Monitoring systemic therapies

Medicines management has long been part of the registered nurse’s role. In recent years, policy changes, in particular the introduction of independent prescribing, have facilitated greater nursing involvement with the initiation and monitoring of dermatological drugs, including biologics.

Nurse-led systemic drug monitoring clinics can enhance care delivery, reduce existing waiting lists and free up medical consultant time, while maintaining an efficient, high quality service. Nurses can also add extra value by introducing individualised health promotion to patients during routine monitoring appointments.

Scope of practice. When determining the appropriate competence level for a nurse working with systemic medicines within the NHS, either initiating, monitoring or both, it is critical to take their banding into account. Private healthcare providers should also ensure that job descriptions are aligned with BDNG role descriptors. The BDNG role descriptors indicate the appropriate level of responsibility for each band within a dermatology setting (see page 12).1 It is recommended that the entry point for systemic monitoring should be band 6, with greater levels of responsibility and independent practice at bands 7 and 8. Band 5 nurses should not be involved in the monitoring of systemic therapy. Table 6.1 demonstrates the roles and responsibilities of dermatology nurses in the monitoring of systemic therapies according to nursing band.

The patient care setting. Monitoring of systemic therapies can take place in secondary or primary care using a shared-care model. Models of care vary between hospitals. Some will have a separate monitoring list that runs alongside a clinician list; the clinician can be approached during the clinic for further advice or guidance. Others will have drug monitoring as its own separate activity.

TABLE 6.1

5 • Not recommended 6 • Runs disease- or therapy-focused nurse-led follow-up clinics with an approved protocol (e.g. for isotretinoin or biologics) • Does not initiate or change treatment 7 • After confirmed treatment decision by relevant clinician, commences and monitors systemic immunosuppressant therapies (e.g. methotrexate, azathioprine, dapsone, ciclosporin) • Orders, interprets and acts on blood tests related to the commencement and monitoring of these therapies • Follows written protocols that include strict parameters for dose changes 8+ • Independently initiates therapies in accordance with local guidance • Monitors more complex cases • Takes greater autonomy and clinical responsibility in the care of patients • May clinically supervise/line manage nurses at lower grades who are involved in monitoring systemic therapies

New systemic therapy monitoring services must be set up to meet local patient needs but the following considerations will be relevant to all services. • Availability of support in case of a medical emergency or clinical query. • Estimation of the number of patients requiring monitoring now and in the future, as this will affect how the service is staffed and the planning for future staff requirements. • The proportion of patients who can be seen virtually at follow up and those who will need to have a face-to-face appointment. If a service is to be delivered remotely, consideration must be given to

how investigations will be carried out and how patients will access prescriptions. • Consideration of how the liaison between primary and secondary care will work. Will there be shared-care monitoring and, if so, how will this work? • Awareness of any local restrictions on independent prescribers, as these will limit what they can prescribe. • A schedule for audit, so that regular monitoring of standards is considered from the outset.

The level of autonomy that nurses have in monitoring patients on systemic therapy will depend on individual service needs. Some nurses will be allowed to work completely autonomously, while others may be required to work under the direction of a medical clinician. It is important that all members of the MDT agree on the scope of practice for the nurse (see above) and that the competencies devised reflect this. Factors that will affect levels of autonomy may include whether the service is secondary or tertiary care and how prescriptive the Clinical Commissioning Group is with regards to choice of treatment (for example, treatment pathways that list biological drugs in order of prescribing preference).

Initiation of treatment may also incur different responsibilities within different settings. It is important when devising any competencies to be explicit about the patient pathway. For example, in some settings the clinician may ask the nurse to initiate a biologic with the nurse autonomously choosing the biologic and completing all the screening. In other settings, the nurse may be asked to initiate a named therapy and complete a brief screening only.

Before developing a competency framework, it is recommended that the MDT work together to devise an overarching protocol that considers the following. • Clarity of the scope and purpose of the clinic (for example, will nurses be initiating treatment or only monitoring it?). • Referral processes (both within and out of the clinic) and inclusion/exclusion criteria for patients (that is, which patients will be considered appropriate [or not] for the monitoring service).

