Human Medicines (Amendment) Regulations

Part of Business of the House (Today) – in the House of Commons at 8:34 pm on 18 March 2019.

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Photo of Ivan Lewis Ivan Lewis Independent, Bury South 8:34, 18 March 2019

I am glad we have had the opportunity to have this debate. Like other hon. Members, I want to focus on the impact these changes could have on those with epilepsy. I thank SUDEP Action, which Norman Lamb mentioned, for the work it has done to bring concerns about this issue to the fore. I also agree with many of the concerns my hon. Friend Jonathan Ashworth expressed in his opening remarks.

The Secretary of State was unable to address bereaved families and clinicians at the recent summit held by SUDEP Action, but will he meet me, other hon. Members and representatives of SUDEP Action and talk directly to families about the concerns they have? If he could agree to do that, it would be very helpful.

Medicines shortages pose a serious risk to people with epilepsy. As hon. Members are aware, it is a high-risk condition, requiring complex, tailored care. As other hon. Members have said, many people with epilepsy are particularly vulnerable to changes to that care. I have recently met families, such as that of Rachel Shah, whose daughter Emily died aged 19 shortly after a non-specialist prescriber made an error with her medication. The family and the non-specialist were entirely unaware of the risks of sudden unexpected death in epilepsy, and the error was not noticed. That is quite shocking.

Studies show that people on existing medications are put at risk when those medicines are changed. Tried and tested systems mean that, when there is a medicines shortage, specialist prescribers with expertise and access to the full patient record are involved in any changes. There are known risk factors that can increase the risk of death among people with epilepsy. However, those can be carefully managed through open, positive relationships between clinicians and patients. Those clinicians have often had responsibility for the patients’ medication schedule, which has often been worked up with the patient over many years.

The serious shortage protocols, passed under the Human Medicines (Amendment) Regulations 2019 give pharmacists the right to supply a different quantity or pharmaceutical quality of medicine in the event of the country experiencing a serious shortage of prescription-only medicines. As other hon. Members have said, pharmacists are skilled professionals in medicines and medicines management, but they are not specialist prescribers. Nor are they specialists in assessing SUDEP or other epilepsy risks in individuals, and they do not have access to full patient records.