Finding the right approach to the screening and management of chronic respiratory diseases like COPD in primary care through community pharmacy

Chronic respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) are among the top ten most common chronic conditions in Australia, causing a significant social and economic burden to the patient, family and healthcare system. In 2014-15, 7 million Australians reported having chronic respiratory diseases (Department of Health – Australian Government, 2018). According to the 2017-18 National Health Survey, a total of 2.7 million Australians had asthma, and around 600,000 had COPD (Australian Bureau of Statistics, 2018). Despite the presence of management guidelines and availability of safe and effective respiratory medication, problems such as under/misdiagnosis, poor understanding of asthma and COPD, have led to the conditions being poorly managed in Australia. As stable asthma and COPD are mainly managed in primary care the work described in this thesis firstly focused on learning about how asthma and COPD are managed in the community worldwide and the different strategies and tools such as the computerised clinical decision support tools, that can be utilised to improve the screening and management of these conditions in primary care. An essential component of the primary healthcare system is community pharmacy. Over the last few decades, there has been a paradigm shift within the profession, from the conventional role of medicine supply to the provision of specialised health services. Pharmacists, thus, have extended their scope of practice to include the delivery of preventative health screening strategies and the provision of a wide range of services that aim at improving the health and well-being of patients. Community pharmacists, globally, have demonstrated the capacity and efficacy in the delivery of disease management programs for various clinical conditions. Given this growing pharmacy-based interest in the public health agenda, screening and management of chronic respiratory diseases such as asthma and COPD undoubtedly represents a potential healthcare area that pharmacists could focus on. In-depth literature reviews conducted on the role of community pharmacists in the screening and management of asthma and COPD indicated that there had been a lot of work done assessing the effectiveness of community pharmacists delivered asthma management interventions, but little is known about their involvement in the screening and management of people with COPD, especially in Australia. Therefore, the overarching aim of this thesis was to explore the effectiveness and feasibility of Australian pharmacy-based COPD screening and management service as part of a proposed future model that could enhance and standardise the delivery of such interventions in Australia. The four published papers, arising from this research, address the different aspects of the overall aim and provide an insight into the Australian status of screening and management of asthma and COPD in pharmacy practice and provide recommendations for a service model in the form of a “wireframe” to develop a computerised COPD screening and management program for future implementation. Aims The main aims of this research were to: 1. Explore the effectiveness of computerised clinical decision support system (CCDSS) in the management of asthma and COPD in primary care; 2. Explore the role of community pharmacists in the screening and management of asthma and COPD; 3. Develop, implement and evaluate a COPD screening program to be delivered in the primary health care setting of community pharmacy; 4. Explore the pharmacist-perceived barriers and facilitators to the implementation of the community pharmacy-based COPD screening service; 5. Develop, implement and evaluate a community pharmacy-based COPD management intervention program delivered by trained community pharmacists; 6. Develop the 'wireframes' for an electronic decision support program for COPD screening and management for future implementation in community pharmacies. Methods Part one of the thesis explores information on the role of primary care, including the role of community pharmacists and the support required for the delivery of screening and management services of chronic respiratory diseases such as asthma and COPD. This is followed by part 2 which describes the review of the literature to assess the role of CCDSS and the role of community pharmacists worldwide in delivering screening and management services to patients with asthma and COPD in primary care. The evidence gathered from these literature reviews informed the development and implementation of a pragmatic and feasible program for delivering COPD screening and management service in Australian community pharmacies. The implementation and testing is described in part 3 of the thesis as three separate studies where the first study focused on assessing the effectiveness of a community pharmacy-based COPD screening service (COPD case-finding study) to identify those at risk of COPD in the community followed by a second study evaluating the pharmacists' perspectives of the implementation design. The third study focused on assessing the effectiveness of a pharmacist delivered COPD management service. The Human Research Ethics Committee at the University of Sydney provided approval for all the three studies. All the participating community pharmacists were trained in Lung Function Testing (LFT) using the PiKo-6® device. They were provided ongoing support from the study coordinator and access to online training videos developed specifically for the study, which incorporated PiKo-6® demonstration, COPD inhaler device demonstrations as well as information on the different aspects of the study. For the screening study, pharmacists invited their patients aged >35 years with a history of smoking and/or respiratory symptoms to participate. High-risk patients were identified via a COPD risk assessment questionnaire (Initial Screening Questionnaire [ISQ]) and underwent Lung Function Testing (LFT). Pharmacists referred patients with a forced expiratory volume in 1 second (FEV1)/forced expiratory volume in 6 seconds (FEV6) ratio 3 indicating high COPD risk. Of the 157 patients who were able to complete LFT, 61 (39%) had a FEV1/FEV6 ratio of 3) were at a significantly higher risk of a FEV1/FEV6 ratio of <0.75, compared to patients with fewer COPD symptoms. A total of 15 (10%) patients were diagnosed with COPD by their GP. Another eight (5%) patients were diagnosed with other medical conditions, and 87% of these were initiated on treatment. Although only half of all screened patients lived in regional areas, 93% of those diagnosed with COPD were from regional areas. Twenty pharmacists provided the feedback questionnaire data, and 15 pharmacists (male 53%; age 39.8±8.6yrs, rural 47%) participated in telephone-based semi-structured interviews. Questionnaire data revealed that pharmacists engaged positively with the service and reported that it was ‘very useful’ for patients and the profession. In-depth qualitative analysis revealed 6 main implementation themes: 1. Patient recruitment (pharmacists lacked patient recruitment skills), 2. Adaptation and entrepreneurship (protocol adaptation increased patient engagement), 3. Training and resource needs (face-to-face training was preferred for skill-based learning), 4. Lack of GP involvement (sub-optimal GP-pharmacist collaboration), 5. Factors related to the full operation or full implementation phase (high professional satisfaction, need for remuneration) and, 6. Suggestions for refining the screening service (raise public awareness about the service, provide service remuneration, use electronic methods to streamline logistics). A number of effective adaptations to the service were reported by pharmacists such as advertising, recruitment practices, patient inclusion criteria and inter-professional communication with GPs, which would be beneficial to implementation. For the COPD management study, 9 pharmacies recruited 40 patients who consented to participate; however 37 attended the baseline visit (visit 1). Thirty-one (84%) patients attended the follow-up visit 2, and 27 (73%) completed the final visit 3. The results of the study indicate that the pharmacists can play an important role in the management of patients with COPD, as there was a significant improvement in the patients’ inhaler technique, COPD awareness, immunisation rate for pneumonia, their COPD action plan ownership, their health care utilization rate and a positive impact on their health-related quality of life, their dyspnoea level, smoking cessation rate, flu vaccination, PR attendance, and medication adherence. Although not a statistically significant change the median mMRC score decreased at study end to 1. 0± 0.6 (0 – 3) with only 6 patients (23%) reporting breathlessness on the mMRC scale of ≥ 2 compared to the median mMRC Dyspnoea score of 1.0 ± 0.9 (0 – 4) with 47% of patients scoring ≥2 at baseline. The mean health-related QoL as measured by the CAT test was 21 ± 6.7, which was in the medium range (20-30) at baseline and changed to 19.3 ± 5.9 (7-35) which is in the mild COPD category at study end; however this was also not a clinically significant improvement. Based on the knowledge gained from both the studies, using the aspects of the interventions described in the thesis, and the feedback from the participating pharmacists, a wireframe was designed for the future development of the COPD screening and management decision support program, which is presented in part 4 of the thesis. Conclusion: The body of work presented in the thesis indicates that pharmacists can play an important role in timely case detection and optimal management of patients with COPD, but require support for future implementation of the service. This support could be in the form of a computerized decision support which is presented as wireframes in this thesis. The effectiveness of the computerised program could be tested in the future through national roll-out of the program embedded in the pharmacy dispensing software by the Pharmacy Guild which could result in better health outcomes for COPD patients, and ultimately reduce the COPD burden on the Australian health care system