• How correspondence, such as letters, from the clinic will be managed. • How patients will be discharged and how patients who do not attend appointments will be managed. • Which drug-specific monitoring protocols will be used (accessing, for example, BAD and NICE guidelines).

All of the above should have clear review dates.

Setting competencies. Once protocols are finalised, competencies can be developed. Competencies should, as a minimum, include topics such as patient assessment, drug monitoring and clinical decision-making, as well as the ability to implement any of the standardised scoring systems used for drugs under NICE guidance. Table 6.2 gives some examples of practical and theoretical competencies for drug monitoring, each of which can be attained at levels 0–5 (see Table 1.2). It should be noted, however, that level 3 is the minimum for all competencies for a nurse to practise independently, and in most services the nurse would be expected to achieve level 4/5 within 6 months.

TABLE 6.2

Practical competencies • Locates and accesses relevant drug monitoring protocols, guidance and SOP • Locates drug monitoring referral and confirms appropriateness (i.e. the referral source/procedure has been followed correctly according to clinical guidelines) • Fulfils full screening criteria and ensures results are satisfactory; explicitly notes any omissions before starting therapy • Confirms treatment has been satisfactorily initiated • Recognises significant out-of-range screening results and discusses with the referring clinician • Confirms the referring clinician’s instructions with regards to starting dose, dose escalation and monitoring requirements • Confirms prescriber has supplied a valid prescription and pharmacy has dispensed to the patient

CONTINUED

TABLE 6.2 CONTINUED

Practical competencies (CONTD) • Knows how the patient will be tracked for follow ups, including remote monitoring • Accesses and reviews blood test results • Accurately orders blood tests for any given monitoring situation • Understands the implications of abnormalities in blood test results (including trends over time) and knows how to escalate appropriately • Assesses and monitors side effects • Instructs patient to take or stop taking their medication based on blood test results and clinical status (knows if they are systemically well) • Completes accurate documentation, including standardised disease severity scoring systems • Sends accurate letters within the prescribed timeframe • Demonstrates actions needed when patient is non-adherent to drug monitoring Theoretical competencies • Can discuss rationale for drug monitoring • Can give examples of inappropriate referrals • Understands the importance of a nurse-led monitoring service • Can locate and is familiar with all relevant SOP and protocols • Has appropriate knowledge of drug parameters and significance of abnormal blood results and the rationale for highlighting in a timely manner • Is aware of their understanding/limitations by providing examples • Can give scenarios of when a patient should be asked to stop taking their medication or seek urgent medical attention

Note: each of the competencies described here can be attained at levels 0–5 (see Table 1.2).

Patient assessment and screening should be tailored to the drug that has been prescribed. For patients starting biological therapy, a prebiologic treatment checklist is available on the BAD’s Biologic Interventions Register (BADBIR) website.2 Investigations should be appropriate to the drug being monitored, with particular attention given if a patient is switching drugs. Ordering unnecessary tests can cause expense and delays in treatment. Appropriate tests for screening should be agreed by the MDT, with reference to the relevant drug protocol.

It is envisaged that band 6 nurses involved in screening and monitoring will work in monitoring clinics for specific therapeutics that have well-established monitoring pathways (for example, isotretinoin). Band 7 and 8 nurses are better placed for more autonomous practice, such as identifying tuberculosis risk factors or highlighting potential contraindications to treatment after a clinician has completed basic screening (for example, if a woman of childbearing potential about to start methotrexate does not wish to use contraception).

Completion of the advanced assessment course is recommended as it allows the nurse to be fully autonomous in patient assessment and screening. This is particularly aligned with the BDNG role descriptors at bands 7 and 8, and band 7 nurses should consider completing the course if they have not previously done so.

When recording severity scores for patients on drugs that require percentage improvements at set time points, it may be worth recording the individual components of the score at baseline and the efficacy time point to determine which elements of the score have not reached the required improvement.

