Real Packaged Clinical Drug (RPCD)

Definition:  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.   

Since this class represents real products as authorised in a jurisdiction, description of additional information, such as excipient substances (flavours, preservatives, sweeteners etc.) or details about the product name parts or product authorisation information can be attached to Real Packaged Clinical Drug concepts, should a national extension wish to do this.  For further details, see section 7.3 above.

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 define their RPCD concepts using Clinical Drug concepts from the international release or national extension as available.   

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 of Real Packaged Clinical Drug

The following is described for Real Packaged Clinical Drugs that contain one 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 Drug class is related to the 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 it contains. 

Representation of packaged medicinal products should use presentation strength whenever possible. 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.

Examples

Stated template view:

Figure 20: Template for a real packaged clinical drug

Example (stated view):

Figure 21: Example of a real packaged clinical drug - stated view

Example (inferred view):

Figure 22: Example of a real packaged 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 level
  • License holding organisation
  • 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 indications
• 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).