R6 Ballot (1st Draft)

This page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

Biomedical Research and Regulation icon Work Group Maturity Level: 1Trial Use Compartments: N/A

This operation is used to return all the information related to one or more products described in the resource or context on which this operation is invoked. The response is a bundle of type "searchset". At a minimum, the product resource(s) itself is returned, along with any other resources that the server has that are related to the products(s), and that are available for the given user. This is typically the marketing authorizations, ingredients, packages, therapeutic indications and so on. The server also returns whatever resources are needed to support the records - e.g. linked organizations, document references etc.

The canonical URL for this operation definition is

 http://hl7.org/fhir/OperationDefinition/MedicinalProductDefinition-everything

Formal Definition (as a OperationDefinition).

URL: [base]/MedicinalProductDefinition/$everything

URL: [base]/MedicinalProductDefinition/[id]/$everything

This is an idempotent operation

In Parameters:
NameScopeCardinalityTypeBindingProfileDocumentation
_since0..1instant

Resources updated after this period will be included in the response. The intent of this parameter is to allow a client to request only records that have changed since the last request, based on either the return header time, or or (for asynchronous use), the transaction time

_count0..1integer

See discussion below on the utility of paging through the results of the $everything operation

Out Parameters:
NameScopeCardinalityTypeBindingProfileDocumentation
return1..1Bundle

The bundle type is "searchset"

Note: as this is the only out parameter, it is a resource, and it has the name 'return', the result of this operation is returned directly as a resource

The key differences between this operation and simply performing a search and using _include and _revinclude are:

  • unless the client requests otherwise, the server returns the entire result set in a single bundle (rather than using paging)
  • the server is responsible for determining what resources to return as included resources (rather than the client specifying which ones).

This frees the client from needing to determine what it could or should ask for, particularly with regard to included resources. It also makes for a much shorter and easier to construct query string. Servers should consider returning appropriate Provenance and AuditTrail on the returned resources, even though these are not directly part of the product data.

When this operation is used to access multiple product records at once, the return bundle could be rather a lot of data; servers may choose to require that such requests are made asynchronously, and associated with bulk data formats. Alternatively, clients may choose to page through the result set (or servers may require this). Paging through the results is done the same as for Searching, using the _count parameter, and Bundle links. Implementers should note that paging will be slower than simply returning all the results at once (more network traffic, multiple latency delays) but may be required in order not to exhaust available memory reading or writing the whole response in a single package. Unlike searching, there is no inherent user-display order for the $everything operation. Servers might consider sorting the returned resources in descending order of last record update, but are not required to do so.

The _since parameter is provided to support periodic queries to get additional information that has changed about the product since the last query. This means that the _since parameter is based on record time. The value of the _since parameter should be set to the time from the server. If using direct response, this is the timestamp in the response header. If using the async interface, this is the transaction timestamp in the json response. Servers should ensure that the timestamps a managed such that the client does not miss any changes. Clients should be able to handle getting the same response more than once in the case that the transaction falls on a time boundary. Clients should ensure that the other query parameters are constant to ensure a coherent set of records when doing periodic queries.

Request: Get all resources linked to a single medicinal product


GET /open/MedicinalProductDefinition/example/$everything
[some headers]

Response: Everything linked to the nominated medicinal product (in this case, built automatically by the publication tooling)


HTTP/1.1 200 OK
[other headers]

