Prescribing and DIY Artificial Pancreas Systems

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In this post we consider how clinicians can follow the standards set by the General Medical Council when making prescribing decisions for people who are using or considering using DIY APS.

In DIY APS, each component of the system that a doctor is responsible for prescribing (insulin, CGM, and insulin pump) are appropriately licensed or authorised within the UK, and the Medicine and Healthcare products Regulatory Agency (MHRA) has regulatory oversight of the corresponding processes. However, the open-source software that are used to modify insulin pumps’ methods of insulin delivery (thus creating the DIY APS) are unregulated components and have not been through the usual approvals processes.

In this blogpost, we consider how doctors can follow the professional standards set by their regulator, the General Medical Council (GMC), when prescribing for a patient using/considering DIY APS. This topic is explored in greater depth in a forthcoming article by Joseph Roberts, Victoria Moore, and Muireann Quigley in Medical Law International. A plain English summary (along with a pre-publication version of the paper itself) will be made available on this site shortly.

We focus here on adult users of DIY APS who are able to make their own treatments decisions, but plan future posts which deal with issues specific to child users of DIY APS and adults who lack capacity.

The GMC’s prescribing guidance contains the professional standards expected of doctors when prescribing. The guidance applies when prescribing medical devices as well as to medicines, and the term ‘prescribing’ is also applicable to scenarios where doctors provide either written information or verbal advice to patients. This means that the following could count as prescribing:

  • Advising a patient to build their own DIY APS
  • Advising a DIY APS user on their use of the system
  • Prescribing the hardware components (insulin pump and CGM)
  • Prescribing pump consumables (such as infusion sets which are necessary for the pump to function)

Prescribing unapproved medical devices

The prescribing guidance contains a specific section (paragraphs 67-74) on prescribing unlicensed medicines. It defines this as medicines ‘that are used outside the terms of their UK licence or which have no licence for use in the UK’. The hardware components of a DIY APS would not fall into this definition, as they are approved by the MHRA. However, whilst some aspects of the guidance are particularly relevant to prescription only medicines, paragraph 4 notes that it should be applied in relation to the other activities where relevant and applicable. This, therefore, could apply to cases where insulin pumps are combined with third-party, unapproved, open-source software to create a DIY APS.

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As such, it would be prudent for clinicians to consider DIY APS akin to an unlicensed medicine when providing care to patients, especially as paragraph 74 of the guidance states that doctors should be careful about using medical devices for purposes for which they were not intended.

Within GMC guidance, the term ‘should’ is used to indicate the degree of flexibility a doctor has in following the guidance (paragraph 5 of Good Medical Practice). It is not a warning to steer doctors from an action which is, in their professional judgement, appropriate.

The guidance recognises that unlicensed medicines are commonly used in some areas of medicine such as in paediatrics, psychiatry, and palliative care, and that they may be used, less frequently, in other areas of medicine (paragraph 67). Although in diabetes care it may be more unusual for unlicensed medicines to be used, GMC guidance is applicable across all specialties and to all doctors considering the use of unlicensed medicines.

In summary, the prescribing guidance says that although doctors should usually prescribe licensed medicines in accordance with the terms of their licence, they may prescribe unlicensed medicines where they conclude that for medical reasons, it is necessary to do so to meet the specific needs of a patient. They should give patients sufficient information about the proposed treatment to allow patients to make an informed decision, and must answers patients’ questions fully and honestly. When prescribing an unlicensed medicine or an unapproved (‘unauthorised’) medical device, doctors must:

  • be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy
  • take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring, and any follow up treatment, or ensure that arrangements are made for another suitable doctor to do so
  • make a clear, accurate and legible record of all medicines prescribed and, where they are not following common practice, their reasons for prescribing an unlicensed medicine.

What does this mean in practice?

Below we look at three questions which some clinicians have been grappling with. We illustrate how the principles set out in the GMC’s prescribing guidance, along with the guidance on consent, might help to answer them.

Q: My patient has built their own DIY APS. Can I continue prescribing the pump, CGM, and consumables?

A: The lack of clinical guidelines or statements from authoritative bodies vouching for the safety of DIY APS can be worrying for doctors who are responsible for prescribing the individual components of DIY APS. This is especially the case where patients are using these in a manner not intended. Clinicians may be concerned about whether the limited safety evidence regarding DIY APS is sufficient to justify their prescribing decisions.

In thinking about what to do, the GMC’s guidance on consent is significant. This guidance stresses the importance of doctors and patients making decisions together. As such, discussing safety concerns and the possible risks with patients, and clearly documenting these discussions, is likely to be more in line with individual patient’s interests than the alternative: refusing to prescribe the required hardware components.

Although clinicians may have safety concerns about the delivery method a patient is using, attempting to force them to stop using DIY APS by withholding prescriptions could severely damage the doctor-patient relationship with the patient and discourage them from being open and honest.

Q: I think my patient would benefit from DIY APS. Can I raise this with them?

A: The professional guidance does not expressly prohibit doctors from discussing DIY APS with their patient. The discussion may however count as prescribing, particularly if they are advising the patient to consider building a DIY APS.

Clinicians, therefore, need to be mindful of the prescribing guidance outlined above, and ensure that the patient has sufficient information to make an informed decision. The GMC’s guidance on consent provides a framework for this.

Essentially, the guidance says that it is important to make clear in any discussion that the treatment does not have MHRA approval and to explain what the likely risks and benefits might be. Doctors should not pressure the patient into accepting any advice given. It is up to them to decide what they wish to do.

Q: My patient wants me to prescribe a CGM so that they can build DIY APS. What should I do?

A: Practically, there may be funding restrictions in place which prevent doctors from doing this. Funding issues aside, whether a doctor chooses to prescribe a CGM will depend upon whether they think it would serve their patient’s needs. So, for example, if a patient has a complete loss of hypoglycaemia awareness, a CGM is likely to be to their benefit. However, the GMC’s consent guidance says that, if, after discussion with the patient, a doctor still considers that the treatment would not serve the patient’s needs, they do not have to provide the treatment.

If, in a doctor’s professional judgement, prescribing a CGM would meet the patient’s needs, and funding arrangements allow for this, they ought not to refuse to prescribe it solely out of concerns that their patient might use it to create a DIY APS.

Written by: Victoria Moore

Funding: Work on this was generously supported by Wellcome Trust Investigator Award in Humanities and Social Sciences 2019-2024 (Grant No: 212507/Z/18/Z), an ESRC Impact Acceleration Award, and a Quality-related Research grant from Research England.