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2002 Final Year Projects
Social Pharmacy and Pharmacy Administration
Anne Marie Lanzon
TIME MANAGEMENT IN PHARMACY
Louise Azzopardi
PHARMACY IN THE CORRIDORS OF PARLIAMENT
Duncan Decelis
LAWS RELEVANT TO PHARMACY AND PHARMACY PRACTICE IN THE 21ST CENTURY
Fiona Caruana
PROTOCOLS ON ALLERGIC REACTIONS
Chris Brancaleone
PROTOCOLS FOR THE CORRECT USE OF OVER-THE-COUNTER COMMON COLD PRODUCTS
TIME MANAGEMENT IN PHARMACY
Anne Marie Lanzon
Background
Time management is about working efficiently and effectively to ensure that the desired results are achieved. The Maltese pharmacist must strive to improve time management so as to provide a cost-efficient, professional service to the community.
Objective
To obtain an overview of how the Maltese community pharmacist spends time using the Time and Motion Study technique.
Design
The community pharmacist’s work activities were classified. Different classifications were studied and the system adopted by Rutter et al was used in a pilot study and modified accordingly. The observer conducted 87 hours of observations. The data collected was analysed using SPSS.
Setting
23 Maltese community pharmacies chosen randomly.
Main outcome measures
Estimation of the time taken and relative frequency for each of the 18 categories identified. Correlating activities according to geographical region, time of day, and presence of a resident consultant.
Results
Out of a total 2,163 observed cases, the time was divided: 22% waiting and personal time, 18% stock control activities, 13% dispensing non-prescription medicines, 11% selling non-pharmaceutical items, 10% dispensing prescriptions, 6% communication, 4% sales transactions, 3% medical representatives. Counselling during dispensing of prescription medicines, clerical work, counter prescribing and education 2% each. House keeping, counselling about non-prescription medicines, and counselling about counter prescribed medicines 1% each. Consultant inquiries, managerial and testing-and-other-services (<1%). On average the pharmacist spends 2 minutes 20 seconds on each of the activities.
Conclusions
Stock control, dispensing non-prescription medicines, and selling non-pharmaceutical items are main activities undertaken by the community pharmacist. Waiting and personal was a major factor, which implies that there is more time to dedicate to professional activities.
References
Rutter PM, Hunt AJ, Darracott R, Jones IF. A subjective study of how community pharmacists in Great Britain spend their time. J. Social Administrative Pharmacy 1998; 15: 252-261.
PHARMACY IN THE CORRIDORS OF PARLIAMENT
Louise Azzopardi
Background
Parliament is considered as the highest institution in Malta. There is no record gathered of the specific references to pharmacy matters in Parliament. Such information would be helpful to both pharmacists and parliamentarians.
Objective
To collect and present in book format references to pharmacy during parliamentary proceedings.
Design
Transcripts of parliamentary sessions of debates relevant to practice of pharmacy since 1964 were identified from a computerised database held by the Office of the Speaker of the House by searching for amendments to the Medical and Kindred Professions Ordinance Chapter 31 (1901) (MKPO). Parliamentary questions and references to the pharmacy profession were identified from indexed records kept at the Parliament Library.
Setting
House of Representatives, Offices and Library, the Palace, Valletta.
Main outcome measures
Contributions to debates, parliamentary questions and amendments to laws related to pharmacy.
Results
Ten amendment bills made to the MKPO and 82 references to other laws such as the establishment of the Pharmacy Board and the control on drugs of abuse were identified. The three main topics discussed in parliamentary questions were drug abuse (612), National Health Scheme free medicines (170) and “out of stock” medicines (152).
Conclusion
Most contributions were made by pharmacists members of parliament in addition to Ministers of Health and Parliamentary Secretaries for Health during debates while parliamentary questions were asked by all strata of members. Except in the case of the establishment of the Pharmacy Board little reference was given to policy related to pharmacy whereas great interest was shown in day to day administrative detail. Perhaps if parliamentarians solve problems at policy levels then the pharmacists could deal better with individual client problems.
LAWS RELEVANT TO PHARMACY AND PHARMACY PRACTICE IN THE 21ST CENTURY
Duncan Decelis
Objective
To propose an update to the laws related to pharmacy and pharmacy practice, in Malta, making them more relevant to nowadays’ needs, and to create an awareness for the need of pharmacists to know the laws governing their profession.
Design
The laws relevant to pharmacy and pharmacy practice in Malta, were collected and confronted with foreign laws, mainly those of the USA, the UK and the EU. A questionnaire was compiled and sent to 200 community pharmacists, practising in Malta. Reports of recent court cases, relevant to the pharmacy profession, were collected and analysed to see how these affected or may in the near future affect the Maltese laws.
Main outcome measures
The awareness and knowledge of Maltese pharmacists, of the laws governing their profession, was measured. Suggestions on what, in their opinion, can or has to be changed to have a more up to date law, which satisfies and complies with the needs of the present, were collected and analysed.
Results
Out of 200 questionnaires sent, 77 (38.5%) were received back. These showed that only a 21% are very well aware of what the law says about their profession, with a 75% saying that they know it well, while the remaining 4% completely lack knowledge about it. An interesting 19% admitted to have infringed the law on one or more occasions and were sent to court. Almost all participants (99%) agreed with the need to update the current pharmacy laws and showed interest in having regular feedback about any changes, by the health authorities.
Conclusion
The findings indicate that there is a need for review of the current laws related to pharmacy and better knowledge of these laws by those who practice the profession.
PROTOCOLS ON ALLERGIC REACTIONS
Fiona Caruana
Background
Pharmacist intervention in the management of allergic reactions requires diagnosis and advice on a possible line of treatment. Establishment of protocols anticipates a therapeutic plan and enhances documentation and accountability in healthcare delivery.1
Objectives
To develop flowchart protocols on responsiveness to symptoms of nose, eye and skin allergies. To evaluate the use of the protocols as a means of assessment for pharmacists in the current diagnosis and management of the conditions considered.
Design
Three protocols, for nose, skin and eye allergy respectively were set up. The protocols were based on a flowchart system using data from current publications. Ten community pharmacies were included in the study. A pilot study was first conducted to analyse the practicality and applicability of the protocols. Subsequently the protocols were used to analyse pharmacist intervention. Ten pharmacies were visited for two hundred and fifty hours and the pharmacist intervention was documented using the protocols. Statistical analysis was carried out using Microsoft Excel 1997.
Main outcome measures
Use of protocols in practical setting, percent compliance by pharmacist with protocols.
Results
A total of 235 cases of nose, eye and skin allergies were identified. For the eye protocol, the average compliance was 52.45 % for 55 cases. Range 3-100%. Eleven cases had 100 % compliance. Sixteen cases were managed with compliance lower than 30% while twenty cases had compliance higher than 70%.
Conclusions
The protocols were found to be less time consuming to follow in practice than initially expected. Steps included in the protocols are necessary for the correct management of allergic conditions. It was noted that always the same pharmacists obtained a high percent compliance to the protocols but almost all pharmacists participating in the study obtained average percentages.
Reference
1. The American Pharmaceutical Association: Drug treatment protocols. Canada. The Institute. 1999: vii.
PROTOCOLS FOR THE CORRECT USE OF OVER-THE-COUNTER COMMON COLD PRODUCTS
Christian Brancaleone
Objectives
To identify the pharmacist intervention in common cold symptoms. To identify factors which influence the pharmacist in dispensing a particular common cold product. To propose the development of protocols for over-the-counter treatment in the common cold for the community pharmacy setting.
Design
The investigator visited the pharmacies for ten-hour visits. The intervention of the pharmacist in front of common cold symptoms was documented using a documentation sheet developed to gather information about the pharmacist’s intervention. Each case was assessed by comparing the pharmacist intervention with pre-established symptom protocols. Reference to pharmaceutical books and journals was used to develop the protocols. A questionnaire was given to 76 community pharmacists. 76 questionnaires have been collected. The 1st part identified how certain factors influence the pharmacist in the dispensing of a cough or cold product. The 2nd part identified the pharmacist’s opinion about drug information on the common cold.
