PHARM Templates Implementationguide

Document Information

This document contains: Implementation Guide Pharmacy Templates (0.90). The text materials belong to category cdapharm.

{{{Topright}}}

HL7 CDA® R2 Implementation Guide: Pharmacy Templates, Release 1

Pharmacy Templates

Implementation Guide

© 2016-2017 Health Level Seven International ® ALL RIGHTS RESERVED.
The reproduction of this material in any form is strictly forbidden without the written permission of the publisher. HL7 and Health Level Seven are register

Important Notes

HL7 licenses its standards and select IP free of charge. If you did not acquire a free license from HL7 for this document, you are not authorized to access or make any use of it. To obtain a free license, please visit http://www.HL7.org/implement/standards/index.cfm.

If you are the individual that obtained the license for this HL7 Standard, specification or other freely licensed work (in each and every instance "Specified Material"), the following describes the permitted uses of the Material.

A. HL7 INDIVIDUAL, STUDENT AND HEALTH PROFESSIONAL MEMBERS, who register and agree to the terms of HL7’s license, are authorized, without additional charge, to read, and to use Specified Material to develop and sell products and services that implement, but do not directly incorporate, the Specified Material in whole or in part without paying license fees to HL7.

INDIVIDUAL, STUDENT AND HEALTH PROFESSIONAL MEMBERS wishing to incorporate additional items of Special Material in whole or part, into products and services, or to enjoy additional authorizations granted to HL7 ORGANIZATIONAL MEMBERS as noted below, must become ORGANIZATIONAL MEMBERS of HL7.

B. HL7 ORGANIZATION MEMBERS, who register and agree to the terms of HL7's License, are authorized, without additional charge, on a perpetual (except as provided for in the full license terms governing the Material), non-exclusive and worldwide basis, the right to (a) download, copy (for internal purposes only) and share this Material with your employees and consultants for study purposes, and (b) utilize the Material for the purpose of developing, making, having made, using, marketing, importing, offering to sell or license, and selling or licensing, and to otherwise distribute, Compliant Products, in all cases subject to the conditions set forth in this Agreement and any relevant patent and other intellectual property rights of third parties (which may include members of HL7). No other license, sublicense, or other rights of any kind are granted under this Agreement.

C. NON-MEMBERS, who register and agree to the terms of HL7’s IP policy for Specified Material, are authorized, without additional charge, to read and use the Specified Material for evaluating whether to implement, or in implementing, the Specified Material, and to use Specified Material to develop and sell products and services that implement, but do not directly incorporate, the Specified Material in whole or in part. NON-MEMBERS wishing to incorporate additional items of Specified Material in whole or part, into products and services, or to enjoy the additional authorizations granted to HL7 ORGANIZATIONAL MEMBERS, as noted above, must become ORGANIZATIONAL MEMBERS of HL7. Please see http://www.HL7.org/legal/ippolicy.cfm for the full license terms governing the Material.

Ownership. Licensee agrees and acknowledges that HL7 owns all right, title, and interest, in and to the Materials. Licensee shall take no action contrary to, or inconsistent with, the foregoing.

Licensee agrees and acknowledges that HL7 may not own all right, title, and interest, in and to the Materials and that the Materials may contain and/or reference intellectual property owned by third parties (“Third Party IP”). Acceptance of these License Terms does not grant Licensee any rights with respect to Third Party IP. Licensee alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize Third Party IP in connection with the Materials or otherwise. Any actions, claims or suits brought by a third party resulting from a breach of any Third Party IP right by the Licensee remains the Licensee’s liability.

Following is a non-exhaustive list of third-party terminologies that may require a separate license:

Terminology	Owner/Contact
Current Procedures Terminology (CPT) code set	American Medical Association https://www.ama-assn.org/practice-management/cpt-licensing
SNOMED CT©	SNOMED CT® International http://www.snomed.org/snomed-ct/get-snomed-ct or info@ihtsdo.org
Logical Observation Identifiers Names & Codes (LOINC©)	Regenstrief Institute, Inc.
International Classification of Diseases (ICD) codes	World Health Organization (WHO)
NUCC Health Care Provider Taxonomy code set	American Medical Association. Please see www.nucc.org. AMA licensing contact: 312-464-5022 (AMA IP services)

Obtaining a CPT Sublicense from HL7

Contact hq@hl7.org about how to obtain a sublicense from HL7 for non-production use of CPT for (i) the development and publication of value sets, profiles, and other artifacts as part of the HL7 Implementation Guides, (ii) as part of defined VSAC value sets, and (iii) to support HL7's terminology services within the Territory.

