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The element SHALL be present and describes the capacity of the packaging.
Because the data can be structured or represented by a text, information can be duplicated and there are no guidelines on how to reconcile that. The dosage instructions can appear three times in a CDA-CH-EMED document: as a structured data, in the non-structured entry and in the original representation.
Propositions:
1. Templates Medication Treatment Plan Item Entry Content Module , Prescription Item Entry Content Module , Dispense Item Entry Content Module : when the dosage instructions are given in structured form, the entryRelationship element for the Dosage Instructions Non Structured Entry Content Module is forbidden. Else, the latter is mandatory.
2. If the structured data and the original representation (StrucDocText or PDF) differ, the source of truth is the former because the original representation can always be regenerated by a machine. A human could change the structured data to match the narrative if needed, by replacing the document or issuing a PADV CHANGE.
Drafted by HUG and CARA.
Magistral preparations are not so common but require much more data (and implementation work) than a regular drug. If we were not to support them, some part of the specifications could be ignored for now: the form code and the ingredients are not important when the GTIN is known, as drug databases usually contain them. The compendium can be used by patients too to get such information.
1. Magistral preparations are not supported for now.
2. Template Manufactured Material Entry Content Module : the product code and name elements shall be filled and cannot contain a null flavor.
3. Template Manufactured Material Entry Content Module : the form code element is not supported, its description is updated.
4. Template Manufactured Material Entry Content Module : the ingredients are not supported, their description is updated.
1. These changes are temporary. Whether they are implemented in the aggregator only or reflected in the ArtDecor specifications is up for discussion.
The concept 1681000175101 | Package - unit of product usage (qualifier value) | is a child of 408103002 |Unit of drug administration (qualifier value)|. After analyzing the hierarchy, we concluded, that 408103002 |Unit of drug administration (qualifier value)| does not quite represent the intended meaning of the Value Set. Therefore, we will not include the suggested code and keep the UCUM code.
In IHE PCC TF2 (revision 11.0), p.187, the dose (doseQuantity) and rate (rateQuantity) are defined by their low and high bounds that are different if a range is given, or equal otherwise (<doseQuantity><low value='' unit=''/><high value='' unit=''/></doseQuantity). In IHE PHARM PRE (revision 1.9), pp.47-48, they are only defined by their value and unit (<doseQuantity value='' unit=''/>).In IHE PCC CDA (revision 2.6), p.141 and p.144, low+high is given in the definition and @value + @unit is shown in the example.The two standards disagree on the correct structure, Stéphane is investigating why PHARM is not following PCC here.In any case, the rateQuantity and doseQuantity IVL_PQ structure should be restrained to either @value + @unit or low + high. The examples that show a doseQuantity with a center are wrong for both PHARM and PCC.I guess the same correction should be applied to the template Dosage Instructions Dosage Change.-
Wait for IHE guidance on this, then constrain both rateQuantity and doseQuantity to the chosen structure.-
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At the projectathon 2020, the following problem popped up: The value set for timing event (such as before meal. After meal etc.) is not the same in FHIR and CDA-CH-EMED. But both value sets are required (by FHIR and IHE PCC, respectively)
- inquire on the international level to resolve this issue