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

Laurence Sophie Jouaville, Carole Ehrhardt, Marie-Laure Kürzinger, Hanka de Voogd and Massoud Toussi

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.