4.11 Resource Contraindication - Content

4.11.1 Scope and Usage

This resource applies to various circumstances where there is a concern about an existing or proposed set of clinical activity. The issue could relate to multiple actions/proposed actions or could be specific to a single action. It does not apply to administrative issues (e.g. lack of user permissions) but could relate to violation of patient consent limitations. Examples include:

• Drug-drug interactions
• Inappropriate therapy (wrong dose, frequency, body site)
• Duplicate therapy

This resource is not intended to be used in defining general prohibitions on actions such as "No NSAIDs", "No solid oral dose forms" or "No MRIs - metalic tatoos". These guidelines can be captured using the AllergyIntolerance, and/or Alert resources. Similarly this resource is not to be used to capture clinical facts that may imply contraindications such as pregnancy, breast feeding, patient preferences, past procedures, etc. These would be represented using Condition, Procedure or other resources.

4.11.2 Boundaries and Relationships

This resources only applies to documenting a risk associated with a specific planned or ongoing action, not a general propensity to risk. The latter would be handled using AllergyIntolerance for substance-specific issues or Alert for other types of issues.

This resource is limited to clinical issues associated with a proposed or ongoing action. It does not cover business/technical issues such as lack of permission, duplicate identifiers and other business rule violations. Business and technical issues are conveyed using the OperationOutcome resource. It is possible to have both OperationOutcome and Contraindication together, where the OperationOutcome might indicate that a requested action was rejected due to a clinical issue and the Contraindication provides the details of the issue.

4.11.3 Background and Context

Contraindications are typically identified by decision support systems. However, they may also be captured directly by clinicians. The latter typically happens for one of two reasons:

1. A clinician wishes to communicate an issue to another clinician whose responsibility it would be to resolve it (e.g. a pharmacist identifying an issue with a prescription prior to putting it on hold)
2. A clinician wishes to pre-emptively identify that an issue is known and being managed (to avoid red flags being raised as part of downstream workflow). E.g. Noting that a duplicate therapy is actually intended.

Decision-support generated contraindications can result from calling a decision-support engine directly (e.g. via a custom OperationDefinition) or as part of an attempt to perform some other function (creating an order, submitting an insurance claim, capturing a medication list). When the contraindications are generated as a byproduct of performing some other sort of action, they may be included in the "response" to the requested action in the same manner as an OperationOutcome. In fact, both may be present - the OperationOutcome indicating that there was a warning or error associated with the request and a Contraindication providing the clinical details. (The OperationOutcome could point to the Contraindication via an extension.)

In those circumstances where requested operations are rejected as a result of a contraindication, the workflow may support allowing the operation to be re-tried provided the identified contraindication is included as part of the submission (possibly also including a mitigation). In doing so, the sender acknowledges the contraindication and takes responsibility for it, thus allowing the requested operation to proceed. See Linking to Contraindications for guidance on how a Contraindication instance might be included as part of another operation.

Systems that require such workflows should document expected behavior as part of their Conformance declarations.

• Structure
• UML
• XML
• JSON
• All

Structure

Name	Flags	Card.	Type	Description & Constraints
Contraindication			DomainResource	Clinical issue with action
patient	Σ	0..1	Patient	Associated patient
category	Σ	0..1	CodeableConcept	E.g. Drug-drug, duplicate therapy, etc. ContraindicationCategory (Required)
severity	Σ	0..1	code	high | medium | low ContraindicationSeverity (Required)
implicated	Σ	0..*	Any	Problem resource
detail		0..1	string	Description and context
date	Σ	0..1	dateTime	When identified
author	Σ	0..1	Practitioner | Device	Who found issue?
identifier	Σ	0..1	Identifier	Unique id for the contraindication
reference		0..1	uri	Authority for issue
mitigation		0..*	Element	Step taken to address
action		1..1	CodeableConcept	What mitigation? ContraindicationMitigationAction (Required)
date		0..1	dateTime	Date committed
author		0..1	Practitioner	Who is committing?

