eHealth Forum 2014, 14 May, Athens · eHealth Forum 2014, 14 May, Athens SESSION: ePrescription for...

An agency of the European Union

Presented by: Panagiotis TelonisBusiness Data and Support Department

eHealth Forum 2014, 14 May, Athens

SESSION: ePrescription for Patient Safety, efficiency and continuity of care

Outline

• EMA vision on interoperability of medicinal product (MP) databases

• Legal basis

• What has been achieved so far

• How can this benefit the eHealth network

• Summary of next steps

2

EMA vision on interoperability of MP databases Focus on substances and medicinal products and how EMA will share

this with all health players / stakeholders

NCA‟sNCA‟s

NCA‟s

IndustryIndustry

Industry

Collect – Validate -Correct - Control - Reconciliate

EMA

Make Available -Secure where necessary

- Open where possible

Open to eHealth services, e.g. electronic health records, e-prescription…

Searchable and available

Accessible through web-services

Accesible through different online channels

Subscribe to information of interest

•Common vocabulary (structured

and unstructured data)

•Common information exchange

standards

•Agreed quality standards

EC – DG

SANCO

3

Legal basis (1)

• Article 57(2), second subparagraph of the new pharmacovigilance legislation (REG 726/2004) requires marketing authorisation holders (MAHs) to submit electronically a core set of information on medicinal products to the Agency

4

What data (Art 57(2), Data Content)

Reference Terminology:

-R1: Pharmaceutical form

-R2: Route of Administration

-R3: ATC codes

-R4: Units of Measurement

-R5: Units of presentation

-R6: Reference source

Substance Information:

- S1: Substance names

- S2: Substance Translations

- S3: Substance synonyms

- S4: Substance class

- S5: Reference source

- S6: International Codes

Structured Medicinal Product Information:

- P1: MAH (Legal Entity)

- P2: QPPV

- P3: PhV Enquiries

- P4: PSMF

- P5: Authorisation country code

- P6: Authorisation procedure

- P7: Authorisation status

- P8: Authorisation number

- P9: Authorisation date

- P10: MRP/DCP/EU number

- P11: Date of withdrawal/revocation/suspension

- P12: Package description

- P13: Orphan drug designation

- P14: Comments (e.g. paediatric use)

- P15: Medicinal product name

- P16: Medicinal product invented name

- P17: Product generic name

- P18: Product company name

- P19: Product strength name

- P20: Product form name

- P21: Pharmaceutical Form

- P22: Route of administration(s)

- P23: Active ingredient(s), Adjuvant(s)

- P24: Excipients

- P25: Medical device(s)

- P26: Strength of active ingredient(s)/adjuvant(s)

- P27: Therapeutic Indication(s)

- P28: ATC code

Unstructured Medicinal Product Information:

- P29: Summary of Medicinal Product Characteristics

Organisation information:

-O1: MAH (Legal Entity)

-O2: QPPV

-O3: PhV Enquiries

-O4: PhV System Master File

Business

Service

Product

P

Business

Service

Substance

S

Business

Service

Organisation

Business

Service

Referentials

O

R

11238

11239

11240

11616

11615

5

Legal basis (2)• Additionaly, the new pharmacovigilance legislation foresees the

use of international standards and terminologies in support of

the identification of medicinal product information.

• The Agency has been leading on the development of these

standards which are referenced in the Commission

Implementing Regulation 520/2012.

• The use of internationally agreed terminology, format and

standards should facilitate the interoperability of systems

and avoids the duplication of encoding activities concerning the

same information.

• It should also allow for an easier information exchange

between regulatory authorities on an international level

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What has been achieved so far

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Article 57(2): Initial submission

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Total number of medicinal product data submissions by MAHs up to 3 Feb 2014

Total number of medicinal products (based on EudraVigilance codes) 459,290

Total number of marketing authorisation holders (legal entities)

established in the EU (corresponding to EudraVigilance codes)3,996

Article 57(2) Submission plan2014-2016

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2013Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2

2014 2015 2016

Transition phase (before ISO IDMP)

June 2014 – December 2014The objective is to enable the MAHs to update, complete, improve the quality and submit the Article 57 data via the simplified process before the end of 2014.

From January 2015

MAHs to continue notifying any changes affecting the Article 57 data by means of the

simplified process within 30 calendar days from the date of which the changes have been

authorised.

December 2013 – June 2014

The aim is:

•For the Agency to upgrade the

Agency's data entry tool and

provide necessary guidance to

support the maintenance

submission

•For industry to start upgrading

in-house IT systems

Preparatory Phase

ISO IDMP standards developed• The Identification of Medicinal Products (IDMP) was initially developed

in the ICH M5 remit in order to facilitate the exchange of information

between pharmaceutical companies and regulatory authorities.

