PhD Stana Bekcic.pdf
Creators: name: Bekcic, Stana
Publisher: name: figshare
Year: 2016
Subjects: subject: 150313 Quality Management
subject: FOS: Economics and business
subject: FOS: Economics and business

description: Vaccination is considered the one of the most useful prevention interventions due to its ability that through targeted activation of the human immune , induce protection against infectious diseases. Every year the immunization saves lives of about three million children. Nevertheless, 2,5 million people worldwide die each year from diseases that can be prevented by the use of vaccines. The most common reasons for this mortality are: the financial aspect, the lack of the necessary health infrastructure and / or lack of facilities management in the supply cold chain.<br>Pharmaceutical / biotechnology industry has a unique role in the development of new receptive vaccines for the prevention and treatment of diseases, and improvment of the lives of patients. Guided by this principle, basic gudelines for vaccine manufacturers relate to the improvement of production, distribution and cost - effective implementation. Production should meet the requirements of legislation and standards of quality management which are the demands of the modern market.<br>The study analyzed legislation requirements - Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP) and market imposed management systems standards: ISO 9001, ISO 14001, OHSAS 18001 ISO 27001 and ISO 17025, which relate to the pharmaceutical company. By using a systematic approach a model of integrated management system (IMS) is developed that meets the needs and tendencies of the modern pharmaceutical business in all markets and that is adaptable to future requirements, and thus allows wider use by producers and distributors of vaccines with different levels of quality systems. The model is based on Deming feedback loop, the so called PDCA cycle. The „Sun” model, is the first model that integrates five quality management system and the requirements of good practices in the production and distribution of vaccines. Also, this is the only IMS model intended for use in the pharmaceutical company.<br>Confidence in the safety of vaccines is critical for both national immunization strategy and for global public health. To preserve the quality of vaccines is one of the biggest risks for distribution of vaccines. In order to ensure efficient and reliable supply chain of vaccines in the cold chain, a questionnaire is developed (tool) to check the contracted distributor of vaccines. The questionnaire was created by Delphi methodology, and five experts, including the researcher (SB), had competence in the process of storage and distribution of vaccines. Created questionnaire is then sent to addresses of 14 experts who have extensive experience in the production and distribution of drugs. The questionnaire responses were created based on the five-degree Likert scale. Just answers that had more than 75 % of consensus were included in the final questionnaire. In order to validate, questionnaire was distributed to the vaccine distributors in the Western Balkans. The results show that the questionnaire could help them discover weaknesses and what they can improve. Questionnaire which was developed by this research is comprehensive and easy for use to verify the ability of contracted vaccine distributors. This will significantly affect the quality and safety of all the participants in the supply chain of vaccines and will help to secure the implementation of immunization through the satisfaction of the most important requirements in the supply chain of vaccines.<br>Each new health technologies, including the new indication of a known drug - vaccine, implies an assessment in terms of clinical, economic and social outcomes. Research area of new vaccine applications is on the rise in recent decades, especially in the areas of cancer.<br>Bladder cancer (BC) is the seventh most common cancer among men worldwide. The frequency is four times lower for women. The early superficial disease stage in 75% of patients is diagnosed due to gross or microscopic blood in the urine. One of the most successful therapies in the treatment of superficial bladder cancer is intravesical administration of Bacillus Calmette - Guérin (BCG). However, this therapy is unsuccessful in 25-40 % of patients who never respond to BCG. BCG vaccine, freeze dried of the domestic manufacturer is not being used according to approvement indications („off-label” use) in the Republic of Serbia. Besides being used to prevent recurrence of superficial bladder tumors, the BCG affects the reduction of progression to tumor, both the stages and grade of the cancer, which indicates the intravesical administration of BCG in particular in cancers of higher grade.<br>In order to examine the attitudes and practice of urologists to the acceptability of new indications of BCG vaccine, freeze dried in the treatment of superficial bladder cancer, a questionnaire was created. A great deal of research was conducted using the Snowball method and delivered to clinicians in the field of urology who then sent to other clinicians. Urologists from ten clinics in northern, central - Belgrade and southern Serbia, participated in the research and all of them share opinion that domestic producer of BCG vaccine, freeze dried should be supported, which would ensure the continuity of supply of a drug for the treatment of superficial bladder cancer. Pharmacoeconomic analysis was performed using the method of costs minimization, which estimated economic outcomes of BCG vaccine, freeze dried of domestic producer in relation to the authorized drug of foreign manufacturers used for the treatment of superficial bladder carcinoma. It is with this that the tools have been developed for effective evaluation of „off-label“ use of the BCG vaccine, freeze dried in therapy for the superficial bladder cancer in the Republic of Serbia. This serves as a support in wider and further clinical studies for regulatory introduction of the new indication and therapy protocol. That would enable a cost efficient and available immunotherapy within the scope of health insurance fund of Serbia, to all the patients suffering from superficial bladder cancer. <br>