Should essential oil therapy in hospitals be treated (and regulated) like a traditional medication? In November 2019, The Joint Commission published a statement addressing the issue of whether or not essential oils should be defined as such, thereby subjected to routine medication management procedures and FDA regulation.

In our latest position paper, we break down the statement and what it means for facilities, and take a look at the current role of integrative aromatherapy practices in traditional healthcare.

You can download the pdf version here.

NAVIGATING AROMATHERAPY IN THE CLINICAL SETTING
What Nurses and Healthcare Facilities Need to Know

Introduction

As the saying goes, ‘what’s old is new again’, and nothing could be more accurate for aromatherapy. For several thousand years, plant-based therapies played an integral role in health and well-being, but with the advent of modern medical practices and chemically-derived drugs, natural remedies such as essential oils were left behind. Increasingly, modern healthcare practitioners –  nurses in particular – have rediscovered the benefits of integrative healing practices. One such practice, of using inhaled essential oil vapor to help manage patients’ stress and nausea symptoms, has gained considerable traction as a viable, low-risk and cost-effective care option in hospitals, surgery centers, hospices and chemotherapy centers.

Therapeutic inhaled essential oil therapy (TIEO), or ‘aromatherapy’, is a designated independent nursing intervention that decreases patient distress while increasing satisfaction with their care by providing patients a way to manage their own symptoms and avoid the interactions and side effects of some traditional medications used to address symptoms. As aromatherapy has become more widely incorporated into standard nursing practices, questions have arisen around its safety implications, as well as the policy and procedures that are required for aromatherapy use in the healthcare environment.

The purpose of this paper is to define the current role of aromatherapy in healthcare facilities, with an emphasis on implications involving The Joint Commission, the Food and Drug Administration (FDA), and the practice of professional nursing.

‘Aromatherapy’ vs. ‘essential oil therapy’

According to the Merriam-Webster dictionary, the definition of “aromatherapy” is “the use of aroma to enhance a feeling of well-being”[1]. Because this definition does not indicate the use of pure, unadulterated essential oils – which are believed to provide the most positive benefits [2] – some experts prefer the term “essential oil therapy” to define the exclusive use of high-quality essential oils (EOs), rather than aromatic fragrances that could contain chemical or synthetic constituents. However, for the purpose of this paper, we will refer to essential oil therapy as “aromatherapy”, to be consistent with language from The Joint Commission and the FDA.

How and where aromatherapy is used in healthcare

While the exact total number of healthcare facilities currently using aromatherapy is unknown, Soothing Scents Inc.* has experienced a significant increase in year-on-year product demand since its introduction in 2004. To date, Soothing Scents’ products can be found throughout the U.S. in over 2,000 healthcare facilities –  from large urban research centers such as the Mayo Clinic, to small rural hospitals and free-standing surgery centers.

The data shows that the most common hospital site using Soothing Scents products is the perioperative area, (which includes pre-operative admissions, operating rooms, Postanesthesia Recovery units (PACUs) and ambulatory surgery units). This stands to reason, as surgical patients commonly suffer both pre-operative anxiety and postoperative nausea and vomiting (PONV). The economic implications of PONV can be significant for a healthcare facility, causing delayed discharge, hospital readmissions, and increased staff and resource utilization. Studies conducted in PACUs have demonstrated that aromatherapy using certain essential oils provides significant PONV rescue relief, resulting in decreased hospital costs due to less anti-emetic use and faster patient discharge [3].

Another division experiencing an uptick in EO use is Labor and Delivery (L&D). Increasingly, nurses are using essential oils during the labor process to help alter pain perception, soothe anxiety, and manage nausea in expectant mothers [4]. This patient population has been known to request aromatherapy products, or seek approval to bring in their own during labor, delivery, and postpartum recovery.

Additional clinical sites using Soothing Scents’  products include:

  • Emergency departments
  • ICUs
  • NICUs
  • Pediatrics
  • Medical/surgical floors
  • Oncology/chemotherapy infusion centers
  • Special procedure units, such as interventional radiology/cardiology cath labs
  • MRIs
  • Hospice
  • Psychiatric/Alzheimer’s care

The Joint Commission statement on aromatherapy and what it means for healthcare facilities

In November 2019, The Joint Commission issued a statement to clarify the question, “do essential oils need to be treated like a drug, and thereby subjected to routine medication management procedures?”

The statement follows:

“According to the FDA, whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.” [5]

For nurses and managers currently using essential oil products in healthcare facilities, it is important to know how to interpret this statement. To break it down, keywords and phrases must be defined and interpreted using the FDA and The Joint Commission’s own language:

1. Medication

The FDA defines “medication” as a drug “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and articles (other than food) “intended to affect the structure or any function of the body of man or other animals” [6]. Therefore, almost any ingested, topical or injectable product that, through its label or labeling (including internet websites, promotional pamphlets, and other marketing material), claims to be beneficial for such uses will be regulated by FDA as a drug.

