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Drug Vocabularies Paul Frosdick, Senior Clinical Pharmacist, National Programme for Information Technology HL7UK 2004 Conference ©NHS Information Authority 2004. All rights reserved Outline • • • • • ©NHS NHS dm+d International harmonisation Dose form vocabulary Dose syntax Questions. Information Authority 2004. All rights reserved Outline • • • • • ©NHS NHS dm+d International harmonisation Dose form vocabulary Dose syntax Questions. Information Authority 2004. All rights reserved NHS dm+d VTM Virtual Therapeutic Moiety ©NHS Information Authority 2004. All rights reserved VMP AMP Virtual Medicinal Product Actual Medicinal Product VMPP AMPP Virtual Medicinal Product Pack Actual Medicinal Product Pack NHS dm+d VTM Virtual Product Ingredient Virtual Therapeutic Moiety Actual Product Excipient Virtual Product Form Virtual Product Route Product Availability VMP AMP Virtual Medicinal Product Actual Medicinal Product Controlled Drug Prescribing Combination Pack Content Drug Tariff Category Licensed Route VMPP AMPP Virtual Medicinal Product Pack Actual Medicinal Product Pack Reimbursement Information ©NHS Information Authority 2004. All rights reserved Supplier Pack Price Product Prescribing Appliance Product Information NPfIT standards approach • • • • • • 1 terminology - SNOMED CT 1 terminology server – Health Language 1 drug database – dm+d - UK SNOMED extensions 1 drug decision support – First Data Bank Europe 1 Decision support framework – Map of Medicine 1 Knowledge source - National Electronic Library for Health • All backed by a standards board • No exceptions ! • Why not the interface ? ©NHS Information Authority 2004. All rights reserved NPfIT standards approach • • • • • • 1 terminology - SNOMED CT 1 terminology server – Health Language 1 drug database – dm+d - UK SNOMED extension 1 drug decision support – First Data Bank Europe 1 Decision support framework – Map of Medicine 1 Knowledge source - National Electronic Library for Health • All backed by a standards board • No exceptions ! • Why not the interface ? ©NHS Information Authority 2004. All rights reserved Outline • • • • • ©NHS NHS dm+d International harmonisation Dose form vocabulary Dose syntax Questions. Information Authority 2004. All rights reserved Requirements, rationale and objectives • HL7 Medicines information special interest group and Vocabulary technical committee • Various national initiatives ongoing US / Australia / UK / Holland • Elements of overlap, parallel and divergent working • Requirement for ‘harmonisation’ to prevent downstream conflicts X . Harmony is not the same as melody. ©NHS Information Authority 2004. All rights reserved . • Objectives • Harmonise medicine information models developed in the UK, USA, Australia and Holland • Analyse and articulate “Use Case’s” models are required to support • Consider model components such as drug routes, dosage forms, ingredients • Consider medicines prescription and administration instructions (SIGS) • Identify the business case for harmonisation. ©NHS Information Authority 2004. All rights reserved Methodology Use case collection • Participants articulated use cases Explicit Implicit • Use cases recorded and debated • Use case patterns identified. ©NHS Information Authority 2004. All rights reserved Methodology Model description and analysis • Participants described models Using local notation • Understanding developed by robust challenge • Core classes identified and defined To support analysis and understanding To develop a parsimonious basis for harmonisation • Standard modelling notation developed • “The Grid” A population table to demonstrate practical examples. ©NHS Information Authority 2004. All rights reserved Results Use case summary Organisation Use Case Aus. FDA NCDPD NHS Translation b/w systems for analysis and clinical care ©NHS VA Facilitate safe & effective ETP, dispensing and claims Common national id, term, model and rules for all health sectors' e-records Collection of regulatory information for publication Dissemination of core regulatory information inc. ingredients and dose forms Identification of core medicines on which 'hooks' for CDS information can be built Information Authority 2004. All rights reserved NLM Results Data models and notation V TM dm+d Object Model Blue Wave Inform atics 15/01/2004 ver 2.0c Change History: V2.0a - First v ersion in this lay out v2.0b - Added constituent pack concepts v2.0c - Remov ed incorrect coments on history f rom 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 f ull f orms 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 f rom any VMP Name A description of the dose f orm. V MP VMP_Form Links a VMP to its dose form. Ev ery VMP that is a drug has exactly one dose f orm. A dose f orm 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 f rom any VMP or AMP or f rom another parent or base ingredient. A VMP may hav e no ingredients attached or it may hav e one or more. Name Name of the ingredient - no history or short f orms 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 recursiv e 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 ref ers 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 ey e-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 f ull and