Background and Importance At height of COVID-19 pandemic surge of delta variant, monoclonal antibodies became a vital treatment option for SARS-COV-2 positive outpatients at high risk of severe disease progression. Casirivimab and imdevimab (C/I) were used under EMA emergency use authorisation (EUA) and there was paucity of real-world data on safety and effectiveness. Aim and Objectives The study aimed to describe drug safety, self-reported symptom burden and vaccination status in SARS-COV-2 positive outpatients within 90 days post-C/I infusion. Material and Methods Prospective multicentric survey of SARS-CoV-2 positive outpatients with mild symptoms at high-risk of severe COVID-19 progression (defined criteria under EUA authorisation for C/I ambulatory administration) was conducted from September 2021 till January 2022 in three teaching hospitals. The data collected using electronic medical records comprised: patient details, vaccination status, date of SARS-COV-2 positive test, indication, adverse drug reaction to infusion, hospitalisation. Structured telephone questionnaire with symptom scoring adapted from BLAZE-1 trial was used on D (day) 0, D+7, D+29 and D+90 post- C/I infusion. Data were analysed using MS Excel. Ethics committee approval was obtained. Results Within studied period 404 out of 471 patients were included (median age 66 years; 57.4% females). Excluded patients included prophylactic C/I, not consented or dropped out. 396 patients had the first COVID-19 episode. The most frequent indications included age over 65 years (55.5%), hypertension (56.8%), diabetes mellitus II (19.4%). C/I infusion was administered with a mean of 2.3 days (range 0–11 days) since virus positivity. 62.4% patients had complete vaccination (2 or 3 doses Comirnaty, 1 dose Janssen vaccine) prior C/I infusion. Adverse events were reported by 11.6% of patients, most commonly chills, fever, diarrhea. Subjective worsening of symptoms after C/I infusion was reported by 3.4% subjects by D+7. 11.6% patients observed no difference in symptom score between D0 and D+7. Altogether 85%; 92% and 93.6% patients reported improvement in symptom burden score by D+7, D+29 and D+90 respectively. Conclusion and Relevance We describe real-life outpatient utilisation of C/I in terms of patient characteristics, self-reported symptom burden and adverse events. Therapeutic value of C/I timely administration is evident in high-risk patients with completed vaccination. References and/or Acknowledgements 1. N Engl J Med. 2021 Jan 21;384(3):229-237 Conflict of Interest No conflict of interest

Background and importance Wrong timing or composition of food or drink with drug administration could have a significant impact on a drug's therapeutic value or safety. To provide better overall quality provided by health care professionals at the hospital this area should also be improved. Aim and objectives This project formed part of a larger study focused on medication administration safety in hospital wards. Project goals consisted of identifying risk areas of nurse medication administration. Analysis of the reality will serve as a base to develop suggestions leading to preventive and corrective actions with consequences for the quality of nursing care provided. One of the risk areas of nursing care is timing drug administration with food as well as food and drink composition. The partial goal was to explore this reality and identify suboptimal and potentially hazardous practices. Material and methods The research was implemented in four selected cooperating hospitals, specifically in three of their wards – surgical, internal, and follow-up wards in the form of a prospective, multicentric, observation–intervention study. In the first part of this study, all nurses administering medications to all patients hospitalised in each of the above-stated wards during the observation period (morning, noon, evening) were observed by a team of unshadowed external investigators (pharmacist and nurse) for three consecutive days. Data were recorded onto a preprepared recording sheet and subsequently typed into a web database. Results During this study, 58 nurses administrating 5330 solid oral drugs for 313 patients over 36 days were observed. We discovered that the timing of the food was suboptimal and potentially severe in 18.1% and 2.4% of cases, respectively. In order to ingst a drug, tea was used in 63% of cases, still water in 22% of cases and coffee with milk in nearly 5.8% of cases. Potentially significant drink–drug interactions were identified in nearly 1.5% of cases. Conclusion and relevance We found that little or no attention was paid to appropriate food, drink and drug management on the wards. These primary data will be used for interventions in this study and as the base for further research. References and/or acknowledgements Conflict of interest Corporate sponsored research or other substantive relationships: Work was supported by a grant from Charles University (SVV 260 551).

