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Definition
The 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 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 concepts, should a national extension wish to do this.
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- 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 table describes the attributes for real packaged clinical drugs (RPCDs) that contain one type of clinical drug only. That is, they are NOT combination (multi-component or kit) products.
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| Semantic tag | (real packaged clinical drug) | |||||
|---|---|---|---|---|---|---|
| Definition status |
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:
| Range
Cardinality
Note
| |||||
Role Group (although for all packages other than combination products it is 1..1) | Attribute:
| Range
Cardinality
Note
| ||||
Attribute:
| Range
Cardinality
Note
| |||||
Attribute:
| Range
Cardinality
Note
| |||||
Example Diagrams
Some examples of real packaged clinical drugs are shown below.
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Gliffy Diagram size 900 name RPCD Template Gliffy pagePin 2
Figure 3442: Template for a simple real packaged clinical drug
Example: simple real packaged clinical drug: stated view followed by the inferred view
Figure 3543: Example of a real packaged clinical drug - stated view
Figure 3644: Example of a real packaged clinical drug - inferred view
Optional Additional Information
As with the real clinical drugs, national extensions may require additional information to be associated with real packaged clinical drugs. This may include characteristics of the packaged product that can be described within the SNOMED CT structure using attributes and values, managed alongside the SNOMED CT structure (e.g. in a reference set) and/or relationships between identification systems should be managed in cross maps.
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In jurisdictions where repackaging and/or "parallel importing" are authorised, a national extension may wish to consider having a relationship between the repackaged or parallel imported real packaged clinical drug and the real clinical drug supplied by the original manufacturer, if that is present within the jurisdiction.
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).
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