Definition: A representation of a medicinal product supplied in a package 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 that contains within the package more than one clinical drug (type).
A combination packaged product may also be called a "component product" or a "multi-component package" as the product itself is a package that contains more than one type of component element (clinical drug) within it; it may also be known as or a "kit". Occasionally a combination packaged product is may be known as a "compound product" but term risks being confused with products that are extemporaneously compounded by a pharmacist from a formula provided by the prescriber for an individual patient (sometimes also known as "magistral products").
Examples of combination packaged products include:
- a package containing clotrimazole cutaneous cream and one or more clotrimazole vaginal tablets for treatment of vaginal candidiasis
- a package containing combinations of ethinyl estradiol and levonorgestrel tablets in different strengths and which may also include inert tablets for oral contraception (note that in this example, the components are themselves multi-ingredient items)
- a package containing amoxicillin, clarithromycin and lansoprazole for treatment of Helicobacter infection
- a package containing a budesonide dispersible tablet and the vehicle to disperse it in, to make a rectal solution for treatment of colitis
- a package containing rasburicase 1.5 mg powder for solution for injection and the diluent solution
The model specification and its relationship pattern for national extensions recommended that combination products in their entirety should be represented only as packaged products (real packaged clinical drugs and, if required as packaged clinical drugs), with their individual components represented as clinical drugs. For practical implementation of a national terminology, mechanisms such as reference sets may be used to group combination packaged medicinal products with other classes of medicinal product (such as clinical drugs) to aid users in finding and selecting these products.
The following diagram gives an example of how the packaged medicinal product classes should be used to describe combination medicinal products:
Figure 25: Diagram of options for a national extension describing combination real packaged clinical drugs
In some representations of combination medicinal products, and particularly in ISO 11615 in IDMP, a "combined dose form" concept is used in the name of the combination product (for example "pessary and cream"). Although useful as a concept to describe the dose form of a combination medicinal product using a single attribute and value, a combination dose form concept does not easily support knowing which component has which dose form. The model used here, whereby each clinical drug is described with its appropriate dose form and they are brought together into the packaged product containing the components, does not require the use of combination dose form concepts. If national extensions have a use case for describing combination medicinal products with a combined dose form, this could be supported in the same way as other optional descriptive information.
For those combination products that contain a diluent as an additional item in the package, national extensions may decide not to explicitly describe the diluent as a component, but merely to describe its presence in the text of the fully specified name for the real packaged medicinal product; alternatively the national extension may author a "diluent" Clinical Drug concept and use that as one of the components of the combination product. If the constitution of the diluent is known (e.g. water for injections, 0.9% sodium chloride solution for injection), the clinical drug for the diluent can be explicitly described. Dual chamber products containing the two components (where one is the diluent) in a single unit of presentation can be described as combination products if required.
Attributes of Combination (Real) Packaged Medicinal Products
Attributes of Combination Packaged Medicinal Products
The Packaged Clinical Drug class is related to the Clinical Drug class by a composition relationship relationship, and therefore the attribute "contains clinical drug" is used to make the association between the Packaged Clinical Drug and the Clinical Drugs it contains.
Representation of packaged medicinal products should use Clinical Drugs that have 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 | (packaged clinical drug) |
| Definition status | 900000000000073002|Sufficiently defined concept definition status (core metadata concept) |
| Relationship group | One relationship group containing one instance of each of the following attributes is required for each clinical drug that the packaged clinical drug is composed of. |
Attribute: Contains clinical drug |
The attribute value should represent the clinical drug that is contained in the packaged product |
Attribute: Count of clinical drug type |
This attribute value should represent the count of distinct Clinical Drugs present in the pack |
Attribute: Has pack size |
The attribute value should represent the amount or quantity of clinical drug present in the package (see 10.3 below) |
Attribute: Has pack size unit |
The attribute value should represent the units for the amount or quantity of clinical drug present in the package (see 10.3 below) |
Attributes of Combination Real Packaged Medicinal Products
| Semantic tag | (packaged clinical drug) |
| Definition status | 900000000000073002|Sufficiently defined concept definition status (core metadata concept) |
Attribute: Has product name |
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: Has supplier |
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) |
| Relationship group | One relationship group containing one instance of each of the following attributes is required for each clinical drug that the packaged clinical drug is composed of. |
Attribute: Contains clinical drug |
The attribute value should represent the clinical drug that is contained in the packaged product |
Attribute: Count of clinical drug type |
This attribute value should represent the count of distinct Clinical Drugs present in the pack |
Attribute: Has pack size |
The attribute value should represent the amount or quantity of clinical drug present in the package (see 10.3 below) |
Attribute: Has pack size unit |
The attribute value should represent the units for the amount or quantity of clinical drug present in the package (see 10.3 below) |
Examples
Example Combination Packaged Clinical Drug (stated view):
Figure 26: Example of a combination packaged clinical drug - stated view
Example Combination Packaged Clinical Drug (inferred view):
Figure 27: Example of a combination packaged clinical drug - inferred view
Example Combination Real Packaged Clinical Drug (stated view):
Figure 28: Example of a combination real packaged clinical drug - stated view
Example Combination Real Packaged Clinical Drug (inferred view):
Figure 29: Example of a combination real packaged clinical drug - inferred view
Use cases for Combination (Real) Packaged Medicinal Products
As for the Real Packaged Medicinal Product, the following use cases are supported by the Combination Real Packaged Clinical Drug concept type:
- The 1:1 "join" between the regulatory representation of combination medicinal products and the clinical representation of them (see below in IDMP Compatibility)
- The 1:1 "join" between the clinical representation of combination 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), although administration records may wish to identify which of the particular component clinical drugs were administered at any particular point in time administration event
- 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; some jurisdictions have different reimbursement arrangements for Combination Real Packaged Clinical Drug products
- Pharmacovigilance – especially for product defects and labelling issues
IDMP Compatibility
Since the ISO 11615 standard treats all Packaged Medicinal Products in the same manner, whether they are standard products or combination products, because the associations between the manufactured item(s) present in the package are described using recursive relationships, the Combination Real Packaged Medicinal Product is equivalent to a Packaged Medicinal Product identified by a PCID. As with the Real Packaged Medicinal Product. the Combination Real Packaged Medicinal Product is a 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 a 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.
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