Empowering Patients to Improve Safety in Polymedication

The research focuses on the challenges and risks associated with polypharmacy,
where patients chronically use five or more medications. Polypharmacy presents
significant risks, such as adverse drug reactions and decreased medication
adherence, particularly in elderly and multimorbid patients. Despite the
interconnected nature of drug-drug and drug-gene interactions, these are often
treated as separate entities. Ignoring these interactions can be hazardous to
patients. Due to the rapidly increasing complexity of these interactions,
extensive patient variability, and the high costs, ethical, and logistical
challenges of large-scale studies, clinical investigations into these
interactions are unfeasible. As a result, there is a substantial knowledge gap
in managing complex medication regimens in practice and providing
scientifically-based guidelines. The SafePolyMed project aims to develop a
patient-centered framework to define, assess, and manage these interactions,
ultimately improving medication safety and empowering patients in their own
health management.

To assess the feasibility of using the developed medication management centre
to empower polypharmacy patients, thereby improving drug safety. Secondary
objectives are to explore if the tool is able to identify patients at risk for
a drug-drug-gene interaction and lower the adverse drug event rate.

The study is a proof of concept study conducted at four institutes located in
Germany, Greece, Slovenia and The Netherlands. Polypharmacy patients will use
the medication management centre (MMC), which provides curated,
patient-specific information about drug interactions and pharmacogenetics. To
assess patient empowerment, patients will receive questionnaires during a 12
week follow-up period.

The MMC that provides patient centred information on drug-drug interactions and
pharmacogenetics affecting personal polytherapy. The MMC will show a selection
of high quality publicly available information such as details on different
types of medications, including their uses, side effects and instructions for
use, in the language of the patient. This information is targeted at an
individual patient*s medication profile to inform patients to better understand
and deal with their personal health information, with regard to drug therapy.
Patients in the Netherlands, Slovenia and Greece also will receive their PGx
profile to further personalise the MMC experience.

Patients are exposed to the regular treatment. In addition, patients will
receive questionnaires at baseline, two, and twelve weeks regarding the use and
experience of the medication management centre, and a close-out interview at
week twelve. In addition, 10ml of blood will be collected during a venipuncture
for pharmacogenetic analyses.

Benefits include having access to the medication management centre for the
duration of the study. Additionally, patients will receive their PGx profile.
This can be used to individualize drug treatment, based on the Dutch
Pharmacogenetics Working Group (DPWG) guidelines.

Overall, minimal risks are expected for subjects as they will receive normal
clinical care. Information from the MMC will be a curation of existing publicly
available data. Any information regarding DDIs and DGIs will be supplemented
with a disclaimer that the patient should not adjust their treatment without
talking to a healthcare provider.