Pharmacovigilance: The patient s Perspective. Souzi Makri Chairperson AGORA EUPATI Fellow Executive Secretary CYPLAR President ENFA
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1 Pharmacovigilance: The patient s Perspective Souzi Makri Chairperson AGORA EUPATI Fellow Executive Secretary CYPLAR President ENFA
2 Scope of presentation Why is Pharmacovigilance important for patients? How are patients educated to contribute to R&D of medicines? AGORA & EUPATI Cooperation with EMA Suggestions Next steps/conclusions
3 What is pharmacovigilance? Pharmacovigilance is the practice of detecting, assessing, understanding and preventing the adverse effects of medicines. Pharmacovigilance enhances patient safety and public health by providing reliable information on the risks and benefits of medicines Source: EUPATI
4 Importance for patients
5 Because: Why is Pharmacovigilance important for patients? Only a patient knows and experiences the actual benefit and harm of medicines An educated patient is an active patient and a safe patient An educated patient has a better way of communicating with his/her physician Patients are the best source of information (experiences, reports, side-effects descriptions) and therefore can add value to research by sharing data
6 The circle of Pharmacovigilance Knowledge around pharmacovigilance affects both the patient and the physician. Proper patient education can help facilitate and build a better communication between patients, doctors and the other stakeholders.
7 Patient Education
8 How are patients educated to contribute to R&D of medicines? By participating in surveys and exchange information and becoming partners in research By participating in drug safety committees and other approving bodies Via efficient and substantial patient-doctor communication (helps in educating the patient) Via patient organisations, patients are encouraged to share data, experiences and feedback helping with enriching and updating existing databases Patient organisations provide the correct and trustworthy educational material to enhance patients knowledge
9 Patient Education & the Pharmaceutical Industry Communication and exchange of information between the industry, patients and regulatory authorities is of vital importance Patient advocacy and the dialogue with the industry and other bodies resulted in harmonization arrangements and raising awareness on drug safety for patients Pharma Industry is supporting patient-led projects, helping in bridging the relationship with patients and creating mutual understanding and respect Continuing professional education, patient education, and sponsorship by industry of drug information activities have also contributed to the safer use of medicines
10
11 AGORA AGORA is an umbrella organisation for organizations representing people with Rheumatic and Musculoskeletal Diseases mainly in Southern Europe.
12 AGORA: working together AGORA, being an organisation consisting of over fourteen countries within Europe, has been building and creating various projects aiming to strengthen the voice of all its country-members on a national, but also a European level.
13 Aims of AGORA Provide all its members with a stronger voice at a national and European level Working towards creating better conditions for people with RMDs Encourage and assist in the foundation and development towards user-led organizations of people with rheumatic and musculoskeletal diseases in Southern Europe Promote supportive attitudes towards rheumatic and musculoskeletal diseases and enable patients to live independent and participate fully in society
14 AGORA Objectives Establish and promote a common agenda for health and advocacy for people with RMDs in Southern Europe Support the rights of people with RMDs Representing the interests of entire RMD community on European and national level Foster innovation and excellence in education and research with the aim to improve treatment and patient care. Encourage and undertake research projects related to RMDs and dissemination of the results of any such research.
15 AGORA Projects for Empowering Patients
16 AGORA Annual Conferences Since its inauguration, Agora has been consistent in organising its annual conferences. During these conferences all our members have the chance to: Discuss the most recent topics related to RMDs Share knowledge on new treatments, methods and other advancements in the area of health for RMDs Exchange experiences and best practices amongst us Encourage open discussion amongst patients and various actors from the healthcare area Focus on the special needs of each member-organisation though various projects and activities
17 AGORA Annual Conferences 1 st Agora Conference 2012, Belgrade 2 nd Agora Conference 2013, Sofia 3 rd Agora Conference 2014, Bari 4 th Agora Conference 2015, Heraklion 5 th Agora Conference 2016, Bucharest 6 th Agora Conference 2017, Zagreb (upcoming)
18 AGORA S The Partners in Treatment Project (PAIT)
19 Partners in Treatment-AGORA project Background In the context of the 2 nd strategic objective AGORA countries are confronted with significant problems related to the health systems such as low percentages of early referral, early diagnosis and rapid start of treatment for people with rheumatic and musculoskeletal diseases. Solution: The need to develop and implement educational programs to improve the relationship between patients and health professionals.
