HL7 Medication and UKCPRS Julie James Partner Blue Wave Informatics 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 • 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 The Pharmacy DMIM Pharmacy Domain Model PORX_DM000000 v10.3 Community Combined Order Institutional Combined Order (PORX_RM132000) (PORX_RM232000) Administration and Supply Order in a community setting Administration and Supply Order in an institutional setting 4 December 2003 Institutional Administration Order Updated to Rim 2.01 (PORX_RM212000) Administration promise in an institutional setting Institutional Administration Promise (PORX_RM213000) Administration promise in an institutional setting Institutional Administration Event (PORX_RM214000) Administration event in an institutional setting Note: This Act represents the core of the act of ordering a medication and administering to a patient. It directly holds the route and dosage instructions. Note: The patient who is going to receive the medication CMET: (PAT) R_Patient [universal] 1..* patient * MedicationAdministration subject classCode*: <= SBADM moodCode*: <= ActMood id*: text: (Summary of act) effectiveTime: activityTime: availabilityTime: priorityCode: confidentialityCode: "N" routeCode: <= RouteOfAdministration approachSiteCode: <= ActSite (Can't have this without a route) doseQuantity: rateQuantity: doseCheckQuantity: SET<RTO<QTY,QTY>> maxDoseQuantity: SET<RTO<QTY,QTY>> typeCode*: <= SBJ (COCT_MT050000) 0..* locatedEntity destination Note: E.g. radioactive substance must be administered in secured location, oral morphine in pharmacy Note: The reason for the medfication order. Eg Treatment of bronchitis Note: Need to redo diagnosis code typeCode*: <= DST 0..* locatedEntity CMET: (LOCE) R_LocationLocatedEntity [universal] location (COCT_MT070000) 0..* playedRole typeCode*: <= LOC ObservationIndication 0..* justifyingObservationIndication classCode*: <= OBS moodCode*: <= EVN id: (used for future maintenance) statusCode: (Complete, Superceded) effectiveTime: confidentialityCode: value*: CE CWE [0..1] <= ObservationValue (e.g. ICD9) targetSiteCode: Note: Eg: Use dose of 50mg if pulse <40bpm or Give medication until pain relieved reason2 typeCode*: <= RSON classCode*: <= OBS moodCode*: <= EVN.CRT code: CE CWE <= ObservationType text*: effectiveTime: value: CMET: (ENC) A_Encounter [universal] (COCT_MT090100) 0..* participant performer typeCode*: <= PRF signatureCode: <= ParticipationSignature signatureText: 0..* assignedEntity typeCode*: <= x_ParticipationVrfRespSprfWit time*: (verification or attestation) modeCode: signatureCode: signatureText: (COCT_MT090300) CMET: (ASSIGNED) R_AssignedPerson [universal] Note: Who confirmed the order or the admin (COCT_MT090100) Note: Who entered the data saying for the order or the admin 0..* assignedEntity precondition dataEnterer typeCode*: <= PRCN checkpointCode: negationInd: conjunctionCode: typeCode*: <= ENT 0..* assignedEntity Note: Who should be called for clarification typically the same as the Author. author1 typeCode*: <= AUT outcome typeCode*: <= OUTC checkpointCode: negationInd: conjunctionCode: 0..* a_SubstanceAdminMaster definition componentOf1 Note: Used to refererence pharmacy protocols governing how a drug should be prescribed/ administered. A_SubstanceAdminMaster classCode*: <= SBADM moodCode*: <= DEF id*: [1..*] (catalogue #) typeCode*: <= INST typeCode*: <= COMP (COCT_MT010000) 0..* encounter pertinentInformation triggerFor typeCode*: <= PERT typeCode*: <= TRIG 0..* alert CMET: (ALRT) A_Alert [universal] (COCT_MT260000) inFulfillmentOf Note: Allows relation of different moods of the act. CMET for Medication ordered This CMET is missing at present and the mechanism will not work. Manufacturer Note: The medication ordered or administered to the patient. Eg Amoxicillin 250mg Tablets classCode*: <= ORG determinerCode*: <= INSTANCE code: CE CWE [0..1] <= EntityCode name*: Note: This is only a link to the MedicinalMaterial entity and carries no information 0..1 manufacturerManufacturer 0..* orderedMedicine 1..* playedEquivalent * consumable OrderedMedicine typeCode*: <= CSM classCode*: <= THER 0..1 playedOrderedMedicine * typeCode*: <= FLFS 0..* medicationAdministrationInstructions 0..* priorMedicationAdministration component1 typeCode*: <= COMP predecessor Note: Allows for modeling revision of an order MaterialMedProduct (COCT_RM230000) Note: Intended to identify problems or warnings associated with an Act that have previously been evaluated and discounted. 0..* pertinentObservationDx (COCT_MT120104) Note: Observations that support the decision on which medication or what dose to use. Eg Body weight, Surface Area, Allergies, Medical conditions Note: Who gave the medication to the patient, typically unused in community and a nurse in secondary care CMET: (ASSIGNED) R_AssignedDevice [universal] overseer 0..