Product I nform ation 4 .0 “Gebrauchsinform ation 4 .0 ( GI 4 .0 ) ” Digital Product Information System for Pharmaceuticals Dr. Georg Lang November 2018
„I downloaded the App and tested it with my medicines. I see an additional benefit by such an App for patients in having a knowledge basis in dialogues with their doctor. When new medications are being prescribed the doctor usually explains briefly the medicine and that is it. With this App patients have something at hand that significantly supports their discussion with the doctor and it is (in my view) easier and for the patient better to understand how the decision for a certain medicine has been made.“ “I was pleased to participate in this project, because Anonymous, online-survey I am very much convinced that patients, who know, why they are taking a medicine, have better health outcomes. We must try – by all means - to overcome the weariness for small fonts, prints on thin paper and the paper leaflets left at home in a drawer.” Ludwig Hammel, Deutsche Vereinigung Morbus Bechterew e.V. 2
GI 4 .0 Project Outline Identification of user-friendly features for electronic product information with • Patients / Senior citizens / Visually Patients/ Regulatory im paired citizens organisations Citizens authorities representa- • Regulatory authorities (BfArM, PEI) tives • Pharm acies Implementation via the trade associations CONSORTI UM vfa and BPI by Pharma Pharmacies / • 1 8 pharm aceutical com panies companies/ Hospital associations/ (AbbVie, Amgen, Bayer, Boehringer Ingelheim, Daiichi Sankyo, DESITIN, pharmacies RLS Grünenthal, Hexal, Janssen-Cilag, Merck Serono, MSD, Mylan dura, Novartis, Pfizer, Roche, Sanofi, TAD, Takeda) • Rote Liste Service Gm bH 3
GI 4 .0 : scope and context scope Digital product Real time, widely-available inform ation Validated, authority approved information system for pharm aceuticals User friendly electronic format - accessible Print option context Proof-of Concept for the European initiative, IATF eProduct Information (EFPIA, Medicines for Europe, AESGP) 4
Developm ent of user-friendly product inform ation Steering Committee-StC (all stakeholders) discussion Successful cooperation with Sponsors Group / I m plem en- Rote Liste tation in GI representatives of patients / 4 .0 Budget Check citizens organisations and regulatory authorities Intensive testing and collection of feedback for continuous Rote Liste/ arvato/ improvement Proposal for volunteers (industry, technical solution Additional evaluation via online patients, people with endorsed by StC visual impairment) survey (360+ responses) Successfully established Rote Liste Service GmbH as reliable partner 5
GI 4 .0 – STRUCTURED content; advanced validated technical solution for autom ated data input/ output INPUT GI 4.0 System OUTPUT Interface Interface Patient XML XML Rote Liste Mobile App Patient Info (iOS, Android) Service Pharma Company DOC XML Website Leaflet DOC (Responsive Design) Pharma Company RTF Leaflet RTF Point of Dispense (Pharmacy) Pharma Company XML Pharmacy Software PPN/NTIN 6 PPN/NTIN Source: arvato
Achievem ents – Proof of the project outline Positive evaluation by all stakeholders : Authorities, patient Softw are link Mobile Apps Online organisations, patients, W ebsite to pharm acy • Integrated function for • Responsive • Interface with senior citizens, visually Data Matrix and Design software impaired citizens, Barcode scan • Print option • Print option PDF individual users, industry, installed installed tested pharmacists Com m itm ent of BPI and vfa for further engagem ent: • Development of additional services • Active support of European project towards an EU wide harmonized approach 7 Source adopted : arvato
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