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Pharmaceutical Dose Form

Describing Dose forms

A Clinical Drug concept has a pharmaceutical dose form, which is the physical manifestation of a medicinal product that contains the active and inactive ingredient substance(s) intended for administration for the patient.

The Clinical Drug concept in the international release is defined by its manufactured dose form, which is the dose form as the item is presented by the manufacturer into the supply chain. This may be the same as the administrable dose form, which is the dose form that can be given to the patient after any necessary transformation (such as dissolution or dispersion) has taken place, or it may be different.

Examples of the relationship between manufactured and administrable dose forms and transformation are given below. Both manufactured dose forms and administrable dose forms are types of pharmaceutical dose form.

Manufactured dose form

Administrable dose form

Transformation

EXCEPTION

The exception to the principle of using the manufactured dose form to describe Clinical Drugs in the international release is for oral antimicrobial liquid products (solutions, suspensions) that are supplied by the manufacturer as powders but undergo dissolution or dispersion prior to dispensing for administration. This exception is because of the need to describe these products using a clinically relevant strength reflecting the concentration of the administered liquid.

Concept model will include attributes necessary to define the concepts to ensure consistent and reproducible modeling of concepts, whose use is primarily to describe or group concepts in the hierarchy.

Any requirement to align to external standards or registries will be explicitly documented.

Concept model will be compatible with the following ISO (International Organization for Standardization) IDMP (Identification of Medicinal Products) standards where appropriate:

ISO 11239 Health informatics, 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
ISO/TS 20440 Health informatics, Implementation guide for ISO 11239 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

Concepts in the 736542009 |Pharmaceutical dose form (dose form)| hierarchy:

shall be sufficiently defined using proximal primitive modeling methodology unless explicitly noted as an exception in the editorial guidelines,
is not intended to eliminate the need for a national extension.

Concepts representing combined pharmaceutical dose forms
- Single concepts describing the multiple dose forms found in kit products such as cream and pessary
- Two pharmaceutical dose forms put together like powder and solvent for solution for injection
Concepts in pattern "x for y for z" (e.g. Powder for concentrate for dispersion for infusion

The 736542009 |Pharmaceutical dose form (dose form)| hierarchy is comprised of the types of concepts as shown in the table below. Detailed editorial guidelines for each distinct concept type, including required attributes and naming guidelines, are found in the sections that follow.

Concept type

Examples

The following definitions explain the differences between dose form intended site and route of administration:

736474004 |Has dose form intended site (attribute)|

Dose form intended site describes the general anatomic location that the dose form has been formulated for administration to or at. The intended site is not intended to describe a precise site or route of administration. For example, eye drops (prepared for ocular intended site) are subject to pharmacopoeial standards for pH and sterility.

410675002 |Route of administration (attribute)|

The route of administration is the path by which the product is taken into, or makes contact with, the body and is a property of the administration action. The route of administration of a medication is determined by the prescriber in their prescription dosage instructions for a particular patient.

736479009 |Dose form intended site (intended site)|

The set of values for dose form intended site that relate to characteristics associated with a pharmaceutical dose form and do not refer to a precise anatomic location.

284009009 |Route of administration value (qualifier value)|

The set of values for route of administration. For medicinal products, these values are associated with the action of administration.

Pharmaceutical dose forms with two or more intended sites will use 'and' in their terming and include all intended sites in the model. Representing combinations of intended sites as a conjunction ('and' in the description) will facilitate searching by end users. The concepts are logically modeled as conjunction.

Pharmaceutical dose forms with two or more administration methods is a less common requirement, thus requests for this type of dose form are reviewed on a case by case basis.

Pharmaceutical Dose Form Naming and Modeling Conventions

Overview

Pharmaceutical dose form concepts (e.g., conventional release oral tablet, prolonged-release oral capsule) that are deemed to be clinically useful and that can be sufficiently defined will be included in the 736542009 |Pharmaceutical dose form (dose form)| hierarchy. Primitive concepts may be included if documented as an exception.