Flow Down Clauses for CPT Sublicense from HL7

CPT content is copyrighted by the American Medical Association and CPT is a registered trademark of the AMA.

HL7, as a party to a license agreement with the AMA, is authorized to grant user a limited, non-exclusive, non-transferable, non-sublicensable license for user to use CPT content for (i) the development and publication of value sets, profiles, and other artifacts as part of the HL7 Implementation Guides, (ii) as part of defined VSAC value sets, and (iii) to support HL7's terminology services within the Territory, each of which shall be considered a non-production use. The sublicense granted hereunder shall automatically terminate upon termination of the agreement between HL7 and AMA, unless prior written consent of AMA is obtained.

The provision of updated CPT content is dependent on a continuing contractual relationship between HL7 and the AMA.

User acknowledge a separate license agreement shall be required, and shall govern any proposed use, including any distribution of CPT content for any other purposes not expressly permitted under this Agreement, and the terms of such agreement will govern such use (e.g., a separate license agreement shall govern production use and commercial purposes). AMA reserves the right to accept or reject licenses based on AMA's evaluation of the proposed use of the CPT content.

User acknowledge that User's development and commercialization of CPT-informed works developed with reference to Licensed Products may only be implemented in the Territory.

User is prohibited from making CPT content publicly available, creating derivative works (including translating), transferring, selling, leasing, licensing, or otherwise making available to any unauthorized party the CPT content, or a copy or portion of CPT content to any unauthorized party, including a subsidiary, affiliate, or other legal entity, however designated, for any purpose whatsoever except as expressly permitted under a separate agreement.

User expressly acknowledges and agrees to the extent permitted by applicable law, use of CPT content is at User's sole risk and CPT content is provided "as is" without warranty of any kind. The AMA does not directly or indirectly practice medicine or dispense medical services. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. CPT content herein does not replace the AMA's Current Procedural Terminology book or other appropriate coding authority. The coding information contained in CPT content should be used only as a guide.

U.S. Government End Users. CPT is commercial technical data, which was developed exclusively at private expense by the American Medical Association (AMA), 330 North Wabash Avenue, Chicago, Illinois 60611. This agreement does not grant the Federal Government a direct license to use CPT based on FAR 52.227- 14 (Data Rights - General) and DFARS 252.227-7015 (Technical Data - Commercial Items).

User expressly consents to the release of its name to the AMA.

Co-Chair, Primary Editor	Melva Peters Jenaker Consulting melva@jenakerconsulting.com
Co-Chair, Primary Editor	John Hatem jnhatem@hotmail.com
Co-Chair	Scott Robertson PharmD scott.m.robertson@kp.org
Co-Chair	Jean Duteau jean@duteaudesign.com
Contributor	Dr Kai U. Heitmann Heitmann Consulting and Services, ART-DECOR Open Tools GmbH, HL7 Germany info@kheitmann.de
Contributor	Giorgio Cangioli, PhD Consultant, HL7 Italy giorgio.cangioli@gmail.com
Contributor	Tom de Jong VZVZ, HL7 The Netherlands tom@nova-pro.nl
Contributor	Dr Christof Geßner Gematik GmbH, HL7 Germany christof.gessner@gematik.de

Introduction

This Implementation Guide provides templates for Medication Order and Medication Statement that can be used by HL7 standards developers and external projects to develop models for pharmacy related content. The implementation guide is intended to provide consistency of pharmacy related models across all uses regardless of the method of transport by:

• creating a library of Universal pharmacy templates that can be used by other Work Groups to derive constrained versions.

Purpose

Background

Historically multiple HL7 Work Groups have developed specifications for pharmacy related content and as a result, there is inconsistency in the models that exist in HL7 V2, V3, CDA and FHIR. The Pharmacy Work Group often receives questions as to how to model pharmacy related content but in some cases, the use case cannot be met with the existing models.

This Implementation Guide provides a library of pharmacy templates that can be used by HL7 Work Groups or external projects to derive constrained versions of models for pharmacy related content.

Scope

The scope of the Implementation Guide is limited to Medication Order and Medication Statement. The content was developed by aligning and harmonizing the existing specifications for Consolidated CDA (C-CDA Release 2.1).

Future releases of the Implementation Guide will include Medication Dispense and Medication Administration.

Ballot Status of the Document

The Implementation Guide is being balloted as Informative with the intention to go to Standard for Trial Use (STU) and then to Normative.

