Human Medicines (Amendment) Regulations — House of Commons, 2019-03-18
Topic: Health
Norman Peter Lamb (Liberal Democrats, Centre to centre-left): I very much agree with the concerns that were raised by the Scottish National party spokesperson, the hon. Member for Central Ayrshire (Dr Whitford). Let me make a general point first. I recognise that this statutory instrument is not being introduced purely for no-deal planning, but clearly, there is a recognition that the risk of shortages increases in a no-deal scenario. To me, it absolutely beggars belief that Cabinet Ministers in this Government were willing last Thursday purposefully to vote against an extension and therefore in favour of the risk of no deal in just a few days’ time, knowing that the risk to patients would increase as a result. It is extraordinary that Ministers in a Government could choose to vote in that way knowing that patients would be put at greater risk I want in particular to address the concerns of patients with epilepsy, including the concerns raised by the really good organisation, SUDEP Action. For those who are unaware, SUDEP means sudden unexpected death in epilepsy, so we are talking here about all those people who lose their lives as a result of epilepsy. There are very real and legitimate concerns about the impacts that the measure will have on those people. To bring this into really sharp focus, Simon Lees, one of the trustees of SUDEP Action, who has epilepsy, was today refused the supply of one of his three epilepsy medications because of a shortage. His brother died from epilepsy shortly after his medication was changed, so the risk to patients is very real As others have said, pharmacists are highly skilled professionals, but they are not specialist prescribers or skilled in assessing the risk of unexpected death through epilepsy. There is a particular concern about people with a learning disability who may also have epilepsy, who are particularly at risk. As the SNP spokesperson said, pharmacists do not have access to the full patient record. The need for consistency for these patients of the supply, dosing, timing and formulation of anti-epileptic drugs is absolutely critical. There is a real risk when medications change. That is why specialist prescribers play such an important role in any change for a patient with epilepsy. Person-centred prescribing and medication management is the most effective way to keep these patients safe, so it is little wonder that those people and the organisation that supports them are so concerned about this issue I also want to make some particular points that SUDEP Action has raised. The current documentation on the protocol indicates that there is no requirement for patients to be made aware of medication changes—that seems extraordinary to me—or a recognition of the channels available to them should they wish to challenge or question those changes. Without those safeguards, people with epilepsy may be unaware of medication changes that have occurred, putting them at significant risk, particularly if these changes result in increased side effects or changing seizure control. It is also unclear whether the pharmacist, the original prescriber or the Government are ultimately accountable for adverse effects—I made this point in my challenge to the Minister—caused by one of the protocols being activated. Should a death occur following a lack of consistency of supply of the usual medication, who will be held to account for that change? As others have said, it seems essential that the Government make publicly available a list of the medications that are at risk of shortage. There should be an early warning system for prescribers so that they are aware of the risks of medications running short in supply In conclusion, there are legitimate and serious concerns here, and that is why I will be joining others in voting in favour of the motion to revoke the regulations.