OAR@UM Collection:

Development of a framework for pharmacist recommended medicines

2026-09-25T10:57:31Z

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.

Applying a pharmacist recommended medicine categorisation framework

2026-09-25T10:30:10Z

Title: Applying a pharmacist recommended medicine categorisation framework Authors: Calleja, Jean Claude; Attard Pizzuto, Maresca; Azzopardi, Lilian M. Abstract: Evidence based processes to categorise medicines that are suitable to be considered for pharmacist recommendation in order to promote safe access to medicines. A score-based framework was developed to categorise medicines according to three categories: Category May be considered as Pharmacist Recommended Medicines (PRM) (67%-100%), Category 2 May be considered as PRMs with strict guidelines, and Category 3: Shall only be recommended by physician. The aim was to apply a pre-developed structured framework to categorise feasibility of medicines to be made available as PRMs. A comprehensive list of all medicines authorised for use in Malta was retrieved from the Malta Medicines Authority database. This dataset was systematically filtered to exclude paediatric only formulations, intravenous preparations, and medicines primarily indicated for chronic conditions, as these were outside the scope of the intended assessment. The refined dataset was then categorised into three distinct groups: (i) medicines already licensed as pharmacist recommended medicines (PRMs), (ii) prescription only medicines (POMs) with direct over the counter (OTC) equivalents, and (iii) POMs without direct OTC equivalents. To verify real world market availability, all products within these lists were cross checked across two independent community pharmacies. Medicines identified as discontinued or no longer commercially available were removed to ensure the lists reflected the current Maltese market landscape. Two medicines from each of the three lists were randomly selected using an online randomisation tool for subsequent evaluation through the developed framework. The six identified medicines were appraised using the pre-developed framework to determine their PRM category. The two licensed PRM products (i) selected were levonorgestrel 1500 micrograms film coated tablets and sildenafil 50 mg film coated tablets. The two POMs with direct OTC equivalents (ii) were naproxen 500 mg gastro resistant tablets and betamethasone 0.1% w/w cream, while the two POMs without direct OTC equivalents (ii) were chloramphenicol 1% w/w eye ointment and nitrofurantoin 50 mg hard capsules. According to the framework, 4 of the 6 medicines scored between 68%-80% and were classified as Category 1. The mean score for the category 1 medicines was: 275 out of 300 for patient safety, 78 out of 100 for access to medicines, 164 out of 200 for overall cost to patient and the healthcare system, and 78 out of 600 for threats to patient. The remaining 2, sildenafil 50mg and chloramphenicol 1%, were classified as Category 2 (46%-66%). The mean scores obtained by the category 2 medicines were 233 out of 300 for patient safety, 86 out of 100 for access to medicines, 155 out of 200 for overall cost to patient and the healthcare system, and 138 out of 600 for threats to patient. The framework was practical to be applied in a real-world scenario for the different groups of medicines. The framework identified the medicine that is currently licensed as a PRM with guidelines to retain the same status (category 2). The framework demonstrated sensitivity to differentiate current POM medicines between category 1 and category 2 mainly through the risk assessment inbuilt within the framework.