* outcomeObservationCriteria CMET: (OBS) A_ObservationDx [minimal] Note: Who wrote the order, typically a doctor AssignedPractitionerOrDevice CMET: (ASSIGNED) R_AssignedPerson [universal] typeCode*: <= AUT time*: (time of creation) modeCode: signatureCode: signatureText: 0..* observationCriteria ObservationCriteria Note: The header for the visit to the primary care physician or a particular hospital stay. Includes information on the relevant financial account 1..* participant * author2 MedicationAdministrationInstructions Equivalent classCode*: <= ROL code: <= RoleCode ManufacturedBy 0..1 scopedManufacturedBy classCode*: <= THER classCode*: <= SBADM moodCode*: <= ActMood text: (Additional free text instructions) These will usually be Realm specific 0..* playedManufacturedBy typeCode*: <= SUCC Note: Need to build a set of descriptions of equivalence such as: - Generic - Allowed alternative brand Note: See Q&A 31 0..* priorMedicationAdministration component / componentOf2 Note: Links together a series of orders or administrations that form part of a series whether scheduled or not or where an order fulfills part of a previous order. typeCode*: <= COMP 0..* medicationAdministration1 pertainsTo 0..* medicationAdministration2 0..1 justifiedMedicationAdministration * typeCode*: <= PERT reason1 / reasonOf Also used for complex doses, or multiple routes. 0..* justifyingMedicationSupply * Note: For a supply, where the supply came from and where it was sent to. Eg Pharmacy, Ward CMET: (LOCE) R_LocationLocatedEntity [universal] 0..* playedRole (COCT_MT070000) destination typeCode*: <= DST 0..* locatedEntity 0..* participant author2 AssignedPractitionerOrDevice typeCode*: <= AUT time*: (time of creation) modeCode: signatureCode: signatureText: CMET: (ASSIGNED) R_AssignedPerson [universal] CMET: (ASSIGNED) R_AssignedPerson [universal] Note: Who wrote the supply request typically the doctor who wrote the medication order, but could also be a nurse or ward pharmacist Ingredient 0..* scopedPackOf * typeCode*: <= PRF signatureCode: <= ParticipationSignature signatureText: CMET: (ASSIGNED) R_AssignedDevice [universal] ReimbursementStatus 1..1 containedSuppliedMedicine * SuppliedMedicine typeCode*: <= ORG 0..* assignedEntity overseer receiver typeCode*: <= x_ParticipationVrfRespSprfWit modeCode: signatureCode: signatureText: typeCode*: <= RCV (COCT_MT090100) CMET: (ASSIGNED) R_AssignedPerson [universal] classCode*: <= CONT determinerCode*: <= KIND 1..1 manufacturedSuppliedMedicine * code*: [1..1] <= PackagedDrugEntity lotNumberText: expirationTime: stabilityTime: Note: Who confirmed the supply typically a pharmacist (COCT_MT090100) 0..* assignedEntity Note: Who entered the data saying what the supply is typeCode*: <= ENT Formulary 0..* formulary classCode*: <= SPLY moodCode*: <= DEF id*: [1..*] (catalogue #) definition author1 typeCode*: <= INST typeCode*: <= AUT 0..* assignedEntity Note: Who should be called for clarification typically the same as the Author. Note: The medication that is being supplied eg Amoxil 250mg tables, 56 tablets Note: Allows relation of different moods of the act. product inFulfillmentOf 0..* playedSuppliedMedication * classCode*: <= THER 0..* priorMedicationSupply predecessor typeCode*: <= SUCC MaterialMedProductPackaged 0..* priorMedicationSupply (COCT_RM220000) Note: Links together a series of supply acts that form part of a series whether scheduled or not or where an order fulfills part of a previous order. component / componentOf typeCode*: <= COMP CMET for Medication ordered 0..* medicationSupply1 Note: This act represents the act of supplying medication to a patient or their representative. It does NOT deal with administering it to the patient. 0..* medicationSupply2 Community Supply Event (PORX_RM124000) Supply Event in a community setting Institutional Supply Order Institutional Supply Event (PORX_RM224000) Supply event in an institutional setting Institutional SupplyPromise (PORX_RM222000) (PORX_RM223000) Supply promise in an institutional setting Supply promise in an institutional setting Payor It doesn’t have an explicit name because this is part of the code SuppliedMedication typeCode*: <= PRD typeCode*: <= FLFS 0..1 scopingPayor * Note: This is anything from an virtual therapeutic moeity to a virtual product pack to an actual product or an actual product pack. It may hold multiple IDs if say, VMP, AMP and AMPP have been identified as part of the product selection process. It isn’t a choice box because several values may be required. Note: See Q&A 31 1..* suppliedMedication * Note: Allows for modeling revision of an order classCode*: <= ROL 1..* playedReimbursementStatus * code*: [1..1] <= RoleCode (COCT_MT090300) origin dataEnterer Note: The formulary which governs what can be supplied classCode*: <= MMAT determinerCode*: <= KIND code: <= EntityCode PackOf classCode*: <= CONT 0..