/library/oar/handle/123456789/111192 Sun, 28 Dec 2025 19:33:46 GMT 2025-12-28T19:33:46Z /library/oar/handle/123456789/130117 Title: Establishing specialist interest groups in pharmaceutical processes Abstract: Special Interest Groups (SIGs) focus on a specific area of interest and require collaboration from their members to develop solutions, advancements, and innovations in a particular field. SIGs have made significant contributions to sustainable health-related processes and developments across various domains. The pharmaceutical sector in Malta is expected to benefit from the establishment of SIGs. The study aimed to establish a SIG in the pharmaceutical sector. This involved (1) identifying areas of interest and (2) setting up a SIG. In Phase I, focus group discussions (FGDs) were conducted with 17 professionals from the community (n=6), hospital (n=6), and industry (n=5). The purpose was to gather data on potential topics of interest for SIGs, motivations, and barriers to joining a SIG. A questionnaire was created and validated for stakeholders from industry, hospital, and community pharmacies. During the second phase of the study, a standard operating procedure was developed based on literature on established SIGs and the FGD results, and was then validated. The final version was used as a guide to establish a SIG. A concept paper on SIGs as tools for continuous professional development was submitted to the journal of the International Pharmaceutical Federation and highlighted several key themes, such as the impact, the increased recognition, and the significance of continuing professional development when conducted through a SIG. FGD Results: A common barrier related to setting up and joining SIGs was lack of time (n=15). Topics of interest mentioned included Pharmacy of your Choice procedures and dispensing (n=3), extemporaneous compounding (n=2), and medical devices (n=3). Questionnaire results: Out of the 202 respondents, 134 (67%) believe that the biggest hurdle to join a SIG is the lack of support, followed by lack of time (64%, n=128). More than half of the respondents chose extemporaneous compounding 54% (n=110), medicines information 54% (n=109), and medication management 51% (n=103). Respondents preferred having both virtual and face-to-face meetings, once a month for one-hour duration, and having activities such as training, workshops, and webinars. The study explored the perception of local professionals on establishment of SIGs. Findings of the research revealed that there is a common interest on extemporaneous compounding across all areas of practice. Description: Pharm.D.(Melit.) Sun, 01 Jan 2023 00:00:00 GMT /library/oar/handle/123456789/130117 2023-01-01T00:00:00Z /library/oar/handle/123456789/123266 Title: Remote assessment of data integrity in pharmaceutical processes Abstract: The increased number of warning letters observed throughout the years led to concerns for manufacturers, regulatory authorities, and society, and the underlying causes for such an increase requires investigation. Acknowledging common breaches in data integrity mentioned in these alerts can be advantageous to the pharmaceutical entities undergoing inspections and can also be used to conduct gap analyses of the processes used in other firms to prepare for inspections by the European Medicines Agency or Food and Drug Administration. The aims of this research study were to identify areas of non-compliance in pharmaceutical processes and to propose measures to improve data integrity for an effective quality management system. During phase one of the study, a literature review was conducted using the search engine Hydi. Keywords ‘data integrity’ and ‘remote assessment’ were applied to find articles published in the last five years to identify data integrity related non-conformities. Non-compliance reports and warning letters between 2017 to 2022 were accessed on EudraGMDP and FDA databases to determine data integrity criteria. The compliance issues identified through literature, non-compliance reports and warning letters were analysed. Articles and guidelines were reviewed to identify the critical areas where there was breach of data integrity for the development of an SOP and checklist tool to be used as guidance to improve data integrity compliance. The SOP and checklist tool were validated by an expert group in data integrity. Forty-six and 168 warning letters issued between 2017 and 2022 by the EMA and FDA respectively were identified. From the identified warning letters, a total of 94 non-compliances identified by EMA and 453 non-compliances identified by FDA were observed. The majority of non-compliances were related to equipment or facilities (19%;n=103) followed by documentation (13%;n=72) and validation (13%; n=72). In the SOP, seventeen topics were included such as documentation and computer controls. The checklist covered sixteen topics related to data integrity including security and access control and audit trails. The identified non-compliances related to data integrity issues highlight the need for more education and training of personnel to minimise the occurrence of non-compliances and guarantee safety and quality of medicinal products. Description: M.Sc. (Melit.) Sun, 01 Jan 2023 00:00:00 GMT /library/oar/handle/123456789/123266 2023-01-01T00:00:00Z /library/oar/handle/123456789/119620 Title: Pharmaceutical regulation, policy