Caustic poisonings are still associated with many fatalities. Studies focusing on the elderly are rare. The purpose of the present study was to compare the clinical outcomes of caustic ingestion injury in elderly and non-elderly adults with regard to gender, intent of exposure, substance ingested, severity of mucosal injury, complications, and mortality. Caustic substance exposures reported to the National Toxicological Information Centre in Slovakia during 1998–2015 were reviewed retrospectively. The patients were divided into two groups: the non-elderly (<60 years) and elderly adults (≥60 years). The mortality rate in the elderly was significantly higher (elderly 23.0% vs. non-elderly 11.3%; p = 0.041). The risk of fatal outcome in the elderly was increased by acid ingestion (OR = 7.822; p = 0.002), particularly hydrochloric acid (OR = 5.714, p = 0.006). The incidence of respiratory complications was almost two times higher in the elderly was 31.1% vs. 17.4% for the non-elderly (p = 0.037). Respiratory complications significantly correlated with an increased mortality rate (p = 0.001) in the elderly whereas there was no association between GI complications and mortality in the elderly (p = 0.480). Elderly patients with respiratory complications had the poorest clinical outcomes. The highest risk of complications and fatalities was observed in patients after hydrochloric acid ingestion.

Background: Potentially inappropriate medication (PIM) use is a highly prevalent problem among older people, making it challenging to improve patient safety. The aim of this study was to assess the use of PIMs among geriatric outpatients (OUTs) in the Slovak Republic according to the EU(7) PIM list and to identify the differences in PIM prescriptions among general practitioners (GPs), internists (INTs) and geriatricians (GERs). Methods: In total, 449 patients (65 years and older) from 4 medical centres who were in the care of GPs (32.5%), INTs (22.7%) or GERs (44.8%) were included in this retrospective analysis. Data were collected from 1.12.2019–31.3.2020. PIMs were identified according to the EU(7) PIM list from patients’ records. PIM prescriptions by GPs, INTs and GERs were assessed. All obtained data were statistically analysed. Results: Polypharmacy (68.8% of patients), and PIM use (73% of patients) were observed. The mean number of all prescribed drugs was 6.7 ± 0.2 drugs per day/patient. The mean number of prescribed PIMs was 1.7 ± 0.1 PIMs per day/patient. Drugs from Anatomical Therapeutic Chemical (ATC) classes C, N and A accounted for the greatest number of PIMs. Significantly higher numbers of prescribed drugs as well as PIMs were prescribed by GPs than INTs or GERs. There were 4.2 times higher odds of being prescribed PIMs by GPs than by GERs (p < 0.001). Conclusions: Polypharmacy and overprescription of PIMs were identified among geriatric patients in our study. We found a positive relationship between the number of prescribed drugs and PIMs. The lowest odds of being prescribed PIMs were observed among those who were in the care of a geriatrician. The absence of geriatricians and lack of information about PIMs among general practitioners leads to high rates of polypharmacy and overuse of potentially inappropriate medications in geriatric patients in the Slovak Republic.

The use of biomarkers within the procedures of the Committee of Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) is discussed herein. The applications for Orphan Medicinal Product designation in the EU are evaluated at two stages. At the time of orphan designation application, the file undergoes an assessment to establish whether the proposed condition is a distinct and serious condition affecting not more than 5 in 10,000 people in the EU, and whether the product is plausible as a therapy for that condition. In cases where therapies already exist, the significant benefit of the candidate product over existing therapies is also evaluated. The orphan criteria are reassessed at the time of marketing authorisation, so that marketing exclusivity for the product in the orphan medical condition can be granted. Within this context, biomarkers have been used in submissions in order to define an orphan condition and to justify that the criteria for orphan designation are met. The current work discusses specific examples from the experience of the COMP, where biomarkers have played a decisive role. Importantly, it identifies the proposal of sub-sets of non-rare conditions based on biomarkers as a challenging issue in the evaluation of applications. In particular two specific requirements for the candidate orphan medicines in relation to the biomarker-based subsets are highlighted: the “plausible link to the condition” and the “exclusion of effects outside the subset”.

Objective: Information about the access of Slovak patients to orphan medicinal products (OMPs) in the literature is rather scarce. The main aim of the study was to analyze the accessibility and availability of OMPs to Slovak patients in the years 2010–2019.Methods: The analyzed OMPs were strictly defined according to the European definition. The date of marketing authorization together with its first appearance in the positive drug list was used to count the time to reach the national market. The data from the National Health Information Centre, the Ministry of Health, and health insurance companies were used as data sources of drug usage, expenditure, consumption, reimbursement of OMPs, as well as the total number of treated patients.Results: Out of the 167 OMPs on the European market, we identified 52% (87) OMPs which had any kind of costs recorded in Slovakia. Out of them, 62% (54) OMPs were directly present on the positive drug list. The remaining 33 OMPs were available on exception. The trend in accessibility and availability of OMPs in Slovakia between the years 2010 and 2019 was decreasing (57% OMPs in 2010 vs. 47% OMPs in 2019). The average time for an orphan medicinal product to reach the Slovak market was almost 4 years, 43.5 months [6—202 months]. Together, 10.4% (8 815 patients) out of the theoretical patients’ estimation according to the prevalence in the orphan designation were treated with OMPs available in Slovakia.Conclusion: Presented data clearly show insufficient accessibility and availability of OMPs in Slovakia. Importance of clearly defined criteria for OMPs supporting patients and healthcare professionals’ involvement in the final decision together with other measures such as social impact, improvement of patients’ quality of life, society wide meaning, or no alternative treatment in the final decision is crucial for transparent and sustainable access to OMPs and innovative treatments in Slovakia.