Interstitial lung diseases (ILDs) are a heterogeneous group of disorders characterized by inflammation and/or fibrosis of the pulmonary parenchyma.1 Idiopathic interstitial pneumonias are the most common condition. Within this subset, idiopathic pulmonary fibrosis (IPF) has the highest prevalence2 and is the quintessential example of fibrotic ILDs.3 In Spain, although the estimated number of patients with IPF is between 8000 and 12 000,4 its incidence is expected to increase due to improved diagnostic methods and population ageing.5 Idiopathic pulmonary fibrosis is characterized by progressive worsening of dyspnoea and lung function and has a poor prognosis,6 with a median survival without treatment of 2–5 years after diagnosis.2,7 In Spain, the leading cause of lung transplantations is ILD (42% of transplantations), ahead of emphysema/chronic obstructive pulmonary disease (35%).8

Among the unmet needs expressed by patients with IPF is the improvement of the multidisciplinary care required by this disease.9 A possible solution is provided by the World Health Organization's proposals regarding chronic conditions; it suggested the implementation of an integrated care model that covers the entire care continuum, from diagnosis until end-of-life, and caters to the patients' needs whilst being patient-centered.10 Hospital pharmacists play a crucial role in this integrated care model for patients with pulmonary fibrosis.11 Their responsibilities include monitoring and educating patients about their treatment, polypharmacy, and, in general, rationalizing pharmacological treatment, advising on adverse reaction prevention and management, monitoring for potential interactions, improving medication adherence and physician follow-up, providing guidance on overcoming daily life challenges by steering patients toward patient care and support programs, and encouraging patients to actively participate in managing their disease.11–14

The Spanish Society of Hospital Pharmacy (SEFH) has incorporated this integrated care model within its chronic patient care model15 and in its definition of pharmaceutical care.16 Within this framework, the objective of this project was as follows: a group of hospital pharmacists were tasked with the development of a checklist (CheckEPID) to facilitate pharmaceutical care for patients with diffuse interstitial lung disease (DILD) who require or are undergoing treatment with antifibrotics.

The management of patients with ILD and/or pulmonary fibrosis is complex and requires a multidisciplinary approach in which hospital pharmacists play a crucial role, particularly, but not exclusively, in the monitoring of pharmacological treatment. The checklist we have developed is intended to help guide such monitoring as part of the pharmaceutical care of patients. It may be particularly useful for centers without a specialized unit for managing such patients.

There was no consensus on the usefulness of 2 items evaluated for inclusion in the list: the item "History of surgical intervention, specifically abdominal surgery in the last 4 weeks" and "Recommendation for relaxation". As mentioned above, the scientific committee decided to retain the former item on the list, given the implications of recent abdominal surgery on starting treatment with nintedamib. Regarding the item on relaxation, it should be noted that the chronic breathing difficulties, coughing, and fatigue experienced by these patients have a negative impact on their emotional wellbeing and quality of life by limiting their daily activities.23,24 Anxiety related to fear of these symptoms and the resulting loss of self-confidence can lead to increased disability and a dangerous vicious cycle.23 Although research in this area is limited, stress control interventions may improve perceived stress and mood in patients with ILD.23 The lack of consensus on the inclusion of such recommendations in the checklist may be due to limited research in this area or to hospital pharmacists lacking sufficient time and/or training to provide such recommendations. As a result, it is possible that other professionals in multidisciplinary teams caring for patients with ILD should be responsible for these types of interventions.

Although not decisive for their inclusion in the list, consensus was not reached on the applicability of 2 items: "Patient stratification according to the SEFH chronic patient model" and "Collection of PRO"; and consensus was inconclusive on the item "Method of measuring PRO". In 2012, the SEFH published a strategic plan for pharmaceutical care in chronic patients with the goal of enhancing their treatment. One of plan's objectives was "A patient-centered approach: stratification as a tool for the new care model".15 Specific stratification models have been published by the SEFH for human immunodeficiency virus infection,25 immune-mediated inflammatory diseases,26 and for patients with respiratory diseases in general,27 but none has yet been developed that is specific to pulmonary fibrosis. This aspect may underlie the lack of consensus on this item regarding its applicability.

