/library/oar/handle/123456789/61742 2025-12-26T10:25:04Z /library/oar/handle/123456789/72754 Title: Pharmacovigilance within a centralised procurement system Abstract: In the effort to ensure access to medications that are not registered on the Maltese market, the Central Procurement Unit (CPSU) within the Ministry for Health is responsible for registering medicines via Article 126a of the EU Directive 2000/83/EC. The registration process requires a pharmacovigilance (PV) framework. This research aimed to identify and establish a robust framework of PV for medicines registered by CPSU and propose action plans for implementation of the framework. The study employed a qualitative research design. As part of the background study, literature review, and observation sessions at CPSU were completed. Focus group discussion and interviews with CPSU, medicines regulatory agency management (Medicines Authority), and staff were executed. Subsequently, a framework was developed within the context of the quality management system of CPSU. This study classified five gaps in a PV system through systematic literature review including underreporting of adverse drug reactions (ADR) and quality of report, lack of streamlined system, weaknesses in training and awareness, moderate monitoring and evaluation, inadequate training and awareness of PV, and need for a stronger collaboration among stakeholders. The focus group discussion revealed five major themes specifically, supply and availability which include product registration and outsourcing of medicinal product, pharmacovigilance and ADR reporting, barriers to PV described through the impact of importation due to market size, Brexit and barriers to ADR reporting, pharmacists’ contributions, challenges and mitigating measures, and continuous improvement. Following the identification of the themes that required addressing, a framework was developed to implement PV in CPSU. The developed framework targeted the inclusion of ADR and medication error reporting, registration status of medicinal products under Article 126a, risk minimization measures, monitoring and evaluation of PV system in CPSU, and qualifications and skills of a PV staff. Validation of the framework was conducted via a focus group and the optimized system was launched within CPSU. The establishment of a PV in CPSU is a patient safety-focused system ensuring access to medicines for which there are a shortage and access issues whilst ensuring quality, safety, and efficacy of the medicinal products. Description: PharmD 2020-01-01T00:00:00Z /library/oar/handle/123456789/72738 Title: Attitudes and beliefs of patients about community pharmacy services Abstract: There were two aims for this study. The first one was to assess the attitudes and beliefs of people living in Malta about community pharmacy services. The second one was to assess the influence of attitudes and beliefs of people about community pharmacy services on four outcomes: utilization of pharmaceutical services, clinical outcomes brought about as a result of pharmacist over the counter (OTC) recommendations, health and adherence to medication. The prospective cohort study consisted of two interviews. For the first interview, performed as a telephone survey, telephone numbers were identified by simple random sampling and 1,126 people accepted to take part in this study. For the second interview 206 people were interviewed from pharmacies and from local councils both chosen by stratified random sampling. The surveys assessed the persons’ demographics, the persons’ overall attitudes and beliefs about community pharmacy services as well as possible reasons for such attitudes and beliefs. The second interview also assessed the general health, clinical outcomes brought about by pharmacists’ OTC recommendations and adherence to medication protocol. Comparative analysis between more positive attitudes and beliefs and outcomes was carried out. The data retrieved showed that overall the attitudes and belief s of the people residing in Malta about community pharmacy services are positive. In fact 91.06% of respondents to the telephone questionnaire stated that they believe and trust that the pharmacist is an important healthcare provider for their general health concerns while in the second questionnaire 95.15% said that they have positive attitudes and beliefs about community pharmacy services. Overall people in Malta tend to make use of pharmaceutical services regularly. In fact 89.61% of respondents to the telephone questionnaire and 88.83% respondents of the second questionnaire stated that they use the pharmaceutical services regularly. People`s results following pharmacists` OTC recommendations are positive (92.54%). When carrying out the comparative analysis between attitudes and beliefs and outcomes it was noted that there was a statistically significant association between more positive attitudes and beliefs about community pharmacy services and a higher utilization of pharmaceutical services (p value = 0.000 for both the telephone survey as well as the pharmacy/local council survey). There was a statistically significant association between more belief in the pharmacist and more positive results with OTC recommendations (p value = 0.000), and more belief in the pharmacist and adherence to medication (p value = 0.001). There was no statistically significant association between more positive attitudes and beliefs and health (p value >0.05). People living in Malta have positive attitudes and beliefs about community pharmacy services and make use of such pharmaceutical services regularly. There is a statistically significant association between more positive attitudes and beliefs towards community pharmacy services or belief in the pharmacist`s help to achieve better clinical outcomes and a number of outcomes. These are more utilisation of pharmaceutical services, more positive outcomes as a result of OTC recommendations and more adherence to medication. These encouraging positive results continue to demonstrate the importance of community pharmacists’ services in the citizens’ daily healthcare. The results reaffirm that attitudes and beliefs do have a strong effect on outcomes. Description: PharmD 2020-01-01T00:00:00Z /library/oar/handle/123456789/72713 Title: Drug dosing in patients with renal impairment Abstract: Inappropriate prescribing (IP) is common in patients with poor renal function in hospital and in outpatient settings. The extent of IP among patients with impaired renal function varies between countries and medical specialities. The aim of this study was to assess the prevalence of IP in a 400-bed acute care hospital and to identify drug classes which are inappropriately prescribed. This study was divided into three main stages. The initial stage was a comparison of medication dosing regimens for chronic kidney disease in medication information sources (British National Formulary [BNF], The Renal Drug Handbook [RDH], UpToDate® [UTD]), which was followed by the development of a medication dosage adjustment guideline for the hospital. The third stage of the study was a retrospective descriptive study that included patients 18 years and older admitted to East Tallinn Central Hospital (ETCH), in Estonia, for more than 24 hours with documented estimated glomerular filtration rates (eGFR) less than 60 ml/min/1.73m2. Patients were selected using stratified random sampling. Medication data and eGFR was collected from electronic health records. The level of agreement for medication dosage adjustments according to renal function between the three sources was less than 50% (46.5%, 44.1%, and 39.6% for BNF, RDH, and UTD, respectively) from 202 recommendations for 71 medications. The guideline developed for the hospital consisted of 54 medications. For the assessment of IP, the study included 399 patients (63% female; 37% male) with an average age of 79 (range 42-99) years. At least one inappropriate prescription was present for 236 (59.1%) patients and 90 patients (38.1%) received ≥3 inappropriately prescribed medications. The prevalence of IP according to eGFR was 32.0% (n=790) with 15% of the prescriptions (n=115) contraindicated in patients with renal impairment. Anticoagulants (n=261, 43.6%) were the most inappropriately prescribed class of medication followed by analgesics (n=85, 33.9%) and antihyperglycemic agents (n=55, 39.6%). Male gender, diabetes, venous thromboembolism, acute kidney injury, length of hospitalisation and surgery performed during hospitalisation were considered to be predictors of IP. The results of the study provide insight for prescribing in patients with renal impairment in hospital settings. IP was a frequent problem among patients with impaired renal function at ETCH. Patients with renal impairment could benefit from a medication dosage adjustment guideline. Description: PharmD 2020-01-01T00:00:00Z /library/oar/handle/123456789/72712 Title: Regulatory policies, education and training in veterinary pharmaceutical sciences Abstract: The responsibility to provide high-quality pharmaceutical care for animal patients challenges pharmacist knowledge regarding indications, dosages and drug administration. The aim of the study is to develop a regulatory and an academic framework in veterinary pharmaceutical sciences. The methodology is divided into two parts. In Part I three questionnaires were developed and disseminated to veterinary surgeons, pharmacists and pet owners to identify the perception of the role of the pharmacist in animal care and challenges of access to medicines. Data generated from the questionnaires was used to design a training programme validated using a modified e-Delphi method, for pharmacists. In Part II the regulatory framework for veterinary medicinal products was analysed by comparing Directive 2001/82/EC, Regulation (EU) 2019/6 and Directive 2001/83/EC. A separate questionnaire to identify the resources required by a National Competent Authority (NCA) to assess veterinary medicinal products, to provide medicines information and to collaborate with other entities was disseminated to EU NCAs that regulate veterinary medicinal products. Respondents from Part I consisted of 21 veterinary surgeons, 92 pharmacists, and 232 pet owners. Seventeen veterinary surgeons prescribed human medicines for use in animals because the veterinary medicinal product needed was not available. Pharmacists were perceived as unprepared to safely dispense and provide advice for medication use in animals by 61 pharmacists, 16 veterinary surgeons and 122 pet owners. Pharmacists (n=68) and veterinary surgeons (n=16) agreed that pharmacists should be trained in veterinary pharmaceutical sciences. Pet owners (n=171) would be more willing to ask a pharmacist for advice if they can be sure that the pharmacist is knowledgeable. The developed validated training programme consists of three main areas, namely veterinary disease states, veterinary pharmacotherapy, and regulation of veterinary medicinal products. In Part II, the analysis of the legal framework showed that the requirements for the dossier for human and veterinary medicinal products are similar. Respondents included ten NCAs. Seven NCAs had a dedicated department, with varying areas of expertise, for veterinary medicines. One NCA indicated that the staff worked in an integrated manner with both veterinary and human medicines. Training for assessors was provided by six NCAs. A proposal for the setup of a support office within a regulatory entity specialised in human medicines to include the assessment of veterinary medicinal products and medicines information in its remit was developed. The trust in the pharmacist taking an active role in animal care could be improved in the fifty-two percent of veterinary surgeons and fifty-three percent of pet-owners who had reservations. Trained pharmacists should strengthen their role with veterinary surgeons and pet owners. Interdisciplinary collaboration provides the best care for animal patients and improves access to safe and effective medicine. The analysis of the regulatory framework and the reflection of the questionnaire for NCAs provides a basis to support the establishment for a support office within an entity specialised in human medicines to include veterinary medicines. Pharmacists should be the drivers to enact change as illustrated in the veterinary-pharmacy bicycle paradigm where trained pharmacists combined with a robust regulatory framework will help in achieving excellence in veterinary services. Description: PharmD 2020-01-01T00:00:00Z