Monitoring. Thorough knowledge of the drug being monitored, including its mechanism of action and relevant blood parameters, is essential. Specific knowledge may be required for certain drugs: for example, mood monitoring for isotretinoin and blood pressure monitoring for ciclosporin. Nurses should also know how to access further information, such as drug interactions and side effects, in a timely manner. For remote monitoring, nurses must develop the skills to conduct effective virtual consultations. Resources for virtual consultations have, since the COVID-19 pandemic, often been

developed at a local level, but guidance is also available on the BAD and devolved NHS websites.3,4

Regardless of the nurse’s band there should be a clear pathway for escalation of queries. It is recommended that all pathways should ensure that nurses are not held back from clinical activities by tasks that can be completed by an administrator, such as collecting blood test results.

Patient education. Routine monitoring appointments are a valuable opportunity for holistic patient education. Useful topics are discussed below.

Comorbidities. The health implications of any comorbidities related to the patient’s condition should be discussed and lifestyle advice offered where appropriate. Having information about local services that support lifestyle changes, such as smoking cessation and weight loss, can enhance the nurse’s ability to support healthy behavioural changes. Motivational interviewing can also help to support behavioural changes.5 Another initiative that is well suited to a dermatology population is Making Every Contact Count, which is supported by NHS England.6

Mental health. Skin disease can be hugely impactful on a patient’s mental health, as discussed in the 2020 report of the All-Party Parliamentary Group on Skin.7 The DLQI (see page 99) only looks at the effect of skin disease on quality of life and does not assess depression and anxiety.8 Therefore, mental health screening should also include use of the Patient Health Questionnaire-9 (PHQ-9; the major depressive disorder module of the full PHQ) and the Generalised Anxiety Disorder assessment (GAD-7).

It is worth becoming familiar with available primary care services, such as cognitive behavioural therapy (along with the process of referral to local therapists) and programmes such as Improving Access to Psychological Therapies.9 Patients can self-refer, but it is worth considering helping the patient to complete the referral in clinic.

Vaccination. There is a unique opportunity to ensure patients are fully vaccinated with all applicable vaccines before they start treatment, as systemics and biologics can affect vaccine responses; indeed, some vaccines are contraindicated without a long washout once treatment is started. Information regarding coronavirus

(COVID-19) vaccines is continually being revised, so nurses should be careful to access the most up-to-date information at www.gov.uk. A good source of information regarding vaccines is the Green Book. 10

Health literacy. The National Literacy Trust estimates that 7.1 million people have poor literacy skills.11 Nurses should ensure that patients fully comprehend any information they are given, especially if poor literacy means written information is not helpful.

Storing medicines. It is important to ensure the patient knows how to store medication properly and how to avoid spoiling their dose prior to use. Biologics are often delivered by homecare companies. If this is the case, realistic timelines for processing and delivering the prescription must be built into the model.

Planning pregnancy. Conception plans must be regularly discussed with patients to allow for treatment adjustments and specialist advice to be sought in a timely manner.

Cancer screening. Patients’ participation in relevant cancer screening programmes should be confirmed at regular intervals. In the UK, programmes are available for cervical, breast and bowel screening.12

Independent prescribing is a well-established practice in dermatological care. It is advisable, but not essential, that band 6 nurses working in a drug monitoring clinic be independent prescribers; nurses of band 7 and 8 competence should be independent prescribers.1 If a nurse working in a monitoring clinic is not an independent prescriber, strategies must be put in place to access new prescriptions in a timely manner: for example, through the use of a patient group direction.

The scope of independent prescribing will be decided locally and should be considered when establishing a monitoring clinic. As per the Royal Pharmaceutical Society’s Competency Framework for all Prescribers,13 nurses should only ever prescribe within their scope of practice (that is, what they are competent to prescribe). However, as competencies are achieved this scope may expand.

