NSW Government-Sponsored Clinical Trial: Management of Dermatology Conditions by Community Pharmacists

The overall aim of this study is to evaluate the clinical and economic impact and implementation of a service model (intervention) delivered by community pharmacists in New South Wales (NSW) and 15 pharmacies in the Australian Capital Territory (ACT), managing four skin conditions for individuals presenting with a suspected diagnosis – Impetigo, Atopic Dermatitis, Mild Plaque Psoriasis and Herpes Zoster. The intervention will be provided under a NSW Health Authority allowing participating NSW pharmacists to supply medications as part of the trial.. For ACT, a discretionary licence will be approved for participating pharmacies. (https://www.act.gov.au/health/businesses/licences-permits-and-registration/medicines-and-poisons-licences/apply-for-a-medicines-poisons-therapeutic-goods-licence-permit). Intervention description The intervention is multicomponent: Pharmacist training Prior to service delivery, pharmacists will be clinically prepared through a training program (either through the Australasian College of Pharmacy or Pharmaceutical Society of Australia) to apply best practice standard of care. Furthermore, study specific research training modules will be completed by pharmacists to ensure efficiency in the consultation process, patient consent, recruitment of patients, timely referral, and quality data collection. The ACP training module is separated in four components, each covering one dermatological condition, and have the following learning objectives: Herpes Zoster Course: - Identify the scope of practice of a pharmacist in the management of Herpes Zoster (Shingles) within professional and legislative frameworks. - Recognise the anatomy, physiology and pathophysiology and understand the epidemiology of Herpes Zoster (Shingles) - Identify the signs and symptoms of Herpes Zoster (Shingles). - Outline the relevant examination skills and patient history to confirm a diagnosis. - Apply an approved clinical pathway to the management of Herpes Zoster (Shingles) in conjunction with documentation, follow-up and referral pathways. Acute Exacerbations of Mild Plaque Psoriasis Course: - Describe the scope of practice of a pharmacist in the management of acute exacerbations of mild plaque psoriasis in adults within professional and legislative frameworks. - Apply the anatomy, physiology and pathophysiology to the signs, symptoms and potential risks of mild plaque psoriasis. - Demonstrate history and examination skills to confirm acute exacerbations of mild plaque psoriasis. - Apply an approved clinical pathway to the management of acute exacerbations of mild plaque psoriasis in conjunction with a patient, including documentation, follow-up and referral pathways. Mild to Moderate Atopic Dermatitis Course: - Identify the scope of practice of a pharmacist in the management of mild to moderate atopic dermatitis within professional and legislative frameworks. - Apply the anatomy, physiology and pathophysiology to the signs, symptoms and potential risks of untreated atopic dermatitis. - Demonstrate history and examination skills, and order relevant pathology, testing, and evaluate these findings, to confirm a diagnosis. - Apply an approved clinical pathway to the management of atopic dermatitis in conjunction with a patient, including documentation, follow-up and referral pathways. Impetigo Course: - Recognise the scope of practice of a pharmacist in the management of impetigo within professional and legislative frameworks. - Recall anatomy, physiology and pathophysiology as it relates to the signs, symptoms and potential risks of untreated impetigo. - Demonstrate history and examination skills and evaluate these findings to confirm a diagnosis. - Apply an approved clinical pathway to the management of impetigo. The PSA training module is also divided by condition and covers the following learning objectives: Herpes Zoster Course: - Describe the clinical features and complications of herpes zoster (shingles). - Explain the transmission and prevention of herpes zoster (shingles). - Identify the pharmacotherapy options for managing acute pain associated with herpes zoster (shingles). - Discuss the need for referral to a medical practitioner in certain cases of herpes zoster (shingles). Acute Exacerbations of Mild Plaque Psoriasis Course: - Recognise the clinical features associated with mild plaque psoriasis. - Evaluate the various treatment options available for mild plaque psoriasis and understand the goals of management. - Discuss the role of pharmacists, in the assessment, referral, and management of plaque psoriasis. Mild to Moderate Atopic Dermatitis Course: - Recognise the clinical features associated with atopic dermatitis. - Evaluate the various treatment options available for atopic dermatitis and understand the goals of management. - Discuss the role of pharmacists in the assessment, referral, and management of atopic dermatitis. Impetigo Course: - Recognise the clinical features associated with impetigo. - Evaluate the treatment options available for impetigo and understand the goals of management. - Discuss the role of pharmacists, in the assessment, referral, and management of impetigo. The University developed modules are intended to cover NSW legislative specific content, the clinical guidelines, research requirements, how to prescribe, and antimicrobial stewardship. The learning objectives for the Introduction to Prescribing course are to: - Describe the process of taking a medical history, utilising clinical decision-making, formulating a provisional diagnosis and prioritising issues. - Collaborate and engage effectively with individuals from different cultures, tailoring consultations to individual consumers and their needs. - Recognise the importance of tailoring consultations to individual consumers and their needs. The