Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Thiocolchicoside containing Medicinal Products for Systemic Use in France, Greece, Italy and Portugal

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23054
• EU PAS number:
  EUPAS11765
• Study ID:
  23054
• Official title and acronym:
  Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Thiocolchicoside containing Medicinal Products for Systemic Use in France, Greece, Italy and Portugal
• DARWIN EU® study:
  No
• Study countries:
  France

  Greece

  Italy

  Portugal
• Study description:
  Thiocolchicoside (TCC) is a semi-synthetic sulfurated colchicoside derivative with a muscle relaxant pharmacological activity, used in the management of non-specific low back pain. TCC is indicated as adjuvant treatment of painful muscular contractures in acute spinal pathology, in adults and adolescents from 16 years onwards. The benefits of TCC containing medicinal products are recognised in clinical practice, and they are widely used by prescribers in the concerned Member States (see Annex 3). An Article 31 referral on thiocolchicoside-containing medicinal products for systemic use was initiated in February 2013. The CHMP has concerns with regard to the potential genotoxicity of thiocolchicoside-containing medicinal products for systemic use. Within the context of minimization measures as per European Commission decision dated 17 January 2014, including a Dear Healthcare Professional Communication, changes to the SmPC, Labelling and Package Leaflet. As per EMA request the present survey will be conducted in complement to a Joint Drug Utilization Study.
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Planned: 02/11/2015

Actual: 20/11/2015

Study start date

Planned: 01/04/2016

Actual: 01/02/2017

Date of final study report

Planned: 31/01/2017

Actual: 01/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Acarpia services farmaceuticos Lda, Alter laboratoire, Angelini, Angenerico SpA, Arrow Generiques, Biogaran, Cristers, Daiichi Sankyo, Doc Generici, Dompe Farmaceutici SpA, EG labo, EG SpA, Epifarma Srl, Farmaceutici Caber SpA, Generis Farmaceutica, Korangi, Laboratorio Farmaceutico CT Srl, MDM, Mylan, Sandoz, Sanofi Aventis Groupe, SF Group Srl, SPA, Teofarma Srl, Union Health Srl.

Study protocol

Initial protocol

1078739-Thiocolchicoside - Survey Protocol_08 Augut2016 _LAST

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)