Investigating the management of potentially cancerous non-healing mouth ulcers in Australian community pharmacies Brigitte Janse van Rensburg1, Christopher R. Freeman1, Pauline J. Ford2, Meng-Wong Taing1, 1School of Pharmacy, 2School of Dentistry, The University of Queensland, QLD, Australia. Correspondence: Dr Meng-Wong Taing, School of Pharmacy, The University of Queensland, Pharmacy Australia Centre of Excellence, 20 Cornwall St, Woolloongabba, QLD 4102, Australia. Email: [email protected] Word count: abstract: 249; main text: 3,433 Tables: 4 (2 supplements) Figures: None Conflicts of interest: None. Source of Funding This research that was funded by an Australian Dental Research Fund grant. The sponsors did not have a role in the design of the study, the collection, analysis and interpretation of the data, or in the writing and submission of this manuscript for publication. Acknowledgments We would like to acknowledge the work of UQ pharmacy student Katelyn Steele with collecting data for this study and the UQ School of Pharmacy, for provision of resources supporting this project. Author Manuscript This is the author manuscript accepted for publication and has undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/hsc.12661 This article is protected by copyright. All rights reserved DR. MENG-WONG TAING (Orcid ID : 0000-0003-0686-2632) Article type : Original Article ABSTRACT We sought to examine the management and referral of non-healing mouth ulcer presentations in Australian community pharmacies in the Greater Brisbane region. Trained simulated patients visited 220 randomly selected community pharmacies within the Greater Brisbane region in 2016. Simulated patients enacted two non-healing (> 1 month) mouth ulcer scenarios: A direct product request (DPR) (n=110) and a symptom based request (SBR) (n=110). Results were documented and evaluated against Australian national pharmacy practice standards. Referral rates for pharmacy staff (pharmacist, pharmacy assistant or mixed – pharmacist and assistant) were also assessed. Australian pharmacy practice standards recommend staff ask six key questions during SBR and DPR consultations to enable informed decision making. Two questions relating to identifying the patient and their symptoms were asked in the majority of interactions (76% and 69% respectively); the remaining four questions relating to symptom duration, treatments tried, other medications and medical conditions were enquired in only 32%, 53%, 31% and 27% of interactions respectively. Simulated patients were referred to the doctor/dentist in only 11.8% of all interactions (both scenarios requiring referral). Overall staff handling of non-healing mouth ulcer consultations was suboptimal compared to national professional standards. In particular, duration of the non-healing mouth ulcer was enquired in less than one third of consultations potentially resulting in low referral rates by staff. This study identifies the need for increased oral cancer awareness and education for community pharmacy staff and reinforcing the importance of practising according to professional standards to effectively screen for potentially cancerous non-healing mouth lesions. Keywords: Mouth neoplasms, referral consultation; service evaluation; community pharmacies Author Manuscript This article is protected by copyright. All rights reserved What is known about this topic: • Oral cacer is a coo aligacy orldide, rakig eighth ad thirteeth for ales ad feales respectiely. • No-healing ulcers persisting for longer than 2-3 weeks should be referred without delay to eliminate the possibility of a potentially cancerous lesion • Couity pharacy staff ca hae a iportat role i the early detectio ad preetio of oral cacer. What this paper adds: • First Australia study iestigatig pharacy aageet of potetial outh cacers • Approximately 10% of staff referred a non-healing mouth ulcer; suboptimal handling of presentations compared to pharmacy professional standards • Need for icreased oral cacer aareess ad educatio for pharacy staff INTRODUCTION In Australia, 2915 new cases of cancer in the oral cavity were diagnosed in 2014.(AIHW) Oral cancer is a common malignancy worldwide, ranking eighth and thirteenth for males and females respectively.(McCullough, Prasad, & Farah, 2010) (Farah, Simanovic, & Dost, 2014) Typically, patients diagnosed are over 40 years of age, and known causal risk-factors include alcohol, tobacco, human papillomavirus, micronutrient deficiency and betel quid use.(Farah, Vu, Allen, McCullough, & Ford, 2012; Ford & Farah, 2013) Importantly, early detection, diagnosis and treatment is known to significantly enhance survival rates and reduce morbidity.