/library/oar/handle/123456789/55591 2025-12-23T18:06:16Z /library/oar/handle/123456789/55795 Title: Patient-centred regulatory audits in community pharmacy Abstract: The pharmacy profession is a patient-centred practice, where the pharmacist translates science to regulated practice. Pharmacy practice has evolved from compliance and adherence to concordance. Could regulation adopt the same concept? The objectives of this research were to: (1) Retrospectively analyse community pharmacy regulatory audit (CPRA) reports, (2) develop, validate and implement an updated tool for CPRAs, and (3) identify and analyse case studies from CPRAs to recommend improvements in patient safety. The methodology involved: (1) retrospective analysis of CPRA reports to extract features that could lead to identification of patient-related deficiencies in community pharmacy practice, (2) development of an updated audit tool using data from the retrospective analysis and interviews with community pharmacists, (3) validation of the audit tool by eight auditors from the Malta Medicines Authority and two community pharmacists, (4) implementation of the audit tool in routine CPRAs, (5) identifying desirable patientrelated improvements through observation, and (6) engaging in informal educational discussions with the practicing pharmacists during CPRAs. Case studies on deficiencies related to patient safety were identified and evaluated. Dossiers, European Public Assessment Reports and consultation with the Marketing Authorisation Holders were sources that provided the background for the case studies analysis. A total of 512 CPRA reports for a 57-month period (January 2012-September 2016) were analysed. Interviews with 12 community pharmacists were performed extracting 14 patient-focused recommendations. The audit tool was implemented during CPRAs in 85 pharmacies over an 11-month period (January-November 2017). Seven case studies were evaluated and analysed including 4 dispensing problems (errors, near misses, lack of proper prescription, unsupervised pharmacy staff), 2 inventory deficiencies (expired items, inappropriate storage temperature) and 1 inequity of treatment between private and government-sponsored patients. Concordance with the pharmacist was reached and actions (N=46) with a patient-centred focus were taken to address the identified deficiencies. Standard operating procedures were developed, such as for temperature recording and for referral of patients to the pharmacist for ailments requiring medicines. Methods for alerts were devised and communication with patients, including when a possible error is detected, were identified. An educational approach by the auditor in CPRAs, reaching concordance to regulation as distinct to forceful compliance, may improve pharmacist motivation and patient care outcomes. Description: PharmD 2018-01-01T00:00:00Z /library/oar/handle/123456789/55794 Title: Rationale for a pharmacist-led medication safety service Abstract: Medication safety is an intrinsic function of hospital quality systems. The aim of the study was to develop a pharmacy-led hospital medication safety service following a psychometric analysis of patient safety attitudes amongst a segment of Mater Dei Hospital staff members. A pre-validated AHRQ questionnaire on patient safety attitudes of staff1 was distributed amongst a pre-selected cohort of 235 participants from areas including anaesthesia, pharmacy and hospital administration. Results were compared with aggregate data from 680 hospitals in the United States of America who had participated in the same survey during 2016. An internal hospital audit was carried out using an international safety tool designed by the ISMP2. Subsequently, a pharmacy-led medication safety service was developed in line with findings. With a response rate of 45 % (N=105), 36 % of the responses revealed an ‘Acceptable’ local patient safety attitude (n=37). Participation in error reporting was low with 52 % not being involved in any reporting (n=55). Eight attitude composite scores exceeded minimum aggregate hospital scores whilst 4 scored below aggregate hospital minima. Findings from the audit together with a Pareto analysis of survey responses, led to the prioritisation of 8 attitude aspects; ‘Supervisor expectations promoting patient safety’, ‘Management support for patient safety’, ‘Overall perceptions on patient safety’, ‘Frequency of events reported’, ‘Teamwork across units’, ‘Staffing’, ‘Handoffs and transitions’ and ‘Non punitive response to error’. Interventions were focused on three domains impacting the medicationuse process; drug distribution dynamics, safety improvement of parenteral medicines, and handling of safety alerts. The study identified how apharmacist-led medication safety service in the hospital setting can contribute to the identification of priority areas to align local practices to established international targets. The approach developed in this study is now being extended to other areas within the hospital. This study can be used as part of a conventional (Plan-Do-Study-Act) PDSA quality cycle and method transfer is appropriate to other hospitals where medication safety services need to be established or updated. Description: PharmD 2018-01-01T00:00:00Z /library/oar/handle/123456789/55790 Title: Access to orphan medication and quality of life in rare diseases Abstract: Over 7000 rare diseases (RD) affect around 60 million patients living in the European Union (EU) and the United States (US). Research on RDs focuses on treatment and care of RDs with limited focus on health related quality of life