EMIF Use Case 17 - Investigating the relationship in paediatric population between dosing of antibiotics (prescribed, dispensed or administered) and patient’s weight. (EMIF UC17)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27797
• EU PAS number:
  EUPAS24458
• Study ID:
  27797
• Official title and acronym:
  EMIF Use Case 17 - Investigating the relationship in paediatric population between dosing of antibiotics (prescribed, dispensed or administered) and patient’s weight. (EMIF UC17)
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Netherlands

  Spain
• Study description:
  Dosing errors are one of the most common types of medication issues and contribute to themortality and morbidity within the paediatric population. Paediatric patients are at a higher riskthan adults of experiencing such problems because of the need for a dose calculation based onthe patient’s age, weight (mg/kg), body surface area (mg/m 2 ), and clinical condition.Antibiotics are the medications most widely prescribed in the paediatric population and one of thedrug classes most commonly reported to be involved in paediatric dosing errors.Despite a number of studies conducted about antibiotics usage in different European countries,the appropriateness of antibiotic dosing (prescribed by doctors in primary or secondary care,dispensed by community or hospital pharmacies, or administered in hospital settings) according tothe child’s age, weight and height (and other related parameters, as Body Mass Index - BMI, BodySurface Area - BSA) has not yet been investigated.In this study, we would like to assess in European Medical Information Framework (EMIF)Electronic Healthcare Records (EHR) databases (DBs) the relationship between dosing ofantibiotics prescribed, administered or dispensed (either for outpatients or inpatient settings) tochildren (age 0-18 yr), and their weight, age and height.
• Study status:
  Ongoing

Research institutions and networks

Institutions

So.Se.Te

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Pedianet network

Italy

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Department of Medical Informatics - Health Data Science, Erasmus Medical Center (ErasmusMC)

Netherlands

PHARMO Netherlands, Pedianet Italy, SIDIAP Spain, IPCI Netherlands

Networks

European Medical Information Framework (EMIF)

European Union

Study timelines

Date when funding contract was signed

Planned: 11/12/2012

Actual: 11/12/2012

Study start date

Planned: 15/06/2018

Actual: 28/06/2018

Data analysis start date

Planned: 03/12/2018

Actual: 03/12/2018

Date of final study report

Planned: 31/07/2019

Sources of funding

Other

More details on funding

EU/EFPIA

Study protocol

Initial protocol

PediatricUseCase_UC17

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable