Pharmacy Projects 2010
Pharmacy Projects
Abstracts
Department of Pharmacy
University of Malta
2010
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Pharmacy Projects 2010
Editor
Anthony Serracino Inglott
Project Tutors
Lilian M. Azzopardi
Anthony Serracino Inglott
Claire Shoemake
Maurice Zarb Adami
Compiled by
Francesca Wirth
Marie Clare Zammit
Layout
Eric Santucci
Department of Pharmacy, University of Malta, Msida, Malta
email: lilian.m.azzopardi@um.edu.mt
t: +356 21 344971
f: +356 21 324835
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Pharmacy Projects 2010
Foreword
One of the main aims of the Pharmacy Symposium is to develop student interest in research and its dissemination.
The project stimulates motivation in pharmacy students as the project selection process takes into consideration
their interests and opinions. The Department of Pharmacy has adopted the carrying out of a student project
as an integral part of its curriculum for over thirty-five years. This does not mean that the curriculum has
remained static. It is good to note that since then many other schools of pharmacy have integrated this project
concept in their curriculum. Malta remains a leader in this area as witnessed by the number of students coming
from different European schools of pharmacy to carry out their project at the Department of Pharmacy of the
University of Malta. The importance of the project is amplified within the context of the European education
system on which the implementation of the Bologna Process and the Lisbon Stategy principles aim to create a
European Higher Education Area by this year.
The interest in the development of the local curriculum and strategy in pharmacy education was shown clearly
by the European Association of Faculties of Pharmacy Malta Declaration established in 2005 where the present
five year pharmacy course structure was approved to be retained. Since then the present Head of Department
of Pharmacy, Professor Lilian M. Azzopardi was invited by the publishing arm of the Royal Pharmaceutical
Society of Great Britain to compile into a book format the lecture notes that form a basis for our curriculum in
Pharmacy Practice. The idea was to initiate the first steps to harmonise the basic needs of pharmacy students
in a structured manner. The concept attracted the contribution of professors from European Universities in
addition to the local academic contributors (Maurice Zarb Adami, Victor Ferrito and Anthony Serracino-Inglott),
Professors Steve Hudson (Strathclyde), Sam Salek (Cardiff), Vincenzo Tortorella (Italy), Benito del Castillo (Spain),
Margarida Caramona (Lisbon) and an introduction by Henri R. Manasse (American Association of Health-System
Pharmacists) and Patricia Vella Bonanno (Malta Medicines Authority).
An important aspect of the Pharmacy Practice Project is that it aims to develop an investigative mind in pharmacy
students. The project assists students to develop generic and sectoral competencies and promotes synergy
between teaching and pharmacy industry as well as pharmacy practice scenarios namely clinical pharmacy,
education and society, communication including e-pharmacy .
In this year’s Annual Pharmacy Symposium, students are presenting their work on aspects of Pharmacy
Information, Development of Protocols, Point-of-Care Testing, Policy and Access to Medicines, Pharmacy
Administration and Evidence-based Clinical Pharmacy and Pharmaceutical Care, Regulatory Affairs, Clinical and
Pharmaceutical Analysis and Industrial Pharmacy.
Professor Anthony Serracino-Inglott
Editor
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Pharmacy Projects 2010
Introduction
In order to achieve development of competences required by pharmacy graduates, a strong and robust
educational system that is able to prepare future pharmacists is required. This means that the educators should
be addressing the questions: What does society need pharmacists to do, and what skills do pharmacists require
to meet the expectations of society?
In this context the Department of Pharmacy of the University of Malta is aware of two aspects required to
address these questions: 1) bridging gaps between academia and stakeholders in pharmacy: pharmaceutical
industry, hospital pharmacies, community pharmacies and pharmacy administration institutions, 2) supporting
graduates to develop research methodology skills and competences.
To this effect the Department of Pharmacy has developed within the curriculum practice-based fieldwork that each
pharmacy student undertakes in the areas of community pharmacy, hospital pharmacy and the pharmaceutical
industry. Such experiential learning is developed based on a documented system that provides the student the
opportunity to develop skills in documentation which are required within a quality assurance environment that
is a reality in many aspects of the practice of pharmacy. Through the large number of collaborative agreements
with European pharmacy schools, students are encouraged to take up some of the fieldwork experience in other
countries by making use of the Erasmus student mobility framework. About 30% of pharmacy students study
for one semester in another pharmacy school.
The Pharmacy Practice Project represents 40 ECTS that are dedicated to the hands-on experience of developing
skills and competences required for research. Such skills are useful to pharmacy graduates whether they practice
their profession in direct patient services or whether they work in the pharmaceutical industry scenario.
Approaching pharmacy education that is based on these two principles helps to provide a common vision for a
clinically and science-led profession. This year was very hectic for the department with the launching of a new
website, the development of a quality system for the department’s laboratories and the active participation
at the 7th Malta Medical School Conference, November 2009 and at the 7th World Meeting on Pharmaceutics,
Biopharmaceutics and Pharmaceutical Technology, March 2010.
Professor Lilian M. Azzopardi
Head, Department of Pharmacy
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Pharmacy Projects 2010
Fifth Year Students
Project Abstracts
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Pharmacy Projects 2010
Pharmacy Information
An English-Maltese Dictionary of Medical and Pharmaceutical Terms
Miran Spiteri
Developing a Drug Information Bulletin
Alison Brincat
History of Pharmacy
Gerard Abela
Newsletter for the Pharmacy Department
Antine Vella
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Pharmacy Projects 2010
An English-Maltese Dictionary of Medical and Developing a Drug Information Bulletin
Pharmaceutical Terms
Alison Brincat
Miran Spiteri
Background: The recognition of the Maltese Language as a
European Language by the EU Commission brought about the
need for translating medicinal documents into Maltese.
Objective: To continue the compilation of the dictionary (from
letter ‘F’) initiated by Camilleri1 and to validate translations with a
linguist, laymen and healthcare professionals.
Design: Terms readily available in Maltese were gathered from the
Glossary of the Medicines Authority2 and Aquilina’s Dictionary3.
Terms not yet translated were extracted from Mosby’s Dictionary4,
translated and reviewed by a linguist. Translations of non-technical
terms were validated by interviewing 51 laymen. All translations
were distributed together with a validation questionnaire to 25
healthcare professionals. Revisions to original translations were
made where appropriate.
Setting: Eight Maltese health centres, community pharmacies
and doctors’ clinics
Main Outcome Measures: Publication of an English-Maltese
dictionary of medical and pharmaceutical terms from letters ‘A’
to ‘K’
Results: A total of 4651 terms (1302 elicited and 3349 newly
translated) starting with letters ‘F’ to ‘K’ were compiled. The
majority (92%) of terms selected for validation by laymen were
understood. Positive feedback was obtained from healthcare
professionals, who agreed with most of the translations and
provided suggestions, which were considered for the final
dictionary.
Conclusion: Many newly translated terms were included in the
dictionary. The dictionary should facilitate translation of medicinal
documents.
References:
1. Camilleri E. An English-Maltese dictionary of medical and
pharmaceutical terms [dissertation]. Msida: University of Malta;
2007.
2. Medicines Authority. Glossary of terms [Online]. Malta:
Medicines Authority; 2004 Apr 30 [cited 2009 Sep 25]. Available
from: URL: www.medicinesauthority.gov.mt/qrd.htm
3. Aquilina J. English-Maltese Dictionary. Valletta: Midsea Books
Ltd; 1999.
4. Mosby’s Medical Nursing and Allied Health Dictionary. 6th ed.
St. Louis: Mosby Inc.; 2002.
Background: Drug bulletins are specialised periodicals with
the aim to provide reliable information about medicines in a
summarised form.1
Objective: To issue a bulletin intended to provide information
on new medicines released on the market and on changes in the
summary of product characteristics specific to the local scenario
and to evaluate its usefulness among pharmacists and pharmacy
students.
Design: Lists of new medicinal products and locally available
medicines that had undergone variations were compiled. Further
information was obtained from regulatory authorities and local
agents. The front cover and a set of templates were created. A
concise article on each drug was written, reviewed by a panel
of experts and published in the bulletin. A questionnaire was
developed, validated and distributed. Five hundred copies of
the questionnaire were distributed for self-administration by
pharmacists and 210 by pharmacy students. The data obtained
was analysed using SPSS® version 17.0 and Microsoft® Excel XP.
Setting: Pharmacy Health Systems, Pharmaceutical Industry,
Medicines Authority and University of Malta
Main Outcome Measures: Compilation and evaluation of the
bulletin
Results: Sixty-six percent (n=471) returned the questionnaire after
the first issue of the bulletin: 73% (n=342) pharmacists and 27%
(n=129) students; 30% (n=142) male and 70% (n=329) female; age
range 18 to >66 years. The respondents agreed that the bulletin
was up-to-date, clear and concise (93%, n=439), user-friendly
(94%, n=443), and useful (97%, n=458). Ninety-six percent (n=454)
stated that the information presented was new to them. In fact,
62% (n=454) pharmacists and 50% (n=212) pharmacy students
strongly agreed that the bulletin helped them to keep informed.
Conclusion: The first issue of the bulletin provided an accessible
means to deliver information about the introduction of recent
medicinal products and variations on the local market. It was
positively received by pharmacists and pharmacy students.
Reference:
1. International Society of Drug Bulletins (ISDB) and World Health
Organization (WHO). Starting or strengthening a drug bulletin: A
practical manual [Online]. ISDB and WHO; 2005 [cited 2009 Nov
3]. Available from: URL: www.who.int/medicines/areas/rational_
use/startingstrengdrugbulletin.pdf.
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Pharmacy Projects 2010
History of Pharmacy
Newsletter for the Pharmacy Department
Gerard Abela
Antine Vella
Background: There were several advances in medicine and
pharmacy following World War II where a number of older drugs
were phased out and newer ones which are still used today were
introduced.
Background: The Pharmacy Department Newsletter is a bimonthly
publication covering pharmacy-related information and activities
carried out by the Pharmacy Department.1
Objective: To portray the historical aspect of the pharmacy
profession by comparing the prescription trend changes through
the post-war period.
Setting: A local community pharmacy
Design: Daily Sales Registers between 1945 and 1970 were
reviewed. The pages reviewed were chosen using random sampling
with 95% Confidence Level. The frequency of drugs listed in these
pages was tabulated according to each year and converted into
a percentage using Microsoft® Office® Excel 2003. Variations in
prescription trends were compared and the most frequently used
drugs were analysed.
Main Outcome Measures: Identification of the most commonly
prescribed drugs and variations in prescription trends during the
specified time frame
Results: A total of 250 different drugs were identified. When
considering the mean percentage of all the values for the whole
period, the most commonly prescribed drugs were aspirin and
potassium citrate. Sulphatiazole, an antibacterial, was also a very
popular drug in 1945, 1946 and 1947 (9.0%, 14.7% and 14.2%
respectively), decreasing to a negligible 0.1% by 1950. Auranti, a
plant extract, was never prescribed in 1945 however prescription
increased by 1950 to 8.3%, becoming the second most prescribed
drug during this year.
Conclusion: Results clearly indicate a change in prescription trends
through the years. Changes in the use of specific products may be
explained by looking at usage trends for other products.
Objective: To disseminate information about the Pharmacy
Department to pharmacists and students.
Design: The newsletter was designed using Microsoft Publisher®
2007. Six issues of the newsletter were published. An evaluation
questionnaire was distributed to 435 pharmacists and 211
pharmacy students after issue 3 and issue 6. Results were compiled
and analysed using SPSS version 17.0.
Setting: Pharmacy Department, University of Malta
Main Outcome Measures: Publication and evaluation of the
newsletter
Results: The newsletter was re-named ‘The Pharmacy Department
Review’. After issue 3, 70% of pharmacists and 30% of students
returned the questionnaire. The readers stated that the newsletter
was informative (pharmacists 82%, students 91%), interesting
(pharmacists 72%, students 80%), enhanced communication
between the Pharmacy Department and the pharmacist
(pharmacists 70%, students 83%) and the use of coloured paper
was effective (pharmacists 77%, students 94%). After issue 6, 73%
of pharmacists and 27% of students returned the questionnaire.
The readers stated that the newsletter was informative
(pharmacists 89%, students 97%), interesting (pharmacists 85%,
students 92%), enhanced communication between the Pharmacy
Department and the pharmacist (pharmacists 73%, students 83%)
and the use of coloured paper was effective (pharmacists 85%,
students 98%).
Conclusion: The majority of the respondents agreed that
the newsletter was informative, interesting and improved
communication between the Pharmacy Department and the
pharmacist.
Reference:
1. Rossi B. The production and evaluation of a pharmacy
department newsletter [dissertation]. Msida (Malta): University
of Malta; 2002.
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Pharmacy Projects 2010
Pharmaceutical Care and
Point-of-Care Testing
The Effects of Treatment on the Quality of Life in Rheumatoid Arthritis
Stephanie Falzon
Pharmaceutical Care of Patients Undergoing Heart Surgery
Natalie Zerafa
Point-of-Care Anticoagulant Monitoring
Melanie Azzopardi
Point-of-Care HbA1c Monitoring
Stephanie Azzopardi
Point-of-Care Diagnostics in Infections
Angele Vella
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Pharmacy Projects 2010
The Effects of Treatment on the Quality of Life Pharmaceutical Care of Patients Undergoing
in Rheumatoid Arthritis
Heart Surgery
Stephanie Falzon
Natalie Zerafa
Background: The evaluation of patient response to therapy, using
Health-Related Quality of Life (HRQoL) questionnaires, may help
to identify areas within HRQoL for which the patient is performing
poorly and help the rheumatology team direct attention to these
areas during treatment.1
Background: Open heart surgery is a procedure which warrants
education about the complexity of drug regimens and lifestyle
modifications. Educating patients about their drugs could improve
their understanding on the importance of continued therapy and
compliance at home following discharge.1
Objective: To assess the impact of different treatments on
HRQoL.
Obective: To evaluate the impact of a pharmacist intervention on
patient compliance to medication and lifestyle changes.
