Suchergebnisse

OBJECTIVES: To determine the perceived, actual and desired knowledge of healthcare professionals regarding free medicines' entitlement, to identify strengths and weaknesses of the present entitlement system and to recommend improvements to the system to enhance patient care and sustainability. METHOD: Qualitative interviews with the Medicines Entitlement Unit (MEU) staff were carried out to identify customer care-related issues encountered. This information was used to devise a questionnaire to assess perceived, actual and desired knowledge on medicines' entitlement. The questionnaire was distributed to physicians, pharmacists and pharmacy technicians. A strengths, weaknesses, opportunities and threats analysis of the medicines' entitlement system was undertaken through qualitative interviews. KEY FINDINGS: A total of 26 strengths, 7 weaknesses, 6 opportunities and 15 threats on the present entitlement system were identified during the discussion sessions with 20 participants. Strengths included legislation, reference documentation and customer care service while the main weakness identified was the current IT system. Opportunities included an improved IT system and premises. Threats identified included manual applications, misconceptions by the public and healthcare professionals and patients' attitudes and expectations. A total of 207 physicians, pharmacists and pharmacy technicians from different professional backgrounds completed the questionnaire. The participants obtained an average score of 72.2%. The respondents obtained a significantly higher mean score (p<0.001) for questions related to Fifth (V) Schedule conditions and entitlement (81.60%), compared to the mean score for the questions related to the Government Formulary List (GFL) and related policies (63.57%). Pharmacists obtained a significantly (p=0.005) higher total mean score (75.89%) than physicians (66.21%). A positive relationship between the self-rating and actual overall knowledge was found; the mean total scores vary significantly between the overall knowledge self-rating (p<0.001). CONCLUSION: The results show that healthcare professionals have appropriate insight of the medicines' entitlement system and are very interested in improving their knowledge. Measures to increase their knowledge should be considered. The weaknesses and opportunities identified should be addressed to improve the current entitlement system both for the patients and healthcare professionals. ; peer-reviewed

Objective: To develop and implement an online bulletin intended to provide information on locally available medicinal products undergoing variation in their Summary of Product Characteristics (SmPC) and inclusions of medicinal products in the Government Formulary List (GFL) and to evaluate the usefulness of the bulletin among healthcare professionals and students. Method: Lists of locally available medicines that had undergone variations and medicinal products added to the GFL during a 6-month time frame were compiled. Additional information was obtained from regulatory authorities and local agents. A concise article was written on each drug, reviewed by a panel of experts and subsequently published in the online bulletin. Following completion of the contents and layout, the material was uploaded on the website of the Department of Pharmacy, University of Malta. A pilot study was carried out to identify shortcomings in the online bulletin design. The launch of the online bulletin started the promotional process which was mainly focused on electronic mail marketing. The data obtained from the validated questionnaire was coded and analysed using SPSS® v.20 and Microsoft® Excel Vista®. Key findings: Sixty seven per cent (n=223) of the respondents returned the questionnaire. The online bulletin was evaluated by 27 medical practitioners, 34 pharmacists, 37 medical students and 51 pharmacy students; of which 35% (n=52) were male and 65% (n=97) were female. The respondents agreed that the bulletin was up-to-date, clear and concise (91%, n=136), user-friendly (97%, n=144), useful (95%, n=142), well-designed (91%, n=136) and easy to access (87%, n=130). Ninety seven per cent (n=145) of the respondents stated that the information present in the bulletin was new to them, whilst 97% (n=144) agreed that the bulletin helped to keep them informed. Conclusion: The online bulletin provided an accessible means to deliver unbiased information about the introduction of recent medicinal products on the GFL and variations in SmPCs of products available on the local market. It was positively received by both healthcare professionals and students. ; peer-reviewed

Objectives Affordability and availability of medicinal products depend on governmental policies, healthcare budgets and pricing. Pharmaceutical price regulation can improve the accessibility and affordability of essential medicinal products. In Europe, medicinal product prices are assigned individually by each country. The study aimed to compare prices of medicinal products indicated for cardiovascular (n = 18) and respiratory disease (n = 9) available for retail in community pharmacies in five European countries. ; Methods Unit dose medicinal product prices in North Macedonia, Malta, Slovenia, Greece and the UK were compared. ; Key findings Malta had the highest unit dose prices for the majority (n = 11) of medicinal products used for cardiovascular disease and the majority (n = 8) of the medicinal products indicated for respiratory disease. ; Conclusion Variation in prices of commonly dispensed medicinal products exists. Having a more thorough knowledge about the prices of medicines in different countries can contribute to making policies that will ultimately make medicines more affordable and accessible to patients. ; peer-reviewed

A poster presentation regarding the availability of reimbursable oncology medicines in European Union member states. Introduction: Oncology medicines are among the costliest of all medicines. Most European Union (EU) member states make decisions to reimburse oncology medicines based on national lists of reimbursable medicines, called positive lists. Aims: ▫ To compare the availability of reimbursable oncology medicines between EU member states. ▫ To determine if a relationship exists between the amount of reimbursable oncology medicines and the member states' economic situation. ; N/A

A poster presentation regarding buprenorphine use compared to methadone. Introduction: Malta had an estimated 6.1 opioid users per 1000 capita in 2010, the third highest rate in Europe. Untreated opioid dependence is associated with higher mortality, increased risk of blood borne infections, and social and economic implications. Opioid misuse is also a common cause of crime and incarceration. The main opioid substitution treatment (OST) in Malta is methadone substitution therapy (MST). Other available OST include buprenorphine, buprenorphine/naloxone and naltrexone. Aims: This study established the 1) opinions and outcomes of MST and buprenorphine/naloxone substitution therapy (BST), 2) cost of treatment of MST which is found on the Maltese Government Formulary List, whereby opioid dependent individuals can obtain free opioid substitution therapy and 3) possible advantages of introducing BST on to this formulary list. ; N/A

