View source for PHARM Templates Implementationguide

__NOTOC__
{{Infobox_Document
|Title     = HL7 CDA® R2 Implementation Guide: Pharmacy Templates, Release 1
|Short     = Pharmacy Templates
|Namespace = cdapharm 
|Type      = Implementation Guide
|Version   = 0.95
|Submitted = Pharmacy Workgroup, HL7 International
|Date      = July 29, 2017
|Status    = Draft
|Period    = Draft
|OID       = n.n.
|Realm     = Universal
|Custodian = HL7
|Copyrighttext = © 2016-2017 Health Level Seven International ® ALL RIGHTS RESERVED.<br>The reproduction of this material in any form is strictly forbidden without the written permission of the publisher. HL7 and Health Level Seven are registered trademarks of Health Level Seven International.
}}

{{:HL7_Important_Note}}

{{:PHARM_Authors_and_Contributors}}

__TOC__
=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=
The Pharmacy Work Group has a set of rich set of existing models that were used as the basis for the implementation guide including HL7 V3 models and FHIR resources.  

This implementation guide was created by the Pharmacy Work Group using the following approach:
*Review of Consolidated CDA (C-CDA) to identify templates that include pharmacy related content
*Compare C-CDA templates to existing Pharmacy HL7 V3 models and Pharmacy FHIR resources to identify differences and gaps
*Create universal templates to that can be constrained for use for new templates

The template rules are formalized using the computable format defined by the HL7 Templates Standard: Specification and Use of Reusable Information Constraint Templates, Release 1<ref name="teits">HL7 Templates Standard: Specification and Use of Reusable Information Constraint Templates, Release 1 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=377</ref> in order to facilitate also the automatic generation of consistent testing and validation capabilities.

= Technical Background =
{{:CDA Background}}

==Identifiers for Templates and Value Sets==
This specification specifies CDA '''Entry Level Templates''' only. They can be re-used in any appropriate context, such as an Entry of 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 (2.16.840.1.113883.10.21.4.7)
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. 2.16.840.1.113883.10.22.9.1 ''UV Use Period''
* 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<ref>ISO/TS 13582:2013 Health informatics -- Sharing of OID registry information</ref>.

{{:DocumentUse}}

==Reading Publication Artefacts==
A reading guide is available that explains the formalisms used to express the publication artefacts, i.e. template meta data and template design. For convenience the guide is included in the appendix.

=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.

<div class="landscape">

=Templates=

==Root Entry Level Templates==
As mentioned before, this specification defines two "root" Entry Level Templates, one for each of the covered use cases.

===UV Medication Order===
The following graph gives an overview of the high-level template components of this template, followed by the actual definition.

{{:2.16.840.1.113883.10.21.4.1/hgraph}}

Symbols: * denotes templates with more than one classification, @ indicates a recursion in the definition
<br>
{{:2.16.840.1.113883.10.21.4.1/dynamic}}

===UV Medication Statement===
The following graph gives an overview of the high-level template components of this template, followed by the actual definition.

{{:2.16.840.1.113883.10.21.4.7/hgraph}}
<br>
{{:2.16.840.1.113883.10.21.4.7/dynamic}}

==Entry Level Templates==
===UV ClinicalStatement Encounter===
{{:2.16.840.1.113883.10.21.4.4/dynamic}}
===UV ClinicalStatement Observation===
{{:2.16.840.1.113883.10.21.4.3/dynamic}}
===UV Dispense Request===
{{:2.16.840.1.113883.10.21.4.2/dynamic}}
==UV Dispense Event Reference==
{{:2.16.840.1.113883.10.21.4.9/dynamic}}
===UV Medication Information (detail)===
{{:2.16.840.1.113883.10.21.4.11/dynamic}}
==UV Medication Information (simple)==
{{:2.16.840.1.113883.10.21.4.10/dynamic}}
==UV Medication Order Reference==
{{:2.16.840.1.113883.10.21.4.8/dynamic}}
===UV Subordinate Substance Administration===
{{:2.16.840.1.113883.10.21.4.6/dynamic}}
===UV Substitution Permission===
{{:2.16.840.1.113883.10.21.4.5/dynamic}}
===UV Use Period===
{{:2.16.840.1.113883.10.21.9.1/dynamic}}

==Templates drawn from C-CDA (not subject to ballot)==
===Comment Activity===
{{:2.16.840.1.113883.10.20.22.4.64/dynamic}}
===Indication (V2)===
{{:2.16.840.1.113883.10.20.22.4.19/dynamic}}
</div>

=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 &amp; 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 the Pharmacy Templates Project Publication Page<ref name="pharmpubpage">Pharmacy Templates Project Publication Page http://hl7intl.art-decor.org/index.php?prefix=pharmcda-</ref>. 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 Publication Page<ref name="pharmpubpage"></ref>. 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 the logical ART-DECOR main server art-decor.org under the ''Governance Group'' '''HL7 International''', the project is reachable at the Project Live Landing Page<ref> Pharmacy Templates Project Live Landing Page http://art-decor.org/art-decor/decor-project--pharmcda-</ref>.
* Any ''Medication on CDA'' specification release in HTML format resides at the Publication Page<ref name="pharmpubpage"></ref>. 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)<ref>Get SNOMED CT http://www.ihtsdo.org/snomed-ct/get-snomed-ct</ref> 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

