SCOPE Joint Action Stakeholder Event Developing capabilities for ADR reporting Marina Lesičar, HALMED 20 21 March 2017 London
Contents Background Topics Partners involved Tool and survey method Main goal SCOPE findings Deliverables and training
- ADR collection Background Focused on national schemes for the spontaneous reporting of ADRs Aimed to provide NCAs for human medicines with a full understanding of and best practice in systems for collecting ADRs
Topics 6 individual topics within WP 4: 1) Audit of national reporting systems HALMED 1a) Medication errors HALMED 2) Patient reporting HALMED 3) Awareness levels MHRA 4) Review of reporting forms MHRA 5) Review of IT systems and Special form of reports HALMED
Partners involved Contributing countries Collaborative institutions AIFA (Italy) OGYEI (Hungary) INFARMED (Portugal) NOMA (Norway) SMCA (Lithuania) SUKL (Czech Republic) LAREB (Netherlands Pharmacovigilance Centre) UMC (Uppsala Monitoring Centre) The University of Nottingham (United Kingdom)
Tool and survey method Web-based surveys were sent to MSs Information was gathered from MSs to understand: their national pharmacovigilance IT system capabilities implementation of patient reporting types and reporting forms developed electronic reporting developments including those from clinical healthcare systems 6 surveys within WP 4: 1) Audit of national reporting systems 84 questions 1a) Medication errors 16 questions 2) Patient reporting 69 questions 3) Awareness levels 52 questions 4) Review of reporting forms 64 questions 5) Review of IT systems and Special form of reports 64 questions
Workflow Development of questions for MSs Final survey sent to MSs Pilot survey sent to MSs Report and deliverables produced Trainings for MSs 2013 April 2014 June 2014 Sept 2016 - April 2017
Main goal - Topics 1, 1a, 2 & 5 Audit of national reporting systems Medication errors Patient reporting Review of IT systems and special form of reports The main goal was to provide snapshots of national pharmacovigilance systems to enable NCAs to improve their systems on the basis of existing practices in various MSs and to maximize efforts in their national spontaneous ADR reporting systems for human medicines
SCOPE findings - Topics 1, 1a, 2 & 5 MSs were asked do they identify ADR reports for drugs subject to additional monitoring in their databases 16 14 12 10 8 6 4 2 0 Identifying ADR reports for drugs subject to additional monitoring 1/24* 4,2% Using a database flag combined with reference data/drug dictionary level 11/26* 42,3% 3/23* 16,7% 15/24* 60,9% Manually Other, please specify We do not identify ADR reports in our database which are subject to additional monitoring *number of respondents
Deliverables and training - Topics 1, 1a, 2 & 5 Identification, Management and Raising Awareness of ADR Reports For Drugs Subject to Additional Monitoring
Deliverables and training - Topics 1, 1a, 2 & 5 Additional monitoring e-learning
Deliverables and training - Topics 1, 1a, 2 & 5 Duplicate Detection: Best Practice Guide Identification, Management and Raising Awareness of ADR Reports For Drugs Subject to Additional Monitoring
Deliverables and training - Topics 1, 1a, 2 & 5 Duplicate detection e-learning
SCOPE findings - Topics 1, 1a, 2 & 5 MSs were asked if they use any indicators or metrics for assessing the quality of the reports 14 13 YES NO
Deliverables and training - Topics 1, 1a, 2 & 5 Tools for Measuring and Improving the Quality of Reports in National Adverse Drug Reactions Databases Duplicate Detection: Best Practice Guide Identification, Management and Raising Awareness of ADR Reports For Drugs Subject to Additional Monitoring
SCOPE findings - Topics 1, 1a, 2 & 5 MSs were asked when they code medication errors 1 When specified in the ADR report & during the assessment of ADR 7 During the assessment of ADR 18 2 When specified in the ADR report Doesn't code medication errors
Deliverables and training - Topics 1, 1a, 2 & 5 Medication Errors Tools for Measuring and Improving the Quality of Reports in National Adverse Drug Reactions Databases Duplicate Detection: Best Practice Guide Identification, Management and Raising Awareness of ADR Reports For Drugs Subject to Additional Monitoring
SCOPE findings - Topics 1, 1a, 2 & 5 MS were asked do they work with patient organisations Work with patient organisations 12/28 MS 16/28 MS 43 % 57 % YES NO
Deliverables and training - Topics 1, 1a, 2 & 5 Collaboration with Patient Organisations to Promote and Support Patient ADR Reporting Medication errors Duplicate Detection: Best Practice Guide Tools for Measuring and Improving the Quality of Reports in National Adverse Drug Reactions Databases Identification, Management and Raising Awareness of ADR Reports For Drugs Subject to Additional Monitoring