* playedPackOf * quantity: RTO<PQ,PQ> (Pack size) 0..* participant performer 0..1 scopingMedicine * classCode*: <= MMAT determinerCode*: <= KIND 0..* scopedIngredientStrength IngredientStrength code*: [1..1] <= DrugEntity (The main entry specified by the user. Use the equivalents for classCode*: <= INGR 1..1 manufacturedMedicine * other more or les specific codes. EG AMP is th emain code, but quantity: RTO<PQ,PQ> (Medicine strength) VTM, VMP and a set of AMPPs are also known) formCode*: <= MaterialForm 0..1 ingredientIngredient * 1..1 containerMedicine * (COCT_MT090100) 0..* assignedEntity Note: Who will receive the supply. It may be the patient, a carer. 0..1 manufacturedMedicine Medicine 0..* pertinentCoverage typeCode*: <= PERT classCode*: <= SPLY moodCode*: <= ActMood id: (defaults to Sub_admin_order.id) code: <= ActPharmacySupplyType (partial, trial, etc. - this would be used to indicate authorization for trial/partial dispense) text: (pharm. instructions) effectiveTime: (Earliest/last allowed dispense, frequency restrictions, etc.) confidentialityCode: repeatNumber: INT "1" (ie this is issue 3 (of 5)) quantity*: [1..1] expectedUseTime: (days supply ordered) 0..* locatedEntity Note: Identifies information about an eligibility check or authorization that has been received in relation to an action. It is initiated from the Supply and provides confirmation back to the SubstanceAdministration pertinentInformation MedicationSupply Note: Changed from COCT_MT070103, but is the the correct CMET? CMET: (COV) A_Coverage [universal] 0..* subjectCoverage (COCT_MT180000) typeCode*: <= RSON classCode*: <= ORG determinerCode*: <= INSTANCE code: <= EntityCode name: 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) 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 Manufacturer classCode*: <= ORG determinerCode*: <= INSTANCE code: CE CWE [0..1] <= EntityCode name*: 0..1 manufacturerManufacturer 1..* playedEquivalent * Equivalent classCode*: <= ROL code: <= RoleCode ManufacturedBy 0..1 scopedManufacturedBy classCode*: <= THER 0..* playedManufacturedBy The medicine entity plays the role of “ordered medicine” 0..1 manufacturedMedicine 0..1 scopingMedicine * Medicine MaterialMedProduct (COCT_RM230000) CMET for Medication ordered OrderedMedicine classCode*: <= THER 0..1 ingredientOfMedicine * classCode*: <= MMAT IngredientStrength determinerCode*: <= KIND classCode*: <= INGR code*: [1..1] <= DrugEntity 0..1 playedOrderedMedicine * 1..* playedIngredientStrength * quantity: RTO<PQ,PQ> (medicine strength) (The main entry specified by the user. Use the equivalents for 1..1 manufacturedMedicine * other more or les specific codes. EG AMP is th emain code, but VTM, VMP and a set of AMPPs are also known) formCode*: <= MaterialForm Ingredient The medicine’s ingredients can be represented using the role of “ingredient strength” and “ingredient” entities classCode*: <= MMAT determinerCode*: <= KIND code: <= EntityCode name: [1..*] Material Medicinal Product - Identified MaterialMedProductIdentified (COCT_RM230001) CMET for Medication ordered OrderedMedicine classCode*: <= THER Medicine classCode*: <= MMAT determinerCode*: <= KIND 0..1 playedOrderedMedicine * code*: [1..1] <= DrugEntity 1..1 manufacturedMedicine * (The main entry specified by the user. Use the equivalents for other more or les specific codes. EG AMP is th emain code, but VTM, VMP and a set of AMPPs are also known) Just carry the dm+d identifier for the medicine in here Material Medicinal Product Pack - Universal Manufacturer classCode*: <= ORG determinerCode*: <= INSTANCE code: CE CWE [0..1] <= EntityCode name*: 0..1 manufacturerManufacturer 1..* playedEquivalent * The supplied medicine entity scopes the role of “pack of” Equivalent classCode*: <= ROL code: <= RoleCode ManufacturedBy 0..1 scopedManufacturedBy classCode*: <= THER 0..* playedManufacturedBy 0..1 manufacturedMedicine 0..1 scopingMedicine * Medicine classCode*: <= MMAT determinerCode*: <= KIND code*: [1..1] <= DrugEntity (The main entry specified by the user. Use the equivalents for other more or les specific codes. EG AMP is th emain code, but VTM, VMP and a set of AMPPs are also known) formCode*: <= MaterialForm The supplied medicine entity plays the role of “supplied medication” 1..1 containerMedicine * 0..* scopedIngredientStrength IngredientStrength classCode*: <= INGR quantity: RTO<PQ,PQ> (Medicine strength) 0..1 ingredientIngredient * Ingredient classCode*: <= MMAT determinerCode*: <= KIND code: <= EntityCode 0..* scopedPackOf * PackOf classCode*: <= CONT 0..* playedPackOf * quantity: RTO<PQ,PQ> (Pack size) 1..1 containedSuppliedMedicine * SuppliedMedicine classCode*: <= CONT determinerCode*: <= KIND 1..1 manufacturedSuppliedMedicine * code*: [1..1] <= PackagedDrugEntity lotNumberText: expirationTime: 0..