A poster presentation regarding the perception of pharmacists and patients of the pharmacist-of-your-choice scheme in community pharmacies. Introduction: The POYC scheme was implemented as a pilot project in December 2007 with the aim being that of facilitating the patient's life. Through this system the patient is able to collect free medicines from the preferred private community pharmacy of one's choice and most importantly from the pharmacist of the patient's choice. Only those patients who are entitled to benefit from the Government's free pharmaceutical service can register with the POYC Scheme. Aims: To investigate issues in the POYC scheme including the problem of out of stock (OOS) medicines, to conduct structured interviews to patients and pharmacists regarding the issues and costs of the POYC system and to propose improvements to the POYC system according to the feedback received from the interviews. ; N/A

A poster presentation about developing GMP systems for partial manufacturing of pharmaceuticals. Introduction: Partial manufacturing refers to the repackaging and re-labelling of medicinal products. This may be required when medicinal products are imported from outside the European Union or brought into a country through parallel importation, and must be carried out within the context of a quality system. Objective: To develop a template of the quality systems utilised in partial manufacturing plants in order to facilitate the application of Good Manufacturing Practice (GMP) in such facilities. ; N/A

A poster presentation regarding the classification of herbal medicines: what is safe for the patient. Introduction: The use of herbal medicines is increasing. One of the possible reasons for the increase in use of herbal medicines may be due to the misconception that herbal medicines are 'natural' and hence safe. Aims: • To analyse how Herbal Medicinal Products (HMPs) are classified within the European Union (EU) and determine whether such a classification safeguards the interests of the patient, • To assess the level of knowledge of pharmacists and health shop employees, • To identify attitudes and perception of patients in a local community pharmacy setting towards HMPs. ; N/A

A poster presentation regarding the economics of medicine use in in vitro fertilisation. Introduction: A report published by the European Commission in 2007 revealed that the Maltese population fertility rate is steadily declining when examined over 15 years. Following the passing of the Embryo Protection Act in 2012, patients looking to undergo IVF treatment can now opt for a partially government funded service at Mater Dei Hospital (MDH). Patients are still required to buy the medication used in IVF treatment, which accounts for the majority of treatment costs. Aims: A feasibility study for state funded IVF treatment in Malta is carried out to assess the sustainability of incorporating IVF medicines in the local government formulary. ; N/A

A poster presentation regarding the simplification of procedures required for registration of medicines. Introduction: A medicine requires a Marketing Authorisation (MA) before it could be made available on the EU market (Directive 2001/83/EC). This registration process ensures the safety, quality and efficacy of medicines on the market. The requirements to obtain a MA are complex and may adversely influence accessibility to medicines. The problem of accessibility to medicines is of particular interest to small countries such as Malta. The availability of high quality medicines that are not very expensive promotes confidence in health systems, health care professionals and the pharmaceutical industry. The research question of this study was: Can registration of medicines in small EU countries such as Malta be simplified? Aims:  To review the processes by which medicines are registered in the EU, with particular interest to small countries  To analyse the strengths and weaknesses of registration processes and identify challenges in the registration process in Malta  To compile a guide intended to simplify the process for the registration of medicines in Malta and in small EU countries ; N/A

A poster presentation regarding a simplified approach for the registration of medicines in small European countries. Introduction: A medicine requires a Marketing Authorisation (MA) before it could be made available on the EU market (Directive 2001/83/EC) to ensure its safety, quality and efficacy. The requirements to obtain a MA are complex and may adversely influence accessibility to medicines. The problem of accessibility to medicines is of particular interest to small countries such as Malta. The research question of this study was: Can registration of medicines in small EU countries such as Malta be simplified? Aims: • To review the processes by which medicines are registered in the EU, with particular interest to small countries such as Malta. • To analyse the strengths and weaknesses of these registration processes and identify problems in the registration process in Malta. • To compile a guide intended to simplify the process for the registration of medicines in Malta and in small EU countries. ; N/A

A poster presentation regarding good distribution practice guidelines. Introduction: An update of the European Union (EU) Guidelines on 'Good Distribution Practice (GDP) of medicinal products for human use' (2013/C 343/01) was published by the European Commission on November 5, 2013. Drug regulation serves to promote and secure public health and well being. Non-adherence to GDP guidelines may lead to an increase in unwanted adverse effects caused by medicines being of poor quality. ; N/A

A poster presentation regarding a mini-scale oral solid dosage production facility. Introduction: The pharmaceutical industry in Malta has flourished in such a way to become an important contributor to the country's economy. Malta's legal and regulatory framework and later on its membership in the European Union (EU) have led to an increase in Malta's pharmaceutical activities. Aims: To determine the potential deliverables of a pharmaceutical mini-scale production facility in Malta; to plan and design such a facility as part of a pre-design study; and to draw up estimates of the capital investment involved in such a project. ; N/A

A poster presentation regarding the analysis of corrections following regulatory inspections. Introduction: A good quality system ensures that the medicinal product's quality is maintained throughout the whole lifecycle, safeguarding patient's well-being. The European Union (EU) lays down directives for Member States to ensure that quality levels are achieved. GMP and GDP inspections are undertaken by regulatory agencies to ensure compliance with the EU Directives. Aims: To analyse the corrections resulting from GMP/GDP regulatory inspections carried out by the regulatory authority on manufacturers and wholesalers. ; N/A