With regard to our ongoing contact regarding the shortage of the anti-seizure medication, Rivotril, it has been indicated by the Health Products Regulatory Authority that the medication will be back in stock by mid-March.
The further reply on this matter is below:
We have received information that the shortages are due to production delays caused by the manufacturing site not receiving the packaging materials required to make the product. We understand the recent delays are due to a delay with the company submitting new import and export licences required to transport the controlled drug to Ireland. We had repeatedly followed up with the company, requested it to expedite the submission of the import and export licences and we offered to expedite the process on our side. As mentioned below the licences have now been approved and the company has recently indicated that the product should come back into stock by mid-March.
The ongoing shortage was also raised in the Dáil via Parliamentary Question by Deputy Michael Moynihan, and the Minister for Health in his reply confirmed that Mid-March is the expected return date. The question and reply in full is included below:
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For Written Answer on : 28/02/2023
Question Number(s): 582 Question Reference(s): 9698/23
Department: Health
Asked by: Michael Moynihan T.D.
______________________________________________QUESTION
To ask the Minister for Health if he is aware of the problems with obtaining rivotril in Ireland at present; if his Department or the HSE are in contact with the company (details supplied) regarding this situation; and if he will make a statement on the matter.
REPLY
Cheplapharm, the company responsible for supplying Rivotril 0.5mg tablets notified the Health Products Regulatory Authority (HPRA) of a shortage that began on 25th November 2022, due to a manufacturing issue. The HPRA has 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. The HPRA has also engaged with the HSE regarding the shortage, as clinical treatment of patients is the remit of the HSE.
Whilst the HPRA has no role in procuring medicines, the HPRA has liaised with suppliers of exempt medicinal products (EMPs*) during the shortage, confirming that the HPRA has no objection to the supply of EMP alternatives and has assurances that there has been some EMP availability.
The issue has been discussed with all other European countries and the European Medicines Agency (EMA). The shortage also significantly impacts other European countries, including Spain, where the product is manufactured.
Cheplapharm has confirmed that the Irish stock has been released from the Spanish manufacturer and estimated that Rivotril would be resupplied to patients in Ireland during the week of 13th March.
*Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations includes an exemption which enables practitioners to prescribe a medicine as an exempt medicinal product (EMP) under that practitioners direct responsibility, in order to fulfil the special needs of that specific patient. If a valid prescription is issued for an EMP in line with the above Regulations, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription.
As EMPs have not been granted a marketing authorisation in Ireland by the HPRA, they would not be assessed by the HPRA for quality, safety or efficacy. If sourced in response to a bona fide unsolicited order as a licensed product from another market these medicines will have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in that country carried out by the respective competent authority for medicines in that state.
We hope that this indicated resupply date will be met. However, people awaiting resupply of the medication will be all too aware that a date last month had originally been indicated for the resupply of this medication - so we understand that there will be still concerns until resupply is fully confirmed. We will continue to liaise with the HPRA on this and provide further updates regarding same 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.