29 February 2024. The CSP is pleased to share updated guidance on the use of PRP within physiotherapy practice.
The CSP has now resolved the number of uncertainties around the legal and regulatory status of PRP through discussions with the MHRA. A full position statement on PRP is available on request directly from the MHRA which references the relevant provisions within The Human Medicines Regulations (2012). We have been asked not to directly publish that statement on our website, however the key points for CSP members are:
MHRA position on the use of PRP
- PRP used for medical purposes is an unlicensed medicine, subject to marketing authorisation and manufacturing licensing to unless an exemption exists.
- Medical practitioners (Dr's) 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 Dr 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.
Frequently asked questions about platelet-rich plasma
What is platelet-rich plasma?
Platelet-rich plasma (PRP) is an ‘orthobiologic’ treatment. These are defined as products obtained from a human source and used in the treatment of, mainly, musculoskeletal conditions.
PRP is created from whole blood. A small sample (15-30ml) of blood is taken from the patient by venepuncture and then placed in a centrifuge machine that spins the blood at high speed to separate out the different types of blood cells. (This may be classed by regulation as a manufacturing process). The platelet rich plasma (PRP) part of the blood is selected, with the other components discarded, and then the PRP reinjected back into the patient at the target site.
Why is PRP regulated?
The Human Medicines Regulations (HMRs) 2012 regulate the use of all medicinal products in the UK. HMRs apply to blood plasma prepared as is PRP within a clinical setting. Importantly, HMRs also apply to any product where a‘medicinal claim’ is made about its action. A medical claim arises when these products are administered with a view to 'restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action'.
How is PRP classified?
PRP is classified as an unlicensed human medicine.
Are there any circumstances in which physiotherapists can use PRP in their practice?
Updated 29 Feb 2024
Yes. Where a physiotherapist works in a clinic that engages a doctor as part of the clinic, the doctor may manufacture and prepare the PRP, and then direct that the physiotherapist administers it to the same patient, within the same clinical practice, and at point of care for that same patient.
As part of autonomous practice and maintaining the direct clinical relationship with the patient, the physiotherapist should remain responsible for the assessment and diagnosis of the patient's condition, and should exercise their own clinical reasoning and decision-making, in conjunction with shared decision-making with the patient, to determine that PRP is the appropriate intervention required for that patient.
In effect, the Dr is required to manufacture and prepare the PRP in order to comply with UK medicines law, and in all other respects, the physiotherapist is responsible for the care of their patient.
Why can doctors manufacture PRP and not all physiotherapists?
It is a requirement within The Human Medicines Regulations 2012 but there is an enabling exemption that means they are exempt from needing a marketing authorisation and manufacturer’s licence for the use of PRP. Dr's are also subject to Blood Safety and Quality Regulations (BSQRs)
Secondly, there is an exemption that allows doctors and supplementary prescribers to request that PRP is prepared under the 'Specials Scheme'. However, this is not a practice enabler for other physiotherapists as they still require an exemption for a marketing authorisation and a manufacturer’s licence which does not exist.
What should l do if I have recently stopped providing patients with a course of PRP?
Updated 29 February 2024.
You may resume services providing that
- you only administer PRP in line with the MHRA position statement above.
- you are a supplementary prescriber and you request that PRP is manufactured, from an authorised manufacturer, for your named patient under the 'Specials scheme'
If you neither have a doctor within you clinic who can manufacture and prepare the PRP for your named patient, at the point of care with the patient, nor are a supplementary prescriber using the Specials Scheme you cannot resume services.
It is important to reassure your patients that the safety of PRP, and the capability of the physiotherapists who administer it, has in no way been questioned as part of this decision. You should explain that regulations surrounding human medicines are complex and the regulator has stated that when physiotherapists are using PRP it is classed as a human medicine. Professional bodies have a duty to inform their members of the consequences of these decisions.
What do I do with the stock of syringes and centrifuge machine that I can't currently use?
Now the position has been clarified with the MHRA, members can now make a decision whether they can resume services or not.
What will happen if I have been doing PRP? What if there is a claim against me?
Insurers will retain cover for all historical activities involving PRP, subject to the policy terms and conditions for activities undertaken before Thursday 8 June 2023. The use of PRP has been excluded from the PLI scheme from 1st July 2023 and members who wish to resume services will need to seek alternative cover for PRP.
For those physiotherapists who have additional business cover with James Hallam, it has also indicated that it will honour past liabilities but exclude events from Thursday 8 June 2023. Members should seek advise from James Hallam to ensure their indemnities remain appropriate for the services they offer.
What about other orthobiologic substances?
Our information paper PD003 already sets out that some types of product are outside the scope of therapeutic injection therapy.
Based on the reasoning provided by the MHRA for PRP, if members have further questions and/or concerns about the use of other interventions and/or products they are using, they should contact the MHRA directly for advice.