Xpandh HDR Medication

This resource is primarily used for the identification and definition of a medication for the purposes of prescribing, dispensing, and administering a medication as well as for making statements about medication use.

Xpandh HDR Medication

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 it's narrative along with other profiles, value sets, etc.

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 manageable, 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).

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.

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.

Medication that was administered or was to be administered.

Several kinds of medication coding could be provided as:

1. The IDMP Pharmaceutical Product Identifier (PhPID), Level 1, [Substance(s)]. Example: Amoxicillin and Clavulanate Potassium; or any other equivalent coded concept;
2. The IDMP Pharmaceutical Product Identifier (PhPID), Level 2 [Substance(s) + Strength + reference strength]. Example: Amoxicillin 875 mg and Clavulanate Potassium 125 mg; or any other equivalent coded concept;
3. The IDMP Pharmaceutical Product Identifier (PhPID), Level 3 [Substance(s) + administrable dose form]. Example: Amoxicillin and Clavulanate Potassium, Oral Tablet; or any other equivalent coded concept;
4. The IDMP Pharmaceutical Product Identifier (PhPID), Level 4 [Substance(s) + strength + reference strength + administrable dose form]. Example: Amoxicillin 875 mg and clavulanate potassium 125 mg, oral tablet; or any other equivalent coded concept 5. The IDMP Medicinal Product Identifier (MPID) or any equivalent Medicinal Product Identifier. IDMP MPID uniquely identifies a Medicinal Product, reflecting (but not replacing) any other authorization numbers allocated by a regulator. MPID implies one (set of) PhPID. The MPID shall use a common segment pattern related to a Medicinal Product, which, when each segment is valued shall define a specific MPID concept.
5. The IDMP Packaged Medicinal Product Identifier (PCID) or any equivalent Packaged Medicinal Product Identifier. Uniquely identifies a Medicinal Product based on its packaging. This implies one MPID can be associated with more than one PCID, if the same Medicinal Product has more than one type of package.
6. Any other kind of code that that identifies, classifies or cluster the administered product (e.g. the medicinal product or the product class)

The value sets used for the PhPID, MPID and PCID identifiers are provisional and include only few equivalent concepts used for exemplification purposes, they will be updated with real IDMP identifiers when they will become available.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

SNOMED CT medications (Pharmaceutical / biologic product) or a code for absent/unknown medication

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.

A coded concept defining if the medication is in active use.

Describes the form of the item. Powder; tablets; capsule.

Administrable Pharmaceutical Dose Form. This code represents the form of the medication (e.g. tablet, capsule, liquid)

Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration.

It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Identifies a particular constituent of interest in the product.

The ingredients need not be a complete list. If an ingredient is not specified, this does not indicate whether an ingredient is present or absent. If an ingredient is specified it does not mean that all ingredients are specified. It is possible to specify both inactive and active ingredients.

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 manageable, 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).

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.

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.

The actual ingredient - either a substance (simple ingredient) or another medication of a medication.

The IDMP ISO 11238 standard addresses the identification and exchange of regulated information on substances. The Global Ingredient Archival System (GInAS) will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances globally consistent with this standard. Those identifiers however are yet available for concrete usage, therefore in this version of the template, SNOMED CT has been chosen as reference terminology also for the active substances. This choice will be revised based on the availability and the maturity of GInAS.

SNOMED CT drug substances

The ingredient may reference a substance (for example, amoxicillin) or another medication (for example in the case of a compounded product, Glaxal Base).

A relationship of two Quantity values - expressed as a numerator and a denominator.

The Ratio datatype should only be used to express a relationship of two numbers if the relationship cannot be suitably expressed using a Quantity and a common unit. Where the denominator value is known to be fixed to "1", Quantity should be used instead of Ratio.

This resource is primarily used for the identification and definition of a medication for the purposes of prescribing, dispensing, and administering a medication as well as for making statements about medication use.

Xpandh HDR Medication

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

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.

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 it's narrative along with other profiles, value sets, etc.

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).

A human language.

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 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, and nor can they have their own independent transaction scope.

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.

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 manageable, 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.

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 manageable, 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).

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.

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.

Business identifier for this medication.

The serial number could be included as an identifier.

