HL7 Medication and UKCPRS HL7, Medication and UKCPRS - Julie James 11 December 2003 HL7 Medication and UKCPRS Julie James Partner Blue Wave Informatics

HL7 Medication and UKCPRS HL7, Medication and UKCPRS - Julie James 11 December 2003 HL7 Medication and UKCPRS HL7 Medication – Messaging about Medicines The Pharmacy D-MIM Describing the Medicine Using the dm+d (UKCPRS) to describe a Medicine in a Message

HL7 Medication – Messaging about Medicines HL7, Medication and UKCPRS - Julie James 11 December 2003 HL7 Medication – Messaging about Medicines Medication Information Special Interest Group (Med Info SIG) Messaging about the Patient-Clinician-Medicine interaction Prescribing medicines Dispensing and supplying medicines Administering medicines Querying about individual patient’s medication(s) Patient Safety Special Interest Group Messaging about Adverse Events that Medicines may cause (the “Yellow Card”) – the Individual Case Safety Report (ICSR) Regulatory and Clinical Research Information Management Technical Committee (RCRIM) The “Structured Product Label” (representation of the Summary of Product Characteristics [SmPC] in a structured format, for clinical and regulatory use Pat Safety SIG Will do messages to support the “systems” errors for medicines in the future (NPSA type reporting)

HL7, Medication and UKCPRS - Julie James 11 December 2003 The Pharmacy DMIM Core components are the Substance Administration Act and the Supply Act – administering a medicine in(to) a patient, and supplying a medicine for use. The “Medicine” description entities (medicine and pack) can be clearly seen on the right hand side

Describing the Medicine HL7, Medication and UKCPRS - Julie James 11 December 2003 Describing the Medicine The Importance of the correctly describing a Medicine HL7 Information Model (the RIM) for messaging Realm-specific (use case driven) Terminology Model for description The need for Harmonisation The Medication CMETs (harmony, not melody) One of the foundations of good therapeutics is ensuring that the patient receives the “correct” medicine. One of the key features of this is the description of that “correct” medicine, so that everyone understands and interprets it in a consistent way. HL7 uses an Information model, not a terminology model. If we try to put a terminology model, that is, something that fully supports how we describe medicines, into the message model, it all gets very difficult, as we do this differently depending on our use cases. International collaborative effort has produced an understanding of the most foundational elements of the various terminology models, which can then be reflected back into the messaging model in the most generic, and therefore widely applicable form, with good understanding of how to sensibly constrain this for realm specific use - Harmony. From this, therefore, the messaging model has two key structures to support description of the medicine in the message: Medicinal Product CMET Medicinal Product Package CMET

Material Medicinal Product - Universal HL7, Medication and UKCPRS - Julie James 11 December 2003 Material Medicinal Product - Universal Equivalent concepts (e.g. brand/generic) can be represented here The medicine’s manufacturer can be represented using the role of “manufactured by” and “manufacturer” entity The medicine entity plays the role of “ordered medicine” The CMET is entered via the role of “Ordered Medicine” from the Substance Administration Act, and describes the medicine that is to be/has been administered to the patient. Because of the variations in patterns of information elements used in prescribing a medicine for a patient, the description of the medicine is abstracted such that all the known patterns can be accommodated within this CMET and the associated Substance Administration act (route, dosage, frequency etc.). Ordered Medicine - Role The “Medicine” entity plays the role of “Ordered Medicine” , which has a role class code of Therapeutic Agent [A manufactured material (player) that is used for its therapeutic properties.] Medicine - Entity Class code - Manufactured material [A subtype of Material representing an Entity or combination of Entities transformed for a particular purpose by a non-natural or manufacturing process] Determiner code - kind Code - the unique electronic “code” for the medicine, and its text name – a dm+d core code Form code * - for therapeutic substances, this is the “dose form” code Manufactured by - Role The “Medicine” may be {0..1} manufactured by a pharmaceutical manufacturer. This is represented by the role of “ManufacturedBy” which again has a role class code of Therapeutic Agent [A manufactured material (player) that is used for its therapeutic properties.] This role is scoped by the entity of “Manufacturer” Class code - ORG [An Entity representing a formalized group of entities with a common purpose (e.g. administrative, legal, political) and the infrastructure to carry out that purpose] Determiner code - Instance Code - unique electronic “code” for the pharmaceutical manufacturer, and its formal text name; a dm+d manufacturer/supplier code Name * - [A non-unique textual identifier or moniker for the Entity] - the “common” text name for the manufacturer Equivalence - Role The “Medicine” as described in the Medicine Entity may have equivalent descriptions that are required to be present in a message. These are carried using the role relationship “Equivalent” Class Code - needs creation of new vocabulary to describe the role relationship between equivalent medicines Code - needs creation of new vocabulary to describe the nature of the equivalence between equivalent medicines (e.g. brand-generic; “orange book” etc.) Ingredients The message may require the description of its ingredients, with or without strength information. This will be particularly important when a “magisterial” medicine (i.e. one that is extemporaneously prepared according to an individually prescribed “recipe”) is being used. This information is carried using the role relationship of “Ingredient Strength”, which is scoped by the Medicine itself, and played by the entity of “Ingredient”. The role “IngredientStrength” has Class code - Ingredient [relates the component {the ingredient} to the scoper {the mixture - the Medicine}] - this can be either active ingredient(s) or excipient(s) (inactive ingredient(s)) Quantity - the amount of the ingredient present in the Medicine The entity “Ingredient” has Class code - Manufactured material Determiner code - Kind Code - the entity code for the Ingredient(s) Name - the common text name for the ingredient(s) The medicine’s ingredients can be represented using the role of “ingredient strength” and “ingredient” entities

