CSP is instructing all physiotherapists to stop providing platelet-rich plasma (PRP) therapy to patients, with immediate effect, because it is classified as a medicinal product.
At the start of 2023, the CSP became aware of a growing number of short courses offering PRP injection therapy training aimed at physiotherapists. It became clear that there were many issues surrounding the practice of PRP injections.
As we investigated this further, we became aware of a number of uncertainties around the legal and regulatory status of PRP. We have therefore been in contact with the relevant regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) and consulted with the CSP's Professional Committee.
The MHRA and the CSP's position on the use of PRP is below.
CSP position statement
The CSP position is that there are no appropriate circumstances that enable physiotherapists to prepare and inject PRP. We base this statement on Medicines and Healthcare products Regulatory Agency (MHRA) guidance which is drawn from the legislation and regulation governing medicines and healthcare products.
Regardless of how the PRP is manufactured, the MHRA believes physiotherapists will be using PRP in clinical practice based on actual or implied claims that PRP is used with the intention of reducing pain and/or promoting healing. Due to the mechanism by which PRP is claimed to achieve these outcomes, the claims are ‘medicinal claims’ and therefore the use of PRP by physiotherapists in clinical practice will come under the remit of Human Medicines Legislation (HMR).
PRP and its use as a medicinal product is subject to needing a marketing authorisation and a manufacturing licence. Physiotherapists are not exempt from these requirements.
As such, physiotherapists cannot provide PRP to patients and this practice must stop immediately.
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?
In physiotherapy PRP is classified as an unlicensed human medicine and as such physiotherapists cannot use it. Supplementary prescribers may be able to use it under supplementary prescribing regulations but would still not have an exemption in respect of marketing and manufacturing.
Are there any circumstances in which physiotherapists can use PRP in their practice?
No. The MHRA understand that physiotherapists will use PRP because it is believed to have properties that can treat disease, or it acts in a pharmacological, immunological or metabolic way to restore or modify a physiological function, e.g. reducing inflammation and therefore swelling and pain, or promoting healing. This would mean PRP is being used as a medicinal product as defined under the Human Medicines Regulations (HMRs) 2012.
PRP and its use as a medicinal product is subject to needing a marketing authorisation and manufacturing licence. Physiotherapists are not exempt from this requirement.
Further clarification from the MHRA indicated that if there is any medicinal claim in relation to the blood product or, where there is a process to alter the blood product – which would be termed manufacturing (albeit in a small scale within a clinic) – would mean that the blood product no longer fell under the Blood Safety and Quality Regulations 2005. Instead it would be subject to HMRs governing human medicines. Also to note that the initial taking of the blood sample does fall under UK blood legislation, different to the ensuing process to make and use PRP.
Following consultation with the MHRA, the CSP position is that there are no appropriate circumstances that enable physiotherapists to prepare and inject PRP
Why can doctors do this and not physiotherapists?
Doctors can prepare PRP. They are still subject to Blood Safety and Quality Regulations (BSQRs) as well Human Medicines Regulations 2012 (HMR) but there is an enabling exemption that means within limits they are exempt from needing a marketing authorisation and manufacturer’s licence for use of PRP.
Secondly, there is an exemption that allows doctors, supplementary prescribers and some others to use an unlicensed medicine. However, this is not a practice enabler for 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 patients currently receiving a course of PRP?
CSP members must stop using PRP in practice. You should stop doing this treatment immediately and explain to the patient you are no longer able to provide this treatment. Good practice would be to provide the patient with a list of local, alternative healthcare professionals who are permitted to do so.
It is understandable that patients may be anxious if their PRP treatment is halted. 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. This includes physiotherapists and podiatrists who have been instructed by their respective professional bodies to stop administering PRP. The CSP is continuing to have urgent discussions with the medicines regulator to explore what further steps can be pursued.
What do I do with the stock of syringes and centrifuge machine that I can't currently use?
Since our update on 8 June 2023, we can inform members that the appropriate group within the Department of Health and Social Care is now exploring the reclassification of PRP, and its use by physiotherapists and podiatrists, with the Medicine and Healthcare product Agency. The CSP is also continuing to discuss the impact on patient care and physiotherapy practice. At this stage, we would advise you to keep hold of your current clinical supplies until there is a final notice issued by MHRA/DHSC and confirmation of this position by CSP.
What will happen if have been doing PRP? What if there is a claim against me?
Insurers will retain cover for all historical activities involving PRP subject otherwise to the policy terms and conditions with effect from Thursday 8June 2023.
This issue is not about insurance but about legality and to that end even if you have insurance elsewhere, PRP as a modality is no longer legally acceptable for physiotherapists to undertake. 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.
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.