<Bundle xml="http://hl7.org/fhir">
  <id value="63e6aa75-3831-4a52-b46a-c99689a3a99e"/>
  <type value="searchset"/>
  <entry>
    <fullUrl value="http://hl7.org/fhir/MedicinalProductDefinition/example"/>
    <resource>
     <MedicinalProductDefinition xmlns="http://hl7.org/fhir">
     	<id value="example"/>
     	<text>
     		<status value="generated"/>
     		<div xmlns="http://www.w3.org/1999/xhtml">
     			<p><b>Generated Narrative</b></p>
     			<p><b>Id</b>: example</p>
     			<p><b>Identifier</b>: {mpid}</p>
     			<p><b>Classification</b>: <span title="Codes: {http://ema.europa.eu/example/WHOAnatomicalTherapeuticChemicalATCClassificationSystem B01AF02}">ATC: B01AF02</span></p>
     			<p><b>Attached Document</b>: (SmPC)</p>
     			<p><b>Master File</b>: (Pharmacovigilence Master File)</p>
     			<p><b>Product Name</b>: Equilidem 2.5 mg film-coated tablets</p>
     			<blockquote>
     				<p><b>Name Part</b></p><p><b>part</b>:Equilidem</p>
     				<p><b>type</b>: <span title="Codes: ">Invented</span></p>
     			</blockquote>
     			<blockquote>
     				<p><b>Name Part</b></p><p><b>part</b>:2.5 mg</p>
     				<p><b>type</b>: <span title="Codes: ">Strength</span></p>
     			</blockquote>
     			<blockquote>
     				<p><b>Name Part</b></p>
     				<p><b>part</b>:film-coated tablets</p>
     				<p><b>type</b>: <span title="Codes: ">Form</span></p>
     				<p><b>Country &amp; Languages</b></p>
     				<table class="grid">
     					<tr>
     						<td>-</td>
     						<td><b>Country</b></td>
     						<td><b>Jurisdiction</b></td>
     						<td><b>Language</b></td>
     					</tr>
     					<tr>
     						<td>*</td>
     						<td><span title="Codes: {http://ema.europa.eu/example/countryCode EU}">EU</span></td>
     						<td><span title="Codes: {http://ema.europa.eu/example/jurisdictionCode EU}">EU</span></td>
     						<td><span title="Codes: {urn:ietf:bcp:47}">EN</span></td>
     					</tr>
     				</table>
     			</blockquote>
     			<p><b>Manufacturing &amp; Business Operations</b></p>
     			<table class="grid">
     				<tr>
     					<td>-</td>
     					<td><b>Type</b></td>
     					<td><b>EffectiveDate</b></td>
     					<td><b>Authorization</b></td>
     				</tr>
     				<tr>
     					<td>*</td>
     					<td>Batch Release</td>
     					<td>2013-03-15 --&gt; (ongoing)</td>
     					<td><span>1324TZ</span></td>
     				</tr>
     			</table>
     		</div>
     	</text>
     	<identifier>
     		<system value="http://ema.europa.eu/example/MPID"/>
     		<value value="{mpid}"/>
     	</identifier>
     	<classification>
     		<coding>
     			<system value="http://ema.europa.eu/example/WHOAnatomicalTherapeuticChemicalATCClassificationSystem"/>
     			<code value="B01AF02"/>
     		</coding>
     	</classification>
     	<attachedDocument>
     		<reference value="DocumentReference/example"/>
     	</attachedDocument>
     	<masterFile>
     		<reference value="DocumentReference/example"/>
     	</masterFile>
     	<name>
     		<productName value="Equilidem 2.5 mg film-coated tablets"/>
     		<part>
     			<part value="Equilidem"/>
     			<type>
     				<coding>
     					<code value="INV"/>
     				</coding>
     			</type>
     		</part>
     		<part>
     			<part value="2.5 mg"/>
     			<type>
     				<coding>
     					<code value="STR"/>
     				</coding>
     			</type>
     		</part>
     		<part>
     			<part value="film-coated tablets"/>
     			<type>
     				<coding>
     					<code value="FRM"/>
     				</coding>
     			</type>
     		</part>
     		<usage>
     			<country>
     				<coding>
     					<system value="http://ema.europa.eu/example/countryCode"/>
     					<code value="EU"/>
     				</coding>
     			</country>
     			<jurisdiction>
     				<coding>
     					<system value="http://ema.europa.eu/example/jurisdictionCode"/>
     					<code value="EU"/>
     				</coding>
     			</jurisdiction>
     			<language>
     				<coding>
     					<system value="urn:ietf:bcp:47"/>
     					<code value="en"/>
     				</coding>
     			</language>
     		</usage>
     	</name>
     	<operation>
     		<type>
     			<concept>
     				<coding>
     					<system value="http://ema.europa.eu/example/manufacturingOperationType"/>
     					<code value="Batchrelease"/>
     				</coding>
     			</concept>
     		</type>
     		<effectiveDate>
     			<start value="2013-03-15"/>
     		</effectiveDate>
     	</operation>
     </MedicinalProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://hl7.org/fhir/ClinicalUseDefinition/example"/>
    <resource>
     <ClinicalUseDefinition xmlns="http://hl7.org/fhir">
       <id value="example"/>
       <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"><valueCode value="brr"/></extension>
       <publisher value="HL7 International / Biomedical Research and Regulation"/>
       <contact>
         <telecom>
           <system value="url"/>
           </telecom>
       </contact>
