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an update on the ongoing flolan supply issues

posted on august 6th 2024

originally posted 6th august 2024. updated 10th september 2024.

for the last few months, we’ve been working in collaboration with the specialist centres, homecare delivery companies, and drug manufacturers gsk to bring you regular updates on supply issues related to flolan – which is also called epoprostenol.

a ‘pause in supply’ in march resulted in less of the drug being imported to the uk than normal, and full, safe stock levels are now not expected to return to normal until november.

regular deliveries continue to come into the country, and we have been advised by gsk that the first planned september shipment is already on its way to the uk and due by thursday 12th september.  another shipment is scheduled to arrive next week (by 16th september).   

there is flolan stock held by wholesalers, homecare delivery companies, and buffer stocks held by patients themselves. as such, there is currently no sign in the uk that any patients will run out of this drug.

however, although we were initially advised they would be reached in june, full stock levels will now not be reached until october.

we at the pha uk, along with ph teams from every affected centre, are meeting regularly with homecare delivery companies and gsk to lessen any potential impact for patients.

we have again insisted that gsk must do everything they can to speed up the process.  we continue to hold them to account for the delays and for the anxiety that these issues have caused within our ph community.

despite multiple requests, gsk have not provided any details as to what caused the temporary halt to production, nor have they provided an apology.  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.

what to do if you are on flolan

it is important that you continue to take your prescribed dose of flolan, rather than ‘stretching it out’ due to concerns over supply.

it is likely that you have already received calls to check your stock levels, and it’s possible you may receive more of these calls. please be honest about how much you have.

this situation has highlighted the importance of patients always holding an additional ‘buffer’ supply of two weeks of this drug at home, but please do not stockpile medication.

this page will continue to be updated, so please check back regularly.

recall and replace: an update

further delays to safety stock levels returning to normal were caused by a major product recall in july.

a large batch of flolan 1.5mg, totaling 10,000 vials, has been recalled and replaced as a precaution due to damage it may have sustained during the packing process – which gsk say is unrelated to the pause in supply which took place in march.

the drug is supplied in glass vials and hairline cracks, not visible to the naked eye, could have affected the sterility of the drug.

all patients identified as having received affected stock have now been contacted by both their specialist centre and homecare delivery company and replacement stock arranged.

if you have any questions or concerns about supply issues or the recall, please contact your homecare delivery company.