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Groupers based on "Dose form intended site" that can be sufficiently defined may be included in the 763158003 |Medicinal product (product)| hierarchy.
For example,
Product manufactured as oral dose form (product)
Product manufactured as parenteral dose form (product)
Product manufactured as <Manufactured dose form FSN> (product)
For example,
Product manufactured as oral dose form (product)
Product manufactured as parenteral dose form (product)
Align naming and case significance with the FSN for the concepts that are selected as the attribute value, excluding the semantic tag.
Product manufactured as <Manufactured dose form PT>
For example,
Product manufactured as oral dose form
Product manufactured as parenteral dose form
Align naming and case significance with the PT for the concept that is selected as the attribute value.
Synonyms are not generally created.
Stated parent
763158003 |Medicinal product (product)
Semantic tag
(product)
Definition status
Defined
Attribute:
Has manufactured dose form
Range: <<736542009
Groupers comprised of two or more existing disposition and/or structure groupers that can be sufficiently defined may be included in the |Medicinal product| hierarchy. High-level grouper concepts support the organization of the combined groupers based on disposition and/or structure:
766779001 |Medicinal product categorized by disposition (product)|
763760008 |Medicinal product categorized by structure (product)|
For some medicinal products, their clinical usefulness is related to the combination of both their structure and their disposition; it is the structure that produces the disposition.
For example,
Clemastine is a substance whose anti-histamine behavior is based upon its structure being ethanolamine derived.
Since structure-based grouping and disposition are characteristics of the active ingredient substance(s) present in the medicinal product, combined 'structure and disposition grouping' concepts are inferred by the classifier to medicinal products and include all their child concepts (medicinal product form and clinical drug concepts), although in a browser, the inferred grouping concepts are shown on the proximal concept only (the "medicinal product containing" concept).
Figure: Medicinal Product showing membership of a structure-and-disposition grouping (ethanolamine derivative and histamine receptor antagonist)
Use the following pattern for the FSN if the combined grouper is comprised of two dispositions or two structural groupers; align naming and case significance with the PT as described in Groupers Based on Structure and Disposition, respectively. The active ingredients must be in alphabetical order and separated by the word “and”.
Product containing <Active ingredient PT> and <Active ingredient PT> (product)
For example,
Product containing norepinephrine reuptake inhibitor and serotonin reuptake inhibitor (product)
Use the following pattern for the FSN if the combined grouper is comprised of one disposition and one structural grouper; align naming and case significance with the FSN for the concept with the FSN as described in Groupers Based on Structure and Disposition, respectively.
Product containing <Structural grouper active ingredient PT> and <Disposition grouper active ingredient PT> (product)
For example,
Product containing piperazine derivative and histamine receptor antagonist (product)
Use the following pattern for the FSN if the combined grouper is comprised of two dispositions or two structural groupers; align naming and case significance with the PT as described in Groupers Based on Structure and Disposition, respectively. The active ingredients must be in alphabetical order and separated by the word “and”.
Product containing <Active ingredient PT> and <Active ingredient PT> (product)
For example,
Product containing norepinephrine reuptake inhibitor and serotonin reuptake inhibitor (product)
Use the following pattern for the FSN if the combined grouper is comprised of one disposition and one structural grouper; align naming and case significance with the FSN for the concept with the FSN as described in Groupers Based on Structure and Disposition, respectively.
Product containing <Structural grouper active ingredient PT> and <Disposition grouper active ingredient PT> (product)
For example,
Product containing piperazine derivative and histamine receptor antagonist (product)
Synonyms matching the FSN are not required.
The |Product containing only x (medicinal product)| concepts are abstract representations of the active ingredient(s) for a medicinal product. The medicinal product contains only the active ingredient(s) specified in the FSN but may also contain a modification of the active ingredient(s) specified in the FSN.
For example,
Product containing only axitinib (medicinal product)
Product containing only abacavir and lamivudine (medicinal product)
Stated parent concept
763158003 |Medicinal product (product)
Semantic tag
(product)
Definition status
Defined
Attribute:
Has active ingredient
Range: <<105590001
There are several use cases that the Medicinal Product containing only concept can support:
In national extensions; where it is useful for various clinical purposes, such as prescribing scenarios (so called "abstract" or "non-product-based" prescribing) and in medication history and in medication profiles
Internationally and nationally in decision support and in protocols and treatment guidelines
Internationally and nationally for interoperability of patient medication information such as in patient summaries
Internationally and nationally for recording adverse events and/or sensitivities to medication, particularly for multi-ingredient preparations where there will be no appropriate single substance concept and it is not possible to say which particular active ingredient is responsible for the issue
In pharmacovigilance, especially for description of concomitant medications where less information may be available (see below in IDMP Compatibility)
In analysis and research
As a supporting attribute for other concepts elsewhere in SNOMED CT
The Medicinal Product containing only concept might be directly compatible with the ISO 11616 concept of a level 1 Pharmaceutical Product (PhPID_SUB_L1), where the "active substance set" comprises the definition of this concept. However, the granularity of description of substance for the PhP1 is not completely clear, but may be more granular than that used for the Medicinal Product containing only concept. The Medicinal Product containing only concept is defined by "only and exclusively the active ingredient substance(s) that it contains but regardless of any modification of those active ingredient substance(s)" whereas the PhP1 will likely use a substance description that includes any modification, including when there are multiple modifications (e.g., a solvated salt modification).
In IDMP, for products using adjuvants, it is probable that the adjuvant would be included as part of the "active substance set" and its role explicitly identified. For example, aluminium hydroxide is used as an adjuvant in several vaccine products (e.g., hepatitis A, hepatitis B) in addition to the antigen itself to enhance the immune response; it is not an active ingredient per se, and it is not an inactive ingredient; it is explicitly an "adjuvant". However, this type of detail of the implementation of the abstract model of ISO 11616 remains unclear, and in its first implementation, the modeling of adjuvants in the vaccine content in the SNOMED CT international edition has not been finalized.
Use the following pattern for the FSN and PT. Align naming and case sensitivity with the FSN for the concept that is selected as the attribute value.
For multiple ingredient drug products, the active ingredients must be in alphabetical order and separated by the word “and”.
Product containing only <Active ingredient FSN> (medicinal product)
Product containing only <Active ingredient FSN> and <Active ingredient FSN> (medicinal product)
Product containing only <Active ingredient FSN> and <Active ingredient FSN> and <Active ingredient FSN> (medicinal product)
For example,
Product containing only axitinib (medicinal product)
Product containing only abacavir and lamivudine (medicinal product)
Product containing only abacavir and lamivudine and zidovudine (medicinal product)
<Active ingredient PT> only product
<Active ingredient PT> and <Active ingredient PT> only product
<Active ingredient PT> and <Active ingredient PT> and <Active ingredient PT> only product
For example,
Axitinib only product
Abacavir and lamivudine only product
Abacavir and lamivudine and zidovudine only product
Synonyms matching the FSN are not required.
Stated parent
763158003 |Medicinal product (product)
Semantic tag
(medicinal product)
Definition status
Defined
Attribute:
127489000 Has active ingredient (attribute)
774826003 |Product containing only benzylpenicillin (medicinal product)| is primitive and is a proximal primitive parent to 786119008 |Product containing only benzylpenicillin in oral dose form (medicinal product form)| plus 2 subtype clinical drugs, and 778490002 |Product containing only benzylpenicillin in parenteral dose form (medicinal product form)| plus 3 subtype clinical drugs. 774826003 |Product containing only benzylpenicillin (medicinal product)| is intentionally not modeled as a supertype of 1234764000 |Product containing only benzathine benzylpenicillin (medicinal product)| and 1234762001 |Product containing only procaine benzylpenicillin (medicinal product)| because clinically the child concepts are not considered as specializations of the supertype, but as sibling concepts.
Range: <105590001
Attribute:
1142139005 Count of base of active ingredient (attribute)
Concrete Type: Integer
Range: >#0..
