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

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

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

Analysis of non-compliances identified in GMP inspections between 2013 and 2022

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

Analysis of non-compliances identified in GMP inspections between 2013 and 2022

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

What does self-medication counseling in Bulgarian community pharmacies look like – a field study

The aim of the study is to identify the current practices of self-medication in Bulgaria, estimate the extent patients are influenced by information about the safety of OTC products and pharmacists’ role and behavior in the process. An anonymous, questionnaire-based, descriptive study was carried out among 280 pharmacists. The majority of the patients (92.6%) ask for pharmacists’ advice before buying OTC products. Most often patients need OTC drugs for mild conditions (80.7%), to save time (63.9%), and because they are unable to consult a physician (61.9%). The medium duration of consultation for an OTC product is between 5 and 10 minutes. The main barriers hindering the process are unwillingness from the patient (72.5%), lack of time (27.5%), and lack of confidentiality (26.6%). OTC medicines are considered safer than prescription-only medicines by pharmacists. Pharmacists could substantially contribute to rational self-medication and alleviate the burden on healthcare systems

Economic Burden of Cervical Cancer in Bulgaria

Bulgaria is among the European Union (EU) countries with the highest burden of cervical cancers and life expectancy below the EU average. The majority of cervical cancer cases (more than 95%) are caused by the human papillomavirus (HPV). The aim of this retrospective, cost of illness study is to identify direct healthcare costs of cervical cancer in Bulgaria from the payer perspective and to calculate indirect costs and the associated years of life lost. Costs data were sourced from the National Health Insurance Fund from January 2018 to December 2020. Years of life lost were calculated based on the country and gender-specific life expectancy. Indirect costs due to productivity loss were calculated using the human capital approach. The total treatment costs for 3540 patients with cervical cancer are EUR 5,743,657 (2018), EUR 6,377,508 (2019), and EUR 6,751,182 (2020). The costs associated with drug acquisition and administration accounted for the majority (63%) of total healthcare costs followed by hospital management costs (14%). An estimated total of 20,446 years of life were lost due to cervical cancer for the period 2018–2020. The costs of productivity losses are estimated at EUR 7,578,014. Our study showed that the economic burden of cervical cancer in Bulgaria is substantial. Focus on cervical cancer prevention via vaccination against the human papillomavirus, timely screening, early diagnosis, and higher vaccine coverage rates could reduce its economic burden in Bulgaria