Material Medicinal Product - Identified Just carry the dm+d identifier for the medicine in here

Material Medicinal Product Pack - Universal HL7, Medication and UKCPRS - Julie James 11 December 2003 Material Medicinal Product Pack - Universal The supplied medicine entity scopes the role of “pack of” The supplied medicine entity plays the role of “supplied medication” The CMET is entered via the role of “Supplied Medicine” from the Supply Act, and describes the medicine that is to be/has been supplied, either directly to the patient or to a ward/unit. It represents a real world object of will be or has been supplied The “Supplied Medicine” plays the role of “Supplied Medication” , which has a role class code of Therapeutic Agent [A manufactured material (player) that is used for its therapeutic properties.] Supplied Medicine - Entity Class code [An HL7 defined value representing the class or category that the Entity instance represents] - Container [A subtype of ManufacturedMaterial used to hold other Entities for purposes such as transportation or protection of contents from loss or damage] Determiner code [An HL7 defined value representing whether the Entity represents a kind-of or a specific instance] - kind; maybe instance Code - the unique electronic “code” for the pack from which the real world supplied medicine is taken from (or is), and its text name Lot Number - the lot or batch number of the pack of the medicine Expiration Time - the expiry date of the pack of the medicine Stability Time - the “expiry date of the pack of the medicine after it has been opened” [e.g. eye drops - 4 weeks after first opening]. The Supplied Medicine is related to the Medicine itself (the stuff contained inside the pack) by the role relationship “Pack of”, which is scoped by the Supplied Medicine entity and played by the Medicine entity. This has Class code - Content [Relates a material as the content (player) to a container (scoper). Unlike ingredients, the content and a container remain separate (not mixed) and the content can be removed from the container. A content is not part of an empty container] Quantity - A ratio (numerator : denominator) specifying the relative quantities of the Entity playing the Role in the Entity scoping the Role, used for Roles that represent composition relationships between the scoping and playing Entities. In composition-relationships (e.g., has-parts, has-ingredient, has-content) the Role.quantity attribute specifies that a numerator amount of the target entity is comprised by a denominator amount of the source entity of such composition-relationship. For example, if a box (source) has-content 10 eggs (target), the relationship quantity is 10:1 Both numerator and denominator must be amount quantities (extensive quantities, i.e., a count number, mass, volume, amount of substance, amount of energy, etc.). Therefore, this quantity is “the pack size”. In this universal CMET, all the other parts of the Medicine are described fully, as they were in the universal Material Medicinal Product CMET. The supplied medicine entity has batch number and expiry information; it will be a dm+d AMPP code

Material Medicinal Product Pack - Identified Just carry the dm+d identifier for the AMPP in here

Route of Administration & Dosage Information Mood = Request Effective time = when to give (frequency) Route code = dm+d route of administration code Dose quantity = how much of the medicine to give [Rate quantity – for a rate, rather than a unit dose] Additional textual instructions, if required

The UKCPRS Programme The “dm+d” – the NHS Dictionary of Medicines and Devices Modelled vocabulary of medicinal product concepts Supporting vocabulary of ingredient, dose forms, suppliers Supporting vocabulary of dosage syntax (separate deliverable)

dm+d – a modelled vocabulary

The “Five Core Classes” of dm+d

Using the dm+d codes for Pharmacy CMETs Propose Promise Request Event Medicine Entity Code (Ordered Medicine) VTM, VMP, VMPP, AMP, AMPP AMPP Supplied Medicine Entity Code (Supplied Medication)

dm+d – Supporting Attribute Vocabulary Ingredient vocabulary Manufacturer or supplier vocabulary Dose Form vocabulary Route of Administration vocabulary

Dosage Syntax A deliverable from a separate UKCPRS/HL7 Med Info SIG workstream A standardised, modelled structure and vocabulary to describe medication dosage for electronic systems Will “fit” into the Substance Administration act sections to message dosage instructions

Questions??? Thank you