Setting
Ten pharmacies situated in Valletta, Qormi, Birkirkara, Zejtun, Zurrieq, Swieqi, Paola, Mosta, Attard, Birzebbuga.
Main outcome measures
Evaluation of the pharmacist’s intervention in common cold symptoms.
Results
75 cases were observed, 20% presented with productive cough, 44% with dry cough, 16% with sore throat, 44% with nasal symptoms. In productive cough, 27% were asked about nature of their sputum. In dry cough, 64% were given the most appropriate medication. No patients presenting with sore throat were asked about any concomitant medication. Only 6% who presented with nasal symptoms were checked for perennial rhinitis or hay fever. 77% of patients who presented with a headache were given the most appropriate medication.
Conclusions
In the majority of cases, the pharmacist recommended an appropriate line of action. The pharmacist could improve the intervention towards cases of common cold in order to obtain more information on the symptom presented.
Elderly
Dorothy Cutajar
DRUGS IN THE ELDERLY
Rachel Mizzi
EVALUATING PHARMACIST INTERVENTION IN COUNSELLING PATIENTS
DISCHARGED FROM A GERIATRIC HOSPITAL
Mark Mercieca
A COMPARISON OF ANTIBIOTIC USE IN ELDERLY INSTITUTIONS
Nicholas Azzopardi
EVALUATION OF THE UNIT DOSE MEDICATION DELIVERY SYSTEM AT ZAMMIT CLAPP HOSPITAL
DRUGS IN THE ELDERLY
Dorothy Cutajar
Background
The elderly population is increasing. Due to physical restricted mobility, the older person may have problems in acquiring drugs and their relative costs.
Objective
To investigate the problems of acquisition and costs of medicines, including time costs [1], by elderly patients who were discharged from Zammit Clapp Hospital (ZCH).
Design
A survey of carers of patients who were discharged home from ZCH 6 months prior to commencement of the study (Group 1). Triangulation [2] achieved by: randomised questioning of elderly persons who were acquiring medicines at Health Centre Dispensaries (HCD) (Group 2). Questioning of all the pharmacists at those HCD (Group 3).
Main outcome measures
ZCH patients’ records. Three types of questionnaires for Group 1, Group 2, and Group 3 interviewees respectively.
Results
Carers of 54 patients were eligible for study. Mean duration of admission at ZCH of patients whose carers were interviewed (16) is 20.1 days (10-30).
The main problems encountered by both Group 1 and Group 2 (15) interviewees were the length of time they had to wait in line to procure medicines, and the unreliability of public transport. The 2 pharmacists working at Paola HCD remarked that waiting areas are not adequate.
Conclusions
Results indicate that carers consider waiting in a long line as a waste of time, especially when the older patient is left at home alone. However, for the semi-dependent older person, who has more free time, this waiting in line is seen as a means of socialization.
References
1. Shefcheck SL, Thomas J III. Consumers’ perceptions of access to medications and attitudes toward regulatory options. J Soc Admin Pharm 1998; 15: 149-163.
2. Smith F. Health services research methods in pharmacy: triangulation. Int J Pharm Pract 1999; 7: 60-68.
EVALUATING PHARMACIST INTERVENTION IN COUNSELLING PATIENTS DISCHARGED FROM A GERIATRIC HOSPITAL
Rachel Mizzi
Background
Prior to being discharged from Zammit Clapp Hospital, geriatric patients receive verbal and written information about their medication by the ward pharmacist.
Objective
To assess the pharmacist counselling system at Zammit Clapp Hospital by monitoring patient knowledge and compliance.
Design
A prospective observational study was undertaken, consisting of a total of 42 patients. The first questionnaire-based interview was performed after the pharmacist counselling session. A second interview was carried out using the same questionnaire at the patient’s residence two weeks later.
Main outcome measures
Determination of the overall number of compliers and non-compliers, comparison between knowledge for first and second interview, comparison between intentional compliance (first interview) and actual compliance (second interview).
Results
Out of a total 42 cases, 28 (67%) patients were compliant and 14 (33%) were non-compliant. Out of the 14 non-compliers, 2 (14%) patients were over-compliant, 3 (21%) patients were under-compliant, and 5 (36%) patients omitted their drugs and 4 (29%) patients were mixed non-compliers. P values for the comparison of knowledge and compliance for the first and second interviews are 0.0498 and 0.0001 respectively.
Conclusions
Results obtained demonstrate that compliance is significantly less than 100%. Furthermore, there was a significant decrease (p= 0.0001) in compliance after 2 weeks from when the patients were counselled about their medication. There was also a significant decrease (p = 0.0489) in knowledge when comparing results for the first and second interview. Therefore, the pharmacist counselling system may certainly be improved in order to enhance compliance.
References
1. Lipton HL, Bird JA: The impact of clinical pharmacists’ consultations on geriatric patients’ compliance and medical care use: a randomized controlled trial. The Gerontologist 1994; 34: 307-315
A COMPARISON OF ANTIBIOTIC USE IN ELDERLY INSTITUTIONS
Mark Mercieca
Background
The use of antibiotics in hospitals has long been a growing concern, not because antibiotics are wrong themselves but because of the way they may be misused leading to bacterial resistance. This is of particular importance in elderly hospitals1.
Objective
To compare the antibiotics used between two elderly institutions.
Design
A study on approximately 50 patients using antibiotics from each institution. The data is used to compare between Zammit Clapp Hospital and St. Vincent de Paule Residence, as well as between two wards at Zammit Clapp.
Main outcome measures
Survey formats for each patient and the antibiotic costs obtained from each hospital’s in-patient’s pharmacy.
Results
Out of 394 cases observed (161 at Zammit Clapp and 233 at St. Vincent de Paule), 41 (25.4%) at Zammit Clapp and 47 (20.2%) at St. Vincent de Paule were prescribed some form of antibiotics. At Zammit Clapp, - 17 patients were on a penicillin only; 7 were on a penicillin in combination with a cephalosporin; 9 were on quinolones only; 6 were on quinolones in combination with a penicillin; and 2 were on other antibiotics. At St. Vincent de Paule, - 16 were on a penicillin only; 5 were on a penicillin in combination with a cephalosporin; 2 were on a penicillin, a cephalosporin, and a quinolone; 12 were on a quinolone only; 6 were on a quinolone and a penicillin; and 6 were on other antibiotics
Conclusion
A significant difference exists between the amount of antibiotics used between the two institutions. Zammit Clapp being an acute hospital has a greater tendency of treating acute infections rather than St. Vincent de Paule.
References
1. Macdonald E.T., Macdonald J.B. Drug Treatment in the Elderly. Chichester: John Wiley & Sons; 1982. p.125.
EVALUATION OF THE UNIT DOSE MEDICATION DELIVERY SYSTEM AT ZAMMIT CLAPP HOSPITAL
Nicholas Azzopardi
Background
The unit dose drug distribution is a pharmacy coordinated system in which medication is presented in single dose packages and is individually dispensed for each patient.
Objective
To evaluate a modified unit dose drug distribution system developed by Manrex™, currently employed at Zammit Clapp Hospital (ZCH).
Design
Areas for improvement were identified based on packaging time studies of blister cards, observation of the drug administration procedures and the distribution of a questionnaire to all physicians, pharmacists and qualified nurses at ZCH.
Main outcome measures
Identify the goals of the medication delivery system. Measure current performance and occurrence of medication errors.
Results
The primary goals were identified as: (i) a reduction in the incidence of medication errors; (ii) more efficient use of nursing personnel; (iii) an improved drug control and monitoring. The questionnaires had a 100% response from the physicians and pharmacists and a 53% (n=32) response from the nursing staff. The majority (>75%) of the respondents from each category agrees that medication errors are rare. Only two of the proposed changes in the system had a response of >50% from each category; (i) Computerise all pharmacy and nursing records and activities (ii) Printing on labels of expiration dates. The packaging time study revealed that an average of 1.3 minutes is needed to pack one 12-day supply blister card. The cost effectiveness, in terms of packaging time, through the use of larger blister packs, could be considered.
Conclusion
The study has shown that the Manrex™ system as employed at ZCH is meeting its goals and performs to the required standards.
Diabetes
Sharon O’Dea
GLYCOSYLATED HAEMOGLOBIN TESTING
Diane Spiteri
COST-BENEFIT STUDY OF GLUCOSE-MEASURING KITS
Liana Vella Zarb
THE NUTRITIONAL ASPECT OF MANAGING DIABETES IN MALTA
GLYCOSYLATED HAEMOGLOBIN TESTING
Sharon O’Dea
Background
Since diabetes is associated with a high percentage of morbidity and mortality, its early diagnosis is essential.
Objective
To evaluate whether glycosylated haemoglobin testing could replace the oral glucose tolerance test in the diagnosis of diabetes mellitus in Malta1.
Design
Patients attending the Diabetes Clinic to have their glucose tolerance tested were included in this study. They had their fasting and/ or random blood glucose levels tested. They were diagnosed by a diabetologist based on these values or, where necessary, their OGTT results. A blood sample was withdrawn from the patients to test their glycosylated haemoglobin value. A questionnaire was used to interview patients for family history of diabetes as well as social and clinical history. This data, as well as the results of the tests carried out, were input into Microsoft® Excel 2000. The fasting blood glucose and 2-hour OGTT plasma concentrations were compared to the HbA1c by using receiver-operating characteristic (ROC) curves. Known cases of diabetes, type 1 diabetics and women with gestational diabetes were excluded from this study.
Main outcome measures
HbA1c, fasting and 2-hour plasma glucose readings.
Results
A total of 150 men and 139 women aged between 22 and 84 participated in this study. Receiver operating characteristic (ROC) curves comparing HbA1c to fasting plasma glucose and 2-hour OGTT plasma glucose had a value of 75% and 76% respectively. Regression analysis for FPG and HbA1c and for 2-hour PG and HbA1c were both highly significant.
Conclusions
HbA1c is a moderately sensitive test, which could detect only 76% true positives, when compared to the OGTT. Thus glycosylated haemoglobin test is not sensitive enough to replace the gold standard.
References
1. Stewart M. Will glycosylated haemoglobin replace the oral glucose-tolerance test? The Lancet 1997; 341: 223-224.
COST-BENEFIT STUDY OF GLUCOSE-MEASURING KITS
Diane Spiteri
Background
The features and cost of 7 glucose meters available on the local market are being evaluated and compared.
Objective
To compare the overall cost of buying and maintaining glucose meters and their benefits.
Design
The features of kits were studied.
1. Ease of use - This consists of considering factors like: a) sample size needed; b) blood collection; c) obtaining sample from patient; d) size and practicality of meter2. 2. Accuracy - Blood samples of 75 patients were tested with the 7 kits. Comparison of results will be done between those obtained by the different kits and also with results given when the same sample was tested in the pathology department in St. Luke‘s hospital. 3. Precision - Blood samples were repeatedly tested by the same kit, for 15 times. Values obtained will be compared. 4. Special features - Features, unique to individual meters were evaluated depending on their relevance to the correct and easier measurement of glucose levels. 5. Costs - Fixed and recurrent costs of each kit were collected from the agents.
Main outcome measures
Glucose-measuring kits to obtain blood glucose readings. The test used in St. Luke‘s hospital, used as a standard for comparison. Local agents, as source of information.
Results
Esprit and Glucovit were found to be useful for professionals who keep records of patients since data is transferable to PCs. Esprit and Elite ensure an easier collection of samples since strips draw up the required blood volume. Prestige, Glucovit and Glucotrend also enable this since strips are outside the meter when blood is applied.
Conclusions
Different features make particular meters ideal for particular users irrespective of the cost.
References
2. American Diabetes Association. Consensus statement: Self-monitoring of blood glucose. Diabetes Care 1992 ; 15 (Suppl. 2) : 56-61.
THE NUTRITIONAL ASPECT OF MANAGING DIABETES IN MALTA
Liana Vella-Zarb
Background
Feeling deprived just because one has diabetes is now a thing of the past. Given the facilities, diabetics may integrate better and feel less burdened with their condition1.
Objectives
The investigation of current eating habits among diabetics, and of the availability or the possibility of providing diabetic alternatives in restaurants across Malta and Gozo.
Design
A questionnaire was compiled, validated, and subsequently used in a patient interview. Inclusion criteria for a patient to be eligible to participate in the study were:- non-insulin-dependent diabetes mellitus (NIDDM); diagnosis of diabetes at least three years ago; and attendance at the Diabetes Clinic. 150 restaurants across the Maltese Islands were then visited and a data collection sheet directed specifically to chefs was adopted.
Setting
Diabetes Clinic, St. Lukes Hospital, Guardamangia.
Main Outcome Measures
Current eating habits of diabetics; and availability of specialised food items in restaurants.
Results
78.5% of patients would prefer restaurants that offer diabetic meals over other restaurants, and 13.2% would consider dining at restaurants offering diabetic alternatives, but not excluding those that do not. None of the restaurants visited offered diabetic meals, but 83% of them were willing to introduce this service in the future. The main reasons why the remaining 17% of restaurants was not willing to offer specialised meals were lack of demand and lack of trained staff.
Conclusions
This study has shown that there is a demand for diabetic meals in Maltese restaurants. The introduction of such a service would not only help in the dietary control of diabetic patients, but it would also help them integrate better and participate more fully in social events without feeling burdened.
References
1. Drury MI. Diabetes Mellitus. Blackwell Scientific Publications; Oxford, 1986; 62-67
Information and Communication Systems
Bernardette Rossi
THE PRODUCTION AND EVALUATION OF A PHARMACY DEPARTMENT NEWSLETTER
Ruth Gauci Borda
THE JOURNAL OF EUROMED PHARMACY
Michael Debrincat
DEVELOPMENT OF A LOCAL ANTI-BACTERIAL ON-LINE FORMULARY
Ernest Formosa
THE INTERNET AND THE PHARMACY COURSE IN MALTA: A CASE STUDY ON ITS IMPACT AS A LEARNING TOOL
Alistair Mallia
PICTOGRAMS IN PHARMACY
Anna Formosa
A POST-GRADUATE COURSE FOR MEDICAL REPRESENTATIVES
THE PRODUCTION AND EVALUATION OF A PHARMACY DEPARTMENT NEWSLETTER
Bernardette Rossi
Background
The Department of Pharmacy Newsletter is a bimonthly publication produced to improve communication between members of staff and students in the Pharmacy Department.
Objective
To establish and improve dynamic communication between lecturers and students; To provide information about activities in the Department; To evaluate the impact of the newsletter on communication between staff and students.
Design
Microsoft Publisher 98 was used to produce the newsletter which consists of four A4 pages in black and white print. The newsletters issued contained a wide range of topics including: Department news, information about the Department’s publications, and historical articles. The newsletters were distributed free of charge. Before issuing the newsletters each issue was given to ten persons in order to check the newsletter in terms of readability, language and presentation. A self-administered questionnaire was developed and inserted in every newsletter. Questions were set to analyse the quality of the newsletter.
Main outcome measures
The newsletters issued were evaluated with regards to content, presentation and language.
Results
Two issues were evaluated. For the first issue 46.6% (62 students) of the pharmacy students strongly agreed while 43.5% (58 students) agreed that the newsletter is a step forward in the enhancement of the communication between students and staff. 25.0% (2 lecturers) of the lecturers strongly agreed while 75.0% (6 lecturers) agreed to this. In the second issue 66.5 % (89 students) of the pharmacy students strongly agreed while 31.1% (44 students) agreed that there was an improvement from the first issue. 55.6% (5 lecturers) of the lecturers strongly agreed while 44.4% (4 lecturers) agreed to this.
Conclusion
The Newsletter was a means of supporting the social life within the Department. Developing the newsletter as extramural means of communication is the next step so as to sustain communication between the department and society.