Cardinality: 1..1
Prolonged-release transdermal patch clinical drug concepts modeled previously using concentration strength normalized to per 1 hour will use presentation strength based on the labeled total amount delivered over time (e.g., /16, /24 [usual manufacturer-documented period], /72 hours), in alignment with product SPCs and international editorial policy.
Opioid patches (e.g., fentanyl, buprenorphine) are an exception and must retain the /1 hour expression, consistent with manufacturer documentation and regulatory standards. This reflects patient safety requirements for these strong, controlled substances. These concepts must also be modeled using presentation strength.
Presentation strength is to be used for all prolonged-release transdermal patch concepts.
The |Has unit of presentation (attribute)| with a value of |Patch (unit of presentation)| is added to all prolonged-release transdermal patch concepts.
Units will reflect the duration, strength, and units as specified in the SPC.
A high-level grouper concept supports the organization of the medicinal product concepts based on disposition: 766779001 |Medicinal product categorized by disposition (product)|
Disposition is a behavior that something can exhibit (or participate in) given the appropriate context in which to do this. For example, a person may be "disposed" (or pre-disposed) to fidget in their seat when in a stressful situation such as an interview. For medicinal products, disposition behavior can be thought of as "mechanism of action" of its active ingredient substance(s): the behavior that the active ingredient substance(s) in the product exhibit when used clinically. Disposition (mechanism of action) is distinguishable from therapeutic role, which is context dependent: for example, the mechanism of action of timolol is as a beta-adrenoceptor antagonist; this action can be used therapeutically to reduce hypertension when administered in a product given orally, or to treat glaucoma when administered in a product intended to be given ophthalmically. Medicinal products can be collected together into groups based on the disposition of their active ingredient substance(s).
Disposition is a characteristic of the active ingredient substance(s) present in the Medicinal Product, therefore disposition grouping concepts are assigned (inferred) by the classifier to medicinal products and to all their descendant concepts (medicinal product form and clinical drug concepts), although in a browser such as the DailyBuild, the inferred grouping concepts will be shown on the proximal concept only (the "medicinal product containing" concept).
Figure: Inferred view of Medicinal product showing membership of a disposition grouping (carbonic anydrase inhibitor)
This section applies to grouper concepts representing a single disposition; groupers comprised of multiple dispositions are described in .
See also
Product containing <Active ingredient PT> (product)
For example,
Product containing histamine receptor antagonist (product)
Product containing histamine H2 receptor antagonist (product)
Align naming and case sensitivity with the PT for the concept that is selected as the 726542003 |Has disposition (attribute)| attribute value for the substance concept used as the attribute value for the 127489000 |Has active ingredient (attribute)|.
<Active ingredient PT>-containing product
For example,
Histamine receptor antagonist-containing product
Histamine H2 receptor antagonist-containing product
Align naming and case significance with the PT for the concept that is selected as the 726542003 |Has disposition (attribute)| attribute value for the substance concept used as the attribute value for the 127489000 |Has active ingredient (attribute)|.
Synonyms matching the FSN are not required.
Stated parent concept
763158003 |Medicinal product (product)
Semantic tag
(product)
Definition status
Defined
Attribute:
Has active ingredient
Range: <<105590001
The |Product containing only x in y dose form (medicinal product form)| is an abstract representation of the active ingredient(s) and dose form intended site for a medicinal product. The medicinal 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. This is the closed world view.
For example,
Product containing only axitinib in oral dose form (medicinal product form)
Product containing only abacavir and lamivudine in oral dose form (medicinal product form)
In other words, "MPF only" represents a medicinal product based on description of only and exclusively the active ingredient(s) it contains and on the (generalized) intended site of use for the product.
For example,
"Product containing only amoxicillin in oral dose form (medicinal product form)" represents products that must contain only amoxicillin (be it amoxicillin sodium or amoxicillin trihydrate), with no other active ingredients in manufactured dose forms such as oral suspension, oral capsule (any type), oral tablet (any type).
Use the following pattern for the FSN and PT. Align naming and case sensitivity with the FSN for the concepts that are selected as the attribute value.
For multiple ingredient drug products, the active ingredients must be in alphabetical order and separated by the word “and”.
Product containing only <Active ingredient FSN> in <Manufactured dose form FSN> (medicinal product form)
Product containing only <Active ingredient FSN> and <Active ingredient> in <Manufactured dose form FSN>(medicinal product form)
Product containing only <Active ingredient FSN> and <Active ingredient FSN> and <Active ingredient FSN> in <Manufactured dose form FSN> (medicinal product form)
For example,
Product containing only axitinib in oral dose form (medicinal product form)
Product containing only abacavir and lamivudine in oral dose form (medicinal product form)
Product containing only abacavir and lamivudine and zidovudine in oral dose form (medicinal product form)
Creation of MPF-only concepts for all possible combinations of active ingredients contained in multiple ingredient products is not recommended at this time (no specific use case has been identified). For example, a product containing three active ingredients would only require creation of one MPF-only concept. If any of the active ingredients is available as a single ingredient product, or as part of another multiple ingredient concept, then appropriate concepts would be created for those products.
<Active ingredient PT> only product in <Manufactured dose form PT>
<Active ingredient PT>- and <Active ingredient PT> only product in <Manufactured dose form PT>
<Active ingredient PT>- and <Active ingredient PT>- and <Active ingredient PT> only product in <Manufactured dose form PT>
For example,
Axitinib only product in oral dose form
Abacavir and lamivudine only product in oral dose form
Abacavir and lamivudine and zidovudine only product in oral dose form
Synonyms matching the FSN are not required.
There are several use cases that the MPF (only) concept can support:
Internationally and nationally in decision support (especially drug interaction checking) and in protocols and treatment guidelines
Internationally and nationally for interoperability of patient medication information such as in patient summaries and medication profiles, where patient information may only be available in using an abstract description (e.g. "patient reports they were taking oral captopril for 5 years")
Internationally for the provision of cross border care, where a particular formulation of a medicinal product from one jurisdiction may not be present in a second jurisdiction; the MPD (only) class can support finding alternatives
A concept at this level, despite using the universal restriction, does not directly correspond to any concept currently in the IDMP suite of standards.
The Level 3 Pharmaceutical Product concept (PhPID_SUB_C3) uses a granular administrable dose form concept for a product which will have an intended site of administration (bearing in mind that the exact implementation of ISO 11616 is not yet known). The MPF uses a more abstract dose form grouping concept where the grouping is on the basis of the intended site of administration for manufactured dose form (with some exceptions for oral antibiotic products that are supplied as powders/granules but dispensed to patients as solutions/suspensions). However, there should be little difference in the intended site of administration between a manufactured dose form and its administrable form for those dose forms that do not require transformation. For some groups of products, the MPF (only) concept has the potential to bring additional value to users beyond PhPID_SUB_C3 because it is a larger grouping concept.
For example, the dose form intended site concept 385276004 |Ocular dose form (dose form)| covers 14 more granular pharmaceutical dose forms, of which two would undergo transformation to different administrable dose forms, but still with the ocular intended site. This means that the single MPF grouping concept will be relevant to a considerably larger group of actual products than the 12 potential PhPID_SUB_C3 concepts for the same active ingredient substance(s) that might exist in IDMP.
As with the Medicinal Product (only) concept, the granularity of description of substance for the PhP3 is not completely clear, but may well be more granular than that used for the MPF (only) concept.
The "Vaccine product containing 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)|
Clinical drugs representing a continuous dose form are modeled using concentration strength attributes. Clinical drugs with a continuous dose form using concentration strength represents a medicinal product based on description of 1) its precise active ingredient substances only and explicitly, 2) the stated basis of strength substance(s) with strength, expressed as concentration strength and 3) with its manufactured dose form (with the exception of reconstituted oral liquid preparations, where the administrable dose form is be used as it is the most clinically relevant).
This is used for product types such as cutaneous semi-solids (without metered actuation), solutions, suspensions, creams, ointments, bulk powders and granules, topical liquids (without metered actuation) including drops, oral liquids, nebuliser liquids and liquid parenteral products.
For example,
Product containing precisely zidovudine 10 milligram/1 milliliter conventional release oral solution (clinical drug)
Attribute:
Has manufactured dose form
Range: 736542009
Attribute:
Count of base of active ingredient
Concrete Type: Integer
Range: >#0..
Cardinality: 1..1
Note
This attribute provides the number of base active ingredient substances present in the medicinal product
In analysis and research
As a supporting attribute for other concepts elsewhere in SNOMED CT
Stated parent
763158003 |Medicinal product (product)|
Semantic tag
(medicinal product form)
Definition status
Defined
Attribute:
Has active ingredient
Range: <105590001
|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.
For example,
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.
In the naming patterns below, 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".
Template:
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)
Template:
<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
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
Synonyms representing abbreviations for product (e.g., MMR, DTaP) will not be included in the International Release due to lack of internationally accepted reference sources.
Stated parent concept
763158003 |Medicinal product (product)
Semantic tag
(medicinal product)
Definition status
Defined
Attribute:
Has active ingredient
|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)
|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
|Has product characteristic| and |Has ingredient characteristic| attribute values should be added as appropriate.
Example of |Has product characteristic (attribute)|:
Hepatitis A adult vaccine
Product containing precisely amikacin (as amikacin sulfate) 250 milligram/1 milliliter conventional release solution for injection (clinical drug)
Product containing precisely clotrimazole 10 milligram/1 gram conventional release cutaneous cream (clinical drug)
Product containing precisely mupirocin (as mupirocin calcium) 20 milligram/1 gram conventional release nasal ointment (clinical drug)
Where Precise active ingredient = BoSS:
Product containing precisely <BoSS FSN> <Concentration strength numerator value FSN> <Concentration strength numerator unit FSN>/<Concentration strength denominator value FSN> <Concentration strength denominator unit FSN> <Manufactured dose form FSN> (clinical drug)
For example,
Product containing precisely amitriptyline hydrochloride 5 milligram/1 milliliter conventional release oral solution (clinical drug)
Product containing precisely buprenorphine 70 microgram/1 hour prolonged-release transdermal patch (clinical drug)
Product containing precisely clotrimazole 10 milligram/1 gram conventional release cutaneous cream (clinical drug)
Product containing precisely zidovudine 10 milligram/1 milliliter conventional release oral solution (clinical drug)
Product containing precisely lopinavir 80 milligram/1 milliliter and ritonavir 20 milligram/1 milliliter conventional release oral solution (clinical drug)
Where Precise active ingredient is not = BoSS:
Product containing precisely <BoSS FSN> (as <Precise active ingredient FSN>) <Concentration strength numerator value FSN> <Concentration strength numerator unit FSN>/<Concentration strength denominator value FSN> <Concentration strength denominator unit FSN> <Manufactured dose form FSN> (clinical drug)
For example,
Product containing precisely amikacin (as amikacin sulfate) 250 milligram/1 milliliter conventional release solution for injection (clinical drug)
Product containing precisely mupirocin (as mupirocin calcium) 20 milligram/1 gram conventional release nasal ointment (clinical drug)
Where Single ingredient with BoSS = Precise active ingredient:
<BoSS PT> <Concentration strength numerator value PT> <Concentration strength numerator unit PT>/<Concentration strength denominator value PT> <Concentration strength denominator unit PT> <Manufactured dose form PT>
For example,
Amitriptyline hydrochloride 5 mg/mL oral solution
Buprenorphine 70 microgram/hour prolonged-release transdermal patch
Clotrimazole 10 mg/g cutaneous cream
Zidovudine 10 mg/mL oral solution
Lopinavir 80 mg/mL and ritonavir 20 mg/mL oral solution
Where Single ingredient with BoSS is not = Precise active ingredient:
<BoSS PT> (as <Precise active ingredient PT>) <Concentration strength numerator value PT> <Concentration strength numerator unit PT>/<Concentration strength denominator value PT> <Concentration strength denominator unit PT> <Manufactured dose form PT>
For example,
Amikacin (as amikacin sulfate) 250 mg/mL solution for injection
Mupirocin (as mupirocin calcium) 20 mg/g nasal ointment
Synonyms converting metric units to percent or parts per millions may be included for medical gas concepts (e.g. Helium 79% and oxygen 21% gas for inhalation, Helium 790,000 ppm and oxygen 210,000 ppm gas for inhalation).
Stated parent
763158003 |Medicinal product (product)|
Semantic tag
(clinical drug)
Definition status
Defined
Exception:
Concepts with product strength that is "not equal to" (e.g. with product strength expressed as a range, greater than, or less than) are primitive
Attribute:
Has manufactured dose form
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)
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
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
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
Concrete Type: Integer
Range: >#0..
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: 0..1
Range: 736542009 |Pharmaceutical dose form (dose form)|
-While the allowed range for this attribute is broader, the CD-precise continuous dose from concepts should only use <736542009 | Pharmaceutical dose form (dose form), excluding grouper concepts based on intended site (e.g. 740596000 |Cutaneous dose form (dose form)|, 385268001 |Oral dose form (dose form)|).
Cardinality: 1..1
Note This is the finished dose form that a medicinal product is presented in by the manufacturer, before any transformation into an administrable dose form has taken place.
Powder and granules for oral suspension, solution, etc., may be modeled using concentration strength and the administrable dose form.
-For example, 1145409004 |Product containing precisely amoxicillin 25 milligram/1 milliliter and clavulanic acid (as clavulanate potassium) 6.25 milligram/1 milliliter conventional release oral suspension (clinical drug)|
Attribute:
Count of base of active ingredient (attribute)
Concrete Type: Integer
Range: >#0..
Cardinality: 1..1
Relationship group
One relationship group containing one instance of each of the following attributes is required for each precise active ingredient.
Has precise active ingredient
Range: <105590001 |Substance (substance) excluding concepts representing structural groupers, dispositions, or combined substances
Cardinality: 1..1 per relationship group
-The Precise Active Ingredient (PAI) cannot be modeled as a substance hydrate or solvate unless the BoSS is expressed as a hydrate or solvate. -Concepts containing pancreatic enzymes will be modeled based on the discrete enzymes; because of variability between real clinical drugs, synonyms representing a total amount in a particular product will not be included in the International Release.
Has basis of strength substance
Range: <105590001 |Substance (substance) excluding concepts representing structural groupers, dispositions, or combined substances
Cardinality: 1..1 per relationship group
Has concentration strength numerator value
Concrete Type: Decimal
Range: >#0..
Cardinality: 1..1 per relationship group
Has concentration strength numerator unit
Range: <767524001 |Unit of measure (qualifier value)| Cardinality: 1..1 per relationship group
Has concentration strength denominator value
Concrete Type: Decimal
Range: >#0..
Cardinality: 1..1 per relationship group
For this pattern, the attribute value must be 1.
The denominator strength value is required for concepts in the International Release even though the value = 1, because including denominators for only some concepts negatively affects the classification results.
Has concentration strength denominator unit
Range: <767524001 |Unit of measure (qualifier value)|
Cardinality: 1..1 per relationship group
For Clinical drug concepts with:
-liquid dose form: the denominator unit should be 258773002 | Milliliter (qualifier value)|.
-semi-solid dose form: the denominator unit should be 258682000 | gram (qualifier value)| for weight/weight concentration and 258773002 |Milliliter (qualifier value)| for weight/volume concentration. Representing semi-solid dose forms in weight/weight concentration is preferred.
The following sections apply to the vaccine product concepts in the |Medicinal product (product)| hierarchy in the International Release. In the International Release, vaccine products are those concepts with |Plays role (attribute) = |Active immunity stimulant role (role)|.
See also the relevant section in Substances on .
When a clinical drug has a BoSS specified in a Summary of Product Characteristics as an anhydrous substance, the PAI is represented as the unmodified substance, i.e., the substance with an unspecified level of hydration.
For example,
1153520006 |Product containing precisely carbidopa anhydrous (as carbidopa) 25 milligram and levodopa 250 milligram/1 each conventional release oral tablet (clinical drug)|
states each tablet "contains 27.0 mg carbidopa (equivalent to 25 mg of anhydrous carbidopa) and 250 mg levodopa." The BoSS is anhydrous carbidopa, so the PAI is Carbidopa.