(Ford & Farah, 2013) Two reasons for delayed treatment include patient delay and professional delay.(Farah et al., 2012) Patient delay is defined as the period between recognition of signs/symptoms and first consultation with a health practitioner. Professional delay is a consequence of delayed Author Manuscript referral to specialist medical or dental practitioners for definitive diagnosis of the tumour.(Gómez et al., 2010; Scott, Grunfeld, Main, & McGurk, 2006) Models have also been used to describe delays in detection and diagnosis with authors Emery et al. proposing a recently refined version of the Anderson model for total patient delay.(Walter, Webster, Scott, & Emery, 2012) This model describes four time intervals (appraisal, help- seeking, diagnostic and pre-treatment) making up the total time between the appearance of signs/symptoms of a This article is protected by copyright. All rights reserved cancer and the commencement of treatment.(Ford & Farah, 2013) The study by Vaughan et al. reports the largest proportion of total delay time arises from patients not presenting to their dentist or doctor.(S. N. Rogers et al., 2007) Factors associated with patient delay include low socioeconomic status, heavy use of alcohol and tobacco, limited access to primary health care and self-medication.(Farah et al., 2012; van der Waal, de Bree, Brakenhoff, & Coebergh, 2011) Community pharmacy staff are in a position to influence patient delay and can have an important role in the early detection and prevention of oral cancer. There are numerous types of oral cancer, with oral squamous cell carcinoma being the most common form. Early signs and symptoms of oral cancer prior to malignant change can include ulceration, changes in texture/colour, swelling, and precursor lesions (leukoplakia, erthroplakia). The most common oral symptoms noticed by patients are persistent lumps, soreness in the oral cavity, abscess and a non- healing sore/ulcer.(Farah et al., 2012) Patients commonly attribute these symptoms to a dental problem, infection or problems with a prosthesis and unfortunately, approximately half of oral cancers worldwide are diagnosed at advanced stages III and IV when the five year survival rate is about 50%, but can be as low as 15%.(van der Waal et al., 2011) More than 75% of UK pharmacists receive questions relating to oral enquiries on a regular basis, with the most frequent concerning mouth ulcers and toothaches.(Dickinson, Howlett, & Bulman, 1995) A study in Johannesburg reported similar findings with mouth ulcers the most common reason for seeking advice (88%).(Gilbert, 1998) A recent Australian study found that more than half of community pharmacists and assistants are involved in identifying signs and symptoms for oral health problems.(Freeman, Abdullah, Ford, & Taing, 2017; Taing, Ford, Gartner, & Freeman, 2016) People with non-healing ulcers may seek advice for management (symptom-based presentation), or directly request products for treatment (direct product request). Community pharmacy staff however, may not be appropriately assessing or managing non-healing mouth ulcers. A UK study reported only 10% of pharmacists referred a patient to a doctor or dentist presenting symptoms suggestive of oral cancer.(Scully, Gill, & Gill, 1989) A study in the US identified only one-third of pharmacists appropriately referred patients presenting with a non-healing ulcer to dentists/doctors, whereas two-thirds recommended purchase of an over the counter product.(Leonard, Isetts, & Leonard, 1996) More recently, studies in the UK and Spain reported higher rates of referral with up to 82% of pharmacist referring a non-healing mouth ulcer.(Evans & Gibbons, 2005; Varela-Centelles et al., 2012) A UK study has shown that pharmacist training for the detection of potentially malignant oral lesions effectively improves referral rates.(S. Rogers, Lowe, Catleugh, & Edwards, 2010) Currently, no studies have evaluated how Australian pharmacy staff manage non-healing mouth ulcer presentations, or whether they appropriately refer these patients. This study is exploratory and will describe pharmacy staff management of non-healing mouth ulcers in two Author Manuscript simulated scenarios; a patient symptom-based presentation (SBR) and a direct product request (DPR). This study will determine whether Australian community pharmacy staff potentially contribute towards patient diagnostic delay of non-healing mouth lesions using standardized patient methodology. This article is protected by copyright. All rights reserved METHODS Simulated patient methodology Simulated patient methodology is commonly used to covertly observe pharmacy staff practices