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Contextualized potential drug-drug interaction clinical decision support

Basics

Contextualized potential drug-drug interaction clinical decision support

1405
Ballot - STU to Normative


FHIR Profile

Create New Standard

Details

This project seeks to develop an implementation guide for potential drug-drug interaction (PDDI) clinical decision support (CDS). The implementation guide will specify both a knowledge representation format for PDDI logic and CDS services for PDDI with electronic health record (EHR) systems. Specifically, the implementation guide will include specifications for:

1) How to represent PDDI logic in CQL and evidence in computational format using the FHIR Clinical Reasoning module.

2) How to use CDS Hooks as a mechanism for EHRs to request PDDI CDS from CDS services.

The project may raise the need to create new FHIR resource(s) (e.g., a resource to represent drug interactions) and/or FHIR profile(s) (e,g, for PDDI context representation). The current scope is the universal realm. We will consider potential realm-specific work in the future.


New information regarding potential drug-drug interactions (PDDIs) is published every day in primary sources such as drug product labeling and the scientific literature. A PubMed search for publications indexed with the Medical Subject Headings keyword “Drug interactions” shows an average of 3,970 publications per year from 2000 through 2016. This suggests that the body of evidence about PDDIs is overwhelming and dynamic. Food and drug regulatory agencies in the United States, European Union, and Japan have issued guidance to industry recommending the use of drug product labeling to communicate potential involvements in drug interactions (Reki? et al. 2017). As it is impossible for clinicians to keep up with the PDDI evidence base, drug experts generate summaries of PDDI evidence from primary sources. These summaries bring PDDI knowledge to clinicians in the form of published drug information compendia, clinical decision support rules, and interaction checking applications. However, there are currently no broadly accepted standards to guide these experts in the knowledge representation and services implementation of PDDI information that would be most effective for clinical decision support. Without international coordination for the extensions and profiles used to express PDDI CDS, needless variation is certain to occur in implementations. This project will provide the opportunity for the international community to collaborate and come to consensus on patterns used in implementations.



Submit for Ballot for Comments - Target: 2018 Sep Ballot Complete Ballot for Comments Reconciliation - Target: 2018 Sep WGM Submit for 1st STU Ballot - Target: 2020 May Ballot Complete 1st STU Ballot Reconciliation - Target: 2020 May WG Submit for 2nd STU Ballot - Target: 2020 Sep Ballot Request STU Publication - Target: 2020 Oct STU Period - Target: 24 months 2020 Oct - 2022 Sep Submit for Normative Ballot - Target: 2022 Sep Ballot Complete Normative Reconciliation - Target: 2022 Sep WGM Submit Publication Request - Target: 2022 Oct Receive ANSI Approval - Target: 2022 Nov Project End Date (all objectives have been met) - Target: 2023 Jan


Project page: http://wiki.hl7.org/index.php?title=PDDI_CDS Document repository: https://github.com/HL7/PDDI-CDS


HL7 FHIR Implementation Guide: CDS Hooks, Release 1 - 1234 Clinical Quality Expression Language - 1108 FHIR Medication knowledge (investigative project from Pharmacy) - 1365

Other (specify in Misc. Notes below),Healthcare Institutions (hospitals, long term care, home care, mental health),Pharmaceutical; EHR, PHR; Clinical Decision Support Systems

1) University of Pittsburgh Medical Center (interest) 2) Wolters Kluwer Health (interest)

N/A

Drug-drug interaction, PDDI CDS

n/a

Yes

N/A

No

2026 June: TSC approved an STU Publication Request for HL7 FHIR® Implementation Guide: Potential Drug-Drug Interaction (PDDI) Clinical Decision Support (CDS), Edition 1 2020 Feb: GDelf Fiol: Submitted a revised PSS with updated target dates. 2020Jan: BRhodes: Planning to Ballot in May 2020 Other Stakeholders: Commercial vendors of drug information compendia
Organization & Realm

Universal

People

Bryn Rhodes, Howard Strasberg, Guilherme Del Fiol, Richard Boyce



Clinical Decision Support Work Group

Pharmacy Work Group

Status & Dates

Active

STU - Reconcile

02/07/2018

09/01/2028

2028 Sept WGM/Ballot

05/01/2028

2028 May WGM/Ballot

2023 Jan Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 2 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Potential Drug-Drug Interaction (PDDI) Clinical Decision Support (CDS), Release 1 2022 Sept Ballot Cycle Info: STU Ballot Results: Postponed Document Name: HL7 FHIR Implementation Guide: Potential Drug-Drug Interaction (PDDI) Clinical Decision Support (CDS), Release 1 (See Jira Ballot Dashboard) 2020 Sept Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 6 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Potential Drug-Drug Interaction (PDDI) Clinical Decision Support (CDS), Release 1 2020 May Ballot Cycle Info: STU Ballot results: Postponed Document Name: HL7 FHIR Implementation Guide: Potential Drug-Drug Interaction (PDDI) Clinical Decision Support (CDS), Release 1 2018 Oct Ballot Cycle Info: COMMENT ONLY Ballot results: Met basic vote requirements. 1 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Potential Drug-Drug Interaction (PDDI) Clinical Decision Support (CDS), Release 1
Approvals

09/27/2018


Not Needed


Not Needed




System Info






06/26/2026

Anne Wizauer