Pharmacy Projects
Abstracts
Department of Pharmacy
University of Malta
2009
Editor
Anthony Serracino Inglott
Project Tutors
Lilian M. Azzopardi
Anthony Serracino Inglott
Claire Shoemake
Maurice Zarb Adami
Compiled by
Francesca Wirth
Marie Clare Zammit
Department of Pharmacy, University of Malta, Msida, Malta
email: lilian.m.azzopardi@um.edu.mt
t: +356 21 344971
f: +356 21 324835
The Pharmacy Project: An Education Tool Enabling
Student Initiative and Participation
The Annual Pharmacy Symposium is an event on the calendar of the Department of Pharmacy where
pharmacy staff and students work together as a team. It is an opportunity for undergraduate and
postgraduate students to present their work and to network within the profession. The modules in the
Pharmacy Practice Project provide the platform for the exposure of students to research methodology
and writing skills. Under the direction of the supervisors, students acquire the basic skills required
to develop competence in approaching research and report writing.
In identifying student projects, the department takes into account local and external developments in
the pharmacy profession. The work presented is a reflection of the excellent collaboration that the
Department of Pharmacy has with other departments in the University and with colleagues in the
healthcare field and the pharmaceutical industry. The department believes that through such collaborations
the gap between academia and practice is minimised and that an objective, empirical approach to
educational development of pharmacists is maintained. Safe, effective and consistent performance
is required of pharmacists in whichever setting they are practising.
Undergraduate teaching and training should provide graduates who can perform and are competent
to develop their skills in the various areas they intend to practice. The Department of Pharmacy also
offers postgraduate programmes for graduates intending to further develop academically their
competences. The final year Master of Science (Pharmacy) postgraduate students are presenting their
projects in the areas of clinical pharmacy, pharmacoeconomics and industrial pharmacy.
It is a pleasure to note that a number of these projects lead to publications in peer-reviewed journals
and to contributions which are later adopted in ‘real-life’ scenarios. The project compliments the
formal teaching schedule and the practical placements that are required within the pharmacy course.
The placement includes practice in community pharmacy and experiential learning in the hospital and
the pharmaceutical industry settings. Students are encouraged to take up mobility programmes such
as the Erasmus programme to broaden their experiences in other countries.
Professor Lilian M. Azzopardi
Head, Department of Pharmacy
3
Pharmacy education providers must offer learning activities that support individuals to develop
sustainable abilities appropriate for both a continually evolving clinical environment and also to satisfy
the needs of a flourishing pharmaceutical industry.
The subject of Pharmacotherapy remains a central area that pivots pharmacy practice. The projects
presented in this area include various topics ranging from compliance issues in hypertension (Charyl
Fava) to osteoporosis (Judith Fenech) and its related vitamin D deficiency (Erica Griscti). The
management of diseases and the drugs used in specific medical areas were tackled in projects by
Suzanne Griscti (rheumatoid arthritis), Jasmine Vella (ophtalmology) and Ambra Cauchi (cancer).
Karen Sapiano investigated the attitude towards preconception care in type I diabetics.
Pharmaceutical Care is a process involving pharmacist intervention such as patient management,
monitoring outcomes and specialist pharmaceutical care. Examples of such projects include those
carried out by Jeffrey Cassar, Sonia Bonnici and Roberta Scalpello.
The development, validation and implementation of Treatment Protocols encourage rational
pharmacotherapy practice. Work on treatment protocols is presented by Deborah Mercieca (common
cold), Steven Ellul (gastro-intestinal tract disorders), Stephanie Liane Magro (paediatric care) and
Ritienne Fenech (antibiotic use).
Educators in pharmacy are challenged to enable not just competence but also capability to administer,
communicate and use Information Technology to keep abreast with the ever changing context. Projects
presented by students carried out to practice their ability to communicate and negotiate effectively
include those by Analise Schembri on devising a course to enhance prescribing competence and by
Daniela Hili and Mark Magro on computerised records regarding the medications themselves and the
recording of medication errors. Sarah Marie Hili prepared a fresh look of a new edition of the ‘Maltese
Directory of Pharmacists’.
Dissemination of information in the pharmacy profession is a key part of education and training. This
includes several forms of media as shown in a number of projects. Formularies are the basic format
for presenting information on medicines. Examples of such formularies are presented by Doriella
Cassar (non-BNF cited items) and Corinne Elbourne (mental disorders). The development of patient
information leaflets by Fabienne Sant Portanier and Maria Scerri (anxiety and depression) are examples
of projects enabling the student to gain information dissemination skills. Other projects in this area
involved the setting up of a Pharmacy Practice Resource Unit (Simone Bartolo), development of a
newsletter to community pharmacists (Rachel Galea) and specific risk assessment (Ruth Gatt).
Pharmacy encompasses a vast array of other subjects which are tackled in student projects such as
those related to Industry, Regulatory Affairs and Clinical Analysis. Claire Galea carried out a project
on Standard Operating Procedures for bioequivalence studies, Stephanie Mallia on the quality of
medical devices and Alfie Palmier on penetration of antibacterial agents.
The Department of Pharmacy has recently launched a Masters of Science (Pharmacy) course where
six students are accepted each year to continue their studies specialising in a specific area. These
postgraduate students present their dissertation in the areas of Clinical Pharmacy (Kristen Buhagiar
and Elaine Vella), Pharmacoeconomics (Pierre Fava, Andrew Corrieri and Clifton Curmi) and Industrial
Pharmacy (Ian Baldacchino).
Professor Anthony Serracino-Inglott
Editor
4
Pharmacotherapy
Compliance Issues in Hypertension
Charyl Fava
Osteoporosis
Judith Fenech
Vitamin D Inadequacy among Maltese Postmenopausal Women
Erika Griscti
Management of Rheumatoid Arthritis
Suzanne Griscti
Preconception Care in Type 1 Diabetics
Karen Sapiano
Drugs Used in Ophthalmology
Jasmine Vella
Use of Interferon alpha-2b, Temozolomide and Pegylated
Liposomal Doxorubicin
Ambra Cauchi
Compliance Issues in Hypertension
Charyl Fava
Osteoporosis
Judith Fenech
Background: Hypertension is a significant condition
in many countries. In Malta, in 2007, 40.7% of deaths
1
were due to diseases of the circulatory system.
Background: Osteoporosis is a bone disease
contributing to yearly mortalities and morbidities.
Objective: To identify risk factors, assess patients’
1
knowledge and evaluate prescribing trends.
Objective: To evaluate compliance amongst
hypertensive patients, to study compliance factors,
to monitor blood pressure and Body Mass Index
(BMI) and to investigate non-compliance rates.
Design: A previously validated patient questionnaire
was used to identify patients’ risk factors, assess
knowledge on osteoporosis and the services offered
2
to them. A healthcare professional (HCP)
questionnaire was designed and validated to evaluate
the prescribing trends. A three gatefold patient leaflet
was also designed. Results were analysed using
®
Microsoft Excel 2007 and the Bio-Medical Data
Package Software.
Design: Hypertensive patients of any gender and age
were recruited randomly on purchasing their
antihypertensive medications. A validated
questionnaire was administered, blood pressure
monitored and BMI calculated. The chi-square test
was used to analyse the data.
Setting: Ten community pharmacies
Setting: Bone Density Unit at St. Luke’s Hospital
and Mater Dei Hospital.
Main Outcome Measures: Patient compliance and
control of hypertension and identified compliance
factors such as age and gender.
Main Outcome Measures: Assessment of patients’
risk factors, knowledge and evaluation of treatment
using the patient questionnaire and evaluation of
prescribing trends using the HCP questionnaire.
Results: One hundred and fifty patients, 37% (n=56)
males and 63% (n=94) females, with a mean age of
57 years participated. Full pharmacological
compliance was found in 78% (n=117) of patients
whilst 22% (n=33) of patients were non-compliant.
The control of hypertension was good in 59% (n=89)
of the patients. There was a statistically significant
correlation between pharmacological compliance
and gender (better in females), age (better in younger
patients) and level of education (better with higher
education), with p values of 0.021, 0.000 and 0.034
respectively. Salt, saturated fat, smoking and alcohol
were statistically significantly correlated to
pharmacological compliance. There was also a
statistically significant correlation between
pharmacological compliance and the control of
hypertension (p = 0.008).
Results: Sixty five patients (2 males, 63 females)
undergoing routine bone density scanning participated
in the study (mean age group > 60 years). The mean
lumbar T score was -2.90 while the mean hip T score
was -1.93. The most common risk factor was a
postmenopausal state (n=54), followed by lack of
exercise (n=38) and family history (n=28). Patients
obtained an average score of 10.2 (51%) when their
knowledge was assessed. Bisphosphonates with
calcium supplements (n=22) were the most commonly
prescribed drugs followed by bisphosphonates alone
(n=9), calcium supplements alone (n=9) and strontium
ranelate (n=9). The doctors referred patients for bone
density scanning in 75% of the scenarios.
Bisphosphonates (33%) and raloxifene (31%) were
mostly prescribed.
Conclusion: Hypertensive patients who buy their
medications are more pharmacologically compliant,
being female, the younger they are and the higher
their level of education. The more the patient is
pharmacologically complaint, the higher the chance
to have the blood pressure controlled. These results
highlight the importance of the healthcare
professionals to give weight to both the
pharmacological and the non-pharmacological
compliance.
Conclusion: Similarly to foreign studies, patients’
knowledge can be improved. Local prescribing trends
compare to established guidelines.
References:
1. National Institute for Clinical Excellence (NICE).
Technology Appraisal Guidance 160. NICE [Online]
2008 [cited 2008 Dec 2]. Available from: URL:
www.nice.org.uk.
2. Fendin S, Jones G, Oldenburg B, Winzenberg T.
The design of a valid and reliable questionnaire to
measure osteoporosis knowledge in women: the
Osteoporosis Knowledge Assesment Tool (OKAT).
BMC Musculoskeletal Disorders 2003; 4(17): 1-7.
Reference:
1. National Statistics Office (NSO). Demographic
Review 2007 [Online]. Malta: Government Printing
Press; 2008 [cited 2008 Jan 24]. Available from:
URL: www.nso.gov.mt.
6
Vitamin D Inadequacy among Maltese
Postmenopausal Women
Erika Griscti
Management of Rheumatoid Arthritis
Suzanne Griscti
Background: Vitamin D is essential for maintaining
1
calcium homeostasis and optimising bone health.
Background: Rheumatoid arthritis (RA) is a chronic
disease which warrants education about the disease
1
and its management.
Objective: To investigate the prevalence of vitamin
D inadequacy among postmenopausal women with
and without osteoporosis and to evaluate the factors
related to vitamin D inadequacy.
Objective: To evaluate the impact of a pharmacist
intervention using the Health Assessment
2
Questionnaire and questionnaires regarding desire
3
4
for information , beliefs about medications and
5
satisfaction on government pharmacy service.
Design: The questionnaire was administered to 300
postmenopausal women. Concentrations of 25hydroxyvitamin D [25(OH)D], 1,25dihydroxyvitamin D (1,25-(OH) 2 D) and 25hydroxyvitamin D3 (25(OH)D3) were determined.
Statistical analysis was carried out using the Pearson
®
chi-square test on SPSS version 16.0.
Design: Eighty patients with RA were interviewed
and divided into Group A (control n=20), Group B
(n=40) and Group C (patients on hydroxychloroquine
n=20). A pharmacist intervention was then offered
to Group B and Group C. An information leaflet on
hydroxychloroquine was given to Group C as part
of the intervention. Patients were re-assessed after
12 weeks.
Setting: Department of Obstetrics and Gynaecology
Outpatients and Immunology Lab, St. Luke’s
Hospital; Zammit Clapp Hospital.
Setting: Rheumatology Clinic, Mater Dei Hospital.
Main Outcome Measures: The medical history
questionnaire evaluated factors related to vitamin D
inadequacy. The Immundiagnostik Enzyme-ImmunoAssay kit determined 25(OH)D concentrations. The
High Performance Liquid Chromatography
determined 1,25-(OH) 2 D and 25(OH)D 3
concentrations.
Main Outcome Measure: Impact of the pharmacist
intervention on the quality of life (QOL) of patients
with RA.
Results: A statistically significant improvement in
the QOL of patients was registered following the
pharmacist intervention (p<0.05). A decrease in the
concern (p<0.05) and an increase in the necessity for
medications (p<0.05) were registered, when compared
to baseline.
Results: The 25(OH)D concentration was determined
from 250 patients; 112 patients (44.8%) had an
inadequate concentration. Risk factors related to
25(OH)D inadequacy included exposure to sunlight
(p=0.047), vitamin D supplementation (p=0.038).
The 1,25-(OH)2D and 25(OH)D3 concentrations were
determined from 166 patients; 46 patients (27.7%)
had an inadequate concentration. Risk factors related
to 1,25-(OH)2D and 25(OH)D3 inadequacy included
vitamin D supplementation (p=0.044), activity
limitation (p=0.006), climbing stairs (p=0.024) and
seasonal (p=0.003). The bone density condition did
not reflect the vitamin D results of the patients.
Conclusion: The pharmacist intervention resulted
in improved patients’ lifestyle, resolved concerns
and increased necessity of patient compliance.
References:
1. Wood J. Rheumatoid arthritis: management with
DMARDs. Pharm J 1999; 263: 162-7.
2. Fries JF, Spitz P, Kraines RG, Holman HR.
Measurement of patient outcomes in arthritis. Arthritis
Rheum 1980; 23: 137-45.
3. Duggan C, Bates I, Struman S, Andersson E,
Astrom K, Carlsson J. Validation of a “desire for
information” scale. Int J Pharm Pract 2002; 10:
31-7.
4. Horne R, Weinman J, Hankins M. The beliefs
about medicines questionnaire: the development and
evaluation of a new method for assessing the cognitive
representation of medication. Psychol & Health
1999; 14: 1-24.
5. Whitehead P, Atkin P, Krass I, Benrimoj SI. Patient
drug information and consumer choice of pharmacy.
Int J Pharm Pract 1999; 7: 71-9.
Conclusions: A high prevalence of vitamin D
inadequacy was found. Pharmacist-initiated
discussions regarding the importance of vitamin D
for bone health and intake of vitamin D supplements
could be implemented to reduce the prevalence of
vitamin D inadequacy.
Reference:
1. Holick MF, Siris ES, Binkley N, Beard MK, Khan
A, Katzer JT et al. Prevalence of Vitamin D
inadequacy among postmenopausal North American
women receiving osteoporosis therapy. J Clin
Endocrinol Metab 2005; 90(6): 3215-24.
7
Preconception Care in Type 1 Diabetics
Karen Sapiano
Drugs Used in Ophthalmology
Jasmine Vella
Background: Pregestational diabetes complicates
1 in 200 pregnancies. Although preconception
glycemic control directly impacts perinatal outcome
for type 1 diabetic women, these women still
frequently enter pregnancy with suboptimal control
1
of glycemia.
Background: Refractive surgery is a popular
procedure used to decrease spectacle or contact lens
dependency. Various drugs are used in this surgery;
1
intra- and/or post-operatively.
Objective: To assess visual outcome after undergoing
photorefractive keratectomy (PRK), to observe the
effect of drugs used on the final outcome, and to
assess patient satisfaction following surgery.
Objective: To assess the level of knowledge and
awareness related to preconception care among
Maltese women with type 1 Diabetes Mellitus (DM)
during the reproductive age.
Design: Self-reporting was carried out on PRK
patients using a questionnaire entitled 'Patient
assessment throughout excimer laser surgery for
refractive error'. Data was entered in a spreadsheet
®
using SPSS version 16.0. Statistical tests included
the two-way ANOVA and the chi-square test.
Design: Thirty seven women, aged 12-30 years with
type 1 DM, who presented at the state managed
diabetes clinic, were administered a brief questionnaire
pertaining to diabetes self-management and
preconception care. The participants were exposed
to an education intervention, and the responses of
the patients before and after the intervention were
®
measured. SPSS version 16.0 was used to analyse
the effects of the intervention statistically.
Setting: Ophthalmic Department, Capua St. James'
Hospital.
Main Outcome Measures: Information including
visual acuity and refraction was obtained from patient
files. Drugs used at all stages were noted.
Setting: Diabetes Outpatient Clinic at St. Luke’s
Hospital and Mater Dei Hospital.
Results: Sixty five patients were studied: 95% of
patients were treated for myopia; the rest were treated
for hyperopia. Visual acuity improved over time in
all patients. Mitomycin-C was used in 12.3% of
patients. Postoperatively, all patients were treated
with the same drug regimen, however, in 35.4% of
patients, fluorometholone was replaced with
dexamethasone, after 4 or 10 weeks. Of the patients
using dexamethasone, 8 patients needed spectacles,
3 patients required re-treatment, while 12 patients
did not need spectacles nor re-treatment. Many
patients still experienced some irritation or dryness
after 6 months; hence lubricating drops were still in
use. The most common visual symptoms were
multiple images and halos. Most patients were
satisfied after 6 months.
Main Outcome Measures: Determination of
knowledge of patients and evaluation of the impact
of the intervention.
Results: Out of the thirty seven patients recruited
by convenience sampling, twenty two patients agreed
to take part in the second part of the study. Sixteen
participants (72.7%) claimed they had no knowledge
about the value of diabetes care before planning a
pregnancy. However, after the intervention, this
number was reduced to 9 respondents (40.9%). Seven
patients (31.8%), who initially specified they had no
knowledge before the intervention, later on, changed
their views. Since the p value (0.016) is less the 0.05
level of significance, this change was significant.
Conclusions: The respondents lacked awareness of
pregnancy-related complications with diabetes. It is
imperative for health professionals to raise these
issues with their adolescent patients during routine
visits.
Conclusion: Visual acuity improved over time in
all patients. Mitomycin-C use was necessary in
patients having a refractive error higher than -8.
Dexamethasone use was due to regression and corneal
haze. Most patients were satisfied with the outcome.
Less satisfied patients were those with prolonged
steroid use, patients needing spectacles or re-treatment.
Reference:
1. Casele HL, Laifer SA. Factors influencing
preconception control of glycemia in diabetic women.
Arch Intern Med 1998; 15(12): 1321-4.
Reference:
1. Titcomb L. Laser surgery for refractive errors.
Pharm J 2006; 29: 511-514.
8
Use of Interferon alpha-2b,
Te m o z o l o m i d e a n d P e g y l a t e d
Liposomal Doxorubicin
Ambra Cauchi
Background: IFN-alpha2b (IntronA) was introduced
on the Government Formulary List (GFL). The
introduction of temozolomide (TMZ) and pegylated
liposomal doxorubicin (PLD) in the national formulary
is controversial.
Objectives: To investigate use and market potential
of IFN-alpha2b, TMZ and PLD and to study the
rational introduction on the GFL of TMZ and PLD.
Design: Five oncologists practising in Malta were
interviewed using three validated questionnaires. The
1
Toronto Side-Effect Scale (TSES) was adapted to
record IFN-alpha2b side-effect incidence.
Setting: Oncology Department, Sir Paul Boffa
Hospital.
Main Outcome Measures: Factors influencing
oncologists’ prescribing and their opinions on
introduction of PLD and TMZ in GFL, incidence and
management of interferon-related toxicities.
Results: Payment of treatment by patients emerged
as a strong factor determining TMZ and PLD
prescription. Their inclusion on the GFL would
increase prescribing (4 oncologists agreed).
Furthermore, 3 oncologists agreed they would prefer
TMZ to current options. Advantages of PLD are not
considered sufficient to offset the financial burden
2
of treatment. Low dose IFN-alpha2b (LDI: 6 MIU/m
SC TIW pushed to 6 weekly if tolerated) is used
instead of high-dose IFN-alpha2b (HDI) to avert high
2
incidence of side effects. Most common side effects
(mean rating scores) encountered with low dose IFNalpha2b were fever (4.4), fatigue-malaise (3.8) and
chills (3.6). Sixteen IFN side-effect management
interventions were adhered to.
Conclusions: TMZ introduction is desired whereas
PLD is less supported. Enforcement of side-effect
management plans could improve patient quality of
3
life.
References:
1. Vanderkooy JD, Kennedy SH, Bagby RM.
Antidepressant side effects in depression patients
treated in a naturalistic setting: A study of buproprion,
moclobemide, paroxetine, sertraline and venlafaxine.
Can J Psychiatry 2002; 47: 174-80.
2. IntronA® (Summary of Product Characteristics).
Belgium: Schering Plough Europe; 2005.
3. Hauschild A, Gogas H, Tarhini A, Middleton MR,
Testori A, Dreno B et al. Practical guidelines for the
management of interferon-alpha2b side effects in
patients receiving adjuvant treatment for melanoma.
Cancer 2008; 112(5): 982-94.
9
Pharmaceutical Care
Diabetic Patient Management
Jeffrey Cassar
Monitoring Outcomes in Infant Colic
Sonia Bonnici
Denture Hygiene within the Institutionalised Elderly Population
Roberta Scalpello
Diabetic Patient Management
Jeffrey Cassar
Monitoring Outcomes in Infant Colic
Sonia Bonnici
Background: Diabetic management centers on selfmonitoring of blood glucose (SMBG), patient
education programmes and screening of HbA1c
levels.
Background: Infant colic is defined as irritability
and crying for more than 3 hours a day, occurring
for more than 3 days a week and lasting for more
than 3 weeks.
Objectives: To identify problems encountered by
type I diabetics during SMBG, to evaluate the
education programme delivered to type II diabetics
and to monitor HbA1c levels of type II patients over
a one year trend.
Objective: To evaluate the use of information material
by healthcare professionals and parents in infant
colic.
Design: A previously, locally prepared leaflet
1
developed in 2004 and an infant colic diary prepared
2
in 2001 , were amended. Healthcare professionals
were provided with the adapted leaflet whilst others
were not. An infant colic diary was given to parents
whose infants suffered from colic. The diaries
collected, were evaluated using the chi-square test
and were compared according to the type of
intervention.
Design: A validated questionnaire was distributed to
25 type I diabetic patients. The data was analysed
with the chi-square test using MedCalc version
10.0.1.0. The education programme was evaluated
1
according to national standards. The HBA1c levels
of 30 type II patients were monitored over one year.
Data was analysed via a correlation study using
MedCalc version 10.0.1.0.
Setting: Five well baby clinics.
Setting: Diabetes Clinic, Mater Dei Hospital.
Main Outcome Measures: Frequency of colic
attacks, management of infant colic.
Main Outcome Measures: Problems of patients
during SMBG, issues discussed in the patient
education programme, correlation of age and routine
HbA1c levels.
Results: Out of 56 diaries, 30 were received and
evaluated. There was a significant difference between
pharmacological and non-pharmacological methods
versus the type of intervention (p = 0.000). The most
non-pharmacological intervention used was hot water
(25.9%) in patients when the leaflet was not used
and movement (16.9%) when the leaflet was used.
The most common pharmacological intervention
recommended was simethicone before a feed, used
in 49.9% of attacks. Diaries completed by parents
that had an intervention from healthcare professionals
that followed the leaflet used remedies that were not
used by parents where the healthcare professionals
were not provided with a leaflet.
Results: SMBG more than once daily was performed
by 64% (n=16) of patients, with 24% (n=6) and 12%
(n=3) monitoring once daily or once weekly
respectively. Internal psychological barriers were
found to significantly affect SMBG practices
(p=0.0018). In the patient education programme
delivered, 10% and 2% were allocated to monitoring
and psychological issues respectively. The correlation
analysis showed no association between age and
changes in HBA1c levels (p=0.730).
Conclusion: There is a clear indication that internal
psychological factors are significant in acting as
barriers to SMBG practices. Psychological issues
were not emphasised during the education
programme. The correlation study showed similar
findings to studies showing no changes in HbA1c
2
levels with increasing age.
Conclusion: Since parents who were given an
intervention by healthcare professionals who had
been provided with the leaflet used various other
remedies, it was shown that the leaflet was effective
and the information provided was utilised by the
parents and the healthcare professionals.
References:
References:
1. Funnell MM, Brown TL, Childs BP, Haas LB,
Hosey GM, Jensen B et al. National standards for
diabetes self-management education. Diabetes Care
2007; 30(6): 1630-7.
2. Wiener K, Roberts NB. Age does not influence
levels of HbA1c in normal subjects. QJM 1999; 92:
169-73.
1. Saliba N. Pharmacist intervention in infant colic
[dissertation]. Msida (Malta): University of Malta;
2004.
2. Mallia G. Infant colic in Malta [dissertation].
Msida (Malta): University of Malta.; 2001.
11
Denture Hygiene within the
Institutionalised Elderly Population
Roberta Scalpello
Background: Oral health is an important component
of overall health, well-being and quality of life for
institutionalised elderly patients. Regular and optimal
oral hygiene measures together with periodic oral
examination will prevent most cases of oral candidiasis
1
in those with dentures.
Objective: To investigate the relationship between
oral hygiene habits, denture stomatitis, denture
cleanliness and the presence and number of yeasts
in an elderly denture-wearing population.
Design: Ninety nine elderly denture wearers (mean
age 83.04) participated in an interview and oral
examination and provided an unstimulated saliva
sample. The saliva samples were processed to
determine the Candida cfu/ml of saliva and to identify
the yeasts down to their species level.
Setting: Government residential homes for the elderly.
Main Outcome Measures: Candida cfu/ml of saliva,
level of denture hygiene, significance of denture
hygiene in preventing oral candidiasis.
Results: Significant correlations were found between
denture cleaning methods and the presence of denture
stomatitis (p=0.020), yeast prevalence (p=0.010) and
Candida cfu/ml (p=0.001) respectively. Denture
stomatitis was significantly correlated to yeast
prevalence (p=0.003), high Candida cfu/ml (p=0.037)
and denture cleanliness (p=0.000) but was not
associated with denture cleaning frequency (p=0.960).
Frequency of cleaning was not related to Candida
cfu/ml (p=0.076) or yeast prevalence (p=0.226). No
relationship was observed between denture cleanliness
and yeast prevalence (p=0.317) or Candida cfu/ml
(p=0.588). Denture wearing habits were not associated
with yeast prevalence (p=0.354), mean Candida
count (p=0.140) or incidence of denture stomatitis
(p=0.301).
Conclusions: Denture hygiene plays an important
role in the maintenance of good oral health. Therefore
there is a pressing need for education of the elderly
population in this regard.
Reference:
1. Apkan A, Morgan R. Oral candidiasis. Postgrad
Med J 2002; 78: 455-9.
12
Treatment Protocols
Validation of Protocols for the Treatment of the Common Cold
Deborah Mercieca
Treatment Protocols for Disorders of the Gastro-Intestinal Tract
Steven Ellul
Validation of Protocols for Paediatric Care
Stephanie Liane Magro
Guidelines for Antibiotic Use in the Community
Ritienne Fenech
Validation of Protocols for the
Treatment of the Common Cold
Deborah Mercieca
Treatment Protocols for Disorders of
the Gastro-Intestinal Tract
Steven Ellul
Background: Protocols for treatment of common
cold can assist pharmacists in determining the best
course of action for patients presenting with common
cold symptoms.
Background: A treatment protocol is considered to
be a set of predetermined criteria that define
appropriate diagnosis and guidelines. Protocols
describe situations in which the pharmacist makes
interventions relative to a course of action for the
effective management of common patient care
problems such as Gastro Oesophageal Reflux Disease
1
(GORD).
Objective: To validate protocols for treatment of
1
common cold developed in a previous local study
and implement them in community pharmacies.
Objective: To develop treatment protocols for gastrointestinal (GI) conditions namely GORD.
Design: Treatment protocols consisting of step-bystep guidelines for the management of GORD and
Upper GI conditions and definition sheets were
developed. These protocols were evaluated by a
review team and were distributed to 10 community
pharmacists to test their applicability and practicality.
®
SmartDraw 2007 was used to design the protocols
®
in a modern, yet practicable way. Microsoft Excel
®
XP and SPSS version 16.0 was used to compile
data.
