Evaluation of the Effectiveness of the Risk Minimization Measures of Sodium Oxybate in the European Union
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ORIGINAL RESEARCH ARTICLE
Evaluation of the Effectiveness of the Risk Minimization Measures of Sodium Oxybate in the European Union Alex Iranzo1 · Pedro Serralheiro2 · Jan‑Christof Schuller3 · Anne‑Françoise Schlit3 · Jürgen W. G. Bentz3 Published online: 28 September 2020 © The Author(s) 2020
Abstract Background Sodium oxybate ( Xyrem®), approved by the European Medicines Agency (EMA) for narcolepsy with cataplexy, is only available through risk mitigation programs due to potential adverse effects including respiratory and central nervous system depression, neuropsychiatric events, and misuse. Objective We report findings from a survey evaluating effectiveness of the European Union X yrem® Risk Management Plan (RMP). Patients and Methods A cross-sectional, online, multiple-choice survey was distributed to randomly selected healthcare professionals (HCPs) from six European countries (April 2016–May 2018). Eligibility criteria: current/potential Xyrem® prescriber and/or sleep disorder specialist; contact information available; on the Xyrem® RMP educational materials mailing list. Primary outcome: proportion of respondents answering each question correctly ( 30 kg/m2 in answer to this question.
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EU Risk Minimization for Sodium Oxybate Table 1 Characteristics of survey respondents All (N = 31)
3.3 Prescriber Awareness of Risk Minimization Checks for Patients Taking Xyrem®
Country, n (%) Belgium 5 (16.1) Germany 9 (29.0) Italy 6 (19.4) Spain 6 (19.4) Sweden 3 (9.7) UK 2 (6.5) Gendera, n (%) Male 19 (65.5) Female 10 (34.5) a Years in medical practice , n (%) 20 years 13 (44.8) Prefer not to say 2 (6.9) Medical specialtyb, n (%) Neurologist 12 (38.7) Sleep specialist 14 (45.1) Pneumologist 1 (3.2) Neuropsychiatrist 1 (3.2) General practitioner 0 (0.0) Other 3 (9.7) Predominant medical practice for prescribing Xyrem®a, n (%) Public practice 19 (65.5) Private practice 0 (0.0) Mix of private and public 3 (10.3) Other 7 (24.1)
Overall, 8/31 respondents could not recall receiving a Xyrem® Healthcare Provider Checklist, and five respondents indicated that they had not used the checklist in the past 12 months; only 18 answered that they ‘always’ or ‘sometimes’ used the checklist (Table 2). Generally, respondents indicated that patients should be reviewed for factors that could influence Xyrem® treatment such as concomitant medications, BMI, and additional risks of respiratory depression prior to treatment initiation (Fig. 2a). The majority of respondents indicated that signs of abuses, misuse or diversion, and signs of criminal use, should be monitored at a follow-up visit following treatment initiation (Fig. 2a). All respondents ‘always’ or ‘sometimes’ completed the activities that are recommended upon treatment initiation with their patients; the majority of respondents indicated ‘always’ (Fig. 2b).
Missing data were classified as ‘other’ and included for all analyses
This study used a cross-sectional, online survey to evaluate the effectiveness of the risk management measures being implemented as par
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