Foreword

      With an increasing number of chronic wounds, growing availability of wound care products and rising costs (Guest et al, 2020), selecting a cost-effective product remains a significant aspect of wound care. Although wounds present a substantial burden to healthcare systems, evidence-based wound care lacks priority (House of Lords, 2017). There has been recognition within the National Health Service (NHS) that there is a need for national recommendations such as the establishment of the National Wound Care Strategy Programme (NWCSP) in the United Kingdom (UK); however, in comparison to other health conditions, wound care remains a relatively low priority. Wounds can be prevalent in all patients, and they often become more difficult to manage in those with comorbidities and long-term health conditions.

      Evidence shows that there is unwarranted variation in wound care across the UK, with an underuse of evidence-based practices and overuse of interventions supported by little to no evidence (Gray et al, 2019; NHS Digital, 2019). It is crucial that clinicians avoid isolated and uncoordinated practices that prevent information or evidence from being shared or implemented, which often leads to decisions that are varied and affect patient care. Evidence-based person-centred care is a priority in clinical practice, with a focus on individual choice and shared decisionmaking, and although in recent years there has been a move away from more paternalistic care, in some organisations there may be a culture of ‘professional exceptionalism’ among some clinicians (Scraggs et al, 2012). When developing a formulary, it is therefore vital to consider clinical and leadership behaviours with particular reference to change management and the mindset needed from staff to standardise practice.

      Evidence shows that inappropriate and unnecessary dressing changes can have a negative impact on both patient wellbeing and healthcare resources (Lindholm and Searle, 2016). Local wound care formularies can streamline and guide the process of appropriate dressing selection, support clinicians to make cost- and clinically effective decisions and promote evidence-based practice. Amid unprecedented challenges and mounting pressures on the NHS, guidance on how to build and implement a formulary is especially relevant at the moment. In addition, there is a need to simplify processes while improving experiences for both clinicians and patients.

      A multidisciplinary group of experts convened for a meeting in Birmingham in June 2023 to develop this Best Practice Statement, focusing on best practice for developing a formulary, use of evidence and change management processes. The group included experts within tissue viability, lymphoedema, wound and vascular care, podiatry, operational management, procurement and education. The aim of this meeting and the resulting document was to learn from shared experiences and provide guidance on best practice, to increase awareness of local wound care formularies and ensure that all patients receive safe, evidencebased and cost-effective care.

This document was developed with the following overall objectives:

■ Establish requirements of a formulary

■ Provide support to those who are developing or updating a formulary

■ Explore the importance of an evidencebased approach to decision-making, including consideration of national recommendations and guidance

■ Consider overall costs and the wider health economy

■ Discuss the need to change mindsets

■ Explore how to evaluate and measure success and effectiveness

■ Identify the challenges to be addressed.

      Due to the multiplication of formularies, a substantial amount of time and effort is wasted on producing local documents. As a result, this statement includes a template to provide practical guidance on how best to develop and use a formulary to achieve best practice. This also provides an opportunity to challenge historical ways of developing a formulary, ensuring evidence is used in the best way to support clinicians and patients.

What makes a good formulary?

      A formulary is a list of medicines or treatments that are considered to have sufficient evidence for safety, efficacy and cost-effectiveness, and have been approved for use within a healthcare organisation. The National Institute for Health and Care Excellence (NICE) has defined local formulary as the ‘output of processes to support the managed introduction, utilisation or withdrawal of healthcare treatments within a health economy, service or organisation’ (NICE, 2015). In the context of wound care, formularies aim to provide clinicians with comprehensive, evidencebased information on wound care products, as well as guiding them in their choice of treatment, so that an optimum environment for wound healing can be achieved.

      Formularies have an important role to play in underpinning safe and effective use of treatments (Department of Health and Social Care, 2012). They aim to support patient access to recommended medicines, treatments, medical devices and technologies that have been approved by NICE. Fundamentally, they aim to promote evidence-based practice – by providing a framework within which it is safe to practice – and can help clinicians differentiate between what may or may not be suitable for a particular patient or wound.

What is the value of a wound care formulary?

      Formularies provide a consistent and standardised approach to wound management, and can ease the decision-making process, by making recommendations and guiding clinicians towards evidence-based and costeffective clinical practice (Song et al, 2019). Additionally, implementation of a formulary has been shown to reduce costs and increase staff efficiency (Yeung et al, 2017; Song et al, 2020). Advances in wound care, an ever-increasing range of products with unknown effectiveness and potential financial constraints can make it challenging for clinicians to choose the right treatments for the right patients (Stephen-Haynes, 2013; Song et al, 2019). This is especially the case for less experienced staff who have not had specialist training in tissue viability, and for whom a formulary may help them to make better product/intervention choices. Therefore, formularies can improve patient safety and ensure that patients receive the right care at the right time. Additional benefits of formularies are listed in Box 1.

      Before implementing a formulary, it may be useful to consider whether there are any downsides that need addressing. There is a possibility that a formulary may curtail individual decision-making, by restricting or limiting the ability of patients to engage in discussions around treatment and make choices independently. Clinicians need to be mindful of these potential downsides, real or imagined, and make sure that the importance of patient involvement is not forgotten when developing a formulary.

      Objectives, goals and scope of a formulary may differ according to department – e.g. mental health versus paediatrics. Nonetheless, it is important that healthcare organisations clearly articulate to clinicians the value of an evidence-based and up-to-date formulary from the outset, including why it’s needed and how it helps. There was a consensus from the expert panel that, in some areas, the way formularies are currently set up inhibits these conversations from taking place, and that where value is not communicated properly, the formulary can seem less useful. Therefore, the way in which value of the formulary is worded and conveyed to clinicians needs to be consistent across organisations. Reasons to follow the formulary must be emphasised and benefits for both patients and clinicians need to be communicated right from the beginning. This approach is consistent with the fundamental principle of systems leadership, which affirms that people will only ultimately own what they themselves create (Dreier et al, 2019).