Lyophilized dose forms are out of scope for the international edition of SNOMED CT.

Naming

FSN

Use the following pattern for the FSN; align naming and case sensitivity with the FSN for the concepts that are selected as the attribute values, excluding the semantic tag. For multiple intended sites, the sites must be in alphabetical order and separated by the word “and”.

Template:

<Dose form release characteristic FSN> <Dose form intended site FSN> <Basic dose form> (dose form)

For example,

Conventional release oral capsule (dose form)
Conventional release oral suspension (dose form)
Prolonged-release oral capsule (dose form)
Conventional release and prolonged-release oral tablet (dose form)
Conventional release cutaneous cream (dose form)
Conventional release vaginal ointment (dose form)
Gastro-resistant oral suspension (dose form)

Use the following pattern for the PT; align naming and case sensitivity with the PT for the concepts that are selected as the attribute values, excluding the semantic tag. For multiple intended sites, the sites must be in alphabetical order and separated by the word “and”. Exclude <Dose form release characteristic> when = 736849007 |Conventional release (release characteristic)|.

Template:

For example,

Oral capsule
Oral suspension
Prolonged-release oral capsule
Conventional release and prolonged-release oral tablet

A synonym matching the FSN is required; other synonyms are not allowed unless explicitly identified as an exception in the Editorial Guidelines.

Exceptions:

Synonyms with eye instead of ocular, ear instead of otic, or nose instead of nasal may be created.

Optional

Pharmaceutical Dose Form Grouper Based on Intended Site

Overview

Pharmaceutical dose form grouper concepts based on intended site of use for the dose form that are deemed to be clinically useful, or which provide a helpful organizing grouper, and that can be sufficiently defined, may be included in the 736542009 |Pharmaceutical dose form (dose form)| hierarchy.

These concepts are used in modeling (medicinal product form) concepts in the International Release; they are not allowed to model (clinical drug) concepts in the International Release.

Naming

FSN

Use the following pattern for the FSN; align naming and case sensitivity with the FSN for the concept that is selected as the attribute value. For multiple intended sites, the intended sites must be in alphabetical order and separated by the word “and”.

Template:

<Dose form intended site FSN> dose form (dose form)
<Dose form intended site FSN> and <Dose form intended site FSN> dose form (dose form)

For example,

Conventional release cutaneous dose form (dose form)
Conventional release oral dose form (dose form)
Conventional release parenteral dose form (dose form)
Conventional release ear and eye and nose drops (dose form)

Use the following pattern for the PT; align naming and case sensitivity with the PT for the concept that is selected as the attribute value. For multiple intended sites, the intended sites must be in alphabetical order and separated by the word “and”.

Template:

<Dose form intended site PT> dose form (dose form)
<Dose form intended site PT> and <Dose form intended site PT> dose form (dose form)

For example,

Cutaneous dose form
Oral dose form
Parenteral dose form
Ear and eye and nose drops

Synonyms are not allowed unless explicitly identified as an exception in the Editorial Guidelines.

Optional

Pharmaceutical dose form grouper concepts based on intended site shall be modeled using the proximal primitive modeling pattern.

Pharmaceutical Dose Form Grouper Without Basic Dose Form

Overview

Pharmaceutical dose form grouper concepts that do not include a basic dose form but are deemed to be clinically useful and that can be sufficiently defined will be included in the 736542009 |Pharmaceutical dose form (dose form)| hierarchy.

Naming

FSN

For concepts with 736472000 |Has dose form administration method (attribute)| = 738996007 |Spray (administration method)|, use the following pattern for the FSN; align naming and case sensitivity with the FSN for the concept that is selected as the attribute value. For multiple intended sites, the intended sites must be in alphabetical order and separated by the word “and”.

Template:

<Dose form release characteristic> <Dose form intended site FSN> <Dose form administration method> (dose form)

For example,

Conventional release cutaneous spray (dose form)
Conventional release nasal spray (dose form)
Conventional release sublingual spray (dose form)

For concepts representing drops with 736472000 |Has dose form administration method (attribute)| = 738994005 |Instill (administration method)|, use the following pattern for the FSN; align naming and case sensitivity with the FSN for the concept that is selected as the attribute value. For multiple intended sites, the intended sites must be in alphabetical order and separated by the word “and”.