Design: The protocols, Non-Prescription Protocol
(NPP) and Prescription Protocol (PP), were evaluated
by a panel of 20 experts, modified accordingly and
formulated into a Protocol Booklet. The pilot study
indicated that a shorter version would be more
practical. Thus, a Protocol Handbook was developed.
Fifteen cases were collected from each pharmacy,
documenting pharmacist intervention (Time 0). The
pharmacists were given the Protocol Booklet and
Handbook. After two weeks of pharmacist review of
the protocols, another fifteen cases were collected
from each pharmacy (Time 1). A total of 206 hours
of observation were spent. Statistical analysis was
conducted using the Mann-Whitney U-test and
Pearson chi-square test.
Setting: Ten community pharmacies in Malta.
Main Outcome Measures: Applicability and
practicality of the protocols.
Setting: Twenty community pharmacies identified
by stratified random sampling.
Results: Protocol boxes were developed. New boxes
compiled were placed according to the criteria
presented at a community pharmacy, thus a continuous
flow in the flowcharts is assured.
Main Outcome Measures: Compliance with
protocols, use of assessment sheets.
Results: The NPP was followed in 74% of cases
(n=444). The average percentage compliance with
the two protocols was 52% (Time 0) and 74% (Time
1), each ranging between 17 and 100% (p=0.000).
The average percentage compliance with NPP was
61% (Time 0) and 79% (Time 1), range 17 to 100%
and 38 to 100% respectively (p=0.000). The average
percentage compliance with PP was 29% (Time 0)
and 57% (Time 1), range 17 to 80% and 17 to 83%
respectively (p=0.000).
Conclusions: Definition sheets are being amended
and discussed with the review team. Protocols will
be disseminated to the 10 pharmacies around Malta,
together with the datasheet and questionnaire to
evaluate their practical implementation.
Reference:
1. Harman RJ, Mason P. Handbook of pharmacy
nd
health care, 2 ed. UK: Pharmaceutical Press; 2002:
18.
Conclusion: The statistically significant increase in
compliance observed after dissemination of the
protocols indicates that these protocols have been
presented in an effective way to provide information
on the management of common cold symptoms.
Reference:
1. Buttigieg-Scicluna C. Development of protocols
for the treatment of common cold [dissertation].
Msida (Malta): University of Malta; 2005.
14
Validation of Protocols for Paediatric
Care
Stephanie Liane Magro
Guidelines for Antibiotic Use in the
Community
Ritienne Fenech
Background: Protocol-based care is advantageous
as it provides safe and high quality care, specially
needed in the paediatric field.
Background: A report issued by the National
1
Antibiotic Steering Committee identified the need
to develop guidelines and to monitor antibiotic use
in the community.
Objectives: To modify previously developed
protocols1, develop new protocols regarding common
paediatric diseases, validate them with a group of
health professionals and assess pharmacist compliance
with the protocols.
Objectives: To develop and validate antibiotic
guidelines for the community and to evaluate their
applicability and practicality, to assess the knowledge
and skills of pharmacists and doctors in the treatment
of common infections and to develop and evaluate
a monitoring system.
Design: Protocols on vomiting, diarrhoea and
1
constipation were modified and protocols on fever,
cough and abdominal pain were developed. Protocols
were validated by a group of professionals consisting
of 4 pharmacists, 3 general practitioners and 3
paediatricians. Subsequently, the protocols were
modified according to suggestions made during the
validation process. Eleven pharmacies where a
paediatrician has a clinic were identified, visited on
a regular basis and the protocols were implemented.
A points system was developed for the protocols.
®
Data was analysed using Microsoft Excel 2003.
Design: Antibiotic guidelines, a monitoring system
and case studies for each infection in the guidelines
were developed and reviewed by 8 experts. An
evaluation form was designed to analyse the
guidelines and monitoring system. The data was
analysed using Student’s paired t–test, Wilcoxon’s
test and Pearson chi-square test at 95% Confidence
Level.
Setting: Forty eight local community pharmacies.
Main Outcome Measures: Participants' knowledge
and skills on a category of infection were assessed
using case studies prior and following administration
of the antibiotic guidelines.
Setting: Eleven community pharmacies.
Main Outcome Measures: Compliance of
pharmacists with the protocols.
Results: Before administration of the guidelines, the
mean scores for pharmacists and general practitioners
(GPs) were 62.84% (n=40) and 60.53% (n=33)
respectively. No significant difference was observed
in most categories for the two professions. After
administration of the guidelines, the mean scores
increased by 22.17% and 24.07% for pharmacists
(n=39) and for GPs (n=33) respectively. Participants
agreed with the monitoring system proposed (87%,
n=47) and found the guidelines useful (96.43%,
n=56) and practical (85.71%, n=42).
Results: A total of 120 cases were collected during
the observation sessions. The majority of patients
presenting at the pharmacies were aged between 4
and 6 years (32%) with newborns to 1 year old age
group being the least common age group (22%). The
most predominant presenting complaint was cough
(44%) and the least predominant presenting complaint
was abdominal pain (8%). The average compliance
for all 6 protocols was 90%: for constipation 93%
(range: 77 to 100%), fever 92% (range: 55 to 100%),
vomiting 91% (range: 78 to 100%), cough 90%
(range: 54 to 100%), abdominal pain 89% (range:
64 to 100%) and diarrhoea 85% (range: 77 to 100%).
Conclusions: The guidelines and monitoring system
would be a step forward to improve antibiotic use in
the community. The mean scores for pharmacists
were similar to that for GPs, thus shedding new light
on the possibility of pharmacists being able to
prescribe antibiotics.
Conclusions: The average compliance of the
pharmacists with the protocols presented is high.
This study shows that pharmacist intervention in the
management of symptoms in paediatric patients
follows very closely evidence-based pharmacy
practice that was presented in the protocols.
Reference:
1. Antibiotic use and resistance in Malta: a report of
a working group setup by the health department.
Malta: Department of Health [Online] 2000. [cited
2 0 0 7 A u g 1 0 ] . Av a i l a b l e f r o m : U R L :
www.slh.gov.mt/pdf/antibiotic%20resistance%20r
eport.pdf
Reference:
1. Azzopardi R. Development of protocols of
paediatric care [dissertation]. Msida (Malta):
University of Malta; 2005.
15
Pharmacy Administration
Devising a Course to Enhance Prescribing Competence
Analise Schembri
Computerised Medication Records
Daniela Hili
Computerised Records of Medication Errors
Mark Magro
The Maltese Directory of Pharmacists: Present Status and Future
Predictions
Sarah Marie Hili
Computerised Medication Records
Daniela Hili
Devising a Course to Enhance
Prescribing Competence
Analise Schembri
Background: Computerised Medication Records
(CMRs) electronically store patient medical data and
1
their medication in a consistent way.
Background : The implementation of a prescribing
course will enable pharmacists to use their expertise
to help patients get the right treatment for their
conditions in new, more patient-focused ways.
Objective: To devise a database to store patient
medication records which can be accessed from a
website created for the project and to indicate
advantages of CMRs over paper-based records.
Objective: To design a prescribing course and to
evaluate the perception of pharmacists and doctors
on its possible implementation.
Design: A database was built using SQL manager
2005 Lite for MySQL and was populated with a total
of 150 medication records. The software program
HAPedit was used to build a website from which a
search for a particular patient medication record could
be carried out. PHP and MySQL languages were
both used. Xara Xtreme was used for the website
design. The website contains several features and
was evaluated by 30 healthcare professionals and 10
®
pharmacy students. Microsoft Excel was used to
present results.
Design: The study was divided into three phases:
1. A literature review assessing the best level of
prescribing; 2. A course (7 modules) designed
following analysis of the course specifications and
development of a course leaflet and supplementary
prescribing background; 3. Questionnaire designed
to evaluate the course and perception of health
professionals on its implementation: Questionnaire,
course leaflet and prescribing booklet were distributed
to pharmacists and doctors. Statistical analysis was
®
carried out using SPSS version 17.0.
Setting: Medication records were collected from
Zammit Clapp Hospital and from patients in the
waiting room of the Birkirkara Healthcentre
Pharmacy.
Setting: Community, clinical (Mater Dei Hospital,
Zammit Clapp Hospital and health centres) and
administrative settings.
Main Outcome Measures: Use of computerised
records.
Main Outcome Measures: Rating scales given to
the course overview; willingness to participate and
possible implementation of course and supplementary
prescribing strategy.
Results: Seventy percent (21) of the healthcare
professionals make use of some form of record
keeping; 19% (4) use computerised records, 52%
(11) use paper-based records and 29% (6) use both.
Ninety eight percent (39) thought that CMRs offer
a great advantage over paper-based records. The
same number of participants stated that they would
use CMRs if a standard system would exist.
Results: Out of the 96 questionnaires; 83 (86%) were
answered: 89% agreed that all the course content
was essential, classifying pharmacogenetics as the
least relevant by doctors 40% (16) and pharmacists
63% (27), 60% (24) of doctors and 100% of
pharmacists agreed that models of consultation and
principles of diagnosis should be included, 63% (25)
of doctors agreed to act as mentors during the
placement period and 93% (40) of pharmacists would
participate, 77% (67) of the respondents believe that
the course provides pharmacists with the tools to
offer a greater contribution as prescribers.
Conclusion: The advantages of CMRs over paperbased records indicated in the evaluation were: data
exchange and sharing, increase legibility of record
and reduction of medication errors.
Reference:
Conclusion: Both physicians and pharmacists agreed
that the course is suitable to enhance the pharmacists’
prescribing competence, recommending slight
changes particularly in oncology, pharmacogenetics
and diagnosis. A teamwork approach while
maintaining distinctive roles between health
professionals is the key to success in such a course.
1. Bemmel JH, Musen MA, Helder JC. Handbook
of medical informatics. Michigan: Springer Verlag
[Online] 1997 [cited 2008 Nov 29]. Available from:
URL:www.mieur.nl/mihandbook/r_3_3/handbook/
home.htm
17
Computerised Records of Medication
Errors
Mark Magro
The Maltese Directory of Pharmacists:
Present Status and Future Predictions
Sarah Marie Hili
Background: A Medication Error (ME) is any
preventable event that may lead to inappropriate
medication use or patient harm, while the medication
is in the control of the healthcare professional, patient,
1
or consumer.
Background: The 6 edition of the ‘Maltese Directory
of Pharmacists’ is an updated compilation of contact
details of locally registered pharmacists, pharmacies,
pharmaceutical agents, importers, wholesalers and
companies, and a list of undergraduate pharmacy
project titles.
th
Objective: To develop a website containing records
of different MEs with the aim of increasing awareness
regarding a major healthcare problem and also
providing adequate prevention advice.
Objective: Updating the ‘Maltese Directory of
Pharmacists’ (2005), evaluating the directory’s
usefulness among its users and psychographic analysis
of local pharmacists.
Design: Two hundred examples of different MEs
were collected from various sources such as the
Australian Prescriber and Hospital Pharmacy Europe
and inserted into a database purposely created using
MySQL. Using PHP programming language, a
website was developed with HAPedit and connected
to the database to represent the MEs online. Certain
features and design enhancements were implemented
to ensure that it would be fully functional and
professional. Xara Xtreme Pro was used to enhance
®
the website design and Microsoft Excel was used
to represent results.
Design: Pharmacists were contacted by telephone
or electronic mail to update their contact details. The
list and contact details of local pharmacies were
updated as well as those of pharmaceutical agents,
importers and wholesalers. The directory includes
an updated list of undergraduate project titles carried
out by pharmacy students along the years. The
directory was self-published to reduce costs. Sponsors
were required to cover the printing costs of the
directory. Various companies were contacted and
sponsors were acquired. The study concerning
pharmacist analysis was carried out using a separate
®
questionnaire and results were analysed using SPSS
16.0. Following printing, the directory will be
distributed to local pharmacies and its usefulness
evaluated.
Setting: Community setting, St Vincent De Paul
Residence.
Main Outcome Measures: Evaluation of the website.
Results: Evaluation was carried out amongst 40
participants (10 medical doctors, 10 pharmacists, 10
nurses and 10 students) and a 100% response rate
was achieved. Thirty three percent (13) of the
participants stated that they have been directly
involved in the occurrence of a ME. Eighty three
percent (33) of the participants strongly agreed that
the website had increased their awareness on MEs.
All the participants (40) stated that the website had
increased their cautious approach whilst handling
medications.
Setting:
Local Pharmacist Manpower.
Main Outcome Measures: Publishing of the ‘Maltese
Directory of Pharmacists’, analysing the role of the
pharmacist in the local pharmacy field, identification
of new and varying trends within the local pharmacy
sector.
Results: Results from the socio-demographic
questionnaire were formatted for the new edition of
the directory.
Conclusion: Current workforce patterns are classified
showing the various socio-demographic factors which
give rise to evolution within the local pharmacy
scene. Such factors are invaluable when planning
future policies within the pharmacy sector.
Conclusion: Results have shown that the website is
capable of increasing awareness on MEs and
increasing cautiousness whilst handling medications.
Reference:
1. National coordinating council for medication error
reporting and prevention. What is a medication error?
[Online] 1998 [cited 2008 December 28]. Available
from: URL:
w w w. n c c m e r p . o r g / a b o u t M e d E r r o r s . h t m l
18
Pharmacy Information
Formulary for Non-BNF Cited Items
Doriella Cassar
Formulary for the Management of Mental Disorders
Corinne Elbourne
Development of Patient Information Leaflets
Fabienne Sant Portanier
Development of Information Leaflets on Anxiety and Depression
Maria Scerri
Newsletter to Community Pharmacists
Rachel Galea
The Pharmacy Practice Resource Unit
Simone Bartolo
Risk Assessment of the Preparation of Intravenous Infusion
Fluids
Ruth Gatt
Formulary for Non-BNF Cited Items
Doriella Cassar
Formulary for the Management of
Mental Disorders
Corinne Elbourne
Background: The ‘British National Formulary’
(BNF), a publication which provides detailed
information about medicinal products available in
the United Kingdom, is used as a major reference
source by Maltese healthcare professionals since a
Maltese national formulary does not exist. In 2006,
1
Micallef developed the ‘Maltese Medicine
Handbook’ (MMH) so as to include those drugs
found locally that were not present in the BNF, thus
making these separate publications ideal to be used
together.