2. Disease

According to the FDA website, “disease or health-related condition” means damage to an organ, part, structure, or system of the body such that it does not function properly (e.g. cardiovascular disease), or a state of health leading to such dysfunctioning (e.g. hypertension).” [7]

3. Nausea

Rather than being classified as a disease, “nausea” is a symptom, described variously as either “stomach distress” [8], an “unpleasant painless subjective feeling that one will imminently vomit” [9], or an “unpleasant sensation of unease and discomfort.” [10]

4. Anxiety

The American Psychological Association (APA) defines “anxiety” as “an emotion characterized by feelings of tension, worried thoughts and physical changes like increased blood pressure” [11]. In other words, a normal reaction to a stressful or troubling event, which usually goes away on its own. Anxiety primes the body to ‘fight or flight’ by releasing adrenaline which causes a cascade of physical responses such as elevations in blood pressure and heart rate.

5. Therapeutic

The word “therapeutic” means to have a beneficial effect on the body or mind [12]. It is a term that can be found applied to a broad range of activities: from specialized medical treatments to relaxing massages, or even a walk in the woods.

Aromatherapy for nausea and anxiety is not a drug

Taken together, these definitions show that when aroma is used to provide a beneficial effect on a subjective feeling or an emotion, it meets the FDA test of not being classified as a drug, or making a drug claim. According to The Joint Commission position statement, aromatherapy products that help patients manage their nausea and anxiety would therefore not be required to adhere to a facility’s routine medication management. This means that essential oil products meeting these standards do not need to be dispensed or regulated by the pharmacy and can be stocked as a regular supply item.

Furthermore, to comply with FDA regulations, aromatherapy manufacturers are obligated to make accurate product claims that reflect the product’s intended use. In recent years, the FDA has issued warnings to large multi-level marketing EO manufacturers for using promotional language that suggested EOs could be used to treat diseases such as cancer, autism and the ebola virus [13,14]. Even though these claims appeared largely in social media posts published by enthusiastic distributors (versus direct claims in the company printed materials), the FDA demanded prompt action to correct the violations. For facilities to comply with The Joint Commission medication management bulletin, they must ensure their aromatherapy products do not claim to treat diseases. Manufacturers, such as Soothing Scents, make products specifically for the medical market, and thus meet these standards by consulting experts to ensure their packaging, website and printed materials consistently reflect the language required by the FDA.

Professional nursing standards 

The definitive compilation of designated nursing interventions, the Nursing Interventions Classification (NIC) [15] lists aromatherapy as an “independent nursing intervention”. By definition, this means that aromatherapy is a patient care action that falls within the scope of nursing knowledge and skills, and can be performed or delegated without obtaining a physician’s permission, or order. [16]

The NIC, initiated by the National Institutes of Health, was created by a research team representing multiple areas of clinical and methodological expertise to provide standardized language defining nursing practice. It is used for nursing curriculum development, healthcare policy and procedure creation, research and third party reimbursement. Updated every five years, the evidence-based manual uses a variety of methods, such as similarity analysis, hierarchical clustering and expert review, to validate the interventions.

Aromatherapy is in the “psychological comfort promotion” section of the NIC, along with other integrative therapies such as healing touch, guided imagery, and massage. For nausea, aromatherapy is considered a comfort and care action, similar to placing a cool cloth on the forehead, or offering a carbonated ginger beverage.

As with any other nursing intervention, aromatherapy requires policies, procedures and professional behaviors to ensure optimal outcomes and patient safety.

These include:

1. Patient education

Patients require instruction on how to use specific aromatherapy products, including visual demonstration as well as oral and printed instructions. The ANCC recommends using the “teach-back method” [17] when instructing patients in the use of aromatherapy products.

2. Method of delivery

An aromatherapy product should be chosen that possesses the safety features required in a healthcare environment; a delivery system that prevents undiluted EOs from contacting the skin, eyes, or mucous membranes of the nose and mouth, and a low enough ambient output to provide benefits only to the desired user. Casual methods such as saturated cotton balls or whole room diffusers are not appropriate for most patient care settings [18].

3. Staff training and certification

Nurses need up-to-date, evidence-based information, to implement aromatherapy confidently, safely and professionally. Many facilities incorporate online training for their nursing staff, such as the ANCC skills competency course, The Use of Therapeutic Inhaled Essential Oils for the Healthcare Setting, which provides nurses with didactic and clinical training as well as a certificate of competency valid for three years. [19]

4. Infection control

Many EOs possess antimicrobial properties and have an unblemished safety record. When using them with vulnerable patients, however, additional safety precautions are required. After a 2016 surgical ICU outbreak of drug-resistant Pseudomonas was found to be linked to a single bottle of essential oil that nursing staff shared between patients [20], many clinical sites have begun to employ single-use products only.

