Patient reporting of adverse drug events - a narrative review

PURPOSE: The aim of this review is to examine the role and experience with direct patient adverse drug reactions reports in the spontaneous reporting systems.MATERIAL AND METHODS: A computerized literature search or relevant English publications regarding the role and characteristics of direct patient reporting from 1996 to 2012 was completed in January 2013. The latest update in the search was performed from September to October 2013.RESULTS: The results show that direct patient reports could contribute to the pharmacovigilance system qualitatively as well as quantitatively. There are a lot of factors that influence patient participation such as personal characteristics, disease perception, and previous experience. Critical issue in the process is considered to be the noise effect on the signal generation.CONCLUSION: Inclusion of patients as a source of information will help to change the perspective of pharmacovigilance. The factors that affect the decision of the patient`s report of an adverse drug reaction and possible external influences that would shape their opinion and could affect the quality of reports are not well studied

Research and analysis of data on the pharmacovigilance system framework in the European Union

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

Study of the clinical pharmacist role in preparation and application of radiopharmaceuticals

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

E-Detailing: Keyways for Successful Implementation of Digital Technologies in the Pharmaceutical Marketing

E-detailing describes the use of IT tools for promotional activities—delivering information for pharmaceutical products to customers (health professionals, medical personnel, and patients). It includes using electronic channels to interact with customers, as well as electronic support for sales reps in their everyday work. It is a strong and potential tool in the pharmaceutical marketing. This chapter describes the advantages and the challenges in the use of e-detailing

Ethical Aspects of Vulnerable Group of Patients in Clinical Trials

The current publication aims to review and analyse the ethical aspects and regulations to protect the category of vulnerable patients, as defined in the European legislation. These patients need special protection and require more detailed approach throughout the clinical trials’ life cycle

Questionnaire Survey Among Hospital Pharmacists On The Effects Of The Change In The Legislation Regulating Clinical Trials In Bulgaria

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

Ad hoc study of the role of hospital pharmacists in clinical trials in Bulgaria

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

Study of pharmacy students` attitudes for scientific researches and/or academic career in Bulgaria

PURPOSE: To determine the attitudes towards participating in research projects among students at the Faculty of Pharmacy, Medical University Sofia.MATERIAL AND METHODS: A questionnaire was devised and distributed during the final compulsory project meeting to the group of pharmacy students enrolled in the scientific project in the beginning of 2012-2013 academic year.RESULTS: Among the 16 students included in the field research experiment study, 15 responded, with an overall response rate of 93.75%. Twenty percent of the students had previously participated in some form of research activity during their master degree education. Thirty three percent of all students surveyed expressed interest in participating in future research during their study and after graduation.CONCLUSION: The pharmacy students sampled reported interest in research, with a minority of the students planning to participate in extracurricular research activities during their university education, and many hoping to be involved in research throughout their future career. However, only a small number of students were interested in pursuing research through completing a PhD program

Marketing authorization procedures with negative opinion from EMA—tendencies and novelties in 2021–2022

Every year the European Medicines Agency conducts scientific assessment of numerous applications for marketing authorization of new medicines via centralized procedure. Relatively few of them are being rejected yearly because of insufficient evidence of quality, efficacy or safety. The current study analyzes the period July 2021–June 2022 in terms of the most frequent reasons for rejection of marketing authorization applications. For the same period, we take a look at the specific procedures for granting accelerated market access laid in the European pharmaceutical regulation. Their role in treatment of unmet medical needs and threats to global health status is pointed out.

AD-HOC study of pharma companies` willingness to conduct PASS/PAES studies in Bulgaria

Introduction: According to the contemporary data very little part of the developed and clinically tested molecules reach the market. Before being authorized for human use, during the clinical trials, the medicinal product is tested in many different ways. Bulgaria is one of the most preferred countries for conducting clinical trials. According to the current regulation the post-authorization studies are divided into two types - PASS (safety studies) and PAES (studies of efficacy) - also known as phase 4 of the clinical trials, taking place in the real clinical practice with patients. Their aim is identification, quantifying and assessment of the importance of the risks, linked to the use of a medicinal product in the clinical practice.Methodology: A questionnaire composed with the aim to assess the willingness of the pharmaceutical companies in Bulgaria to conduct PASS/PAES has been carried out. Subjects of the study were pharmaceutical companies and representatives of marketing authorization holders (MAH) in Bulgaria - innovative companies, members of the Association of the research-based pharmaceutical manufacturers in Bulgaria (ARPharM) and generic companies, members of the Bulgarian generic pharmaceutical association (BgPharmA).Results: Currently in international perspective half of the questioned pharmaceutical companies and two of the generic ones conduct PASS with total number of studies varying between 1 and 20 studies per company. Only one of the innovative companies conducts PAES. Nowadays only one of the questioned innovative companies has current PASS and PAES in Bulgaria.Conclusion: The results of the conducted study show that from regulatory and logistic point of view in Bulgaria all the required conditions for conduction of PASS and PAES are present. Although this legal tool is not yet widely popularized in the activities of the regulatory authority and MAHs, the existing conditions have the potential to speed up the development of this sector of the pharmaceutical industry