1331919008 |Product containing precisely carbidopa anhydrous (as carbidopa) 12.5 milligram and entacapone 200 milligram and levodopa 50 milligram/1 each conventional release oral tablet (clinical drug)|
states, "Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa anhydrous (as 13.5 mg carbidopa monohydrate) and 200 mg of entacapone." The Boss is anhydrous carbidopa, so the PAI is Carbidopa.
Products that provide passive immunity should be modeled using the general Medicinal product guidance.
The Count of active ingredient (attribute) relationship has been added to certain single-ingredient valproic acid or sodium valproate clinical drug concepts to prevent incorrect subsumption under multiple-ingredient concepts (such as those containing both sodium valproate and valproic acid). This modeling ensures correct classification, particularly when substances share a base moiety but differ at the modification level.
For example,
765633006 |Product containing precisely sodium valproate 200 milligram/1 each prolonged-release oral tablet (clinical drug)| includes a |Count of active ingredient (attribute)| to prevent it from being inferred as a parent of 1204385002 |Product containing precisely sodium valproate 200 milligram and valproic acid 87 milligram/1 each prolonged-release oral tablet (clinical drug)|.
In addition, when any concept in a sibling set requires the additional |Count of active ingredient| attribute to classify correctly, this attribute should also be added to all sibling concepts for consistency.
Medicinal Product Form - An abstract representation of a medicinal product described by its active ingredient substances and a grouping dose form concept (based on the intended site of administration for the dose form group) but without reference to any product strength.
The grouping dose form concepts are the immediate children of 736542009 |Pharmaceutical dose form (dose form)| and are described in detail in the section Pharmaceutical Dose Form Grouper Based on Intended Site. These grouper concepts gather all the formulations (solid, semi-solid, liquid, or gaseous manufactured dose forms) that have the same intended site of administration. The intended site of administration of a dose form concept is a description of the general body site (i.e., not exactly anatomically explicit - no laterality etc.) where the dose form will be administered.
For example,
Products formulated with a dose form of eye drops are required to meet various pharmacopoeial standards of sterility, particulate contamination, and pH, as they are intended to be administered to an ocular site.
For further information, see section 5.3.2.7 of ISO 11239:2012 Health informatics - Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.
The following high level vaccine-related grouper concepts are included in the |Medicinal product| hierarchy.
787859002 |Vaccine product (medicinal product)|
836368004 |Vaccine product containing bacteria antigen (medicinal product)|
1290123005 |Vaccine product containing protozoa antigen (medicinal product)|
836369007 |Vaccine product containing virus antigen (medicinal product)|
In the naming patterns below, align naming and case sensitivity with the PT for the concept that is selected as the attribute value for the 127489000 |Has active ingredient (attribute)|.
Single ingredient vaccine
Vaccine product containing <Active ingredient PT excluding "antigen"> antigen (medicinal product)
Multiple ingredient vaccine
Vaccine product containing <Active ingredient PT excluding "antigen"> and <Active ingredient PT excluding "antigen"> antigens (medicinal product)
For example,
Vaccine product containing bacteria antigen (medicinal product)
Vaccine product containing virus antigen (medicinal product)
Vaccine product containing bacteria and virus antigens (medicinal product)
Single ingredient
<Active ingredient PT excluding "antigen">-containing vaccine product
Multiple ingredient
<Active ingredient PT excluding "antigen">- and <Active ingredient PT excluding "antigen"> antigens-containing vaccine product
For example,
Bacteria antigen-containing vaccine product
Virus antigen-containing vaccine product
Bacteria- and virus antigens-containing vaccine product
Synonyms matching the FSN are not required.
The "Vaccine product containing" concept is an abstract representation of the active ingredient(s) in a vaccine product. It means that the vaccine product must contain the active ingredient(s) specified in the FSN but may also contain a modification of the active ingredient(s) specified in the FSN or may contain additional active ingredient(s).
For example,
836374004 |Vaccine product containing Hepatitis B virus antigen (medicinal product)|
836389008 |Vaccine product containing Vaccinia virus antigen (medicinal product)|
Both "Vaccine product containing" and "Vaccine product containing only" concepts may be created for products that only have one active ingredient.
For example,
836374004 |Vaccine product containing Hepatitis B virus antigen (medicinal product)|
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.
In the naming patterns below, align naming and case sensitivity with the PT for the concept that is selected as the attribute value for the 127489000 |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 a virus, the word "virus" may be omitted and added before "antigens".
Vaccine product containing <active ingredient PT> (medicinal product)
For example,
Vaccine product containing Hepatitis B virus antigen (medicinal product)
Vaccine product containing Haemophilus influenzae type B antigen (medicinal product)
<Active ingredient PT>-containing vaccine product
For example,
Hepatitis B virus antigen-containing vaccine product
Haemophilus influenzae type B antigen-containing product
Synonyms matching the FSN are not required.
Synonyms corresponding to the disorder that is the target of the vaccine are not allowed; they may be applied to the "Vaccine product containing only" concepts.
Pharmaceutical dose form grouper concepts specifying "infusion and/or injection" are modeled using General Concept Inclusions (GCIs).
For example,
1208958005 |Conventional release solution for infusion and/or injection (dose form)|
1236769008 |Gas for conventional release dispersion for infusion and/or injection (dose form)|
Stated parent concept
763158003 |Medicinal product (product)
Semantic tag
(medicinal product)
Definition status
Defined
Attribute:
Has active ingredient
Stated parent concept
763158003 |Medicinal product (product)
Semantic tag
(medicinal product)
Definition status
Defined
Attribute:
Has active ingredient
1237269000 |Concentrate for conventional release solution for infusion and/or injection (dose form)|
The following are out of scope for the international release but can be added to national extensions, concepts that specify:
"infusion or injection"
"infusion and injection"
Clinical drugs modeled using pharmaceutical dose form groupers for “infusion and/or injection” are in scope for the International Release.
For example,
1252729004 |Product containing precisely ofloxacin 2 milligram/1 milliliter conventional release solution for infusion and/or injection (clinical drug)| is modeled with |Has manufactured dose form (attribute)| of |Conventional release solution for infusion and/or injection (dose form)|.
In cases where corresponding clinical drugs for both injection and infusion exist, the grouper for “infusion and/or injection” should be created. In other words, when creating a new clinical drug for infusion and an existing injection concept exists with the same substance and strength, then the grouper "for infusion and/or injection" should be created.
For example,
Range: <<105590001 |Substance (substance)|
Cardinality: 0..*
Exception: Top level grouper 787859002 |Vaccine product (medicinal product)| does not have a Has active ingredient (attribute).
Attribute:
Plays role
Range: <<766940004 |Role (role)|
Cardinality: 0..*
While the allowed range is broader, top level vaccine-related grouper concepts should have one and only one Plays role (attribute) with attribute value = 318331000221102 |Active immunity stimulant therapeutic role (role)|.
Range: <105590001 |Substance (substance) excluding concepts representing structural groupers, dispositions, or combined substances
Cardinality: 1..*
While the allowed range is broader, "Vaccine product containing" concepts in the International Release should have one and only one |Has active ingredient| attribute.
For content in the International Release, this attribute value should represent the organism antigen, not a modification or subtype, unless explicitly identified as an exception.
Exceptions: Vaccine product containing concepts for the following substance subtypes are included (to support vaccination certificates):
161000221102 |Antigen of Corynebacterium diphtheriae toxoid (substance)|
551000221106 |Antigen of Clostridium tetani toxoid (substance)|
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 with attribute value = 318331000221102 |Active immunity stimulant therapeutic role (role)|.
A grouper is a concept designed to aggregate concepts based on specific characteristics or commonalities. Medicinal products and their representations in a terminology can be put into groups in many ways, both in terms of abstraction and aggregation of product descriptions. In the SNOMED CT medicinal product model, the following grouping concepts will be used:
Groupings based on the pharmaceutical characteristics of manufactured medicinal products, and the primary subject of this model and documentation: in each of the sections below, these various model classes and their attributes are defined, described in detail and diagrams provided. In addition, their relationship to IDMP is described and a note as to their population status within the upcoming releases of SNOMED CT is provided.
