Definition

The :  A representation of a medicinal product as it is supplied in a package by a by a single organisation (manufacturer or supplier) in a single jurisdiction under a single name (which may be a trade or brand name) for placement into the supply chain.  It is a subtype of and real world equivalent to the Packaged Clinical Drug (PCD ) class described above.   

Use cases

The following use cases are supported by the Real Packaged Clinical Drug concept class:

• Describing medication process activities: prescribing, dispensing, administration and medication statements; of these, dispensing and administration will use this concept when it is available to clearly state which actual packaged product (or content from it) was used/supplied to the patient (with batch/lot and expiry information if required, either manually or by automatic identification and data capture (AIDC) - for example scanning the bar code on the package
• Compliance monitoring, using pack size information to calculate whether a patient is following the dosage instructions correctly (how quickly a repeat supply of a package of medication is required)
• Anti-counterfeiting: in support of initiatives such as the Falsified Medicines Directive (see amended Directive 2001/83/EC) using AIDC and which requires scanning of medicines at the point of supply (to the patient)
• Reimbursement: national or local systems may set pricing or eligibility against actual packaged products
• Pharmacovigilance – especially for product defects and labelling issues
• The association between the clinical representation of medicinal products and their representation in the supply chain for supply chain management

Discussion

The real packaged clinical drug represents the product as its packaged products that are marketed into the supply chain in any jurisdiction. A small number of regulatory authorities license medicines at this level, with each package having a separate authorisation, others allow all the different package sizes to be authorised in by the single authorisation of the RCD.  Real packaged clinical drugs must be represented using the closed world view; they contain only the content as stated in the logical definition.  Since this class represents real product packages Since this class represents real products as authorised in a jurisdiction, description of additional non-defining information, such as excipient substances (flavours, preservatives, sweeteners etc.) or details about the product name parts or product authorisation information and product availability information can be attached to Real Packaged Clinical Drug real packaged clinical drug concepts, should a national extension wish to do this.  For further details, see section 7.3 above

The real clinical packaged drug is the marketed (therefore "real") instantiation in any one country of the abstract packaged clinical drug in the international edition and as such, real packaged clinical drugs classify as child concepts of the packaged clinical drug, if the national extension has authored these concepts..

As described above in the PCD section, this national extension model does not represent intermediate layers of packaging; it represents only the outer package used in the supply chain.  

National extensions that require the Real Packaged Clinical Drug class should real packaged clinical drug concepts can define their RPCD concepts using Clinical Drug concepts from the international release or national extension as available.   real clinical drug concepts from their national extension or, if only real packaged clinical drug concepts are authored without RCDs, using clinical drugs from the international edition or national extension.  However, if real packaged clinical drug concepts are authored without RCDs, there is little opportunity for grouping of concepts on the right-hand/real side of the model; although real packaged clinical drug concepts with the same product name and supplier would have the required attributes to group them together, there is no parent grouper concept to place them under, so the grouping would be hard to show.  If real packaged clinical drug concepts without RCDs and without PCDs, then the stated and inferred views will be equivalent, there will be no grouping concepts for the real packaged clinical drug concepts to be associated with.

Existing national terminology equivalents:

• Actual Medicinal Product Pack (AMPP) in NHS dm+d and Belgian SAM
• Trade Product Pack (TPP) in in AMT/NZ ULM
• Semantic Branded Drug Pack (BPCK) in RxNorm
• the "Product" class in the Dutch Z-Index

Attributes

...

The following is described for Real Packaged Clinical Drugs table describes the attributes for real packaged clinical drugs (RPCDs) that contain one Clinical Drug only, that is type of clinical drug only. That is, they are NOT combination (multi-component or kit) products. See Section 11 below for Combination Products..

The real packaged clinical drugs The Real Packaged Clinical Drug class is related to the Real Clinical Drug real clinical drug class by a composition relationship relationship, and therefore the attribute "contains real clinical drug" is used to make the association between the Real Packaged Clinical Drug and the Real Clinical Drugs the real packaged clinical drug and the (real) clinical drug it contains. 

Representation of real packaged medicinal products should use presentation strength (either only or in addition to concentration strength) whenever possible in order to be able to accurately describe the number of presentation units present in the package. The exception will be for continuous products such as semi-solid dose forms of creams, gels etc. where strength pattern 3a is used (see international Editorial Guidelines).   In all cases the pack size and pack size unit should relate to the denominator unit of the strength.

Semantic tag		(real packaged clinical drug)
Definition status		Scg expression 900000000000073002 |Sufficiently defined concept definition status (core metadata concept) Note: This can only be the case if extensions author concepts to represent real clinical drugs and/or product names and manufacturer / supplier organisations
Attribute:  Scg expression 1142143009 |Count of clinical drug type|		Range INT (integer) Cardinality 1..1 Note This attribute provides the number (count) of distinct clinical drug (concepts) present in the package.  For all non-combination packages, this value should be "one"
Attribute:  Scg expression 774158006 |Has product name|

Range:

(to be used if xxx is valued with a clinical drug concept rather than a real clinical drug concept)		Range Scg expression < 774167006 |Product name (product name)| Extensions must author product name concepts within their extension using the root

of

of  Concept t 774167006 |Product name (product name)|

 from

from the Qualifier hierarchy Cardinality

:

1..1 Notes The attribute value should represent the (authorised) product name; this may (or may not) be a trademarked name, and is often referred to as the "brand name" (see section

10.1

below)
Attribute:  Scg expression 774159003 |Has supplier|

Range:

