# Module MEDICATION #
## Core Dataset Module Medication ##
| Note | Under construction!|
|---|---|
||This Implementation Guide represents the current working version of the module 'Medication'. The respective version published for productive use can be found on [this page of the Medical Informatics Initiative](https://www.medizininformatik-initiative.de/Kerndatensatz/Modul_Medikation/IGMIIKDSModulMedikation.html).|
The present specification describes the FHIR representation of the core data set module 'Medication' of the Medical Informatics Initiative.
The use cases of the module, as well as the associated FHIR profiles and terminology resources, are described below in their binding form.
|Publication|-|
|---|---|
|Date|09.04.2021|
|Version|1.0.7|
|Status| Active|
|Realm| DE|
### Table of Contents
* IG MII CDS module Medication
* Description of the module
* Context in overall project/ References to other modules
* References
* Use cases/ information model
- Descriptions of scenarios for the application of the modules
- Data sets incl. descriptions
- UML
* Technical implementation
- FHIR profiles
- Terminologies
### Impressum
This guideline was created within the framework of the Medical Informatics Initiative (MII) and is subject to the voting process of the Interoperability Forum and the technical committees of HL7 Germany registered association per governance process.
### Contact
* Martin Boeker, Med. Fakultät und Universitätsklinikum der Universität Freiburg
* Julian Saß, Berlin Institute of Health (BIH)
* Karoline Buckow, TMF – Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V.
* Sylvia Thun, Berlin Institute of Health (BIH), Charité Universitätsmedizin
Questions about this publication can be asked at any time at [chat.fhir.org](https://chat.fhir.org/login/) in the stream 'german / mi-initiative'.
Comments and criticism are always welcome in the form of ‘Issues’ in the Simplifier project.
**Authors (alphabetical order)**
* Alexander Zautke (HL7 e.V.)
* Caroline Bönisch (HiGHmed)
* Danny Ammon (SMITH)
* Editha Räuscher(TMF e.V.)
* Heinrich Lautenbacher (DIFUTURE)
* Julian Saß (HiGHmed)
* Karoline Buckow (TMF e.V.)
* Martin Boeker (MIRACUM)
* Matthias Löbe (SMITH)
* Sebastian Semler (TMF e.V.)
* Susann Wrobel (SMITH)
* Susanne Zabka (MIRACUM)
* Sylvia Thun (HL7 e.V.)
* Thomas Ganslandt (MIRACUM)
### Copyright notice, use information
Copyright © 2019: TMF e. V., Charlottenstraße 42, 10117 Berlin
The content of this specification is public. There are no restrictions on subsequent use or publication rights.
For usage rights of the underlying FHIR technology, see the FHIR Base Specification.
Some code systems used are published and maintained by other organizations. The copyright of the respective publisher is valid.
### Disclaimer
* The content of this document is public. Please note that parts of this document are based on FHIR Version R4, which is copyrighted by HL7 International.
* Although this publication has been prepared with the greatest care, the authors cannot accept any liability for direct or indirect damage that might arise from the content of this specification.
## Description of the module medication ##
The MEDICATION module contains data elements for the documentation of drug regulation and administration. It is part of the basic modules of the core data set of MII.
The following types of drug administration documentation can be distinguished in a medication entry:
1. medication in hospital (mainly partial/ partly inpatient)
2. discharge medication
3. outpatient medication
4. self-medication
5. medication in the context of clinical studies
6. medication documentation for the national medication plan
Specifications on medication can range from the mere documentation of the administration of a preparation in a treatment case to a detailed structured recording of individual administrations with coding of active ingredient, dosage form, route of administration and dose according to internationally established standards. Fully structured medication documentation also regularly takes place in intensive care units in patient data management system, and in some cases also in regular inpatient care as part of systems for visit documentation or dedicated prescription systems. In addition, case-related documentation often takes place in hospital pharmacy systems, e.g. in the context of in-house production of infusion solutions or batch documentation.
Data on types 2 and 3 (discharge and outpatient medication) should be available via medication plan data. For type 4 (self-medication), no patient-related documentation can currently be foreseen (conceivable via patient portals). Study medication (type 5) is often recorded in electronic data capture systems in a structured manner but without semantic storage (except for the coding of side effects in MedDRA as a mandatory component of the pharmacovigilance reporting chain). Limitations may arise here, if necessary, due to the blinding of study drugs.
The active ingredient of a medication should be available as a minimum.
In a further expansion stage, the following data elements should also be available (depending on the source data):
- trade names of the preparations
- dose and unit of measure
- dose regimen
- dosage form
- place and route of application
The data records in the module are structured in such a way that the information can be specified with different levels of detail according to the existing initial data (for example, only specification of the active ingredient vs. all specifications of the preparation including active ingredients, or only description of the dosage vs. structured information on the dosage).
## Context in overall project/ References to other modules ##
Medication prescription is a core process of routine care and occurs at all MII-clinics. The proportion of digitally documented prescriptions varies greatly between the sites in terms of the degree of structuring, the populations covered, and drugs. An overall view of the availability of structured medication data at the consortium sites is currently not available. This circumstance is taken into account by the proposed staggered provision - depending on the available data.
Medication data are of central importance for a variety of issues, e.g. in pharmacovigilance or also as inclusion/exclusion criteria for study collectives. In the audit queries compiled by the Data Sharing AG, they are listed in the proposals of e.g. the SMITH consortium. In addition, the MEDICATION module is required for the cross-consortium Use Case POLAR - Polypharmacy.
### Reference to Person module ###
Medication data is assigned to a patient using references from the MEDICATION module to the [PERSON](https://simplifier.net/guide/medizininformatikinitiative-modulperson-implementationguide/igmiikdsmodulperson) module.
