“Common training framework” for postgraduate education (specialization) in hospital pharmacy

Общата рамка на обучение е новоучредено в Европейския съюз е правно средство за постигане на автоматично признаване на професионална квалификация във всички страни. Тя е създадена от най-новата ревизия на Директива на Европейския съюз за професионалните квалификации. Европейската асоциация на болничните фармацевти е една от първите организации, които се опитват да го приложат.The common training framework is a newly established in European union legal tool to achieve automatic professional qualification recognition across all countries. It has been created by the most recent revision of the European Union‘s Professional Qualifications Directive. The European association of hospital pharmacists is one of the first organizations trying to implement it

SPECIFICS OF THE PROCEDURE OF AUTHORIZATION OF THE USE OF MEDICINES FOR RARE DISEASES IN EUROPE

Introduction and Aim: Nowadays between 27 and 36 million Europeans suffer from rare diseases. Worldwide 3,5%-5,9% from the population is affected from more than 6000 different illnesses classified as “rare”. Usually there are no specific treatment and drugs, which is a problem, that our society is forced to deal with.The aim of this study is to make a review of the current legislation, whichregulates the designation and authorization for a market use of drugs used for treatment of rare diseases.Material and methods: The information for the study is collected from EMA’s web-based archiveof documents and guidelines and the European law, regarding orphan drugs.Results and discussion: The fundamental regulations are formulated in REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL , different modulations and further regulations have been adopted through the years. The market authorization of orphan drugs goesthrough different phases and is closely monitored by representatives from the Committee for Orphan Medicinal Products (COMP) and European Medicines Agency (EMA). The procedure is complex but more and more new medications, since 2000, go successfully through it.Conclusion: Despite the new-found compounds and the rise in the production of orphan drugs, there are still unmet needs of the patients suffering from rare diseases. The procedure of market authorization for such type of medicine is well-established through the Regulations adopted from the Commission through the years. New changes in them are to be made soon

Possibilities For Conducting Treatment With Unauthorized Medicinal Products In Bulgaria

The regulation of drug use has been developing rapidly over the last 50 years, with an emphasis on the safety, quality and efficacy of medicinal products through the introduction of authorization procedures for a medicinal product;It has been established that there are a number of circumstances that require exceptions to the existing requirements for the use of only authorized drugs - pediatric and geriatric patients, highly resistant diseases, patients in the terminal phase and others.Similar situations are provided for in the Law on Medicinal Products in Human Medicine (LMPHM) - groups of drugs are defined that could be used without an authorization for use under strictly defined specific conditions;One of the most frequently used options is that for the treatment of a specific patient with a medicinal product not authorized in Bulgaria, as this is done according to Art. 266a of the LMPHM

Implementation of central preparation of cytostatics in Bulgaria

Introduction: Centralized dissolution of cytostatics in a hospital pharmacy is a modern and economical way of preparing this type of medicinal product. It uses an aseptic method of operation that guarantees the quality of the solutions obtained while ensuring the safety of personnel and protecting the environment.Aim: The aim of this article is to evaluate the implementation of the change in an ordinance of the Ministry of Health of the Republic of Bulgaria for the introduction of centralized dissolution of cytostatics in hospital pharmacies of oncology and/or onco-hematology wards three years after its adoption.Methodology: A survey conducted by telephone and/or through online communication among the heads of hospital pharmacies in hospitals in Bulgaria was used. The implementation period was March-April 2019.The results were analyzed and compared with the registers of the Ministry of Health.Results: Out of 40 medical establishments with oncology and/or onco-hematology wards, 18 have centralized dissolution of cytostatics in hospital pharmacies compared to 3 before adopting the ordinance. Another few are in the process of reconstructing the pharmacies and their upcoming introduction. Nurses participate in cytostatic dissolution activities in 60 percent of hospital pharmacies in violation of the legal framework..Conclusion: The process of introducing centralized dissolution of cytostatics in hospital pharmacies in Bulgaria has begun. There are still a number of challenges for healthcare institutions, mainly related to the financial investments that need to be made. A serious problem is the lack of sufficiently qualified staff in hospital pharmacies, which often requires that nurses perform their activities

Reference Pricing And Generic Entry Of Medicinal Products From The Therapeutic Group Erythropoetins

Изследването показва, че влиянието върху стойността на продажбите при терапевтичната група на еритропоетините е подобно на други също 100% реимбурсирани лекарствени продукти. Наблюдават се различия единствено в размера на намалението на стойността, което при еритропоетините е 16,25%. По-слабото влияние на лекарствените политики в групата на биоподобните най-вероятно се дължи на забавеното навлизане на такъв тип лекарства, за които се изискват специфични изпитвания, доказващи биоеквивалентността, и най-вероятно по-малката възможност за алтернативи при прилагането на лекарствените продукти. Средното намаление на цената на лекарствените продукти от групата на еритропоетините за периода 2011-2017 е 29,4% (-50,68% ÷ +69,1%) от 40,12 лв. до 28,35 лв.The study shows that the impact on sales value of the erythropoietin therapeutic group is similar to other 100% reimbursed medicinal products. The only difference is for decrease in the value of erythropoietins are 16.25%. The weaker impact of drug policies in the biosimilar group is most likely due to the delayed penetration of this type of medication requiring specific trials demonstrating bioequivalence and, most likely, less opportunity for alternatives to drug administration. The average decrease in the price of medicinal products from the erythropoietin group for the period 2011-2017 was 29.4% (-50.68% ÷ + 69.1%) from 40,12 BGN to 28,35 BGN