Principles that underpin a successful wound care formulary

      It is important that formularies are kept fluid and dynamic, and they should be regularly reviewed and revised as guidance changes and new products emerge. They also need to be accessible to the public, so that patients and service users can understand the treatments available locally on the NHS. Ultimately, formularies help standardise practice and the most important factors that underpin their development are [Figure 1]:

■ Patient safety

■ Patient/staff (user) experience, including patient outcomes

■ Cost-effective care.

Figure 1. Main factors to be considered when developing a formulary

 

      Since its origins, the goals of medicine have been to improve wellbeing and ‘do no harm’. However, harm resulting from unsafe care is common and can have adverse health and economic consequences (English et al, 2021). Using products that are not clinically or economically effective can lead to suboptimal care and cause harm, including omission of care, inappropriate care or a failure of clinicians to follow national guidance. These suboptimal approaches in practice can all lead to a deterioration in the patient’s condition. Implementing a formulary can support clinicians to follow the principles of healthcare ethics and apply them effectively to clinical practice, thereby minimising the risk of iatrogenic harm.

Managing formulary content

     Removing or mandating choice may be appropriate to a certain degree; however, clinicians should avoid viewing this as a loss of autonomy, as it can help with reducing variation in practice. Making use of a list of categories related to wound care can also help in the initial development stages, and support clinicians to determine what would be the most essential subgroup(s) to focus on when developing the formulary (Box 2). To build a successful formulary, clinicians may also benefit from deciding on categories (e.g. intended use, wound type and clinical evidence) in order to group products and interventions

Governance

      The main elements of clinical governance are considered to include the following: clinical effectiveness and evidence-based practice; clinical audits; risk management; continuous learning; education and training; patient involvement; information and data; and staff management [Figure 2].

Figure 2. Governance structure (adapted from Kaini, 2013)

      Governance is a key feature of the ongoing lifecycle of a wound care formulary to ensure that it is represented fully and appropriately, is reviewed consistently, has a review date, includes targeted education, is audited and allows for risk management. These governance structures can help facilitate wound care formulary development at the organisational level. This value-driven approach will assist in delivering high standards and ensure safety of care is enhanced (Veenstra et al, 2017). A traditional top-down, one-size-fits-all approach may undermine local reform initiatives; therefore, a bottom-up perspective, which considers operationalisation and recognises teamwork as critical to high-quality care, is needed.

Ensuring a collaborative approach for formulary users

      It is expected that both clinicians and patients will have access to the formulary; therefore, building a formulary needs to be inclusive. It is essential that there is ‘buy-in’ from everyone involved, so the formulary represents the views and perspectives of both the staff and patients who use it. Clinicians may be less likely to use a formulary that they have not been involved in developing or updating; therefore, involving a diverse group of professionals is critical, and formularies need to be co-created with all relevant stakeholders, including partner organisations; manufacturers of products; clinical groups and networks; patients or patient representative groups; local people and communities; and other local decisionmaking groups. Stakeholders can have a role to play in the development and updating of local formularies, and can help determine the scope of the formulary, including size of the patient population to be covered and range of products/interventions to be included.

      Although involvement of the multidisciplinary team is vital [Box 3], in order to bring these different groups of people together and take responsibility for developing and maintaining the formulary, a formulary lead needs to be identified, who will take the lead on developing the formulary and involving relevant stakeholders. The lead person should have expert knowledge of wound healing together with expert understanding of the product form, function and specification, and how this compares to similar products in the range. The group should be facilitated by a person with product management experience to assure timely completion.

      Pharmaceutical staff involved in the formulary should have relevant skills and expertise – e.g. understanding of devices/ products, how they work and how they relate to local practice. It is important that they also have detailed knowledge of differences between products that are considered similar, in terms of mode of action, efficacy and safety.

Product selection

      Having a clear scope about the specific group of patients that the formulary is aiming to target is crucial, to ensure the formulary meets the needs of the intended audience and patient population.

      When choosing to list a product within a formulary, clinicians need to define the specification that will guide their choices. The first consideration for clinicians is to strive for the highest level of evidence available for each product type, with specific reference to any national guidance or recommendations, such as the NWCSP, Professional Record Standards Body and/ or NICE technology appraisals. Clinicians should also strive for the highest level of evidence that is available. If robust evidence concerning cost-effectiveness exists to show that one product delivers better outcomes, then it should be selected. If there is no evidence available to differentiate between products, user experience can be a useful alternative to propose a product for inclusion within the formulary. However, user experience is a subjective measure.

      Other factors that should be considered when selecting a product are size(s), material, standards, adherence or nonadherence, design and price (with a focus on long-term treatment cost rather than cost per unit). According to a study by Raepsaet et al (2023), further outcomes that could be considered for dressings are ‘ability to stay in place’, ‘leakage’, ‘pain’, ‘dressing-related periwound skin changes’, ‘changes in wound size over time’ and ‘overall satisfaction’. Although the aim of this study was to develop a core outcome set for evaluating the effectiveness of bordered foam dressings in the treatment of complex wounds, the findings may be useful for all dressing types.

      While some products are very distinctive and unique, others appear more similar – e.g. many foams are similar in their mode of action but differ in quality, and clinician preference may dictate what products they choose to use. Evidence should override preference in most instances, unless a clinician has reason to believe that a different treatment option is in the best interests of the patient, in which case all decision-making needs to be justified and documented.

