Additive: "A substance added in small amounts to something else to improve, strengthen, or otherwise alter it." - 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 medication ingredient(s) that is dissolved into or mixed into some medium 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 120 mg of Acetaminophen.

"Contains the identifier of the medical substance/treatment administered.... If the substance administered is a vaccine, CVX codes may be used to code this field...." - HL7 Version 2.8, RXA-5 “A role for the product when merely refered to as one that might be administered. This is the role through which the product model would be entered for electronic prescribing.” – HL7 Version 3 (Role->AdministerableMaterial). "Identifies the medication that was administered. This is either a link to a resource representing the details of the medication or a simple attribute carrying a code that identifies the medication from a known list of medications." - HL7 FHIR, MedicationAdministration.medication[x]

Biological products, also known as biologics, "replicate natural substances such as enzymes, antibodies, or hormones in our bodies. [They] can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues. Biologics are made from a variety of natural resources - human, animal, and microorganism - and may be produced by biotechnology methods. Gene-based and cellular biologics... may make it possible to treat a variety of medical conditions, including illnesses for which no other treatments are available." - FDA 101 "A material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity." - HL7 FHIR, BiologicallyDerivedProduct. Note that the FHIR BiologicallyDerivedProduct resource combines both type-level and instance-level properties into a single resource; the FHIM separates these into two classes (BiologicProduct and BiologicProductInstance), which reference each other.

"A material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity." - HL7 FHIR, BiologicallyDerivedProduct. Note that the FHIR BiologicallyDerivedProduct resource combines both type-level and instance-level properties into a single resource; the FHIM separates these into two classes (BiologicProduct and BiologicProductInstance), which reference each other.

Identifies a class of devices characterized by their manufacturer, model name/number, software version, etc. This class differs from the Device Instance class in that this class represents all instances of a kind of device whereas the Device Instance class represents one individual. For example, the Device class might describe a Color LaserJet Model CMJ1312 made by Hewlett Packard. The DeviceInstance class might describe the individual Color LaserJet Model CMJ1312 that has serial number 1234. "A contrivance or an invention serving a particular purpose, especially a machine used to perform one or more relatively simple tasks." (The American Heritage Stedman's Medical Dictionary). "A ManufacturedMaterial used in an activity without being substantially changed through that activity." - HL7 V3

"Describes the calibrations that have been performed or that are required to be performed." - HL7 FHIR, DeviceMetric.calibration

"Describes the characteristics, operational status and capabilities of a medical-related component of a medical device." - HL7 FHIR, DeviceComponent

This class identifies an individual device. The Id property is commonly known as a serial number. "Identifies the Equipment Instance (e.g., Analyzer, Analyzer module, group of Analyzers, etc.) responsible for the production of the observation...." - HL7 Version 2.8, OBX-18.

"Describes a measurement, calculation or setting capability of a medical device." - HL7 FHIR, DeviceMetric

"A record of a device being used by a patient where the record is the result of a report from the patient or another clinician."- HL7 FHIR, DeviceUseStatement

Dispense: "To make up and distribute (medicine), especially on prescription." – Dictionary.com A Medicinal Product Instance or a Locally Manufactured Product (which is made up of Medicinal Product Instances) that was distributed to the Patient or the Patient’s care giver.

A categorization of a medication. Medications may be classified by various characteristics including Mechanism of Action, Mode of Action, Therapeutic Effect, Chemical Action, Pharmacokinetics, etc. These categorizations are used for multiple purposes including clinical decision support, drug-drug interaction checks, and drug-allergy interaction checks.

“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).” – HL7 Version 3 (Role->Ingredient). "Identifies a particular constituent of interest in the product." - HL7 FHIR, Medication.ingredient

This class provides an indication of what methodology was used to calculate the price of a medication. There are multiple methods acceptable to or mandated by payer organizations. "Code indicating the method by which [the Ingredient Cost Submitted field] was calculated." - NCPDP Telecommunication (Field 423-DN, Data Dictionary 201104).

“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).” – HL7 Version 3 (Role->Ingredient).

Food: "Any nourishing substance that is eaten, drunk, or otherwise taken into the body to sustain life, provide energy, promote growth, etc." - Dictionary.com This Class describes a manufactured or distributed product intended for human or animal consumption. This class may be referenced by a nutrition order or by food safety related activities, among other uses. Note that the phrase "manufactured or distributed" is intended to include produce that has been harvested, for example a pineapple harvested and sold by the Dole corporation, or frozen shrimp harvested and sold by the Bubba Gump corporation.

This class identifies an individual saleable unit of a food product such as a bottle of Ensure, and is used to convey information about the actual food product provided to a patient. Note that ordinarily, a product instance would be expected to have an Id property (commonly known as a serial number), however few food products are identified individually. The association to manufacturing lot provides a lot number, which is usually the information of interest for tracking adverse events or responding to manufacturer recalls.

