Special Populations are categories of patients that differ in age or in specific disorders. Consequently, the pharmacovigilance activity is more complex in their cases. It was discussed at the third edition of the European Pharmacovigilance Congress. Here is what Giovanni Furlan, Head of security risk, Director of Pfizer, reported on geriatric patients.
Geriatric patients, especially those aged 75 and over, react differently than patients in the middle age group. This is due to different pharmacokinetics and pharmacodynamics and to the presence of multiple age-related disorders and consequently the greater number of drugs taken that cause an increased risk of adverse reactions caused by interactions.
Furthermore, patients with geriatric conditions, such as, for example, delirium, falls, syncope or urinary incontinence, have a greater risk of adverse reactions with consequent increased risk of worsening of pre-existing geriatric conditions.
The polypharmacy is associated with poor adherence to drugs which increases the risk of hospitalizations, worsening of illnesses and death. The different expectations that elderly patients have from taking drugs is one of the main reasons for non-compliance. For them it is more important to have a better quality of life, rather than an extension of the same.
However, clinical trials of drugs are present on a sample of mid-range people, tending to exclude the elderly, this due to doubts about the real benefit of the treatment or due to blocking conditions on the part of the patient as difficulty in accessing the center of evidence due to logistical barriers or physical disability or lack of information on the availability of clinical trials.
Some proposals to improve adherence to clinical studies could be to provide transport and/or housing, family involvement in the informed consent process, simplification of information consent, implementation of face-to-face communication, abolishing the exclusion criteria that do not allow registration of older people including slow and gradual approach strategies to the drug.
In conclusion it can be said that the adverse reactions and expectations of benefit of a given drug on the elderly, are different compared to the general population, it is a separate tariff benefit for risk/benefit ratio and implement post-marketing pharmacovigilance activities and perform a survey of the separate signal for this precise category.