Healt risk assessment in therapeutic substitution due to medicine shortages

Nestašice lekova narušavaju kontinuitet u primeni terapije pacijentu i uzrokuju brojne zdravstvene rizike tokom propisivanja, izdavanja i primene alternative u okviru terapijske supstitucije uzrokovane nestašicom. Rizici i greške do kojih dovode nisu dovoljno istraženi u okviru procesa upravljanja nestašicama kroz terapijsku supstituciju. Cilj istraživanja bio je procena modaliteta i ograničenja u upravljanju zdravstvenim rizicima, kao i identifikacija, rangiranje i analiza zdravstvenih rizika vezanih za antimikrobnu supstituciju u skladu sa njihovom ozbiljnošću i verovatnoćom. Istraživanje je sprovedeno kroz upitnik i detaljni intervju zdravstvenih radnika, a potom i kroz zdravstvenu analizu vrste i ishoda greške u 6 evropskih univerzitetskih bolnica u Austriji, Belgiji, Grčkoj, Hrvatskoj, Srbiji i Španiji. Više od 60% bolničkih farmaceuta vidi procenu zdravstvenih rizika kao strategiju za upravljanje nestašicama, od kojih je 26,4% upoznato sa analizom vrste ishoda i greške, 23,5% sa analizom ključnih uzroka, a po 14,7% sa zdravstvenom analizom vrste ishoda i greške i analizom opasnosti i kritičnih kontrolnih tačaka. Prema 29,4% bolničkih farmaceuta procena zdravstvenih rizika je deo protokola za upravljanje nestašicama, 14,7% je upoznato sa nacionalnom legislativom koja definiše njenu primenu, dok njih 35,5% sprovodi u okviru multidisciplinarnih timova, a njih 88,2% ne razmenjuje ishode procene sa nacionalnim regulatornim telima. Ključne barijere u primeni procene zdravstvenih rizika su neadekvatno znanje i veštine potrebne za sprovođenje procene, neadekvatna informaciono-tehnološka infrastruktura u bolnicama, neefikasna ekstrakcija i razmena podataka o pacijentu i leku od značaja za procenu. Zdravstvenom analizom vrste i ishoda greške u 6 evropskih bolnica identifikovano je 74 grešaka, od kojih 53 hazard skora iznad 8. Ozbiljnost grešaka se u bolnicama u Hrvatskoj, Grčkoj i Srbiji razlikovala pre i nakon sprovođenja korektivnih mera predloženih od strane istraživačkog tima (p<0,005). Verovatnoća grešaka se razlikovala između svih 6 bolnica pre i nakon primene korektivnih mera (p<0,005). Najveći broj uzroka grešaka je identifikovan u bolnici u Hrvatskoj 46 (28,2%), a najniži u bolnici u Španiji 16 (9,8%). Korektivne mere kojima se smanjuje vrednost hazard skora grešaka i do 83% su strukturirana komunikacija između svih zaintersovanih strana u sprovođenju zdravstvene zaštite tokom nestašica, uvođenje obaveznog elektronskog propisivanja lekova i veće učešće bolničkog farmaceuta u praćenju efikasnosti terapije i zaliha lekova na bolničkom odeljenju.Medicine shortages disrupt the continuity of patient treatment and cause numerous clinical risks throughout prescribing, dispensing and administering of alternatives within therapeutic substitution occurring in the course of a shortage. Although clinical risks and associated failures emerging from managing shortages through therapeutic substitution are not thoroughly explored, the aim of this research is to determine current models and limitations in health risks assessments implementation as well as to identify, rank and analyse health risks in antimicrobial substitution according to seriousness and probability. A survey and a detailed interview were conducted among healthcare professionals, followed by healthcare failure mode and effect analysis in six European university hospitals in Austria, Belgium, Croatia, Greece, Serbia and Spain. Hospital pharmacists (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, naming Failure Mode and Effect Analysis (26.4%), Root Cause Analysis (23.5%), and both the Healthcare Failure Mode and Effect Analysis and the Hazard Analysis and Critical Control Point (14.7%). While hospital pharmacists (29.4%) report risk assessment as integrated into mitigation strategy protocols, are aware of legislation stipulating risk assessment implementation in shortages (14.7%) and conduct risk assessment within multidisciplinary teams (35.3%), 88.2% claimed not to have reported risk assessment outputs to their respective authorities. The major obstacles facing health risk assessment are found to be not possessing sufficient knowledge and skills for their application, inadequate hospital information-technology support, as well as both the inefficient data extraction and exchange related to patients and the medicine needed for assessment. Healthcare Failure Mode and Effect Analysis conducted in 6 hospitals revealed 74 failure modes, with 53 of a hazard score higher than 8. The severity of failure modes differed before and after corrective actions in the hospitals in Croatia, Greece, and Serbia (p<0.005). Their probability differed in all study hospitals (p<0.005) when compared prior to and following corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in the hospital in Croatia 46 (28.2%) and the lowest in the hospital in Spain 16 (9.8%). The proposed corrective actions addressing and lowering failure modes hazards scores up to 83% are structured communication among stakeholders, introducing electronic prescribing, strengthening pharmacists' involvement in treatment effectiveness and stock assessment at the wards

