Posted on March 27th 2024
UPDATED TUESDAY 23rd APRIL 2024
At the end of March, we made our PH community aware of a supply issue affecting Flolan, which is also called epoprostenol. This is prescribed intravenously for around 200 adults and children with pulmonary hypertension in the UK.
Please note, this issue affects BOTH 1.5mg Flolan and 0.5mg Flolan strengths.
The manufacturers, GlaxoSmithKline (GSK), made us aware of a ‘pause in supply’ which has resulted in less of the drug being imported to the UK than normal, since the end of March.
The drug is only manufactured in Italy, and we have been told this is a global issue affecting all patients around the world.
The situation as of Tuesday 23rd April:
We have been advised by GSK that there is enough stock to last until three more scheduled deliveries arrive in May. More deliveries are scheduled for June, and we have been advised that ‘manufacturing is recovering’.
The situation is certainly looking more positive than it did a few weeks ago, and the Pulmonary Hypertension Association (PHA UK), along with PH teams from every affected centre, are continuing to work hard with NHS England and GSK to lessen any potential impact for patients.
We will continue to provide updates on a regular basis, at least every week.
At the moment, GSK have not provided any details as to what caused the temporary halt to production. However, we have been assured that it has not caused any potential risk to the quality and safety of Flolan in use at present or in the future.
Therefore, we are reassured it is safe for you to continue taking this drug.
Please carefully check your current stock levels of Flolan at home. You will receive phone calls from your homecare delivery company, asking how much you hold, so please take or return these calls as a priority.
It is important that you are accurate and honest about your stock levels when called.
We understand that this situation may cause you concern, but it’s very important that you continue to take the prescribed dosage of Flolan; please do not try to ‘stretch it out’ to make your supply last longer.
Patients prescribed this drug should not stockpile supplies because of this situation.
This situation has highlighted the importance of patients always holding an additional ‘buffer’ supply of two weeks of this drug at home.
PH teams at the affected centres and the PHA UK are working hard with GSK (the manufacturer) and homecare delivery companies to try to get these supply issues resolved as quickly and safely as possible.
The PHA UK asked GSK for a formal statement and an apology to patients affected by this issue. This is what they provided: “We take our responsibility to ensure reliable and consistent supply of medicines extremely seriously and regret we are currently experiencing temporary issues relating to the supply of Flolan. We are working hard to resolve the situation as quickly as possible and commit to keeping the PHA regularly updated.”
If you have not already been called about your current stock levels, please contact your homecare delivery company urgently.
Please do not contact your specialist centre as all the information available will be updated here. The team there will not know any more details.
We will continue to review the situation and to provide updates via this web page and on our social media channels.
“I understand that this is worrying for those who may be affected by this supply interruption, which is the failing of the manufacturers, not the NHS.
Like us, you may be wondering what caused the production problem. The manufacturers GSK have declined to give us details, citing ‘confidential information’. This is extremely disappointing.
You may have seen rumours, or discussions about this issue, circulating on social media. Please be aware that not all online information is accurate, and ensure you obtain information from reputable sources, such as this website.
Our intention here is to inform you, not panic you, and we would like to reassure you that the situation is looking more positive than it did a few weeks ago.
The specialist centres and the PHA UK are still working flat out, at the highest levels, to lessen any potential impact on patients. We will continue to update you.“