and accessibility to Orphan Drugs (ODs). The aims of this study were to 1) analyse and compare regulations and policies related to accessibility of ODs in the EU and US 2) describe OD accessibility and the health needs of the Maltese RD population and 3) create a health related quality of life (HRQOL) assessment tool for RD patients and caregivers. The HRQOL tool explores issues of diagnosis, mental health, use of health and support services and general quality of life. The methodology included (1) assessment of OD accessibility policies in 29 countries based on 6 themes (national OD policies, OD designation, marketing authorisation, marketing exclusivity, incentives and pricing) identified during retrospective analysis of literature (2) identifying issues encountered by Maltese RD patients by (i) interviewing policy makers (ii) conducting literature review (iii) and analysing data from RD registers (3) development, validation (by 7 experts) and administration of HRQOL tool to patients and caregivers (N=225) in the EU (n=137) and the US (n=88). The tool included 30 close ended Likert scale questions divided into four sections collecting information on the demographics, personal care and independence, mental and social health and access to treatment. The results showed that out of the 29 countries assessed, 17 EU countries had OD policies and 6 countries (including the US) had financial incentives for OD development. OD designation, marketing authorisation and market exclusivity were centralised in both the EU and US by the EMA and FDA respectively. Malta had no OD plans in place and RD patients in Malta had poor access to ODs when compared to other EU countries. Statistical analysis of the HRQOL indicated a significant difference (p<0.05) between RD patients in the EU and US. A significant difference was observed when RD patients were asked to report how they felt during everyday activities such as dressing (p=0.001), eating (p<0.001) or participating in everyday activities (p=0.014) with the US RD patients scoring lower in all areas. The financial burden of RDs was significantly higher (p<0.001) in the US as the Likert mean score was 3.00±1.065 while EU RD patients reported 4.44±0.512 on the Likert scale (1 = Financial burden, 5 Not a burden). Poor OD accessibility was reported by both groups with 44 (32%) EU respondents and 27 (31%) US respondents reporting it is ‘almost impossible’ to receive treatments for their RD. EMA has granted 140 ODs with market authorisation compared to 415 approved ODs in the US. There are differences between countries on the degree of accessibility, pricing and reimbursement. Poor HRQOL may be related to issues of accessing medicines, diagnosis, psychosocial support, and coping with stigma and uncertainty. US based RD patients scored poorly when compared with their EU counterparts in relation to mental health, personal care and independence and ability to afford ODs. Description: PharmD 2018-01-01T00:00:00Z /library/oar/handle/123456789/55733 Title: Chronic obstructive pulmonary disease exacerbations : cost, risk factors and impact of long-acting muscarinic antagonists Abstract: Health care resource utilisation (HCRU) data for chronic obstructive pulmonary disease (COPD) exacerbation-related hospitalisations can be used to drive the introduction of long-acting muscarinic antagonists (LAMAs) in the Maltese National Health Service (NHS). An understanding of the predictors for COPD exacerbations leading to hospitalisation may assist in developing guidelines for LAMA use, which prioritise patients who would benefit most from this therapy. A data collection proforma was designed and validated. All the hospital admissions during February-April 2017 were screened and a total of 148 COPD exacerbation-related admissions were identified. The cost estimates for these admissions were computed using an activity-based costing (ABC) approach. A case-control study was used to identify the predictors for COPD exacerbation-related hospitalisation. A total of 81 cases were recruited by convenience sampling from the identified admissions. Another 81 patients were recruited from respiratory outpatients as control subjects, during the same time frame. Control patients had to be clinically stable without a COPD exacerbation-related hospitalisation during the previous year. The data collection proforma was completed for recruited cases and control patients. Data was gathered from patients’ medical records and via patient selfreport. Pre-validated tools (COPD assessment test (CAT), EQ-5D-3L, inhaler adherence scale, inhaler technique scores) were completed through a semi-structured interview. The total estimated hospitalisation cost amounted to €225,000. Parsimonious logistic regression identified six significant predictors for hospitalisation. CAT scores above 18.9 (OR 1.193; 95% CI 1.096-1.299), a history of at least 2 past COPD exacerbation related hospitalisations (OR 1.702; 95% CI 1.238-2.339), and at least 3 concomitant comorbidities (OR 1.593; 95% CI 1.025-2.474), were positively associated with the occurrence of a hospitalisation. Lack of inhaled long-acting beta agonists (LABA) therapy (OR 6.494; 95% CI 0.041-0.587), emergency nebuliser use in the last 3-months (OR 4.537; 95% CI 1.209-17.039) and intravenous (IV) antibiotic use in the last 3 months (OR 8.545; 95% CI 1.093-66.827), were also positively associated with the occurrence of a hospitalisation. The identified predictors for COPD exacerbation-related hospitalisation may be used to prioritise patient access to LAMA therapy. Description: PharmD 2018-01-01T00:00:00Z