Epilepsy Ireland have been in continued contact with the Health Products Regulatory Authority (HPRA) and the manufacturer (Cheplapharm) regarding the ongoing shortage of the anti-seizure medication, Rivotril.
It was expected that the medication would be resupplied by the beginning of this month. However, we are aware that this has not happened. This has been confirmed by several people who are urgently awaiting the resupply of the medication for their own epilepsy, or for their loved one’s epilepsy.
The shortage, which extends back to last year, and the ongoing delay in resupply has led to some speculation that there are plans to discontinue the medication in Ireland. This concern has been mentioned in several calls that have been fielded by Epilepsy Ireland. However, the HPRA have confirmed to Epilepsy Ireland that the manufacturer has not given any indication of discontinuing Rivotril in Ireland. We hope this information will be of some solace to people who are urgently awaiting resupply.
With regard to the overall issue of resupply, we have contacted both the manufacturer and the HPRA for updates.
We are extremely disappointed with the reply from Cheplapharm, which offered no information as to why the date for resupply was not met. In our view, the lack of information being made available to people with epilepsy is totally unacceptable and we have made this known to both the manufacturer and the HPRA.
It also appears that the company have not yet provided further information to HPRA on the reasons for this further delay. However, the HPRA have provided the following update on the regulatory steps being taken to aid resupply:
We have repeatedly offered the company regulatory flexibility, including expedited controlled drug licences, contacting the Spanish authorities to expedite controlled drug licences from their perspective (the product is manufactured in Spain) and offering temporary authorisation for the company to import its product from another market to help mitigate the impact of this shortage on patients. We are seeking clarification on what caused the delay with resupply and if there is any way we can assist from a regulatory perspective. We have followed up with the company again today for more information. Additionally, we have engaged with the HSE regarding the shortage, as clinical treatment of patients is outside our remit.
Whilst the company has yet to respond to the cause of the delay, this afternoon, it confirmed that it has received the export licences from the Spanish authorities to allow export and to bring stock into Ireland. We are seeking an update on the logistics and resupply to patients.
While we know that the continued delay is frustrating and concerning for all awaiting resupply of this medication, the granting of export licenses is – we hope –the beginning of the end of this extended shortage. We are continuing to follow up on this and when further information becomes available, we will provide a further update on our website.
Unfortunately, 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. Any decision to change or switch medications is a clinical decision, and it is of the utmost importance that you speak to your medical team on this. If you are not attending a specialist, please contact your GP and access specialist advice via them.
It is possible that your prescriber could write a prescription for a medicine that is not authorised in Ireland, but is available in another market – this is referred to as an “exempt medical product”. While the exempt product would contain the same active ingredient as Rivotril, and can be sourced by your pharmacist, there are also potential risks involved in switching between different formulations of the same drug, and these should be discussed with your medical team. For more on this, visit our information section on Interchangeability.