Generated Narrative: StructureDefinition MedicationKnowledge-uv-epi Name Flags Card. Type Description & Constraints MedicationKnowledge 0..* MedicationKnowledge Definition of Medication Knowledge Interfaces Implemented: MetadataResource #xD; identifier #xD; system 1..1 uri The namespace for the identifier value #xD; value 1..1 string The value that is unique #xD; code 0..0 Code that identifies this medication #xD; status 0..1 code active | inactive | entered-in-error #xD; name 0..* string Common name for the medication #xD; indicationGuideline 1..* BackboneElement Guidelines for administration of the medication #xD; indication 1..* CodeableReference(ClinicalUseDefinition Indication (ePI)) Indication for use that applies to the specific administration guideline #xD; dosingGuideline 1..* BackboneElement Guidelines for dosage of the medication #xD; treatmentIntent #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; dosage 1..* BackboneElement Dosage for the medication #xD; type 1..1 CodeableConcept Category of dosage (e.g., Target, Maximum, Minimum) #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; dosage 1..* Dosage Dosage for the medication #xD; administrationTreatment 0..0 Type of treatment the guideline applies to #xD; patientCharacteristic #xD; type 1..1 CodeableConcept Categorization of specific characteristic that is relevant to the administration guideline Binding: Patient Characteristic Type (ePI) (example) #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; Documentation for this format
HL7 International / Biomedical Research and Regulation
MedicationKnowledge (ePI) - ported from Business Friendly ePI Outline
Information about a medication that is used to support knowledge.
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Must have either extensions or value[x], not both
May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Business identifier for this medication.
This is a business identifier, not a resource identifier (see discussion).
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
usual | official | temp | secondary | old (If known)
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Identifies the purpose for this identifier, if known .
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Allows users to make use of identifiers when the identifier system is not known.
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Identifier.system is always case sensitive.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
Time period when id is/was valid for use
Time period during which identifier is/was valid for use.
Role.effectiveTime or implied by context
Organization that issued id (may be just text)
Organization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
A code that specifies this medication, or a textual description if no code is available. Usage note: This could be a standard medication code such as a code from RxNorm, SNOMED CT, IDMP etc. It could also be a national or local formulary code, optionally with translations to other code systems.
Depending on the context of use, the code that was actually selected by the user (prescriber, dispenser, etc.) will have the coding.userSelected set to true. As described in the coding datatype: "A coding may be marked as a "userSelected" if a user selected the particular coded value in a user interface (e.g. the user selects an item in a pick-list). If a user selected coding exists, it is the preferred choice for performing translations etc. Other codes can only be literal translations to alternative code systems, or codes at a lower level of granularity (e.g. a generic code for a vendor-specific primary one).
A coded concept that defines the type of a medication.
coding.code = //element(*,MedicationType)/DrugCoded/ProductCode coding.system = //element(*,MedicationType)/DrugCoded/ProductCodeQualifier coding.display = //element(*,MedicationType)/DrugDescription
RXO-1.1-Requested Give Code.code / RXE-2.1-Give Code.code / RXD-2.1-Dispense/Give Code.code / RXG-4.1-Give Code.code /RXA-5.1-Administered Code.code / RXC-2.1 Component Code
A code to indicate if the medication is in active use.
This status is intended to identify if the medication in a local system is in active use within a drug database or inventory. For example, a pharmacy system may create a new drug file record for a compounded product "ABC Hospital Special Cream" with an active status. At some point in the future, it may be determined that the drug record was created with an error and the status is changed to "entered in error". This status is not intended to specify if a medication is part of a particular formulary. It is possible that the drug record may be referenced by multiple formularies or catalogues and each of those entries would have a separate status.
This element changes the interpretation of all descriptive attributes.
A coded concept defining if the medication is in active use.
Creator or owner of the knowledge or information about the medication
The creator or owner of the knowledge or information about the medication.
Codes that identify the different jurisdictions for which the information of this resource was created
Lists the jurisdictions that this medication knowledge was written for.
The codes could have varying granularity from a country or group of countries down to a specific district.
Associated or related medication information
Associated or related medications. For example, if the medication is a branded product (e.g. Crestor), this is the Therapeutic Moeity (e.g. Rosuvastatin) or if this is a generic medication (e.g. Rosuvastatin), this would link to a branded product (e.g. Crestor.
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The category of the associated medication knowledge reference.
Associated documentation about the associated medication knowledge
Associated documentation about the associated medication knowledge.
The set of medication resources that are associated with this medication
Links to associated medications that could be prescribed, dispensed or administered.
Category of the medication or product (e.g. branded product, therapeutic moeity, generic product, innovator product, etc.).
Associated documentation about the medication
Associated documentation about the medication.
The category of documentation about the medication. (e.g. professional monograph, patient education monograph).
The instructions for preparing the medication
The instructions for preparing the medication.
The date range for which the cost is effective
The date range for which the cost information of the medication is effective.
The category of the cost information. For example, manufacturers' cost, patient cost, claim reimbursement cost, actual acquisition cost.
The source or owner for the price information
The source or owner that assigns the price to the medication.
The price or category of the cost of the medication
The price or representation of the cost (for example, Band A, Band B or $, $$) of the medication.
