Ensuring the quality and safety of medicinal products is of paramount importance to the pharmaceutical industry. Good manufacturing practice (GMP) regulations are part of a pharmaceutical manufacturer’s quality management system and ensure that medicinal products are manufactured, imported and controlled consistently to quality standards appropriate to their intended use. The aim of the present study is to analyze the non-compliant operations identified during GMP inspections carried out by national competent authorities (NCA) in the EU/EEC between 2013 and 2022. A retrospective analysis of non-compliance reports published in the EudraGMDP database between 2013 and 2022 was performed. Overall, 99 reports by 21 national competent authorities were analyzed presenting the results of inspections in 19 countries. A total of 1458 deficiencies were identified, of which 544 (37%) were classified as major and 127 (9%) as critical. The most common non-compliant operations were the manufacturing of active substances (49 deficiencies) and the preparation of non-sterile products (47 deficiencies). In 41 cases, the NCA recommended suspension or voiding of the certificate of suitability (CEP) and in 36 cases revocation of the GMP certificates. The observed deficiencies highlight the importance and need for continuous monitoring and improvement of manufacturers’ production processes and quality management systems.
The administration of an excessive amount of or unnecessary drugs is a prerequisite for numerous drug-related problems, non-compliance, non-adherence to medicinal therapy, exacerbation and poor control of chronic diseases, and failure in achieving the treatment goals. The aim of this study was to assess patients’ awareness on drug use (administration, adherence to drug therapy) and to identify the possible drug-related problems with patients, using 5 or more medicines on Bulgarian territory. The data were collected implementing a structured study tool – a questionnaire for assessment of patients’ therapy using 5 or more drugs prescribed by a physician, including OTC and/or food supplements. The study provided an identification of factors affecting skipping of doses, modification of regime and analyzed the relationships and interdependencies between number of diagnoses and adverse drug effects rate; number of administered drugs and reported problems and unawareness of the medicinal product indications and health state. The results showed that it was necessary to introduce the Medication Review (MR) service in Bulgarian pharmaceutical practice. That will provide possibilities for development of pharmacists’ role in dispensing medical products, it will help in reducing drug-related problems and increasing the effectiveness of the treatment and adherence to medical therapy.
10 August 2020 in Journal of IMAB – Annual Proceeding (Scientific Papers)
The aim of the following article is to present the role of multidisciplinary team in the implementation of integrated care for patients scheduled for surgical treatment of osteoarthritis. It can include different professionals from health care and social sectors depending on patients` needs. Integrated provision of care is connected to a system evaluation of every aspect of the health status of the patient by different health care professionals and team planning of the procedures needed for the patient. Care provided by multidisciplinary team help for the improvement of activity after surgical intervention, functional abilities, psychological and social health
31 July 2015 in Journal of IMAB – Annual Proceeding (Scientific Papers)
Global processes and the development of macro factors in health over the last 10 years have increasingly greater pressure on changing health systems towards integration and the provision of integrated health and social services. Improving coordination and communication structures in health systems is crucial to improve the effectiveness and benefits in the process of introduction of integrated care. As an essential element of the reform of health systems internationally "integrated care" seeks to overcome the traditional division between health and social care. Due to the shift of care from inpatient to outpatient treatment, integrated care is becoming more valuable as a way to meet the care needs in the community. The aim is to present the benefits of integrated care as a conception in research and practical plan
Digitalization and eHealth literacy are closely interconnected, as digital transformation in healthcare changes the way people access, understand, evaluate, and use online health information. In recent years, a validated instrument has been widely used to assess and measure these changes: the eHealth Literacy Scale (eHEALS). The aim of this study was to culturally and linguistically adapt the eHEALS questionnaire for use in the Bulgarian population. The study sample included 157 women (53%) and 140 men (47%). Most had completed higher education (68%), were employed (83%), and reported no chronic conditions (72%). The internal consistency of the Bulgarian version of the eHealth Literacy Scale (eHEALS) instrument was evaluated using Cronbach’s alpha. The 8-item version showed an alpha of 0.955, while the 10-item version achieved 0.938, demonstrating excellent reliability for both versions. In line with commonly accepted standards, alpha coefficients exceeding 0.90 indicate outstanding internal consistency, confirming that both scale formats are reliable tools for use in the Bulgarian population.