• Subsequently it was adopted by International Standard Development

Organisation (SDOs) as part of the Joint Initiative project. The

Joint Initiative includes the following organisations:

• European Committee for Standardization (CEN)

• International Organization for Standardization (ISO)

• Health Level 7

• Clinical Data Interchange Standards Consortium (CDISC)

• International Health Terminology Standards Development Organisation (IHTSDO)

• GS 1

• ISO IDMP standards were finalised in October 2012 within ISO TC 215

“Health Informatics” - WG6 10

ISO IDMP Objectives• Developed in response to a worldwide demand for

internationally harmonised specifications for medicinal

products

• Facilitates the activities of medicines regulatory agencies

worldwide by jurisdiction for a variety of regulatory activities

• Development, authorisation and life cycle management of

medicinal products

• Pharmacovigilance and risk management

• Provides the basis for the unambiguous identification and

characterisation of medicinal products across region

• The scope of the work in ISO was widened to also support

activities in the health care domain e.g. e-prescription 11

International standards:

ISO IDMP package comprises five standards :

ISO 11615:2012(E), Health Informatics, Identification of Medicinal

Products (IDMP) standard „Data elements and structures for unique

identification and exchange of regulated medicinal product

information‟



identification and exchange of regulated pharmaceutical product

information‟

12

International StandardsISO 11238:2012(E), Health Informatics, Identification of Medicinal


identification and exchange of regulated information on

substances‟



identification and exchange of regulated information on

pharmaceutical dose forms, units of presentation, routes of

administration and packaging‟



identification and exchange of units of measurement13

ISO IDMP Standards

14

ISO-11240

Units of

Measure

ISO-11239

Pharmaceutical

Dosage Form

ISO-11238

Substance

ISO-11616 Pharmaceutical Product

(Scientific composition)

ISO-11615 Medicinal Product – Regulatory Information

Controlled Vocabularies

Presentation title (to edit, click View > Header and Footer)16

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MP

PhP


Marketing Authorisation

MPID: DE 479 6763

German name: Pharmacyllos*

Authorised by: BfArm

Marketing Authorisation

MPID: FR 549 6731

French name: Cyllaron*

Authorised by: ANSM

Pharmaceutical product

Unique ID: PhPID

e.g. 4976AXZ

The patient receives a prescription for ‘Pharmacyllos’ from her German doctor….

… she then travels to France where she wants to redeem the prescription…

17(*) Medicinal product names are fictional and for illustrative purposes only..

How can this benefit the ehealth networkExample: prescribing the medicine in one country and dispensing it in another country

Summary of next steps

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Art 57 data cleaning

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• 107,000 Substance names (in English and national languages) are currently available in Art.57 Dictionary and can be already used.

• 500,000 medicinal products records fully up-to-date by end of 2014 in the EudraVigilance Dictionary.

• Validation of all the product data will progress in parallel

• ISO IDMP implementation roadmap for 2016 switch over will be progressed in parallel.

• From 31 Dec 2014, EMA will have an European Medicinal product and substance dictionary fully operational.

Data Content (Substance CVs)

• 107,000 Substance names (in English and national languages)

are currently available in Art.57 Dictionary

• De-duplication of Article 57 IDs (EVCodes) was completed in

April 2014

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What EMA is doing to improve data quality


• Improving technical business rules and validation

• Article 57 Quality Control Methodology for MAH to improve data quality during

maintenance submission

• Stakeholder training and e-learning covering the submission plan and the

maintenance business processes

• Guidance and revised xEVMPD training material

• IT functionality to support MAHs in maintenance submission and data quality

improvement

• Monthly Teleconferences and IWG meetings are scheduled to support industry

in the implementation of the agreed plan.

• EMA will continue liaise with EU regulatory Network and Industry

representatives to initiate the development of an ISO IDMP implementation

plan and the roadmap for ISO IDMP implementation

Article 57 Business cases 2014-2016

Data analysis

EudraVigilance (EV) data analysis and Signal management

Reporting and coding of medicinal product and substance information

in ICH ICSRs

Data analytics and business intelligence

Regulatory actions and legal obligation

Regulatory action to safeguard public health (e.g. Referrals, PSUR

repository, Literature monitoring)

Support calculation of Pharmacovigilance fee

Communication with stakeholders

European medicines web portal

Granting access to EudraVigilance data (proactive and reactive)

EU / International data exchange

Support to PRAC for communication with MAHs

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Ongoing IDMP stardardisation work

• The International Community identified the need for

implementation guides for the ISO IDMP and the need for

describing how the ISO IDMP IDs will be created and

maintained globally

• Implementation Guides for ISO IDMP standards will be developed as

prCEN/ISO/Draft Technical Specification (DTS)

• Core principles for Maintenance of Identifiers and Terms will be

developed as prEN ISO/Draft Technical Report (DTR) 14872

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Ongoing IDMP stardardisation work (2)

ISO ballots were closed 19th March on:

– Draft Technical Specification (DTS) on 11238 (substance)

– Draft Technical Report (DTR) 14872 (maintenance)

Next ISO meetings:

May 2014: ISO TC215/CEN/TC251 Joint meeting (Japan) to discuss:

– Result of the ballot and next steps for ISO DTS on Substance and DTR

14872 on Maintenance

– Next steps on ISO 11615/11616/11240/11239 DTS (MPID, PhPID,

Unit of Measurement, Pharmaceutical Forms, routes of administration etc.. )

October 2014: ISO TC215/CEN/TC251 Joint meeting in Germany

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How can the Art57 dictionary benefit the

ehealth network

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• The content of the Art57 dictionary will be made publically available and this can be used for identification of the specific products cross-border because it contains all the medicinal product authorised in the EU market.