Audience

• Clinical and Public Health laboratories
• Immunization Registries
• Pharmaceutical Vendors
• EHR/PHR vendors
• Clinical Decision Support Systems
• HIS Vendors
• Emergency Services Providers
• Healthcare Institutions
• Pharmacists
• Physicians and other Clinicians

Relationships with other projects and guides

• Consolidated CDA (C-CDA)
• HL7 Version 3 Pharmacy Models
• HL7 FHIR® Pharmacy Resources

Principles and background

Please Note

Nothing in here yet. Do we want to report about

• the new method to represent normal, split and tapered dose information in CDA Substance Administrations?
• do we want to tell people that we reduced the richness of the original Pharmacy V3 templates drastically to ease implementation?
• do we want to mention FHIR profile work that influenced heavily the development of the CDA templates?
• And/or more general other design principles?

Technical Background

What is a CDA

CDA R2 is "… a document markup standard that specifies the structure and semantics of clinical documents for the purpose of exchange” [CDA R2, Section 1.1]. Clinical documents, according to CDA, have the following characteristics:

• Persistence
• Stewardship
• Potential for authentication
• Context
• Wholeness
• Human readability

CDA defines a header for classification and management and a document body that carries the clinical record. While the header metadata are prescriptive and designed for consistency across all instances, the body is highly generic, leaving the designation of semantic requirements to implementation.

Templated CDA

CDA R2 can be constrained by mechanisms defined in the “Refinement and Localization” section of the HL7 Version 3 Interoperability Standards. The mechanism most commonly used to constrain CDA is referred to as “templated CDA”. This specification created a set of artifacts containing modular CDA templates (and associated value sets) for the purpose of the International Patient Summary, and the templates can be reused across any number of CDA document types.

There are different kinds of templates that might be created. Among them, the most common ones are:

• CDA Document Level Templates constrain fields in the Clinical Document Architecture (CDA) header, and define containment relationships to CDA sections.
  For example, a History-and-Physical document-level template might require that the patient’s name be present, and that the document contain a Physical Exam section.
• CDA Header Level Templates constrain fields for parts of the CDA header, like the patient (record target), the author, participations or the service event.
• CDA Section Level Templates constrain fields in the CDA section, and define containment relationships to CDA entries.
  For example, a Physical-exam section-level template might require that the section/code be fixed to a particular LOINC code, and that the section contain a Systolic Blood Pressure observation.
• CDA Entry Level Templates constrain the CDA clinical statement model in accordance with real world observations and acts.
  For example, a Systolic-blood-pressure entry-level template defines how the CDA Observation class is constrained (how to populate observation/code, how to populate observation/value, etc.) to represent the notion of a systolic blood pressure.

Open and Closed Templates

Open templates permit anything to be done in the underlying standard that is not explicitly prohibited. This allows templates to be built up over time that extend and go beyond the original use cases for which they were originally designed.

Closed templates only permit what has been defined in the template, and do not permit anything beyond that. There are good reasons to use closed templates, sometimes having to do with local policy. For example, in communicating information from a healthcare provider to an insurance company, some information may need to be omitted to ensure patient privacy laws are followed. Most templates developed for CDA are of the open sort.

Template versioning

Template versioning is needed to enable template designs to evolve over time.

Template versioning enables template designers to control and shape the conformance statements that make up a template’s design over time tailoring the design to fit the template’s intended purpose.

Each template version is associated with a particular template. The template – as a whole – has a mandatory globally unique, non-semantic, identifier. The identifier serves as the identifier of the original intent of the template and as the identifier of the set of versions that represent the template over time.

Template versions have a mandatory timestamp (date and optional time), called the “effective date”. The date can be seen as the point in time when the template version “came into being”, i.e. was recognized as existent by the governance group. Use of the template prior to this date would be considered an invalid use of the template.

For further information on Templates, Template Versions and related topics refer to the HL7 Templates Standard.

Identifiers for Templates and Value Sets

This specification specifies the CDA Entry Level Templates only that can be re-used in any appropriate context, such as a Medication section. Two "root" Entry Templates are provided as entry points for the two described use cases:

• UV Medication Order (2.16.840.1.113883.10.21.4.1)
• UV Medication Statement (2.16.840.1.113883.10.21.4.2)

These templates use other Entry Level Templates that are all listed in a subsequent section of this document.

This specification uses the following OIDs for the artefacts that are registered at the HL7 OID registry.