"The non-proprietary, generic substance as which the same medicines is known in the literature independent of a specific manufacturer." - HL7 V3

A Device Instance that was embedded into a Patient. This class is used to describe a manufactured item (which may include biological material) that is or was at one time introduced into the Patient’s system.

A labeler is an organization that repackages medicinal products for sale. In some cases a manufacturer is also the labeler.

A product that was created by a pharmacist or by a clinician by compounding two or more ingredients. 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.

"Any manipulation of product post-collection that is intended to alter the product. For example a buffy-coat enrichment or CD8 reduction of Peripheral Blood Stem Cells to make it more suitable for infusion." - HL7 FHIR, BiologicallyDerivedProduct.manipulation

The organization that produced an item of interest. Note that this is a broad definition in that food products and biologically derived products are not manufactured per se, but are harvested, packaged, and distributed like other manufactured products. Therefore, we are using the term Manufacturer to include the organization from which a food product or a biologically derived product originated. "Contains the manufacturer of the medical substance administered when it is a manufactured substance." - HL7 Version 2.8, RXD-20. "Describes the details of the manufacturer of the medication product. This is not intended to represent the distributor of a medication product." - HL7 FHIR, Medication.manufacturer

This class identifies a batch of material or products that were manufactured over a defined time period. The definition of a batch or lot is determined by the manufacturer, based in part on the nature of the manufacturing process, and on the historical information that can be accessed (such as the shipment of raw materials used, the equipment used, quality assurance tests, etc.) by the use of the lot number. The purpose of this class in the FHIM is to contain lot identifier and expiration date information about a product to facilitate inventory control processes, manufacturer recall processes, and adverse event reporting. "Information that only applies to packages (not products)." - HL7 FHIR, Medication.batch

“A specification of a kind of medicine, food material, or any product for the purpose of (a) describing a specific product with classification categories and (b) referring to a kind of product or material for describing drug-drug interactions or adjunct treatments. The classifying category may refer to any of various classifications and abstractions of products by any aspect, including, mechanism of action category, physiologic effect category, chemical structure category, or "clinical drug" category. This may also be used to represent a specific material or an ingredient when specifying drug-drug interactions or adjunct treatments.” – HL7 Version 3 (Material->MaterialKind).

Medicinal Product: Any substance or combination of substances presented for treating or preventing disease or with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals. – adapted from UK Nursing and Midwifery Council Directive 65/65/EEC Represents a product produced and marketed as a medicine or drug. This class represents the product irrespective of the container size in which it is packaged. For example, if a product is marketed in bottles of 30 tablets and bottles of 60 tablets, this class describes the product (i.e., the tablets and the characteristics of those tablets), whereas the Packaged Medicinal Product class describes the characteristics peculiar to each kind of saleable product.

This class identifies an individual saleable or dispensable unit of medication, and is used to convey information about the actual drug produced, dispensed, or administered. Note that the Id property (commonly known as a serial number) would be used to identify the saleable unit. It is widely anticipated that saleable units will have such Ids in the future, but it is currently not common practice. "A product instance is (a) an individual product instance, i.e., an individually identified thing with a serial number; (b) a product lot, i.e., a set of things of the same kind (e.g., 1000 for expressing a number of tablets) or an amorphous mass (e.g., 100 L of a liquid raw material), or (c) any subset, member, or portion of a product lot. The distinction between an individual thing and a lot is made in the quantity attribute, which is set to 1 (one) for individual items, or any number e.g., 1000 or amount 100 L for sets of things or amorphous masses respectively." - HL7 Version 3.

A needle is either "a slender, solid, usually sharp-pointed instrument used for puncturing tissues, suturing, or passing a ligature around or through a vessel" - Farlex Partner Medical Dictionary, or "a fine hollow tube, with a cutting tip, used to access subdermal tissues; used in conjunction with a syringe to administer fluid agents (e.g. local anesthetic), collect blood or aspirate fluids." - Illustrated Dictionary of Podiatry and Foot Science. This class represents a needle which may be specified in a protocol, a procedure order, or in the documentation of a procedure performed. While we are primarily thinking of hollow needles, this class can be used for both solid and hollow needles as the properties of gauge and length apply to both. It is noted that needles are technically a kind (i.e., a subtype) of Device, but we have modeled Needle as a type of Product, since needles are fungible commodities and because there is no need to assign or track serial numbers to individual needles.

A radiopharmaceutical used in the diagnosis, management, and treatment of disease.

This class represents a medication or pharmacy-stocked item that can be ordered by a prescribing clinician and ultimately dispensed to the patient or a caregiver for the patient. This class points to the Product hierarchy, which may be downcast as needed to indicate the medicinal product (e.g., using an RxNorm code) or the packaged medicinal product (e.g., the NDC code).