Deliverables and training - Topics 1, 1a, 2 & 5 Feedback to Patient ADR Reports Collaboration with Patient Organisations to Promote and Support Patient ADR Reporting Medication errors Duplicate Detection: Best Practice Guide Tools for Measuring and Improving the Quality of Reports in National Adverse Drug Reactions Databases Identification, Management and Raising Awareness of ADR Reports For Drugs Subject to Additional Monitoring
Deliverables and training - Topics 1, 1a, 2 & 5 An Active Approach to Comparisons of Adverse Drug Reaction Reports from Patients and Healthcare Professionals Feedback to Patient ADR Reports Collaboration with Patient Organisations to Promote and Support Patient ADR Reporting Medication errors Duplicate Detection: Best Practice Guide Tools for Measuring and Improving the Quality of Reports in National Adverse Drug Reactions Databases Identification, Management and Raising Awareness of ADR Reports For Drugs Subject to Additional Monitoring
Deliverables and training - Topics 1, 1a, 2 & 5 IT Systems for ADR Reporting: Best Practice Guide Feedback to Patient ADR Reports Most advanced ADR IT systems, Advanced specific An Active functions Approach developed to Comparisons of Adverse Drug Reaction Reports from Patients and Healthcare Professionals Additional benefits ADR IT systems are well developed and operative Additional improvements Collaboration with Patient Well Organisations developed to possible Promote and Support Patient ADR Reporting Medication errors Duplicate Detection: Best Practice Guide No ADR IT system in place Tools or very for basic Measuring and Improving the system Basic Quality of Reports in National Adverse Drug Reactions Databases Strong support needed Identification, Management and Raising Awareness of ADR Reports For Drugs Subject to Additional Monitoring
Main goal - Topic 3 Awareness Levels The main goal was to enable NCAs to increase awareness of their individual national spontaneous ADR reporting systems for human medicines, through the sharing of good practice and a set of tools
SCOPE findings - Topic 3 Baseline awareness levels of NCA 54% of NCAs (15) have no estimate of HCP awareness 69% (18) have no estimate of member of public awareness of their NCA Baseline awareness levels of NCA national ADR reporting scheme: 31% (8) have estimated awareness levels with HCPs for their respective national ADR system 19% (5) have estimated awareness levels with member of public of their respective national ADR system
SCOPE findings - Topic 3 30 25 27 23 Promotional activities used by NCAs 20 20 15 10 5 4 6 8 8 0 Information on reporting on institution s web pages Call for ADR reporting in educational materials and DHCP letters Making publicly available an annual report on ADR reporting Social media (Facebook, Twitter) E-learning Media campaigns (billboards, radio, TV, internet, newspapers) Information via regional centres
Deliverables and training - Topic 3 Increasing Awareness of National Adverse Drug Reaction Reporting Systems: Best Practice Guide Raising Awareness of National Adverse Drug Reaction Reporting Systems: Case Studies by Country Raising and Measuring Awareness Levels for ADR Reporting Systems through Campaigns and Regional Monitoring Centres
Deliverables and training - Topic 3 Awareness Levels E- learning HCP e-learning
Deliverables and training - Topic 3 Social media campaign 7-11 November 2016 21 countries took part Support from Heads of Medicines Agency Working Group for Communications Professionals Use of animations, polls, infographics, articles, press release etc Twitter, LinkedIn, Facebook, websites
Deliverables and training - Topic 3 Social media campaign 7-11 November 2016 13% increase in reporting (1,056 reports) in EU over campaign week 2,562,071 people were reached 337,781 people viewed the animation 22,584 likes, clicks, retweets and shares on Twitter, Facebook, LinkedIn and Youtube All participants indicated it was worthwhile running 88% would support another campaign
Main goal - Topic 4 Review of reporting forms The main goal was to carry out a review of ADR reporting forms across the EU for all types of reporting forms such as electronic and paper forms, patient and healthcare profession forms and forms for areas of special interest
Deliverables and training - Topic 4 Paper ADR Reporting Forms Handling Telephone Calls from the Public
Deliverables and training - Topic 4 Telephone Reporting e- learning
Deliverables and training - Topic 4 Electronic reporting web-form
Adriana Hilde Marin Anna Sandra Dubravka Darko Kendal Paul Sara-Lisa Louise Nikica Nenad Tahira Vanja Marina DDG Viola Ivana Katarina Mick Emily Petar Margarida Gyorgyike Jelena Rita Alicia Kristina Linda Mitul Željana Sarah Fatima
Questions? Contact: marina.lesicar@halmed.hr