IMI – Industry guidelines and ethical considerations for Myopia control report

TitleIMI – Industry guidelines and ethical considerations for Myopia control report
Publication TypeJournal Article
Year of Publication2019
AuthorsJones, L., B. Drobe, J. González-Méijome, L. Gray, T. Kratzer, S. Newman, J. Nichols, A. Ohlendorf, S. Ramdass, J. Santodomingo-Rubido, K. Schmid, D. Tan, K. - O. Tan, F. Vera-Diaz, Y. - L. Wong, K. Gifford, and S. Resnikoff
JournalInvestigative Ophthalmology and Visual Science
Volume60
PaginationM161-M183
KeywordsAnxiety, Article, atropine, biometry, certification, child, clinical decision making, Conflict of interest, cost effectiveness analysis, drug cost, drug efficacy, drug industry, drug information, drug manufacture, drug marketing, drug safety, education, Ethical prescribing, ethics, eye care, eye drops, Glaucoma, health care cost, health insurance, human, Informed consent, interferometry, intraocular pressure, introversion, keratomileusis, knowledge, legal liability, lifelong learning, medical device, medical practice, morphine, myopia, Myopia control, off label drug use, ophthalmoscopy, patient autonomy, perioperative period, pharmacist, practice guideline, prescription, Prevalence, priority journal, proton pump inhibitor, quality control, quality of life, refraction error, retina detachment, risk management, stakeholder engagement, Visual acuity, visual impairment
Abstract

PURPOSE. To discuss guidelines and ethical considerations associated with the development and prescription of treatments intended for myopia control (MC). METHODS. Critical review of published papers and guidance documents was undertaken, with a view to carefully considering the ethical standards associated with the investigation, development, registration, marketing, prescription, and use of MC treatments. RESULTS. The roles and responsibilities of regulatory bodies, manufacturers, academics, eye care practitioners, and patients in the use of MC treatments are explored. Particular attention is given to the ethical considerations for deciding whether to implement a MC strategy and how to implement this within a clinical trial or practice setting. Finally, the responsibilities in marketing, support, and education required to transfer required knowledge and skills to eye care practitioners and academics are discussed. CONCLUSIONS. Undertaking MC treatment in minors creates an ethical challenge for a wide variety of stakeholders. Regulatory bodies, manufacturers, academics, and clinicians all share an ethical responsibility to ensure that the products used for MC are safe and efficacious and that patients understand the benefits and potential risks of such products. This International Myopia Institute report highlights these ethical challenges and provides stakeholders with recommendations and guidelines in the development, financial support, prescribing, and advertising of such treatments. Copyright 2019 The Authors.

DOI10.1167/iovs.18-25963