Pharmacy Practice and Medicine Formulation
11:25 - 13:05 | Lecture Room 203 (Level 2)
Chair: Prof. Lilian M. Azzopardi
Ms Alessia Stivala
Department of Pharmacy, Faculty of Medicine and Surgery
Introduction: Pharmacists rely on regulatory compliance as the basis of safe practice, and evolving patient needs increasingly call for extending this foundation through professional judgement.
Purpose: To identify patient needs and develop strategies to overcome challenges in meeting these needs.
Method: An anonymised online questionnaire to gather pharmacist insights was developed. A focus group was conducted to validate the questionnaire and clarify concepts such as going beyond the call of duty in pharmacy practice. Thematic analysis was performed on the qualitative data gathered. Ten cases were designed based on the questionnaire and focus group insights.
Results: Four main themes were identified in the thematic analysis, namely, ‘Going Beyond Duty’, ‘Barriers to Going Beyond Duty’, ‘Regulations’ and ‘Sustainability’. Ten case studies were designed to address patient needs. Each case was organised into four sections: Scenario outlining the patient need, Practice Challenges describing the pharmacist’s difficulties, Thematic Links connecting the case to the study’s themes, and Resolutions detailing both immediate pharmacist actions and broader systemic actions. The cases addressed continuity of care gaps, adherence support for patients with literacy barriers, non-formulary prescriptions, emotional distress, conflicting prescriber instructions, medication shortages, extended opening hours, support for non-English speakers, prescription support following bereavement and financial constraints.
Discussion: Pharmacists go beyond their duty through patient advocacy, individualised medicine support, after-hours professional service, follow-ups, and emotional care, reflecting a shift toward patient-centred practice. Sustaining these efforts remains challenging, and the developed case studies demonstrate this by presenting realistic, practice-based challenges in which pharmacists navigate complex patient needs within routine constraints.
Ms Raquel Formosa
Department of Pharmacy, Faculty of Medicine and Surgery
The study aimed to investigate the contribution of pharmacist-led ferritin point-of-care testing (POCT) on patient needs, outcomes and care pathway optimisation. Objectives include: appraising available ferritin POCT, validating a selected device, developing a framework for pharmacist-led ferritin POCT, and assessing feasibility in community pharmacy. During this prospective cohort study, a suitable ferritin POCT was selected and validated against laboratory-based results in 20 patients. Eligible patients meeting pre-defined inclusion criteria were recruited by convenience sampling. Following the POCT and pharmacist consultation, patients were categorised as ‘normal’ or ‘abnormal’ ferritin levels, receiving tailored pharmacist advice. Follow-up was conducted four weeks post-intervention. Validation against laboratory assays revealed no statistically significant difference (χ²=0.00, p=1.000), indicating strong agreement. Thirty patients were recruited, predominantly female (n=25), aged 35–54 years (n=12), with a mean body mass index of 27kg/m². Common comorbidities included gastro-oesophageal reflux disease (n=12), menorrhagia (n=7), and previous anaemia (n=7), with 12 taking drugs predisposing to low iron (most frequently proton pump inhibitors). Fatigue (n=22) and dizziness (n=20) were the most repeatedly reported symptoms. Abnormal ferritin results were identified in 24 participants, of whom 14 were on prior iron supplementation. All patients received individualised advice, including iron supplementation (n=10) and referral (n=9). At follow-up, 15 reported symptomatic improvement, 19 were adherent to iron supplementation, and 23 were satisfied with the service. Incorporating ferritin POCT into community pharmacy practice locally enhances healthcare accessibility, supports early intervention, improves health literacy and reinforces the pharmacist’s role in proactive health management.
Mr Jean Claude Calleja
Department of Pharmacy, Faculty of Medicine and Surgery
This study aimed to develop and validate a structured framework for identifying medicines suitable as pharmacist鈥憆ecommended medicines (PRMs). A focus group of eight healthcare professionals, six pharmacists and two general practitioners, defined the framework’s domains, assigned weightings based on their importance to patient health, and created a scoring algorithm for PRM classification. Domain鈥憇pecific questions were identified through a literature review, and scoring for each question was refined through four additional focus groups of three relevant professionals each. Face and content validation was then conducted by five community pharmacists.