Rational use of antibiotics and the importance of pharmacists’ support

There has been a growing concern related to increased antimicrobial resistance (AMR) caused by inappropriate and extensive use of antibiotics around the world. There are many factors contributing to this negative trend such as poor awareness and inadequate resources, inappropriate prescribing, uncontrolled dissemination, etc. The COVID-19 pandemic only made it worse, introducing overuse of antibiotics to prevent superinfections. And again, the pandemic is where the antimicrobial stewardship programs came to light, leading to increased focus on infection prevention rather than control with antibiotics. Pharmacists are more and more trying to control AMR. They have a significant role in coordinating their efforts with both doctors and patients in order to lower the rate of prescription checks, drugs for minor sickness, over-the-counter (OTC) issuance of drugs, overdosing, repetitive prescription usage as well as discarding antibiotics.The article concludes that the support from pharmacists for the rational use of antibiotics is essential for the achievement of better treatment

Who should consult patients about medicines according to the information provided in leaflets?

Materials and methods: Information was extracted from the patient leaflets of 2500 medicines with marketing authorization and available on the Bulgarian market, representing all anatomical groups of the ATS classification. The analysis in the present study focused on one criterion, namely which medical specialist is indicated in the leaflet in the field "consult (ask questions to) if you need with...".Results: In 63.4% of the leaflets, it is written that if more information is needed, the patient should consult a doctor or pharmacist. In 19.4% of leaflets, patients are referred for consultation with a pharmacist only. In 7.7% of leaflets, several options are listed, namely: doctor, pharmacist or nurse. Only 3.3% of the drugs studied gave a recommendation to seek information only from a doctor.Conclusion: The pharmacist was the most frequently cited healthcare professional for medication consultation, listed in 90% of patient leaflets. In this regard, he should be prepared to give advice on the correct way of taking the medicines and rational medicinal use

Role of the list of standard terms in the European Pharmacopoeia for the establishment of the different existing pharmaceutical forms

The type and content of pharmacopoeias have changed many times over the years, until in 1964 the first European Pharmacopoeia was introduced under the jurisdiction of the Council of Europe as part of the implementation of the Convention on the Development of a European Pharmacopoeia.An important section of the European Pharmacopoeia is the list of standard terms. It is drawn up by the Commission of the European Pharmacopoeia, which is part of the European Directorate for the Quality of Medicines and Healthcare (EDQM), at the request of the European Commission, to be used in applications and marketing authorizations and packaging information, in the package leaflet, in the summary of product characteristics and in electronic communications.The main purpose of the study is to make a detailed analysis of the List of Standard Terms available in Bulgarian, as well as the database of standard terms maintained by the European Directorate for the Quality of Medicines in order to make a comparison between them and to identify the most the common dosage forms in them as well as the most common routes of administration.The results of the study show that the largest number are the standard terms referring to medicinal products intended for oral administration and injection. And the most common terms for dosage forms are those for solutions and powders. We also found that the most complete and up-to-date source of information on standard terms for medical devices is the database of standard terms maintained by the European Directorate for the Quality of Medicines, as it is constantly updated. Based on these facts, we can say that the European database is the gold standard for compiling lists of standard terms in each Member State of the Commission of the European Pharmacopoeia. The Bulgarian list of standard terms, on the other hand, is not updated often enough, it is recommended that this be done at shorter intervals, as new terms are constantly appearing. This is best done with each release of an updated version of the pharmacopoeia

Electronization Of Healthcare In Bulgaria

Електронизацията на здравеопазването, като една световна тенденция, все повече се налага и в България. Досега у нас са електронизирани някои отделни дейности и услуги и са изградени локални регистри и бази данни, но няма цялостно софтуерно решение и единна информационна система, която да обслужва електронното управление на здравния сектор. Електронизацията на здравеопазването в нашата страна ще допринесе за осигуряването на гражданите и медицинските специалисти със систематизирана и обобщена медицинска информация, която е от значение в процеса на диагностика, определяне на терапевтичен план, както и предоставяне на лечение и рехабилитация.The electronization of healthcare, as a global trend, is increasingly being imposed in Bulgaria. Until now, some individual activities and services have been electronised and local registers and databases have been built, but there is no complete software solution and a unified information system to serve egovernment in the health sector. The electronisation of healthcare in our country will contribute to providing citizens and medical professionals with systematized and generalized medical information that is important in the process of diagnosis, setting a treatment plan, and providing treatment and rehabilitation

Dynamics And Sourses Of Adverse Drug Reaction Reports Related To COVID-19 Vaccines In Bulgaria

Objective: To track and analyze the dynamics of adverse drug reaction reports of authorized COVID-19 vaccines in the database of the national competent authority in Bulgaria – Bulgarian Drug Agency (BDA) and to identify the sources of ADR in our country during the considered time period.Material and methods: For the analysis of ADR reports, the specialized database of the national competent authority in Bulgaria was used, containing information on all reported adverse drug reactions for the period 01.01.2018 - 31.03.2022.Results and conclusions: The first report of an ADR with a suspected connection to a vaccine against COVID-19 (with the trade name Comirnaty) was received in the BDA on 27.12.2020, on the first day of the start of the vaccination process in Bulgaria and the EU.The number of ADRs reported after SARS-CoV-2 immunization in the period of the study was about 2.3 times greater than the number of ADRs reported after taking any other drugs. Patients showed a higher activity in reporting ADRs for the studied period (90% of all reports were submitted by patients), which is significantly higher than previous periods. The increase in the number of ADR reports is not smooth, but 3 peaks are emerging: in the months of February, July and November of 2021