### Reference to Procedure module ###
The ingestion, administration or arrangement of a medicament may relate to a procedure being performed, e.g., the administration of a contrast medium prior to a radiological diagnosis. In this context, the MEDICATION module specifies, among other things, the medication, dose and the time of administration. The [PROCEDURE](https://simplifier.net/guide/medizininformatikinitiative-modulprozeduren-implementationguide/igmiikdsmodulprozedur) module is used to define the procedure. The data structures of this module make it possible to express the reference to the procedure via references from MEDICATION to PROCEDURE.
The relationship between these two modules is also relevant for use cases related to OPS. For billing purposes, selected expensive drugs are recorded on a case-by-case basis in hospitals using Chapter 6 of the OPS catalog. In this case, the clinical documentation of the drug therapy described in this module can be linked to the procedure classification according to OPS.
### Reference to Diagnosis module ###
The MEDICATION module contains links to [DIAGNOSIS](https://simplifier.net/guide/medizininformatikinitiative-moduldiagnosen-implementationguide/igmiikdsmoduldiagnose) module, which enable to identify the underlying disease as the cause (reason for treatment) for drug therapy.
## References ##
Specifications drawn up for the [KBV Patient-specific Medication Plan V2.6](https://www.kbv.de/media/sp/Medikationsplan_Anlage3.pdf) or [Medication Plan PLUS](https://simplifier.net/medikationsplanplus) and for the [International Patient Summary](https://international-patient-summary.net) were taken into account when creating the medication documentation data set.
For terminology related to medication (drugs, substances, etc.), the ISO standards [Identification of Medicinal Products (IDMP)](https://www.ema.europa.eu/en/human-regulatory/overview/data-medicines-iso-idmp-standards-overview) should be considered.
The specification for the Medication Plan PLUS is used to model the data set and FHIR profiles. However, it is not possible to adapt this specification to the medication plan. This is mainly due to the fact that the Medication Plan PLUS is based on the FHIR version STU3, while the MII works with FHIR R4. Some elements in the data structure of FHIR resources differ fundamentally between the versions, e.g. the specification of an effect size within a medication resource.
## Use Cases/ Information Model ##
### Description of the scenarios for the application of the modules ###
Specific examples:
**Information on medication during inpatient treatment with corresponding documentation of the OPS:**
Example: A patient with breast cancer is treated with chemotherapy during her inpatient stay. The attending physician prescribes therapy with doxorubicin (Caelyx), once every four weeks. The prescription of the active substance or drug is documented.
In accordance with the instructions for the use of the prescribed drug, the dose of 85 mg of doxorubicin in 5% glucose solution is prepared for the patient to form a solution for infusion. The infusion solution, its individual components and the duration of administration are recorded.
After administration of the infusion, the OPS code 6-002.87 (pegylated liposomal doxorubicin, parenteral 80 mg to less than 90 mg) is coded.
### Datasets including descriptions
The medication module includes data records on the medication itself (drug, formulation, active ingredient), on patient use (duration of intake, dosage) and meta information (status, references, author, date, etc.).
The official and approved version of the information model for the medication module can be found on ArtDecor. To standardize the representation, the information model was also mapped as a FHIR Logical Model:
(**INSERT LINK/SNAP**)
It should be noted that the logical model aims purely at mapping the data elements and their description. The data types and cardinalities used are not to be regarded as mandatory. This is finally determined by the FHIR profiles. For each element within the logical model there is a 1: 1 mapping to an element of a specific FHIR resource.
| Logical record | Description |
| -------- | -------- |
| MedicationEntry | Documents the prescription, administration or medication plan for one or more drugs |
| MedicationEntry.Identifier | Identifier of the medication entry |
| MedicationEntry.Status | Process status of the described medication status |
| MedicationEntry.Medicine/ActiveIngredient/Formulation | The medication that is being prepared, planned, or administered. It can be a finished medicinal product or a formulation. It is also possible to specify only the active ingredient. |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.MedicinalProduct | This means both a composite product ID (PhPID) such as the central pharmaceutical number (PZN) and product identifiers (GTIN). |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.MedicinalProduct.MedicationName | Medicinal product name or trade name. Designation of a finished medicinal product according to the Information Center for Medicinal Specialties (Informationsstelle für Arzneispezialitäten- IFA) or in-house catalog. |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.MedicinalProduct.MedicationCode | Identification of a finished medicinal product by its code, e.g. Pharmaceutical central number (Pharmazentralnummer- PZN), IDMP Pharmaceutical Product Identifiers (PhPID), IDMP Medicinal Product Identifier (MPID), Pharmacy Product Number (PPN) |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.MedicinalProduct.MedicationPotency | Potency according to trade name |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.Formulation | Formulation entry |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.FormulationFreeTextLine | Description of the Formulation |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.ActiveIngredient | Active ingredient |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.ActiveIngredient.ActiveIngredientName (general) | Name of an active substance that is taken from an active substance classification. In most cases WHO-INN (international non-proprietary name of the World Health Organization) in the English version. Note: In Germany there are sometimes spelling variants or other names, for substances without WHO INN registered substance name. |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.ActiveIngredient.ActiveIngredientCode | Code of an active substance that is taken from an active substance classification, e.g. ASK, UNII. |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.ActiveIngredient.ActiveIngredientName (active) | "Active ingredient" of the drug product according to approval (see e.g. AMIS database), can be the name of the active ingredient (general) or a "derivative" of the substance (e.g. salt, ester, etc. name, then e.g. Modified INNs (INNMs) |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.ActiveIngredient.ActiveIngredientCode (active) | Code of an active substance that is taken from an active substance classification e.g. ASK, UNII. This is the "active ingredient" of the medicinal product according to the approval (cf. eg AMIS database), it can be the active ingredient code (general) or the code for a "derivative" of the substance (eg salt, ester etc.) |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.ActiveIngredient.Amount/Potency | Potency, amount of the active substance per dose unit according to the dosage form (1 tablet, 1 ampoule, 1 mL, etc.) |
