Vaccine Product containing only Concepts
Overview
The Vaccine Product "only" concept is an abstract representation of the active ingredient(s) in a vaccine product. It means that the vaccine product must contain only the active ingredient(s) specified in the FSN but may also contain a modification of the active ingredient(s) specified in the FSN. The vaccine product "containing only" may be sufficient to serve as an interoperability layer or to support prescribing use cases.
For example,
|Vaccine product containing only Hepatitis B virus antigen (medicinal product)|
|Vaccine product containing only Vaccinia virus antigen (medicinal product)|
|Vaccine product containing only Hepatitis A and Hepatitis B virus antigens (medicinal product)|
|Vaccine product containing only Bordetella pertussis and Clostridium tetani and Corynebacterium diphtheriae antigens (medicinal product)|
Both vaccine product "containing" and vaccine product "containing only" concepts may be created for products that only have one active ingredient (e.g. 836374004 |Vaccine product containing Hepatitis B virus antigen (medicinal product)| and 871822003 |Vaccine product containing only Hepatitis B virus antigen (medicinal product)|). Vaccine product "containing" concepts are not created for multiple ingredient vaccine products; vaccine product "containing only" concepts are created for multiple ingredient vaccine products.
Modeling and terming for vaccines that have variable composition (e.g. influenza that may be specific to a year or hemisphere) will be addressed at a future date when use cases and requirements are better understood.
Modeling
Stated parent concept
763158003 |Medicinal product (product)
Semantic tag
(medicinal product)
Definition status
Defined
Attribute:
Has active ingredient
Range: <105590001 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances
Cardinality: 1..*
There is no technical limit on the number of Has active ingredient attributes that may be added to a concept; a practical limit may be imposed at a later date.
For content in the International Release, this attribute value should represent either the organism antigen, or the organism antigen(s), including modifications or subtypes, that are contained in a manufactured product.
Attribute: Has ingredient qualitative strength
Range: < 1149484003 |Ingredient qualitative strength (qualifier value)|
Cardinality: 0..*
Attribute: Has target population
Range: < 27821000087106 |Product target population (qualifier value)|
Cardinality: 0..1
Attribute:
Plays role
Range: <<766940004 |Role (role)|
Cardinality: 0..*
While the allowed range is broader, Vaccine product "containing" concepts should have one and only one |Plays role (attribute)| of 318331000221102 |Active immunity stimulant role (role)|.
Attribute:
Count of base of active ingredient
Range: < 260299005 |Number (qualifier value)|
Cardinality: 1..1
For content in the International Release, this attribute value should represent the total number of discrete active ingredients, excluding modifications or subtypes.
Attribute:
Count of active ingredient
Concrete Type: Integer Range: >#0.. Cardinality: 1..1
Terming
FSN
Use the following pattern for the FSN; align terming and case sensitivity with the PT for the concept that is selected as the attribute value for the |Has active ingredient (attribute)|. For multiple ingredient vaccine products, the active ingredients must be listed in alphabetical order, separated by the word "and", and the word "antigen" will be omitted. For concepts where all active ingredients are virus, the word "virus" may be omitted and added before "antigens".
Vaccine product containing only <Active ingredient PT> (medicinal product)
Vaccine product containing only <Active ingredient PT> and <Active ingredient PT> antigens (medicinal product)
Vaccine product containing only <Active ingredient PT> and <Active ingredient PT> and <Active ingredient PT> antigens (medicinal product)
For example,
Vaccine product containing only Hepatitis B virus antigen (medicinal product)
Vaccine product containing only Hepatitis A and Hepatitis B virus antigens (medicinal product)
Vaccine product containing only Bordetella pertussis and Clostridium tetani and Corynebacterium diphtheriae antigens (medicinal product)
|Has product characteristic| and |Has ingredient characteristic| attribute values should be added as appropriate.
Example of |Has product characteristic (attribute)|:
Adult vaccine product containing only Hepatitis A virus antigen (medicinal product)
Pediatric vaccine product containing only Hepatitis A virus antigen (medicinal product)
Adult vaccine product containing only acellular Bordetella pertussis and Clostridium tetani toxoid and Corynebacterium diphtheriae toxoid antigens (medicinal product)
Example of |Has ingredient characteristic (attribute):
Vaccine product containing only Clostridium tetani and low dose Corynebacterium diphtheriae antigens (medicinal product)
Vaccine product containing only Clostridium tetani and low dose Corynebacterium diphtheriae and inactivated Human poliovirus antigens (medicinal product)
Preferred Term
Use the following pattern for the PT; align terming and case significance with the PT for the concept that is selected as the attribute value for the |Has active ingredient (attribute)|. For multiple ingredient vaccine products, the active ingredients must be listed in alphabetical order, separated by the word "and", and the word "antigen" will be omitted. For concepts where all active ingredients are virus, the word "virus" may be omitted and added before "antigens".
<Active ingredient PT> only vaccine product
<Active ingredient PT> and <Active ingredient PT> antigen only vaccine product
<Active ingredient PT> and <Active ingredient PT> and <Active ingredient PT> antigen only vaccine product
For example,
Hepatitis B virus antigen only vaccine product
Hepatitis A and Hepatitis B virus antigens only vaccine product
Bordetella pertussis and Clostridium tetani and Corynebacterium diphtheriae antigens only vaccine product
|Has product characteristic| and |Has ingredient characteristic| attribute values should be added as appropriate.
Example of |Has product characteristic (attribute)|:
Hepatitis A virus antigen only adult vaccine product
Hepatitis A virus antigen only pediatric vaccine product
Adult acellular Bordetella pertussis and Clostridium tetani toxoid and Corynebacterium diphtheriae toxoid antigens only vaccine product
Example of |Has ingredient characteristic (attribute):
Clostridium tetani and low dose Corynebacterium diphtheriae antigens only vaccine product
Clostridium tetani and low dose Corynebacterium diphtheriae and inactivated Human poliovirus antigens only vaccine product
Synonym
Synonyms matching the FSN are not required.
Synonyms corresponding to the disorder that is the target of the vaccine are allowed. For multiple ingredient vaccine products, the disorders must be listed in alphabetical order and separated by the word "and". Note that these are not true synonyms; they may be updated and identified as "near-synonym" descriptions when that functionality becomes available.
For example,
Hepatitis B vaccine
Hepatitis A and Hepatitis B vaccine
Diphtheria and pertussis and tetanus vaccine
|Has product characteristic| and |Has ingredient characteristic| attribute values should be added as appropriate.
Example of |Has product characteristic (attribute)|:
Hepatitis A adult vaccine
Hepatitis A pediatric vaccine
Diphtheria toxoid and acellular pertussis and tetanus toxoid adult vaccine
Example of |Has ingredient characteristic (attribute):
Low dose diphtheria and tetanus vaccine
Low dose diphtheria and inactivated poliomyelitis and tetanus vaccine
Synonyms representing abbreviations for product (e.g., MMR, DTaP) will not be included in the International Release due to lack of internationally accepted reference source.
Exemplars
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