Medication MRCM Extensions

Defining

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<373873005|Pharmaceutical / biologic product| OR <999000071000168104|Package (physical object)|

• 999000071000168104|Package (physical object)| – is an extension concept akin to 781405001 | Medicinal product package| as a parent for device packages.

Defines the type of container that a product is packaged in.

Most products are modelled with just the primary packaging, which allows a medicine to be physically handled. Examples include ampoule, bottle, blister pack, syringe and so on. It does not include an article intended for ingestion. For example, an oral capsule (containing granules) is not considered a container.

“Secondary” packaging is only modelled for “Packs of Packs”. These may be packs of existing package concepts, or packs of multiple containered clinical drug products:

• Xiaflex (1 x 900 microgram vial, 1 x 3 mL inert diluent vial), 1 pack
• Gardasil injection, 10 x 0.5 mL syringes
• Nexium Hp7 (14 x Nexium tablets, 28 x Amoxil capsules, 14 x Klacid tablets), 1 pack

Values are predominately from the 706437002|Container (physical object)| subhierarchy.

Where a product is provided in or intrinsically combined in a device that plays an active role in delivering the medication, this attribute specifies the type of device. For example

• Implanted drug delivery system
• Intrauterine drug delivery system

Defines the denominator unit of measure for a composite (ratio) unit of measure concept. For example 258798001|Milligram/milliliter (qualifier value)| is defined as

=== 415777001|Unit of mass concentration|:{700000071000036103|Has denominator units|=258773002|Milliliter|},{700000091000036104|Has numerator units|=258684004|milligram|}

Defines the numerator unit of measure for a composite (ratio) unit of measure concept. For example 258798001|Milligram/milliliter (qualifier value)| is defined as

=== 415777001|Unit of mass concentration|:{700000071000036103|Has denominator units|=258773002|Milliliter|},{700000091000036104|Has numerator units|=258684004|milligram|}

Concentration strength ratio value - the same as the SNOMED International 1142138002|Has concentration strength numerator value| and 1142137007|Has concentration strength denominator value| value combined into a single decimal value. This is necessarily normalised to a denominator value of 1.

Concentration strength composite unit of measure equivalent to SNOMED International 733725009|Has concentration strength numerator unit| and 733722007|Has concentration strength denominator unit| combined into a single property with a composite unit value.

The value of the total quantity of an ingredient in a product concept.

For a discrete dose form product with no concentration strength, this will be the only strength representation - or example a 500 mg paracetamol tablet is represented as having a total quantity of 500 mg of the ingredient paracetamol.

For products where a concentration and a product size is known, then the total quantity of the ingredient is also known and modelled with this property and its associated unit property. For example Aflibercept 2 mg/0.05 mL injection has a total quantity of 2 mg of aflibercept, and a concentration of 40 mg/mL of aflibercept.

As above, this is the unit of measure for the total quantity property.

Notable that this unit of measure is not a composite or ratio value, but a single scalar unit as total quantity represents a quantity, not a ratio.

Defines sub pack relationships for kit/multipack products. An outer kit pack defines 999000011000168107|Contains packaged clinical drug (attribute)| to other <781405001 |Medicinal product package (product)| concepts that it contains - i.e. that are sub packs of the kit/multipack.

This is used to define packages concepts where a product may contain two or more different packages within it - for example a blister strip and a tube of cream, or three separate packets of blister strips such as Nexium HP7.

It is also used where necessary to support clinical use cases to define blister strips within an overall package of blister strips. For example in Australia individual strips from a pack of 4 blister strips in an oral contraceptive can be dispensed separately, therefore these are modelled as a pack for each blister strip, and an overall pack containing 4 of these sub packages.

The number of different types of contained packages in a multipack product. This represents the number of unique concept identifiers that are targets of the 999000011000168107|Contains packaged clinical drug| for this multipack product.

This is used to simulate universal restriction and prevent subsumption in rare cases where two or more multipacks exist where they contain subsets of each other's contained package concepts.

For example if a multipack concept contains packages A, B and C, and another multipack contains A and B, then the latter pack will subsume the former. This attribute is designed to prevent that subsumption as each multipack product would have 3 and 2 as values for this property respectively.

Equivalent to 774160008|Contains clinical drug| but for device products in the physical object hierarchy. This allows device package product concepts to define the devices that they contain.

Equivalent to the 1142143009|Count of clinical drug type| but for device products in the physical object hierarchy. This represents the number of different unique target concepts for the package concept's 999000081000168101|Contains device (attribute)|.

Defines the number of unique ingredient substance concepts from all the contained products for a package concept.

AMT does not simulate universal restriction at the equivalent of the clinical drug level. As a result concepts at this level subsume each other.

However at the generic package level "packaged clinical drug", this causes in rare cases subsumption between the packaged clinical drug concepts when universal restriction is desired.

This resolves this subsumption in these rare cases.

Used to provide other details not formally modelled which are required as part of the product's definition. This includes details such as colours and flavours which are not formally modelled in AMT, as well as other special product details.

This has previously been used as a non-defining property in AMT of primitive concepts, as somewhat of a catch all for other defining aspects we have no way to formally model. This has been elevated to allow the concepts to be defined in terms of these values, with a view to ultimately lifting out some of these characteristics in future if there is a defined need.

Moving this to a defining property and providing existing values as suggested values in data entry (to avoid typos and arbitrary variation) has help detect and avoid duplicates.