| MedicationEntry.Medicine/ActiveIngredient/Formulation.DosageForm | Dosage form according to EDQM |
| MedicationEntry.DurationOfIntake | Duration of intake for an ordered, planned or performed medication administration. In the case of single doze, the duration can also be point-by-point (zero). |
| MedicationEntry.DurationOfIntake.Starting.Point.Of.Intake | Starting point of intake |
| MedicationEntry.DurationOfIntake.End.Point.Of.Intake | End date or time of ingestion, up to which day or time including the drug should be taken |
| MedicationEntry.DurationOfIntake.DurationOfTheIntake | Duration (interval in days, weeks, months, etc.) of the intake |
| MedicationEntry.Dosage-FreeText | Dosage (free text): there can be several textual entries for the dosage. |
| MedicationEntry.Dosage-FreeText.FreeText | Doage in free text |
| MedicationEntry.Dosage-Structured | Dosage (structured) |
| MedicationEntry.Dosage-Structured.Sequence | Sequence number of the dose entry. If there are several entries for dosing, the sequence (priority) of the entries is determined. |
| MedicationEntry.Dosage-Structured.TimeIndication | Time of ingestion as part of the dosing schedule. Detailed examples can be found at http://wiki.hl7.de/index.php?title=cdamedp:Dosierbeispiele - Not available for allocation because no future dosing scheme has to be specified. |
| MedicationEntry.Dosage-Structured.TimeIndication.TimePoint | Exact time at which medication should be given |
| MedicationEntry.Dosage-Structured.TimeIndication.Daily-related Repetition | Specifies a periodic time interval during which repetition is based on activities of daily living or other important events that are time-dependent, but not entirely determined by time |
| MedicationEntry.Dosage-Structured.TimeIndication.Daily-related Repetition.TimeOfTheDay | e.g. in morning, at noon, in evening, at night |
| MedicationEntry.Dosage-Structured.TimeIndication.Daily-related Repetition.Offset | Offset to part of the day e.g. 30 minutes before |
| MedicationEntry.Dosage-Structured.TimeIndication.PeriodicInterval | A time interval that repeats itself periodically. Periodic intervals have two properties, phase and period. The phase indicates the "type of interval" that is repeated every period. The repetition interval (periodic interval sequence) indicates the duration of each occurrence or the time between the occurrences (period) or the anchor time (start time) at which the periodic interval sequence begins (phase). |
| MedicationEntry.Dosage-Structured.TimeIndication.PeriodicInterval.Phase | Anchor time (start time) at which the periodic interval sequence begins |
| MedicationEntry.Dosage-Structured.TimeIndication.PeriodicInterval.Period | Duration of each occurrence or the time between occurrences |
| MedicationEntry.Dosage-Structured.IntakeAtNeed | Intake of the drug when needed |
| MedicationEntry.Dosage-Structured.TypeOfAdministration | Pharmaceutical application is broken down into three properties: type of administration , route of administration and place of administration |
| MedicationEntry.Dosage-Structured.Dose | Can be specified as a quantity (SimpleQuantity, Range) or as a quantity per unit of time (Ratio). Maximum dosages within a unit of time or maximum lifetime dose are possibly important. |
| MedicationEntry.Note | Information about the drug |
| MedicationEntry.ReasonForTreatment | The reason for treatment can be a problem, symptom or diagnosis (condition). |
| MedicationEntry.RelationToRegulation | Depending on the requirements, different references to the case, treatment plan, etc. can be made here. |
| MedicationEntry.RelationToDuty | Relation to duty |
| MedicationEntry.DateOfEntry | Date of the documentation entry |
| MedicationEntry.Author/informant of the entry | Responsible health professional who created the process or provided information about the process. |
| MedicationEntry.Author/informant of the entry.OrganizationsName | Name of the organization |
### UML
As a more abstract version of an information model and to better illustrate the relationships between the technical concepts, a UML class diagram was created based on the specifications in ART-DECOR. Concepts depicted as groups in ART-DECOR are modeled as separate classes, which here have associations with one another. This logical model is only used to map the data elements and their descriptions. The data types and cardinalities used are not to be regarded as mandatory. This is finally determined by the FHIR profiles. The assignment of the FHIR elements to the ART-DECOR specification is described in the comment field in the ART-DECOR.
(**INSERT GRAPH**)
## Technical Implementation
### FHIR-Profile
The work of the core dataset specifications is based, where possible, on international standards and terminology. In particular, the [International Patient Summary](http://hl7.org/fhir/uv/ips/history.html) should be emphasized here. An adaptation to the general conditions of the German health care system takes place through the use of the [German basic profiles](https://simplifier.net/guide/basisprofil-de-r4/home) of HL7 Germany.
All elements of the core data set, adapted to the details and requirements for the use cases of the medical informatics initiative, are described below in the form of FHIR StructureDefinitions. The need to adapt the FHIR profiles is explained in text form below the respective profiles.
| Note | Mandatory / must-support elements |
| -------- | -------- |
| | For elements that are mandatory or marked as must-support, reference is made at this point to the corresponding rules of the [IPS](https://build.fhir.org/ig/HL7/fhir-ips/design.html#must-support), which also apply to this ImplementationGuide. |
#### Medication
Contains the medication that is being prepared, planned, or administered. It can be a finished medicinal product or a formulation. It is also possible to specify only the active ingredient. The specification of at least one active ingredient is required.