5. Storage and safety data sheets

To prevent degradation, essential oils in liquid form must be kept tightly sealed in dark-colored glass bottles, away from sunlight and heat. In addition, OSHA requires a safety data sheet (SDS) for each EO used in a healthcare facility. These must be kept readily accessible in order to obtain information about first aid and clean up procedures in the event of a spill. Aromatherapy products,  such as Soothing Scents inhalers, capture the EOs in a wick, which prevents the possibility of a spill or any contact with the liquid, making them easier to use and store safely.

6. Documentation

Accurately linking aromatherapy interventions to patient outcomes allows data collection for research, evaluation, and benchmarking, which makes it measurable. In turn, this data can be used to assess the impact aromatherapy has on healthcare costs and patient care. Using a tool such as a nausea scale [21] pre- and post- aromatherapy use is a way to professionally measure, assess and share patient outcome information.

Conclusion

Aromatherapy has become a common treatment option in healthcare facilities across the United States. Happy to provide patients with a natural way to ease their suffering, nurses have been the earliest adopters of this modality, and often go to great effort to introduce it into their clinical setting. Although aromatherapy products designed for the healthcare environment do exist, hospitals have shown reservations towards paying for them. The result is that in some clinical areas, aromatherapy is introduced in a casual manner without proper implementation of correct nursing policy and procedures. It is hoped that by empowering nurses and administrators with the information they need, aromatherapy can take its rightful place as a non-drug nursing intervention that offers a safe and effective way to soothe patient distress.

 

For more information on The Joint Commission statement, visit their website at  www.jointcommission.org. You can read and save this position paper in pdf format here.

Written by Wendy Nichols [CRNA, MS, BSN] and Stephanie Carver [RN, BSN]
 

References

  1. The Merriam Webster Dictionary, definition “Aromatherapy”: https://www.merriam-web ster.com/dictionary/aromatherapy2 2. Ratajc, Petra. “What Is Aromatherapy” The Tisserand Institute. https://tisserandinstitute. org/what-is-aromatherapy-petra-ratajc/
  2. Soothing Scents study booklet: https://soothing-scents.com/research/#our-studies
  3. Cenkci, Zehra. “The effect of aromatherapy on pain, comfort and satisfaction during childbirth.” New Trends and Issues Proceedings on Humanities and Social Sciences, 4.2; (2017)
  4. Standard FAQs, Aromatherapy and Essential Oils. The Joint Commission: https://www. jointcommission.org/standards/standard-faqs/nursing-care-center/medication-manage ment-mm/000002262/
  5. “Human Drugs: Overview”, The US Food and Drug Administration: https://www.fda.gov/ industry/regulated-products/human-drugs#drug
  6. “Code of Federal Regulations Title 21”, The US Food and Drug Administration:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.14

  1. The Merriam Webster Dictionary, definition “Nausea”. https://www.merriam-webste.com/ dictionary/nausea
  2. Nausea and vomiting: Hasler WL, Chey WD Gastroenterology. 2003 Dec; 125(6):1860-7.
  3. Singh, Prashant, et al. “Nausea: A Review of Pathophysiology and Therapeutics.” Therapeutic Advances in Gastroenterology, Jan. 2016, pp. 98–112, doi:10.1177/1756283X15618131.
  4. “Anxiety”, American Psychological Association: https://www.apa.org/topics/anxiety/
  5. The Merriam Webster Dictionary, definition “Therapeutic”: https://www.merriam-web ster.com/dictionary/therapeutic
  6. Warning letter Young Living, The US Food and Drug Administration: https://www.fda. gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ doterra-international-llc-09222014
  7. Warning letter Young Living, The US Food and Drug Administration: https://www.fda. gov/inspections-compliance-enforcement-and-criminal-investigations/warning-let ters/young-living-09222014
  8. Butcher, Howard K., et al. Nursing interventions classification (NIC). Elsevier Health Sciences, 2018.
  9. Daniel, R., R. N. Grendell, and F. R. Wilkins. “Nursing fundamentals, caring & clinical decision making, medication administration.” (2010): 903-04.
  10. http://www.teachbacktraining.org/home
  11. Soothing Scents, “Best Practices for Diffusing Essential Oils for the Health Care Environ ment”, eBook: https://soothing-scents.com/wp-content/uploads/2019/12/Best-Practices-for-Diffusing-Essential-Oils-in-the-Health-Care-Environment-by-Soothing-Scents.pdf
  12. Soothing Scents, “The Use of Therapeutic Inhaled Essential Oils for the Health Care Setting”, digital course: http://programs.soothing-scents.com/
  13. Mayr A, Hinterberger G, Lorenz IH et al. “Nosocomial outbreak of extensively drug-resistant Pseudomonas aeruginosa associated with aromatherapy”. American Journal of Infection Control. 2017 Apr 1;45(4):453-455.
  14. British Journal of Anaesthesia 108 (3): 423–9 (2012) Advance Access publication 25 January 2012 . doi:10.1093/bja/aer50522. https://journals.lww.com/nursing/Fulltext/2010/11000/Weigh_the_benefits_of_using_a_0_to_5_nausea_scale.8.aspx