Template:

<Dose form release characteristic> <Dose form intended site FSN> <Dose form administration method> (dose form)

For example,

Conventional release nasal drops (dose form)
Prolonged-release eye drops (dose form)

For concepts representing drug delivery systems, use the following pattern for the FSN; align naming and case sensitivity with the FSN for the concept that is selected as the attribute value. For multiple intended sites, the intended sites must be in alphabetical order and separated by the word “and”.

Template:

<Dose form release characteristic> <Dose form intended site FSN> drug delivery system

For example,

Prolonged-release intrauterine drug delivery system (dose form)
Prolonged-release transdermal drug delivery system (dose form)

For concepts with 736472000 |Has dose form administration method (attribute)| = 738996007 |Spray (administration method)|, use the following pattern for the PT; align naming and case sensitivity with the PT for the concept that is selected as the attribute value. For multiple intended sites, the intended sites must be in alphabetical order and separated by the word “and”. Exclude <Dose form release characteristic> when = 736849007 |Conventional release (release characteristic)|.

Template:

<Dose form release characteristic> <Dose form intended site FSN> <Dose form administration method>

For example,

Cutaneous spray
Nasal spray
Sublingual spray

For concepts representing drops with 736472000 |Has dose form administration method (attribute)| = 738994005 |Instill (administration method)|, use the following pattern for the PT; align naming and case sensitivity with the PT for the concept that is selected as the attribute value. For multiple intended sites, the intended sites must be in alphabetical order and separated by the word “and”. Exclude <Dose form release characteristic> when = 736849007 |Conventional release (release characteristic)|.

Template:

<Dose form release characteristic> <Dose form intended site FSN> <Dose form administration method>

For example,

Nasal drops
Prolonged-release eye drops

For concepts representing drug delivery systems, use the following pattern for the PT; align naming and case sensitivity with the PT for the concept that is selected as the attribute value. For multiple intended sites, the intended sites must be in alphabetical order and separated by the word “and”. Exclude <Dose form release characteristic> when = 736849007 |Conventional release (release characteristic)|.

Template:

<Dose form release characteristic> <Dose form intended site FSN> drug delivery system

For example,

Prolonged-release intrauterine drug delivery system (dose form)
Prolonged-release transdermal drug delivery system (dose form)

A synonym matching the FSN is required; additional synonyms are not allowed unless explicitly identified as an exception in the Editorial Guidelines.

Exceptions:

Synonyms with eye instead of ocular, ear instead of otic, or nose instead of nasal may be created.

Optional

Grouper concepts concepts that do not include a basic dose form shall be modeled using the proximal primitive modeling pattern.

Pharmaceutical Dose Form Supporting Hierarchies

The 736542009 |Pharmaceutical dose form (dose form)| subhierarchy of 362981000 |Qualifier value (qualifier value)| contains concepts which support the Medicinal product model.

Editorial guidelines for the supporting hierarchies required to support creation of sufficiently defined pharmaceutical dose form concepts are documented in the following sections.

Basic Dose Form

Overview

The basic dose form represents a general type of pharmaceutical formulation (e.g., tablet, capsule, cream, ointment, solution, emulsion) used for medicinal products. To support fully defining concepts in the 736542009 |Pharmaceutical dose form (dose form)| hierarchy, a hierarchy representing basic dose form is required.

The 736478001 |Basic dose form (basic dose form)| hierarchy is a descendant of 362981000 |Qualifier value (qualifier value)|.

Modeling

Descendants shall be modeled as follows.

Use the following pattern for the FSN; align naming and case sensitivity with the FSN for the concept that is selected as the attribute value, excluding the semantic tag.