THE JOURNAL OF EUROMED PHARMACY
Ruth Gauci Borda
Objective
To enhance the presentation of the Euromed Journal and to persuade health care professionals and newly graduated students to contribute to the success of the journal by submitting their own research work for publication.
Design
Perusing previous issues and seeking the opinion of pharmacists and pharmacy students regarding improvements which might enhance the journal; approaching potential contributors in the medical field inviting them to consider the publishing their research work; soliciting firms previously advertising in the journal to renew their sales promotion and interviewing other firms with the scope of convincing them to include the Journal of Euromed Pharmacy in their advertising budget.
Main outcome measures
Determination of the interest which health care professionals in general and pharmacists in particular have in being provided with the Euromed Journal; establishing whether these professionals are themselves actually interested in research work and, if so, whether they are prepared to share their experiences with their colleagues by participating in the publication of the journal.
Results
Health care professionals are interested in being provided with a journal at least on a quarterly basis. Few professionals agreed that they should contribute financially to the publication of the journal and expected these issues to be financed by pharmaceutical companies. Efforts to find contributors of articles for publication were successful. Advertising in the journal did not give satisfactory results and could not finance completely the issue of the journals.
Conclusion
For a limited period the financing of the publication of the Euromed Journal has to be made good by the University. Regular and interesting issues will eventually attract the interest of pharmaceutical firms to advertise in the journal and thus contribute to the mutual interest of both the medical profession as well as of the firms themselves.
DEVELOPMENT OF A LOCAL ANTI-BACTERIAL ON-LINE FORMULARY
Michael De Brincat
Background
At present there is no updated on-line or off-line formulary of medicines that are available in Malta.
Objective
To develop and maintain an on-line formulary for antibacterial drugs available in Malta. The antibacterial class was chosen due to its widespread use.
Design
A questionnaire was developed to compile data on what pharmacists and pharmacy students preferred as regards the on-line formulary presentation. The data was analysed using the Biomedical Data Package software. A database of anti-bacterial medicines was then developed by compiling information from pharmaceutical importers. The drugs were classified according to the British National Formulary1 and for drugs not found in this formulary, the package insert of the respective medicine was used. Once the formulary was launched a second questionnaire was developed to determine the utility of the formulary.
Main outcome measures
Determination of the preferences of pharmacists and pharmacy students as regards the content and design of the formulary. Evaluation of the on-line formulary.
Results
Out of a total of 285 respondents, 60% were females and 40% were males while the mean age was 29.2 years. 235 said that they had access to the Internet and 261 thought that an on-line formulary would make drug information retrieval easier and faster. 106 had already searched for drug information using foreign on-line formularies. The majority of participants requested the following information to be included in the formulary: indications; side-effects; contra-indications; cautions; dose; formulations; price and drug interactions.
Conclusions
Pharmacists have access to the Internet and are prepared to follow information on-line.
References
1. British Medical Association and Royal Pharmaceutical Society of Great Britain. The British National Formulary. Pharmaceutical Press: London. September 2001.
THE INTERNET AND THE PHARMACY COURSE IN MALTA: A CASE STUDY ON ITS IMPACT AS A LEARNING TOOL
Ernest Formosa
Objectives
Study 1 – To assess the importance of the Internet and the Pharmacy Department Website to Pharmacy students. Study 2 – To determine the effectiveness of a Medicinal Chemistry website.
Design
Study 1 – The Pharmacy Department Website was developed after obtaining the students’ general opinion by means of a primary. The Website’s format was based on standard templates provided by the CSC Department, University of Malta. A secondary questionnaire to evaluate the importance of the Department Website and the Internet in the Pharmacy course was then distribute. Study 2 – Several Medicinal Chemistry demonstrations were developed and placed online with the facility of viewing the course material in 3D. A general questionnaire was distributed to evaluate the importance of such online learning-aids in the Pharmacy course.
Setting
Department of Pharmacy, University of Malta
Main outcome measures
Both study 1 and study 2 questionnaires were distributed to Pharmacy students. With regards to study 2, first year students were considered to have no sufficient knowledge to judge the usefulness of the Medicinal Chemistry Website.
Results
Results from the primary survey show that out of 63 students, 59 (94%) had access to the Internet and that another 94% used Pharmacy-related sites to complement their research. The results show that 51 students (81%) confirm that the Pharmacy Website is a useful source of information.
Conclusion
Internet usage among pharmacy students was found to be very high. Since most students declared that they use the internet as a source of information, this preliminary study already confirms that the internet is an important aspect of the course.
References
Kasser Barbara. Using the Internet. 4th edition. USA: Que Corporation; 1998. p. 4, 5.
PICTOGRAMS IN PHARMACY
Alistair Mallia
Objective
To produce and evaluate the understanding of new pictograms in replacement of pictograms which where not found to be understood by the Maltese community.
Design
Redesign of nine pre-tested pictograms with poor understanding in the Maltese community.1 The redesigned pictograms were tested by a questionnaire based survey of patients visiting 5 community pharmacies in Malta. The redesigned pictograms were: Pictogram 1- take medicine on empty stomach, Pictogram 2- take medicine on full stomach, Pictogram 3- take medicine before food, Pictogram 4- take medicine after food, Pictogram 5- do not take alcohol with this medicine, Pictogram 6- do not drive while taking this medicine, Pictogram 7- do not stop this medicine, Pictogram 8- do not expose yourself to sun while taking this medicine, Pictogram 9- shake well before use.
Setting
Community pharmacies situated in Birzebbugia, Bugibba, Msida, Qrendi and Zurrieq, Malta.
Main outcome measures
Establishment of pictogram-understanding by patients.
Results
70 patients who visited one of the 5 community pharmacies participated in the study. 44.3% understood the meaning of pictogram 1, 45.7% understood pictogram 2, 82.9% understood pictogram 3 while 84.3% understood pictogram 4. Pictogram 5 was interpreted correctly by 97.1% while pictogram 6 was understood by 98.6% of patients. Pictogram 7 was only understood by 4.3% of the patients. 67.1% understood pictogram 8 while pictogram 9 was correctly interpreted by 65.7% of patients.
Conclusions
The results suggest that the redesigned pictograms 3, 4, 5 and 6 are widely understood among the Maltese community. They showed an 8%, 9%, 59% and 64% increase in correct interpretation respectively, when compared to the results obtained by Paris in 1991. Pictograms 1, 2, 7, 8 and 9 need further redesign and testing.
References
1. Paris, A. Communications in Pharmacy [dissertation]. Msida (Malta): University of Malta. 1991.
A POST-GRADUATE COURSE FOR MEDICAL REPRESENTATIVES
Anna Formosa
Background
Presently, there is a concern about the level of training, and hence, the ethical and professional conduct of medical representatives, as the employment and training criteria depend on the employing company.
Objective
To see whether or not a post-graduate course for medical representatives should be implemented or not, with the effect of increasing job effectiveness.
Design
In Part 1, questionnaires were distributed to medical representatives with the purpose of acquiring knowledge of their opinion regarding the subject. In Part 2, a number of experts were consulted to have an idea of how to draft the course material.
Setting
The Association of Medical Representatives
Main outcome measures
Should the course be implemented, how, for whom, and for how long.
Results
Out of 45 questionnaires sent to medical representatives, and 13 received back, 10 were eligible for the study. 100% were pharmacists. 78% agreed that a course for medical representatives should be implemented. 80% thought it should be obligatory. Only 50% showed their interest in attending. 50% wanted a separate course for practicing medical representatives and those who wish to follow this profession as opposed to 0 % who thought this course should be open for practicing medical representatives only. The average length of each session preferred for a part-time course was 1 _ hour for a number of sessions of 2 per week, while 83% of the 70% who marked the question concerning price preferred Lm75-Lm100 range for a part-time course.
Conclusions
Further results are still required to reach a valid conclusion. 78% of medical representatives answering the questionnaire are in favour of this course. This is a positive result.