       <type value="contraindication"/>
       <subject>
         <reference value="MedicinalProductDefinition/example"/>
       </subject>
       <!-- example product is contraindicated with Hepatic disease -->
       <contraindication>
         <diseaseSymptomProcedure>
           <concept>
             <coding>
               <system value="http://ema.europa.eu/example/contraindicationsasdisease-symptom-procedure"/>
               <code value="hepatic-example-code"/>
             </coding>
             <text value="Hepatic disease associated with coagulopathy and clinically relevant bleeding risk"/>
           </concept>
         </diseaseSymptomProcedure>
       </contraindication>
     </ClinicalUseDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://hl7.org/fhir/ClinicalUseDefinition/example-indication"/>
    <resource>
     <ClinicalUseDefinition xmlns="http://hl7.org/fhir">
       <id value="example-indication"/>
       <!-- example product is indicated for Prevention of venous thromboembolic events, in adults (18+) -->
       <!-- product is for 18 years and above -->
       <contained>
         <Group>
           <id value="group"/>
           <type value="person"/>
           <membership value="definitional"/>
           <characteristic>
             <code>
               <coding>
                 <system value="http://ema.europa.eu/example/characteristic"/>
                 <code value="age-range"/>
               </coding>
             </code>
             <valueRange>
               <low>
                 <value value="18"/>
                 <unit value="a"/>
               </low>
             </valueRange>
             <exclude value="false"/>
           </characteristic>
         </Group>
       </contained>
       <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"><valueCode value="brr"/></extension>
       <publisher value="HL7 International / Biomedical Research and Regulation"/>
       <contact>
         <telecom>
           <system value="url"/>
           </telecom>
       </contact>
       <type value="indication"/>
       <subject>
         <reference value="MedicinalProductDefinition/example"/>
       </subject>
       <!-- example product is indicated for Prevention of venous thromboembolic events -->
       <indication>
         <diseaseSymptomProcedure>
           <concept>
             <coding>
               <system value="http://ema.europa.eu/example/indicationasdisease-symptom-procedure"/>
               <code value="Pulmonary-embolism-and-thrombosis-example-code"/>
             </coding>
             <text value="Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults."/>
           </concept>
         </diseaseSymptomProcedure>
         <diseaseStatus>
           <concept>
             <coding>
               <system value="http://ema.europa.eu/example/diseasestatus"/>
               <code value="Recurrent"/>
             </coding>
           </concept>
         </diseaseStatus>
         <intendedEffect>
           <concept>
             <coding>
               <system value="http://ema.europa.eu/example/intendedeffect"/>
               <code value="PRYLX"/>
             </coding>
           </concept>
         </intendedEffect>
       </indication>
       <population>
         <reference value="#group"/>
       </population>
     </ClinicalUseDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://hl7.org/fhir/ClinicalUseDefinition/example-interaction"/>
    <resource>
     <ClinicalUseDefinition xmlns="http://hl7.org/fhir">
       <id value="example-interaction"/>
       <!-- example product interacts with other drugs -->
       <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"><valueCode value="brr"/></extension>
       <publisher value="HL7 International / Biomedical Research and Regulation"/>
       <contact>
         <telecom>
           <system value="url"/>
           </telecom>
       </contact>
       <type value="interaction"/>
       <subject>
         <reference value="MedicinalProductDefinition/example"/>
       </subject>
       <interaction>
         <interactant>
           <itemCodeableConcept>
             <coding>
               <system value="http://ema.europa.eu/example/interactant"/>
               <code value="alphaconazole"/>
             </coding>
           </itemCodeableConcept>
         </interactant>
         <interactant>
           <itemCodeableConcept>
             <coding>
               <system value="http://ema.europa.eu/example/interactant"/>
               <code value="betaconazole"/>
             </coding>
           </itemCodeableConcept>
         </interactant>
         <type>
           <coding>
             <system value="http://ema.europa.eu/example/interactionsType"/>
             <code value="Inhibitor"/>
           </coding>
         </type>
         <effect>
           <concept>
             <text value="Increased plasma concentration"/>
           </concept>
         </effect>