Medication that was administered or was to be administered.

Several kinds of medication coding could be provided as:

1. The IDMP Pharmaceutical Product Identifier (PhPID), Level 1, [Substance(s)]. Example: Amoxicillin and Clavulanate Potassium; or any other equivalent coded concept;
2. The IDMP Pharmaceutical Product Identifier (PhPID), Level 2 [Substance(s) + Strength + reference strength]. Example: Amoxicillin 875 mg and Clavulanate Potassium 125 mg; or any other equivalent coded concept;
3. The IDMP Pharmaceutical Product Identifier (PhPID), Level 3 [Substance(s) + administrable dose form]. Example: Amoxicillin and Clavulanate Potassium, Oral Tablet; or any other equivalent coded concept;
4. The IDMP Pharmaceutical Product Identifier (PhPID), Level 4 [Substance(s) + strength + reference strength + administrable dose form]. Example: Amoxicillin 875 mg and clavulanate potassium 125 mg, oral tablet; or any other equivalent coded concept 5. The IDMP Medicinal Product Identifier (MPID) or any equivalent Medicinal Product Identifier. IDMP MPID uniquely identifies a Medicinal Product, reflecting (but not replacing) any other authorization numbers allocated by a regulator. MPID implies one (set of) PhPID. The MPID shall use a common segment pattern related to a Medicinal Product, which, when each segment is valued shall define a specific MPID concept.
5. The IDMP Packaged Medicinal Product Identifier (PCID) or any equivalent Packaged Medicinal Product Identifier. Uniquely identifies a Medicinal Product based on its packaging. This implies one MPID can be associated with more than one PCID, if the same Medicinal Product has more than one type of package.
6. Any other kind of code that that identifies, classifies or cluster the administered product (e.g. the medicinal product or the product class)

The value sets used for the PhPID, MPID and PCID identifiers are provisional and include only few equivalent concepts used for exemplification purposes, they will be updated with real IDMP identifiers when they will become available.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

SNOMED CT medications (Pharmaceutical / biologic product) or a code for absent/unknown medication

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.

A coded concept defining if the medication is in active use.

Describes the details of the manufacturer of the medication product. This is not intended to represent the distributor of a medication product.

Describes the form of the item. Powder; tablets; capsule.

Administrable Pharmaceutical Dose Form. This code represents the form of the medication (e.g. tablet, capsule, liquid)

Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration.

It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Specific amount of the drug in the packaged product. For example, when specifying a product that has the same strength (For example, Insulin glargine 100 unit per mL solution for injection), this attribute provides additional clarification of the package amount (For example, 3 mL, 10mL, etc.).

Identifies a particular constituent of interest in the product.

The ingredients need not be a complete list. If an ingredient is not specified, this does not indicate whether an ingredient is present or absent. If an ingredient is specified it does not mean that all ingredients are specified. It is possible to specify both inactive and active ingredients.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

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 manageable, 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.

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 manageable, 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).

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.

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.

The actual ingredient - either a substance (simple ingredient) or another medication of a medication.

The IDMP ISO 11238 standard addresses the identification and exchange of regulated information on substances. The Global Ingredient Archival System (GInAS) will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances globally consistent with this standard. Those identifiers however are yet available for concrete usage, therefore in this version of the template, SNOMED CT has been chosen as reference terminology also for the active substances. This choice will be revised based on the availability and the maturity of GInAS.

SNOMED CT drug substances

The ingredient may reference a substance (for example, amoxicillin) or another medication (for example in the case of a compounded product, Glaxal Base).

Indication of whether this ingredient affects the therapeutic action of the drug.

True indicates that the ingredient affects the therapeutic action of the drug (i.e. active). False indicates that the ingredient does not affect the therapeutic action of the drug (i.e. inactive).

A relationship of two Quantity values - expressed as a numerator and a denominator.

The Ratio datatype should only be used to express a relationship of two numbers if the relationship cannot be suitably expressed using a Quantity and a common unit. Where the denominator value is known to be fixed to "1", Quantity should be used instead of Ratio.

Information that only applies to packages (not products).

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

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 manageable, 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.

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 manageable, 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).

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.

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.

The assigned lot number of a batch of the specified product.

When this specific batch of product will expire.