Background: To date healthcare professionals (HCPs)
at Mount Carmel Hospital make use of a drug list
which contains the pharmaceutical products including
the dose and the formulation in which they are
available at the hospital.
Objectives: To develop a formulary for a psychiatric
hospital, to identify information requested by HCPs
to be included in the formulary and to print and
evaluate the final draft of the formulary.
Design: The formulary was compiled after giving
out 200 questionnaires at the hospital which was
aimed to identify information which the HCPs wanted
to include in the formulary. HCPs suggested the
development of guidelines on the use of medications
as part of the formulary. During the development of
the formulary, guidelines were developed according
to the National Institute for Clinical Excellence
(NICE) and Maudsley guidelines, both UK guidelines,
and guidelines of the American Psychiatric
Association. Both the formulary and the guidelines
were evaluated by HCPs. Once compiled, both were
submitted for printing and 100 copies were given to
HCPs for evaluation.
Objective: To maintain and evaluate the MMH,
assess updates and include details of medical devices.
Design: A list of medicinal products available in the
local market, issued by the Malta Medicines Authority,
was used to identify products not listed in the BNF.
Details included for all the medicinal products were:
trade name, marketing agent holder, active ingredient,
PoM/OTC status, dosage form, dosage strength,
dosage regimen, consumer price and local distributor.
Details included for all the medical devices were:
trade name, marketing agent holder, local distributor
and consumer price. For drugs not listed in the BNF,
the following information was also included:
indications, cautions, contraindications, side-effects
and dose.
Setting: Mount Carmel Hospital.
Main Outcome Measures: Compilation and
evaluation of formulary and guidelines.
Setting: Community pharmacies.
Main Outcome Measures: Updating the first edition
of the MMH and evaluation of the contents, use and
costs.
Results: The size of the printed handbook is A5 and
consists of 4 main chapters which include: Hypnotics
and Anxiolytics, Anti-depressants, Antipsychotics
and Anti-Manic drugs. The handbook contains 5
guidelines which include: Depression, Anxiety
Disorder, Schizophrenia, Insomnia and Bipolar
®
Disorder. Using SPSS Version 16.0, it is evident
that the information within the formulary has been
rated well by all the respondents and that all book
features were also rated well by all respondents: 98%
of the HCPs found the formulary useful and 96%
also found the guidelines useful.
Results: The publication includes 595 items, of
which, 566 are medicinal products (and their different
dosage forms) and 29 are medical devices. Two
hundred seventy eight items of the previous
publication were updated, 102 items were removed
and 317 items were added.
Conclusions: The considerable amount of changes
that had to be done to the present edition suggests
that this publication should be updated more
frequently than every 3 years.
Conclusion: The developed formulary provides
improved information and knowledge about the
available medications. It can be carried around, stored
easily, is concise and contains tables for better
comparison of products.
Reference:
1. Micallef S. Compiling a formulary for non-BNF
cited products [dissertation]. Msida (Malta):
University of Malta; 2006.
20
Development of Patient Information
Leaflets
Fabienne Sant Portanier
Development of Information Leaflets
on Anxiety and Depression
Maria Scerri
Background: Written drug information, usually in
the form of Package Inserts (PIs) or Patient Package
Inserts (PPIs), aims to provide brief, concise and
comprehensible information to patients.
Objective: To analyse design factors contributing to
the reading ease of Patient Information Leaflets
(PILs) for non-prescription medicines (NPMs) and
improve the readability of one PIL from each of 18
pharmacological classes.
Background: The awareness of depression and
anxiety is important since their symptoms may be
ignored by people suffering from these conditions.
Objective: Developing and validating information
leaflets regarding depression and anxiety.
Design: Information leaflets about depression and
anxiety were designed. Questionnaires regarding
these two conditions were formulated and the testretest reliability method with 10 individuals was
adopted to test reliability of interpretation of the
questionnaires. Both leaflets and questionnaires were
reviewed by a review panel. The questionnaires were
distributed to 40 participants. Following the
distribution of the leaflets, the same questionnaire
was re-distributed to the same participants to be able
to assess the educational value of the leaflets. Results
®
were entered in a Microsoft Excel sheet and the
BMDP package software 2007 was used to compare
the responses using correlation coefficient and t-test.
Design: A sample of 264 NPMs was classified into
18 pharmacological classes. Design factors together
with Flesch/Flesch-Kincaid readability scores were
evaluted. One NPM from each class was edited and
readability values were recalculated. The edited PILs
were distributed to patients using the product.
Setting: A community pharmacy in Balzan.
Main Outcome Measures: Design factors analysed:
presence of leaflet, PI or PPI, English version, number
of facades, text organisation, text and background
colour, date of revision, pictorial representations,
active and direct style, boldface and underlining,
explanation of medical terminology, number of
languages present.
Setting: Gan Frangisk Abela Junior Collage; Felice
Pharmacy, Zabbar
Main Outcome Measures: Reliability of the
questionnaire, impact of leaflets on knowledge
Results: Of the 243 NPMs analysed 60 (24.7%)
contained a PI, and 119 (49%) contained a PPI. Sixty
four (26.3%) lacked a PI, however 59 (92.2%) had
sufficient information on the outer packaging. One
language was present for 127 (70.9%) of the PIs.
English was available for 166 of the PIs (92.7%).
Only 52 (29.1%) PIs had two or more languages
present. Medical term explanations were available
for 65.9% (118) of the PIs. Nearly half of the PIs
obtained a Flesch-Kincaid score of 6.1 to 8.0, meaning
th
the text is comprehendable for 6 grade students and
60% of PIs obtained a Flesch reading score of more
than 48.9.
Results: A Flesch Reading Ease Score of 70 and 75
were obtained for the “Anxiety” and “Depression”
leaflets respectively. From the test-retest reliability
testing, the correlation coefficients for each
questionnaire were 0.7 and 0.8 respectively.
Conclusion: The Flesch Reading Ease Scores for
both leaflets indicate that the leaflets are fairly easy
to read and understandable from an age above 13
years. Since these leaflets are aimed for people older
than 16 years this result was very satisfactory. The
correlation coefficients for both questionnaires were
greater than 0.6 indicating reliability of data generated.
Conclusion: More than a quarter NPMs did not
contain a PI. The English language was not present
for 13 (7.3%) NPMs. Based on the Flesch-Kincaid
scores obtained, the text can be considered to be
difficult in nature for approximately 20% of the PIs
analysed.
21
Newsletter to Community Pharmacists
Rachel Galea
The Pharmacy Practice Resource Unit
Simone Bartolo
Background: The Active Pharmacist is a newsletter
issued on behalf of a local pharmaceutical company,
Actavis Malta, in collaboration with the Department
of Pharmacy at the University of Malta and directed
towards community pharmacists.
Background: The Pharmacy Practice Resource Unit
(PPRU) is a source of drug information and is
equipped with medications, diagnostic tests and an
extemporaneous area to resemble the appearance of
a community pharmacy. Its use helps the future
pharmacist develop skills necessary to enable the
best and safest use of medicines.¹
Objective: To develop and evaluate the newsletter.
Design: Four issues of The Active Pharmacist were
prepared. The newsletter consisted of four A4 size
pages designed using FreeHand MX. The articles
included news from the pharmaceutical industry,
information regarding new drugs available on the
local market and information about medical conditions
and treatment. Articles discussing chronic conditions
were endorsed by medical specialists in the areas
concerned. Two hundred and fifty copies of each
issue were distributed, together with a questionnaire
that was developed to evaluate the newsletter.
Objectives: To collect pharmaceutical preparations,
medical devices and recently launched products, to
identify discontinued products and display them
accordingly, to increase the number of books, journals,
drug literature and extemporaneous materials, to
provide internet access and to obtain sponsors.
Design: New and previously present preparations
were listed and arranged according to pharmacological
class. The aesthetic appearance and use of space
was improved. Drug literature was filed and books
were shelved. A computer was installed and a glass
show case for displaying diagnostic devices and
discontinued medications was provided.
Pharmaceutical importers and medical representatives
were contacted and asked for any of their products,
including their product literature. An appointment
was offered to those who wished to view the PPRU.
Foreign pharmacy practice laboratories were studied
for ideas improve the PPRU. A list of local
pharmaceutical importers and manufacturers was
compiled.
Setting: Community and hospital pharmacies.
Results: Evaluation of the questionnaires resulted
in a response rate of 50.3% (n=1000). Two hundred
and seventy nine (55.5%) respondents were females.
With regards to the design and layout of the
newsletter, respondents agreed that the newsletters
had an attractive (99%, 497) and professional (96.8%,
487) layout, the font used was clear (97%, 488) and
that the illustrations were sufficient to complement
the articles (85.7, 431). They agreed that the articles
were both interesting (97.4%, 490) and informative
(97.3%, 489), useful (93.4%, 470) and well written
(91.7%, 461).
Setting: The PPRU, Pharmacy Department,
University of Malta.
Main Outcome Measures: Medicines, medical
devices and drug information made available at the
PPRU.
Conclusions: The newsletter was received well by
the pharmacists. Many of the pharmacists suggested
that there should be a continuation in the publication
of such newsletters as they believed they were
interesting, easy to read, practical and were a good
method of communication between the
pharmaceutical industry and the pharmacist.
Results: The PPRU now includes 6 books, 809
medicines, a computer tower and a showcase.
Conclusion: The PPRU is still in its development
and is being used for pharmacy practice tutorials.
Reference:
1. Colin-Thomé D. Realising the potential of
pharmacists. Royal Pharmaceutical Society of Great
Britain [Online] 2006 [cited 2008 Nov 8]. Available
from: URL:
www.rpsgb.org.uk/pdfs/pharmrolebrief.pdf
22
Risk Assessment of the Preparation of
Intravenous Infusion Fluids
Ruth Gatt
Background: It is recommended that regular risk
assessments of the preparation of aseptic products
are carried out to help minimise the risks associated
1
with intravenous (IV) therapy.
Objective: To develop a questionnaire that can be
used locally to carry out risk assessments of the
preparation of IV infusion fluids in medical wards.
Design: An extensive literature review was carried
out. A first draft was developed, based on 2 validated
questionnaires used in recent risk assessment studies
2,3
in the United Kingdom. New questions were added
to the drafted questionnaire to include aspects of
risks not highlighted in the previously developed
questionnaires. The questionnaire was reviewed by
4 healthcare professionals (3 pharmacists and 1 nurse)
and the respective recommendations were integrated
into a final draft.
Setting: Six General Medical Wards, Mater Dei
Hospital.
Main Outcome Measures: Identification of the
hazards present in the ward environment and the
current practices used during the preparation of IV
infusion fluids.
Results: The final draft of the questionnaire entitled
‘Questionnaire on the Preparation of Intravenous
Infusion Fluids’ consists of 6 A4 pages and is divided
into 7 distinct sections, namely: (1) General
Information, (2) Types of Infusions Prepared, (3)
Preparation Environment, (4) Preparation Practice,
(5) Training, (6) Policies/Guidelines, (7) Comments
and Suggestions.
Conclusions: The questionnaire was designed to be
user-friendly for nurses in the local general hospital
setting as a risk assessment tool for preparation of
IV infusion fluids.
References:
1. National Patient Safety Agency (NPSA). Promoting
safer use of injectable medicines. NPSA [Online]
2007 [cited 2008 Feb 6]. Available from: URL:
www.npsa.nhs.uk/EasysiteWeb/getresource.axd?A
ssetID=2265&type=Full&servicetype=Attachment
2. Beaney AM, Goode J. A risk assessment of the
ward-based preparation of parenteral medicines.
Hospital Pharmacist 2003; 10:306-8.
3. Munro MJ, Millar BW, Radley S. A risk assessment
of the preparation of parenteral medicines in clinical
areas. Hospital Pharmacist 2003; 10:303-5.
23
Regulatory Affairs, Industrial Pharmacy and Clinical
Analysis
Quality of Medical Devices
Stephanie Mallia
Standard Operating Procedures for Bioequivalence Studies
Claire Galea
Penetration of Antibacterial Agents in the Peripheries
Alfie Palmier
Quality of Medical Devices
Stephanie Mallia
Standard Operating Procedures for
Bioequivalence Studies
Claire Galea
Background: Patients as well as healthcare
professionals are increasingly confronted with new
devices for blood pressure and blood glucose
measurement. However, clinical usefulness of
measurements is limited by the accuracy of the
1
device.
Background: Bioequivalence Studies (BS) are
financially intensive undertakings requiring significant
investment in personnel, facilities and equipment.
Objectives: To prepare a set of Standard Operating
Procedures (SOPs) for a BS to be used as a template
for future BS.
Objective: To compare medical devices used for
point-of-care testing and home monitoring of blood
pressure and blood glucose by testing different blood
pressure monitors and blood glucose meters.
Design: SOPs describing a pilot BS were prepared,
comparing a generic preparation of doxazosin 8mg
®
(slow-release) with its patented counterpart Cardura
1
2
XL carried out by Abela and Tanti.
Design: A single-site, single-visit comparison of 4
blood pressure monitors (ICO Medical mercury
sphygmomanometer, S+K™ Manuell 50 KC anaeroid
®
sphygmomanometer, A&D Medical UA-767 Plus,
®
and Hartmann Digital HG 140) and 4 blood glucose
®
®
meters (Accu-chek Active, Glucometer Elite,
®
®
OneTouch Horizon and Major II). Fifty volunteers
were recruited for each study.
Setting: Department of Pharmacy, University of
Malta; Viticulture Laboratory, Ghammieri.
Main Outcome Measures: SOP library that can
serve as a template for future BS.
Results: The created SOPs (n=29) were a result of
identification of the processes and sub-processes,
both clinical and analytical that were fundamental
to the execution of the BS protocol. SOPs were subclassified into categories general and specific. General
SOPs were formulated to ensure their applicability
to future BS. All created SOPs were standardised in
a format that was laid out in the Master SOP.
