EMA. Guideline on good pharmacovigilance practices (GVP): Module V—risk management systems (Rev 2). EMA/838713/2011 Rev 2*. 2017.

EMA. Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I—educational materials. EMA/61341/2015. 2015.

Slatko GH. Risk evaluation and mitigation strategy (REMS): FDA perspective on what physicians need to know. Am Fam Physician. 2015;92(9):771–2.

PubMed  Google Scholar 

Mouchantaf R, Auth D, Moride Y, Raine J, Han SY, Smith MY. Risk management for the 21st century: current status and future needs. Drug Saf. 2021;44(4):409–19. https://doi.org/10.1007/s40264-020-01033-z.

Article  PubMed  PubMed Central  Google Scholar 

Russell A, Morrato EH, Lovett RM, Smith MY. Quality of reporting on the evaluation of risk minimization programs: a systematic review. Drug Saf. 2020;43(5):427–46. https://doi.org/10.1007/s40264-020-00905-8.

Article  PubMed  Google Scholar 

Artime E, Qizilbash N, Herruzo R, Garrido-Estepa M. Risk minimisation evaluation with process indicators and behavioural or health outcomes in Europe: systematic review. Pharm Med. 2020;34(6):387–400. https://doi.org/10.1007/s40290-020-00361-w.

Article  Google Scholar 

Vora P, Artime E, Soriano-Gabarró M, Qizilbash N, Singh V, Asiimwe A. A review of studies evaluating the effectiveness of risk minimisation measures in Europe using the European Union electronic Register of post-authorization studies. Pharmacoepidemiol Drug Saf. 2018;27(7):695–706. https://doi.org/10.1002/pds.4434.

Article  PubMed  PubMed Central  Google Scholar 

Smith MY, Morrato E. Advancing the field of pharmaceutical risk minimization through application of implementation science best practices. Drug Saf. 2014;37(8):569–80. https://doi.org/10.1007/s40264-014-0197-0.

Article  PubMed  PubMed Central  Google Scholar 

Smith MY, Frise S, Feron J, Marshall R. Improving the safety of medicines via digital technology: an assessment of the scope and quality of risk minimization websites in the United States and United Kingdom. Drug Saf. 2022;45(3):259–74. https://doi.org/10.1007/s40264-022-01165-4.

Article  PubMed  PubMed Central  Google Scholar 

Jacquot E, Collin E, Ladner A, Tormos A, Hamm L, Perez-Gutthann S, et al. Agomelatine drug utilisation study in selected European countries: a multinational, observational study to assess effectiveness of risk-minimisation measures. Pharm Med. 2019;33(4):311–9.

Article  CAS  Google Scholar 

Levinson DR. FDA lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety: services DoHaH; 2013. Contract No.: OEI-04-11-00510.

Mazzaglia G, Straus SM, Arlett P, da Silva D, Janssen H, Raine J, et al. Study design and evaluation of risk minimization measures: a review of studies submitted to the European medicines agency for cardiovascular, endocrinology, and metabolic drugs. Drug Saf. 2018;41(2):191–202. https://doi.org/10.1007/s40264-017-0604-4.

Article  PubMed  Google Scholar 

Gridchyna I, Cloutier AM, Nkeng L, Craig C, Frise S, Moride Y. Methodological gaps in the assessment of risk minimization interventions: a systematic review. Pharmacoepidemiol Drug Saf. 2014;23(6):572–9. https://doi.org/10.1002/pds.3596. (Epub 2014 Feb 24).

Article  PubMed  Google Scholar 

Agyemang E, Bailey L, Talbot J. Additional risk minimisation measures for medicinal products in the European Union: a review of the implementation and effectiveness of measures in the United Kingdom by one marketing authorisation holder. Pharmaceut Med. 2017;31(2):101–12. https://doi.org/10.1007/s40290-017-0184-8. (Epub 2017 Mar 29).

Article  PubMed  PubMed Central  Google Scholar 

Grupstra RJ, Goedecke T, Scheffers J, Strassmann V, Gardarsdottir H. Review of studies evaluating effectiveness of risk minimization measures assessed by the European Medicines Agency between 2016 and 2021. Clin Pharmacol Ther. 2023;114(6):1285–92. https://doi.org/10.1002/cpt.3034. (Epub 2023 Oct 16).

Article  PubMed  Google Scholar 

Artime E, Qizilbash N, Garrido-Estepa M, Vora P, Soriano-Gabarró M, Asiimwe A, Pocock S. Are risk minimization measures for approved drugs in Europe effective? A systematic review. Expert Opin Drug Saf. 2019;18(5):443–54. https://doi.org/10.1080/14740338.2019.1612875.

Article  PubMed  Google Scholar 

Da Silva-Tillmann B, Wilson MC, Doshi H, Lievano F, Perrott M, Renz C. Digital additional risk minimization measures: an exploratory study using qualitative feedback from healthcare professionals and patients across six countries. Pharm Med. 2022;36(1):21–32.

Article  Google Scholar 

Horne R, Weinman, J, Barber N, Elliott R, Morgan M, Cribb A, et al. Concordance, adherence, and compliance in medicine taking. National Co-ordinating Centre for NHS Service Delivery and Organisation R & D (NCCSDO). December 2005.

Morrato EH. Social science theory as a framework for designing and evaluating pharmaceutical risk management dissemination and implementation strategies. In: Sprafka JM, editor. Risk management principles for devices and pharmaceuticals. 3rd ed. Rockville: Regulatory Affairs Professionals Society; 2023. (ISBN: 978-1-947493-84-1).

Google Scholar 

Bronfenbrenner U. Toward an experimental ecology of human development. Am Psychol. 1977;32(7):513–31.