(to be used if xxx is valued with a clinical drug concept rather than a real clinical drug concept)		Range Scg expression < 774164004 |Supplier (supplier)| Extensions must author concepts to value supplier organisation information within their extension using the root

of

of  Concept t 774164004 |Supplier (supplier)|

from

from the Qualifier hierarchy Cardinality

:

1..1 Notes The attribute value should represent the holder of the marketing authorisation or authorisation for supply; this may or may not be the organisation responsible for the actual manufacture of the product (see section

10.2 below

below)
Role Group  [1..*] (although for all packages other than combination products it is 1..1)	Attribute: Scg expression 774160008 |Contains clinical drug|	Range Scg expression < 763158003 |Medicinal product (product)|

- descendants only (see Note 1 above in the PCD section)

Cardinality

:

1..1

The attribute value should represent

Note This attribute value represents the clinical drug that is contained in the packaged product It is currently not possible to explicitly specify an expression to describe the range of clinical drugs - either

a CD or an RCD

Attribute:

Count of clinical drug type

• Range: 260299005|Number (qualifier value) - descendants only
• Cardinality: 1..1

This attribute value should represent the count of distinct Clinical Drugs present in the pack

Attribute:

Has pack size

• Range: 260299005|Number (qualifier value) - descendants only
• Cardinality: 1..1 (per relationship group)

The attribute value should represent

from the international edition or real clinical drugs from a national extension - to populate this attribute, since (for example) a range cannot currently recognise a set of concepts with a particular semantic tag - in this case "(clinical drug)" or "(real clinical drug)".  This may be possible in the future; alternatively the range expression might be expressed as: "all products with a dose form, precise ingredient substance and basis of strength substance". For the interim, the range is specified as the descendants of the root medicinal product concept: 763158003 |Medicinal product (product)|.
	Attribute:  Scg expression 1142142004 |Has pack size|	Range INT (integer) Cardinality 1..1 Note This attribute represents the amount or quantity of clinical drug present

in the package (see section 10.3 below)

Attribute:

Has pack size unit

• Range: 767524001 | Unit of measure (qualifier value) - descendants only (see Note 2 above in the PCD section)
• Cardinality: 1..1 (per relationship group)

The attribute value should represent the units for the amount or quantity of clinical drug present in the package (see 10.3 below)

Examples

Stated template view:

Image Removed

Figure 20: Template for a real packaged clinical drug

Example (stated view):

Image Removed

774163005 |Has pack size unit|

Example Diagrams

Some examples of real packaged clinical drugs are shown below.

Stated template view:

Figure 34: Template for a simple real packaged clinical drug

Example: simple real packaged clinical drug described using real clinical drug: stated view followed by the inferred view

Image Added

Figure 35: Example of a real packaged clinical drug described using a real clinical drug - stated view

Image Added

Figure 36Figure 21: Example of a real packaged clinical drug - stated drug described using a real clinical drug - inferred view

Example

...

Image Removed

: simple real packaged clinical drug described using clinical drug: stated view followed by the inferred view

xxx

Figure 37: Example of a real packaged clinical drug described using a clinical drug - stated view

xxxx

Figure 38Figure 22: Example of a real packaged clinical drug drug described using a clinical drug - inferred view

Optional

...

Additional Information

The following information may be additionally used to describe the Real Packaged Clinical Drug concept in a national extension. With the exception of container information, the attribute concepts and values to populate these, if this data is to be held in a structured form, would need to be authored into the extension using reference sets.

• Package/container type (e.g. bottle, box, jar, tube) (see 10.6 below); some use cases may also require information about sterile wrapping of some medicinal product packaging
• License information - for those jurisdictions that license at a package level rather than at the Real Clinical Drug levelLicense holding organisationreal clinical drug level
  
  • License identification ("authorisation number")
  • Licensing class and/or legal status of supply
• Usage information (prescribability within a particular jurisdictional context) including legal status and licensed indicationsstatus 
• Reimbursement information
• Administration device supplied in the package (e.g. medicine spoon, vaginal applicator, applicator brush for cutaneous liquid products)
  

Use cases supported by Real Packaged Clinical Drug

The following use cases are supported by the Real Packaged Clinical Drug concept class:

• The 1:1 "join" between the regulatory representation of medicinal products and the clinical representation of them (see below in IDMP Compatibility)
• The 1:1 "join" between the clinical representation of medicinal products and their representation in the supply chain and particularly for support of AIDC – automatic data capture identification. See also Section 12 - Cross maps
• Describing medication process activities: prescribing, dispensing, administration and medication statements; of these, dispensing and administration will use this concept when it is available to clearly state which actual packaged product (or content from it) was used/supplied to the patient (with batch/lot and expiry information if required, either manually or by AIDC)
• Compliance monitoring, using pack size information
• Anti-counterfeiting: in support of initiatives such as the Falsified Medicines Directive (see amended Directive 2001/83/EC) which will use AIDC and which will require scanning of medicines at the point of supply (to the patient)
• Reimbursement: national or local systems may set pricing or eligibility against actual packaged products
• Pharmacovigilance – especially for product defects and labelling issues
  

IDMP Compatibility

This concept as defined is equivalent to the Packaged Medicinal Product of ISO 11615, which in that standard is identified by a PCID. As the representation of the "real world product" authorised for sale and/or supply that exists for all jurisdictions and which is marketed into the supply chain for use, it is the concept that should form the 1:1 join between representation in the regulatory domain (IDMP) and representation in the clinical domain (SNOMED CT and national medicinal product terminologies), even if some national medicinal product terminologies choose not to represent it, but only an abstraction of it (i.e. the Real Clinical Drug class of concepts).