Prevalence and characterization of patients on polypharmacy across the three Area Vasta of the Tuscany Region (POLY-TUSC)

01/07/2026
01/07/2026
EU PAS number:
EUPAS1000001044
Study
Finalised
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Study summary
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Study identification

EU PAS number

EUPAS1000001044

Study ID

1000001044

Official title and acronym

Prevalence and characterization of patients on polypharmacy across the three Area Vasta of the Tuscany Region (POLY-TUSC)

DARWIN EU® study

No

Study countries

Italy

Study description

Population aging and multimorbidity increase polypharmacy (≥5 concurrent drugs) and hyper-polypharmacy (≥10 drugs) prevalence, exposing frail adults to drug-drug interactions (DDIs), adverse events, prescribing cascades, and hospitalizations. Monitoring this regional phenomenon is key for health planning. Tuscany, divided into three "Area Vasta" territories (Central, North-West, South-East), represents a highly relevant setting due to its healthcare structure and ongoing 2023–2025 prescriptive appropriateness initiatives.
The aims of te study are to: (1) quantify polypharmacy prevalence among Tuscan residents aged ≥40 during 2023–2025, describing demographic profiles and therapeutic combinations by Local Health Authority (ASL) aggregated by Area Vasta; (2) characterize polypharmacy patients in nursing homes (RSA), integrated home care (ADI), and those with exemptions for chronic cardiovascular, rheumatological, or gastroenterological diseases. Additionally, (3) evaluate exposure to potentially inappropriate medications (PIMs) and severe DDIs in patients aged ≥65 using the 2023 AGS Beers Criteria.
The study is a retrospective descriptive observational cohort study using Tuscany's administrative databases (registry, outpatient prescriptions, direct distribution, exemptions) from 2023–2025. Residents aged ≥40 on Dec 31 each year with ≥3 years of observation will be included. Polypharmacy and hyper-polypharmacy are defined as dispensing ≥5 or ≥10 distinct ATC 4th-level drugs in the same month for ≥3 months/year. Descriptive statistics will be stratified by ASL (aggregated by Area Vasta) and age (40–64, 65–84, ≥85 years). PIMs and DDIs for patients ≥65 will be mapped via ATC codes. Mapping polypharmacy patterns will support regional health programming and economic sustainability. Evidence on PIMs and DDIs will provide tools for structured deprescribing and therapeutic optimization, improving safety for elderly and fragile patients.

Study status

Finalised
Research institutions and networks

Institutions

Networks

Centro Regionale di Farmacovigilanza della Toscana

Contact details

Sandra Donnini 0000-0001-6617-1644

Primary lead investigator
ORCID number:
0000-0001-6617-1644

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
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Sources of funding
No external funding
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable