The CSP has resolved uncertainties around the legal and regulatory status of platelet-rich plasma (PRP) therapy through discussions with the Medicines and Healthcare products Regulatory Agency (MHRA).
The key points for CSP members are:
- PRP used for medical purposes is an unlicensed medicine, subject to marketing authorisation and manufacturing licensing to unless an exemption exists.
- Medical practitioners (doctors) are exempt from marketing authorisation and manufacturing licensing requirements, provided the PRP is supplied to either a named patient during the treatment of that patient, or to a patient of another doctor within the same medical practice.
- There is no mechanism, or exemption, by which any individual physiotherapist can manufacture PRP themselves at all.
- A supplementary prescriber physiotherapist may request that PRP, as an unlicensed medicine, is manufactured from a licensed manufacturer, to fulfil the special needs of an individual patient under the ‘Specials’ scheme. The ‘Specials’ scheme is not accessible to independent prescriber physiotherapists or non-prescriber physiotherapists.
- A doctor may manufacture PRP in a clinic for a named patient, and then direct that a physiotherapist administers it to the same patient, within the same clinical practice, and at point of care for that same patient.
- Any physiotherapist may administer PRP when directed to do so by a doctor, dentist, nurse independent prescriber, or pharmacist independent prescriber but not on the direction of any other type of independent prescriber.
CSP professional adviser Pip White said: 'We are pleased to have reached an understanding with the MHRA as to the legal position on the use of PRP within physiotherapy practice. Members must be aware however that the use of PRP is not covered by the CSP PLI scheme.'
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