Name Flags Card. Type Description & Constraints CrossBorderProduct 0..* Base DRAFT: Medicinal Product in crossborder eP/eD This logical model cannot be the target of a reference medicinalProductIdentifier 0..* II MPID or national identifier packagedProductIdentifier 0..* II PCID or national pharmaceuticalProductIdentifier 0..* II PhPID atc 1..1 CD ATC code packSize 1..* PQ Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries) fullName 0..* ST Name of the product doseForm 1..1 CD Authorised dose form for eD; authorised or pharmaceutical for eP constitution 1..* Class Content of the product - defines ingredients, manufactured items, or device ingredient 0..* Class Ingredients, by default only active ingredients role 1..1 CD (might not be needed if only active ingredients are expected) substance 1..1 CD Substance strengthInfo 1..* Class Concentration or presentation strength strength 1..1 RTO Concentration or presentation strength of the precise active ingredient referenceStrenth 0..* Class Reference strength; according to the substance+strength type above referenceSubstance 1..1 CD Substance for reference strength strength 1..1 RTO Reference strength manufacturedItem 0..* Class Manufactured item if the prescription contains more than one type of items doseForm 1..1 CD Manufactured item dose form ingredient 0..* Class See Ingredient above unitOfPresentation 0..* CD Unit of presentation for the manufactured item containedQuantity 0..1 PQ Manufactured item quantity for liquids (3ml/vial) manufacturedItemQuantity 1..1 PQ Number of such manufactured items in this product (5 vials) device 0..* Class Administrative device included in the product deviceQuantity 1..1 PQ Number of such devices device 1..1 CD Device coded marketingAuthorisationHolder 0..1 ST MAH name - do we need more? routeOfAdministration 1..* CD Route of Administration - if we need it on product level Documentation for this format
DRAFT: Medicinal Product in crossborder eP/eD
Integrating the Healthcare Enterprise (IHE)
DRAFT. Crossborder eP/eD/PS medicinal product as a implementation-agnostic logical model
IHE http://www.ihe.net/Governance/#Intellectual_Property
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)
Authorised dose form for eD; authorised or pharmaceutical for eP
Content of the product - defines ingredients, manufactured items, or device
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
Additional content defined by implementations
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.
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
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 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 element that contains them
Ingredients, by default only active ingredients
(might not be needed if only active ingredients are expected)
Concentration or presentation strength of the precise active ingredient
Reference strength; according to the substance+strength type above
Manufactured item if the prescription contains more than one type of items
Unit of presentation for the manufactured item
Manufactured item quantity for liquids (3ml/vial)
Number of such manufactured items in this product (5 vials)
Administrative device included in the product
Route of Administration - if we need it on product level