2004

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CODE – Pharmaceutical IndustryDiscussion Form on

ePrescription & ePharmacy

Dr Stephen Chu

University of Auckland Health Informatics

2004

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Agenda

Definitions

Forces that shape the development of ePrescription and ePharmacy– Government and industry initiatives

– International standards

– Consumer behaviours

Enabling technologies

Implications: – Discussion questions

2004

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Why ePharmacy matters ?

Some statistics (Health and Disability Services Overview, 2001; http://www.moh.govt.nz):

– Total GP Visits per day by all New Zealanders:

• 50,000 (also see WAVE report, Oct 2001, p.38)

– Emergency department attendance: 1960/day

– Hospital outpatient dept visits: 4000/day

– Older people in long term residential care:

• 274000 Majority likely to haveprescriptions requiringservices of communitypharmacies

Over the Counter (OTC) medications from pharmacies, supermarkets and convenience stores: Big market

2004

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What is ePrescription ?

Electronic prescription (ePrescrpition) is the electronic transmission of prescription information on pharmaceutical products from legally and professionally qualified / registered health practitioners to registered pharmacies (or dispensing system).

The ePrescription legally authorizes the receiving pharmacy (or dispensing system) to dispense the prescribed products identified in the prescription to a subject of care

2004

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What is ePharmacy ?

Includes:– ePrescription

– Request and supply of Over-the-Counter products

– Consumer (providers and subject of care) education

– Supply chain management – eBusiness

– Consumer relations management

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Government & Industry Initiatives

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Australia’s MediConnetMediConnect (formerly know as Better Medication Management System) is Australia’s effort to develop a national project to help improve quality and safety in management of medicine

Aim is to support ePrescription and to reduce adverse drug events

Electronic MediConnect record will be stored with Health Insurance Commission (HIC) which administers Medicare and other government health programs

2004

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Australia’s MediConnet

http://www.mediconnect.gov.au

Pilo

t pr

ojec

t in

tri

al

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Australia’s MediConnet

What will be recorded?

Personal information such as name, address, date of birth and Medicare card or Department of Veterans' Affairs (DVA) file number

Medicine history including: prescription medicines, over-the-counter medicines, adverse drug reactions

Consumers determine what to record and who can have access to the information

2004

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Australia’s MediConnetMediConnect is being field tested in 2003 in two locations:– Launceton (Tasmania)– Ballarat (Victoria)

Only GP – Community Pharmacies in 2003

Hospital to follow later– Individual hospital ePrescription project in trail

Evaluation in progress

Report to follow later

2004

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Australia’s MediConnet

Standards– HL7 V2.3.1 ePrescription messaging

standard used for formatting ePrescription data

– No standard medication terminology yet• Uses Australia’s own Pharmaceutical

Benefit Scheme (PBS) codes• If PBS code not applicable to drug

prescribed, transmit drug name as free text

2004

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Standard Drug Terminology

Needs standard drug codes and terminology to enable sharing of core drug data that are human readable and computer processableto support:– Electronic prescribing (by brand or generic names)

– Computer assisted dispensing of medication

– Linkage of drugs to knowledge source

– Drug utilisation and complications reporting

– Electronic commerce and supply chain management

2004

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Standard Drug Terminology

Drug terminology data set is intended to describe the core data:– Generic and proprietary drug names

– Active ingredients

– Prescribable therapeutic moieties

– Drug classification or grouping structures

– Drug dose forms

– Unit of measure for drug strength

To be mapped to standard terminology, e.g. SNOMED

2004

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VMPVirtual Medicinal

Product

DrugFormRoute

VMPPVirtual Medicinal

Product Pack

AMPPActual Medicinal

Product Pack

VirtualProduct

Ingredient

ControlledDrug

Prescribing

CombinationPack Content

Drug TariffCategory

Pack Price

ReimbursementInformation

ApplianceProduct

Information

ProductPrescribing

AMPActual Medicinal

Product

ActualProduct

Excipient

ProductAvailability

VTMVirtual

TherapeuticMoiety

UKCPRSComposite Model

Drug Form

Drug Route

The UK drug dictionary conceptual model

The proposedAustralian nationaldrug terminologymodel and drugdictionary willlikely to be based on theUK model

