Suchergebnisse

Въведение: Употребата на специфични радиоактивни лекарствени продукти и медицински изделия за визуализиране морфологията на органи, техните функции и дисфункции, както и стадиране и лечение на заболявания е уникална възможност на нуклеарната (ядрената) медицина. В този процес важна роля има участието на клиничен фармацевт, който да следи и контролира потенциалните рискове както и да съдейства за оптималното им приложение.Цел: Целта на проучването е да се потърсят възможности за оптимизиране процесите на приготвяне и прилагане на радиофармацевтици в клиничната практика в България чрез участието на клиничен фармацевт в мултидисциплинарния екип от медицински специалисти в отделенията по Нуклеарна медицина.Материали и методология: Проучени са литературни източници по ключови думи: радиофармацевтици, клиничен фармацевт, нуклеарна медицина, добри практики, национален стандарт по нуклеарна медицина от научните бази данни: Scopus, Medline, Google Scholar, Springer, Embase и др. Извършен е анализ на действащото законодателство в Република България, което регламентира извършването на дейности с радиоактивни лекарствени продукти, радиофармацевтици, радионуклидни генератори, китове и радионуклидни прекурсори, както и регулацията на обучението на специалисти, участващи в тези дейности.Резултати и дискусии: Всички радиофармацевтични лекарствени продукти (РФЛП) крият потенциален риск от лекарствени взаимодействия (ЛВ) и нежелани лекарствени реакции (НЛР). Познавайки характеристиките на лекарствените продукти и на радиоактивните ЛП, клиничните фармацевти имат изключително важно място в терапевтичния или диагностичен процес както за избягването на посочените рискове, така и за консултиране на пациента какво поведение да има, ако нежеланите събития не могат да бъдат избегнати и/или са настъпили. Потенциални лекарствени взаимодействия с радиофармацевтични лекарствени продукти са промени в биологично разпределение на РФЛП във физиологичните компартименти, променена абсорбция, ускорено елиминиране, фармакологични, фармацевтични и/или токсикологични взаимодействия. Някои РФЛП могат да удължат или намалят натрупването им в таргетните органи и да повлияят диагностичните или терапевтични резултати.Заключение: Участието на клиничен фармацевт при приготвянето и приложението на радиоактивни лекарствени продукти, радионуклидни генератори, китове и радионуклидни прекурсори би могло да създаде реална възможност за оптимизиране на тези процеси, както и подобряване на терапевтичните и диагностични резултати за пациента в клинични условия. ; Introduction: The use of a specific type of radioactive medicinal products and medical devices is a unique opportunity of Nuclear medicine for visualization the morphology of organs, their functions and dysfunctions as well for staging and treatment of diseases. Very important role in this process has the clinical pharmacist through monitoring and control of a potential drug related risks and assistance for ensuring optimal application of this specific kind pharmaceuticals.Objective: To explore a various opportunities for optimize the preparation and application processes of radiopharmaceuticals in clinical setting in Bulgaria through the participation of a clinical pharmacist in the multidisciplinary team of healthcare specialists in the Nuclear medicine departments.Materials and methodology: The systematic review of literature data is based on key words: radiopharmaceutical, clinical pharmacist, nuclear medicine, good practices, national standard of nuclear medicine in the following bibliographic databases: Scopus, Medline, Springer, Embase, and others. The analysis is performed grounded on the current legislation of the Republic of Bulgaria, which regulates activities pertaining to radioactive pharmaceutical products, radiopharmaceutical, radionuclide generators, kits, radionuclide precursors, as well as the educational regulations for all experts participating in such activities.Results and discussions: All radiopharmaceutical medicinal products (RPMP) hide potential risk of drug interactions (DI) and adverse drug reactions (ADR). The expertise of a clinical pharmacist plays an important role in the therapeutic and diagnostic processes and is applicable to avoiding potential risks, consulting the patient regarding their behavior in the event such risks cannot be avoided or have already taken place. Potential DI with RPMP present changes in the biological distribution of the radiopharmaceuticals in the physiological compartments, changed absorption, accelerated elimination, pharmacological, pharmaceutical and/or toxic interactions. Some RPMP can extend or reduce their accumulation in the targeted organs and influence the diagnostic and therapeutical results.Conclusion: The participation of a clinical pharmacist in the preparation and application of radioactive medicinal products, radionuclide generators, kits, and radionuclide precursors as a part of the healthcare team can present a real opportunity for the optimization of such processes, as well as the improvement of the diagnostic and therapeutic outcomes of the patients in a clinical setting.