The role of community pharmacists in screening and subsequent management of chronic respiratory diseases: a systematic review

Objective: The purpose of this review was to evaluate the role of community pharmacists in provision of screening with/without subsequent management of undiagnosed chronic obstructive pulmonary disease (COPD) and uncontrolled asthma.Methods: An extensive literature search using four databases (ie. Medline, PubMed, International Pharmaceutical Abstracts (IPA) and Scopus) with search terms pharmacy, screening, asthma or COPD was conducted. Searches were limited to the years 2003-2013, those in English and those reporting research with humans. Data retrieval, analysis and result presentation employed a scoping review method.Results: Seventeen articles met the inclusion/exclusion criteria, of which fifteen studies were based on people with asthma and two were based on people with COPD. Only seven asthma studies and one COPD study involved screening followed by subsequent management. More than half of the people screened were found to be poorly controlled and up to 62% of people were identified at high risk for COPD by community pharmacists. The studies varied in the method and type of asthma control assessment/screening, the type of intervention provided and the outcomes measured. The limitations of the reviewed studies included varying definitions of asthma control, different study methodologies, and the lack of long-term follow-up. While many different methods were used for risk assessment and management services by the pharmacists, all the studies demonstrated that community pharmacists were capable of identifying people with poorly controlled asthma and undiagnosed COPD and providing them with suitable interventions.Conclusion: The literature review identified that community pharmacists can play an effective role in screening of people with poorly controlled asthma and undiagnosed COPD along with delivering management interventions. However, there is very little literature available on screening for these chronic respiratory conditions. Future research should focus on development of patient care delivery model incorporating a screening protocol followed by targeted management interventions delivered by the community pharmacist

COMMUNITY-BASED STUDY ON PREVALENCE AND PATTERN OF SELF-MEDICATION PRACTICES AND ITS ASSOCIATED FACTORS IN S.S LAYOUT, DAVANGERE