A coded concept defining the category of a medication.
Program under which a medication is reviewed
The program under which the medication is reviewed.
Type of program under which the medication is monitored
Type of program under which the medication is monitored.
Guidelines for administration of the medication
Indication for use that applies to the specific administration guideline
Indication or reason for use of the medication that applies to the specific administration guideline.
The overall intention of the treatment, for example, prophylactic, supporative, curative, etc.
A reference to a code defined by a terminology system.
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Allows for alternative encodings within a code system, and translations to other code systems.
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
The identification of the code system that defines the meaning of the symbol in the code.
The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
Need to be unambiguous about the source of the definition of the symbol.
fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Need to refer to a particular code in the system.
fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
A representation of the meaning of the code in the system, following the rules of the system.
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
C*E.2 - but note this is not well followed
fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
If this coding was chosen directly by the user
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
Plain text representation of the concept
A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Very often the text is the same as a displayName of one of the codings.
The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
Category of dosage (e.g., Target, Maximum, Minimum)
The kind of dosage being defined, such as the intended target dose, or a maximum or minimum boundary. This allows differentiation between standard therapeutic doses and limit thresholds.
Type of treatment the guideline applies to
The type of the treatment that the guideline applies to, for example, long term therapy, first line treatment, etc.
Characteristics of the patient that are relevant to the administration guidelines
Characteristics of the patient that are relevant to the administration guidelines (for example, height, weight, gender, etc.).
Categorization of specific characteristic that is relevant to the administration guideline
The categorization of the specific characteristic that is relevant to the administration guideline (e.g. height, weight, gender).
The specific characteristic (e.g. height, weight, gender, etc.).
Categorization of the medication within a formulary or classification system
Categorization of the medication within a formulary or classification system.
The type of category for the medication (for example, therapeutic classification, therapeutic sub-classification)
The type of category for the medication (for example, therapeutic classification, therapeutic sub-classification).
Either a textual source of the classification or a reference to an online source.
Specific category assigned to the medication
Specific category assigned to the medication (e.g. anti-infective, anti-hypertensive, antibiotic, etc.).
Information that only applies to packages (not products).
The packaged medication that is being priced
A reference to a PackagedProductDefinition that provides the details of the product that is in the packaging and is being priced.
Potential clinical issue with or between medication(s)
Potential clinical issue with or between medication(s) (for example, drug-drug interaction, drug-disease contraindication, drug-allergy interaction, etc.).
Information on how the medication should be stored, for example, refrigeration temperatures and length of stability at a given temperature.
Reference to additional information about the storage guidelines.
Duration that the medication remains stable if the environmentalSetting is respected.
Setting or value of environment for adequate storage
Describes a setting/value on the environment for the adequate storage of the medication and other substances. Environment settings may involve temperature, humidity, or exposure to light.
Identifies the category or type of setting (e.g., type of location, temperature, humidity).
Value associated to the setting. E.g., 40° – 50°F for temperature.
Regulatory information about a medication
Regulatory information about a medication.
Specifies the authority of the regulation
The authority that is specifying the regulations.
Specifies if changes are allowed when dispensing a medication from a regulatory perspective
Specifies if changes are allowed when dispensing a medication from a regulatory perspective.
Specifies the type of substitution allowed
Specifies the type of substitution allowed.
Specifies if regulation allows for changes in the medication when dispensing
Specifies if regulation allows for changes in the medication when dispensing.
Specifies the schedule of a medication in jurisdiction
Specifies the schedule of a medication in jurisdiction.
The maximum number of units of the medication that can be dispensed in a period
The maximum number of units of the medication that can be dispensed in a period.
The maximum number of units of the medication that can be dispensed
The maximum number of units of the medication that can be dispensed.
The period that applies to the maximum number of units
The period that applies to the maximum number of units.
Minimal definition information about the medication
Along with the link to a Medicinal Product Definition resource, this information provides common definitional elements that are needed to understand the specific medication that is being described.
Definitional resources that provide more information about this medication
Associated definitions for this medication.
Describes the form of the item. Powder; tablets; capsule.
When Medication is referenced from MedicationRequest, this is the ordered form. When Medication is referenced within MedicationDispense, this is the dispensed form. When Medication is referenced within MedicationAdministration, this is administered form.
The intended or approved route of administration
The intended or approved route of administration.
Identifies a particular constituent of interest in the product.
A reference to the resource that provides information about the ingredient.
A code that defines the type of ingredient, active, base, etc
Indication of whether this ingredient affects the therapeutic action of the drug.
Specifies how many (or how much) of the items there are in this Medication. For example, 250 mg per tablet. This is expressed as a ratio where the numerator is 250mg and the denominator is 1 tablet but can also be expressed a quantity when the denominator is assumed to be 1 tablet.
Specifies descriptive properties of the medicine
Specifies descriptive properties of the medicine, such as color, shape, imprints, etc.
Code specifying the type of characteristic of medication
A code specifying which characteristic of the medicine is being described (for example, colour, shape, imprint).
The description should be provided as a CodeableConcept, SimpleQuantity or an image. The description can be a string only when these others are not available.