Shannon Doogue, Case Manager at Medical Protection, explores and discusses two new and potentially challenging areas of prescribing in primary care.

The ongoing warring in in Eastern Europe has forced millions of frightened Ukrainian citizens and their families to flee their precious home in search of asylum. Ireland, as well as many other countries around Europe, has committed to assisting refugees by providing them with access to the same public healthcare services available to Irish citizens.

The Temporary Protection Directive was established, which simply means that on arrival to Ireland, all Ukrainian refugees are entitled to a medical card with a simplified application process. This initiative lasts for nine months, after which a full application must be made for a full medical card. The directive highlights a strong humanitarian commitment to the vulnerable people who find themselves unprecedently displaced in the world. It is worth noting that situations like this can lead to a feeling of the ground shifting under the soles of practitioners, who are expected to provide the promised medical care.

More recently, the ongoing outbreak of the viral disease monkeypox has again left practitioners feeling a sense of uncertainty and vulnerability with regard to prescribing medication.

These scenarios, as with any new situation, invite questions from healthcare practitioners on whether they are appropriately supported to treat patients affected by either situation. They can also evoke concerns about prescribing appropriate medications.

General prescribing obligations

Firstly, when looking at the issue of prescribing, it may be helpful to consider regulatory and legal responsibilities when a practitioner provides a prescription to patients in any circumstances.

In the Guide to Professional Conduct and Ethics for Registered Medical Practitioners (8^th edition (amended), 2019),¹ the Medical Council makes clear that one of the overarching responsibilities of doctors is “to give care and treatment that meets your patients’ needs” (paragraph 1.3). 

In addition to this, the general rule is that any doctor who signs a prescription bears ultimate responsibility for it. The fundamental medicolegal principles of prescribing are neatly summarised in the Medical Council’s guidelines: “As far as possible, you should make sure that any treatment, medication or therapy prescribed for a patient is safe, evidence-based and in the patient’s best interests…” (Paragraph 42.5).

Upon receipt of such a request to provide prescriptions, practitioners have a regulatory obligation to consider the Medical Council’s ethical and professional expectations that they will give treatment and care that meets the needs of their patient, and that they will do so by working within their area of competence and expertise. The Medical Council also expects practitioners to ensure that any treatment prescribed is appropriate and reasonable for the patient.

Therefore, there is an obligation on practitioners to balance the risk of prescribing a medication with not prescribing or prescribing an alternative, especially in unusual circumstances where, for example, they may have limited or no medical history available to them. Naturally, where practitioners are minded to provide any prescription, they would need to satisfy themselves that they have sufficient knowledge to discuss this treatment with the patient, including any possible side effects that the patient may experience. This information should be given to the patient before prescribing, so that the patient can consider the medication or treatment and give their informed consent.

Seeking informed consent

Neatly bringing me to a second common concern amongst practitioners is the matter of obtaining informed consent and providing appropriate information for patients to engage in decisions regarding their care. The Medical Council’s expectations in this regard are encapsulated in paragraphs 9 and 11 of the Guide, which advise that when patients give consent, they are making a voluntary choice. Practitioners should assist patients in making decisions that are informed and right for each individual. In order to obtain valid consent prior to any medical investigation, examination or treatment, practitioners need to ensure that patients are provided with the appropriate amount of information to make an informed decision regarding their care. If the patient has not been supplied with enough information, consent is not valid, and that can lead to a host of other issues such as complaints, referral to the regulator or litigation.

The amount of information a patient needs before making a decision will vary according to a number of factors including the nature of their condition, the type of investigation recommended, the complexity of the treatment, any risks associated with the treatment or procedure, and the risks of non-treatment, and the patient’s own wishes and beliefs. Naturally, it is appreciated that patients would require more detailed information about treatments that have a high risk of failure or side-effects that could impact the patient’s employment, social or personal life.

When discussing options with the patient, practitioners should then confirm that the patient understands the information they have given them, ask whether the patient has any questions and if they would like more information before making a decision. It is critical that doctors are open and honest regarding the information provided to patients and to communicate in accessible language to ensure the patient understands the information. Doctors should bear in mind that some refugees may speak little or no English. Practices may wish to make use of the HSE’s multilingual aid,² a resource intended to assist health staff to communicate more effectively with patients while awaiting the services of an interpreter. It is currently available in 18 languages.