* playedSuppliedMedication * SuppliedMedication stabilityTime: classCode*: <= THER The supplied medicine entity has batch number and expiry information; it will be a dm+d AMPP code Material Medicinal Product Pack - Identified MaterialMedProductPackagedIdentified (COCT_RM220001) CMET for Medication ordered SuppliedMedication 0..* playedSuppliedMedication * classCode*: <= THER SuppliedMedicine 1..1 manufacturedSuppliedMedicine * classCode*: <= CONT determinerCode*: <= KIND code*: [1..1] <= PackagedDrugEntity lotNumberText: Just carry the dm+d identifier for the AMPP in here Route of Administration & Dosage Information MedicationAdministrationRequest classCode*: <= SBADM moodCode*: <= RQO id*: (placer number, etc.) text: (Summary of act) statusCode*: "ACTIVE" effectiveTime: priorityCode: confidentialityCode: "N" routeCode: <= RouteOfAdministration approachSiteCode: <= ActSite (Must have a route to go with) doseQuantity: rateQuantity: doseCheckQuantity: SET<RTO<QTY,QTY>> maxDoseQuantity: SET<RTO<QTY,QTY>> 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 0..* medicationAdministrationInstructions component3 typeCode*: <= COMP MedicationAdministrationInstructions classCode*: <= SBADM moodCode*: <= RQO text: (Additional free text instructions) 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 VTM dm+d Object Model Blue Wave Informatics 10/11/2003 ver 2.0c Change History: V2.0a - First version in this layout v2.0b - Added constituent pack concepts v2.0c - Removed incorrect coments on history from suppliers and supplier llink Ingredients A VTM is the abstract conceptual representation of the material defining the prescriber's therapeutic intent, divorced from formulation, dose or strength. List of ingredients and excipients . Note Within the file of ingredient substances will be entries relating to the following:1) Complete substances which act as actual ingredients of medicinal products. For example: heparin sodium or cyclizine lactate (as distinct from heparin and cyclizine). This class of substances may or may not be a salt or other type of derivative.- A VTM cannot exist unless it is linked to a VMP Name The current name in short and full forms VMP_Ingredient Links VMP to the set of active ingredients common to the AMPs linked to the VMP VMP_VTM Links a set of VMPs to a VTM A VMP that is a drug may not be linked to a VTM or it may be linked to one VTM. Each VTM must be attached to one or more VMPs DoseForm Dictionary of terms for the physical conformation of the drug as normally dispensed. A Dose Form may be orphaned from any VMP Name A description of the dose form. VMP VMP_Form Links a VMP to its dose form. Every VMP that is a drug has exactly one dose form. A dose form may not be linked to a VMP or it may be linked to one or many A VMP is the conceptual representation of one or more clinically equivalent Actual Medicinal Products the purpose of which is to support the representation of the fundamental reality of the concept. Its core description requires product name, strength and dosage form, but is devoid of explicit or implicit information attributable to manufacturer or pack. 2) Base substances which may or may not be available as actual ingredients. For example, heparin or cyclizine. For each link the quantity of the ingredient or of its base is stored. An ingredient may be orphaned from any VMP or AMP or from another parent or base ingredient. A VMP may have no ingredients attached or it may have one or more. Name Name of the ingredient - no history or short forms An ingredient may not be be attached to any VMP or it may be attached to one or more. Base Ingredient For salts etc a recursive pointer to the base ingredient. Strength An indication of the quantity of the ingredient in the product AMP_Ingredient Links AMPs to ingredients marked as “Interesting Excipients”. The quantity of ingredient is not stored. An AMP may be linked to no ingredients or to one or more. AMP An ingredient may not be linked to any AMP or it may be linked to one or more. An AMP is the representation of a single unit dose of a medicinal product that is (or has been) made or marketed by a specific manufacturer or supplier. Its core description requires product name, strength, dosage form and manufacturer, but is devoid of explicit information attributable to pack size. Strength Basis An indication of whether the strength refers to the ingredient or its base The unit dose is the smallest single entity of the product that can be physically handled with the following defined deviations: Continuous liquids excluding eye-drops: where the unit dose is expressed in terms of the accepted normal sub-unit used as the basis of administration AMP_Suppliers Links a set of AMPs to the company that supplies