Dr Toni Hazell identifies five key learning points from the updated GMC guidance Good practice in prescribing and managing medicines and devices

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Dr Toni Hazell

  • with whom the medicolegal responsibility for prescribing rests
  • how to conduct safe prescribing, whether face to face or remotely
  • potential pitfalls to be aware of, such as off-label prescribing and self-prescribing.

Read this article online at: GinP.co.uk/455994.article

The General Medical Council (GMC) have updated their guidance, Good practice in prescribing and managing medicines and devices.1 The guidance is useful for routine general practice, and also contains some sections on remote prescribing that are of particular relevance in the COVID-19 pandemic.1 The term ‘prescribing’ not only refers to supplying prescription-only medicines, but also to prescribing devices, dressings, and activities (such as exercise) and advising patients on the use of over-the-counter medicines and other remedies.1

1. Be aware of your medicolegal responsibilities when signing a prescription

The first line of the updated GMC guidance states: ‘You are responsible for the prescriptions that you sign’.1 This may seem obvious, but responsibility can appear blurred when GPs prescribe drugs not usually initiated in primary care on the advice of a consultant. Examples include disease-modifying antirheumatic drugs, many antipsychotics, and hormones used in the care of patients with gender dysphoria. These drugs are usually prescribed under shared care, which is defined by NHS England as a particular form of the transfer of clinical responsibility from a hospital or specialist service to general practice in which prescribing by the GP, or other primary care prescriber, is supported by a shared care agreement’.2 The GMC guidance contains links to similar information for the devolved nations of the UK.1

You should only enter into a shared-care agreement if the following criteria are met:

  • all parties communicate effectively and work together1
  • you are able to keep yourself informed about the medicines that are prescribed for the patient, recognise common and serious side-effects, and remain up to date with the relevant guidance1
  • appropriate clinical monitoring arrangements are in place, and the patient and healthcare professionals involved understand them1
  • voluntary, willing, and informed consent has been provided by the patients, their carers, and all clinicians involved.2

There may be some patients for whom you do not feel that shared care is safe, in which case the GMC advises that you should ask for further information or advice from the clinician who is sharing care responsibilities or from another experienced colleague. If you are still not satisfied, you should explain this to the other clinician and to the patient, and make appropriate arrangements for their continuing care’.1 This may include the long-term provision of prescriptions from secondary care.

Transfer of responsibility under shared care without GP consent is a breach of the standard hospital contract and should be refused.3 Monitoring of drugs such as methotrexate is not contractually part of the GP core contract and, if undertaken in primary care, should be resourced as an enhanced service—the absence of such funding may be a reason for a practice to decline to take part in shared care.3

2. Determine whether remote prescribing is safe

Remote prescribing has increased during the COVID-19 pandemic, and it seems unlikely that it will go away when the pandemic ends. For some patients, particularly those who work or have caring responsibilities, it is convenient and safe. The GMC makes it clear that the prescriber must ‘… be satisfied that you can make an adequate assessment, establish a dialogue and obtain the patient’s consent through the mode of consultation you are using’, and that remote prescribing is not always suitable.1 Reasons to consider a face-to-face consultation are listed in Box 1.

Box 1: When is a face-to-face consultation preferable to a remote consultation?1

Circumstances in which a face-to-face consultation may be more appropriate than a remote consultation include when:

  • you are unsure of a patient’s capacity to decide about treatment
  • you need to physically examine the patient
  • you are not the patient’s usual doctor or GP and they have not given you consent to share their information with their regular prescriber; this is particularly important if the treatment needs following up or monitoring, or if you are prescribing medicines where additional safeguards are needed
  • you are concerned that a patient does not have a safe and confidential place to access healthcare remotely, for example, because of domestic abuse
  • you are concerned that a patient may be unable to make a decision freely because they are under pressure from others.

Adapted from General Medical Council. Good practice in prescribing and managing medicines and devices. London: GMC, 2021. Available at: www.gmc-uk.org/-/media/documents/prescribing-guidance-updated-english-20210405_pdf-85260533.pdf

Reproduced with permission.

There are added issues to consider if you are speaking to a patient who is overseas. It is clearly impossible to ask the patient to come in, and you should think about how you or local healthcare professionals will monitor their condition.1 You should also consider how you would get any prescription to the patient, whether you need to be registered with the regulatory body of the country where the patient is staying at the time of the advice, and whether you are indemnified to give such advice.1 GPs receive indemnity cover under the Clinical Negligence Scheme for General Practice, and this cover still applies if the patient is overseas provided they are registered in England.4

Cover from your defence union is another matter, and information on this subject ranges from unclear as to whether advice and support would be offered should a complaint or lawsuit arise from this circumstance,5 to a clear statement that support will not be offered if the patient is not located in the UK.6 Going through a complaint or lawsuit without the support of your defence organisation is an unpleasant process and that, in addition to the GMC’s point about the possible need for registration in the country where the patient is staying,1 suggests that it would be wise to exercise caution—in general, your advice should be limited to recommending that the patient seeks local medical attention.

3. Ensure you have enough information to prescribe safely if you are not the usual GP

Primary care is more fragmented now than in the past. Out-of-hours care is not provided by the registered GP, and remote care is also available from private organisations. If you are not the patient’s usual prescriber, then the GMC advises that you should ask for the patient’s consent to contact their GP or other treating doctors if needed, and to share information with their GP when the episode of care is completed.1 The patient does not have to give this consent, but if it is not forthcoming then you ‘… must be able to justify a decision to prescribe without that information’.1 However, the GMC advises that: ‘If failing to share information could pose a risk to patient safety … you cannot prescribe’.1

The balance of risks and benefits will clearly vary depending on the situation, the patient’s co-morbidities, and the drug that you are considering prescribing, but you should not feel pressured into prescribing if you are not happy that it is safe to do so. If you feel that your organisation is putting you into this position, then you have a responsibility to raise it, as per the GMC’s advice:1

If it’s not possible to clarify or ask for more information from the patient in the environment you are working, you should consider whether it is safe to prescribe, and raise concerns as appropriate. For example, it may be appropriate to raise concerns if the system in which you’re working involves prescribing remotely on the basis of a questionnaire and there is no mechanism for two-way dialogue or communication with patients’.