If our aim is to implement a patient-centered approach, we must deepen our understanding of how pulmonary fibrosis affects the patients' daily lives and identify the optimal methods to measure its impact. Nevertheless, there are very few PRO measures specifically designed for individuals with ILD or pulmonary fibrosis, and experience is very limited in those that have been developed or adapted for these patients.28 Thus, we find it unsurprising that no consensus was reached regarding its applicability. However, it is also plausible that in this case, and in that of implementing a stratification model, pressure on healthcare services may have influenced its assessment in relation to its applicability.

A possible limitation of this project is the scarce participation of first- and second-level hospitals. In our setting, there is debate on whether these diseases should be treated in referral units (located in third-level hospitals) or if centers with a relevant patient volume can provide the needed level of specialization.29 We believe that third-level hospitals are better placed to provide treatment due to the high volume of patients they treat for these diseases. Another possible limitation is that the attribute usefulness alone was the final criterion used to include items in the checklist. The reason for this decision lay in the definition participants received regarding "usefulness" ("the suitability/relevance of the information or action mentioned for its inclusion in the checklist"). However, it is relevant to note that for the checklist to be useful and generalizable to hospital pharmacy services that care for these patients, it must be applicable. Therefore, a field study should be conducted to assess the viability of this checklist in real-life conditions. Integrated patient support programs for IPF have demonstrated benefits for patients in terms of medication adherence.30 Although the results are very preliminary, a retrospective study has shown that a patient-directed pharmacy program for IPF had a positive impact on adherence to antifibrotic treatment.31 It would be of interest to conduct a further study to evaluate the impact of using this checklist on antifibrotic treatment outcomes and patient satisfaction with care.

Overall, we believe that this checklist can complement previous initiatives29 and, through pharmaceutical care, contribute to improving the integrated care of patients with ILD who require or are undergoing treatment with antifibrotics.

This is not a human research study, but rather a project to develop recommendations provided by an expert group. A systematic process (i.e., a modified Delphi method) was followed to obtain their opinions and reach a consensus on recommendations. Thus, given the nature of the project, it does not require mandatory approval from an Ethical Research Committee. The experts participated voluntarily and gave their written agreement to participate. Their responses are presented as an anonymized group.

The Delphi process that led to this Consensus Statement was facilitated by Ampersand Consulting, with the support and funding of Boehringer Ingelheim (BI). BI did not influence the opinions of the participating experts or the final consensus. The authors adhere to the authorship criteria recommended by the International Committee of Medical Journal Editors (ICMJE) and did not receive any payment related to the development of this Consensus Statement. Dr. Fernando Rico-Villademoros, from COCIENTE S.L., provided editorial and writing support, which was contracted and funded by BI. BI had the opportunity to review the manuscript for accuracy from a medical and scientific standpoint, and in regard to potential intellectual property considerations.

Marta Calvin Lamas and Miguel Ángel Calleja Hernández were responsible for the concept and design of the study. All authors were responsible for the intellectual content of the project, analysis and interpretation of the results, and preparation and revision of the manuscript. The final version of the manuscript was reviewed and approved by all authors, who consider themselves responsible for it. All authors met the authorship criteria outlined by the International Committee of Medical Journal Editors.

All authors accept their responsibility as defined by the International Committee of Medical Journal Editors (available at http://www.icmje.org/).

In the case of publication, the authors exclusively assign reproduction, distribution, translation, and public communication rights (through any audio, video, or electronic medium) of their work to Farmacia Hospitalaria and, by extension, to SEFH. For this purpose, a rights transfer letter will be signed upon submission of the manuscript through the online manuscript management system.

Among the unmet needs expressed by patients with interstitial lung disease is the improvement of multidisciplinary care required by this disease. To this end, it would be valuable to implement a patient-centered integrated care model that covers the entire care continuum and addresses all their needs. In such an integrated care model, hospital pharmacists would play a crucial role in the care of patients with pulmonary fibrosis.

The Spanish Society of Hospital Pharmacy (SEFH) has incorporated this integrated care model within its chronic patient care model and in its definition of pharmaceutical care. Overall, we believe that this checklist can complement previous initiatives and, from a pharmaceutical care perspective, contribute to improving the integrated care of patients with interstitial lung disease who require or are on antifibrotic therapy.