      Guidance for each product should also include the following: indications/list of uses; limitations/contraindications; cost (if possible to determine); precautions; examples of an appropriate wound type for treatment by the product; recommended duration of use; and correct method of application and removal. Importantly, this guidance can be in the form of pathways to support appropriate usage. In this way, formularies can hold clinicians to account and facilitate positive change.

Reducing unwarranted variation

      Research has found that there is unwarranted variation in the assessment and treatment of wounds, due to underuse of evidence-based practices and ineffective use of interventions (Gray et al, 2019). However, some variation may be necessary, as every patient is unique, with different needs, preferences and choices. There may need to be some flexibility in exceptional circumstances, such as end of life, allergies, patient wishes or choice and cultural beliefs/ religious considerations; however, this should be justified, documented and audited, so that trends can be identified. Ensuring the patient is comfortable at all times is a priority and, in some cases, symptom management may take priority over healing – to relieve symptoms of the wound, or side effects caused by treatment, that will make the individual more comfortable but won’t necessarily heal the wound. Clinicians should refer to local symptom control guidelines to ensure that all prescribing is in accordance with the formulary.

An effective formulary needs to be restrictive to aid decision-making

     If the formulary is too broad or adaptable, it may become impotent as a means of standardising practice; for example, there shouldn’t be multiple choices of a single type of foam. Therefore, there needs to be a balance between providing and restricting choice.

Supporting innovation

      Innovation is a critical driver to enable healthcare organisations to deliver better outcomes for patients. The World Health Organization (WHO) defines health innovation as a new or improved solution with the transformative ability to accelerate positive health impact (WHO, 2023). As new products emerge, it is important that clinicians avoid making changes for the sake of it; however, they should evaluate relevant products and consider whether they need to be added to the formulary. This evaluation process needs to link to innovation and current guidance, and it can be helpful to think of innovation as a spectrum, starting with small, incremental improvements at one end, through to large, transformational change at the other end.

Pathways for care

      Wound care formularies are of limited use without defined evidence-based pathways to support clinical decision-making and guide care. Early diagnostics and intervention pathways need to be given priority over product selection, and they must be in place prior to formulary development. It is important to note that these pathways must reflect the products that are on the formulary, so they can be reviewed and amended in line with the formulary. Once a diagnosis has been determined, an appropriate pathway should be followed that considers aetiology, and appropriate products from the formulary that are congruent with the pathway stage for the condition being treated.

      Anecdotal evidence suggests that formularies have failed in the past due to:

■ The scope of the formulary being too big; for example, formularies that include wounds on every area of the body

■ All relevant stakeholders not being involved in the creation of the formulary – e.g. input from a podiatrist must be sought if foot pressure ulcers are being included.

Defining formulary scope, with clear inclusion and exclusion criteria, needs to be determined from the outset

      Formulary scope should be defined together with a review of all the possible wounds and product types to include. This may be useful when deciding what the formulary should cover as a minimum. For example, specialistic centres such as a burns unit may necessitate the inclusion of specialised dressings within the formulary.

      Regardless of who is involved in constructing the formulary, unavoidable tension can sometimes exist between the clinician’s professional autonomy and what the organisation considers to be best practice. For example, clinicians may sometimes find themselves in a position where their clinical judgement clashes with what their organisation’s procedures are, especially as each patient is unique, with different needs and interests. Therefore, following guidance (e.g. NICE, the Scottish Intercollegiate Guidelines Network [SIGN], Clinical Resource Efficiency Support Team [CREST]) that has been developed nationally to support clinicians is paramount, to ensure standardised, evidence-based practice is delivered nationwide.

NICE guidance

      The NHS Constitution for England provides patients with the right that medicines and treatments that have been recommended by NICE, for use in the NHS, should be made available to them – if determined clinically appropriate by a clinician – and, therefore, they should be included in the formulary adopted by local healthcare providers and commissioners (NICE, 2015).

      Essentially, NICE advises the NHS regarding treatments that should be made available, and it follows a robust process involving external independent clinicians and academics in evaluating clinical evidence. NICE is asked to review new and existing medicines, medical devices, diagnostic technologies, surgical procedures and health promotion activities when their availability varies across the country (NICE, 2023a). Following a NICE technology appraisal (TA), NICE makes a recommendation as to whether a medicine or treatment should be made available across the whole of the NHS. The NHS is then obliged to fund and resource a medicine once NICE has recommended it and, therefore, where NICE guidance is available for a product – or there is recommendation against the use of a product – this should not be ignored without clear justification.

     Anyone can ask NICE to consider a device, diagnostic or digital technology for NICE guidance (NHS, 2023b). A misconception can sometimes exist among clinicians that companies pay NICE to evaluate and assess their products, and make a positive recommendation for them. However, the NICE medical technology guidance process is completely funded by the Department of Health and Social Care.

Link to familiar structures and tools

     Before treatment takes place, it is essential that clinicians comprehensively and holistically assess patients and their wounds. To help simplify the decisionmaking process, the wound care formulary needs to link to known/familiar structures and frameworks; for example, wound bed preparation (WBP) and the TIMERS framework. Referred to as the management of a wound to optimise healing, WBP is a framework for the assessment, diagnosis and treatment of wounds to create an optimal environment for healing (Falanga, 2000; Schultz et al, 2003; Wounds UK, 2021). The TIMERS tool, which builds on WBP, should be included within the assessment process to help structure decision-making. The original TIME concept was expanded to TIMERS by Atkin et al (2019), which is comprised of six components that underpin WBP (Tissue, Inflammation/Infection, Moisture balance, Edge of wound/Epithelialisation, Repair and Regeneration, Social factors).