short Semantic Normal Form together with the of f icial source of the name, a prev ious name and reasons f or change HideName If this f lag is set the name is hidden f rom v iew Continuous semi-solids and ey e-drops: where a consistent, physically measurable unit or sub-unit cannot be defined and which is therefore not instantiated. AMP_VMP Links a set of AMPs to their corresponding VMP An AMP must hav e a VMP but only one VMP A VMP must be linked to at least one AMP and can be linked to sev eral AMPs An AMP cannot exist unless it is linked to one or more AMPPs Name The current name in f ull and short Semantic Normal Form, a prev ious v alue and reason f or change. Each f lav our of a AMP has a separate entry . Prescribability Indicates if product should not be prescribed by VMP Availability The licence and “specials” status. Freeness A set of f lags indicating if VMP is sugar f ree, CFC f ree etc. Regulation VMP_Route Inf ormation on regulatory restrictions and rules about the product such as Controlled Links VMP to the set of licensed routes Drug Schedule common to the AMPs linked to the VMP. Component Flag A VMP may hav e no routes linked, or it Indicates if the product is normal, a compound product or a constituent product. may be linked to one o r more routes. VMPP_VMP 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 Route 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 AMP_Route Regulation Inf ormation on reglatory restrictions and rules about the product such as CSM notif ication. Links an AMP to the set of routes that have been licensed for the product. Reimbursement Inf ormation on reimbursement An AMP may hav e no linked Routes or it may hav e one or more routes. Component Flag Indicates if the product is normal, a compound product or a constituent product. A route may not be linked to any AMP or it may be linked to one or more AMPs AMPP_AMP A VMP must hav e 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 hav e one or more AMPPs AMP P VMPP 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. 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. 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 f ull and shortened Semantic Normal Forms. Each AMPP must hav e one and only one VMPP Size The size of the pack is described in quantity and units. Reimbursement Inf ormation on reimbursement including “of f icial” 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 f ull and short Semantic Normal Form. Availability The licence and “specials” status. Regulation Inf ormation on regulatory restrictions and rules about the product such as Legal Category , restrictiv e f ormularies, allowed prescription f orms etc. Reimbursement Inf ormation on reimbursement including indicativ e 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 hav e 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 hav e one and only one Parent AMPP Each Parent AMPP may be linked to one or more CHILD AMPPs ©NHS Information Authority 2004. All rights reserved 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 hav e any AMPs or it may hav e 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. 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 prev ious name f or that company Results Core concepts • • • • • • • • • • • ©NHS Therapeutic moiety Actual therapeutic moiety (ATM) Virtual therapeutic moiety (VTM) ATM + form VTM + form VTM + route Virtual medicinal product Clinical drug Actual medicinal product Actual medicinal pack Combination product Information Authority 2004. All rights reserved Results Core concepts • • • • • • • • • • • ©NHS Therapeutic moiety Actual therapeutic moiety (ATM) Virtual therapeutic moiety (VTM) ATM + form VTM + form VTM + route Virtual medicinal product Clinical drug Actual medicinal product Actual medicinal pack Combination product. Information Authority 2004. All rights reserved Results Core attributes • Ingredient Active ingredient Base ingredient Inactive ingredient Significant inactive ingredient • Ingredient strength • Dose form • Route of administration. ©NHS Information Authority 2004. All rights reserved Results Core attributes • Ingredient Active ingredient Base ingredient Inactive ingredient Significant inactive ingredient • Ingredient strength • Dose form • Route of administration. ©NHS Information Authority 2004. All rights reserved Current progress • This work is adopted as a new work item for ISO/TC215 WG6 to deliver the parsimonious standard for core items within a drug terminology • Its output will become jointly HL7 and ISO supported • Will provide structure and definition for core concept classes and attributes to inform harmonious development of drug terminologies internationally. ©NHS Information Authority 2004. All rights reserved Outline • • • • • ©NHS NHS dm+d International harmonisation Dose form vocabulary Dose syntax Questions. Information Authority 2004. All rights reserved • Objectives • Harmonise medicine information models developed in the UK, USA, Australia and Holland • Analyse and articulate “Use Case’s” models are required to support • Consider model components such as drug routes, dosage forms, ingredients • Consider medicines prescription and administration instructions (SIGS) • Identify the business case for harmonisation. ©NHS Information Authority 