https://www.um.edu.mt/library/oar/handle/123456789/33275 Sat, 04 Apr 2026 07:32:41 GMT 2026-04-04T07:32:41Z https://www.um.edu.mt/library/oar/handle/123456789/33356 Title: Distribution of anti-infective agents in ischaemic peripheries Abstract: The aims of the study were to analyse the distribution of gentamicin in patients with different degrees of peripheral artery disease (PAD) and to develop pharmacokinetic equations to predict gentamicin concentrations in patients with PAD. Patients undergoing debridement of a wound or an amputation procedure were included. Patients received a 120mg or 240mg intravenous dose of gentamicin once daily. Patients were classified according to the degree of PAD. Tissue and serum samples were collected at the time of intervention. Gentamicin was extracted from the tissue samples by optimising a sodium hydroxide method described by Brown et al. Gentamicin concentrations were determined by Fluorescence Polarization Immunoassay (FPIA). Blood and tissue samples were obtained from 61 patients, 41 male and 20 female. Nineteen patients were free from the disease or had borderline PAD, 9 patients had mild or moderate PAD and 26 patients had severe PAD. The degree of PAD was not known in 7 cases. Forty-eight patients had Type 2 diabetes, 8 patients had Type 1 diabetes and 5 patients were non-diabetic. The concentration of gentamicin in peripheral skeletal muscle tissue was dependent on the serum concentration, degree of PAD, gender and age. For patients with ischaemic lower extremity wounds (patients with mild or moderate and severe PAD), the concentration of gentamicin was significantly lower (p=0.010) than the concentration in non-ischaemic wounds and the concentration in female patients was also significantly lower than in male patients (p=0.047). The pharmacokinetic equation for gentamicin concentrations in skeletal muscle tissue was: Expected Cmuscle = -15.709 + 0.624 Cserum + 0.216 Age + PAD + 2.402 Gender* The concentration in peripheral subcutaneous tissue was 0.663 times the concentration in skeletal muscle tissue (p=0.000). The pharmacokinetic equation for gentamicin subcutaneous tissue concentrations was: Expected Csubcutaneous = 0.663 Cmuscle - 0.220* Gentamicin showed greatest penetration in male patients without PAD. For patients with severe PAD, higher doses of gentamicin may be required to achieve the same effect. 1. Brown SA, Newkirk OR, Hunter RP, Smith GG, Sugimoto K. Extraction methods for quantification of gentamicin residues from tissues using fluorescence polarization immunoassay. J Assoc Off Anal Chem 1990; 73(3): 479-483. * Where: Cmuscle = Skeletal muscle tissue concentration CJlg/g) Csubcutaneous = Subcutaneous tissue concentration CJlg/g) Cserum = Serum concentration CJlg/mL) Age = Age in years PAD = 3.881 for patients with nil or borderline PAD PAD = 1.813 for patients with mild or moderate PAD PAD = 0 for patients with severe PAD Gender - 1 for male patients Gender = 0 for female patients Description: M.PHIL. Sat, 01 Jan 2011 00:00:00 GMT https://www.um.edu.mt/library/oar/handle/123456789/33356 2011-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/33317 Title: Development of a quality management system for clinical pharmacy services Abstract: A quality management system (QMS) can assist a hospital to improve the quality of professional services provided. The aims of this study were to: (1) Analyse current clinical pharmacy service provision at Zammit Clapp Hospital (ZCH) and (2) Develop, validate, implement and evaluate standard operating procedures (SOPs) for the same hospital operating at the Rehabilitation Hospital Karin Grech (RHKG) to match current clinical pharmacy service provision and to guide new service development. A time and motion study was undertaken using a validated data collection form to obtain a detailed description of defined current pharmacy activities within the hospital and to quantify the use of the pharmacists' time in carrying out these activities. During an 18-day period, 6000 minutes of direct observation of the work activities of 3 pharmacists on 3 wards and in the pharmacy were carried out. SOPs for the clinical pharmacy services currently provided and for newly identified clinical pharmacy services were developed. Each SOP was validated twice by a core validation panel of 9 pharmacists and other healthcare professionals from within and outside the hospital included as relevant. The validated SOPs were tested for applicability and practicality through an observation study,. Subsequently, all the pharmacy staff were trained to follow the resulting final version of the SOPs. After 1 month of implementation, an evaluation of each SOP and the QMS was undertaken by the pharmacy staff using two self-administered questionnaires. Out of the 6000 minutes of observation, 3636 minutes (60.60%) were dedicated to 'Clinical' activities. Ward round (1348 minutes), patient discharge (723 minutes) and prescription monitoring (562 minutes) activities were the most predominant 'Clinical' activities. Seventeen SOPs were developed: 'Master', 'Training', 'Patient Admission', 'Patient Profiling', 'Prescription Monitoring', 'Ward Round', 'Patient Discharge', 'Adverse Drug Reactions', 'Patient Medication Trolley Check', 'Emergency Trolley Check', 'Controlled Drugs', 'Medication Errors', 'Student Placements/Practical Sessions', 'Continuing Professional Development Sessions', 'Patient/Carer Interview', 'Clinical Trials' and 'Clinical Pharmacy Services Reports'. The most important validation amendments for all 17 SOPs were the inclusion, modification and/or elimination of information, improved presentation and improved comprehensiveness. From the evaluation of the SOPs post-implementation, all the pharmacy staff agreed that each SOP was fit for purpose, easy to follow during training, user-friendly for reference during daily activities and supports development of a consistent service. During the first month of implementation, the SOPs which were referred to most were the 'Patient Profiling' and 'Continuing Professional Development Sessions' SOPs (both n=7). In the OMS evaluation, all the pharmacy staff agreed that the OMS contributes to meeting the hospital's policies and goals, sets direction to the pharmacy staff and interdisciplinary team and improves service control. The time and motion study extended the definition of the pharmacist's activities undertaken and quantified the amount of time dedicated by pharmacists to the provision of clinical pharmacy services. The SOPs developed draw on standards applicable to health care with the advantage that they provide a comprehensive approach to clinical pharmacy services. The system developed is now implemented, will need to be regularly reviewed and updated and can be transferred to other hospital settings with minor amendments. Description: M.PHIL. Sat, 01 Jan 2011 00:00:00 GMT https://www.um.edu.mt/library/oar/handle/123456789/33317 2011-01-01T00:00:00Z