Procena zdravstvenih rizika u primeni supstitucione terapije tokom nestašice lekova

Nestašice lekova narušavaju kontinuitet u primeni terapije pacijentu i uzrokuju brojne zdravstvene rizike tokom propisivanja, izdavanja i primene alternative u okviru terapijske supstitucije uzrokovane nestašicom. Rizici i greške do kojih dovode nisu dovoljno istraženi u okviru procesa upravljanja nestašicama kroz terapijsku supstituciju. Cilj istraživanja bio je procena modaliteta i ograničenja u upravljanju zdravstvenim rizicima, kao i identifikacija, rangiranje i analiza zdravstvenih rizika vezanih za antimikrobnu supstituciju u skladu sa njihovom ozbiljnošću i verovatnoćom. Istraživanje je sprovedeno kroz upitnik i detaljni intervju zdravstvenih radnika, a potom i kroz zdravstvenu analizu vrste i ishoda greške u 6 evropskih univerzitetskih bolnica u Austriji, Belgiji, Grčkoj, Hrvatskoj, Srbiji i Španiji. Više od 60% bolničkih farmaceuta vidi procenu zdravstvenih rizika kao strategiju za upravljanje nestašicama, od kojih je 26,4% upoznato sa analizom vrste ishoda i greške, 23,5% sa analizom ključnih uzroka, a po 14,7% sa zdravstvenom analizom vrste ishoda i greške i analizom opasnosti i kritičnih kontrolnih tačaka. Prema 29,4% bolničkih farmaceuta procena zdravstvenih rizika je deo protokola za upravljanje nestašicama, 14,7% je upoznato sa nacionalnom legislativom koja definiše njenu primenu, dok njih 35,5% sprovodi u okviru multidisciplinarnih timova, a njih 88,2% ne razmenjuje ishode procene sa nacionalnim regulatornim telima. Ključne barijere u primeni procene zdravstvenih rizika su neadekvatno znanje i veštine potrebne za sprovođenje procene, neadekvatna informaciono-tehnološka infrastruktura u bolnicama, neefikasna ekstrakcija i razmena podataka o pacijentu i leku od značaja za procenu. Zdravstvenom analizom vrste i ishoda greške u 6 evropskih bolnica identifikovano je 74 grešaka, od kojih 53 hazard skora iznad 8. Ozbiljnost grešaka se u bolnicama u Hrvatskoj, Grčkoj i Srbiji razlikovala pre i nakon sprovođenja korektivnih mera predloženih od strane istraživačkog tima (p<0,005). Verovatnoća grešaka se razlikovala između svih 6 bolnica pre i nakon primene korektivnih mera (p<0,005). Najveći broj uzroka grešaka je identifikovan u bolnici u Hrvatskoj 46 (28,2%), a najniži u bolnici u Španiji 16 (9,8%). Korektivne mere kojima se smanjuje vrednost hazard skora grešaka i do 83% su strukturirana komunikacija između svih zaintersovanih strana u sprovođenju zdravstvene zaštite tokom nestašica, uvođenje obaveznog elektronskog propisivanja lekova i veće učešće bolničkog farmaceuta u praćenju efikasnosti terapije i zaliha lekova na bolničkom odeljenju.Medicine shortages disrupt the continuity of patient treatment and cause numerous clinical risks throughout prescribing, dispensing and administering of alternatives within therapeutic substitution occurring in the course of a shortage. Although clinical risks and associated failures emerging from managing shortages through therapeutic substitution are not thoroughly explored, the aim of this research is to determine current models and limitations in health risks assessments implementation as well as to identify, rank and analyse health risks in antimicrobial substitution according to seriousness and probability. A survey and a detailed interview were conducted among healthcare professionals, followed by healthcare failure mode and effect analysis in six European university hospitals in Austria, Belgium, Croatia, Greece, Serbia and Spain. Hospital pharmacists (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, naming Failure Mode and Effect Analysis (26.4%), Root Cause Analysis (23.5%), and both the Healthcare Failure Mode and Effect Analysis and the Hazard Analysis and Critical Control Point (14.7%). While hospital pharmacists (29.4%) report risk assessment as integrated into mitigation strategy protocols, are aware of legislation stipulating risk assessment implementation in shortages (14.7%) and conduct risk assessment within multidisciplinary teams (35.3%), 88.2% claimed not to have reported risk assessment outputs to their respective authorities. The major obstacles facing health risk assessment are found to be not possessing sufficient knowledge and skills for their application, inadequate hospital information-technology support, as well as both the inefficient data extraction and exchange related to patients and the medicine needed for assessment. Healthcare Failure Mode and Effect Analysis conducted in 6 hospitals revealed 74 failure modes, with 53 of a hazard score higher than 8. The severity of failure modes differed before and after corrective actions in the hospitals in Croatia, Greece, and Serbia (p<0.005). Their probability differed in all study hospitals (p<0.005) when compared prior to and following corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in the hospital in Croatia 46 (28.2%) and the lowest in the hospital in Spain 16 (9.8%). The proposed corrective actions addressing and lowering failure modes hazards scores up to 83% are structured communication among stakeholders, introducing electronic prescribing, strengthening pharmacists' involvement in treatment effectiveness and stock assessment at the wards

