Status: Ongoing First registered on: 07/06/2018
Last updated on: 20/12/2019
1. Study identification
EU PAS Register NumberEUPAS24364
Official titleMonitoring prEscription druG Abuse using DOctor Shopping bEhavior
Study title acronymMEGADOSE
Study typeObservational study
Brief description of the studyPrescription drug abuse is a major challenge in public health, in particular in countries such as France, one of the main consumers of medication in Europe. A single source of information is rarely sufficient to measure such a complex phenomenon. This project entitled MEGADOSE (Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior) may complete efficiently the available data from the addictovigilance centres allowing the health authorities (French Drug Agency) to answer to the main general questions (What are the main prescription drug abused in France? What are the national trends in prescription drug abuse? What is the impact of a public health measure on prescription drug abuse). The general aim of this project is to provide an up-to-date and nationally consolidated estimation of the risk and the extent of abuse associated with more of 100 psychoactive drugs in the French population, using doctor-shopping method on National SNIIR-AM. The primary objective of this study is to assess medication availability and the extent and risk of abuse of all psychoactive reimbursed drugs at a national level according to the doctor shopping method. All psychoactive drugs will be ranked according to their DSQ (used as a proxy of the extent of abuse) and their DSI (used as a proxy of abuse potential). Three levels of analysis will be performed: analysis at the class, medications and formulation level (dosage, route of administration, extended or immediate release). The secondary objectives include: i) a geographic approach (spatial analysis) in order to assess differences of psychotropic drugs exposure and abuse between areas and to highlight the detection of an emerging signal in specific areas; ii) a dynamic approach (temporal analysis) to assess the evolution of abuse and the impact of measures between 2010 and, 2015 and 2016.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUPCET
Department/Research groupPharmacology Department
Organisation/affiliationUPCET
Website/Homepage
Details of (Primary) lead investigator
Title Dr
Last name MICALLEF
First name Joelle
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

Pharmacoepidemiology INSERM 1027
Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed05/12/2016
Start date of data collection01/01/2010
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyAgence nationale de sécurité du médicament et des produits de santé61
Research councils
EU funding scheme
OtherAssistance publique – Hôpitaux de Marseille39
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Micallef
First name Joëlle
Address line 1Assistance publique – Hôpitaux de Marseille
Address line 2Service de pharmacologie clinique 
Address line 3264 Rue Saint Pierre 
CityMarseille 
Postcode13005 
CountryFrance
Phone number (incl. country code)33491387563 
Alternative phone number 
Fax number (incl. country code) 
Email address joelle.micallef@ap-hm.fr
Public Enquiries
Title Professor 
Last name Micallef 
First name Joëlle 
Address line 1Assistance publique – Hôpitaux de Marseille 
Address line 2Service de pharmacologie clinique 
Address line 3264 Rue Saint Pierre 
CityMarseille 
Postcode13005 
CountryFrance 
Phone number (incl. country code)33491387563 
Alternative phone number 
Fax number (incl. country code) 
Email address joelle.micallef@ap-hm.fr 
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