Setting: A Community Pharmacy.
Main Outcome Measures: Comparison of results
obtained by the different blood pressure monitors
and blood glucose meters using the paired sample ttest and the Pearson correlation coefficient.
Results: The blood glucose levels recorded by the
different meters had a statistically significant
®
difference (p < 0.05). Glucometer Elite and
®
OneTouch Horizon showed the best correlation
®
®
whilst Accu-Chek Active and Major II showed the
least correlation. There was a statistically significant
difference between diastolic blood pressure values
recorded by Hartmann Digital and all the other 3
monitors (p < 0.05). The ICO Medical and S+K™
Manuell 50 KC showed the best correlation whilst
®
®
A&D Medical and Hartmann Digital showed the
least correlation.
Conclusion: Although the SOPs produced
exhaustively dissected the entire BS, these were not
subjected to a validation exercise owing to the fact
that the pilot study was terminated prior to SOP
completion. Furthermore, the pilot phase of the study
has not yet been extended to a fully fledged BS. Once
this occurs it will become imperative to challenge
the prepared SOPs to the scrutiny of the personnel
who will make use of them, and to effect amendments
as necessary. This validation process will confer
robustness to the procedures and make them suitable
for distribution in the laboratory according to GLP
principles.
Conclusion: Different blood glucose meters gave a
statistically different result but show a good
correlation. The diastolic blood pressure values
®
obtained by Hartmann Digital are statistically
significantly different from the values obtained by
the other blood pressure monitors. The best correlation
was found between the mercury sphygmomanometer
and the aneroid sphygmomanometer.
References:
1. Abela A. Bioequivalence of doxazosin slow release
tablets: A pilot study [dissertation]. Msida (Malta):
University of Malta; 2008.
2. Tanti A. Bioequivalence studies: A cost
effectiveness study [dissertation]. Msida (Malta):
University of Malta; 2008.
Reference:
1. O'Brien E, Waeber B, Parati G, Staessen J, Myers
MG. Blood pressure measuring devices:
recommendations of the European Society of
Hypertension. BMJ 2001; 322:531-6.
25
Penetration of Antibacterial Agents in
the Peripheries
Alfie Palmier
Background: Diabetes Mellitus patients may present
peripheral vascular complications such as ulceration
and gangrene.
Objective: To determine a method to analyse plasma
and tissue concentrations of amoxicillin and
metronidazole using High Performance Liquid
Chromatography (HPLC) and Solid Phase Exraction
(SPE).
Design: A HPLC method was developed for the
analysis of amoxicillin and metronidazole in plasma
1
and tissue. Swine tissue samples were allowed to
soak in a known concentration for 24 hours whilst
plasma was spiked with known volumes. SPE was
used as a sample preparation technique. Resolution
of peaks was achieved with a mobile phase of 30:70
v/v acetonitrile-25mM potassium phosphate buffer
containing 0.25% triethylamine, 2% methanol and
-1
2% acetic acid (pH4.5) at a flow rate of 0.5mlmin .
A 5 micrometer phenyl column, equipped with a
fluorescent detector pre-set at an emission wavelength
of 440nm and 444nm for amoxicillin and
metronidazole respectively.
Setting: Pharmacy Department Laboratories for the
preparation of the mobile phase and SPE; Allied
Research Unit for tissue preparation; Ghammieri
Laboratory for HPLC analysis.
Main Outcome Measures: Development of
analytical methods.
Results: The analysis of both anti-bacterial agents
is possible using a reversed phase HPLC system and
SPE extraction techniques. The method yields
retention times of 3.8 and 4.3min for amoxicillin and
metronidazole respectively. Both agents easily
permeate through muscle tissue over a period of 24
hours. Amoxicillin is unstable above a temperature
of ±5.0°C, this was evident in repeated analysis.
Metronidazole on the other hand shows notable
degradation in light over a period of 48 hours.
Reference:
1. Storms ML, Stewart JT. Development of a
reversed–phase liquid chromatographic method for
the analysis of amoxicillin, metronidazole and
pantoprazole in human plasma using solid phase
extraction. Journal of Liquid Chromatography &
Related Technologies 2002; 25(16):2433-43.
26
MASTER OF SCIENCE (PHARMACY)
Integrated Quality Systems
Ian Baldacchino
An Evaluation of a Pharmacist-Run Anticoagulation Clinic
Kristen Buhagiar
An Economic Study for the Establishment of a Chlor-Akali Plant
in Malta
Andrew Corrieri
Generic Medicines in Malta
Clifton Curmi
Osteoporosis: Better Bone Health
Pierre Fava
Evaluation of Pharmacist Clinical Interventions in a Geriatric
Hospital Setting
Elaine Vella
MASTER OF SCIENCE (PHARMACY)
Integrated Quality Systems
Ian Baldacchino
The aims were to assess impact of the new ICH Q10 standard on pharmaceutical industry, to carry
out interviews with persons working in the pharmaceutical industry, to perform gap analysis in a live
environment to determine what is required prior to an ICH Q10 assessment and to develop an
implementation plan. Interviews with Medicines Authority, Qualified Persons and key people in the
field were undertaken. A pilot implementation of ICH Q10 was carried out.
An Evaluation of a Pharmacist-Run Anticoagulation Clinic
Kristen Buhagiar
Patients attending the anticoagulation clinic at Zammit Clapp Hospital were interviewed. Their
perception of a pharmacist-run anticoagulation clinic was assessed. Correlation analysis was used to
investigate the reliability of a dosing algorithm compared to the method of warfarin dosing currently
used to keep patients within therapeutic range. Results favoured using this algorithm (p = << 0.05).
With the current method of dosing, patients are often being under-coagulated for long periods rather
than kept within range (p=0.001).
An Economic Study for the Establishment of a Chlor-Akali Plant in Malta
Andrew Corrieri
The aim was to study the impact a Chlor-Alkali plant using the latest technologies will have on the
island’s pharmaceutical economy. Malta is ideal due to the available primary raw material (salt water).
The end products are important in the manufacture of pharmaceuticals, disinfectants and medical
devices. Due to the high electricity consumption, the construction of a perpetual power plant is
considered. Around 40% of the total power needed can be generated using the hydrogen produced.
Generic Medicines in Malta
Clifton Curmi
As healthcare costs in the developed world continue to increase, generic copies of successful branded
drugs are becoming more and more popular worldwide. The cost of medicines has an impact on the
quality of life of patients and the economy of the country. Malta is becoming a niche for the
pharmaceutical industry, particularly the generic industry. Encouraging competition in the pharmaceutical
market through increasing the use of generic medicines promotes cost containment and stimulates the
innovation needed to provide added value products.
Osteoporosis: Better Bone Health
Pierre Fava
The study identifies factors that increase patient visits to a doctor, the main driving factors behind
patients’ complaints and what factors preoccupy patients the most, for example loss of independence.
The study focuses on the development of a tool that can be used by clinicians to assess past and present
patient history at a glance and that can also be used when advising a patient to visit a specialist in the
field. The tool helps develop a better understanding of the priorities of both doctors and patients
coupled with education and enhanced communication that will ensure success in interventions and
treatment.
Evaluation of Pharmacist Clinical Interventions in a Geriatric Hospital Setting
Elaine Vella
Clinical pharmacists make many recommendations to improve the care of hospitalised patients. This
study aimed to survey clinical interventions by pharmacists at Zammit Clapp Hospital, their acceptance
by clinicians and their significance. During a 3-month period, pharmacists recorded specific details
of their interventions on a documentation form designed to standardise data collection. A total of 263
interventions were documented of which 80% were accepted by physicians. The highest percentage
of interventions were adjustments to dose, frequency and time of dose.
28
FOURTH YEAR STUDENTS PROJECT DESCRIPTIONS
History of Pharmacy
Gerard Abela
The study aims to portray the history of the prescribing trends in pharmacy throughout the years. The
names of the drugs and the year in which they were prescribed are being collected from the Daily
Sales Register of a local community pharmacy. The data will be divided into groups according to
the time frame to analyse variations in prescribing trends. From the data collected between 1945 and
1950, sulphathiazole was the most commonly prescribed drug in 1945, 1946 and 1947 but was much
less popular between 1948 and 1950.
Bioequivalence: The Case of Doxazosin
Svetlana Agius
Accreditation is a procedure by which an authoritative body gives formal recognition that an institution
or person is competent to carry out specific tasks. The project aims to understand the requirements
of ISO 17025 for achieving accreditation of a bioequivalence testing laboratory, to evaluate the
laboratory and determine the degree of conformity to ISO 17025. Existing documentation is reviewed
and missing documentation is developed to facilitate accreditation of the laboratory.
Point-of-Care Anticoagulant Monitoring
Melanie Azzopardi
Seventy patients receiving warfarin had their INR monitored at a community pharmacy using the
CoaguChek®S device. Patient knowledge of anticoagulation therapy was assessed (time 0). An
educational intervention was held and patient knowledge is reassessed through a second interview
after 3 months. The effectiveness of this educational intervention will be demonstrated using Chisquared analysis. A regression model will be established by comparing the Coaguchek®S INR result
with reference laboratory result, which will be used to propose anticoagulant dosage adjustments in
collaboration with prescribers.
Point-of-Care HbA1c Monitoring
Stephanie Azzopardi
A random sample of 50 diabetic patients (18 males, 32 females) were interviewed and subjected to
HbA1c testing, followed by an educational intervention and distribution of a booklet (time 0). HbA1c
testing was repeated after 3 and 6 months to assess progress in diabetes control. The mean age was
64 years (range 34-81 years) and mean duration with diabetes was 11 years. The educational intervention
resulted in a lower mean %HbA1c in the second (7.6%) and third (7.7%) visit compared to the first
visit (7.9%).
GDP: The Example of a Wholesaler
Vanessa Azzopardi
Wholesalers occupy an essential niche in the pharmaceutical supply chain providing a link between
manufacturers and patients. Wholesalers must conform to established standards to achieve Good
Distribution Practice. A booklet of Standard Operating Procedure templates is currently being compiled,
as an addition to the Green Guide, to ensure that a high level of medicinal product quality is maintained.
The booklet will be validated by an expert team of five persons.
Assessing the Feasibility of Computerising Patient Profiles in a Geriatric Hospital
Rodianne Bondin
A computer program for pharmacy patient profiles previously designed using Microsoft Access, was
updated and a test run is being carried out at Karin Grech Hospital (KGH). Patients admitted to KGH
are identified and the time taken by the pharmacists to fill in the profile electronically is recorded and
compared to the time taken to fill in the profile manually. The daily cost of medications per patient
is calculated using the computer program.
29
Distribution of Free Medicine in Malta
Gilles Briffa Rizzo
The ‘Pharmacy of Your Choice’ scheme, is a new system of free medicine distribution in Malta which
was launched in January 2008. This scheme was introduced as a pilot study in the localities of
Gharghur, Mgarr. Mellieha, Naxxar, Mosta and St. Paul’s Bay, as an alternative to the previous
Government Dispensary System. A questionnaire is developed to determine the perception of the
public in these localities focusing on issues such as ‘patient-pharmacist confidentiality’, ‘out of stock
items’ and ‘queues’.
Developing a Drug Information Bulletin
Alison Brincat
A Drug Information Bulletin has been compiled to reflect the current pharmaceutical information of
new medicinal products placed on the local market and variations in the Summary of Product
Characteristics of locally available drugs. The bulletin is designed to be user-friendly and practical.
It is divided into two categories: the first focusing on new medicinal products available and the other
deals with variations. The bulletin is being distributed to 1000 pharmacists and students. Evaluation
of the publication is undertaken.
Is the Pharmacy Department Meeting the Needs of the Pharmaceutical Industry?
Glorianne Camilleri
The undergraduate pharmacy curriculum has been mapped out focusing on industrial pharmacy related
topics, and compared with that offered by the University of Perugia, Italy, and other universities in
the United Kingdom and France. Eleven pharmaceutical companies operating in Malta were listed
and their contact persons identified. A set of eight questions were formulated and these are being used
for interviews with pharmacists working in the areas of Quality Assurance, Quality Control, Research
and Development, Regulatory and Production. Suggestions will be presented in a discussion paper.
Implementation of Protocols on Allergy Disorders
Kathlene Cassar
Locally developed protocols on the management of skin, nose and eye allergies were presented in an
A3 poster and disseminated in 20 community pharmacies. To encourage the integration of protocols
into day-to-day care, patient education material, medication records and focus groups were used.
Observational studies were carried out to assess practicality of implementation of the protocols and
pharmacists’ compliance. Sixteen out of the 20 pharmacists agreed on the need for protocols as a
supporting tool in community pharmacy. The main limitation was a high workload leading to time
constraints.
Health, Travel and the Use of Medication
Maria Cuschieri
One hundred tourists (52 males, 48 females) were interviewed during their stay in a hotel, to identify
which health problems are most commonly encountered whilst travelling by air. The availability of
medication from local community pharmacies to tourists during their stay in Malta was also evaluated.
None of the tourists said they ever had a problem with acquiring their medication (0 %). Information
is being gathered from the Malta International Airport and various sources regarding health problems
whilst travelling. This is being compiled in booklet form.
The Effects of Treatment on the Quality of Life in Rheumatoid Arthritis
Stephanie Falzon
Two quality of life questionnaires were administered to 80 Rheumatoid Arthritis (RA) outpatients.
These questionnaires are being re-administered to the same patients after six months of treatment.
Data is being analysed using SPSS® version 17.0. Results show that general health is most affected
by RA whilst social functioning is least affected. An overall improvement in disability resulted after
six months. The lowest scores for disability resulted with treatments containing three or four drug
combinations and methotrexate in combination with glucocorticoids.
30
Training and Development for Pharmaceutical Industry Personnel
Stefanie Farrugia
The project aims to evaluate the feasibility of training and development programmes for local
pharmaceutical industry personnel, making best use of resources available and to introduce the concept
of training as a motivation, by creating appropriate training needs which combine both obligations
of Good Manufacturing Practice and personal development and growth. Feedback from employees
at local pharmaceutical industries will be used to develop appropriate training course.
