The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a product licence update for the botulinum toxin-A (BoNT-A) medicine Dysport® to make it clear that is can be administered by any appropriately trained and qualified healthcare professionals for the management of focal spasticity within licensed indications.
Previously the licence had stated it could only be administered by physicians, which had led to some CSP members experiencing difficulties using it in practice.
Ipsen, the pharmaceutical company which holds the licence for Dysport® had sought changes to the product licence, following its own work with several CSP members who highlighted the clear clinical need for physiotherapists, in administering Dysport® as part of spasticity management services.
CSP professional adviser Pip White, who also worked with Ipsen on the regulatory and governance aspects of the submission, said: ‘Physiotherapists have a clear and established role in leading care pathways for patients with spasticity. The role of BoNT-A can be critical to delivery of effective rehabilitation programmes.
‘We had been concerned to hear from members of local challenges to the ability of appropriately trained physiotherapists being able to administer BoNT-A.’
Ipsen medical adviser Janet Pong said the CSP’s direct involvement in contributing to the evidence submission to the MHRA had been ‘pivotal to the success’ of the work of achieving the licence change.
BoNT-A has been used as an accepted part of care for a range of conditions for many years, and its role in spasticity management is recognised within several NICE guidelines (NICE spasticity in children and young people and cerebral palsy in adults).
Guidelines on safe and effective delivery
For the use of BoNT-A in spasticity services, members are expected to follow the RCP Guideline for spasticity management, which sets out the training expectations required to deliver safe and effective BoNT-A therapy (Royal College of Physicians, Spasticity in adults: management using botulinum toxin. National guidelines, 2018).
Ms White added: ‘This is great news for patients and it is also excellent to see the role that physiotherapists play in the use ofBoNT-A therapy formally recognised through medicines licensing controls.’
Dr Stephen Ashford, consultant physiotherapist at Northwick Park Hospital, London, said: ‘We are delighted by this news and it means the role of the physiotherapist in administration of botulinum toxin for spasticity management is recognised.
‘This license update will empower the way we already work, reflects what is best for patients and will ensure the standard of spasticity services across the NHS is maintained.’
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