In general, a practitioner is legally responsible for any prescription they choose to issue. They would be expected to obtain any necessary information to help them decide whether they consider the treatment to be appropriate and whether they are in a position to provide it. Doctors should then weigh up the risk of providing the medication/s with not prescribing, considering all the available information they have. After considerable contemplation, if the practitioner is happy that the prescription is appropriate and reasonable for the patient, then it is acceptable for them to provide it as they would any prescription to a regular patient. Where practitioners remain unhappy with the prescription, it would be their decision as to whether they choose to sign the prescription or not. Essentially, in that circumstance it would be a judgment call for them to make.

If a doctor were to decline to provide a particular prescription to a Ukrainian refugee or to prescribe the smallpox vaccine for a monkeypox-exposed patient, this might potentially invite a complaint or unwanted criticism. While this risk shouldn’t coerce any practitioner into prescribing medication, they would be expected to be able to give a reasoned answer about how they came to the decision to facilitate the request or, alternatively, not to prescribe the medication. If the practitioner has documented in the medical records the rationale for their decision, this would help mitigate any criticism they might face.

Prescribing on recommendation of a colleague

The use of Imvanex vaccine to treat monkeypox exposed patients has led practitioners to question their professional obligation to prescribe the vaccine on recommendation of a colleague. Where a specialist’s input is sought and considered, it is important that the prescriber is aware that they are still responsible for any prescription that they personally sign.

With this in mind, practitioners should ensure that they have been provided with sufficient information from their specialist colleagues, such that they would find themselves in a position to safely prescribe the medication for the patient.

The Medical Council has not made specific reference to the issue of prescribing on the recommendation of a colleague in its current guidance. However, it is important that prescribers maximise patient safety by ensuring that the prescription is needed, appropriate for the patient and within the limits of their competence to prescribe.

In the absence of tangible detailed Irish guidance, it may be interesting to review and consider General Medical Council (GMC) prescribing guidance.³ Although this guidance applies to UK doctors, and the GMC has no jurisdiction over Irish registered practitioners, nevertheless doctors in Ireland may wish to consider the principles within this guidance if faced with a particular dilemma.

The GMC provides specific guidance regarding prescribing on the recommendation of colleagues as follows:

•  Practitioners are responsible for any prescriptions they sign.

•  They should only prescribe medicines where they have adequate knowledge of the patient’s health and are satisfied that the medicines serve the patient’s needs.

•  Before prescribing, doctors must consider whether the information they have is sufficient and reliable enough to enable them to prescribe safely.

•  Practitioners must ensure they have obtained the patient’s informed consent before administering any treatment.

•  Should a practitioner choose to prescribe based on the recommendation of another doctor, nurse or other healthcare professional, they must be satisfied that the prescription is needed, appropriate for the patient and within the scope of their competence.

Off-label

Another predominant concern among prescribing practitioners is the off-label usage of Imvanex for monkeypox. Off-label or off-licence indications refer to licensed medicines with full Marketing Authorisation to be prescribed for unlicensed indications or in unlicensed dosages, or used outwith the terms of their Marketing Authorisation.

In general terms, the responsibility that falls on healthcare professionals when prescribing a medicine which is off-label or off-licence may be greater than when prescribing a licensed medicine within the terms of its licence. Prescribers should pay particular attention to the risks associated with using a licensed medicine off-label or off-licence. These risks may include adverse reactions, product quality, or discrepant product information or labelling eg absence of information for some medicines, information in a foreign language for unlicensed imports and potential confusion for patients or carers when the Patient Information Leaflet is inconsistent with a medicine’s off-label use.

However, just for reassurance, prescribers may prescribe off-label or off-licence medicines where, on the basis of an assessment of the individual patient, they conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient. Prescribers must be in a position to describe the adverse incidents risks to the patient and inform the recipient about the “off-label” use of the vaccine in response to monkeypox.

Wrap up

Ultimately, when considering whether to prescribe any medication, a practitioner must apply their clinical judgement and come to a decision based on a weighing up of their legal, ethical and professional obligations as outlined.

When analysing any such situations, it is strongly recommended that a practitioner’s reasoning, rationale and decision-making process is evidenced, in detail, within the patient’s medical records to limit any scope for criticism stemming from prescribing treatment.

Reassurance

As a member of Medical Protection, you can request assistance with an adverse event, complaint or claim relating to any regular aspect of your role as a prescribing practitioner. This includes the prescribing of medication to patients regardless of their civic status or prescribing off-label medication. Please do not hesitate to contact Medical Protection if you encounter a prescribing dilemma and would like to discuss this in more detail.

References

Medical Council - Guide to Professional Conduct and Ethics for Registered Medical Professionals
National Social Inclusion Office - HSE Multilingual Resources and Translated Information
General Medical Council - Good practice in prescribing and managing medicines and devices