Design Comments: A text description of the product. While the data type ED would allow for a full product monograph to be carried in this attribute, this practice is to be avoided, because product monograph document structures (Structured Product Labeling) should be used instead for such documents. The description attribute is mainly to be used for brief descriptions which users of product catalogs can use to quickly distinguish this product from other similar products in a list of products.

Design Comments: Indicates a type of hazard or threat associated with the product.

Design Comments: An indicator of special handling requirements for the product. E.g., keep at room temperature, store upright.

Design Comments: The principle form of a product, such as dosage form of a medicine. Values may be drawn from the MaterialForm HL7 vocabulary table or from other external code value sources. Notice the difference between an (Administered) Medicine and a PackagedMedicine. Both have formCodes. A box or vial is usually not a medicine Product.formCode but a PackageProduct.formCode, unless the entire box or the entire vial is meant for direct administration as a single unit. In principle, the formCode is a very coarsely-grained (high level) product class that focuses on physical appearance. At the top, it usually distinguishes between physical state of matter (solid, liquid, gaseous), and, because solids may be amorphous (e.g., powders), would allow distinguishing solid shaped from amorphous masses. The former can be individually handled and counted, whereas the latter (amorphous masses) can only be measured and require primary containers for handling. Thus the formCode has implications for how the product is quantified (counted vs. measured) and whether a primary container (e.g., vial) may be expected.

Design Comments: The amount of time after date of manufacture that the manufacturer no longer ensures the safety, quality, and/or proper functioning of the material. Only the interval width is valued.

Design Comments: This role links the product (optionally) with the manufacturer of that product. Used when the entry point is the Product (E_ProductKind). When entry point is ManufacturedProduct (E_ProductListed) this manufacturer role should not be used.

Design Comments: A role representing the relationship between the product as contained in a package and its package. For example, insulin injectable liquid in a vial; tablets in a bottle.

Design Comments: Links the product as a component of a system or assembly. The system may be a defined product labeled elsewhere or it may be an anonymous product which is only used to specify that additional parts are also needed to make that system complete.

For example, a hose system used within several intravenous infusion pump systems would refer to those pump systems but would not describe the pump systems in detail. On the other hand, the label for one of those pumps (not including the hose system) would have to refer to the hose system in a similar manner.

The line:

<manufacturedProduct>

<code ... />

<name>FlexiFuse Line</name>

<asPartOfAssembly>

<wholeProduct>

... no code specified here ...

<part>

<partProduct>

<code ... />

<name>PreciFuse Pump</name>

</partProduct>

</part>

</wholeProduct>

</asPartOfAssembly>

</manufacturedProduct>

The pump itself:

<manufacturedProduct>

<code ... />

<name>PreciFuse Pump</name>

<asPartOfAssembly>

<wholeProduct>

... no code specified here ...

<part>

<partProduct>

<code ... />

<name>FlexiFuse Line</name>

</partProduct>

</part>

</wholeProduct>

</asPartOfAssembly>

</manufacturedProduct>

Notice that in either case the assembly itself remains anonymous because it has not a defined product code. Notice also that the pump itself does not come with the line, and hence the line cannot be described as a component of the pump.

However, let's assume that that same FlexiFuse line is also a part of kit comprised of the portable version of the PreciFuse Pump product and 10 such lines. In that case the kit that is sold under a specific registered product code would also be specified as an assembly with a code. In that case the other parts of the assembly need not be described:

<manufacturedProduct>

<code ... />

<name>FlexiFuse Line</name>

<asPartOfAssembly ... />

<asPartOfAssembly ... />

<asPartOfAssembly ... />

<asPartOfAssembly>

<wholeProduct>

<code .../>

<name>PreciFuse PorterPump Kit</name>

</wholeProduct>

</asPartOfAssembly>

</manufacturedProduct>

and the kit would be described as:

<manufacturedProduct> <code ... /> <name>PreciFuse PorterPump Kit</name> <formCode ... KIT .../> <part> <quantity value="1"/> <partProduct> <code .../> <name>PreciFuse PorterPump</name> </partProduct> </part> <part> <quantity value="10"/> <partProduct> <code .../> <name>FlexiFuse Line</name> </partProduct> </part> </manufacturedProduct>

Design Comments: Specifies the original innovator product which is the reference product for a generics product. This class allows referencing the original innovator or reference product as a MaterialKind on the scoper-end of this role, and a code specifying precisely in what way this product is bio-equivalent to the reference product (equivalence evaluation code).

