufactured item, pharmaceutical product and medicinal product differ. The administrative form may itself be complex, for example if a powder and a solvent have to be combined in order to arrive at the solution to be administered to a patient. The manufactured dose form would refer to the powder and the solvent as two distinct components, whereas the administrable dose form would refer to the made up solution ready for injection into the patient. The unit of presentation (how the administrable form is presented for use with the patient) would be a syringe. UNICOM – D9.6 Page 37 of 42 Effervescent tables also illustrate the difference between the manufactured dose form, which may be a tablet, and the administrable dose form which is a liquid in which precise concentration of the active substance may not be known because the exact volume of water in the glass used by the patient could not be known. Concentration may be expressed in standardised units e.g. 5mg/ml, or in terms of what is administered e.g. 25mg/5ml, because 5ml is the intended quantity to be administered. It can be an important patient safety issue to verify how concentration has been expressed, so that the correct volume is administered to the patient. Petra goes on to illustrate these concepts through several examples. The errors in existing databases and the work in progress to correct these Jeff explains the work being undertaken at the EMA to update its databases of medicinal products, in order to ensure the safety of the prescription and dispensing of medicines, especially in the case of substitutions and cross-border prescribing and dispensing. The process of correcting and enriching is part of the EMA process for adopting IDMP. UNICOM – D9.6 Page 38 of 42 Aiming for 100% correctness is the target, but challenging to achieve, which he illustrates with examples or errors, inconsistencies between similar products from different companies, and differences in the data between countries. He then illustrates the information that is needed to specify several different kinds of product including a tablet, a powder, a liquid, pre-filled syringe etc. The different patterns of product specification are being mapped, within the UNICOM project, to the process for defining PhPIDs and for communication via HL7 FHIR messages. UNICOM – D9.6 Page 39 of 42 8.9 Using IDMP in Adverse Event reporting Topic Using IDMP in Adverse Event reporting Presenters Anja van Haren (CBG/MEB) Barry Hammond (MedDRA) Sarah Vaughn (MHRA) Panellists : Julie James (Blue Wave Informatics) Jane Millar (SNOMED International) Source 9 Using IDMP in Adverse Event reporting and Individual Case Safety Reports.mp4 YouTube URL https://www.youtube.com/watch?v=nQNk36neKVI Duration 1 hour 24 minutes Target audience ● Health and care professionals, especially prescribers and dispensers ● EHR system and pharmacy system developers Learning objectives ● To understand how safety reports travel between and are used by different actors ● To appreciate the challenge of precisely identifying a medicinal product from the information often provided in reports ● To understand how coders work to trace the identity of a medicinal product ● To appreciate that medicinal product information from an EHR system or from a 2D data matrix, could assist in this identification Synopsis The process of safety reporting Anja starts be explaining the term Pharmacovigilance, and the terms frequently used in this field. This science was one of the drivers behind the development of IDMP. She then describes the process of reporting on adverse events relating to medicines, from the perspectives of a clinician and a medicines regulator. Healthcare professionals need to contribute to pharmacovigilance knowledge through individual case safety reports (ICSR), so regulators can examine these and where appropriate update the product information relayed back to healthcare. Safety reporting information flows IDMP is needed to improve the efficiency of safety reporting, and the accuracy of linking each reported adverse event to the right product. Aja walks through the information flows relating to the experience and reporting of adverse events. These flows include healthcare, medicines regulators, the pharma industry and the WHO monitoring centre. UNICOM – D9.6 Page 40 of 42 Many of these organisations use their own, different, product dictionaries. This requires each organisation to map incoming report information to their locally-used dictionaries, which would not be required if IDMP is used throughout the flow. Coding the information in an ICSR The ICSR report corresponds to an ISO standard, the use of which is now mandatory in the EU. This standard has placeholders for communicating IDMP information. EDQM dose form and presentation are also being used, and the next step will be the incorporation of IDMP identifiers for pharmaceutical products (PhPID) and medicinal products (MPID). The information in an ICSR can vary in the precision with which the medicinal product is specified. In a study of matching the submitted description (the “verbatim”) of 150 ICSRs to coded medicinal products with blinded experts revealed a concordance of mapping in only 15% of cases. This illustrates the scale of the challenge. The generation of ICSRs from EHR systems would be expected to be more accurate, since the verbatim description would come from its medical product database. Guidance on coding the verbatim in an ICSR Anja and colleagues have developed guidance, through UNICOM, on the completion of ICSRs and the incorporation of IDMP coding, which should ideally be adopted and endorsed by ISO. Sarah explains and walks through the quality process that the guideline contains. There are four major steps: check the drug verbatim, interpret the context to impute the drug information, decide if it is more appropriate to use a current or historic identifier, and then to select the MPID or the PhPID. She outlines the clues in the ICSR content that could help with imputing the correct drug information, and illustrates this with some examples. A historic identifier may be appropriate if something (e.g. media publicity) stimulates a number of retrospective adverse event reports relating to a dug that has an old, discontinued, identifier. UNICOM – D9.6 Page 41 of 42 ICSR coding guide recommendations Barry then summarises the recommendations within the guide. These cover having granular PhPIDs, investigate the value of the imputed drug information, using the information within the GTIN (2D data matrix) on the packaging to improve medicinal product identification, placing the coding guidance with an owner such as ISO or ICH, improved versioning and grouping concepts of PhPID, for coding tools to better present contextual information, making greater use of ontologies and looking further into the requirements for medicinal product dictionaries. He went into further detail on the value of having more granular, global, PhPIDs and grouping concepts, and the global agreement requirements for ensuring a global PhPID. The imputed drug information field has recently been added to the ICSR structure, because the verbatim drug description can be imprecise: Barry illustrates how additional context information can assist a coder to impute the medicinal product more accurately than the verbatim alone and the name parts. The structure of name parts will need to change as IDMP contains a richer structure than the existing ICSR standard. Smart tools such as NLP could further improve the accuracy and efficiency of coding. Photographing or scanning the 2D data matrix on a package would provide the most complete information, which will increasingly be possible with e prevalence of smart phones. Revising ICSR standard The ICSR standard is in the process of being revised and Barry outlines several areas of improvement that could now be made. Discussion The question and answer session with the audience included a number of clarification points about the presentation, and the challenges of product imputation. It was also noted that it would be ideal if the details of the indication for prescribing a medicine and the adverse effect of a medicine on a patient could be captured in a structured and coded form, using an internationally recognised clinical terminology.