Implementation of 21st Century Cures Act Expanded Access Policies Requirements.

The US Food and Drug Administration (FDA) expanded access pathway allows patients with life-threatening or serious conditions to access investigational drugs outside of trials, under certain conditions. The 21st Century Cures Act ("Cures Act") requires certain drug companies to publicly disclose their expanded access policies. We characterized the proportion of applicable US biopharmaceutical companies, with an oncology related drug, implementing Cures Act requirements for expanded access policies and whether available policies contain the information described in the Act. We found about one-third of applicable biopharmaceutical companies (32%, 140/423) implemented the Cures Act requirement to have a public expanded access policy. Less than one-third of public policies contained all described information (31%, 44/140). Larger companies and those with at least one drug receiving an FDA expedited designation (59% vs. 21%; P < 0.001), or at least one FDA-approved drug (57% vs. 28%; P < 0.001) were more likely to have a public policy. Our results suggest the Cures Act may be having a limited impact on its goals of supporting timely medical decisions and closing informational gaps for patients and doctors around expanded access to investigational oncology therapies, especially for products sponsored by smaller and newer companies.

Psychiatric understanding and treatment of patients with amputations.

Amputation changes the lives of patients and their families. Consequently, the patient must adapt to altered body function and image. During this adaptation process, psychological problems, such as depression, anxiety, and posttraumatic stress disorder, can occur. The psychological difficulties of patients with amputation are often accepted as normal responses that are often poorly recognized by patients, family members, and their primary physicians. Psychological problems can interfere with rehabilitation and cause additional psychosocial problems. Therefore, their early detection and treatment are important. A multidisciplinary team approach, including mental health professionals, is ideal for comprehensive and biopsychosocial management. Mental health professionals could help patients set realistic goals and use adaptive coping styles. Psychiatric approaches should consider the physical, cognitive, psychological, social, and spiritual functions and social support systems before and after amputation. The abilities and limitations of physical, cognitive, psychological, and social functions should also be considered. To improve the patient's adaptation, psychological interventions such as short-term psychotherapy, cognitive behavioral therapy, mindfulness meditation, biofeedback, and group psychotherapy can be helpful.