https://www.um.edu.mt/library/oar/handle/123456789/103157 2026-04-14T22:55:03Z https://www.um.edu.mt/library/oar/handle/123456789/106927 Title: Cannabis for medical use in rare diseases Abstract: Rare diseases (RDs) are severe and usually chronically debilitating and RD patients often lack effective and accessible treatment options. Medicinal Cannabis (MC) is used for symptoms such as pain, spasticity, nausea and vomiting, seizures and anxiety which may be experienced by RD patients. The aim of the study was to identify RDs for which MC can be used and issues related to its use in patients with RDs. The methodology was in two parts: (1) systematic literature review using search engines: PubMed and MEDLINE. Open access peer review journal articles, published between January 2010 – October 2021 were included; (2) development, validation and dissemination of two questionnaires: for RD patients and for healthcare professionals (HCPs) in Malta. The literature revealed 36 papers that described the use of MC as a possible therapeutic option in 22 different RDs, mainly epileptic conditions (n=7) and neurodegenerative diseases (n=6). Respondents of the questionnaire for HCPs (n=101) were pharmacists (n=40), general practitioners (n=17) and occupational therapists (n=13), with more than 11 years of practice (n=46). HCPs encountered two to four RD patients a year on average. Symptoms experienced by RD patients were pain (n=51), mainly chronic neuropathic pain (n=31), anxiety (n=34) and muscle spasticity (n=33). Fifty-nine HCPs agreed to reply to MC related questions. Twenty-six of 59 HCPs have used MC in their practice. Fifty two out of 59 HCPs consider it to be effective for pain relief, 38 for anxiety and 38 for muscle spasticity. Thirty six out of 59 HCPs agreed on the use of MC in their practice. Regarding the side-effects of MC, confusion (n=30) and addiction (n=29) were reported to be of the most concern. Study included thirty-eight patients with RDs, mostly 41-50 years old (n=11) and reported pain (n=24), anxiety (n=22) and muscle spasticity (n=10) as commonly experienced symptoms associated with RD. Seven reported experiencing side-effects associated with the currently used medications. Two respondents had been prescribed MC by a HCP, though 20 would consider MC use to relieve symptoms of their disease. Confusion, possibly associated with MC usage, was reported as the side-effect causing most concern (n=8). Eighteen patients were not concerned with MC side-effects. Literature supports the use of MC for management of RDs. MC can be effective to relief pain, anxiety and muscle spasticity possibly experienced by RD patients. HCPs and RD patients consider that MC can be used in management of RD symptoms. In lack of efficacious treatment options for RD patients, MC can be an alternative therapy for symptom relief Description: Pharm.D.(Melit.) 2022-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/106926 Title: Age-related pharmacovigilance perspectives Abstract: Drug-related falls are of particular concern in older persons and lead to an increase in morbidity and mortality. Strategies to identify risk of drug-related falls could contribute to optimize patient care. This aim of the research was to apply pharmacovigilance processes in clinical pharmacy practice within a patient-centric approach and to reduce drug-related falls for older people through medication risk assessment. The methodology consisted of a four-stage design: (i) A literature scoping exercise to identify fall-risk assessment tools (FRATs); (ii) a pre-intervention study where an identified FRAT was applied retrospectively to evaluate the extent of deprescribing in 55 older patients at a rehabilitation hospital with a history of falls from January to July 2021, using pharmacy patient profiles as a data source; (iii) a presentation of the selected FRAT tool and findings by the researcher to the clinical pharmacists at the rehabilitation hospital so that FRAT was to be used in their daily deprescribing activities; (iv) a post-intervention study starting one month after introducing the selected FRAT tool to the pharmacists, for assessment of the degree of deprescribing in 58 older patients with a history of falls from October 2021 to January 2022. A model for medication risk management for older people was developed. Literature review (n=88) classified five multifactorial tools and three medication-based tools. The STOPPFall (Seppala et al., 2020) tool from the medication-based category was chosen. From the pre-intervention results, the average age of patients was 81 years (65% females). Hypertension (n=45), diabetes (n=25) and cardiovascular diseases (n=25) were the most prevalent comorbidities. Antidepressants (n=35), diuretics (n=34), opioids (n=31), and benzodiazepines (n=23) were the most frequent fall risk-increasing drugs (FRIDs) prescribed (N=162). Significant deprescription rates were evident for opioids (97%, p<0.01) and benzodiazepines (70%, p=0.030). Diuretics (47%), antipsychotics (46%), and antidepressants (37%) showed lower deprescription rates. During the intervention, 9 pharmacists participated who were informed about STOPPFall and encouraged to apply the tool in practice. The post-intervention resulted in an average age of 79 years (71% females). The most common chronic conditions were cardiovascular diseases (n=40), hypertension (n=40), and diabetes (n=23). Diuretics (n=41), opioids (n=39), and antidepressants (n=26) were the most prescribed FRIDs (N=181). Opioids (97%, p<0.01) and antipsychotics (67%, p=0.027) were significantly deprescribed. Lower deprescription rates were observed for benzodiazepines (53%), antidepressants (31%), and diuretics (27%). The intervention indicated that the majority of the deprescription rate did not significantly differ when comparing the pre- and post-analyses. A model targeting deprescribing as a pharmacist’s pharmacovigilance task in a multidisciplinary approach that must be embedded in a patient centric system was designed. This research resulted in the usage of the chosen medication-based fall risk assessment tool within the KGH pharmacy department to assess the range of deprescribing for older patients’ high risk of falls and the model was developed as part of the medication risk management. Description: Pharm.D.(Melit.) 