The data source contains the following information

Disease information

Does the data source collect information with a focus on a specific disease? This might be a patient registry or other similar initiatives.

Yes

Disease details, other

The AIFA Monitoring Registries Platform is used to monitor the pharmaceutical treatment of specific diseases or clinical conditions. In this way, the wMRs collect data useful to qualify the appropriateness use of the pharmaceutical in the clinical practice (i.e: clinical paramenters in the diagnosis of the disease, including rare diseases; clinical setting; individual genetic data profile; presence/absence of a specific biomarker). However, these data are collected only in treated eligible population for the reimbursement by the Italian Healthcare Service, so the main aim of wMRs is not to monitor the overall disease in Italy (as in a disease registry), but only its treatment and outcome.

Rare diseases

Are rare diseases captured? In the European Union a rare disease is one that affects no more than 5 people in 10,000.

Yes

Pregnancy and/or neonates

Does the data source collect information on pregnant women and/or neonatal subpopulation (under 28 days of age)?

No

Hospital admission and/or discharge

No

ICU admission

Is information on intensive care unit admission available?

No

Cause of death

Captured

Cause of death vocabulary

Other

Cause of death vocabulary, other

Specific for each registry and often common for registries in a certain therapeutic area.

Prescriptions of medicines

Captured

Prescriptions vocabulary

other

Prescriptions vocabulary, other

Internal vocabulary

Dispensing of medicines

Captured

Dispensing vocabulary

other

Dispensing vocabulary, other

Internal vocabulary

Advanced therapy medicinal products (ATMP)

Is information on advanced therapy medicinal products included? A medicinal product for human use that is either a gene therapy medicinal product, a somatic cell therapy product or a tissue engineered products as defined in Regulation (EC) No 1394/2007 [Reg (EC) No 1394/2007 Art 1(1)].

Yes

Contraception

Is information on the use of any type of contraception (oral, injectable, devices etc.) available?

No

Indication for use

Does the data source capture information on the therapeutic indication for the use of medicinal products?

Captured

Indication vocabulary

Other

Indication vocabulary, other

SmPC therapeutic indication

Medical devices

Is information on medicinal devices (e.g., pens, syringes, inhalers) available?

No

Administration of vaccines

No

Procedures

Does the data source capture information on procedures (e.g., diagnostic tests, therapeutic, surgical interventions)?

Captured

Procedures vocabulary

Other

Procedures vocabulary, other

SmPC

Clinical measurements

Is information on clinical measurements (e.g., BMI, blood pressure, height) available?

Yes

Healthcare provider

Is information on the person providing healthcare (e.g., physician, pharmacist, specialist) available? The healthcare provider refers to individual health professionals or a health facility organisation licensed to provide health care diagnosis and treatment services including medication, surgery and medical devices.

Yes

Genetic data

Are data related to genotyping, genome sequencing available?

Captured

Genetic data vocabulary

Other

Genetic data vocabulary, other

It depends according to the medicinal product

Biomarker data

Does the data source capture biomarker information? The term “biomarker” refers to a broad subcategory of medical signs ( objective indications of medical state observed from outside the patient), which can be measured accurately and reproducibly. For example, haematological assays, infectious disease markers or metabolomic biomarkers.

Captured

Biomarker data vocabulary

Other

Biomarker vocabulary, other

It depends according to the medicinal product

Patient-reported outcomes

Is information on patient-reported outcomes (e.g., quality of life) available?

No

Patient-generated data

Is patient-generated information (e.g., from wearable devices) available?

No

Units of healthcare utilisation

Are units of healthcare utilisation (e.g., number of visits to GP per year, number of hospital days) available or can they be derived? Units of healthcare utilisation refer to the quantification of the use of services for the purpose of preventing or curing health problems.

Yes

Unique identifier for persons

Are patients uniquely identified in the data source?

Yes

Diagnostic codes

Captured

Diagnosis / medical event vocabulary

Other

Diagnosis / medical event vocabulary, other

It depends according to the medicinal product

Medicinal product information

Captured

Medicinal product information collected

Brand name
Dose
Formulation
Package size
Strength

Medicinal product vocabulary

AIC

Quality of life measurements

Not Captured

Lifestyle factors

Captured

Lifestyle factors collected

Alcohol use
Tobacco use

Sociodemographic information

Captured

Sociodemographic information collected

Age
Country of origin
Gender
Type of residency