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Is the Medicines and Healthcare products Regulator Agency (MHRA) guidance on sodium valproate acceptable to women of childbearing age?

机译:药品和医疗保健产品监管机构(MHRA)对育龄妇女的钠丙酸钠的指导是否可接受?

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BACKGROUND:The UK Medicines and Healthcare products Regulatory Agency (MHRA) published guidelines restricting the use of sodium valproate in women of childbearing age unless they consented to the pregnancy prevention programme (PPP), receiving counselling by an epilepsy specialist, or meeting exclusion criteria.METHODS:We contacted every woman of childbearing age on valproate for epilepsy in NHS Tayside (122).RESULTS:Seventeen out of 122 (13.9%) responded to the initial invitation to attend, and 25 out of 122 (20.4%) responded to a letter sent to their GP. Twenty-five attended, 21 completed a consent form, seven switched to another drug and three attended to express dissatisfaction with the MHRA guidance. There were 53 patients identified with learning difficulties. Consent was only taken from three patients, with carers declining to sign consent because the patient was not sexually active.CONCLUSION:Our study suggests that patients and carers do not wish to stop valproate or engage in PPP despite being made aware of MHRA guidance.
机译:背景:英国药品和医疗保健制品监管机构(MHRA)公布的指导方针限制了育龄妇女在育龄妇女中使用醋酸钠,除非他们同意怀孕预防计划(PPP),通过癫痫专家接受咨询或满足排除标准。方法:我们联系了NHS Tayside(122)的癫痫血管生长时代的每个女性。结果:第122个(13.9%)的十七个(13.9%)回应了初始邀请,122名(20.4%)回应发送给他们的gp的信。 21分21人完成了同意书,七个转向另一个药物,三名涉及与MHRA指导表示不满。有53名患者确定了学习困难。同意仅从三名患者中获取,因为患者没有性活跃,所以有护理人员的同意。结论:我们的研究表明,患者和护理人员不希望妨碍VALPROATE或者从事PPP,尽管正在意识到MHRA指导。

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