Disease severity tools. Some systemic drugs used to treat skin conditions are subject to NICE guidance. This means that they can only be prescribed for patients that meet certain criteria. These criteria

usually involve the use of validated disease severity scoring tools, such as the EASI14 and PASI.15

Both the EASI and PASI recognise that their respective conditions can vary in appearance and extent on different body parts (Figure 6.1). Therefore, these screening tools involve assessment of four body regions – the head and neck, upper limbs (hands and arms), trunk (chest, abdomen and back), and lower limbs (buttocks, thighs, legs and feet) – which are examined and scored separately before weighting the score in the final calculation. Both the EASI and PASI require grading of common signs and symptoms of the disease as well as calculating the body area affected. Scoring is best performed in an area in which natural lighting is available.

The EASI is used for patients with eczema. Examples are available online.16,17 The EASI assesses the severity and extent of eczema according to appearance (erythema, oedema/papulation, excoriation and lichenification) and the amount of body area covered for each of the four body regions described above. The range of absolute EASI scores is 0–72, with 0 indicating no eczema and a score greater than 21 indicating severe eczema.18 No specific baseline score is required to start treatment, but a 50% EASI improvement is required at certain time points for treatments such as dupilumab and baricitinib to be continued.

The PASI is a quantitative rating score that measures the severity and extent of psoriatic lesions according to appearance (erythema, induration/thickness and scaling) and the amount of body area covered for each of the four body regions described above. Examples are available online.19,20 The range of absolute PASI scores is 0–72, with 0 indicating no psoriasis and a score greater than 10 indicating severe psoriasis. Patients with psoriasis must have a PASI score of at least 10 before biological therapy is considered and must demonstrate 50% improvement or more by a given time point for the drug to be continued. For example, if a patient starts adalimumab with a PASI score of 15, by week 16 their PASI score must be 6 or lower to continue treatment in accordance with NICE guidance.

Patients with high impact site disease (psoriasis on sensitive areas like the face and genitals, which can have a huge impact on quality of

(a)

(b)

Figure 6.1 The appearance and extent of (a) eczema and (b) psoriasis varies on different body regions in different people.

life) struggle to access biological therapy, as it is hard for their psoriasis to score 10 on the PASI. Some dermatology services now accept a modified version of the PASI, as the reduced cost of biosimilars has made targeted treatment a more attractive option in these patients. BAD guidance for biologics supports the treatment of patients with severe psoriasis at localized sites that is associated with significant

functional impairment and/or high levels of distress, regardless of their PASI score.21

Training is essential to ensure effective use of these tools and to minimise inconsistencies when calculating disease severity. Local consensus can be maintained by regular team scoring of the same patient to ensure consistency within the service. Patients being reviewed in a secondary care setting for the first time may not be used to having their skin graded and examined in depth. It is always good practice to talk through planned procedures with patients and to ensure that their privacy and dignity are maintained, including offering a chaperone.

Post-inflammatory hyper- or hypopigmentation should never be scored as active disease for either scoring system. However, it is worth noting that these changes in skin colour can be as concerning to the patient as the skin condition itself, and patients should be warned of the possibility of skin colour changes when starting a new treatment.

Care should be taken that erythema is not underscored in skin of colour. In dark-skinned individuals, erythema can present as darkening of the skin, with redness visible only in those with severe or very severe disease (Figure 6.2). Any training in the use of the EASI/ PASI and other skin assessment tools should include images of the appearance of the disease in skin of colour.

Figure 6.2 Erythema on dark skin in a child with eczema.

Patient-oriented outcome measures can be used to assess the relationship between disease severity and health-related quality of life.

