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The tags hl7:manufacturedMaterial/pharm:ingredient/pharm:quantity/{numerator, denominator} are placed in the hl7 namespace but should probably be in the pharm namespace.The XML schema, usual CDAR2 models and CH-PHARM (https://art-decor.org/art-decor/decor-templates--ch-pharm-?id=1.3.6.1.4.1.19376.1.9.1.3.1&effectiveDate=dynamic) indicate so.The example is also wrong on this point.
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The inner pharm:ingredient has a cardinality of 0…*, whereas IHE PHARM PRE §6.3.4.1.3.10 indicates that:
- "the <pharm:name> element SHALL be present", so the minimal cardinality should be 1.- the maximal cardinality should also be 1, because the outer pharm:ingredient is associating a name and a code to a quantity.
The XML schema has a cardinality of 0…1 for this element (it can also be improved).
Set the cardinality of the inner pharm:ingredient to 1…1.
After discussion with Stéphane, we are proposing the following changes to the ingredient quantity:The ingredient quantity (pharm:ingredient/pharm:quantity) is represented as a ratio, it does not make sense to only have the numerator or the denominator and the IHE PRE profile does not explain how to process an incomplete ratio. The cardinalities of hl7:numerator and hl7:denominator should then be set to 1…1; if it's unknown, the whole pharm:quantity can be omitted.To improve the template, the following changes can also be made:
- comes from CH-EMED Ticket #27, CH EMED Medication Profile (MedicationStatement) (Michaela Ziegler, ahdis ag) · Issue #27 · ehealthsuisse/ch-emed (github.com) , I copy from there:
Is the package size defined as optional or required? There are currently different requirements.
- Check with IHE PHARM MTP if optionality is really 1..1 and if yes, a NullFlavor would be possible. If yes we would leave FHIR Medication.amount 0..1 for MedicationStatment but with mustSupport.from pharm PRE, line 735f: "The element SHALL be present and describes the capacity of the packaging. If the capacityQuantity is given in countable units, the unit attribute SHALL NOT be present. If the capacityQuantity is given in non-countable units, the unit attribute SHALL be present and the value SHALL be out of the UCUM code system."
- Quentin, how do you see this: "Check with IHE PHARM MTP if optionality is really 1..1 and if yes, a NullFlavor would be possible"
The <code> element of the <manufacturedMaterial> describes the medication. This may be coded using a controlled vocabulary, such as RxNorm, First Databank, or other vocabulary system for medications, and should be the code that represents the generic medication name and strength (e.g., acetaminophen and oxycodone -5/325), or just the generic medication name alone if strength is not relevant (Acetaminophen).
The medication may be either• a brand/product or• described as a generic/scientific name or• a descriptor of a magistral preparation/compound medicine
The product code (as well as the package code) is a GTIN, thus preventing the coding of active ingredients (e.g. paracetamol instead of DAFALGAN cpr 500 mg), drugs unavailable in Switzerland imported legally by pharmacies or patients (e.g. Colchicine has no GTIN but is included in guidelines from the Schweizerische Gesellshaft für Rheumatologie; prescription from a foreign physician documented in the medication plan by a swiss clinician) or magistral preparation.
Consequences for adoption and quality of care are likely, if the exchange format is constraining the ability of a clinician to document accurate information based on the situation.
Propositions:
1. Template Manufactured Material Entry Content Module : allow an ATC or a GTIN as product code. The description is updated to recommend using the GTIN code and to require it if it’s known in the case of a dispense. The packaging code remains the GTIN.
2. This change is probably definitive, we don’t foresee any reason to change it again in the future.
Drafted by HUG and CARA with the help of specialists from Pharma24 and imad
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 element SHALL be present and describes the capacity of the packaging.