MPs express concerns over Government’s medication Serious Shortage Protocols

Yesterday (18 March) in Westminster, MPs have debated the Human Medicines (Amendment) Regulations 2019, which changed the 2012 law – which previously has protected patient’s healthcare, by setting out specific guidance and regulation about medications, devices and treatments for patients in the UK.

Expressing significant concern, MPs have highlighted how the Government’s recent changes to this law could put the lives of those living with health conditions at significant risk.

These legal changes, which have introduced Serious Shortage Protocols, have become law without following the usual public consultation or parliamentary scrutiny legal changes usually receive because it has been linked to Brexit. However, these laws are permanent so could be used at any point in future, for many years to come.  

We provided a briefing paper for MPs to support their involvement in the debate.

Key points from the debate:

• Jonathan Ashworth MP opened the debate. He highlighted the Government's acknowledgment in the Explanatory Memorandum to the law that there could be a cost saving linked to the shortage protocols, yet also that there could be a risk to lives! How can this be the Government's position?
• Norman Lamb MP highlighted Epilepsy as a risky condition, where lives could be put at risk if Serious Shortage Protocols do not include safeguards to protect patients affected by medication shortages. He acknowledged the work SUDEP Action has done to raise awareness of this important issue. The issue of risks to those living with multiple health conditions and the adverse effects patients could face from any of these medications being change was raised as a concern
• Anne Marie Morris MP (Chair of the All-Party Parliamentary Group on Medicines) spoke in favour of annulling the recent law changes and raised a number of concerns about the protocols and the risk to patients if a pharmacist changes a patient’s prescription without consulting with the original prescriber
• MPs urged Government to:
  1. Engage with the third sector who have significant expertise and could support the Government in creating shortage plans which put patients first and reduce risks to life.
  2. Also, to release a list of medications facing shortage, so clinicians can support and advise their patients - yet this list is currently being kept private by Government because of 'commercial confidentiality'
• Philippa Whitford MP (Member of the Health Select Committee) raised awareness of how changes of medication doses and types could confuse patients and put those who are vulnerable at risk eg: swapping one 20mg tablet for to two 10mg tablets or swapping a patient from tablets to liquid form. And that this should be removed from protocols. She suggested the massive surge in shortages in the last nine months, coincides with the Government contingency plans for Brexit. She urged the plans to take into account the individual patients rather than ignoring what they need to cope with medication shortages safely and well. She noted the dangers of these changes to people with epilepsy if these changes are made without awareness of medical notes and patient history (which their original prescriber & the patient themselves will know well).  She asked ‘why not tell prescribers first that there is likely to be a shortage, rather than wait for patients to be told by the pharmacist that they are short of medicines’.  She said the law was not well thought through
• Norman Lamb MP also shared the story of our SUDEP Action Trustee Simon Lees (who lost his brother to SUDEP), who has himself recently experienced a medication shortage for his anti-epilepsy medication. He raised concern that current plans do not state patients will be informed of medication changes they may face. He asked Government twice, who would be held to account should an epilepsy death happen as a result of these shortage protocols 
• Ivan Lewis MP spoke in support of SUDEP Action and urged the Secretary of State for Health and Social Care to meet with SUDEP Action about preventing epilepsy deaths. He shared the story of our SUDEP Action Trustee Rachel Shah, who lost her daughter Emily following a medication change error. He asked the Government to take the time and care needed and put patient safety first. To do this, Government needed to:
  1. Do all it could to exhaust the causes of medical shortages;
  2. it needed an impact and risk assessment
  3. a published operational framework protective with shared decision-making and patient centred care at its heart
• The Minister responding on behalf of Government (Jackie Doyle MP), acknowledged the concerns raised, stating future consultation on shortage protocols would involve with 'expert panels' would happen to reduce risks, and these would be signed off by the Minister should a shortage be needed - however could not give specifics for epilepsy,  and although they mentioned there would be opportunities for patients, the wider clinical community or the voluntary sector to be involved, did not provide details on how this would be managed
• Helen Goodman MP queried the process in which these legal changes came about, given it is sometimes linked to Brexit, but in other instances not. She questioned if these are not due to Brexit, why are there so many shortages happening at the moment? She spoke of issues her constituents with epilepsy are also raising with her on this issue. She asked Government why the protocols for key conditions were not published alongside the legal documentation for MPs to scrutinise? 
• Government stated Epilepsy would not have a blanket exemption, so could face some shortages and medications changes. However, later in the debate it was stated that it would not be appropriate to include epilepsy in a shortage protocol... giving mixed messages. Ivan Lewis MP requested an exemption for those with epilepsy would be put into writing, which Jackie Doyle MP confirmed 
• Jackie Doyle MP acknowledged Government hoped these protocols would not be needed, though previously stated they would likely be needed as a result of Brexit.

Ivan Lewis MP, and Norman Lamb MP who both spoke at our recent Prevent21 Summit on Tackling Epilepsy Deaths, spoke on behalf of SUDEP Action. You can watch both of their speeches here: https://www.youtube.com/watch?v=_BWokDJuujA (Ivan Lewis MP) and https://youtu.be/38n_FF9mOWY (Norman Lamb MP)

Unfortunately, the motion to annul the law did not get majority support, so the changes made to the law still stand, and medicines serious shortage protocols could still be used. However, 240 MPs did stand by us in flagging the dangers of these protocols and voted for the law to be annulled (292 sadly voted against us).

Find out if your MP stood alongside SUDEP Action here: http://bit.ly/HowDidMyMPVote

So what now? 

SUDEP Action thanks the MPs who took the time to attend the debate and highlight the vital importance that plans are put in place to protect people with epilepsy who could be affected by a medication shortage. We now await Government to respond to MPs requests to meet with us to discuss this issue and how they can work with us to tackle epilepsy deaths. We will be writing to them about this shortly. 

This issue is far from over and we will be working with the MPs who supported the debate, our supportive clinicians, researchers, people living with epilepsy and our bereaved families to continue to highlight the issues with these protocols, in the hope that the Government will take on board our concerns and put careful plans in place to protect those living with the condition. 

You can watch the debate here: http://bit.ly/SSP-Debate

If you continue, like us, to be worried about medicines shortages, you could write to your local MP about this issue, and either thank them for supporting us, or express your concern if they did not. Some MPs hold local surgeries, so you could even arrange to meet them to discuss this with them in person. (See the hyperlink above for how your MP voted, and you can find contact details of your MP here. Please let us know if you do make contact!)

If you have epilepsy, know someone living with the condition, or are a clinician who supports those with epilepsy and are concerned about what this means for you, please see our Medication Shortages and Managing Risks page. 
It is vital that people with epilepsy do not stop taking or make changes to their medication without speaking to the clinician who originally prescribed their medication – if you have concerns over this, please speak to the clinician who helps to manage your epilepsy and these epilepsy helplines may also be able to provide you with advice.