2022-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/106925 Title: A comparative approach of pharmaceutical regulation in Europe and Japan Abstract: Japan and EU regulatory bodies historically have in principle mutually agreed on the requirements and regulatory processes to provide drugs in a timely manner while ensuring safety, quality, and efficacy. However, there are still a number of pharmaceutical regulations in Japan and the EU which are different. The aims of the study were (i) to compare pharmaceutical regulations in Japan and those in the EU and identify differences and similarities and (ii) to identify perceptions of healthcare professionals (HCPs) about Japanese and European regulations. The study focused on Japanese and European regulations applied in: (i) research and development (R&D), (ii) application for marketing authorization (MA), (iii) manufacturing, (iv) distribution, (v) post-marketing, and (vi) clinical use. The regulations were obtained from websites of regulatory bodies, official websites (such as the Organization for Economic Co-operation and Development), laws, and journals. Perceptions of HCPs were evaluated through a focus group discussion consisting of doctors and pharmacists from Japan and Malta. Regulatory harmonization between Japan and the EU was identified in the R&D, MA application, and manufacturing phase. In the R&D phase, the data obtained under Good Laboratory Practice (GLP) is mutually accepted, and clinical trials are conducted by referring to the same guidelines. The Common Technical Document (CTD) used for the MA application is in common for Japan and the EU. Products manufactured under Good Manufacturing Practice are mutually accepted. Regulatory differences were also identified. The GLP inspection fees in Japan are based on the category of the test facilities and products, while in Malta, fees are based on the number of inspectors and location of the inspected site. Fees for GCP inspections in Japan are based on inspection types, while those in the EU are based on clinical trial activities. Module 1 of the CTD is region-specific. The Japanese CTD focuses on product-development history while, the EU CTD focuses on product information and environmental risk assessment. Japan categorizes over-the-counter (OTC) drugs according to their risk-based classification which enables non-pharmacist personnel and non-pharmacy outlets to sell a particular category of OTC products. In Malta, all medicinal products must be dispensed from pharmacies. Supplying emergency contraception (EC) requires a prescription in Japan, while EC can be purchased directly from a pharmacy without a prescription in Malta. The principles underlying regulations in the post-marketing phase were similar between Japan and the EU. Japan does not have a system to promote public reporting of adverse drug reactions (ADRs). Two types of drug information documents are used in Japan and the EU. The Japanese Drug Information Sheet (DIS) and European Patient Information Leaflet (PIL) are intended for patient use. The Japanese Package Insert and European Summary of Product Characteristics are used by HCPs. A total of eighteen HCPs took part in the FGD. Fourteen participants considered that the DIS is personalized, which is deemed to be effective to increase adherence (n=10). Fifteen participants agreed that the PIL contains plentiful information which can be counterproductive (n=13). Ten HCPs agreed that accessibility is an advantage in the Japanese OTC distribution system, and 11 HCPs perceived that pharmacist intervention in OTC sales is necessary for patient safety. Six out of 9 Maltese HCPs perceived that there is an ethical dilemma in the EC supply in Malta. Regulatory harmonization between Japan and the EU did not cover regulations related to the ADR reporting system, the public distribution of non-prescription medicines, and drug information documents. The use of personalized drug information would benefit patients by facilitating the understanding of presented information. It is envisioned that it is possible with discussion and allowance for some cultural differences for harmonization to be achieved between Japan and the EU. Description: Pharm.D.(Melit.) 2022-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/106921 Title: Patient-centred training for pharmaceutical good distribution practice in Pharmacy of Your Choice (POYC) Abstract: The World Health Organization (WHO) advocates for a "responsive" healthcare system that meets people's needs, and patient-centredness in healthcare emphasizes the importance of a patient's values and preferences in the delivery of care. The Ministry of Health's Pharmacy of Your Choice (POYC) is devoted to offering the highest quality pharmaceutical service in Malta while also maintaining a patient-centred service by integrating patient-centered Good Distribution Practice (GDP) training within the POYC workforce. The focus of this research is to address the training needs of POYC’s health workforce in terms of pharmaceutical good distribution practices, with an emphasis on a more patient-centred approach. The methodology consists of two phases. Phase 1 tackled the needs assessment. A questionnaire aimed at assessing the core competencies of the services of the POYC workforce was compiled, validated, and disseminated to the respondents. An interview, gathering feedback from stakeholders about the status of the POYC workforce services, was conducted. The study findings from Phase 1 led to Phase 2, which was the development and evaluation of a patient-centred training course on pharmaceutical GDP. A validated questionnaire was prepared and delivered to 27 POYC respondents after a literature review of the research topic. Study findings indicate that the most common training needs highlighted by the participants are good distribution practices (Mean = 4.3), organization and personnel (Mean = 4.1), patient-centred care philosophy (Mean = 4.1), and training and development (Mean = 4.1. Enhancement of pharmaceutical services through improved patient access and comfort; quality assurance; a fully integrated system of medicine prescription from the hospital to community pharmacy; a holistic and community-based patient-centric approach in healthcare service; consistency of medicine delivery; and the preparedness of POYC to handle an emergency like the COVID-19 pandemic, were the five themes that emerged from the interviews. The mixed methods training needs assessment led to the creation of the "Roadmap to Patient-Centred Care Good Distribution Practice for the Pharmacy of Your Choice Workforce" online training course. The pilot implementation of the online training course was completed by 12 participants. The appropriate training course on pharmaceutical good distribution practice was needed to meet the revised EU GDP guidelines and to ensure a patient-centred approach to the GDP process within POYC. Description: Pharm.D.(Melit.) 2022-01-01T00:00:00Z