Further to our ongoing communications regarding the shortage of the Anti-Seizure Medication Rivotril, we have a further update to share with those affected. The Health Products Regulatory Authority (HPRA) have informed Epilepsy Ireland that resupply is now not expected until 2nd April.
This marks the third missed date for resupply and in our correspondence to the HPRA, we have reflected the anger and worry that is being felt by people affected by this shortage – questioning what assurances have been given to ensure that this date will be met, and indeed, whether there are any repercussions for the manufacturers for continuing to miss confirmed resupply dates.
Below is an extract from the response we received on this:
I understand your concerns and I want to assure you that we fully appreciate the impact this shortage is having on patients and that we take this issue seriously. Companies like Cheplapharm are responsible for supplying their medicines to patients. The HPRA, as the regulator of medicine authorisation, amongst other aspects, can not legally force any company to supply its products. When medicines go short, we work based on the shortage Framework agreed upon with relevant stakeholders, patient and healthcare professional representatives, the pharmaceutical industry, and the HSE. While our shortage Framework has been agreed upon with relevant stakeholders, it is not legally binding. The European Commission is currently looking at revising the medicines legislation, and as part of that, we, with our EU colleagues and the EMA, have submitted proposals for changes to be made regarding shortages, including requirements to notify and provide timely updates on resupply updates. For this particular shortage, we engaged with the company, Cheplapharm, and continue to do so regularly, including this week. We have repeatedly offered the company regulatory flexibility, including expediting controlled drug licences required to transport the product to Ireland and offering temporary authorisation for the company to import its product from another market to help mitigate the impact of this shortage on patients in Ireland.
We appreciate that the changing date can cause uncertainty and worry for patients and we have flagged to the company that this change has prompted a lot of queries. On a broader scale, this is an issue we intend to address as part of one of our recommendations on increasing the accuracy of notification detail provided to the HPRA stemming from the Two year review. There is little we can do to verify the transport arrangements being made by the company but we received an update today that a delivery has been scheduled for 29th March and this is in line with the information we have received from one of the main wholesalers in Ireland. We also had a meeting with European colleagues today regarding this shortage; we have received information that other member states are experiencing a similar issue with resupply being pushed back to the end of this month, as such Ireland is not disproportionately affected by this.
It is welcome to see that the HPRA are working with their European colleagues not only on resolving this issue, but also on the wider issue of medicines shortages.
However, this week, there continues to be disappointment, anger and worry around another delay to Rivotril supply. We are acutely aware that due to the number of missed deadlines, many people will be equally sceptical as to whether the new date of April 2nd will be met. Unfortunately, we are unable to give patients affected any guarantees that the issue will be resolved, but with a delivery date scheduled for the 29th March, we are hopeful that this will see the end of this shortage.
In the meantime, the only advice which we can provide to any person taking Rivotril and who may be running out of supply is to speak to your medical team as soon as possible. While there are alternatives available, any decision to change or switch medications is a clinical decision, and is not without risks e.g. to seizure control. If you are not attending a specialist, please contact your GP and access specialist advice via them.
RTÉ Radio 1 and Claire Byrne Live recently featured a piece around the impact the shortage of Rivotril is having. Epilepsy Ireland contributed to the piece, outlining our disappointment with the current situation, as well as highlighting the impact on people with epilepsy and their families. You can listen back by visiting the RTÉ website.