Direct oral anticoagulants (DOACs) have gradually entered the Czech market as alternatives to vitamin K antagonists and parenteral anticoagulants since 2008. Considering the eventual changes, the aim was to evaluate drug use and expenditure patterns on anticoagulants in the Czech Republic. A retrospective utilization study was conducted retrieving data from the State Institute for Drug Control database, including reports on drug supplies from distributors with anatomical therapeutic chemical classification (ATC) codes B01AA, B01AB, B01AE, B01AF, and B01AX. The utilization on national level was expressed as the ratio of the number of defined daily doses per 1000 inhabitants per day (DDD/TID). Expenditures on all anticoagulants were also assessed. Data was analyzed using PASW (version 18.0). Between January 2007 and December 2017, the national anticoagulant utilization rate increased continuously from 14.15 to 27.67 DDD/TID. The use of DOACs was 0.002 DDD/TID in 2008, increased to 6.04 DDD/TID in 2017. Warfarin utilization, after a small decrease in 2008, has shown nearly stable levels in the recent years (70.9% of all anticoagulants; mean 11.55 DDD/TID over the last 5 years), while its increase was halted by the spread of DOACs utilization (p < 0.05). In 2017, over half of the expenditures (51.1%) were due to oral anticoagulants, whereof 47.6% was related to DOACs. The results reflected a growing utilization and increasing costs of all anticoagulants, especially in DOACs at the expense of warfarin. Still, additional information regarding patient persistence and prescribing patterns is needed for a better understanding of oral anticoagulant utilization.

Background Antibiotic prophylaxis (AP) plays an important role in the prevention of surgical site infections in cardiac surgery. Despite the availability of many guidelines, the daily practice of AP is still far from optimal. Purpose The first aim of the study was to evaluate the management of rational AP by means of a pre-intervention audit. The second aim was to assess whether the clinical practice of AP was improved after pharmacists' interventions. Material and methods Six parameters of AP (indication of AP, use of appropriate agent, proper initial dose, correct timing of first dose, perioperative redosing, adequate duration of AP) were evaluated by pharmacists during the pre-intervention audit at the Cardiovascular Surgery Clinic between March and April 2015. The data were obtained from medical records and the hospital information system. Based on the results of the pre-intervention audit and regional requirements, the local guidelines (LG) for AP were updated by microbiologists and pharmacists according to the Surgical Antimicrobial Prophylaxis Guidelines of American Society of Health-system Pharmacists. Two years' later a post-intervention audit was performed where implementation of new LG were assessed by measuring the same six parameters as the pre-intervention audit. The results of both audits were compared at 50 cardiac surgeries. Results AP was used in all indicated surgeries during the pre-intervention and post-intervention audit. Incorrect antibiotics were used in 11 per cent of all surgeries in the pre-intervention audit, while all antibiotics were appropriately chosen in the post-intervention audit. Appropriate initial doses were given in only 2 per cent in the pre-intervention audit compared with 92 per cent in the post-intervention audit. The correct timing of AP was increased from 76 per cent to 96 per cent t after the implementation of new LG. Perioperative redosing was given in none of the indicated cases in the pre-intervention audit compared with 100 per cent after intervention. AP was prolonged for more than 48 hours in 51 per cent in the pre-intervention audit versus 18 per cent in the post-intervention audit. The number of surgeries where all parameters were in accordance with the guidelines was increased from 0 per cent to 80 per cent after interventions. Conclusion Poor acceptance of international guidelines was identified during the pre-intervention audit. The clinical practice of AP was improved after pharmacists' interventions. Reference and/or acknowledgements Bratzler DW. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm 2013;70:195–283. No conflict of interest.

The XXVth Slovak-Czech Conference on Hemostasis and Thrombosis (with international participation) was held in May 24 to 26, 2018, at the Hotel Victoria in Martin—a most typical Slovak city and a cultural center of Slovakia. The conference, reflecting the mutual understanding of two neighboring nations, Slovakia and Czech Republic, with common interests in the field of hemostasis and thrombosis, was jointly organized by the Slovak Society on Hemostasis and Thrombosis of the Slovak Medical Society, and the Czech Society on Thrombosis and Hemostasis of the Czech Medical Society of Jan Evangelista Purkyně. The conference takes place each year, and the location alternates between Slovakia and Hradec Kralove in the Czech Republic, with the main input from Professor Jaroslav Maly, MD, PhD, and Associate Professor Petr Dulicek, MD, PhD, as organizing members of the Scientific Committee. In general, the conference's aim is to summarize current knowledge and future trends of research within the field of hemostasis and thrombosis in both countries—Slovakia and Czech Republic—via a series of invited and submitted presentations. The expectation is that the conference will continue to progress understanding of hemostasis and thrombosis and the strong mutual cooperation and ties of these countries.

