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.
The purpose was to assess the level of medication adherence (MA) and related factors among individuals with acromegaly. The secondary goal was to assess the quality of life of patients and whether and how it correlates with the level of adherence. A prospective one-year study was conducted among patients with acromegaly diagnosed, treated, and monitored in the reference center for rare endocrine diseases in Bulgaria in 2021. Clinical data, patients reported outcomes, and health economics data were collected to define the predictors of non-adherence to medicines. Medication adherence level was assessed through a free Morisky–Green 4-item questionnaire. A total of 179 patients with acromegaly were observed. Approximately 62% were female, 50% were between 41 and 60 years, and the mean age at diagnosis was 40.4 years. The response rate to the questionnaires was 53% (n = 95; mean age 53.5 years, 73% female and 26% male). Patients with high levels of MA reported higher median values for the 36-Item Short Form Health Survey (SF-36) in comparison with those with low levels: 65.5 vs. 48.5 (p = 0.017). Similar results for EQ-5D-3L (3-level EuroQol 5D version) values and the level of MA were found: 0.656 vs. 0.796 (p = 0.0123). A low level of adherence was revealed in 34.7% of the patients, with no difference among different age groups. A significant positive determinant for adherence was years lived with acromegaly (OR = 5.625, 95% CI 1.7401–18.1832, p = 0.0039), as shorter duration was related to higher odds for high level of adherence. The current study demonstrates the importance of MA assessment for patients with acromegaly in Bulgaria. The medication adherence to the prescribed therapy among the observed group of patients with acromegaly varied as the percentage of adherent patients was around 65%. Still, there are low-adherent patients, and the responsible factors should be further investigated.
Pharmacovigilance is a vital component of public health systems, aiming to ensure the safe use of medicinal products. In this study, an artificial intelligence (AI)-based model was developed using TensorFlow to predict the likelihood of adverse drug reactions (ADRs) based on molecular structure and predefined criteria. Data from DrugBank, MedDRA, and SIDER databases were extracted, integrated, and structured in a relational model. A feedforward neural network was trained using chemical and pharmacological descriptors such as SMILES and ATC codes. The model showed consistent performance in estimating ADR risk, highlighting the potential role of AI in supporting early safety assessments. This method may enhance post-marketing surveillance through more timely and data-driven risk identification. Despite certain limitations, AI-assisted modeling represents a valuable addition to pharmacovigilance and patient safety awareness strategies.
Drug repurposing is often promoted as a faster, lower-risk alternative to de novo discovery, yet substantial barriers continue to limit successful implementation. We performed a scoping review of articles included in PubMed and ScienceDirect with the aim to identify and categorize challenges and analyze the intersections between them. Our review included 73 articles which revealed scientific, clinical, regulatory, economic, and implementation barriers, with the principal being the clinical translation of generated candidates. Scientific challenges include the necessity for new Phase II/III trials to validate efficacy, safety, and optimal dosing in new therapeutic contexts. Across disease areas, domain-specific barriers include subgroup-dependent responses in oncology, resistance and penetration challenges in anti-infectives, and data scarcity in rare diseases. Computational and AI-assisted approaches face fragmented data, model robustness, and insufficient validation. In addition, off-patent drugs face evidence requirements as rigorous as those for de novo entities, yet lack the market exclusivity incentives required to attract private investment. Additionally, an “institutional bottleneck” hinders academic researchers from bringing findings “on-label” due to a lack of regulatory infrastructure and collaborative frameworks. We conclude that drug repurposing requires a distinct translational paradigm involving multi-stakeholder collaboration and early regulatory engagement to bridge the gap between laboratory discovery and patient access.
22 June 2024 in Biotechnology & Biotechnological Equipment
The current article examines and analyzes the actions taken by the European Commission, specifically through the Directorate-General Health Emergency Preparedness and Response Authority (HERA) – an organization that anticipates threats and potential health crises, through intelligence gathering and building the necessary response capacities), aimed at supporting member states in limiting the spread of MPOX (monkeypox – an infectious disease caused by the monkeypox virus). It explores specific pharmaceutical products and vaccines procured by HERA and how they have been distributed among member states. The article raises questions about the compliance in purchasing pharmaceutical products and vaccines lacking approval for use within the European Union, highlighting the potential new regulatory challenges for Bulgaria if it needs to secure medications for treatment of human smallpox disease such as Jynneos and TPOXX (Tecovirimat) for its citizens. In conclusion, the article notes the swift response of HERA through the procurement of the Jynneos vaccine and TPOXX medicinal product. This swift response may have contributed to the decline of MPOX cases in the European region, potentially due to collaborative efforts among health authorities at both European and national levels. This success underscores the importance of cooperation among health authorities at various levels in combating infectious diseases.