      Another tool that is used in clinical practice for the management of wounds, and could be integrated within a formulary, is the MOIST concept (Moisture balance, Oxygen balance, Infection control, Support Strategies and Tissue management). MOIST is a wound healing concept that builds on the existing TIME concept and takes into consideration several novel therapeutic options that have become available since the TIME concept was first introduced (Dissemond et al, 2022). MOIST aims to improve the local treatment of wounds and address factors that can adversely affect desired clinical outcomes (Gray et al, 2013), and it can be applied following a full patient assessment as part of holistic wound management.

Bringing the wound care formulary to life

      Finding a mentor can be a valuable and necessary step for clinicians who are new to leading on the development of a formulary. Clinicians should consider reaching out to their professional networks, attending relevant conferences and workshops, and joining professional online platforms and communities to seek guidance from individuals with experience in formulary management.

      It is essential that the wound care formulary is easy to use; for example, where possible including pictures of packaging and not just dressings, so that products are easier to identify in practice. The focus of the formulary should be on generic product categories (e.g. foam or hydrocolloid dressings). Brands can be added that fit with the product specification, but clinicians should be aware that these can change over time due to market pressures. As wound care formularies become more digitalised, it may be easier to include more information. Clinicians are also likely to benefit from an image library – e.g. access to high-quality and copyright-free pictures of wounds, and tissue types, in multiple skin tones. This may be especially useful for clinicians and patients that have reading or visual difficulties, as well as an accessibility guide and alternative text (alt-text) to explain what is in each image.

      Populating the wound care formulary with images makes it visually appealing, which may encourage more clinicians to use the resource. Where appropriate, QR codes and interactive links should be included – e.g. links to wound assessment forms and various tools. It may also be necessary to translate the document into multiple languages, so that it is accessible to all patients. The formulary could also be converted into various formats to make it more user-friendly – e.g. small, condensed booklets that can be attached to key rings or lanyards.

      Symbols could also be added to the formulary; for example, a currency symbol to indicate an expensive/high-spend item – and to consider if a product linked to a lower overall spend rather than unit spend would achieve an equivalent outcome – red flag symbols to alert clinicians to important clinical information or a symbol to show that a product is recommended by NICE for a specific condition/indication.

Patient preferences

      Patient advocacy is a critical element of care that involves considering the patient’s choices, needs and preferences (WUWHS, 2020). In the early stages of a formulary, product choice may be minimal and not reflect the patient’s needs; therefore, individual choice needs to be respected and advocated for in practice – e.g. through inclusion of a patient and public involvement (PPI) representative on the board of the formulary group. Mechanisms of collecting patient and public feedback to improve services in day-to-day practice also need to be put in place – e.g. questionnaires, involvement of Patient Advice and Liaison Services (PALS) and local involvement networks (LINKs), and local evaluation of products through patient experience and feedback.

      Information, such as leaflets and online videos, should be provided to patients on how to use specific products and their purposes. Clinicians should make sure that patients know what to expect and how a product works – e.g. what the dressing is made of, the issues the dressing is designed to address and how it may help. Many patients will want to be made aware of the clinical evidence and guidance that supports a chosen product; therefore, clinicians should bear in mind that product selection is a collaborative process that involves the patient as much as possible. This is becoming increasingly important as patients often share information they have read online with their clinicians, so healthcare professionals need to keep up-to-date as new evidence emerges.

      Self-care/supported self-management is another important element of care that the formulary needs to consider. Formularies can provide opportunities for patients to engage with their own care, including timely access to over-the-counter options (e.g. emollients and moisturisers); education about self-care; guidance on product/ dressing use; information on potential side effects and lifestyle modifications; and possible access to telemedicine and other digital health tools. Wherever possible, selfcare should be encouraged for individuals deemed suitable (LeBlanc et al, 2018). Some patients are more able or willing to engage in self-care than others, so patients need to be assessed – both physically and mentally – as having capacity and capability to self-care (Dowsett and Nichols, 2021). It is necessary for clinicians to engage in honest and realistic conversations with patients about expectations, and what their goals and preferences are concerning treatment.

The importance of evidence-based practice

Reflective Question: Can you think of a time when your decisionmaking differed from NICE guidance? What was the outcome and how did you determine that your clinical expertise was superior in these cases?

       Evidence-based practice combines clinical expertise, the latest and best available evidence and the patient’s unique circumstances and value systems, to standardise practice and improve patient outcomes (Abu-Baker et al, 2021). Once a formulary committee has been established, there needs to be a review of existing national and local guidance and policies (e.g. NICE), as well as the current published clinical evidence. Where there is good-quality evidence, such as NICE recommendations as well as relevant and current evidence from randomised controlled trials (RCTs), it is easier to justify the inclusion of a particular product within the formulary. Clinical effectiveness and safety of products can be determined through systematic reviews, meta-analyses, RCTs, cohort studies and case series [Figure 3].

      Evidence levels can vary, and clinicians need to be flexible in their practice to treat wounds using the evidence that’s available.

      Otherwise, lack of high-level evidence may make good products unavailable. On the other hand, clinicians should also ensure there is accountability for applying a product that is not evidence-based for the treatment of specific wounds. Evidence-based, goldstandard practice is not always delivered, even when the evidence exists. Formularies and pathways, therefore, have a vital role to play in providing a tool to help drive change.