learning objectives for the three recorded presentations are to: Introduction - Identify the specific legislative requirements and regulations imposed by the NSW Health Authority and ACT Health Licence applicable to the dermatology trial. • Requirements needed for pharmacies to participate in the dermatology trial. • Restricted substances involved in the dermatology trial. • Regulatory and compliance requirements for the supply of these substances. - Understand the professional requirements and responsibilities of pharmacists participating in the dermatology trial. - Identify the financial incentives and support available for participating pharmacies and pharmacists in the dermatology trial. - Discuss the potential costs for participating pharmacies and pharmacists in the dermatology trial. - Describe the technological tools and software platforms used in the delivery of the dermatology service. - Explain the criteria and processes for enrolling patients in the dermatology trial. • Consent requirements for pharmacies and pharmacists to participate in the trial. • Informed consent process for patients engaging in the service. • Workflow involved in delivering the dermatology service. Clinical Guidelines - Outline the components of the dermatology conditions clinical practice guidelines. - Recognise the ‘red flags’ and ‘referral’ points. - Explain the treatment options available under the NSW Health Authority and ACT License. Antimicrobial Resistance and Stewardship - Recognise the common pathogens of skin and soft tissue infections. - Recognise the risks of antimicrobial resistance in relation to mupirocin. - Outline antimicrobial stewardship principles in relation to dicloxacillin; flucloxacillin; cefalexin; trimethoprim + sulfamethoxazole. - Recognise the risks of acute rheumatic fever and rheumatic heart disease in relation to impetigo. - Outline the resistance potential of antivirals. MedAdvisor will also provide training to participating pharmacists as part of the contractual agreement with the University of Newcastle on the use of the software. This training is delivered online. The training only needs to be completed once and may take up to 10 hours depending on progress. This training is available to complete up to 3 weeks prior relative to intervention delivery. Once pharmacists have confirmed their completion of these mandatory training during the consenting process, they will be an ‘approved pharmacist’ which under the NSW Health Authority certifies them to provide the consultation service. Pharmacies and pharmacists must comply with three main obligations: - The pharmacist will comply with the Clinical Guidelines, including that the pharmacist makes a record in MedAdvisor pharmacy software, or an approved system by the Ministry of Health, regarding the supply (as per NSW Health Authority). - The pharmacist must keep a clinical record for 7 years that contains (as per NSW Health Authority and ACT Licence): • sufficient information to identify the patient; • the date of the treatment; • the name of the pharmacist who undertook the consultation; • any information known to the pharmacist that is relevant to the patient’s diagnosis or treatment (for example, information concerning the patient’s medical history); • any clinical opinion reached by the pharmacist; • actions taken by the pharmacist; • particulars of any medication supplied for the patient (such as form, strength and amount); • notes as to information or advice given to the patient in relation to any treatment proposed by the pharmacist who is treating the patient; • any consent given by a patient to the treatment proposed. - The pharmacist will ask for the patients consent to be followed up by the research team at 7-14 days depending on the condition. Pharmacy consultation The structured consultation is summarised as follows: - Participant eligibility assessment, in which the pharmacist will assess if the patient meets the inclusion/exclusion criteria to participate in the study. - Service offering, during which the pharmacist will explain the features of the study and will ask the patient if is willing to participate. - Provision of the Patient information sheet and informed consent form. The pharmacist will undertake a structured consultation with the patient in the community pharmacy, anticipated to take 10-20 minutes, applying the co-designed clinical guidelines which considers the recommendations from the Australian Therapeutic Guidelines. During the clinical assessment of the patient, the pharmacist will elicit relevant clinical information, including medical conditions, medication history and assessed for the possibility of one of the four dermatological conditions, in line with the approved clinical guidelines. If the patient is a usual patient of the pharmacy, their medication dispensing history may be checked on the computer record, if not a patient medication history will be performed. Further information may be obtained from the patients’ Electronic Health Record (EHR). After the clinical assessment, the pharmacist will use the approved clinical guidelines to determine the management approach which may include treatment, or GP or ED referral: 1. Provision of conservative management and self-care advice (e.g., symptom control, future prevention advice), 2. Supply of medications: If a medication is prescribed, the patient will be provided with the relevant Consumer Medicines Information and/or a self-care card. The medications available for prescribing will depend on the skin condition as indicated by the NSW Authority and ACT Licence. 