ISSN: 2161-1165

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  • Research Article   
  • Epidemiology (Sunnyvale) 2019, Vol 9(1): 372
  • DOI: 10.4172/2161-1165.1000372

Evaluation of the Effectiveness of Risk Minimisation Measures Targeting Physicians on Prescribing Practices of Thiocolchicoside Containing Medicinal Products for Systemic Use

Laurence Sophie Jouaville1*, Carole Ehrhardt2, Marie-Laure Kürzinger3, Hanka De Voogd4 and Massoud Toussi1
1Real World Evidence Solutions, IQVIA, France
2Global Pharmacovigilance, Global Safety Sciences, Risk Management, Sanofi, France
3Epidemiology and Benefit Risk Evaluation, Sanofi, France
4Global Clinical Sciences, Vaccines & Anti-Infectives, Mylan, Netherlands
*Corresponding Author : Laurence Sophie Jouaville, Real World Evidence Solutions, IQVIA, Tour D2, 17 Bis Place Des Reflets, TSA 64567, 92099 La Defense Cedex, France, Tel: 33 (0)1 73 20 43 67, Email: sjouaville@fr.imshealth.com

Received Date: Nov 30, 2018 / Accepted Date: Mar 18, 2019 / Published Date: Mar 28, 2019

Abstract

Introduction: In 2014, Risk Minimisation Measures (RMMs) concerning thiocolchicoside for systemic use were implemented in all European countries marketing the product. A Direct Healthcare Professional Communication (DHPC) and Educational Materials (EMs), were distributed to health care professionals to increase awareness related to genotoxicity risk.

Objectives: The objective of this study was to measure the effectiveness of RMMs, by ascertaining the proportion of targeted physicians who understood and implemented the latest prescribing conditions and safety information about systemic thiocolchicoside provided in the DHPC and EMs.

Methods: A cross-sectional web-based survey of prescribers of systemic thiocolchicoside was conducted in France, Greece, Italy and Portugal. Sampling targets for responding physicians were determined based on country specific prescribing patterns. Frequency of correct responses was calculated for six knowledge questions and information related to recent patients’ prescriptions of TCC was analysed.

Results: Among 651 responding physicians, 68.6% remembered having received either the DHPC or the EM or both. Knowledge was the highest for contraindications to the use of systemic thiocolchicoside, related to patients’ age (85.0%), pregnancy (87.6%), and lactation (80.3%) and was lower (49.1%) regarding restriction of use in women of childbearing potential not using contraception. Overall, knowledge of the right indication for use of systemic thiocolchicoside was 63.2%, while knowledge of dose and duration of treatment was higher for the oral form (78.9%) than for the injectable form (55.4%). These results were confirmed by the analysis of recent patients’ prescriptions. Knowledge varied by physician specialty and country and was higher for physicians who reported receiving either the DHPC or the EM or both.

Conclusion: This study reveals geographical as well as across prescribers’ specialty contrasts in the knowledge of key messages of systemic TCC containing medicinal products associated RMMs. In addition, the results showed that when risk minimisation materials (DHPC and EM) receipt was acknowledged by physicians, it improved their knowledge and attitude towards appropriate systemic TCC prescribing to patients.

Keywords: Direct healthcare professional communication; Risk minimisation measures; Thiocolchicoside

Citation: Jouaville LS, Ehrhardt C, Kürzinger ML, de Voogd H, Toussi M (2019) Evaluation of the Effectiveness of Risk Minimisation Measures Targeting Physicians on Prescribing Practices of Thiocolchicoside Containing Medicinal Products for Systemic Use. Epidemiology (Sunnyvale) 9: 372. Doi: 10.4172/2161-1165.1000372

Copyright: © 2019 Jouaville LS, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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