Canonical: https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/Medication
(**INSERT LINK/SNAP**)
| FHIR-Element | Explanation |
| -------- | -------- |
| Medication.ID | Must support, but optional |
| Medication.meta | Must support, but optional |
| Medication.identifier | Business-Identifier of the medication |
| Medication.code | The code from an external code system for a medicine/product or an active ingredient class. |
| Medication.status | Indicator of whether the medication is currently being used or whether it can be prescribed. |
| Medication.manufacturer | Manufacturer |
| Medication.form | Dosage form |
| Medication.amount | Potency according to trade name |
| Medication.ingredient | Active ingredient |
| Medication.batch | Information about the medicine such as expiration date |
| FHIR-Element | Logical record |
| -------- | -------- |
| Medication | Medication.MedicationEntry.Medicine/ActiveIngredient/Formulation |
| Medication.code | Medication.MedicationEntry.Medicine/ActiveIngredient/Formulation.MedicinalProduct |
| Medication.code.coding:Pharmazentralnummer.display | Medication.MedicationEntry.Medicine/ActiveIngredient/Formulation.MedicinalProduct.MedicationName |
| Medication.code.coding:Pharmazentralnummer.code | Medication.MedicationEntry.Medicine/ActiveIngredient/Formulation.MedicinalProduct.MedicationCode |
| Medication.code.coding:atcClass.display | Medication.MedicationEntry.Medicine/ActiveIngredient/Formulation.MedicinalProduct.MedicationName |
| Medication.code.coding:atcClass.code | Medication.MedicationEntry.Medicine/ActiveIngredient/Formulation.MedicinalProduct.MedicationCode |
| Medication.amount | Medication.MedicationEntry.Medicine/ActiveIngredient/Formulation.MedicinalProduct.MedicationPotency |
| Medication.code.text | Medication.MedicationEntry.Medicine/ActiveIngredient/Formulation.Formulation.FreeTextLine |
| Medication.ingredient | Medication.MedicationEntry.Medicine/ActiveIngredient/Formulation.ActiveIngredient |
| Medication.ingredient.strength | Medication.MedicationEntry.Medicine/ActiveIngredient/Formulation.ActiveIngredient.Amount/Potency |
| Medication.form | Medication.MedicationEntry.Medicine/ActiveIngredient/Formulation.DosageForm |
#### Examples
**Example of a medication resource for a finished medicinal product with details of a central pharmaceutical number, dosage form, active ingredient and strength**:
```
{
"resourceType": "Medication",
"id": "ExampleMedicationASS100",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/Medication"
]
},
"code": {
"coding": [
{
"system": "http://fhir.de/CodeSystem/ifa/pzn",
"code": "06312077",
"display": "ASS 100 - 1a Pharma TAH Tabletten"
},
{
"system": "http://fhir.de/CodeSystem/dimdi/atc",
"code": "B01AC06",
"display": "acetylsalicylic acid"
}
]
},
"form": {
"coding": [
{
"system": "http://standardterms.edqm.eu",
"code": "10219000",
"display": "Tablet"
}
]
},
"ingredient": [
{
"itemCodeableConcept": {
"coding": [
{
"system": "http://fhir.de/CodeSystem/ask",
"code": "00002",
"display": "Acetylsalicylsäure"
}
]
},
"strength": {
"numerator": {
"value": 100,
"system": "http://unitsofmeasure.org",
"code": "mg",
"unit": "milligram"
},
"denominator": {
"value": 1,
"system": "http://standardterms.edqm.eu",
"code": "10219000",
"unit": "Tablet"
}
}
}
]
}
```
**Example of a medication resource for an infusion solution with details of the dosage form, active ingredient and strength, as well as other components in the form of a reference to a separate medication resource for the glucose solution. In this case, Medication.code only contains the text element**:
```
{
"resourceType": "Medication",
"id": "ExampleMedicationRezeptur",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/Medication"
]
},
"code": {
"text": "Infusion bestehend aus 85mg Doxorubicin aufgeloest zur Verabreichung in 250ml 5-%iger (50 mg/ml) Glucose-Infusionsloesung"
},
"form": {
"coding": [
{
"code": "11210000",
"display": "Solution for infusion",
"system": "http://standardterms.edqm.eu"
}
]
},
"ingredient": [
{
"isActive": true,
"itemCodeableConcept": {
"coding": [
{
"code": "L01DB01",
"display": "Doxorubicin",
"system": "http://fhir.de/CodeSystem/dimdi/atc"
}
]
},
"strength": {
"denominator": {
"code": "mL",
"system": "http://unitsofmeasure.org",
"unit": "milliliter",
"value": 250
},
"numerator": {
"code": "mg",
"system": "http://unitsofmeasure.org",
"unit": "mg",
"value": 85
}
}
},
{
"isActive": true,
"itemReference": {
"reference": "Medication/7f27cb8d-940b-43fd-ab8b-fee5b7a9b060"
}
}
],
"status": "active"
}
```
**The medication resource referenced in the previous example**:
```
{
"resourceType": "Medication",
"id": "ExampleMedicationGlucoseloesung",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/Medication"
]
},
"code": {
"coding": [
{
"code": "03705422",
"display": "Glucose 5% B.braun Ecoflac Plus",
"system": "http://fhir.de/CodeSystem/ifa/pzn"
},
{
"code": "V06DC01",
"display": "Glucose",
"system": "http://fhir.de/CodeSystem/dimdi/atc"
},
{
"code": "V06DC01",
"display": "glucose",
"system": "http://www.whocc.no/atc"
}
]
},
"form": {
"coding": [
{
"code": "11210000",
"display": "Solution for infusion",
"system": "http://standardterms.edqm.eu"
}
]
},
"ingredient": [
{
"isActive": true,
"itemCodeableConcept": {
"coding": [
{
"code": "12829",
"display": "Glucose",
"system": "http://fhir.de/CodeSystem/ask"
},
{
"code": "50-99-7",
"display": "Glucose",
"system": "urn:oid:2.16.840.1.113883.6.61"
},
{
"code": "5SL0G7R0OK",
"display": "ANHYDROUS DEXTROSE",
"system": "http://fdasis.nlm.nih.gov"
},
{
"code": "67079006",
"display": "Glucose (substance)",
"system": "http://snomed.info/sct"
}
]
},
"strength": {
"denominator": {
"code": "ml",
"system": "http://unitsofmeasure.org",
"unit": "ml",
"value": 1000
},
"numerator": {
"code": "g",
"system": "http://unitsofmeasure.org",
"unit": "g",
"value": 50
}
}
},
{
"isActive": false,
"itemCodeableConcept": {
"coding": [
{
"code": "00343",
"display": "Wasser für Injektionszwecke",