Поддържането на система за проследяване на лекарствената безопасност е задължение на всички притежатели на разрешение за употреба и на регулаторните институции на страните-членки. Европейската агенция по лекарствата (ЕМА) играе ключова роля на координатор на всички основни процеси в пост-маркетинговото наблюдение на лекарствените продукти. Чрез създаването на редица интегрирани системи и способи за вътрешна комуникация ЕМА цели обмяна на опит и сътрудничество между експертите от всички държави-членки с цел осигуряване на високо качество при оценяването на събраните данни. ; The maintenance of a pharmacovigilance system is a legal obligation of all marketing authorization holders and regulatory authorities in the member states. The European Medicines Agency (EMA) plays a key role as a coordinator of the main processes in the post-marketing surveillance of the medicinal products. With the creation of several shared systems and internal communication tools EMA aims at exchange of experience and collaboration between the experts of all member states in order to insure high quality data evaluation.

Introduction: The aim of this survey is to assess the current knowledge and experience of medical doctors in regard to off-label use and to determine whether it is legal, according to them, as the local current legislation on medicinal products does neither prohibit nor explicitly permit such use. Materials and methods: One hundred medical doctors from inpatient and outpatient medical care participated and answered 10 questions. The inclusion criteria were to have a degree in medicine and right to prescribe medications. Statistical analysis was performed using the SPSS v19.0 statistical program. Results: The results show that 8 out of 10 medical doctors have knowledge in regard to the meaning of the term "off-label". More than half (62%) stated they have prescribed off-label medicine in their medical practice. Half of the respondents (49%) experienced some kind of trouble when prescribing off-label. In regard to whether the law allows this practice, opinions were divided. To a larger extent (88%), medical doctors support the introduction of clearer rules for off-label use in Bulgaria. Conclusion: Edical doctors have significant knowledge about off-label use, but feel uncertainty in their actions when they use medicines off-label. It is necessary to consider regulating this use at a national level, following the good examples of other European Union (EU) member states, until a harmonized solution within EU is found.

Introduction: The aim of this survey is to assess the current knowledge and experience of medical doctors in regard to off-label use and to determine whether it is legal, according to them, as the local current legislation on medicinal products does neither prohibit nor explicitly permit such use. Materials and methods: One hundred medical doctors from inpatient and outpatient medical care participated and answered 10 questions. The inclusion criteria were to have a degree in medicine and right to prescribe medications. Statistical analysis was performed using the SPSS v19.0 statistical program. Results: The results show that 8 out of 10 medical doctors have knowledge in regard to the meaning of the term "off-label". More than half (62%) stated they have prescribed off-label medicine in their medical practice. Half of the respondents (49%) experienced some kind of trouble when prescribing off-label. In regard to whether the law allows this practice, opinions were divided. To a larger extent (88%), medical doctors support the introduction of clearer rules for off-label use in Bulgaria. Conclusion: Edical doctors have significant knowledge about off-label use, but feel uncertainty in their actions when they use medicines off-label. It is necessary to consider regulating this use at a national level, following the good examples of other European Union (EU) member states, until a harmonized solution within EU is found.