Medicinal product - grouping based on active ingredient substance(s)
Medicinal product form - grouping based on active ingredient substance(s) combined with a grouping of the site of administration of manufactured dose form (parenteral dose forms, oral dose forms etc.)
These concepts are also grouped using the site of administration of manufactured dose form as a grouping concept
Clinical drug - a grouping based on active ingredient substance(s), with their strength, combined with manufactured dose form
Groupings based on the structural or behavioural characteristics exhibited by the active substance(s) that the products contain:
Disposition - grouping based on mechanism of action of the active ingredient substance(s) in the product
Structure - grouping based on structural patterns of the active ingredient substance(s) in the product
Structure and Disposition - combination of the above
The Clinical Drug "containing precisely" (CD-precise) concept is an abstract representation of the precise active ingredient, basis of strength substance (BoSS), strength, and manufactured dose form of a drug product. It implies that the drug product must contain only the precise active ingredient(s) specified in the FSN.
All Clinical Drugs that contain multiple active ingredient substances will have parent MP and MPF concepts that have the same set of active ingredient substances.
The limitation of the Clinical Drug class to the closed world view by the description of its precise active ingredient substances only precludes description of excipient substances, such as flavours, preservatives, sweeteners, etc., as ingredients in a Clinical Drug. These substances can have significance for allergies, etc., but can only be reliably described for individual authorised manufactured products, and as such, are not within the scope of the international edition.
Similarly, by limiting the Clinical Drug class in the international edition to expression of strength either as concentration strength or as presentation strength, medicinal product concepts that could usefully have both concentration and presentation strength (for example, some liquid products such as liquid parenteral products or liquids for inhalation via a nebuliser) will have only concentration strength in the international edition.
Use cases supported by the clinical drug concept include:
As the abstract representation of products that are authorised, although without any sense of the excipient substances, the clinical drug concept is the source from which all other representation of medicinal product concepts flows; it acts as a clinically relevant grouper concept for medicinal products, and as such can support:
international cross-border care delivery
International and national interoperability of patient medication information, such as within patient summaries
This class forms part of the medicinal product content provided in the international edition, although for liquid products, only concentration strength representation is provided.
Clinical Drug concepts in the international release are defined by their precise active ingredient substance(s) and their basis of strength substance, as described above. A concept that grouped clinical drugs by their strength and basis of strength substance only (i.e., disregarding the precise active ingredient substance) may be appropriate in some contexts in national extensions (e.g. 'amlodipine 10mg conventional release oral tablet' as a concept with three child concepts 'amlodipine (as amlodipine besiliate) 10mg conventional release oral tablet' and 'amlodipine (as amlodipine mesiliate) 10mg conventional release oral tablet' 'amlodipine (as amlodipine maleate) 10mg conventional release oral tablet'. A Clinical Drug grouping concept of this nature would be a "Basis of Strength Substance Clinical Drug" concept as opposed to a "Clinical Drug containing Precisely" concept.
Although a Clinical Drug might look directly compatible with the IDMP concept of "Manufactured Item", in IDMP, a Manufactured Item is an "actual manufactured item (the tablet, liquid, cream contained within the package) as it is delivered from the manufacturer but before any transformation, if applicable, for administration to or use by the patient"; it is therefore a representation of a real entity, rather than an abstract entity. They are therefore not directly compatible classes of entities. A Manufactured Item is described by substances in a variety of roles, including excipient substances, not just its active substance(s) and their strengths. A Manufactured Item can be related to an appropriate Clinical Drug on the basis of its active ingredient substance(s) and relevant strength so that the Clinical Drug being an abstracted representation of the Manufactured Item, but they are not equivalent. The Manufactured Item concept in IDMP is equivalent to the Real Clinical Drug concept of the SNOMED national extension model.
On the basis that the IDMP concept of a Pharmaceutical Product could be defined by substance(s) playing only an active ingredient role, then the Clinical Drug concept is more directly compatible with the IDMP Pharmaceutical Product concept however if it is intended that the IDMP Pharmaceutical Product does include excipient substances, then there is no compatibility. Even then, the IDMP Pharmaceutical Product concept is clear that the dose form attribute is populated by the administrable dose form rather than the manufactured dose form, whereas, for everything other than products presented as reconstituted oral liquids, the Clinical Drug uses the manufactured dose form. Although for probably the majority of medicinal products the manufactured dose form is also the administrable dose form, for the minority for which this is not the case (for example, parenteral products presented as powders or granules that must be dissolved or dispersed prior to administration to the patient) this difference is significant. It is therefore not possible to state any direct class level equivalence between a Clinical Drug and an IDMP Pharmaceutical Product.
There is some compatibility between an IDMP PhP4 concept and a Clinical Drug. However, it is not yet clear as to how the "active substance - strength" description will be described in IDMP implementation. The SNOMED Clinical Drug is explicit in stating the basis of strength substance in its relevant granularity as required for patient care; IDMP is currently less clear as to how that will be done and what effect that will have on the description of a Pharmaceutical Product. In addition, IDMP allows for "active substance - strength" to be described by using either (and possibly even both) a Substance and Specified Substance. The distinction between Substance and Specified Substance in IDMP is thus: a substance is "any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical" whereas a Specified Substance is one that is "defined by groups of elements that describes multi-substance materials or specifies further information on substances relevant to the description of Medicinal Products". Specified substances are substances like simeticone, which are mixture substances, or substances that are defined by pharmacopoeial specification (like water for injection) or substance where a particular manufacturing process is specified (as for biosimilar products). For SNOMED CT, all such substances, with the possible exception of 'water for injection') could be present in the Substance hierarchy and are therefore candidate concepts to be used in the ingredient role attributes of concepts in the Medicinal Product hierarchy; as such the IDMP distinction between Substance and Specified Substance has no material effect.
The guidance below applies to both discrete and continuous dose forms.
Align FSN and PT naming and case sensitivity with the concepts selected as attribute values.
For multiple-ingredient drug products, the BoSS must be in alphabetical order and separated by the word “and”.
Synonyms matching FSNs are not required.
The following units of measure should not be abbreviated in any descriptions; always spell out:
microequivalent
microliter
microgram
microliter (with GB spelling microlitre)
Descriptions that include abbreviations for drug unit, such as ‘mg’, ‘g’, ‘mg/’, 'unit/g', 'unit/mg', 'microgram/g', and 'microgram/mg' have a case sensitivity indicator of cl, |Only initial character case insensitive (core metadata concept)|. These descriptions are cI; the first character of the description may or may not be capitalized, while the case of the rest of the description cannot be changed.
For example,
3500544012 |Acetaminophen 500 mg oral tablet|
3692869013 |Betamethasone (as betamethasone dipropionate) 500 microgram/g and salicylic acid 30 mg/g cutaneous ointment|
4550119010 |Cyclophosphamide 500 mg powder for solution for injection vial|
While not an abbreviation, gram is the standard international metric unit of mass and is lowercase in descriptions.
For example,
258682000 |gram (qualifier value)| is Entire term case sensitive
1230118007 |Product containing precisely bacitracin 250 unit/1 gram and neomycin sulfate 5 milligram/1 gram and sulfacetamide sodium 60 milligram/1 gram conventional release cutaneous powder (clinical drug)| is Only initial character case insensitive
For solids and semi-solids, a concentration strength will be mass/mass (weight/weight) – usually mg/g.
Solid = pill, tablet, suppository, tape, patch, lozenge, implant, gum, capsule, etc.
Semi-solid = cement, cream, gel, ointment, paste, poultice
For liquids, a concentration strength will be mass/volume (weight/volume) – usually mg/mL.
Liquid = solution, suspension, tincture, spirit, emulsion, foam, lotion, oil, lacquer, etc.
Requests for new concepts that conflict with the above require a clear justification for the variance.
International Unit as a description is arbitrary, and to be understood, each product requires reference to a particular bioefficacy specification for that entity. Therefore, international unit is neither a meaningful nor comparable description at Clinical Drug level. International unit will be represented as unit in Clinical Drug descriptions. Abbreviations will not be used.