Design Comments: Relates a multiple-component product to one of its components. For example, relates a contraceptive product to its separate estrogen and progestin tablets in a single container. The quantity of each part is represented as the Part.quantity. (The quantity of the parent product would be "1" for a single wheel containing both medications in this example.)

Note the difference between part, ingredient and content. A part is a structural part, typically with an integral boundary and spatially distinguishable from other parts and the whole product. An ingredient is distributed throughout the product and not spatially distinct from other ingredients. A content is what is inside the lumen of a container and can in principle be emptied out of the container.

Design Comments: Relates a product (typically medicine) to a substance which it contains as an ingredient. Ingredients can be specified for medicines or other products, including devices, but they always mean the same thing: a material (here: chemical substance) in the make-up of the main product, not a structural part or content of a container, and not a material added later into a device for operation. For medicines and food this is obvious. For devices, an example for ingredient would be latex in a chest tube (but not an inhalant in a nebulizer device).

Design Comments: An identifier used by the manufacturer to indicate a particular product type or line. E.g., catalog number.

Design Comments: A name for the packaged product, usually the same as the name of the product (except where the name contains some reference to the packaging (e.g., "tempo super-pack", "tic-tac easy-box").

Design Comments: A text description of the packaged product. This may include a discussion of the container.

Design Comments: Captures the number of product units the package would contain if fully loaded.

Design Comments: The type of container cap. In some cases, it is important for this to be consistent with decapping, piercing or other automated manipulation. Notions such as "child-proof cap" or "resealable bag" may also be indicated here.

Design Comments: This role links the packaged product (optionally) with the manufacturer of that packaged product (distinguishable from the manufacturer of the product inside) and (more importantly) links the packaged product with the associated approval, policy, and characteristics and other information specifically applicable to that packaged product and distinguishable from other package products and the product inside.

Design Comments: A role representing the relationship between an (inner) package and its larger (outer) package. This is the standard way to describe "intermediate" packaging, which regularly occur with non-solid medicines. For example, a solution for injection (Medicine) is packaged in a vial (a primary package or sometimes called "intermediary" package) and then several such vials are packed in a carton. Notice that the vial is not the Medicine, it is the content in the vial which is the medicine; the vial is just a necessary packaging to hold the liquid.

Design Comments: Generalization to specify a classification to the Product, Substance or Moiety. For example, one can specify any or all of (a) cellular/molecular action (e.g., Ca-channel blocker); (b) physiologic effect (e.g., vasodilator); and (c) molecular/chemical class (e.g. aminopenicillin).

Design Comments: If specified, limits the time range when this identifier is or was valid for the product.

Design Comments: An identifier used by the manufacturer to indicate a particular product type or line. E.g., catalog number.

Design Comments: Links any of the roles played by the product to a variety of additional product information.

Design Comments: Labels a product, part, or package as the unitary item for uniform billing standards. For example, on the product in the form of a tablet to indicate that the product is billed by the tablet (each); to a product in cream form to indicate it is billed volume or mass; on a vial or sachet package to indicate it is billed by vial or sachet (each).

Design Comments: Allows indicating that the stated characteristic does not apply. Note: it is better to make a complete affirmative statement in the Characteristic itself, rather than relying on negation indicator in the participation. For example, rather than saying "pre 1938 product" with negationInd = true, say "post 1938 product" and leave the negation indicator at its default, false, meaning no negation.

Design Comments: May specify a certain use of the generalization relationship. Since things may be classified in various ways, this code may be used to allow systems with limited understanding of the classes to show the classes in distinguished slots (e.g., product by effect, by mechanism of action, by chemical nature, etc.) Note that this code can not influence the simple interpretation of the relationship as an "is-a" relationship, i.e., the specialized kind role should not be used to indicate classes that may sometimes hold but not all the time, or that only hold under specific considerations. The latter might be an example of a similarity relationship, for which the "equivalent entity" role should be used instead.

Design Comments: Activities that may "produce" the product in some way, such as the possible Supply activity and the reconstitution activity by which, e.g., a powder is being mixed with water to form a syrup or an injectible liquid. Currently these activities do not include the manufacturing activity proper, but if a use case for describing manufacturing activity arose, it would be one of the specializations of this "Production" choice.

Design Comments: Specifies that and how a product may be traded. This can distinguish a product which is only available as a field-reconstituted item but not sold in that form, from one that is sold. Or it can distinguish a product actually available in the market as a kit, from the parts of the kit that are not independently available.

May also indicate a list of suppliers that state that they supply this product (e.g. a local pharmacy has the medicine and can potentially dispense the medicine, or a wholesaler who carries the product in their catalog.)

This may also be the beginning of formulary data structures.