Aktivnosti savremenih obaveštajnih službi u kiber prostoru

Espionage between countries dates back hundreds of years. Since the Internet was released for commercial use, developed countries started to exploit the advantages of computers and the Internet in espionage. Intelligence activity seeks to exploit all advantages and disadvantages of the mass use of information and communications technology (ICT) for purposes of intelligence activities. There is no serious intelligence service in the world which is not interested in this way of intelligence research, primarily because of the cost-effectiveness of such activity in comparison to other ways of collecting classified information. Nowadays, great powers are accusing each other of cyber espionage, the core issues being when one was spying on the other and who hired whom for that purpose. Cyberspace, by its nature, denies answers to these questions; in cyberspace it is very difficult to discover the identity of any malicious actor, as well as to prove the performance and ordering of such illegal operations. That is why the activities of the intelligence services in cyberspace will be ever more present, which will likely lead to changes in the way of intelligence gathering.Špijunaža između država je stara stotinama godina. Od puštanja interneta u komercijalnu upotrebu razvijene zemlje počinju da koriste prednosti računara i interneta u toj aktivnosti. Obaveštajna delatnost teži da iskoristi sve prednosti i mane masovne upotrebe informaciono-komunikacione tehnologije (IKT) za obavljanje obaveštajnih aktivnosti. Nema ozbiljne obaveštajne službe u svetu koja nije zainteresovana za ovaj način obaveštajnog istraživanja, pogotovo zbog ekonomičnosti ovakve aktivnosti u odnosu na druge načine prikupljanja poverljivih podataka. U aktuelnoj navali međusobnog optuživanja velikih država za kiber špijunažu nema nevinih. Suštinska pitanja su kada je neko nekoga špijunirao, i ko je koga unajmio u te svrhe. Kiber prostor se, po svojoj prirodi, protivi pronalaženju odgovora na ova pitanja - u njemu je veoma teško otkriti identitet zlonamernog aktera, kao i dokazati sprovođenje i naručivanje takvih nelegalnih operacija. Zbog toga će i aktivnosti obaveštajnih službi u kiber prostoru biti sve izraženije, što će, po svoj prilici, voditi ka promenama u načinu prikupljanja obaveštajnih podataka