      When putting together an evidence-based formulary, it is important not to rely solely on empirical evidence or clinical judgement. Taking a person-centred approach is essential to translate the pyramid of evidence to the needs of individuals, and products need to be considered that align with patients’ needs, preferences, expectations and values. Therefore, shared decisionmaking tools can be especially useful to help integrate patient perspectives into formulary decision-making. The product specification can include these elements; for example, level/type of evidence available and patient self-care information/support.

MYTH

NICE guidance fails to consider patients’ needs and preferences

TRUTH

NICE considers all three components of the threecircle model developed by Sackett et al (1996) when drafting their recommendations, by working with clinicians, people who use services and carers.

A new take on evidence-based practice

      The fundamental aims of evidence-based practice are to reduce variations in practice, enhance quality of care, improve outcomes for patients and reduce costs (Melnyk and Fineout-Overholt, 2019). Research shows that evidence-based practice is associated with improved clinical outcomes, patient safety and quality of care (Connor et al, 2023). However, there is limited use of evidence-based practice in wound care, and ritualistic and paternalistic practice is commonplace (Grothier, 2018).

      Sackett et al (1996) developed a threecircle model of evidence-based medicine, which proposes that the most appropriate clinical decision is based on three elements: the best available research evidence; patients’ values, preferences and individual circumstances; and practical proficiency/ expertise of the clinician [Figure 4]. In this model, Sackett et al (1996) gave clinical expertise the highest role and most emphasis (highest placed circle). However, it was agreed by the expert panel, that as person-centred care becomes the norm, more consideration needs to be given to the patient voice, including their preferences and values.

Reviewing the evidence and making decisions

      Cochrane reviews represent the highest level of evidence; however, clinicians shouldn’t lose sight of other forms of evidence. Before making a decision, critical appraisal of the evidence should be undertaken, and all relevant empirical evidence should be considered. A staged approach that considers each level of the hierarchy of evidence could be taken. It is important to bear in mind that NICE may have considered the evidence already and have made recommendations based on robust critical appraisal of the published evidence; however, if there are currently no recommendations from NICE concerning a specific product, clinicians will need to assess what evidence there is for themselves.

Best Practice Statement: Those reviewing evidence within the team should have critical appraisal skills

Reflective Question: Do you feel you have the knowledge and skills to critically appraise the available evidence and select evidence to support formulary decisions?

      All evidence, irrespective of funding or whether the material belongs to a company, should be critically appraised. Clinicians need to consider how strong the methodology is and make sure they are aware of any potential biases. In particular, company literature can be useful for product information, including mode of action, sizes and formats of products, as well as additional clinical evidence references. In regard to decision-making, it is essential to understand that effectiveness can be made up of many different things. The ultimate aim should be to have the right clinician treat the right patient at the right time and with the appropriate treatment. Patient values and preferences matter; therefore, there is a need to understand how the research translates into clinical practice. Although qualitative data can sometimes be dismissed as weak research, it can be very useful and helps capture patients’ lived experiences. All clinicians providing wound care have a responsibility to learn how to appraise clinical evidence and identify any gaps in their knowledge – e.g. through personal development processes.

Considering clinical generalisability

      Understanding generalisability of research can help clinicians identify the best available evidence. When assessing evidence, clinicians need to determine whether the research involves specific cohorts of patients in clinical practice. Clinicians should avoid being too narrow in the interpretation of evidence and consider how the results will guide treatment decisions instead. It can be helpful to think of generalisability as a continuum of ‘more/less generalisable’, rather than a dichotomy of ‘generalisable/ not generalisable’ (Kamper, 2020).

Considering cost

Best Practice Statement: When evaluating the performance and costeffectiveness of the formulary each year, it is important to consider not just unit costs, but also the costs involved in the entire patient journey, as well as the impact the formulary has on patient outcomes

Reflective Question: How do you ensure that you consider all costs involved with a patient episode of care in relation to patient outcomes?

      The total annual NHS cost of managing 3.8 million patients with a wound was estimated to be £8.3 billion (Guest et al, 2020). Wounds pose a substantial health economic burden on healthcare organisations, so considering the costs of a formulary is important. The aim of a formulary is to support clinically and costeffective prescribing of wound care products. Choosing the correct dressing should reduce time to healing, promote cost-effectiveness and improve patients’ quality of life (Dabiri et al, 2016); therefore, evidence-based wound care will reduce costs when compared with cheaper alternatives that are unsupported by robust clinical evidence.

Appropriate use of resources

      Resources should be utilised efficiently, so that the formulary can have the greatest value while maintaining financial sustainability. When monitoring the success of the formulary, it can be useful to measure improvement and value generated by the formulary against the associated costs – e.g. by conducting a cost-effectiveness analysis. Clinicians should make sure that all long term costs are considered, including those related to patient outcomes, productivity of staff, formulary compliance and increased patient adherence to care. Efficiencies and costs associated with the formulary can also be measured by involving relevant stakeholders, to identify areas that require improvement or potential cost-saving opportunities. Defining the scope and purpose of the formulary (e.g. to improve patient outcomes and/or reduce spend) is essential, so that clinicians can consider whether clinical benefits of the formulary outweigh the potential risks and associated costs. 

Preventing waste and promoting sustainability

      Choosing the right product during the first assessment can help prevent waste. Clinicians can minimise wastage by ensuring they check packaging for the correct product, size, format and expiry date before opening. Clinicians also need to be familiar with the use of the product and comply with storage and temperature requirements (e.g. store upright’). The formulary needs to refer clinicians to the proper procedures for safe disposal or return of faulty or expired items, in order to minimise waste. For example, there need to be instructions not to throw away open packaging and, instead, keep the materials, record the barcode number on the box, take photos if necessary and contact a named person.