For example,
1237145006 |Product containing precisely octocog alfa 1000 unit/1 vial powder for conventional release solution for injection (clinical drug)|
Preferred term: Octocog alfa 1000 unit powder for solution for injection vial
The |Has presentation strength numerator unit| will still continue to have a value of |International unit (qualifier value)| even though unit is stated in the FSN and PT.
Concepts with product strength that is "not equal to" are modeled as primitive, with attributes added as described in the corresponding subpages, except that strength numerator attributes will not be added. The appropriate Medicinal Product Form-only (MPF-only) concept will infer as a parent.
Expression of product strength in metric units is preferred.
To avoid semantically equivalent concepts, product strength for metric units are normalized as follows:
Use milligram if value is <1000; if > 1000, convert to gram.
Use microgram if value is <1000; if > 1000, convert to milligram.
Use nanogram if value is <1000; if > 1000, convert to microgram.
Use picogram if value is <1000; if > 1000, convert to nanogram.
Similarly, if a unit is less than one, convert to a smaller unit. gram → milligram → microgram → nanogram → picogram
For example,
If the value is less than one gram, convert value to milligrams.
To avoid semantically equivalent concepts, product strength for units are normalized as follows:
Use million unit if value is > 1000000 unit
The following units are not allowed unless specifically noted as an exception:
408165007 |Mega u (qualifier value)|
Repeating decimals are rounded to three decimal places (with 5 and above rounded up and 4 and below rounded down). In general, avoid decimal points.
The Precise Active Ingredient (PAI) cannot be modeled as a substance hydrate or solvate unless the BoSS is expressed as a substance hydrate or solvate.
Concepts containing pancreatic enzymes are modeled based on the discrete enzymes; because of variability between real clinical drugs, synonyms representing a total amount in a particular product will not be included in the International Release.
Clinical drugs containing precisely x are modeled with a count based on the substance(s) to support a closed world view (i.e., a count of 1 will not infer a count of 2). The closed world view does not apply to dose forms. A very rare case can arise where, for example, a clinical drug that is for an x ear and eye drop is a subtype of both the clinical drug x eye drop and the clinical drug x ear drop. This makes real world sense where all descendants of x clinical drug eye drop are for use in the eye, and a small subgroup of them may also be acceptable for use in the ear.
For example,
1220547004 |Product containing precisely gentamicin (as gentamicin sulfate) 3 milligram/1 milliliter conventional release eye drops (clinical drug)| correctly infers a subtype of 1142217003 |Product containing precisely gentamicin (as gentamicin sulfate) 3 milligram/1 milliliter conventional release ear and eye drops (clinical drug)|.
Internationally and nationally in decision support and in protocols and treatment guidelines, when a more complete description of a product is required than MP or MPF
In pharmacovigilance, especially for description of concomitant medication
In analysis and research
nanogram
picogram
unit
A high-level grouper concept supports the organization of the hierarchy based on structure: 763760008 |Medicinal product categorized by structure (product)|
All substances have spatial arrangement of the atoms and molecules and bonds that they are constituted from and which therefore govern the final shape that the substance takes; this arrangement is their "structure". Substance structures often follow patterns so that similar structures are grouped together and often share particular name patterns. Medicinal products can be collected together into groups based on the structural pattern(s) of their active ingredient substance(s).
Structure-based grouping is a characteristic of the active ingredient substance(s) present in the medicinal product, therefore structure-based grouping concepts are assigned (inferred) by the classifier to medicinal products and include all their child concepts (medicinal product form and clinical drug concepts) although in a browser such as the DailyBuild, the inferred grouping concepts will be shown on the proximal concept only (the "medicinal product containing" concept).
Inferred view of Medicinal product showing membership of a structural grouping (sulfonamide)
Product containing <active ingredient> (product)
Align naming and case sensitivity with the Preferred Term for the concept that is selected as the attribute value for the 127489000 |Has active ingredient (attribute)|.
For example,
Product containing prostaglandin (product)
Product containing A series prostaglandin (product)
<Active ingredient>-containing product
Align naming and case significance with the Preferred Term for the concept that is selected as the attribute value.
For example,
Prostaglandin-containing product
A series prostaglandin-containing product
Synonyms matching the FSN are not required.
Stated parent concept
763158003 |Medicinal product (product)
Semantic tag
(product)
Definition status
Defined
Attribute:
Has active ingredient
Range: << 105590001
The |Product containing x in y dose form (medicinal product form)| concept is an abstract representation of active ingredient(s) and dose form intended site for a medicinal product. The medicinal product must contain the active ingredient(s) specified in the FSN but may also contain a modification of the active ingredient(s) specified in the FSN or may contain additional active ingredient(s) as well.
For example,
Product containing axitinib in oral dose form (medicinal product form)
Product containing abacavir and lamivudine in oral dose form (medicinal product form)
In other words, "MPF containing" represents a medicinal product based on description of active ingredient substances it contains and on the (generalized) intended site of use for the product.
For example,
"Product containing amoxicillin in oral dosage form" represents the group of products that must contain some amoxicillin (be it amoxicillin sodium or amoxicillin trihydrate or amoxicillin base), but may also contain other active ingredients, such as clavulanic acid, in manufactured dose forms such as oral suspension, oral capsule (any type), oral tablet (any type).
The main use case for the MPF (containing) is for analysis, as an aggregation concept for use in research.
A concept at this level with the open world view does not correspond to any concept currently in the IDMP suite of standards.
Use the following pattern for the FSN and PT. Align naming and case sensitivity with the FSN for the concepts that are selected as the attribute value.
For multiple ingredient drug products, active ingredients must be in alphabetical order and separated by the word “and”.
Product containing <Active ingredient FSN> in <Manufactured dose form FSN> (medicinal product form)
Product containing <Active ingredient FSN> and <Active ingredient FSN> in <Manufactured dose form FSN> (medicinal product form)
Product containing <Active ingredient FSN> and <Active ingredient FSN> and <Active ingredient FSN> in <Manufactured dose form FSN> (medicinal product form)
For example,
Product containing axitinib in oral dose form (medicinal product form)
Product containing abacavir and lamivudine in oral dose form (medicinal product form)
Product containing abacavir and lamivudine and zidovudine in oral dose form (medicinal product form)
Creation of MPF-containing concepts for all possible combinations of active ingredients contained in multiple ingredient products is not recommended at this time (no specific use case has been identified). For example, a product containing three active ingredients would only require creation of one MPF-containing concept. If any of the active ingredients is available as a single ingredient product, or as part of another multiple ingredient concept, then appropriate concepts would be created for those products.
<Active ingredient PT>-containing product in <Manufactured dose form PT>
<Active ingredient PT>- and <Active ingredient PT>-containing product in <Manufactured dose form PT>
<Active ingredient PT>- and <Active ingredient PT>- and <Active ingredient PT>-containing product in <Manufactured dose form PT>
For example,
Axitinib-containing product in oral dose form
Abacavir- and lamivudine-containing product in oral dose form
Abacavir- and lamivudine- and zidovudine-containing product in oral dose form
Synonyms matching the FSN are not required.
An abstract representation of a medicinal product without reference to its dose form or its strength.
The grouper 763158003 |Medicinal product (product)|, a stated descendant of |Pharmaceutical / biologic product (product)|, was created to support top-level hierarchy changes in the future but avoids removing, renaming, or repurposing the existing |Pharmaceutical / biologic product (product)| concept.
The top level concepts in the hierarchy will primarily be sufficiently defined grouper concepts.
Any requirement to align to external standards or registries will be explicitly documented. Concept model will be compatible with ISO's Identification of Medicinal Products (IDMP) standards (where appropriate).
Age ranges (e.g., adult, pediatric, infant, junior, adolescent)
Exception: Vaccine products MP-only concepts may be modeled with Has target population (attribute) that specifies a target population.
Adjuvants
Allergy immunotherapy products
Should be represented in a national extension because of the manufacturer-specific variability regarding standardization and expression of strength.
