Streamlining the Development and Maintenance of a Local Wound Care Formulary

Wound product selection and formulary utilization are commonly overlooked aspects of care that have the potential to greatly impact the bottom line of any organization. A poor understanding of product indications and recommendations can quickly lead to suboptimal care, claim denials, and financial losses. 

Clinicians typically face several hurdles in the product selection process. The growing number of products and associated variability in reimbursement structure pose a challenge to many of us.^1,2 Additionally, the evidence supporting superiority of any one type of dressing is currently limited, due in part to the relative paucity of randomized controlled trials (RCTs) on the topic and to significant design biases in many of these existing RCTs.³ Uncertainty resulting from these obstacles may lead to decisions that are not evidence-based or do not bring clear benefit to patients.

Local wound care formularies can streamline appropriate product selection and utilization by clinical staff, thereby increasing the team’s efficiency, improving clinical outcomes, and decreasing product waste.³ Thoughtful product selection involves consideration of individual factors, such as wound characteristics, the patient’s clinical condition/comorbidities, and personal circumstances/preferences, in combination with product-related factors such as safety, efficacy, and cost-effectiveness and cost. Local wound care formularies represent a group of products that have been carefully pre-selected by the team based on the criteria above, negating the need for guesswork or excessive time spent researching product information during direct patient care, when time is often restricted. 

Why is it important to develop a local wound care formulary?

In addition to the benefits outlined above, other advantages include: 

• Increased clinical staff efficiency: Local formularies reinforce use of products that have been carefully evaluated and deemed both clinically appropriate and cost-effective by the local clinical team. As clinicians have ample opportunities to use the products, they learn to extract the maximum benefit of each.
• Inventory cost-savings: Many clinicians order products by brand name, not realizing there might be a sufficient equivalent product in stock under a different brand name. As a result, products accumulate and expire. Formularies can help facilities eliminate redundancies, avoid waste, and take advantage of bulk purchase discounts. 
• Coordination of care across partnering institutions: If clinicians at referring institutions are aware of the products used by the receiving institution, they may consider ordering products that are on the receiving institution’s formulary to avoid substitution or interruption of care.

Who should be involved in the development of a local wound care formulary?

Many larger institutions have contracts with medical supply distributors, in which about 70-90% of products used by the institution must be ordered from the distributor. However, even under these contracts, many hospital-based wound clinics, private offices, and post-acute care institutions may have the freedom to develop their own local wound care formulary, independently from the hospital or larger facility they may be part of. If independent formulary development is possible, the team developing the local formulary should include a mix of key stakeholders, such as local management, clinicians (physicians, qualified healthcare professionals, nurses, medical assistants, other clinical healthcare professionals), revenue cycle team members, and maybe even patients. The decision making group should cumulatively possess the skill set and experience needed to develop and implement the local formulary. 

What considerations need to be made when designing a local wound care formulary?

Before deciding which products should be part of the local wound care formulary, it is advisable that the formulary team consider the following questions in order to define resources, needs and limitations: 

• Is your facility restricted to a certain manufacturer or distributor? As mentioned, many healthcare organizations have “blanket” orders with a specific distributor, and contractual penalties may incur if the organization orders more than a certain percentage of products outside of this “blanket” order from another distributor or manufacturer. In this case, knowing which products are carried by the distributor will save the formulary team time. 
• Is your facility part of a single setting or does it interact with other settings? You may want to add products used by the other partnering institutions in your formulary to facilitate transition of care.
• What types of conditions are frequently treated by your facility? Understanding your case mix will help establish what type of products need to be represented in the formulary. 
• Do clinicians have a strong preference and/or experience with specific products? If so, it may be worthwhile considering including them in the formulary, and not replace them with products that are less familiar to the team.

What steps should be taken when developing a local wound care formulary?

