EREMI - Longitudinal study in patients aged 0 to 15 years hospitalised for at least 3 days after receiving at least one drug: risk of adverse drug reactions associated with off-label/unlicensed prescriptions
Head :
Kassai Koupai Behrouz, Clinical Investigation Centre Hospices Civils de Lyon /Inserm EPICIME (Epidemiology, Pharmacology, Clinical Research and Medical information, Mother and Child) UMR 5558/CNRS
Last update : 09/06/2020 | Version : 1 | ID : 39007
| General | |
| Identification | |
| Detailed name | Longitudinal study in patients aged 0 to 15 years hospitalised for at least 3 days after receiving at least one drug: risk of adverse drug reactions associated with off-label/unlicensed prescriptions |
| Sign or acronym | EREMI |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | MMS/MTE/AR1411279 |
| General Aspects | |
| Medical area |
Pediatrics |
| Pathology (details) | Adverse drug reactions |
| Health determinants |
Iatrogenic Medicine |
| Keywords | drug, ADEs, Adverse drug episodes, adverse effect, market authorisation, prescription, Hospitalisation, MA, child, adolescent |
| Scientific investigator(s) (Contact) | |
| Name of the director | Kassai Koupai |
| Surname | Behrouz |
| Address |
Bâtiment les tilleuls, 59 boulevard Pinel 69003 Lyon Service Pharmacotoxicologie, HCL 168 avenue Lacassagne 69003 Lyon |
| Phone | (+33) 4 27 85 77 32 |
| behrouz.kassai-koupai@chu-lyon.fr | |
| Unit | Clinical Investigation Centre Hospices Civils de Lyon /Inserm EPICIME (Epidemiology, Pharmacology, Clinical Research and Medical information, Mother and Child) UMR 5558/CNRS |
| Organization | Hospices Civils de Lyon (HCL) |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | CIC Pédiatrique - Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon (HCL) / CIC pédiatrique - Hôpital Robert Debré, Assistance publique – Hôpitaux de Paris (AP-HP) |
| Funding | |
| Funding status |
Public |
| Details | ANSM Financing 2012 - Axis 2: Analysis of off-label drug use |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon (HCL) |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Hôpital Robert Debré, Assistance publique – Hôpitaux de Paris (AP-HP) |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Name of the contact | Nguyen |
| Surname | Kim An |
| Address |
Bâtiment les tilleuls, 59 boulevard Pinel 69003 Lyon Service Pharmacotoxicologie, HCL 168 avenue Lacassagne 69003 Lyon |
| Phone | 0427855290 |
| kim-an.nguyen@chu-lyon.fr | |
| Unit | UMR5558/LBBE |
| Organization | Hospices Civils de Lyon/UCBL |
| Name of the contact | Kassai |
| Surname | Behrouz |
| Address |
Bâtiment les tilleuls, 59 boulevard Pinel 69003 Lyon |
| Phone | 0427856317 |
| behrouz.kassai@chu-lyon.fr | |
| Unit | UMR5558/LBBE |
| Organization | Hospices Civils de Lyon/UCBL |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services A population file |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Automated prospective extraction of drug administrations from the HCL Hospital Information System / Active and spontaneous detection of adverse drug events |
| Database objective | |
| Main objective |
To compare the probability of occurrence of an adverse drug reaction (ADR) after a licensed prescription drug versus the probability of occurrence of an ADR after prescribing a drug off-label or unlicensed in patients aged 0-15 years hospitalized at least 3 days
Secondary objectives: • Compare the proportion of pediatrics inpatients presenting at least one ADR among inpatients with at least one off-labels or unlicensed prescription drug with the proportion of inpatients presenting at least one ADR among inpatients with all licensed prescription drugs • To describe, in terms of marketing autorisation and indications, the medicinal products prescribed by paediatric age group. • Identify the factors influencing the risk of developing ADRs after prescribing a drug • To estimate the seriousness and avoidability of ADRs |
| Inclusion criteria |
Children from 0 to 15 years old [0 ; 15[ (including term and preterm newborn infants).
Hospitalised for at least 3 days. Receiving at least one medication |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) |
| Population covered |
Sick population |
| Pathology | Y40-Y59 - Drugs, medicaments and biological substances causing adverse effects in therapeutic use |
| Gender |
Male Woman |
| Geography area |
Local |
| Detail of the geography area | Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon (HCL) / Hôpital Robert Debré, Assistance publique – Hôpitaux de Paris (AP-HP) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2013 |
| Date of last collection (YYYY or MM/YYYY) | 2016 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 6227 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Nature and clinical context of ADEs |
| Declarative data (detail) |
Face to face interview Phone interview |
| Details of collected declarative data | Spontaneous reporting of ADEs by medical teams / Aid to reporting ADEs actively detected by the EREMI team |
| Biological data (detail) | Creatinine level |
| Administrative data (detail) | Admission dates, Duration of stay. Extractions from the hospital information system (prescriptions, doses, anthropomorphic and biological data) |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medicines consumption |
| Procedures | |
| Data collection method | During hospitalisation |
| Quality procedure(s) used | Methodology: HCL Paediatric Clinical Investigation Centre; Biostatistics: Biostatistics department of HCL/UMR CNRS 5558; Management of the database: ClinInfo, Lyon |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) Monitoring by contact with the referring doctor Monitoring by crossing with a medical-administrative database |
| Details on monitoring of participants | Duration of monitoring of patients who have had an ADE after discharge: 1 month |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | PMSI |
| Promotion and access | |
| Promotion | |
| Link to the document | http://adc.bmj.com/content/99/Suppl_2/A62.2.abstract?sid=0943db08-e27a-4da7-bb7a-909ec1a19723; http://www.sciencedirect.com/science/article/pii/S0929693X14719591; http://www.sciencedirect.com/science/article/pii/S0929693X1472130X; http://www.sciencedirect.com/science/article/pii/S0929693X14721311; http://www.sciencedirect.com/science/article/pii/S0929693X14722432 |
| Other information | NCT02852590, protocol available on clinicaltrial.gov (https://clinicaltrials.gov/ct2/show/NCT02852590?term=EREMI&rank=1) |
| Access | |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) | Request from M Behrouz.Kassai (behrouz.kassai-koupai@chu-lyon.fr or Mrs Kim An Nguyen: kim-an.nguyen@chu-lyon.fr |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
