D9.5 IDMP Implementation guidance to EHR and eRx system suppliers - FHIR representation of the Core Data Set Module Medication

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 D9.5: IDMP Implementation guidance to EHR and eRx system suppliers - FHIR representation of the Core Data Set Module Medication Version: 1 Status: Final version Dissemination Level1: PU Due date of deliverable: 30.09.2023 Actual submission date: 14.7.2023 Work Package: WP9: IDMP adoption by eRX system suppliers Lead partner for this deliverable: IDMP1 Partner(s) contributing: IHD Deliverable type2: R Main author(s): Ursula Tschorn IDMP1 Julie James IHD Other author(s): Hugh Glover 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 Resource consumption estimate: Person months Ursula Tschorn (IDMP1) 0.5 Julie James ( IHD) 0.25 Hugh Glover (IHD) 0.25 UNICOM – D9.5: IDMP Implementation guidance to EHR and eRx system suppliers Page 2 of 16 Revision history Version Date Changes made Author(s) 0.1 14.12.2022 First draft Ursula Tschorn (IDMP1) 0.1 29.1.2023 Editing document structure and first complete draft Ursula Tschorn (IDMP1) 0.2 14.6.2023 Draft 0.2 Julie James (IHD), Hugh Glover (IHD) 0.3 28.6.2023 Focusing on the comparison of FHIR resources Julie James (IHD), Hugh Glover (IHD) 0.4 30.6.2023 Formatting and restructuring Ursula Tschorn (IDMP1) 1.0 5.7.2023 Final version delivered to Empirica Ursula Tschorn (IDMP1) Statement of originality This deliverable contains original unpublished work except where clearly indicated otherwise.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 – D9.5: IDMP Implementation guidance to EHR and eRx system suppliers Page 3 of 16 Deliverable abstract This deliverable is intended to assist EHR (Electronic Health Record) and eRx (electronic prescribing) system suppliers in implementing IDMP (Identification of Medicinal Products) standards. The document focuses on explaining the correlation between various HL7 FHIR (Fast Healthcare Interoperability Resources) resources used to describe medicinal products. By understanding this connection, system suppliers can choose the appropriate resources for their specific use cases and understand the role of IDMP data in supporting their systems. Additionally, the document aims to elucidate how different systems and domains recognize medicinal products, with IDMP using "identifiers" and patient care relying on "codes". Keywords: IDMP implementation, EHR, eRx system suppliers, HL7 FHIR resources, Medicinal products, Interrelationship, Identifiers, Codes, Patient care 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. © 2019-2023. The participants of the UNICOM project. UNICOM – D9.5: IDMP Implementation guidance to EHR and eRx system suppliers Page 4 of 16 TABLE OF CONTENTS Revision history ....................................................................................................................................... 2 Deliverable abstract ................................................................................................................................. 3 List of abbreviations ................................................................................................................................. 5 Executive summary ................................................................................................................................. 6 1 Introduction – the Two Domains....................................................................................................... 7 1.1 Patient Care: ePrescription, eDispensing and eMedication List ............................................. 7 1.2 Regulatory: e(Marketing Authorisation )Application Form etc. ................................................ 7 2 The FHIR Medication Related Resources ........................................................................................ 8 3 Identifiers and Codes for Medicinal Products................................................................................. 10 3.1 Identifiers and Codes for Medicinal Products ........................................................................ 11 3.1.1 Master Data Management Systems .................................................................................. 11 3.1.2 Terminology management systems................................................................................... 11 4 Using Identifiers and Codes in the FHIR Resources ..................................................................... 12 5 Real World Practice: Relating Medication Definition resources to Medication Module resources 13 6 Conclusions .................................................................................................................................... 15 7 Appendix: A note about ISO 11616 ................................................................................................ 15 LIST OF FIGURES Figure 1 - FHIR Release R5 Home Page with relevant modules highlighted Module medication .......... 9 Figure 2 - Terminology for kinds of passport application ...................................................................... 12 Figure 3 - Codes versus identifiers in the two sets of FHIR resources ................................................. 13 Figure 4 - Making use of IDMP data in Real World systems – mythical product .................................. 14 Figure 5 - Making use of IDMP data in Real World systems – actual product - Monuril ....................... 15 LIST OF TABLES Table 2-1 - Ressource content of Medications and Medications Definition Module ............................. 10 Table 4-1 - Medication Definition Module use an identifier ................................................................... 13 UNICOM – D9.5: IDMP Implementation guidance to EHR and eRx system suppliers Page 5 of 16 List of abbreviations Abbreviation Complete form API application programming interface CAPs centrally authorised products CDA clinical document architecture CDS clinical decision support eAF electronic application form eDispensing electronic Dispensing EHR Electronic Health Record eMedication electronic Medication ePrescription electronic prescription eRx electronic prescribing FHIR (Fast Healthcare Interoperability Resources HL7 Health Level Seven IDMP Identification of Medicinal Products MPD medicinal product dictionary NCA national competent authority PhPID pharmaceutical product identifier SmPC Summary of Product Characteristics SNOMED CT SNOMED clinical terms SPOR substances, products, organisations and referentials UNICOM – D9.5: IDMP Implementation guidance to EHR and eRx system suppliers Page 6 of 16 Executive summary This document aims to support IDMP implementation for EHR and eRx system suppliers by describing the interrelationship between the different HL7 FHIR resources that are used to describe medicinal products. By explaining this interrelationship, system suppliers can implement those resources that are appropriate for their use cases and know how IDMP data can or is supporting that. This document also aims to explain the different ways that medicinal products are recognised in the different systems and domains – by “identifiers” in IDMP and by “codes” in patient care. UNICOM – D9.5: IDMP Implementation guidance to EHR and eRx system suppliers Page 7 of 16 1 Introduction – the Two Domains 1.1 Patient Care: ePrescription, eDispensing and eMedication List There are several key Medication processes in patient care, each of which generates information that can/must be shared across healthcare professionals and providers: In primary/community care, eRx is the process for the electronic generation of a prescription for a medicinal product using clinical software, and usually includes transmission of that prescription directly to a pharmacy so that it may be dispensed for the patient. The source of the prescription may be an authorised prescriber working in the community (e.g., a doctor or prescribing pharmacist) or it may be from a hospital, either as a discharge prescription or as an outpatient/clinic prescription. The clinical software that performs eRx is usually either the prescribing module of a larger clinical system such as an Electronic Health Record (EHR) system or is in a standalone electronic prescribing system. Both will keep a record of that prescription, which becomes part of the patient’s Medication List. When a prescription has been generated, it is usually communicated to a pharmacy for dispensing: traditionally the paper prescription was transported to the pharmacy by the patient or the carer; with e-Prescribing, the prescription can be communicated electronically. The simplest but least efficient method is to fax a copy of the prescription to the pharmacy, but there is little benefit for any party in the system. More structured specific prescription communications, using either a proprietary format such as the French hospital system PN13 through to the standardised HL7 V2, V3 including clinical document architecture (CDA) messages and more recently FHIR Medication resources can be used. These structured communications have the benefit of reducing or eliminating the need for data entry in the pharmacy, reducing the risk of transcription error and speeding the processes, including clinical decision support checking. Electronic dispensing (eDispensing) is the process for the electronic retrieval of an e-Rx and the dispensing of the medicine to the patient. An eDispensing system is usually able to take all the information from the structured e-Rx and use it directly, for example by producing a dispensing label for the medicine with the dosage instructions from the prescription transformed to dosage instructions for the patient using language that the patient can comprehend. The e-Dispensing system will keep an electronic record of the dispensing and may also manage stock control and the reimbursement process for the prescription (possibly by sending a structured message describing the dispensing, along with the request for reimbursement), depending on the healthcare culture it is operating in. An electronic Medication (eMedication) List is a list of the medicinal products that have been prescribed, dispensed and/or administered to a patient over time. Depending on the system and healthcare culture, it may be available only to the healthcare professionals using the system that undertook the medication process (prescribing, dispensing or administration) or it may be shared to other healthcare professionals by various means. In all of these processes, identifying the medication implicated in the electronic prescription (ePrescription), in the eDispensing and in the eMedication List, whether that is in the FHIR Medication resources or other types of structured communication, is of extreme importance so as to provide good quality care. 1.2 Regulatory: e(Marketing Authorisation)Application Form etc. In the medicines regulatory domain, just as in patient care, there are key processes that occur and which generate information that must be shared in the domain, primarily between the national competent authorities for medicines regulation and the pharmaceutical companies, but also between the NCAs and their national eHealth agency or agencies, and medicinal product dictionary providers. At present, most of these processes are document based, on the publication of the Summaries of Product Characteristics, but with the advent of the implementation of IDMP, some of these processes are using structured data based on IDMP and the IDMP FHIR resources. For example, the EMA’s DADI project, in conjunction with UNICOM’s Work package 3, has developed the web-based Human Variations electronic application form (eAF) for centrally authorised products (CAPs) based on the IDMP/Medication Definition FHIR resources. UNICOM – D9.5: IDMP Implementation guidance to EHR and eRx system suppliers Page 8 of 16 2 The FHIR Medication Related Resources FHIR has 15 resources that are used for representing medication or associated processes. The home page for the R5 release of FHIR (Index - FHIR v5.0.0 (hl7.org)) allocates each of these resources to one of two “modules”. One set is labelled as “Medications” and the other is labelled as “Medication Definition”. The screen shot below shows the display of the two modules on the FHIR specification home page. UNICOM – D9.5: IDMP Implementation guidance to EHR and eRx system suppliers Page 9 of 16 Figure 1 - FHIR Release R5 Home Page with relevant modules highlighted Module medication UNICOM – D9.5: IDMP Implementation guidance to EHR and eRx system suppliers Page 16 of 16 “intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide.” Clearly, as part of the suite of IDMP standards, this is supporting the product lifecycle in the regulatory domain. However, this abstract goes on to say: In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g., e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. This suggests that “IDMP” could directly provide “identifiers” to support patient care. This seems to run counter to all that has been said above about the interrelationship between the two domains. Whilst this is theoretically possible, there are many reasons why it is unlikely to be practical. These reasons have been described in detail in other deliverables from the UNICOM project; a small are summarised here: ► • ISO 11616 proposes a “formal association of particular data elements” – but unfortunately this is only a small part of what is needed for an MPD. The editorial policy is of equal importance, but no such policy exists to support 11616, so it remains a theoretical model surrounded by significant uncertainty. ► • Clinical systems – for eRx, eDispensing and eMedication List - are well established and widely used; MPD are embedded within these and change would be expensive and unnecessary unless there is significant additional benefit – and currently no benefit for that change has been forthcoming. ► To serve the needs of the patients and clinicians that use them, the scope of most MPD is somewhat wider than “authorised medicinal products”, so in any one clinical setting, it is likely that IDMP data would require augmentation; currently there is no facility to do this. ► Globally, there are now several decades worth of incredibly valuable historic data about medicines use, all coded using existing MPD. It is undeniably attractive to have an unequivocal global identifier for each medicine, especially to support clinical research; and indeed, such a terminology does exist in SNOMED CT, supported directly by national MPD extension systems. Again, the benefit of introducing something new has not been forthcoming for the patient care domain.