Ensuring patient-centred care beyond compliance

2026-09-25T10:22:53Z

Title: Ensuring patient-centred care beyond compliance Authors: Stivala, Alessia; Vella Szijj, Janis; Serracino-Inglott, Anthony Abstract: Background: Pharmacists base safe practice on regulatory compliance, yet evolving patient needs increasingly require the exercise of professional judgement beyond these standards; Objective: 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. Focus group discussions involving two community pharmacists, one hospital pharmacist, one academic pharmacist, one regulatory pharmacist and one layperson were conducted to validate the questionnaire and clarify concepts such as ‘going beyond the call of duty’ in pharmacy practice. Thematic analysis was performed on qualitative data gathered. The ‘Pharmacist Perspective on Patient Needs Questionnaire’ was disseminated online to pharmacists. The questionnaire gathered quantitative and qualitative insights into the regulatory, professional, and service-related barriers faced. Ten case studies and relevant patient-centred strategies were designed based on questionnaire and focus group insights. Validation of these cases was done through a focus group session.; Results: Thematic analysis identified four main themes with corresponding sub-themes: Going Beyond the Call of Duty, Barriers to Going Beyond the Call of Duty, Regulations and Sustainability. Among the pharmacists surveyed (N=39), the three most frequently encountered patient needs were: polypharmacy (n=30), low health literacy (n=27) and care coordination (n=24). Frequency ratings across the 14 identified patient needs differed significantly (Friedman Test, p<0.001). Kruskal Wallis tests revealed that professional role was found to significantly influence the frequency of encountering low health literacy (p = 0.030), financial constraints (p = 0.013), and post discharge support (p = 0.024). Years of experience significantly affected frequency ratings for financial constraints (p = 0.018) and care coordination (p = 0.021). When describing actions that ‘go beyond the call of duty’ four pharmacists provided no specific examples, characterising such efforts as either too frequent to recall or a fundamental part of practice. Inductive content analysis of the remaining responses (n=35) identified five categories of support: medication access (n=11), medication management support (n=9), emotional support (n=9), practical support (n=2), and patient advocacy (n=3).The ten case studies were 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 prescription that a patient cannot afford, emotional distress, conflicting prescriber instructions, medication shortages, extended opening hours, support for foreigners, prescription support following bereavement and financial constraints.; Conclusion: Pharmacists go beyond their duties by providing care that extends past regulatory expectations and centres on the patient’s wellbeing. The cases illustrate the challenges of sustaining this approach by presenting realistic, practice-based scenarios in which pharmacists navigate complex patient needs within routine constraints.

Developing professional competencies in pharmaceutical distribution auditing

2026-09-25T10:16:30Z

Title: Developing professional competencies in pharmaceutical distribution auditing Authors: Serracino-Inglott, Anthony; Mamo, Maria; Abbas, Amar; Magri, Audrey; Giordano, Lara; Mifsud Buhagiar, Luana Abstract: Background:; Pharmaceutical distribution auditing is a critical mechanism for safeguarding medicines supply chains in line with Good Distribution Practice (GDP), identifying operational risks, and supporting corrective and preventive measures that contribute to continued improvement. Regulatory authorities form an important part of this ecosystem, working alongside stakeholders and industry to ultimately serve patients. In this context, the Malta Medicines Authority (MMA) undertakes initiatives aimed at strengthening professional competence, which is essential to ensuring robust oversight as pharmaceutical distribution networks continue to evolve. Accordingly, this initiative sought to strengthen pharmaceutical distribution auditing by building on academic training and providing an applied perspective, equipping professionals with the knowledge, skills, and competencies required to support the integrity and performance of medicines supply chains.; Method:; The MMA Academy for Patient Centred Excellence and Innovation in Regulatory Sciences, licensed as a Further and Higher Education Institution, developed a programme leading to an Award in Pharmaceutical Distribution Auditing, accredited by the Malta Further and Higher Education Authority as Level 6 on the Malta/European Qualifications Framework. The course was delivered in October 2025 and comprised 50 learning hours (2 ECTS), including 22 hours of face-to-face content led by subject-matter experts. Topics addressed include auditing principles, GDP requirements, risk-based planning, documentation and data integrity, corrective and preventive action plans, regulatory inspection preparedness, quality systems and management of outsourced activities. Programme effectiveness was evaluated through a post-course electronic evaluation tool consisting of a 5-point Likert scale. Data collected was analysed to evaluate participants’ feedback.; Results:; Nineteen local and international participants, practicing in private or public sectors, successfully completed the programme (N=19). Evaluation responses (n=16) demonstrated consistently positive feedback across all aspects assessed. Most respondents (70%) assigned the highest overall rating to the course, whilst all participants agreed that the course met their expectations and indicated that they would recommend it to colleagues. Feedback highlighted the quality and organisation of the course, the expertise and engagement of the speakers and the interactive learning environment as key strengths. The structured content and practical focus were perceived as particularly valuable in supporting the application of GDP principles in professional practice.; Conclusion:; Outcomes indicate that this educational intervention was highly valued by participants and effective in supporting the intended learning objectives related to pharmaceutical distribution auditing. By facilitating knowledge exchange and strengthening professional competencies in pharmaceutical distribution auditing, the programme contributes to capacity-building by translating participants’ academic learning into practical competencies. Continued development and expansion of such targeted initiatives shall further support preparedness in increasingly complex healthcare and regulatory environments.