The digitization of health systems is a topic of immense significance for the modern world. It holds the potential to transform the delivery of healthcare services, enhancing their quality, efficiency, and accessibility. Electronic prescriptions are a key element of this process, but it is crucial to ensure their implementation protects patients’ personal data and privacy. This article examines the digitization of health systems in Bulgaria, with a focus on electronic prescriptions. It highlights aspects of data protection, the potential risks associated with data misuse, and the advantages of electronic prescriptions.

The aim of the study was to analyze the presence of undeclared sildenafil, tadalafil, and vardenafil in food supplements (FSs) for erectile dysfunction. The presence of sildenafil, tadalafil, and vardenafil was determined using the generated ultraviolet (UV)-spectra and mass-spectrometry (MS)-spectra as well as chromatograms produced by the photodiode array (PDA)-detector and ion trap MS-detector. The results were processed by Xcalibur ver. 2.0.7. Fourteen of the 20 analyzed FSs contained undeclared ingredients. Sildenafil was present in 12 of them. Many violations and discrepancies between the label information and the real composition of the FS were identified. 70% of the samples contained undeclared ingredients of an erectile dysfunction medicinal product. The quantities varied within broad limits from 2 mg per tablet to 116.55 mg per tablet. Sildenafil was present in amounts exceeding 16.55 mg that is the maximum recommended dose, thus creating risk of overdose. Besides that, food supplements adulterated with sildenafil analogues are a health risk for consumer’s health as there is no evidence of modified sildenafil toxicity. All analyzed FSs were claimed to be 100% natural, not provoking side effects. No information for any FS contained indications of age limits or risk for interaction with other FSs or medical products.

Background/Objectives: Among the therapeutic options available for managing PCOS, metformin improves insulin sensitivity, reduces androgen levels, and helps restore menstrual regularity and ovulation. While primarily used for its metabolic effects, metformin therapy may also influence reproductive parameters, including AMH levels, which are pivotal in improving ovarian function and predicting therapeutic outcomes in PCOS. The aim of this study was to search the scientific literature and analyze the correlation between AMH levels and metformin hydrochloride therapy in women with PCOS and IR. Methods: A systematic review of the scientific literature was conducted using the following keywords: polycystic ovarian syndrome, anti-Mullerian hormone, insulin resistance, metformin, treatment, biomarker, and metabolic syndrome. This review was aimed at investigating the potential of AMH as a biomarker of the effectiveness of metformin therapy in patients with PCOS and IR. Results: Metformin treatment in PCOS patients has shown significant reductions in serum AMH levels with prolonged therapy. As an insulin sensitizer, metformin improves insulin sensitivity, reduces hyperinsulinemia, and suppresses hyperandrogenism. This process inhibits the growth of antral follicles, which is reflected in decreased AMH levels. Conclusions: Reductions in AMH levels and improvements in insulin sensitivity can serve as indicators of treatment efficacy and enhancements in reproductive function for these patients. AMH could be considered a prognostic marker for evaluating the effectiveness of metformin therapy. A decrease in AMH levels following treatment may indicate improved ovarian function and a reduction in polycystic morphology. However, further research is necessary to confirm these findings and to determine the optimal dosages and duration of treatment.

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.

The presented article provides a systematic review of the pharmaceutical legislation (EU Pharmaceutical Package) – the current proposal of the European Commission for a new Directive, repealing and replacing Directives and modifying Regulations of the European Parliament and of the Council, incorporating the relevant parts of the Regulation concerning medicinal products for pediatrics, Regulation for orphan drugs and others, aiming at revision of the pharmaceutical legislation in the context of antimicrobial resistance and challenges facing the introduction of innovative antimicrobial medicines in Europe. It outlines a critical analysis on the impact of the changes in the context of introduction of innovative antimicrobial medicinal products with an emphasis on unsatisfied medical demands of the European population. The revision of the pharmaceutical legislation provides an argument to consider that the proposed Pharmaceutical Package could resolve some of the issues associated with the access to novel antibiotic medicines. It is necessary to find a consensus and a balance between, on the one hand, meeting the need for antibiotics for the citizens of the European Union and, on the other hand, providing timely access to generic medicines to meet the needs of the population.