"system": "http://fhir.de/CodeSystem/ask"
},
{
"code": "7732-18-5",
"display": "WATER",
"system": "urn:oid:2.16.840.1.113883.6.61"
},
{
"code": "059QF0KO0R",
"display": "WATER",
"system": "http://fdasis.nlm.nih.gov"
},
{
"code": "11713004",
"display": "Water (substance)",
"system": "http://snomed.info/sct"
}
]
}
}
],
"status": "active"
}
```
#### Extensions
For active ingredients, the option should be given to differentiate between the exact active ingredient (which can be a salt, ester, etc.) and the pure active ingredient when calculating the dose information, and to indicate whether the calculation is based on the derivative (more rarely) or the pure one / "general" substance (mostly). For this reason, an extension was defined which can be specified in addition to the active ingredient coding. This extension refers to a ValueSet with codes for:
* IN (ingredient),
* PIN (precise ingredient ),
* or MIN (multiple ingredients)
Also see [Terminologies](https://simplifier.net/guide/MedizininformatikInitiative-ModulMedikation-ImplementationGuide/Terminologien)
(**INSERT LINK**)
Another extension makes it possible to map references between the active ingredients. Thus, an active ingredient that is classified as a "precise" active ingredient can be clearly assigned to a "general" active ingredient. This allows, for example, the conversion that "10 mg bisoprolol hemifumarate" corresponds to "8.49 mg bisoprolol".
(**INSERT LINK**)
#### Medication Administration
This Medication Administration resource is used to track drug administrations including oral medication, self-administration, injections, intravenous doses etc.
Canonical: https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/MedicationAdministration
(**INSERT LINK/SNAP**)
| FHIR-Element | Explanation |
| -------- | -------- |
| MedicationAdministration.id | Must support, but optional |
| MedicationAdministration.meta | Must support, but optional |
| MedicationAdministration.identifier | Business Identifier of Medication Administration |
| MedicationAdministration.instantiates | External protocol or guideline to be followed |
| MedicationAdministration.partOf | Reference to the event in which the administration takes place |
| MedicationAdministration.status | Status of the administration, e.g. in progress or completed |
| MedicationAdministration.statusReason | Indication of why medication was not administered. |
| MedicationAdministration.category | Indicator for administration in the inpatient or outpatient sector |
| MedicationAdministration.medication[x] | Reference to the drug to be administered |
| MedicationAdministration.subject | Recipient of the medication |
| MedicationAdministration.context | Relation to the event in which the administration takes place |
| MedicationAdministration.supportingInformation | Further information on administration |
| MedicationAdministration.effective[x] | Time or period of administration |
| MedicationAdministration.performer | Performing person |
| MedicationAdministration.reasonCode | Reason for administration |
| MedicationAdministration.reasonReference | Reference to FHIR resource as the reason behind the administration |
| MedicationAdministration.request | Reference to request |
| MedicationAdministration.device | Device that is used for administration |
| MedicationAdministration.note | Administration note |
| MedicationAdministration.dosage | Details of how the medication was administered |
| MedicationAdministration.eventHistory | Reference to events that may be of interest for the administration |
| FHIR-Element | Logical record |
| -------- | -------- |
| MedicationAdministration.identifier | Medication.MedicationEntry.ID |
| MedicationAdministration.status | Medication.MedicationEntry.Status |
| MedicationAdministration.medication[x] | Medication.MedicationEntry.Medication/ActiveSubstance/Formulation |
| MedicationAdministration.effective[x] | Medication.MedicationEntry.DurationOfIntake |
| MedicationAdministration.dosage.text | Medication.MedicationEntry.DosageFreeText |
| MedicationAdministration.dosage | Medication.MedicationEntry.DosageStructured |
| MedicationAdministration.note | Medication.MedicationEntry.Note |
| MedicationAdministration.reasonCode | Medication.MedicationEntry.ReasonForTreatment |
| MedicationAdministration.reasonReference | Medication.MedicationEntry.ReasonForTreatment |
| MedicationAdmnistration.request | Medication.MedicationEntry.RelationToRegulation |
| MedicationAdministration.dateAsserted | Medication.MedicationEntry.DateOfEntry |
Example
**Example of a MedicationAdministration resource with information on the application route and dosage**
```
{
"resourceType": "MedicationAdministration",
"id": "ExampleMedicationAdministration",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/MedicationAdministration"
]
},
"dosage": {
"dose": {
"code": "mg",
"system": "http://unitsofmeasure.org",
"unit": "mg",
"value": 85
},
"rateRatio": {
"denominator": {
"code": "h",
"system": "http://unitsofmeasure.org",
"unit": "hour",
"value": 1
},
"numerator": {
"code": "mL",
"system": "http://unitsofmeasure.org",
"unit": "milliliter",
"value": 250
}
},
"route": {
"coding": [
{
"code": "20045000",
"display": "Intravenous use",
"system": "http://standardterms.edqm.eu"
}
]
}
},
"effectivePeriod": {
"end": "2020-01-06T11:20:00.000+00:00",
"start": "2020-01-06T10:20:00.000+00:00"
},
"medicationReference": {
"reference": "Medication/8b67be5c-d83a-417c-864e-85fb5e9f4d52"
},
"status": "completed",
"subject": {
"reference": "Patient/688f4605-71c0-48ef-a2d8-cd03a6d3dee1"
}
}
```
#### Medication statement
The Medication Statement documents the prescription of a drug or the consumption by a patient. MedicationStatement can indicate that the patient is currently taking, has taken in the past, or will take a medication in the future. These can be prescription drugs as well as OTC drugs that a patient takes on his own responsibility.
The main difference between the actual administration of a medication (Medication Administration) and the Medication Statement is that the medication administration has complete administration information and is based on the actual information of the person who administered the medication. In comparison, MedicationStatement has the character of a medication plan, for example. It is not clear whether the patient actually took or was given these medicines.
Canonical: https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/MedicationStatement
(**INSERT LINK/SNAP**)
| FHIR-Element | Explanation |
| -------- | -------- |
| MedicationStatement.id | Must-support, but optional |
| MedicationStatement.meta | Must support, but optional |
| MedicationStatement.identifier | Business identifier of the medication entry |
| MedicationStatement.basedOn | Background information on how the medication was entered |
| MedicationStatement.partOf | Specification if the medication entry is part of a procedure, for example |
| MedicationStatement.status | Indication of whether the medication entry is open or closed |
| MedicationStatement.statusReason | Reason for the status |
| MedicationStatement.category | Is it an inpatient, outpatient or patient-reported entry |
| MedicationStatement.medication[x] | Reference to medication |
| MedicationStatement.subject | Recipient of the medication |
| MedicationStatement.context | Reference to event such as case or treatment episode |
| MedicationStatement.effective[x] | Point in time or period |
| MedicationStatement.dateAsserted | Time of the establishment of the entry |
| MedicationStatement.informationSource | Source of information |
| MedicationStatement.derivedFrom | Reference to Related Events |
| MedicationStatement.reasonCode | Reason of entry |
| MedicationStatement.reasonReference | Reference to further information that is the cause of the entry |
| MedicationStatement.note | Note |
| MedicationStatement.dosage | Details of administration such as dose or route of administration |
| FHIR-Element | Logical record |
| -------- | -------- |
| MedicationStatement.identifier | Medication.MedicationEntry.ID |
| MedicationStatement.status | Medication.MedicationEntry.Status |
| MedicationStatement.medication[x] | Medication.MedicationEntry.Medication/ActiveSubstance/Formulation |
| MedicationStatement.effective[x] | Medication.MedicationEntry.DurationOfIntake |
| MedicationStatement.dosage.text | Medication.MedicationEntry.DosageFreeText |
| MedicationStatement.dosage | Medication.MedicationEntry.DosageStructured |
| MedicationStatement.note | Medication.MedicationEntry.Note |
| MedicationStatement.reasonCode | Medication.MedicationEntry.ReasonForTreatment |
| MedicationStatement.reasonReference | Medication.MedicationEntry.ReasonForTreatment |
| MedicationStatement.basedOn | Medication.MedicationEntry.RelationToRegulation |
| MedicationStatement.partOf | Medication.MedicationEntry.RelationToDuty |
| MedicationStatement.dateAsserted | Medication.MedicationEntry.DateOfEntry |
| MedicationStatement.informationSource | Medication.MedicationEntry.Author/InformantOfTheEntry |
Examples
Example of a MedicationStatement resource describing that a patient takes a medication once every four weeks. The information on medication can be found in a medication resource that is referenced.