Design Comments: The activity of reconstituting a medication or other product for delivery and use. E.g., mixing powder with water to provide a solution.

Design Comments: Specifies the kind of production activity performed by an establishment.

Design Comments: An indication of the nature of the reconstitution activity.

Design Comments: Reveals the products used as inputs into the reconstitution activity.

Design Comments: Activities that may "produce" the product in some way, such as the possible Supply activity and the reconstitution activity by which, e.g., a powder is being mixed with water to form a syrup or an injectible liquid. Currently these activities do not include the manufacturing activity proper, but if a use case for describing manufacturing activity arose, it would be one of the specializations of this "Production" choice.

Design Comments: A Role of the Product (or Medicine) as a ManufacturedProduct. May be the main entry point to the Common Product Kind Model.

Design Comments: This Role.id is available to make specific references to the product use description from elsewhere in a document or message.

Design Comments: A relationship that links the product to its use as a device. Particularly, that links a device producing observations to the definitions of such observations, and a device that delivers therapeutic services to a definition of these services.

Design Comments: Links a Medicine as a ManufacturedProduct with the SubstanceAdministration definition representing the labeled route.

Design Comments: A choice between the simple SubstanceAdministration containing but a route code and full-featured administration instructions.

Design Comments: The only purpose of the SubstanceAdministration class in the Medicine model is to represent the labeled route.

Design Comments: #nosuffix

Design Comments: A code that provides information about the type of manufacturer activity that the performing entity is capable of carrying out.

Design Comments: A text description of the type of manufacturer activity that the performing entity is capable of carrying out.

Design Comments: A specification of the time period during which the performing entity is capable of carrying out the act in question.

Design Comments: Links the production activity to an establishment.

Design Comments: Activities that may "produce" the product in some way, such as the possible Supply activity and the reconstitution activity by which, e.g., a powder is being mixed with water to form a syrup or an injectible liquid. Currently these activities do not include the manufacturing activity proper, but if a use case for describing manufacturing activity arose, it would be one of the specializations of this "Production" choice.

Design Comments: A code specifying in what way the equivalent entity (player) is considered equivalent to is reference entity (scoper). This is used to reference materials submitted from another source (e.g., repackagers, OTC, etc.) Examples: no known or suspected bioequivalence problems; potential bioequivalence problems have been resolved with evidence supporting bioequivalence; bioequivalence problems have not been fully resolved.

See also: U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Approved drug products with therapeutic equivalence evaluations. Available from: http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm.

Design Comments: The identifier for the product in the context of its being part of another product. This is used in order to make specific references to a product as part of another.

Design Comments: A ratio specifying the amount of a part (numerator) in an amount (denominator) of the whole Medicine. It is important to note that as all Role quantities the numerator and denominator stand for the amount of the exact kind of entity specified as the part and whole respectively, and not something else. For example, when the medicine is a kit with tablets being the parts, the numerator numbers the amount of tablets of the same kind in the kit. However, if the kit consists of 2 vial-packaged liquids, each vial holding 3 mL, the part quantity specifies the total amount of this liquid (e.g. 6 mL), not 2 (vials). Thus all quantities have the exact same interpretation which is important to draw any quantitative inference from these relationships (e.g. "how much ingredient is in a package?").

Design Comments: An identifier to establish mostly internal references as a SubstanceAdministration.consumable for the unambiguous specification of dose quantity without having to repeat the entire content. Example:

<section ... DESCRIPTION ...> <subject> <manufacturedProduct> <manufacturedProduct> <ingredient classCode="ACTIM"> <id root="60a4db80-573d-11db-b0de-0800200c9a66"/> <quantity .../> <ingredientSubstance .../> </ingredient> </manufacturedProduct> </manufacturedProduct> </subject> </section> ... <section ... DOSAGE AND ADMINISTRATION ...> <excerpt> <highlight> <substanceAdministration> ... <consumable> <ingredient classCode="ACTIM"> <id root="60a4db80-573d-11db-b0de-0800200c9a66"/> </ingredient> </consumable> ... </substanceAdministration> </highlight> </excerpt> </section>

Design Comments: Sometimes be used to indicate the ingredient is no longer used but was in the product during the time given. Notice that as product information is maintained over time, other information may also be outdated, and this time range may not be the most complete manner to keep this history information. If the effectiveTime is not specified (as it would usually be the case), the meaning is that there is no specific limit of validity of the ingredient information, and that the information is indeed valid at the time it was originally composed.

Design Comments: Used to indicate that the manufacturer considers the presence of the ingredient a trade secret. This could be the case for inactive ingredients.