Microbiological Testing Requirements of the Local Industry
Maria Fenech
Since not all pharmaceutical products can be produced as sterile preparations, microbiological control
is essential. A feasibility study for setting up a microbiological laboratory that is run according to
Good Manufacturing Practice is being conducted. The European Pharmacopeia is reviewed and each
microbiological test is divided into various steps. The equipment, apparatus, microbiological media
and the amount of purified water needed are listed, and quotations are obtained from local companies.
Once cost analysis is performed, break-even analysis shall be conducted.
Manufacture of Active Pharmaceutical Ingredients
Wei Liu
The study is divided into three inter-related sections which are past, present and the future of Active
Pharmaceutical Ingredient (API) manufacture. The methodologies employed include literature review
and semi-structured interviews which are not limited to a set number of questions, but with leading
keywords to promote discussion. The interviews carried out during visits to the API plants in Malta
were tape-recorded and converted into verbatim transcriptions.
Drugs and Art
Clint Pace
Art is a single area of human culture which has evaded the social clampdown on illegal drugs and
where drug use is generally accepted. The association of the artist with drugs is under evaluation as
people’s impressions do not always reflect reality. Local artists will be assessed on their drug habits
and whether they consider drugs as a necessity or a commodity to service their talent.
Prescribing of Analgesics by the Community Pharmacist
Simone Pace O’Shea
A pilot study was carried out to assess the feasibility of the documentation system developed which
involved keeping medical records of 30 patients at a community pharmacy. Protocols were written
for the prescribing of analgesics by pharmacists when dealing with 6 different pain conditions (back,
dental, dysmenorrhoeal, arthritic, musculoskeletal and headache). A review panel consisting of 20
individuals from different professions was chosen to evaluate the protocols prepared. The system will
be applied in a community pharmacy and evaluated.
Stability Testing of Medical Oxygen
Gayle Papps
The effects of increasing temperature and humidity levels on the stability of medical oxygen in cylinders
are not well established or officially documented. This project investigates influence of increased
temperature and humidity levels on oxygen purity, impurity traces of carbon monoxide, carbon dioxide
and water, pressure, and cylinder rusting over six months and one year. Statistical analysis is used
to determine any significance between each temperature and humidity level investigated, as well as
any difference between the six month and one year period.
31
Satisfaction with Pharmacy Services
Annelise Saliba
Two locally developed self-administered questionnaires were reviewed and psychometrically evaluated.
One questionnaire was distributed to 15 community pharmacies in Gozo to assess the pharmacists’
attitudes towards a more patient oriented service and supplementary phamacists’ prescribing. The
other questionnaire is being distributed to a random sample of 400 members of the general public to
assess their perceptions with regards to community pharmacy services. Cronbach’s alpha correlation
coefficient for community pharmacist and general public questionnaires was 0.91 and 0.82 respectively.
Descriptive statistics are carried out and the Pearson chi-square test is used.
Protocols for Introducing New Drugs in Cancer Care
Francesca Schembri
The guidelines published by the National Institute for Health and Clinical Excellence (UK) and Food
and Drug Agency (USA) for the use of capecitabine in breast and colon cancer were obtained and are
being reviewed. Key issues concerning the drug’s clinical efficacy, toxicity, effect on the quality of
life and affordability were identified and 5 documents were designed to guide analysis of these issues.
A system of scores will be designed to quantify benefits and risks of this drug. A framework will be
developed to support decisions of funding and accessibility to new drugs.
Production of Modified Release Dosage Forms
Karl Schembri
A review and comparison of the different methodologies used in the production of modified release
dosage forms is carried out. The review consists of a discussion of the various techniques used,
highlighting the advantages and disadvantages, information on the excipients used, description of the
manufacturing equipment and a discussion about the different parameters that affect the production
process. To date, different pelletizing techniques, ion exchange resins, osmotic pumps and diffusion
controlled systems have been discussed.
Pilot Study of Setting-Up a Museum Related to the Healthcare Professions
Elaine Seychell
The project focuses on three particular sections: pharmacy, dentistry and urology. It will serve to
transform what was once a haphazardly arranged set of historical items into a collection of educational
significance. The pharmacy section is being prepared and will be set up in the Pharmacy Department.
The dentistry and urology sections are exhibited in the foyer of the Medical School at Mater Dei
Hospital. Photographs of artefacts from private and public collections will be displayed together with
the rest of the items.
The Effect of Medicinal Plants on Maltese Honey
Silvan Spagnol
Samples of local honey are currently being screened for pharmacological activity using the Brineshrimp test. The major floral sources of these samples have been determined by pollen analysis.
Consequently, it will be possible to establish whether the floral source has any effect on the activity
of honey. It would also be possible to identify the presence of phytochemicals in honey and compare
them to those found in the flowers-of-origin. Current and potential pharmaceutical applications of
honey will be discussed accordingly.
An English-Maltese Dictionary of Medical and Pharmacy Terms
Miran Spiteri
The compilation of an English-Maltese Dictionary of medical and pharmacy terms (from letter ‘F’)
is undertaken. Translated terms published in Aquilina’s ‘English-Maltese Dictionary’ and in the
Medicines Authority ‘Glossary of Terms’ are used as the references source. To date, 1,591 words of
'Mosby's Medical, Nursing and Allied Health Dictionary' starting with letters 'F', 'G' and 'H' have
been translated and validated with linguists and laymen. Validation with healthcare professionals is
now being carried out using questionnaires and a booklet of translated terms is being compiled.
32
Point-of-Care Diagnostics in Infections
Angele Vella
After 14 different types of point-of-care diagnostic kits for the rapid detection of microorganisms were
identified, the test for the detection of Helicobacter pylori (H. pylori) was chosen to run a feasibility
study for the local community pharmacy setting. Twenty patients presenting to a community pharmacy
and suspected of being infected with H. pylori will have a fingerstick blood sample taken and tested
using the Ulti Med H. pylori Test Cassettes. The practical and pharmacoeconomic implications to
run such a service in a community pharmacy setting will be evaluated.
Newsletter for the Pharmacy Department
Antine Vella
‘The Pharmacy Department Review’ is a bimonthly publication that aims to enhance communication
between the Pharmacy Department and its past and present pharmacy students. To date three newsletters
have been issued in full colour using glossy paper. The newsletter is circulated to pharmacists and
students both in printed and electronic format. The ‘Maltese Directory of Pharmacists’ compiled by
Christianne Mizzi in 2005 was used to obtain the electronic addresses particularly those of nonpracticing pharmacists.
Sale of Non-Prescription Medicines from Pharmacies: Price Comparisons
Rebecca Vella
Retail prices of Non-Prescription Medicines (NPMs) available locally will be compared to their
respective counterparts in the United Kingdom. The sample will be defined by price per gram of
Active Ingredient, using a specifically formulated Price Index. A price comparison between originator
NPMs in Malta and their generics will also performed. Patient and pharmacist questionnaires were
formulated and distributed. The results of these questionnaires were statistically evaluated and
conclusions were drawn. An educational patient leaflet regarding the process involved in the setting
of prices to medicines will be developed.
Microbiological Testing Requirements in the Production of Intravenous Fluids
Thomas Vella
The local annual demand for intravenous fluids has been determined from Mater Dei Hospital records.
Business proposals of similar investments and price estimates sent by foreign turnkey contractors are
being used to calculate the cost of establishing and running an intravenous fluid manufacturing facility
in Malta. An in-depth review of the Blow-Fill-Seal production process is being carried out. European
Union standards on aspects of microbiological testing, cleanroom design, quality assurance and Good
Manufacturing Practice are being studied through Eudralex Guidelines and the European Pharmacopoeia.
Determination of Amylase in Gastric Juice
Kirsten Zammit
Hyperamylasaemia detection through the quantification of salivary and pancreatic alpha-amylase in
gastric juice may lead to an understanding of effects brought about by Proton Pump Inhibitors (PPIs).
A clear relationship is seen between gastric pH and the salivary and pancreatic alpha-amylase enzymes.
Thirty seven patients were tested. Twenty eight patients were taking PPIs: 21 of these were examined
for both enzymes and 7 were tested for pancreatic amylase only. The remaining 9 patients were not
on PPIs and were tested for both enzymes as a control.
Pharmaceutical Care of Patients Undergoing Heart Surgery
Natalie Zerafa
Fifty patients undergoing heart surgery were interviewed using the ‘Past Medical History’ and ‘Assessing
Treatment Outcome’ questionnaires. Twenty five patients were used as the control group and 25
patients were offered a pharmacist intervention. This intervention consisted of a treatment chart
presenting a simple pictorial explanation of each drug and dosage regimen. All (n=50) the patients
were interviewed 6 weeks after the operation, and the results were compared. The mean percentage
compliance score showed statistically significant differences between the two groups.
33
THIRD YEAR STUDENTS PROJECT DESCRIPTIONS
EU GMP: Inspection of Suppliers
Rowena Marie Agius
Good Manufacturing Practice (GMP) guidelines promote harmonisation of pharmaceutical manufacturing
and inspection practices among Member States. GMP philosophy requires that all materials used in
the production of medicinal products should only be purchased from appropriate suppliers which will
then be named in the relevant specifications. Issues to be assessed include the data required for
assessment prior to preliminary inspections, the relevant issues addressed during the inspection of
facilities manufacturing of raw materials and the areas of training to be covered in this field.
Waste Management in Pharmacy
Karen Attard
The waste management options currently available in all the pharmaceutical sectors in Malta are being
reviewed and the legal aspects are assessed. Questionnaires will be distributed to community pharmacists
and members of the public to identify how pharmaceutical waste is managed. Waste management
in the pharmaceutical industry and in hospital will also be evaluated by interviews. A comparative
review of pharmaceutical waste management with well established industrial companies in other
countries will be carried out.
Methods to Improve Yield in the Production of Slow Release Oral Dosage Forms
Nicolette Bartolo
One of the main focuses of the pharmaceutical industry is the continuous research and development
undertaken to improve the yield as well as the efficiency of the followed process. Factors affecting
yield were studied and monitored in order to develop new methods or modify current methods used
for the production of slow release oral dosage forms. Before implementing the method on an industrial
scale, a test is established to validate the method devised according to Good Manufacturing Practice.
Examples of Standard Operating Procedures in Pharmacy
Jessica Briffa
Standard Operating Procedures (SOPs) are specific instructions written down step-by-step to facilitate
and guide the person through a repetitive activity in a particular environment. They help to achieve
a good quality system and also aid in minimising variation. SOPs may be found in all areas of
pharmacy: community, clinical, industrial pharmacy, and distribution of medicinal products. They are
to be reviewed and validated in order to keep the quality system up-to-date.
Use of Anti-Infective Agents During Pregnancy
Nathalie Brincat
Total avoidance of pharmacological treatment during pregnancy is dangerous and unrealistic. However,
anti-infective agents used must ideally prevent any complications resulting from the infection whilst
causing minimal resistance. Following a pilot study carried out on eleven patients at the general
hospital, a prospective study is being carried out to document the use of anti-infective agents during
pregnancy where the relationship between urinary tract infections and risk factors such as age, period
of gestation and gravidity are determined.
Pain Relief After Caesarean Section
Luana Buhagiar
This prospective study will compare pain scores post-caesarean section. One group will have in situ
uterine repair while the other will have the uterus exteriorised. It will assess whether preoperative
perception of experimental pain can predict the level of post-caesarean section pain and analgesic
consumption. Patients will be visited the day before their operation, to undertake sensory tests, and
four more times post-operatively to record pain scores. Two pilot studies have been carried out on
40 patients. Results are being statistically analysed.
34
Content of Sulphur Dioxide (SO2) in Wine
Ghislaine Calleja
Consent was obtained from ‘Marsovin’ to carry out the following analyses on samples of wine:
Addition of sulphur dioxide (SO2) and parameters in the wine which alter the amount of SO2 added
such as pH variations of different wine; and determination of the amount of free SO2 and total (bound
and free) SO2 present in the wine samples using the Ripper method (an iodometric titration) and the
official method outlined by the European Union. Validation of these methods is being undertaken.
Prevalence, Management and Characteristics of Endometriosis
Lorraine Camilleri
A retrospective study is being carried out to determine the prevalence together with the clinical and
laparoscopic characteristics of endometriosis among infertile Maltese women. The pilot study consisted
of gathering data from 24 patient files who underwent a laparoscopy. A data sheet was compiled and
results were analysed using SPSS®. Additional data will be gathered and the final results will be
compared to previous studies in order to establish similarities and differences between Maltese
endometriotic patients and the general endometriotic population.
Bioequivalence: GLP Requirements and Accreditation
Samantha Camilleri
A methodology that aims to acquire Good Laboratory Practice (GLP) accreditation from the Malta
Standards Authority (MSA) for the analytical process and the laboratory at the Department of Pharmacy
for a bioequivalence study is developed. Presently, the ISO 17025 Guidelines are in the process of
being obtained. The Standard Operating Procedures required for GLP achievement are currently being
compiled.
Protocols for Skin Disorders
Anna Maria Cassar
Evaluation of prescriptions issued at the Dermatology Department at Sir Paul Boffa Hospital is being
carried out to identify trends in the management of skin disorders. Patient compliance and perception
of skin disorders will be evaluated by using health related tools including the Dermatology Life Quality
Index Scores (DLQI). A pharmacist intervention plan will be developed and tested for this setting.
Chronopharmacology in Hypertension
Deborah Janice Cassar
The project will evaluate the effects of morning vs. evening doses of the antihypertensive agents
perindopril and valsartan on circadian blood pressure. An Ambulatory Blood Pressure Monitor
(ABPM) will be attached to the patient. Blood pressure and heart rate will be recorded over a 24 hour
period. The patient shall take his/her medication for 7 days at the opposite time. The ABPM will
again be attached for 24 hours. Blood pressure and heart rate measurements will be compared to
determine the time at which the drug produces its optimum therapeutic effects.