Quality of Life
Lisa Galea
ASSESSMENT OF THE QUALITY OF LIFE IN PATIENTS WITH ACNE
Clarissa Captur
QUALITY OF LIFE OF POST-MENOPAUSAL WOMEN TAKING HORMONE REPLACEMENT THERAPY
Keith Galea
ERECTILE DYSFUNCTION
ASSESSMENT OF THE QUALITY OF LIFE IN PATIENTS WITH ACNE
Lisa Galea
Background
acne is usually maximal during adolescence, thus affects aspects of this important phase of social development1.
Objective
To measure quality of life (QOL) in patients with acne.
Design
Two questionnaires were adopted through patient interview: a general questionnaire on health – Short Form-36 (SF-36)2 and a disease-specific questionnaire–Acne Disability Index (ADI)1. For each acne patient, the dermatologist was asked to grade acne severity according to the American Academy of Dermatology Consensus Conference on acne classification3. Sociodemographic parameters were collected. Patient asked to participate after informed consent.
Setting
Patients attending out-patient dermatology clinic; Sir Paul Boffa Hospital. Floriana.
Main outcome measures
Association between clinical severity against patients’ QOL; association between sociodemographic parameters and patients’ QOL; patients’ willingness to pay for drug treatment as a trade-off for improved quality of life.
Results
65 patients participated, of which 45% (n=29) were males and 55% (n=36) were females. QOL in patients with mild acne better than QOL in patients with severe acne. Only statistically significant with overall SF-36 score (p<0.01). Majority of patients were students - mean age: 19. Most patients opted to pay Lm25 for hypothetical cure; 91% preferred treatment rather than equivalent in money.
Conclusion
Factors other than severity contribute to effects of acne on QOL. Psychosocial effects of acne on QOL are influenced more by patients’ self-perception of their acne than by the objective severity of disease.
References
1. Motley RJ, Finlay AY. How much disability is caused by acne? Clin Exp Dermatol 1989;14:194-198.
2. Finlay AY. Quality of life measurement in dermatology: a practical guide. Br J Dermatol 1997;136:305-14.
3. Poochi, Shalita AR, Strauss JS. Report of the consensus Conference on acne classification. (Washington DC, March 24 and 25, 1990.) J Am Acad Dermatol 1991:24:495-500.
QUALITY OF LIFE OF POST-MENOPAUSAL WOMEN TAKING HORMONE REPLACEMENT THERAPY
Clarissa Captur
Background
The efficacy of oestrogen therapy in relieving vasomotor symptoms is well-documented. However effect variables beyond symptomatic relief and secondary benefits affecting mood have seldom been evaluated.
Objective
To establish the QoL of postmenopausal women taking hormone replacement therapy.
Design
Fifty postmenopausal women, aged between 45 to 65 years, who had never been treated, were being treated or had previously been treated with HRT, attending Gynae-Out-Patient’s Clinic, St. Luke’s Hospital, GwardaMangia, Malta, completed two self-administered QoL questionnaires, namely the SF-36® Health Survey and the Women’s Health Questionnaire (WHQ). An ANOVA test was used to statistically determine whether variations occurred between the three groups.
Main outcome measures
Percent averages of scales, summary measures, dimensions and total scores of both questionnaires were evaluated to assess aspects related to QoL during the menopause.
Results
The QoL scores obtained using the SF-36® questionnaire did not exhibit any significant difference between the three groups, for both the physical health and mental health summary measures (p>0.05). A similar lack of difference was also observed with the WHQ study (p>0.05).
Conclusions
The QoL of postmenopausal women taking oestrogen replacement therapy was not found to be superior to that of women who had never been treated or had previously been treated with HRT. A larger sample size would be required in order to detect meaningful differences in this study, where QoL is an important end-point.
References
1. Utian WH. Menopause, hormone therapy and quality of life. In: Hammond CB, Haseltine FP, Schiff I, eds. Menopause. Progress in clinical and biological research. New York: AR Liss, 1989; 320: 193-209.
2. Ware JE. Standard SF-36 Health Survey. U.K.: Medical Outcomes Trust; 1992.
3. Hunter MS. The Women’s Health Questionnaire: a measure of emotional and physical well being in mid-aged women. Psychology and Health 1992; 7: 45-54.
ERECTILE DYSFUNCTION
Keith Galea
Objective
Erectile dysfunction is a common male sexual disorder, which has far-reaching psychological and medical significance. To determine the Incidence of Erectile Dysfunction in Maltese men and to determine the most common causes of erectile dysfunction in Malta such as age, medicines such as thiazides and neuroleptics. To assess the knowledge of the Pharmacist and Doctors about Erectile Dysfunction.
Design
A questionnaire to establish the knowledge of pharmacists and doctors in Malta was drawn up. These were distributed to 200 pharmacies and 200 doctors around Malta and Gozo. From 200 questionnaires 34% were collected from the pharmacists and 22% from the doctors. A questionnaire on the incidence of Erectile Dysfunction was also drawn up. This was distributed to 300 patients taken at random from 18 up to 65 years of age. From 300 questionnaires 45% were handed in.
Setting
St. Luke’s Hospital, Private Pharmacies and Clinics.
Main outcome measures
The Excel program was used in order to convert the questionnaires into statistical data. A comparison between the results of the doctors and pharmacists was also made.
Results
The results show that 48% of doctors attended a seminar about this condition compared to none of the pharmacists.
Conclusions
The incidence of Erectile Dysfunction in Malta is comparatively less than that of United States with an estimated prevalence rate of 39% in men 40 years old.
Substance Abuse
Matthew Gatt
MEMORY DEFICITS ASSOCIATED WITH MDMA USE
Nikola Todorovic
DOPING IN SPORTS
George Lee Mifsud
FORENSIC APPROACH TO ALCOHOL ANALYSIS-BREATHALYSER TEST
Janice Cassar Giacomotto
MDMA ACTIVITY AND ANALYSIS
MEMORY DEFICITS ASSOCIATED WITH MDMA USE
Matthew Gatt
Background
Recreational use of the illicit drug “ecstasy” (3,4-methylenedioxy-methamphetamine or MDMA) has increased dramatically in recent years. This widespread popularity has given rise to a number of concerns, since animal and human research has shown that repeated doses can lead to cognitive deficits caused by serotonergic neurodegeneration.1
Objective
To determine whether cognitive memory performance in MDMA users is compromised, and if so, whether this decrement is specifically associated with their past exposure to MDMA and not other illicit drugs.
Design
Five experimental groups were tested, consisting of ecstasy and marijuana users, a marijuana control group, polydrug users who use ecstasy as a primary drug, polydrug users who have never taken ecstasy and a non-drug control group. The sample was selected using an opportunity sample. Verbal consent was obtained from the participants as requested by the Research Ethics Committee for confidentiality reasons. The participants were then asked to complete the General Information Questionnaire and the General Drug Use Questionnaire. The sample was administered the Stroop Neuropsychological Screening Test, parts of the Extended Rivermead Behavioural Memory Test and the Test of Everyday Attention. Finally, urine analysis was carried out.
Results
The Statistical Software Package for the Social Sciences (SPSS 10.0) was used for the interpretation of data. Initial pilot testing corroborates previous research findings, and indicates that MDMA use seems to have an impact on memory and attentional processes.
Conclusion
The present findings provide evidence that memory impairment correlates with the degree of MDMA exposure and not with the other illegal drugs consumed by the participants.
References
1. Bolla KI, McCann UD, Ricaurte GA. Memory impairment in abstinent MDMA (“ecstasy”) users. Neurology 1998;51(6):1532-7.
DOPING IN SPORTS
Nikola Todorovic
Background
Most campaigns of prevention from doping have been relied on the pharmacists considered as one of the main actors in this field. Complete review study of substances banned by the IOC was included, highlighting the use of new doping agents. A feasibility study of setting up a laboratory for testing athlete’s blood and urine samples is carried out in the second part of the study.
Objectives
To assess community pharmacists knowledge of banned substances in sport. This study has been conducted in order to examine their knowledge and attitudes in front of doping, to evaluate their role in the prevention campaign.