Design: The study was divided into 2 phases. During phase
1, 75 rheumatoid arthritis (RA) patients were recruited and
administered the HRQoL questionnaires, Short Form Health
Survey-36 (SF-36) and Health Assessment Questionnaire (HAQ).
After 6 months (phase 2), the patients were re-administered
both questionnaires. Data compiled from phase 1 and phase 2
questionnaires were analysed using SPSS® v. 17.0. Data was then
correlated to various drug regimens to identify the treatment with
the greatest improvement on HRQoL.
Setting: Rheumatology Outpatient Clinic, Mater Dei Hospital
Design: Eighty patients who underwent a coronary artery bypass or
heart valve surgery were interviewed on the day of discharge using
a developed questionnaire (Past Medical History questionnaire).
Subsequently, pharmacist intervention was offered to 40 of these
patients (experimental group). As part of the intervention, a
chart giving a pictorial explanation of the time of day together
with a colour photograph of each tablet prescribed was used. The
patient was counselled to comply to paracetamol and exercise
training and on the avoidance of alcohol and smoking during
the recovery period. All patients were re-interviewed 8 weeks
after discharge using a second questionnaire (Assessing Patient
Compliance questionnaire).
Main Outcome Measures: Evaluation of the treatment with the
greatest improvement on HRQoL in RA
Setting: Cardiac Surgical Ward and Outpatients Clinic, Mater Dei
Hospital
Results: The mean score obtained for the HAQ in phase 2 was
significantly lower than that obtained for phase 1 (p<0.05). The
mean scores during phase 2 for the SF-36 domains: physical
functioning, role physical and pain, were significantly higher
than the mean scores obtained for phase 1 (p<0.05). When
comparing the disability index to treatment groups, the lowest
scores for disability were identified among patients treated with
methotrexate in combination with glucocorticoids followed by
patients treated with triple therapy and quadruple therapy.
Main Outcome Measure: Impact of the pharmacist intervention
on patient compliance to medication and lifestyle changes postcardiac surgery
Conclusion: After 6 months of therapy, there was an overall
improvement in disability, physical functioning, bodily pain
and emotional factor. Methotrexate in combination with
glucocorticoids was found to be most effective in improving the
HRQoL in RA patients.
Results: A statistically significant difference between the two
groups in the mean percentage compliance was registered
following the pharmacist intervention (p=0.000). Patients in the
experimental group had a higher mean percentage compliance
score (88%) than patients in the control group (66%).
Conclusion: This pharmacist intervention resulted in improved
patient compliance to medication and lifestyle modifications. The
intervention provides patients with sufficient information to help
them achieve optimal benefit from the recommendations and
medication prescribed.
Reference:
1. Daul P, Grisanti J. Monitoring Response to Therapy in Rheumatoid
Arthritis. Perspectives from the Clinic. Bull NYU Hosp Jt Dis. 2009;
67(2): 236-242.
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Reference:
1. Oborne A, Dodds LJ. Seamless pharmaceutical care: The needs
of community pharmacists. Pharm J 1994;253:502-506.
Pharmacy Projects 2010
Point-of-Care Anticoagulant Monitoring
Point-of-Care HbA1c Monitoring
Melanie Azzopardi
Stephanie Azzopardi
Background: The number of patients requiring oral anticoagulation
is increasing and this is reflected in an increased burden on
outpatients’ clinics.
Background: HbA1c tests measure the amount of glycosylated
haemoglobin in the blood over the preceeding 2 to 3 months and
are an important tool in the assessment of glycaemic control in
diabetes.
Objective: To investigate feasibility and efficacy of the pharmacist’s
intervention in anticoagulant management.
Design: Seventy randomly selected patients receiving oral
anticoagulation were interviewed. An educational session and
booklet served to improve patients’ anticoagulant knowledge.
Patients’ knowledge was reassessed to determine effectiveness
of the educational intervention using Chi-square analysis (t=3
months). INR monitoring was performed on each patient
using the CoaguChek®S device. Fifty community pharmacists
were interviewed to investigate pharmacists’ perception on
implementation of INR monitoring service in community
pharmacies. A regression model was established by comparing
the INR issued by the CoaguChek®S and the laboratory. An
established dosing algorithm1 was amended and used to perform
dosing adjustment.
Setting: Nineteen community pharmacies
Main Outcome Measures: Patients’ anticoagulant knowledge, INR
result from CoaguChek®S monitoring device and dosing algorithm
Results: Forty-one patients were female and 29 were male (n=70),
the mean age was 65.4 years (range 44-84 years). Following the
educational intervention there was a significant improvement in
patient knowledge (p <0.050). Fifty-five patients would prefer
to have their INR monitored in a community pharmacy and 51 of
these trusted the CoaguChek®S result. Twenty-eight community
pharmacists were willing to offer INR monitoring in their pharmacy.
Out of the 70 patients who had their INR checked with the
CoaguChek®S device, 33 patients were within their target range,
21 patients were below and 16 patients were above their target
range. A regression analysis demonstrated the strong correlation
between the two methods of INR testing (R=0.903).
Conclusion: The combination of pharmacists’ knowledge and
the aid of point-of-care devices can yield a more efficient and
personalised service leading to improved compliance, therapy
outcome and patient satisfaction.
Objective: To identify the potential use of HbA1c tests as a
monitoring tool in assessing the level of diabetes management in
type 2 diabetic patients in community pharmacies.
Design: Fifty type 2 diabetic patients recruited randomly were
interviewed (phase 1, t0) and subjected to an HbA1c test using
the DCA® 2000+ HbA1c analyzer. Patient’s knowledge on diabetes
was supported by an educational session and distribution of a
purposely designed booklet. In the second and third phase (t=3
and t=6 months respectively), the 50 patients were re-interviewed
and an HbA1c test re-performed to assess progress in diabetes
control. The data was compiled using SPSS® version 17.0 and the
Pearson Correlation and One-Way ANOVA tests used.
Setting: Ten community pharmacies
Main Outcome Measures: HbA1c levels over 6 months; influence
of variables on HbA1c levels
Results: Thirty-two patients were female and 18 were male with
a mean age of 64 years (range 34-81 years) and mean duration
with diabetes was 11 years. Most of the patients (t0=29, t3, t6=27),
had a high HbA1c level (>7%) in all 3 phases and one patient had a
borderline HbA1c level (7%) at both t3 and t6. There was a decrease
in the mean %HbA1c in the second (7.6%) and third (7.7%) phase
compared to the first phase (7.9%). HbA1c is influenced by
frequency of medical examinations, exercise intensity and family
history of diabetes (p<0.05) but unaffected by gender, age, coexisting conditions and other risk factors.
Conclusion: The majority of patients had a high HbA1c level
(>7%) implying that their diabetes was poorly controlled. These
preliminary findings support the relevance for HbA1c monitoring
and patient follow-up within a point-of-care setting by community
pharmacists.
Reference:
1. Ebell MH. Evidence-based adjustment of warfarin (coumadin)
doses. Am Fam Physician 2005;71:763-5.
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Pharmacy Projects 2010
Point-of-Care Diagnostics in Infections
Angele Vella
Background: Point-of-Care (POC) tests give rapid results allowing
for immediate action to be taken resulting in an improved health
outcome.1 One such test detects the presence of Helicobacter
pylori– the most common cause of gastritis and peptic ulcers.2
Objective: To identify the availability and accessibility of POC
tests for the rapid detection of microorganisms and to evaluate
the feasibility of implementing a H. pylori POC testing service in a
community pharmacy setting.
Design: Manufacturing companies and suppliers of POC tests were
contacted and data received was reviewed. Seventeen patients
suffering from dyspepsia participated in the study. Patients were
18 years old and over, without accompanying alarm signs and
symptoms, not previously investigated and not on antibiotics. They
were tested for H. pylori using Ulti Med H. pylori Test Cassette and
asked to fill in a questionnaire.
Setting: A community pharmacy
Main Outcome Measures: Feasibility of H. pylori POC testing in a
community pharmacy; patients’ perception
Results: Fifteen types of POC tests that detect the presence of
microorganisms causing infections or their toxins or antibodies
were identified. From the 17 patients tested, 13 patients agreed
that H. pylori rapid tests should be carried out in a community
pharmacy. The average price patients would be willing to pay for
this service is €7.43 which includes the cost (€6.00) to perform
the test.
Conclusion: Patients were in favour of this service offered in a
community pharmacy and the majority are ready to pay for the
test.
References:
1. Price CP, St John A, Hicks JM, editors. Point-of-care testing. 2nd
ed. Washington: AACC Press; 2004.
2. Marshall BJ, McCallum RW, Guerrant R, editors. Helicobacter
pylori in peptic ulceration and gastritis. Boston: Blackwell Scientific
Publications; 1991.
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Pharmacy Projects 2010
Pharmacotherapy and
Treatment Protocols
Prescribing of Analgesics by Community Pharmacists
Simone Pace O’Shea
Implementation of Protocols on Allergy Disorders
Kathlene Cassar
Validation of Protocols for Skin Conditions
Trevor Darmanin
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Pharmacy Projects 2010
Prescribing of Analgesics by Community Implementation of Protocols on Allergy
Pharmacists
Disorders
Simone Pace O’Shea
Kathlene Cassar
Background: Protocol prescribing involves a formal agreement
and written guideline (protocol). The protocol is a document that
describes the activities pharmacists must perform when exercising
their prescribing authority.1
Background: Protocols guide pharmacists through a structured
approach, to take informed decisions and ensure patient safety
when dispensing treatment for any given symptoms.
Objective: To develop protocols for the community pharmacist
when responding to symptoms of pain and to implement a system
for protocol prescribing of analgesics.
Design: A pilot study was carried out to keep records of 30 randomly
selected patients regarding their condition and the analgesics
being dispensed or prescribed. The 6 most common areas of pain
were identified and protocols were written for the following:
dental pain, dysmenorrhoea, arthritis, musculoskeletal pain, back
pain and headache. The protocols were reviewed by a panel of
20 individuals and subsequently implemented in a community
pharmacy for 6 months. Two patient groups, each consisting of
30 patients, were randomly chosen: Group 1 - implementation of
protocols and Group 2 - no protocols used. SPSS® version 16.0 was
used to analyse the data collected.
Objectives: To prepare and implement protocols to help
community pharmacists in the management of allergic conditions.
To assess motivators and barriers for the implementation of
protocols in community pharmacies.
Design: Three protocols on allergy management developed in
a local study were reviewed.1 A concise version was developed,
to improve practicality of the protocols. These protocols provide
a guideline in diagnosing and managing allergic rhinitis, allergic
conjunctivitis, urticaria, eczema and closely related conditions.
Each protocol was presented as a flowchart in an A3 poster
together with corresponding text. Focus groups were organised
amongst pharmacists participating in the study. Three patient
information leaflets were designed to serve as an educational
tool and distributed to pharmacists together with the protocols.
Allergy cases relevant to the study were documented through
observation sessions.
Setting: A local community pharmacy
Setting: Twenty randomly selected local community pharmacies
Main Outcome Measures: Patient medication records;
development and evaluation of protocols for prescribing of
analgesics
Results: Review of the protocols by the panel revealed that
practicality and format were a major issue, with a mean score
on the Likert scale of 3.9 and 3.7 respectively (5 being the
maximum). From the implementation study, mean time taken by
the pharmacist with Group 1 was 4.5 minutes and with Group 2
was 3 minutes. The p-value for the two-independent sample t-test
(0.000) implies that there is a significant difference between group
1 and 2 intervention time. When using the protocols pharmacists
showed a mean percentage compliance of 92% (range: 70%100%).
Main Outcome Measures: Pharmacists` compliance to the
protocols; barriers and incentives encountered during protocol
implementation
Results: A total of 271 allergy cases were encountered. An
average compliance to the protocols of 62% was recorded. The
highest compliance score (66%) was obtained with the eye
protocol, followed by the nose and skin protocols each with 60%
compliance. Main barriers identified for the implementation of
protocols were the low staffing levels (n=20) and high workload
(n=20) leading to time constraints.
Conclusion: The difference in time between Group 1 and 2 patients
should not hinder pharmacists from using the protocols, since
they ensure good pharmaceutical care during the prescribing of
analgesics.
Conclusion: Pharmacists were willing to adopt these protocols,
however they highlighted the need for protocols to be designed
according to both local needs and resources available, and to be
updated regularly. Attention to protocol presentation, practice
setting and patient presentation provide a good insight on current
barriers and motivators for the implementation of protocols.
Reference:
Reference:
1. Nissen LM. Destiny or dream? Prescribing rights for pharmacists
in Australia. Aust Pharm 2007; 2(2): 130-701.
1. Caruana F. Protocols on allergy drugs [dissertation]. Msida
(Malta): University of Malta, 2002.
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Pharmacy Projects 2010
Validation of Protocols for Skin Conditions
Trevor Darmanin
Background: Protocols facilitate correct diagnosis and selection
of optimal treatment.¹ Their use encourages the necessary
communication between pharmacist and patient and promotes
the professional image of the pharmacist.²
Objective: To review, update and implement previously developed
protocols¹ on the treatment of eczema, athlete’s foot and insect
bites and stings.
Design: The study consisted of an ‘update phase’ during which
the protocols were reviewed and modified to include aspects
of pharmacist prescribing. During the ‘validation phase’ further
updates were made after the protocols were reviewed by a focus
group. The protocols were implemented for 6 weeks to evaluate
their practicality during the ‘experience phase’. The protocols were
assessed through a questionnaire based on a grading system.
Setting: Three randomly selected local community pharmacies
Main Outcome Measures: Evaluation of pharmacist experience
with the developed protocols; assessment of the usefulness, userfriendliness and practicality of the protocols
Results: Three hundred and sixty-eight changes were made to
the original protocols. Most (n=216) changes were related to the
format and presentation of the protocols. Other changes included
addition/deletion (n=96) and modification (n=56) of pre-existing
protocol processes. The pharmacist evaluation of the usefulness,
practicality and user-friendliness of the protocols achieved an
average grading of 97.4%.