```
{
"resourceType": "MedicationStatement",
"id": "ExampleMedicationStatementCaelyx",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/MedicationStatement"
]
},
"status": "active",
"medicationReference": {
"reference": "Medication/bbc6c5a1-62df-44fa-a907-d066476ac7f9"
},
"subject": {
"reference": "Patient/688f4605-71c0-48ef-a2d8-cd03a6d3dee1"
},
"effectiveDateTime": "2020-01-02T09:30:00+01:00",
"dosage": [
{
"text": "Doxorubicin (Caelyx) 50 mg je Quadratmeter Koerperoberflaeche alle vier Wochen per intravenoeser Tropfinfusion",
"timing": {
"repeat": {
"frequency": 1,
"period": 4,
"periodUnit": "wk"
}
},
"route": {
"coding": [
{
"system": "http://standardterms.edqm.eu",
"code": "20045000",
"display": "Intravenous use"
}
]
}
}
]
}
```
**MedicationStatement example with an offset**:
```
{
"resourceType": "MedicationStatement",
"id": "ExampleMedicationStatementOffset",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/MedicationStatement"
]
},
"dosage": [
{
"route": {
"coding": [
{
"code": "20053000",
"display": "Oral use",
"system": "http://standardterms.edqm.eu"
}
]
},
"text": "L-Thyroxin 125 Mikrogramm täglich eine Tablette oral eine halbe Stunde vor dem Früchstück",
"timing": {
"repeat": {
"frequency": 1,
"offset": 30,
"period": 1,
"periodUnit": "d",
"when": [
"ACM"
]
}
}
}
],
"effectiveDateTime": "2020-05-27T17:57:00+01:00",
"medicationCodeableConcept": {
"coding": [
{
"code": "02532793",
"display": "L-THYROXIN 125 Henning Tabletten",
"system": "http://fhir.de/CodeSystem/ifa/pzn"
}
]
},
"status": "active",
"subject": {
"reference": "Patient/example"
}
}
```
**MedicationStatement example for periodic interval:**
```
{
"resourceType": "MedicationStatement",
"id": "ExampleMedicationStatementPeriodischesIntervall",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/MedicationStatement"
]
},
"dosage": [
{
"route": {
"coding": [
{
"code": "20053000",
"display": "Oral use",
"system": "http://standardterms.edqm.eu"
}
]
},
"text": "Marcumar jeden Montag-, Mittwoch- und Freitagabend",
"timing": {
"repeat": {
"dayOfWeek": [
"mon",
"wed",
"fri"
],
"frequency": 1,
"period": 1,
"periodUnit": "d",
"when": [
"CV"
]
}
}
}
],
"effectiveDateTime": "2020-05-27T17:57:00+01:00",
"medicationCodeableConcept": {
"coding": [
{
"code": "05541338",
"display": "Marcumar",
"system": "http://fhir.de/CodeSystem/ifa/pzn"
}
]
},
"status": "active",
"subject": {
"reference": "Patient/example"
}
}
```
Example of a MedicationStatement resource derived from the OPS code * 6-007.nm *: The MedicationStatement contains the references to patient, procedure and medication. The OPS code is mapped via the [module procedure] (https://simplifier.net/medizininformatikinitiative-modulprozeduren). The reference to the procedure resource is made via the MedicationStatement.partOf element. For the sake of completeness, in addition to the MedicationStatement resource, the referenced Medication and Procedure resources are also listed below.
```
{
"resourceType": "MedicationStatement",
"id": "ExampleMedicationStatementIntravenousUse",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/MedicationStatement"
]
},
"dosage": [
{
"doseAndRate": [
{
"doseRange": {
"high": {
"code": "mg",
"system": "http://unitsofmeasure.org",
"unit": "milligram",
"value": 2600
},
"low": {
"code": "mg",
"system": "http://unitsofmeasure.org",
"unit": "milligram",
"value": 2400
}
}
}
],
"route": {
"coding": [
{
"code": "20045000",
"display": "Intravenous use",
"system": "http://standardterms.edqm.eu"
}
]
},
"text": "Parenterale Applikation von 2.400 mg bis unter 2.600 mg Thiotepa"
}
],
"effectiveDateTime": "2018-05-26",
"medicationReference": {
"reference": "Medication/8b455da3-931e-481f-abfe-da291cbba54e"
},
"partOf": [
{
"reference": "Procedure/ce33960c-02c9-4888-9448-9a8b7906e369"
}
],
"status": "completed",
"subject": {
"reference": "Patient/fe1f7a9a-f33e-4dbe-9ee5-246e2d3baada"
}
}
```
**The medication resource referenced from the previous MedicationStatement**:
```
{
> "resourceType": "Medication",
> "id": "ExampleMedicationThiotepa",
> "meta": {
> "profile": [
> "https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/Medication"
> ]
> },
> "ingredient": [
> {
> "extension": [
> {
> "url": "https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/wirkstofftyp",
> "valueCoding": {
> "code": "IN",
> "display": "ingredient",
> "system": "https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/CodeSystem/wirkstofftyp"
> }
> }
> ],
> "itemCodeableConcept": {
> "coding": [
> {
> "code": "905Z5W3GKH",
> "display": "thiotepa",
> "system": "http://fdasis.nlm.nih.gov"
> },
> {
> "code": "7962",
> "display": "thiotepa",
> "system": "http://fhir.de/CodeSystem/ask"
> },
> {
> "code": "52-24-4",
> "display": "thiotepa",
> "system": "urn:oid:2.16.840.1.113883.6.61"
> }
> ]
> }
> }
> ]
> }
```
**The procedure resource, which contains the OPS code**:
```
{
"resourceType": "Procedure",
"id": "ExampleProcedure",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/core/modul-prozedur/StructureDefinition/Procedure"
]
},
"category": {
"coding": [
{
"code": "182832007",
"display": "Procedure related to management of drug administration (procedure)",
"system": "http://snomed.info/sct"
}
]
},
"code": {
"coding": [
{
"code": "6-007.nm",
"display": "Parenterale Applikation von 2.400 mg bis unter 2.600 mg Thiotepa",
"system": "http://fhir.de/CodeSystem/dimdi/ops",
"version": "2020"
}
]
},
"performedDateTime": "2018-05-26",
"status": "completed",
"subject": {
"reference": "Patient/fe1f7a9a-f33e-4dbe-9ee5-246e2d3baada"
}
}
```
### Terminologies
| Note | |
| -------- | -------- |
|  | In addition to international terminology, the MEDICATION module also defines its own code systems. It should be noted that all CodeSystems also contain an implicit ValueSet, which can be found in the respective FHIR CodeSystem resource. |
Whenever possible, terminology and unique codes should be used that conform to international standards. For medicinal products and dosage information, these are the ISO standards for the [Identification of Medicinal Products (IDMP)](https://www.ema.europa.eu/en/human-regulatory/overview/data-medicines-iso-idmp-standards-overview), which are mainly implemented in the regulatory context. The following are suggested as IDMP-compliant terminology and unique identification codes:
**Active substances**
The suggested unique identifiers (code) for active substances are:
* Substance codes from the German BfArM (ASK) catalog of medicinal substances. It has to be clarified how this ASK no. is made publicly available via URI / URL via BfArM / DIMDI or ABDATA (§31b SGB V). https://www.dimdi.de/dynamic/de/arzneimittel/arzneimittel-recherchieren/amis/datenbankinformation-amis-oeffentlicher-teil-arzneimittel/
* [Unique Ingredient Identifier (UNII)](https://en.wikipedia.org/wiki/Unique_Ingredient_Identifier) of the US Substance Registration System. This is not available in Germany.
