Human Medicines (Amendment) Regulations

Ivan Lewis Excerpts

Monday 18th March 2019 Commons Chamber

[Mr Ivan Lewis (Bury South) (Ind)]

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 the right hon. Member for North Norfolk (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 the Member for Leicester South (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.

[Jackie Doyle-Price]

With your indulgence, Madam Deputy Speaker, I would just like to reassure the right hon. Member for North Norfolk (Norman Lamb) and the hon. Member for Bury South (Mr Lewis). We do not consider that treatment for epilepsy would be appropriately covered by a serious shortage protocol, for exactly the reasons that they have both outlined: this is specialist prescribing and very bespoke to the patient. In the event of a shortage of epilepsy drugs, the clear guidance would be for the pharmacist to refer the patient back to their prescriber. The shortage protocols will be very tightly defined, within given circumstances, as to what drug will be an appropriate alternative treatment; they are by no means meant to be very one size fits all.

[Mr Lewis]

I think the Minister for that reassurance. I think we will want to see that in writing. Having that clarity is incredibly important, so that when the guidance is published, the reassurance is there for people with epilepsy and their families. That is incredibly important.

We should remember that laws that sought to allow change in the prescription of epilepsy medications were rejected in 2010 after a public consultation that highlighted major patient safety concerns. MHRA guidance in 2017 included vital safeguards against switching medication for people with epilepsy. These issues have therefore been interrogated in the past.

A precautionary approach concerned with patient safety would include analysis and openness about the causes of medical shortages; include an impact and risk assessment; aim to avoid any risk of worsening medical shortages; follow good practice in the regulation of medical shortages; include training and communication arrangements for all affected; and include clear, robust and timely accountability to patients and the public for adverse events and avoidable deaths. Nurses and clinicians are currently unable to gain access to a number of medications. They need to know which are on the list of likely shortages, and whether all the possibilities of measures to prevent such shortages have been exhausted.

People with epilepsy are recognised to be a high-risk group in current legislation. They must be protected against shortages of any medications that they take—not just their epilepsy medication—by a requirement in the legislation, and in any accompanying guidance, for the involvement of a specialist prescriber at all times. To be fair, that is the assurance that the Minister sought to give this evening.

It is not good enough to say in the explanatory memorandum that protocols will not apply to certain epilepsy treatments for which a brand is required. Any change in the 2017 MHRA guidance on epilepsy medication should be avoided, although, if such a change is required owing to a serious shortage, it must follow public consultation with the involvement of the third sector and patients. I think that patient groups feel they have been excluded from the process thus far. I urge the Minister to agree—in the spirit in which she has engaged with the House this evening—to meet SUDEP Action along with me, and other Members, if the Secretary of State is not willing or does not have time to do so.

The Government should make publicly available the list of medications that are at risk of shortage. If people living with long-term health conditions, and their clinicians, know about serious shortages that may affect them, they should have opportunities to contribute to any consultations and debates. An early-warning system for prescribers is essential, but it must be extended to all specialist prescribers. Many are on the front line, trying to ensure continuity of medication for patients, and they will be able to provide the necessary reassurance for those patients if they are aware of potential shortages.

We should not forget the anxiety that this will cause among people who are already extremely vulnerable, and the fact that that anxiety could lead to further health problems. All who are involved in the chain need to be able—where appropriate—to offer the maximum clarity, information and reassurance. The Government should also publish an operational framework and guidance to ensure that there is good practice and medicine shortages can be managed safely. They should commit themselves to patient-centred and shared care decision-making.

Perhaps this is the most important point that has been made so far: it is still not clear where accountability lies in the event of an adverse event—worst of all, a death—when there has been a failure of continuity of supply lines. That issue has been highlighted by the Pharmacists’ Defence Association. Obviously the association is very concerned about the potential negative effect on pharmacists, but a greater concern relates to the potential impact on patients and families.

This legislation is not simply another complication caused by Brexit. It may present serious challenges for many years to come. It is first and foremost about patient safety, and in those circumstances, the Government need to take appropriate time and care when making their decisions.