      According to Guest et al (2017), an unhealed wound is associated with a significantly higher cost to healthcare systems than a healed wound. Therefore, clinicians need to conduct a full and comprehensive assessment, and follow evidence-based pathways to reduce time to healing. This has the most benefit in terms of sustainability and can help reduce the number of wound dressing changes, which reduces resource use, waste and energy used to travel to and from the patient’s home.

      As well as the economic cost to organisations, clinicians should consider the environmental impact of a formulary. By considering whether specific products are environmentally friendly, clinicians can predict and anticipate where carbon savings may be made. Moreover, using products that are manufactured in the same country in which they are being used is beneficial. To support net zero strategies, each healthcare organisation should have an accountable lead and a ‘Green Plan’, which sets out their aims, objectives and plans to achieve environmental improvements and carbon reduction. 

      Wound care formularies can represent highspend items, and this will require a tender process for purchasing, and a suitable impact assessment. Procurement and sustainability colleagues can support with this and provide guidance on the range of questions required as part of the product specification. Moreover, the supplier will be required to submit their corporate Green Plan, which supports reduced carbon emissions and social value offerings.

Best Practice Statement: Access to the right care at the right time is the most important aspect of cost-effectiveness and sustainability

Reflective Question: How would you go about making the case for the use of a treatment option that has been recommended by NICE? (see Box 4 for guidance)

Best Practice Statement: When developing a formulary, make sure to involve individuals who don’t just have critical appraisal skills, but also have real-world understanding and the knowledge/skills to apply this in practice

      Furthermore, engaging with industry partners, who may have net zero strategies and sustainability targets, can help when developing a formulary. For example, some products may comprise of components that can be returned to industry for recycling rather than going to landfill. Industry expertise may also help clinicians to identify areas for improvement in regard to creating more sustainable practices.

Considering overall costs and the wider health economy

      Routes of supply can affect cost considerations related to a formulary, including differences in cost, convenience and immediacy. Different supply routes may have varying costs for the same products, and it is important not to overlook indirect labour costs associated with delivering certain types of care – e.g. negative pressure wound therapy (NPWT) – that require a trained healthcare professional to administer. Focusing on the overall health economy is critical; however, there is a need to articulate this better to both clinicians and procurement staff.

      During the initial scoping out of the formulary, it is essential to consider the patient population and who the formulary will serve. Clinicians need to avoid looking at unit costs in isolation, since an increase in patient population or length of time to healing will lead to an increase in cost. Therefore, clinicians need to assess cost per patient rather than cost per dressing change. Additionally, there may be other factors at play that can influence cost, including ritualistic care and treating all patients in the same way.

Cost models and risk management

      Cost models (e.g. NICE cost models) can provide a useful framework for assessing the financial implications of formulary development. They can also assist with estimating and allocating spend for the formulary. However, costs do fluctuate because of variations in care, and unexpected events can happen (e.g. products being removed and supply chain issues). It is helpful to keep in mind that costs will also likely rise when a new product is first implemented. Therefore, contingency plans must be in place, which could include seeking additional funding or implementing a cost-saving initiative. There was a consensus from the expert panel that transactional wound care is often delivered by healthcare assistants, and since the formulary may be used by unregistered professionals, a contingency plan – that assesses patient care, staff safety and data protection – must be in place.

      Appropriate use of a formulary supports risk reduction strategies for patients and organisations, which inevitably saves on costs. Healing patients quicker creates savings in terms of product expenditure and staff time, but also reduces the risk of costly complications of delayed healing, including infection and hospital admission. Adherence to evidence-based pathways, which are supported by the formulary, may also help reduce harm and risk of litigation.

Making the case to procurement

      When conveying the need for a product to procurement, it is essential that clinicians present a compelling argument that highlights the clinical, operational and financial benefits of the product. As primary users of products, clinicians are best placed to judge whether they are fit for purpose (Chapman and Hudson, 2021). Clinicians should inform procurement of exact product specifications, how products work together, the challenges faced when using specific products in practice and how these problems can be addressed with the help of procurement [Box 4].

Best Practice Statement: Individuals and organisations need to encourage and support the removal of barriers to change

Best Practice Statement: Enabling change supports evidence-based practice

Reflective Question: Can you think of any circumstances in which it is acceptable to choose between applying or ignoring the evidence?

      It is widely recognised that organisational culture, and its associated behaviours, has a direct impact on patient care (BusseyJones and Genao, 2003). Therefore, it may be the case that clinicians choosing not to follow, or to even ignore, the formulary is a symptom of deeper cultural issues within the organisation or the service. Healthcare organisational culture represents the shared ways of thinking, feeling, talking and behaving that underpin local practice. It has been suggested that healthcare organisations are made up of multiple cultural subgroups, which may be driving forces for change or undermining initiatives that support quality improvement (Mannion and Davies, 2018). Building a healthy culture requires the creation of a curious mindset that becomes open to adaptive change – consisting of small, incremental adjustments, rather than major, structural change – and developing a formulary is a step in the right direction.

      Changing culture takes time, and a shift in mindset is critical in an environment where individuals may fear change and loss. It is essential for healthcare organisations to create and embrace an open culture in which staff feel able and supported to speak out and share concerns (Department of Health, 2015). The establishment of a lifelong culture of learning is essential, and education related to effective wound care and product selection should be offered to all staff using the formulary. Building a culture of openness may also help clinicians to acknowledge where mistakes have been made and learn from them, share best practice and develop the confidence to speak up for patients.