• The root OID for templates is 2.16.840.1.113883.10.21
  • Entry Level templates are summarized under 2.16.840.1.113883.10.21.4, e.g. 2.16.840.1.113883.10.21.4.5 UV Substitution Permission
  • “other” assistance templates are summarized under 2.16.840.1.113883.10.21.9, e.g. 2.16.840.1.113883.10.22.9.2 UV Normal Dosing
• The root OID for Value Sets is 2.16.840.1.113883.11

The sub branches for templates follow the recommendations of HL7 International and ISO 13582

How to read this document

All artifacts (templates, value sets etc.) listed with the status Draft or Pending are subject to ballot comments.

Artifacts with other status information, especially Final or Active are not (directly) part of the ballot and some artifacts actually even come from external sources. Reference artifacts are indicated by the symbol

ref

. These reference artifacts are also not subject to the ballot, as they might be balloted elsewhere already.

The PDF version contains a ruler on the left side of the pages. A ruler has the page number on top of it and allows locating a line at the page by simply specifying the number at the scale tick. This is more precise and allows also commenting on graphics and pictures.

For example if you have a comment on page 29 because of a typo (see figure), you simply specify the error with its location p0029-04.

Of course you can also refer by classical chapter and section numbers. The use of the ruler has the ballot team's preference, though.

To locate a typo on page 29 as a ballot comment, simply specify the location p0029-04.

Functional requirements and high-level use cases

The following use cases are relevant to the pharmacy domain for both community and institutional settings:

• Prescribing a medication (aka Prescription or Order or Request)
• Dispensing a medication
• Recording the administration of a medication
• Recording the use of a medication (in the past, current or future)

The following definitions are relevant to this Implementation Guide:

• “Prescribing” is an activity that can be performed by a variety of healthcare professionals and involves a variety of orderable items (see glossary entry). For the purposes of the following Implementation Guide, prescribing is defined as the act of prescribing a medication in either an ambulatory or an institutional setting. This could include initiating a new medication order or making all kinds of modifications to existing orders.
• “Dispensing” is an activity undertaken to fulfill the logistical requirements of a prescription. It supplies the materials needed to perform the prescribed actions by those who will perform them. Examples of dispensing include eyeglasses, contact lenses and medications. For the purposes of the following ballot material, dispensing is defined as supplying a medication in fulfillment of a prescription or medication order. While dispensing in these circumstances would usually be performed by a pharmacist, other health care providers such as nurses or physicians might also dispense medications.
• “Administration” is an activity undertaken to give medication to the patient. In the community, this process is usually not recorded, since the majority occurs in the patient's home; only administrations undertaken by a healthcare professional, such as vaccination, tend to be formally documented. Administration of medication in the institutional setting is usually recorded on a dose-by-dose basis, and may be messaged on that basis, or a summary of all the administrations occurring during an inpatient stay may be described.

Templates

Root Entry Level Templates

Entry Level Templates

Id	2.16.840.1.113883.10.21.5	Effective Date	valid from 2017‑01‑02
Status	Draft	Version Label
Name	SubstitutionPermission	Display Name	UV Substitution Permission
Description	Information about a substitution permission for this adminstration.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.21.5
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Used by / Uses	Used by 0 transactions and 1 template, Uses 0 templates Used by as Name Version 2.16.840.1.113883.10.21.1 Containment UV Medication Order 2015‑10‑07 17:53:30
Relationship	Specialization: template 2.16.840.1.113883.10.12.300 (2005‑09‑07)
Example	Example <act classCode="ACT" moodCode="DEF" negationInd="false">   <templateId root="2.16.840.1.113883.10.21.5"/>  <code code="TE" codeSystem="2.16.840.1.113883.5.1070" displayName="therapeutic alternative"/>  <entryRelationship typeCode="RSON">     <act classCode="ACT" moodCode="EVN">       <!-- Reason no substitution -->     </act>  </entryRelationship></act>
Item DT Card Conf Description Label hl7:act 1 … 1 M (Substit… @classCode cs 1 … 1 F ACT @moodCode cs 1 … 1 F DEF @negationInd bl 0 … 1   Used to convey that the specified type of substitution is not allowed. hl7:templateId II 1 … 1 M (Substit… @root uid 1 … 1 F 2.16.840.1.113883.10.21.5 hl7:code CE 1 … 1 The type of substitution that this permission relates to. (Substit…   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.16621 ActSubstanceAdminSubstitutionCode (DYNAMIC) hl7:entryRelationship 0 … 1 C Used when substitution is not allowed and may indicate the reason for why substitution is not allowed. (Substit… @typeCode cs 1 … 1 F RSON   Example <entryRelationship typeCode="RSON">   <code code="PAT" codeSystem="2.16.840.1.113883.5.8" displayName="Patient request">     <originalText>Patient objects</originalText>  </code></entryRelationship> hl7:act 1 … 1 (Substit… @classCode cs 1 … 1 F ACT @moodCode cs 1 … 1 F EVN hl7:code CD 1 … 1 (Substit…   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19719 SubstanceAdminSubstitutionNotAllowedReason (DYNAMIC)   Schematron assert role  error     test not(hl7:entryRelationship[@typeCode='RSON']) or (@negationInd='true')     Message Only if substitution is not allowed indicate the reason for why substitution is not allowed