Zloupotreba kiber prostora kao sredstva masovne komunikacije

Security threats to information systems may be grouped into certain types. The classification may be done according to the way of threat posing, namely techniques and instruments used for their implementation, as classification criteria. In the former research of the cyber security area, security threats in cyber space are most often identified with cyber attacks of technical type (attacks based on the use of malicious programs - malware, and attacks aimed to obstruct the services - distributed denial of service) and those attacks in cyber space which are based on the deception of other users of cyber space and the abuse of their trust (social engineering and phishing). Apart from different types of cyber attacks, which definitely represent one form of abuse of cyber space, specific abuse of this space as regards its function as a means of mass communication is also evident. In this sense, the category of cyber space security threats includes, besides the two above-mentioned aspects of cyber attacks, also 'the abuse of cyber space as a means of mass communication', as a special type of threats, in view of their destructive capability against individuals and the society as a whole. The paper presents detailed classification of security threats in cyber space, and the emphasis is put on the identification, classification and description of those phenomena that can be subsumed under a subcategory of 'the abuse of cyber space as a means of mass communication. In this sense, events of cyber space abuse for information warfare and support of terrorism are described and explained in detail.Bezbednosne pretnje informacionim sistemima moguće je grupisati u određene vrste. Klasifikacija se može sprovesti u odnosu na način izazivanja pretnji, tj. tehnika i instrumenata koji se koriste radi njihovog ostvarivanja, kao kriterijuma klasifikacije. U dosadašnjim istraživanjima u području kiber bezbednosti, bezbednosne pretnje u kiber prostoru najčešće su poistovećivane sa kiber napadima tehničkog tipa (napadi zasnovani na upotrebi malicioznih programa − malware i napadi usmereni na opstrukciju usluga − distributed denial of service) i onim napadima u kiber prostoru koji se zasnivaju na obmanjivanju drugih korisnika kiber prostora i zloupotrebi njihovog poverenja (socijalni inženjering − social engineering i fišing − phishing). Osim različitih vrsta kiber napada koji, svakako, predstavljaju jedan vid zloupotrebe kiber prostora, evidentno je i specifično zloupotrebljavanje ovog prostora u odnosu na njegovu funkciju sredstva za masovnu komunikaciju. U tom smislu, kategoriji bezbednosnih pretnji u kiber prostoru, osim već pomenuta dva aspekta kiber napada, pripisujemo i 'zloupotrebe kiber prostora kao sredstva masovne komunikacije', kao posebnu vrstu pretnji, s obzirom na njihov destruktivni potencijal u odnosu na pojedince i društvo u celini. U radu je predstavljena detaljna klasifikacija bezbednosnih pretnji u kiber prostoru, a težište je na identifikaciji, klasifikaciji i deskripciji onih fenomena koji se mogu podvesti pod potkategoriju 'zloupotreba kiber prostora kao sredstva masovne komunikacije'. U tom smislu, detaljno su opisani i objašnjeni fenomeni zloupotrebe kiber prostora za informaciono ratovanje i za podršku terorizmu