EAN Code attached to

2004

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The UK drug dictionary UML model

VTM_PK[1] : SNOMED IDName[1] : SNOMED Name

Virtual Therapeutic Moeity{defn = A VTM is the abstract conceptual representation of

the material defining the prescriber's therapeutic intent,divorced from formulation, dose or strength.}

VPI_PK[1] : SNOMED IDvirtualProductName[1] : SNOMED NamecombinationProductIndicator[0..1]basisOfPreferredName[1]dateOfNameApplicability[0..1]previousName[0..1]basisOfPreviuousName[0..1]raesonForNameChange[0..1]virtualProductPrescribingStatus[1]sugar-freeIndicator[0..1]

Virtual Medicinal Product{defn = A VMP is the conceptual representation of one ormore clinically equivalent Actual Medicinal Products thepurpose of which is to support the representation of thefundamental reality of the concept. Its core description

requires product name, strength and dosage form, but isdevoid of explicit or implicit information attributable to

manufacturer or pack.}

VMPP_PK[1] : SNOMED IDcombinationProductIndicator[0..1]virtualProductQuantity[0..1]virtualProductQuantityPerUnit[0..1]

VMPP{defn = A VMPP is the conceptual representation of each

and every AMPP that exists for its associated AMPs. }

AMPP_PK[1] : SNOMED IDcomponentOnlyPackIndicator[0..1]dispensingStatus[1]

Actual Medicinal Product Pack{defn = 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) arepresent in the pack. One AMP may have one or manyAMPPs, including being involved in component pack

AMPPs.

Attributes therefore include information about pack price(EAN codes) etc.}

AMP_PK[1] : SNOMED IDcomponentOnlyProductIndicator[0..1]actualProductName[1]dateOfNameApplicability[0..1]previousName[0..1]supplier[1]licensedRoute[0..*]licensingAuthority[0..1]flavour[1]

Actual Medicinal Product{defn = An AMP is the representation of a single unit dose of a medicinal productthat is (or has been) made or marketed by a specific manufacturer or supplier. Itscore description requires product name, strength, dosage form and manufacturer,

but is devoid of explicit information attributable to pack size.

The unit dose is the smallest single entity of the product that can be physicallyhandled with the following defined deviations:

Continuous liquids excluding eye-drops: where the unit dose is expressed interms of the accepted normal sub-unit used as the basis of administration

Continuous solids: where the unit dose is expressed in terms of the acceptednormal sub-unit used as the basis of administration

Continuous semi-solids and eye-drops: where a consistent, physicallymeasurable unit or sub-unit cannot be defined and which is therefore not

instantiated.}

SNOMED_PK[1] : SNOMED IDname[1] : SNOMED Name

SNOMED CT UK Ext{defn = This is the SNOMED-CT UK

extensions}

1

0..*

Instantiates

1

1..*

is a pack of

1

0..*

is a pack of

1 0..*

instantiates

1

1..*

instantiates

1

1

has

1

1

has

1

1

has

1

1

has

R_PK[1] : SNOMED IDVPR_FK[1]

Route{def = A licensed mode of administration of the medicinal product. The route information shall be

represented as a code taken from the associated PCCD list of medicinal product routes.

NOTE: The identifier will be taken from the SNOMED core term entry}

1

0..* has a

VPI_PK[1] : SNOMED IDingredient_FK[1] : SNOMED IDbasisOfPharmaceuticalStrength[0..1]pharmaceuticalStrengthValue[1]pharmaceuticalStrengthUnits[1] : SNOMED ID

Virtual Product Ingredient{documentation = Information about an ingredient substance

that are contained within a Virtual Medicinal Product.