Участието на болничните фармацевти в провеждането на клинични изпитвания е важно, за да се осигури качество и проследимостта при съхранението, разпределянето и отчетността на изпитвания лекарствен продукт (IMP). Задължителен текст, регулиращ този процес, стана част от местното българско фармацевтично законодателство през 2015 г. През последните години много промени по отношение на тази регулация могат да бъдат наблюдавани при провеждането на клинични изпитвания. Болничните фармацевти са отговорни за управлението на изследователските лекарствени продукти, както е дефинирано според Добрата клинична практика. Те имат жизненоважна роля във връзка с клиничните изпитвания, които са да защитят участниците, медицинските специалисти и доверието, като гарантират, че проучваните лекарства са подходящи за употреба и се снабдяват, обработват, съхраняват и използват безопасно и правилно. На база на направения анализ на данните от анкетата, проведена с магистър-фармацевти, които са управители на болнични аптеки, могат да се направят следните изводи: 1. Наблюдава се увеличаване на броя на клиничните изпитвания, в екипите на които се включват магистър-фармацевти. 2. Създадени са необходимите условия от страна на лечебните заведения за съхраняване на изпитваните лекарствени продукти в болничната аптека при провеждането на клинични изпитвания. 3. Магистър-фармацевтите, управители на болнични аптеки, се чувстват уверени и добре подготвени за активно участие в провеждането на клинични изпитвания. ; The participation of hospital pharmacists in the conduction of clinical trials is important in order to have quality and traceability of storage, dispensing and accountability for the investigational medicinal product (IMP). A mandatory section regulating this process became a part of the local Bulgarian pharmaceutical legislation in 2015. During the last years, many changes in regard to this regulation can be followed in the conduct of clinical research. Hospital pharmacists have become the responsible ones for IMP management as defined in the Good Clinical Practice. They have a vital role in relation to clinical research, which is to safeguard participants, healthcare professionals and trust by ensuring investigational medicinal products are appropriate for use and are procured, handled, stored and used safely and correctly. The following conclusions can be drawn from the analysis of the data from the survey conducted with master pharmacists who are managers of hospital pharmacies: 1. There is an increase in the number of clinical trials involving master pharmacist teams. 2. The necessary conditions have been created by the medical establishments to store the tested medicinal products in the hospital pharmacy and to carry out clinical trials. 3. Master pharmacists and hospital pharmacy managers feel confident and well prepared to participate actively in clinical trials.

Introduction: The proper management of unused and expired pharmaceuticals by community pharmacies, wholesalers and pharma companies in Bulgaria is a long and hard process. Drugs should be treated as dangerous products, so only specially licensed companies for waste transportation and destruction are allowed to deal with expired medicines. In order to protect our natural resources and keep medication out of the hands of our children, animals ect. the best way of drug destruction is incineration.Materials and Methods: The aim of this study is to compare the Bulgarian regulations for destruction of expired drugs to best practices in other countries, European union and USA.Results: Before the process of destruction of drugs in Bulgaria, there has to be a set of documentation prepared and submitted to the Bulgarian Drug Agency (BDA). This set consists of several documents, certifying permission by different authorities for destruction of the listed expired drugs. A part of the requested documentation is a list of pharmaceuticals, which must include: brand name, manufacturer, dosage form, package size, batch number. Only after the order is disclosed by the Bulgarian Drug Agency, the expired medications could be submitted for destruction by incineration. In our country we have only one working incinerator in Bulgaria. It is situated in Sofia and unfortunately does not work all the time, which leads pharmaceutical companies to prefer contracting a company for transportation and destruction of expired drugs abroad.Conclusion: The problem of destruction of expired drugs is ongoing not only in Bulgaria, but also in many other countries. To avoid the risks of abuse and accidental poisoning, as well as other problems that unused, unwanted or expired pharmaceuticals pose, they shouldn't be kept in homes. If thrown away or flushed down a toilet, however, antibiotics, hormones and other drugs can get into lakes, rivers and other water supplies, where they can affect humans and animals, the researchers said. Many countries have implemented national strategies and programs for unwanted drug returns in open pharmacies and then for them to be returned back to sponsor companies. However, considering the current Regulations and situation in Bulgaria, Pharmaceutical companies are not motivated to support drug return.

