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.

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.

BACKGROUND: Patients’ compliance is a leading factor in achieving determined endpoints of a treatment process. Low patient compliance with prescribed therapeutic plan is very common in both ambulatory practice and clinical trials. Non-adherence of subjects in clinical studies can seriously jeopardize validity of results obtained during randomized clinical trials (RCTs). METHODS: Both systematic literature review and cross-sectional survey were conducted among physicians and patients to determine evaluation of therapy adherence by both groups. RESULTS: According to the analytical reviews in published articles, the most common definition of therapy adherence or compliance is “the ability and willingness of patients to abide to a prescribed therapeutic regimen”. There is a strong correlation between patient adherence to the therapeutic regimen determined by the study protocol of RCTs, and the validity of efficacy and safety evaluation of the investigated medicinal product. Analysis of the results from the conducted survey lead to the conclusion that 35% of physician’s state that the results of ongoing therapy are highly dependent on patient compliance. As far as patients are concerned, almost half of the respondents have answered they comply with the prescribed therapy and would evaluate the treatment process as successful. Both patients and medical professionals declare their willingness to participate in clinical trials and strictly stick to the requirements of the study protocol.Conclusion: These results decisively confirmed that the control of a disease is a bilateral process between the patient and the doctor. Patient satisfaction with their current therapy directly correlates with the results of treatment. Majority of patients evaluate their possible participation in a clinical trial as an opportunity to get an access to a better medical service. Both medical professionals and patients declare their strong motivation to comply with the therapeutic plan if it is a part of a clinical study protocol.

Wearable health-tracking technologies are increasingly incorporated into prenatal care to enable continuous, noninvasive monitoring of maternal and fetal health. Devices such as smartwatches, fitness trackers, smart rings, and medical-grade biosensors can collect longitudinal data on physiological parameters, including heart rate, physical activity, sleep patterns, and pregnancy-specific indicators. When integrated with mobile health (mHealth) platforms and artificial intelligence (AI)–based analytics, these technologies offer opportunities for earlier identification of pregnancy-related complications and more personalized care. This narrative review summarizes current evidence on the application of wearable technologies during pregnancy, with a focus on monitoring capabilities, clinical utility, and integration into prenatal healthcare. Relevant peer-reviewed literature published between 2015 and 2025 was identified through searches of PubMed, Scopus, Web of Science, and Google Scholar. The reviewed literature indicates that wearable devices show promise for monitoring maternal activity, sleep, and cardiovascular parameters, while emerging systems aim to assess fetal heart rate, movement, and uterine activity. However, variability in data accuracy, limited clinical validation, privacy concerns, and user acceptance challenges continue to constrain widespread implementation. Further large-scale, methodologically robust studies and standardized regulatory frameworks are needed to support the safe and effective integration of wearable technologies into routine prenatal care.

The goal of the current study is to compare the cost of assisted reproductive technologies (ART) and cost-effectiveness of biotechnology products used in in vitro fertilization (IVF) procedures before and after the COVID-19 outbreak. We performed a cross sectional, observational, retrospective study of patients admitted at the biggest reference IVF clinic in Bulgaria before and after the COVID-19 outbreak with 1237 participants. Information was from patients’ records; micro-costing and cost-effectiveness analysis were performed for evaluating the unit cost per successful pregnancy with different biological products. The analysis showed that the cost of therapy is lower with recombinant gonadotropins (1543.19 BGN) in the pre-COVID-19 period and with the urinary gonadotropins (1534.03 BGN) in the second period. In addition, during the second period we observed higher expenses due to additional costs for cryopreservation. During the pre-pandemic period the less effective therapy (0.14% clinical pregnancies) was the combination therapy, as well as bearing a higher cost (1749.36 BGN). The cost-effective alternative during the first, (ICER= −7000 BGN per successful pregnancy) and the second period (ICER= −2800 BGN per successful pregnancy) is the therapy with recombinant hormones. It was prescribed in 37% of the patients. After the COVID-19 outbreak the overall cost of IVF increased, even though controlled ovarian hyperstimulation cost decreased. Additional procedures are playing а role for this increase. In both periods, before and after the COVID-19 outbreak, short protocols with recombinant hormones appear to be more effective and cost-effective as an alternative.

Polycystic ovary syndrome (PCOS) is an endocrine disorder prevalent in women of reproductive age, often requiring complex pharmacological management. The heterogeneity of the syndrome and the use of on- and off-label therapeutic agents—ranging from insulin sensitizers and ovulation inducers to oral contraceptives and herbal supplements—pose significant challenges, including adverse effects, drug interactions, and poor adherence. This narrative review explores the role of pharmacists in identifying and mitigating drug-related problems (DRPs) associated with PCOS therapy. Through thematic synthesis of the current literature, the study highlights common DRPs such as suboptimal drug selection, inappropriate dosing, prolonged therapy duration, and treatment-related safety concerns. It underscores the value of pharmacists’ interventions in enhancing medication adherence, optimizing therapeutic regimens, providing patient education, and monitoring adverse events. A structured, patient-level pharmaceutical care model is proposed, emphasizing personalized assessment, interdisciplinary collaboration, and continuous follow-up. The integration of clinical pharmacists into PCOS care teams has the potential to improve treatment effectiveness, patient satisfaction, and long-term health outcomes. Pharmacists’ contributions are especially critical given the widespread use of off-label therapies and supplements with variable evidence of benefit. Tailored pharmaceutical care can thus bridge the existing gaps in PCOS management and enhance the quality of life for the affected individuals.