Age-Appropriate Doses and Formulations For The Elderly May Bolster Smarter Prescribing Habits

Clinical trials using elderly patient participants are few and far between, despite the elderly being the fastest-growing portion of the world’s population. Because of this, age-appropriate therapy formulations and doses are often limited or not available at all, business intelligence firm GBI Research says. The company’s latest report states that many elderly people live with multiple conditions and illnesses and take five or more pharmaceutical therapies every day.

The risk of adverse drug reactions, events, hospitalizations and death is significantly increased when the clinical trial population is dissimilar to the individuals being treated. Indeed, as many as a one in three emergency admissions to hospital are drug-related.

Off-label prescriptions are more common for older patients, as industry clinical trials commonly exclude geriatric patients due to a higher risk profile. Around 80 percent of nursing home patients are regularly prescribed off-label antipsychotic treatments for management of delirium, agitation and psychosis, symptoms of Alzheimer’s disease, and schizophrenia.

The International Conference on Harmonisation (ICH) published an update to its E7 guidelines in 2010, determining that the number of elderly patients who are part of a study population should directly represent the treatment population and not be limited to the previously required 100 patients. In addition, the publication from ICH E7 noted that elderly patients over 75 years of age should participate in clinical trials, even those with other pre-existing conditions and on concomitant medications.

GBI Research states in its report that it believes that research and development into treatments with age-appropriate dosing and formulation may create smarting prescribing behaviors of approved drugs, including blood thinners, diabetes treatments, antipsychotics and pain medications for diseases in the elderly. It also notes the opportunities available to companies who take the lead in the development of treatments to combat age-related diseases, such as dementia, sarcopenia, and neurodegenerative diseases.