This will include those substances which are deemed to be'active' ingredients. Excipient information is associated with

Actual Medicinal Products.,

defn = These are the significant Active Ingredients commonto all Actual Medicinal Products associated with the VMP,

eg = co-amoxiclav 250/125 would have two entries, one foramoxycillin 250mg, the other for clavulanic acid 125mg.}

1

0..*

has

VMP_PK[1] : SNOMED IDCD_PK[1]changeDate[1]oldCD_PK[1]

Controlled Drug Prescription{documentation = If a controlled drug category change date is included in the record, this attribute

shall be used to convey the category on and subsequent to that date, otherwise the category is to beinterpreted as the category at the release of the current version of the dictionary.,

def = Information relating to Virtual Medicinal Products where these are drugs and in particular wherethe drug is controlled under the Misuse of Drugs Act.}

1

1 has

CPC_PK[1] : SNOMED IDCPC_FK[*] : SNOMED ID

Combination PackContent

{documentation = Used toidentify the component

packs within a combinationpack }

VMPP_PK[1]dtPaymentCategory[1]dtPrice[1]dtPricePrevious[1]

Drug Tariff Category{documentation = Information relating to the

categorisation of drugs, appliances, chemical reagentsand oxygen as provided in the Drug Tariff.

}

AMPP_PK[1] : SNOMED IDprice[1]dateOfPriceValidity[0..1] : DatepricePriorToChangfeDate[0..1] : int

Medicinal Product Price{def = the price charged for an Actual

Medicinal Product Pack}

AMPP_PK[1]schedule11Indicator[0..1]

Product Prescribing{def = Information relating to the prescribing

of Actual Medicinal Product Packs. Thisinformation is required in the act of

prescribing but is also important withindispensing, administration and the

reimbursement of fee domains}

API_PK[1]reimbursementStatus[1]applianceReimbursementStatusDate[0..1]applianceReimbursementPreviousStatus[0..1]sizeOrWeight[0..1]colour[0..1]orderNumber[0..1]

Appliance Product Information{def = General information specific to appliances

}RI_PK[1]prescriptionCharges[0..1]dispensingFees[0..1]thresholdQuantity[0..1]brokenBulkIndicator[0..1]limitedStabilityIndicator[0..1]calendarPackIndicator[0..1]specialContainerIndicator[0..1]zeroDiscountListAIndicator[0..1]FP34DPrescriptionItem[0..1]

Reimbursement Information{def = Information relating to financialreimbursement to dispensing agents.

Note: The information within this file willrelate particularly to drugs and reagents.

}

AP_PK[1] : SNOMED IDingredient_FK[1] : SNOMED IDpharmaceuticalStrengthValue[1]pharmaceuticalStrengthUnits[0..1] : SNOMED ID

Actual Product Excipient{documentation = Used to provide information about excipient

substances contained in the Actual Medicinal Product.

Note 1: Information about active ingredients are associated with theVirtual Medicinal Product. This facility may be used to provide

information about excipients.

Note 2: The excipient information is not guaranteed to be complete.The absence of excipient information does not imply the absence of all

or any excipient product.}

AP_PK[1] : SNOMED IDstatusType[1]statusChangeDate[0..1]previousStatusType[0..1]ststusChangeReason[0..1]

Product Availability{documentation = Informationabout the availability status

for the product.}

1

0..* has

1

1

has

1

1

has

*

0..*

has

1

0..*

has1

0..* has

1

0..*

has

1

1

has

UKCPRS Class Model

SNOMED_PK[1] : SNOMED IDname[1] : SNOMED Name

SNOMED CT Core{defn = This is the set of SNOMED terms that are present

in the core of the UK cut}

1

1

has

1

0..*has SNOMED ingredient

1

0..*

has SNOMED ingredient

1

0..*

has a

FR_PK[1]

FormRoute{defn = The physical conformation of the drug and its mode(s) of administration. The form-route

information shall be represented as a code taken from the associated PCDD approved list ofmedicinal product forms and routes.Examples: oral tabletoral suspension intravenous injectiondeep

intramuscular injectioneye drops

NOTES: 1. The form aspect shall be specifically the form at administration which may bedifferent from the form at dispensing

2. Generally an entry in this field will be a form + route combination. However, this is notalways the case. For example, if a VMP represents a product which is especially formulated for

multiple route, an entry may be made which reflects this.

