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Purpose This study evaluated the effectiveness of risk minimisation measures (RMMs) implemented following the 2014 referral for valproate in Europe. Methods: Cross‐sectional survey was conducted over 2‐month period in 2016 among physicians who prescribed valproate in France, Germany, the United Kingdom, Spain and Sweden. The web‐based questionnaire included five endpoints to evaluate physicians' knowledge on (a) prescribing valproate only for epilepsy and bipolar disorder in women if other treatments were ineffective or not tolerated; (b) ensuring supervision by experienced physicians while treating these conditions; (c) considering alternative treatments for women planning pregnancy, regular review of treatment needs and re‐assessing the benefit–risk balance in women and girls reaching puberty; (d) informing patients about the risks of taking valproate during pregnancy and (e) advising women on effective contraception during their treatment. Results: Among 1153 physicians, 95.5% responded prescribing valproate for epilepsy and bipolar disorder in women only if other treatments are ineffective/not tolerated; 66.5% supervised while treatment; 76.6% considered alternative treatments for women planning pregnancy; 92.1% informed patients about the risks of taking valproate during pregnancy and 94.4% advised patients on the use of effective contraception during its treatment. Overall, 25.8% physicians recalled receiving both educational material (EM) and Dear Healthcare Professional Communication (DHPC). All endpoint rates were higher for physicians who acknowledged receipt of both DHPC and EM compared to physicians who did not receive them. Conclusions: Although results varied across geography and physician speciality, majority of physicians had good knowledge about the indication and safety aspects of prescribing and using valproate. [ABSTRACT FROM AUTHOR]

Background: The alglucosidase alfa (Myozyme®) Safety Information Packet ("previous SIP") was updated to improve readability and content ("updated SIP"). We compared the previous and updated SIPs. Methods: A two‐wave pre‐post multicountry survey was conducted among health care professionals (HCPs) who prescribed or monitored patients on alglucosidase alfa in the largest European Union ("EU5") countries and Poland. Wave (W) 2 started 15 months after completion of W1 and the implementation of the updated SIP. Changes between the waves were analysed. Results: Forty‐six HCPs (34 physicians/12 nurses) participated in W1 and 52 in W2 (42 physicians/10 nurses); 22 participated in both waves. Nonsignificant differences were observed between waves 1 and 2 for awareness (75.6% in W1 and 82.4% in W2) and receipt (77.7% in W1 and 74.5% in W2) of the SIP, reading (88.6% in W1 and 89.5% in W2) and usage (88.2% in W1 and 89.5% in W2) among receivers of the SIP, or the overall knowledge about immunological testing (61.1% in W1 vs 55.1% in W2). Frequency of performance of immunological testing was significantly higher in W2 than in W1 (50.3% vs 34.4%; P =.024) with a tendency for increases in the appropriate performance of all types of testing in W2. Conclusions: Both versions of the SIP showed relatively high awareness, receipt, reading, and usage, with an overall trend for most measures to improve numerically in W2. The updated SIP did not require further changes. [ABSTRACT FROM AUTHOR]

Introduction: To understand the importance of the preference methods criteria to stakeholders at each decision point in the Medical Product Lifecycle (MPLC) and to determine the suitability of commonly applied preference methods (Discrete Choice Experiment [DCE], swing weighting [SW], probabilistic threshold technique [PTT], Best-Worst Scaling case 1 [BWS1], Best-Worst Scaling case 2 [BWS2]) for a given decision-point. Methods: Nineteen preference methods criteria of an existing performance matrix were incorporated in an online survey of industry, regulatory, and health technology assessment (HTA) stakeholders. All methods criteria were given a relative weight based on the SW ranking and point allocation task in the survey. Based on this relative weight and the performance matrix values, an overall suitability score was calculated for each method per critical decision point along the MPLC. Several sensitivity analyses were conducted for which the performance matrix was adapted. Results: In total 59 industry, 29 regulatory, and 5 HTA representatives completed the survey. In general, 'estimating trade-offs between characteristics', and 'estimating weights for treatment characteristics' were important preference method criteria throughout all MPLC decision points, while other preference method criteria were most important only for specific MPLC stages. Both BWS1 and BWS2 seem equally suitable across decision points, DCEs seem most suitable during clinical development and regulatory launch, and SW and PTT seem most suitable throughout industry decision points. Sensitivity analysis showed substantial impact of slight changes in the performance matrix. Conclusions: With rapid changes in preference research, performance matrices of preference methods should continue to be re-evaluated as more and more evidence accumulates. While DCE is the most applied preference elicitation method, other methods should also be considered to address the needs of MPLC stakeholders. Development of evidence-based guidance documents for designing, conducting, and analyzing such methods could enhance their use. [ABSTRACT FROM AUTHOR]