20 PAIT Project deliverables Text materials: Creation of a website dedicated to the project, in English and accessible to all our members and other people Quick reference cards, in English and translated to all languages of AGORA s member-organisations Companion Guide for the Self-Management of Rheumatoid Arthritis, in English and translated to all languages of AGORA s member-organisations Workshops- Training programs: Train the Trainers two-day workshops offered in English to all our memberorganisations Some materials were developed after the end of the courses ( Train the Trainers communicational platform, training material, discussion roomrestricted to workshop participants) Train the Trainers implementation on memberorganisatons level: examples of AGORA members implementing the training program
21 Agora-GAfPA workshop: Biosimilars & Biologics Self-management workshop What: Two-day workshop offered by Agora for 1 representative of each Agora-member association. Where and when: Budapest, Hungary, in January Content: Two trending subjects related to RMDs: a) Biologic and Biosimilar medication and treatments for RMDs b) The use of self-management programs for RMDs (a follow up of the Train the Trainers course and the Partners in Treatment Project (PAIT) of Agora). Participation: Stakeholders from the healthcare sector, representatives from pharmaceutical companies &RMDs patients.
22 EUPATI EUPATI is a public private partnership within the Innovative Medicines Initiative Joint Undertaking, launched in February It is a patient-led project coordinated by the European Patients Forum, with EGAN(Patients Network For medical research and Health) EURORDIS and EATG (European Aids Treatment Group) in key roles including a consortium of patients organisations, academia, NGOs and industry 33 organisations The aim is to build competencies & expert capacity among patients and the health-interested public
23
24 EUPATI Objectives: Develop and disseminate objective, credible, correct and up-todate public knowledge about medicines R&D Build competencies & expert capacity among patients & public Facilitate patient involvement in R&D to collaborate in academic research, industry research, authorities and ethics committees
25 EUPATI empowers patients EUPATI educates patients and patient advocates on: Discovery of Medicines & Planning of Medicine Development Non-Clinical Testing and Pharmaceutical Development Exploratory and Confirmatory Clinical Development Clinical Trials Regulatory Affairs, Medicinal Product Safety, Pharmacovigilance &Pharmaco-epidemiology HTA principles and practices
26 EUPATI Education targeted at different levels: EUPATI Patient Expert Training courses for 100 patient experts (completed) EUPATI Educational Toolbox for patient advocates (launched 27 January 2016) EUPATI Internet Library for individuals (Encyclopaedia, Short video documentaries, Patient interviews, micro-lectures (as podcasts), Images, diagrams)
27
28 Cooperation between patient organisations & EMA
29 The European Medicines Agency (EMA) and patients have been actively interacting since the creation of the Agency in Some of EMA s objectives as to the involvement of patients is to: Measure the impact/value of patient involvement in EMA activities Acknowledge and promote visibility of patient input into the EMA s activities Offer training for patients involved in EMA activities
30 The stakeholders relations framework From the European Medicines Agency (EMA) "Stakeholder relations management framework", published 16 June 2016 EMA/48651/2016
31 How are patients and consumers involved in EMA activities? as members of the Management Board as members of scientific committees being consulted on disease-specific requests by the scientific committees and working parties taking part in discussions on the development and authorisation of medicines reviewing written information on medicines prepared by the Agency being involved in the preparation of guidelines taking part in EMA's conferences and workshops.
32 How can we improve the existing situation?
33 Suggestions There needs to be a close cooperation between all stakeholders There needs to be better control on the available and new medication Patient organisations must become partners in the decisionmaking and policy-making procedures when it comes to approving new medication Patients need to be invited to participate to surveys and collect data to improve the existing process of drug approvals Pharmaceutical companies need to work in close cooperation with patient organisations and other platforms in order to provide the correct information on new drugs and promote drug safety Patient organisations must lead patients and promote drug safety via educational material and other activities
34 Conclusions/Next Steps Proper patient education A good communication between doctor and patient A good cooperation between patient organisations and the EMA (or other consumers medicine organisations) A good cooperation between patient organisations and pharmaceutical companies Patients to share data and participate in surveys to improve the existing situation
35 Thank You
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