# Presentation: 531055

## Creating a standards-based open source system for safe prescribing. 

- Gunther Schadow
- Regenstrief Institute andIndiana University
- School of Informatics,Indianapolis, IN

## Project Goal: e-Prescribing Software

- Affordable
- Open Source
- Easy to Deploy
- Require Little Configuration
- Encourage Safety
- Built-In Drug Knowledge
- Built-In Decision Support Functions
- Low Key Remniders as-you-go
- Targeting Small Practices
- Without tons of Informatics staff
- But who are open, curious about HIT.

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Features

- Lists
- Allergies
- Problems
- Medications

- Easy data entry
- Coding through free text entry
- (auto-complete)
- Understands SIGs (dose, frequency, etc.)
- convert into structured data, for reasoning
- Immediate feedback on errors or other issues.

- Output
- Printed Script
- Patient List
- Chart List
- Electronic messages as needed.

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Knowledge and Data Repository

- Relational Database

- HL7 Java SIG API

- Hibernate

- Basic Configuration

- Site Configuration(Users)

- SNOMED ProblemList Terms+ UMLS Synonyms

- Observation Master(LOINC)

- FDA/NLM DailyMed SPLStructured Product Labels

- NDF-RTRxNorm

- Patient Data
- Batch Submission

- HL7 v2 Messages

- HL7 v3 Messages &CDA Documents

- E-Prescribing
- Application

**Knowledge and****Data Integration**

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Open Source, Collaborations

- Contributions by
- Sun Microsystems
- Kaiser Permanente
- Regenstrief Institute
- NCI/caBIG (caAdapter)
- Blackstonebay Software
- Axoloti
- Miscellaneous Volunteers
- Community Supported
- Project home: http://aurora.regenstrief.org/javasig
- Forum: java@lists.hl7.org

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Standards Based

- Why?
- Interoperability
- Design patterns and detailed object models reviewed by worldwide community of HIT experts.
- Less work to do on conceptual design
- Design for reuse (build once, reuse many times)
- (Somewhat more work in detailed implementation)
- Minimize user configuration needs.
- How and What?
- Health Level-7 version 3
- Reference Information Model
- Medication/Pharmacy and Patient Care Standards
- Understand any HL7 v3 message and document payload
- Accept HL7 v2 messages by mapping to HL7 v3
- Terminologies
- LOINC, SNOMED CT, UMLS Terms
- NDF-RT, RxNorm, NDC, FDA SRS UNII

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Lightweight Terminology

- Infrastructure includes interfaces to
- NCI caBIG EVS
- UMLS through JDBC and Relational Database
- Hooks for Common Terminology Service (CTS)
- But we don’t seem to need them
- Knowledge master files and (trusted) data sources contribute codes, terms and synonyms.
- We periodically run our word-indexer
- To index words, phrases and codes
- Context sensitive, i.e., by field
- In case of observation value by observation code
- User enters text (any of the synonyms),
- Auto-completion maps to concept in the background
- Unrecognized term stored as original text

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Knowledge Needs for e-Prescribing

- Medication Terminologies
- NDC (only packaged products)
- FDA Listing, NDF-RT, Multum, FDB NDDF
- RxNorm – integrates many UMLS sources
- FDA SRS UNII (for ingredients)
- Problem List and Allergy Terminologies
- (ICPC), ICD-9, (ICD-10)
- SNOMED CT (and VA/KP Subset)
- Clinical Decision Support Knowledge
- Currently best open access source: NDF-RT
- Commercial Offerings: FDB, Micromedex
- Upcoming FDA SPL labels (post-PLR)

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Structured Product Labeling (SPL)

- HL7 v3 Standard, Sponsored by FDA
- 2004/5 Electronic Labeling Guidance (SPL R2)
- Includes medication model
- 2005/6 Physicians Labeling Rule (PLR, SPL R3)
- Includes clinical knowledge model
- 2006/7 Launch of DailyMed
- Now contains over 3257 SPL labels
- Currently only original innovator labels
- 2007/8? E-Listing Rule (SPL R4, in preparation)
- Will include all marketed drugs (covering all drug NDC codes)
- Provisions for devices, veterinary, and dietary supplements, food labels included in SPL R4

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## SPL: 3 Levels

- Label Document
- Medication Model
- Description
- How Supplied
- Clinical Decision Support Knowledge
- Indications
- Dosage
- Issues
- Interactions
- Contraindications
- Adverse Effects

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Medication Module (SPL R3)

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## SPL Intuitive Drug Model

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Drug Terminologies

- Terminologies support some reasoning
- about existence
- What drugs, with what ingredients, packaging exist?
- about abstractions, generalizations
- Drug classes and their members.
- “Clinical Drugs”
- FDA Listing, Multum, RxNorm
- Terminologies alone do not cover reasoning about purpose, effect, interactions etc.
- More complete knowledge bases are needed
**NDF-RT includes some pharmacological knowledge**
- may-treat,
- mechanism-of-action,
- physiologic-effect,
- chemical-class
- some pharmacokinetics

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Hierarchies that are not - RxNorm

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Hierarchies – Arbitrary Abstractions

- Packaged Medicine MISRF BP (NDC-11)

- Manufactured Medicine MISRF B (NDC-9)

- Generic Formulation MISRF (e.g. Multum_id)

- Ingredient combination, route, no form no strength (MIsRf)

- Moiety combination, strength, no form no route (MiSrf, RxN:SCD)

- Moiety combination, route, no form no strength (MisRf)

- Moiety combination (Misrf)

- Ingredient combination only (MIsrf)

- Moiety combination, route, abstract form, no strength (MisR*F*)

- Ingredient combination strength, no route no form (MISrf)

- Moiety combination, form no route no strength (MisrF, RxN:SCDF)

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Two Approaches to Drug Names

- Pre-coordinated,
- Complete set of (standard) drug names.
- Only RxNorm Clinical Drugs are not enough,
- Doctors want brand names too, sometimes.
- May want to formulate creams, cocktails, etc.
- Didn’t seem satisfactory in testing with end-users.
- Regenstrief system has a manually fine-tuned set of drug names.
- New: Post-coordinated  approach
- As prescriber types in the drug name, we parse it and fill a description template similar to SPL.
- Can be used to query for matching medicines.

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## Post CoordinatedOrder Structure

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007

## JCAHO Reconciliation

- 63% of reported medication errors that resulted in injury caused by communication problems
- 50% of those avoidable through medication reconciliation
- Recommendation:
- Put the medication list in a highly visible place ...
**Reconcile medications at each visit**
**physicians, nurses should be involved.**
**Provide patient with a complete list of medications**.

- Copyright (c) 2007 Regenstrief Institute, Inc.

- 07/05/2007