<Contraindication xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <patient><!-- 0..1 Reference(Patient) Associated patient --></patient>
 <category><!-- 0..1 CodeableConcept E.g. Drug-drug, duplicate therapy, etc. --></category>
 <severity value="[code]"/><!-- 0..1 high | medium | low -->
 <implicated><!-- 0..* Reference(Any) Problem resource --></implicated>
 <detail value="[string]"/><!-- 0..1 Description and context -->
 <date value="[dateTime]"/><!-- 0..1 When identified -->
 <author><!-- 0..1 Reference(Practitioner|Device) Who found issue? --></author>
 <identifier><!-- 0..1 Identifier Unique id for the contraindication --></identifier>
 <reference value="[uri]"/><!-- 0..1 Authority for issue -->
 <mitigation>  <!-- 0..* Step taken to address -->
  <action><!-- 1..1 CodeableConcept What mitigation? --></action>
  <date value="[dateTime]"/><!-- 0..1 Date committed -->
  <author><!-- 0..1 Reference(Practitioner) Who is committing? --></author>
 </mitigation>
</Contraindication>

{
  "resourceType" : "Contraindication",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "patient" : { Reference(Patient) }, // Associated patient
  "category" : { CodeableConcept }, // E.g. Drug-drug, duplicate therapy, etc.
  "severity" : "<code>", // high | medium | low
  "implicated" : [{ Reference(Any) }], // Problem resource
  "detail" : "<string>", // Description and context
  "date" : "<dateTime>", // When identified
  "author" : { Reference(Practitioner|Device) }, // Who found issue?
  "identifier" : { Identifier }, // Unique id for the contraindication
  "reference" : "<uri>", // Authority for issue
  "mitigation" : [{ // Step taken to address
    "action" : { CodeableConcept }, // R!  What mitigation?
    "date" : "<dateTime>", // Date committed
    "author" : { Reference(Practitioner) } // Who is committing?
  }]
}

Structure

Name	Flags	Card.	Type	Description & Constraints
Contraindication			DomainResource	Clinical issue with action
patient	Σ	0..1	Patient	Associated patient
category	Σ	0..1	CodeableConcept	E.g. Drug-drug, duplicate therapy, etc. ContraindicationCategory (Required)
severity	Σ	0..1	code	high | medium | low ContraindicationSeverity (Required)
implicated	Σ	0..*	Any	Problem resource
detail		0..1	string	Description and context
date	Σ	0..1	dateTime	When identified
author	Σ	0..1	Practitioner | Device	Who found issue?
identifier	Σ	0..1	Identifier	Unique id for the contraindication
reference		0..1	uri	Authority for issue
mitigation		0..*	Element	Step taken to address
action		1..1	CodeableConcept	What mitigation? ContraindicationMitigationAction (Required)
date		0..1	dateTime	Date committed
author		0..1	Practitioner	Who is committing?

UML Diagram

XML Template

<Contraindication xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <patient><!-- 0..1 Reference(Patient) Associated patient --></patient>
 <category><!-- 0..1 CodeableConcept E.g. Drug-drug, duplicate therapy, etc. --></category>
 <severity value="[code]"/><!-- 0..1 high | medium | low -->
 <implicated><!-- 0..* Reference(Any) Problem resource --></implicated>
 <detail value="[string]"/><!-- 0..1 Description and context -->
 <date value="[dateTime]"/><!-- 0..1 When identified -->
 <author><!-- 0..1 Reference(Practitioner|Device) Who found issue? --></author>
 <identifier><!-- 0..1 Identifier Unique id for the contraindication --></identifier>
 <reference value="[uri]"/><!-- 0..1 Authority for issue -->
 <mitigation>  <!-- 0..* Step taken to address -->
  <action><!-- 1..1 CodeableConcept What mitigation? --></action>
  <date value="[dateTime]"/><!-- 0..1 Date committed -->
  <author><!-- 0..1 Reference(Practitioner) Who is committing? --></author>
 </mitigation>
</Contraindication>

JSON Template

{
  "resourceType" : "Contraindication",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "patient" : { Reference(Patient) }, // Associated patient
  "category" : { CodeableConcept }, // E.g. Drug-drug, duplicate therapy, etc.
  "severity" : "<code>", // high | medium | low
  "implicated" : [{ Reference(Any) }], // Problem resource
  "detail" : "<string>", // Description and context
  "date" : "<dateTime>", // When identified
  "author" : { Reference(Practitioner|Device) }, // Who found issue?
  "identifier" : { Identifier }, // Unique id for the contraindication
  "reference" : "<uri>", // Authority for issue
  "mitigation" : [{ // Step taken to address
    "action" : { CodeableConcept }, // R!  What mitigation?
    "date" : "<dateTime>", // Date committed
    "author" : { Reference(Practitioner) } // Who is committing?
  }]
}