Once resources, needs and limitations have been assessed, the following steps can be taken:⁴ 

• Identify products that have been used by your facility. This step may be easier if all products are gathered in a single area such as the supply room. List all available products by product type (e.g., alginate, foam), brand, and size. 
• Your formulary will need specific product types, depending on factors such as type of conditions seen at your facility and interventions offered. Ensure the product types needed to cover the needs of your patient mix are represented in the formulary.
• Evaluate brands in each product type, and eliminate redundancies. Ideally, each product type will have multiple sizes for staff to choose from. If one brand does not cover all sizes needed, try to limit to 2-3 brands. Criteria for decision making include available evidence supporting use of the product/brand, their indications and ability to meet the needs of the case mix (i.e., patients, wounds) treated at the facility, patient safety, clinicians’ and/or patients’ preference, and cost. 
• If a new product brand is being considered for inclusion in the local formulary, it is important to have a representative provide samples so the team can trial the product before inclusion. 
• After the formulary team agrees with the products in the formulary, feedback and approval by the Hospital Value Analysis Team or Improvement Team (or a similar group) may be needed. 
• Clinical staff may need to be educated on how to use the products on the formulary, and in-service training can be organized by the formulary team or the manufacturer.
• If clinicians need to use a product that is not on the current formulary, ideally it may be ordered, pending management approval. Management would then track usage of these products, which can eventually be considered for inclusion in the formulary.
• The formulary should be reviewed, updated and rebalanced annually.

What resources are available to develop a local wound care formulary?

Traditionally, local formularies have been developed manually. Formulary decision-making is carried out after clinical, reimbursement, and pricing information is accumulated. Sources of information include scientific literature, manufacturers’ instructions for use (IFU) and expert opinion/experience. Depending on the number of products to be evaluated and resources assigned to the project, this process may take months or even years. The resulting formulary is often presented in a document or intranet format, which can be printed and shared with internal stakeholders and with partnering institutions. However, these formats do not allow for easy dissemination or updates.

Technological developments have allowed advancements in formulary creation, implementation and maintenance. Digital applications such WoundReference’s Formulary Module allow formulary teams to develop and implement their local formularies in a few weeks as opposed to months or years.⁴ Digital formularies can expedite decision making by automatically categorizing brands by product type, and aggregating all required information in a single place. Furthermore, they can promote staff education, facilitate collaboration among partnering institutions, and be easily updated/maintained. 

Conclusion

Product selection in wound management can be a complex task, due to the increasing number of dressings with unknown effectiveness and potential financial constraints. Local wound care formularies can facilitate the process of dressing selection and reinforce use of clinically appropriate and cost-effective supplies. Despite known benefits, the creation and implementation of local wound care formularies are frequently postponed, as the project may be perceived as daunting. Digital formularies can streamline the creation, implementation and maintenance of local formularies, and thus promote cost-effective wound management. 

Elaine H. Song is a plastic surgeon, and Co-Founder and CEO of WoundReference, Inc. Catherine T. Milne is an advanced practice Wound, Ostomy Continence Nurse at Connecticut Clinical Nursing Associates, and member of the Advisory Editorial Board for WoundReference, Inc. Samantha Kuplicki is an Advanced Practice Registered Nurse, board certified as an Adult-Gerontology Clinical Nurse Specialist and Certified Wound Specialist with Utica Park General Surgery at Hillcrest Healthcare System, and member of the Advisory Editorial Board for WoundReference, Inc. Kathryn Whiston-Lemm is an Acute Care Nurse Practitioner and Certified Wound Ostomy Nurse with Queen of the Valley Medical Center, and member of the Advisory Editorial Board for WoundReference, Inc. Tiffany Hamm is an Advanced Certified Hyperbaric Registered Nurse, Certified Wound Specialist and Co-Founder, Chief Nursing Officer of WoundReference, Inc. Jeff Mize is a Registered Respiratory Therapist, Certified Hyperbaric Technologist, Certified Wound Care Associate and Co-Founder, Chief Clinical Officer of WoundReference, Inc. 

1. Baeyens TA. Wound care guidelines and formulary for community nurses. J Wound Care. 2000 Mar;9(3):106–8.

2. Aviles F. Let’s Be Frank: Integrating advanced therapy products into your wound clinic business model. Today’s Wound Clinic. 2018; 12(7):21–23. 

3. National Institute for Health and Care Excellence. Available from: https://www.nice.org.uk/advice/ktt14/chapter/Evidence-context

4. Song EH, Smith A, Milne C. How to set up and optimize your wound care formulary. WoundReference, Inc. Available from: https://woundreference.com/blog?id=setting-up-and-optimizing-your-formulary-with-woundreference