Special Interest Groups - Drug Safety in Older Patients Group

The ISoP Special Interest Group on Drug Safety in Older Patients

Drug Safety in Older Patients group established in 2022

At ISoP 2018 Annual Meeting in Geneva, a very successful pre-conference course on Drug Safety in Older Patients was organized. Some of the course speakers realized the topic was a neglected but very important field that required further development. Their collaboration, with help of additional colleagues from the University Hospital of Pisa, resulted in an article that was published in Drug Safety in 2020.
Furlan G, Caduff-Janosa P, Sottosanti L, Cappello E, Valdiserra G, Tuccori M. Drug Safety in Geriatric Patients: Current Status and Proposed way Forward. Drug Safety 43, 853-866 (2020).
The article became the starting point for several presentations delivered by Giovanni Furlan who led the proposal for a SIG for ISoP.

Older patients’ characteristics and specific drug safety challenges in these patients

Older patients are the population that consumes more drugs, but they have been traditionally underrepresented in clinical trials. This has improved in recent years, but underrepresentation remains for frail older patients: those with multiple comorbidities, on many drugs or who are not independent due to physical impairments are frequently not enrolled in clinical trials since they meet exclusion criteria or are not able to meet clinical trial requirements.

Older patients are a very heterogenous population that differs from the general population due to different pharmacokinetic and pharmacodynamic characteristics. Currently elderly patients are identified based on age only with further stratification according to age bands (e.g., 65-74, 75-84, ≥85 years). Such an approach ignores aging as a subjective process that depends on genetic, environmental, social and economic factors.

In fact, while the prevalence of comorbidities and polypharmacy increases with age, fit older patients may not suffer from comorbidities and can still enjoy an active lifestyle as the adults. On the other hand, frail older patients frequently suffer from geriatric conditions, such as delirium, syncope falls, sarcopenia and cachexia that medicinal products can aggravate.

The consequence of older patients’ heterogeneity is that their preferences and values can be very different. For example, a fit elderly cancer patient with no comorbidities can have increased survival as a priority, even if it is at the expense of suffering from severe adverse reactions. An older frail cancer patient with many comorbidities that reduce his/her life expectancy might have quality of life as a priority. Therefore, the benefit-risk balance of a drug that is favorable in fit older patients can be unfavorable in frail older patients.

Since some older patients’ subpopulations have different characteristics from adult patients, unique challenges characterize these patients both from a clinical and regulatory perspective.
Examples include:
• The efficacy and safety of many drugs in frail older patients remains not well characterized
• Current regulations define and stratify older patients by age only without considering frailty
• Drug benefit-risk balance does not stratify older patients by frailty, life expectancy, and comorbidities
• Clinical study endpoints do not consider that the values and preferences of frail older patients can be different from those of fit older patients
• Medication errors and sub-optimal compliance with drug intake characterize older patients (especially those who take multiple drugs) due to their physical impairments that limit their ability to take drugs.
• Adverse reactions that mimic or aggravate geriatric conditions are under-recognized
• Older patients who are physically or cognitively impaired might have difficulties in understanding medicinal product’s risks
• Due to the above-mentioned issues, older patients can be prescribed with and/or take medicines inappropriately

SIG mission and objectives

The mission of the SIG is to promote the safe use of medicines in the different older patients’ subpopulations.
The SIG will achieve this mission by bringing pharmacovigilance experts together with other stakeholders to better understand and mitigate the risk of using medicines in older patients.

The main objectives are to:
• Increase the awareness that elderly patients are a heterogeneous population and influence the regulatory environment to reflect this aspect in relevant regulations (that should be implemented consistently world-wide)
• Stimulate the research to identify, in the different diseases, which benefits, and risks are important for the different older patients’ subpopulations. Medicinal products should be developed and prescribed according to these preferences.
• Keep abreast of scientific discussions and studies on the risks of drug safety in older patients
• Contribute to increasing older patients’ medicines intake compliance and to decreasing medication errors

SIG members are very welcome to propose new or different objectives based on their interests and expertise.