PURPOSE: The aim of our research is to study the role and responsibilities of the hospital pharmacists in conducting clinical trials in Bulgaria.MATERIAL AND METHODS: A special questionnaire was developed in the Faculty of Pharmacy, MUSofia. A total number of 30 hospital pharmacies were contacted and included in the study. Three of them refused to take part in the survey. The interview was via phone and included 4 questions (3 closed and 1 open). Mainly the head hospital pharmacy manager of the participating health institutions was interviewed.RESULTS: Analysis of the results shows that current practice in Bulgaria allowed hospital pharmacists to be involved in clinical trials but this case is not prevalent. The majority of the trials, conducted in our country that includes hospital pharmacies were with narcotic investigational products, which according to the specific local legislation can only be located at the site of the hospital pharmacy in a special metal shelf box. However there are lots of trials conducted without participation of hospital pharmacist/research pharmacist.CONCLUSION: The participation of the hospital pharmacist can be extended - to help manage adverse events, monitor the effect of the drugs under the study and awareness for the drug-to-drug interactions. There are protocols where apart from the investigational product - there are non-drugs under the study, i.e. placed on the market which should be dispensed at the beginning of the trials during the washout period and again here is the place for the research pharmacist to control these non-investigational products.

Introduction: The off-label use of medicines is a common practice that covers a wide range of therapeutic areas in both, adults and children. So far, the extent of off-label use among neurology patients in Bulgaria has not been studied. The aim of this study is to provide data on the off-label use in neurology patients in Bulgaria and to contribute to planning actions by the European Commission and EMA to provide a harmonized guideline and to regulate the off-label use of medicines within the European Union. Materials and methods: The data on prescriptions of 360 neurology outpatients, treated in a 1 – year period, were recorded and provided for analyses. The Summaries of Product Characteristics, were used as reference documents for assessment of prescriptions. Results: The results from this study show that most neurology patients (63%) were exposed to off-label use. Most of the medicines prescribed off-label (90%), were used for a therapeutic indication, other than the one listed in the authorized product information. Meloxicam is found to be the most commonly prescribed off-label medicine. Other medicines, like trasadone, pentoxyfylline and fupentixol / melitracen were prescribed less frequently, but deserve special attention, as they were found to be used off-label to a very large extent, some of them in 100% of prescriptions. Half of the top 10 medications, most commonly used off-label in neurology, were found to be non-steroidal anti-inflammatory drugs. Conclusion: The results reveal a big gap between the authorized medicines and the real medical needs. Further studies based on a larger number of medical centers are needed to establish more accurate data on off-label prescribing in neurology patients on a national level.

Introduction: The off-label use of medicines is a common practice that covers a wide range of therapeutic areas in both, adults and children. So far, the extent of off-label use among neurology patients in Bulgaria has not been studied. The aim of this study is to provide data on the off-label use in neurology patients in Bulgaria and to contribute to planning actions by the European Commission and EMA to provide a harmonized guideline and to regulate the off-label use of medicines within the European Union. Materials and methods: The data on prescriptions of 360 neurology outpatients, treated in a 1 – year period, were recorded and provided for analyses. The Summaries of Product Characteristics, were used as reference documents for assessment of prescriptions. Results: The results from this study show that most neurology patients (63%) were exposed to off-label use. Most of the medicines prescribed off-label (90%), were used for a therapeutic indication, other than the one listed in the authorized product information. Meloxicam is found to be the most commonly prescribed off-label medicine. Other medicines, like trasadone, pentoxyfylline and fupentixol / melitracen were prescribed less frequently, but deserve special attention, as they were found to be used off-label to a very large extent, some of them in 100% of prescriptions. Half of the top 10 medications, most commonly used off-label in neurology, were found to be non-steroidal anti-inflammatory drugs. Conclusion: The results reveal a big gap between the authorized medicines and the real medical needs. Further studies based on a larger number of medical centers are needed to establish more accurate data on off-label prescribing in neurology patients on a national level.