Conclusion: The changes to the previously published protocols
produced a final version which was determined to be useful,
user-friendly and practical for use in the community pharmacy
scenario.
References:
1. Vella S. Development of a protocol for skin conditions
[dissertation]. Msida (Malta) University of Malta; 2005.
2. Desselle SP, Zgarrick DP. Pharmacy management: Essentials for
all practice settings. New Jersey: McGraw-Hill Professional, 2008.
P.101.
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Pharmacy Projects 2010
Pharmacy Administration
Assessing the Feasibility of Computerising Patient Profiles at Karin Grech Hospital
Rodianne Bondin
Satisfaction with Pharmacy Services
Annelise Saliba
Health, Travel and the Use of Medication
Maria Cuschieri
Protocols for Introducing New Drugs in Cancer Care
Francesca Schembri
Pilot Study of Setting Up a Museum Related to the Healthcare Professions
Elaine Seychell
Drugs and Art
Clint Pace
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Pharmacy Projects 2010
Assessing the Feasibility of Computerising Satisfaction with Pharmacy Services
Patient Profiles at Karin Grech Hospital
Annelise Saliba
Rodianne Bondin Background: Computerised pharmacy systems reduce medication
errors and enable effective financial management.1
Objective: To test a computerised program for the maintenance of
pharmacy patient profiles and to calculate the cost of medications
per patient using the computerised system.
Design: A computer program designed appropriately for Karin
Grech Hospital was accessed and updated. A test run was carried
out (January - September 2009). The time taken to complete
the paper and computerised profiles was recorded. Changes in
medications for patients included in the study were followed until
discharge. The cost of medications per patient was calculated.
Eighty four patients (28 from each ward: M3, M4, M8) were
recruited for the study in order of presentation to the investigator.
Thirty five patients were male (mean age: 77, range: 46-95 years)
and 49 were female (mean age: 81, range: 64-99 years). Results
were analysed using SPSS® version 17.0 and the One-Way ANOVA
test used.
Setting: Karin Grech Hospital
Main outcome measures: Time taken to complete paper and
computerised profiles (recorded using a stop watch); cost
of medications per patient (calculated using the computer
program).
Results: The average time taken to complete one patient profile
was 16 minutes 50 seconds (paper profile) and 17 minutes 41
seconds (computer profile). The difference in time taken was
not significant (p=0.468). The average cost of medications per
patient per day was: €3.19 (M3), €3.51 (M4) and €3.64 (M8). The
average cost of medications per day for males was higher than
that for females (€3.89 and €3.14 respectively). Variations in cost
according to ward and gender were not significant (p=0.917 and
p=0.411 respectively).
Conclusions: Computerising patient profiles improves accessibility
of patients’ information and enables costing of inpatient drug
treatment.
Background: The role of the pharmacist has become more
patient care-oriented over the years; evolving from a profession
that simply dispenses pharmaceutical products to one that helps
patients make the best use of medications.1
Objective: To identify patient-oriented interventions provided by
Gozitan community pharmacists and to determine the perception
of the Gozitan public regarding pharmacist-led professional
services.
Design: Psychometrically evaluated locally developed selfadministered community pharmacist and general public
questionnaires2 were distributed to 15 community pharmacists
in Gozo and to 450 Gozitan consumers respectively. Statistical
analysis was undertaken using SPSS® version 17.0.
Setting: Community pharmacies in Gozo
Main Outcome Measures: Pharmacist perception on issues
of supplementary pharmacist prescribing and participation
in Continuing Professional Development (CPD) programmes,
perception of the Gozitan public regarding pharmacist-led
professional services
Results: Eleven pharmacists were in favour of the local
implementation of supplementary pharmacist prescribing. The
majority of pharmacists (n=9) claimed that they were willing to
participate in CPD programmes. Sixty-five percent (n=293) of
the public were satisfied with the information provided by the
pharmacist regarding their medication(s), however, only 45%
(n=203) agreed that the pharmacist should be able to prescribe
certain medications without the doctor’s permission.
Conclusion: The results obtained are encouraging since
the majority of the pharmacists were willing to accept the
implementation of supplementary pharmacist prescribing in Gozo
and Gozitan consumers had a very good overall perception of the
community pharmacist. Since most pharmacists were willing to
participate, a CPD programme was organised as a pilot to identify
possibilities to offer this activity in Gozo.
References:
Reference:
1. Jenkins D, Cairns C, Dobson L, Barber N. Costing inpatient drug
treatment. IJPP 1995; 3:106-9.
1. American Society of Health System Pharmacists. The expanding
role of the pharmacist and the reimbursement dilemma [Online].
US: ASHP [cited 2009 Nov 8]. Available from URL: http://www.
ashp.org/s_ashp/docs/files/role_pharm.pdf
2. Wirth F. Perception of the pharmacist [dissertation]. Msida
(Malta): University of Malta; 2007.
17
Pharmacy Projects 2010
Health, Travel and the Use of Medication
Maria Cuschieri
Protocols for Introducing New Drugs in Cancer
Care
Francesca Schembri
Background: Air travel is considered to be one of the safest forms
of travel, however the environment within the aircraft cabin may
have adverse effects on passengers. 1
Objective: To analyse difficulties encountered by passengers when
travelling by air and to evaluate the availability of medication to
tourists from local community pharmacies.
Design: A questionnaire for tourists was developed, validated and
reliability testing was carried out. One hundred tourists selected
by random sampling were interviewed; 25 tourists from each of
the following age groups, < 20 years, 21-45 years, 46-60 years
and > 61 years. Statistical analysis was carried out using SPSS®
version 17.0 using the Pearson Chi-square test with a 0.05 level
of significance.
Setting: Hilton Hotel Malta
Main Outcome Measures: Health problems related to travelling by
air; availability of medication to tourists from local pharmacies
Results: Forty tourists suffered from chronic health conditions
which varied significantly with age (p= 0.011). Cardiac problems
(n=9) and respiratory problems (n=6) were more common in males
compared to females (n= 3 and n=4 respectively) (p= 0.024). Most
(n=29) of the tourists suffering from chronic health conditions did
not feel restricted to travel. Eighty-five tourists believed that a
Health and Travel handbook should be made available to increase
awareness. None of the tourists encountered a problem when
acquiring their medication from local community pharmacies.
Conclusion: Tourists suffering from chronic health conditions did
not feel restricted to travel by air. More awareness is necessary
regarding the risks associated with air travel. Tourists did not
encounter any problems when buying their medication from local
pharmacies.
Reference:
1. Voss MW. Air travel for the chronically ill and elderly. Am Fam
Physician 1983; 27: 235-43.
Background: The increase in the incidence of cancer patients
and development of new expensive anticancer treatments
are challenging the sustainability and efficiency of a country’s
healthcare system.1
Objectives: To identify a framework for the introduction of new
anticancer drugs and to introduce a documentation system to
enhance the accountability and transparency of such framework.
Design: The first phase of the study, involved the collection of
data relating to the process of evaluation of anticancer drugs by
different healthcare professionals and organisations. The second
phase involved collection of data on the clinical use of anticancer
drugs. During the third phase, a framework and a documentation
system were designed based on data collected in the previous
phases of the study.
Setting: Local National Health Service
Main Outcome Measures: Development of a framework and a
documentation system for introducing new anticancer drugs to
the local National Health Service
Results: The framework developed highlights the need for the
evaluation of new anticancer drugs to be based on both clinical and
economic terms. The framework proposes that the clinical point of
view is analysed by a group of oncologists whereas the economic
perspective is evaluated by the Drug and Therapeutics Committee
(DTC). The framework is backed by a proper documentation system
that involves a set of forms whose objectives are to enhance the
system’s transparency and accountability by acting as a form of
control on the entire system.
Conclusion: A multidisciplined and specialised system that ensures
a better evaluation of anticancer drugs, which is essential in
managing the allocation of limited resources, has been developed
and proposed.
Reference:
1. Meropol NJ, Schulman KA. Cost of cancer care: Issues and
implications. JCO [serial online] 2007;25(2):180-186 [cited
2009 Jan 17]. Available from: http://dceg.cancer.gov/files/
genomicscourse/meropol-011007.pdf.
18
Pharmacy Projects 2010
Pilot Study of Setting Up a Museum Related to Drugs and Art
the Healthcare Professions
Clint Pace
Elaine Seychell
Background: The Maltese Islands have a historical heritage
dating back to 5000 BC providing a society rich in culture.1 Despite
the increasing interest in medical and pharmaceutical history,
collection items are still being lost or left to deteriorate in various
locations.
Objective: To identify artefacts related to healthcare professions
and to transform a selection of haphazardly arranged set of items
into small displays of educational significance.
Design: Three themes were chosen for the displays: pharmacy,
dentistry and urology. For the pharmacy section, a display cabinet
was specifically designed and constructed, whilst for the dentistry
and urology sections 2 cabinets were provided by the Faculty of
Medicine and Surgery. Related historical artefacts belonging to
the faculty and to private collectors were catalogued and are being
exhibited. Photographs of items stored or displayed elsewhere
were also included.
Setting: Foyer at Medical School, Mater Dei Hospital; Board
Room, Department of Pharmacy, University of Malta
Main Outcome Measures: An organised, well presented catalogue
and display of 19th and 20th century artefacts
Results: The display is divided into: (i) Dental display (32 items)
- development of local anaesthesia and dental instruments, (ii)
Urology display (19 items) - lithotomy surgical instruments,
sets of tools containing catheters and dilators, irrigating and
bladder syringes, analytical instruments and apparatus used
in the collection of urine and (iii) Pharmacy display (35 items) equipment used to prepare and dispense medicaments, ampoules
belonging to different classes of drugs, dispensary bottles and
genito-urinary tools.
Conclusion: The displays allow historical information to be passed
from one generation to the next and create greater awareness
towards the appreciation of the history of medicine.
Reference:
1. Savona-Ventura C. Ancient and medieval medicine in Malta
[before 1600AD]. Malta: Publishers Enterprises Group Limited;
2004. p. 15-6.
Background: Artists are often associated with drug abuse. The
public is inundated with stories of rehabilitation and relapsing
artists. However, is such a situation due to a higher incidence of
drug abuse by artists or is it the inevitable result of the artist and
his work being constantly at the forefront of the public psyche?
Objective: To put the relationship of artists and drugs at present
and in recent history into perspective and to investigate the
possible influence of drugs on creativity.
Design: A questionnaire was developed and made available
online and distributed by post. These methods were used for
confidentiality reasons due to the legal aspect of the subject.
Microsoft Office Excel® 2003 and SPSS® version 18.0.1 were used
to analyse data.
Setting: Local professional and amateur artists
Main Outcome Measures: Drug abuse among local artists;
attitudes towards drug abuse
Results: A total of 174 artists filled in the questionnaire. While
53% of the respondents agreed that artists use drugs to influence
their art, only 3% agreed that artists require drugs to produce
good art. Seventy-nine percent of the respondents disagreed that
drugs are an integral part of an artist’s lifestyle. However, 68%
have smoked marijuana; 42% of these do so occasionally or often.
Thirty-six percent of professional artists and 64% of amateur
artists admitted that they abuse drugs.
Conclusion: Despite artists claiming that the public’s perception
of their drug habits is not justified, the incidence of drug abuse
is higher when compared to the rest of the population.1 None of
the artists listed drugs as a source of inspiration or enhancement
to ideas. This shows that drug abuse, when present, is an activity
that is considered separate from their talents.
Reference:
1. European Monitoring Centre for Drugs and Drug Addiction. The
state of the drug problem in Europe [online]. Lisbon: EMCDDA;
1995 [cited 2009 Dec 01]. Available from: URL: http://www.
emcdda.europa.eu/publications/annual-report/2009.
19
Pharmacy Projects 2010
Regulatory Affairs and
Pharmacoeconomics
GDP: The Example of a Wholesaler
Vanessa Azzopardi
Distribution of Free Medicine in Malta
Gilles Briffa Rizzo
Sale of Non-Prescription Medicines from Pharmacies: Price Comparisons
Rebecca Vella
20
Pharmacy Projects 2010
GDP: The Example of a Wholesaler
Vanessa Azzopardi
Background: Pharmaceutical companies are responsible for
development and production of medicinal products which are
then distributed to pharmacies to be available for patients. In this
pharmaceutical supply chain, wholesalers bridge the gap between
the two. By adhering to Standard Operating Procedures (SOPs),
wholesalers ensure that products are stored and transported
under the appropriate conditions to retain the quality, safety and
efficacy of the product.
Objective: To develop SOP templates to serve as an addition to
Rules and Guidance for Pharmaceutical Distributors 2007 by the
Medicines and Healthcare products Regulatory Agency (MHRA),
known as the Green Guide.
Design: SOPs at three different local wholesalers were analysed
and interviews were held with the Responsible Persons and the
Medicines Authority. The information collected, together with
the Directive 2004/27/EC amending Directive 2001/83/EC and
the guidelines for Good Distribution Practice (GDP) 94/C63/03
were used to create SOP templates which were compiled in a
booklet. Flowcharts were devised and included as an appendix.
The booklet was then validated.
Setting: Three local wholesalers in Malta
Main Outcome Measures: Compilation and validation of SOP
templates
Results: The size of the booklet is A5 and consists of 15 SOPs
describing the different operations which take place at a
wholesaler. These are: Master SOP, Self-inspection, Purchasing of
Stock, Receipt of Goods, Cleaning and Maintenance, Pest Control,
Storage, Sale of Medicinal Products, Delivery of Goods, Returns,
Control of Samples, Handling of Complaints, Training of Staff,
Product Recalls and Controlled Dangerous Drugs.
Distribution of Free Medicine in Malta Gilles Briffa Rizzo
Background: Both in-patients in Government hospitals and outpatients, benefit from free medicine according to their entitlement
and medical conditions. At the start of 2008 the Pharmacy Of Your
Choice (POYC) scheme was launched enabling patients to collect
their free medicine from a community pharmacy of their choice
and from a pharmacist they trust.
Objective: To monitor the progress and implementation of the
POYC scheme in Malta and to compare it to the previous system
of free medicine distribution.