2004. All rights reserved Dose form vocabulary Aim • A concept based international reference terminology for dose forms • For use in all domains – Clinical AND Regulatory • Inclusive – Caters for synonymy – Captures but deprecates redundancy. ©NHS Information Authority 2004. All rights reserved Dose form vocabulary • What do we need to “Fully Define” Dose Form Concepts? State of Matter Site Prepared For Release Characteristics Delivery Device • BUT, this will NOT “define” a number of the primitives. Does this matter……? ©NHS Information Authority 2004. All rights reserved Dose form vocabulary • Earlier work had provided some resources A long list of terms Some “provenance” Some idea of deprecation (e.g. use in term) Some idea of synonymy • Provisional axes for classifying dose forms State of matter Delivery device Site prepared for Release characteristics ©NHS Information Authority 2004. All rights reserved Methodology • • • • • • • ©NHS Break impasse and navel gazing Develop simple tool Multiple modellers with domain expertise Model independently Collate and resolve conflicts Validate within HL7 and regulatory community Publish. Information Authority 2004. All rights reserved ©NHS Information Authority 2004. All rights reserved Results • First pass has identified synonymy, deprecation, possible fifth axis • Being reviewed and refined by harmonisation group • Formal evaluation within international HL7 community prior to and during January working group meeting. ©NHS Information Authority 2004. All rights reserved Outline • • • • • ©NHS NHS dm+d International harmonisation Dose form vocabulary Dose syntax Questions. Information Authority 2004. All rights reserved • Objectives • Harmonise medicine information models developed in the UK, USA, Australia and Holland • Analyse and articulate “Use Case’s” models are required to support • Consider model components such as drug routes, dosage forms, ingredients • Consider medicines prescription and administration instructions (SIGS) • Identify the business case for harmonisation. ©NHS Information Authority 2004. All rights reserved Dose syntax • UKCPRS requirement • Although drug models vary internationally, dosing instructions tend not to • Develop for UKCPRS but within international arena – HL7 • Allows messaging element to be interoperable regardless of domain • Work in progress. ©NHS Information Authority 2004. All rights reserved DoseInstructions 1..* + contains 1 Device/Preparation Instruction DoseInstructionClause + sequence() : int 0..1 + value() : CD + uncodedValue : ST + sequence() : int + conjunction : CD Action + sequence() : int + value() : CD + uncodedValue : ST 0..1 Instruction 0..1 + sequence() : int + value() : CD + uncodedValue : ST Quantity + + + + 0..1 sequence() : int value() : IVL<RTO<PQ>> valueQulaifier : ST note(): ST Qualifier 0..1 + sequence() : int + value() : CD + uncodedValue : ST 0..* 0..1 QuantityUpperBound Timing + value() : IVL<RTO<PQ>> + note(): ST + + + + sequence() : int value() : IVL<RTO<PQ>> valueQulaifier : ST note(): ST Method 0..1 0..1 RouteSiteMethod + sequence() : int + value() : CD + uncodedValue : ST + sequence() : int Site 0..1 TimingStartStop Notation error. Coincident lifetime. ©NHS + + + + + namedStartEvent() : CD namedStopEvent() : CD fixedStartDate() : TS fixedStopDate() : TS duration() : IVL<TS> Information Authority 2004. All rights reserved 0..1 + sequence() : int + value() : CD + uncodedValue : ST 0..* TimingUpperBound + duration() : IVL<TS> + interval() : IVL<TS> 0..1 Route + sequence() : int + value() : CD + uncodedValue : ST Class descriptions • DoseInstructions – The whole dose instruction – Simple to complex • DoseInstructionClause – Component element of a compound instruction – Links to permit construction of the whole – E.g. “and”, “then”, “or” • Action – The action required to get medication into the patient – E.g. “take”, “chew”, “apply”. ©NHS Information Authority 2004. All rights reserved Class descriptions • Quantity – The amount to be consumed as a single dose – Simple, options, ratios, qualified – E.g. 1 tablet, 1 or 2 tablets, 1mg/kg bodyweight, tablet colour • QuantityUpperBound – To support dose ranges – E.g. 1mg/kg to 5mg/kg • Timing – The how often the dose is to be consumed – Simple, dose duration, treatment duration, dose intervals – E.g. twice a day, over 6 hours, for 5 days, 8 hourly. ©NHS Information Authority 2004. All rights reserved Class descriptions • TimingStartStop – To support detailed timing instructions – E.g. Starting 5 days after …, Stop 1 week before … • TimingUpperBound – To support timing ranges • RouteSiteMethod – The route of entry, site of entry, method of administration – E.g. intravenous into fast running drip – Built from individual components. ©NHS Information Authority 2004. All rights reserved Class descriptions • Instruction – Further instructions to the patient – E.g. “when required for pain relief”, “as instructed on the pack” • Device/preparationInstructions – Detail on medication preparation – E.g. “Dissolve in water before taking”, “Sprinkled onto food”. ©NHS Information Authority 2004. All rights reserved Further work • Refinement • Ballot • Vocabulary content. ©NHS Information Authority 2004. All rights reserved Questions? ©NHS Information Authority 2004. All rights reserved