Prescribing dilemmas: skin problems

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Scenario 1: Prescribing a drug off-licence

You are a community pharmacist independent prescriber (PIP) with a special interest in dermatology. You have gained experience in the use of systemic treatments for eczema and psoriasis after spending time with a local dermatologist.

You recently referred Mr Johnston, a 54-year-old with chronic plaque psoriasis, to the nearest hospital dermatology department because his psoriasis had failed to adequately respond to topical therapy and was worsening. Initially, Mr Johnston was prescribed methotrexate but this was stopped because of the side-effects.

His dermatologist has seen some new and impressive data on the use of azathioprine in psoriasis. He asks if you can initiate Mr Johnston on azathioprine 50mg twice daily (an off-licence use) for six months. Mr Johnston tells you that his psoriasis is making him feel quite depressed and he is eager to start on the new drug.

Mr Johnston also has hyperlipidaemia, which is currently managed with atorvastatin 20mg. How would you respond?

Information gathering

You are aware of the patient’s worsening psoriasis and its effect on his mental health. What remains unclear is whether a trial of azathioprine will stop his psoriasis from deteriorating. While this is an off-licence use, it is perfectly acceptable to use a treatment in this manner.

Published guidance

General Medical Council (GMC) guidance states: “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 ... You should only prescribe medicines if you have adequate knowledge of the patient’s health and you are satisfied that the medicines serve the patient’s needs.”

Patient needs and safety

You have to decide if prescribing azathioprine will fully meet the needs of the patient and support safe prescribing. Community Pharmacy England says that PIPs can prescribe off-licence or off-label, “but only when this is accepted clinical practice and where they accept clinical/legal responsibility for their prescribing decision”.

A relevant question therefore is: does the use of azathioprine in this case fall within the realms of ‘accepted clinical practice’?

Ethical issues

When making a decision, PIPs need to adhere to the four pillars of bioethics:

• Respect for autonomy: Will Mr Johnston understand the implications of prescribing a drug off-licence and which might not be accepted clinical practice. As there is limited clinical data on the potential adverse effects of azathioprine when used in psoriasis, as a PIP you are taking full responsibility for prescribing the drug
• Non-maleficence: By not issuing azathioprine, there is a risk of a further deterioration in
  Mr Johnston’s psoriasis and he is already starting to feel depressed about his skin condition
• Beneficence: Provision of azathioprine may help to improve Mr Johnston’s psoriasis or at least halt its deterioration
• Justice: Who will the decision affect? In this case, not providing treatment could impact on the patient’s mental wellbeing. It may also strain your good relationship with the dermatologist.

Action

The most appropriate option (see Table 1) is probably to prescribe azathioprine, provided the consultant agrees to a shared care management plan. Section 75 of the GMC guidance states: “Shared care requires the agreement of all parties, including the patient. It is essential that all parties communicate effectively and work together.”

In Section 77, the guidance adds that when delegating responsibility, the consultant must be satisfied that the individual (i.e. the PIP) has the qualifications, experience, knowledge and skills needed to assess the patient.

Scenario 2: Further supply of treatment without a clinical review

In this scenario, 4-year-old Mollie has been diagnosed with atopic eczema by her GP and prescribed an emollient and clobetasone 0.05% cream. Both items have been placed on repeat prescription for a total of three issues, with a proviso that no further supplies of clobetasone cream should be made without seeing the patient. 

You provide ongoing prescribing support for Mollie after the initial three months. One afternoon, Mollie’s mother Jill calls the pharmacy requesting a further supply of clobetasone cream because she is still struggling with itchy and sore skin. Due to work commitments, she cannot bring Mollie to see you at the pharmacy.

From her medical records, you see that Mollie has previously had a total of three repeats of each treatment but nothing for the last three months. How would you respond to Jill’s request for a further supply of clobetasone cream?

Information gathering

You know that Mollie has previously received three issues of her emollient and clobetasone cream but no treatment for the last three months. What remains unclear is whether Jill fully understands how best to manage her daughter’s eczema. The lack of any current treatment suggests that this could well be the case.

Published guidance

General Medical Council (GMC) guidance states: “You are responsible for the prescriptions you sign. You are also accountable for your decisions and actions when supplying or administering medicines and devices.” It adds that prescribers need to “take account of the patient’s needs and any risks arising from the medicines”.

Guidance from the GPhC also re-emphasises the importance of PIPs taking responsibility for any prescribing decisions they make. 

Patient needs and safety

GMC guidance states: “You should only prescribe medicines if you have adequate knowledge of the patient’s health and you are satisfied that the medicines serve the patient’s needs.”

Does the current telephone consultation allow you to fully meet the needs of the patient and therefore support safe prescribing? As you have not seen Mollie, it is impossible in this instance to make an adequate assessment of her eczema.

Ethical issues

The bioethical principles highlighted in this case can be summarised as follows:

• Respect for autonomy: recognising the rights of the patient, or in this case, their carer, and that they are in a position to make an informed choice about their daughter’s treatments
• Non-maleficence: by not issuing the clobetasone cream, there is a likelihood of a deterioration in Mollie’s eczema, which might even become infected warranting further treatment
• Beneficence: provision of a prescription for clobetasone will improve Mollie’s eczema and prevent further worsening
• Justice: in the present situation, who will your decision to prescribe affect? Failure to provide treatment could impact on Mollie’s eczema. There is also a real concern that in the future, Jill may not wish to consult with a PIP and this might impact upon the wider public perception of PIPs.

Action

There are several potential options available, as outlined in Table 2. Although there is no correct answer, you should be in a position to fully defend your actions if called upon to do so.

In this scenario, the best option might be to issue a one-off prescription for clobetasone cream. This is unlikely to cause any serious harm, especially if you are able to offer advice on its appropriate use.

The telephone consultation also gives you an opportunity to explain how seeing Mollie in person would allow for a full assessment of her eczema, as well as the provision of ongoing management and prescribing support.

Although this goes against GMC advice, GPhC guidance advises that PIPs consider the impact of their prescribing on the patient and this also involves a consideration of the consequences of not issuing treatment.