* Unique key, the CAS Registry Number, from the Chemical Abstracts Service Database (CAS).
* SNOMED CT codes from the substance hierarchy. These codes are not included in the German databases (PharmNet / AMIS and ABDATA).
* The registered substance names can be used to name the substances, which are usually, but not always, the WHO-INNs (International Non-proprietary Names). In the MII, the German spelling should be used, which in some cases differs slightly from the English version.
* It is recommended to use [ATC codes](https://www.whocc.no/atc_ddd_index/) (Anatomical-Therapeutic-Chemical Classification) only with reservation for the coding of active substances, as it is not possible to clearly assign an ATC code to a substance.
In the area of active substances, it should be possible to differentiate between the exact active substance (which can be a salt, ester, etc.) and the pure active substance when calculating the dose information, and to indicate whether the calculation is based on the derivative (less often) or the "pure" / "general (normalized)" substance (mostly) is based. For this reason, an extension was defined that can be attached to the active ingredient coding. This extension refers to a ValueSet, which contains the following codes:
* IN (ingredient - general active substance),
* PIN (precise ingredient - exact active substance),
* or MIN (multiple ingredients - Combination code for several active substances).
This code system https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/CodeSystem/wirkstofftyp defines the following codes:
| **CodeDisplay** | **Definition** |
|-------------|-------------|
| IN ingredient | The name of the substance. |
| PIN precise ingredient | The name of the substance expressed precisely as a salt or ester of the ingredient. |
| MIN multiple ingredients | The name of the substances in a combination product. |
Additional Language Displays
#### Medicinal products
For the identification of medicinal products it is suggested:
* the [central pharmaceutical number (PZN)](https://de.wikipedia.org/wiki/Pharmazentralnummer) These numbers must be made accessible via a publicly available URL / URI. (§31b SGB V)
* [Pharmaceutical Product Identifier (PHPID)](https://www.fda.gov/industry/fda-resources-data-standards/pharmaceutical-product-identification), which are part of the ISO-IDMP standards, but are currently not available.
#### Combined drug packs
In the case of combined drug packs, the drug consists of several components that have different active ingredients, dosage forms, dosages or dosage units, two variants are currently permitted in the presentation on the medication plan and in the carrier:
> - *Variant 1: a common PZN* The combined finished medicinal product is coded in the medication plan with a PZN so that this medicinal product can be displayed as a medication entry. The dosage should then be entered as free text by the user in order to take the two components into account. In addition, a bound additional line can provide space for further explanations.
> - *Variant 2: two or more PZN*s The individual components of the finished medicinal product are coded by two or more PZNs in the medication plan. In this case, the combined finished medicinal product is to be presented by subdividing it into corresponding, consecutive medication entries. Structurally, it is currently not possible to establish a connection between medication entries that would indicate that they belong together as a combined finished medicinal product. If necessary, the user can create this connection with suitable texts - possibly with a separate subheading.
#### Administration type and dosage form
The following should be used for the type of application and dosage form:
* Standard terminology of the [EDQM (European Directorate for the Quality of Medicines and Health Care)](https://standardterms.edqm.eu/) "Routes and Methods of Administration" and "Pharmaceutical Dose Forms".
* Alternatively, the name of a dosage form can be given in the form of the IFA code. Requirements according to the KBV medication plan. Key table: https://applications.kbv.de/S_BMP_DARREICHUNGSFORM_V1.02.xhtml
The standard terminology of the EDQM should preferably be used here, as they conform to the ISO standards for "Identification of Medicinal Products".
| URI | Source | Comment |OID (for non-FHIR systems)|
| -------- | -------- | -------- |--------|
| http://fhir.de/CodeSystem/ifa/pzn | [Central pharmaceutical number (PZN)](https://de.wikipedia.org/wiki/Pharmazentralnummer) | | 1.2.276.0.76.4.6|
| http://fhir.de/CodeSystem/dimdi/atc | [ATC codes](https://www.whocc.no/atc_ddd_index/) (Anatomical-Therapeutic-Chemical Classification) | German version ||
| http://fhir.de/CodeSystem/ask | Drug catalog number | |1.2.276.0.76.5.308|
| http://fdasis.nlm.nih.gov | UNII [Unique Ingredient Identifier](https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory) | [Using UNII with FHIR](http://hl7.org/fhir/unii.html) |2.16.840.1.113883.4.9|
| urn:oid:2.16.840.1.113883.6.61 | [CAS registry system](https://www.cas.org/cas-data/cas-registry) | unique numerical identifier of a substance in the CAS Registry system |2.16.840.1.113883.6.61|
| http://standardterms.edqm.eu | EDQM [Standard Terms](https://standardterms.edqm.eu/) | |0.4.0.127.0.16.1.1.2.1|
| http://snomed.info/sct | SNOMED CT [snomed.org](https://www.snomed.org/) | [Using SNOMED CT with FHIR](http://hl7.org/fhir/snomedct.html) |2.16.840.1.113883.6.96|
| http://unitsofmeasure.org | UCUM [unitsofmeasure.org](https://ucum.org/trac) | [Using UCUM with FHIR](http://hl7.org/fhir/ucum.html) |2.16.840.1.113883.6.8|
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