4. Take extra care with unlicensed prescribing

In the UK, drugs prescribed in primary care are granted a licence for use for a specific indication and dose by the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency.7 The licensing procedure confirms that the drug has been assessed for efficacy, safety, and quality.7

It is sometimes necessary to prescribe a drug that is unlicensed for a particular patient. This may be because the patient is a child or a pregnant woman (pregnant women and children are often excluded from clinical trials), or because you are prescribing the drug for an indication outside of its licence. One example is use of the combined oral contraceptive pill in a continuous manner, which is outside of the product licence as listed in the British National Formulary8 but supported by commonly used guidelines,9 and therefore completely defensible. The GMC states that: ‘You should usually prescribe licensed medicines in accordance with the terms of their licence. However, you may prescribe unlicensed medicines where, on the basis of an assessment of the individual patient, you conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient’.1 Further examples of reasons for off-label prescribing are given in Box 2.

Box 2: Reasons for prescribing outside of the product licence1

Prescribing unlicensed medicines may be necessary in the following instances:

  • there is no suitably licensed medicine that will meet the patient’s need. Examples include—but are not limited to—where:
    • there is no licensed medicine applicable to the particular patient—for example, if the patient is a child and a medicine licensed only for adult patients would meet the needs of the child
    • a medicine licensed to treat a condition or symptom in children would nonetheless not meet the specific assessed needs of the particular child, but a medicine licensed for the same condition or symptom in adults would do so
    • the dosage specified for a licensed medicine would not meet the patient’s need
    • the patient needs a medicine in a formulation that is not specified in an applicable licence
  • a suitably licensed medicine that would meet the patient’s need is not available. This may arise where, for example, there is a temporary shortage in supply
  • the prescribing forms part of a properly approved research project
  • there is a serious risk to public health, and the MHRA has temporarily authorised the sale or supply of an unlicensed medicine, such as a vaccine or treatment, in response.

MHRA=Medicines and Healthcare products Regulatory Agency

Adapted from General Medical Council. Good practice in prescribing and managing medicines and devices. London: GMC, 2021. Available at: www.gmc-uk.org/-/media/documents/prescribing-guidance-updated-english-20210405_pdf-85260533.pdf

Reproduced with permission.

5. Do not prescribe for yourself or your family

The GMC is clear that: ‘Wherever possible, you must avoid prescribing for yourself or anyone you have a close personal relationship with’.1 Fitness-to-practise cases have arisen from self-prescribing, some of which have led to restrictions on the doctor’s practice.10,11 If you absolutely have to, then make sure that your documentation is clear and be prepared to defend your decision.1

Summary

Prescribing is a key part of our practice, and it is useful to have clear, unambiguous guidance from the GMC as to what we can and can’t do. Use it to guide your own practice, and be aware that it can also be cited as part of your decision to refuse to carry out prescribing that you consider to be unsafe, so that you can continue to work within the established principle of ‘first, do no harm’.

Dr Toni Hazell

Part-time GP, Greater London

References

  1. General Medical Council. Good practice in prescribing and managing medicines and devices. London: GMC, 2021. Available at: www.gmc-uk.org/-/media/documents/prescribing-guidance-updated-english-20210405_pdf-85260533.pdf
  2. NHS England. Responsibility for prescribing between primary & secondary/tertiary care. London: NHS England, 2018. Available at: www.england.nhs.uk/wp-content/uploads/2018/03/responsibility-prescribing-between-primary-secondary-care-v2.pdf
  3. NHS England. NHS standard contract 2020/2021—service conditions (full length). London: NHS England, 2019. Available at: www.england.nhs.uk/wp-content/uploads/2019/12/3-full-length-service-conditions-20-21.pdf
  4. NHS Resolution. COVID-19—guidance for general practice. London: NHS Resolution, 2020. Available at: resolution.nhs.uk/wp-content/uploads/2020/06/COVID-19-Guidance-for-general-practice.pdf
  5. Medical Protection website. COVID-19 and remote consultations—how we can help. www.medicalprotection.org/uk/articles/covid-19-and-remote-consultations-how-we-can-help (accessed 9 April 2021).
  6. Medical and Dental Defence Union of Scotland website. Prescribing for patients overseas. www.mddus.com/advice-and-support/advice-library/prescribing-for-patients-overseas (accessed 9 April 2021).
  7. NHS website. Medicines information. www.nhs.uk/conditions/medicines-information/ (accessed 9 April 2021).
  8. British National Formulary website. Contraceptives, hormonal. Available at: bnf.nice.org.uk/treatment-summary/contraceptives-hormonal.html (accessed 9 April 2021).
  9. The Faculty of Sexual & Reproductive Healthcare. FSRH clinical guideline: combined hormonal contraception. London: FSRH, 2020. Available at: www.fsrh.org/standards-and-guidance/documents/combined-hormonal-contraception/
  10. Moberly T. Physician, don’t heal thyself: the perils of self prescribing. BMJ 2014; 349: g7401.
  11. Medical Defence Union website. Self-prescribing. www.themdu.com/guidance-and-advice/guides/self-prescribing (accessed 9 April 2021).