Objectives: Self-medication practice is an element of self-care and it is the use of medication without the prescription of health-care professionals. This community-based prospective observational study was undertaken with the aim to evaluate the prevalence and pattern of self-medication practices and to assess the knowledge, attitude, and belief of the subjects toward this practice. Methods: This study was carried out in S.S Layout, Davangere, for a period of 6 months. The data were collected in predesigned validated questionnaire. A total of 400 subjects were participated in the study. Results: Among 400 individuals, 280 subjects were practicing self-medication, and this practices were high among females 174 (62%) than males 106 (38%). The majority of subjects participated in this study were students (36%). The most common indications for self-medication practice were headache (30%) followed by fever (25%) and heartburn (13%). The highly used drug in this practice was acetaminophen (57%). The most commonly used category of drugs for self-medication were analgesics (57%) followed by antacids (17%) and others (anti-hypertensive, anti-diarrheal, anti-pyretic, anti-histamines, and laxative) (13%). The main reasons for self-medication practice were no need to visit the doctor for minor illness (62%), long distance to health center (24%), and inability to pay for health-care cost (6%). Conclusion: This study shows that self-medication is widely practiced among students in our society. There is dire need to make them aware about the pros and cons of self-medication in order to ensure safe usage of drugs. Interventions are required to reduce the frequency of misuse of drugs

Novel Derivatives of Eugenol as a New Class of PPARγ Agonists in Treating Inflammation: Design, Synthesis, SAR Analysis and In Vitro Anti-Inflammatory Activity

The main objective of this research was to develop novel compounds from readily accessed natural products especially eugenol with potential biological activity. Eugenol, the principal chemical constituent of clove (Eugenia caryophyllata) from the family Myrtaceae is renowned for its pharmacological properties, which include analgesic, antidiabetic, antioxidant, anticancer, and anti-inflammatory effects. According to reports, PPARγ regulates inflammatory reactions. The synthesized compounds were structurally analyzed using FT-IR, 1HNMR, 13CNMR, and mass spectroscopy techniques. Molecular docking was performed to analyze binding free energy and important amino acids involved in the interaction between synthesized derivatives and the target protein. The development of the structure–activity relationship is based on computational studies. Additionally, the stability of the best-docked protein–ligand complexes was assessed using molecular dynamic modeling. The in-vitro PPARγ competitive binding Lanthascreen TR-FRET assay was used to confirm the affinity of compounds to the target protein. All the synthesized derivatives were evaluated for an in vitro anti-inflammatory activity using an albumin denaturation assay and HRBC membrane stabilization at varying concentrations from 6.25 to 400 µM. In this background, with the aid of computational research, we were able to design six novel derivatives of eugenol synthesized, analyzed, and utilized TR-FRET competitive binding assay to screen them for their ability to bind PPARγ. Anti-inflammatory activity evaluation through in vitro albumin denaturation and HRBC method revealed that 1f exhibits maximum inhibition of heat-induced albumin denaturation at 50% and 85% protection against HRBC lysis at 200 and 400 µM, respectively. Overall, we found novel derivatives of eugenol that could potentially reduce inflammation by PPARγ agonism

Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol

Introduction Chronic kidney disease (CKD) is increasingly recognised as a growing global public health problem. Early detection and management can significantly reduce the loss of kidney function. The proposed trial aims to evaluate the impact of a community pharmacy-led intervention combining CKD screening and medication review on CKD detection and quality use of medicines (QUM) for patients with CKD. We hypothesise that the proposed intervention will enhance detection of newly diagnosed CKD cases and reduce potentially inappropriate medications use by people at risk of or living with CKD.Methods and analysis This study is a multicentre, pragmatic, two-level cluster randomised controlled trial which will be conducted across different regions in Australia. Clusters of community pharmacies from geographical groups of co-located postcodes will be randomised. The project will be conducted in 122 community pharmacies distributed across metropolitan and rural areas. The trial consists of two arms: (1) Control Group: a risk assessment using the QKidney CKD risk assessment tool, and (2) Intervention Group: a risk assessment using the QKidney CKD plus Point-of-Care Testing for kidney function markers (serum creatinine and estimated glomerular filtration rate), followed by a QUM service. The primary outcomes of the study are the proportion of patients newly diagnosed with CKD at the end of the study period (12 months); and rates of changes in the number of medications considered problematic in kidney disease (number of medications prescribed at inappropriate doses based on kidney function and/or number of nephrotoxic medications) over the same period. Secondary outcomes include proportion of people on potentially inappropriate medications, types of recommendations provided by the pharmacist (and acceptance rate by general practitioners), proportion of people who were screened, referred, and took up the referral to visit their general practitioners, and economic and other patient-centred outcomes.Ethics and dissemination The trial protocol has been approved by the Human Research Ethics Committee at the University of Sydney (2022/044) and the findings of the study will be presented at scientific conferences and published in peer-reviewed journal(s).Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12622000329763)