Design
Questionnaire in which 50 Serbian community pharmacists have randomly been selected and interviewed by a selected questionnaire. Also 50 Maltese community pharmacists were assessed. Review studies of banned drugs and methods and feasibility study of setting up a laboratory were carried out.
Results
The questioned pharmacists seemed to have little knowledge about doping, in particular out of the five families of prohibited substances in which they mainly mentioned anabolic steroids 80% and stimulants 39%. Only 32% of them think doping can also concern children, 37% had have to face this problem in the latest 12 months. For 65% of the questioned pharmacists, doping is a serious public health problem and 45% of them consider it as a kind of drug addiction. 82% of them do not feel themselves prepared enough.
Conclusions
The pharmacists’ involvement in doping prevention claims an action in two parts: to change their behaviours when faced with doping. They have to consider doping as any over health issue and secondly the need to be provided with prevention efficient “tools” for their sports patients. Lastly considering doping as a public health issue and not only as a marginal practice restricted to the athletic elite is really essential.
FORENSIC APPROACH TO ALCOHOL ANALYSIS-BREATHALYSER TEST
George-Lee Mifsud
Objective
To investigate the variations of the breathalyser test with gender, weight and food ingestion. Determination of the elimination rate and its relation to alcohol intake. Trends for breathalyser use in Malta.
Design
33 healthy individuals (age 18-23), who satisfied pre-determined inclusion and exclusion criteria, and who fasted from alcohol and food 24 and 2hrs respectively prior to the study participated. Two 25ml doses of spirit (40% v/v) were dispensed to each participant at 20 min interval who submitted to a breathalyser test prior to the first and second doses. After the second dose 4 breath tests were made at 20 min intervals.
Setting
Department of Pharmacy. University of Malta.
Main outcome measures
The breathalyser value was compared to variables such as age, weight, height, sex, weekly alcohol and testing time.
Results
Women achieved higher breath alcohol values than males (3.763 ug/100ml of breath higher). Body weight is indirectly proportional to breath alcohol values (eg: 50kg and 70kg give 18 and 14 ug/100ml of breath respectively). Consumption of food before ingestion of alcohol gives lower breath alcohol values. The elimination rate has an average of 0.02298g/100 ml of blood every hour. Females have higher elimination rates (0.00255 g per 100ml of/hr). Elimination rates were found to increase with weekly alcohol consumption. In Malta people caught driving under the influence of alcohol is decreasing.
Conclusions
The above factors all cause variations in intersubject breath-alcohol values which are essential in courts and scientific evaluation.
References
1. John S.O. Forensic toxicology. International Association of forensic toxicologist, London.1980, pp95
2. Olaf H. D. The Forensic Pharmacology of Drugs of Abuse. New York: Oxford University Press;2001.Chapter 6.
MDMA ACTIVITY AND ANALYSIS
Janice Cassar Giacomotto
Background
Europe has been widely affected by the abuse of amphetamine and “ecstasy”, in particular during the last decade.1
Objective
To analyse the SAR of MDMA and to estimate the purity of local ecstasy tablets.
Design
Using Personal Cache“, the 3-dimensional structure of MDMA and the energy levels of the different conformations, which the molecule may adopt, were studied. This programme will also be used to analyse the docking of the drug to its receptor.
Local ecstasy tablets are to be analysed using a GC-MS.
Main outcome measures
1. Energy levels 2. Percentage of MDMA
Results
The SMILES string for MDMA is O1C2C=C(CC(NC)C)C=CC=2OC1.
The energy of the MDMA molecule in this conformation is 113.9562 Kcal/mol. Optimisation produced a final structure with an energy level of 23.2786 Kcal/mol. The difference in the energy level between these conformations is 90.6776 K/cal/mol.
A model of the 5HT1A receptor was obtained.
Conclusion
The MDMA structure is made up of a heterocyclic ring and an organic ring, to which a basic side chain is attached. MDMA has a chiral centre at the alpha carbon, and thus it exists either as (+)-MDMA or as (-)-MDMA. The methyl group on the nitrogen atom, increases the lipid solubility of the molecule. This results in faster onset, but shorter duration of action. Also the N-CH3 bond makes the molecule too large to fit comfortably into the brain serotonin 5-HT2A receptor.2 Optimisation of the MDMA molecule generated 89 possible conformations, with a difference of 90.6776 Kcal/mol between the original and final structures. This shows that the molecule is under considerable strain.
References
1. Economic and Social Council. Youth and drugs: a global overview. Vienna: the Institute; 1999: 8.
2. Nichols D. The chemistry of MDMA. In: Holland J. Ecstasy: the complete guide. Vermont: Park Street Press; 2001: 49-50.
Blood Products
Ruth Debono
EVALUATION OF LEUKOCYTE DEPLETED PLATELETS
Ruth Theuma
A FEASIBILITY STUDY FOR THE QUALITY CONTROL TESTING OF HUMAN ALBUMIN
Stefan Psaila
QUALITY CONTROL AND QUALITY ASSURANCE OF BLOOD PRODUCTS
EVALUATION OF LEUKOCYTE DEPLETED PLATELETS
Ruth Debono
Background
The removal of contaminating leukocytes from blood components, which cause post transfusion reactions, is being widely practised in many countries and is gradually being practised in Malta.
Objective
To determine the efficiency of the leukocyte depletion system of platelet units processed by filtration.
Design
A study on platelet concentrates for clinical use was undertaken. Units of platelet concentrates either collected from single donors or pooled together from platelet rich buffy coats, were studied. White blood cell numbers in processed platelets were counted prior to, and after white blood cell reduction by filtration was carried out. Analysis was carried out within 24 hours of filtration. The concentrations of present leukocytes was quantified by flow cytometry, after washing cells from citrate and incubating with fluorescent antibody directed against CD 45; the leukocyte common antigen. Thiazole orange, a fluorescent dye was also used for cell labelling which as a property, binds to the DNA in the nucleus of cells.
Main outcome measures
Flow cytometric determination of the post filtration leukocyte count of 72 platelet concentrates and comparison to European and American standards.
Results
The data obtained showed that the residual white blood cell count of only 2 (6.25%) single donor, and 4 (10%) pooled platelets; (8.3% of total samples) exceeded 1x106 leukocytes per unit. The leukocyte count of all samples (n=72) did not exceed 5x106 leukocytes per unit (mean = 0.55x106). Filtration reduced the leukocyte count from 0.93x108 (mean pre filtration) to 5.5x105 (mean post filtration).
Conclusions
The present study indicates that 91.7% of all filtered samples had the residual white blood cell count within European Guidelines. This means that the leukocyte depletion system in Malta meets European standards since these call for 90% of all samples tested to fall within the threshold.
A FEASIBILITY STUDY FOR THE QUALITY CONTROL TESTING OF HUMAN ALBUMIN
Ruth Theuma
Background
A quality control test routinely carried out on human albumin solutions is the determination of prekallikrein activator (PKA). Albumin solutions must not exceed the EP1 limit of 35 IU PKA per mL.
Objective
To evaluate the feasibility of setting up the service of PKA testing of human albumin in Malta.
Design
The PKA concentrations of albumin solutions from different batches were calculated by comparison with a reference preparation calibrated in International Units. The PKA levels as determined locally were compared to those that were determined in a standard laboratory abroad. The trends in use of albumin in Malta were analysed and compared with other countries.
Setting
Biomedical Analysis Laboratories , University of Malta.
Main outcome measures
Determination of PKA levels of albumin solutions. Determination of annual consumptions of albumin.
Results
The PKA levels of the albumin solutions tested were below 35 IU PKA per mL. The consumption of albumin in Malta for the year 2000 was 43.32 kg, which is approximately 0.1083 g per capita.
Conclusions
Local PKA testing on human albumin solutions is quite feasible, although validation of the test and accreditation of the laboratory in Malta should be done. Performing the PKA test in Malta would be more cost-effective than paying for the test to be done abroad. Performing the PKA test would also be of major importance if human albumin had to be manufactured in Malta.