The DLQI. Patients should also be asked to complete the DLQI to ensure the impact of their condition on activities of daily living is captured. The DLQI comprises ten questions that patients can use to self-assess the effect of their skin problem on different aspects of their daily life.22 Examples are available online.23,24

The DLQI asks, over the last week: • how itchy, sore, painful or stinging has your skin been? • how embarrassed or self-conscious have you been because of your skin? • how much has your skin interfered with you going shopping or looking after your home or garden? • how much has your skin influenced the clothes you wear? • how much has your skin affected any social or leisure activities? • how much has your skin made it difficult for you to do any sport? • has your skin prevented you from working or studying? If no, how much has your skin been a problem at work or studying? • how much has your skin created problems with your partner or any of your close friends or relatives? • how much has your skin caused any sexual difficulties? • how much of a problem has the treatment for your skin been: for example, by making your home messy or by taking up time?

The patient assesses each of these questions as very much (3), a lot (2), a little (1) or not at all (0). The higher the total score the more the patient’s quality of life is impaired (0–1, no effect; 2–5, small effect; 6–10, moderate effect; 11–20, very large effect; 21–30, extremely large effect).

The DLQI also has a ‘not applicable’ option for each of the questions. If a patient replies ‘not applicable’ to more than a couple of questions it is a good idea to discuss their answers further. For example, it may be that they have scored ‘not applicable’ for how their skin disease impacts sport because they do not want to use communal changing rooms where their skin disease may be visible and, as a result, do not play any sport. If they say that they would use changing rooms and play sport if they did not have a skin disease, then they should consider changing their score to ‘very much’.

The POEM. For adults and children with eczema, the PatientOrientated Eczema Measure (POEM) can also be utilized as it focuses on the impact of eczema symptoms from the patient’s perspective, not just on objective disease severity.25 The POEM asks, over the last week, because of the eczema: • on how many days has your/your child’s skin been itchy? • on how many nights has your/your child’s sleep been disturbed? • on how many days has your/your child’s skin been bleeding? • on how many days has your/your child’s skin been weeping or oozing clear fluid? • on how many days has your/your child’s skin been cracked? • on how many days has your/your child’s skin been flaking? • on how many days has your/your child’s skin felt dry or rough?

The patient, or patient’s parent, assesses each of these questions as no days (0), 1–2 days (1), 3–4 days (2), 5–6 days (3), or every day (4). The higher the total score the greater the severity of the condition (0–2, clear or almost clear; 3–7, mild; 8–16, moderate; 17–24, severe; 25–28, very severe).26 As these scores are completed by the patient, it is advisable to ask them to complete them before or at the start of the consultation to ensure their answers are not affected by any actions during the visit.

Courses and training. When developing the skills to work within systemic drug monitoring clinics, the following opportunities are available for professional development. • Consider taking an independent prescribing and advanced assessment module, which can usually be accessed at local universities that run postgraduate nursing courses. • Consider undertaking an MSc in clinical dermatology. • Join the Biologics subgroup of the BDNG to access the plethora of resources. • Attend relevant BDNG conference/study events. • Register for events sponsored by pharmaceutical companies.

These are often virtual, free to attend and scheduled at convenient times. • Consider a preceptorship or shadowing at a centre of excellence.

Who to talk to. It is helpful to liaise with colleagues in immunemediated inflammatory disease departments as they will be using the same or similar drugs. Networking with colleagues in other dermatology departments can also be useful. Representatives of pharmaceutical companies can also be a useful source of information about specific drugs and homecare options.

• Nurse-led systemic drug monitoring clinics can enhance care delivery, reduce waiting lists, free up medical consultant time and provide an opportunity for additional health promotion. • All roles and responsibilities must be clearly aligned with the BDNG role descriptors; the entry level for systemic monitoring is band 6, with greater levels of responsibility and independent practice at bands 7 and 8. • New systemic therapy services should be planned with capacity increases in mind. • Take time to involve the whole MDT in ensuring robust protocols are developed for the effective and safe monitoring of patients, including scope of practice, referral and discharge processes, and appropriate administrative support to collect remote blood tests and field patient queries. • Core knowledge domains include patient assessment and screening tailored to the drug that has been prescribed, knowledge of the drug being monitored (including its mechanism of action and relevant blood parameters), holistic patient education, and use of disease severity and quality of life assessment tools.

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