Represents a saleable unit of a medicinal product. This unit will typically (but not necessarily) contain a number of doses of medicine in one package, e.g., a 30 tablet bottle, a 20 ml tube. This class exists because different size containers will have different inventory codes and it is the packaged product that is generally associated with the manufacturing lot in which it was produced. For example, a 30 count bottle will have a different NDC than a 60 count bottle. Also, for manufacturing practicalities, the manufacturing lot and expiration date are on the bottle, not on each tablet. "A product in a container, or package. Represents the entirety of a product that has been packaged in a container for sale or supply; this representation of the Packaged Medicine may be in its real or actual form as something made, or described more conceptually, generically, or virtually, but it must represent a product contained in a package." - HL7 V3 Note that an important difference exists between the FHIM Packaged Medicinal Product and the nascent FHIR Medication.Package construct in that the FHIM does not adequately describe those situations where one has more than one drug form in the same package. For example, a package that has both an injectable liquid and a lotion. The FHIR Medication.Package appears to separate the contents better. The FHIM may in the future incorporate a separation of the drug forms into separate classes.

A product is any tangible or intangible good or service that is a result of a process and that is intended for delivery to a customer or end user. More specifically for the purposes of the FHIM Common Product model, a product is a commodity offered for sale; an article of commerce; a kind of merchandise that is involved in the provision of healthcare (e.g., an x-ray machine), consumed during the provision of care (e.g., a prosthesis, a medication, a bandage), or is itself the subject of healthcare-related activities (e.g., testing the surface of a machine for pathogens, testing food for food-borne pathogens). This class deals with things that can be ordered, purchased, consumed, administered, maintained, and/or disposed of even if the thing is originally naturally occurring. However, do not use this class to indicate that a patient is allergic to eggs. Use Substance for generic eggs. But to order a gross of Farmer Smith’s eggs, or to test an egg from a box of Farmer Smith’s eggs, this class is appropriate. Note that in situations where the same product may be sold in "saleable units" of different sizes, this class defines the product itself, whereas the saleable units are described in other classes. For example, if Pfizer sells Lipitor 40 MG Tablets in a 30 count bottle and a 90 count bottle, the product in those bottles is identical (and indeed may have come from the same manufacturing lot), but the bottles have different National Drug Codes. In this example, this class would contain Pfizer Lipitor 40 MG Tablet, while the PackagedMedicinalProduct class will contain information about the 30 and 90 count saleable units.

Placeholder for some act that causes the "countdown" to start where a product must be used within a certain time. For example, a product may need to be used within 30 days of opening the package, or within 24 hours from when a drug was reconstituted.

"The production specification such as component revision, serial number, etc." - HL7 FHIR, DeviceComponent.productionSpecification

A reprocessor is an organization that performs additional processing and manufacturing upon a existing device that has previously been used on a patient such that it can be used again on another (or the same) patient.

"Procedure request to obtain this biologically derived product." - HL7 FHIR, BiologicallyDerivedProduct.request

Substance: "The tangible matter of which a thing consists; a specific type of matter, esp. a homogeneous material with a definite composition." - Collins English Dictionary This class represents a substance, either manufactured or found naturally, which might be referenced by clinical records. This class may represent ingredients in a medication, a substance to which the patient was exposed or which the patient consumes, or an analyte, among many other potential uses. "The Substance entity is used to describe any material that functions as an ingredient of the Medicine." - HL7 Version 3. "The actual ingredient - either a substance (simple ingredient) or another medication." - HL7 FHIR, Medication.ingredient.item[x] "A homogeneous material with a definite composition." - HL7 FHIR, Substance

"A substance can be composed of other substances." - HL7 FHIR, Substance.ingredient

"Substance may be used to describe a kind of substance, or a specific package/container of the substance: an instance." - HL7 FHIR, Substance.instance

This class records information that can identify and track devices through distribution and use. This information is or will be required by multiple jurisdictions; currently the United States Food and Drug Administration (FDA) is the first jurisdiction to issue regulations on Unique Device Identifiers. Other countries will likely use the same identifiers or will require some variant, which will be included in this class in the future. See: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification "In 2013, the FDA released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device labelers to include a unique device identifier (UDI) on device labels and packages.... Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use. A UDI is a unique numeric or alphanumeric code that consists of two parts: a) a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and b) a production identifier (PI), a conditional, variable portion of a UDI that identifies such things as: i) the lot or batch number within which a device was manufactured; ii) the serial number of a specific device; iii) expiration date of a specific device; iv) the date a specific device was manufactured; v) and others." - from FDA "UDI Basics" website "Unique device identifier (UDI) assigned to device label or package." - HL7 FHIR, Device.udi

Vehicle: "A substance of no therapeutic value that is used to convey an active medicine for administration." - Stedman's Medical Dictionary When a medication is created by a pharmacist or by a clinician by compounding two or more ingredients, this class represents the ingredient(s) into which the active medication is dissolved or mixed in order to transport the medication to the intended site or to ease in administration. Common examples include mixing medications in flavored syrup for children, reconstituting a dried medication in distilled water, or mixing a medication into a cream for topical application. In the example of Acetaminophen 120 MG/5ML cherry-flavored Elixir, this class represents the 5 ml of cherry flavored syrup. "Defines the volume measurement in which the drug strength concentration is contained. For example, Acetaminophen 120 MG/5ML Elixir means that 120 MG of the drug is in a solution with a volume of 5 ML." - HL7 Version 2.8, RXO-25.