3. Appropriate and timely referral, if required, according to the following categories by the clinical guidelines: - Referred to an Emergency Department – the patient’s condition requires immediate medical attention by the emergency department or an urgent care clinic. - Referred to a GP – the patient’s condition requires medical review with a medical practitioner at the next available appointment is appropriate due to patient circumstances (comorbidity, chronic disease etc.) - Referred for further investigation – the patient’s condition may be suitable for treatment by the pharmacist; however, referral is warranted to further investigate the condition or for testing. - Referred outside of the trial – the patient is outside the scope of the trial by eligibility criteria and needs medical evaluation. - Referred for further treatment – the patient needs treatment that is outside the scope of the medicines that can be prescribed by pharmacists. The reason for referral must be clearly communicated verbally and in writing to the patient and provided with the appropriate referral documentation using the secure communications software when the patient is able to indicate a regular GP to contact. This communication will also include information regarding advise and treatment received. 4. Provision of follow up advice (e.g., expectation around duration of symptoms which should respond to appropriate treatment therapy within 7 - 14 days depending on the condition) and to see GP urgently if their symptoms worsened or no improvement, if symptoms persist after treatment, symptoms reoccur or if further symptoms manifest. The participant will usually present via a walk-in approach with symptoms that may be reflective of one of the four dermatological conditions, although can make appointments if required. The first step will be the pharmacist to request that the patient read the Participant Information Statement and understand the consenting process using an electronic device (e.g., mobile phone). This information will be accessed by the participant scanning a pharmacy specific QR code via this device. If they do not have a mobile device, then the pharmacy will offer to use an alternate device e.g., iPad or similar. If the participant, after reading the Participant Information Statement, provides consent (copies of which will be sent to the participants email address), the pharmacist will then proceed with the consultation, guided by an IT program, in a private consultation room in the pharmacy. Following this consultation, the pharmacist will make the appropriate clinical decisions and provide advice to the participant. This will be a single consultation, although the patient may be advised to consult their medical practitioner if symptoms persist or if they experience any adverse events. Patients assessed as eligible to participate in the trial will be followed up at different time frames depending on the condition. The follow up will include a brief survey administered by The George Institute either via SMS message or email with a link to a case report form using George Data Systems (GDS). Information will be collected on the primary outcome measure of symptom resolution/relief rate, any additional care provided, changes to treatment, service satisfaction and overall experience of care. Basic demographic (educational level, employment status, cultural status) and clinical information (condition, reason for consult, symptom description, other professional visits and other medications use) will also be captured. The follow up survey will be sent to patients by SMS and/or email, 7 or 14 days after the consultation depending on the condition: - 7 days for Impetigo, Psoriasis and Herpes Zoster (Shingles) - 14 days for Atopic Dermatitis. Up to 3 reminders will be sent to all patients that do not complete the survey at two, four and six days after the initial sending date. Patients that do not complete the survey after these reminders will be assumed as lost to follow up and will not be contacted further. Financial implications for patients In NSW, the cost of the consultation with patients ($35) will be paid for by the NSW Government to pharmacies, irrespective of the outcome of the consultation. The patient will meet out of pocket expenses for any medicines or products provided. In the ACT, the cost of the consultation will be paid for by the patient receiving the service to pharmacies, irrespective of the outcome of the consultation. The patient will also meet out of pocket expenses for any medicines or products provided. The approved pharmacist will be trained to clearly communicate all costs that may be involved in receiving treatment at the earliest point possible and throughout the consultation. Medicines will not be subsidised by the Pharmaceutical Benefits Scheme (PBS). A statement has been included in the in the patient information statement and consent form so that the patient is informed of any costs associated with receiving the service. Implementation strategy There will be follow up training and ongoing support for pharmacies and pharmacists as part of a translational and implementation strategy through the study period. Practice change facilitators will visit these pharmacies to provide ongoing support, answer any queries, ensure quality data is being collected, and collect implementation data. The implementation component of the study will be underpinned by the Consolidated Framework for Implementation Research (CFIR), in particular the use of an adapted implementation model for community pharmacy. Implementation factors (barriers, causes and facilitators) and the Dougherty strategy classification systems, adapted to community pharmacy, will be used. The ongoing support system will be through a practice change facilitator assigned as a research support to each pharmacy involved in the trial. On average, the facilitator will contact the pharmacy monthly. Pharmacies will be classified as low, medium or high contact based on several parameters including number of monthly consultations, number of pharmacists delivering the intervention, and the fidelity of consultation data. Targeted additional contacts will occur depending on this classification.