Patients’ perspectives on a drug safety monitoring system for immune-mediated inflammatory diseases based on patient-reported outcomes

Author:

Kosse Leanne J1,Weits Gerda1,Vonkeman Harald E23ORCID,Tas Sander W4,Hoentjen Frank5,Van Doorn Martijn BA6ORCID,Spuls Phyllis I7,D’Haens Geert R8ORCID,Nurmohamed Michael T9ORCID,van Puijenbroek Eugène P110ORCID,Van Den Bemt Bart JF1112,Jessurun Naomi T1ORCID

Affiliation:

1. Netherlands Pharmacovigilance Centre Lareb, ‘s-hertogenbosch, The Netherlands

2. Department of Rheumatology, Medisch Spectrum Twente, Enschede, The Netherlands

3. Department of Psychology, Health & Technology, University of Twente, Enschede, The Netherlands

4. Department of Rheumatology & Clinical Immunology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & Immunology Center (ARC), Amsterdam, The Netherlands

5. Department of Gastroenterology, Radboudumc, Nijmegen, The Netherlands

6. Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands

7. Department of Dermatology, Amsterdam UMC, Amsterdam Public Health, Immunity and Infections, University of Amsterdam, Amsterdam, The Netherlands

8. Department of Gastroenterology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

9. Department of Rheumatology, Reade and Amsterdam Rheumatology & Immunology Center (ARC), Amsterdam, The Netherlands

10. University of Groningen, Groningen Research Institute of Pharmacy, PharmacoTherapy, Epidemiology & Pharmacoeconomics, Groningen, The Netherlands

11. Department of Pharmacy, Sint Maartenskliniek, Nijmegen, The Netherlands

12. Department of Pharmacy, Radboudumc, Nijmegen, The Netherlands

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Medicine

Reference36 articles.

1. History of Pharmacovigilance

2. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience

3. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation a. OJ L348/1 2012.

4. Experiences with Adverse Drug Reaction Reporting by Patients

5. Patient-reported outcomes: A new era in clinical research

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