• Request for searches in the art57 dictionary can already be sent to EMA under acceptance of specific caveats with regards to data completeness & quality.

• The dictionary also contains the translations of most substance names in the EU languages, the SPCs for all the products, indications for each product and also the ATC code and the INN.

• Full specifications and project plan can be found in the Art57 dedicated webpage at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000594.jsp&mid=WC0b01ac058078fbe1

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000594.jsp&mid=WC0b01ac058078fbe1

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000594.jsp&mid=WC0b01ac058078fbe1

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In addition EMA through its Business Intelligence system (BI) could make available for free:

a) Specific reports, e.g. to help identify which products that are sold in specific countries containing specific substances or combination of substances, etc.

b)It will also be possible to search and use the pharmaceutical product concept. Indeed, the EMA dictionary can be used for representing the Pharmaceutical Product independently from its commercial form, identified as Non Proprietary Medicinal Preparation (NPMP based solution).


ehealth network

• Addressing through BI, proposals like the following (Ref. to eHN

discussions)

• Synchronizing EMA with national systems, or alternatively, offering a

unique European IT platform for drugs where all needed attributed

(ISO related) are managed.

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ehealth network

What do the ISO IDMP standards provide that is of use to ePrescription

• Linkage between all medicinal packages on the pharmacy shelves

across the EU

• Phpid – links all packets on the shelf to all others that have same

characteristics

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PhPID Type Level Composition

PhPID Active

Substance Stratum

L1 Substance(s) Term

L2 Substance Term(s) + Strength + Reference Strength (if applicable)

L3 Substance Term(s) + Administrable Dose Form

L4 Substance(s) Term+ Strength + Reference Strength (if applicable) + Administrable Dose Form

PhPID Specified

Substance Stratum

L1 Specified Substance(s) Term

L2 Specified Substance Term(s) + Strength + Reference Strength (if applicable)

L3 Specified Substance Term(s) + Administrable Dose Form

L4 Specified Substance(s) Term+ Strength + Reference Strength (if applicable) + Administrable Dose Form

What is the main barrier? language

Resolved by global substance ID (language independent)

Thank you!

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Background Material

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Where the xEVMPD data is used?

Example 1: Data provided in the xEVMPD is used within the Eudravigilance system to codify (in ISO MPID and Substance IDs – 11615 & 11238):

Medicinal Products Names reported in Safety Reports (i.e. in ICSRs B.4.k.2.1)

Active Substance Names reported in Safety Reports (i.e. in ICSRs B.4.K.2.2)

Example 2: Data provided in the xEVMPD is used for the creation of the Scientific Product Database (in ISO the PhPIDs -11616 ):

Grouping of products based on the same Active Ingredient(s), Strength(s) and Pharmaceutical Dose Form(s).

The Scientific Product Database is the reference database for the EV Data Analysis System and the Signal Detection

Example 3: Data provided in the xEVMPD is used for the creation of the Product Index (in ISO MPIDs and PhPIDs listing: 11238+11615+11616 IDs) to serve as reporting possibilities in Safety Reports

Example 4: The data will also be used within the EMA and EU regulatory network for life cycle management of medicinal products

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Where the xEVMPD data is used?

Example 3: Data provided in the xEVMPD is used for the creation

of the Product Index (in ISO MPIDs and PhPIDs listing:

11238+11615+11616 IDs) to serve as reporting possibilities in

the Safety Reports

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Index of:• Product name and their parts • Active ingredient(s)• Active ingredient(s) + Pharma

Forms+Strength

Similar to the requirements of an e-prescriber

Training and general information


Overall information on Art.57 legal requirements and plan is

available on EMA corporate website:

Free e-learning module provided at:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/gener

al/general_content_000596.jsp&mid=WC0b01ac058079126e

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000596.jsp&mid=WC0b01ac058079126e

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000596.jsp&mid=WC0b01ac058079126e

Data GovernanceArt.57 data content is available at:


Chapter 3.II is detailing all the

data submission business

process and requirements

Data Content and validation (CVs)

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Art.57 data content is available at:

Data Content and validation (CVs)

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Art.57 data content is available at:

AbbreviationsMA – Marketing

PhV – Pharmacovigilance

NCA – National Competent Authorities (National

Drug Regulators)

EDI – Electronic Data Interchange

UCUM – Unified Code for Units of Measure

EDQM – European Directorate for the Quality of

Medicine

SPC – Summary of Product Characteristics

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