         <management>
           <text value="Careful monitoring of dose"/>
         </management>
       </interaction>
     </ClinicalUseDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://hl7.org/fhir/ClinicalUseDefinition/example-warning"/>
    <resource>
     <ClinicalUseDefinition xmlns="http://hl7.org/fhir">
       <id value="example-warning"/>
       <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"><valueCode value="brr"/></extension>
       <publisher value="HL7 International / Biomedical Research and Regulation"/>
       <contact>
         <telecom>
           <system value="url"/>
           </telecom>
       </contact>
       <type value="warning"/>
       <category>
         <coding>
           <system value="http://hl7.org/fhir/clinical-use-definition-category"/>
           <code value="DriveAndMachines"/>
           <display value="Effects on Ability to Drive and Use Machines"/>
         </coding>
       </category>
       <subject>
         <reference value="MedicinalProductDefinition/example"/>
       </subject>
       <warning>
         <description value="May cause drowsiness. Avoid driving or operating heavy machinery."/>
       </warning>
     </ClinicalUseDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://hl7.org/fhir/ClinicalUseDefinition/example-undesirable"/>
    <resource>
     <ClinicalUseDefinition xmlns="http://hl7.org/fhir">
       <id value="example-undesirable"/>
       <!-- common side effect -->
       <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"><valueCode value="brr"/></extension>
       <publisher value="HL7 International / Biomedical Research and Regulation"/>
       <contact>
         <telecom>
           <system value="url"/>
           </telecom>
       </contact>
       <type value="undesirable-effect"/>
       <subject>
         <reference value="MedicinalProductDefinition/example"/>
       </subject>
       <undesirableEffect>
         <symptomConditionEffect>
           <concept>
             <coding>
               <system value="http://ema.europa.eu/example/undesirableeffectassymptom-condition-effect"/>
               <code value="Anaemia"/>
             </coding>
           </concept>
         </symptomConditionEffect>
         <classification>
           <coding>
             <system value="http://ema.europa.eu/example/symptom-condition-effectclassification"/>
             <code value="Blood-and-lymphatic-system-disorders"/>
           </coding>
         </classification>
         <frequencyOfOccurrence>
           <coding>
             <system value="http://ema.europa.eu/example/frequencyofoccurrence"/>
             <code value="Common"/>
           </coding>
         </frequencyOfOccurrence>
       </undesirableEffect>
     </ClinicalUseDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://hl7.org/fhir/ClinicalUseDefinition/example-contraindication"/>
    <resource>
     <ClinicalUseDefinition xmlns="http://hl7.org/fhir">
       <id value="example-contraindication"/>
       <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"><valueCode value="brr"/></extension>
       <publisher value="HL7 International / Biomedical Research and Regulation"/>
       <contact>
         <telecom>
           <system value="url"/>
           </telecom>
       </contact>
       <type value="contraindication"/>
       <subject>
         <reference value="MedicinalProductDefinition/example"/>
       </subject>
       <contraindication>
         <diseaseSymptomProcedure>
           <concept>
             <text value="Concomitant treatment with any other anticoagulant agent"/>
           </concept>
         </diseaseSymptomProcedure>
         <otherTherapy>
           <relationshipType>
             <coding>
               <system value="http://ema.europa.eu/example/therapyrelationshiptype"/>
               <code value="Co-therapy(with)"/>
             </coding>
           </relationshipType>
           <treatment>
             <concept>
               <coding>
                 <system value="http://ema.europa.eu/example/medication"/>
                 <code value="Oralanticoagulants"/>
               </coding>
             </concept>
           </treatment>
         </otherTherapy>
         <!-- or -->
         <otherTherapy>
           <relationshipType>
             <coding>
               <system value="http://ema.europa.eu/example/therapyrelationshiptype"/>
               <code value="Co-therapy(with)"/>
             </coding>
           </relationshipType>
           <treatment>
             <concept>
               <coding>
                 <system value="http://ema.europa.eu/example/medication"/>
                 <code value="Lowmolecularweightheparins"/>
               </coding>
             </concept>
           </treatment>
         </otherTherapy>
       </contraindication>
     </ClinicalUseDefinition>
    </resource>
  </entry>
</Bundle>

 

For more information about operations, including how they are invoked, see Operations.