OAR@UM Collection:
/library/oar/handle/123456789/33275
2025-12-24T21:46:08ZDistribution of anti-infective agents in ischaemic peripheries
/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.2011-01-01T00:00:00ZDevelopment of a quality management system for clinical pharmacy services
/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 ¸£ÀûÔÚÏßÃâ·Ñ 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.2011-01-01T00:00:00Z