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Thiocholchicoside ICPE 2019


EVALUATION OF THE EFFECTIVENESS OF RISK MINIMISATION MEASURES TARGETING PHYSICIANS ON PRESCRIBING PRACTICES OF THIOCOLCHICOSIDE (TCC) CONTAINING MEDICINAL PRODUCTS FOR SYSTEMIC USE Background: In 2014, risk minimisation measures (RMMs) concerning thiocolchicoside (TCC) for systemic use were requested to be implemented in all European countries marketing the product following an Article 31 Referral procedure. In addition to labelling and pack size restrictions, a direct healthcare professional communication (DHPC) and educational materials (EMs) were distributed to health care professionals (HCP) to increase awareness related to genotoxicity risk (based on non-clinical studies). Objectives: This study aimed 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 TCC provided in the DHPC and EMs. Methods:  A cross-sectional web-based survey of prescribers of systemic TCC was conducted in France, Greece, Italy and Portugal in 2017. 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 were provided overall, by country and by physician type (general practitioners, rheumatologists, orthopaedists-orthopaedic surgeons). Results: The recruitment rate (completers/eligible) was 71.4%. 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 TCC, 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 TCC 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 (p = 0.002). Conclusions: This study revealed geographical as well as across prescribers’ specialty contrasts in the knowledge of TCC RMMs. In addition, the results showed that when risk minimisation materials (DHPC and EM) receipt was acknowledged by physicians, it significantly improved their knowledge and attitude towards appropriate systemic TCC prescribing to patients.

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Language : English


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