Facilitating change towards evidencebased practice

      In order to successfully communicate the importance of evidence-based practice, clinicians need to consider enablers and resistors to change. A force field analysis was carried out by Shafaghat et al (2021), which identified key driving forces (DFs) and restraining forces (RFs). To facilitate change, DFs must prevail over RFs – either by reducing/eliminating RFs or strengthening/ promoting DFs. Figure 5 shows the DFs and RFs that are most relevant to wound care in the UK, as identified by the expert panel. However, it is important to note that enablers and barriers to change may differ according to individual organisations/departments.

      As healthcare organisations embrace evidence-based care, the focus needs to be on enabling the enablers and disabling the barriers. Weighting of these forces should also be considered, as some are more powerful than others; for example, Shafaghat et al (2021) found that ‘relevant, reliable, interpretable and understandable evidence’ and ‘interaction between researchers and decision-makers’ were the strongest DFs, and ‘lack of organisational commitment and support’ and ‘lack of relevant/high-quality evidence’ were the strongest RFs.

Increasing engagement

      Implementation strategies need to be considered from the beginning and all the way through the process of building and maintaining a formulary. Right from the early stages, clinicians can support this by considering who will be in charge of each part of the implementation plan. There is a need to foster a culture of responsibility and overcome ‘professional exceptionalism’, where individuals think ‘the guidance doesn’t apply to me’ or ‘my patients are different’. One way in which healthcare organisations can improve implementation of evidence-based practice is by increasing engagement and involving clinicians in the process. Strategies that clinicians can follow to support this are listed in Box 5.

      Everybody using the formulary has a responsibility to understand and use it properly. Clinicians also need to consider whether strategies are needed to make the formulary visible to more junior staff. Levels of engagement can vary across different departments and organisations.

Best Practice Statement: The wound care formulary and its associated pathways should be identified within local policies and, therefore, be locally enforceable

      Inclusivity at all levels is vital and a ‘top-down’ approach should be avoided – educators and academics can help by teaching the concept and principles of good wound assessment and treatment, as well as the importance of using local formularies and pathways, to pre-registration students as a way to deliver evidence-based care.

Education and training

      Education is a key strategy to implement change. Clinicians should be provided with agreed appropriate training and education on wound assessment and how to use the formulary safely. Training should incorporate the available wound care products, their mode of action and the expected outcome of use. The importance of evidence-based wound care needs to be emphasised in regard to its ability to improve patient outcomes and workforce efficiencies, increase morale and result in sustainability gains. All staff need to be trained on the safe application and removal of dressings. It is also important to understand any potential challenges staff, within a community or hospital setting, may experience when delivering wound care and to try to mitigate against these. Regular educational workshops and training programmes may also help inform and familiarise clinicians with the products on the formulary, helping ensure consistency and reduce unwarranted variation in practice. Organisations should also consider the use of a digital capability framework, so clinicians can self-assess their own levels of capability and seek appropriate further support and education to ensure safe and effective practice.

Addressing challenges and measuring success

Reflective Question: What support do you need in your personal practice and local organisation to make it easier for you to follow the evidence and deliver best practice?

Best Practice Statement: Post-implementation of a wound care formulary, an accountable local team should ensure aims and objectives of the formulary are met and maintain responsibility for ongoing monitoring of clinical relevance, effectiveness and cost control

      There are many harmful misconceptions that can hinder the development and success of formularies in practice. Clinicians may perceive formulary development as existing outside of their remit, and that it will be timeconsuming and difficult. Limited resources, budget constraints and potential legal and regulatory requirements can also prevent clinicians from supporting the initiative. Changing the way in which care is delivered will help improve patients’ quality of life and free up time for clinicians; therefore, a change in mindset is essential, including:

■ A proactive approach that emphasises preventative measures and early intervention, rather than treating problems as they arise

■ A shift from basing decisions on what happens to be in the dressing cupboard, rather than an objective assessment and clinical rationale

■ A move away from choosing products because ‘this is what we have always used’

■ A person-centred, holistic and individualised approach.

Measuring success

      Success of the formulary should be determined by the achievement of predefined goals. Clinicians need to be clearabout what success looks like and who will report on it. By communicating the difference the formulary will make, there is a greater chance of increasing engagement. To evaluate and measure success and effectiveness, clinicians should, as a priority, consider patient outcomes and healing rates, which products are being used most, in what quantities, and whether they are being chosen appropriately. Other measures should include patient and clinician satisfaction and any adverse events. Costs should only be monitored over a longer period of time, as there may be initial cost increases while behaviour patterns are still being changed; for example, if a more expensive product is added to the formulary, costs will likely rise but the benefits will only be seen once wounds start to heal, so there will be an overall reduction in cost and resource use.

Post-implementation audit

      Once the formulary has been implemented, ongoing audits are useful to monitor overall cost and clinical effectiveness. To encourage continuous improvement, and maximise benefits of the formulary, cost audits need to be compared with the available budget and use of resources in relation to wound care practice. To ensure good governance, there need to be accountable individuals within the organisation to oversee these processes post-implementation of the formulary, and to determine where improvements have been made to patient care and clinical services. There are some direct delivery services that provide live spend and usage data, which may be effective in monitoring formulary use.

Developing key performance indicators

      To ensure the formulary is meeting its objectives, key performance indicators (KPIs) should be set and monitored over time. KPIs are a useful tool to measure the performance of the formulary. Developing local KPIs needs to be a multidisciplinary effort. For example, in the context of a wound care formulary, a KPI that measures the formulary’s use of products, as well as exception reporting, will help establish whether the formulary meets the needs of the local population and will address any educational gaps. For a wound care formulary, KPIs could include percentage of adherence to the formulary, percentage of clinician variation per patient or percentage of positive patient experience scores. Establishing KPIs can also help measure patient satisfaction and identify trends in product usage to inform decisions related to product selection. If a KPI is not met, there should be a review and an improvement plan put into place.

