Atopic dermatitis (AD) is an inflammatory, chronic and relapsing skin disease. It typically involves an increase in type 2 immune responses, an impaired skin barrier, and greater colonisation by Staphylococcus aureus1,2. It has characteristic symptoms such as erythema, oedema, xerosis, erosions, excoriations, exudation, crusting/scabs and lichenification, which vary depending on the patient's age and the lesions' level of chronicity3. In patients with moderate-to-severe AD, skin lesions can cover a large area and be accompanied by intense, persistent itching, with a significant impact on the patient's quality of life, disturbed sleep, anxiety or depression1,4,5. It is often associated with other type 2 inflammatory diseases like asthma, allergic rhinitis or food allergies, which increase the burden of the disease even more6. AD is one of the most common skin diseases, with an estimated prevalence of 1–10% in adults and 10–20% in children. In Spain, the prevalence of AD is estimated at 7.2% in the adult population, with moderate–severe forms accounting for 41–69% of patients7.

The aim of AD treatment is to reduce the symptoms, prevent flare-ups, minimise the risks in the treatment, and control the illness in the long term6. The introduction of new drugs in treating AD implies a change in the therapeutic strategy for these patients. However, these kinds of treatment increase the complexity in overall management of the patient and make it especially important optimise a multidisciplinary approach. Given this context, the hospital pharmacist (HP) takes a prominent role in the team. Since 2014, the Spanish Society of Hospital Pharmacy (SEFH in Spanish) has been working hard to meet outpatients' needs with initiatives such as the MAPEX project (Strategic Map of Outpatient Pharmaceutical Care)8. To define the strategic map of pharmaceutical care for patients with AD, it is necessary to identify the actions at the macro, meso and micro levels to be developed by HP, and the ideal framework that favours and values their contribution. This strategy will help HP to develop their role, facing the challenges posed by the present and future needs of this type of patients. Thus, as a starting point, this project was created with the aim of analysing and agreeing upon pharmaceutical care of patients with AD, as well as identify needs and laying down recommendations.

Based on the above mentioned, this study's aims are: 1) To use the Delphi method to determine the level of consensus among HPs as regards the factors involved in the current approach to patients with AD; 2) To identify potential areas for improvement in hospital pharmacy in terms of dealing with patients with severe AD; and 3) To contribute to adequate pharmaceutical care for patients with AD by drawing up recommendations.

A total of 42 HPs invited to participate in the study accepted and completed both Delphi rounds. Table 1 shows the distribution of the participating hospitals by Autonomous Communities (regions of Spain). In terms of types of hospital, 24 of them were tertiary hospitals, 15 secondary and 3 primary.

The initial questionnaire contained 51 statements divided among the three aforementioned blocks (with 12, 29 and 10 statements respectively) (Fig. 1). Table 2 gives the results from the study, including the results where consensus was obtained in the first round and those in the second.

Fig. 1.

Delphi study flow chart.

(0,14MB).

In the first round, discrepancy was reached for 5 questions, which went on to the second round, dividing them into 7 to make them more understandable, so that the final results came from 53 statements. After the two Delphi rounds, consensus was reached on 41 of the 53 items (77.4%). There were nine items in which the majority agreed (17.0%), while there was a discrepancy in three items (5.7%).

The aim of the Delphi is to obtain an opinion, level of agreement, or consensus on a current topic or concern from among a group of experts in Hospital Pharmacy. This is an iterative and anonymous process with controlled feedback and analysis of the results widely used in health sciences. Although the Delphi methodology has been applied in some previous studies of AD in clinicians9,10, no previous studies comprising a consensus of hospital pharmacists have been published on AD using the Delphi technique. This Delphi consensus gives a real-life clinical perspective on handling severe AD from the HP's point of view and provides recommendations on the different aspects included in dealing with patients with severe AD. Furthermore, unmet needs are revealed that could improve the patients' care through the hospital pharmacy.

This study highlights that severe AD patients' quality of life is clearly impaired. According to a report published by the European Federation of Allergy and Airways Diseases Patients' Associations (EFA), 45% of the participants showed severe symptoms and recognised that AD influences their daily life, as well as their social and sexual relationships. In addition, 13% of patients stated that they had missed more than 11 days a year from work or school11. Also, patients with severe AD often have other type 2 inflammatory diseases such as asthma, allergic rhinitis, or food allergies11,12.

On the other hand, it is striking to see the high percentage of experts who appear as indifferent to the statements related to non-T2 comorbidities as infections, resulting in “non-consensus” for this item. Despite this, the majority (62%) agree that severe AD is associated with secondary bacterial infections (superinfections), which aggravate skin inflammation and often require antibiotic treatment.

Regarding AD, the need for continuous training and the creation of a pharmaceutical care guide has been highlighted since, as shown in the high participation in this study, it is a pathology that is growing in importance and interest among HPs.