them. Each AMP is supplied by one and only one supplier. A Supplier may not have any AMPs or it may have one or more products. Suppliers A list of Suppliers of medicinal products. The name used will be that which appears on the product package and may be a manufacturer, a wholesaler or a marketing agent. Continuous solids: where the unit dose is expressed in terms of the accepted normal sub-unit used as the basis of administration A VMP cannot exist unless it is linked to one or more AMPs and to one or more VMPPs Continuous semi-solids and eye-drops: where a consistent, physically measurable unit or sub-unit cannot be defined and which is therefore not instantiated. Name The current name in full and short Semantic Normal Form together with the official source of the name, a previous name and reasons for change AMP_VMP HideName If this flag is set the name is hidden from view A VMP must be linked to at least one AMP and can be linked to several AMPs Links a set of AMPs to their corresponding VMP An AMP must have a VMP but only one VMP An AMP cannot exist unless it is linked to one or more AMPPs Name The current name in full and short Semantic Normal Form, a previous value and reason for change. Each flavour of a AMP has a separate entry. Prescribability Indicates if product should not be prescribed by VMP Freeness A set of flags indicating if VMP is sugar free, CFC free etc. Regulation Information on regulatory restrictions and rules about the product such as Controlled Drug Schedule Component Flag Indicates if the product is normal, a compound product or a constituent product. VMPP_VMP Availability The licence and “specials” status. Route AMP_Route Regulation Information on reglatory restrictions and rules about the product such as CSM notification. Links an AMP to the set of routes that have been licensed for the product. Reimbursement Information on reimbursement An AMP may have no linked Routes or it may have one or more routes. Component Flag Indicates if the product is normal, a compound product or a constituent product. VMP_Route Links VMP to the set of licensed routes common to the AMPs linked to the VMP. A VMP may have no routes linked, or it may be linked to one o r more routes. A route may not be linked to any VMP or it may be linked to one or more VMPs A VMPP is linked to one and only one VMP A VMP must have one or more VMPPs A licensed route of administration of a medicinal product. A route may be orphaned from any VMP or AMP. Name Description of the route of administration A route may not be linked to any AMP or it may be linked to one or more AMPs AMPP_AMP Links a set of AMPPs to their “parent” AMP. Each AMPP must link to one and only one AMP. Each AMP must have one or more AMPPs AMPP VMPP A VMPP is the conceptual representation of each and every AMPP that exists for the linked AMPs. This includes a conceptual representation of AMPPs that exist to represent the components of a compound AMPP. An AMPP is the representation of each and every saleable/available pack (container of dose units) of an AMP, in terms of description of quantity, of how many 'dose units' of the AMP (or weight, for solids and semi-solids) are present in the pack. AMPP_VMPP A VMPP cannot exist unless it is linked to one or more AMPPs and to a VMP Links a set of AMPPs to the corresponding VMPP Name A description of the pack in full and shortened Semantic Normal Forms. Each AMPP must have one and only one VMPP Size The size of the pack is described in quantity and units. Reimbursement Information on reimbursement including “official” reimbursement price where it exists. Component Flag Indicates if the pack is normal, a compound pack or a constituent pack. Each VMPP may be linked to one or more AMPPs An AMPP may also be the representation of the number of “dose units” of an AMP present as a constituent of a compound pack. This constituent pack may exist only in a conceptual form or it may also be a saleable/available AMPP. An AMPP cannot exist without a parent AMP Name The current name in full and short Semantic Normal Form. Availability The licence and “specials” status. Regulation Information on regulatory restrictions and rules about the product such as Legal Category, restrictive formularies, allowed prescription forms etc. Reimbursement Information on reimbursement including indicative price ChildVMPP_ParentVMPP Component Flag Indicates if the pack is normal, a compound pack or a constituent pack. A recursive link from a constituent child VMPP to the corresponding parent compound VMPP Each Child VMPP must have one and only one Parent VMPP Each Parent VMPP may be linked to one or more CHILD VMPPs ChildAMPP_ParentAMPP A recursive link from a constituent child AMPP to the corresponding parent compound AMPP Each Child AMPP must have one and only one Parent AMPP Each