Design: A questionnaire was compiled following observation in
10 community pharmacies which were participating in the pilot
study of the POYC scheme. The questionnaire was distributed to
400 patients currently registered under the POYC scheme.
Main Outcome Measures: Patient compliance with the POYC
scheme
Setting: Community pharmacies
Results: Eighty-four percent of patients were not satisfied with
the previous Government dispensary system, predominantly
because they had to wait for 1 to 1.5 hours to collect their free
medicine. Patients agreed that the shift from one system to the
other was relatively easy. The main drawback of the new system
was medications that were ‘Out of Stock’.
Conclusion: Patients were satisfied with the POYC scheme and
perceived it as user-friendly, efficient and well managed. However
due to medications frequently being ‘out of stock’, patients
still have to collect some of their medications from a Hospital
Dispensary or a Government Dispensary therefore the problem of
long queues has not been completely overcome.
Conclusion: The developed booklet provides guidance to
wholesalers to obtain the required level of GDP which together
with training, can ensure that the high level of product quality
achieved during production will be maintained and medicines
meet appropriate standards of safety, quality and efficacy until
they reach the patient.
21
Pharmacy Projects 2010
Sale of Non-Prescription Medicines from
Pharmacies: Price Comparisons
Rebecca Vella
Background: The price of medicines is an issue of public concern
locally and prompts price comparisons.1
Objectives: To identify price variations between non-prescription
medicines (NPMs) in Malta and United Kingdom (UK), to compare
prices of originator and generic NPMs in Malta and to determine
the attitude of Maltese patients and pharmacists towards these
price variations.
Design: Separate lists of retail prices of NPMs in Malta and UK
were compiled. A price index was derived to compare prices.
Questionnaires to assess patient and pharmacist perception of
medicine prices were developed. Results were analysed using
Microsoft® Excel® 2007 and SPSS® version 15.0.
Setting: Community pharmacies in Malta and Gozo
Main Outcome Measures: Lists of retail prices of NPMs in Malta
and UK per milligram of active ingredient; price index for each
active ingredient; price differences between Malta and UK and
between originator and generic NPMs in Malta
Results: A total of 396 and 824 NPMs were included in the
price list for Malta and UK respectively. Only 149 of the active
ingredients in these lists were available in both countries. Prices
of NPMs in Malta were found to be 8% higher. Fifty-seven percent
of pharmacists ‘sometimes’ advise patients to switch from an
originator NPM to its generic. However, 37% of pharmacists only
do so when the price difference between the two products is
considerable. Most (38%) patients interviewed would switch to
cheaper NPMs only if there is a price difference of €2 to €4.50.
Conclusion: Overall, medicines in Malta are more expensive than
in UK. Several reasons including importation expenses may be
accountable. However pharmacists and patients are reluctant to
switch from originator to generic NPMs unless there is a significant
price difference.
Reference:
1. Zarb Adami M. Cost of medicines: Keywords in
pharmacoeconomics. Msida (Malta): University of Malta; 1999.
22
Pharmacy Projects 2010
Clinical and
Pharmaceutical Analysis
Determination of Amylase in Gastric Juice
Kirsten Zammit
Bioequivalence: The Case of Doxazosin
Svetlana Agius
The Effect of Medicinal Plants on Maltese Honey
Silvan Spagnol
Stability Testing of Medical Oxygen
Gayle Papps
23
Pharmacy Projects 2010
Determination of Amylase in Gastric Juice
Bioequivalence: The Case of Doxazosin
Kirsten Zammit
Svetlana Agius
Background: Proton pump inhibitors (PPIs) lower the acidity
of stomach gastric juice to produce a pH in which salivary and
pancreatic amylase may be present.
Introduction: Bioequivalence studies are important in the
development of generic medicinal products. Quality must be
assured in every step of the testing procedure to ensure that the
results generated are credible and reliable.
Objective: To determine whether an excess amount of pancreatic
and salivary amylase is present in gastric juice for patients on PPI
therapy.
Design: A previously designed methodology1 using the Reflotron®
was adopted to analyse different types of amylase in gastric juice.
Two types of strips were used for analysis: Total Amylase to test
both salivary and pancreatic amylase and Pancreatic Amylase to
test for pancreatic amylase only. Samples were collected from
patients on PPI therapy: omeprazole (n=33), rabeprazole (n=4),
esomeprazole (n=3) and lansoprazole (n=1) and from patients not
on such treatment (controls n=20). Results were analysed using
Microsoft® Excel 2007 and SPSS® version 17.0.
Setting: Endoscopy Unit, Mater Dei Hospital; Research laboratory,
Department of Pharmacy, University of Malta
Main Outcome Measures: Determination of gastric juice pH in
relation to amylase activity; possible association between types
of PPIs, different omeprazole regimes and patients remaining
symptomatic despite treatment
Results: Pearson correlation coefficient showed a positive
relationship between pH and amylase activity and PPI type
(p<0.05). A significant increase in activity was observed for
symptomatic and non-symptomatic patients through a pairedsample t-test. Amylase activity was significantly different in dosage
regimens involving omeprazole 40mg twice daily (n=1) and 20mg
taken as required (n=4) (p<0.05).
Conclusion: PPI treatment increases the pH concentration in the
stomach allowing an increased amylase activity. Different PPI
regimes and patients who were still symptomatic despite PPI
therapy have also presented a significant effect on the amylase
activity present in the sample.
Reference:
1. Scicluna Giusti W. Determination of pancreatic amylase in
gastric juice [Masters dissertation]. Msida (Malta): University of
Malta; 2008.
24
Objective: To develop a quality management system (QMS)
for a bioequivalence study on doxazosin tablets based on the
requirements of ISO 17025: 2005 and Good Clinical Practice EU
guidelines.
Design: A review of the standards available for bioequivalence
studies was carried out. ISO 17025: 2005 and Good Clinical
Practice EU guidelines were chosen to develop the QMS. Literature
review was carried out on the interpretation and implementation
of these standards followed by a gap analysis for each standard
chosen. Quality system documentation was developed based on
a four-tier system: the quality manual, quality system procedures,
working procedures and supporting documentation. The system
was based on a pilot bioequivalence study carried out by Abela in
20081 on doxazosin tablets.
Setting: Department of Pharmacy, University of Malta
Main Outcome Measures: Gap analysis to identify nonconformance with the standard; development of QMS
documentation to minimise errors and improve the quality of
bioequivalence testing
Results: The ISO 17025: 2005 gap analysis showed that there was
an 89% non-conformance with the requirements of the standard.
Fifteen quality system procedures were developed including
procedures for training, equipment and control of records.
Conclusion: The QMS was developed to improve the quality of
testing activities during bioequivalence studies by standardisation
of the activities.
Reference:
1. Abela A. Bioequivalence of doxazosin slow release tablets: A
pilot study [dissertation]. Msida (Malta): University of Malta;
2008.
Pharmacy Projects 2010
The Effect of Medicinal Plants on Maltese Stability Testing of Medical Oxygen
Honey
Gayle Papps
Silvan Spagnol
Background: Despite the alleged medicinal properties of Maltese
honey, studies that support pharmaceutical applications of this
natural product are limited.1
Objective: To identify current and potential pharmaceutical
applications of honey.
Design: A pollen reference library was created. The pollens
present in 21 honey samples were identified by comparing them
to those in the library. The Brine-Shrimp test was conducted
using different concentrations of honey and the LC50 for each
sample was calculated. Honey samples were tested for major
plant metabolites by phytochemical analysis. These tests were
also carried out on extracts of flowers of plants whose pollen was
prevalent in honey.
Setting: Research Laboratories, Institute of Agriculture, University
of Malta
Main Outcome Measures: Determination of the botanical
origin of honey; screening honey for pharmacological activity;
identification of any plant metabolites present in honey
Results: Four honey samples were found to be monofloral, 15
samples were polyfloral, while the remaining 3 samples lacked
the presence of pollens. The majority of samples gave a positive
result in all the phytochemical tests. At the 95% confidence level,
all honey samples, except those in which pollens were absent,
showed an activity that is significantly higher than that of a sugar
solution (control).
Conclusion: The polyfloral nature of most samples is expected
since local wildlife is restricted to small areas. There seems to be a
relationship between the presence of pollens and pharmacological
activity of honey, suggesting that samples lacking the presence
of pollens may be adulterated. It may be concluded that honey
shows a degree of pharmacological activity which is due to both its
osmotic and chemical properties, with the latter being attributed
to proteins, flavonoids and terpenoids.
Background: Stability testing establishes how the quality of an
active substance or finished product varies with time under the
influence of different environmental factors.1 According to a
stability study carried out by Poligas Ltd, medical oxygen shows
stability and little degradation. Samples used were exposed to
temperature and moisture conditions for 3 months; storage
temperatures never exceeded 45°C and humidity testing was not
carried out.2
Objective: To establish the effects of increased temperature
and moisture conditions on the purity and impurities of medical
oxygen in cylinders.
Design: The study included 14 cylinders (cylinder volumes 7L, 10L
and 35L) that were randomly sampled from 14 different batches
of medical oxygen to investigate changes over 12 months. Seven
of the 14 cylinders were exposed to a controlled temperature
environment of 35°C and the other 7 cylinders were exposed to
fluctuating environmental temperatures for 9 months. The effects
of increased moisture content within cylinders were investigated
using 8 cylinders (cylinder volumes 7L and 35L) exposed to 4
moisture levels (0-15ppm, 16-30ppm, 31-45ppm, >45ppm) for 6
months.
Setting: Poligas Ltd.
Main Outcome Measures: Stability of medical oxygen
Results: No significant change in purity and impurities of medical
oxygen was found at ambient temperatures with time. A significant
decrease (p=0.000) in percentage of oxygen purity in 35L cylinders
at ambient temperature conditions was obtained. This could be
due to standard vacuuming times of cylinders irrespective of
cylinder volume prior to filling with medical oxygen.
Conclusions: No significant change in percentage of oxygen
purity and impurities was found when increasing temperature
and moisture conditions for the 7L and 10L cylinders. Adjusting
vacuuming times according to cylinder volume prior to filling
should be considered to avoid changes in purity for the 35L
cylinders.
Reference:
References:
1. Gatt M. A basic study on the quality of Maltese honey
[dissertation]. Msida (Malta): University of Malta; 2005. p.14.
1. The European Agency for the Evaluation of Medicinal Products .
Guidelines on Stability Testing. London: EMEA; 2003. p.3.
2. Poligas Ltd. Common Technical Documentation: Module 3.
Malta: Poligas Ltd; 2006. p.42.
25
Pharmacy Projects 2010
Industrial Pharmacy
Training and Development for Pharmaceutical Industry Personnel
Stefanie Farrugia
Is the Pharmacy Department Meeting the Needs of the Pharmaceutical Industry?
Glorianne Camilleri
Manufacture of Active Pharmaceutical Ingredients
Wei Liu
Production of Modified Release Dosage Forms
Karl Schembri
Microbiological Testing Requirements of the Local Industry
Maria Fenech
Production of Intravenous Fluids
Thomas Vella
26
Pharmacy Projects 2010
Training and Development for Pharmaceutical Is the Pharmacy Department Meeting the
Industry Personnel
Needs of the Pharmaceutical Industry?
Stefanie Farrugia
Glorianne Camilleri
Background: When employees are properly motivated through
training they could work at 80-90% of their capabilities as
opposed to the delivery of 20-30%, just enough to retain their
job.¹ Training evaluation can be undertaken if an organised
training documentation system is in place.
Background: The local generic pharmaceutical industry is
continually expanding and attracting foreign investment due
to Malta’s legal framework.1 The University of Malta (UOM) is
responsible for well-qualified graduates, including pharmacists, to
work in this sector.
Objectives: To investigate how training is done and how
pharmaceutical training documentation could be facilitated and
developed through the use of customised software. To develop
a training session that meets the requirements of the local
pharmaceutical industry in accordance to GMP guidelines.
Objective: To evaluate the present requirements of the
pharmaceutical industry in terms of skilled manpower.
Design: The study was carried out in a local pharmaceutical
company over a 3-year period (2007–2009) during which the
number of employees increased from 84 to 178 and a training
software system implemented. Data was gathered through
observation, interviews and questionnaires. Statistical analysis
was undertaken using Microsoft® Excel® 2007 and SPSS® version
17.0 using the paired sample t-test. A p value less than 0.05 was
considered statistically significant.
Setting: Arrow Pharm Malta Ltd.
Main Outcome Measures: SOP training compliance before and
after the study
Results: Training compliance was significantly (p<0.05) improved
following development of the training software. Data from
questionnaires given to employees showed a statistically
significant result in training preferences and assessments (N =
149). Workshops (56%) were the preferred form of training and
multiple choice questions (79%) were the preferred method of
assessment.
Conclusions: Organised training documentation gave the
pharmaceutical company better control over training and
compliance was improved. Involving employees and incorporating
realistic examples during training makes the sessions more
successful and cost-effective.
Design: The programme of study units at the Department of
Pharmacy, UOM, was analysed and a map of the study units
related to Industrial Pharmacy was drawn up. A list of all local
pharmaceutical companies was compiled and structured
interviews were conducted with managers and pharmacists
willing to participate. The study units were used as a reference
during the interviews.
Setting: Actavis, Arrow Pharm Ltd., Baxter, CombinoPharm,
Medichem, Poligas Ltd, Siegfried Generics
Main Outcome Measures: Competences and skills expected from
pharmacy graduates
Results: Seven out of eleven local pharmaceutical companies were
included in the study. Thirty-one interviews were carried out with
14 managers, 12 pharmacists and 5 pharmacists with managerial
positions. Various skills were identified as requirements to work
in industry, the most common being: having a solid scientific
background and knowledge of Good Manufacturing Practice
(GMP) and Regulatory Affairs. Only 8 out of the 31 participants
stated that pharmacists possess these skills. Fifteen participants
claimed that the programme of study units is not sufficient for
students interested to work in industry. All agreed about the
importance of training in industry.