=List of all artifacts used in this guide=
==CDA Templates==
* [[2.16.840.1.113883.10.21.4.1]] UV Medication Order
* [[2.16.840.1.113883.10.21.4.2]] UV Dispense Request
* [[2.16.840.1.113883.10.21.4.3]] UV ClinicalStatement Observation
* [[2.16.840.1.113883.10.21.4.4]] UV ClinicalStatement Encounter
* [[2.16.840.1.113883.10.21.4.5]] UV Substitution Permission
* [[2.16.840.1.113883.10.21.4.6]] UV Subordinate Substance Administration
* [[2.16.840.1.113883.10.21.4.7]] UV Medication Statement
* [[2.16.840.1.113883.10.21.4.8]] UV Medication Order Reference
* [[2.16.840.1.113883.10.21.4.9]] UV Dispense Event Reference
* [[2.16.840.1.113883.10.21.4.10]] UV Medication Information (simple)
* [[2.16.840.1.113883.10.21.4.11]] UV Medication Information (detail)
* [[2.16.840.1.113883.10.21.9.1]] UV Use Period

===References (re-used) from current C-CDA===
* [[2.16.840.1.113883.10.20.22.4.64]] Comment Activity
* [[2.16.840.1.113883.10.20.22.4.19]] Indication (V2)

===Unconstrained Templates from the original CDA specification===
* [[2.16.840.1.113883.10.12.151]] CDA Organization
* [[2.16.840.1.113883.10.12.152]] CDA Person
* [[2.16.840.1.113883.10.12.153]] CDA AssignedEntity
* [[2.16.840.1.113883.10.12.310]] CDA LabeledDrug
* [[2.16.840.1.113883.10.12.311]] CDA Material
* [[2.16.840.1.113883.10.12.312]] CDA ManufacturedProduct
* [[2.16.840.1.113883.10.12.313]] CDA PlayingEntity
* [[2.16.840.1.113883.10.12.315]] CDA Device
* [[2.16.840.1.113883.10.12.316]] CDA RelatedEntity
* [[2.16.840.1.113883.10.12.318]] CDA Author (Body)
* [[2.16.840.1.113883.10.12.319]] CDA Informant (Body)
* [[2.16.840.1.113883.10.12.320]] CDA Subject (Body)
* [[2.16.840.1.113883.10.12.321]] CDA Participant (Body)
* [[2.16.840.1.113883.10.12.322]] CDA Specimen
* [[2.16.840.1.113883.10.12.323]] CDA Performer (Body)
* [[2.16.840.1.113883.10.12.324]] CDA Reference
* [[2.16.840.1.113883.10.12.325]] CDA ExternalAct
* [[2.16.840.1.113883.10.12.326]] CDA ExternalObservation
* [[2.16.840.1.113883.10.12.327]] CDA ExternalProcedure
* [[2.16.840.1.113883.10.12.328]] CDA ExternalDocument
* [[2.16.840.1.113883.10.12.329]] CDA Precondition

==Value Sets ==
===Medication Time Units (UCUM)===
{{:2.16.840.1.113883.11.21.1/dynamic}}
===ActStatusActiveCompletedAbortedSuspended===
{{:2.16.840.1.113883.11.21.2/dynamic}}

===Referenced HL7 Version 3 Value Sets===
*2.16.840.1.113883.1.11.13955 ActEncounterCode
*2.16.840.1.113883.1.11.16208 ActPharmacySupplyType
*2.16.840.1.113883.1.11.16866 ActPriority
*2.16.840.1.113883.1.11.15933 ActStatus
*2.16.840.1.113883.1.11.19708 ActSubstanceAdministrationCode
*2.16.840.1.113883.1.11.14570 AdministrableDrugForm
*2.16.840.1.113883.1.11.11526 HumanLanguage
*2.16.840.1.113883.11.20.9.18 MoodCodeEvnInt
*2.16.840.1.113883.1.11.78 Observation Interpretation (HL7)
*2.16.840.1.113883.1.11.14079 ObservationMethod
*2.16.840.1.113883.1.11.14581 RouteOfAdministration
*2.16.840.1.113883.1.11.19719 SubstanceAdminSubstitutionNotAllowedReason
*2.16.840.1.113883.1.11.10706 TimingEvent
*2.16.840.1.113883.1.11.19447 x_ActRelationshipEntryRelationship
*2.16.840.1.113883.1.11.19890 x_ActStatusActiveComplete

==Datatypes ==
Datatypes for element definitions used
*ANY – ANY
*BL – Boolean
*CD – Concept Descriptor
*CE – Coded with Equivalents
*CS – Coded Simple Value
*ED – Encapsulated Data
*EN – Entity Name
*II – Instance Identifier
*INT – Integer
*INT.NONNEG – Interval of Integer, non-negative
*IVL_INT – Interval of Integer
*IVL_PQ – Interval of Physical Quantity
*IVL_TS – Interval of Time Stamp
*IVXB_TS – Interval Boundary of Time Stamp
*PIVL_TS – Periodic Interval of Timezone
*PQ – Physical Quantity
*RTO_PQ_PQ – Ratio Physical Quantity / Physical Quantity
*ST – Character String
*TEL – Telecommunication Address
*TS – Time Stamp

Datatypes for attributes used
*bl – boolean code
*cs – code
*uid – identifier

{{:Reading_Guide_for_Publication_Artefacts}}

=References=
==Literature==
* Boone KW: The CDA Book. Springer 2011, ISBN 978-0-85729-336-7

==Links==
<references>
==Figures==
<references group="Figure">