Best Practice Statement: To maintain transparency, state within the formulary that any company support and products included have been chosen by the formulary group and may change subject to review

Process, outcome and balancing measures

      Once measures and KPIs have been chosen, there is a need to identify whether or not certain changes are actually improvements. Process, outcome and balancing measures are the three types of measures that are often used in improvement efforts (NHS England, 2017; Box 6). To monitor improvements due to the formulary, process and outcome measures are essential and, where necessary, a balancing measure to monitor any unintended consequences that can be either positive or negative.

Working with companies and industry

      There is an opportunity to work in collaboration with wound manufacturer companies and industry partners to help develop the formulary. This needs to be transparent and in line with the organisation’s policy. Industry experts, clinicians and local representatives can help support clinicians – e.g. by providing relevant clinical evidence and training programmes, and easy access to up-to-date information about their products. However, transparency is key, and any conflicts of interest need to be declared – e.g. ‘inclusion of a product does not constitute company endorsement’. Clinicians need to ensure they adhere to their professional code of conduct and maintain an ethical approach when working in collaboration with commercial companies. See Appendix 1 for a real-life case study that details the experiences of clinicians working with industry to develop and implement an evidence-based wound care formulary into clinical practice.

Ongoing wound care formulary development

      Ongoing development of the wound care formulary requires as much attention as the initiation and planning stages, especially as healthcare priorities change and new evidence emerges. The maintenance process is dependent on regular reviews, and clinicians should make sure there is a process and system in place to facilitate these. Tools such as version control should be enlisted to track and manage changes to the formulary, and a record should be kept locally concerning rationale and justification on why certain changes were made (e.g. products added/removed), as per the evidence. It is paramount that the formulary keeps up-to-date, and digitalisation of health has made this easier to do. In addition, any adverse incidents should be reported immediately as per local policies, and procedures and appropriate action should be taken.

Checklist tool for developing a wound care formulary

Appendix 1

Developing and implementing a wound care formulary: a real-life case study from the Isle of Wight

      In this case study, Joy Tickle – a Tissue Viability Nurse Consultant – provides a real-world account of the recent and successful introduction of a wound care formulary, and associated clinical care pathways, at the Isle of Wight NHS Trust. Prior to the formulary, there was a lack of evidence-based care, and ritualistic practice and unwarranted variation were common, which resulted in poor clinical outcomes. This case study offers valuable insights into the processes and strategies employed to introduce an evidence-based wound care formulary into practice.

      A successful formulary takes time to develop and implement; it is not a quick fix, and for Joy’s team, the process took between 12 and 18 months. A joint effort is vital, and, in this real-life scenario, it required a diverse group of representatives from various groups, including medicines management, clinicians (e.g. tissue viability, podiatry, acute teams and community professionals), clinical commissioning groups (CCGs), audit teams and patients. Although it may not be necessary to involve some groups from day one (e.g. documentation groups and IT teams), their input should be sought as the formulary develops.

      Accurate diagnosis is critical to ensure that patients receive the right treatment for the right patient at the right time. Formularies also need to include products that are relevant to local patient populations, so the target population of the formulary should be established right at the start. Simplicity is key, and while there needs to be choice to accommodate for different types of wounds, patients’ needs and comorbidities, it is important not to overcomplicate a formulary. Formularies need to quickly and effectively guide clinicians in their choice of treatment, as well as provide confidence and reassurance to clinicians that they are making the right decisions. Making the right decision for individual patients is paramount, so in this real-life case study, clinicians were able to prescribe offformulary by completing an exemption form.

      For Joy and her team, successful implementation of the formulary would not have been possible without the help of Urgo Medical. It can be beneficial to seek support from industry, as long as both sides are open and transparent with each other from day one. For example, working with a particular partner does not mean that clinicians must include their products in the formulary, and it should be made clear within the formulary that inclusion of a product does not constitute company endorsement.

      It is important to consider various forms of evidence, and Joy’s team looked at recommendations from National Institute for Health and Care Excellence (NICE) as well as clinical trials, randomised controlled trials (RCTs) and anecdotal evidence. There is a significant fact-finding and informationgathering process involved in the construction of a formulary, but clinicians do not always have the time to identify, read and digest all the available research. Working with industry, therefore, was invaluable for Joy’s team, as Urgo Medical provided the experts and clinicians who could review the evidence and information related to products.

      Education is a key component of the implementation stage to ensure the formulary is used correctly. Various industry partners represented on the formulary supported its launch event as well as the education provided regarding product evidence and mode of action. There was also an opportunity for clinicians to familiarise themselves with the clinical pathways, meet all the company representatives who were included in the formulary and ask questions. Education needs to be offered to clinicians on wound assessment, wound management and differential diagnosis, as well as training on how to use the formulary. In this real-life scenario, education was provided via different formats, such as face-to-face workshops and digital platforms. To discuss care options and choices with their patients, it is important to encourage clinicians to use the local formulary and evidence-based pathways.

      Formularies are not set in stone, and they should be updated as new evidence and research emerges. In this way, formulary development is ongoing and requires just as much attention as the initial planning and implementation stages. In this real-life scenario, Joy and her team found that the formulary helped streamline decisionmaking and promote clinically and costeffective practice. Clinicians should avoid reinventing the wheel, as there are examples and support available that can help guide organisations that are looking to introduce an evidence-based wound care formulary into clinical practice.

Appendix 2

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This article is excerpted from the WOUNDS UK 2023 | BEST PRACTICE STATEMENT by Wound World.