Conclusion: All the participants agreed with the relevance of
hands-on practical experience placements incorporated within
the programme of study units of the Department of Pharmacy.
Reference:
Reference:
1. Monappa A, Saiyadain MS. Training and Development. In:
Personnel Management. 2nd ed. McGraw-Hill; 1996. P. 173.
1. Malta Enterprise. Pharmaceuticals and healthcare. PharmaMalta
[serial online] 2008 July 1; [cited 2009 Dec 8]. Available from: URL:
http://www.maltaenterprise.com/pharmaceuticals.aspx
27
Pharmacy Projects 2010
Manufacture
Ingredients
Wei Liu
of
Active
Pharmaceutical Production of Modified Release Dosage
Forms
Karl Schembri
Background: Active Pharmaceutical Ingredients (APIs) are the key
components of a drug product. It is the API in a drug formulation
which produces the pharmaceutical action. To ensure the quality
of APIs, regulations and guidelines were developed by various
international and national medicinal authorities.
Objective: To investigate how GMP guidelines are implemented
in the API industry and how compliance with GMP guidelines is
achieved.
Design: The study consisted of 2 parts: The first part involved
the analysis of the most important documents regarding the
regulations of API manufacture; the second part involved indepth interviews with API plant managers in Malta. Interviews
were tape-recorded and transcribed verbatim. Due to the small
sample size of the interviews (n=3), coding and quantitative
analysis were done manually. The results are presented as themes
identified from the interview data and relevant documents, and
then compiled in tables and graphs.
Setting: Amino Chemicals and Solea Pharma
Main Outcome Measures: GMP requirements in API manufacture,
themes presented by the plant managers
Results: The ICH Q7A is the most influential document which
governs API manufacture worldwide and consists of detailed
guidelines on every aspect of the API manufacturing process,
including documentation involved in all stages, distribution and
recalls. Implementation of the ICH Q7A in the API industry covers 6
systems: Quality, Facilities and Equipment, Materials, Production,
Packaging and Labelling and Laboratory Control. Compliance
is achieved through self-audit exercises implemented by the
manufacturer and inspections by the regulatory authorities.
Conclusion: Greater enforcement of GMP in the API manufacturing
process is a necessary measure to ensure the quality of APIs and,
the quality of drug products.
28
Background: In 2008, modified release dosage forms generated
global sales of nearly 21 billion dollars.1 Different techniques are
used in the manufacture of such dosage forms.
Objectives: To review the different methods used in the
production of modified release dosage forms, to classify modified
release dosage forms available in Malta according to their method
of production and to determine the patent status of such dosage
forms.
Design: An extensive literature review was carried out to describe
the different techniques used to produce modified release dosage
forms. Oral modified release dosage forms available in Malta were
classified according to their production method. The innovator
formulations were distinguished from the generic formulations.
The patent status of originator products was determined. The
occurrence of hydroxypropylmethylcellulose (HPMC) was also
recorded.
Setting: University of Malta Library, Pharmaceutical Industry
Main Outcome Measures: Number of products produced by
different manufacturing methods; number of innovator and
generic products available in Malta; number of products under
patent; occurrence of hydroxypropylmethylcellulose in products
Results: Diffusion Controlled Matrix formulation was the most
common method of manufacture for formulations available in
Malta since it represented 42% (n=22) of the total formulations
available (n=52). Hydroxypropylmethylcellulose is present in the
majority of formulations (n=37, 71%). Out of the 52 formulations,
43 are originator products and 9 are generics. Nineteen originator
products have their patent in force whilst the patent for another
24 originator products expired.
Conclusion: Compilation of information regarding the production
of modified release dosage forms is important to provide an indepth knowledge on their methods of manufacture. Reasons
for the common occurrence of diffusion controlled matrix
formulations include its low production cost, ease of manufacture
and long history of use.
Reference:
1. Espicrom Business Intelligence. Drug Delivery Technologies:
Controlled-release Players, products & prospects to 2018. [Online]
2009 [cited 2009 November 26]. Available from: URL:www.
the-infoshop.com/report/es94090-d-delivery-tech.html
Pharmacy Projects 2010
Microbiological Testing Requirements of the Production of Intravenous Fluids
Local Industry
Thomas Vella
Maria Fenech
Background: In Malta some of the pharmaceutical companies do
not have their in-house microbiological testing facility and need
to sub-contract testing of their samples.
Objective: To determine the microbiological tests required and to
verify the feasibility of setting up an accredited local microbiology
laboratory.
Design: Six pharmaceutical companies participated in the study.
The methods specified in the European Pharmacopeia1 were
sub-divided into steps and the resources needed were identified.
Using quotations provided, the costing process was conducted
for media preparation and the testing methods. The annual costs
incurred for the running of the laboratory and the annual financial
costs were calculated. Following the costing process a break-even
analysis was conducted.
Setting: Pharmaceutical companies and the biological section at
the Malta National Laboratory
Main Outcome Measure: Break-even analysis
Results: A total estimate of 9,491 tests were required to be carried
out annually within the companies. A bank loan of €118,000
payable over 15 years at 15% interest per annum would be required
for start up. It was estimated that an overdraft of €52,000 would
be needed, assuming that it would be fully used each year and an
annual interest of €2,600 paid. Break-even will occur following the
first year, once 8,154 tests are carried out representing 86% of the
total samples. By the 5th, 10th, 15th, and 16th year, this percentage
would decrease to 82%, 77%, 72% and 52% respectively, due to
the reduction in the annual financial costs.
Conclusion: The setting up of the laboratory is considered feasible
and can offer a competitive service, easy access to the laboratory
whilst saving on courier charges and handling.
Reference:
1. European Directorate for the Quality of Medicines.
European Pharmacopoeia 6th ed. (Suppl 6.5). France: European
Pharmacopoeia; 2009.
Background: Malta currently imports intravenous fluids at
relatively high costs due to transportation expenses. The setting
up of a Medical Solutions Production Center for manufacturing a
wide range of intravenous infusions would benefit the Maltese
healthcare system by providing them at lower cost.
Objective: To review the production and testing of intravenous
fluids using Blow-Fill-Seal technology and gauge the feasibility
of setting up a Blow-Fill-Seal plant in Malta. The potential for
exportation and future expansion are considered.
Design: The annual consumption of each product was obtained
from the Government Pharmaceutical Stores and a database of
the intravenous fluids used in Malta was compiled. Requirements
for the Mediterranean region were estimated. The requirements
of composition, sterility and microbiological testing stated by the
European Pharmacopoeia were studied. A literature review of
intravenous fluid production using Blow-Fill-Seal technology was
carried out. Four different scenarios were taken into consideration
when conducting the feasibility study: Addressing only local
demand, conducting a break-even analysis; and determining the
maximum capacity of production with 1 shift and 2 shifts.
Setting: Industrial Pharmacy (Aseptic Processing)
Main Outcome Measures: Demand of intravenous fluids in Malta
and the Mediterranean region, estimating fixed and variable
costs, estimating capital expenditure. Profit or loss after 5 years of
operation were used as indicator of feasibility.
Results: Local demand for intravenous fluids is 694,820. The
combined annual consumption of Libya, Morocco, Algeria, Tunisia
and Sicily is estimated to be 145,004,800 units. The cost for
setting up a facility in Malta producing 2,500,000 units annually
is €2,172,000. The project would generate employment for 17
workers. The break-even point is when 787,000 units are sold.
Operating at maximum capacity results in a profit of €6,561,000
after 5 years.
Conclusion: The financial analysis shows that the domestic
demand is not enough to warrant the construction of this facility.
Production at maximum capacity would make the project feasible,
provided that surplus units are exported.
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Pharmacy Projects 2010
Master of Science (Pharmacy)
Project Descriptions
The Pharmaceutical Cost of Ageing
Monica Galea
Compliance and Medication Problems in Chronic Conditions
Maresca Pizzuto
Care Issues and Medication Review
Janis Vella
Medicine Prices in Malta and their Relation to Economic Indicators
John Vella
INR Testing: Cost Analysis between a Laboratory and a Point-of-Care System
Gordon Zammit
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Pharmacy Projects 2010
The Pharmaceutical Cost of Ageing
Monica Galea
Population ageing and healthcare expenditure are prominent topics discussed worldwide. The aim of the study
was to determine the type and cost of drug treatment provided in relation to increasing age. Four hundred and
ninety-one patients, registered with a community pharmacy as part of the Pharmacy Of Your Choice scheme,
were recruited. The average daily cost per patient was €1. Cardiovascular drugs constituted 80% of prescriptions
and 50% of the total expenditure. Findings suggest that cost increases with age and that gender and setting
influence the treatment provided (p = <0.05).
Compliance and Medication Problems in Chronic Conditions
Maresca Pizzuto
The aim of the project was to determine the level of medication compliance in patients with a chronic condition
and to determine the type and frequency of medication-related problems identified by a community pharmacist.
Out of the 75 patients interviewed, only 33 patients said they never missed a dose. The most common medicationrelated problems identified were non-compliance in 42 patients and adverse drug reactions in 41 patients.
Pharmacists, therefore, have a pivotal role in optimising compliance to pharmacotherapy.
Care Issues and Medication Review
Janis Vella
The objective of the study was to perform a review of patient medication regimens and to ensure that these
regimens are adequate and rational. Eighty patients who collected their medication through the Pharmacy Of
Your Choice Scheme form a community pharmacy were studied. Thirty-one patients experienced side-effects
and 19 patients were at risk of clinically significant drug interactions. Pharmacist-led medication reviews can
help optimise pharmacological therapy with minimal medication- related problems.
Medicine Prices in Malta and their Relation to Economic Indicators
John Vella
A sample of 435 medicines was taken from those available for sale in community pharmacies in Malta and their
retail prices analysed for the period 2002 to 2009. Two indices, one simple price composite and one volumeweighted, were constructed from the sample prices and compared to the Retail Price Index and the Rate of
Inflation. The study indices exhibited an increase equal to two-thirds that shown by the generally excepted
indicators for the cost of living.
INR Testing: Cost Analysis between a Laboratory and a Point-of-Care System
Gordon Zammit
The study estimated that 0.95% of the Maltese population receives anticoagulation therapy. All INR testing in the
public sector is performed at the Coagulation Laboratory within the Pathology Department at Mater Dei Hospital
as a centralised service. Direct cost analysis shows that the cost per INR test using a Point-of-Care system (€
4.217) is lower than that of a centralised laboratory system (€ 4.946). Point-of-Care INR testing may provide
significant improvements in patient access to the service, quality of service and treatment outcome.
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Pharmacy Projects 2010
Fourth Year Students
Project Descriptions
32
Pharmacy Projects 2010
EU GMP: Inspection of Suppliers
Rowena Marie Agius
Extensive literature review was carried out and meetings with Qualified Persons were held to identify Good Manufacturing
Practice (GMP) requirements and formulate a general pre-audit questionnaire. An open-ended questionnaire is devised to
obtain general information about the company being assessed, assess the effectiveness of the quality management system
and ensure that GMP requirements are met. The questionnaire will be validated. Requirements for active pharmaceutical
ingredients and printed packaging material will be identified to develop a questionnaire specific to these suppliers.
Waste Management in Pharmacy
Karen Attard
The waste management options in all pharmaceutical sectors in Malta are being evaluated. Questionnaires were used to
obtain information on waste management in community pharmacies and households. Unstructured face-to-face interviews
were carried out for pharmaceutical industries and hospitals. Results show that there is no official waste management
procedure for community pharmacies and households for safe disposal of pharmaceutical waste, resulting in a negative
impact on the environment. The pharmaceutical industry, being highly regulated, has adopted alternative methods of
disposal. Hospital waste management practice will be evaluated.
Methods to Improve Yield in the Production of Slow Release Oral Dosage Forms
Nicolette Bartolo
Process parameters which could affect the yield of slow release oral dosage forms were identified. Numerical data of 28
batches concerning the process parameters was gathered and statistical analysis was undertaken. The time required to
apply venlafaxine on sugar spheres depends on the velocity of the pump. The types of waste which affected the yield were
extraction and selection waste. The surface roughness of the pellets was affected by the spray pressure. The dissolution of
the pellets was statistically correlated to the surface roughness.
SOPs in Pharmacy
Jessica Briffa
A template of the general layout of a Standard Operating Procedure (SOP) was created. Four other master SOP templates
were developed for community pharmacy, clinical pharmacy in a hospital setting, industrial pharmacy and wholesalers.
Examples of common SOPs from these four areas are being collected and will be compiled in a booklet together with the
templates. This would serve as a guide for SOP writing in any area of the pharmaceutical sector.
Urinary Tract Infections in Pregnancy
Nathalie Brincat
Data from 43 patients on signs and symptoms, screening test results and antibiotics used for urinary tract infections during
pregnancy were collected. Dysuria was found to be more common in multigravida patients (p=0.009) whilst nausea and
vomiting were found to be more common when age of gestation was less than 28 weeks (p=0.032). Co-amoxiclav was the
antibiotic mostly prescribed (n=22), followed by nitrofurantoin in penicillin-hypersensitive patients (n=8).
Pain Relief after Caesarean Section
Luana Buhagiar
A prospective study to determine post-caesarean section pain predictors is being carried out. Pre-operative pressure and
electrical pain threshold/tolerance have been estimated in 65 patients. Following surgery, patients marked their pain scores
on numerical rating scales at time intervals. Results indicate that electrical pain threshold, measured by PainMatcher preoperatively can predict pain scores at 6 and 24 hours post-operatively (r=-0.26, P<0.02; r=-0.23, P<0.04; respectively), and
the dose of paracetamol consumed within 48 hours of surgery (r=-0.33, P<0.005).
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Pharmacy Projects 2010
The Content of Sulfur Dioxide in Wine
Ghislaine Calleja
Sulfur dioxide (SO2) is used in wine production due to its antimicrobial and antioxidant properties. However, since its
addition to wine is limited due to the allergic effects it may induce, it is necessary to determine free and total SO2 present
in wine, as outlined by the EEC methods of analysis. The rapid determination by iodometric titration is generally being used
rather than the reference aeration/oxidation method. A draft application is being drawn up for funding to establish the
feasibility of a new, cost-effective, rapid and accurate method for SO2 determination.