and access to medicines Abstract: Access to Medicines has become core to the European debate. Whilst complex legislation targets medicines’ quality, safety and efficacy, patients experience disparate levels of access to these therapies. Paradigms for improvement mainly focus on an individual barrier. This study looked beyond standard, isolated criteria and explored access determinants in the wider and dynamic health system context, by addressing following research aims. - To identify and evaluate factors which may impact on Access to Medicines. - To propose methodologies which enable sound decision-making strategies to be adopted in the area of Access to Medicines. Using primarily qualitative techniques, stakeholders’ perceptions of barriers to medicines’ access were investigated and the influence of policy and regulation examined. A systematic mixed-method, step-wise approach was adopted with each stage of study informing the next. The results of a literature review, and unstructured interviews and questionnaires with health care professionals, were used to design semi-structured interviews seeking experts’ perspectives on health care provision, payer advocacy, health economics, pharmaceutical policy and regulation. A focus group was used to consolidate and validate the study proposals. The findings demonstrate that more concerted and concrete action is necessary at Member State and European Union level. Deterrents to medicines’ access are entrenched and often replicated at various health system strata. The results endorse the need for a tool-kit which seamlessly bridges regulatory and health care needs. Through the identification of core determinants, a supportive framework coordinated at European level was developed to evidence and optimise medicines’ access. It enables Member States to adopt a transparent, cohesive and documented national policy which explicitly upholds Access to Medicines and provides direction towards fostering this goal. Whilst allowing for country-specific customisation, the gradual realisation of the framework can facilitate progressive harmonisation of scientific norms and processes. The access framework developed through this study creates an integrated evaluation cycle embedded in European health systems, streamlining best-practice guidelines to medicines’ access. Description: Ph.D.(Melit.) Sun, 01 Jan 2023 00:00:00 GMT /library/oar/handle/123456789/119620 2023-01-01T00:00:00Z /library/oar/handle/123456789/118105 Title: Post-Brexit and availability of medicines Abstract: The United Kingdom (UK) officially left the European Union (EU) single market and customs union on December 2020. Since the UK is now considered a third country of the EU, unavailability of medicinal products from the UK across EU member states is expected. Small member states such as Malta have sourced their medicine supply from the UK. The unavailability of or insufficient supply of medicines represents a significant obstacle to patients' access to medicines. The aim of the study was to understand how Brexit has affected medicine availability in Malta. The objectives were: to identify which medicines are not available post-Brexit and to recognize experiences of different pharmaceutical sectors involved in the supply chain when it comes to medicine availability after Brexit. The study was divided into 2 phases. Phase 1 was a review of databases which includes the Government Formulary List (GFL) and the Malta Medicines Authority (MMA) Marketing Authorization database. The status of the marketing authorizations of medicines in the GFL, as well as, the status of medicines in the MA database from the MMA website were identified. Applications to make medicines with identified Withdrawn and Invalidated MA from the UK available were checked. Phase 2 consisted of individual semi-structured interviews to determine the stakeholders’ perspectives and experiences post-Brexit. A total of 542 Marketing Authorizations (MA) with the MA Holder based in the UK were withdrawn and a total of 544 MA were Invalidated MA from the UK since they no longer met EU legislation requirements. Twenty-nine stakeholders participated in the interviews. Challenges related to Brexit reported by the stakeholders (N = 29) were: Financial costs (n = 26); Brexit is an unprecedented event (n = 23); and Public’s attitude towards medicines (n = 21). The interviewees unanimously stated (n = 29) that although the unavailability of medicines is caused by different events happening concurrently such as the Covid-19 pandemic, escalating conflicts between nations and reports of Active Pharmaceutical Ingredient manufacturing concerns, Brexit had an impact on Malta’s medicine availability. Medicine unavailability has impacts on economic, clinical, and humanistic levels especially relevant to member states with small pharmaceutical markets such as Malta where unavailability of medicines is a problem. Sourcing out medicines from different EU countries would allow greater availability of medicines. Measures established, primarily regulatory measures, such the use of Article 20 of the Medicines Act; address the availability problems. Not only do the measures provide short-term solutions and help prevent medicines shortages, but also lay down the ground work in the long run. Description: Pharm.D.(Melit.) Sun, 01 Jan 2023 00:00:00 GMT /library/oar/handle/123456789/118105 2023-01-01T00:00:00Z