References
1. The Public Health Committee and the European Pharmacopoeia Commission: European Pharmacopoeia, 3rd ed. Council of Europe, Strasbourg 1997; 95.
QUALITY CONTROL AND QUALITY ASSURANCE OF BLOOD PRODUCTS
Stefan Psaila
Background
Health authorities when procuring blood products have the responsibility to check the safety of the product before administration to the patient. Such practice is implemented in Malta, the Albumin and Immunoglobulin G bought for the use in state hospitals is send to NISBC to be controlled for safety.
Objective
The objectives of this project are to develop a Quality Assurance and Quality Control programme for the local testing of Albumin and Immunoglobulin G, to acquire the experience needed for such testing and to assess the equipment and facility for such testing in Malta.
Design
A list of chemicals, reagents and reference solutions was compiled. The chemicals were bought through local agents while the reference solutions were bought directly from the European Pharmacopoeia Institute. All the tests listed in the respective monograph within the European Pharmacopoeia were carried out on both albumin 4% solution and Immunoglobulins 5% solution.
Main Outcome Measures
The Quality Assurance programme has been implemented according to Good Laboratory Practice regulations1. Quality Control of Albumin and Immunoglobulin G were performed according to European Pharmacopoeia.
Results
The test solutions are within the prescribed limits of the European Pharmacopoeia. The Quality Assurance programme was correctly implemented according GLP regulations.
Conclusions
Quality Control and Quality Assurance programmes need to be correctly implemented so as to ensure safety of the final products. The Quality Assurance programme implemented ensured the success of the Quality Control programme. The experience acquired during this study should be used to implement such programmes locally. The Albumin and Immunoglobulin G acquired is of the quality acquired.
Reference
1. World Health Organisation. Requirements for the collection, Processing and Quality Control of blood, Blood Components and Plasma Derivatives, WHO Technical Report series 786,Geneva: World Health Organisation, 1989
Pharmaceutical Analysis
Roberto Brincat
DETERMINING THE EFFECT OF TEMPERATURE ON THE STABILITY OF OXYTOCIN DURING TRANSPORT
Bruno Attard
EVALUATION AND VALIDATION OF QUOTED BIOAVAILABILITY VALUES
Graziella Scicluna
FEASIBILITY STUDY FOR SETTING UP A QUALITY CONTROL TESTING PROGRAMME
DETERMINING THE EFFECT OF TEMPERATURE ON THE STABILITY OF OXYTOCIN DURING TRANSPORT
Roberto Brincat
Objectives
To determine to what extent temperature fluctuations during international transport adversely effect the potency and hence the quality of oxytocin injection. The study will also determine whether the logging of time and temperatures during transport could give an indication on the expected percentage degradation.
Design
An analytical procedure was developed to allow rapid and efficient analysis of the nonapeptide hormone oxytocin using HPLC. A stability study was carried out over a period of 96 days from which an Arrhenius’ plot would be drafted. The oxytocin injectable solution was also tested for pH. Container temperatures were recorded during export from Malta to Amsterdam over the entire journey on a monthly basis.
Setting
The i-Button Loggers were attached to the last pallet of pharmaceuticals to be exported logging time and temperatures every 15 minutes and were returned to Malta via courier service. The analytical work was carried out in the QC Lab of Pharmamed Ltd. using HPLC and pH meters as well as a range of stability chambers.
Main outcome measures
Measurement of pH and percent active ingredient in all 35 Oxytocin-Ject® vials used in the stability study as well as monthly container time and temperature loggings.
Results
During the export process container temperatures were mostly above the recommended storage conditions for oxytocin injection (2-8°C). The stability study indicates that oxytocin degrades considerably at temperatures of above 30°C. pH readings did not change significantly throughout the study.
Conclusions
Provided the transportation duration is controlled, products such as oxytocin, when exported to Amsterdam, are expected to remain within the limits laid down by the pharmacopoeias.
References
Hogerzeil HV, Walker GJA, Goeje de MJ, Stability of injectable oxytocics in tropical climates. Geneva: World Health Organization, 1993; WHO/DAP/93.6: p.7-28
EVALUATION AND VALIDATION OF QUOTED BIOAVAILABILITY VALUES
Bruno Attard
Background
Bioavailability, defined as the measurement of the true rate and the total amount of drug which reaches the general circulation from an administered dosage form1, is crucial to the clinical response obtained. Analytical methods used in bioavailability and bioequivalency testing must nowadays be properly validated, as lack of validation data is grounds for refusal to approve application for marketing.
Objective
Design of an appropriate method of validation of HPLC methods of analysis used to arrive at quoted bioavailability values, and estimation of the typical cost of such a study.
Design
Parameters crucial to the repeatability of analysis by HPLC were identified, and used in the compilation of a database of HPLC methods of analysis of pharmaceutical compounds from blood. A protocol was then designed to ensure proper validation of HPLC methods of analysis. The cost of bioavailability studies for a number of pharmaceutical entities was carried out.
Main outcome measures
A standard method of validation of HPLC analytical methods, and the cost of bioavailability studies for a selected number of pharmaceutical entities.
Results
A protocol to be used in the validation of HPLC methods of analysis was designed. Costing of analysis for a number of pharmaceutical entities was carried out.
Conclusions
In the analysis of pharmaceutical compounds by HPLC validation of the analytical method is crucial. Costing of a number of bioavailability studies using HPLC for a number of pharmaceutical entities showed that a number of expenditures are inherent to all bioequivalence studies.
References:
1. DiSanto AR. Bioavailability and Bioequivalency Testing. In: Gennaro AR, editor. Remington: The Science and Practice of Pharmacy. 19th edition. Pennsylvania: Mack Publishing Company; 1995: 605.
FEASIBILITY STUDY FOR SETTING UP A QUALITY CONTROL TESTING PROGRAMME
Graziella Scicluna
Background
The Government Pharmaceutical Services (GPS) purchases pharmaceuticals for the Maltese Department of Health (MDH). To date, no facility exists locally that undertakes QC testing on imported pharmaceuticals. Thus samples are sent to laboratories abroad for the required analysis. An International Standards Laboratory has been set up in Malta and although the laboratory does not currently undertake testing of pharmaceuticals, it is equipped for such analysis.
Objective
Carrying out a feasibility study to evaluate the possibility of setting up a QC testing programme to be undertaken locally at the International Standards Laboratory.
Design
The study was initiated by review of pharmaceutical legislation1. Interviews were carried out and data gathered from GPS followed by data analysis. Four products were randomly selected. Total cost and time taken for testing each of the four products locally will be compared with that in laboratories abroad.
Main outcome measures
Indicators of extent and cost of testing, time taken for testing and trend analysis of data collected.
Results
The products currently sent abroad for testing include blood products, ‘Specials’, and products directly imported from wholesale dealers overseas. The average annual total cost for testing is Lm13,319.19. Data analysis involved determination of extent of testing contracted out by MDH during the last four years. Products selected include Anti-haemophilia FactorVIII, Immunoglobulins, Magnesium glycerophosphate tablets and Adrenaline injections.
Conclusions
If the local QC testing turns out to be feasible, its implementation would result in revenue generated locally as opposed to the current situation in which the MDH is paying laboratories abroad. It would also be possible for the laboratory to offer the service of QC testing of pharmaceuticals to foreign customers.
References
1. European Commission. Eudralex, The rules governing medicinal products in the European Union.
Pharmacotherapeutics
Clifton Curmi
CHRONOPHARMACOLOGY OF ANTIHYPERTENSIVES
Stefania Debattista
THE USE OF LOSARTAN AND CARVEDILOL IN HEART FAILURE
Katerina Nezvalova
ANTIEPILEPTIC DRUGS USED IN PAEDIATRIC PATIENTS
Katrine Briffa
LATERAL FORMULATION: THE USE OF SIDE EFFECTS
Rita Sammut
THE USE OF GENERIC ALTERNATIVES IN MALTA
CHRONOPHARMACOLOGY OF ANTIHYPERTENSIVES
Clifton Curmi
Background
Chronopharmacology studies the influence of time of administration of drugs on absorption, distribution, drug protein binding, metabolism and elimination of drugs1.