As for treating severe AD, the participants in this study reached a high consensus in considering that dupilumab has covered the significant pharmacotherapeutic need there was among patients with severe AD, which is logical if one takes into account that since cyclosporine was approved over 20 years ago, no new systemic treatment had been approved for treating severe AD. Furthermore, it is the first treatment that has enabled long-term use, thanks to its safe profile, critically with chronic disease, and also the first approved treatment for patients ≥6 years old. The participants agreed by consensus that dupilumab provides significantly fast, sustained and clinically relevant long-term improvements in severe AD patients, as well as in quality of life, and improves persistence compared to conventional treatment with immunosuppressants. This consensus is supported by published evidence that dupilumab treatment is effective and well tolerated, with rapid onset of action on signs, symptoms and quality of life in patients with moderate to severe AD13. The new treatments for severe AD recently approved in Spain have introduced new mechanisms for action and they must demonstrate their effectiveness and safety in real life.

This study also achieved a broad consensus in recommending the use of patients' experience indicators in managing severe AD. Evaluation instruments such as PREMs and PROMs (patient-reported outcome measures and patient-reported care experience measures, respectively) are increasingly being promoted as a way of enabling clinicians to efficiently evaluate and respond to aspects of health that are relevant to patients and their caregivers13–15. Major studies suggest that the information provided by PREMs and PROMs can improve communication with the patient, raise awareness of issues that might otherwise go unidentified, and improve care plans and multidisciplinary collaboration14. In fact, successful cases regarding AD have been described in other countries16.

Nonetheless, barriers have been identified to full integration of these techniques in practice, such as a lack of training in applying them or difficulty in interpreting the data17. In order to boost their use, it is essential for these instruments to be seamlessly integrated into clinical practice and for the information to be summarised in easily understandable reports on priority areas for patients and their environment14,18,19.

The HP must be given greater relevance and contribute to the management of patients with severe AD, from participating in defining treatment protocols and the patient's training so as to achieve maximum adherence, to optimise medication therapy management and evaluating the health outcomes. In recent years, the culture of measuring health outcomes has been growing in Spain. For example, the Valtermed registry gets information from different innovative pharmaceutical products recently on the market20.

This study has shown that the commonly used scales do not take a holistic view of the impact of AD on patients' lives. The SCORAD scale (Scoring Atopic Dermatitis) measures the extent of the affected areas, the severity of the lesions and the subjective symptoms, whereas the EASI (Eczema Area and Severity Index) does not include subjective symptoms3,21. The participants in this study unanimously stated that scales and measurements of the impact of AD on patients that take into account symptoms such as itching, sleep and quality of life should be agreed upon in order to globally assess the response to treatment. For example, nearly 93% of the participants recommended using Quality of Life scales such as the DLQI and the POEM scale.

Collaboration between HPs and other specialists remains essential. It is crucial to create multidisciplinary teams that include the hospital pharmacist in order to achieve comprehensive, coordinated and sustainable care from all health professionals. The HPs not only take part in dispensing medication; they also have a relevant role in setting out treatment protocols, educating the patient and monitoring the adherence, compliance, effectiveness and safety of the prescribed treatment22, helping to improve patients' clinical response22.

Additionally, it should be noted that this consensus has several strong points, such as the use of the Delphi method and participation from a panel of AD experts. Since it involves a consensus, it has been possible to include more topics than would normally be dealt with in a systematic review or guidelines, which are generally based on a strict method that restricts the scope of the research. Nevertheless, consensus also has its limitations. Not all statements reached 100% agreement. Furthermore, although these recommendations show experts' points of view, they are not universal; the patient's individual characteristics and convenience should always be taken into account before choosing the type of treatment.

Finally, the creation of a clinical practice guideline for the pharmaceutical care could help to optimise therapeutic medication management and health outcomes in severe AD, as well as the development of new observational studies to determine its impact on patients' clinical outcomes and quality of life.

We are confident that this analysis helps to improve the care and quality of life for patients with severe AD from the perspective of the HPs who care for them in the multidisciplinary team.

A consensus has been reached in recognising the impact of severe AD on the patients suffering from it, as well as on the need to use scales that take into account the patient's quality of life (as well as relevant symptoms), and indicators of the patient's experience. It has also been demonstrated that it is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team. Furthermore, access to new drugs must be improved so that action may be taken as soon as possible in the patients' therapeutic programme. It is acknowledged that dupilumab has meant a breakthrough for patients with severe AD. The creation of a practical guideline is recommended for pharmaceutical care to manage AD. Finally, this Delphi consensus has highlighted the key role the HP must play within the multidisciplinary team caring for patients with severe AD.

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  This Delphi consensus has highlighted the key role that hospital pharmacists must play within the multidisciplinary team caring for patients with severe atopic dermatitis.

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  Scales should be used that consider the patient's quality of life (as well as relevant symptoms like itchiness), in addition to indicators of their experience (like sleep, or anxiety/depression).

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  It is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team.

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  It is advisable to use drugs that have demonstrated long-term effectiveness and safety for patients with severe AD, given the disease's chronic nature.

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  Finally, access to new drugs must be improved so that action may be taken as soon as possible in the course of the patient's therapy.

This project has been funded by Sanofi. The sponsor took no part in designing, implementing, interpreting or writing the document.