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Pharmacy Projects 2010 Pharmacy Projects Abstracts Department of Pharmacy University of Malta 2010 1 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: [email protected] t: +356 21 344971 f: +356 21 324835 2 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 3 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 4 Pharmacy Projects 2010 Fifth Year Students Project Abstracts 5 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 6 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. 7 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. 8 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 9 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. 10 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. 11 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. 12 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 13 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. 14 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. 15 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 16 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. 29 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 30 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. 31 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). 33 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. 34 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. 35 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. 37 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. 38 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. 41 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. 42 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. 43 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. 44 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. 45 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. 46 Pharmacy Projects 2010 Second Year Students Project Descriptions 47 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. 48 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. 49 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. 50 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. 51 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. 52