RATIONALE, AIMS, AND OBJECTIVES Falls are among the major problems occurring in hospital setting, when drugs are viewed as important modifiable risk factor of falling. The aim was to analyse the effect of pharmacotherapy on the risk of falls in hospitalized patients. METHODS A multicentre prospective case-control study was conducted in 2017 retrieving data from four hospitals in South Bohemia, Czech Republic. An online database was constructed to collect patient and fall-related data. Each fall that occurred during hospitalization was assigned to appropriate controls (no fall during hospitalization) based on gender, age, length of hospitalization, and the number of drugs. Univariate and multivariate correlations were performed with a significance level of P < .05. RESULTS A total of 222 fall cases (107 males; median age, 81 y) and 1076 controls (516 males; median age, 80 y) were included. According to the first ATC level classification, drugs from groups S, N, and P were significantly associated with fall-related risk compared with controls (P < .05); further analysis of ATC levels showed that only psycholeptics (N05), antipsychotics (N05A), and tiapride were significantly associated with falls. Regression analysis revealed use of psycholeptics N05 (OR = 2.06; 95% CI, 1.56-2.76), or ophthalmologicals S01 (OR = 2.72; 95% CI, 1.37-5.41), as factors with the highest fall-related risk. CONCLUSIONS Apart from the commonly considered fall-risk increasing drugs, other groups, such as ophthalmologicals, should also be considered; however, regarding clinical practice, it is difficult to evaluate the effects of individual drugs in the context of other risk factors of falls, due to the multifactorial nature of falls.

Background Generic drugs and generic substitution belong to the tools by which healthcare costs may be reduced. However, low awareness and reluctance among healthcare professionals towards generic drugs may negatively affect the rational use of generic substitution. Methods The study aimed to analyze opinions and attitudes towards generic drugs and generic substitution among Czech physicians including their understanding of generic substitution legislative rules and the physicians´ previous experience in this field. Using random allocation, 1551 physicians practicing in the Czech Republic were asked to participate in the sociological representative survey conducted from November to December 2016, through face-to-face structured interviews comprising 19 items. Factor analysis as well as reliability analysis of items focused on legal rules in the context of physicians’ awareness were applied with p -value of < 0.05 as statistically significant. Results Of a total of 1237 (79.8%) physicians (43.7% males; mean age 47.5 ± 11.6 years, 46.3% general practitioners) 24.8% considered generic drugs to be less safe, especially those with specialized qualification ( p < 0.01). However, only 4.4% of the physicians noticed any drug-related problems, including adverse drug reactions associated with generic substitution. The majority of physicians felt neutrally about performing generic substitution in pharmacies, nor they expressed any opinion on characteristics of generics, even though a better understanding of the legislation and higher need of accordance of substituted drugs were associated with more positive attitudes towards generic substitution ( p < 0.05). Physicians showed low knowledge score of legislative rules (mean 3.9 ± 1.6 from maximum 9), nevertheless they overestimated the law, as they considered some rules valid, even if the law does not require them. Cronbach alpha of all legislative rules that regulate generic substitution increased from 0.318 to 0.553 if two optional rules (physician consent and strength equivalence) would be taken into account. Conclusions There is no sufficient awareness of generic drugs and generic substitution related issues among Czech physicians, although a deeper knowledge of legislation improves their perception about providing generic substitution.

Background Falls are very frequent health problems in patients hospitalised in healthcare facilities. Regarding prevention of falls, it is essential to analyse all of the factors, including medications which may be potential contributors to falls and consequently efficiently minimise these risk factors. Purpose The aim of this study was to describe a group of patients who fell during hospitalisation, assess the iatrogenic impact on falls as well as other risk factors, and identify other drug related problems (DRPs) not directly associated with falls. Material and methods A retrospective observational study was conducted in the rehabilitation care centre from March to November 2014. Patients who had a fall during their hospitalisation were included. Data were collected from medical records containing personal and medication history as well as information concerning the fall. Analysis regarding the relationship between pharmacotherapy and the fall comprised identification of drugs with a potential risk of fall and assessment of the individual risk based on other risk factors presented in each patient. Identification, evaluation and solution of all the DRPs were determined by SAZE (signal analysis measurement elimination) analysis. Data were processed by descriptive analysis. Results The study sample comprised 150 inpatients (53.3% women). Mean age was 66.2 years (SD=18.4). 12.0% of patients experienced repeated falls. The most frequent diagnosis with risk of fall were arterial hypertension (79.0%), musculoskeletal disorders (59.3%), balance disorders (58.0%) and diabetes mellitus (34.0%). In total, patients used 1286 drugs, of which 55.1% had a potential risk of fall. Based on an assessment of the individual risk of falls, zolpidem, tramadol and benzodiazepines were the most frequent drugs used by patients. Unclear indication, high dose and unsuitable use of drug were the most common DRPs unrelated to the fall. Conclusion Based on individual assessments, we identified cases in which falls caused by use of drugs could not be omitted. In the case of falls, it is necessary to search for possible causes of the fall and not forget the most commonly used drugs by patients. Clinical pharmacists with such experience in collaboration with other health professionals can contribute to solving this health problem. No conflict of interest