Parent AMPP may be linked to one or more CHILD AMPPs A supplier may be an orphan with no link to an AMP or to another supplier. Name The name of the supplier together with a previous name for that company The “Five Core Classes” of dm+d VTM A VTM is the abstract conceptual representation of the material defining the prescriber's therapeutic intent, divorced from formulation, dose or strength. A VTM cannot exist unless it is linked to a VMP Name The current name in short and full forms VMP_VTM Links a set of VMPs to a VTM A VMP that is a drug may not be linked to a VTM or it may be linked to one VTM. AMP Each VTM must be attached to one or more VMPs An AMP is the representation of a single unit dose of a medicinal product that is (or has been) made or marketed by a specific manufacturer or supplier. Its core description requires product name, strength, dosage form and manufacturer, but is devoid of explicit information attributable to pack size. VMP A VMP is the conceptual representation of one or more clinically equivalent Actual Medicinal Products the purpose of which is to support the representation of the fundamental reality of the concept. Its core description requires product name, strength and dosage form, but is devoid of explicit or implicit information attributable to manufacturer or pack. The unit dose is the smallest single entity of the product that can be physically handled with the following defined deviations: Continuous liquids excluding eye-drops: where the unit dose is expressed in terms of the accepted normal sub-unit used as the basis of administration Continuous solids: where the unit dose is expressed in terms of the accepted normal sub-unit used as the basis of administration A VMP cannot exist unless it is linked to one or more AMPs and to one or more VMPPs Name The current name in full and short Semantic Normal Form together with the official source of the name, a previous name and reasons for change AMP_VMP HideName If this flag is set the name is hidden from view A VMP must be linked to at least one AMP and can be linked to several AMPs Links a set of AMPs to their corresponding VMP Continuous semi-solids and eye-drops: where a consistent, physically measurable unit or sub-unit cannot be defined and which is therefore not instantiated. An AMP must have a VMP but only one VMP An AMP cannot exist unless it is linked to one or more AMPPs Name The current name in full and short Semantic Normal Form, a previous value and reason for change. Each flavour of a AMP has a separate entry. Prescribability Indicates if product should not be prescribed by VMP Freeness A set of flags indicating if VMP is sugar free, CFC free etc. Availability The licence and “specials” status. Regulation Information on regulatory restrictions and rules about the product such as Controlled Drug Schedule Regulation Information on reglatory restrictions and rules about the product such as CSM notification. Component Flag Indicates if the product is normal, a compound product or a constituent product. Reimbursement Information on reimbursement Component Flag Indicates if the product is normal, a compound product or a constituent product. VMPP_VMP A VMPP is linked to one and only one VMP AMPP_AMP A VMP must have one or more VMPPs Links a set of AMPPs to their “parent” AMP. Each AMPP must link to one and only one AMP. Each AMP must have one or more AMPPs AMPP VMPP A VMPP is the conceptual representation of each and every AMPP that exists for the linked AMPs. This includes a conceptual representation of AMPPs that exist to represent the components of a compound AMPP. An AMPP is the representation of each and every saleable/available pack (container of dose units) of an AMP, in terms of description of quantity, of how many 'dose units' of the AMP (or weight, for solids and semi-solids) are present in the pack. AMPP_VMPP A VMPP cannot exist unless it is linked to one or more AMPPs and to a VMP Links a set of AMPPs to the corresponding VMPP Name A description of the pack in full and shortened Semantic Normal Forms. Each AMPP must have one and only one VMPP Size The size of the pack is described in quantity and units. Reimbursement Information on reimbursement including “official” reimbursement price where it exists. Component Flag Indicates if the pack is normal, a compound pack or a constituent pack. Each VMPP may be linked to one or more AMPPs An AMPP may also be the representation of the number of “dose units” of an AMP present as a constituent of a compound pack. This constituent pack may exist only in a conceptual form or it may also be a saleable/available AMPP. An AMPP cannot exist without a parent AMP Name The current name in full and short Semantic Normal Form. Availability The licence and “specials” status. Regulation Information on regulatory