Prevalence, Characteristics and Management of Endometriosis
Lorraine Camilleri
A retrospective study is being carried out to determine the prevalence and clinical and laparoscopic characteristics of
infertile Maltese women with endometriosis. Results from the pilot study (n=24) indicate that infertility associated with
endometriosis occurs primarily in women aged between 25 and 33 years and most commonly presents with dysmenorrhoea
(n=16) and dyspareunia (n=9). Patients were divided according to primary infertility (n=17) and secondary infertility (n=6).
Treatment strategies implemented consisted of goserelin (n=9), ovulation induction (n=1), combined oral contraceptives
(n=1) or adjunctive therapy (n=4).
Setting up a Pharmacovigilance System for Medical Oxygen
Samantha Camilleri
Oxygen treatment in patients is widespread, however, oxygen may cause adverse drug reactions (ADRs). The aim of the
study is to set up a pharmacovigilance system within a medical oxygen manufacturing facility to collect and evaluate
information about suspected ADRs, allowing all parties to assume their responsibilities. This system aims to increase
awareness and ADR reporting. Presently, 17 out of 29 SOPs, including the Master SOP, have been compiled. On completion,
registration with Eudravigilance, formulation of an e-mail address and a 24-hour reporting service, training documentation
and periodic safety update reports will complete the database.
Protocols for Skin Conditions
Anna Maria Cassar
Dermatology Life Quality Index Scores (DLQI) were calculated on a sample of 10 patients attending the Dermatology Clinic
at Sir Paul Boffa Hospital. A treatment plan will be developed specifically for each patient participating in the study with
the aim of supporting the patient to improve therapeutic compliance. Pharmacist participation in the dermatology clinic
health team is assessed.
Chronopharmacology in Hypertension
Deborah Cassar
Patients are being recruited to measure 24-hour blood pressure profiles using ambulatory blood pressure monitors.
The effect of morning vs. evening dosing of valsartan and perindopril on circadian blood pressure is evaluated. Patients
suffering from hypertension and taking no medications as well as normotensive patients are being recruited as controls.
Initial results indicate that both mean systolic and diastolic blood pressure values are significantly lower when patients
administer perindopril in the evening.
Patient Safety in the Intensive Therapy Unit
Lara Chetcuti
A set of ‘Drug Infusion Guidelines’ containing brief information regarding the preparation and administration of infusions is
compiled with the aim of reducing medication errors. Drugs administered via intravenous infusion in the Intensive Therapy
Unit (ITU) have been identified. A draft copy of the guidelines is being distributed to nurses to validate content and layout.
The draft copy will be amended accordingly and a final copy will be made available in the ITU. A questionnaire will be
administered to evaluate its usefulness.
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Pharmacy Projects 2010
Pharmaceutical Statistics: Malta, Where Does It Stand?
James Cini
Local official government pharmaceutical statistics regarding pharmacists, consumption and expenditure of pharmaceuticals
and illicit substances are being collected, reviewed and compared to statistics from other EU and non-EU countries. Most
local pharmaceutical statistics were collected through the internet, printed reports and on-site visits. Preliminary results
indicate that Malta compiles similar statistics to those compiled in the UK, for example, statistics related to pharmaceutical
expenditure in hospitals, drug misuse and vaccinations in children.
Chronopharmacology in Diabetes
Michelle Antoinette Cole
Glycaemic control in relation to the type of insulin is studied considering the time of insulin administration, food administered
and exercise performed. The Medtronic MiniMed CGMS® System Gold™ was used for 72 hours on 10 patients with type 1
diabetes recruited from the Diabetes and Endocrine Clinic at Mater Dei Hospital. The mean glucose readings of both the
CGMS and blood glucose monitoring system did not differ significantly. The results have been used to adjust treatment and
improve glycaemic control of the patients.
Side-Effects of Methotrexate Treatment in Rheumatoid Arthritis
Krista Cuschieri
Methotrexate is a disease-modifying anti-rheumatic drug (DMARD) widely used in the treatment of autoimmune diseases.
The project focuses on incidence, awareness, action taken and patient compliance related to the side-effects associated
with methotrexate treatment. A questionnaire to test patients’ knowledge on their treatment regimen for methotrexate
has been formulated and validated by a group of experts.
Point-of-Care Testing: Hypercholesterolaemia
Stephanie Cutajar
The pharmacist intervention in improving the lipid profile is evaluated and the correlation between BMI and the lipid
parameters (Total Cholesterol, Triglycerides, HDL and LDL) is analysed. Fifty patients were recruited by convenience sampling
from a community pharmacy and are being tested using the Reflotron® Plus in 3 visits each with a 4-month interval. Initial
results indicate that the lipid parameters generally improved, although not significantly for all BMI categories, with LDL
increasing slightly in the overweight group.
Stability Study of Drugs in Transport
Helga Farrugia
Temperature can have an effect on the stability of active pharmaceutical ingredients during transport. Raw fluvastatin was
transported to 6 European countries with a Humistick data logger, during different seasons in the year 2008-2009. The
increase in percentage impurity was analysed using High Performance Liquid Chromatography. Paired sample t-test showed
a statistically significant increase in impurity level for winter and spring (p<0.05). The Pearson co-efficient for winter (0.762)
and spring (0.399) indicate that there is a positive relationship between temperature and percentage impurity.
Distribution of Anti-Infective Agents to the Peripheries
Lara Fiorentino
A method to analyse the distribution of gentamicin in skeletal muscle and subcutaneous tissue using Fluorescence
Polarisation Immunoassay Technology was developed. The skeletal muscle tissue extraction method was validated using
tissue spiked with gentamicin at concentrations of 0, 1, 4, 8, 10 and 25µg/g. This method was found to be linear with a
mean percentage recovery of 86.6±6.7%. The analysis was carried out on 47 patients who underwent an amputation or
debridement procedure and who were being treated with gentamicin. Preliminary results indicate a correlation between
the concentration of gentamicin in tissue and that in serum.
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Pharmacy Projects 2010
Determination of Impurities in Ethanol 96%
Katrina Gatt
As specified in the European Pharmacopoeia, the UV absorption for ethanol 96% displays a maximum of 0.40 at 240 nm,
0.30 between 250 nm and 260 nm and 0.10 between 270 nm and 340 nm. The impurity level for ethanol stocked by a local
industry was found to be above this recommended level and it is assumed that the additional impurity may originate from
the container. This study outlines the identification of the unknown impurity using GC-MS and the risk assessment of using
ethanol as a raw material in the manufacture of pharmaceutical products.
Implementation of the POYC Scheme and Interprofessional Relations
Rosanne Mahoney
The impact of the Pharmacy Of Your Choice scheme on interprofessional relations is being analysed and evaluated
quantitatively and qualitatively using questionnaires addressed to physicians (private and public) and pharmacists, and
through observational case studies at a local community pharmacy. During the observational case studies various drug
related problems (DRPs) are identified and classified according to a classification system based on the Pharmaceutical Care
Network Europe classification of DRPs. Twenty-one cases of DRPs have been collected during 81 hours of observation.
Validation of Clinical Pharmacy Services
Maria Mamo
A time and motion observation study was carried out to identify and quantify activities performed by pharmacists at
Karin Grech Hospital. A list of Standard Operating Procedures (SOPs) for clinical pharmacy services was drawn up. Master,
Training, Patient Discharge, Patient Admission and Emergency Trolley Check SOPs were developed, validated, tested
for applicability and practicality, implemented and evaluated. The Patient Medication Trolley Check SOP is currently in
the implementation stage and the Controlled Drugs SOP is undergoing validation. SOPs for Prescription Monitoring and
Profiling will be developed.
An Evaluation of the Medication Administration System at Zammit Clapp Hospital
Stefan Meli
An observation study is conducted to evaluate the medication administration system used at Zammit Clapp Hospital.
This will gauge the performance of the medication administration system by measuring the medication error rate and
frequency of different types of errors. Preliminary results indicate a medication error rate of 44%. This was calculated by
dividing the number of incorrect administrations (107) by the number of opportunities for error (245). The most common
error was the administration of solid dosage forms without adequate amount of fluids (30 out of 136 errors, 22%).
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 worldwide. Information about the history of the Federation from its initiation
in 1912 is retrieved, considering the pharmaceutical topics and achievements given most importance internationally over
the years such as setting standards for tobacco cessation, Good Pharmacy Practice and counterfeit medicines. This is
mainly being done through gathering information about the conferences, such as the programmes of each event and postconference reviews, from 1912 to date.
Investigating the Angiotensin Converting Enzyme Inhibiting Properties of Naturally-Occurring
Terpenes Using in silico Models
Sarah Jane Mifsud
An analysis of the ligand (captopril)-protein contacts as outlined in the pdb 1UZF was crucial in establishing an optimum
binding modality for the triterpenes within the angiotensin converting enzyme ligand binding pocket considered in this
study. Attention was given to the preservation of the observed contacts, specifically the hydrogen bonding contacts, in
establishing an optimum docking modality for these molecules. SCORE algorithm showed similar or superior binding
affinity of the triterpenes as compared to that of captopril.
36
Pharmacy Projects 2010
Pharmaceutical Policy and Access to Medications
Amanda Pace
Pharmaceutical policies are an inter-related network of different areas which require a specific framework for the
representation of the National Medicines Policy in Malta. The tool for this study is the Descriptive Logic Model which
depicts the WHO framework study areas where the entry of a pharmaceutical product into the Maltese market is the
case scenario. Three descriptive models were developed for 2001, 2006, and 2009. The models showed that further
study is required on pricing, reimbursement, procurement and entitlement to free medication to be able to formulate
recommendations.
Patient Management in Colorectal Cancer
Ilona Pirotta
The quality of life and side-effects following chemotherapy were assessed over 6 cycles of treatment, via interview-based
questionnaires conducted with 44 newly diagnosed colorectal cancer patients at Sir Paul Boffa Hospital between June 2009
and January 2010. Chemotherapy treatment included both adjuvant (5-flourouracil) and metastatic therapy (FOLFOX or
FOLFIRI). Occurrence of risk factors and patients’ knowledge and expectations of chemotherapy were evaluated. Data is
currently being analysed using SPSS® version 17.0. A ‘Patient’s Medicine Guide’ has been updated, validated, and is being
distributed to patients at the Oncology Department.
Maintaining a Formulary for Zammit Clapp Hospital
Stephanie Rapa
Updating and maintenance of a formulary for Zammit Clapp Hospital, which presents information on pharmaceuticals
and medical devices available, is undertaken. This is carried out using the recent list of medicinal products available from
the Government Formulary List and selecting drugs according to prescriber criteria. The frequency of updates of the
Government Formulary List was evaluated by analysing the pharmaceuticals and medical devices added and removed.
The formulary will be evaluated by 8 geriatricians.
Palliative Care in Cancer Patients
Ryan Sacco
The quality of life (QOL) and compliance to medications of 14 patients (8 males and 6 females) receiving palliative care at
the Malta Hospice Movement were assessed using the McGill QOL Questionnaire and a Compliance Questionnaire. During
home visits, an educational intervention was carried out and 2 information booklets were distributed. After 3 home visits,
pharmacist intervention was evaluated. There was an improvement in both QOL total score, from 5.1 to 6.3 (Rating score
1-10) and number of fully compliant patients, from 36% (5 patients) to 79% (11 patients).
Pharmacoeconomics and Biological Agents in Rheumatoid Arthritis
Cynthia Said
Rheumatoid arthritis is a chronic, inflammatory disease affecting approximately 1% of the population. This autoimmune
disease results in significant functional disability and morbidity, hence the socio-economic impact on the patient and society.
Patients currently on biological therapy will be interviewed using the generic questionnaire SF-36, Health Assessment
Questonnaire (HAQ) and DAS-28, to assess improvement in quality of life. Pharmacoeconomic studies of biological agents
(etanercept, rituximab and adalimumab) are being analysed and compared.
Pharmacist Intervention in Ear, Nose and Throat disorders
Rebecca Ann Said
The aim of this study is to determine the prevalence of rhinitis in Malta and to evaluate pharmacist intervention and patient
compliance to medications prescribed. A Maltese version of the Morisky 8-item scale medication adherence questionnaire
has been developed and validated according to a standard linguistic validation process. Patient records have been reviewed
to determine trends in ENT outpatient visits. One hundred patients will be interviewed using the Morisky questionnaire
and a patient information leaflet will be distributed during patient interviews.
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Pharmacy Projects 2010
Validation Instruments for Community Pharmacy: An Update
Claire Anne Scicluna
An observation study and literature review were carried out to review a locally developed quality care system ‘Validation
Instruments for Community Pharmacy’. The tools were updated to include new areas such as information technology, repeat
prescribing, disposal of unwanted medicines and signposting. An additional tool, Clinical Governance, was identified. The
updated system will be evaluated by a focus group and disseminated electronically. These instruments will quantitatively
measure the standards of professional services provided by community pharmacists and the impact of the intervention on
patient care.
Pharmacist Intervention in the Management of Parkinson’s Disease
Akram Shueb
Pharmacist intervention was carried out and evaluated in 22 patients (12 males, 10 females, mean age 73 years). The
intervention plan was carried out during the first visit followed by evaluation during the second visit after 6 to 8 weeks.
The intervention tools used included a treatment medication chart, 2 advice leaflets and a pharmacist-run discussion
with patients and their caregivers. Outcomes were measured using the PDQ-39 quality of life questionnaire, a compliance
questionnaire and an intervention evaluation sheet.
Identification of Impurities in Medical Gases
Amy Smith
In the context of a sound quality control system, samples of medical oxygen and nitrogen-low oxygen are withdrawn for
analysis at each production stage. The assay of medical oxygen and nitrogen-low oxygen quantifies the purity of the sample
and the impurities. A quality product review is being carried out using this data to highlight any trends. Data from June
to November 2009 was collected, inputted into Microsoft Excel and presented graphically. Preliminary results indicate a
variation in the level of impurity over time.