3. The automatic construction of the form+route description from the entries for virtualproduct form and virtual product route would not be reliable.

}

1

0..* has

1

1has

1

1has

VPF_PK[1]name[1]

PCDD Forms{def = PCCD list of

medicinal product forms}

1

1has

VPR_PK[1]name[1]

PCDD_Routes{def = A licensed mode of

administration of themedicinal product#

}

1

1

has

Information relating the Virtual Medicinal Product to its form and route(s) of administration both as a combined concept and also as separate concepts

Note 1: Although this information is commonly used for drugs, there are instances where the distinction between products registered (licensed) as drugs andappliances is blurred and where form and route information for these products is important. For example: Zn Oxide bandage

Note 2: There are an increasing number of occasions where manufacturers are using the Medicinal Devices Agency (MDA) for approval as an alternative tothe more stringent Medicines Control Agency (MCA). This leads to products being classified as devices rather than drugs.

FR_PK[1]name[1]

PCDD FormRoute{def = PCDD approvedlist of medicinal product

forms and routes.}

1

1 has

F_PK[1] : SNOMED IDVPF_FK[1]

Form{defn = The physical conformation of the drug. The form-information shall be represented as a

code taken from the associated PCCD list of medicinal product forms.

NOTE: 1. This is the categorical form, i.e. the form as normally dispensed

NOTE:2. The identifier will be taken from the SNOMED core term entry,

eg = effervescent tablet, sachet, injection}

CD_PK[1]name[1]

CD Schedule{documentation = Theprescribing/dispensing

classification of amedicinal product in

terms of its controlleddrug status.}

1

1

has

1

*

has component packs

1

1

has SNOMED untis

1

1

has SNOMED units

2004

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The Central Medicine RepositoryAustralia is planning to build a national Central Medicine Repository

Aim: to provide a trusted and authenticated source of ‘publicly’ available medicine data

To support– More accurate transmission of prescription data

– Quality and efficient clinical decision support

– Greater efficiencies in pharmaceutical supply chain

– Better data analysis for admin and research

2004

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The Central Medicine Repository

To be built and maintained by EAN Australia

Uses EAN (European Article Numbering) code at product level

Content updates to be done by pharmaceutical manufacturers

Needs to be supported with a standard drug terminology/coding system

2004

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The Central Medicine RepositoryGENERIC CONCEPT

GENERIC CONCEPT EAN (PK)Generic Concept Full NameGeneric Concept Common NameATC CodeSNOMED CT Link

PRODUCT

PRODUCT EAN (PK)GENERIC CONCEPT EAN (FK)Label NameBrand NameTherapeutic Goods Administration LinkPack-Other DescriptionTrade Product LinkManufacturers Product CodeProduction Information Identif ierConsumer Medicines Information Identif ierMaterial & Safety Data Sheet Identif ierProduct PhotographTrade Release DateDate Product MarketedDate Product CeasedDate Last Batch ExpiresDate Database Last UpdatedAuthor of Last UpdateQuality Approved Date

PRODUCT PACKAGEPRODUCT EAN (FK)PACKAGE ID (FK)Packages per Product

PACKAGEPACKAGE ID (PK)Package Type

PACKAGE MEDICATIONPACKAGE ID (FK)MEDICATION ID (FK)Volume/Weight AmountVolume/Weight UnitItems per Package

MEDICATIONMEDICATION ID (PK)Form Code (FK)

MEDICATION INGREDIENTMEDICATION ID (FK)ACTIVE INGREDIENT ID (FK)

ACTIVE INGREDIENTACTIVE INGREDIENT ID (PK)EQUIVALENT INGREDIENT ID (FK)Active Ingredient NameStrength-Active AmountStrength-Active Amount Unit (FK)Strength-Active per Volume/Weight AmountStrength-Active per Volume/Weight Unit (FK)

EQUIVALENT INGREDIENTEQUIVALENT INGREDIENT ID (PK)Equivalent Ingredient NameStrength-Equivalent AmountStrength-Equivalent Amount Unit (FK)