Objective
To investigate the chronopharmacological properties of antihypertensive medications adopting an established method using the ambulatory blood monitor as a tool of investigation.
Design
The TM-2421/2021 automatic ambulatory blood pressure monitoring system was used. 25 patients taking atenolol were recruited and were first required to take atenolol in the morning for five days and then cross over to evening administration for another five days. After each treatment period these patients were monitored hourly for 24 hours using the ambulatory blood pressure monitor. The control patients (not taking any medication) had their blood pressure monitored for a 24h period using the ambulatory blood pressure monitor.
Main outcome measures
Systolic and diastolic blood pressure profile
Results
The blood pressure profile was noted to be preserved with atenolol when the drug was administered in the morning and even when administered in the evening, however evening administration of atenolol produced statistically significant lower diastolic blood pressures (p<0.05) when compared to diastolic blood pressures following morning administration. Comparison of blood pressures of study patients and control patients showed that blood pressures were relatively lower for test patients compared to control patients particularly the diastolic blood pressures (p<0.05) of both morning and evening administration.
Conclusion
Atenolol administered at different times of the day exerts a different effect on blood pressure levels and profiles. Administration of atenolol in the evening might result in better control of the diastolic and systolic blood pressure.
References
1. Bjorn Lemmer . Chronopharmacology: Cellular and biochemical interactions. United States of America: Marcel Dekker Inc.; 1989.
THE USE OF LOSARTAN AND CARVEDILOL IN HEART FAILURE
Stefania Debattista
Objective
To review the frequency of hospitalizations and mortality as a result of heart failure in the past years.
To assess the use of Losartan and Carvedilol in the treatment of Heart Failure.
Setting
The patients were interviewed at their own home.
Main Outcome Measures
Frequency of hospitalizations and mortality according to age groups and gender from 1991 - 2000. Change in QOL, tolerability and the overall treatment satisfaction in patients starting on Losartan and Carvedilol.
Results
Study 1
The frequency of hospitalizations and mortality due to heart failure is continually increasing. At present, it is the most common cause of hospitalization in patients over 85 years and the 3rd commonest cause of death in patients over 85 years. It is commoner in males at young age groups and much more commoner in females with increase in age.
Study 2
12 patients which initiated treatment with Carvedilol were recruited for the study. These patients were interviewed by means of SF-36 and the LWHF before initiation of treatment (baseline). These patients will be interviewed again at 6 weeks and at 12 weeks. Change in QOL, side effects and treatment satisfaction will be determined.
Study 3
10 patients who are intolerant to ACE inhibitors and have been changed over to Losartan were recruited for the study. These patients will be interviewed by means of SF-36 and LWHF questionnaire before and after treatment.
Conclusions
Despite many advances in the treatment of heart failure, it is still a very important cause of hospitalization and mortality in this country. Heart Failure is a chronic condition thus HRQOL is a very important aspect and should thus be taken into consideration when initiating treatment.
ANTIEPILEPTIC DRUGS USED IN PAEDIATRIC PATIENTS
Katerina Nezvalova
Background
Quality of Life in children with epilepsy is an important indicator of the success of therapy of antiepileptic drugs. This can be related to individual drug therapy and it’s outcome.
Objective
Evaluating drug therapy in paediatric patients with active epilepsy and assessing their quality of life.
Design
Patient information and drug histories were gathered from 100 patients (41 male and 59 female) attending paediatrics out patients in SLH. These comprise 31.4% of all epileptic paediatric patients attending this clinic. 103 satisfied inclusion and exclusion criteria (age 5-10, with active epilepsy, not suffering from chronic renal failure and malignancies), 3 had to be excluded due to congenital malformations.
A quality of life questionnaire was filled by the child or child’s guardian.
Main outcome measures
Drug regimen used for each patient, incidence and frequency of epileptic syndromes and quality of life.
Results
81 subjects had an age of onset of epilepsy of < 2 years, 14 between 2 and 5 years and 5 of > 5 years. 10 had developmental delays, 2 had abnormal interictal EEG readings. 65 were on monotherapy and 35 were on polytherapy. All medications were taken perorally. 45 patients were taking sodium valproate, 22 carbamazepine, 12 lamotrigine, 8 clonazepam, 4 phenytoin, 1 phenobarbitone, 3 vigabatrin, 2 ethosuximide, 2 diazepam and 1 topiramate. Distribution of seizures was classified as: uncertain 47, localisation related 28, generalised 21 and undetermined 4. Most frequent seizures were major motor 61 and complex partial with secondary generalisation 39.
Conclusion
Most patients on monotherapy have a better quality of life. A QoL questionnaire could prove useful in the selection of drugs in cases of refractory epilepsy as this will reduce the incidence of side-effects.
LATERAL FORMULATION: THE USE OF SIDE EFFECTS
Katrine Briffa
Background
No drug is absolutely free of some capacity to produce undesired reactions. These undesired reactions might be harmful or harmless. They may even be desirable.1 The idea of lateral formulation has led to exploiting the drug for its side effect, rather than its main effect, as the side effect was found to be useful in different situations.
Objective
Provide an insight into side effects and drugs which have useful side effects.
Discuss selected drugs, which are now used for what was previously their side effect.
Investigate new ideas into lateral formulation.
Design
A detailed explanation on adverse drug reactions, how they occur, and their significance was given. Classes of drugs with their useful side effects in specific situations were listed and discussed. Aspirin, finasteride (as Propecia), tricyclic antidepressants and antihistamines, were the drug or drug classes selected and a detailed explanation on their development and actions was given. New ideas into lateral formulation and new ideas for development were investigated.
Main outcome measures
1. Usefulness of side effects of drugs; 2. Potential new uses for older drugs; 3. Improved patient outcomes at low cost
Results
Valuable information on adverse drug reactions, drugs with useful side effects and new developments in lateral formulation was obtained. The importance of this re-examination of drug uses and the opportunity for development was noted.
Conclusion
The use of the lateral formulation concept has shown to be an important guide for the development of new ideas for treatment of several conditions. The idea of older drugs being recycled for new uses may prove profitable.
References
1. Martin EW. Adverse Drug Reactions. In: Alexander SF, Farage DJ, Hassan Jr WE, editors. Hazards of Medication. Philadephia: J.B. Lippincott Company; 1971. P. 321-365.
THE USE OF GENERIC ALTERNATIVES IN MALTA
Rita Sammut
Objective
This study aims to put some light whether generics are equivalent to brand name products in terms of price, therapeutic effectiveness and quality control.
Design
A questionnaire based- survey for doctors, pharmacists and patients.
Results
A total of 150 questionnaires for pharmacists, 100 for doctors and 62 for customers were distributed. 66.7% of the pharmacists and doctors agreed that generic drugs offer the desired therapeutic effect as their branded counterparts. 83% of pharmacists and 66.7% of doctors believe that the use of generic names for better professional communication should be encouraged. 85% of pharmacists agreed, and 100% of doctors disagreed that the responsibility for selection of medicinal products should be left in the hands of the pharmacists. 83% of pharmacists and 90% of doctors consider generics as having a positive impact on the pharmaceutical world. The questionnaire for patients revealed that they do not know the difference between generic and original drugs. Only 24% agreed that the formulations are different whilst 15.5% said that there is no difference. 62% of customers prefer that their doctor prescribes the branded drug although they pay more. 88% agree that the patient should be given the opportunity to choose between the generic and the original.
Conclusions
What really has to improve is education of health care professionals, who are uninformed about the safety and efficacy of generic drugs. The use of generics as a substitute should be encouraged, especially in governmental hospitals, where they can get the same therapeutic effect as the original drugs, but at a cheaper price. Also the patients should be more involved in selecting a generic or a brand name drug. This will improve patient compliance. From this study it is evident that customers are becoming better informed on medicinals and so demand more from the healthcare professionals.
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