https://www.um.edu.mt/library/oar/handle/123456789/144 2026-09-28T22:15:17Z https://www.um.edu.mt/library/oar/handle/123456789/149473 Title: Wearables and mobile applications : pharmacist-led patient monitoring Authors: Grech, Ylenia; Azzopardi, Lilian M. Abstract: Background: The healthcare industry is rapidly transforming with the emergence of digital health, particularly through mobile applications and wearable devices to offer easier patient monitoring. Despite their potential, barriers such as limited awareness and education restrict widespread adoption of digital technologies for patient monitoring. Community pharmacists, given their accessibility and trusted position as healthcare providers, are well positioned to contribute to bridge the digital gap between patients and digital health platforms. This study aimed to assess the use of mobile applications and wearable devices by patients to monitor their health, to identify challenges encountered by both patients and community pharmacists when using digital tools and to explore how pharmacists may empower patients to use these tools effectively. Method: A literature review of existing articles on digital technologies in healthcare was conducted to capture latest terminology and concepts. Two questionnaires were developed; one targeting patients and the other community pharmacists. The questionnaires were validated for content by a multidisciplinary panel comprising two physicians and two pharmacists for both questionnaires, with additional feedback from two laypersons for the patient version. The panel provided feedback on layout, clarity, and relevance contributing to the final version of concise and user-friendly questionnaires. The pharmacist questionnaires were distributed electronically via Google Forms through the registration body and respondents were allowed eight weeks for submission. For patients, hundred paper questionnaires in English and Maltese were distributed in ten geographically spread pharmacies across Malta and Gozo, selected by convenience sampling from the six districts in Malta. To ensure confidentiality, completed questionnaires were placed in a sealed box. Data collection was subsequently analysed for quantitative analysis. Results: From the patient questionnaires, 616 responses were collected. Only 30% of patients use mobile applications or wearable devices to monitor their health, with 74% of them having tertiary education, 70% being female and the majority residing in the Northern Harbour. The most monitored parameters were pulse (52%), sleep and calories (45%). Amongst non-users, 45% stated that lack of awareness and education regarding digital health was the main barrier that prevented them from using digital health monitoring tools. From the pharmacist questionnaires, 73 responses were collected. Of these, 56% had never recommended a mobile application or wearable device to patients. A large majority (85%) of community pharmacists reported not feeling adequately trained in digital health, while 99% stated more patient education about digital health is required. The main challenges pharmacists face when recommending digital health tools are difficulties in communicating with patients who lack understanding and insufficient knowledge about the latest technologies, which affects their confidence in recommending these tools. Conclusion: The findings demonstrate limited use of digital health among patients and highlight the pharmacists’ training needs. While patients primarily face barriers of awareness and education, pharmacists identify confidence and knowledge gaps as obstacles when promoting these tools. Addressing these issues could enhance the role of pharmacists as facilitators of digital health adoption. 2026-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/149471 Title: Challenges and enablers of pharmaceutical 3Dprinting at point-of-care Authors: Gatt, Elton; Sammut Bartolo, Nicolette; Azzopardi, Lilian M. Abstract: Background: Additive manufacturing (AM) using threedimensional (3D) printing presents a promising opportunity for producing personalised pharmaceutical dosage forms at the point-of-care (POC). By enabling decentralised manufacture in settings such as hospitals, primary care pharmacies and potentially patients’ homes, AM could enhance treatment individualisation, improve accessibility and support patient-centred care. Despite these advantages, translation into routine clinical practice remains limited. This study aimed to identify principal challenges and enabling factors associated with pharmaceutical AM to support safe integration of AM technologies in real-world pharmaceutical scenarios. Method: A systematic review was conducted in January 2025 to identify challenges and enablers associated with pharmaceutical AM, with emphasis on decentralised and POC applications. Searches were performed across leading electronic databases supplemented by reference list screening and regulatory authority websites. The review followed the PRISMA framework, and eligible studies were appraised using the CASP qualitative checklist. Data were analysed using inductive thematic analysis, with a subset independently double-coded to ensure inter-rater reliability. A validated structured POC manufacturing gap analysis tool was developed to assess Good Manufacturing Practice (GMP) compliance and readiness for AM implementation within healthcare environments. Results: The systematic search yielded 49 studies eligible for full-text assessment. Inductive coding identified 161 unique subtheme codes across the dataset, generating 747 coded entries capturing distinct concepts related to pharmaceutical AM. These subthemes were synthesised into ten overarching descriptive themes representing both enabling and limiting factors for implementation. Key enablers included stakeholder collaboration and professional education, emerging technological developments, future implementation pathways, and the potential of AM to support personalised and patient-centred therapeutic approaches. Major barriers included challenges related to quality control and Quality by Design (QbD) integration, regulatory gaps and uncertainty, technical implementation and scalability limitations, and the ambiguity between pharmaceutical compounding and industrial manufacturing frameworks. Additional constraints related to digital maturity and secure data exchange infrastructure; as well as ethical, legal and social considerations surrounding decentralised pharmaceutical production. A structured POC manufacturing gap analysis tool was developed, comprising nine sections aligned with the chapters of EudraLex Volume 4, Part I, reflecting core GMP principles. Each section incorporates weighted scoring criteria contributing to an overall compliance score, enabling the assessment of a facility’s level of GMP alignment and readiness for safe AM integration. Conclusion: The findings indicate that adoption of pharmaceutical 3D printing is constrained less by technological capability than by regulatory and infrastructural rigidity. Ambiguity between extemporaneous compounding and industrial manufacturing frameworks represents a critical bottleneck for implementation in decentralised healthcare settings. However, emerging regulatory sandboxes such as hospital exemptions and POC manufacturing frameworks together with harmonised international approaches may provide viable pathways to support responsible innovation. Successful integration of pharmaceutical AM requires coordinated progress in regulatory clarity, digital infrastructure and operational readiness. Addressing these interconnected barriers depends on collaborative efforts across research, policy development and clinical practice. Ultimately, embedding AM within transparent, patientcentred, and ethically robust governance frameworks is essential to realise its potential for safe, scalable and equitable personalised medicine at the POC. 2026-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/149469 Title: Assessing healthcare professionals' access to medicines information Authors: Agius, Loredana; Azzopardi, Lilian M. Abstract: Background: Drug Information sources available in Malta include the British National Formulary (BNF), the Maltese Medicines Handbook and the Malta Medicines Authority (MMA) database.(1) Each of these sources has limitations, highlighting the need for an integrated information system that provides readily accessible information on medicinal products available on the Maltese market for healthcare professionals Method: The MMA database was downloaded from the MMA website and the duplicates were removed. Using Microsoft Excel, each item was assigned a random number electronically and a sample was generated. The first 800 items were selected from the 4065 items and assessed with respect to the availability of information in the BNF. The BNF 85 edition (2023, 85 edition) was used. The last step included an expert consultation to discuss data integration and digital frameworks regarding medicine information. Results: Out of the 800 items, 679 items (85%) were found in the BNF, whilst 121 items (15%) were not found in the BNF. The 121 items that were listed in the MMA database but were not found in the BNF were further analysed according to the therapeutic class. Drugs acting on the Cardiovascular System were the most frequent drugs not found in the BNF (27 drugs), while drugs acting on the Respiratory (14 drugs) and the Central Nervous System (12 drugs) followed. The 679 medicinal products that were in the MMA database and were found in the BNF were further analysed according to the strength and formulation of the product. 10 items were found with the API only, 11 items were found with the API and strength only, 65 items were found with the API and formulation only and the remaining items amounting to 593 items were found with the API, strength and formulation. The consultation indicated that a multidisciplinary team of at least three experts would be required: a software developer to build the system, an AI/machine-learning specialist to maintain data relevance, and a pharmaceutical expert to validate the information. Conclusion: This study highlights gaps between the MMA database and BNF listings. Such discrepancies may affect healthcare professionals’ access to complete and locally relevant medicines information. The findings support further research into healthcare professionals’ expectations, as well as the development of proposals for an online medicines information system that leverages the use of artificial intelligence. Established digital frameworks, such as medicXKG( 2), demonstrate how regulatory and clinical data can be effectively integrated. 2026-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/149410 Title: Development of a framework for pharmacist recommended medicines Authors: Calleja, Jean Claude; Attard Pizzuto, Maresca; Azzopardi, Lilian M. Abstract: Improving access to medicines is widely recognised as a key factor for better patient outcomes, particularly within primary care settings where timely treatment is essential¹. The criteria used to determine which medicines are appropriate for pharmacist recommendation remain inconsistent and highly variable across jurisdictions. The aim was to design and validate a structured, evidence based framework which may be used to identify medicines that may be appropriately classified as pharmacist recommended medicines (PRMs). A focus group discussion was conducted with eight healthcare professionals, comprising two regulatory pharmacists, two community pharmacists, two hospital pharmacists, and two general practitioners. This multidisciplinary group defined the framework’s sections and domains, assigned relative weightings according to perceived impact on patient health, and developed the scoring equation used for PRM categorisation. Domain-specific options were identified through a targeted review of literature. Inclusion criteria for the literature included studies published in English, free full access, published between 2016-2026 and peer reviewed. Another focus group composed of three subject-matter experts for each section of the framework was convened to determine the scores for each option. The resulting framework underwent face and content validation by five community pharmacists to ensure clarity, relevance, and practical applicability. The final framework consisted of 34 domains distributed across four sections: (A) Patient Safety, (B) Access to Medicines, (C) Overall Cost to Patients and the Healthcare System, and (D) Overall Risk. Consensus was reached for 77 of the 122 scoring options, with most disagreements arising in Section A, where participants were unable to agree on 18 of the 38 options. For options without consensus, mean scores were applied to ensure balanced representation of all expert opinions. Each section was weighted according to its relative importance, and the weighted section scores were aggregated to generate an overall score. This score was then normalised against the score of a “ideal medicine.” The ideal medicine was defined as a medicine which provides the maximum benefit, i.e. obtains maximum scores in section A (+300), section B (+100) and section C (+200), and has no threats with a zero score in section D (0). Based on the final value, each medicine was classified into one of three categories: 1) May be considered as PRM (67%-100%), 2) May be considered as PRM with guidelines (34%-66%), 3) Shall only be recommended by physicians (0%-33%). This study provides a validated, structured framework to categorise pharmacist recommended medicines, integrating expert consensus, weighted scoring, and practical evaluation. Its application may support more consistent decision making, enhances access to medicines, reduce the burden on general practitioners and the healthcare system, and strengthen the pharmacist’s role in improving patient outcomes within primary care. 2026-01-01T00:00:00Z