Nanotechnology has led to rapid advancements in the development of pharmaceuticals, imaging and diagnostic devices, drug delivery vehicles and therapeutic agents. Nanomedicine—a subfield of nanotechnology that combines basic and medical sciences—uses nanoscale materials for diagnosis, monitoring, prevention and treatment of disease.
These innovations have revolutionized how medical professionals think about disease diagnosis and treatment at the cellular level. However, nanomedicine faces developmental challenges due to high costs, unspecified standards and regulations, and unknown biological interactions, effects and toxicities.
The April issue of the AMA Journal of Ethics® (@JournalofEthics) explores the roles of ethics in shaping legislation, organizational policy and public discussion about nanomedicine, and gives you an opportunity to earn CME credit.
“How Should Physicians Help Patients Understand Unknowns of Nanoparticle-Based Medicines?” When a patient wants to enroll in a clinical trial to gain early access to an apparently promising but unproven intervention, her physician should clarify differences between participating in research and receiving treatment to help her avoid therapeutic misconception, make a thoughtful decision, and consider relevant clinical and ethical details.
When an unproven intervention is a nanodrug, a physician’s role is especially difficult, because though nanomedicine might offer real benefits, it can also pose unexpected or even unprecedented harms. Thus, a physician should help a patient explore possible outcomes while promoting realism, countering hype, and preserving hope.
“Should a Psychiatrist Prescribe a Nanodrug to Help Parents Monitor a Teen’s Adherence?” This article explores ethical questions about tracking medication adherence in a 16-year-old patient with schizophrenia. Relevant stakeholders are the teen, the parents and society. How those stakeholders’ interests should be considered is explored in the context of the psychiatrist’s professional care management responsibilities and the burdens each stakeholder must bear over the course of the patient’s care.
“Should Trackable Pill Technologies Be Used to Facilitate Adherence Among Patients Without Insight?” Aripiprazole tablets with sensor offer a new wireless trackable form of aripiprazole that represents a clear departure from existing drug delivery systems, routes or formulations. This tracking technology raises concerns about the ethical treatment of patients with psychosis when it could introduce unintended treatment challenges.
The use of “trackable” pills and other “smart” drugs or nanodrugs assumes renewed importance given that physicians are responsible for determining patients’ decision-making capacity. This article focuses on guidance for capacity determination and informed consent for such nanodrugs.
“Regulating Nanomedicine at the Food and Drug Administration.” Complex and emerging nanoscale products challenge the existing FDA regulatory framework and illuminate its shortcomings for combination products that integrate multiple mechanisms of therapeutic action. This article surveys current FDA regulatory structures and nanotechnology-specific guidance, discusses relevant nanomedicine products, and identifies regulatory challenges.
The journal’s editorial focus is on commentaries and articles that offer practical advice and insights for medical students and physicians. Submit a manuscript for publication. The journal also invites original photographs, graphics, cartoons, drawings and paintings that explore the ethical dimensions of health or health care.
Upcoming issues of the AMA Journal of Ethics will focus on advanced cardiopulmonary care ethics and limits to patient preferences. Sign up to receive email alerts when new issues are published.