Survey on the use of medicines information Preliminary review from - - PowerPoint PPT Presentation

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Survey on the use of medicines information Preliminary review from - - PowerPoint PPT Presentation

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Survey on the use of medicines information Preliminary review from the HCPWP topic group on information on medicines EMA PCWP and HCPWP joint meeting Session on communication and information on medicines Presented by Laurent Brassart (EMA)

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An agency of the European Union

Survey on the use of medicines’ information

Preliminary review from the HCPWP topic group on information on medicines EMA PCWP and HCPWP joint meeting Session on communication and information on medicines

Presented by Laurent Brassart (EMA) and Joan Peppard (EAHP) on 8 March 2016 HCPWP Topic Group on information on medicines

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Introduction

  • Since the establishment of the EMA, the European Regulatory network strives to provide users with

transparent information on medicines

  • In parallel, the framework of information on medicines continuously evolves e.g. with IT progress,

internet, globalisation, or clinical practice guidelines

  • Demand for more information and individualised care, scientific progress with new therapies, and,

growing amount and channels of information, question how HCPs use all this information in practice

1 EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

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Current interactions between Regulators and HCPs

  • rganisations favour the following assumptions:
  • SmPC itself (or through compendia or formulary) is the document of reference for use of a medicine
  • Clinical practice guidelines are more and more used for therapeutic choice
  • Educational material and DHPC are punctual or targeted information corresponding to specific situations
  • Public assessment report are used to prepare guideline or independent information on medicines, in

addition to other sources such as medical journal

  • Use depends on HCPs’ roles and may regionally differ (e.g. depending on organisation of health system)
  • Package leaflet and summary of public assessment report are rather used by patients and consumers

2 EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

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Survey objective

To get a better grasp of what is in use and why of the information available considering the extent and variety of audiences, needs and documents, as well as the diversity of medical practice and access to information between countries in Europe

3 EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

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Survey methodology

  • Survey among members of HCP organisation eligible for interaction with EMA, or, in contact

with EMA and confirming their interest in participating (11 January 2016 - 1 February 2016)

  • All “EMA eligible organisations” + 15 others having volunteered
  • Basic online survey listing different types of medicines information and asking participants

to inform whether they use them and for which purpose

  • Analysis plan:
  • Responses from EU/EEA participants having answered at least one question beyond profiling
  • % users of each documents, the purposes of their use - Analyses to focus on regulatory information
  • Sub analyses: per region or profession depending on number of participants profiling
  • Descriptive analyses

4 EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

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EU/EEA participants profiling

Number of participants 92% from EU/EEA >75% providing answers beyond profiling >500 answering all questions

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Overall profiling Region 4 most represented countries: Italy, Germany, UK and Belgium Age Balanced from 26 to 65 year old Profession 22% GP , 23% Specialist, 47% Pharmacist, 4% Nurse, 4% others About 75 % informed on participation in information or guideline activities

EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

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Limitations of the survey

  • Organisations in contact with EMA, which cascaded survey to participants
  • Documents questioned in the survey distributed through different channels
  • Self-selecting audience (probably high interest in information on medicines)
  • Not equally spread throughout Europe or between professions
  • Geographical analyses; United Nations Sub European regions: EU/EEA population and Pharmacists
  • Comparisons between GPs, Specialists, Pharmacists, Nurses

6 EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

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Extent of use of the different types of documents – all EU/EEA participants

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0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% Summary of Product Characteristics Package Leaflet Public Assessment Report Summary of Public Assessment Report Educational material Direct health professional communication (DHPC) Medicines compendia Medicines formulary Clinical practice guideline Medical journal used not used

EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

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Purposes of uses of documents - all EU/EEA participants

8 All participants Therapeutic decision Dosing information Safety management Storage, preparation or administration Preparation of clinical practice guidelines Informing patients SmPC 56 % 78% 68% 60% 40% 45% Package Leaflet 11% 34% 24% 37% 10% 51% Public Assessment Report 30% 19% 34% 11% 25% 14% Summary of Public Assessment Report 25% 15% 25% 9% 19% 16% Educational material 32% 33% 59% 21% 27% 34% DHPC 45% 41% 59% 26% 30% 26% Medicines compendia 52% 66% 52% 45% 32% 32% Medicines formulary 46% 64% 46% 35% 29% 25% Clinical practice guideline 74% 57% 48% 26% 48% 31% Medical journal 69% 48% 52% 26% 52% 26% EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

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Comparison of use between European regions (all EU/EEA participants)

9 EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% Summary of Product Characteristics Package Leaflet Public Assessment Report Summary of Public Assessment Report Educational material Direct health professional communication (DHPC) All Western Europe Northern Europe Eastern Europe Southern Europe

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Comparison of use between European regions - Pharmacists

10 EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% Summary of Product Characteristics Package Leaflet Public Assessment Report Summary of Public Assessment Report All Pharmacists Western Europe Northern Europe Eastern Europe Southern Europe

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Comparison of use between professions (All EU/EEA participants)

11 EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% Summary of Product Characteristics Package Leaflet Public Assessment Report Summary of Public Assessment Report Educational material Direct health professional communication (DHPC) All Specialist non-GP GP Nurse Pharmacist Other

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Use of clinical practice guidelines and medical journals per profession (All EU/EEA participants)

EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% Clinical practice guideline Medical journal All Specialist non-GP GP Nurse Pharmacist Other

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Non-EU/EEA responses

  • 25 countries outside EU/EEA

Africa, Northern or South America, Asia, Non-EU/EEA European countries

13 EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% Summary of Product Characteristics Package Leaflet Public Assessment Report Summary of Public Assessment Report non-EEA EEA

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Do you prefer access to information through electronic media

  • r on paper format?

EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016 14

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Main survey outcomes and discussion

  • Baseline on use of medicines information by Healthcare Professionals
  • Healthcare Professionals use many sources of information
  • Regulatory information:
  • All HCPs use SmPC, for many purposes from dosing information to preparation of

therapeutic guidelines.

  • Package leaflet used to inform patients, with higher use by nurses
  • High use of Educational material and DHPC, in particular for safety management
  • >50% use Public assessment report but it is less known or accessible. Regional difference?
  • EU information also used outside EU/EEA
  • Need for further research?

15 EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016

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Acknowledgements

All participating organisations and respondents Topic group members HCPWP Co-Chairs

  • I. Rondak, M. Mitroiu

Esther van Vliet

16 EMA PCWP/HCPWP joint meeting - Session on communication and information on medicines – 8 March 2016