restrictions and rules about the product such as Legal Category, restrictive formularies, allowed prescription forms etc. Reimbursement Information on reimbursement including indicative price ChildVMPP_ParentVMPP Component Flag Indicates if the pack is normal, a compound pack or a constituent pack. A recursive link from a constituent child VMPP to the corresponding parent compound VMPP Each Child VMPP must have one and only one Parent VMPP Each Parent VMPP may be linked to one or more CHILD VMPPs ChildAMPP_ParentAMPP A recursive link from a constituent child AMPP to the corresponding parent compound AMPP Each Child AMPP must have one and only one Parent AMPP Each Parent AMPP may be linked to one or more CHILD AMPPs Using the dm+d codes for Pharmacy CMETs Propose Promise Request Event VTM, VMP, VMPP, AMP, AMPP VTM, VMP, VMPP, AMP, AMPP VTM, VMP, VMPP, AMP, AMPP AMPP Supplied AMPP Medicine Entity Code (Supplied Medication) AMPP AMPP AMPP Medicine Entity Code (Ordered Medicine) dm+d – Supporting Attribute Vocabulary VTM dm+d Object Model Blue Wave Informatics 10/11/2003 Ingredients A VTM is the abstract conceptual representation of the material defining the prescriber's therapeutic intent, divorced from formulation, dose or strength. ver 2.0c Change History: V2.0a - First version in this layout v2.0b - Added constituent pack concepts v2.0c - Removed incorrect coments on history from suppliers and supplier llink List of ingredients and excipients . Note Within the file of ingredient substances will be entries relating to the following:1) Complete substances which act as actual ingredients of medicinal products. For example: heparin sodium or cyclizine lactate (as distinct from heparin and cyclizine). This class of substances may or may not be a salt or other type of derivative.- A VTM cannot exist unless it is linked to a VMP Name The current name in short and full forms VMP_Ingredient Links VMP to the set of active ingredients common to the AMPs linked to the VMP VMP_VTM Links a set of VMPs to a VTM A VMP that is a drug may not be linked to a VTM or it may be linked to one VTM. Each VTM must be attached to one or more VMPs DoseForm VMP VMP_Form Dictionary of terms for the physical conformation of the drug as normally dispensed. A Dose Form may be orphaned from any VMP Name A description of the dose form. Links a VMP to its dose form. Every VMP that is a drug has exactly one dose form. A dose form may not be linked to a VMP or it may be linked to one or many A VMP is the conceptual representation of one or more clinically equivalent Actual Medicinal Products the purpose of which is to support the representation of the fundamental reality of the concept. Its core description requires product name, strength and dosage form, but is devoid of explicit or implicit information attributable to manufacturer or pack. Ingredient vocabulary 2) Base substances which may or may not be available as actual ingredients. For example, heparin or cyclizine. For each link the quantity of the ingredient or of its base is stored. An ingredient may be orphaned from any VMP or AMP or from another parent or base ingredient. A VMP may have no ingredients attached or it may have one or more. Name Name of the ingredient - no history or short forms An ingredient may not be be attached to any VMP or it may be attached to one or more. Base Ingredient For salts etc a recursive pointer to the base ingredient. Strength An indication of the quantity of the ingredient in the product AMP_Ingredient Links AMPs to ingredients marked as “Interesting Excipients”. The quantity of ingredient is not stored. An AMP may be linked to no ingredients or to one or more. AMP An ingredient may not be linked to any AMP or it may be linked to one or more. An AMP is the representation of a single unit dose of a medicinal product that is (or has been) made or marketed by a specific manufacturer or supplier. Its core description requires product name, strength, dosage form and manufacturer, but is devoid of explicit information attributable to pack size. Strength Basis An indication of whether the strength refers to the ingredient or its base The unit dose is the smallest single entity of the product that can be physically handled with the following defined deviations: Continuous liquids excluding eye-drops: where the unit dose is expressed in terms of the accepted normal sub-unit used as the basis of administration AMP_Suppliers Links a set of AMPs to the company that supplies them. Each AMP is supplied by one and only one supplier. A Supplier may not have any AMPs or it may have one or more products. Suppliers A list of Suppliers of medicinal products. The name used will be that which appears on the product package and may be a manufacturer, a wholesaler or a marketing agent. Continuous solids: where the unit