FORMFORM CODE (PK)DescriptionParent FormActive Indicator

UNIT OF MEASUREUNIT CODE (PK)AbbreviationDescriptionType

Data model for the Central Medicine Repository(developed by thePharmaceutical coding project)

2004

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New ZealandePharmacy currently being planned

Aims:– Support ePrescription from general practice to

community pharmacies– Prescription and utilisation reporting to Public

Health Organization

Central ePrescription database to be built and maintained by a private company –Healthlink

Use secured health intranet, IPSec protocol

National-wide pilot: likely 3rd quarter 2004

2004

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ePharmacy in New Zealand

Datastore

ePharmacyCentralRepository

GP Consultation

Patient

Community Pharmacy

Health Intranet

IPSec ProtocolePrescription

Medication history

HealthIntranet

MedicationHistory

+Prescriptioninformation

ePrescription

Authorization

Reporting

Healthlink

Public health organization

2004

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ePharmacy in New ZealandStandards– Will use HL7 V2.3.1 ePrescription

messaging standard– Will use Pharmac drug codes

Healthlink: awaiting standard drug terminology and code set

Will collaborate with Australia in standard drug terminology development

Hospital-based ePrescription pilots– CMDHB: in progress; ADHB: to follow soon

2004

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International Standard

International Standards Organization (ISO)– ISO/TC215 WG6:

• ePharmacy (business) process framework

– ISO/TC215 WG5: • Patient healthcare card standard including standard

definitions for medication data to be stored on healthcare card

– HL7 Medication Information Special Interest Group: huge amount of work done

– CEN

2004

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ISO/TC215 WG6 ePharmacy Process Framework

2004

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Consumer Behaviours

Increasing acceptance of information and communication technologies

Increasing exposure and utilisation of Internet technology– Wisconsin state ePharmacy website connecting

residents to online Canadian pharmacies established in December 2003

– Received 80,000 hits in 3 months (as reported on 27 February 2004)

2004

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Enabling Technologies

Smart card technology– Patient healthcare cards

– To be piloted by 4 EU countries in 2004 summer Olympic games

– 160 millions to be issued by 6 EU countries by 2006

eKiosk (USA/EU experiences)– Located in clinics, hospitals, local libraries, local

councils, super markets

– Provides secured ePharmacy access

2004

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Implications ?

Changes to business processes and supply chain management

Changes to customer relations management

Potential for direct consumer marketing and education

Pressures on pricing structure

Issues of quality and reliability

2004

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ePharmacy Discussion Questions

What are the implications (benefits/negative impacts) of ePharmacy adoption for:

– Pharmaceutical manufacturers – Pharmaceutical companies – Pharmacists– GP’s – Consumers?

How might DTC initiatives in this environment impact the current industry balance of power?

– Pharmac– Internet pharmacies – GP information flows to consumer

2004

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ePharmacy Discussion Questions

Will such e-initiatives involve full-spectrum CRM?– Who is the customer (GP’s, consumers, pharmacists)?– What are the customer contact points (eKiosks/smart

cards)?

Who owns the relationship with the consumer (patient) in an e-pharmacy model?

– Manufacturer– Pharmaceutical company– Govt – GP

Role in national drug repository development

Who owns the data and who can access/view it?

2004

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ePharmacy Discussion QuestionsIn the evolution of ePharmacy– What are the business visions of your company?

– How does your company’s business model fit?

– What would be the desirable/optimal business model for ePharmacy?

– How does ePharmacy change your company’s business strategy and direction?

– How can your company capitalise on the DTC and CRM potentials?

– What are the issues associated with ePharmacy? How best could these issues be addressed?

2004

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Research & Development Potentials

CODE invites the Pharmaceutical Industry to collaboratively:– Explore the implications and potentials of

ePharmacy

– Identify the business needs of the industry:• eBusiness models and optimal strategies

• Broadening of business potentials

• Supply chain management

• DTC and CRM

– Engage in collaborative research activities to meet the industry needs

2004

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Thank You

stephen.chu@auckland.ac.nz(09) 373 7599 Ext 87716