Template:

Basic dose form with <State of matter> state of matter (basic dose form)

For example,

Basic dose form with liquid state of matter (basic dose form)
Basic dose form with solid state of matter (basic dose form)

Use the following pattern for the PT; align naming and case sensitivity with the PT for the concept that is selected as the attribute value.

Template:

<State of matter PT> state of matter

For example,

Liquid dose form
Solid dose form

A synonym to match the FSN is required.

Additional synonyms are not allowed unless explicitly identified as an exception in the Editorial Guidelines.

Preferred; not required.

Use the following pattern for the FSN where X is the basic dose form:

X (basic dose form)

For example,

Cream (basic dose form)
Gel (basic dose form)
Suppository (basic dose form)
Tablet (basic dose form)

Exceptions:

Plural form to be used for Granules (basic dose form)

Use the following pattern for the PT where X is the basic dose form:

For example,

Cream
Gel
Suppository
Tablet

Exceptions:

Plural form to be used for Granules

Synonyms are not allowed unless explicitly identified as an exception in the Editorial Guidelines.

Text definitions are not required but are encouraged.

Dose Form Administration Method

Overview

The dose form administration method represents a general type of method of administration (e.g., apply, chew, spray, swallow) that a dose form is designed to be administered by (e.g. a chewable tablet is formulated to be administered by chewing). To support fully defining concepts in the 736542009 |Pharmaceutical dose form (dose form)| hierarchy, a hierarchy representing dose form administration method is required.

The 736665006 |Dose form administration method (administration method)| hierarchy is a descendant of 362981000 |Qualifier value (qualifier value)|.

Naming

FSN

Use the following pattern for the FSN where X is the administration method and is in the form of an imperative:

X (administration method)

For example,

Administer (administration method)
Apply (administration method)
Instill (administration method)
Spray (administration method)
Swallow (administration method)

Use the following pattern for the PT where X is the administration method:

For example,

Administer
Apply
Instill
Spray

Synonyms are not allowed unless explicitly identified as an exception in the Editorial Guidelines.

Preferred; not required.

Dose Form Intended Site

Overview

|Dose form intended site| should not be confused with route of administration, which is a concept used in dosage instructions for the administration of a particular medicinal product to a particular patient.

Naming

FSN

Use the following pattern for the FSN where X is the intended site:

X (intended site)

For example,

Oral (intended site)
Otic (intended site)
Parenteral (intended site)
Vaginal (intended site)

Use the following pattern for the PT where X is the intended site:

For example,

Oral
Otic
Parenteral
Vaginal

Synonyms are not allowed unless explicitly identified as an exception in the Editorial Guidelines.

Preferred; not required.

Dose Form Release Characteristic

Overview

736480007 |Dose form release characteristic (release characteristic)| represents a general type of pattern of release (e.g., conventional, modified, delayed, prolonged) of the active ingredient substance(s) from the dose form.

|Dose form release characteristic (release characteristic)| is a descendant of 362981000 |Qualifier value (qualifier value) that supports fully defining the 736542009 |Pharmaceutical dose form (dose form)| hierarchy.

Naming

FSN

Use the following pattern for the FSN where X is the release characteristic, adding a hyphen when appropriate Combined release-characteristic concepts may be created to support modeling of concepts that display multiple release characteristics in a single formulation.

X (release characteristic)

For example,

Conventional release (release characteristic)
Delayed-release (release characteristic)
Prolonged-release (release characteristic)*
Modified-release (release characteristic)**
Delayed-release and prolonged-release (release characteristic)

Use the following pattern for the PT where X is the release characteristic, adding a hyphen when appropriate:

For example,

Conventional release
Delayed-release
Prolonged-release
Modified-release

Synonyms are not allowed unless explicitly identified as an exception in the Editorial Guidelines.

Preferred; not required.

Dose Form Transformation

Overview

736477006 |Dose form transformation (transformation)| represents a process where a dose form is transformed from that supplied by the manufacturer into a new dose form, usually to make it suitable for administration (e.g., dissolving a "powder for solution for injection" dose form into a "solution for injection" dose form). This may occur as part of the dispensing act or immediately before administration.