Ayurvedic medicine
Brand names
Color (e.g., color of tablet, capsule, or solution)
Composite products
Excipients
Flavors
Investigational products/Products under development but not marketed in any member country
Exceptions may be made on a case-by-case basis; such as:
Adding investigational products that are being widely used in a pandemic
European Medicines Agency's Human Medicines Under Evaluation
Packs
Products intended only for non-human use
Products no longer marketed or available for sale
Existing concepts representing products that are no longer marketed or available for sale will be retained as active concepts in the International Release. Requests for new content will be considered for inclusion on a case-by-case basis.
Relevant omissions (e.g., sugar-free, preservative-free)
Routes of administration not explicitly represented
Sterility
Tall man lettering
Descriptions that include tall man lettering [partial capitalization of drug names to distinguish from similar sounding drugs] should be authored in a national or local extension.
Traditional medicine products
Concepts shall be sufficiently defined using proximal primitive modeling methodology unless explicitly noted as an exception in the editorial guidelines.
Concept model supports neither universal restrictions nor nesting.
Content in the
Stated parent
763158003 |Medicinal product (product)
Semantic tag
(medicinal product form)
Definition status
Defined
Attribute:
Has active ingredient
Range: <105590001
Attribute:
Has manufactured dose form
Range: <736542009
Clinical drug concepts representing discrete dose form (e.g., tablets, capsules, pessaries, suppositories, sachets, patches, ampules or vials containing solid dose forms such as powders or granules, and metered dose delivery products such as inhalers and spray) are modeled using presentation strength attributes; concentration strength attributes are not allowed for these concepts in the International Release. Clinical drugs with a discrete dose form using presentation strength represents a medicinal product based on description of 1) its precise active ingredient substances only and explicitly, 2) the stated basis of strength substance(s) with strength, expressed as presentation strength with unit of presentation and 3) with its manufactured dose form.
For example,
Product containing precisely abacavir 300 milligram/1 each conventional release oral tablet (clinical drug)
Product containing precisely abacavir 600 milligram and lamivudine 300 milligram/1 each conventional release oral tablet (clinical drug)
Product containing precisely afatinib (as afatinib dimaleate) 30 milligram/1 each conventional release oral tablet (clinical drug)
Product containing precisely aztreonam 500 milligram/1 vial powder for conventional release solution for injection (clinical drug)
Product containing precisely flucloxacillin (as flucloxacillin sodium) 250 milligram/1 vial powder for conventional release solution for injection (clinical drug)
Product containing precisely budesonide 200 microgram/1 actuation conventional release powder for inhalation (clinical drug)
Product containing precisely nicotine 7 milligram/24 hour prolonged-release transdermal patch (clinical drug)
When a product has a metered delivery, the strength is "per actuation" not as a concentration.
For example
1263426000 |Product containing precisely xylometazoline hydrochloride 140 microgram/1 actuation conventional release nasal spray (clinical drug)|
Use one of the following patterns for the FSN and PT.
Where Precise active ingredient = BoSS and Unit of presentation = discrete solid dose form (e.g. capsule, lozenge, pessary, suppository, tablet):
Product containing precisely <BoSS FSN> <Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>/<Presentation strength denominator value FSN> each <Manufactured dose form FSN> (clinical drug)
For example,
Product containing precisely abacavir 300 milligram/1 each conventional release oral tablet (clinical drug)
Product containing precisely abacavir 600 milligram and lamivudine 300 milligram/1 each conventional release oral tablet (clinical drug)
Product containing precisely atropine sulfate 600 microgram/1 each conventional release oral tablet (clinical drug)
Where Precise active ingredient is not = BoSS and Unit of presentation = discrete solid dose form (e.g. capsule, lozenge, pessary, suppository, tablet):
Product containing precisely <BoSS FSN> (as <Precise active ingredient FSN>) <Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>/<Presentation strength denominator value FSN> each <Manufactured dose form FSN> (clinical drug)
For example,
Product containing precisely doxazosin (as doxazosin mesilate) 4 milligram/1 each conventional release oral tablet (clinical drug)
Product containing precisely disopyramide (as disopyramide phosphate) 150 milligram/1 each prolonged-release oral tablet (clinical drug)
Where Precise active ingredient = BoSS and Unit of presentation = other discrete dose form (e.g. actuation, vial, sachet)
Product containing precisely <BoSS FSN> <Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>/Presentation strength denominator value FSN> <Presentation strength denominator unit FSN> Manufactured dose form FSN> (clinical drug)
For example,
Product containing precisely aztreonam 500 milligram/1 vial powder for conventional release solution for injection (clinical drug)
Product containing precisely budesonide 200 microgram/1 actuation conventional release powder for inhalation (clinical drug)
Where Precise active ingredient is not = BoSS and Unit of presentation = other discrete dose form (e.g. actuation, vial, sachet)
Product containing precisely <BoSS FSN> (as <Precise active ingredient FSN>) <Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>/<Presentation strength denominator value FSN> <Presentation strength denominator unit FSN> Manufactured dose form FSN> (clinical drug)
For example,
Product containing precisely flucloxacillin (as flucloxacillin sodium) 250 milligram/1 vial powder for conventional release solution for injection (clinical drug)
Product containing precisely buserelin (as buserelin acetate) 100 microgram/1 actuation conventional release nasal spray (clinical drug)
Where BoSS = Precise active ingredient:
<BoSS PT> <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <Manufactured dose form PT> <Has unit of presentation PT>
For example,
Abacavir 300 mg oral tablet
Abacavir 600 mg and lamivudine 300 mg oral tablet
Atropine sulfate 600 microgram oral tablet
Codeine sulfate 15 mg oral tablet
Where BoSS is not = Precise active ingredient:
<BoSS PT> (as <Precise active ingredient PT>) <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <Manufactured dose form PT> <Has unit of presentation PT>
For example,
US PT: Doxazosin (as doxazosin mesylate) 4 mg oral tablet
GB PT: Doxazosin (as doxazosin mesylate) 4 mg oral tablet
US/GB PT: Disopyramide (as disopyramide phosphate) 150 mg prolonged-release oral tablet
US PT: Floxacillin (as floxacillin sodium) 250 mg powder for solution for injection vial
Synonyms matching the FSN are not required.
Product containing precisely codeine sulfate 15 milligram/1 each conventional release oral tablet (clinical drug)
Aztreonam 500 mg powder for solution for injection vial
Budesonide 200 microgram/actuation powder for inhalation
Buserelin (as buserelin acetate) 100 microgram/actuation nasal spray
Ivacaftor 25 mg oral granules sachet
GB PT: Flucloxacillin (as flucloxacillin sodium) 250 mg powder for solution for injection vial
Attribute:
Has unit of presentation
Range: <732935002 |Unit of presentation (unit of presentation)|
Cardinality: 1..1
Note:
This is the countable entity in which the clinical drug is presented
See for the various patterns of use for the unit of presentation
Attribute:
Count of base of active ingredient (attribute)
Concrete Type: Integer
Range: >#0..
Cardinality: 1..1
Relationship group
One relationship group containing one instance of each of the following attributes is required for each precise active ingredient.
Attribute:
Has precise active ingredient
Range: <105590001 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances
Cardinality: 1..1 per relationship group
Note:
The PAI cannot be modeled as a substance hydrate or solvate unless the BoSS is expressed as a hydrate or solvate.
Concepts containing pancreatic enzymes are modeled based on the discrete enzymes; because of variability between real clinical drugs, synonyms representing a total amount in a particular product will not be included in the International Release.
Attribute:
Has basis of strength substance
Range: <105590001 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances
Cardinality: 1..1 per relationship group
Attribute: Has presentation strength numerator value
Concrete Type: Decimal
Range: >#0..
Cardinality: 1..1 per relationship group
Attribute: Has presentation strength numerator unit
Range: <767524001 |Unit of measure (qualifier value)|
Cardinality: 1..1 per relationship group
Attribute: Has presentation strength denominator value
Concrete Type: Decimal
Range: >#0..
Cardinality: 1..1 per relationship group
For this pattern, the attribute value is 1.
