Pharmaceutical Dose Form

Editorial guidelines for the  736542009 | Pharmaceutical dose form (dose form)| hierarchy and for supporting hierarchies required to support creation of sufficiently defined pharmaceutical dose form concepts are documented in the following pages.

General Assumptions and Requirements

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 763158003 | Medicinal product (product)| 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.

Out of Scope

• Concepts representing combined dose forms (e.g. single concepts describing the multiple dose forms found in kit products such as cream and pessary)
• Concepts in pattern "x for y for z" (e.g. Powder for concentrate for dispersion for infusion)
• Concepts representing proprietary dose forms

Overview

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.

For the purposes of the following editorial guidelines, pharmaceutical dose form refers to the physical manifestation of a medicinal product that contains the active ingredient substance(s) and inactive ingredient substances that are intended for administration for the patient.

Dose form intended site vs. Route of administration

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.

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