The RCPod is instructing all podiatrists to stop providing platelet-rich plasma (PRP) therapy to patients, with immediate effect, after its classification as a medicinal product.

At the start of 2023, the Chartered Society of Physiotherapy (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. The CSP shared this information with the RCPod.

As the CSP investigated further, it became aware of several uncertainties around the legal and regulatory status of PRP. The CSP has been in contact with the relevant regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The RCPod has consulted with its Clinical Senate and with its Medicines and Medical Devices Committee.

The MHRA's, the RCPod’s and the CSP’s position on the use of PRP is below.

RCPod position statement

The RCPod position is that there are no appropriate circumstances that enable podiatrists 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 podiatrists 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 podiatrists 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. Podiatrists are not exempt from these requirements.

As such, podiatrists cannot provide PRP to patients and cessation guidance issued on Thursday 8 June 2023 still stands. 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 (taking blood from the patient’s arm) 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 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 podiatry, PRP is classified as an unlicensed human medicine and as such podiatrists 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 podiatrists can use PRP in their practice?

No. The MHRA understand that podiatrists 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. Podiatrists 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 of note, 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 RCPod position is that there are no appropriate circumstances that enable podiatrists to prepare and inject PRP. This includes under Prescription Only Medicines- Administration (POM-A), Supplementary Prescribing (SP) and Independent Prescribing (IP) annotation.

Why can doctors do this and not podiatrists?

Doctors can prepare PRP. They are still subject to Blood Safety and Quality Regulations (BSQRs) as well as 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 the 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 podiatrists 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?

RCPod 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 podiatrists 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 podiatrists 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 podiatrists and physiotherapists who have been instructed by their respective professional bodies to stop administering PRP. The professional bodies are 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 (DHSC) is now exploring the reclassification of PRP, and its use by podiatrists and physiotherapists, with the Medicine and Healthcare product Regulatory Agency (MHRA). The RCPod is also continuing to discuss the impact on patient care and podiatry 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 the RCPod.

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 otherwise to the policy terms and conditions with effect to 8 June 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 podiatrists to undertake.