The Community Pharmacist as a Health Promoter
Gillian Spiteri
Newsletters for the community pharmacist and the setting up of health promotion events targeting patrons visiting the
community pharmacy are prepared to encourage community pharmacists to adopt the role of a health promoter. To
date, 5 newsletters have been issued in the form of a hard-copy gazette and 5 events have been held in the pharmacy.
Questionnaires for pharmacists and patrons were disseminated to evaluate these activities.
Pharmacoeconomic Analysis of Generic Drug Use
Federica Spiteri Maempel
The generic drug market in Malta will be analysed by investigating the generics available in a community pharmacy setting.
A price comparison between such drugs and their patent counterparts will be carried out using the defined daily dose.
A generic/originator price ratio will be established and compared to the Eurostat average to evaluate the local situation.
Prices of parallel importation products will be compared to those of generic and originator products to determine whether
such products result in significantly reduced prices for the consumer.
Pharmacy Journal
Janet Sultana
Peer-reviewed journals provide an important framework for the dissemination of new and existing knowledge, for the
stimulation of further research and for professional development. The aim of the project is to develop, publish and
distribute an edition of the Journal of EuroMed Pharmacy. This edition will be evaluated in terms of impact on evidencebased pharmacy practice. Articles are currently being submitted and edited simultaneously.
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Pharmacy Projects 2010
Public Perception of the Pharmacist
Francesca Tabone
Two locally developed, self-administered questionnaires were reviewed and psychometrically evaluated. One questionnaire
was distributed to 50 community pharmacies to identify to what extent community pharmacists are focusing on patientoriented services. The second questionnaire is being distributed to 500 members of the general public to assess their
perception regarding the community pharmacist and services offered in community pharmacies. Guttman Split-Half
Coefficient for the community pharmacist and general public questionnaires was 0.910 and 0.879 respectively. A discussion
paper is being drawn up presenting results from the current study and other previous studies.
39
Pharmacy Projects 2010
Third Year Students
Project Descriptions
40
Pharmacy Projects 2010
Evidence-Based Clinical Pharmacy
Anthea Abela
An extensive systematic literature review to investigate the impact of clinical pharmacy in the primary and secondary care
scenarios is currently being carried out. Studies which report the evaluation of pharmacist intervention in clinical settings
on quality of life, cost-effectiveness of medical care and management of side-effects are compiled.
Point-of-Care Testing: Faecal Occult Blood
Adrian Agius
The availability of Faecal Occult Blood (FOB) test kits locally is being carried out. A pilot study including participants from
10 pharmacies in Malta, selected by stratified random sampling, will be undertaken to evaluate cost, reliability and userfriendliness of the kits. Questionnaires will be used to assess the opinion of the participants and pharmacists on the
feasibility of carrying out the test in the primary care setting.
Care Issues in a Heart Failure Clinic
Marie Claire Aquilina
The pharmacist’s participation in identifying care issues in the Heart Failure Clinic at Mater Dei Hospital will be investigated.
Patients will be assessed by a questionnaire and will be provided with an individualised treatment chart and advice. After 6
weeks, they will be reassessed with the same questionnaire in order to validate the pharmacist’s role in improving quality
of life, safety and compliance in this setting.
Pharmacist Intervention in the Use of Diuretics in Elderly Patients
Sean Ryan Atkins
Pharmacist intervention will be evaluated by assessing 35 geriatric patients on diuretic therapy at Zammit Clapp Hospital.
The intervention tools include a treatment medication chart, an information leaflet and a pharmacist-patient discussion prior
to discharge. Outcomes will be measured before and after the intervention using the SF-36v2® quality of life questionnaire
and a knowledge assessment questionnaire on lifestyle measures.
Protocols in Dental Conditions
Daniela Attard
Treatment protocols for common dental conditions presented in community pharmacies and dental clinics namely
xerostomia, recurrent aphthous mouth ulcers and dental abscesses will be developed. A list of locally available products
for the management of the conditions will be compiled. Once validated by a group of qualified experts, the protocols will
be disseminated and evaluated to assess applicability and practicality.
The Pharmacy Practice Resource Unit
Jaclyn Azzopardi
Medical representatives are being contacted to obtain medicines and medical devices which are not currently available in
the Pharmacy Practice Resource Unit (PPRU) which is hosted within the Department of Pharmacy. Students will be asked
to evaluate the resources available in the PPRU.
Development of Diabetes Outcome Indices
Sarah Baldacchino
The reliability and robustness of previous locally developed Diabetes Outcome Indices will be studied. The indices will
be implemented at the Diabetes Clinic at Mater Dei Hospital for a 1-year period, in the monitoring of Type 2 diabetic
patients aged 25-79 years with a history of diabetes over 5 years. The indices will evaluate the outcome before and after
a pharmacist education intervention.
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Pharmacy Projects 2010
Adverse Drug Reaction Database
Stephanie Bezzina
A computerised database consisting of drugs which cause rheumatological and nervous system adverse drug reaction
(ADR) signs and symptoms will be developed using MySQL (Standard Query Language). A scale of the frequency of each
ADR will be included. A website incorporating the database will be designed using PHP (a hypertext processing language).
Human Papillomavirus Screening and Vaccination
Angie Marie Brincat
The knowledge on human papillomavirus infection and prophylaxis amongst the general population and healthcare
providers is assessed. Three questionnaires will be developed and psychometrically evaluated. The questionnaires are
addressed to young adults, pharmacists and healthcare professionals.
Management of Urinary Tract Infections in Pregnant Women by Community Pharmacists
Katya Busuttil
Evidence-based information on the management of urinary tract infections (UTIs) during pregnancy was compiled to
prepare short, user-friendly protocols for community pharmacists. A questionnaire consisting of closed-ended questions
will be developed and distributed to a sample of community pharmacists to assess pharmacist perception and experience
with the protocols in the management of UTIs during pregnancy.
Quality Improvements in Good Distribution Practice Suzanne Buttigieg
Good Distribution Practice (GDP) helps promote harmonisation within the pharmaceutical chain. GDP guidelines were
analysed. The quality system involved in the distribution of medications intended for human use is being reviewed.
Improvements which can be applied to the GDP system are being identified and evaluated. Trials of this updated system
will be carried out and evaluated.
Devices Used for Dispensing
Deborah Cachia
Compliance and cost effectiveness of various dispensing devices available internationally, was assessed. Availability of
these devices in Malta and practicality aspects of implementing these devices in different settings will be evaluated. Time
factors, economic aspects and stability of medications will be evaluated. Patient groups and settings most likely to benefit
from such devices will be identified.
A Register of Biological Agents in Rheumatology
Florinda Camilleri
A register of biological agents within the Rheumatology Unit at Mater Dei Hospital will be established. The register is based
on a comparative review of the British, Swedish and European registers and will also include a section for pharmaceutical
care issues. Patient consent forms are compiled and relevant approval from patients, Ethics Committee and consultants
obtained.
Oral Anticancer Treatment
Stephen Camilleri
A list of oral anticancer drugs available in Malta was compiled and is being updated. A questionnaire will be distibuted
to all healthcare professionals at the Oncology Unit at Boffa Hospital to identify safety practices when handling and
dispensing these medications. Guidelines to ensure patient safety will be developed. The pharmacist’s intervention in
patient education will be established.
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Pharmacy Projects 2010
Dissemination of Protocols: Gastro-Intestinal Disorders Marija Carmen Carbonaro
Previously developed treatment protocols for gastro-intestinal disorders are adapted to obtain shorter, more practical
versions. The revised protocols will be disseminated in both printed and electronic format. Pharmacists’ perception of and
compliance to the protocols in the community setting will be assessed and the potential of the protocols as a training tool
is evaluated.
An Evaluation of the Oestrogen Receptor Modulating Abilities of the Extract of Padina pavonica
Using in silico Techniques
Maria Cassar
The chemical structure of the extract from the seaweed Padina pavonica with selective oestrogen receptor modulator
(SERM)-like properties will be drawn and optimised in SYBYL, docked into the ligand binding pocket of the oestrogen
receptor using the bound coordinates of 17ß-oestradiol as obtained from Protein Data Bank deposition. Comparative
binding modality, affinity and pharmacophore studies will be performed using SCORE and Ligbuilder.
Drug Design at the Peroxisome Proliferator-Activated Receptor
Julienne Ciantar
The ADOPT trial has shown that Peroxisome Proliferator-Activated Receptor (PPAR) agonists are associated with an
increased incidence of fractures. This project investigates, through a de novo drug design approach, two different bound
conformations of the PPAR receptor, to identify a single pharmacophore that could act as a lead in the development of
more selective, safer agonists.
Nutrition in Diabetic Patients
Ramona Cini
Questionnaires will be distributed to diabetic patients, restaurant owners and pharmacists to identify their perception on
nutrition in diabetes. Previously developed special menus catered for diabetic patients will be compiled in a booklet, given
to patients and evaluated. Findings from this project are being prepared for dissemination through scientific platforms.
Storage of Medicines and Medical Devices
Daphne Coleiro
Storage conditions of medicines and medical devices are being investigated in two community pharmacies, at Mater Dei
Hospital and Zammit Clapp Hospital. Temperature and humidity readings will be recorded and compared to standard
requirements. A risk assessment will be carried out to determine drug safety at the maximum temperature and longest
time exposure.
Aeromonas hydrophila Gastroenteritis in the Maltese Population: Diagnosis, Epidemiology
and Treatment
Lisa Cuschieri
A small mass of stools is emulsified in tryptone water and a drop is plated out on Ryan’s medium. After incubation, suspect
colonies will be subcultured and a series of tests shall be performed to identify the genus and species of the bacterium.
Those cultures belonging to the Aeromonas hydrophila complex shall undergo antibiotic sensitivity tests for improved
treatment of bacterial gastroenteritis.
Good Manufacturing Practice in the Partial Manufacturing of Pharmaceuticals
Aaron Demanuele
EU, WHO and FDA Good Manufacturing Practice guidelines are compared and analysed according to their application in
partial manufacturing plants and the local scenario. Guidelines for the set up and inspection of a partial manufacturing
plant are compiled. Templates for Standard Operating Procedures for partial manufacturing plants are developed.
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Pharmacy Projects 2010
Creation of Two- and Three- Dimensional Molecular Databases Using Steroids and NSAIDs as
Case Studies
Luke Doublet
The aim of the project is to create a two- and three-dimensional structures database using steroids and NSAIDs as case
studies. A list of steroid and NSAID structures will be created using Microsoft Excel. Their interactions with receptors of
interest will be highlighted. The utility of these databases will be tested in the context of a pilot study carried out among
undergraduate pharmacy students.
Evaluation of a Novel Series of Semi-Synthetically Designed ACE Inhibiting Molecules
Deborah Louise Farrugia
A continuation of an in silico study that gave the first confirmations of the hypothesis that terpenoid extract of the
Hawthorne plant had Angiotensin Converting Enzyme (ACE) inhibitory properties. Comparative Molecular Dynamic studies
using the Captopril/Terpene:ACE complexes will further validate this hypothesis. The Protein Data Bank deposition used
in this study will be 1UZF, and Molecular Dynamics will be performed using the AMBER software suite.
Women’s Health
Daniela Fenech
The project involves a pre-post test design with 3 phases: pre-intervention, intervention and post-intervention phase.
Pre-intervention involves the distribution of self-administered questionnaires to assess knowledge on eating disorders,
preconceptual pregnancy and osteoporosis. During the intervention phase, information on the condition will be available
on www.sahhti.org. In the post-intervention phase, the questionnaires will be re-administered to the same participants.
Bar Coding in Pharmacy
Marie Colette Galea
The aim of the study is to identify and evaluate the potential applications of bar codes in a pharmaceutical setting. This
would include bar coding medications and patient medication records to facilitate the reduction of medication errors.
Intellectual Property and Pharmacy
Lara Giudice
Legislation affecting intellectual property will be assessed to determine its influence on the pharmaceutical industry. A
study about patentability and provisions by which the industry must abide, including the Bolar Provision, and consequences
which arise when these provisions are not respected will be examined. The effects of intellectual property on competition
and pricing will be investigated.
Androgen Receptor Binding Modalities and Prostate Cancer
Alexandra Grima
The X-ray Crystallographic model of the Androgen Receptor (AR) bound to testosterone was obtained from the Protein
Data Bank. Abiraterone was constructed using SYBYL, and docked into the AR ligand pocket using the bound conformation
of testosterone as a template. Comparative binding modality, binding affinity and comparative Molecular Dynamic studies
were performed in an attempt to identify opposing pharmacological effects.
Dissemination of Protocols: Common Cold
Lawrence Mayo
Previously locally developed protocols on common cold that have been validated and disseminated in booklet format to
community pharmacies will be evaluated using a questionnaire. The applicability and practicality of disseminating the
protocols in electronic format is studied.
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Pharmacy Projects 2010
Blood Pressure Control in Maltese Dialysis Patients
Anne Marie Mercieca
This prospective study will determine adequacy of long-term blood pressure control and analyse factors associated with
poor control in dialysis patients. The effects of dialysis and hypertension on the quality of life of these patients and the
degree of compliance to antihypertensive medications will be evaluated. Factors causing non-compliance and ways to
improve compliance through adequate patient education will be identified.
Newsletter for Community Pharmacy
Caroline Mercieca
A newsletter for community pharmacists is published bimonthly and distributed to community pharmacies in Malta and
Gozo. It presents contemporary topics and articles on treatment of conditions commonly encountered in the community
pharmacy, for example insomnia, smoking and obesity, with emphasis on the local scenario. Importance is also given to
critical pharmacy issues in Malta such as the accessibility to medicines.
Design of Family Ligands for the HIV-1-Protease Enzyme
Chantelle Micallef
HIV-1 proliferates with the assistance of its own aspartic protease (HIV-PR) to produce infectious components which makes
it ideal for the design of molecules with the ability to inhibit this virus. The X-Ray crystallographic deposition PDB ID
BEA388 has been selected as a template. Molecular modelling will be performed in SYBYL and design and affinity studies
will be performed using Ligbuilder and X-Score respectively.
