The proper way to introduce a new treatment
Introducing a new technique or treatment can bring benefits to patients and be personally rewarding for doctors in private practice. However, it is not without its risks. Dr Clare Stapleton explores the issues.
At some point, you may be the person introducing an intervention or equipment into the hospital where you do your private practice, whether it be something that is already established elsewhere or a completely novel technique.
Any novel therapy should always have patient benefits at its core. The evidence for this could come from the National Institute for Health and Care Excellence (NICE) guidance or research studies where the technique has been adopted at an earlier phase.
In the case of an interventional technique not yet the subject of published NICE guidance, the Royal College of Surgeons of England advises within Good Surgical Practice (section 1.2.4) that you should contact the Interventional Procedures Programme at NICE to learn the status of the procedure.
You may also wish to liaise with your specialty association, which may have further information on the technique, its use and whether it is recommended by them to
be used in the circumstance you propose.
Onboarding
Where the proposal is novel, but licensed and used elsewhere, its introduction through an agreed service evaluation process may be appropriate.
If unlicensed, then this would need to follow a research proposal route and have the necessary approvals.
Any new technique will require approval by the relevant committee at the institution you propose to introduce it at.
Private providers will almost certainly have existing policies that govern the process of introducing new techniques or treatments into their institution. It is important to ask for a copy of this policy at the outset and follow it.
Failure to do so may result in your introduction being unsuccessful and may put you at risk of criticism.
Your own evidence of how it will benefit patients will be helpful in reassuring a private provider and your team that they should support your change in practice.
All doctors have an obligation to regularly monitor and improve their own standard of care as described in the GMC’s Good Medical Practice (see box below)
This is never more important than when you are introducing a technique not previously established in an institution.
Training colleagues
It is essential when introducing a technique to demonstrate that you, and those involved in supporting the performance of the technique or care of the patient, have received appropriate training.
It would be unwise to begin practising a new procedure or using new equipment without clear evidence of your training, experience and competence in that technique.
You will most likely be asked for this evidence when seeking agreement with the private provider. As set out in Good Medical Practice: ‘You must recognise and work within the limits of your competence.’
Maintaining skills
You will also be required to develop and maintain your skills in the technique by attending regular educational activities specific to this aspect of your practice.
There may well be other healthcare professionals you work with who will not have experience or knowledge of this new treatment or technique.
Training the whole team will be vital to its safety and success, as they may assist in its delivery or the care provided to the patient. The private provider, if they agree to its introduction, may ask you to be involved in training others and monitoring their competence.
Training may incur a financial cost. It would be important to agree in advance who is going to be responsible for delivering, funding, and monitoring this training.
It is a good idea to include professionals who may not be directly involved but have a role in caring for patients; for example, ward staff, outpatient staff, pharmacists and GPs, who will be caring for the patients in the community.
These professionals should be aware of any impact the new technique may have on their management of these patients and be fully informed of any variance to their usual care.
Consent process
The consenting process for any patient undergoing a newer technique will be required to be in line with GMC guidance on decision-making and consent.
Patients and their carers should be informed of the benefits and risks in comparison with previously used and alternative techniques.
The Royal College of Surgeons of England also emphasises that you should tell patients if the technique is relatively new and be open about your experience and training, as well as your outcomes to date.
There may be no published patient information leaflets available at the institution you plan to introduce the technique to. You should be involved in drafting these leaflets and ensure that the information within them is clear, accurate and in line with any established national guidance.
The Royal College of Surgeons of England recommends that you discuss the proposal with your colleagues locally. You may find that the introduction is more easily accepted when your colleagues understand what you are doing and are on board with the decision.
Conflict of interest
Doctors should be mindful of the possibility of a conflict of interest and appreciate their professional obligations, particularly where there is a commercial organisation involved in the introduction of a new technique.
The Association of the British Pharmaceutical Industry’s code of practice sets out the ethical framework for organisations that promote medicines.
Medical technology companies have an equivalent association – the Association of British HealthTech Industries – which has published its code of business practice for its members.
You should ensure that you are open with the private providers and patients about any financial interest.
You should follow local policy on commercial interests of doctors working within that organisation.
The GMC has its own guidance for registrants within Good Medical Practice as well as further guidance on financial and commercial arrangements and conflicts of interest. It states:
36. You must be open and honest with patients about any interests you have that may affect (or could be seen to affect) the way you propose, provide or prescribe treatments, or refer patients. You must follow our more detailed guidance on financial and commercial arrangements and conflicts of interest.
94. You must not allow any interests you have to affect, or be seen to affect the way you propose, provide or prescribe treatments, refer patients, or commission services.
95. If you are faced with a conflict of interest, you must be open about it with patients and employers, declare it in line with local and national arrangements, and be prepared to exclude yourself from decision making. You must follow our more detailed guidance in Financial and commercial arrangements and conflicts of interest.
Gaining expertise and practising using a relatively new technique or treatment can bring many benefits to your patients, as well as being personally rewarding. However, it is not without its risks and can be time consuming and expensive.
An understanding of the potential pitfalls and your professional obligations in this area are essential components of a successful new addition to your private practice.
Dr Clare Stapleton (right) is medico-legal consultant at Medical Protection