Article  Google Scholar 

McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988;15(4):351–77.

Article  CAS  PubMed  Google Scholar 

Bahri P, Morales DR, Inoubli A, Dogné J-M, Straus SMJM. Proposals for engaging patients and healthcare professionals in risk minimisation from an analysis of stakeholder input to the EU valproate assessment using the novel analysing stakeholder safety engagement tool (ASSET). Drug Saf. 2021;44(2):193–209. https://doi.org/10.1007/s40264-020-01005-3.

Article  PubMed  Google Scholar 

Smith MY, Morrato EH. Dissemination and implementation science. In: Bahri P, editor. Communicating about risks and safe use of medicines: real life and applied research. Singapore: Springer Nature Singapore Pte Ltd; 2020. p. 385–413.

Google Scholar 

Huynh L, Toyserkani GA, Morrato EH. Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA risk evaluation and mitigation strategies (REMS) (2014–2018). BMC Health Serv Res. 2021;21(1):779. https://doi.org/10.1186/s12913-021-06808-3.

Article  PubMed  PubMed Central  Google Scholar 

Smith MY, Russell A, Bahri P, Mol P, Frise S, Freeman E, et al. The RIMES statement: a checklist to assess the quality of studies evaluating risk minimization programs for medicinal products. Drug Saf. 2018;41(4):389–401. https://doi.org/10.1007/s40264-017-0619-x.

Article  PubMed  Google Scholar 

EMA. Guideline on good pharmacovigilance practices (GVP): Module XVI—risk minimisation measures: selection of tools and effectiveness indicators (Rev 3). EMA/204715/2012 Rev 3*. 2021.

Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health. 2010;31:399–418.

Article  PubMed  Google Scholar 

Horne R, Cooper V, Wileman V, Chan A. Supporting adherence to medicines for long-term conditions: a perceptions and practicalities approach based on an extended common-sense model. Eur Psychol. 2019;24:82–96. https://doi.org/10.1027/1016-9040/a000353.

Article  Google Scholar 

Morgan M, Horne R. Explaining patients' behaviour. In: Horne R, Weinman J, Barber N, Elliott RA, Morgan M, editors. Concordance, adherence and compliance in medicine taking: a conceptual map and research priorities. London: National Institute for Health Research (NIHR) Service Delivery and Organisation (SDO) Programme. https://www.ahpo.net/assets/NCCSDO%20Compliance%202005.pdf. Accessed 30 June 2023.

Kahneman D. Thinking, fast and slow. New York: Farrar, Straus and Giroux; 2011.

Google Scholar 

Piette JD, Heisler M, Horne R, Caleb AG. A conceptually based approach to understanding chronically ill patients’ responses to medication cost pressures. Soc Sci Med. 2006;62(4):846–57. https://doi.org/10.1016/j.socscimed.2005.06.045.

Article  PubMed  Google Scholar 

Horne R. Decisions about medicines: scientific evidence in contest. Academy of Medical Sciences Invited paper, 2017. https://acmedsci.ac.uk/file-download/26991434. Accessed 30 June 2023.

Horne R, Chapman SC, Parham R, Freemantle N, Forbes A, Cooper V. Understanding patients’ adherence-related beliefs about medicines prescribed for long-term conditions: a meta-analytic review of the Necessity-Concerns Framework. PLoS ONE. 2013;8(12): e80633. https://doi.org/10.1371/journal.pone.0080633.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Foot H, La Caze A, Gujral G, Cottrell N. The necessity-concerns framework predicts adherence to medication in multiple illness conditions: a meta-analysis. Patient Educ Couns. 2016;99(5):706–17. https://doi.org/10.1016/j.pec.2015.11.004.

Article  PubMed  Google Scholar 

Horne R, Coombes I, Davies G, Hankins M, Vincent R. Barriers to optimum management of heart failure by general practitioners. Br J Gen Pract. 1999;49(442):353–7.

CAS  PubMed  PubMed Central  Google Scholar 

Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, et al. Why don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999;282(15):1458–65. https://doi.org/10.1001/jama.282.15.1458.

Article  CAS  PubMed  Google Scholar 

Casey DE Jr. Why don’t physicians (and patients) consistently follow clinical practice guidelines? JAMA Intern Med. 2013;173(17):1581–3. https://doi.org/10.1001/jamainternmed.2013.7672.

Article  PubMed  Google Scholar 

Desveaux L, Saragosa M, Kithulegoda N, Ivers NM. Understanding the behavioural determinants of opioid prescribing among family physicians: a qualitative study. BMC Fam Pract. 2019;20(1):59. https://doi.org/10.1186/s12875-019-0947-2.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Guastella V, Delorme J, Chenaf C, Authier N. The prevalence of off-label prescribing of transmucosal immediate-release fentanyl in France. J Pain Symptom Manag. 2022;63(6):980–7. https://doi.org/10.1016/j.jpainsymman.2022.02.016.

Article  Google Scholar 

Horne R, Weinman J, Hankins M. The Beliefs about Medicines Questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health. 1999;14:1–24. https://doi.org/10.1080/08870449908407311.

Article  Google Scholar 

Collins M-K, Moreau JF, Opel D, Swan J, Prevost N, Hastings M, et al. Compliance with pregnancy prevention measures during isotretinoin therapy. J Am Acad Dermatol. 2014;70(1):55–9. https://doi.org/10.1016/j.jaad.2013.08.034.

Article  PubMed  Google Scholar 

Molloy GJ, Graham H, McGuinness H. Adherence to the oral contraceptive pill: a cross-sectional survey of modifiable behavioural determinants. BMC Public Health. 2012;12:838. https://doi.org/10.1186/1471-2458-12-838.

Article  PubMed  PubMed Central  Google Scholar 

Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015;10:53.