Appendix (Informative)

Acronyms and abbreviations

C-CDA	Consolidated CDA
CDA	Clinical Document Architecture
DSTU	Draft Standard for Trial Use
EDQM	European Directorate for the Quality of Medicines & Healthcare
EHR	Electronic Healthcare Record
HL7	Health Level Seven
HP	Healthcare Professional
IDMP	IDentification of Medicinal Products (ISO Standard)
IHE	Integrating the Healthcare Enterprise
ISO	International Organization for Standardization
JIC	Joint Initiative Council on SDO Global Health Informatics Standardization
LOINC	Logical Observation Identifiers Names & Codes
MPID	Medicinal Product Identifier
PCID	Medicinal Product Package Identifier
PhPID(s)	Pharmaceutical Product Identifier(s)
SDO	Standard Developing Organization
STU	Standard for Trial Use
UCUM	Unified Code for Units of Measure

Glossary

• Prescribing is an activity that can be performed by a variety of healthcare professionals and involves a variety of orderable items (see glossary entry). For the purposes of the following Implementation Guide, prescribing is defined as the act of prescribing a medication in either an ambulatory or an institutional setting. This could include initiating a new medication order or making all kinds of modifications to existing orders.
• Dispensing is an activity undertaken to fulfill the logistical requirements of a prescription. It supplies the materials needed to perform the prescribed actions by those who will perform them. Examples of dispensing include eyeglasses, contact lenses and medications. For the purposes of the following ballot material, dispensing is defined as supplying a medication in fulfillment of a prescription or medication order. While dispensing in these circumstances would usually be performed by a pharmacist, other health care providers such as nurses or physicians might also dispense medications.
• Administration is an activity undertaken to give medication to the patient. In the community, this process is usually not recorded, since the majority occurs in the patient's home; only administrations undertaken by a healthcare professional, such as vaccination, tend to be formally documented. Administration of medication in the institutional setting is usually recorded on a dose-by-dose basis, and may be messaged on that basis, or a summary of all the administrations occurring during an inpatient stay may be described.

Integrated examples

The Medication on CDA specification releases are published at Project Publication Page. The actual release has a link to the XML materials as which the W3C schemas are part of; it also includes example CDA document instances. A set of use cases have been defined and represented in Medication on CDA format.

It is likely that the publication site will move to hl7.org permanently, we will inform about that process.

Validation artifacts

You can test your implementation (instances) against the Medication on CDA specification. To download materials to your computer for local testing and validation consider...

• ...the W3C schemas (actually valid for any CDA specification) located at the Project Publication Page. The actual release has a link to the XML materials as which the W3C schemas are part of; it also includes example CDA document instances.
• ..the ISO schematron, automatically generated by the tool. These are files to do validation locally by associating IPS CDA instances with the main schematron using an XML editor or to use the derived XSLT conversions and apply the according XSLT derivation to your local IPS CDA instance.

For further information you can follow the documentation.

Operational information

• The original specification is hosted on one of the ART-DECOR main servers, the project is reachable at the Live Project Landing Page.
• Any Medication on CDA specification release in HTML format resides at Project Publication Page. It is likely that the publication site will move to hl7.org permanently, we will inform about that process.

Licenses

Following is a non-exhaustive list of third-party terminologies that may require a separate license:

• SNOMED CT: SNOMED International (formerly know as International Healthcare Terminology Standards Development Organization IHTSDO) or info@ihtsdo.org
• Logical Observation Identifiers Names & Codes (LOINC): The Regenstrief Institute, Inc.
• Unified Code for Units of Measure (UCUM) : Regenstrief Institute, Inc. and the UCUM Organization
• EDQM Standard Terms  : European Directorate for the Quality of Medicines & Healthcare (EDQM)

List of all artifacts used in this guide

CDA Templates

• 2.16.840.1.113883.10.21.1.1 xxxxx

Value Sets

• 2.16.840.1.113883.11.21.2 xxxxx
• 2.16.840.1.113883.11.22.3 xxxxy

References

Literature

• Keith W. Boone: The CDA TM Book. Springer 2011, ISBN 978-0-85729-336-7