Creation of Two- and Three-Dimensional Molecular Databases Using Drugs Acting on the CNS
and Antibiotics as Case Studies
Michael Miller
Two- and three- dimensional (2D/3D) databases using drugs acting on the central nervous system and antibiotics as case
studies will be assembled using computer software such as Symyx and VMD. Particular examples will be selected for
molecular representation, taking into consideration areas of structural importance related to receptor binding. Once
generated, their use as valid educational tools will be presented and evaluated on a student cohort.
Dissemination of Protocols: Paediatrics
Martina Muscat
Six previously locally developed protocols for the treatment of paediatric ailments were reviewed and modified. A protocol
handbook is currently being compiled and an electronic version of the protocols will be developed. These will be evaluated
by a focus group and disseminated to community pharmacies to assess their applicability and practicality. Their potential
use as training tools for students will also be evaluated.
Good Laboratory Practice
Corinne Muscat Terribile
A quality system based on Good Laboratory Practice guidelines for the laboratories at the Pharmacy Department is being
set up. An evaluation questionnaire has been developed to evaluate the current quality system. Validation of draft Standard
Operating Procedures (SOPs) for the laboratory equipment will be undertaken and new SOPs will be developed.
Pharmaceutical Services in Lifestyle Modifications
Vanessa Petroni
Health care professionals and experts in the areas of weight control, sexual health and drug and alcohol abuse will be
interviewed. Five individuals suffering from anorexia, bulimia, obesity, alcoholism and drug abuse will be interviewed.
Questionnaires will be distributed to individuals in various age groups. Results from these questionnaires will be used to
develop information leaflets for each age group. Other methods to disseminate information will be evaluated.
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Pharmacy Projects 2010
Compendium of Medicines Used in Veterinary Practice
Bernard Soler
An electronic compendium database for veterinary medicines used in Malta is assembled. The compendium will be made
available both in electronic and book format. The data provided includes generic, trade name(s), indications, dosage form(s),
dosage regimen(s), side-effects, mode of action, and local supplier. The publication will be evaluated by veterinarians and
pharmacists by means of an interview and a questionnaire.
Herbal Medicine Formulary
Maria Spiteri
A formulary on herbal medicines available locally is evaluated. The indications and side-effects are sub-divided into
principal, major and minor where appropriate to make the formulary more user-friendly for laymen and professionals. A
list of herbal medicines available locally is compiled and 20 monographs have been reviewed and updated. A new section
containing an indication and contra-indication index is included.
Protocols in Eye Conditions
Bianca Stivala
New protocols will be designed, as a tool to set up standards for implementation by pharmacists when presented with
conjunctivitis, external segment conditions and dry eye. The protocols will aid the pharmacist in diagnosing the condition,
offering appropriate treatment and monitoring the patient according to evidence-based practice. Pharmacist compliance
to the protocols will be assessed.
Point-of-Care Testing in Gynaecological Disorders
Anne Marie Zammit
This project will be carried out to compare practicality and reliability of a point-of-care diagnostic kit to the normal laboratory
procedure, for the detection of micro-organisms causing bacterial vaginosis. Seven manufacturers have been identified to
supply the diagnostic kits. The clinical benefits for the patient, gynecologist and pharmacist and the cost effectiveness of
the kits will be evaluated.
Quality of Medical Devices
Kimberly Zammit
Fifty volunteers are recruited to compare the accuracy of medical devices used for point-of-care testing of blood glucose
and blood pressure respectively. Statistical analysis will be carried to compare the relative accuracy of the devices. A table
is created to include cost, accuracy, advantages and disadvantages of each device.
A Mini-Scale Production Facility
Ruth Zerafa
Scaling laboratory reactions up to the manufacturing level is not a simple linear process. The use of intermediate batch
scales is important to avoid errors in the manufacturing plant saving time and money. The local need for a mini-scale
production facility is established. An evaluation of the resources required to set up such a facility in Malta is carried out
and the cost-effectiveness estimated.
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Pharmacy Projects 2010
Second Year Students
Project Descriptions
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Pharmacy Projects 2010
Quality Management System for the Non-Clinical Pharmacy Services at Karin Grech Hospital
John Agius
Non-clinical Standard Operating Procedures (SOPs) will be developed to ensure the non-clinical processes at Karin Grech
Hospital (KGH) meet quality system requirements. Quality management systems, through implementation of these SOPs,
allow for continual improvement in standards of services at KGH.
Auditing of the SOPs for Clinical Pharmacy Services at Karin Grech Hospital
Jonathan Agius
Standard Operating Procedures (SOPs) for clinical pharmacy services which are being implemented at Karin Grech Hospital
will be audited. Examples of such SOPs include Patient Discharge and Patient Admission.
Pharmaceutical Care in Heart Surgery
Danika Agius Decelis
Post-operative pain is a common occurrence following open heart surgery. With reference to previous studies, pain
prevention and pain relief in such patients will be studied, with emphasis on the different medications and regimens that
can be used to avoid or ease post-operative pain.
Point-of-Care Testing: H. pylori
Daniel Attard
The implementation of a Helicobacter pylori point-of-care testing service in a primary care setting will be evaluated.
Limitations of the system in terms of reliability and practicality in the local scenario will be studied.
Pharmacovigilance
Elise Axiak
The implementation and validation of a pharmacovigilance process for a particular product with a local marketing
authorisation, for example medical oxygen will be followed-up. This is achieved through the development and validation
of Standard Operating Procedures and through the design and implementation of a training course.
An English-Maltese Dictionary for Pharmaceutical and Medical Terms
Ruth Bonnici
The English-Maltese dictionary of medical and pharmaceutical terms initiated by Camilleri in 2007 (A to E) and continued
by Spiteri in 2010 (F to I) will be continued (J to M). The translated terms will be validated with laymen, healthcare
professionals and linguists.
Creation of a Two/Three-Dimensional Molecular Database of Drugs Used to Target the
Endocrine System
Denise Borg
Efficient information retrieval is vital in bioinformatics. A two/three-dimensional drug database will be constructed to
facilitate the understanding of abstract concepts, and where relevant, highlight the interaction of the molecules with their
endogenous receptors. Its usefulness will be evaluated.
Pharmaceutical Care and the Management of Psychiatric Conditions
Ann Bugeja
An evaluation of pharmaceutical care that can be introduced at Mount Carmel Hospital shall be carried out. An understanding
of requirements for pharmacist intervention in the management of psychiatric conditions and accessibility to drug therapy
shall be drawn up.
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Pharmacy Projects 2010
Prescribing of Analgesics in Community Pharmacy
Christina Cachia
The use of non-prescription analgesics and their self-administration among young adults will be examined. Prescribing
systems of analgesics for community pharmacists will be developed and evaluated.
Creation of a Two/Three-Dimensional Molecular Database of Drugs Used in Malignant Disease
and Immunosuppression
Ryan Camilleri
The aim of this project is to merge the laws of chemistry with computational advances. Cue depth images and lighting
effects will enable three-dimensional rendering of drugs and their receptors. A searchable two/three-dimensional drug receptor database will be constructed.
Comparative Costs of Medicines: Cardiovascular System
Mark Cardona
The aim of this project is to compare the cost of cardiovascular medicines consisting of the same active ingredient or
belonging to the same class of drugs. The cost-effectiveness will be evaluated by highlighting the efficacy, safety, sideeffects and disease management.
Drug Administration Systems in Elderly Patients
Angela Cassar
The drug administration system is compared in two elderly institutions by evaluating the current performance regarding
packaging time, distribution procedures and the occurrence of medication errors. The data will be analysed and critical
areas of improvement will be identified.
Creation of a Two/Three-Dimensional Molecular Database of Drugs Used to Target the
Respiratory System
Sara Jo Cassar
An appreciation of the intricacies of torsion and conformation of complex molecules found in contemporary
therapeutic armamentaria will be done through the construction of two/three-dimensional molecular structural databases
which highlight key drug interactions with their endogenous cognate receptors. The perceived impact on their audience
will be assessed.
Access to Pharmacy Services
Simon Corrieri
Pharmacy services are easily accessible to consumers visiting their local pharmacy. The setting up of various consumer
aids, such as a consumer helpline, will be studied to determine whether there is public interest in having pharmacist
services at all times.
Formulary for Non-BNF Cited Items
Daniel Corso
Updating and assessing the use of the ‘Maltese Medicine Handbook’, last published by Cassar in 2009. This handbook
is a compilation containing medicinal products available in the local scenario that are not listed in the British National
Formulary.
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Pharmacy Projects 2010
Pharmaceutical Care and the Management of Venous Thromboembolism
Bernice Cuschieri
An investigation of the role of the pharmacist in the prophylaxis of venous thromboembolism (VTE) and the identification
of pharmaceutical care issues in the management of VTE to minimise risks and maximise the patient’s quality of life.
Metabolic Syndrome and Patient Management
Leanne Cutajar
Patients with metabolic syndrome (hyperlipidemia, hypertension and diabetes) will be monitored for at least six months
to evaluate current treatment compared to disease-specific checklists and to assess use of biological markers for the
evaluation of drug therapy.
Patient Access to Medications
Attilio Degiorgio
The access of medications to patients in Malta will be analysed through various measures, for example web systems,
media, telephone and mail. The data collected will be compared to systems in other countries. Proposals to improve access
to medication will be suggested.
Creation of a Two/Three-Dimensional Molecular Database of Drugs Used in Obstetric,
Gynaecological and Urinary Tract Disorders
Mariana Ellul
Through dedicated software, this project aims to design two/three-dimensional molecular databases that highlight both
the structural nuances of a series of drug molecules and where applicable, their relationships to the receptor whose effect
they modulate in vivo.
Preparing a Course for Pharmacist Prescribing
Andrew Fenech
A locally developed course for supplementary pharmacist prescribing will be updated and evaluated. The feasibility of
its implementation within the local scenario will be investigated. The perception of pharmacy students and pharmacists
regarding this course will be assessed.
Design of Novel HMG-CoA Reductase Inhibitors
Denise Formosa
The project targets the 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMG-CoA reductase) enzyme in the context
of an in silico drug design study. Using a known statin as a lead molecule one will attempt to elaborate a new analog series
of molecules with potential for the development into novel hypercholesterolaemic drugs.
Gastric Amylase Activity and Use of Proton Pump Inhibitors
Charlene Galea
The effect of different proton pump inhibitors on gastric amylase activity in gastric juice will be evaluated. Samples of
gastric juice will be obtained from patients undergoing gastroscopy. The results will be compared to those from previous
local studies.
Investigating the Anti-Oestrogenic Effects of Ephedrine
Kathryn Galea
Formulations containing ephedrine are used in weight loss formulations. This study investigates the potential antioestrogenic effect of ephedrine using in silico techniques. Findings will be discussed at a molecular level.
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Pharmacy Projects 2010
Pharmacist Recommended Non-Prescription Medicines
Sephora Galea
The aim of this study is to investigate the actions of the community pharmacist before recommending a non-prescription
medicine. The introduction of a prescribing role for Maltese community pharmacists will be assessed and compared to the
situation in other countries.
Chronic Renal Failure and Bone Density
Daniela Ghio
Chronic renal failure (CRF) leads to osteodystrophy, characterised by bone demineralisation. A study to evaluate and
compare bone density regression in patients suffering from CRF will be undertaken to identify prevalence of bone density
disorders, patient monitoring and management.
INR Testing and Anticoagulation Drug Therapy Monitoring
Elena Marie Mifsud
The pharmacist intervention in administering the optimum dose of anti-coagulants in patients who require a longer
prothrombin time will be evaluated. This includes INR testing and dose adjustments within a supplementary pharmacist
prescribing scenario.
Penetration of Clindamycin to the Peripheries
Martina Mifsud
A method for the analysis of clindamycin will be developed. This method will be used to determine drug concentrations in
peripheral tissue and blood in patients suffering from diabetic foot ulcers or peripheral vascular disorders.
Development of Computational Chemistry Practicals
Noel Pace
The aim of this project is to develop computational chemistry practical sessions using the modern, flexible and powerful
computers available at the Department of Pharmacy synergistic with the traditional didactic tuition to deliver a more
holistic approach to education. Their usefulness will be validated among the undergraduate pharmacy students to whom
these practicals will be addressed.
Investigating the Anti-Oestrogenic Effects of Synephrine
Christina Pace Bardon
Citrus aurantium is a major component of weight loss preparations, in which synephrine is the active ingredient. The antioestrogenic potential of synephrine will be investigated through an in silico study using molecular modelling and docking
to quantify and explain this effect.
Drug Design at the Peroxisome Proliferator-Activated Receptor
Stephanie Portelli
The peroxisome proliferator-activated receptor (PPAR) is a target for the design of drugs with hypoglycaemic effects such
as the thiazolidinediones. The aim of the study is to create an in silico tool to help predict the affinity of potential ligands
to this receptor.
Preparing Continuing Professional Development for Pharmacists
Jessica Spiteri
The changing role of the pharmacist requires application of a range of new skills into daily practice. The aim of this project
is to produce evidence-based updates to enhance pharmacists’ knowledge in specific disease states and to assess the
impact of this activity.
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Pharmacy Projects 2010
Pharmaceutical Care in Dialysis Patients
Christopher Tate
The pharmacist intervention in the management of renal failure dialysis patients will be assessed. Drug-related problems
in these patients will be identified and their clinical impact will be assessed.
Using Quality of Life Tools in English and Maltese
Caroline Vella
To assess the use of quality of life tools in the local scenario. Non-disease specific tools: SF 12 and SF 36 will be translated
to Maltese and psychometrically evaluated. Disease specific tools for specific disease states that are particularly relevant
to the local setting will be identified and translated.
Directory of Pharmacists
Marcus Zarb Cousin
The current edition of the ‘Directory of Pharmacists’ by Hili (2009) will be improved and updated. Questionnaires will be
distributed to pharmacists to obtain information on their current job and to estimate future manpower requirements for
the profession.
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