The final framework includes 34 questions across four weighted domains: (A) Patient Safety, (B) Access to Medicines, (C) Overall Cost to Patients and the Healthcare System, and (D) Overall Threats. Weighted scores are combined and normalised against an ideal medicine, producing a percentage used to classify medicines into one of three categories: (1) May be considered as PRM, (2) May be considered as PRM with guidelines, or (3) Shall only be recommended by physicians. To test the framework, two locally available PRMs and two prescription鈥憃nly medicines were randomly selected and evaluated. Three medicines were classified as Category 1 and one as Category 2.
This validated framework provides a systematic, evidence鈥慴ased method for assessing medicines appropriate for pharmacist recommendation in minor acute conditions. Its use may enhance timely access to treatment, prevent disease progression, and reduce pressure on healthcare services.
Mr Elton Gatt
Department of Pharmacy, Faculty of Medicine and Surgery
Background and Objective: Additive Manufacturing (AM) using 3D printing offers the opportunity to personalise medicines at the point of care (POC). Translation to clinical practice is constrained by gaps in regulation and practical application in the clinical setting. The research aims to identify gaps, develop risk mitigation strategies, and propose a quality management system to support the safe and effective application of additive manufacturing technologies in pharmaceutical settings.
Methodology: This five-phase mixed-methods study consists of establishing regulatory baselines through literature review and interviews (Phase 1), a gap analysis of POC AM against conventional Good Manufacturing Practice (Phase 2), prioritisation of quality procedures and mitigation of safety risks (Phase 3), and development of a tailored hospital-based quality management system for AM manufacturing of medicines (Phase 4). Phase 5 validates feasibility through focus groups and cost analysis, culminating in a decision-support tool for choosing between AM and traditional manufacturing.
Results: A three-tier framework has been developed, which identifies interlinked barriers: 1) the structural level: regulatory uncertainty and lack of standards necessitate specific POC pathways; 2) the intermediate level, highlighting operational/digital maturity gaps, compounding-manufacturing ambiguities, and stakeholder fragmentation; and 3) the fundamental level, where sustainable integration requires adaptive regulation, robust quality infrastructure, and ethical frameworks. Together, these tiers address systemic gaps in quality assurance and scalability, establishing the legitimacy and trust required for decentralised production.
Conclusion: This study integrates risk analysis, pharmaceutical quality management system development, and feasibility modelling into a validated framework, enabling safe and sustainable implementation of 3D-printed medicines at the point-of-care.
Ms Karolina Szyrner
Department of Pharmacy, Faculty of Medicine and Surgery
The increasing availability of cannabis-based consumer products presents analytical and regulatory challenges. This study aimed to develop, validate, and apply High-Performance Liquid Chromatography with ultraviolet detection (HPLC-UV) methods for the quantitative determination of cannabinoids in cannabidiol (CBD)-based products, containing low concentrations (<0.2%, w/w) of delta-9-tetrahydrocannabinol (Δ鈦�-THC).
Chromatographic separation was carried out using an Agilent 1260 Infinity series system equipped with a C18-AR column (250mm × 4.6mm, 5µm). Isocratic elution was performed using a mobile phase of acetonitrile and 0.5% acetic acid (75:25, v/v) at a flow rate of 1.5 ml/min. The methods were validated in accordance with International Council for Harmonisation (ICH) guidelines [1] and were applied to quantify 5 cannabinoids: CBD, Δ鈦�-THC, cannabinol (CBN), cannabidiolic acid (CBDA) and tetrahydrocannabinolic acid (THCA) in oil-based products (n=23), cosmetics (n=10), plant material (n=10) and edible (n=5) matrices. Acceptable validation performance was achieved for specificity, linearity (R²>0.99), accuracy (99.76–108.35% for oils, and 81.11–95.59% for cosmetics), precision (RSD≤15%) and robustness.
Measured CBD concentrations in oils ranged from 2.25–19.7%, and in cosmetics from 0.13–4.58%, with one cosmetic containing no detectable CBD. Δ鈦�-THC was detected in six oil samples (0.014–0.165%) and was not detected in cosmetics. Label accuracy deviations exceeded ±10% in 19 products.
The developed analytical framework is intended to be further adapted to additional matrices, such as resin and e-liquid cannabis products, to support harmonised quality control across diverse formulations.