Data Augmentation for Generating Synthetic Electrogastrogram Time Series

Objective: To address an emerging need for large amount of diverse datasets for proper training of artificial intelligence (AI) algorithms and for rigor evaluation of signal processing techniques, we developed and evaluated a new method for generating synthetic electrogastrogram (EGG) time series. Methods: We used EGG data from an open database to set model parameters and statistical tests to evaluate synthesized data. Additionally, we illustrated method customization for generating artificial EGG alterations caused by the simulator sickness. Results: Proposed data augmentation method generates synthetic EGG with specified duration, sampling frequency, recording state (postprandial or fasting state), overall noise and breathing artifact injection, and pauses in the gastric rhythm (arrhythmia occurrence) with statistically significant difference between postprandial and fasting states in >70% cases while not accounting for individual differences. Features obtained from the synthetic EGG signal resembling simulator sickness occurrence displayed expected trends. Conclusion: The code for generation of synthetic EGG time series is freely available and can be further customized to assess signal processing algorithms or to increase diversity in datasets used to train AI algorithms. The proposed approach is customized for EGG data synthesis, but can be easily utilized for other biosignals with similar nature such as electroencephalogram.Comment: three figures and two table

The Hydrothermal Synthesis of 1D Biomedical Hydroxyapatite Nanostructures

Poster presented at the 16th Annual Conference of the Materials Research Society of Serbia - YUCOMAT 2014, Herceg Novi, Montenegro, September 1–5, 201

Interaction of biomaterial containing calcium hydroxyapatite/poly-l-lactide with simulated body fluid

The purpose of biomaterials is to replace a part or a function of the body in a safe, physiologically and economically acceptable way. The process of the reconstruction of bone defects has always been a big problem in orthopedics and maxillofacial surgery. Since hydroxyapatite (HAp) was detected as a component, the predominant constituent and the integral element of Mammalian bones, the development of the phospate ceramics as potential materials for implantation was enabled. This study investigated whether and in which way biomaterial calcium hydroxyapatite/poly-L-lactide (HAp/PLLA) interacts with the ionic composition of the human plasma. The simulated body fluid (SBF) is an artificial fluid that has the ionic composition and ionic concentration similar to the human blood plasma. HAp/PLLA was incubated for 1, 2, 3 and 5 weeks in SBF. The surfaces of both treated and untreated materials were analyzed on a scanning electron microscopy (SEM), and were also exposed to the energy dispersive X-ray spectroscopy (EDS), while SBF was submitted to the measuring of pH and electrical conductivity. However, our results indicate that the degradational changes of the material HAp/PLLA in SBF start from the surface of the treated material and that observed changes are the consequence of dissolution of its polymer component and the precipitation of the material similar to hydroxyapatite on its surface. This material shows good characteristics that place it among good candidates for the application in orthopedics and maxillofacial surgery

Synthesis of BCP and BCP/PLGA biomaterials by ultrasonic spray pyrolysis

The most significant mass part of the bony tissue consists of calcium phosphate ceramics. This paper describes method of obtaining fine particles of biphasic calcium phosphate (BCP) as well as fine particles of biphasic calcium phosphate covered by polymer, poly-lactide-co-glycolide (BCP/PLGA), by ultrasonic spray pyrolysis. Methods used for characterization of obtained particles of BCP and BCP/PLGA are Infrared Spectroscopy (IR) and Scanning Electron Microscopy (SEM) techniques.Physical chemistry 2004 : 7th international conference on fundamental and applied aspects of physical chemistry; Belgrade (Serbia); 21-23 September 200

Managing Medicine Shortages Toolkit

Medical practitioners must act quickly and responsibly when faced with the shortage of an emergency care drug in order to prevent any adverse consequences and continue to provide safe, optimal care to patients. However, delivering reliably safe care must be carried out actively. Guidelines therefore must be put into place in order to meet the challenges when combating a shortage as to be able to account for providing care under difficult situations. Furthermore, these guidelines must take into account any regulations stipulating policies in clinical practice. This toolkit seeks to provide a variety of good practices in risk assessment including prospective methods, which serves as informal requirements to be implemented in healthcare settings. The recommendations of, when applied in practice, must also be done in a process-driven manner