Clinical Aspects in the Intensive Therapy Unit
Lara Chetcuti
Having identified the drugs most commonly used in the Intensive Therapy Unit (ITU), further research
will be carried out regarding the administration, potential adverse effects, drug interactions and other
aspects related to their use. Highlighting such aspects should result in a better understanding of the
drugs being administered to patients in the ITU, leading to an improvement in patient safety. The
information gathered will be evaluated and practical solutions will be implemented.
Pharmaceutical Statistics: Malta, Where Does It Stand?
James Cini
The project aims to determine the statistics related to pharmacy which are kept in Malta and by whom
such statistics are kept. The project will also compare statistics related to pharmacy which are available
locally and those which would be available in other EU countries and other non-EU countries. Various
pharmaceutical statistics in Malta and other countries are currently being compiled. This is being
done primarily via the internet.
35
Chronopharmacology in Diabetes
Michelle Antoinette Cole
This study evaluates the importance of time in relation to the administration of insulin. Adult patients
with type 1 diabetes receiving only insulin therapy will be identified at the Diabetes Clinic at Mater
Dei Hospital and will be placed on the Continuous Glucose Monitoring System (CGMS) for 72 hours.
Any hypo and hyper-glycaemic events not identified with conventional testing methods, the dawn
phenomenon, and pre and post-prandial variations will be identified, analysed and addressed.
Chronopharmacology in Rheumatoid Arthritis
Krista Cuschieri
Rheumatoid Arthritis (RA) is a chronic disease mainly affecting the joints. Since RA is a circadiandependent disease, it is likely that chronopharmacology may have an important contributory role in
improving drug therapy. Patient medication timing will be assessed and modified, and assessment
of disease state will be carried out via questionnaires. Analysis will be performed to evaluate the
relationship between the time of drug administration, efficacy and side effects of drug therapy
experienced in RA patients.
Point-of-Care Testing: Hypercholesterolaemia
Stephanie Cutajar
The evaluation of the impact of pharmacist intervention through a prospective intervention study is
carried out. Fifty patients are recruited by convenience sampling. Patients with cardiovascular risk
factors and patients already being treated for hypercholesterolaemia are selected. Patients will be
tested in a community pharmacy setting using the Reflotron® Plus device for a full lipid profile test,
by collecting a capillary sample of blood through finger pricking. Patients will be tested at an initial
visit and in another two follow-up visits.
Drug Stability Study in Transport
Helga Farrugia
The objective is to devise a possible relationship between temperature and humidity fluctuations with
respect to the degradation of a cold storage Active Pharmaceutical Ingredient (API) during transport.
Raw fluvastatin will be exported to six European countries together with a Humistick data logger.
High Performance Liquid Chromatography analysis will be carried out to assess any degradation of
raw fluvastatin. Any statistically significant difference will then be verified using SPSS® version 16.0.
Distribution of Anti-Infective Agents to the Peripheries
Lara Fiorentino
The distribution of clindamycin, gentamicin and ciprofloxacin in peripheral tissues in patients suffering
from diabetes and peripheral vascular disorders is evaluated. A retrospective study to identify the
antibiotics used in these patients will be carried out. The concentration of clindamycin and ciprofloxacin
will be determined using High Performance Liquid Chromatography, and the concentration of
gentamicin will be assessed using Fluorescence Polarisation Immunoassay Technology. The study
should indicate whether the level of antibiotic present at the site of infection is adequate to produce
eradication of microorganisms.
Quality Control of Medical Gases
Katrina Gatt
This study will follow guideline descriptions of practices and procedures as per the Good Manufacturing
Practice (GMP) requirements under Manufacturing Control, and will rely upon information gathered
from a leading gas manufacturing industry in Malta, taking medical oxygen as the main consideration
since it is the main in-house gas. It shall be tested at varying temperature and moisture conditions
during its manufacture and storage to find the optimal combination that enhances its integrity.
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Implementation of POYC Scheme and Inter-Professional Relations
Rosanne Mahoney
The impact of the Pharmacy Of Your Choice (POYC) scheme on inter-professional relations will be
evaluated through a qualitative and a quantitative approach. A random sample of community pharmacies
at the pre-pilot and in the pilot phase shall be included in the study so as to have a case-controlled
study approach. Further post-pilot studies will eventually be carried out. Questionnaires will be used
to understand patients’, pharmacists’ and other healthcare professionals’ perception.
Validation of Clinical Pharmacy Services
Maria Mamo
An observation study was carried out to identify and quantify activities performed by clinical pharmacists
at Zammit Clapp Hospital (ZCH) using a time and motion study technique. Standard Operating
Procedures for patient discharge, patient admissions, prescription monitoring, checking of patient
medication trolleys and emergency trolley will be developed, validated, tested for applicability and
practicality and implemented to evaluate clinical pharmacy services offered at ZCH.
Patient Dispensing at Zammit Clapp Hospital
Stefan Meli
An evaluation of the new medication administration system presently used at Zammit Clapp Hospital
will be carried out. This will be done by means of an observation study which will gauge performance
by measuring the medication error rates. The data obtained will be compared to data from previous
studies regarding both similar and different systems. Factors which lead to the optimisation of the
medication administration system will be identified and analysed.
History of FIP
Lynn Marie Mifsud
The International Pharmaceutical Federation (FIP) is the global federation of national associations
representing 2 million pharmacists and pharmaceutical scientists around the world. Retrieving
information about the history of the Federation from its initiation in 1912, considering the different
personalities involved in FIP from around 90 countries and the achievements from time to time such
as setting standards for Tobacco Cessation, Good Pharmacy Practice and Counterfeit medicines.
Investigating the Binding Modality of Terpenoids with the Angiotensin Converting
Enzyme
Sarah Jane Mifsud
Contemporary rational drug design studies continue to exploit available X-Ray crystallographic data
defining the 3D structure of the Angiotensin Converting Enzyme (ACE) for the development of novel
antihypertensive agents. This study is an in silico based investigation into the binding affinity of
terpenes for the ACE using captopril as a template. The main outcome of this study will be a prediction
as to whether or not this class of compounds has potential in the management of blood pressure in
humans.
Pharmaceutical Policy and Access to Medication
Amanda Pace
A phase involving identification of inclusion factors and information relevant to access to medication
and pharmaceutical policy is currently underway. Such factors will include the pharmaceutical package,
counterfeit medicines, safety through parallel trading, prudent use of antibiotics, and access to orphan
drugs. A framework based on the World Health Organisation model will be constructed.
Colorectal Cancer
Ilona Pirotta
Newly diagnosed patients undergoing chemotherapy for colorectal cancer are recruited from Sir Paul
Boffa Hospital. During patient interviews carried out on the first and on follow-up visits patients will
be asked to complete self-administered questionnaires: to evaluate quality of life (SF-36), to estimate
occurrence of side-effects and the impact of nausea and vomiting by using the Morrow Assessment
of Nausea and Emesis scale (MANE). During the first interview, occurrence of risk factors (social
life, dietary habits and medical conditions), patients’ knowledge and expectations of chemotherapy
and of risk of side-effects are also assessed.
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Maintaining a Formulary for Zammit Clapp Hospital
Stephanie Rapa
Development and maintenance of a formulary which includes drugs and medical devices used in an
institution is an ongoing process and is essential to promote patient safety and to guide healthcare
professionals. An evaluation of the updates frequency is undertaken by adding and deleting various
pharmaceuticals and non-pharmaceuticals. The formulary includes all forms and strengths of drug
products, price and an adverse drug reaction card. Views of healthcare professionals at ZCH will be
evaluated and followed during the updating of the formulary by means of self administered questionnaires.
Palliative Care in Cancer Patients
Ryan Sacco
Thirty patients attending the Malta Hospice Movement will be assessed and three home visits with
an interval of four weeks will take place upon contacting the patient. During the patients’ visits a drug
documentation sheet shall be completed and all interventions will be noted on a pharmacist documentation
sheet. The impact of the pharmacist interventions will be evaluated using questionnaires that address
compliance and quality of life.
Pharmacoeconomics and Biological Agents in Rheumatoid Arthritis
Cynthia Said
Biological agents are pivotal in the current but moreover in the future management of Rheumatoid
Arthritis. The cost-effectiveness of these drugs shall be established on a local level.
Statistics of patients suffering from Rheumatoid Arthritis and who are currently on biological agents
have been collected. Questionnaires will be devised and distributed to patients that are currently on
biological agents and to those that are on Disease Modifying Anti-Rheumatic Drugs. The responses
of patients, on different treatment shall then be comparatively evaluated.
Pharmacist Intervention in ENT Disorders
Rebecca Said
The intervention of the pharmacist in ENT outpatients at Mater Dei Hospital will be evaluated. This
will be done using pre and post-intervention questionnaires. Patient leaflets will be designed to provide
information about specific ENT conditions and the respective medications prescribed. Fifty patients
will be selected to participate in the study. Patient compliance to medications and other pharmaceutical
care issues will be evaluated and assessed in order to identify the outcomes of the pharmacist’s
intervention.
Validation Instruments for Community Pharmacy: An Update
Claire Anne Scicluna
An observation study and literature review is being carried out to review a quality care system that
was developed locally namely ‘Validation Instruments for Community Pharmacy’. The system will
be updated to include new areas such as clinical governance and information technology. The updated
system will be evaluated by a group of professionals and elaborated electronically. These instruments
grade the setting of the pharmacy and equipment available together with the value of professional
pharmacy services in a community setting.
Pharmacist Intervention in the Management of Parkinson’s Disease
Akram Shueb
Pharmacist intervention in the management of Parkinson’s disease at Zammit Clapp Hospital is
evaluated. The intervention tools used include a treatment medication chart, patient information sheets
and a pharmacist-run discussion with patients and carers. Outcomes will be measured using the PDQ39 Quality Of Life questionnaire, a compliance questionnaire and an intervention evaluation sheet.
Thirty-five patients will be included in the study and the intervention plan will be carried out during
the first visit followed by evaluation during the second visit after four to six weeks.
38
Identification and Synthesis of Impurities
Amy Smith
The European Pharmacopoeia (2007) method is the reference method for the determination of residual
solvents in pharmaceutical materials. Methods to resolve volatile impurities in solid dosage forms
using Headspace Gas Chromatography (HSGC) are being investigated with particular attention on
impurities arising from Class 3 solvents: acetone and alcohol. Other issues being addressed include
cost-effectiveness, reduction of analysis time and detection of compounds at or below their control
limits.
Newsletter for Community Pharmacy
Gillian Spiteri
To develop a newsletter issued every two months to be distributed to community pharmacies that will
disseminate information on health promotion activities, such as the WHO Calendar of Events. Seven
topics were chosen according to the themes selected. The newsletter will be used to develop health
promotion schemes in the pharmacy, focusing primarily on the pharmacy display window. Posters
and leaflets will be provided by the Health Promotion and Disease Prevention Department.
Pharmacoeconomic Analysis of Generic Drug Use
Federica Spiteri Maempel
The generic market in Malta will be analysed by investigating which generics are available locally,
the costs of such drugs, and the classes that they fall into. The marketing strategies used to promote
generic drugs will be assessed through research and information gathered from pharmaceutical
companies. Perception will be investigated by means of questionnaires administered to professionals
and to patients. Finally, a case study will be conducted on two locally-produced generic products.
Their cost and efficacy will be analysed by means of a questionnaire, also targeted towards professionals
and patients.
Pharmacy Journal
Janet Sultana
Authors are being approached to contribute in articles and three authors have been recruited. Instructions
to authors are being developed. Publishers will be contacted for price quotations and layout design.
The articles obtained will be edited. Peer-reviewers will be found for the articles to enhance their
quality. A mailing-list comprising pharmacists, physicians and pharmacy students will be compiled.
A questionnaire will be developed to assess the quality of the journal and to determine the role of
journals in the pharmacy sector in Malta.
Public Perception of the Pharmacist
Francesca Tabone
Locally developed self-administered community pharmacist and general public questionnaires were
reviewed and are undergoing validation and reliability testing. The community pharmacist questionnaire
will be distributed to 50 community pharmacies chosen by stratified random sampling to identify to
what extent community pharmacists are focusing on a patient-oriented service. The public questionnaire
will be distributed to 500 members of the public by convenience sampling to assess their perception
regarding the community pharmacist and services offered. A discussion paper will be drawn up
presenting different perceptions from this study and other previous studies.
39
SECOND YEAR STUDENTS PROJECT DESCRIPTIONS
Evidence-Based Clinical Pharmacy
Anthea Abela
To investigate documented evidence showing the impact of clinical pharmacy in both the primary and
secondary care scenarios. The study will deal with the effect of clinical pharmacy on quality of life,
cost-effectiveness of treatment and management of side-effects and how the interventions of clinical
pharmacists positively influence clinical practice.
Point-of-Care Testing: Faecal Occult Blood
Adrian Agius
The availability of Faecal Occult Blood (FOB) point-of-care testing kits will be assessed. FOB test
kits will be compared with respect to cost, reliability, user-friendliness and applicability to the primary
care setting. Standard Operating Procedures for applicable professional services will be developed.
Care Issues in a Heart Failure Clinic
Marie Claire Aquilina
To introduce and validate the pharmacist’s role in the relatively new Heart Failure Clinic (HFC) at
Mater Dei Hospital by analysing the degree of patient awareness and compliance towards prescribed
pharmacological treatment, providing instructions on the use of these medications and identifying
pharmaceutical care issues to improve the patients’ compliance, safety and quality of life.
Pharmacist Intervention in the Use of Diuretics in Elderly Patients
Sean Ryan Atkins
Geriatric patients on diuretic treatment will be investigated. The study will evaluate the impact of
the clinical pharmacist’s intervention in diuretic prescribing according to previously developed
protocols, compliance with the protocols and effect on the quality of life of patients. The effect of
implementation of the protocols on patient outcomes will be assessed.
Protocols in Dental Conditions
Daniela Attard
Treatment protocols for common dental conditions, such as xerostomia, dental abscess and recurrent
oral aphthous ulcers will be developed and evaluated in local community pharmacies and dental clinics.