The denominator strength value is required for concepts in the International Release, even if the value = 1, because including denominators for only some concepts negatively affects the classification results.
Attribute: Has presentation strength denominator unit
Range: <767524001 |Unit of measure (qualifier value)|
While the allowed range for this attribute is broader, the CD-precise concepts representing discrete dose forms should only use <732935002 |Unit of presentation (unit of presentation).
Cardinality: 1..1 per relationship group
Stated parent
763158003 |Medicinal product (product)
Semantic tag
(clinical drug)
Definition status
Defined
Exception:
Concepts with product strength that is "not equal to" (e.g. with product strength expressed as a range, greater than, or less than) will have a definition status of Primitive.
Attribute:
Has manufactured dose form
Pre-filled pens or cartridges are discrete dose forms as they can be counted. In the International edition of SNOMED CT, clinical drugs presenting in pre-filled pens or cartridges are modeled with normalized concentration strength.
Example of pre-filled pen:
One pre-filled pen for injection contains 2 mg semaglutide in a 1.5 mL solution
FSN: 782102009 |Product containing precisely semaglutide 1.34 milligram/1 milliliter conventional release solution for injection (clinical drug)|
Lyophilized dose forms are out of scope for the international edition of SNOMED CT.
Range: <736542009 |Pharmaceutical dose form (dose form)
While the allowed range for this attribute is broader, the CD-precise
discrete dose form concepts should only use <736542009 |Pharmaceutical dose form (dose form)|, excluding grouper concepts based on intended site (e.g. 740596000 |Cutaneous dose form (dose form)|, 385268001 |Oral dose form (dose form)|)
Cardinality: 1..1
Powder and granules for oral suspension, solution, etc. may be modeled using
concentration strength and the administrable dose form (e.g. 1145409004 |Product
containing precisely amoxicillin 25 milligram/1 milliliter and clavulanic acid (as clavulanatepotassium) 6.25 milligram/1 milliliter conventional release oral suspension (clinical drug)||Product containing x (medicinal product)| concepts are abstract representations of the active ingredient(s) for a medicinal product.
For example,
Product containing axitinib (medicinal product)
Product containing abacavir and lamivudine (medicinal product)
The medicinal product must contain the active ingredient(s) specified in the FSN but may also contain a modification of the active ingredient(s) specified in the FSN or may contain additional active ingredient(s). For example, "Product containing amoxicillin" represents products that must contain some amoxicillin (with any type of modification, be it amoxicillin sodium, or amoxicillin trihydrate, or no modification, as in amoxicillin (base)), but may also contain other active ingredients, such as clavulanic acid. This is the open world view.
In stating “abstract representations...for a medicinal product”, the concept definition implies that at least one medicinal product exists, or has existed globally, that has that set of active ingredient substance(s). This precludes the possibility of generating MPs representing theoretical, or indeed all possible, combinations of sets of active ingredient substances.
The main use case for describing products containing some active ingredient substance(s) is for analysis, as an aggregation concept for use in research.
A concept at this level with the open world view does not correspond to any concept currently in the IDMP suite of standards, although it could act as a parent (higher level grouper) concept for PhP1 concepts, if use case(s) were identified to require this.
Use the following pattern for the FSN and PT. Align naming and case sensitivity with the FSN for the concept that is selected as the attribute value.
For multiple ingredient drug products, the active ingredients must be in alphabetical order and separated by the word “and”.
Product containing <Active ingredient FSN> (medicinal product)
Product containing <Active ingredient FSN> and <Active ingredient FSN> (medicinal product)
Product containing <Active ingredient FSN> and <Active ingredient FSN> and <Active ingredient FSN tag> (medicinal product)
For example,
Product containing axitinib (medicinal product)
Product containing abacavir and lamivudine (medicinal product)
Product containing abacavir and lamivudine and zidovudine (medicinal product)
<Active ingredient PT>-containing product
<Active ingredient PT>- and <Active ingredient PT>-containing product
<Active ingredient PT>- and <Active ingredient PT>- and <Active ingredient PT>-containing product
For example,
Axitinib-containing product
Abacavir- and lamivudine-containing product
Abacavir- and lamivudine- and zidovudine-containing product
Synonyms matching the FSN are not required.
When a clinical drug is created, the following supertypes must either already exist or must be created:
For example,
1172863005 Paracetamol 1 g oral tablet has the following supertypes:
These concepts in the International Release, their descriptions, and their |Has active ingredient (attribute)| value, represent the base ingredient, not a modification.
For example,
1204319004 |Product containing precisely retinol (as retinol palmitate) 50000 unit/1 milliliter conventional release solution for injection (clinical drug)| has medicinal product and medicinal product form supertypes with retinol, not retinol palmitate. Retinol palmitate is a modification of Retinol and thus should not be used in the creation of the medicinal product and medicinal product form supertypes.
Stated parent
763158003 |Medicinal product (product)
Semantic tag
(medicinal product)
Definition status
Defined
Attribute:
127489000
Has active ingredient (attribute)
Exceptions to use a modified substance are explicitly identified below:
Benzylpenicillin
When the active ingredient has an Is modification of (attribute) value of 323389000 |Benzylpenicillin (substance)|.
1234765004 |Product containing only benzathine benzylpenicillin in parenteral dose form (medicinal product form)|
323404007 |Product containing benzathine benzylpenicillin (medicinal product)|
Benzylpenicillin is the base, but use the modified substance in the FSN for the MP/MPF.
Chemical element compound with multiple modification
Instances where the chemical element compound has two or more Is Modification of (attribute)s
422232005 |Calcium lactate gluconate (substance)|
-Has |Is modification of (attribute)| = Calcium gluconate
-Has |Is modification of (attribute)| = Calcium lactate
1359973006 |Copper (64-Cu) labeled somatostatin analog (substance)|
-Has |Is modification of (attribute)| = Somatostatin analog
-Has |Is modification of (attribute)| = Copper-64
Chloral hydrate
273948005 |Chloral hydrate (substance)| is a modification of Chloral. However, chloral is unstable on its own and always exists in the hydrated form.
778711000 |Product containing only chloral hydrate in oral dose form (medicinal product form)|
386735001 |Product containing chloral hydrate in oral dose form (medicinal product form)|
775158004 |Product containing only chloral hydrate (medicinal product)|
Liposome or lipid complex substances
< 414612001 |Liposomal
agent (substance)
These subtypes have some sort of modification, but they can be used to create:
Product containing only x (medicinal product)
Product containing only x in y dose form (medicinal product form)
Do not use to create:
Product containing x (medicinal product)
Product containing x in y dose form (medicinal product form)
426490000 |Vincristine liposome (substance)|
768664009 |Amphotericin B phospholipid complex
(substance)|
427544000 |Amphotericin B cholesteryl sulfate complex
(substance)|
Pegylated substance
There is no technical way to identify these concepts, though they will often begin with peg-.
385544005 |Pegfilgrastim (substance)|
770965008 |Pegvaliase (substance)|
Radiopharmaceutical
< 89457008 Radioactive isotope (substance)|
783865003 |Product containing only cyanocobalamin (58-Co) (medicinal product)|
783867006 |Product containing only cyanocobalamin (58-Co) in oral dose form (medicinal product form)|
783856005 |Product containing sodium iodide (131-I) in parenteral dose form (medicinal product form)|
783854008 |Product containing sodium iodide (131-I) (medicinal product)|
Silver sulfadiazine
387112002 |Silver sulfadiazine
(substance)| is a modification of 74523009 |Sulfadiazine (substance)|
864009007 |Product containing only silver sulfadiazine in cutaneous dose form (medicinal product form)|
771756000 |Product containing silver sulfadiazine in cutaneous dose form (medicinal product form)|
Sodium valproate
387481005 |Sodium valproate (substance)| is a modification of 387080000 |Valproic acid (substance)|
766519009 |Product containing precisely sodium valproate 40 milligram/1 milliliter conventional release oral solution (clinical drug)|
1204386001 |Product containing precisely sodium valproate 133 milligram and valproic acid 58 milligram/1 each prolonged-release oral tablet (clinical drug)|