dose is expressed in terms of the accepted normal sub-unit used as the basis of administration A VMP cannot exist unless it is linked to one or more AMPs and to one or more VMPPs Continuous semi-solids and eye-drops: where a consistent, physically measurable unit or sub-unit cannot be defined and which is therefore not instantiated. Name The current name in full and short Semantic Normal Form together with the official source of the name, a previous name and reasons for change AMP_VMP HideName If this flag is set the name is hidden from view A VMP must be linked to at least one AMP and can be linked to several AMPs Links a set of AMPs to their corresponding VMP An AMP must have a VMP but only one VMP Name The current name in full and short Semantic Normal Form, a previous value and reason for change. Each flavour of a AMP has a separate entry. Freeness A set of flags indicating if VMP is sugar free, CFC free etc. Component Flag Indicates if the product is normal, a compound product or a constituent product. VMPP_VMP Name The name of the supplier together with a previous name for that company An AMP cannot exist unless it is linked to one or more AMPPs Prescribability Indicates if product should not be prescribed by VMP Regulation Information on regulatory restrictions and rules about the product such as Controlled Drug Schedule A supplier may be an orphan with no link to an AMP or to another supplier. Availability The licence and “specials” status. Route AMP_Route Regulation Information on reglatory restrictions and rules about the product such as CSM notification. Links an AMP to the set of routes that have been licensed for the product. Reimbursement Information on reimbursement An AMP may have no linked Routes or it may have one or more routes. Component Flag Indicates if the product is normal, a compound product or a constituent product. VMP_Route Links VMP to the set of licensed routes common to the AMPs linked to the VMP. A VMP may have no routes linked, or it may be linked to one o r more routes. A route may not be linked to any VMP or it may be linked to one or more VMPs A VMPP is linked to one and only one VMP A licensed route of administration of a medicinal product. A route may be orphaned from any VMP or AMP. Name Description of the route of administration A route may not be linked to any AMP or it may be linked to one or more AMPs A VMP must have one or more VMPPs AMPP_AMP Links a set of AMPPs to their “parent” AMP. Each AMPP must link to one and only one AMP. Each AMP must have one or more AMPPs AMPP VMPP A VMPP is the conceptual representation of each and every AMPP that exists for the linked AMPs. This includes a conceptual representation of AMPPs that exist to represent the components of a compound AMPP. Dose Form vocabulary An AMPP is the representation of each and every saleable/available pack (container of dose units) of an AMP, in terms of description of quantity, of how many 'dose units' of the AMP (or weight, for solids and semi-solids) are present in the pack. AMPP_VMPP A VMPP cannot exist unless it is linked to one or more AMPPs and to a VMP Links a set of AMPPs to the corresponding VMPP Name A description of the pack in full and shortened Semantic Normal Forms. Each AMPP must have one and only one VMPP Each VMPP may be linked to one or more AMPPs Size The size of the pack is described in quantity and units. An AMPP may also be the representation of the number of “dose units” of an AMP present as a constituent of a compound pack. This constituent pack may exist only in a conceptual form or it may also be a saleable/available AMPP. An AMPP cannot exist without a parent AMP Name The current name in full and short Semantic Normal Form. Reimbursement Information on reimbursement including “official” reimbursement price where it exists. Availability The licence and “specials” status. Component Flag Indicates if the pack is normal, a compound pack or a constituent pack. Regulation Information on regulatory restrictions and rules about the product such as Legal Category, restrictive formularies, allowed prescription forms etc. Reimbursement Information on reimbursement including indicative price Component Flag Indicates if the pack is normal, a compound pack or a constituent pack. ChildVMPP_ParentVMPP A recursive link from a constituent child VMPP to the corresponding parent compound VMPP Each Child VMPP must have one and only one Parent VMPP Each Parent VMPP may be linked to one or more CHILD VMPPs Route of Administration vocabulary ChildAMPP_ParentAMPP A recursive link from a constituent child AMPP to the corresponding parent compound AMPP Each Child AMPP must have one and only one Parent AMPP Each Parent AMPP may be linked to one or more CHILD AMPPs Manufacturer or supplier 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