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Master Thesis Identifying Patients in Community Pharmacies to Become UNIVERSITY OF COPENHAGEN FACULTY OF HEALTH AND MEDICAL SCIENCES Master Thesis Nina Scheel Andersen (vsg237) Identifying patients in community pharmacies to become active participants in new medicines development Development and evaluation of a new recruitment technique derived from a public-private partnership Department of Pharmacy, School of Pharmaceutical Sciences Faculty of Health and Medical Sciences, University of Copenhagen Internal supervisor: Susanne Kaae External supervisor: Camilla Krogh Lauritzen Submitted on: 31 August 2020 Name of department: Department of Pharmacy Author(s): Nina Scheel Andersen (vsg237) Title and subtitle: Identifying patients in community pharmacies to become active participants in new medicines development – Development and evaluation of a new recruitment technique derived from a public- private partnership. Topic description: This thesis is written within the field of social and clinical pharmacy. The thesis concerns the development and evaluation of a new recruitment technique to recruit patients through community pharma- cies to be engaged in medicines research and development in a pharmaceutical company. Internal supervisor: Susanne Kaae External supervisor: Camilla Krogh Lauritzen Submitted on: 31 August 2020 Grade: Number of study units: £ 2 £ 3 Number of characters: 152,934 2 Preface This master thesis had a volume of 45 ECTS credits and was conducted from 31 August 2019 to 31 August 2020, partly at the Department of Pharmacy, School of Pharmaceutical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; and at LEO Pharma A/S, Ballerup, Denmark. The supervisors were Susanne Kaae as the internal supervisor from the University of Copenhagen, and Camilla Krogh Lauritzen as the external supervisor from LEO Pharma A/S. I would like to use this preface to thank all the people who supported me during my master thesis. This period has been a very interesting, educational, and exciting part of my life but occasionally also one of the hardest. However, it was all worth it, and I could not have done it without the huge help and support from the following people. First, a huge thank you to all the patients who showed an interest and participated in my project. Your help was tremendous. My deepest gratitude to my internal supervisor Susanne Kaae who was there for me all along with unlimited support, both academically and emotionally. Further, I would like to express a huge thank you to LEO Pharma’s Patient Engagement Team, Camilla Krogh Lauritzen, Lasse Funch Jacobsen, Søren Holm, and Torben Löser, who provided their full support during the project. Especially, my deepest gratitude to Camilla for being my external supervisor and allowing me to write my thesis within your team. Further, I would like to thank the additional LEO Pharma employees who supported me. A great thank you to Jacob Lenau and Skovlunde Pharmacy, as much as Ute Pørksen and Ballerup Pharmacy, for letting me use your pharmacies and supporting me significantly. A great thank you to Bente Buus Nielsen and Michael Koehler from FAIM for your excessive support during the project. A great thank you to Ballerup Municipality, especially Jette Rau, with your countless support during the project. Finally, a heartfelt thank you to my family and friends who supported me impressively all along the thesis period. Nina Scheel Andersen | Copenhagen, Denmark | August 2020 3 Abstract Aim/Background: The aim of this thesis is to concept-test and investigate how people with a rare disease diagnosis can be identified in a community pharmacy to be engaged in medicines research and development in a pharmaceutical company. To that end, a new project was estab- lished as a public-private partnership between the master thesis student, Ballerup Pharmacy, Skovlunde Pharmacy, Ballerup Municipality, the patient organisation of autoimmune diseases in Denmark (FAIM), and LEO Pharma. Methods: A Plan-Do-Study-Act cycle was used to develop the recruitment technique for recruit- ing patients to medicines research and development. Plan contains the preparational meetings leading up to the project start where several decisions were made. Do contains the practical, non- scientific parts of the project, which were the training of pharmacy staff, marketing campaign, recruitment process, patient introduction, patient preparation, and workshops at LEO Pharma. Study contains the scientific methods of the project, which were the following; semi-structured interviews with the project’s partners and patients; focus groups with the patients; and a quantita- tive overview of the patient contact. Act contains the recommendations for the further develop- ment of the project. Results: During the three-month recruitment phase, 17 patients inside the scope of the project made contact to participate whereof nine patients ended up participating in interviews, and hereof five patients in workshops as well. The community pharmacies were considered positive places of recruitment by both patients and the project’s partners. According to the patients, the workshops lived fully or almost fully up to their expectations, and the scientists from LEO Pharma were described as listening and understanding. However, the patients were unable to mention who the project’s partners were, but they found the partners’ involvement positive. Overall, the project’s partners were positive with the execution of the project and surprised by a larger number of patients being recruited than expected. The partners believed that the project has a future as a new concept of recruiting patients to medicines research and development. Conclusions: The concept-testing of recruiting people with a rare disease diagnosis through community pharmacies to be engaged in medicines research and development was accom- plished. Overall, patients and partners found the project positive, and it has the potential to become a new practice of recruitment for patient engagement in new medicines development. 4 Table of contents PREFACE ............................................................................................................................. 3 ABSTRACT .......................................................................................................................... 4 LIST OF ABBREVIATIONS ................................................................................................. 7 LIST OF APPENDICES ........................................................................................................ 8 1. INTRODUCTION .............................................................................................................. 9 1.1 Thesis statement ......................................................................................................................................................... 10 1.2 Research questions ..................................................................................................................................................... 10 1.3 Purpose ........................................................................................................................................................................ 10 2. BACKGROUND ............................................................................................................. 11 2.1 History of patient engagement .................................................................................................................................. 11 2.2 Legislation on patient engagement ........................................................................................................................... 13 2.3 Roadmap for patient engagement in medicines R&D ............................................................................................ 14 2.4 Coverage of existing literature .................................................................................................................................. 16 2.4.1 Stakeholder expectations ...................................................................................................................................... 17 2.4.2 Best practices of patient engagement ................................................................................................................... 19 2.4.3 A master framework needed ................................................................................................................................. 19 2.4.4 Recruiting patients ................................................................................................................................................ 19 2.5 Roles and responsibilities in the project ................................................................................................................... 20 2.6 About the partners of the project ............................................................................................................................. 22 2.7 Conclusion ................................................................................................................................................................... 24 3. METHODOLOGY ........................................................................................................... 25 3.1 Plan .............................................................................................................................................................................. 26 3.2 Do ................................................................................................................................................................................
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