Practicality and compliance with the protocols will be evaluated using questionnaires.
The Pharmacy Practice Resource Unit
Jaclyn Azzopardi
The Pharmacy Practice Resource Unit (PPRU) is a mock pharmacy set up in the Department of
Pharmacy. This unit will be updated by increasing the number of medications and medical devices
and by providing additional information about these items. The aim is to provide access to medicines
and related information for use by tutors and students.
Development of Diabetes Outcome Indices
Sarah Baldacchino
The robustness and reliability of previously locally developed Diabetes Outcome Indices will be
studied. The indices will be implemented in the monitoring of patients with type 2 diabetes.
Adverse Drug Reactions Database
Stephanie Marie Bezzina
A computerised database of Adverse Drug Reactions (ADRs) organised alphabetically according to
the body system on which they exert an effect (for example: constipation and gastric ulceration within
the gastro-intestinal system). Each ADR will be linked to a list of drugs which cause this reaction
and the frequency at which it occurs.
40
Human Papilloma Virus Screening and Vaccination
Angie Marie Brincat
Screening techniques for Human Papilloma Virus (HPV) will be evaluated in terms of cost and patient
acceptability. Epidemological data on screening carried out and follow-up of results will be collected.
Implementation of prophylaxis of HPV infection is assessed.
Management of Urinary Tract Infections in Pregnant Women by Community
Pharmacists
Katya Busuttil
A locally developed protocol ‘Treatment of urinary tract and vaginal infections in pregnancy by
community pharmacists’ will be updated and evaluated. The protocol will be used to assess the
management of these infections in pregnancy and to provide a tool for community pharmacists to
support a valid pharmacist intervention.
Pancreatic Amylase Assessment
Gabriella Buttigieg
This study will evaluate pancreatic amylase activity in gastric juice. Samples of gastric juice will be
obtained from patients undergoing gastroscopy, and who are currently not on any proton pump inhibitor.
The results obtained from these samples will be compared to data obtained from previous local studies.
Quality Improvements in Good Distribution Practice
Suzanne Buttigieg
The process involved in the distribution of medicines will be reviewed. Improvements which can be
applied to the Good Distribution Practice system will be identified and evaluated. Trials of this updated
system will be carried out and evaluated.
Devices Used for Dispensing
Deborah Cachia
Practicality aspects of implementing pill box organisers in different settings will be assessed.
Time factors, economic aspects and stability of medicines will be evaluated. Patient groups and
settings that are most likely to benefit from these systems will be identified.
Formulary for Non-BNF Cited Items
Daniela Camilleri
Updating and maintenance of the publication which presents information on medication and medical
devices not listed in the British National Formulary (BNF) will be undertaken. The formulary will
be updated using the list of medicinal products available from the Medicine's Authority and by
contacting local importers. Feasibility and practicality of presenting the document in an electronic
version will be assessed.
Side-Effects of Biological Agents in Rheumatology
Florinda Camilleri
The side-effects caused by biological agents in the treatment of rheumatic conditions will be investigated.
The treatment course of patients receiving biological agents at Mater Dei Hospital will be followed
and the occurrence of side-effects will be analysed.
Directory of Pharmacists
Sephora Camilleri
An update and publication of a new edition of the ‘Maltese Directory of Pharmacists’ will be undertaken.
Data of enlisted pharmacists is updated and new data compiled from the new graduates since the last
publication. This data will be used to analyse the trends in the pharmacists’ workforce compared to
the previous edition.
41
Oral Anti-Cancer Treatment
Stephen Camilleri
The study will evaluate the patient safety issues and care issues relating to the use of oral anti-cancer
treatment. Pharmacist intervention with respect to patient compliance will be evaluated.
Dissemination of Protocols: Gastro-Intestinal Disorders
Marija Carmen Carbonaro
To review previously developed treatment protocols for gastro-intestinal disorders and to enhance
their applicability to pharmacists within the community setting. The protocols will be updated and
published to increase community pharmacists’ acceptance and compliance.
Creation of Two- and Three- Dimensional Molecular Databases Using
Antihypertensive Drugs and Hypoglycaemic Agents as Case Studies
Jerome Caruana
Transformation of two-dimensional (2D) to three-dimensional (3D) structures is fundamental in
education. Molecular visualisation software and cue depth enhanced computer graphics now enable
the computational construction of rotatable 3D structures. This project will compile a series of 2D
and 3D structures of antihypertensive and hypoglycaemic molecules which will be presented and
validated in the context of undergraduate chemistry and pharmacy practice tuition.
Drug Administration Systems in Elderly Patients
Angela Cassar
Drug administration systems to elderly patients at elderly institutions will be assessed to ensure that
the correct drug is administered to the patient via the right route, in the right dose and at the right time.
Designing High Affinity Ligands for HER2 Receptors using Herceptin as a Template
Maria Cassar
Herceptin is the monoclonal antibody used in the treatment of breast cancer against the HER2 receptor
which is found over expressed in about 20 to 30% of patients suffering from breast cancer. This study
aims to investigate the binding modality of Herceptin to the HER2 receptor in order to design ligands
with improved affinity for the receptor.
Drug Design at the Peroxisome Proliferator Receptor
Julienne Ciantar
The Peroxisome Proliferator Receptor (PPAR) forms part of the Nuclear Receptor Superfamily. It
is a subject of contemporary research owing to the fact that its activation by the thiazolidinedione
group of antidiabetic drugs increases insulin sensitivity. This project aims to design molecules with
the potential to act as leads in a drug design process and ultimately producing molecules capable of
agonistic activity at the PPAR.
Nutrition in Diabetic Patients
Ramona Cini
Previously developed special menus catered for diabetic patients in local restaurants will be reviewed
and updated and applied to hotel restaurants. Pharmacists will be interviewed to assess the education
they provide to diabetic patients regarding their diet.
Storage of Chemicals and Equipment
Daphne Cristine Coleiro
The effect of temperature in community pharmacies on the storage of medicines and medical devices
will be studied. The storage condition of medicines and medical devices in the hospital setting will
be assessed and compared to standard requirements.
42
Aeromonas hydrophila Gastroenteritis in the Maltese Population: Diagnosis,
Epidemiology and Treatment
Lisa Cuschieri
Aeromonas hydrophila, which is a soil and aquatic organism, is a cause of gastro-intestinal disease
contracted through the consumption of contaminated foods or beverages such as water and raw sea
food. Since this organism is not tested for at the bacteriology laboratory at Mater Dei Hospital, this
study will serve to determine the incidence of Aeromonas gastroenteritis and to improve treatment.
GMP: Packaging in a Small Manufacturing Plant
Aaron Demanuele
Several issues related to packaging that Good Manufacturing Practice (GMP) guidelines address will
be looked into and evaluated, using the example of a small manufacturing plant. A comparison will
be carried out between the European and American GMP guidelines. Examples of aspects of GMP
that could be improved are training requirements, inspections, validation, packaging and materials.
The Creation of Two- and Three- Dimensional Molecular Databases Using Steroids
and NSAIDs as Case Studies
Luke Doublet
Chemistry is an area which benefits from the use of visual aids. A two-dimensional (2D) and threedimensional (3D) database using steroids and NSAIDs as case studies will represent interactions with
receptors, visualisation of torsion, orientation of rings and individual atoms. The databases will be
tested through a pilot study carried out among undergraduate pharmacy students.
Design of Novel Analgesics Targeting the TRPV-1 Receptor
Deborah Louise Farrugia
Drugs acting at TRPV-1 receptors could potentially treat neuropathic pain associated with multiple
sclerosis, chemotherapy or amputation, as well as pain associated with the inflammatory response of
damaged tissue, such as osteoarthritis. This study will use TRPV-1 receptors as a target to produce
high affinity drug-like ligands with the potential to antagonise this receptor and consequently produce
pain relief.
Women’s Health
Daniela Fenech
Information and guidelines concerning conditions and diseases unique or more prevalent in women
will be electronically accessible on www.sahhti.org, an MPSA-run website and evaluated. A prospective
study will be carried out in community pharmacy to evaluate the impact of dissemination of leaflets
addressing women’s health.
Barcoding in Pharmacy
Marie Colette Galea
The aim of this study is to identify and evaluate the potential applications of barcodes in the community
and hospital pharmacy settings. This would include barcoding medications and patient medication
records to facilitate the reduction of medication errors.
Intellectual Property and Pharmacy
Lara Giudice
Legislation affecting intellectual property will be examined to determine its effects on the pharmaceutical
industry. The provisions created by the legislation by which the industry must abide and the
consequences which may arise when these provisions are not respected will be studied.
Androgen Receptor Binding Modalities and Prostate Cancer
Alexandra Grima
A structure activity relationship will be carried out on the antiandrogenic drug abiraterone. Abiraterone
blocks formation of testosterone by inhibiting CYP17A1 (CYP450c17), an enzyme known as 17
alpha-hydroxylase/17,20 lyase. This enzyme is involved in the formation of dehydroepiandrosterone
and androstenedione which may be metabolised into testosterone. Phase II clinical trials are indicative
of the validity of abiraterone in the management of prostate cancer.
43
Dissemination of Protocols: Common Cold
Lawrence Mayo
Previously locally developed common cold protocols will be reviewed and distributed to community
pharmacies by means of a booklet and evaluated. The practicality of the availability of the protocols
in electronic format will also be evaluated.
Blood Pressure Control in Maltese Dialysis Patients
Anne Marie Mercieca
A prospective study will be carried out to determine the prevalence of high blood pressure in Maltese
dialysis patients. Quality of life issues, compliance to prescribed antihypertensive treatment and
control of blood pressure in these dialysis patients will be investigated. The improvement of these
factors through effective patient education will be evaluated.
Newsletter for Community Pharmacy
Caroline Mercieca
A newsletter for community pharmacists, providing articles on various contemporary topics of interest
and areas such as the importance of protocols in the community pharmacy, will be published bimonthly.
Special emphasis is given to a regular feature on the Pharmacy Of Your Choice (POYC) scheme.
Design of Ligand Families for the HIV-1-Protease Enzyme
Chantelle Micallef
HIV-1 protease (HIV-PR) is essential in the life cycle of HIV. HIV-PR cleaves newly synthesised
polyproteins to create mature components of an infectious HIV virion. Inhibition of HIV-PR disrupts
the ability of HIV to replicate, making HIV-PR inhibition the subject of much pharmaceutical research.
This project aims to design a series of leads whose structure and activity relationship studies indicate
their suitability as HIV-PR inhibitors.
The Creation of Two- and Three- Dimensional Molecular Databases Using Drugs
Acting on the CNS and Antibiotics as Case Studies
Michael Miller
Advanced computer software offers realistic three-dimensional (3D) representations of molecules in
isolation, or bound to receptors. Such representations are considered as invaluable educational tools
in chemistry and the biosciences. This project aims to create 2D/3D databases using drugs acting on
the CNS and antibiotics as case studies. Their use as valid educational tools will be evaluated on a
student cohort.
Dissemination of Protocols: Paediatrics
Martina Muscat
Six previously locally developed protocols on vomiting, constipation, diarrhoea, abdominal pain,
cough and fever will be reviewed. The protocols will be disseminated to local community pharmacies.
Applicability and practicality will be assessed and pharmacist compliance with the protocols will be
evaluated.
Good Laboratory Practice
Corinne Muscat Terribile
A quality system based on Good Laboratory Practice guidelines will be developed for the laboratories
at the Department of Pharmacy. The system will be evaluated and implemented. Organisational,
safety and technical aspects pertaining to particular settings will be developed.
Development of Computational Chemistry Practicals
Noel Pace
Computational chemistry practical sessions will be developed to be synergistic with the traditional
didactic tuition so that a more holistic approach to education is delivered. Their applicability and
practicality will be validated among undergraduate pharmacy students to whom these practicals will
be addressed.
44
The Pharmaceutical Services in Lifestyle Modifications
Vanessa Petroni
This study concerns the pharmacist intervention in the maintenance of patients’ health status. Various
factors affecting a healthy life including weight control, drug abuse, smoking, alcohol abuse and sexual
health will be discussed. The study will focus on the outcome of the latter three on the population
and pharmacist interventions will be assessed.
Compendium of Medicines Used in Veterinary Practice
Bernard Soler
To compile a practical and concise, yet comprehensive, veterinary pharmaceutical compendium as a
source of reference to veterinarians, pharmacists in the agroindustry and community pharmacists.
The compendium will be available in electronic format to provide the user with information on the
selection and use of veterinary medicine available in Malta in different animal species.
Herbal Medicine Formulary
Maria Spiteri
A previously developed formulary on herbal medicine available locally will be evaluated. Updating
and maintenance of the formulary will be undertaken. New herbal medicines with a local Marketing
Authorisation will be identified and added to the formulary. The updated formulary will be evaluated.
Protocols for Eye Conditions
Bianca Maria Stivala
New protocols will be designed as a tool to set up standards for implementation by pharmacists when
presented with ocular conditions of varying severity in both the hospital and community setting. The
protocols will focus on the pharmacist’s role in the management and follow-up of patient care.
Pharmacist compliance with the protocols will be assessed.
Point-of-Care Testing in Gynaecological Disorders
Anne Marie Zammit
The feasibility of the provision of point-of-care testing for gynaecological disorders from primary
care settings will be evaluated. The tests may be used to prevent, identify or monitor treatment of
such disorders. Pharmacist intervention in the management of gynaecological disorders and the
implementation of point-of-care testing will be assessed.
Quality of Medical Devices
Kimberly Zammit
The safety and efficacy of medical devices will be tested on a group of patients using different medical
devices. Statistical tests will be used to determine whether the recordings obtained from the different
medical devices show a good correlation. The project will also aim to assess whether the quality of
performance of medical devices is improved when the user is informed appropriately on the use of
the device.
Mini-Scale Production Facility
Ruth Zerafa
A feasibility study will be carried out on the current available mini-scale production facilities so as
to identify which of these facilities can be incorporated in the local scenario for teaching and training
purposes. This will involve the assessment of cost, size, materials required, maintenance and other
criteria with respect to each mini-scale production facility considered.
45