E-PIL Belgium & Luxembourg Pioneer Pilot Project London, the - PowerPoint PPT Presentation

E-PIL Belgium & Luxembourg Pioneer Pilot Project London, the 28th of November 1

Why such a pilot project in Belgium and Luxembourg? Convenience of electronic Patient A specific context in Europe Information Leaflet PATIENT • 2015: recommendations in Nivel Report • Continued access to the most • European Commission report on improvement recent information of product information • Personalised and user-friendly information A specific context in Belgium and • Quick access and dissemination HEALTH CARE of the most recent information Luxembourg PROFESSIONAL • Supporting the mission of • Personalised and user-friendly Public Health • internet access up to 85% * in Be and to 97% in information Lux* * . • use of social media (69% )* 2014: a survey in hospital pharmacists showed a wide use of electronic support for patient information Survey*** • 90% pro switch paper version to electronic version ENVIRONMENT • Flexibility in update of • Reducing environmental impact • 44% use both the paper and the electronic version the information, (paper and production) reducing product recalls • 55% only the electronic version Source: * https: / / economie.fgov.be/ fr/ themes/ line/ les-tic-en-belgique/ le-tic-en-chiffres 2 * * Lux Figures in 2015 * * * Survey conducted in 2014 with the help of pharma.be and the hospital pharmacists association; survey filled out by 199 respondents.

Objectives and outline of the pilot PATIENT The package leaflet for a To demonstrate e-PI L is • Only for a selection of selection of centrally approved equivalent to paper PI L m edicines ± 15 medicinal products restricted to to provide information on medicines in different hospital use and marketed in safe and effective use of therapeutics areas Belgium and/ or Luxembourg is medicines to healthcare • Hospital-only HEALTH CARE no longer included in their GOVERNEMENT PROFESSIONAL professionals and patients • NO ambulatory paper version but is available in the context of hospital • Central products only via online consultation of used medicines trusted w ebsites OBJECTIVE CONCEPT SCOPE 2 1 3 ENVIRONMENT PHARMACEUTICAL COMPANIES Time-limited project of 24 months 3

Roadmap PATIENT Regulatory considerations HEALTH CARE No more paper product information leaflet inserted in the package GOVERNEMENT PROFESSIONAL ⇒ Not in line with article 58 of EU Directive 2001/83/CE (implemented April 2018 – June 2018: in Belgian and Luxembourg legislation) Call for candidates October 2017 –December 2017: supported by the BE & Request of Derogation to article LUX authorities 58 prepared by the BE & LUX Validation by the BE & authorities and submitted to EU LUX authorities of each commission proposed medicine as 2016-2017 : Consultation and candidate Conditions: limited number of engagement of association medicines restricted to hospital hospital pharmacists setting; time limited project ENVIRONMENT PHARMACEUTICAL COMPANIES Obtained in December 2017 4

Practical setting and methodology Operational setting PATIENT Inform National Competent 01 Aug 2018: Communication 21 months QP Authorities of Batch release to pharmacists batch release the batch and distribution together with numbers and of batches each batch of 24 months for release dates KPI analyses without paper concerned of concerned PIL inserted medicines batches HEALTH CARE GOVERNEMENT PROFESSIONAL Online consultation of product information Via pharma.be e-notice Via Competent Authorities • Adaptive site website & official • Search engine commented list of medicines Xml layout • (CBIP-BCFI) • Chapter by chapter ENVIRONMENT PHARMACEUTICAL COMPANIES 5

Key performance indicators and follow-up of the pilot project Steering com m ittee : • pharma industry representatives PATIENT • hospital pharmacists • BE & LU competent authorities KPI s • Defined and monitored by the steering committee HEALTH CARE • Survey in hospital pharmacists (t= 0= baseline; t= 12months; t= 24months) to evaluate the access, the GOVERNEMENT PROFESSIONAL use and the reading of electronic PI Ls during the pilot project • Incl. capture of the feedback for the healthcare professionals in hospitals (nurses, physicians) • Baseline survey during summer 2018: response rate: 100% Lux, 92% Be - Results under analysis • Survey for participating pharma companies (t= 12months; t= 24months) to evaluate the questions due to the absence of paper patient information leaflet in the packaging. ⇒ key outcom es to dem onstrate: ENVIRONMENT PHARMACEUTICAL • allow to provide sufficient, adequate and tailored (e.g. language) information to healthcare COMPANIES professionals and patients with no need to print the patient information • positive impact on daily practice of hospital pharmacists 6

Thank you! Nathalie Lam bot I nge Vandenbulcke nl@pharma.be inge.vandenbulcke@fagg.be 0032471/ 92.76.27 0032 2 528.40.00 Visit our website : www.pharma.be https: / / www.famhp.be/ en